cyrilzakka/clinical-trials huggingface dataset:
A Study of IMC-A12 in Combination With Sorafenib in Participants With Advanced Cancer of the Liver

To determine if IMC-A12 given in combination with Sorafenib is safe and effective for participants with advanced liver cancer.

The purpose of this study is to determine progression-free survival (PFS) in participants with unresectable hepatocellular carcinoma who have received no prior systemic therapy when treated with IMC-A12 administered every three weeks in combination with oral sorafenib administered twice daily.

Eligibility Criteria:
Inclusion Criteria:

* The participant has histologically or cytologically confirmed, unresectable HCC
* The participant has at least one target lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesion(s) must not lay within a previously irradiated, ablated, or chemoembolized area. If a lesion does lie in such an area, there must be evidence of growth on successive imaging studies, including tumor hypervascularity, in order for such a lesion to be considered a target lesion
* The participant has not received prior systemic therapy for HCC. Participants may have received prior embolization, chemoembolization, intra-arterial chemotherapy infusion, ethanol injection, radiofrequency ablation, or cryosurgery
* The participant has fasting serum glucose \<160 milligrams/deciliter (mg/dL) or below the upper limit of normal (ULN) and/or hemoglobin A1C \<7%. If baseline nonfasting glucose \<160 mg/dL, fasting glucose measurement is not required
* The participant has the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* The participant has brain metastases
* The participant has acute hepatitis
* The participant has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range and that they are on a stable dietary or therapeutic regimen for this condition
* The participant has congestive heart failure \> class II New York Heart Association (NYHA), unstable angina pectoris, new onset of angina pectoris, myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy
* The participant has experienced a hemorrhage or bleeding event ≥ National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 3 within 4 weeks prior first dose of study therapy
Metformin in Postmenopausal Women With Metabolic Syndrome

The purpose of this study is to determine the effects of metformin on cardiovascular risk factors in postmenopausal women with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women aged 45-60 years with metabolic syndrome according to The American Heart Association and The National Heart, Lung, and Blood Institute

Exclusion Criteria:

* Previous cardiovascular diseases
* Contraindicated to metformin: serum creatinine \>1.4 mg/dL, liver disease, alcoholism, congestive heart failure, chronic hypoxic lung disease, prior history of lactic acidosis
* Previous administration of metformin, other hypoglycemic drugs, lipid-lowering drugs, sex steroids, antiplatelet drugs within 3 months before enrollment
* Fasting blood sugar ≥ 200 mg/dL or HbA1c \>8%
* Serum triglyceride ≥500 mg/dL
* Abnormal EKG
A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)

This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. Vonapanitase is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether vonapanitase when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.


Eligibility Criteria:
Inclusion Criteria:

1. Age of at least 18 years.
2. Life expectancy of at least 6 months.
3. Diagnosis of CKD.
4. Planned creation of a new radiocephalic AVF (revision of an existing AVF is not eligible).
5. Ability to understand and comply with the requirements of the entire study and to communicate with the study team.
6. Written informed consent using a document that has been approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
7. If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit and be willing to use contraception from the time of the screening visit to 2 weeks following study drug administration. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra-uterine device.

Exclusion Criteria:

1. Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell or squamous cell skin cancer, or any cancer in situ.
2. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
3. Previous treatment with vonapanitase (PRT-201).
4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent.
V-Sensors for Vitals: Assessment of the Accuracy of a Vital Sign Sensor Mounted on a Smartphone

This trial seeks to demonstrate clinical accuracy and safety of the integrated V-Sensor when used by the general, healthy adult population interested in measuring their vital signs outside of the clinical setting.

The five vital signs are blood pressure, pulse, respiration, SpO2, and temperature. The user tests two devices mounted on two smartphones.

* Temperature: Each user will use the V-sensor mounted on a smartphone to obtain his/her temperature interfaced with a temperature specific 'app'. Before and after the the temperature is obtained using the V-Sensor, the temperature will be obtained using an equivalent thermometer.
* Blood Pressure: Each user will test his/her blood pressure using the two sensors mounted on the two phones interfaced with a blood pressure specific 'app'. Before and after each measurement, a reference measurement using a mercury sphygmomanometer will be taken.
* Pulse, Respiration, SpO2: Each user will test his/her pulse, respiration, and SpO2 using 2 V-sensors mounted on two separate smartphones interfaced with a Pulse, Respiration, and SpO2 'app'. Before and after each measurement, a reference measurement using equivalent reference devices will be taken.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* 18 and 80 years old
* no history or risk for developing lymphedema
* no arteriovenous fistula in the right arm
* no right limb amputation up to and including the right index finger
* ability to obtain 3 readings from the device during the screening/training session.

