cyrilzakka/clinical-trials huggingface dataset:
Phase 1, Single and Repeat Dose Study to Assess Safety, Tolerability, and Pharmacokinetics (PK) of GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)

This is a two parts study, a single ascending dose followed by 14-days repeat dosing. The single ascending dose part will assess two dose levels of GSK3923868 or placebo across two treatment periods 1 and 2 in a single cohort of participants with a washout period of a minimum of 5 days after each treatment periods. The repeat dose part will assess repeated one dose level of GSK3923868 or placebo in treatment period 3 with up to 14 days of follow up in the same cohort of participants. The duration of study participation for treatment period 1, 2 and 3 will be 6, 6 and up to 29 days (including follow up), respectively.


Eligibility Criteria:
Inclusion Criteria:

* Between 40 and 70 years of age.
* Confirmed diagnosis of COPD for greater than (\>) 6 months.
* Participant is a smoker or an ex-smoker with a smoking history of at least 10 pack years.
* A female participant is eligible to participate if she is not pregnant or breastfeeding and agrees to use contraceptives during the study (for women of childbearing potential only).

Exclusion Criteria:

* Participant has poorly controlled or unstable COPD.
* Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled.
* Participant has had a respiratory tract infection treated with antibiotics within 4 weeks prior to screening.
* Participant requires regular treatment with oral corticosteroids or has received a course of oral or parenteral corticosteroids within 4 weeks prior to screening.
* Participant requires long-term oxygen therapy.
* Current enrolment or past participation in a clinical trial within 30 days before this study starts.
* Positive tests for human immunodeficiency virus (HIV), hepatitis B and C, or Coronavirus disease-19 (COVID-19).
* Positive pre-study drug (except for as results of opioids prescribed for medical reasons and/or inadvertent consumption of poppy seeds) /alcohol screening result.
Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy

This clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND)

This open label, phase I/II non-randomised clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND). Patients will receive one or two cycles of 177Lu-PSMA followed by surgery. The primary objective is to determine the radiation absorbed dose in the prostate and involved lymph nodes. Secondary objectives include evaluating imaging response to therapy using PSMA-PET, biochemical response, pathological response, adverse effects of Lu-PSMA and surgical safety, and health-related Quality of Life (QoL).

Eligibility Criteria:
Inclusion Criteria:

* Patient has provided written informed consent.
* Male patient aged 18 or over at the time of screening
* Histologically confirmed adenocarcinoma of the prostate, in a patient scheduled for RP and PLND with curative intent
* High or high-intermediate risk localised or locoregional prostate cancer (HRCaP) by European Association of Urology (EAU) criteria, including any of the following:

  * PSA \> 20 ng/mL
  * ISUP grade group 3-5
  * Clinical T-stage by digital rectal examination (DRE) of T2c or higher
  * N1 disease (involvement of lymph nodes at or below the bifurcation of the common iliac arteries)
  * defined radiologically (CT/ MRI, or PSMA PET).
* High PSMA avidity on 68Ga-PSMA PET/CT, defined as an SUVmax of ≥ 20
* Normal baseline haematological function; haemoglobin 13.5-17.5g/dl), total white blood cell count (4-11 x 109/l), platelets (150-400 x 109/l), neutrophils (2-7.5 x 109/l) and lymphocytes (1-4 x 109/l)
* Normal baseline serum biochemistry; sodium 135-145 nmol/l, potassium 3.5-5 nmol/l, chloride 98-108 nmol/l, urea 3-9.2 nmol/l, creatinine 60-120μmol/l
* Willing and able to comply with all study requirements including all treatments and required assessments including follow up

Exclusion Criteria:

* Prostate cancer with significant neuroendocrine or other rare variant pathology
* Prior treatment for prostate cancer including radiotherapy and/or androgen deprivation therapy.
* Evidence of metastatic disease involving bone, viscera, or lymph nodes superior to the common iliac bifurcation based on CT, MRI, WBBS or PSMA PET/CT.
* Renal impairment \[GFR \< 60mL/min\].
* Sjogren's syndrome.
* A history of or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
What is the Optimal Training Model for Cervical Awareness?

