cyrilzakka/clinical-trials huggingface dataset:
The Alusti Test:Functional Evaluation Scale of Physical Performance in the Geriatric Population

With the Alusti Test, which is created by Josu Alustiza Navarro considering the existing tests, the physical performances of geriatricians with different levels and cognitive capacity are evaluated in a very short time and without tiring the patient. There are 2 versions, short and full. The short version is applicable to 100% of the large population, including "and cases of cognitive impairment. With the full version, it has nearly 85-90% applicability."

However, there is no study regarding the English version and validity reliability of the 'Alusti Test.

For this purpose, it is to investigate the English validity and reliability of the functional assessment scale of physical performance (Alusti Test) for the geriatric population and to provide a measurement tool to be used in the English literature to the sciences who want to work in this field.


Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 65,
* volunteering
* to be able to read and write
* To be able to read and write in Turkish

Exclusion Criteria:

* None
Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody


Eligibility Criteria:
Main Inclusion Criteria:

* Male and female healthy adults aged at least 18 years, with written informed consent and either no childbearing potential or negative pregnancy test

Main Exclusion Criteria:

* History of immunodeficiency or immunosuppressive therapy,
* Known Human Immunodeficiency Virus (HIV); OR
* Drug addiction including alcohol dependence
Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy

To evaluate the long-term safety and tolerability of ACE-031 administration in subjects with Duchenne muscular dystrophy (DMD) who participated in Study A031-03. \[Note: This study was terminated based on preliminary safety data. Pending further analysis of safety data and discussion with health authorities, a new ACE-031 trial will be planned.\]


Eligibility Criteria:
Inclusion Criteria:

* Completion of participation in Study A031-03 and Investigator approval
* Continuation of corticosteroid therapy at the same absolute dose and schedule as on Study A031-03

Exclusion Criteria:

* Participation in any other therapeutic clinical trial
* Plans to have surgery during the course of the study
Comparison Imaging System Between Spatially Modulated Quantitative Spectroscopy and Skin Spect Dermoscopy

The purpose of this study is to obtain skin spectroscopic data from two imaging systems.

Comparison groups:

* Skin Spect dermoscope
* Spatially modulated quantitative spectrometer

The researcher can compare the spectroscopic data from the two systems as well as the relative concentrations of melanin, oxy- and deoxy- hemoglobin calculated from the measurements.

Skin Spect can measure larger area of skin, whereas Spatially modulated quantitative spectrometer is a point-based measurement.Therefore, larger nevi will require multiple Spatially modulated quantitative spectrometer measurements for comparison with corresponding sub-regions of the larger Skin Spect measurements. Only sub-regions of the image data from Skin Spect that match the locations Spatially modulated quantitative spectrometer acquired data will be used in this correlation study.

This researcher ensure that the spectral data collected by the two instruments are collected from the same spatial locations, should lesion heterogeneity be present.

Eligibility Criteria:
Inclusion Criteria:

* Skin lesion a mole located on flat surface of the body

Exclusion Criteria:

* Mole located on complex surface
* Pregnant women
Effects of Hemiplegic Shoulder Pain

The purposes of this study is to investigate the differences in upper extremity function, sleep quality, and functional independence between patients with and without hemiplegic shoulder pain (HSP).

HSP is defined as musculoskeletal pain in the affected shoulders of individuals after stroke.Numerous studies have found an association between post-stroke shoulder pain and range of motion, sensory impairment, subluxation, spasticity, and complex regional pain syndrome. HSP is a problem that, starting from mild discomfort, leads to gradual functional impairment, ultimately resulting in increasing disability and decreased independence.In the literature, the relationship between HSP and upper extremity function, functional independence, and sleep quality has not been clarified.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Have had a stroke at least three months ago
* Volunteers who can understand or communicate test instructions

Exclusion Criteria:

* Having a history of shoulder surgery
* Having serious shoulder problems before stroke
* Having other neurological conditions
Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate

A 4 week intake of drug to find a natural substance that may modify energy balance and may enhance health in combination with lifestyle changes with possible decrease in body weight.

