cyrilzakka/clinical-trials huggingface dataset:
A Study of HR071603(Ketamine Nasal Spray) in Healthy Subjects

The study is being conducted to evaluate the safety and pharmacokinetics of HR071603 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Obtain informed consent prior to the start of any activity related to the trial, and have a thorough understanding of the purpose and meaning of the trial and be willing to comply with the protocol;
2. Healthy males aged between 18 and 45 (including both ends);
3. Weight ≥ 50kg, body mass index (BMI) in the range of 18.5 \~ 23.9 (including both ends);
4. During the trial and within 30 days after the administration, willing to take contraceptive measures and ensure that no sperm is donated.

Exclusion Criteria:

1. A subject considered by the investigator to be unsuitable for nasal spray administration;
2. Allergic to any component of the study drug;
3. The underlying disease is not suitable for participation in the trial;
4. 12-lead ECG results in the screening period are abnormal and clinically significant
5. Liver dysfunction;
6. Serum creatinine \> 1.2 × ULN during screening period;
7. Screening for infectious diseases screening hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, human immunodeficiency virus (HIV) antibody test positive;
8. Subject has been thoroughly examined, and the results are abnormal and clinically significant;
9. Major operations were performed within 3 months before the screening period.
10. Donate whole blood/plasma within one month before the screening period, or donate whole blood/plasma more than 400 ml within three months before the screening period;
11. Positive urine drug test;
12. The alcohol breath test is positive; or the average daily intake of alcohol exceeds 15g;
13. Nicotine test is positive;
14. History of drug abuse or alcohol abuse;
15. In the past three months, over five cups of coffee or tea per day were consumed in an average;
16. Any prescription drugs, over-the-counter drugs and health products were used within 2 weeks before screening.
17. Participated in clinical trials of any drug or medical device within 3 months before screening ;
18. Any other medical or psychological condition, which in the opinion of the Investigator, might create undue risk to the participant or interfere with the participant's ability to comply with the protocol requirements, or to complete the study.
Time From PCI to Cancer Surgery and Cardiovascular and Oncologic Outcomes

To evaluate the association between time from PCI to cancer surgery and cardiovascular and oncologic outcomes in early-stage cancer patients, A retrospective, population-based cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database.

Early-stage-cancer patients with a history of PCI who underwent cancer surgery (N = 3621) were included. The patients were divided into two groups based on the time between the dates of PCI and cancer surgery (\&lt;12 months and ≥12 months). Patients were stratified into early-surgery and late-surgery, defined as patients who underwent surgery ≥1 and \&lt;1 month after cancer diagnosis. Outcomes included bleeding, spontaneous myocardial infarction (MI), repeat revascularization, cancer recurrence, and death.

Eligibility Criteria:
Inclusion Criteria:

* men and women aged ≥18 years who were diagnosed with cancer and underwent cancer surgery within 1 year following diagnosis.
* patients who underwent PCI (procedure code: M6551-M6572, O1640-O1649, OA640-OA649) prior to the cancer surgery

Exclusion Criteria:

* participants who received neoadjuvant or adjuvant treatment for cancer
GCS-100LE in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Phase 1/2, open-label, dose-escalation study to assess the safety and tolerability of GCS-100 in combination with etoposide and dexamethasone in patients with relapsed or refractory diffuse large B-cell lymphoma.

This study will investigate the safety and efficacy of the combination of GCS-100 with etoposide and dexamethasone. In vitro data demonstrates potentiation of the killing of lymphoma cells when GCS-100 is combined with dexamethasone or etoposide (Linda Baum, unpublished data; Finbarr Cotter et al, Annals of Oncology, vol 16, 205, Suppl 5.) GCS-100 will be administered in increasing doses to define a maximum tolerated dose (MTD) in combination with these chemotherapeutic agents. When the MTD is defined, the cohort will be expanded to characterize the efficacy of this combination.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients who are 18 years of age or older with diffuse large B-cell cell lymphoma (DLBCL) relapsed or refractory after initial therapy who:

  * Are not candidates for autologous stem cell transplant.
  * Have relapsed after autologous or allogeneic stem cell transplant.
  * Have relapsed or refractory disease after 3 successive chemotherapy regimens.
* ECOG Performance Score 0-2
* Creatinine clearance \> 60 mL/min/1.73 m2.
* Total bilirubin ≤2.0 X Institutional Upper Limit of Normal (IULN)
* AST (SGOT)/ALT (SGPT) ≤2.5 X IUNL, or ≤5X IUNL in patients with liver involvement of DLBCL
* Absolute neutrophil count \>1,000 /_L; hemoglobin \>9 g/mL; platelet count \> 75,000 /_L at screening.
* Patients must be capable of understanding the purpose and risks of the study and able to provide written consent.
* Patients must be willing and able to comply with the prescribed treatment protocol and evaluations

