cyrilzakka/clinical-trials huggingface dataset:
Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia

Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to impaired endothelial function and dysregulation of the angiotensin system that occurs during the preeclamptic pregnancy and persists postpartum, despite the remission of clinical symptoms. The purpose of this investigation is to determine the mechanisms contributing to this lasting blood vessel damage caused by reduced endothelial function in women who have had preeclampsia compared to women who had a healthy pregnancy. Identification of these mechanisms and treatment strategies may lead to better clinical management of cardiovascular disease risk in these women.

The purpose of this study is to examine the microvascular differences in women who have had preeclampsia following activation of protective angiotensin receptors in the skin. This will help increase understanding of the mechanisms of angiotensin II receptors in these women, and how activation of these receptors may restore microvascular function.

In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) the investigators examine the blood vessels in a dime-sized area of the skin.


Eligibility Criteria:
Inclusion Criteria:

* women who had preeclampsia and women who did not have preeclampsia
* 12 weeks to 5 years postpartum
* 18-45 years old

Exclusion Criteria:

* history of hypertension or metabolic disease before pregnancy
* history of gestational diabetes
* skin diseases
* current tobacco use
* current antihypertensive medication
* statin or other cholesterol-lowering medication
* currently pregnant or planning to become pregnant
* body mass index less than 18.5 kg/m2
* allergy to materials used during the experiment.(e.g. latex),
* known allergy to study drugs
Efficacy of Potassium Sodium Hydrogen Citrate Therapy on Renal Stone Recurrence and/or Residual Fragments After Shockwave Lithotripsy and Percutaneous Nephrolithotomy in Calcium Oxalate Urolithiasis

Extracorporeal shock wave lithotripsy (ESWL) and Percutaneous nephrolithotomy (PCNL) become the therapy of choice for renal stone. Although providing good results, stone recurrence is usually found as the therapies do not change the underlying metabolic abnormality. Among the metabolic disorders, hypocitraturia is an important risk factor for calcium nephrolithiasis. This study evaluate the preventive effects of potassium sodium citrate on stone recurrence as well as stone growth post ESWL or PCNL, in patients with calcium-containing stones.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* stone free or had residual calcium oxalate stone fragments with a less than 4 mm. diameter at eight weeks after ESWL or PCNL

Exclusion Criteria:

* renal tubular obstruction
* serum creatinine \> 2 mg/dl
* urinary tract infection (bacteria \> 100,000 in urine culture)
* hypersensitive or contraindication to Potassium sodium hydrogen citrate
* insertion Double-J Stent
* history of arrhythmia, myocardial infarction or digitalis administration
Effect of Physical Therapy Exercise Program and Low-Level Laser Therapy on the Treatment of Cervicogenic Somatosensory Tinnitus

To determine the effectiveness of adding a physical therapy exercise program to low-level laser therapy on the treatment of chronic tinnitus treatment


Eligibility Criteria:
Inclusion Criteria:

* Age ranged from 45 to 55 years old both sex
* Unilateral tinnitus
* Stable tinnitus for at least 3 months
* suffering from severe chronic non-fluctuating subjective cervicogenic somatic tinnitus (CST)

Exclusion Criteria:

* tinnitus with clear ontological etiologies as perforation of the tympanic membrane
* external otitis media
* conductive hearing loss
* patients with a traumatic cervical spine injury, tumors
* Any history of exposure to ototoxic drugs/substances
* psychotic disorders with auditory hallucination
Cerebrospinal Fluid Biomarkers in Bariatric Surgery

The goal of this project is to understand why bariatric surgery is such an effective treatment for obesity with a focus on brain mechanisms. Cerebrospinal fluid (CSF) neuropeptide, hormone and protein levels will be measured as a surrogate for changes in brain activity in participants before and after bariatric surgery as compared with participants before and after diet-induced weight loss. The investigators are studying neuropeptides and hormones that are know to be involved with the regulation of appetite and body weight to determine if some of the changes that are expected to occur after diet-induced weight loss do not occur after bariatric surgery. In addition, proteomic analysis will be used to uncover new protein biomarkers that are unique to surgical weight loss. The results of these studies will help explain why bariatric surgery is so effective in achieving long-term weight loss. Understanding how the central nervous system responds to bariatric surgery could help the development of alternative nonsurgical therapies for obesity and its metabolic complications.

Peripheral metabolic signals communicate levels of energy stores to the brain and elicit a host of neuronal responses that maintain energy balance; such regulatory mechanisms make it difficult to maintain diet-induced weight loss. The goal is to understand how these central regulatory mechanisms are circumvented following surgical alterations in the gut in subjects after Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (SG) compared to carefully matched diet- induced weight loss controls who achieve weight loss on a low calorie liquid diet. Surgery participants will be patients who have already chosen to have a bariatric surgery procedure with their doctor. Diet participants will be provided with the low calorie liquid diet for approximately 3 months and will be monitored weekly throughout the study.

