cyrilzakka/clinical-trials huggingface dataset:
Exercise Intervention in Female School Children: Effect on Blood Pressure, Body Mass Index (BMI), and Maths Scores

Healthy physical activity decreases blood pressure in young female school children. It also has effects on BMI and maths scores.

* Primary Objective: To compare the effect of 6 months healthy physical activity on blood pressure in female school children (9-13 yrs) with those who have routine physical activity
* Secondary objective: To compare the effect of 6 months of healthy physical activity on body mass index and maths scores with those who have routine physical activity
* Study Design: It would be a non-randomized experimental study (community intervention trial). It is designed to test the effectiveness of exercise on reducing blood pressure and the effect on BMI and maths scores
* Setting: The study would be conducted in 4 public sector schools in Karachi.
* Study Population: The study population would be selected from 4 local public sector schools near our hospital, The Aga Khan University Hospital. Two schools would have intervention and 2 schools would serve as controls. Both groups would have a base line screening for the outcome variables and then at 6 months
* Intervention: The intervention is 30 minutes of healthy physical activity; 4-times/week would be carried out for a period of 6 months. This would be carried out by certified physical trainers who are experts in training children in aerobic exercise. Intervention group will have half an hour session on exercise motivation and its benefits. The routine activity group will have a similar session at baseline.
* Sampling technique: convenience sampling
* Sample Size : A sample size of 126 (63 in each arm) achieves 80% power to detect a difference of 4.3 mm in systolic blood pressure between the null hypothesis mean of 110.3 and an alternative hypothesis mean of 105.7 with an estimated standard deviation of 9.7 and with significance level (alpha) of 0.05 using one sided one sample t test. Assuming that there could be a 10% dropout rate we plan to take a total sample size of 140 students. We multiplied the total sample size by 2 to account for the design effect between clusters (schools) and achieved a total sample size of 280 that is 140 in each arm.
* Dependent variables or outcome variables: Primary outcome measure would be the blood pressure. Secondary outcome measures would be body composition including weight, BMI, central obesity, and maths score. Independent variable would be demographics (age, school class) and the intervention of healthy physical activity and measurement of food intake frequency

Eligibility Criteria:
Inclusion Criteria:

* Female children of age 9-11 yrs who are enrolled in the public sector school with a compound facility would be included in the study. Intervention would be offered to those only who will have normal age specific weight in percentiles.

Exclusion Criteria:

* Those who are suffering from any chronic illness due to they which cannot participate and those who are mentally or physically disabled will be excluded from the study.
Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment of Adult High-risk Acute Lymphoblastic Leukemia

To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia.

To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with high-risk acute B-lymphoblastic leukemia
* Complete remission was achieved after induction chemotherapy, and autologous CD19-CAR-T was successfully prepared
* Eligible for autologous hematopoietic stem cell transplantation
* No major organ dysfunction

Exclusion Criteria:

* Combined with malignant tumors of other organs
* With a serious infection that is not under control
* Syphilis, AIDS, hepatitis B, hepatitis C, any one of them positive
* Patients who have had an allergic reaction to the drugs used in this study or similar drugs
* Other patients deemed unsuitable for inclusion by the investigators
Acute MRI in Transient Ischemic Attack

The purpose of this study is to detect acute ischemic lesions in patients admitted with symptoms of transient ischemic attack (TIA).

Diffusion weighted Imaging (DWI) is today one of the best ways to detect ischemic lesions after TIA. The problem is that this only gives the diagnosis in 30% of the cases.

It is possible that the addition of Arterial spin labeling (ASL) perfusion imaging and diffusion tensor imaging will make it possible to give a more accurate diagnosis.

The purpose of this study is to detect acute ischemic lesions in patients admitted with symptoms of transient ischemic attack (TIA).

Diffusion weighted Imaging (DWI) is today one of the best ways to detect ischemic lesions after TIA. The problem is that this only gives the diagnosis in 30% of the cases.

It is possible that the addition of ASL-perfusion imaging and diffusion tensor imaging will make it possible to give a more accurate and selective diagnosis of TIA.

Patients admitted with clinical signs of TIA can be included. Patients will be examined with the TIA protocol in reference to the standardized clinical care:

1. 1,5 tesla gradient echo and 3 tesla Susceptibility weighted imaging (SWI) to detect microbleed as sign of small vessel disease.
2. Axial T2 FLAIR to detect white matter lesions.
3. Axial DWI to detect areas with impeded diffusion.

