cyrilzakka/clinical-trials huggingface dataset:
A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma

An open-label multi-center phase Ib/II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 plus lenvatinib as the first-line therapy for patients with advanced hepatocellular carcinoma.

This is a multi-center, multi-cohort, open-label phase 1b/2 clinical study to evaluate the anti-tumor activity, safety, PK profile, immunogenicity and potential biomarkers of AK104 plus lenvatinib for the treatment of advanced hepatocellular carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent form voluntarily.
* Histologically or cytologically documented hepatocellular carcinoma.
* BCLC stage C, and non-resectable BCLC stage B .
* At least one measurable lesion according to RECIST criteria.
* ECOG of 0 or 1.
* Adequate organ function.
* Estimated life expectancy of ≥3 months.
* For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent.

Exclusion Criteria:

* Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
* History of hepatic encephalopathy or liver transplantation.
* Clinical significance of hydrothorax, ascites or pericardial effusion.
* Central nervous system metastases and/or carcinomatous meningitis.
* Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
* Occurred arteriovenous thromboembolic events within 6 months before the first administration.
* Tumor volume \> 50% liver volume; portal vein tumor thrombus or inferior vena cava tumor thrombus.
* Inadequately controlled arterial hypertension.
* Attack of symptomatic congestive heart failure (LVEF\<50%); History of congenital long QT syndrome.
* Known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease.
* Severe infections.
* Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy,
* Enrollment of another clinical study within 4 weeks prior to the first administration of study drugs.
* Unable to receive an enhanced CT or MRI scan of the liver.
A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

The purpose of this study is to assess the safety, tolerability, and efficacy of ALN-PCSSC in participants with homozygous familial hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, ≥12 years of age with a diagnosis of homozygous familial hypercholesterolemia by genetic confirmation or a clinical diagnosis based on a history of an untreated low-density lipoprotein cholesterol (LDL-C) concentration \>500 mg/deciliter (dL) \[13 millimoles/liter (mmol/L)\] together with either xanthoma before 10 years of age or evidence of heterozygous familial hypercholesterolemia in both parents.
* Stable on a low-fat diet.
* Stable on pre-existing, lipid-lowering therapies (such as statins, cholesterolabsorption inhibitors, bile-acid sequestrants, or combinations thereof) for at least 4 weeks with no planned medication or dose change for the duration of study participation.
* Fasting central lab LDL-C concentration \>130 mg/dL (3.4 mmol/L) and triglyceride concentration \<400 mg/dL (4.5 mmol/L).
* Body weight of 40 kilograms (kg) or greater at screening.

Exclusion Criteria:

* LDL or plasma apheresis within 8 weeks prior to the screening visit, and no plan to receive it during the study because of the attendant difficulty in maintaining stable concentrations of LDL-C while receiving apheresis.
* Use of mipomersen or lomitapide therapy within 5 months of screening.
* Previous treatment with monoclonal antibodies directed towards PCSK9 within 8 weeks of screening.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer

This will be a non-blinded, non-randomized study to further our knowledge of and experience with lymph node surgery. The investigators are interested in documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy (SLNB) with inguinal-femoral lymph node dissection (IFLND). The study will be open at the Winthrop P. Rockefeller Cancer Institute at The University of Arkansas for Medical Sciences (UAMS). Dr. Pamela Stone, Dr.Alexander Burnett, and Dr. Juan Roman will be responsible for accruing subjects to this study. It will be open to all patients presenting to the Winthrop P. Rockefeller Cancer Institute with vulvar cancer requiring lymph node evaluation for the ipsilateral and/or contralateral groin who have not had prior groin surgery or radiation to the groins. Patients must meet inclusion and exclusion criteria to be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Female patients 18-100 years of age.
* All races and ethnicities.
* Being seen in the Winthrop P. Rockefeller Cancer Institute for vulvar cancer requiring lymph node evaluation for the ipsilateral or contralateral groin.
* Willing participation following informed consent process.

Exclusion Criteria:

* Has not had prior groin surgery or radiation to the groins.
* Any condition the PI or study physician determines that will put the subject at risk during the procedure.
* Allergy to blue dye used in lymphatic identification.
* Pregnant or breast feeding.
Bronchiolitis: Evaluation of Wang's Score as a Predictor of the Duration of Oxygen Therapy in Bronchiolitis

Evaluation of Wang's score as a predictor of the duration of oxygen therapy in bronchiolitis

Bronchiolitis is a viral disease of very variable evolution going from a simple outpatient treatment to the necessity of hospitalization in intensive care.

This epidemic disease is found all year round with a seasonal peak from mid-October to late winter.

