cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers

The purpose of this study is to evaluate the safety and tolerability of two dose levels of OP0201 and placebo, when administered intranasally in healthy adults subjects.


Eligibility Criteria:
Inclusion Criteria includes but is not limited to:

1. Body mass index of 18 to 30 kg/m2 (inclusive) and a minimum body weight of 50 kg at Screening.
2. Able and willing to follow study instructions (including compliance with daily study treatment administration) and likely to complete all required study visits as assessed by the Investigator's judgement.
3. Female subjects must agree to use an acceptable method of contraception (for pregnancy considerations and contraceptive requirements).
4. Female subjects who are of childbearing potential must have a negative urine pregnancy test result at Screening and Day -1 prior to randomization.
5. Male subjects must agree to use contraception
6. Subjects must agree to refrain from immersing their head fully under water (eg, swimming, diving) from the time of signed informed consent until after the study exit visit.
7. Physiologic tympanogram classified as Type A (normal) by the Investigator or designee.

Exclusion Criteria includes but is not limited to:

1. History or presence of significant medical condition or a clinically significant abnormal finding, as determined by the Investigator.
2. Presence of a clinically significant abnormal olfactory test finding at Screening defined as a total UPSIT score \<35 (for females) and \<34 (for males).
3. Clinically significant ear disorder/disease currently or within 6 weeks prior to Screening.
4. History of tympanostomy tubes in one or both ears within 1 year prior to Screening.
5. Upper respiratory tract infection or pharyngitis currently or within 6 weeks prior to Screening.
6. Allergy or sinus conditions (eg, sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to Screening.
7. Clinically relevant blockage of one or both nasal passages, in the Investigator's opinion.
8. Gastroesophageal reflux disease currently or within 6 weeks prior to Screening.
Potassium Citrate to Prevent Age Related Bone Loss

Osteoporosis, a disease in which the bones become weak and are more likely to break, is a major health problem in the United States. Too much acid in the body appears to be linked to loss of calcium via urine, bone loss, and muscle breakdown. The purpose of this study is to determine the effect of various doses of potassium citrate, a supplement that can neutralize acid, on bone density and muscle mass in older, healthy adults.

Over 10 million adults in the United States have osteoporosis, and another 18 million have low bone mass, a risk factor for developing this disease. Each year, approximately 1.5 million fractures are associated with osteoporosis. Adequate intake of calcium and vitamin D is the current nutritional approach to preventing age-related bone loss. However, even with sufficient levels of these nutrients, bone loss can still occur. Too much acid in the body, caused by diet, aging, and protein metabolism, appears to be linked to loss of calcium via urine, bone loss, and muscle breakdown. Potassium citrate can neutralize acids. The purpose of this study is to determine the effect of various doses of potassium citrate on bone density and muscle mass in older, healthy adults.

This study will last 6 months. Baseline measurements will take place from Weeks 1 through 4. During this time, participants will first receive a placebo over a 2-week period. Participants will then undergo a calcium balance study, involving consumption of certain study foods for 12 days and an overnight stay at the research unit for a calcium absorption test. The calcium balance study will be followed by blood collection. At Week 5, participants will be randomly assigned to receive either potassium citrate or placebo daily. For the first 9 weeks of treatment, there will be weekly blood collection and periodic urine collection for all participants. At Month 6, blood and urine will again be collected, and participants will complete questionnaires on diet and physical activity, and a second calcium balance study.

Eligibility Criteria:
Inclusion Criteria:

* Good general health

Exclusion Criteria:

* Abnormal kidney, liver, or bone function
* Currently taking medications that might affect potassium or bone
Pharmacokinetic Study of Peginterferon Beta-1a in Japanese and Caucasian Adult Healthy Participants.

The primary objective of this study is to characterise the pharmacokinetics (PK) of BIIB017 (Peginterferon Beta-1a) administered as a single 125 μg subcutaneous (SC) dose in Japanese and Caucasian adult healthy participants. The secondary Objective is to assess the safety and tolerability of a single 125 μg subcutaneous (SC) dose of BIIB017 in Japanese and Caucasian adult healthy participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a BMI of 19 to 29 kg/m2, inclusive, and minimum body weight of 45.0 kg at Screening and at Baseline.
* Japanese subjects must have been born in Japan and have both parents and grandparents of Japanese origin. Additionally, Japanese subjects should have lived outside of Japan for less than 5 years and maintained a similar diet since leaving Japan (to be verified by a questionnaire at Screening).
* Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 90 days after their last dose of study treatment.
* Non smoker or be willing to abstain from using tobacco and tobacco-containing products for 24 hours prior to clinic admission and during the In-Clinic Period and to smoke no more than 10 cigarettes (or equivalent) per day throughout the remainder of the study.
* Must be willing to refrain from all alcohol consumption for 48 hours prior to Day 1 and during the In-Clinic Period and to limit the intake of alcohol to no more than 2 units per day throughout the remainder of the study.

