cyrilzakka/clinical-trials huggingface dataset:
Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma

Chemoembolization (TACE) is used in the majority of advanced hepatocellular carcinomas. Randomized clinical trials indicated that TACE improves overall survival in patients with good liver function (Child-pugh A or B). However, the shortcoming of TACE is obvious: hypoxia induced neoangiogenesis after blockage of blood supply of the tumor; repeat TACE deteriorates liver cirrhosis due to toxicity of chemotherapeutic agent to the parenchyma liver. Thalidomide has been reported to have antiangiogenic and antimetastatic effects. The objectives of adjuvant therapy with thalidomide for chemoembolization is to evaluate overall survival and time to progression.


Eligibility Criteria:
Inclusion Criteria:

* Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
* Age ≥ 18 years and ≤ 80 years
* At least one tumor nodule with one uni-dimension of ≥ 2 cm
* Child-Pugh Class A or B
* Total bilirubin ≤ 1.5 x upper limit of normal
* ALT and AST ≤ 2.0 x the upper limit of normal
* PT-INR\<2.3,PTT \< 1.5 x upper limit of normal
* Serum creatinine ≤ 1.5x upper limit of normal
* Peripheral white blood cell count of or more than 3×10(9)/L
* Peripheral platelet of or more than 50×10(9)/L
* Expected survival time not less than 3 months
* ECOG score 0-2

Exclusion Criteria:

* Tumor thrombi in main branch of portal vein
* Tumor involvement more than 70% of whole liver
* With extrahepatic metastasis
* Prior systemic chemotherapy or chemoembolization
* Congestive heart failure \> NYHA class 2
* History of HIV infection
* Active clinically serious infections (\> 2 NCI-CTC Version 3.0)
* Recurrence of HCC after liver transplantation
* Pregnant or breast-feeding
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
* Known or suspected allergy to any agent given in association with this trial
* Patients unable to swallow oral medication
* Inclined to thrombosis
* Inclined to hemorrhage or active hemorrhage with 1 month
The Effect of Acyl-Ghrelin on Kidney Function and Blood Pressure in Healthy Volunteers

Ghrelin (growth hormone release inducer) is produced in the stomach. The active form of Ghrelin is Acyl-Ghrelin. Acyl-Ghrelin stimulates the Ghrelin receptors. Ghrelin receptors are detected in the distal tubules in mice and animal studies have shown that Ghrelin increases the absorption of sodium in the renal tubules. Ghrelin infusion directly into the renal artery of rats increased sodium reabsorption in the distal nephron, presumably via the epithelial sodium channels (ENaC).

The purpose of the study is to measure the acyl-ghrelin induced effects on GFR, tubular transport of sodium and water in different nephron segments and central and peripheral blood pressure in a randomized, cross-over, single-blind, placebo-controlled dose-response study.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years,
* BMI 18,5-30kg/m2,
* women must use contraception.

Exclusion Criteria:

* Tobacco smoking,
* substance abuse,
* consumption of more than 7 units of alcohol/week for women and more than 14 units/week for men,
* medical treatment except for contraception,
* pregnancy or nursing,
* allergy to acyl-ghrelin,
* significant clinical signs of heart-, lung-, liver-, kidney-, endocrine-, brain- or neoplastic disorders,
* clinically significant abnormal findings in screening blood samples,
* urine sample or ECG,
* office blood pressure over 140/90 mmHg,
* donation of blood within 1 month of the first day of investigation.
The Additive Effect of Cognitive Behavioral Treatment (CBT) to Conventional Weight Loss Intervention Program for Young Adults With Intellectual Disabilities

In this randomized case control study we will evaluate the additive effect of psychological intervention, i.e CBT-cognitive behavioral treatment in a multi-strategy weight loss program composed of physical activity intervention and nutritional programme.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with over-weight or obese subjects with learning disability who have completed "Nitzan Onim" two-year training program and live in housing within the community
* Subjects who sign an informed consent

Exclusion Criteria:

* Subjects with out over-weight or obese subjects with out learning disability subjects who have no completed "Nitzan Onim" two-year training program and live in housing within the community
Extinction Learning in Youth With Tourette Syndrome

Aversive sensory phenomena such as premonitory urges play a central role in the behavioral treatment model of tics. Extinction learning and extinction recall are learning processes implicated within this model, but have not been directly evaluated in youth with Tourette syndrome (TS). This study examines extinction learning and extinction recall in youth with TS using an experimental task. This study will also explore the relationship between extinction processes (i.e., extinction learning and extinction recall) and treatment outcomes with behavior therapy. Findings from this investigation will be used to update the behavioral treatment model, which serves as the basis for evidence-based behavioral interventions.


