cyrilzakka/clinical-trials huggingface dataset:
Identification of Genetic Polymorphism Related to Acute Kidney Injury After Liver Transplantation Through Genome-wide Association Study (GWAS) in Korean Population

Some of the liver transplantation recipients experience postoperative acute kidney injury due to various causes including genetic factors. Prevention of postoperative acute kidney injury is essential for postoperative care in liver transplantation recipients. The aim of this study is to investigate the relationship between gene polymorphisms and the occurrence of acute kidney injury after liver transplantation by performing genome-wide association study (GWAS).


Eligibility Criteria:
Inclusion Criteria:

1) adult patients scheduled for liver transplantation

Exclusion Criteria:

1. Patients on dialysis
2. patients not able to read, or understand the consent form
3. ethnicity, other than asian
4. patients refusal
A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects

This double-blind, randomized, placebo-controlled, 2-Part study will evaluate the pharmacokinetics and safety of RO4917523 in healthy Japanese and Caucasian volunteers. In Part 1, healthy Japanese volunteers will be randomized to receive 2 oral doses of either RO4917523 or placebo, with a washout period of 21 days between dosing. In Part 2, healthy Japanese and Caucasian volunteers will be randomized in cohorts to receive either RO4917523 or placebo orally daily for 14 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese (Part 1 + 2) or Caucasian (Part 2) adults, 18- 50 years of age
* Japanese subjects must have Japanese parents and grandparents who were born in Japan
* Caucasian subjects must have 4 Caucasian grandparents
* Body mass index (BMI) 18.5 to 26 kg/m2, and a body weight of at least 45 kg
* Non-smoker for at least 90 days prior to dosing Day 1

Exclusion Criteria:

* Participation in a clinical trial with an investigational drug within 90 days prior to dosing Day 1. (Volunteers having participated in Part 1 will not be allowed to participate in Part 2 and vice versa)
* History or evidence of any clinically significant disease or disorder
* Pregnant or lactating women
* Positive for hepatitis B, hepatitis C or HIV
* Positive drug screen test, positive cotinine test and/or positive alcohol test
* Any confirmed significant allergic reactions to any drug, or multiple allergies in the judgement of the investigator
To Access the Safety and Effects of Intravenous Administration of AMX-818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

This first-in-human (FIH) Phase 1 open-label multicenter dose-escalation and dose-expansion study is designed to evaluate the safety, pharmacokinetics, and preliminary activity of AMX-818 as a single agent and in combination with pembrolizumab in participants with HER2+ tumors across multiple tumor types. The study will be conducted in four parts:

* Part 1 (dose escalation): Single-agent AMX-818
* Part 2 (dose escalation): AMX-818 plus pembrolizumab
* Part 3 (dose expansion): Single-agent AMX-818
* Part 4 (dose expansion): AMX-818 plus pembrolizumab

The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 52 months.


Eligibility Criteria:
Inclusion criteria:

* Written informed consent by the participant (or legally acceptable representative if applicable)
* Life expectancy of at least 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Diseases under study, prior lines of therapy, and human epidermal growth factor receptor 2 (HER2) status, per local tests

Exclusion criteria:

* Significant cardiopulmonary disease and recent cardiac events
* History of major organ autoimmune diseases
* Acute or chronic infections

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Prospective Study of HIV Infection in Hemophiliacs

To examine mechanisms of individual differences in the progression of HIV infection in hemophiliacs.

BACKGROUND:

In the late 1980s, hemophiliacs were transfused with a variety of blood products, including large amounts of cryoprecipitate. In comparison to other cohorts, hemophiliacs are CMV(-), resulting in a comparison group for the study of this virus as a potential cofactor. In contrast, non A, non-B hepatitis is common in comparison to other cohorts, and preliminary data prior to 1990 suggested that this chronic disease predisposes to more rapid progression of HIV infection.

