cyrilzakka/clinical-trials huggingface dataset:
Project LIFT - Promoting Healthy Behavior Through a Wearable Fitness Device and Financial Incentives

Project LIFT is a randomized, controlled trial that tests the effectiveness of a remotely-monitored, home-based exercise program utilizing wearable fitness trackers to monitor steps taken per day, health engagement questions, and financial incentives. 120 subjects will be randomized into 3 arms: 1) usual care - no fitness tracker or incentive, 2) a fitness tracker + no incentives, and 3) fitness tracker plus financial incentives.

Obesity is the most common diseases in the United States - an estimated 35% of adults are obese. Among kidney (KT) and liver transplant (LT) recipients, weight gain and obesity is associated with poor graft function. Yet, within a year of transplantation, habituation to a sedentary lifestyle, changes in metabolism, and immunosuppression drugs contribute to an average 4-10 kg weight gain for recipients. Recent innovations in wearable device technology can passively monitor an individual's physical activity. Additionally, incentives and health questions designed using insights from behavioral economics have been shown to motivate device engagement and improvements in health behaviors. A remotely-monitored exercise program could improve behavior change and potentially be durable because it takes advantage of the high motivation for improving health in this population. The objective of this study is to use a randomized, controlled trial to test the efficacy of a home-based exercise program using wearable devices, health engagement questions and financial incentives. Participants in the intervention arm will establish a baseline step count during the first two weeks, followed by a 12-week intervention period and a 4-week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Adult Kidney transplant, Liver transplant, Simultaneous liver-kidney, or kidney-pancreas transplant recipients at the Hospital of the University of Pennsylvania within 2-24 months of transplantation
2. Ability to read and provide informed consent in English to participate in the study
3. Possess a smartphone with a data plan and willing to receive text messages
4. Willing to walk and sync wearable daily during the 2-week run-in in order to determine baseline \[for Arms 2 \& 3\]
5. Willing to provide a final weight at study end.

Exclusion Criteria:

1. Inability to provide informed consent
2. Does not have daily access to a smartphone compatible with the wearable device
3. Unable or unwilling to complete the baseline measurements and survey, or perform the exit interview and weigh-in
4. Already enrolled in a financial incentive-based exercise program using a wearable device
5. Use of a wearable accelerometer or pedometer outside of the study protocol for step-tracking; (e.g., Fitbit; using phone step-tracker is acceptable; using existing wearable for cycling or swimming is acceptable)
6. Any other medical conditions that would prohibit participation in a physical activity program
7. Severe vision, hearing, or mobility impairment precluding participation.
The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial

The purpose of this study is to examine the effects of blood pressure medications on cognition and blood flow in hypertensive elderly patients with cognitive impairment. The hypothesis is that treatment with an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme inhibitor (ACEI) will be associated with a slower rate of further cognitive decline, improved cerebral blood flow and its regulation, and preserved physical function as compared to treatment with a diuretic (HCTZ), independent of blood pressure level.

There is mounting evidence that hypertension, which affects more than 65% of the US elderly population, accelerates cognitive decline and increases the risk of functional disability among older individuals. Hypertension is also associated with cerebral blood flow reduction and dysregulation which contribute to further cognitive and functional impairment. Drugs that inhibit angiotensin II (ACEI and ARB) are commonly used antihypertensives and may have a protective effect on cognitive function, cerebral blood flow and physical function compared to other antihypertensives such as hydrochlorothiazide (HCTZ).

A total of 100 individuals will be recruited for this pilot 3-arm randomized study to investigate the effects of: (i) 12 months treatment with candesartan (ARB) compared to hydrochlorothiazide (HCTZ) and (ii) 12 months treatment with lisinopril (ACEI) compared to HCTZ and (iii) to estimate the effect size difference between lisinopril and losartan on cognition, cerebral blood flow regulation, and functional measures in a sample of elderly hypertensive individuals with objective evidence of cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* 60 years or older
* Hypertension
* Cognitive criteria: score either 10 or less out of 15 for the executive clock draw test 1 (CLOX1) or less than or equal to 1 standard deviation from the corresponding age specific mean on the immediate memory subtest

Exclusion Criteria:

* Intolerance to ACEI or ARB
* History of congestive heart failure
* History of diabetes mellitus
* History of stroke (less than 6 months)
A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome

The purpose of this study is to evaluate the efficacy and safety of subcutaneous Telitacicept versus placebo in subjects with active primary Sjogren's Syndrome.

