cyrilzakka/clinical-trials huggingface dataset:
The Influence of Low Frequency Repetitive Transcranial Stimulation (r-TMS) Treatment on Motor and Cognitive Measurements in Patients With Parkinson's Disease

The aim of the study is to test the effects of low frequency deep rTMS using the novel H-coil on the motor, affective and cognitive deficits in patients with Parkinson's disease (PD) and to establish its safety in this population.

The investigators anticipate to recruit 10 patients to an open pilot study. All patients will receive an active rTMS stimulation and will be given 12 treatment sessions, over a period of up to 4 weeks. Each of the 12 daily treatment sessions (lasting about 30 minutes each), will be consisted of 25 stimulation trains over the prefrontal cortex (20Hz trains, 2 seconds each with an inter-train interval of 20 seconds) and one train of 15 minutes at 1 Hz over the the motor cortex.

The following outcome measures will be taken prior to the treatment (screening visit), and at day 1, 10, 30, 60, and 90:

1. Unified Parkinson's Disease Rating Scale (UPDRS )
2. Clinical Global Impression of Severity (CGIS)
3. Pegboard test.
4. Tapping test
5. Up \& Go test
6. Abnormal Involuntary Movement Scale (AIMS) Mood and affect Beck Depression Inventory (BDI) Cognition

1. Mini mental State examination (MMSE) 2. Digit forward and backward tests. 3. Word fluency. 4. Frontal Assessment Battery (FAB)

Side effects will be closely monitored by the researchers and will be promptly reported to the IRB


Eligibility Criteria:
Inclusion Criteria:

* PD patients aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn \& Yahr stages II - IV while "off".
* Participants on antidepressants should be at least 2 months on stable therapy

Exclusion Criteria:

* Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
* Patients on neuroleptics.
* Patients with dementia or any unstable medical disorder.
* History or current Unstable hypertension.
* History of head injury or neurosurgical interventions.
* History of any metal in the head (outside the mouth).
* Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
* History of migraine or frequent or severe headaches.
* History of hearing loss.
* The presence of cochlear implants
* History of drug abuse or alcoholism.
* Pregnancy or not using a reliable method of birth control.
* Participation in current clinical study or clinical study within 30 days prior to this study
Food Allergen Eliminations and Combined Protocols for Obesity Reduction: a Preliminary Comparison Study

Screened subjects will be tested for hidden food allergies. Subjects will eliminate all food that showed leukocyte reactions for 90-days. Subjects will then also be invited to use the Willis Exercise protocol. Body composition testing and Body Mass Index calculation will be accomplished at enrollment and after completion of the 90-day study.

Subjects will first be screened for cardiovascular pathologies and then tested for hidden food allergies. After the results subjects will eliminate all food that showed leukocyte reactions for 90-days. Subjects will then also be invited to use the Willis Exercise protocol (Aerobic-surge exercise \> 75% max heart rate, for 2-minutes, 5/day. Body composition testing and Body Mass Index calculation will be accomplished at enrollment and after completion of the 90-day study.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is \> 20 years of age and is willing and able to provide signed informed consent.
2. The subject has a BMI \> 30.
3. The subject is between the ages of 20 to 75 years of age.

Exclusion Criteria:

1. Cardiovascular Heart Disease and this includes but is not limited to history of myocardial infarction, atrial fibrillation, etc.
2. History of cerebral vascular event (stroke), traumatic brain injury, Parkinson's disease or any other neural injury or disease.
3. Diabetes Mellitus (Type I or II)
4. Pregnancy
5. Participation in any other weight loss protocols, diets, or medication.
Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2)

To determine the prevalence and natural history of pulmonary and cardiac complications associated with HIV infection in utero, in infancy, and during early childhood.

BACKGROUND:

In 1982, a year after the discovery of AIDS in adults, cases were described in children. Subsequent reports clearly indicated that pulmonary and cardiac diseases contributed significantly to morbidity and mortality in children infected with the human immunodeficiency virus.

The initiative was developed by the staff of the Division of Lung Diseases and the Division of Heart and Vascular Diseases after consultation with members of the pulmonary, cardiology, and pediatric communities. The Request for Proposals was released in August 1988 and awards made in May 1989.

DESIGN NARRATIVE:

In this prospective natural history study, research was conducted on the response of the immature lung to Pneumocystis carinii and other opportunistic lung infections, as well as on the etiology and pathogenesis of lymphocytic pulmonary disorders. The types, incidence, course, outcome, and origin of cardiac disorders were also determined. In addition to the pulmonary and cardiovascular measurements, data on the effects of co-infection with other viruses, CMV and EBV, were obtained.