This study is a double-blind, placebo-controlled, single center, randomized, parallel arm clinical trial to test the impact of Dihydrocapsiate (placebo, 3 and 9 mg/d) ingested for 4 weeks on resting metabolic rate and fat oxidation measured by indirect calorimetry.

Eligibility Criteria:
Inclusion Criteria:

* Men between 20-60 years old
* Healthy as assessed by medical history and standard medical exam
* Weight-stable
* Body mass index of 25 to 34.9 kg/m2
* Non-smoker
* Sedentary lifestyle: not being physically active grater than 3 days/week for 20 min each time for the previous 6 months, and not participating in regular resistance exercise.

Exclusion Criteria:

* Subjects enrolled in a diet to increase or decrease body weight
* Special diet or food aversiions to common foods
* Has allergy to chilli pepper
* Eating chilli peppers on a daily basis
* Usually consuming more than 2 cups of tea or coffee/day
* Usually consuming more than 4 cans of caffeinated soft drinks a day
* Usually consuming more than 3 standard alcohol drinks/day
* Regular use of medications (weight loss drugs, drugs affecting energy metabolism, drugs for depression)
* Usual intake of illicit substances
* Claustrophobia
* Participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
To Estimate the Efficacy of Treatment With TNFi as Monotherapy or Combination Therapy With MTX and Compare and Contrast Efficacy With Tofacitinib as Monotherapy and Combination Therapy in a Real World Setting.

To estimate the efficacy of treatment with TNFi as monotherapy or combination therapy with MTX and compare and contrast efficacy with Tofacitinib as monotherapy and combination therapy in a real world setting.


Eligibility Criteria:
Inclusion Criteria:

* RA patients in Corrona initiating a TNFi biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) during follow-up in Corrona with no prior use of Tofacitinib

Exclusion Criteria:

* Patients with no history of cDMARD but history of 1+ biologics - these cases will be excluded from analyses
* Patients using combination therapy with a cDMARD other than MTX will be excluded
* Patients using combination therapy of MTX and another cDMARD will be excluded
Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism

A cataract is a clouding of the lens that occurs naturally with age. Cataract surgery involves removal of the cloudy lens and replacement with an artificial one. A special laser (femtosecond laser) is now being used to help make cataract surgery safer and more accurate . The femtosecond laser can also be used to correct astigmatism, an irregular curvature of the cornea, at the time of cataract surgery through a procedure called astigmatic keratotomy (AK). This study is gathering information about the specific laser settings that are used to perform astigmatic keratotomies (AK) during cataract surgery. This information will be used to improve the outcomes of patients that receive cataract surgery with astigmatic keratotomies in the future.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18 years of age
* Sex: male or female
* Patients who are planned to undergo femtosecond laser-assisted cataract surgery with astigmatic keratotomy at the Schein Ernst Mishra Eye clinic within the next 60 days of their cataract consultation visit. Subjects with planned single or bilateral cataract eye surgeries are eligible. Planned opposite eye surgery must be within 2-4 weeks of first cataract surgery.
* Fluent in written and spoken English

Exclusion Criteria:

* Patients with corneal dystrophies, including anterior basement membrane dystrophy, keratoconus, and Fuch's endothelial corneal dystrophy.
* Age \< 18 years
* Pregnant women
* Cognitive impairment
* Prisoners
A Proof of Concept Study of the Safety, Tolerability, and Efficacy of Avastin (Bevacizumab) in Patients With Chemo-naive Chronic Lymphocytic Leukemia

This single arm study evaluated the bone marrow response, safety, and tolerability of 6 months treatment with Avastin (bevacizumab) monotherapy in patients with chronic lymphocytic leukemia. Patients received 8 cycles (21 days duration) of Avastin monotherapy (15mg/kg) with 6 months of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, ≥ 18 years of age.
* B-chronic lymphocytic leukemia not yet requiring treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* No previous treatment of chronic lymphocytic leukemia (CLL) by chemotherapy, radiotherapy, or immunotherapy.
* Life expectancy \> 6 months.