Cervical cancer represents the fourth most prevalent malignant disease and the fourth leading cause of mortality among women on a global scale. Despite screening and preventive vaccination efforts, cervical cancer remains a significant cause of morbidity and mortality in low- and middle-income countries.

A number of studies have been conducted with the aim of raising awareness about HPV and cervical cancer. However, there is currently no evidence-based consensus on the most effective method of education. The objective of this study is to identify the optimal training method by conducting a randomised controlled trial among healthcare professionals. The training methods under consideration are as follows: 1) Video-based training, 2) Classical lecture training, 3) Brochure, 4) Audio recording (Radio broadcast).

Prior to the commencement of the designated training methods, participants will be required to complete a web-based pre-test. Subsequent to this, the system will automatically assign each participant to a training intervention. Upon completion of the training programme, participants will be required to undertake a second test, the results of which will inform the selection of the most effective training method.

Eligibility Criteria:
Inclusion Criteria:

Being over 18 and under 40

* Female doctors, female nurses and female health technicians
* Working in our hospital
* Having sufficient mental capacity
* Not having a visual or auditory disability
* Volunteering to participate in the study

Exclusion Criteria:

* Under 18 and over 40
* Not being a healthcare worker
* Not having enough mental capacity
* Having a visual or auditory disability
* Patients who did not volunteer to participate in the study
A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo

The purpose of this study is to estimate the effect of oral Boniva (ibandronate sodium)taken once monthly versus placebo on bone quality and strength at the hip at one year.


Eligibility Criteria:
Inclusion criteria:

* Ambulatory, postmenopausal women who are diagnosed with osteoporosis.
* Must be able to stand or sit upright for at least 60 minutes and swallow a tablet whole.

Exclusion criteria:

* Have been treated with other bisphosphonates or using chronic steroids within the past 6 months.
* Have a history of major upper GI diseases or have severe kidney dysfunction.
* Have a spine fracture (identified on x-ray).
Oral Contraceptive Pill and GnRH Antagonist Versus Long Protocol in IVF Patients

Recent controversy has arisen regarding the use of the pill for cycle planning in GnRH antagonist IVF cycles. The investigators performed this study to compare such a protocol with the gold-standard still today, which is the long-agonist protocol with no previous use of the pill.


Eligibility Criteria:
Inclusion Criteria:

* 1st or 2nd IVF cycle
* BMI \<30 kg/m2
* regular menstrual cycles
* basal FSH \<10 IU and E2 \<60 pg/ml

Exclusion Criteria:

* Polycystic ovaries
* endometriosis
* previous ovarian surgery
* previous low ovarian response
Co-occurence of Mental Illness and Problematic Alcohol Use: an Internet-based Cognitive Behavior Therapy Intervention

The goal of this clinical trial is to learn if internet-based cognitive behavior therapy (ICBT ) works to treat co-occurent of problematic alcohol use and mental illness including mild to moderate symptoms of either depression, anxiety, stress or disturbed sleep.

The main questions the study aims to answer are:

* Does the ICBT program lower the self-rated suffering from mental illness?
* Does the ICBT program lower the self-reported alcohol intake? Researchers will compare the ICBT program to the participants who are rancomized to a control grout that receives weekly attention from the research team, to see if the treatment works. In both groups, the participants will have the opportunity to ask for support from a therapist during the week days.

Participants are adults living in Sweden. They will:

* Receive an ICBT program supported by a trained therapist. It consists of modules that the participants will work with on their computer for 10 weeks. Some modules will be compulsory and other optional for the participants.
* Fill out forms to rate their mental illness and alcohol intake at the start and the end of the study as well as once every week during treatment.

Primary outcome measures are depression, anxiety and stress symptoms (measured with Depression Anxiety and Stress Scale 21 (DASS-21)) and alcohol intake measured with self-reported amounts. Other, secondary, outcome measures used will for example be about insomnia symptoms and disability assessment. Pre-treatment measurement, post-treatment measurement and 6-months and 12-months follow up is planned to be collected through an online survey.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* AUDIT ≥ 6 points for women and ≥ 8 points for men
* Symptoms of depression, anxiety disorder and/or stress-related illness
* Adequate ability to speak, read and write Swedish
* Having access to the internet and a smartphone, computer or other device.