Exclusion Criteria:

* Treatment with experimental (unlicensed) drug within 3 weeks of treatment.
* Previous chemotherapy, or major surgery within 21 days prior to first study treatment, or radiation therapy within 6 weeks.
* Rapidly progressive disease or organ function threatened by disease
* Serious, uncontrolled active infections.
* Serologically positive for HIV, HBV, or HCV.
* Clinically significant cardiac, pulmonary, and/or hepatic dysfunction
* Lymphoma involving the central nervous system
* Female patients who are pregnant or breast feeding.
* Patients not capable of understanding the purpose and risks of the study and or unable to provide written consent.
* Patients not willing and or unable to comply with the prescribed treatment protocol and evaluations
Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"

The purpose of this study is to evaluate the safety in patients with prostate cancer receiving the drug in the routine clinical setting.

The drug being tested in this study is called Leuprorelin acetate (Leuplin PRO for Injection Kit 22.5 mg). Leuprorelin acetate is being tested to treat people who have prostate cancer.

This study will look at the safety in patients with prostate cancer receiving the drug in the routine clinical setting.

The study will enroll approximately 300 patients.

• Leuprorelin acetate

This multi-center trial will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

* Participants with prostate cancer will be included.

Exclusion Criteria:

* Participants with previous history of hypersensitivity to any of the ingredients of the drug or synthetic LH-RH or LH-RH derivatives
Melatonin Effects on Genital Herpes in Brazilian Women

Genital herpes is a common and increasingly-common infection worldwide. The annual incidence in the United States is 1.75 per 1000 inhabitants. The etiologic agent is the herpes type 1 and 2 strains simplex virus. Classical Treatment is with acyclovir which decreases the duration of the disease and prevents rashes but has no curative effect. Also, studies show herpes resistance to acyclovir which has stimulating research into new drugs to treat this condition. Authors suggest melatonin way be a therapeutic agent in herpetic disease due to its modulatory action in immune and inflammatory responses when administered in adequate doses. Therefore, the aim of this study is to evaluate the effects of melatonin in the treatment of genital herpes as well as compare it to acyclovir in a double-blind, prospective and randomized, investigation. Outcome measures will include clinical evaluation of patients and laboratory endpoints.

The authors have investigate the relationship of estrogen-dependent malignant tumors with reduced levels of melatonin. It is speculated that the indoleamine can be classified as anti-estrogenic drug, both by its action on estrogen synthesis with aromatase inhibition and by its interference with estrogen receptors. Experimentally melatonin prevents promotion and growth of mammary tumors in rodents, probably by interacting with epithelial cell receptor; increasing local immunity by acting as an antioxidant agent and by inhibiting telomerase activity in tumor cells .

Eligibility Criteria:
Inclusion criteria:

* clinical and laboratory diagnosis of genital herpes
* real time polymerase chain reaction for herpes type 2
* serology

Exclusion criteria:

* immunodeficiencies
* pregnant women
Preoxygenation With High Flow Nasal Cannula Prolongs Normoxia Time During Induction of Anaesthesia of Bariatric Patients and is Superior to Conventional Preoxygenation With Face Mask.

To compare preoxygenation for induction of general anaesthesia with High Flow Nasal Cannula vs preoxygenation with face mask in patients undergoing bariatric surgery. The hypothesis is that preoxygenation with High Flow Nasal Cannula prolongs normoxia time during induction of anaeshesia and is superior to conventional preoxygenation with face mask. Primary endpoint will be the time during which spO2 \> 92 %. Secondary endpoint will be paCO2.


Eligibility Criteria:
Inclusion Criteria:

* age over 18
* elective bariatric surgery
* written consent

Exclusion Criteria:

* preexisting lung diseases, congenital heart diseases
* known difficult airway
* SpO2 \< 92% under ambient air conditions
* known diaphragmal hernia
* clinically relevant reflux
Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

The purpose of this study is to evaluate the efficacy of BGB-11417 in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)


Eligibility Criteria:
Key Inclusion Criteria

1. Participants with a histologically confirmed diagnosis of CLL/SLL based on the International Workshop on CLL (iwCLL) criteria:

   1. Treatment intolerance or failure during or after treatment with chemoimmunotherapy (CIT) and BTK inhibitors (BTKi) or
   2. Treatment intolerance or failure during or after treatment with BTKi for CIT-ineligible participants as assessed by the investigator.
2. Participants who require treatment based on the iwCLL 2018 criteria
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
4. Life expectancy of \> 6 month

Key Exclusion Criteria

1. Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or low risk (Gleason score ≤ 6) localized prostate cancer
2. Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results
3. A known history of or currently suspected Richter's syndrome
4. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or prior chimeric cell therapy (unless ≥ 6 months after cell infusion)
5. Prior allogeneic stem cell transplant

Note: Other protocol defined Inclusion/Exclusion criteria may apply
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to \<18 years of age with moderate-to-severe atopic dermatitis.