Exclusion Criteria:

* Central nervous system (CNS) involvement by lymphoma or any evidence of spinal cord compression.
* Computed tomography (CT) scan based evidence of tumor invading major blood vessels.
* Gastrointestinal (GI) tract involvement by CLL.
* Active viral, bacterial, or fungal infection.
* Uncontrolled hypertension, cerebrovascular accident/stroke (≤ 6 months prior to randomization), myocardial infarction (≤ 6 months prior to randomization), unstable angina (≥ New York Heart Association (NYHA) Grade IV), thrombosis within 6 months before enrollment, NYHA Grade II congestive heart failure, or serious cardiac arrhythmia requiring ongoing medication.
Community-based Program to Treat Childhood Obesity

This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight in children and teens. This study will recruit 150 participants between the ages of 6-12 and 13-17.

This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight. Overweight and obese study participants will be grouped with peers of similar ages and their parent/guardians. The participants will be divided into 2 groups, child (6-12 yrs. old) and teens (13-17 yrs. old) and will be accompanied by their parent/guardian. 150 participants will be recruited for this study.

This 6-month program (12 in-person group workshop sessions and 12 at-home sessions) takes the best components of current evidence for individual treatment and places them in a comprehensive community based program. These include:

* Parental involvement
* Reduction in consumption of sugar sweetened beverages
* Reduction of screen time
* Self-monitoring
* Physical activity
* Stimulus control

Eligibility Criteria:
Inclusion Criteria

* Children and teens between the ages of 6-17
* BMI percentile ≥85
* Participation of a parent/guardian

Exclusion Criteria:

* Enrollment in another weight loss program or study
* Diagnosis of type 1 or type 2 diabetes
* Pre-existing medical conditions (e.g., Prader Willi) that affect weight and appetite
* Medications (e.g., steroids) that affect weight or appetite
* Serious or unstable medical or psychological conditions that, in the opinion of the Principal Investigator, would compromise the participant's safety or successful participation in the study
Evaluation of Efficacy and Safety of a Single Dose of CTX001 in Participants With Transfusion-Dependent β-Thalassemia and Severe Sickle Cell Disease

This is a single-dose, open-label study in participants with transfusion-dependent β-thalassemia (TDT) or severe sickle cell disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) using CTX001.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants with TDT and SCD:
* Eligible for autologous stem cell transplant as per investigator's judgment.
* Participants with TDT:
* Diagnosis of TDT as defined by:
* Documented homozygous β-thalassemia or compound heterozygous β-thalassemia including β-thalassemia/hemoglobin E (HbE). Participants can be enrolled based on historical data, but a confirmation of the genotype using the study central laboratory will be required before busulfan conditioning
* History of at least 100 milliliter (mL)/kilograms (kg)/year or 10 units/year of packed red blood cells (RBC) transfusions in the prior 2 years before signing the consent or the last rescreening for patients going through re-screening
* Participants with SCD:
* Diagnosis of severe SCD as defined by:
* Documented SCD genotypes
* History of at least two severe VOCs events per year for the previous two years prior to enrollment

Key Exclusion Criteria:

* Participants with TDT and SCD:
* A willing and healthy 10/10 human leukocyte antigen (HLA)-matched related donor is available per investigator's judgement
* Prior hematopoietic stem cell transplant (HSCT)
* Clinically significant and active bacterial, viral, fungal, or parasitic infection as determined by the investigator
* Participants with TDT:
* Participants with associated α-thalassemia and \>1 alpha deletion, or alpha multiplications
* Participants with sickle cell β-thalassemia variant
* Participants with SCD:
* History of untreated moyamoya syndrome or presence of moyamoya syndrome at screening

Other protocol defined Inclusion/Exclusion criteria may apply.
Vitamin D Levels Following Topical Application of Vitamin D Ointment

This is a pre-post open label trial to assess the change in Vitamin D blood levels following treatment with three doses of topical Vitamin D3 in subjects with existing Vitamin D deficiency.