This is a phase Ⅲ, multi-center, randomized, double-blind, placebo-controlled study. Subjects with active primary Sjogren's Syndrome (pSS) will be randomized to receive subcutaneous Telitacicept 80 mg, Telitacicept 160 mg or placebo weekly for a total of 48 weeks. Subjects are allowed to be transferred to another group after Week 24 by the investigator so that those randomized to the placebo group are able to receive either Telitacicept 80 mg or Telitacicept 160 mg afterwards. Subjects who are randomized to Telitacicept 80 mg and Telitacicept 160 mg groups will remain in the previous treatment group even if the investigator chooses to transfer them. Subjects and investigators are blinded throughout the study.

Eligibility Criteria:
Main Inclusion Criteria:

1. Written informed consent provided.
2. Males and females, 18-70 years of age.
3. Fulfilled the classification criteria of pSS according to ACR/EULAR (2016).
4. Anti-SSA antibody tested positive at screening.
5. ESSDAI score ≥ 5 at screening.

Main Exclusion Criteria:

1. Secondary Sjogren's syndrome.
2. Severe organ involvement related to pSS in the opinion of the investigator, including but not limited to a) severe vasculitis (not cutaneous vasculitis) affecting the kidney, gastrointestinal system, cardiac, pulmonary or central nervous system (CNS); b) active CNS or peripheral nervous system involvement requiring high dose corticosteroids; c) severe kidney involvement, e.g. GFR \< 60 ml/min, serum creatinine \> 2 mg/dL, or proteinuria \> 3g/d; d) severe pulmonary involvement, e.g. shortness of breath at rest, FVC \< 60% or DLCO \< 40%; e) muscle diseases requiring high dose corticosteroids; f) lymphoma.
3. Received sodium hyaluronate eye drops, artificial tears or artificial saliva within 7 days prior to screening.
4. Received live vaccine within 28 days prior to randomization.
5. Active hepatitis or history of severe liver diseases.
6. HIV positive.
7. Patients with malignant tumors.
8. Received investigational pharmaceutical within 28 days or 5 half-lives prior to randomization, whichever is longer.
9. Nursing or pregnant female, or male or female who prepared for parenthood during the study.
10. Any condition that, in the opinion of the investigator, makes it unsuitable for the subject to participate, e.g., poorly controlled high blood pressure, diabetes, heart failure or mental illness.
Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of double-blind treatment and 52 weeks of open-label extension.


Eligibility Criteria:
Inclusion Criteria:

* Histologic evidence of EoE
* Clinical symptoms of EoE including dysphagia

Exclusion Criteria:

* Primary causes of esophageal eosinophilia other than EoE
Time Window for Ischemic Stroke First Mobilization Effectiveness

Early mobilization was thought to be effective in patients with acute ischemic stroke. As the essential component of stroke unit care, early mobilization has already been part of routine clinical practice. However, it is uncertain that which and when medical service focusing on functional recovery should be delivered after the emergency interventions for stroke. Besides, the optimal time window, for delivering early mobilization after acute ischemic stroke, has not been verified with strong evidence.

