cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of TAK-079 in Healthy Participants

The purpose of this study is to characterize the pharmacokinetic and safety and tolerability profile of TAK-079 following a single intravenous (IV) infusion or subcutaneous (SC) administration at escalating dose levels in healthy participants.

The drug being tested in this study is TAK-079. TAK-079 is being tested to find a safe and well-tolerated dose and to assess how TAK-079 is processed by the body. This study will look at pharmacokinetics, side effects, and laboratory results in people who take TAK-079 and is designed as a randomized single dose-rising study.

Therefore, each subsequent cohort will not start until the previous cohort has completed and the results are reviewed. Each participant will receive TAK-079 or placebo once only as an IV infusion or by SC administration. The starting dose for IV will be 0.0003 mg/kg and SC dose of 0.01 or 0.03 mg/kg was determined based on the no-observed-adverse-effect-level (NOAEL) results from the 13-week good laboratory practice (GLP) monkey toxicology study. If this dose is well-tolerated, the next group will receive a higher dose, etc, until a maximal tolerated dose is reached with the highest dose not to exceed 1.0 mg/kg.

This single-center trial will be conducted in the United Kingdom. The overall time to participate in this study is up to 17 weeks. Participants will make 11 visits to the clinic, including one 10-day period of confinement in the clinic. All participants will be contacted by telephone 14 days after the last visit to the clinic for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy male or female with no child bearing potential who is 18 to 55 years of age inclusive.
2. The subject weighs at least 70 kilogram (kg) for cohort 1 and subsequent cohorts 50 kg (110.2 lb) and less than 100 kg (220.5 lb) and has a body mass index (BMI) range of 18.5 to 30 kilogram per square meter (kg/m\^2), inclusive at Screening Visit 1.
3. A male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 6 months after last dose of study medication.

Exclusion Criteria:

1. Has received any investigational compound within the last 3 months or 5\*T1/2 of the investigational compound,whichever is longer, prior to the day of study medication (Day 1).
2. Has received any live vaccinations, within the last 3 months prior to Screening or is expected to receive any vaccinations during the study or for 1 month after the Day 78 Study Exit visit.
3. Has received any other biologic medical products at any time in the past.
4. Has a positive drug or alcohol screening result, or a history of drug or alcohol abuse.
5. Has a positive test result for hepatitis or human immunodeficiency virus antibody.
6. Has any signs of an acute infection or history of frequent or chronic infection, or herpes zoster.
7. Has active or latent tuberculosis (TB)
8. Considered unfit for the study by the Principal Investigator.
Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

The purpose of this study was to observe the clinical efficacy and adverse reactions of rhTPO in the treatment of pregnancy-induced thrombocytopenia.

The project is undertaken by Qilu Hospital of Shandong University and other 6 well-known hospitals in China. The investigators anticipate to undertaking a concurrent control, multicentre trial including 60 pregnancy associated ITP adult patients which are ineffective for first-line treatment or platelets infusion and 30 healthy pregnancy control. 30 of the ITP patients are selected to receive rhTPO(given different dose according to the platelet count, the risk of bleeding and delivery), the other ITP patients are selected not to receive rhTPO. Platelet count, bleeding and other symptoms of ITP patients and their newborns are evaluated after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of the rhTPO for the treatment of pregnancy with ITP.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. 18-50 years of age; gestational age over 32 weeks;
3. No response to the treatment of glucocorticoids and / or intravenous immunoglobulin (a stable dose of glucocorticoid could be accepted);
4. Platelet transfusion was not effective.
5. Platlet count of the patients \<30\* 10\^9/L and had the risk of bleeding or bleeding.
6. No obvious abnormalities in liver and kidney function had (1.5 times higher than normal limit of the serum urea nitrogen, creatinine, serum transaminase and bilirubin );
7. No severe cardiac and pulmonary dysfunction;
8. No history of mental illness;
9. Voluntarily signed written informed consent.

