cyrilzakka/clinical-trials huggingface dataset:
Study in Parkinson's Disease of Exercise

The purpose of this study is to learn more about the effects of exercise on patients who have been recently diagnosed with Parkinson's disease (PD). The investigators are going to test two levels of exercise (moderate to vigorous) against no exercise. The investigators think that exercise may reduce the symptoms the of PD, and the investigators hope to learn what level of exercise will offer the most benefit.

The overall objective of this study is to determine the futility or non-futility of conducting a randomized controlled trial to determine the effects of exercise on the progression of PD symptoms. The primary aim is to determine whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% HRmax or 80-85% HRmax) and adhere to the exercise protocol.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary Parkinson's disease
* In a Hoehn and Yahr stage less than stage III
* Disease duration is less than 5 years
* Not likely to require dopaminergic therapy within 6 months

Exclusion Criteria:

* Use of any PD medication within 60 days prior to the beginning the study, including levodopa, direct dopamine agonists, amantadine, Rasagiline (Azilect), Selegiline (Eldepryl), Artane (trihexyphenidyl).
* Duration of previous use of medications for PD that exceeds 90 days
* Expected to require dopaminergic therapy in the next 6 months
* Poorly controlled or unstable cardiovascular disease
* Uncontrolled hypertension
* Hypo- or hyperthyroidism, abnormal liver function, abnormal renal function
* Mild cognitive impairment (Montreal Cognitive Assessment score\<26/30)
* Depression that precludes ability to exercise (Beck depression score\>13)
* Disorders that interfere with ability to perform endurance exercises
* Regular participation in vigorous endurance exercise
* Evidence of serious arrhythmias or ischemic heart disease
* Any clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study
Blood Antioxidant Status in Chronic Hepatitis C Patients Before and After Antioxidant Supplementation: a Randomized Clinical Trial

The objective of the present study is to evaluate the antioxidant status in the blood of HCV patients treated with pegylated interferon (2a 1.5 ug/kg; 2b 180 ug) combined with ribavirin (1000 to 1250 mg) before and after supplementation of vitamins E, C and the mineral zinc (800 mg,500 mg and 40 mg; respectively) during six months.

The WHO estimated that around 170 million people are infected by HCV, about 3% of the world population. HCV is the leading cause of acute hepatitis and chronic liver disease, which may lead to cirrhosis and hepatocellular carcinoma.

The combined therapy with interferon with or without pegylation associated with ribavirin has shown greater sustained virological response than monotherapy with interferon-alpha, however this response still represents around 60% of cases. The mechanisms by which HCV causes cellular damage are not yet well understood, however immune liver damage, direct cytotoxic damage mediated by different viral products and also oxidative stress have been implicated in the pathogenesis of chronic hepatitis C. Several studies support that reactive oxygen species (ROS) and oxidative stress are involved in the pathogenesis of hepatitis C, despite that increased ROS levels in HCV patients might be beneficial by suppressing HCV replication. ROS are involved in several diseases and cause oxidative damage to lipids, DNA, proteins and carbohydrates.

Eligibility Criteria:
Inclusion Criteria:

* without the presence of illnesses associated with systemic diseases, no chronic alcoholism, without HIV coinfection, and were not participating in other studies.
* Patients with hepatitis C were selected according to the Clinical Protocol and Guidelines for Therapeutic Hepatitis C Viral.
* Group I - All subjects were negative for HCV, HBV, HIV, HBsAg, anti-HBc total, anti-HCV and normal serum transaminases.

Exclusion Criteria:

* Patients with one of the following laboratory abnormalities were also excluded: leukocytes, neutrophils, platelets, serum creatinine 1.5 times upper limit of normal, elevated thyroid stimulating hormone, alpha-fetoprotein above normal limits, and/or focal lesion on ultrasound performed within 1 month of study entry.
The CATALYST Study

The CATALYST study is an implementation study that will characterize and assess the implementation of an enhanced service delivery package providing informed choice of pre-exposure prophylaxis (PrEP) products among women at PEPFAR sites in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe.