Key Exclusion Criteria:

* Known history of, or positive test result at Screening for human immunodeficiency virus (HIV).
* Known history of, or positive test result for hepatitis C virus (test for hepatitis C virus antibody \[HCV Ab\]) or hepatitis B virus (test for hepatitis B surface antigen \[HBsAg\]).
* Subjects with a history of malignant disease, including solid tumours and haematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured or subjects with cervical cancer stage 0 if completely excised).
* History of severe allergic or anaphylactic reactions in the opinion of the Investigator.
* Known allergy to any interferon or any component of BIIB017.
* History of suicidal ideation or an episode of clinically significant depression (as determined by the Investigator) within 3 months prior to Day 1.
* Any previous treatment with prescription or investigational pegylated drugs. The prior use of over-the-counter pegylated products, including cosmetics, is allowed.
* Previous treatment with any interferon product.
* History of hypersensitivity or intolerance to paracetamol, ibuprofen, or naproxen, that would preclude use of at least 1 of these during the study.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated Primary Liver Cancer

To evaluate the predictive value of ctDNA in response, relapse for liver cancer patients treated with immune checkpoint inhibitors

In the study, 300 advanced primery liver cancer patients who received immune checkpoint inhibitors at first-line setting (N=200) or second-line setting (N=100) will be recruited. By analyzing the ctDNA and peripheral blood mononuclear cell (PBMC) collected before and after the first cycle of ICI treatment, the dynamic changes of bTMB, ctDNA and the composition of immune cells will be detected. Combined with the tumor markers AFP, DCP and CA19-9, a noninvasive multiparameter model will be developed.

Eligibility Criteria:
Inclusion Criteria:

* Primary liver cancer diagnosed according to the clinical diagnostic criteria, or histopathological or cytological examination;
* 18-80 years old, no limit on gender;
* ECOG performance status of 0-2, with expected survival time of more than 12 weeks;
* According to RECIST V1.1, there must be at least one measurable lesion;
* Patients who are suitable for ICIs treatment and willing to comply with required protocols and give permission to use the data for clinical research and products development;
* Patients who join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.

Exclusion Criteria:

* Patients with other primary cancers;
* Patients with a severe parenchymal disease and unable to accept ICIs treatment;
* Patients with a psychiatric disorder and unable to comply with this study;
* Patients with symptomatic brain metastasis, anticipated complications or cognitive disorders that are associated with brain metastasis;
* Adverse events related to prior anti-tumor treatment (except for hair loss of any grade) did not return to grade 1 or better;
* History of cells or organ transplantation;
* History of hypersensitivity to the drug administered in this study or contrast media for CT and MRI;
* Patients who accepted hepatic local therapy (including ablation therapy, percutaneous injection of ethanol or acetic acid (PEI/PAI), high-intensity focused ultrasound (HIFU), transarterial chemoembolization (TACE)) within 14 days prior to initiation of the study;
* Other reasons that the researchers think not suitable for ICIs treatment
Evaluation of Different Imaging Modalities in Regional Lymph Nodes Staging in Patients With Breast Cancer

The regional lymph node status is considered to be an important prognostic factor regarding the long-term survival of breast cancer (BC) patients (Cetin IA, et al . 2020). The knowledge of whether lymph nodes are tumor-infiltrated or not is essential since nodal involvement has decisive therapeutic consequences such as axillary lymph node dissection (ALND), axillary radiotherapy, and neoadjuvant or adjuvant systemic chemotherapy (Diessner J et al . 2023). To provide individualized therapeutic options and optimized therapy.

The following data will be collected from electronic or paper medical data records as:

1) Age 2 )Sex 3)Family history of breast cancer 4)Menopausal status 5 )Body mass index (BMI) 6) Histological type of BC as reported in pathology 7) The results of the lymph node status. 8)Registered data will be collected from the hospital databases and clinical sheers. 3 9) The gold standard reference in the evaluation of suspicious lymph nodes by nodal biopsy and postoperative pathology. Imaging technique and interpretation The imaging diagnostic for BC (MRI, CT, mammography, and ultrasound) patients are carried out by the Department of Diagnostic and Interventional Radiology of the Hospitals in the research and interpreted by radiologists at the time of BC diagnosis. The radiological reports for each patient and each imaging technique will be analyzed about the lymph node status. The nodal status will be reported as benign, indeterminate, and infiltrated as stated by the ACR lexicon. Mammography and US For mammography, we will use full-field digital mammography systems with the option of additional tomosynthesis for further characterization of the primary tumor at NCI with the commercially available The BC patients routinely receive an ultrasound exam including the evaluation of the breast and the axilla with the lymphatic drainage pathways as a part of the follow-up process active lymph nodes. p values lower than 0.05 will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

1. Patient consenting to participate in the study.
2. Patients who can tolerate the imaging modalities and have proven to tolerate the contrast agents . 3) Breast cancer patients coming for an initial assessment with or without clinical regional lymph nodes positive status.