Exclusion Criteria:

1. A history of serious allergies to biologics;
2. The history of thrombosis;
3. Thromboembolic or hemorrhagic disease;
4. Patients who are deemed unsuitable for the study by the investigator.
Study of Relatlimab in Combination With Nivolumab in Chinese Participants

The purpose of this study is to evaluate the safety and drug levels of relatlimab combined with nivolumab in Chinese participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologic or cytological confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable) except for participants with primary central nervous system (CNS) tumors.
* Participants must have received, and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (immune check inhibitor-experienced or non-experienced population may be included), if such a therapy exists. Participants who refuse or are ineligible for standard therapy will be allowed to enroll provided their refusal/ineligibility is documented in medical records.
* Eastern Cooperative Oncology Group (ECOG) 0 to 1.

Exclusion Criteria:

* Participants with history of severe and/or life-threatening toxicity related to prior immune therapy (eg, anti-cytotoxic T-lymphocyte-associated protein 4 \[anti-CTLA-4\] or anti-programmed cell death protein 1 \[anti-PD-1\]/programmed death-ligand 1 \[PD-L1\] treatment or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy).
* Participants with an active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
* Prior treatment with LAG-3 targeted agents.

Other protocol-defined inclusion/exclusion criteria apply
Can PLIA Reduce Early Post-operative Pain After PAO Surgery?

The goal of this clinical trial is to compare different peri-incisional local infiltrative anesthesia (PLIA) methods in patients ages 13 to 50 undergoing a periacetabular osteotomy (PAO). The main questions to answer here are:

1. Does PLIA impact post-operative pain after PAO?
2. Does PLIA impact pain medication usage as measured by morphine equivalent dosing (MED) after PAO?
3. Does the timing of PLIA administration impact post-operative pain and MED after PAO? Participants will be asked to complete some surveys; demographics survey, General Self-Efficacy Scale (GSE) and the Pain Resilience Scale. All other information will be gathered from the patients medical chart.

Researchers will compare three groups. 1.) Patients who do not receive PLIA. 2.) Patients who receive PLIA after their incision is closed. 3.) Patients who receive PLIA throughout PAO.

Patients will be approached at their preoperative appointment. This is the only time researchers will conduct study related activities with patients. All other information will be gathered by chart review. Following consent, patients will be asked to complete surveys through REDCap® using a tablet or computer. These include a self-efficacy survey and a grit survey. Patients will then be randomized in a 1:1:1 ratio. 1.) Patients who do not receive PLIA. 2.) Patients who receive PLIA after their incision is closed. 3.) Patients who receive PLIA throughout PAO.

Patients will be blinded to which group they are in, meaning they will not know whether they received the injection or not. Patients may ask to be told what study group they were in at their standard-of-care, 3 month follow-up visit.

Following surgery, patients in all treatment arms will be provided with the same intravenous (patient-controlled analgesia) and oral pain medications scheduled as needed per standard of care.

The research team will review patient medical records to record narcotic use and visual analog scale (VAS) pain scores post-operatively until discharge from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent or young adult diagnosed with hip dysplasia indicated for PAO at University of Iowa Hospital and Clinics.

Exclusion Criteria:

* Unable to provide informed consent.
* Pregnant or breast-feeding individuals
* Prisoner or ward of the state
* Allergy or medical contradiction to any of the study medications
* Patients undergoing femoral osteotomy or surgical hip dislocation with PAO will be excluded
Acute Kidney Injury in Patients With Acute Respiratory Distress Syndrome

Several studies suggested that ARDS may have important adverse effects on renal function, but few studies have specifically addressed the risk factors of AKI and its impact on the outcome in theses patients.