Exclusion Criteria:

* history of arrhythmia
* arteriovenous fistula in the right arm
* lymphedema or high risk for developing lymphedema in the right arm
* inability to follow the procedures of the study
* inability to hold the study device as instructed
* inability to obtain 3 readings from the study device during the screening session
* previous enrolment into the current study
* enrolment of the Investigator or Sponsor, his/her family members, employees and other dependent persons.
Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes

This is a randomized, double-blind, active-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

1. Evogliptin 5mg Group: Administration with Evogliptin 5mg add-on to metformin for 0-52 weeks.
2. Sitagliptin 100mg Group: Administration with Sitagliptin 100mg add-on to metformin for 0-24 weeks, and with Evogliptin 5mg add-on to metformin for 24-52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with 6.5%≤HbA1c≤11.0% at screening
* Subjects treated with 1,000mg/day or higher dose of metformin for at least 6 weeks prior to screening among people treated with metformin monotherapy for at least 12 weeks before screening
* Subjects with 20kg/m2≤BMI≤40kg/m2 at screening

Exclusion Criteria:

* Subjects with fasting plasma glucose≥270mg/dL at screening
* Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
* Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening
* Subjects with ALT and AST 2.5 times or higher than upper normal range
Fast Track Surgery for Abdominal Surgery in Rwanda

Fast Track Surgery (FTS) was started in colorectal surgery, but was later applied to other surgical fields. Core elements include epidural or regional anaesthesia, perioperative fluid management, minimally invasive surgical techniques, pain control, and early mobilization and feeding. Beneficial effects of FTS include reduced costs, early hospital discharge, and increased availability of hospital beds.The main aim of this study was to explore the efficacy of FTS in the Rwandan surgical setting and to demonstrate the benefits of FTS.

it is study comparing the management of surgical patients using traditional management and fast track surgery. the study was done on patients undergoing elective abdominal surgery only

Fast track surgery (FTS) uses a multifaceted approach to reduce the stress response to surgery, thereby improving outcomes and decreasing length of hospital stay. The core elements of FTS include: epidural or regional anesthesia, peri-operative fluid management, minimally invasive techniques, optimal pain control, early initiation of oral feeding and early mobilization. The combination of these approaches has led to a significant reduction in complication rates, morbidity and mortality rates, duration of hospital stay and costs of hospitalization, and greatly improved postoperative recovery The main aim of this study was to explore the efficacy of FTS in the Rwandan surgical setting and to demonstrate the benefits of FTS.

This randomized control trial was conducted in CHUK over a period of three months (October - December, 2015). For patients in the FTS arm, the study investigator would assess patients on a daily basis and work with the primary surgical team. The study investigator would prompt the primary surgical team for early feeding, mobilization, pain control and fluid management recommendations.

Data were collected on variables including postoperative analgesia, mobilisation, resuming oral feeding, hospital stay and complications. The primary outcome was duration of postoperative hospital stay and secondary outcome was major complications.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted for elective abdominal surgery

Exclusion Criteria:

* patients with comorbidity, American Society of Anesthesiologists score greater than 2
Safety and Immunogenicity of a Paediatric Dose of Virosomal Hepatitis A Vaccine

The primary purpose of the original study was to assess whether the protection afforded by the paediatric dose of Epaxal vaccine against hepatitis A was not inferior to the protection afforded by the standard dose of Epaxal. The aim of the follow-up phase was to perform a computer based modelling analysis of the long term protection afforded by the paediatric dose, and to compare this with the standard dose and also with an alternative hepatitis A vaccine (Havrix Junior).


Eligibility Criteria:
Inclusion Criteria:

Original study:

* Males or females aged \>=12 months and 16 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject when applicable and from the parent/legal guardian of the subject. - Free of obvious health problems as established by medical history and/or clinical examination before entering the study.

Follow up phase:

* Subjects enrolled and randomized in the primary study and having received two doses of the study vaccine

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this means prednisone, or equivalent, \>=0.5 mg/kg/day. Inhaled and topical steroids were allowed.)
* Planned administration/administration of a vaccine not foreseen by the study protocol within 4 weeks prior to the first dose of study vaccine
* Previous vaccination against hepatitis A
* Seropositive for anti-HAV antibodies (\>=10 mIU/mL)
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness
* Acute disease at the time of enrolment
Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia

To determine the effects of Lidocaine patch on the pain and hyperalgesia induced by intradermal capsaicin

A randomized, double-blinded, placebo controlled methodology will be conducted. At the session subjects will be exposed to placebo patch and lidocaine patch. Prior to study drug administration, a baseline neurosensory test on the volar aspect of both forearms will be performed and baseline vital signs will be measured. A placebo patch and a lidocaine patch will then be applied to the volar aspect of each forearm. The arms will be randomized to which arm receives placebo and which one receives the lidocaine patch. After four hours of application the right forearm patch will be removed the neurosensory testing will be repeated on the right forearm. After completing the testing, capsaicin (10µl, 10 mg/ml) will be injected intradermally on the volar aspect of the right forearm. Elicited and spontaneous pain scores, blood pressure, heart rate, and respiratory rate will be measured at the time of injection and every 2.5 minutes for 10 minutes. A McGill Pain Questionnaire will be administered at the time of capsaicin injection only. Ten minutes after the capsaicin injection, the hyperalgesic area will be established to von Frey hair, stroking, and heat; the flare response will be outlined; and neurosensory testing will performed halfway between the edge of this defined area and the capsaicin injection site. At the completion of the testing on the right forearm, the left forearm patch will be removed and the procedures described for the right forearm will be repeated for the left forearm.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above