Eligibility Criteria:
Youth with TS will be eligible for participation if they meet the following inclusion criteria:

* age 8-17 years (inclusive)
* have moderate tic severity or greater as evidenced by a YGTSS Total Tic Score greater than 13 (\>9 for youth with motor or vocal tics only)
* have not received more than 4 previous sessions of HRT
* be fluent in English.
* Medication free or on a stable dose of psychiatric medication for 8 weeks prior to enrollment.

Exclusion criteria for youth with TS:

* An inability to complete rating scales
* Attend study visits.
A Study of the Safety and Effectiveness of Topiramate on Insulin Sensitivity in Overweight or Obese Patients With Type 2 Diabetes

The purpose of this study is to investigate (1) the effect of topiramate on insulin sensitivity in overweight or obese patients with type 2 diabetes mellitus and (2) the safety of topiramate in type 2 diabetic patients. The study will also investigate the effect of topiramate on body weight, body fat, fat distribution, and metabolic control including both glucose and lipid levels.

Topiramate is not approved for the treatment of obesity. This double-blind, placebo controlled study investigates the effect of topiramate on insulin sensitivity in overweight or obese patients with Type 2 Diabetes. After a screening phase, patients are randomized to receive either topiramate (96 milligrams\[mg\] twice daily) or placebo for 9 months in the double-blind phase. After 9 months, patients have the option to continue in the open-label phase and receive treatment with topiramate for 1 year. Patients in the placebo group then receive topiramate with dosage increasing gradually to 96 mg twice daily, with the option of increasing to 256 mg twice daily. Patients in the topiramate group continue with the maintenance dose received during the double-blind phase, with the option of increasing to 256 mg twice daily. Assessments of effectiveness made monthly include insulin sensitivity, body composition (as measured by computed tomography \[CT\]), body weight and Body Mass Index (BMI), waist and hip circumferences, fasting lipid profile, fasting glucose and hemoglobin type A1c (HbA1c) levels, and blood pressure. Safety evaluations, including incidence of adverse events, clinical laboratory results, vital signs, and electrocardiograms \[ECGs\]), are performed throughout the study. The study hypothesis is that topiramate will improve insulin sensitivity in type 2 diabetic patients and will be well tolerated. Patients will be randomized to receive 192 mg/day (96mg twice daily) of topiramate, or placebo, per mouth for 9 months, with an option of topiramate treatment increasing to 256mg/day both groups during the extension period of 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a history of Type 2 diabetes for 6 months, treated either by diet alone or by sulfonylurea for at least 6 months
* Hemoglobin A1c between 6.5% and 10%
* BMI between 27 and 50
* Non-smokers
* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception

Exclusion Criteria:

* Unstable endocrine disease
* Significantly abnormal liver function or kidney functions
* History of schizophrenia, major depressive disorder or eating disorder
* History of epilepsy, kidney stones or substance (alcohol) abuse
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants

A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants

NOTE: Detailed description has not been entered.

Eligibility Criteria:
Inclusion Criteria:

* Male or female infant born at \>36 weeks of gestation and aged 2 months (42 to 98 days) at the time of consent (the day of birth is considered day of life 1).
* Healthy infant determined by medical history, physical examination, and clinical judgment to be eligible for the study.

Exclusion Criteria:

* Previous vaccination with licensed or investigational pneumococcal vaccine.
* Prior receipt of diphtheria, tetanus, pertussis, or polio vaccines.
* Previous receipt of \>1 dose of hepatitis B vaccine.
* Prior hepatitis B vaccine must have been administered at age \<30 days.
* Major known congenital malformation or serious chronic disorder. Receipt of blood/plasma products or immunoglobulins
Michigan Men's Diabetes Project 2