DESIGN NARRATIVE:

Disease-free survival rates were determined in HIV-infected hemophiliacs. The effects of co-factors such as intensive transfusion, concomitant cytomegalovirus or chronic NANB hepatitis infection were ascertained. Host-virus interaction was assessed through the use of plasma cultures, specific antibody titers, and markers of immune changes detected by flow cytometry and immune function assays. The immunology of asymptomatic stable infection was investigated. The safety of volunteer donor blood products was determined in seronegative patients exposed to over 50,000 donors yearly and the risk of sexual transmission of HIV to spouses of seropositive patients was monitored.

Eligibility Criteria:
No eligibility criteria
Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips.

To investigate the efficacy and safety of OA1 Extract capsules in the treatment of patients with knee or hip osteoarthritis (OA).

This trial was a 12 weeks' randomized, double-blind, placebo-controlled study. The study was approved by the Institutional Review Board of Chung Shan Medical University hospital, and signed informed consent was obtained from each patient. Sixty patients of osteoarthritis of knees or hips were enrolled in this study. Inclusion criteria were: age 20 to 80 years; primary osteoarthritis in at least 1 knee or hip, verified; at least moderate pain during 2 weeks before random assignment to treatment, as identified by the Western Ontario and McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale for more than 4.

Primary outcome measures were WOMAC at week 12.

Secondary outcome measures were WOMAC at week 4 and 8; Visual analogue scale (VAS) , Quality of life by SF-36, patient global assessment (PGA), at week 4, 8 and 12; serum levels of osteocalcin, C-terminal telopeptide(CTX), Hs-CRP, and ESR.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥20 years old 2. Written informed consent obtained 3. Been diagnosed with knee or hip osteoarthritis 4. The physician interpretation of X-ray identification and joint space narrowing or bone spurs confirmed 5. In randomized trials before entering if used steroids or non-steroid medications osteoarthritis stable doses required at least one week 6. The WOMAC osteoarthritis index of the degree of pain assessment in the past two weeks at least\> 4ppm pain

Exclusion Criteria:

* 1. Pregnant or breast-feeding women. 2. Chemotherapy or radiation therapy in cancer patients
Crystalloids Versus Colloids During Surgery

The purpose of the study is to test whether colloid-based goal-directed intraoperative fluid management leads to less perioperative morbidity compared to crystalloid-based goal-directed intraoperative fluid management. Goal-directed therapy is based on measurements by an Esophageal Doppler Device.

For a long time there is a raging debate whether crystalloid solutions or colloid solutions are better suited for fluid therapy. Early proponents both for crystalloids \[Shires 1961\] and colloids \[Shoemaker 1979\] deserve credit for elucidating important facts about volume replacement therapy - without answering the primary question. Elaborate reviews comparing crystalloid and colloid therapy for critically ill patients have been performed in the late nineties and updated recently \[Roberts 2004\]. However, it has been suggested that both questions and answers of reviews leave us none but wiser \[Webb 1999\]. Although a plethora of studies comparing crystalloid vs. colloid therapy in the last decades have been published, volume replacement therapy is still considered to be based on dogma and personal beliefs \[Boldt 2003\].

Goal-directed intraoperative fluid therapy monitored by Esophageal Doppler identifies volume-responders, thereby decreasing length of stay in hospital in orthopedic \[Sinclair 1997\], cardiac \[Mythen 1995\], and abdominal surgery patients \[Gan 2002, Wakeling 2005, Noblett 2006\]. However, all these studies have been performed with a colloid to be the substance applied. Thus, it has been questioned whether monitoring with the Esophageal Doppler monitor, or the application of additional colloid improved outcome \[Horowitz, Kumar 2003\].

Consequently, the researchers will use Esophageal Doppler Monitoring for intraoperative goal-directed fluid therapy to compare the effects of crystalloid vs. colloid therapy on various organ systems, assessing combined perioperative morbidity \[Bennett-Guerrero 1999\] .

Eligibility Criteria:
Inclusion Criteria:

* After written informed consent patients undergoing elective open colon surgery, or open hysterectomy or myomectomy, or spine surgery or hip replacement will be included in the study.