Surgery participants will be studied at 3 time-points:

1. Before the intervention
2. After surgery at 10-15% weight loss
3. At 12 months after surgery

Low calorie diet participants will be studied at 2 time-points:

1. Before intervention
2. At 10-15% weight loss (approximately 12 weeks on the diet)

At each time-point subjects will have a lumbar puncture (spinal tap) for cerebrospinal fluid (CSF) sampling and blood will be collected in the fasting state and in response to a liquid meal challenge. Body weight, waist and hip circumference will be measured.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* BMI 35-55

Exclusion Criteria:

* No clinically significant medical conditions
* No use of tobacco
* No alcohol or drug abuse
* No recent weight change (+/-5%) within prior 6 months
* No medications that may affect body weight or blood glucose
* No diabetes medications, beta-blockers, opiates or glucocorticoids
* No pregnancy, breastfeeding, or planning to become pregnant during the study (diet group only)
* No lactose intolerance
Clinical Evaluation of Frequency Allocation for Bimodal CI Users

This study will examine experienced, bimodal cochlear implant (CI) patients who receive an alternative frequency allocation table (FAT) to determine how it improves sound quality, device satisfaction, and speech perception abilities with respect to the standard default FAT. The goal of this study is to investigate how improving place-pitch mismatch in bimodal CI users affects 1) sound quality, 2) satisfaction, and 3) speech perception.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Regular usage of a cochlear implant device with at least 18 active electrodes, and compliance with programming/appointments
3. Received a cochlear implant at least 6 months ago and use a hearing aid in the contralateral ear
4. Pure tone average (.5, 1, and 2kHz) between 30 and 70 dB (decibel) hearing level in the contralateral (hearing aid) ear
5. Standard FAT use for all programs prior to study participation
6. No known anatomical abnormalities in either ear
7. English speaking
8. No known cognitive impairments
9. At least 25% of subjects should use the Cochlear EA32 electrode

Exclusion Criteria:

1. Under age 18
2. Non-English speaking. Participants that are Non-English speaking are excluded from this study due to the use of speech testing materials that are validated in the English language. Additionally, study team members are not equipped to appropriately score speech testing materials validated in other languages.
3. Cognitively impaired
4. Non-consistent device usage
5. Greater than 70 dB hearing level pure tone average in the contralateral ear
6. Normal hearing or mild hearing loss in the contralateral ear
7. Non-standard FAT programs
8. Use of any frequency transposition programming in hearing aid.
The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing

The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the management of ischemic foot ulcers. All consecutive patients presenting with a foot ulcer at the outpatient Vascular surgery clinic of our hospital were evaluated. If non-invasive parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was performed and a PTA was carried out when feasible during the same session. All patients were followed until healing, amputation, death, or for at least two years. Short-term and long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients with worsening ulcers after PTA underwent bypass grafting or amputation.

The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the management of ischemic foot ulcers.

Methods: All consecutive patients presenting with a foot ulcer at the outpatient Vascular surgery clinic of our hospital were evaluated. Preoperative evaluation included foot pulse assessment, ankle-brachial-index (ABI) and duplex scanning. If non-invasive parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was performed and a PTA was carried out when feasible during the same session. All patients were followed until healing, amputation, death, or for at least two years. Short-term and long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients with worsening ulcers after PTA underwent bypass grafting or amputation.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed patients with ischemic foot ulcer and
* patients aged 18 years or older.

Exclusion Criteria:

* refusal to participate
* refusal of PTA therapy
* lesions not amenable to endovascular revascularization by vascular team's consensus based on preinterventional imaging
* absolute contraindication to contrast media injection, as determined by the investigator
* uncontrollable coagulopathy
* unwilling or unable to provide informed consent or return for required follow-up evaluations and
* previous or concurrent participation in another clinical research study
Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza

Currently, there is only one treatment which only need one single oral dose for influenza in children five years above (Baloxavir marboxil) in China. This study will test a medicine for influenza in children younger than 5 year of age to see if it is safe and effective.

This is a multicenter, randomized, double-blind, controlled Phase III clinical study.

The study evaluates the pharmacokinetics, safety and efficacy of ADC189 tablets/granules following a single oral dose in children aged 2 to 11 years with influenza.


Eligibility Criteria:
Key Inclusion Criteria:

* 1. Patients aged 2 to 11 years at screening, both sex;
* 2. Patients were diagnosed with Influenza A Vairus Infection/Influenza B Virus Infection.
* 3. Parents willing and able to comply with study requirements, under the judgment of investigators .
* 4. Onset of symptoms no more than 48 hours before presentation for screening.

