cyrilzakka/clinical-trials huggingface dataset:
Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion and Left Atrium Enlargement

This study evaluates the safety and efficiency of surgical prevention of atrial fibrillation in patients with valvular heart disease and left atrium enlargement

Preservation or appearance of AF(atrial fibrillation) after mitral valve surgery substantially reduce the number of excellent and good results of the operation in the long-term period, causing circulatory insufficiency, increased pulmonary hypertension, increasing the risk of thromboembolic events and stroke.

Significant predictors of AF after surgery are the initial size of the left atrium more than 6.0 cm, stenotic lesions and rheumatic genesis of mitral defect. 80% of patients in this group had AF during the first year after operation.

Eligibility Criteria:
Inclusion Criteria:

* rheumatic mitral valve lesion
* the absence a history of AF
* sinus rhythm
* left atrium size more than 6.0 cm

Exclusion Criteria:

* refusal to participate in the study
* aortic stenosis / regurgitation
* coronary atherosclerosis
Adherence in Upper Extremity Home-based Rehabilitation

The objective of the proposal is to determine the feasibility of implementing Ecological Momentary Assessment (EMA) and Motivational Interviewing (MI) methods to enhance adherence for a 4-week self-initiated arm training protocol. A non-randomized feasibility study using a 4-week UE training protocol will be conducted in 15 individuals within the first 12 months post-stroke living in the community. EMA data will be collected using a mobile app to automate real-time collection of adherence data on a daily basis. MI will be used to produce self-generated training plans (training goals, training schedule), guided by the therapist before the start of training.

Using a mixed methods design, the study will collect quantitative data before, during, and after training. Qualitative data will be collected after the training period and analyzed to explain the quantitative findings in depth, within the context of everyday life. Study aim 1 is to evaluate the feasibility of using EMA to measure adherence and of applying the MI approach. Quantitative data will include four indicators of adherence and accuracy. Interview responses will be used as qualitative data to elucidate participants' acceptance of the MI approach and feedback on using the EMA app. Study aim 2 is to explore to what extent UE outcomes change after the 4-week self-initiated home-based rehabilitation program. Outcomes will include UE use in real-world environments and self-perceived changes in UE use.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\> 18 years old) diagnosed with stroke at least 6 months ago at the time of screening
* Living in the community
* Have presence of UE motor impairment on the affected side (Fugl-Meyer Assessment scores \< 66)
* Availability of mobile technology (tablet or smartphone) with internet connection to use phone app and Zoom videochat)
* Be medically stable
* Able to provide written consent

Exclusion Criteria:

* Currently receiving active occupational or physical therapy for the treatment of the affected UE
* Presence of severe cognitive impairment (Mini Mental Status Exam \<24)
* Self-reported moderate to severe pain of the affected UE with use
* Presence of unilateral spatial neglect (Star Cancellation Task scores \< 44)
* Presence of neurological diagnosis other than stroke.
Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy

This application proposes a prospective, single arm feasibility clinical trial of a 12-week period of combined endurance and resistance training in survivors of childhood cancer who were treated with doxorubicin and/or daunorubicin and have impaired cardiac function.

Baseline and post intervention imaging, laboratory, and neuropsychological evaluations will be used to determine the effects of the intervention on body composition, serum lipid profile, exercise tolerance, and neurocognitive functioning. Participants will be called weekly to monitor compliance with the intervention. Incentives will be given at intervals during the trial to optimize compliance with the intervention.

This study will evaluate the feasibility of a 12-week exercise intervention on the cardiac function of survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy.

As a secondary objective, the study will document the effect of a 12-week exercise intervention on exercise tolerance, as determined by measurement of peak VO2 and peak exercise workload, shortening fraction, ejection fraction, and left ventricular wall thickness, and assess the impact of the intervention on neurocognitive functioning in survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy.