Exclusion Criteria:

* Patients having severe cardiac or renal insufficiency
* Patients with severe coronary artery disease
* Patients with insulin-dependent diabetes mellitus
* Patients with severe COPD
* Patients with symptoms of infections or sepsis
* Patients with allergy to hydroxyethylstarch.
Screening Volunteers for Clinical Trials

Background:

- The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health needs healthy volunteers for vaccine clinical trials. This is a screening study that is used to identify healthy volunteers who may be eligible to participate in other clinical trials at the Vaccine Research Center that evaluate investigational vaccines, monoclonal antibodies, and injection devices. The VRC conducts studies that will allow researchers to better understand the immune system and how vaccines and monoclonal antibodies work.

Objectives:

- To screen healthy volunteers for clinical trials at the NIAID VRC.

Eligibility:

- Healthy people between 18 and 60 years of age. They must be available to take part in clinical trials and be able to provide blood for research studies.

Design:

* Screening for healthy volunteers to participate in clinical trials is an ongoing process.
* Volunteers will be asked about their medical history, including sexual activity and drug use, and a detailed physical exam will be performed.
* Blood and urine samples may be collected, and possibly other tests as needed to evaluate the volunteer's health status.
* Volunteers will not receive any investigational product in this screening protocol....

The purpose of this study is to recruit and screen potential study subjects, mostly healthy volunteers, to determine if they are eligible for clinical trials of investigational products. This screening study also aims to characterize and analyze demographic information as well as laboratory and other medical findings in terms of how they may affect the eligibility of subjects for specific early phase clinical trials. All work will be conducted by the VRC Clinic of the National Institutes of Health or other IRB-approved sites that are collaborating with NIAID/VRC. Educational and recruitment materials on the investigational products and protocols will be

reviewed with and provided to subjects during participation in the screening protocol.

Eligibility Criteria:
* INCLUSION CRITERIA:

Age: 18 years of age or older

Able and willing to complete the informed consent process

Agree to have blood and/or tissue samples collected and stored for future studies of investigational products, the immune system, and/or other medical conditions

EXCLUSION CRITERIA:

A condition in which repeated blood draws or injections pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access

A condition that requires active medical intervention or monitoring to avert serious danger to the participant s health or well-being

Known to be pregnant or breast-feeding
A Study of [68Ga]Ga-NOTA-RG2 PET Imaging in the Diagnosis of Hepatocellular Carcinoma

The aim of this study was to establish and optimize the imaging method of \[68Ga\]Ga-NOTA-RG2, as well as its physiological and pathological distribution characteristics, and on this basis to evaluate the diagnostic efficacy of the above imaging agents in patients with hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Hepatocellular carcinoma patients

  1. Age between 18 and 65 years old, gender is not limited.
  2. Patients with suspicious intrahepatic spaces detected by MR and considered to be hepatocellular carcinoma with AFP\>200 ug/L who have not undergone surgery.
  3. Patients with hepatocellular carcinoma confirmed by puncture pathology
  4. Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
  5. Willingness and ability to cooperate with all programs of the study.

Exclusion Criteria:

* Subjects meeting any of the following criteria will be excluded from the study:

  1. Patients receiving anti-tumor therapy prior to the PET/CT scan.
  2. Suffering from severe other neurological disorders, or gastrointestinal, cardiovascular, hepatic, renal, hematologic, respiratory, immunodeficiency, and other serious diseases.
  3. Alternative subjects with conditions that contraindicate PET/CT scanning. This includes, but is not limited to, elevated blood glucose that is not effectively controlled; pregnant, lactating, or breastfeeding women; those who are unable to receive repeated intravenous injections; those who may be hypersensitive to the drug and its components (including a history of severe allergies or anaphylactic reactions, especially to the drug being examined); and hermetic phobias.
  4. Within the past year, have participated in other research protocols or clinical care, in addition to the radiation exposure expected from participation in this clinical study, which has resulted in radiation exposure in excess of an effective dose of 50 mSv.
  5. Alternative subjects have undergone major surgery within the last 3 months; experimental drug or device therapy (of uncertain efficacy or safety) within 1 month
  6. The alternate subject has any clinical condition that, in the opinion of the Sponsor of this study, may cause or has the potential to cause harm from this agent.
Dietary Intervention for Low Free Sugars in Children With Non-alcoholic Fatty Liver Disease