The risk factors for progression to severe or prolonged bronchiolitis have been highlighted, but the duration of hospitalization is difficult to predict, which leads to organizational difficulties in the services and additional anxiety for the families.

The management of beds during winter epidemics can be a source of difficulties for hospitalization services, with the need to temporarily increase reception places or transfer children to other hospitals.

Oxygen rescue is the main factor limiting the discharge of the pediatric ward. This criterion seems to us more suitable than the total duration of hospitalization.

Indeed, other factors such as the family environment or food difficulties can delay the child's departure from the service. Their assessment seems to be more subjective, their assessment may vary from one doctor to another.

Better management of beds during winter epidemics could help to avoid changes in service during hospitalization, thus facilitating relationships between caregivers and families.

Eligibility Criteria:
Inclusion Criteria:

* Infants under 2 years
* Infants consulting at the emergency department of the University Hospital of Rennes for a first or second episode of bronchiolitis with criteria for hospitalization

Exclusion Criteria:

* Children transferred from another department such as pediatric intensive care unit
* Children for whom Wang's score could not be established
* Child over 2 years old at diagnosis
* Child with a 3rd episode of bronchiolitis or more.
PRP in Recurrent Implantation Failure

The endometrial function and endometrial receptivity have been accepted to be major limiting factors in the establishment of pregnancy. In spite of improved almost all aspects of IVF: ovarian stimulation, embryo culture and transfer, the pregnancy rates still not satisfactory. The bottleneck is the process of implantation.

Recurrent implantation failure (RIF) is one of the nightmares in reproductive medicine and despite several strategies that have been described for management; there is no universal agreement yet.

Recently, intrauterine infusion of platelet-rich plasma (PRP) is described to promote endometrial growth and receptivity, PRP has been investigated as a therapeutic approach for several medical disorders in dermatology and rheumatology, but its use in IVF is still limited.

Objective:

To evaluate the effectiveness of intrauterine perfusion of autologous platelet-rich plasma in the improvement of pregnancy rate in RIF patients.

After ethical committee approval was obtained, 150 infertile women with history of RIF gave their written consent to be included in this study. All were recruited from the outpatient clinic of Al-Baraka fertility hospital - with age below 40 yrs, body mass index (BMI) below 30 kg/m2, whose uteri were morphologically normal as confirmed by HSG and U/S to limit additional factors that may affect the results of the study - Divided into 2 comparable groups; all participants underwent antagonist protocol, oocytes retrieval, fertilization and embryo transfer; In the study group, intrauterine infusion of 0.5 to 1 ml of platelet-rich plasma (PRP) was performed 48 hrs before blastocyst transfer, pregnancy tests were done 12 days after ET.

Eligibility Criteria:
Inclusion Criteria:

* female infertile patients with history of recurrent implantation failure
* age below 40 yrs.,
* body mass index (BMI) below 30 kg/m2.

Exclusion Criteria:

* haematological and immunological disorders
* hormonal disorders,
* chromosomal and genetic abnormalities and uterine abnormalities (acquired or congenital) as confirmed by HSG and U/S to limit additional factors that may affect the results of the study
Post-Licensure Study of the Safety of GARDASIL™ in Males (V501-070)

This is a post-licensure safety observation cohort study to describe the general safety of GARDASIL™ (a quadrivalent human papillomavirus vaccine) in males.


Eligibility Criteria:
Inclusion criteria:

* Male vaccinated with at least one dose of GARDASIL™ after the October 2009 FDA date of first licensure of GARDASIL™ for males

Exclusion criteria all cohorts:

* Female
* Male vaccinated prior to the October 2009 FDA date of first licensure of GARDASIL™ for males
* Male who received all doses of GARDASIL™ outside of the health plan

Exclusion criteria, Regimen Completers cohort:

* Male \< 9 and \> 26 years of age at first dose
* Male not part of health plan at each dose
* 3-dose vaccination regimen given over a period \> 12 months
* Less than 28-day interval between first and second dose
* Less than 12 weeks between the second and third dose
* Less than 24 weeks between first and third dose

Exclusion criteria, Autoimmune cohort:

- Male with less than 12 months of health plan membership prior to first dose of GARDASIL™
A Prospective, Observational Study to Assess and Evaluate the Use of Glucophage XR Therapy in the Management of Patients With Type 2 Diabetes

This was an observational, prospective, multicentric study conducted in a cohort of subjects with type 2 diabetes and prescribed with Glucophage XR therapy from hospitals or clinics in Hong Kong, Indonesia, Korea, Malaysia, Philippines and Singapore. Glucophage XR is being used in the Asia Pacific region for the treatment of subjects with type 2 diabetes. This study was designed to provide information on the day to-day experience of using Glucophage XR in the management of subjects with type 2 diabetes and its use in routine clinical practice in Asia Pacific region.