Eligibility Criteria:
Inclusion Criteria:

* Treated at St. Jude Children's Research Hospital (SJCRH)
* Ages 0 - 17 years at time of treatment
* Treated for any type of cancer
* ≥ 10 years from date of diagnosis
* ≥ 2 years after completion of active cancer therapy
* ≥ 18 years of age
* Treated with doxorubicin and/or daunorubicin (any cumulative dose)
* Ejection fraction of \< 55% without medications
* Does not currently meet the Centers for Disease Control (CDC) recommendations for exercise for adults

Exclusion Criteria:

* Ejection fraction ≤ 40%
* Pregnant females (Positive Urine pregnancy Test).
* History of congenital heart disease
* History of myocardial infarction
* History of acute coronary syndrome
* Individuals with pacemakers or implanted defibrillators
* History of radiation therapy that included any part of the heart
* ≥1-mm J-point depression (depression measured 80 msec after J-point) with ST segment flat or down-sloping in the majority of complexes in any ECG lead except AVR with exercise testing.
* All patients will be classified using the recommendations of the American Heart Association. Patients found to be in Class A, C or Class D will not be eligible for study
Implementation of a Web-based App for Screening in Men in a Malaysian Primary Care Setting

The purpose of this study is to determine how to successfully implement ScreenMen in the primary care setting. ScreenMen is a mobile web-based app that has been developed to increase the uptake of screening in men. ScreenMen undertook a vigorous and systematic approach in its development. It was developed based on theories, evidence and needs of men. ScreenMen particularly target men in the age group of 20 to 50 years as this group of men usually do not attend any health screening. This research is necessary because ScreenMen has yet to be implemented in the primary care setting. The study will last about five months and your participation will be about five months.


Eligibility Criteria:
Inclusion Criteria:

1. Healthcare providers that were involved in the clinic health screening program.
2. Patients who were aged 18 years and above were eligible to participate.

Exclusion Criteria:

1. Temporary healthcare providers (working in the clinic less than six months during the study period) and those who were away on leave.
2. Patients who did not understand Bahasa Malaysia, English or Mandarin, cognitively impaired, had an active psychiatric illness or were too ill.
US Selumetinib Registry

The purpose of this study is to understand treatment patterns and assess long-term effectiveness and safety outcomes associated with selumetinib treatment as well as to explore clinical and non-clinical factors affecting those outcomes in patients with neurofibromatosis type 1 (NF1) and plexiform neurofibromas (PNs) who started selumetinib between the ages of 2 to 18 years inclusive, and initiated selumetinib treatment on or after 10 April 2020 in a real-world setting.

This is a US observational registry of pediatric NF1 PN participants treated with selumetinib.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with NF1 and PN
* Started selumetinib between the ages of 2 to 18 years inclusive, and initiated selumetinib treatment on or after 10 April 2020, including patients who:
* Discontinued selumetinib before enrollment; or
* Initiated treatment before enrollment and are currently on selumetinib; or
* Initiated selumetinib on the day of enrollment or intend to initiate selumetinib within 3 months after enrollment
* Able to give written informed consent. Participant or participant's parent/legal guardian must be willing and able to give written informed consent and the participant (if minor) must be willing to give written informed assent.

Exclusion Criteria:

* Participants currently participating in any clinical trials at time of enrollment or initiation of selumetinib.
BMI Effect on the Response to Ovulation Induction in Letrozole vs Clomid

There is an increased prevalence of high Body mass index (BMI) all over the world.High BMI is shown to have an impact on the female reproductive system.It can contribute to both ovulatory and anovulatory subfertility.

Clomiphene citrate and Letrozole have been used for treatment of infertility.Both are used for induction of ovulation.

Clomiphene citrate is an estrogen receptor antagonist .It increases serum FSH and it has its limitation due to his antiestrogenic effect,it has an ovulation rate 70-80% but pregnancy rate is only 22% because of its anti-estrogenic effect on endometrium and poor cervical mucus (Legro RS et al.,2007) Letrozole is an aromatase inhibitor which inhibits the production of estrogen, which influences the action of the brain's hypothalamus and pituitary on the functioning of the ovaries by increasing FSH.Due to the antiestrogenic effect of clomiphene citrate,Letrozole can be used as an alternative.

The investigators are comparing the effect of both medications on the outcome of the induction of ovulation in women with high BMI.

