cyrilzakka/clinical-trials huggingface dataset:
Neural Control and Cardiac-Vascular Function in Women With PTSD (VA Psychological Assessment)

The purpose of this research is 1) to investigate the role of the sympathetic nervous system and cardiac-vascular function in women with PTSD; and 2) to determine whether lifestyle modifications (exercise training and healthy eating) would be effective in reducing sympathetic activity, improving cardiovascular function, and improving psychiatric and quality of life outcomes in women with PTSD. It is hypothesized that (1) women with PTSD will have over-activation of the sympathetic nervous system and impaired cardiac-vascular function compared with women who are trauma free, and (2) lifestyle modifications can reduce sympathetic activity, improve cardiac-vascular function, and improve psychiatric symptoms and quality of life in women with PTSD.

This is a collaborative study between the Institute for Exercise and Environmental Medicine (IEEM; Texas Health Resources/University of Texas Southwestern medical Center) and VA North Texas Healthcare System (VANTHCS). The overall study was conceptualized and initiated by Dr. Qi Fu and her research team at the IEEM. IEEM researchers will be responsible for recruitment of non-veteran women without a diagnosis of PTSD, physiological assessments, and the lifestyle modification intervention. VANTHCS researchers will be responsible for recruitment of women veterans with PTSD and psychological assessments. The procedures taking place at VANTHCS (recruitment of women Veterans with PTSD and psychological assessments) will fall under a separate study (overseen by VANTCHS IRB and RDC) and will not include the procedures and intervention that will take place at the IEEM (which will be overseen by a separate IRB). Data will be shared between the sites per data sharing agreement. This clinical trials entry reflects the VANTHCS study. Outcome measures gathered by the IEEM research team are included in this entry due to the data sharing agreement.

Eligibility Criteria:
Inclusion Criteria:

1. Be either a female veteran with a current diagnosis of PTSD (for the PTSD group) or a female non-veteran without a current diagnosis of PTSD (for the non-PTSD control group).
2. Be between the ages of 18-65.
3. Sedentary (exercises less than three times a week for thirty minutes or less).

Exclusion Criteria:

1. Any evidence of cardiopulmonary and neurological diseases by history or by physical examination.
2. Chronic kidney disease (serum creatinine \> 1.5 mg/dL).
3. Peripheral vascular disease.
4. Peripheral neuropathy.
5. Current substance use disorder other than tobacco related.
6. Endurance-trained athletes due to the effects of exercise training on sympathetic neural control and cardiac-vascular function.
7. Current pregnancy.
Microdialysis and Pharmacokinetic Study of TR-701

The purpose of this study is to measure the penetration of TR-700 into subcutaneous adipose tissue and skeletal muscle after a single oral dose of 600 mg TR-701

This study will be conducted in two parts: a Pilot Study and a Main Study. The Pilot Study will be conducted to assess recovery of exogenously administered TR-700 (microbiologically active moiety) via microdialysis. In the Main Study, pharmacokinetics of TR-700 will be determined in both soft tissues (via microdialysis) and plasma after a single oral dose of 600 mg TR-701 (prodrug).

Eligibility Criteria:
Inclusion Criteria:

* Body mass index of 20 to 29 kg/m2
* Agree not to consume any products containing tobacco, alcohol, quinine, grapefruit, caffeine, or high levels of tyramine
* Agree not to use any other medication
* Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control

Exclusion Criteria:

* History of gastric or duodenal ulcer within 1 year before enrollment
* Has known or suspected hypersensitivity or intolerance to heparin, if an indwelling cannula (e.g., heparin lock) is used
* Recent febrile illness (less than 72 hours before the first intake of study medication).
* Significant blood loss (300 mL) or donation of blood within the 60 days before the Screening visit
* Women who are pregnant or breast-feeding
SARS-CoV-2 (COVID-19) Antibody PrevalencE in an Adult London HIV Cohort

Prospective, observational SARS-CoV2 serological surveillance single London HIV outpatient center study using NHS participants

The main aim of this study is to find out how many people living with HIV (PLWH) attending a major HIV centre in London, have already been infected with SARS-CoV2 so far which will be determined through serological blood tests detecting the presence of antibodies to SARS-CoV2, or have developed antibodies in response to vaccination.

