cyrilzakka/clinical-trials huggingface dataset:
Effect Of Brain Gym Exercises On Postural Stability In Children With Down Syndrome

This study will be conducted to detect the effect of brain gym exercises on postural stability in children with down syndrome .

Evaluation procedures:

History of the patients was carefully taken to collect data about their general conditions, physical activity and current medication. The procedures of this study were divided in the following main parts:

-Preparatory Procedures:

* All medical and demographic data of subjects will be collected
* The role of physical therapy importance in improving their life will be explained.
* The basic vital signs of all patients will be monitored (BP, temperature, respiratory rate, and HR).
* The patients will be instructed to report any side effects during the treatment sessions .

explained to the children and to their parents, before conducting the study. All the participants were screened (examined) according to inclusion and exclusion criteria. then met the parents of the participants, told them about the study, and received a written approval from them .

All the children were firstly screened for balance deficit (static , dynamic and functional balance) by using

* Single leg stance Test (SLS) for static balance assessment
* Timed up and Go Test (TUG) for dynamic balance assessment
* Paediatric Balance Scale (PBS) for functional balance assessment

  * the assessment and the treatment program, were conducted for each child individually, before and after the treatment period.

assessment :

* Single leg stance Test (SLS) for static balance assessment
* Timed up and Go Test (TUG) for dynamic balance assessment
* Paediatric Balance Scale (PBS) for functional balance assessment

TTT :

Group A will receive brain gym exercises and physiotherapy, while Group (B) will receive physiotherapy alone.

brain gym exercises will be applied for 12 weeks , 3 per week .

Therapist Will ask the child to drink a cup of water ,then investigators apply these exercises :

Cross Crawl - Elephant - Belly breathing -The owl - Arm activation -positive points - Energizer - foot flex - neck rolls -the grounder -Brain Buttons -Hook Up Sitting position - Thinking Caps- Lazy Eights - The Rocker-Calf pump - The gravity glider exercise.

Eligibility Criteria:
Inclusion Criteria:

-

Child characteristics:

* Their age ranged from six to twelve years.
* Both genders will be included.
* ALL children were mentally sub-normal and they were able to understand the command that will give to them (IQ ranged from 60 - 70) according to the national research centre reports.
* Their weight and height will be within normal ranges.
* They were able to stand on the balance check system and maintain stability on it.

Exclusion Criteria:

hildren with DS, who might have one or more of the following will be excluded:

* Children with severe mental retardation.
* Children who have any associated disorders or any congenital abnormalities that may affect balance.
* Children with visual defects that can affect their performance.
* Obese children.
Reflux in Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction

The purpose of this study is to investigate the incidence of reflux in patients with spinal cord injury in relation to the lesion level, duration of injury and bladder management

Vesico-ureteral reflux was the main cause for renal failure and reduced life expectancy in patients with neurogenic bladder dysfunction due to spinal cord injury. Neurogenic detrusor overactivity leads to high intravesical pressure and may induce reflux. Decreasing intravesical pressure and increasing bladder capacity is necessary to prevent reflux and secondary renal failure.

Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury
* Neurogenic lower urinary tract dysfunction
* Written informed consent

Exclusion Criteria:

* Lower urinary tract dysfunction due to other causes than spinal cord injury
Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed SP0961 (NCT01118949) to continue to receive Lacosamide.


Eligibility Criteria:
Inclusion Criteria:

* Subject completed the SP0961 (NCT01118949) study
* Subject is expected to benefit from participation in an open-label extension study with Lacosamide, in the opinion of the investigator

Exclusion Criteria:

* Subject meets the withdrawal criteria for SP0961 (NCT01118949) or is experiencing an ongoing Serious Adverse Event (SAE)
SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era

SCOPE is an observational, prospective study of HIV-1 infected volunteers designed to provide a specimen bank of samples with carefully characterized clinical data. SCOPE specimens will be used to examine multiple questions involving virologic, immunologic, and host factors involved in HIV-1 infection, progression, non-progression, response to treatment, control of HIV-1 virus, and evolution of drug resistance.

SCOPE is an observational, prospective study of HIV-1 infected volunteers designed to provide a specimen bank of samples with carefully characterized clinical data. Samples from SCOPE will be used to examine:

1. Virologic, immunologic, and host factors involved in the natural control of HIV-1 infection (long term non-progression and/or virologic control of HIV-1 without antiretroviral therapy)
2. Virologic and immune correlates associated with disease progression
3. Evolution of antiretroviral drug resistance
4. Factors associated with transmission or acquisition of HIV infection

Enrolled subjects are seen at San Francisco General Hospital every four months for a detailed interview, saliva collection, and blood draw. Baseline visits take approximately one hour, follow up visits take approximately 20-40 minutes. No personal identifiers are used for specimen bank samples.