This is a Randomized controlled trial .The researchers include160 women with BMI more than 30 who were suffering from subfertility for more than 2 years. The investigators will randomise them into 2 groups. Group A:They were prescribed 100 mg of clomiphene citrate from day 2-5 of the cycle for 5 days. Group B : They were prescribed 5 mg of Letrozole from day 2-5 of the cycle.

Vaginal ultrasound was performed on day 11 of the cycle, After at least one follicle reached 15 mm, The patient was encouraged to have sexual intercourse every other day for few days.The patients will have a midluteal progesterone level to confirm ovulation and will have a pregnancy test in 2 weeks if missed period. The researchers will compare the number of mature follicles, endometrial thickness on the day when there are mature follicles, occurrence of pregnancy, multiple pregnancies, and miscarriages .

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-45 years old.
* History of subfertility for 2 years.
* No previous IVF
* Intact tubes as evidenced by HSG or Hycosy
* Normal Sperm parameters according to WHO criteria.
* Ability to have regular intercourse during the ovulation induction phase of the study.

Exclusion Criteria:

* Age less than 18 years old or older than 45 years old.
* FSH\> 15 mIU/ml
* Tubal factor of infertility
* Male factor of infertility
* Current pregnancy,abnormal uterine bleeding.
* History of use of hormonal contraception in the last 3 months.
* Untreated medical problems: thyroid disease,hyperprolactinemia or contraindication to pregnancy as uncontrolled diabetes or severe heart disease.
* Contraindications to clomiphene citrate: hypersensitivity to clomid.
* Contraindications to letrozole: hypersensitivity to letrozole .
Progressive Rehabilitation Following Total Knee Arthroplasty

The purpose of this study is to evaluate the effectiveness of a progressive resistance rehabilitation program (PROG) after total knee arthroplasty (TKA) compared to a traditional rehabilitation program (TRAD).

The investigators hypothesized:

* PROG will result in greater improvements in functional outcome measures such as: stair climbing test (SCT), timed-up-and-go test (TUG), six minute walk test (6MW), the Knee Injury and Osteoarthritis Outcome Survey (WOMAC), and knee range of motion (ROM).
* PROG will result in greater improvements in quadriceps muscle strength gains after TKA compared to TRAD.
* PROG will result in greater improvements in muscle mass and central activation compared to TRAD.

Over 500,000 total knee arthroplasties (TKAs) are performed each year in the United States to alleviate pain and disability associated with knee osteoarthritis (OA), and this number is expected to grow to 3.48 million per year by the year 2030. TKA reduces pain and improves self-reported function compared to pre-operative levels, but post-operative deficits in walking speed (20% slower) and stair climbing speed (50% slower) can persist for years. Stair climbing performance is the single largest residual deficit after TKA with seventy-five percent of TKA patients reporting difficulty negotiating stairs after surgery. Collectively, these findings suggest that current rehabilitation does not adequately target the impairments that lead to long-term deficits in functional mobility after TKA.

The aim of the proposed trial is to evaluate the effectiveness of a progressive resistance rehabilitation program (PROG) after TKA compared to a traditional rehabilitation program (TRAD). The PROG intervention will involve intensive rehabilitation using progressive resistance exercise and faster progression to functional strengthening exercises. The TRAD intervention represents the synthesis of previously published TKA rehabilitation programs. Our preliminary data suggest that the PROG intervention has low risk and results in improved functional mobility and muscle strength. The investigators will measure function and strength at six time points (pre-op; 1, 2, 3, 6, and 12 months after TKA). The investigators will also evaluate the contribution of changes in muscle mass (atrophy/hypertrophy) and central activation to changes in muscle strength following PROG and TRAD interventions.

Eligibility Criteria:
Inclusion Criteria:

* undergoing a primary, unilateral knee arthroplasty
* body mass index \< 40 kg/m2

Exclusion Criteria:

* severe contralateral leg OA (\< 5/10 pain with stair climbing) or other unstable orthopaedic conditions that limit function
* neurological conditions that affect muscle function
* vascular or cardiac problems that limit function
* uncontrolled diabetes
* pregnancy
Effects of Lateral Wedge Insoles, Knee Taping on the Management of Knee Osteoarthritis

Knee osteoarthritis (OA) is a degenerative, progressive and wide spread disease, which may lead the patient to severe outcomes e.g. pain, loss of joint motion, inflexibility, disability and decreases the quality of life (QOL). As it affects the adults of older age, therefore should be emphasized.Effectiveness of Mulligan knee taping, lateral wedge insoles and traditional physical therapy(Ultrasound therapy with stretching and strengthening exercises) with home exercises as baseline treatment were assessed through RAPA and complete KOOS questionnaire.