This study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.


Eligibility Criteria:
Inclusion Criteria:

* Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI, including any applicable systemic AD treatment washout.
* For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria:

* Developed an serious adverse events (SAE) during their participation in parent study KGBI deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
* Developed an AE during their participation in the study KGBI that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
* Met the criteria for permanent study intervention discontinuation in study KGBI, if deemed related to lebrikizumab or led to investigator- or sponsor-initiated withdrawal of participant from the study (for example, noncompliance, inability to complete study assessments, etc.)

Note: If study KGBI is still blinded at the time of rollover to study KGBJ, conditions deemed related to the study treatment will be considered related to lebrikizumab.

* Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.
The Life InSight Application Study (LISA)

Background:

It is widely recognised that spiritual care plays an important role in physical and psychosocial well-being of cancer patients but there is little evidence based research on the effects of spiritual care. The investigators will conduct the first randomized controlled trial on spiritual care using a brief structured interview scheme supported by an e-application. The aim is to examine whether an assisted reflection on life events and ultimate life goals can improve quality of life of cancer patients.

Design:

Based on the findings of the investigators previous research, the investigators have developed a brief interview model that allows spiritual counselors to explore, explicate and discuss life events and ultimate life goals with cancer patients. To support the interview, the investigators created an e-application for a PC or a tablet. To examine whether this assisted reflection improves quality of life the investigators will conduct a randomized trial. Patients with advanced cancer not amenable to curative treatment options will be randomized to either the intervention or the control group. The intervention group will have two consultations with a spiritual counselor using the interview scheme supported by the e-application. The control group will receive care as usual. At baseline and one and three months after randomization all patients fill out questionnaires regarding quality of life, spiritual wellbeing, empowerment, satisfaction with life, anxiety and depression and health care consumption.

Discussion:

Having insight into one's ultimate life goals may help to cope with a life event such as cancer. This is the first randomized controlled trial to evaluate the role of an assisted structured reflection on ultimate life goals to improve patients' quality of life and spiritual well being. The intervention is brief and based on concepts and skills that spiritual counselors are familiar with, it can be easily implemented in routine patient care and incorporated in guidelines on spiritual care.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age with advanced cancer not amenable to curative treatment.
* Life expectancy ≥ 6 months.

Exclusion Criteria:

* Karnofsky Performance Score \< 60.
* Insufficient command of the Dutch language to fill out Dutch questionnaires.
* Current psychiatric disease
Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis

Sodium lauryl sulfate (SLS) is an anionic detergent that has been used as the major or sole surfactant in most dentifrices. But it is known to local irritating factor to oral mucosa and skin and results in many side effects. This study was to compare the effects of SLS-free dentifrice and SLS-containing dentifrice in patients with recurrent aphthous stomatitis (RAS).


Eligibility Criteria:
Inclusion Criteria:

* The volunteers had a history of regularly recurring oral ulcerations of at least 6 months duration, with more than one episode per month

Exclusion Criteria:

* already using an SLS-free dentifrice
* taking medications affecting oral ulcers (e.g., corticosteroids)
* having chronic oral mucosal disease (ex, lichen planus, pemphigus vulgaris, pemphigoid, and etc.)
* having allergies to food or medications
* being pregnant
The Effects of Using Virtual Reality Glasses During the Non-Stress Test

The aim of this study to determine the effect of virtual reality glasses use on anxiety, stress and fetal well-being during the non-stress test. Personal information form was used as data collection form, Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version) was used to assess distress, State-Trait Anxiety Inventory (STAI) was used to assessanxiety.