Acute respiratory distress syndrome is considered an acute diffuse lung injury in which an inciting inflammatory event is followed by hypoxemic respiratory failure. Despite advances in the management of ARDS, the mortality remains high. The LUNG SAFE study reported that hospital mortality was 34.9% in patients with mild ARDS, 40.3% in patients with moderate ARDS, and 46.1% in patients with severe ARDS. Understanding the prognostic factors in ARDS is essential for decreasing its mortality. Acute kidney injury (AKI) is a common and challenging medical condition in critically ill patients, in which there is a sudden renal impairment during hours to days and it is known to be associated with increased mortality .Other adverse outcomes associated with AKI includes chronic kidney disease (CKD) and high cardio-vascular complications. The incidence of AKI in hospitalized adults was reported to be 22% with a mortality rate of 24%. The severity of AKI ranges from stage 1 to stage 3 according to The KDIGO (Kidney Disease: Improving Global Outcomes) system, based on decreased urine output over time, or increases in serum creatinine, or both.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients (≥18 years old)
* diagnosis of ARDS according to Berlin definition

Exclusion Criteria:

* Patients with preexisting chronic kidney disease
* AKI prior to the onset of ARDS
Phase I Cetuximab and Concurrent Radio-chemotherapy

To determine the MTD toxicity of standard dose cetuximab together with concurrent individualized, isotoxic accelerated radiotherapy and cisplatin-vinorelbine

Phase I trial with escalating doses of vinorelbine and standard doses of radiotherapy, cisplatin and cetuximab.

Eligible patients receive 2 cycles of carboplatin (AUC 5) day 1 and gemcitabine (1250 mg/m2) days 1,8. One cycle duration is 21 days.

Patients without progressive disease (PD) according to the RECIST criteria (appendix 1) will be entered in the phase I dose-escalation part of the study. Chest radiation is given concurrently with cetuximab, cisplatin and vinorelbine. The latter drug will be escalated in three steps until dose-limiting toxicity occurs.

On day 43, i.e. 14 days after the last gemcitabine delivery, radiotherapy is started.

Radiotherapy: In all patients in every dose-step, the radiation will be given as follows: first 3 weeks: 1.5 Gy BID to a dose of 45 Gy in 30 fractions, then 2 Gy QD to a mean lung dose (MLD, this is related to radiation-induced lung damage) of 19 Gy. Maximum dose: 69 Gy given in 5.5 weeks. Maximum dose to the spinal cord: 50 Gy.

Cetuximab: All patients will receive a starting dose 400 mg/ m2 7 days before the beginning of radiotherapy (i.e. day 36), thereafter a weekly dose 250 mg/ m2 during the course of radiotherapy for 5 consecutive weeks. Cetuximab will be delivered at the same days as chemotherapy.

Cisplatin: In all patients in every dose-step, cisplatin will be given as follows: Step 1, 2 and 3: 50 mg/ m2 days 43, 50; 40 mg/m2 day 64.

Vinorelbine will be escalated in three steps:

Step 1: 10 mg/ m2 days 43, 50; 8 mg/m2 days 66 and 73. Step 2: 20 mg/ m2 days 43, 50; 8 mg/m2 days 66 and 73. Step 3: 20 mg/ m2 days 43, 50; 15 mg/m2 days 66 and 73.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed non-small cell lung cancer
* Inoperable stage III (UICC 2002; sixth edition) (no pleural effusion)
* WHO performance status 0 or 1
* Less than 10% weight loss in the last 6 months
* Lung function: FEV1 at least 50% and DLCO at least 50% of the predicted value
* No recent severe cardiac disease
* Adequate bone marrow function
* Adequate renal function
* Adequate hepatic function
* Life expectancy more than 6 months
* Measurable cancer
* Willing and able to comply with study prescriptions
* 18 years or older
* Not pregnant or breast feeding
* Written informed consent
* No previous radiotherapy to the chest

Exclusion Criteria:

* Not non-small cell lung cancer histology
* Mixed pathology
* History of prior chest radiotherapy
* Recent (\<3 months) myocardial infarction
* Uncontrolled infectious disease
* Less than 18 years old
* Inadequate pulmonary function
* Other active malignancy
Efficacy and Safety of Intravascular High-pressure Cutting Balloon Catheters for PCI

The purpose of this study was to evaluate the safety and efficacy of intravascular high-pressure cut balloon catheter compared to cut balloon catheter during PCI, and to support product registration and clinical application.