(Total scantime 10min)

If no signs of ischemic lesions is detected the following additional research scan-protocol will be initiated:

1. Perfusion without contrast: Arterial spin labeling (ASL) with the ability of showing signs of ischemia.
2. Diffusion tensor imaging (DTI): Has a higher sensitivity than DWI in displaying local ischemic lesions.

(Total additional scantime 10min)

All in All 20min in the scanner.

Eligibility Criteria:
Inclusion Criteria:

* Clinical signs of TIA
* Informed consent
* No serious respiratory or cardiac implications

Exclusion Criteria:

* Contraindications to MRI
Correlations Between Fine Manual Motor Skills and Speech Articulation

The aim of this study is to examine the relationship between cerebral motor control during a manual task and during an articulary task, using functional MRI in a cohort or young adults aged between 18 and 35.

The literature reveals a well-established relationship between manual motor skills and speech from an anatomical and functional point of view. Some studies indicate a proximity between the motor cortical regions corresponding to the hand and the mouth, with a mutual interaction of the two functions from the earliest stages of life (for example, the Babkin reflex). Experimental data shows that hand movements can be influenced by mouth movements. Neurophysiological studies have demonstrated the existence of a link between these two systems in humans and monkeys.

To date, no study has identified the common cortical networks that are active during these two limb movements in a given sample of subjects. The aim of this study is to determine whether such networks exist. The results could be therapeutically relevant, particularly for stroke patients, by enabling more effective restoration of articulatory abilities through complementary limb movements.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female between the ages of 18 and 35
2. Right-handed
3. Member of beneficiary of a social security insurance
4. Signature of an informed consent

Exclusion Criteria:

1. Disorders of fine manual motor skills and/or articulatory disorders
2. A neurological history that has affected the subject's cerebral function (stroke, head injury)
3. Contraindication to MRI (presence of ferromagnetic material in the body, claustrophobia)
4. Pregnant women
5. Taking medication that may alter the cerebral haemodynamic signal
Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence

The objective of this study is to compare the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle training in the treatment of stress urinary incontinence. The hypothesis of this study is that home pelvic floor muscle training is as effective as outpatient pelvic floor muscle training for the treatment of stress urinary incontinence.

Success with the pelvic floor muscle training (PFMT) is hampered by non-adherence, which is related to factors such as inability to contract the pelvic floor muscles and lack of motivation. Thus under supervision by a physiotherapist (outpatient training), PFMT has the potential of improving adherence to training and has been demonstrated to be more effective when compared to unsupervised PFMT (home training). The objective of this study is to compare the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle training in the treatment of stress urinary incontinence. This is a randomized controlled trial and which will be conducted at the Division of Urogynecology and Reconstructive Pelvic Surgery at the Federal University of Sao Paulo, Brazil. As a primary endpoint, the standardized volume test pad (250 mL) will be used. To assert that one of the groups (home PFMT or outpatient PFMT) is superior to the other, it will be necessary to find 38.5% more patients cured when the groups are compared. Secondary outcome measures will be used, assessment of the pelvic floor muscles function, urinary symptoms, quality of life and subjective cure.

Eligibility Criteria:
Inclusion Criteria:

SUI and mixed urinary incontinence with predominant symptoms of SUI with ≥ 2 g of leakage measured by pad test

Exclusion Criteria:

younger than 18 years old chronic degenerative diseases pelvic organ prolapse greater than stage I by POP-Q neurologic or psychiatric diseases inability to contract PFMs previously undergone pelvic floor re-education programs and/or previous pelvic floor surgeries
Telemetric Arrhythmia and Syncope Diagnosis - Evaluation of Arrhythmia Treatment Efficacy

The purpose of this study is to assess efficacy of prolonged Full Disclosure ECG monitoring and signal analysis using advanced GSM telemetric technology to prescribe the most appropriate treatment of arrhythmia.

Non-invasive methods enabling long-term ECG monitoring in patients with paroxysmal symptoms, such as tachycardia or palpitations increase the probability of detecting infrequent but dangerous events with profound clinical significance. Patients with recommendation for the first catheter ablation of Paroxysmal Atrial Fibrillation in the reference center will be included in the study. Eligible patients will have 14-day telemetric ECG monitoring. Based on detected arrhythmia events, patient's medical history and available documentation the most appropriate treatment will be recommended. Patients will undergo invasive procedures of ablation or pacemaker implantation or can be treated pharmacologically. After the invasive treatment or initiation of pharmacotherapy the 14-day telemetric ECG monitoring will be repeated to assess efficacy of the treatment.