However, it is not know whether the presence of antibodies from natural infection means anything more than a marker that someone has been exposed to SARS-CoV2 previously. It is not know whether this means someone is any less likely to be reinfected in the future or how it will affect possible future infections with SARS-CoV2. Whilst further data on natural and vaccine induced antibody responses is awaited, those with the presence of anti-SARS-CoV2 antibodies continue to be advised to take the same precautions as everyone else in terms of reducing the risk of getting COVID-19: regularly washing hands, wearing a mask and remaining socially distant where possible.

Now that vaccination has commenced it is also unclear what markers of vaccine induced immunity will develop, including in PLWH. This study will help better determine whether HIV should be an additional 'priority' group for vaccination, and also what antibody responses exist in PLWH who have been vaccinated

The intention is to invite the cohort in for an annual set of HIV related blood tests, covering those who are scheduled for bloods, as well as those who may have missed scheduled blood monitoring appointments during the COV19 lockdown period. In addition to these tests the study proposes offering serological testing for SARS CoV-2 as part of this surveillance study. Participation will be voluntary, and informed consent will be obtained. Participants will be informed of their result along with information about the uncertainty of its meaning, beyond indicating previous infection or vaccination.

The study aims to test for the presence of specific antibodies that target SARS-CoV2 in people living with HIV, as a marker of whether someone has been infected before. This will help create a better understanding of whether living with HIV puts people at a higher risk of becoming infected with SARS-CoV2 compared to the general population, and which other factors or characteristics may affect this risk. This will help identify who might be more at risk of getting COVID-19 in the future and will help plan for future COVID-19 vaccine strategies.

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV infection
* Registered patient at ICDC
* Age ≥18 years at study entry
* Able to comprehend study patient information leaflet

Exclusion Criteria:

* Unable to give informed consent and participant without a good understanding of verbal and written English
Myofascial Stretch With And Without Functional Massage In Children With Cerebral Palsy

Cerebral palsy is one of the most common childhood disabilities, and it occurs with an incidence of 2-2.5 per 1000 living births. Children with CP have various impairments including neuromuscular and musculoskeletal problems such as spasticity, dyscoordination, loss of selective motor control, and weakness. CP can be classified according to the severity of motor deficits as mild, moderate, or severe. Several other classification systems exist based on the pathophysiology, etiology, and distribution of motor deficits. The aim of the study to evaluate the effects of functional massage and myofascial stretch on spasticity and motor function of CP Children. Study will be conducted in 22 patients in experimental and control group. Pre and Post values will be evaluated. The tools used will be Modified Ashworth Scale (MAS) and Gross Motor Function Measure (GMFM). The significance of this study is that it will define for us that to how much extent we can improve the Spastic and painful condition of lower limb of CP child. Data will be analyzed using SPSS 22.0 mean and standard deviation will be calculated. Appropriate the statistical test will be used after checking normality of data.


Eligibility Criteria:
Inclusion Criteria:

* Age of 6 and 12 year
* Both genders
* Children between level Ⅰ- Ⅳ based on Gross Motor Classification System(GMFCS)

Exclusion Criteria:

* The existence of dyskinesia or dystonia
* History of muscle lengthening surgery
* Presence of uncontrolled seizures
Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine in Osteomuscular Treatment

The purpose of this study is to evaluate the safety and efficacy of an association with one anti-inflammatory and one muscle relaxant plus caffeine compared to one anti-inflammatory plus caffeine in the treatment of osteomuscular pain in adults.