The proposed study investigates safety and efficacy of a new topical vitamin D3 compound. The purpose of this Phase 1 trial is to determine whether topical application makes Vitamin D bioavailable to the systemic circulation in sufficient quantities to treat hypovitaminosis D. The study will assess the change in serum 25-hydroxy (25-OH) vitamin D concentrations following 3 doses of 100,000 IU or 3 doses of 300,000 IU of topical vitamin D3 ointment in volunteers with vitamin D deficiency. Adults with serum 25-OH vitamin D concentrations of \< 20 ng/ml will receive a total of 300,000 IU or 900,000 IU in divided doses of topical vitamin D once per week for three weeks. Two 0.75 ml applicators of ointment will be applied to each upper arm (50,000 IU or 150,000 IU per arm) by study staff. Blood will be drawn at baseline prior to the first dose (Day 0) and on Days 7, 14, and 21. Total serum 25-OH vitamin D will be assayed at each draw. Parathyroid hormone, a measure of clinical effects of low vitamin D levels, will be checked at baseline and on day 21. Serum albumin adjusted calcium levels will be checked with each draw to check for possible effects of too much vitamin D absorption. The study will determine whether the topical application of Vitamin D ointment is able to correct existing vitamin D deficiency.

Eligibility Criteria:
Inclusion Criteria:

1. Known vitamin D deficiency based on blood work obtained prior to study consent defined as serum 25-hydroxyvitamin D less than or equal to 20 ng/mL within 30 days prior to study entry.
2. Adult, age 18 to 85 years, male or female
3. If on oral vitamin D therapy, have been on a stable dose for the previous 90 days.

Exclusion Criteria:

1. History of chronic liver disease with elevated liver function tests, chronic kidney disease (stage 3 or greater, eGFR \<60 mL/min), uncontrolled thyroid disease (elevated thyroid function tests), primary or secondary hyperparathyroidism, hypercalcemia, or multiple endocrine neoplasia.
2. Hypercalcemia defined as either elevated corrected serum calcium \>10.2 mg/dL) measured within 3 months prior to study.
3. estimated glomerular filtration rate (eGFR) \<60 mL/min within 3 months prior to study.
4. Active cancers
5. Women who are pregnant or breastfeeding.
6. Individuals who are unable to give informed consent
7. Individuals with psoriasis, active eczema or other skin disease, or who are currently receiving treatments or medications for skin disease.
8. Individuals who do not agree to refrain from using tanning beds for the duration of the study.
9. Individuals who do not agree to avoid submerging the ointment site in water for 8 hours after ointment application.
Continuation of Oral ONC201 in Treating Patients With Advanced Solid Tumors

This phase I trial studies the long-term side effects of the continuation of oral ONC201 in treating patients with solid tumors that have spread to other places in the body who have previously benefited from receiving this drug. Oral ONC201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To evaluate the long-term safety and tolerability of ONC201 (oral ONC201) administered orally in patients with advanced cancers.

SECONDARY OBJECTIVES:

I. To characterize pharmacokinetics of ONC201. II. To assess serum biomarkers of therapeutic response to ONC201. III. To assess preliminary antitumor activity of ONC201 as a single agent in advanced solid tumors.