Eligibility Criteria:
Inclusion Criteria:

SCOPE is currently recruiting HIV-1 infected subjects with any of the following criteria:

1. Documented HIV viral load less than 2000 copies/ml WITHOUT taking antiretroviral therapy
2. Undetectable HIV viral load with CD4 T-cells consistently less than 350 for the last 12 months while taking a stable antiretroviral regimen.
3. Antiretroviral naive and planning to start an antiretroviral regimen - any CD4 or HIV viral load acceptable.
4. Long-term Non Progressors: HIV-positive at least 10 years, no antiretroviral therapy for the past 10 years or more, any viral load acceptable, CD4-T cell count always above 500.

Exclusion Criteria:

1. Active opportunistic infection or systemic treatment for opportunistic infection within the last 4 months (oral candidiasis acceptable)
2. Active treatment for cancer
3. Active treatment for hepatitis C requiring interferon based therapy
4. Immunosuppressive therapy taken within the last 4 months
Effects of HIIT on Metabolic Syndrome

The project aims to find out the differences between two different types of structured training interventions have on the lipid profile of persons with diagnosed dyslipidemia. Each training intervention will last for 12 weeks. Subjects participating in the project will undergo a series of tests before and after the training intervention which will allow us to make conclusions.

The purpose of this project is to compare the effect that two different types of aerobic training modes have on the lipid profile of subjects with pre-symptoms of metabolic syndrome. One training mode will involve High-Intensity Interval Training and the other will involve medium intensity continuous training. The desired outcomes of this project are to know the effects of both modes of training have on the long-term on the lipid profile in order to help develop a nonpharmacologic alternative to prevent or treat metabolic syndrome and to know how affective and enjoyment responses are affected by the different modes of training. The Project lasts for 16 weeks. Training will take place during weeks 3 and 14 of the project. The project will be described fully to the participants during the 1st week. In addition to this, their rights as participants will be explained in addition to any possible ethical issues that might require clarifying. Once the subjects have agreed to take part in the research they will undergo a series of tests in order to asses their cardiorespiratory fitness and their lipids profile. Before starting the training intervention participants will be randomly assigned to one of the 3 different groups; Control, Medium Intensity Continuous Training and Low Volume High-Intensity Interval Training. Between weeks 3 and 14 subjects will take part in 3 training sessions per week. At week 15 and 16 subjects will undergo the same tests as during week 1 and 2.

Eligibility Criteria:
Inclusion Criteria:

* Fasted Blood Glucose \>100 mg/dL
* Total Cholesterol \>200 mg/dL
* Blood Pressure \>130/90 mmHg
* Do not partake in more than 150 min/week of moderate to vigorous exercise

Exclusion Criteria:

* Existing or past medical history of vascular disease, cancer, diabetes, osteoporosis, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease.
* Musculoskeletal injuries
* Neuromuscular disorders or injuries
* Individuals with a pacemaker
Femom System Compared to the Standard of Care CTG

The goal of this observational study is to evaluate the safety and performance of the femom system compared to the standard of care CTG for antepartum fetal monitoring in pregnant women with singleton gestation \> 32+0 weeks of pregnancy. The main questions it aims to answer are to assess the agreement between femom data collection (FHR, MHR, UA), and values measured via the standard of care used for prenatal monitoring (i.e. CTG). The secondary objective is to test concordance in clinical interpretability of femom traces and the standard of care CTG traces.

Participants will have the femom device and CTG attached to their abdomen. The femom device will be attached for about 30 minutes while they are wearing the device for the NST.


Eligibility Criteria:
Inclusion Criteria:

1. Female age between 18-50-year-old
2. Singleton pregnancy.
3. Should be at and above 32+0 weeks of pregnancy.
4. Able to speak and read English to understand and sign the Informed Consent.

Exclusion Criteria:

1. Participants with an intellectual or mental impairment.
2. Participants with a known allergy or hypersensitivity to ECG gel electrodes.
3. Known fetal cardiac or genetic abnormality.
4. Clinically unstable participants who require immediate medical care.
5. Participants with existing dependent or unequal relationships with any member of the research team, the researchers(s) and/or the person undertaking the recruitment/consent process.
6. Participants with implantable electronic devices such as pacemaker or ICD.
7. Participants with medical skin condition in the abdominal area (such as wounds, cuts in the skin, skin rash, etc.)
Comparison of Restoration in Vitreous Hemorrhage Patients With DME After or Not Removing Inner Limiting Membrane

This study is conducted to compare the anti-VEGF effect and visual function in vitreous hemorrhage patients with diabetic macular edema after pars plana vitrectomy with inner limiting membrane peeling or not


Eligibility Criteria:
Inclusion Criteria:

* Patients with vitreous hemorrhage with diabetic macular edema and require vitreous surgery