* Double-blind,randomized, multicenter
* Maximal experiment duration: 9 days
* 02 or 03 visits and a phone contact
* Evaluate the efficacy of an association with one anti-inflammatory and one muscle relaxant agent with caffeine compared to the one muscle relaxant agent plus caffeine in the treatment of osteomuscular pain in adults.
* Adverse events evaluation

Eligibility Criteria:
Inclusion Criteria:

* Signed Consent of the patient;
* Participants presenting musculoskeletal pain, moderate or moderately severe, with VAS (visual analog scale) greater than 40 mm for a period of less than seven (7) days.

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study;
* Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
* Patients with history of hypersensitivity to any of the formula compounds;
* Participation in clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Patients who were in use of drugs that can interfere with evaluation;
* History of with rheumatic diseases, fibromyalgia, osteoarticular diseases, dystonia, dystrophies and myopathies, acute infectious diseases, gastric duodenal ulcer or gastritis;
* Renal or hepatic impairment.
Effect of Face Scanning on Accuracy of Dental Implant Placement in Fixed Implant Supported Maxillary Prostheses

The study will compare the accuracy of surgical guides fabricated by two different scanning protocols; facially driven scanning versus dual scanning protocol regarding the deviation of implant placement.

Twelve completely edentulous patients will be selected for full arch maxillary guided implants placement with immediately loaded restoration. The patients will make a complete oral and radiographic examination before inclusion in this study. All patients will receive maxillary and mandibular complete dentures that will be made in a conventional way. The patients will be randomly divided into two equal groups; group (I) and group (II). In both groups two CBCT scans will be made. A CBCT scan will be made for each patient while wearing the radiographic stent and another CBCT scan will be made for the radiographic stent alone. However, for patients in group II a face scan will be added to previous scans. For each patient in group I, the DICOM files will be exported to Blue Sky implant designing software (Langenhagener, Mdi Europa GmbH), fusion of the scan prosthesis via the markers is accomplished and the ideal surgical site and optimal implant dimensions will be selected. All the surgical guides will be planned to be totally limiting in this study. The immediate provisional restoration will be planned on the software according to the previously planned implants sites. The surgical guide will be 3D printed. The approved tooth arrangement will be subsequently sent as an STL file to a milling machine. For each patient in group II, the DICOM files and the STL files obtained from the face scans will be exported to Blue Sky implant designing software (Langenhagener, Mdi Europa GmbH). The facial scan will be used to define the interpupillary and midsagittal planes and to examine the tooth form and buccal corridor width with regard to the patient's smile line. Both files data will be superimposed and the planning for the implants sites, surgical guide and immediate restoration will be done as in group I. After implant insertion, CBCT scan will be made for each patient while wearing the scan appliance. Superimposition of CBCT scans pre and post implant insertion and restoration will be made. Deviations between planned and placed implant will be measured in the lateral apical, lateral coronal and angular aspects. Also, the patient satisfaction will be measured on a likert scale.

Eligibility Criteria:
Inclusion Criteria:

- The inclusion criteria will be completely edentulous patients, non-smokers, 50-70 years in age, have Good oral hygiene and motivation.

Exclusion Criteria:

* The excluded patients will include patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, the need for extensive bone grafting in planned implant site, pregnancy, patients under bisphosphonate treatment, and limited mouth-opening for executing the guided implant surgery.
Large Cohort of 1000 Patients With Severe Myopia

The prevalence of myopia and severe myopia are increasing and will affect 50% and 10% of the population respectively. Severe myopia exposes an increased risk of glaucoma, cataract, retinal detachment and myopic maculopathy, a source of visual impairment.

To date, no European cohort study has been conducted to estimate the rate of these complications and to study the predictive parameters.

This study allows to describe the evolution of different ophthalmological parameters of a population of strong myopes during their follow-up for 10 years using multimodal imaging techniques of the retina.

Prospective, longitudinal, multicentric, non-randomized cohort study with constitution of a biological collection.