Eligibility Criteria:
Inclusion Criteria:

1. Be between 18 and 80 years of age (including boundary values) and have a life expectancy of more than 12 months；
2. Be able to understand the purpose of the study, voluntarily participate in and sign the informed consent, and be able and willing to accept the follow-up established in this study;
3. Ischemic cardiomyopathy with single or multiple coronary artery lesions and diagnostic evidence \[e.g., stable angina, unstable angina, or occult ischemia (evidence of myocardial ischemia)；
4. Investigator is believed that the target atherosclerotic plaque needs to be incised and that predilation (if necessary) can enable the incised balloon to pass through the lesion；
5. The presence of coronary artery stenosis confirmed by imaging examination, suitable for percutaneous coronary intervention, coronary vessel stenosis ≥70%; Or ≥50% (visual) with evidence of ischemia, TIMI ≥ level 1；
6. The patient had autogenous coronary angiogenesis or restenosis, requiring stent treatment；
7. The reference vessel diameter of target lesion was 2.0mm-4.0mm, and the lesion length was ≤20mm；
8. When there are multiple lesions that need to be treated, only one in situ coronary lesion is selected as the target lesion, and the non-target lesion must be located on different vascular branches；

Exclusion Criteria:

1. Patients with bleeding tendencies, contraindications to antiplatelet and anticoagulant therapy, who are unable to undergo anticoagulant therapy；
2. Have had any myocardial infarction within a week；
3. People who have an allergic reaction to contrast media or can't take medication
4. There was severe renal failure with or without dialysis, glomerular filtration rate (eGFR) \<30ml/min/1.73m2 or serum creatinine level \>2.0 mg/ dl；
5. cardiogenic shock；
6. Patients who have received heart transplants；
7. Patients who are not eligible for coronary artery bypass surgery；
8. The patient had active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery；
9. The patient had a stroke or transient ischemic attack within 2 months before surgery；
10. Patients in the pregnancy or lactation period；
11. Participants are currently participating in any other clinical trial within 1 month prior to the trial；
12. Patients deemed unsuitable for inclusion by other investigators；
13. Severe calcified lesions and twisted lesions or lesion sites \> 45 degrees angled；
14. Lesions with significant endometrial tears
15. Unprotected left main lesion；
16. The contrast showed a blood clot；
17. Scaffold fracture lesion；
18. Distal stent lesion after stent implantation；
Coffee Consumption and NASH in the French Population.

The aim of our study is to evaluate the effect of coffee consumption on the risk of severe liver fibrosis in French patients with NASH.


Eligibility Criteria:
Inclusion Criteria:

Any newly diagnosed case of NASH histologically proven graded according to SAF criteria

Or Metabolic syndrome defined by the IDF 2005 criteria:

* waist size\> 94cm (men) or\> 80cm (women)
* and the presence of at least two of the following criteria:

  * blood pressure: Systolic ≥ 130mmHg OR diastolic ≥ 85 mmHg OR antihypertensive treatment
  * Triglycerides ≥ 1.5g / L or lipid-lowering therapy
  * HDL cholesterol \<0.4 g / L (men) or \<0.5 g / L (women) or lipid-lowering therapy
  * fasting blood glucose:\> 1 g / L or type 2 diabetes AND Hepatic steatosis diagnosed on liver imaging And liver fibrosis (diagnosed with a FibroScan\> 6 KPa)

Exclusion Criteria:

