cyrilzakka/clinical-trials huggingface dataset:
Long-term Safety of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis (EYEGUARD-X)

The objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab.


Eligibility Criteria:
Inclusion Criteria:

* either completed participation to one of the following: CL3-78989-002 open-label extension, or X052130/CL3-78989-005 double-masked period or open-label period, or X052131/CL3-78989-006 double-masked period or open-label period, or currently benefiting from gevokizumab compassionate use after participation in gevokizumab uveitis studies
* Male or female, age ≥18 (or legal age of majority in the country) at selection.
* For subject with reproductive potential, a willingness to use highly effective contraceptive measures

Exclusion Criteria:

* Meeting criteria for discontinuation of any of gevokizumab uveitis previous study.
* Infectious uveitis and masquerade syndrome
* History of severe allergic or anaphylactic reaction to study drug administration during previous study or to gevokizumab or any of its excipient.
* Currently active infectious disease.

Other protocol-defined inclusion/exclusion criteria may apply
Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of Visceral Leishmaniasis (VL) in India.

The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of VL in India.

Primary objective: Comparison of the efficacy of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate with regards to final cure rates

Secondary objective:. Comparison of the safety of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate when administered in the proposed dosage regimens.

Eligibility Criteria:
Inclusion Criteria:

* Children and adults 2-65 years of age (inclusive) of either gender.
* Diagnosis of VL confirmed by spleen or bone marrow aspirate.
* Clinical signs and symptoms compatible with VL.
* Biochemical and haematological test values as follows:
* Haemoglobin \> 3.5g/100mL
* White blood cell count \> 0.75 x109/L
* Platelet count \> 40 x 109/L
* AST, ALT and alkaline phosphatase \< 5 times upper normal limit
* Prothrombin time \< 4 seconds above control
* Serum creatinine levels - 1.5 times upper normal limit
* Serum potassium levels within normal limits
* HIV negative.

Exclusion Criteria:

* A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or CNS disease; diabetes; tuberculosis; other infectious or major psychiatric diseases) that may introduce variables that affect the outcome of the study.
* Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
* Proteinuria (\> 2+).
* A history of allergy or hypersensitivity to amphotericin B
* Previous treatment for VL within two weeks of enrollment into the study.
* Prior treatment failures with amphotericin B.
Bioequivalence Study of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets Under Fed Conditions

The purpose of this study is to assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg under fed conditions.

This study assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare in healthy human adult subjects with the single oral administration under fed conditions with a washout period of 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy human subjects between 18-50 years of age (inclusive), weighing as per the standard height and weight chart of Life Insurance Corporation of India (II Underweight and Overweight Min. \& Max. Chart)
* Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days to commencement of the study.
* Subjects whose screening laboratory values are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
* Informed consent given in written form according to section 10.3 of the protocol.
* Female Subjects:

  1. of child bearing potential practicing an acceptable method of birth control for the duration of study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
  2. postmenopausal for at least 1 year.
  3. surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject.

Exclusion Criteria:

1. History or presence of significant:

   i. Cardiovascular, pulmonary, hepatic, renal hematological; gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
   * Alcohol dependence, alcohol abuse or drug abuse within past one year.
   * Moderate to heavy smoking (\> 10 cigarettes/day) or on assumption of tobacco products.
   * History of difficulty in swallowing.
   * Clinically significant illness within 4 weeks before the start of the study
   * Asthma, urticaria or other allergic type reactions after taking any medication.
2. Subjects who, through completion of the study, would have donated in excess of

   * 500 ml of blood in 14 days, or
   * 500 - 800 m l of blood in 14 days (unless approved by the Principal Investigator)
   * 1000 ml of blood in 90 days
   * 1250 ml of blood in 120 days
   * 1500 ml of blood in 180 days
   * 2000 ml of blood in 270 days
   * 2500 ml of blood in 1 year
3. Participation in another clinical trial within the preceding 28 days of study start.
4. Subjects who have:

   * Systolic blood pressure less than 90 mm of Hg and more than 150 mm of Hg
   * Diastolic blood pressure less than 60 m of Hg and more than 95 mm of Hg. Minor deviations (1-3 mm Hg) at check-in may be acceptable at the discretion of the physician/investigator
   * Pulse rate below 50/min. and above 105/min.
5. Female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.
Study of the Effect of Intramuscular Ephedrine on the Incidence of Nausea and Vomiting During Elective Cesarean Section

The purpose of this research study is to investigate if the incidence of nausea and vomiting that subjects experience during and after a Cesarean section can be reduced by giving a shot of the drug ephedrine into the thigh muscle at the time of spinal anesthesia administration.