Glucophage (metformin) is the standard first line therapy for subjects with type 2 diabetes mellitus (DM). The consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes has recommended metformin therapy in concurrent with lifestyle intervention at diagnosis. It has been well accepted that subjects' compliance with therapy tends to decrease as the dosage frequency increases and hence the regimens should be simplified as far as possible to support good compliance with therapy. The use of an extended release formulation of metformin (Glucophage XR) supports the simplification of treatment of subjects with type 2 diabetes by allowing a once daily administration of metformin.

OBJECTIVES

Primary objective:

* To assess the tolerability of Glucophage XR therapy when used in routine clinical practice in subjects with type 2 diabetes

Secondary objective:

* To assess the effectiveness of Glucophage XR therapy on the maintenance of glycaemic control

The study does not involve any active involvement of the subjects and does not require any change from the standard medical management of the subjects. Each subject will be followed upon starting Glucophage XR therapy and until at least 12 weeks of treatment or discontinuation of treatment, whichever being earlier.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with type 2 diabetes
* Subjects who have been given Glucophage XR for the treatment of the type 2 diabetes

Exclusion Criteria:

* Subjects treated with Glucophage XR before the study initiation
* Contraindicated use of Glucophage XR based on local label
* Subjects who plan to continue on another oral anti diabetic therapy during the course of the study
Trazodone on OSA Endotypes

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Some OSA patients with low arousal threshold wake up prematurely during an obstructive event and do not have time for spontaneous upper airway (UA) dilator muscle recruitment. As a consequence they are exposed to apnea and hypopnea cycling. In this protocol the investigators will test the effect of trazodone administered before sleep on OSA traits and OSA severity during sleep.

Two overnight home sleep studies will be performed: a drug night and a placebo night. The patient will breath spontaneously (without CPAP) for both nights. On the study nights, subjects be instrumented with a full polygraphy for monitoring sleep, and respiratory events. Trazodone 100 mg will be given 30 min before lights out. At least four hours of sleep with high quality signal acquisition will be required for a study to be judged adequate. After the first overnight study is completed, there will be a one-week washout period prior to crossing over to the other treatment.

Eligibility Criteria:
Inclusion Criteria:

* Moderate-to-severe OSA (AHI ≥ 15 events/hr)

Exclusion Criteria:

* All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements.
* Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
* Use of SNRIs/SSRIs.
* Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
* Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:
* Other sleep disorders: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias.
* Hypersensitivity to the study drug (angioedema or urticaria)
* Contraindications to DAW2020
* Use of medications that lengthen QTc interval
* Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease
* Severe claustrophobia.
To Evaluate the Health Effect of Particular Fatty Acids Profiles From Eggs

In a previous study, 24 volunteers consumed two conventional eggs or two eggs naturally enriched with omega 3, 5 and 7 every day for 3 months. It was shown that these eggs were well tolerated and that the omega enrichment led to a reduction in waist circumference of 3 cm in 3 months.

The objective of Omegasnack study was therefore to go further in the evaluation of these effects on waist circumference; 1) confirm the effects of these eggs on waist circumference when included in a snack, 2) determine whether this reduction in waist circumference is linked to a reduction in muscle and/or fat mass (subcutaneous and/or visceral) and 3) evaluate whether these effects are associated with a modification in the accumulation of ectopic fat in the muscle and/or liver.


Eligibility Criteria:
Inclusion Criteria:

* Woman or man, aged of 18 to 75 years;
* Abdominal obesity: waist circumference for men \> 94cm and \> 80cm for women;
* Body mass index ≥ 25kg/m2 and ≤30kg/m2;
* For women: use of effective contraception;
* Provision of signed and dated informed consent form;
* Stated willingness to comply with all study procedures and availability for the duration of the study;
* French speaker.

Exclusion Criteria:

* Uncontrolled systolic blood pressure \> 160/100 mmHg;
* For premenopausal women: pregnant women or women planning to get pregnant within 3 months or lactating women;
* For menopausal women: less than 6 months of menopause;
* For Perimenopausal women: presenting symptoms;
* Type II diabetes (controlled or uncontrolled), Type I diabetes;
* Medical history or actual cardiovascular disease (myocardial infarction, angina, transient ischemic attack, lower limb arteriopathy);
* Medical history or actual severe psychiatric, hepatic, pancreatic, kidney, pulmonary or gastrointestinal problem
* Thyroid disorder;
* Cancer \< 3 years before the screening visit;
* Smokers or who have stopped smoking within the last 6 months before the screening visit;
* Subject presenting allergy or food intolerance to eggs;
* Subjects who are not able to understand and follow study procedures;
* Drug addiction problem (regular consumption);
* Recent change of body weight \> 7% (\< 2 months before the inclusion);
* Within 1 month before the screening visit, change in the chronic (\> 7 days in a row) intake or dosage of drug(s) or product(s) modifying the glucose and/or lipid metabolism;
* Current or recent (\< 2 months before the screening visit) intake of dietary supplements rich in n-3 polyunsaturated fatty acid (including tablets, pills, capsules, enriched-oils);
* Vegan diet;
* Consumption of fish \> 3 times per week;
* Women who drink more than 2 glasses of alcohol per day (\> 20 g of alcohol per day or \> 140g/week) or men who drink more than 3 glasses of alcohol per day (\> 30 g of alcohol per day or more than 210g/week);
* LDL \> 159 mg/dl or Total cholesterol \> 239 mg/dl;
* Subjects having participated to another clinical trial \< 1 month before the screening test visit.
First Line Hepato Cellular Carcinoma (HCC)