This study will include major and minor patients with high myopia

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 6 years
* Severe myopia in at least one eye, defined as

  * a refractive error ≤ -6.00 diopters OR
  * an axial length ≥ 26.50 mm
* Follow-up performed at at least one of the participating centers
* Express consent to participate in the study
* If age \< 18 years: express consent of the person(s) exercising parental authority
* Affiliated or beneficiary of a health insurance

Exclusion Criteria:

* Visual acuity \< 5 letters on the ETDRS (equivalent to "finger count" or less) in both eyes
* Disorders of the transparent media in both eyes with opacities that may affect image quality
* Syndromic myopia of genetic origin (Stickler syndrome type 1 and 2, Marfan syndrome, Ehler-Danlos disease type 4, Knobloch syndrome) or inherited retinal dystrophy (X-linked retinitis pigmentosa, congenital stationary night blindness of Schubert-Bornshein type, Bornholm eye disease)
* Patient who does not wish to continue to be followed in one of the participating centers
* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman
Outcome Of Using Transfixing K Wire ln DDH With Hypoplastic Head And Severe Generalised Ligamentous Laxity

This study is to evaluate the outcome of using transfixing hip k wire in Developmental dysplastic hip in patients with hypoplastic head and severe generalised ligamentous laxity.

The goal of treatment in developmental dysplasia of the hip (DDH) is to obtain and maintain a stable concentric reduction.

Surgical treatment is done by open reduction through a medial approach or anterolateral approach with pelvic osteotomy,capsulorhaphy, femoral shortening and derotational osteotomy.

Transfixing the femoral head with Kirschner wire during open reduction has long been thought to provide stability to the hip without damaging the femoral head or the acetabulum and to decrease the risk or re-dislocation.

The aim of this study is to assess the effect of transfixing the hip with Kirschner wire during the operative treatment of hip dysplasia in children after the walking age on the final radiological and clinical results and to compare the risks with the benefits of adding this step.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 1 year and younger than 7
2. Patients with hypoplastic head
3. Patients with severe ligamentous laxity (Beighton score ≥ 4)

Exclusion Criteria:

1. Patients younger than 1 year and older than 7 years old.
2. Beighton score \< 4
3. Secondary hip dislocation (neuromuscular disorder) as cerebral palsy , myelodysplasia or arthrogryposis.
A Randomised Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID in Comparison to 400 mg Lopinavir (LPV) Plus 100 mg RTV p.o. BID in Combination With Standard Background Regimen in ARV Therapy naïve Patients.

Evaluation of safety and efficacy of Tipranavir (TPV) boosted with Ritonavir (RTV) versus an active control arm (Lopinavir / RTV) in antiretroviral (ARV) therapy naïve HIV-1 infected patients


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent prior to trial participation.
2. HIV-1 infected males or females \>= 18 years of age.
3. No previous ARV therapy.
4. Any CD4+ T lymphocyte count \< 500 cells / µl.
5. HIV-1 viral load \>= 5000 copies/mL at screening.
6. Screening laboratory values that indicate adequate baseline organ function.
7. A prior AIDS defining event is acceptable as long as it has resolved or the subject has been on stable treatment (e.g. opportunistic infection; no ARV) for at least 2 weeks before screening

Exclusion criteria:

1. Female patients of child-bearing potential who:

   * have a positive serum pregnancy test at screening or during the study,
   * are breast feeding,
   * are planning to become pregnant
2. Use of investigational medications within 30 days before study entry or during the trial
The Efficacy of Glucerna SR in Chinese Drug-naïve Subjects With Type 2 Diabetes

The purpose of the study is to evaluate the effect of Glucerna SR treating newly-diagnosed type 2 diabetes patients (NDM) on glycemic stability, with the application of CGMS (continuous glucose monitoring system) and to further realize the safety and effect of Glucerna SR on daily and day-to-day amplitude of blood glucose fluctuation.

Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response. About 24% of the total energy provided by Glucerna SR is due to monounsaturated fatty acids, which can help keep good metabolic state in accordance with the recommendations of the American Heart Association. The aim of the study is to evaluate the effect of Glucerna SR treating newly-diagnosed type 2 diabetes patients (NDM) on glycemic stability, with the application of CGMS (continuous glucose monitoring system) and to further realize the safety and effect of Glucerna SR consumed as a meal replacement at breakfast meal on daily and day-to-day amplitude of blood glucose fluctuation.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type 2 diabetes mellitus
* FPG≤13mmol/l and/or 2hPG≤18mmol/l
* HbA1c≥7.0%
* BMI (Body Mass Index)≥18.5kg/m2

Exclusion Criteria:

* Patients taking any class of injectible or oral hypoglycemia agents to manage their hyperglycemia.
* Female patients are in gestation, lactation or intend to be pregnant in the study period.
* Patients are with type 1 diabetes, or other special types of diabetes, or gestational diabetes mellitus.
* Patients with drug hypersensitivity.
* Patients with obvious hepatic or renal diseases (ALT, T-Bil\>1.5 times of upper limit)
* Patients with severe or unstable angina, or heart failure (NYHA class III/IV)
* Patients having acute complications, or chronic complications maintained insulin therapy or insulin therapy under stress.
* Patients with chronic consumptive diseases like cerebrovascular disease, tumor, tuberculosis, or hematopathy, psychosis, autoimmune disease or severe digestive dysfunction.
Bone Microstructure After Gastrectomy Evaluating by Using HR-pQCT

Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. The aim of the present study was to evaluate osteoporosis by using high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.

The patients after gastrectomy loss appetite and decrease the weight. Total gastrectomy especially cause severe sarcopenia and metabolic change. Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. The primary tools for assessing volumetric density and bone structure are quantitative computed tomography (QCT) and more recently, high-resolution peripheral quantitative computed tomography (HR-pQCT). However the validation of osteoporosis with HR-pQCT before and after gastrectomy remain elusive. The aim of the present study was to evaluate osteoporosis by using HR-pQCT before and after after endoscopic resection, distal gastrectomy, and total gastrectomy in the patients with gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* Planning ESD, DG, or TG due to gastric cancer
* Provide signed informed consent

Exclusion Criteria:

* pregnancy
* Current use of the following osteoporosis agents; Teriparatide, Denosumab, and bisphosphonate
* Hyperthyroidism
* Hyperparathyroidism
* Present malignancy (except in situ carcinoma)
* Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy
* Other diseases which affect bone metabolism
* Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
* Received \> 3 months (or equivalent) of osteoporosis treatment
* Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania

The purpose of this study is to descriptively evaluate the persistence among adults treated with mirabegron or antimuscarinics in Australia, South Korea and Taiwan.

This study will also assess the persistence to the overall Overactive bladder (OAB) treatments of a patient, regardless of treatment discontinuation or switch to other OAB medications.

This study is entirely descriptive using secondary medical claim and pharmacy prescription data. No formal comparisons between users of mirabegron and antimuscarinic will be made. Furthermore, no a priori hypothesis testing is intended.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a new prescription of the index medication within the index period;
* Patient received orally administered monotherapy for OAB on index date.

Exclusion Criteria:

* Patient with prior dispensing record of the index medication during the pre-index period;
* Patient received onabotulinumtoxin A and/or surgical intervention as part of the OAB treatment between the pre index and post-index period;
* Patient diagnosed with stress incontinence (International Classification of Diseases-10 (ICD-10) N39.3 or equivalent) or had dispensing record of medication for stress incontinence (duloxetine) before index date;
* Patient with urinary tract infection (ICD-10 N30.0 or equivalent) (for National Health Insurance Research Database (NHIRD) and Health Insurance Review and Assessment (HIRA) database) or a co-prescription of any antibiotics (for NostraData) on index date.