The overall study goal is to characterize and assess the implementation of an enhanced service delivery package providing informed choice of pre-exposure prophylaxis (PrEP) products among women at U.S. President's Plan for AIDS Relief/U.S. Agency for International Development (PEPFAR/USAID) delivery sites in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe. The study will be conducted in two stages, with currently approved oral PrEP and PrEP rings offered in Stage I, and the addition of CAB PrEP in Stage II after it has been approved by the regulatory authority in each country. The study goal will be accomplished by conducting a mixed-methods implementation study involving several components:

1. Component 1: Prospective cohort study of women at PEPFAR/USAID delivery sites that are delivering HIV PrEP, including daily oral PrEP, monthly PrEP rings, and bimonthly CAB PrEP

   1. Descriptive nested cohort study to evaluate the performance characteristics of different HIV testing strategies among participants who initiate CAB PrEP
   2. Descriptive nested cohort study to evaluate the feasibility and validity of a prevention effective use (PEU) measure among a subset of PrEP users
2. Component 2: Mixed-methods process evaluation involving implementers and key stakeholders

   1. Nested costing study across Lesotho, Uganda, and Zimbabwe study sites
   2. Nested qualitative study to understand community acceptance of PrEP and informed choice of PrEP products

Eligibility Criteria:
Inclusion Criteria:

* Tested HIV-negative as determined by the national HIV testing algorithm at a CATALYST site on the same day as enrollment
* Self-identify with at least one of the following populations:

  1. Adolescent girl or young women (AGYW) ages 15-24 years
  2. Female sex worker (FSW) ages 18 years and older
  3. Pregnant and breastfeeding populations (PBFP) ages 15 years and older
  4. Individuals assigned female at birth of any gender identity ages 15 years and older
  5. Individuals assigned male at birth who identify as women ages 15 years and older
  6. Other women ages 25 years and older
* Interested in learning about HIV prevention
* Willing to be contacted for follow-up by phone or other means (e.g., through a community health worker)
* Willing and able to provide informed written consent for participation

Exclusion Criteria:

* For participants ages 15-17 years, potential participants under the age of 18 may be excluded from study participation based on country guidelines and the age of consent. This determination will vary by country, including countries' definitions of emancipated minors. Country-specific informed consent forms will outline the country-specific inclusion criteria related to age.
* Certain sub-categories of participants may be excluded based on country guidelines.
A Food Effect Study of TS-142 in Healthy Subjects

This is a study to assess the food effect of TS-142 preliminary market formulation tablet in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

1. Japanese male who are aged 18 years or older but less than 40 years at the time of informed consent
2. Body Mass Index (BMI) of 18.5 or more and less than 25.0 at the screening test
3. Subjects who are judged by the investigators as an eligible for the clinical trial participation based on the screening tests and the tests conducted at treatment period 1.

Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

1. Subjects who are judged to have any disease by the principal investigator or sub-investigator and are not considered healthy
2. Subjects who have any unsuitable medical history for participation in this study, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrinological, metabolic, hematologic, immunologic, dermatological, neurological, or psychiatric diseases
3. Subjects who have any medical histories including sleep-associated symptoms, narcolepsy-like symptoms, suicidal ideation, or suicidal attempts

Other protocol defined exclusion criteria could apply.
MAsS Scan as a Predictor of Morbidity and Mortality in Patients With Liver Disease

The purpose of the study is to study the muscle assessment score (MAsS, utilizing MRI, as an objective measure of frailty and muscle composition to serve as a predictor of morbidity and mortality in patients with liver disease.

Prospective study of patients seen at the Univ. of Chicago Medical Center hospital and ambulatory clinics. The assessment of the MAsS score will require an additional 8-10 minutes in the MRI for each patient already undergoing MRI exam.

Four groups of pts. who are already scheduled for MRI for routine clinical purposes will be evaluated.

1. Pts. hospitalized with acute hepatic decompensation for whom MRI is otherwise indicated for clinical evaluation.
2. Pts. with hepatobiliary neoplasia
3. Pts.undergoing transjugular portosystemic shunt (TIPS) placement
4. Pts. with chronic liver disease undergoing magnetic resonance elastography for routine monitoring

Eligibility Criteria:
Inclusion Criteria:

* Patients who are already scheduled for an MRI for routine clinical purposes will be evaluated

Exclusion Criteria:

* \<18 yrs. of age
The Effect of Dry Needling Treatment Combined With Physical Therapy in Patients With Cervical Spondylosis

In this study, it was aimed to determine whether dry needling treatment applied to the trigger points in the trapezius muscle in patients with chronic neck pain due to cervical spondylosis makes an additional contribution to the treatment results of the physical therapy and rehabilitation program.

Among the evaluated patients, the patients meeting the inclusion and exclusion criteria will be randomized into 2 groups using the random numbers table.

While physical therapy and rehabilitation program will be applied to one group, dry needling treatment will be applied to the trigger points in the upper trapezius region with the same program to the other group. Patients will be evaluated before treatment (day 0) and at the end of treatment (day 21).