This research project is designed to study the medication ephedrine, when it is given as a routine part of the anesthesia for elective Cesarean section. Ephedrine is a medication that is widely used in labor and in vaginal and operative (Cesarean section) deliveries to help maintain a woman's blood pressure within its normal range, especially after spinal and epidural anesthesia has been administered. The purpose of this study is to determine if ephedrine, when given intramuscularly (\<IM\> as a shot in the muscle), at the time of spinal anesthesia administration, can help to decrease the incidence of nausea and vomiting subjects experience during and after a Cesarean section. This study will compare women who receive ephedrine to a similar group of women who receive a normal saline placebo. In addition to looking at the difference in the incidence of nausea and vomiting perioperatively, this study will also evaluate if the administration of IM ephedrine helps the baby to receive more blood from the placenta after anesthesia has been administered to the mother. This will be evaluated by performing a simple blood test, drawn from the umbilical cord, after the baby is born.

Eligibility Criteria:
Inclusion Criteria:

* Must be pregnant with a single baby
* Must be at term in their pregnancy (estimated gestational age of at least 38 weeks)
* Must be scheduled for an elective Cesarean section
* Must be between 60-70" tall
* Must be free of severe systemic disease (ASA class I or II)

Exclusion Criteria:

* Contraindication to spinal anesthesia
* Any allergy to any of the medications included in the study
* History of pregnancy-induced hypertension or preeclampsia
* History of preexisting hypertension
* Diabetes mellitus
* Hyperemesis gravidum
* Previous perioperative nausea and vomiting
* History of motion sickness
* Women carrying a fetus with a known abnormality will also be excluded from the study
De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma

The purpose of this study is to explore the efficacy and safety of image guided de-escalation protocols in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). So the investigators studied whether toxicities reducing treatment with omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with locoregionally advanced nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of nasopharyngeal carcinoma
* Stage III or IVA according to UICC/AJCC 8th staging system
* Age ≥18
* No prior anti-tumor treatment
* Karnofsky Performance Score (KPS)≥70
* Adequate blood supply
* Informed consent obtained

Exclusion Criteria:

* Can not take contrast-MRI imaging
* Pregnant
* Combined with other malignant tumor (except basal cell carcinoma of skin)
Evaluation of a Two-tiered Cross-age Teaching Model for Food Literacy-based Education

This project will serve adolescents from low-income and historically underserved communities through expansion of existing after-school programs. Adolescents from these communities tend to have slower academic progression and higher high school dropout rates. Extracurricular activities, including informal education through after-school programming, have been suggested to improve these rates and increase college enrollment by supporting traditional classroom-based education. The proposed project aims to educate high school-aged adolescents in food, agriculture, natural resources, and human (FANH) sciences through informal food literacy education. The project also includes a two-tiered cross-age teaching model, allowing for adolescents to be educated by college interns and to become educators for younger youth. Existing curricula, that encompass FANH sciences, will be utilized at each stage of the project. The purpose of the project is not only to educate adolescents in FANH sciences, but also to advance their motivation and efficacy for graduating high school, attending college, and majoring in FANH sciences. The project aims to accomplish these objectives through empowering adolescents to obtain knowledge, skills, and excitement for food literacy. As this model has not been utilized previously, this project will produce a best practices guide for implementing the existing curricula within a two-tiered cross-age teaching model. Additionally, the college internship and mentoring program created through this project will be continued at the initial sites and expanded to other communities. This will allow for a sustainable approach to educating adolescents in FANH sciences and providing mentorship that encourages future enrollment in college.


Eligibility Criteria:
Inclusion Criteria:

* There are two groups of participants (adolescents and younger youth) that will be recruited for this study. Adolescent participants must be high school-aged, approximately 13-17 years. Younger youth must be upper elementary school-aged, approximately 9-12 years. Participants for both age groups will be recruited from existing afterschool programs within each participating school district. Comparison youth for both age groups will be recruited from other students within the same school districts.

For the 2019-2020 and 2020-2021 school years, the participating school districts will be in Pittsburg and Williams, California.

Exclusion Criteria:

* Youth from other school districts
The Impact of Group Commitment Contracts on Smoking Cessation and Weight Loss

We will conduct a randomized controlled trial to evaluate the effectiveness of group commitment contracts for smoking cessation and weight loss.

Initial screening will be conducted online via the Qualtrics survey platform. Respondents meeting the inclusion/exclusion criteria will immediately be randomized into one of the intervention arms described below, and then take a baseline survey. This baseline survey will also be conducted online via the Qualtrics survey platform. The initial screening, randomization, and baseline survey should take approximately 15 minutes total and can be completed anywhere the participant has an internet connection.