The TIME Trial is a pragmatic, investigator-initiated, multi-center, randomized, 3-arm parallel group, clinical trial. This trial will be conducted in 57 general hospitals in mainland China affiliated with the China Stroke Databank Center and will enroll 6033 eligible patients with acute ischemic stroke. Participants will be randomly allocated to either (1) the very early mobilization group in whichmobilization is initiated within 24 hours from stroke onset, (2) the early mobilization group in which mobilization begins between 24 and 72 hours poststroke, or (3) the late mobilization group in which mobilization is started after 72 hours poststroke. The mobilization protocol is otherwise standardized and identical for each comparison group. Mobilization is titrated by baseline mobility level and progress of patients throughout the intervention period. The primary outcome is death or disability assessed with the modified Rankin scale at 3 months poststroke. Secondary outcomes include impairment score of the National Institutes of Health Stroke Scale, dependence in activities of daily living as measured using the modified Barthel Index, cognitive ability assessed with the Mini-Mental State Examination, incidence of adverse events, hospital length of stay, and total medical costs.

Study design: an Investigator-Initiated Prospective Multicenter Randomized 3-Arm Clinical Trial

Sample size: 1500 cases

Eligibility Criteria:
Inclusion Criteria:

* 1 diagnosed with ischemic stroke through anamnesis, clinical symptoms, and radiographic assessment;
* 2 aged 18 years or older;
* 3 of ischemic stroke within 12 hours before eligibility check;
* 4 able to verbally respond to the instructions;
* 5 with stable vital signs (systolic blood pressure 120-180 mmHg, heart rate 50-100/min, body temperature \<37.5◦C, blood oxygen saturation \>92%)
* 6MMSE score \> 16;
* 7participation in the TIME Trial and sign the consent form.

Exclusion Criteria:

* 1 diagnosed with hemorrhagic stroke;
* 2 NIHSS score \< 2;
* 3 pre-morbid modified Ranking Scale (mRS) score of 3-5;
* 4 refusing randomization;
* 5 having severe limb dysfunction or systemic diseases rendering them unable to cooperate in the mobilization intervention;
* 6 having severe cognitive and mental dysfunctions;
* 7 currently enrolled in another trial or having participated in a clinical trial within 6 months before stroke onset.
A Clinical Study Evaluating the Safety and Efficacy of CS-101 in Treating Subjects With β-thalassemia

The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-101 in treating β-thalassemia.

CS-101 is an autologous CD34+ cell suspension, edited by ex vivo base editing technology, which modifies the BCL11A binding site in HBG promoter, so that it loses the ability to bind to BCL11A, which can re-induce the production of γ-globin chain and increase the concentration of fetal hemoglobin(HbF) in the blood, compensating for the function of missing adult hemoglobin HbA to achieve clinical cure. The therapy addresses two major challenges in the current treatment of the disease: lack of matching donors and graft-versus-host diseases in allogeneic hematopoietic stem cell transplantation.

Eligibility Criteria:
Key Inclusion Criteria：

* 6 to 35 years old(inclusive) male or female subjects at the time of informed consenting
* Diagnosis of β-thalassemia, genotypes include but are not limited to β+β0，βEβ0，β0β0, etc
* History of at least≥8 units/year of packed RBC transfusions in the prior 12 months prior to the screening period
* Generally in good condition, Karnofsky performance score≥60 points for subjects≥16 years old at the time of autologous hematopoietic stem cell collection, or Lansky Play-Performance score≥60 points for subjects under 16 years old, or equivalent clinical evaluation as the investigator site's common practice

Key Exclusion Criteria:

* Treatment with other investigational medications or other experimental interventions 30 days prior to signing informed consent or within 6 half-lives of the drug, whichever is longer.
* Subjects who have received or are receiving thalidomide and/or Luspatercept, when their drug-drug interaction on the efficacy and safety of CS-101 cannot be ruled out, unless at least there are 3 test results showing the total hemoglobin level before transfusion is below 9g/dL in the past 6 months before screening.
* Previously received allogeneic hematopoietic stem cell transplantation or gene(edited) therapy.
* Subjects have available related fully matching donors and are eligible and prepared for allogeneic hematopoietic stem cell transplantation.
* Those with active infections, including but not limited to: HIV, hepatitis B, hepatitis C, cytomegalovirus, Epstein-Barr virus and treponema pallidum test positive, or known tuberculosis, parasitic infection, etc. who are judged by the investigator to be unsuitable to participate in this study.
* Echocardiography results with ejection fraction below 45%.
* Advanced liver disease, defined as：

Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \>3 × upper limit of normal (ULN) or:

Baseline International Normalized Ratio (INR) \>1.5 × ULN.