Key Exclusion Criteria:

* 1. Patients with severe influenza.
* 2. Pregnant or breast-feeding females
* 3. Patients with acute respiratory infection, tympanitis, sinusitis, or acute asthma attack within 2 weeks before screening.
* 4. Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications.
* 5. Other antiviral therapy is required during screening.
Associations Between Air Pollutants Exposures and Respiratory System Study

Epidemiological investigations has suggested exposure to air pollution linked with respiratory disease, especially chronic obstructive pulmonary disease. However, the potential mechanisms of adverse effects remains scare. The present study will assess the association between air pollutants and respiratory related parameters to elucidate possible mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* Long-term residents, aged \>23 and \<82 years

Exclusion Criteria:

* Severe cardiopulmonary diseases, active inflammatory diseases, cancer
Phosphodiesterase 5 Inhibitors (PDE5i) (Sildenafil) as Medical Expulsive Therapy in Distal Ureteral Stones

Urolithiasis is one of the most common urological diseases. The risk of urolithiasis is estimated to be between 5% and 12% all over the world with increased incidence in male rather than female (2:1) respectively . Ureteral stones account for 20% from all urinary tract stones, more than 70% of the ureteral stones found in the lower third of the ureter . The incidence of urinary stones has been increasing day by day. Medical expulsive therapy (MET) of ureteral stones is the investigators' concern in this study. Stone location, size, number, ureteral spasm, mucosal edema or inflammation and ureteral anatomy are the factors affecting passage of the ureteral stones. So, MET is based on mechanism that stone passage is facilitated by the relaxation of ureteral smooth muscle , increasing hydrostatic pressure proximal to the stone and decreasing exciting edema . There are many oral medication could be used as MET such as adrenergic blockers, calcium channel blockers, prostaglandin synthesis inhibitors, glyceryl trinitrate and steroid treatment . Calcium-channel blockers and adrenergic α-antagonists are the main that has been proposed to enhance stone passage as expulsive medical therapy. Cyclic nucleotides are degraded by phosphodiesterases enzymes (PDEs). So using of PDE inhibtors may play role in relaxation of smooth muscle of the ureter. A study was done for evaluation of three PDE5 inhibtors, sildenafil , vardenafil and tadalafil, they found that PDE5 inhibitors can reverse the tension of isolated human ureteral smooth muscle via cGMP-mediated pathways.


Eligibility Criteria:
Inclusion Criteria:

1. Male Patient aged from 18-65 years.
2. Lower third ureteric stones at or below sacro-iliac joint .
3. Stone size rang from 5- 10 mm.
4. Unilateral ureteric stone

Exclusion Criteria:

1. Patients who had recurrent fever.
2. Patient underwent ESWL.
3. Patient with rising serum creatinine \> 2mg/dl.
4. Patient with history of uretero-vesical reimplantation.
5. Stone larger than 10 mm
Lamotrigine Extended-Release In Elderly Patients With Epilepsy

This study is being conducted to determine the safety and tolerability of lamotrigine (LTG) in elderly patients with epilepsy. This study will be carried out using an extended-release formulation of lamotrigine (LTG-XR) that will allow once-a-day dosing.


Eligibility Criteria:
Inclusion criteria:

* Confident diagnosis of epilepsy
* Currently treated with one or two antiepileptic medications
* Able to complete a seizure diary

Exclusion criteria:

* History of hypersensitivity to lamotrigine
* Progressive diseases that would interfere with the study objectives
Treatment of Diabetes and Depression in Hispanics and African Americans and Its Effect on A1c and Quality of Life.

This proposed study will test the following hypothesis: Treating depression in Hispanics and African Americans with diabetes will improve their HbA1c and quality of life while on intervention and six months after intervention.

The medication to be used will be sertraline (Zoloft). Sertraline (Zoloft)has been proven in clinical trials to be an effective and well tolerated prescription medication that improves the quality and enjoyment of life for adults suffering from depression . Sertraline is an antidepressant and a member of the family of medications known as selective serotonin reuptake inhibitors (SSRIs). It has excellent tolerability and minimal drug-drug intereactions.

The hypothesis will be tested by the following specific aims:

1. To determine if treating mild to moderate depression with sertraline (Zoloft) in patients with diabetes improves HbA1c.
2. To determine if treating mild to moderate depression with sertraline (Zoloft) in patients with diabetes improves quality of life.