Patients with no record of arrhythmia requiring treatment during the first 14 days ECG monitoring will terminate participation in the study. The referring physician will be informed. Further diagnosis or treatment should be performed at the referring physician's center according to the best clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Age - between 18 and 80 years old
* Physician recommendation for ablation treatment of arrhythmia
* Patient informed consent
* Declarative and feasible compliance (patient understands basic instructions regarding device use)

Exclusion Criteria:

* Inability to comply with the study protocol
* Lack of patient cooperation
An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects

A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2% brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin analogue in glaucoma or ocular hypertension subjects


Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years of age;
2. Give written informed consent;
3. Be in good general health as determined by your doctor;
4. Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
5. If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills);
6. Understand the study instructions, and be able to follow the study instructions; and
7. Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.

Exclusion Criteria:

1. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
2. Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
3. Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit
Comparison of Efficacy Between Fractional Microneedling Radiofrequency and Bipolar Radiofrequency for Acne Scar

Compare the efficacy and safety profile of microneedling radiofrequency and that of bipolar radiofrequency treatment for acne scar.

Efficacy and safety of microneedling radiofrequency for acne scar Efficacy and safety bipolar radiofrequency treatment for acne scar compare the efficacy and safety profile of microneedling radiofrequency and that of bipolar radiofrequency treatment for acne scar

Eligibility Criteria:
Inclusion Criteria:

* moderate acne scar
* mild to moderate acne lesions

Exclusion Criteria:

* taking acne medication oral drugs within 2 months topical drugs within 2 weeks
* taken anu procedures for acne scar within 6 months
* taking steroid,nonsteroidal antiinflammtory drugs, isotretinoin
* underlying diabetes mellitus, keloid, or any malignancy
Thromboelastography Guided Blood Product Transfusion for Upper Gastrointestinal Bleeding in Cirrhosis

The goal of this clinical trial is to compare resuscitation strategies in patients with cirrhosis and gastrointestinal bleeding. The main question it aims to answer is whether thromboelastography guided resuscitation decreased the amount of fresh frozen plasma patients receive. Patients will receive blood products guided by thromboelastography in the intervention group. Researchers will compare the patients who undergo thromboelastography guided resuscitation to those who receive usual care to see which strategy leads to the use of less blood products, specifically less fresh frozen plasma.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older
* Octreotide order placed for the indication of upper gastrointestinal bleeding in cirrhosis

Exclusion Criteria:

* None
Dysport® Adult Upper Limb Spasticity Extension Study

The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

This was a phase III, multicentre, prospective, open label, repeat treatment cycles, extension to the double study Y-52-52120-145 (Study 145) . The study included both rollover subjects from Study 145 and de novo subjects. The primary study objective was to assess the long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles. The secondary study objective was to assess the long term efficacy of repeated treatment with Dysport®.

Eligibility Criteria:
Inclusion Criteria:

* Completion of the double blind study, Y-52-52120-145

Exclusion Criteria:

* Major limitation in the passive range of motion in upper limb
A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities (PRESTO)

This study will investigate the acceptability and efficacy of 12 weeks of: Smart-device app-based (MyZone) Asynchronous Virtual, Synchronous Virtual, and in-person aerobic training in individuals at risk for Cardiovascular Disease (CVD) who do are not meeting American Heart Association (AHA) guidelines for physical activity. The study aims to 1) Assess the effect of several approaches to remote aerobic training on measures of physical activity, cardiovascular fitness and CVD risk, and 2) Quantitatively and qualitatively evaluate exercise training program fidelity, implementation, effectiveness, and remaining barriers to acceptance.

Participants will be asked to undergo Cardiopulmonary Exercise Testing (CPET) before and after 12-weeks of training via one of the 4 modalities (random assignment) listed above. They will respond to questions regarding acceptability of the interventions.


Eligibility Criteria:
Inclusion Criteria:

1. \>45 years
2. At risk for CVD (participants must have one or more of the following risk factors: hypertension, hyperlipidemia, Type 2 Diabetes Mellitus, smoking, obesity, family history of premature CVD)
3. Not meeting AHA physical activity guidelines for at least 3 months prior to screening

   * Hypertension:

     * Systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg and/or
     * Use of anti-hypertensive medication
   * Hyper / dyslipidemia

     * LDL cholesterol levels ≥160 mg/dL and/or
     * HDL cholesterol \<50mg/dL for women, \<40mg/dL for women, in addition to fasting triglycerides \>150mg/dL
   * Diabetes Mellitus:

     * Hemoglobin A1c levels ≥6.5%, fasting glucose levels ≥126 mg/dL, or 2-hour glucose levels ≥200 mg/dL after an oral glucose tolerance test and/or
     * Use of any diabetes medication
   * Smoking:

     o Current regular tobacco use.
   * Obesity:

     o BMI ≥30 kg/m².
   * Family History of Premature Cardiovascular Disease:

     * Having a first-degree relative (parent, sibling) who developed CVD before age 55 for biological males or age 65 for biological females.