OUTLINE:

Patients receive oral ONC201 orally (PO) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patient has completed participation in one of the ONC201 protocols, has not shown tumor progression while on study treatment, and has tolerated the study drug without unacceptable toxicities
* Patient has not met criteria for withdrawal from the base protocol
* Patient is willing to comply with protocol requirements and procedures, and keep scheduled study visits
* Patient agrees to practice effective contraception during the entire study period unless documentation of infertility exists
* Patient is able to understand and is willing to sign the informed consent form

Exclusion Criteria:

* Patient is receiving concomitant standard and/or investigational anticancer therapy; local palliative radiotherapy is permissible upon discussion with the principal investigator
* Patient has alcohol or substance abuse which, in the opinion of the investigator, would interfere with compliance or safety
* Patient has any condition or laboratory abnormality which, in the opinion of the investigator, would pose additional risk in administering the study drug to the patient
Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)

The purpose of this study is to assess whether feeding highly antioxidant spices of providing these same antioxidants as capsules is able to affect cardiovascular risk measures. Because this is a new area of research, the investigators will use many measures to assess this question including blood markers, tests of blood vessel health, measures of blood pressure responses, measures of clotting activity, and other inflammation measures.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-65
* BMI 25-40
* Non tobacco user
* Resting BP \< 160/100
* Fasting Glucose \< 126 mg/dL

Exclusion Criteria:

* Tobacco use
* Use of female hormones
* Breastfeeding or planning to become pregnant during the study
* Use of lipid-lowering or blood pressure medications
* Chronic Inflammatory Disease or osteoarthritis requiring regular use of medication
* Chronic use of any form of anti-inflammatory or anti-psychotic drugs
* Use of daily aspirin or supplements (except stable dose of calcium)
* History of heart attack or stroke, renal or hepatic disease, implanted medical devices, gastrointestinal disease
* Allergy or intolerance to any study foods
* Injury to fingers or arms that would interfere with vascular and blood pressure measurements
* Inability to comply with study protocol
* Allergy to adhesives or latex
* Aerobic exercise exceeding 2 hours per week
Smoking Cessation in Women With Gynecological Conditions

This feasibility study will compare two smoking cessation methods, traditional nicotine replacement therapy and Electronic Nicotine Delivery Systems (electronic cigarettes) in patients with gynecological conditions.

This study will allow women with serious gynecological conditions to sample both traditional nicotine replacement therapy (NRT) and Electronic Nicotine Delivery Systems (electronic cigarettes, ENDS). Whether the woman samples NRT or ENDS first will be randomized. Women will choose the product they wish to try for a 6-week intervention period for smoking cessation. Women choosing NRT will receive a 6-week intervention of a daily nicotine patch plus either nicotine gum or lozenges to use (as needed) throughout the day. The ENDS group will receive an electronic cigarette device with refills to last the 6-week duration of the study. Both groups will receive identical tobacco cessation counseling. As part of the study, each subject will complete a survey conducted at baseline, 6-weeks into the study during intervention, and upon completion of a 6 week follow-up period in which participants receive no intervention. At the 12-week measurement period we will add a qualitative interview that will allow us to ask the women whether the methods were acceptable, caused any problems, and if so, what the problems entailed.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Smokers (defined as those who have smoked at least daily for the last year and who have smoked greater than or equal to 10 or more combustible cigarettes per day during the last year.
* Patients with diagnoses of Cervical Dysplasia, Cervical Cancer and Lower Genital Tract Dysplasia and Cancer
* Ages 18-65 years

Exclusion Criteria:

* Patients unwilling to commit to a 6-week intervention that may include either NRT or ENDS.
* Patients with previous diagnoses of or treatment for cancer - with the exception of non-melanoma skin cancer.
* Presence of any known stroke, heart disease, heart attack, or irregular heart beat.
* Pregnancy and lactation.
* Plan to continue to use other nicotine in addition to the products supplied by the study. These would include: chewing tobacco, snuff, an additional nicotine patch or other nicotine containing products.
* High blood pressure, not well controlled with medication.
* Patients using a non-nicotine "smoking cessation medication."
* Patients taking a prescription medicine for depression or asthma.