Exclusion Criteria:

1. The patient's preoperative vitreous hemorrhage resulted in the failure of OCT to scan the macular region
2. The patient with a history of anti-VEGF therapy
3. Patients with DME in the contralateral eye requiring anti-VEGF therapy
4. Patients with contraindications of vitreous cavity resection
5. The patient has a history of intraocular surgery
6. The patient has active inflammatory disease
7. The patient has other retinal diseases that affect vision
8. The patient has other systemic diseases that required treatment with anti-VEGF drugs
9. Patient with contraindications to anti-VEGF therapy
Insulin Glargine at Bedtime or in AM Versus NPH

To compare the efficacy and safety of once-nightly insulin glargine versus a single morning injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients inadequately controlled on combination oral agents.

Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when used as a once-nightly or morning basal insulin injection in type 2 diabetic patients who are inadequately controlled on combination oral agents has been controversial. Inner city ethnic minority patients with diabetes are a particularly challenging population of diabetic patients to treat. This study investigates whether insulin glargine may be a more effective or safer first-line basal insulin than NPH in this population.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18-75
* Type 2 diabetes diagnosed for at least 1 year
* Treatment with stable doses of oral agents (alone or in combination) for at least 2 months
* Inadequate glycemic control (hemoglobin A1c ≥ 7.5%) on maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione
* No past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)
* Hemoglobin A1c between 7.5% and 12%
* Body mass index (BMI) between 20 and 40 kg/m2

Exclusion Criteria:

* Current or previous chronic use of insulin (other than for treatment of gestational diabetes)
* History of confirmed (or clinical suspicion of) type 1 diabetes
* Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception
* Current pregnancy or lactation.
* Subjects for whom insulin therapy is contraindicated or for whom, in the opinion of the investigator, therapy with insulin is not indicated
* Subjects with advanced proliferative diabetic retinopathy
* Subjects who work night shifts or who are unable to stay on a consistent daily meal schedule
* History of any clinically significant renal, hepatic, cardiovascular, neurological, endocrinological or other major systemic disease that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the data difficult.
* Subjects who will likely require or initiate therapy with drugs which may interfere with glucose metabolism during the course of the study
* Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
* Subjects who are unable or unwilling to comply with all components of the study protocol, including contacting the investigators at specified times and attending all scheduled follow-up visits.
Health-related Quality of Life in Colon Cancer

This study investigates health-related Quality of life in colon cancer patients in Västmanland, Sweden, at diagnosis, at 6 months, 1, 2 and 3 years after diagnosis, measured by the well-validated EORTC QLQ-C30 questionnaire.

See above.

Eligibility Criteria:
Inclusion Criteria:

All patients diagnosed with colon cancer in Region Västmanland 2012-2016.

Exclusion Criteria:

Language problems, declined inclusion,
Bioresorbable Polymer-Coated EES in Patients at High Bleeding Risk Undergoing PCI Followed by 1-Month DAPT

Objective: To evaluate the safety of bioresorbable polymer-coated everolimus-eluting Synergy® stent followed by 1-month dual antiplatelet therapy in patients at high-bleeding risk.

Study population: Real world high-bleeding risk (HBR) patients with coronary artery disease (stable as well as acute coronary syndromes) who qualify for percutaneous coronary interventions.

Study size: A total of 1023 patients will be enrolled. Study design: Prospective, single-arm, multicentre trial, powered for non-inferiority with respect to objective performance criteria (OPC).

Antiplatelet therapy: Dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor for a duration of 1 month, after which single antiplatelet therapy with aspirin will be recommended indefinitely. In case of need for oral anticoagulation, patients will receive an oral anticoagulant in addition to a P2Y12 inhibitor without aspirin for 30 days.

Primary endpoint: Composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 1-year follow-up.


Eligibility Criteria:
Inclusion Criteria:

All patients will need to have symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, or acute coronary syndromes (including NSTE-ACS and STE-ACS) and presence of one or more coronary artery stenoses \>50% in a native coronary artery or a saphenous bypass graft that treated with one or multiple Synergy® stents.