The Michigan Men's Diabetes Project 2 (MenD 2) is an 18-month pilot randomized clinical trial. We are looking to recruit 60 Black men with type 2 diabetes (need to have diagnosis for at least 6 months) that are over the age of 21. Interested participants need to be under the care of a physician for their diabetes, have access to reliable transportation for study activities, and be willing to participate in 4 health assessments where they will get their A1C, blood pressure, height, and weight measured and they will complete a survey. All participants will receive 10 hours of diabetes self-management education with a Certified Diabetes Care and Education Specialist. Participants randomized to the intervention arm will also be offered 6 months of monthly diabetes self-management support (DSMS) sessions with trained Peer Leaders who are also Black men with type 2 diabetes. After the 6 months of support, this group will transition into 6 months of ongoing support where they can continue DSMS and/or other diabetes related initiatives that are important to the group and chosen by the group. Due to the COVID-19 pandemic, DSME and DSMS sessions will likely be held via Zoom, ongoing support sessions have potential to be in person. The 4 health assessments will take place at baseline, 3-months, 9-months, and 15-months.


Eligibility Criteria:
Inclusion Criteria:

* Black/African American males, age 21 years or older with diagnosis of T2D for six months, transportation to attend program activities, under the care of a physician for diabetes, and willing to attend group delivered sessions.

Exclusion Criteria:

* We considered restricting eligibility to a higher-risk population of participants with A1c ≥ 8%. Preliminary data suggest that over 50% of the proposed study sample will have an A1c ≥ 8%. Focusing on all older Black men with T2D allows us to cast a wide net for secondary prevention and public health impact.
A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Subjects

The purpose of this study is to evaluate the pharmacokinetic similarity of AK104 with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of AK104 with different manufacturing process.


Eligibility Criteria:
Inclusion Criteria:

1. Males aged 18 to 45;
2. Body Mass Index (BMI) is 19.0\~28.0 kg/m2, and body weight is 50.0\~80.0kg ;
3. Signing informed consent form before the trial and having a full understanding of the trial content, process and possible adverse reactions;
4. Able to complete the study according to the requirements of the study protocol.

Exclusion Criteria:

1. Those with a history of digestive tract, respiratory, cardiovascular, endocrine, urinary, neurological, hematological, metabolic and other systemic diseases;
2. Those with a history of autoimmune diseases;
3. Those with a history of malignant tumor, unless it is a skin squamous cell carcinoma, basal cell carcinoma or cervical cancer in situ that has been successfully resected and has no evidence of metastasis;
4. Regular drinkers within 6 months prior to screening;
5. Those who are suspected or confirmed to be allergic or have had severe drug or food allergy reactions in the past, have a clear history of allergies and/or are allergic to the study drug or its components after inquiries;
6. Those who have used anti-PD-1/PD-L1 or/and anti-CTLA-4 drugs in the past;
7. Those who have been vaccinated with live or attenuated-live vaccines within 3 months before screening, or who are expected to receive vaccines during the study period;
8. Those who lost blood, donated blood or received any blood product transfusion of ≥400 ml within 3 months before screening;
9. Those who received major surgery or hospitalization due to illness within 3 months before screening;
10. Abnormal laboratory tests with clinical significance at screening;
11. Positive drug screening result;
12. Have a childbirth plan within 6 months from the screening period to the trial drug administration, or who are unwilling to take the contraceptive measures specified in the protocol during the trial period.
MAGNETIC RESONANCE IMAGING in Superficial Soft Tissue Masses

This study responds to these raise up questions: Can we use Diffusion Weighted MR complemented with numerical ADC values \& in association with routine MRI in the discrimination between different malignant and benign superficial soft tissue masses.

In the clinical practice, there is a large number \& variety of superficial soft tissue masses. The differentiation of such masses represents a major obstacle for the surgeons. Benign \&malignant neoplasms as well as non-neoplastic swellings may have similar clinical presentation. The differentiation between malignant \& benign superficial soft tissue neoplasms is required for appropriate therapeutic planning and decisions. Masses can be characterized in terms of their size, number, component \&vascularity using US and Doppler US. However, US is operator dependent \& may display a number of artifacts that can result in misinterpretation. So MRI is superior in the assessment of such soft tissue masses due its brilliant soft tissue discrimination. Some features that will help distinguish malignant from benign lesions are evident on MRI examination such as signal characteristics,enhancement pattern,margin,lobulation,necrosis, haemorrhage,internal septation,peritumoral edema and extension through the deep fascia .However very forcful tumors may show benign behavior \& appear similar to benign masses , Thus further histopathology is required for accurate diagnosis. Diffusion weighted MRI visualizes the random microscopic motion of molecules. Diffusion-weighted imaging (DWI) is the technique which allows measurement of the Brownian motion of water in the tissue microenvironment depending on the organization of the tissue, integrity of cell membranes, and tortuosity of extracellular space. Apparent Diffusion Coefficient (ADC) is a numerical parameter which is calculated from DWI. Previously, DWI technique was used with great success in the central nervous system (CNS), in the differentiation between benign and malignant tumors in addition to its great value in early diagnosis of recent strokes. Nowadays, DWI was used in the differentiation between malignant and benign soft tissue masses. Malignant tumors have abundant cellularity than benign tumors hence they have more restricted diffusion. The addition of quantitative ADC values plays a fundamental role in more accurate diagnosis of malignant superficial soft tissue neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* patients with superficial soft tissue masses clinically
* patients underwent us detection of superficial soft tissue masses
* uncharactized superficial soft tissue mass by other modalities