* Age \<18 years
* Viral hepatitis and other chronic liver diseases
* Alcohol consumption\> 20g / day for women, 30g / day for men
* Liver biopsy or FibroScan dating more than 6 months before inclusion.
* History of bariatric surgery
* Serious psychiatric pathology (psychosis, dementia, severe depression) and patients under legal protection (tutelage, guardianship)
* Solid cancer or progressive hematology or \<2 years (except basal cell carcinoma or localized squamous cell carcinoma)
* Severe and terminal chronic renal insufficiency (estimated GFR \<30mL / min)
* Recent myocardial infarction \<6 months
Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors

Exercise adoption enhances well-being and recovery from breast cancer. Researchers trained American Cancer Society volunteers to provide exercise counseling to breast cancer survivors and the survivors increased their exercise in the short-term. This RCT examines the effects of three maintenance conditions on survivors' exercise participation at longer follow-ups. The cost-effectiveness of the three groups will be examined to guide implementation of this peer mentoring approach in community-based organizations.

The current study, a randomized controlled trial (RCT), represents the next step of the efforts to to extend the research on physical activity to the community setting; community volunteers will deliver the intervention, thereby making physical activity interventions much more accessible to survivors. In partnership with the National American Cancer Society office (Atlanta, GA) and Reach To Recovery (RTR) programs in North Carolina, South Carolina, and Georgia, researchers at the University of South Carolina's College of Nursing will share skills, experience and resources to examine the effects of RTR coaches offering a theoretically-based 3-month exercise program among 150 breast cancer survivors to increase moderate-to-vigorous physical activity (MVPA) followed by self-monitoring (i.e. exercise logs) and feedback reports in Months 4-9 (Reach Plus), monthly phone calls from RTR coaches, self monitoring and feedback reports in Months 4-9 (Reach Plus Message) or weekly email/text messages, self-monitoring and feedback reports in Months 4-9 (Reach Plus Message). In this three group study, researchers will assess survivors' exercise, fatigue, mood, quality of life, and self-reported physical functioning at baseline, 3, 9 and 12 months. The costs of the methods vary and data on costs will be collected to guide the selection of maintenance strategies for dissemination. If the results are promising, researchers will proceed with a dissemination trial wherein the large network of RTR volunteers can expand the scope of their services to benefit breast cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

Women aged 21 years or over will be eligible if they:

* Have been diagnosed in the past 5 years with Stage 0-3 breast cancer.
* Are able to read and speak English.
* Are ambulatory.
* Are sedentary (i.e., do not meet recommendations for moderate-intensity PA \[30 minutes/ day or more for at least 5 days/ week\] or vigorous-intensity PA \[20 minutes/day or more for at least 3 days/week\]
* Are able to walk unassisted.
* Have access to a telephone.

Exclusion Criteria:

Women with:

* More advanced disease (Stage 4).
* Medical or psychiatric problems (e.g., substance abuse, coronary artery disease, peripheral vascular disease, diabetes, and orthopedic problems) that may interfere with protocol adherence will not be included.
* Participants will be asked to provide consent for medical chart review to extract disease and treatment variables. Eligible participants will obtain medical clearance from their physicians.
Analgetics vs Analgetics and Antibiotics for Pediatric Clinical and Sonographic Orchitis or Epididymitis

Some children are admitted to pediatric emergency department due to epididymitis or orchitis. Some of them are treated by analgetics only whie some are treated by analgetics with antibiotics. The study will compare clinical presentation between groups and will compare pediatric urologic outpatient clinic follow up findings.

Some children are admitted to pediatric emergency department due to epididymitis or orchitis. Some of them are treated by analgetics only whie some are treated by analgetics with antibiotics. The study will compare clinical presentation between groups and will compare pediatric urologic outpatient clinic follow up findings.

Eligibility Criteria:
Inclusion Criteria:

* All children admitted to pediatric emergency department due to epididymitis or orchitis

Exclusion Criteria:

* No sonographic or laboratory exam
* Antibiotic treatment before diagnosis
* No outpatient follow-up
* Known urologic congenital malformations
* Admission to inpatient department or emergency surgery