A 48-week dietary intervention program was conducted in children aged 5-14 years with a diagnosis of NAFLD, who were randomized into a low free sugar diet group and a regular diet group. The primary objective of this study is to determine whether a low free sugar dietary intervention program improves liver function, fasting glucose, fasting insulin, lipid profile and hepatic steatosis in children with NAFLD. The effects of the intervention will be analyzed and compared at weeks 12, 24 and 48.


Eligibility Criteria:
Inclusion Criteria:

* Age: above 5 years old and below 14 years old;
* Guardian's consent and signing of informed consent;
* WHO growth and development curves as the reference standard, overweight is defined as BMI greater than or equal to the 85th percentile of the WHO growth curves for children, and obesity is defined as BMI greater than or equal to the 95th percentile of the WHO growth curves for children;
* Liver imaging performance meets the diagnostic criteria of diffuse fatty liver.

Exclusion Criteria:

* Age \<5 years or \>14 years;
* Previous history of alcohol consumption;
* Non-cooperation with the study, inability to comply with the study treatment or study visit.
* Past or active hepatitis B virus infection;
* Past or active hepatitis C virus infection;
* Chronic or acute liver failure;
* Cholestasis;
* Hepatomegaly;
* Cystic fibrosis;
* α1-antitrypsin deficiency;
* Autoimmune hepatitis;
* Tyrosinemia;
* Galactosemia or any recognized liver disease, any physical condition deemed by a physician to be unable to complete the trial. Physical Condition.
Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Pantoprazole 80 mg in Healthy Subjects

Primary objective:

* Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with pantoprazole 80 mg/day compared to given alone in healthy male subjects
* Compare the pharmacokinetic profiles of clopidogrel active metabolite when clopidogrel is given either alone or concomitantly with pantoprazole

Secondary Objective:

* Compare the pharmacokinetic profiles of clopidogrel when clopidogrel is given either alone or concomitantly with pantoprazole

The total study duration per subjects is 8 - 9 weeks broken down as follows:

* Screening: 2 to 21 days before the first dosing
* Period clopidogrel/placebo: 7 days including 5 days treatment
* Period clopidogrel/placebo + pantoprazole: 14 days including 12 days treatment
* Washout between periods: at least 14 days after last dosing with respect to clopidogrel treatment
* End of study: 7 to 10 days after the last dosing

Eligibility Criteria:
Inclusion Criteria:

Healthy male subject:

* as determined by medical history, physical examination including vital signs and clinical laboratory tests:
* with a body weight between 50 kg and 95 kg and with a Body Mass Index (BMI) between 18 and 30 kg/m²

Exclusion Criteria:

* Evidence of inherited disorder of coagulation/hemostasis functions
* Smoking more than 5 cigarettes or equivalent per day
* Abnormal hemostasis screen
* Unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration
* Any contraindication to clopidogrel and/or pantoprazole

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability

The purpose of this study is to investigate the feasibility, effectiveness, and duration of treatment response of periosteal electro-acupuncture (osteopuncture) for osteoarthritis (OA)-associated chronic knee pain.

Knee osteoarthritis (OA) is painful in 6.8% of men and 11.4% of women age 63-93, with over 20 million Americans affected nationwide, and may lead to a variety of untoward consequences including limitations in physical function, postural instability, sleep disturbance, psychosocial disability, and substantial utilization of health care resources. While oral analgesics represent the mainstay of treatment for chronic pain associated with knee OA, non-responders with limiting comorbidities may have few therapeutic alternatives.