Moreover, in order to be included patients will need to meet at least 1 of the following HBR criteria:

1. Age ≥75 years
2. Oral anticoagulation planned to continue after PCI
3. Hemoglobin \<11 g/l,
4. Transfusion within 4 week before inclusion
5. Platelet count \<100'000
6. Hospital admission for bleeding in previous 12 months
7. Stroke in previous 12 months
8. History of intracerebral hemorrhage
9. Severe chronic liver disease
10. Creatinine clearance \<40 ml/min
11. Cancer in previous 3 years
12. Planned major surgery in next 12 months
13. Glucocorticoids or NSAID planned for \>30 days after PCI
14. Expected non-adherence to \>30 days of dual antiplatelet therapy

Exclusion Criteria:

1. Cardiogenic shock
2. Major active bleeding at the time of PCI
3. Expected non-adherence with 1 month DAPT
4. Known intolerance to aspirin, clopidogrel, or ticagrelor
5. Inability to provide informed consent
6. Currently participating in another trial before reaching first endpoint
Treatment of Complex Regional Pain Syndrome, a Long-term Follow-up

Complex regional pain syndrome, CRPS, is an uncommon but often very disabling chronic pain syndrome characterized by, beside pain: sensory disturbances, peripheral autonomic changes and inflammatory features. The diagnosis is subdivided in CRPS type 1 where no nerve injury has been identified, and CRPS type 2 when a major nerve injury has been verified.

A combination of exposure in vivo, a form of behaviour therapy where the patient is gradually confronted with avoided movements and activities, and interventions directly targeting a hypothesized cortical reorganisation is an interesting novel approach for treating CRPS.

The present study consists of (1) a qualitative interview study with 10-15 subjects that has received this form of treatment, in order to better understand their experience and effects of the treatment, and (2) a case series with long-term follow-up of 3-5 subjects that received the treatment för 5-8 years ago, in order to study the long term effects of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Has participated in multimodal treatment for CRPS at Uppsala University Hospital

Exclusion Criteria:

* Other serious physical or mental condition
Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer

The aim of this prospective, longitudinal Swedish multi-center study is to assess the quality of life, treatment-related morbidity, unmet needs and satisfaction with care after treatment for vulvar cancer, evaluated by a validated questionnaire.

PRIMARY OBJECTIVES:

Information about:

* General and vulvar-cancer-specific quality of life before and after any treatment for newly diagnosed vulvar cancer
* Treatment-related morbidity after any treatment for newly diagnosed vulvar cancer
* Unmet needs of patients with newly diagnosed vulvar cancer
* Satisfaction with care after any treatment for newly diagnosed vulvar cancer in Sweden.

OUTLINE:

The study is planned as a prospective, longitudinal multi-centre study in Sweden. Since 2017, the treatment of vulvar cancer patients has been accredited to four tertiary referral university hospitals in Sweden; the Sahlgrenska University hospital in Gothenburg, the Linköping University hospital, the Skåne University hospital in Lund and the Karolinska University hospital in Stockholm.

150 patients are estimated for inclusion during a time frame of about 18 months.

Eligible patients will be asked to complete a validated questionnaire at different points of time (before and after treatment). Calculating a response rate of about 50% - 60%, this will result in at least 80 completed questionnaires.

The questionnaires consist of the following parts:

* European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-C30
* European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-VU-34 (Vulva-specific module)
* Hospital Depression and Anxiety Scale (HADS)
* Supportive Care Needs Survey Short Form, excerpt (SCNS-SF34)
* European Organisation for Research and Treatment of Cancer (EORTC)-PATSAT (Patient Satisfaction), excerpt
* Demographic data
* 25 self-constructed (and validated) questions

RESULTS:

Results are expected to be available in 2021.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of vulvar cancer, all stages, all planned treatments
* Informed consent

Exclusion Criteria:

* Disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia
Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal

This study is an open-label, randomized, single-center, single-dose, two-way crossover study of the PK properties of Androxal in healthy male subjects. Twelve male subjects will each receive a single dose of Androxal 25 mg in both the fed and fasting state.


Eligibility Criteria:
Inclusion Criteria:

1. Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
2. Male; age 18-60 with a BMI of 25-42 kg/m2 inclusive
3. No significant abnormal findings at the screening physical examination as evaluated by the Investigator;
4. Normal laboratory values (or abnormal but not clinically significant) at screening as determined by the Investigator;
5. Subject is willing to remain in the clinic for the screening visit and 2 overnight treatment visits (approximately 36 hours for the treatment visit)
6. Must be able to swallow gelatin capsules;
7. Must be willing to remain in the clinic for the treatment visits

Exclusion Criteria:

1. Known hypersensitivity to Clomid;
2. Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
3. A hematocrit \>54% or a hemoglobin \>17 g/dL.
4. Subject with a significant organ abnormality or disease as determined by the Investigator;
5. Any medical condition that would interfere with the study as determined by the Investigator;
6. Participation in a clinical trial with investigational medication within 30 days prior to study medication administration;
7. An acute illness within 5 days of study medication administration;
8. Positive urine drug screen at the screening visit;
9. Known history of HIV and/or Hepatitis B or C
10. Tobacco (nicotine products) use in the 3 months prior to the study;
11. A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude, as determined by the Investigator;
12. History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism);
13. History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, or known history of QTc interval prolongation;
14. An employee or family member of an employee of the study site or the Sponsor;
15. Previous participation in a clinical study of Androxal.