The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Histologic or cytologic confirmed diagnosis of HCC.
* Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies
* Child-Pugh Class A
* ECOG performance status 0-1
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC
* History of active cardiac disease
* Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)
* Any other hemorrhage/bleeding event \>= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices
* Inability to swallow tablets or untreated malabsorption syndrome
ADYNOVATE Drug Use-Results Survey

The purpose of this survey is to understand the following items in the actual clinical use of ADYNOVATE in patients:

1. Unexpected adverse drug reactions
2. Occurrence of adverse drug reactions in the actual clinical use
3. Factors that may affect safety and efficacy
4. Occurrence of Factor VIII inhibitor development in patients with coagulation factor VIII deficiency (hereinafter hemophilia A)
5. Safety and efficacy for hemophilia A patients who received routine prophylactic therapy and on-demand therapy


Eligibility Criteria:
Inclusion Criteria:

* Hemophilia A patients who receive ADYNOVATE, including previously treated patients with Factor VIII deficiency (PTPs), and previously untreated patients with Factor VIII deficiency (PUPs) who are treated with ADYNOVATE.

Exclusion Criteria:

* Patients not administered ADYNOVATE.
Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome

The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg in the percentage reduction of LDL-C in Subjects with metabolic syndrome after 6 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Metabolic syndrome patient; Presence of 3 or more of the following:

  * Abdominal obesity (waist circumference): men \> 90cm(36 inch), women \> 80cm(32 inch)
  * Triglycerides ≥ 150 mg/dL (1.70 mmol/L)
  * HDL-C: men \< 40 mg/dL (1.04 mmol/L), women \< 50 mg/dL (1.3 mmol/L)
  * BP ≥130/≥85 mmHg or subject receiving anti-hypertensive treatment
  * Fasting blood glucose 110 mg dL (6.11 mmol/L) - 125 mg/dL (6.94 mmol.L)
* Elevated LDL-C concentrations reported within 4 weeks of visit 1 as follows;

  * ≥ 130 mg/dL (3.36 mmol/L) to \< 220 mg/dL (5.69 mmol/L) in statin naive subjects (subjects who have not taken any lipid-lowering therapy known to affect LDL-C in the 4 weeks prior to visit 1)
  * ≥ 100 mg/dL (2.59 mmol/L) to \< 160 mg/dL (4.14 mmol/L) in subjects who have taken a lipid lowering drug(s) within 4 weeks of visit 1
* Triglyceride levels \< 400 mg/dL (4.52 mmol/L)
* Women of childbearing potential should be using a medically acceptable form of chemical or mechanical contraception.

Exclusion Criteria:

* History of known diabetes mellitus
* Use of anti-hyperglycaemic medication.
* History of serious or hypersensitivity reactions to HMG-CoA reductase inhibitors, in particular history of myopathy.
* No CHD or CHD Risk Equivalents and 0-1 Risk factors and Framingham 10-Year risk is \<10%.
* History of heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia).
* Active arterial disease such as unstable angina pectoris, myocardial infarction, transient ischaemic attack (TIA), cerebrovascular accident (CVA), coronary artery bypass surgery (CABG) or angioplasty within 2 months prior to entry in the dietary lead in period
* Uncontrolled hypothyroidism defined as thyroid stimulating hormone (TSH) \> 1.5 times the upper limit of normal (ULN) at Visit 2 or subjects whose thyroid replacement therapy was initiated within 3 months of entry into dietary lead-in phase.
* Current active liver disease (alanine aminotransferase \[ALT\] \> 2 x ULN) or severe hepatic impairment.
* Unexplained serum CK \>3 times ULN (e.g. not due to recent trauma, intramuscular injections, heavy exercise, etc).
* Serum creatinine \> 176 umol/L (2.0 mg/dL)
* History of alcohol, or drug, abuse or both.