A total of 60 patients with medial compartment 3rd grade knee osteoarthritis were recruited and randomly divided into three groups, 20 in each group.The data was collected through general demographic questionnaire, rapid assessment of physical activity (RAPA) to determine physical activity level and Knee injury and Osteoarthritis Outcome Score (KOOS) to determine the level of pain severity, stiffness, functional activities, recreational activities and Quality of life for enhancing functional independence while having osteoarthritis. For between-group analysis, one way ANOVA was used and for within-group analysis longitudinal repeated measures analysis of variance (RM-ANOVA) with Tukey's multiple comparisons test was used.

Eligibility Criteria:
Inclusion Criteria:

* Knee OA in the age group of 40-70 year.
* Knee OA due to aging.
* Knee OA due to family history

Exclusion Criteria:

* Knee OA due to Trauma.
* Knee OA due to any knee pathology.
The Impact of Riboflavin on Sports-related Concussion

The purpose of this study is to investigate the effectiveness of riboflavin to decrease the duration of time for a student-athlete to return to participation in sports after a sports related concussion.


Eligibility Criteria:
Inclusion Criteria:

* All UVa and JMU student-athletes over the age of 18 years old who are diagnosed with a sports related concussion

Exclusion Criteria:

* Less than 18 years old
* Greater than 24 hours have elapsed since the concussion occurred.
* The student-athlete has already participated in the study during which he/she took Riboflavin
* Non-sports related concussion not incurred while participating in the sport or training for the sport. As an example, a student-athlete who sustains a concussion as a result of a motor vehicle accident will be excluded from the study for that concussion.
* A previous concussion within the last 12 months.
* Any concussion that is complicated by a cranial bleed, skull fracture, additional severe injury (e.g. torn knee ligament) that might affect the return to normal activities above and beyond the sport-related concussion.
* If the student athlete is cognitively impaired to a level that prevents verbal communication, the consent will be deemed 'opted out' and the student-athlete will not be enrolled in the study.
Impact and Cost of a Pharmacist Pneumococcal Vaccination Program With PNEUMOVAX® 23 at an Urban Senior Center

The overall goals of this program are to measure the impact of a pharmacist pneumococcal vaccine education program (PPVP) using a senior center model of care and provide the pneumococcal vaccine to eligible participants.

Hypotheses

1. PPVP will result in improved knowledge and awareness in older minorities in the senior center setting (primary hypothesis);
2. Participants who are vaccinated through the project will experienced increased trust in receiving vaccines from a pharmacist;
3. Participants will be satisfied with and trust the PV information provided by pharmacists in the PPVP;
4. PPVP is an efficient approach to educating patients in the senior center based on its costs;
5. Participating pharmacists will be activated to implement PPVP learnings in their practice.


Eligibility Criteria:
Inclusion Criteria:

A. Inclusions for PPVP:

1. Age ≥ 50 years old
2. Can attend a 1.5-hour session at CIP
3. Cognitively intact based on responses to an Abbreviated Mental Test Score (AMTS) of ≥7 (see Appendix for AMTS instrument)
4. Can speak and read English at ≥4th grade level as evidenced by ability to read a brief passage
5. Access to a telephone

B. Inclusions to receive the optional pneumococcal vaccination:

Patient meets ≥1 of the following criteria for receiving their first pneumococcal vaccination:

1. All adults age 65 years and older who have not had the vaccine previously
2. Age 50-64 years with any of the following conditions:

   1. Cigarette smokers age 19 years and older
   2. Chronic cardiovascular disease (e.g., congestive heart failure, cardiomyopathies; excluding hypertension)
   3. Chronic pulmonary disease (including COPD and emphysema, and for adults ages 19 years and older, asthma)
   4. Diabetes mellitus
   5. Alcoholism
   6. Chronic liver disease, cirrhosis
   7. Candidate for or recipient of cochlear implant
   8. Functional or anatomic asplenia (e.g., sickle cell disease, splenectomy)
   9. Immunocompromising conditions or on immunosuppressive therapy
   10. Chronic renal failure or nephrotic syndrome

OR

Patient meets ≥1 of the following criteria for receiving a booster dose of the pneumococcal vaccination:

1. Adults age 65 years and older who received their first dose for any indication when they were younger than age 65 years.
2. Adults age 50-64 who have not received the vaccine for ≥5 years and have one of the following conditions:

   1. Functional or anatomic asplenia (including persons with sickle cell disease or splenectomy patients);
   2. Chronic renal failure (including dialysis patients) or nephrotic syndrome;
   3. Immunocompromising conditions or on immunosuppressive therapy

Exclusion Criteria:

A. Exclusions to the PPVP program: none

B. Exclusions to receiving the optional pneumococcal vaccine:

1. Participant has a history of allergic reaction to pneumococcal vaccine
2. Participant has a history of allergic reaction to any component of any vaccine
3. Participant with moderate or severe illness (these individuals will be advised to speak to their doctor regarding the vaccine)
SAR3419 in Acute Lymphoblastic Leukemia

Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objectives:

* Response duration
* Progression Free Survival
* Minimal residual disease
* Safety
* Pharmacokinetics

The duration of the study for an individual patient will include:

* The screening period = up to 4 weeks prior to the first administration of SAR3419.
* The treatment period:

  * Induction period = 4 to 8 weeks
  * Maintenance = up to a total maintenance treatment of 6 months
  * A safety follow-up period of 42 days after the last dose.
* Any patient who discontinues the study treatment without disease progression will be followed every 2 months until disease progression, initiation of a new anti-cancer therapy, death or end-of-study date, whatever comes first.

Eligibility Criteria:
Inclusion criteria:

* Previously treated Acute Lymphoblastic Leukemia of B cell origin (including Burkitt's lymphoma) in relapse or primary refractory. Patients in first relapse will be eligible regardless of the first remission duration.
* No more than 3 prior salvage therapies.
* Philadelphia positive patients failing treatment with imatinib mesylate are accepted.
* CD19 positive patients.

Exclusion criteria:

None

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Skin Microbiota in Skin Disease and Eczema

Background: The skin microbiota influence skin health in several skin diseases and atopic dermatitis (AD). Presence of Staphylococcus have been associated to a sever course of the disease.

Objectives: The aim of the study is to investigate the influence of bacteria, and the skin microbiota on the inflammation and skin barrier. Moreover, dysbiosis in the microbiota, the inflammation profile, the skin barrier damage will be related to objective and patient oriented measures.

Importance: Knowledge of interactions between host defense, skin barrier and bacterial colonizing skin can facilitate development of new prevention and treatment strategies to control microbial impact in skin diseases and eczema.

The role of the skin microbiome in atopic eczema and other skin diseases remains to be investigated. There are reports indicating an association of skin-colonization of Staphylococcus aureus (S. aureus) and the severity of the disease. Skin colonizing pathogens might be important cofactor for persistence of eczema and other skin diseases, as well as the commensal, non-pathogenic, microflora of the skin might have protective effects. The aim of this research project is to investigate the skin microbiome in patients with eczema and other skin diseases and elucidate the relation to skin barrier impairment and severity of the skin disease.

Specifically, we will:

* Determine the skin microbiome and metagenome in skin of patients with eczema and other skin diseases.
* Straighten out the relationship between the skin microbiome, the skin barrier, contact allergies, quality of life, eczema control and severity in patients with eczema and other skin diseases.
* Identify biological markers, such as antimicrobial peptides, cytokines and gene-expression profiles in skin, and other factors contributing to the development and persistence of eczema and other skin diseases.

Eligibility Criteria:
Inclusion Criteria: Skin diseas, atopic eczema, eczema

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Exclusion Criteria:

* Inabillity to give informed concent