Enrollment of participants began in May 1990 and continued through April 1993 in Group I and through January 1994 for Group II. The cohort was followed at specified intervals for an additional three years beyond the end of recruitment for clinical examination, cardiac, pulmonary, immunologic, and infectious studies and for intercurrent illnesses (The cohorts were followed through January 1997). Follow-up ranged from 2.5 to 6.6 years. The study ends in July 2002. Analysis of the database, preparation of manuscripts and follow-up of adult type pulmonary function studies in infants currently followed at sites conducting the Womens \& Infants Transmission Study (WITS) continue through July 2002

Eligibility Criteria:
No eligibility criteria
vNOTES Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic.

Objective: To compare the vNOTES approach versus conventional laparoscopic approach used in elective Salpingo-oophorectomy surgery for benign disease or bilateral salpingectomy for sterilization.

Study design: Prospective cohort, randomized controlled trial.

Study population: Planned Salpingo-oophorectomy for benign disease or bilateral salpingectomy for sterilization.

Primary outcome - Adherence to planned surgical route, intra-operative parameters \& complications, post-operative parameters \& complications, rate of satisfaction.

Objective: To compare the vNOTES approach versus conventional laparoscopic approach used in elective Salpingo-oophorectomy surgery for benign disease or bilateral salpingectomy for sterilization.

Study design: Prospective cohort, randomized controlled trial.

Study population: women aged over 18 who are planned to elective Salpingo-oophorectomy for benign disease or bilateral salpingectomy for sterilization.

Primary outcome - Removal of the ovaries and/or fallopian tubes according to the allocated technique, without conversion.

Secondary outcome - Duration of the surgical procedure, Duration of hospital admission (after surgery), The need for analgesics, and pain Numerical Rating Scale score , Post operation infection (up to 4 weeks from surgery), Need for medical examination/treatment or appearance of surgical complication up to 4 weeks form surgery (using Clavin Dindo Class), Bleeding assessment during surgery, Dyspareunia assessment - up to 3 months from surgery, Patient satisfaction from the surgical procedure will be measured with Patient Global Impression of Improvement (PGI-I).

Eligibility Criteria:
Inclusion Criteria:

1. Women aged between 18 and 80 years.
2. women who seek for definitive surgical sterilisation.
3. women who planed for Elective bilateral salpingectomy or Salpingo-oophorectomy for a non-malignant indication

Exclusion Criteria:

1. history of rectal surgery.
2. rectovaginal endometriosis
3. suspected malignancy
4. History of pelvic inflammatory disease.
5. active lower genital tract infection.
6. Virgo women
7. pregnancy
8. Failure to provide written informed consent prior to surgery
Effects of Prebiotics on Cognition and Health

This research intervention aims to examine the effects of prebiotic consumption on changes in behavioral and biological measures of cognition and stress among adults.

Evidence-based dietary strategies provide behavioral means benefiting physical and cognitive function. Pertinent to the proposed work, dietary intake has been recently shown to have the potential to directly influence the gut microbiota composition as well as brain function. Specifically, the consumption of prebiotics or fibers metabolized by gut bacteria may also play a role. These foods are readily available in the marketplace, however, their implications for physical and cognitive function are not clear. Accordingly, the proposed study aims to investigate effects of prebiotic beverage consumption on changes in behavioral and biological measures of cognition and stress among adults.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Between the ages of 25-45 years at the time of consent
* BMI ≥18.5 kg/m2
* Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task.
* Ability to drop-off fecal sample within 15 minutes of defecation

Exclusion Criteria:

* Current pregnancy or lactation
* Tobacco use
* Dairy allergy or intolerance
* Prior diagnosis of metabolic and gastrointestinal disease (cardiovascular disease and type 1 or type 2 diabetes, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.)
* Prior diagnosis of cognitive or physical disability, including ADHD, severe asthma, epilepsy, chronic kidney disease
* Use of any anti-psychotic, anti-depressant, antianxiety, or ADD/ADHD medications
* Use of medications that alter normal bowel function and metabolism (e.g., recent antibiotic use, laxatives, enemas, anti-diarrheal agents, narcotics, antispasmodics, diuretics, anticonvulsants).
* Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band)
Comparison of the Efficacy of High Intensity Laser Therapy and Low Level Laser Therapy in the Carpal Tunnel Syndrome

Carpal tunnel syndrome is the most common entrapment neuropathy and is frequently encountered in clinical practice. Although there is no standard protocol for its treatment, conservative treatment methods are preferred. In our study, we aimed to clinically compare the efficacy of high and low intensity laser treatments in patients with carpal tunnel syndrome. By using methods such as electromyography and ultrasound, we aimed to provide a more objective evaluation

Our study was designed as a prospective, randomised, controlled, single-centre trial. A total of 63 patients aged 18-65 years with electrophysiologically diagnosed mild to moderate carpal tunnel syndrome and 114 hands were included in the study. Patients were divided into 3 groups. Patients in all three groups wore a neutral wrist splint of appropriate size. The second group included patients who additionally received low level laser therapy (LLLT), and the third group included patients who additionally received high intensity laser therapy (HILT). All groups underwent clinical, electrophysiological, and ultrasonographic examinations at the beginning of the treatment, at 1st month, and at 3rd month after the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 65 years
2. Mild CTS (sensory conduction velocity at the second finger wrist \< 41.26 m/sec, motor distal latency \< 3.60 msec) or Moderate CTS (sensory conduction velocity at the second finger wrist \< 41.26 m/sec and motor distal latency \> 3.60 msec) according to the electrophysiological data were included in the study.