If our hypothesis proves correct and this treatment of depression is efficient and easy in a county hospital population of African Americans and Hispanics, researchers can move forward in finding fast and efficient means of diagnosing depression in vulnerable populations, including low-literate patients. This study is critical in that it stands to improve the HBA1c (and other metabolic parameters) and quality of life of our underserved minority community, which sadly suffers from a higher rate of almost every disease, including diabetes. Treating mild to moderate depression in a county hospital population of African Americans and Hispanics may improve quality of life and reduce/prevent complications and early death. Secondary outcomes include reduced hospitalizations, fewer missed appointments, and improved adherence to medication.

Eligibility Criteria:
Inclusion Criteria:

* All patients (men, women) who are African American or Hispanic over the age of 21 who have been diagnosed with type 2 diabetes and have a HbA1c of greater than 8.0%. Subjects with neuropathic pain will be included in the study. Their pain will be assessed via a validated pain scale. Their primary care providers will treat their pain as necessary.

Exclusion Criteria:

* Pregnant women, patients on dialysis, patients with liver disease or liver enzymes elevated three times above normal, patients with blood pressure greater than 160 systolic or 95 diastolic on two consecutive visits, patients with history of severe depression (as determined by hospitalization or the HAM-D survey) or suicide attempts, patients on therapy for depression, patients already taking SSRI's, and patients with psychotic features or bipolar disease.
Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe

This study is conducted over 18 months. The main objective of this study is to test and compare the relevance and reliability of different tools for measuring the anosognosia.

Secondary objectives are :

* identify the relevant test who are able to evaluate more specially the cognitive processes involved in anosognosia
* explore the links between the anosognosia manifestations and the psychological manifestations

This experimental protocol is proposed to 40 patients who have a moderate or severe traumatic brain injury. All of this protocol is 2 hours, tasks are administered in the order named.

To measure anosognosia, this protocol is to administer 4 questionnaires used in clinical routine who have proposed to patients and their therapist and relative who know them well. The chosen measure is the difference between the results of the patient and that of the therapist or relative. Others evaluations are administrated to question the beliefs capacity during 2 certainty of judgment tasks replicated or adapted articles from the literature (tasks of guessing and task of judgments facts).

The patients are also evaluated through several executive tasks (who come from battery of tests called 'Groupe de Reflexion sur l'évaluation des fonctions exécutives') and global cognitive efficiency tasks from the Wechsler Adult Intelligence Scale (involving non-verbal reasoning, psychomotor speed and general knowledge). These different tests measure the capacity of inhibition, mental flexibility, planning and information generation.

At last, mood and coping strategy questionnaires are proposed to patients for complete this protocol.

This protocol are also administered to 40 volunteers who have not had traumatic brain injury to monitor standards in general population (because all these tasks are not systematically standardized).

Eligibility Criteria:
Inclusion Criteria:

* patients with a moderate or severe traumatic brain injury occurred at least 3 months ago (Glasgow ≤ 12 or duration of post-traumatic amnesia \> 1 week)
* patients ≥ 18 years old and who have signed a letter of information

Exclusion Criteria :

* motor, sensitive and phasic disorders who are not allowing the test passation
* neurological or psychiatric antecedents
* patients who refused to participate in the study
* non affiliation to a social security scheme
* patients under guardianship or trusteeship
The Effect of Pilates on Muscle Strength, Balance Performance, Gross Motor Skills, Social Skills in Children With ASD

The purpose of this randomized controlled study was to determine the effects of Pilates Training by comparing the effects of Aerobic Training on muscle strength, balance performance, gross motor skills and social skills in children with autism.

As a result of this study Aerobic Training and Pilates Training are both effective in the improvement of balance performance and gross motor skills in children with autism, with more improvement in muscle strength in Aerobic Training. Pilates Training could be considered as an alternative training to increase physical activity in children with autism.

The purpose of this randomized controlled study was to determine the effects of Pilates Training by comparing the effects of Aerobic Training on muscle strength, balance performance, gross motor skills and social skills in children with autism.

As a result of this study Aerobic Training and Pilates Training are both effective in the improvement of balance performance and gross motor skills in children with autism, with more improvement in muscle strength in Aerobic Training. Pilates Training could be considered as an alternative training to increase physical activity in children with autism.

This study will answer whether pilates practice has an effect on Muscle Strength, Balance Performance, Gross Motor Skills and Social Skills in Children With Autism.

Demographic information of the participants was recorded.Muscle strength for shoulder flexors, hip flexors and knee extensors were performed with Hand-held dynamometry.The one-legged standing test was used to evaluate static balance performance.Test of Gross Motor Development (TGMT-2) was used to evaluate gross motor skills of participants. The Autism Social Skills Profile Turkish Form (ASSP- T) was used to evaluate social skills of participants.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with autism,
* Not having physical disabilities or neurological disorders,
* Having the ability to follow the instructions given during evaluations and training,
* Having the ability to perform the requested training

Exclusion Criteria:

* Not being a volunteer,
* Having a health problem that prevents exercise.