4) Breast cancer patients planned to have(breast-conserving surgery or mastectomy)as well as lymph node surgeries(sentinel lymph node v biopsy and/or axillary lymph node dissection.

Exclusion Criteria:

1)Patients denying consent to participate in the study 2) Patients who are not fit for further imaging evaluation (patients who exceed the weight limit, patients who are sensitive to contrast material, etc). 3) Patients with bilateral MRM and AC

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Effects of mCIMT vs CT on Upper Extremity Motor Function and ADLs in Chronic Stroke Patients

"Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running.

Interventions such as gait training and vibrational therapy have shown promise in enhancing muscle function and body movements. A new device, EKKO, uses vibrational waves based on Neurotransmission Cognitive Theory to improve gross motor skills in children with CP by applying mechanical vibrations to nerve points. This study aims to compare the efficacy of EKKO therapy with traditional conservative treatments (such as range of motion exercises and balance training) in improving gross motor function in children with CP. Conducted over six months with randomized controlled trials, the research seeks to provide evidence-based insights into optimizing rehabilitation strategies for better motor performance and quality of life for CP patients.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be under the age of 40-75 years
* Diagnosis: stroke

Exclusion Criteria:

* patients suffering from motor dysfunction due to other diseases (e.g., cerebral palsy, traumatic brain injury, and Parkinson's disease
* Balance problem
* Rheumatic diseases
* High spasticity
A Study of Patient Concerns and Treatment Satisfaction in Patients Being Treated With Finacea Foam for Rosacea

To survey rosacea patients about their concerns, treatment satisfaction, and quality of life associated with their Finacea Foam treatment


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Diagnosis of rosacea by a medical professional
* Currently using Finacea Foam as topical monotherapy for rosacea
* Willing and able to provide voluntary, informed consent to participate in this study

Exclusion Criteria:

- Use of any other topical treatment for rosacea at the time of enrollment
Behavioral Intervention to Maintain Physical Capacity and Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to investigate to what extent patients with COPD, who have participated in physical training for 12 weeks, can maintain their physical activity behaviour and physical capacity on a long-term basis if they get a behavioural medicine intervention.

Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease and the number of patients is increasing. Persons with COPD have a low physical capacity and a low physical activity level. The risk of premature morbidity and mortality is high especially in persons with a low level of physical capacity and activity. Rehabilitation including physical training is recommended and results in decreased morbidity and mortality and increased physical capacity and quality of life. Unfortunately improvements decrease if patients do not maintain their physical activity level.

To change physical activity behaviour in is challenging. Different methods as Social Cognitive Theory, SCT and the Transtheoretical model, TTM have been suggested as theoretical framework. According to SCT, to improve physical activity behaviour you should use goal-setting, outcome expectancy, self-efficacy, and self-monitoring.

To use motivational interviewing (MI) improves the success of a behaviour change.

Patients will be randomized after the 12-week training period, tested, and thereafter both the intervention group and the control group will get information about the importance of physical activity and the recommendations.

Thereafter patients in the intervention group will receive weekly telephone calls for the first month, telephone calls every second week for the following two months and thereafter monthly telephone calls for the following three months. The telephone calls will be in accordance with MI and discuss goal-setting, out-come expectancy, and self-monitoring.

Patients will be tested after 6,12,and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD at Uppsala and Umeå university hospitals, who have participated in physical training at the hospital for 12 weeks.
* Diagnose of COPD

Exclusion criteria:

* Understand the Swedish language
* Be able to be physically active
Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip

To prevent periprosthetic joint infection (PJI), optimal penetration of antibiotics into the joint-space is needed. In revision arthroplasty, the incidence of PJI is increased compared to primary arthroplasty. In this study, the penetration of antibiotic agents into the synovial fluid and bone will be analyzed. The concentration of antibiotics will be related tot the to the susceptibility (minimal inhibitory concentration; MIC-90) of microorganisms that frequently cause PJI.