Exclusion Criteria:

* Ongoing psychological treatment.
* Ongoing medication for AUD
* Recent changes (within the past three months) in psychiatric medication or planned changes during the treatment period. New medication prescribed during the study shall be reported but will not lead to exclusion
* Severe psychiatric disorders based on a Mini-International Neuropsychiatric Interview (MINI) interview and reported medical history
* Severe medical conditions that may impede participation in the study
* Severe cognitive impairment
* Current suicidality
* Severe alcohol addiction where specialized treatment is more appropriate
* Risk for severe alcohol withdrawal symptoms with a need for medical treatment. Participation is possible after completing alcohol withdrawal treatment within the ordinary health-care system, accessible to the Swedish population.
* Substance use disorder, other than alcohol or nicotine, within the past six months.
Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure

Vibration response imaging (VRI) technology, provides a radiation-free dynamic image of the lung, by visualizing vibration energy emitted during the respiration cycle (lung sounds). Airflow in the lungs during the respiration cycle creates vibrations that propagate through the lung tissue; these vibrations are affected by the structural properties of the lungs and may vary in space, time and frequency. Moreover, any structural alteration, such as a bronchial obstruction or space occupying infiltration, is reflected in a corresponding modification of the vibration response.

As obstructions that occur in airways alter airflow, the VRI may provide additional lung function information prior to treatment for airway obstruction and during follow-up. Moreover, the VRI may provide the physician immediate evaluation of the improvement of air flow distribution, quantitative and qualitative measurements. Furthermore, the VRI is a non-invasive, radiation free procedure which is simple and doesn't require the level of patient effort required for lung function test and other evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Patient is able to read and understand the Informed Consent Form and he/she will sign the Informed Consent.
* Male or female in the age range of 18-85 years.
* Body Mass Index \>20.
* Patient presented with airway obstruction and who are designated to undergo intervention

Exclusion Criteria:

* Chest wall deformity;
* Spine deformity (including severe scoliosis or kyphosis);
* Hirsutism;
* Potentially contagious skin lesion on the back;
* Skin lesion that would interfere with sensor placement;
* Patient is pregnant;
* Cardiac pacemaker or implantable defibrillator;
Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors

The purpose of this study is to investigate the prevalence of signs and symptoms of hypogonadism in three groups of testicular cancer survivors.

Recent studies have shown that metabolic syndrome is common among testicular cancer. Patients with low levels of testosterone appear to be at higher risk of metabolic syndrome.

A substantial number of testicular cancer survivors might be in a state of "compensated hypogonadism" with testosterone levels low in the normal range due to an increased LH-drive from the pituitary gland.

Whether this specific groups of testicular cancer survivors are at increased risk of cardio-vascular disease and might benefit from testosterone substitution is yet to be clarified.

Eligibility Criteria:
Inclusion Criteria:

* Earlier treatment of testicular germ cell cancer
* No sign of relapse \> 1 year since latest treatment
* Testosterone \< 12 nmol/L and luteinizing hormone \> 8 IE/L OR
* Testosterone \> 12 nmol/L and LH \> 8 IE/L OR
* Testosterone and LH within their normal ranges

Exclusion Criteria:

* Testosterone substitution
Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics Analysis