* MRI during the screening period showed heavy iron overload and is judged by the investigator to be unable to participate in the study.
Inhaled Treprostinil for PAH: Open-label Extension

Open-label extension of RIN-PH-302.


Eligibility Criteria:
Participation and completion of all required visits for study RIN-PH-302.
Efficacy of an Antiage Aesthetic Treatment for the Middle and Inferior Third of the Face

Primary endpoint of the study is to evaluate clinically and by non-invasive instrumental evaluations the aesthetic performance, on the third middle and inferior of the face, of "MonoDermà HA Bio-revitalizing gel", an intradermal filler containing hyaluronic acid, combined to a low level laser therapy (LLLT) to obtain a stable photo-cross-linking effect inside the dermis.


Eligibility Criteria:
Inclusion Criteria:

* female sex;
* Caucasian race;
* non smokers;
* no alcohol abuse and/or drug use;
* 40-65 years;
* FVLS 2-4 ;
* available and able to return to the study site for the post-procedural follow-up examinations;
* accepting not to change their habits regarding food, physical activity, cosmetic and cleansing products for the face;
* accepting not to expose their face to strong UV irradiation (UV session and/or sun bathes) during the entire duration of the study, without appropriate sun protection;
* accepting to sign the informed consent form.

Exclusion Criteria:

* Pregnancy (only for female subjects not in menopause);
* lactation (only for female subjects not in menopause);
* smokers;
* alcohol abuse and/or drug use;
* female subjects not in menopause, who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
* female subjects not in menopause, who do not accept to perform the pregnancy test at T0 and T1 (before the 1st and the 2nd aesthetic procedure);
* Body Mass Index (BMI) variation (± 1) during the study period;
* having performed face treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 6 months beginning of the study;
* having used permanent filler in the past;
* change in the normal habits regarding food, physical activity, face cosmetic, cleansing and make-up use during the month preceding the test;
* sensitivity to the test filler or its ingredients, including delayed hypersensitivity to hyaluronic acid and granulomatous reactions (to be assessed by the investigator during the baseline);
* subjects whose insufficient adhesion to the study protocol is foreseeable;
* participation in a similar study currently or during the previous 9 months;
* dermatitis;
* presence of cutaneous disease on the tested area, as lesions, scars, malformations;
* subjects that tend to develop hypertrophic scars;
* recurrent facial/labial herpes;
* clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne);
* diabetes;
* endocrine disease;
* hepatic disorder;
* renal disorder;
* cardiac disorder;
* pulmonary disease;
* cancer;
* neurological or psychological disease;
* inflammatory/immunosuppressive disease;
* drug allergy;
* anticoagulants and antiplatelet drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment started more than 1 year ago);
* using of drugs able to influence the test results in the investigator's opinion.
OCT Technology Development to Assess Ocular Integrity and Characterize Ocular Integrity and Intraocular Scatterers

The purpose of this study is to develop and demonstrate new technologies that will enable a non-contact, compact eye imaging system based on OCT to assist an early responder in acute care settings (like an emergency room) to help assess eye trauma and inflammation (swelling inside the eye).