Periprosthetic joint infection (PJI) is a feared complication of joint replacement, with an incidence of 0.5-1% after primary joint replacement and 3-5% after revision arthroplasty. For orthopaedic surgery involving a prosthesis, the administration of systemic antibiotic prophylaxis is strongly recommended to prevent PJI. Cefazolin is widely used as agent of choice in surgical antibiotic prophylaxis. Previous studies, all performed in patients undergoing primary joint replacement, demonstrated that the concentration of cefazolin in bone and synovial fluid was dose-dependent and exceeds the MIC90 for methicillin susceptible Staphylococcus aureus (MSSA), when given as 1 to 4 gram single dose shortly before incision. When a PJI is already present, clindamycin is used as treatment option in PJI caused by staphylococci (when combined with rifampicin) or cutibacteria. A limited number of studies have been performed to analyse the penetration of clindamycin into bone. These studies showed that clindamycin penetrates well into the bone and concentrations exceeded the MIC90 for MSSA. No studies have been performed to analyse the penetration of antibiotic agents into the periarticular tissue in patients who will undergo revision arthroplasty. In revision arthroplasty a foreign body (prosthesis) is in situ and periarticular tissue condition can be compromised due to previous surgical procedures and the presence of bone reaction to the prosthesis. It is not known whether the difference in PJI incidence after primary and revision arthroplasty may be explained by different penetration of the surgical antibiotic prophylaxis. The aim of this explorative study is to analyse the penetration of cefazolin and clindamycin into synovial fluid and bone and whether the concentration of the agents exceeds the MIC90 for micro-organisms frequently causing PJI.

Eligibility Criteria:
Inclusion Criteria:

1. Age 16 years or older.
2. Scheduled second stage revision arthroplasty (reimplantation) of the hip prosthesis during clindamycin 600mg three times a day orally for PJI, started at least 3 days before reimplantation (steady state).

Exclusion Criteria:

1. Antibiotic prophylaxis other than cefazolin 2000mg i.v.
2. Cefazolin use within 4 days previous to the reimplantation, other than the single dose administration of surgical prophylaxis just before incision.
3. Clindamycin loaded bone cement in situ.
4. BMI more than 35 kg/m2.
Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine Induced Paravertebral Block in Patients Undergonig Thoracotomy

This study evaluates the effect of adding dexmedetomidine as an adjuvant to bupivacaine in patients undergoing thoracotomy when administered peri-neurally in thoracic paravertebral space.

Thoracotomy is associated with severe postoperative pain that could be reduced with an aggressive analgesic therapy in the early postoperative period. The use of thoracic paravertebral block is an effective analgesic approach for post-thoracotomy pain. Several local anesthetic adjuvants have been reported to extend the duration of paravertebral block.

Alpha-2 agonists including dexmedetomidine appear to be the most effective in this context. The study will include an intervention group which will receive a combination of 20 ml bupivacaine 0.5% and dexmedetomidine 0.5 ml (50 microgram). The control group will receive 20 ml bupivacaine 0.5% plus 0.5 ml normal saline perineurally. Thoracic paravertebral catheter will be inserted preoperatively. Visual analogue pain score will be assessed at different intervals.

Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologists physical status class \|\|or \|\|\|.
* Patients scheduled for elective thoracotomy.

Exclusion Criteria:

* Pneumonectomy, decortication, pleural biopsy.
* Additional chest wall resection.
* Emergency surgery.
* Central and peripheral neuropathies.
A Study to Assess Frequency of Undetectable Minimal Residual Disease (uMRD) in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Venetoclax Tablets ± Intravenously (IV) Infused Rituximab in Routine Clinical Practice in Japan

Most cases of Chronic lymphocytic leukemia (CLL) remain an incurable disease with the goal of therapy being to improve quality of life and to prolong survival. This study will evaluate the participant's related outcomes and experience of CLL in adult participants who are treated in the Japan.

Study participants will receive oral treatments of Venetoclax±Rituximab for CLL as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed various treatments Venetoclax±Rituximab will be enrolled. Around 89 participants will be enrolled in the study in sites in Japan.

Participants will receive oral venetoclax tablets ± intravenously (IV) infused rituximab treatments for CLL according to the approved local label. The overall study duration will be 27 months.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with relapsed/refractory (2 Line \[2L\]+) chronic lymphocytic leukemia (CLL) in Japan based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria at the time of informed consent (IC).
* Treatment with Venetoclax±Rituximab for 24 months who are not treated with any other concurrent CLL treatment.
* Expected to visit the hospital at + 3 months after treatment with Venetoclax±Rituximab for 24 months.

Exclusion Criteria:

* No data on information on the start and end dates or continuation of treatment with Venetoclax.
* Participating in other clinical trials.
A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens

This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy, reproductive-aged women using three different regimens of oral contraceptives (OCs). Two extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal
* Not pregnant or breastfeeding
* Weight \<200 lbs
* Currently taking oral contraceptives in the standard 28-day regimen for at least two months

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
* Pregnancy within the last 3 months
* Smoking \> 10 cigarettes per day