Exclusion Criteria:

* MRI claustrophobia
* recurrent cases
* patients under treatment
Comparing Paper-based and Tablet-delivered Informed Consent for Older Adults

The investigators will develop and test a tablet-delivered informed consent process. In a preliminary phase of the study, older adults will provide feedback on a prototype tablet-delivered consent by participating in a focus group. In a separate second phase, older adults will be randomly assigned to a tablet-delivered or paper-delivered consent condition in which their comprehension of material covered in the consent will be assessed.

Clinical research is crucial for advancing healthcare, but patients must be able to make informed and voluntary choices about whether or not to participate in a research study. The informed consent process aspires to convey the purpose of research, the procedures involved, and the potential harms and benefits of taking part. Yet, the challenge of making informed consent easy to follow and understand is great: there are specific challenges for older research populations.

This study will develop and test a tablet-delivered informed consent process. The study will have two phases.

In the first phase, focus groups comprised of older adults will give their impressions of both a prototype tablet-delivered and paper consent, and the prototype will be refined according to feedback.

The second phase will evaluate whether older subjects judge a tablet-delivered consent to be more user-friendly than a paper-based version. It will also evaluate whether older subjects who participate in a tablet-delivered consent process have a better understanding of the research than those who participate in the paper-based version, and whether they remember the research details more fully after a one-week delay.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years and older
* Cognitively intact
* Ability to speak and read English

Exclusion Criteria:

* Legal blindness
* Severe hearing loss not corrected by assistive device
* Inability to use hands to swipe a tablet's touch screen
* No working telephone in the home
Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)

The primary objective of the study was to assess the efficacy of Dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 years or older;
2. Chronic AD that had been present for at least 3 years before the screening visit;
3. Patients with documented recent history (within 6 months before the screening visit) of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable;
4. Willing and able to comply with all clinic visits and study-related procedures.

Exclusion Criteria:

1. Prior participation in a Dupilumab clinical trial;
2. Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit;
3. The following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the first 4 weeks of study treatment:

   * Systemic corticosteroids;
   * Immunosuppressive/immunomodulating drugs;
   * Phototherapy for AD;
4. Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit;
5. Treatment with certain biologics;
6. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit;
7. Planned major surgical procedure during the participant's participation in this study;
8. Participant was a member of the investigational team or his/her immediate family;
9. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
10. Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study;

Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial therefore not all inclusion/exclusion criteria are listed.
6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder (GAD)

This is an open-label, multi-site, 6-month study of an investigational compound in elderly outpatients, age 65 years old or above, to assess the long-term safety and tolerability of the compound in the treatment of elderly subjects with Generalized Anxiety Disorder (GAD).

Termination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Men or women age \> 65 years.
* A primary diagnosis of Generalized Anxiety Disorder according to the Diagnostic and Statistical Manual-IV (DSM-IV).
* Subjects must have a HAM-A score of 16 or higher at both screening and baseline visits.

Exclusion Criteria:

* Women who are pregnant or contemplating pregnancy (eg, via in vitro fertilization) during the study through 30 days after the last dose of study medication.
* Subjects with evidence of a current (within the past 6 months) clinically significant or unstable hematological, autoimmune, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, immunological or retinal disorder; subjects with an active infection within the past 2 months.
* Subjects who have an ongoing, unresolved, clinically significant cardiovascular or cerebrovascular medical problem.
* Mini Mental Status Exam (MMSE) score \<24 or possibility of undiagnosed dementia, cognitive or amnestic disorder, including, but not limited to mild cognitive impairment.