Exclusion Criteria:

1. Established diagnosis of atherosclerotic CVD
2. Presence of any serious medical conditions that would not allow safe participation in exercise according to the American College of Sports Medicine (ACSM) and the AHA (56-58)
3. Pregnant or anticipating pregnancy
4. Plan to be away for \>2 weeks during the intervention period
5. Presence of any biopsychosocial factors that the principal investigator deems as having significant potential to interfere with effective study participation
Preop Conformal Radiotherapy - Prostate

Radical prostatectomy and radical radiation therapy remain the standard treatment approaches for patients with clinically localized prostate cancer (T1, T2).Radical prostatectomy is most effective when the disease is organ confined at the time of surgery. However, in many series up to 60% of patients have positive resection margins at the time of surgery and there is evidence to suggest that these patients may not be curable by surgery alone. A number of preoperative clinical variables including clinical stage, serum Prostate Specific Antigen (PSA) and Gleason scorea re helpful in determining the probability of finding organ confined disease at the time of syrgery.


Eligibility Criteria:
* Histologically confirmed carcinoma of the prostate
* High risk localized disease defined as clinical T1 or T2 plus \[ (i) Gleason ¡Ý7, PSA\>10 ng/ml and \<35 ng/ml OR (ii) PSA \>15 ng/ml and less \<35 ng/ml (any Gleason) \]
* No evidence of pelvic lymph node metastases on CT scan within 4 months of surgery
* No evidence of distant metastases on bone scan within 4 months of surgery
* No contraindication to pelvic radiation therapy
Effects of Delta-9-THC and Iomazenil in Healthy Humans

The study aims to examine the combined effects of delta-9-tetrahydrocannabinol (∆-9-THC or THC) and iomazenil on thinking, perception, mood, memory, attention, and electrical activity of the brain (EEG). THC is the active ingredient of marijuana, cannabis, "ganja", or "pot". Iomazenil is a drug that works opposite to drugs like valium. The purpose of this study is to determine whether the administration of iomazenil will alter the effects of THC.


Eligibility Criteria:
Inclusion Criteria:

* Exposed to cannabis at least once in their lifetime

Exclusion Criteria:

* Cannabis naïve
* History of hearing deficit
Inhaled Nitric Oxide by Oxygen Hood in Neonates

Inhaled nitric oxide (iNO) improves oxygenation in term infants with respiratory failure. However, iNO has been primarily used in infants receiving mechanical ventilation. This study is a pilot study to determine if iNO given into an oxygen hood is effective in improving oxygenation in term and near-term infants who have poor oxygenation but who are not yet mechanically ventilated.

Inhaled nitric oxide (iNO) is currently used in the management of ventilated neonates with hypoxemic respiratory failure. We have shown that iNO administered by oxygen hood reduces pulmonary vascular resistance in hypoxia- and group B streptococcus-induced pulmonary hypertension in an animal model (J Perinatol 2002; 22:50-6). Our objective was to determine the feasibility of iNO administration by oxygen hood in neonates with respiratory failure. Methods: A masked randomized controlled trial was performed on eight infants with respiratory failure. Inclusion criteria were: gestation\>34 weeks, age\<7 days, with post-ductal arterial line, and A-aDO2 400-600 on two consecutive blood gases. Infants were randomized to study gas (iNO at 20 ppm or equivalent flow of O2) for 1 hr which was then weaned over the next 4 hours. The iNO was introduced into an oxygen hood using an INOvent (INO Therapeutics, Inc). The primary outcome was the PaO2 one hour after randomization. Environmental leakage of NO and NO2 were measured. Results: Four infants were randomized to iNO and four to O2 (controls). Two of the four infants given iNO had an increase in PaO2 of \>100 mm Hg, while oxygenation was unchanged in the controls. Methemoglobinemia and other adverse effects were not noted in any infant. Environmental levels of NO and NO2 were minimal (\<1ppm) to undetectable at \>0.3m from the hood. Conclusions: Administration of iNO by oxygen hood is feasible. Larger randomized controlled trials are required to measure the efficacy and determine an appropriate target population for this technique.

Eligibility Criteria:
Inclusion Criteria:

* gestation \>34 weeks at birth
* age \<7 days
* post-ductal arterial line
* an A-aDO2 of 400 to 600 on two blood gases, at least 30 minutes apart.

Exclusion Criteria:

* Infants with major malformations
* Infants with cardiac disease