INTERVENTION: Respondents who meet the inclusion/exclusion criteria will be randomized into one of the following arms:

1. Control Arm (No Intervention)
2. Group Contract Arm
3. Individual Monetary Rewards Arm
4. Individual Commitment Contract Arm

Subjects in Arms #2-4 will be cross-randomized into two subgroups:

A. Additional information treatments on the likelihood of success of the different incentives and contracts, with the goal of shifting "naives" to "sophisticates."

B. No additional information treatments.

FOLLOW-UP SURVEY: After the participants finish their contract, they will be emailed a link to the follow-up survey that will be administered online via the Qualtrics survey platform. The survey should take approximately 5 minutes and can be completed anywhere the participant has an internet connection. Participants will be directly prompted to answer whether they have been able to quit smoking or lose their target weight in the past six months. If a participant self-reports a claim of smoking cessation or successful weight loss, they will be asked to furnish at-home verification of their claim.

IN-PERSON VERIFICATION: A randomly selected subset of successful participants will be asked for in-person verification of their claim with a urine test (smoking cessation) or in-person weigh-in (weight loss) at a Quest Diagnostics location of their choice.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Has smartphone with capability to reach internet daily and download app
* Able and willing to visit Quest location or take an at-home verification test
* Willing to furnish a payment method for commitment contract stakes

If completing a smoking cessation contract:

* Daily smoker

If completing a weight loss contract:

* Has access to a functioning scale
* Interest in losing weight at a pace of 2 lb or fewer per week, with a target BMI at or above 18.5

Exclusion Criteria:

* Pregnancy
* Any terminal illness
Daily Wear Corneal Infiltrative Event Study

This DWCIE Study is a prospective cohort study of patients fit to the FDA approved and marketed lotrafilcon A (Ciba Vision, Air Optix Night \& Day Aqua) soft contact lenses for daily wear (DW) with monthly disposal. 218 healthy myopic (nearsighted) or hyperopic (farsighted) patients with minimal or no astigmatism and no contraindications to DW lens use will be followed for 1 year. The primary outcome is the risk of development of a corneal inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main exposure of interest is microbial contamination of study lenses.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must be at least 15 years old.
2. The patient must be free of any anterior segment disorders.
3. The patient must have a spectacle corrected spherical refractive error between +5.50 D and -11.00 D with less than or equal to 1.00 D refractive cylinder.
4. The patient must be correctable to 20/25 or better with spectacles.
5. Flat and steep corneal curvatures from Simulated Keratometry readings must be between 39.00 and 48.00 D.
6. Can be successfully fit with lotrafilcon A lenses at the enrollment visit.

Exclusion Criteria

1. The patient has worn rigid gas permeable lenses within the last 30 days or polymethylmethacrylate lenses within the last 3 months.
2. The patient must not be a current successful daily wear user of lotrafilcon A lenses. They may have tried lotrafilcon A lenses in the past, but must not have successfully worn these lenses for daily wear within the last 12 months.
3. The patient has an autoimmune disease (except for Hashimoto's Thyroiditis), immunocompromising disease, connective tissue disease, atopic dermatitis, insulin dependent diabetes, or any other systemic disease that in the investigator's opinion will affect ocular health.
4. The patient is taking chronic systemic medications such as corticosteroids, antimetabolites, or non-steroidal anti-inflammatory agents or any other medication that in the investigator's opinion will affect ocular physiology or study participation.
5. The patient has any ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
6. The patient is taking any ocular medications. If a patient was previously taking any ocular medications, the medications must have been discontinued at least 2 weeks prior to enrollment.
7. The patient must have less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales. Slit lamp findings higher than grade 2 bias the patient toward an adverse event and it may be difficult to detect true change related to contact lens use.
8. The patient is pregnant.
High Intensity Walking to Reduce Frailty

The purpose of this study is to evaluate a physical therapist (PT) led gait training intervention for 100 older adults with pre-frailty or frailty. The goals of this study are To determine the effect of gait training intensity on frailty, mobility, physical functioning, and quality of life, as well as balance and healthcare utilization.

Frailty is a leading cause of dependency among older adults, affects up to 60% of older adults, and is associated with an increased risk for falls, hospitalizations, institutionalization, and death. Exercise is the most widely recommended treatment for improving physical function among the frailty, but the optimal type or intensity of exercise is unknown. Walking is a preferred physical activity among older adults, however, there are no clear guidelines on the best intensity of walking to reduce frailty. The specific goal of this project is to compare a high intensity walking (HIW) intervention (70-80% of heart rate maximum) to a moderate intensity walking (MIW) intervention (50-60% of heart rate maximum) for pre-frail or frail older adults to determine the impact on frailty, mobility, balance, quality of life, and healthcare utilization.