Exclusion Criteria:

1. Patients with local (osteophytes, ganglion cysts, lipomas, muscle and tendon abnormalities, etc.) and systemic (diabetes mellitus, acromegaly, hypothyroidism, pregnancy, etc.) diseases causing symptoms were included in the study.) causing CTS,
2. Patients who underwent surgical treatment for CTS
3. Patients who received injections for CTS in the last 6 months
4. Patients diagnosed with severe CTS on EMG (SAP not obtained in sensory conduction studies and/or CMAP \< 5 mV in motor conduction studies)
Effects of Fractional CO2 Laser Treatment on Vaginal Symptoms and Sexual Dysfunction in Women With Systemic Sclerosis

Women affected by Systemic Sclerosis and Vulvovaginal Atrophy will be submitted to a cycle composed of five vaginal CO2 laser treatment (SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy - Hi Scan V2LR con sonda vaginale a 360 °, dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μm smart stack 1-3, emission mode deka pulse) every 30-40 days.

At 1-month follow up from the last vaginal laser treatment (6 months from baseline) vagina and sexual health will be assessed by a 1-5 Likert scale, a 0-10 Visual Analogue Scale for vulvovaginal symptoms and the Female Sexual Function Index.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Systemic Sclerosis; - vulvovaginal symptoms

Exclusion Criteria:

* gynecological neoplasia; - pregnancy; - pelvic organ prolapse; - vaginal and urinary infection; - pudendal neuropathy
Post Trial Access Program of TAK-577 for Von Willebrand Disease (VWD)

The post-trial access program allows eligible participants to gain access to unlicensed treatment on compassionate grounds. Recombinant von Willebrand factor (rVWF) also known as TAK-577, is a medicine to help treat Von Willebrand Disease (VWD). This post-trial access program enables continued access to children and adults who are benefitting from treatment on study SHP677-304 (NCT03879135) study.

This is a post-trial access program in which the drug being given is called TAK-577. This study will provide access to TAK-577 before marketing authorization for eligible participants with severe VWD who are benefitting from treatment on study SHP677-304 and cannot adequately be treated via the current standard of care and cannot enter a clinical trial.

All participants will receive TAK-577 as a sequential intravenous infusion based on their weight.

This is a multi-center, international program. Participants will continue treatment until a benefit is no longer derived from the treatment (or treatment is no longer tolerable), the sponsor decision to end the program, the participant chooses to discontinue the treatment, or TAK-577 becomes commercially available for children.

Eligibility Criteria:
Inclusion Criteria:

1. Participant has completed the treatment period of the SHP677-304 study (at least 12 months on study treatment).
2. Participant had good clinical response to rVWF treatment.
3. Participant does not have access to any comparable or satisfactory alternative replacement therapy available at country level.
4. Participant will be/has been negatively impacted by discontinuation of rVWF.
5. Participant and/or a parent(s)/legal guardian is informed of the nature of the post-trial access program and can provide written informed consent for themselves or the child to participate (with assent from a child when appropriate) before treatment).

Exclusion Criteria:

1. Participants with known hypersensitivity/intolerance to the study drug will not be eligible for this study
Plyometric Exercise to Improve Rapid Force Production in Older Men

Rapid force production declines as a consequence of ageing. Given the functional relevance of rapid force production, exercise interventions in older adults should aim at improving the capacity to produce force rapidly. To improve this capacity, exercises should be performed with the intention to develop high speeds, as supported by previous work.

Human locomotion fundamentally consists of multi-joint movements and rapidly coupled eccentric-concentric muscle actions, known as stretch-shortening cycle (SSC) activities or plyometrics. Plyometrics might therefore be used to optimize power production. However, there is limited research on the feasibility of plyometrics in older adults and its potential effects on rapid force production and functional capacity. This study will test the feasibility of a 12-week plyometric exercise intervention in older men and compare its effects on rapid force production to a traditional resistance exercise or walking intervention.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* No systematic engagement in (resistance) exercise in the 12-months prior to participation
* Cardiovascular disease
* Neurological disorders
* Cognitive malfunctioning
* Severe knee or hip problems
Doppler Flow Measurements in Patients With Misoprostol Treatment for Arrested Pregnancy

Testing the whether Doppler studies after cytotec treatment can predict success of treatment.