Eligibility Criteria:
Inclusion Criteria:

- Pre-clinical: employees or students (over the age of 18) of the Duke Eye Center or Biomedical Engineering willing to be imaged with OCT system

- Pilot (ER): patients (over the age of 18) presenting emergently to the Duke Emergency room with traumatic eye injuries and/or suspected open globe

- Pilot (Uveitis): patients presenting to the Duke Eye Center with active uveitis and microhyphema or hyphema; patients who have independently consented to undergo vitreous tap or biopsy for their uveitis care at the Duke Eye Center

Exclusion Criteria:

- Pre-clinical: subject cannot be a direct report to any of the PIs or other key personnel of this study

- Pilot (ER): hemodynamically unstable, unable to consent

- Pilot (Uveitis): unable to consent; cornea or lens opacity/scar which would block the imaging modality
Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections

Hepatitis B immunization has been offered to all grade 4 students (age 9-10) in the province of Quebec, using Engerix-B at a dose of 10 mkg. The peak incidence of hepatitis B occurs between age 15 and 35; the proportion of vaccinated children who will still be protected at this age is currently unknown. This study is designed to determine:

* persistence of immunity until age 25
* persistence of immunological memory as demonstrated by an anamnestic response following a booster dose
* the effect of a booster dose on immunogenicity at either 5, 10 or 15 years after the primary vaccination course (at age (15, 20 or 25).

Three doses of Engerix-B vaccine (10 mkg) were administered according to 0, 1, 6 month schedule to 1126 9-10 year-old children.

The primary objective of the study is to evaluate the persistence of antibodies to Engerix-B in all subjects at age 25 and to compare the levels obtained in those given a booster injection at age 15 or 20 with those receiving no booster injection.

Secondary objectives

* To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert
* To determine the antibody levels of one third of subjects at age 15, 5 years after primary vaccination (Group A)
* To determine the effect on antibody levels of a booster injection at age 15 years given to one third of the subjects (Group A)
* To determine the antibody levels of subjects in groups A and B at age 20, 5 years after booster (Group A), 10 years after primary vaccination (Group B)
* To determine the effect on antibody levels of a booster injection at age 20 years given to one third of the subjects (Group B)
* To determine the effect on antibody levels of a booster injection at age 25 years given to one third of the subjects (Group C)
* To determine the antibody levels of subjects in Group A and Group B one year after their 5 or 10 year booster
* To evaluate safety

Eligibility Criteria:
Inclusion Criteria:

* Previously completed the 1995 to 1996 Hepatitis B vaccination program vaccinations (Primary study) to the best of his/her knowledge and already enrolled and followed in the long term study
* Must be HBc negative
* Required standard interval between last dose of primary immunization and booster vaccination
* Written informed consent obtained from the subject
* Free of obvious health problems as established by medical history and clinical examination before entering into the study
* Previously completed routine childhood vaccination to the best of his/her knowledge
* If the subject is female, and the potential of pregnancy exists, it must be asked prior to immunization by the study nurse. According to the protocol d'immunisation du Québec, Engerix-B is not contra-indicated during pregnancy. However, if a participant thinks she could be pregnant (sexually active and no oral contraception or intra uterine device), a pregnancy test will be carried out. In case of pregnancy, the booster vaccination will be performed after delivery.

Exclusion Criteria:

- Not applicable
Pharmacodynamic Study of Cilostazol in Healthy Volunteers

The primary objective of this study is to investigate the effects of Cilostazol, Acetylsalycylic acid and Clopidogrel alone as well as combinations of Cilostazol/Acetylsalicylic acid and Cilostazol/ Clopidogrel on ex-vivo Platelet Function (PF) testing.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian male subjects
* Able to read, to write and to fully understand German language
* Provision of written informed consent before screening and baseline
* BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
* Good general health as determined by the investigator by medical history, physical examination, vital signs, electrocardiogram, baseline and safety lab

Exclusion Criteria:

* Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms
* Known predisposition to bleeding (e.g. active peptic ulceration, recent (within 6 month) haemorrhagic stroke, proliferative diabetic retinopathy, poorly controlled hypertension)
* Use of antibiotics within thirty (30) days prior to screening and until baseline visit
* Clinically significant abnormalities in medical history, physical examination, vital signs, electrocardiogram, baseline and safety lab
* Supine pulse rate \> 100 beats/min or \<50 beats/min
* Systolic blood pressure \<100 or \>140 mmHg
* Diastolic blood pressure \<50 or \>90 mmHg
* Concomitant use of any other medication including over-the-counter preparations