Material and Method

This research was conducted between between October 2021 and February 2022 in Fethi Sekin City Hospital. When power analysis was performed, the sample size was calculated to be at least 71 women for each group (71 experiments, 71 controls). During the NST procedures, VR glasses were given to the participants in the experimental group by the researcher for the intervention. Data collection form for experimental and control groups before the NST procedures; Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version) and State-Trait Anxiety Inventory (STAI) were applied two times before and after NST procedure. After the NST procedures, both groups were re-administered. Descriptive statistics and independent t-test were used for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* not carrying any risk factors (e.g., preeclampsia, intrauterine growth retardation (IUGR), premature rupture of membranes, gestational diabetes)
* having a singleton pregnancy and no vision problems
* No uterine contraction on the tracing paper at the end of NST
* having eaten at least two hours before NST
* not smoking or drinking alcoholic beverages at least two hours before NST
* having a systolic blood pressure value in the range of 90-140 mmHg and a diastolic blood pressure value in the range of 60-90 mm/Hg
* not having any problems related to the health of the fetus (such as fetal anomaly, intrauterine growth retardation)
* having no communication barriers.

Exclusion Criteria:

* presence of fetal distress and emergency intervention planned by the physician
* uterine contraction as a result of NST
Study of 3D Scanning for Adolescent Scoliosis

The investigators aim to validate three-dimensional topographical scanning technology as a tool for evaluation of scoliosis. Through the incorporation of 3D topographical technology in the measurement of deformity, the investigators hope to validate a novel approach to quantify deformity progression and provide an accessible alternative to traditional radiographic workup.

The study design will be prospective observational. Patients 10 to 18 years old being evaluated or followed for scoliosis will be included. Those unable to complete the consent and assent processes will not be enrolled. Members of the research team will review the clinic schedule through EPIC each week to identify eligible patients. Member of the patient's care team, such as the physician, will introduce the study to the patient. If the patient and the patient's caregivers are interested in learning more and/or participating, a member of the research team will provide study-related information and obtain informed consent via written or electronic consent, assent, and, if necessary, short form consent.

If a patient consents to participate, members of the research team will conduct the 3D topographical scan in a private room in the clinic. This involves 360 degree scans using a smartphone camera. Participants will also receive any standard of care x-rays during the visit. The investigators will then analyze the ability of the 3D smartphone scan to estimate the Cobb Angle measured on the X-ray, to infer the magnitude of the scoliosis deformity.

Eligibility Criteria:
Inclusion Criteria:

* Ages 10 and 18 years old

Exclusion Criteria:

* Scoliosis caused by another condition (e.g., secondary scoliosis)
* Parents/guardians unable to consent
* English is not the primary language (to avoid miscommunication)
Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients

This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT neoadjuvant regimen in patients with stage III breast cancer.

2 treatment cycles of chemotherapy (one cycle = 2 weeks) must be administered to each patient before breast surgery.

The required number of patients has been calculated following Simon's method. 43 patients will be enrolled in two phases: first, 29 patients must be enrolled, and at least 2 pathological complete responses obtained. Patients recruitment will continue until 43 patients have been enrolled. Assumptions are that there is a 95% probability to obtain a rate of pathological complete responses of at least 10%.

Eligibility Criteria:
Inclusion Criteria:

* Stage III breast cancer disease, with histological confirmation by true-cut or open-biopsy.
* Ages between 18 and 75 years old. Patients older than 70 must have an adequate quality of life to be eligible.
* Patients cannot have received previous treatment with chemotherapy, hormone therapy, radiotherapy or immune therapy.
* Performance status of 0,1, 2 Eastern Cooperative Oncology Group (ECOG).
* At least a 6 month life expectancy.
* Neutrophils \> 1500; platelets \> 100000; haemoglobin \> 10 mg/dL.
* Adequate renal and hepatic functions, with serum creatinine \< 1.2 mg/dl and total bilirubin \< 2 mg/dl.
* Adequate contraceptive methods during the study and up to 3 months after.
* Adequate cardiac function assessed by physical exam, electrocardiogram and left ventricular ejection fraction \> 55%.

Exclusion Criteria:

* Inflammatory carcinoma or stage I, II or IV breast cancer disease.
* Males.
* Active infection.
* Other neoplasms except for basal skin carcinoma or cervical in situ carcinoma adequately treated. Other previous neoplasms are allowed if diagnosed and treated more than 5 years before study registration.
* Concomitant serious disease provoking organ failure (heart, renal, hepatic, respiratory).
* Pre-existing motor or sensorial neuropathy \> grade 1.
* Inability for treatment compliance.
* History of hypersensitivity to compounds such as cremophor, cyclosporine or vitamin K.
* History of arrhythmias or congestive heart failure, even when controlled; or active cardiac blocking of second or third grade.
* History of myocardial infarction in the previous 6 months.
* Hypertension not controlled.
* Pregnant or lactating women.