Exclusion Criteria:

* Pregnancy.
* Allergy to lidocaine
* Current painful condition
* Current use of analgesics for the treatment of pain
* Lack of ability to understand the experimental protocol and to adequately communicate in English. The neurosensory testing we plan to perform requires the complete cooperation and understanding of the subject. It would be impossible to perform these studies on patients who do not adequately communicate in English.
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-64232025 in Healthy Participants

The purpose of this study is to assess the safety and tolerability of JNJ-64232025 following single ascending intravenous (IV) study intervention administrations and a single subcutaneous (SC) intervention administration in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non-childbearing potential (postmenopausal or permanently sterile)
* Have a body mass index (BMI) between 19 and 30 kilogram per meter square (kg/m\^2) (BMI = weight/height\^2), and a body weight of 50 to 100 kilogram (kg), inclusive
* Healthy on the basis of medical history, a physical examination, vital signs, and 12 lead electrocardiogram (ECG) performed at screening
* Healthy on the basis of clinical laboratory tests performed at screening and Day -1
* A woman must have a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test on Day -1

Exclusion Criteria:

* Has history of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
* Has a disease or disease treatment associated with immune suppression or lymphopenia, these include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenism, and chronic granulomatous disease
* Has a personal history of or conditions associated with thromboembolic events or bleeding disorders, including (but not limited to) myocardial infarction (MI), cerebral vascular accident (CVA)/stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), hemophilia, or menometrorrhagia
* Has history of allergy or adverse reactions to shellfish, aluminum, aluminum hydroxide keyhole limpet hemocyanin (KLH), tetanus or tetanus toxoid or its excipients
* Has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or to any components of the formulation of JNJ-64232025 and its excipients used in this study
Melatonin for Neuroprotection Following Perinatal Asphyxia

The aim of this study is to examine the effect of combining melatonin to whole body cooling on the brain injury and outcome of neonates following perinatal asphyxia.

This is a prospective study on 30 neonates with moderate to moderately to severe hypoxic ischemic encephalopathy (HIE) . HIE infants are randomized into two groups: Whole body cooling group (N = 15; receive 72 hours of whole body hypothermia) and melatonin/ hypothermia group (N = 15; receive hypothermia and 5 daily enteral doses of melatonin 10 mg/kg). Serum melatonin, plasma superoxide dismutase (SOD),and serum nitric oxide (NO) are measured at enrollment and after 2 weeks for the two HIE groups. The HIE groups underwent electroencephalography at enrollment and at 2 to 3 weeks. Brain MRI was performed after 2 weeks of life. Neurologic evaluations and Denver Developmental Screening Test II assessments were performed at 6 months. A group of healthy newborns will be used as a control for baseline labs.

Eligibility Criteria:
Inclusion Criteria:

* Inborn infants at term gestation (38-42 weeks)
* Apgar scores ≤ 3 at 5 minutes and/or delayed first breath (\>5 minutes after birth)
* Profound metabolic or mixed acidosis with serum bicarbonate levels of \<12 mmol/L in initial blood gas analyses
* Evidence of moderate or moderate to severe encephalopathy, such as lethargy, seizures, abnormal reflexes, or hypotonia, in the immediate neonatal period

Exclusion Criteria:

* Twin gestation
* Maternal neuro-endocrinal disturbances including diabetes mellitus
* Chorioamnionitis or congenital infections
* Low birth weight less than 2.5 kg
* Congenital malformations of the central nervous system or gastrointestinal anomalies
* Chromosomal abnormalities
* After 6 hours of birth.
* Patients in extremis such as: (1) hypoxemia requiring supplemental oxygen 100% FiO2, (2) life threatening coagulopathy, or (3) deep coma.
Targeted Metabolomics and Spent Embryo Culture Medium

More than 8 million babies have been born through in vitro fertilization (IVF). Non-invasive observation of embryos in vitro to better understand their development is becoming increasingly important. Morphology has been used as standard from the beginning, but has the disadvantage of subjectivity. Now the emphasis in basic and clinical research is on developing rapid, quantitative, non-invasive tests. Hence comes the idea of metabolic profiling of spent embryo culture medium (SECM) as a biomarker. This could be useful for understanding and improving the nutritional environment of oocytes and embryos. The goal of our study is to determine metabolic profiles of the SECM in combination with morphological assessments to better understand the nutritional requirements of the embryo. The goal would be to optimize media specifically, depending on patient and embryo characteristics ("personalized medicine") ("the embryo in vitro as patient").

Following successful fertilization (day 1), each embryo will be cultured for 5-6 days (day 5-6) to form the blastocyst. Then, morphological evaluation will be performed by an expert embryologist to confirm poor and good embryo quality. At the end of the culture, 50 µl of SECM will be collected from each embryo and stored for metabolomics analysis. Samples including medium only and no embryos will be used as controls. The metabolome will be characterized in SECM samples using the respective assay targeted kit.

Eligibility Criteria:
Inclusion Criteria:

- Available spent embryo culture medium (SECM) samples with Informed consent

Exclusion Criteria:

* Diabetes