This is an observational study of patients with lupus nephritis aiming to find biomarkers that can predict patients' response to immunosuppressants. We planed to collect 100 lupus nephritis patients' peripheral blood,kidney tissues and urine before and after treatment (mycophenolate mofetil or cyclophosphamide, in combination with glucocorticoids). Then multi omics analysis, including single cell RNA-seq, ATAC-seq and CITE-seq, will be performed to find new biomarkers for patients' response and prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 16-60 years.
2. Fulfilling the 2012 SLICC classification for SLE.
3. Renal biopsy pathology was clearly classified as III \\ IV \\ V+III \\ V+IV within 6 months.
4. Renal biopsy reveals active disease.
5. 24-hour urinary protein was tested twice within two weeks, both of which were greater than 1g.
6. The patients have never received glucocorticoid/immunosuppressants or received standard treatment for more than 1 month without change. The standard treatment should fulfill: a. prednisone 0-20mg/day, or equivalent other glucocorticoids; b. acceptable immunosuppressants, including Tacrolimus ≤ 4mg/d, methotrexate ≤ 15mg/week, azathioprine ≤ 100mg/d and MMF ≤ 1g/d.
7. Informed consent obtained.

Exclusion Criteria:

1. Other concomitant connective tissue diseases or autoimmune diseases.
2. Neuropsychiatric lupus, alveolar hemorrhage, retinal lesions, pulmonary arterial hypertension, or other severe organ involvement.
3. Pregnant or lactating women.
4. Current infections that require antibiotic or antiviral treatment.
5. Other kidney diseases.
6. Platelet \< 50×10\^9/L.
7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that is greater than 1.5 times the upper limit of the normal value.
8. Total bilirubin or blood lipid that is greater than 2 times the upper limit of the normal value.
9. Other conditions that not suitable for inclusion in the study, assessed by the investigators.
A Randomized, Controlled Phase III Trial of Sorafenib With or Without cTACE in Patients With Advanced HCC

This is a randomized, multi-center, open-labeled, phase III study in patients with advanced HCC. A total of 338 patients will be randomized (1:1) into one of the two treatment arms, to receive sorafenib with (Arm Combination-treatment; Arm C) or without (Arm Sorafenib alone treatment; Arm S) cTACE.

All the patients will be initially given sorafenib within 72 hours after the randomization. Treatment should continue until the criteria for treatment discontinuation are met.

After the treatment period, patients will undergo follow up for survival every 12 weeks (±7 days) from the last dose, and the survival follow up will be performed for at least 1.5 years after the last patient's last treatment.

The superiority of the Arm C (cTACE+Sorafenib) over the Arm S (Sorafenib) in the OS period will be verified in the ITT set and FAS using a stratified log-rank test. Stratification factors consist of mUICC stage (III vs. IV), Vascular invasion (none and Vp1-2 vs. Vp3-4 and any other presence), Child-Pugh score (5 vs. 6-7), serum AFP level (≥200 ng/mL vs. \<200 ng/mL). The significance level is 5% (one-sided).

Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in the study, patients must meet the following criteria:

1. Signed written informed consent
2. Clinical or histological diagnosis of HCC based on the guidelines of the Korean Liver Cancer Study Group and the National Cancer Center Korea
3. At least one typical enhanced index lesion in the liver that is bi-dimensionally measurable by multiphasic spiral CT scan or dynamic contrast-enhanced MRI, and size of largest tumor is 15 cm or less at enrollment.
4. Tumor conditions confirmed by abdominal imaging (contrast enhanced CT ± MRI) and chest imaging (CT) performed within 4 weeks prior to the treatment initiation:
5. Age of at least 20 years.
6. ECOG Performance Status of 0, 1 or 2.
7. Child-Pugh class A or B (Child-Pugh score ≤ 7).
8. Life expectancy of at least 16 weeks.
9. Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements (no transfusion, no restoration), conducted within 14 days prior to screening:
10. Female patients at least 1 year postmenopausal, surgically sterile or those of childbearing potential must have a negative urine pregnancy test within 14 days prior to the first treatment, and have to use at least one medically acceptable and effective contraceptive method for the last 2 months prior to Screening Visit: methods of effective contraception result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as a barrier method (implant, injectable contraceptives, oral contraceptives, intrauterine contraceptive device), hormonal IUD, sexual abstinence or vasectomized partner.