The aims of this research study are to (1) reduce pain severity and disability in community-dwelling older adults with OA-associated chronic knee pain using periosteal electroacupuncture (osteopuncture), and (2) improve the physical performance, psychosocial function, sleep, and appetite of these individuals. 88 older adults with persistent knee pain and x-ray evidence of OA, no other rheumatologic disorders, no history of knee surgery, and no prominent pain in sites other than the knee(s) will be randomized to receive either osteopuncture or control osteopuncture once a week for 6 weeks. All outcome measures for pain and disability, as well as physical performance, psychosocial function, sleep, and appetite, will be collected pre-treatment, at the completion of the 6-week protocol, and 3 months later.

Eligibility Criteria:
Inclusion Criteria:

* Radiographic evidence of knee OA on a standing AP X-ray
* Bilateral knee pain for at least 3 months with pain of at least moderate intensity every day or almost every day

Exclusion Criteria:

* Non-ambulatory, or severely impaired mobility (i.e., require the use of a walker)
* Folstein Mini-Mental State Examination score of less than 24
* Severe visual or hearing impairment
* Knee pain due to factors other than OA, e.g. rheumatoid or psoriatic arthritis, gout, pseudogout, metastatic cancer
* Significant pain in parts of the body other than the knee or acute knee pain
* A large knee effusion or severe mechanical instability of the knee
* History of corticosteroid injection in the affected knee(s) during the preceding 3 months
* History of hyaluronic acid injection in the affected knee(s) during the preceding 3 months
* Acute or terminal illness
* Immune suppression
* Anticoagulation therapy
* Presence of a pacemaker
* Prior acupuncture treatment
BSEP Function Rescue During Childhood Inhereditary Cholestatic Diseases

The purpose of the study is to improve the prognosis of inhereditary cholestasis caused by ABCB11 gene mutations by using BSEP function rescue drugs

Bile acids function as detergents to aid digestion and as signaling molecules to regulate gene expression and metabolism. They are synthesized from cholesterol in the liver, secreted into bile and re -turned from chyme to liver in portal- vein blood 6-10 times per day (enterohepatic circulation. Enterohepatic circulation of bile acids involves more than 20 transporters among which bile salt export pump (BSEP), encoded by ABCB11 plays a key role. BSEP medi-ates the secretion of bile acids across the canalicular membrane of hepatocytes into bile to provide the osmotic pressure for bile flow. Mutations in ABCB11 can cause absence or dysfunction of BSEP leading to cholestasis. Bile acid accumulation in hepatocytes caused by BSEP dysfunction is associated with a range of liver dis-eases, ranging from transient neonatal cholestasis to fatal progressive familial intrahepatic cholestasis (PFIC), with jaundice, growth retardation, cirrhosis, liver failure and death. Our current indicates that more than 70% patents with ABCB11 mutations need liver-transplantation or dead during follow-up. In recent years, some targeted drugs including 4-phenylbutyrate(for patients with BSEP trafficking abnormal), ivacaftor(for patients with abnormal BSEP transport function), and gentamicin (for patients with none sense mutations) have emerged make it possible for individual targeted therapy possible.

Eligibility Criteria:
Inclusion Criteria:

* with signed informed consent form from the guardian, and the patient if applicable.
* aged from 2 month to 18 years old.
* with cholestatic disease caused by ABCB11 biallelic mutation.
* Long-term residence in China.

Exclusion Criteria:

* Currently receiving or previously received experimental drugs.
* The child is already in the stage of liver failure, or in unstable state that are not suitable for drug treatment according to the researcher's judgment: serious complications such as bleeding tendency and skin rash.
* accompany with other chronic liver disease (viral hepatitis B and C, autoimmune hepatitis, wilson disease, cystic fibrosis, primary biliary cirrhosis, biliary atresia, sclerosing cholangitis, bile acid synthesis defects, and infections, cholestasis caused by space-occupying and other reasons).
* Suffered from congenital TORCHES infection, including toxoplasma gondii, rubella virus, cytomegalovirus, herpes simplex virus, EB virus, syphilis, HIV, etc.
* With any other major medical conditions that may affect drug absorption, metabolism, or excretion based on the researcher's judgment.
* Known or suspected hypersensitivity to any experimental drugs or their indigents.
* Patients with alcohol or drug dependence.
* In receiving any investigational drugs or within 60 days before enrollment.