Eligibility Criteria:
Inclusion Criteria:

* Receiving services from CJE SeniorLife
* Pre-frailty or frailty as determined on the SHARE-FI.
* Able to ambulate at least 10 feet with moderate assistance (\<50% physical assistance) or less. Participants will be able to use their assistive device (e.g. cane or walker) during sessions.
* \> 65 years of age
* Provision of informed consent and clearance for participation as determined by the Exercise and Screening for You (EASY)

Exclusion Criteria:

* Uncontrolled cardiovascular, metabolic, renal, or respiratory disease that limits exercise participation (e.g., previous heart attack within 3 months of enrollment or uncontrolled diabetes)
* Resting blood pressure \> 180/110 mmHg.59
Fluid Lavage of Open Wounds (FLOW): Pilot Trial

The purpose of this trial is to investigate whether irrigation solution (soap vs. saline solution), or irrigation pressure (high vs. low) will decrease the rate of infection among patients with open fracture wounds.

Open fractures are an important source of morbidity and are associated with delayed union, nonunion, and infection. Preventing infection through meticulous irrigation and debridement is an important goal in management, and different lavage fluids and irrigation techniques (e.g. high or low pressure lavage) have been described for this purpose. There are, however, a limited number of randomized trials comparing irrigating solutions or irrigating technique. We compared the use of castile soap versus normal saline, as well as high versus low pressure pulsatile lavage on the rates of reoperations and complications in patients with open fracture wounds.

Eligibility Criteria:
Inclusion Criteria:

* skeletally mature
* sustained an open fracture of the appendicular skeleton (type I to IIIb).

Exclusion Criteria:

* vascular deficit
* \[any\] allergy to detergents or castile soap
* previous wound infection or osteomyelitis
* previous fracture with retained hardware in the injured extremity
* operative management more than 24 hours after injury
* use of immunosuppressive medication within six months
* immunological deficiency or disease conditions
* fractures of the hands (distal to the carpus) or toes
Dose-effect Relationship of Tai Chi on Health Promotion in Different Age Groups

The purpose of this study is to investigate the physical and mental health status of middle-aged and elderly people of different ages and practicing Tai chi for different periods of time, so as to provide a strong theoretical basis and practical guidance for delaying age-related aging and preventing and treating the occurrence and development of chronic diseases.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 20-79 years.
* People who practice Tai chi for a long time.
* People with long-term exercise habits.
* People who have no habit of exercising.

Exclusion Criteria:

* People currently participating in other interventions (e.g., nutrition, psychological, exercise, health education).
* People with cognitive impairment and movement disorders.
* Cardiovascular and cerebrovascular events (physician-diagnosed heart disease, such as coronary heart disease, hypertensive heart disease, acute myocarditis, pulmonary heart disease, etc.) in the past 6 months.
* People with other serious chronic diseases, such as asthma, cancer, chronic heart failure, severe depression, or other mental disorders.
Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to Therapy

Currently the only approved use for rapamycin (sirolimus) is for immunosuppression after renal transplantation.

This trial is designed to determine whether rapamycin is safe and effective treatment for patients with polycystic kidney disease (ADPKD). Patients will be followed by volumetric magnetic resonance imaging (MRI) to observe for change in kidney (and cyst) size. Blood and urine samples will also be collected to evaluate for change in biomarkers with treatment.

This is a 2 year, open label trial to evaluate the role of rapamycin as treatment for ADPKD. Patients will be randomized 2:1 to the rapamycin arm or to standard therapy. The dose of rapamycin will be adjusted so that patients obtain 24 trough levels of 4-6ng/ml. There will be a volumetric MRI measurement at the start and end of the treatment period. Patients will be monitored every 4 months throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* adult ADPKD patients aged 18-70
* combined kidney volume \>1200 ml
* estimated creatinine clearance \>60 ml/min
* absence of implanted ferromagnetic objects

Exclusion Criteria:

* Age \>70
* uncontrolled hyperlipidemia
* Proteinuria \>500 mg/day
* unstable cerebral aneurysm
* active coronary artery disease
* diagnosis of another systemic condition affecting kidney function (ie: diabetes, hepatitis B or C, HIV)
* diagnosis of cancer other than skin cancer
* pregnancy or lactation
* presence of implanted ferromagnetic objects