Exclusion Criteria:
Effect of a Mindfulnes Program "Healthy Under Stress" on Stress: A Prospective Intervention Study

Stress describes a state of worry and mental tension that results from an imbalance between demands and coping strategies, as well as the disruption of physiological homeostasis. It represents an important ability to adapt to environmental factors, and chronically has negative psychological and physical consequences. The mind-body medical program "Healthy in Stress" according to Esch aims to strengthen the individual's ability to deal with stress through comprehensive training. The main target parameter is stress reduction, measured using the Perceived Stress Scale (PSS).

After baseline (t0), all participant will receive the following intervention:

The intervention lasts eight weeks, with a two-hour session held once a week. The selected topics include nutrition, mindfulness, exercise, relaxation techniques, dealing with stressors, effective communication and the promotion of a supportive social network.

t1 (at the end of the program).

t2 (3 months after t0).

Eligibility Criteria:
Inclusion Criteria:

* Employees, patients and family members of the Robert-Bosch-Krankenhaus (RBK) and Bosch Health Campus of all specialties.
* Informed consent.

Exclusion Criteria:

* Physical or mental condition which, in the opinion of the investigator does not allow the patient to participate in the study.
* Participation in other clinical studies with behavioral, psychological or complementary medical interventions.
* Insufficient knowledge of the German language.
Phase I/II Study of AZD2171 in Combination With Paclitaxel/Carboplatin in Japanese Non-Small Cell Lung Cancer Patients

The National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of cediranib at 30mg in first line non-small cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase II efficacy and tolerability analysis by the study's Data Safety Monitoring Committee. Although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity and therefore the study was considered not to have met the pre-defined criteria for automatic continuation into Phase III. As the design of Study 040 is similar to that of Study BR24, AstraZeneca has suspended recruitment into Study 040.


Eligibility Criteria:
Inclusion Criteria:

* Having histologically or cytologically confirmed NSCLC
* Patients with previously untreated advanced/metastatic (Stage IIIB/IV) or postsurgery recurrent NSCLC
* WHO performance status 0-1

Exclusion Criteria:

* Untreated unstable brain or meningeal metastases
* Patient with inappropriate laboratory tests values
* Patient with poorly controlled hypertension
Safety of T Regulatory Cell Therapy in Subjects With COVID-19 Induced Acute Respiratory Distress Syndrome

This study is to evaluate the feasibility and safety of treatment with related donor Human Leukocyte Antigen (HLA) matched or haploidentical allogeneic T regulatory cells in patients with COVID 19 induced ARDS.

Study treatment will be administered in 1 to 2 doses, with the possibility of a second infusion given 14 days after the initial infusion.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years to 75 years
* All patients at entry are required to be at high risk for the development of ARDS or receiving mechanical ventilatory support
* Provision of signed written informed consent from the patient or patients legally authorized representative
* Only patients who are committed to full life support (Do not resuscitate (DNR) allowed)
* Initiation of study drug within 120 hours of the diagnosis of acute lung injury (ALI)/ARDS
* COVID positive by PCR testing

Exclusion Criteria:

* Concurrent illness that shortens life expectancy to less than 6 months
* Inability to obtain adequate study follow-up
* Greater than 90 hours since first meeting ARDS criteria per the Berlin definition
Effectiveness of Resin Sealants: Retrospective Cohort Study

This retrospective cohort study assessed sealant clinical success applied to pit and fissure by dental undergraduate students at Piracicaba Dental School - Brazil.

A population presenting 1st/2nd permanent molars with sealed occlusal surfaces were considered. Dental records were reviewed for: patient's caries risk (High/Low); operator experience (scores 1 to 4, beginners to seniors); number of follow-up visits; isolation procedure; sealant/tooth type; and age at placement. Posteriorly, the patients were called to dental evaluation and the sealed teeth were classified regarding the sealant presence, partial presence or absence, with or without caries, or sealant replacement to a restorative material in Satisfactory or Unsatisfactory, considering the caries presence/absence. Successful outcome was considered in the caries absence.

Eligibility Criteria:
Inclusion Criteria:

* A population presenting first and second permanent molars with sealed occlusal surfaces by dental undergraduate students at Piracicaba Dental School Brazil.

Exclusion Criteria:

* First and second permanent molars with sealed occlusal surfaces by dentistry.