All women who are treated with Cytotec for a missed abortion at 1st trimester will have a follow up ultrasound exam.

Doppler measurements will be performed but will be hidden from the clinicians. After the conclusion of treatment, data on Doppler would be vevealed in order to see if positive Doppler after Cytotec is predictive of failure of treatment or the need in several doses of cytotec.

Eligibility Criteria:
Inclusion Criteria:

* Women with miss abortion who choose treatment with cytotec

Exclusion Criteria:
Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines

This study will compare a local anesthetic technique that has been used to treat subjects suffering from transformed migraines (chronic migraines) versus medical management with traditional antidepressant Amitriptyline / Elavil.

Subjects will be randomized into one of two treatment groups to compare the safety and efficacy of the therapies. Subjects will recieve either sphenopalatine ganglion nerve block with 5% lidocaine gel into the nasopharynx or medical management with traditional antidepressants, Elavil, to produce a reduction in the frequency and severity of the headache.

We propose that there will be a difference in the outcomes when comparing the two methods of treating transformed migraines and that one research arm will result in more patient satisfaction and greater efficacy in the treatment of subjects

Arm one will receive Sphenopalatine Ganglion Nerve Block weekly for 4 weeks

Arm two will receive Amitriptyline / Elavil daily for 30 Days

Eligibility Criteria:
Inclusion Criteria:

1. Male and female age 18-90
2. Subject have formal medical diagnosis of migraine headache
3. Subjects currently require treatment for headache
4. Subjects who have received optimal medical management from migraines including triptans (Imitrex, Amerge and Relpax)
5. Subjects who have recieved optimal medical management for migraines including anticonvulsants (Depakote, Lamictal, klonopin

Exclusion Criteria:

1. Less than 18 years of age
2. Subjects will be excluded if they are already being treated with lidocaine (patch or other vehicle) for chronic pain
3. Untreated Heart Failure
4. Pregnancy
5. Individuals unwilling to comply with study procedures and follow-up
Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness Study

This trial consists of two linked substudies.

Substudy 1: Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness Study

Substudy 2: Activating Messages for Enhancing Primary Care Practice (AMEP2): Toxicity Study

The purpose of the Effectiveness Study is to assess the comparative effectiveness of three multimedia educational interventions (a targeted educational video, a tailored interactive multimedia computer program, and an "attention control") for increasing the likelihood that primary care patients with significant depressive symptoms will seek appropriate care (n = 510). The primary study outcomes are provision of minimally acceptable initial care, reductions in depression-related stigma, and improvement in depression symptoms. (See Process of Care and Patient Outcomes in Primary Outcome Measure section.)

The purpose of the Toxicity Study is to assess the potential benefits (reduced stigma) and harms (inappropriate prescribing) associated with three multimedia depression educational interventions when administered to patients with few or no depressive symptoms (n = 308). The primary outcomes relating to this outcome are reducing depression-related stigma and reducing unnecessary prescribing. (See Toxicity in Primary Outcome Measure section.)

Both studies will look at the secondary outcome measure of patient requests for depression treatment.

This project is an investigator-initiated study involving two sequential phases and is funded by the National Institute of Mental Health. Phase I included the use of marketing research (i.e. focus groups, adaptive conjoint analysis, and other survey methods) to produce two clinic-based interventions: a public service announcement (PSA) and interactive multimedia computer program (IMCP). The two clinic-based interventions are intended to include messages that will activate patients to talk with their physicians about specific health concerns (depression) and/or any depressive symptoms they've been experiencing. In Phase II (as described in this registration protocol), those interventions will undergo assessment in a randomized controlled effectiveness trial (RCT) in primary care settings in Sacramento and San Francisco.

Eligibility Criteria:
Inclusion Criteria:

* Age 25-70
* Visual acuity and manual dexterity to operate a laptop computer

Exclusion Criteria:

* Currently being treated for depression with anti-depressant medications
PACU Stay After Lower Limb Revascularisation

This study aims to describe the postoperative functions of patients with ischaemic lower extremities after undergoing revascularisation surgery . Primary endpoints will focus on complications in the post-anaesthesia care unit (PACU) which prevent discharge from PACU to the general ward. This include Aldrete scores and other complications that can be registrered descriptively. Furthermore, the study seeks to compare the complications outcomes between acute and elective revascularisation surgery.

As above

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptoms of ischaemic lower extremities for instance intermittent claudication, resting leg pain, non-healing/gangrenouswounds and acute cold leg.
* Patients who underwent one or more of the following surgical procedure: PTA + TEA, TEA, bypass, thrombectomy, embolectomy, femoral-femoral crossover bypass, axillary-femoral bypass.

Exclusion Criteria:

* Only PTA intervention
* Only thrombolysis intervention