The randomization and evaluation of the patients will be done by Gül Tuğba Bulut, while the injection of the patients will be done by Alper Mengi.

Gender, age, education level, occupation, neck pain duration, body mass index of the patients included in the study will be recorded.

The patients will be evaluated in terms of pain intensity, number of active trigger points in the upper trapezius muscle, functional status, quality of life, anxiety and depression at before (day 0) and after treatment (day 21).

Eligibility Criteria:
Inclusion Criteria:

* Having neck pain for at least 3 months
* Restriction of neck movements and/or pain during movement
* Tenderness in neck paravertebral muscles and neural foramen with compression
* Detection of narrowing of intervertebral disc spaces, subchondral sclerosis, osteophyte on cervical radiograph
* Active trigger point in the upper trapezius muscle during the examination.

Exclusion Criteria:

* Having motor, sensory or reflex abnormalities due to spinal root compression
* Whiplash injuries
* Cervical spinal stenosis
* Having undergone cervical vertebra surgery
* History of interventional procedure on the cervical region in the last 6 months
* Central or peripheral nervous system disorders
* Spondylolisthesis
* Inflammatory neck pain
* History of infectious, chronic inflammatory disease, malignancy
* Not being cooperative
* Having open wounds, infections or sensory defects on the skin where the application will be made
* Fibromyalgia
* Advanced osteoporosis or osteomalacia
* Active psychiatric illness.
An Observational Study of Patients With Chronic Hepatitis C Undergoing Treatment With PegIntron and Rebetol in Clinical Practice in Belgium (Study P05494)(WITHDRAWN)

This is an observational study of patients undergoing treatment with PegIntron and Rebetol for chronic hepatitis C in clinical practice in Belgium. Treatment will not be administered as part of the study. Safety parameters will be assessed retrospectively. Efficacy parameters, such as relapse rates and sustained virologic response rates, will be assessed prospectively. The objective of the study is to examine any associations between safety, virologic, histologic, demographic parameters and patient outcome (relapse rates and sustained virologic response rates).


Eligibility Criteria:
Inclusion Criteria:

* Male and female adult (18 years or older) subjects for whom the treating physician has decided to start treatment with PegIntron® and Rebetol® and reaching the End-of-Treatment time point.
* For the prospective component, evidence of treatment response at EOT after a complete course of therapy as per SmPC.
* Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
* Subjects must be diagnosed with chronic hepatitis C (genotypes 1, 2, 3, 4, 5 or 6).
* Subjects must be free of any clinically significant disease that would interfere with study participation.

Exclusion Criteria:

* For prospective component of the study: patients not achieving End-of-Treatment response after a complete course of therapy as per SmPC.
The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health

The purpose of this study is to investigate whether exposure to hypertensive disorders of pregnancy and/or a preterm birth results in alterations in the cardiovascular system during infancy.

While the incidence of cardiovascular disease has reduced dramatically, coinciding with favourable changes in risk factors, cardiovascular disease remains the single largest cause of mortality and premature mortality in the United Kingdom. Identification of novel biological pathways that underlie disease susceptibility raises the potential for new early primary prevention strategies to complement classical management. There is particular interest in the role of early environment in 'programming' risk of cardiovascular disease in later life and growing evidence that various early life exposures impact cardiovascular health in the longer term.

The investigators have therefore designed the EPOCH study to investigate whether those individuals born to hypertensive pregnancies and/or to a preterm birth demonstrate differences in the cardiovascular phenotype at birth, or whether they develop any differences over the first three months of life and whether this varies with other perinatal factors. This study also allows investigation of the short term impact of perinatal interventions used in this cohort. Comprehensive multi-modality non-invasive imaging measures of cardiovascular structure and function allow precise quantification of cardiovascular phenotype in this population.

Eligibility Criteria:
Inclusion Criteria:

* Available for assessment within the neonatal period,
* Parent is willing and able to give informed consent for participation in the study,
* Physical condition is suitable to allow non-invasive vascular testing,
* Mother meets criteria for inclusion in the study and is willing to participate in the study. (Aged \>/= 16 years and Is able and willing to give informed consent for participation in the study, and is able and willing to give informed consent for her infants participation in the study. )
* Cases: Diagnosed during pregnancy with preeclampsia or gestational hypertension and/or delivered preterm (\<37 weeks gestation)
* Controls: No history of gestational hypertension or preeclampsia during this pregnancy and delivered at term (\>37 weeks gestation)

Exclusion Criteria:

* Parent is unwilling to give consent,
* Unavailable for assessment of cardiovascular system,
* Physical condition unsuitable to allow for non-invasive testing of cardiovascular system,
* Evidence of congenital cardiovascular disease (with the exception of Persistent Patent Ductus Arterious (PDA) and Atrial Septal Defect (ASD)),
* Cardiorespiratory instability at time of proposed measures,
* Active infection at time of proposed study measures,
* Mother of infant is excluded from the study. (Aged \<16 years, unable or unwilling to consent to study or Physical condition post delivery such that it would preclude participation in the study)
An Institutional Audit of the Short Term Complications and Long Term Outcomes of Patients Undergoing Laparoscopic Sacrocolpopexy for Vault/cervical Prolapse.

An institutional audit of the short term complications and long term outcomes of patients undergoing laparoscopic sacrocolpopexy for vault/cervical prolapse.

The aim of this study is to audit the outcomes of laparoscopic sacrocolpopexy procedures done in our unit. The investigators aim to permanently monitor outcomes of this procedure correcting vaginal vault prolapse or cervical descent. Auditing institutional performance with pelvic floor procedures is increasingly being required by (inter)national societies in pelvic floor medicine, so that patients can be counseled on outcomes they can expect at a given institution.

Sacrocolpopexy is offered to patients with symptomatic prolapse (≥stage II) of the vaginal apex (vault or cervix). The procedure involves dissection of the promontory and the vaginal vault, suturing of two meshes to the anterior and posterior aspect of the vagina using minimally three rows of sutures on each side, and one row at the apex. Thereafter the mesh is fixed with staples to the promontory and the peritoneum closed, with staples and a running suture.

The investigators started auditing this procedure 20 years ago because of the conversion to laparoscopy.

High anatomical and subjective cure rates are reported on the medium term (range 12-60 months), though long-term data (60 months or longer) are scarce and most studies focus on anatomical outcomes.4 The investigators recently published medium term outcomes of patients operated up to 2014 1. Now the aim is to extend this audit to patients operated since 2014 and install a process of permanent monitoring our performance with this operation. The investigators also want to use the availability of outcomes in large numbers and/or the long term, to detect potential rare or long term complications, and study the effects of small technical increments such as extending dissections, associate other pelvic floor reconstructive procedures or the change in bio-materials used for this operation. All these may affect outcome.

Primary outcome is a subjective outcome, using a patient-centered approach and report patient reported out-comes. Additional outcomes such as anatomical failure, or complications, both by occurrence and time point, re-interventions, and pelvic floor functional outcomes are secondary outcomes that allows the investigators to benchmark their performance to previous studies and other series. Key in an objective assessment process is that patients are examined by an experienced clinician not involved in the management, which will also be used herein.

Eligibility Criteria:
Inclusion Criteria:

To be eligible, female subjects must meet the following inclusion criteria:

1. Having undergone laparoscopic sacrocolpoexy at our unit.
2. Agreeing to participate in the study, including completion of study-related procedures, evaluations and questionnaires, and giving informed consent.
3. Follow up period of at least 6 months since the operation.

Exclusion Criteria:

None apart from not meeting the above criteria
Communication Bridge Pilot Study

The aim of this study is to evaluate the effectiveness and feasibility of evidence-based interventions in individuals living with mild to moderate primary progressive aphasia (PPA) that address communication-focused outcomes.

The purpose of this study is to evaluate the effectiveness and feasibility of evidence-based interventions in individuals living with mild to moderate primary progressive aphasia (PPA) that address communication-focused outcomes. The study team aims to enhance the personal relevance and therapeutic impact of goal attainment scaling (GAS) while building self-efficacy within a self-management framework.

This study will be a continuation of one of the largest non-pharmacologic intervention studies for individuals with PPA to date. It will add critical information regarding the effectiveness of telepractice interventions for communication disorders in adults with primary progressive aphasia specifically, and in dementia more broadly. The goal of this study is to maximize functional communication and life participation for the participants.

Eligibility Criteria:
Inclusion Criteria (person with PPA):

1. Meets diagnostic criteria for PPA based on neurologist and supporting medical assessments (extracted from medical records)
2. English as primary language used in daily communication activities (by self-report)
3. Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
4. Adequate vision (aided or unaided) for reading a newspaper, or other functional materials (by self-report)
5. Able to pass technology screening and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)
6. Geriatric Depression Scale score ≤ 9
7. Mild-moderate PPA informed by a structured interview with a speech-language pathologist and a standardized testing battery.

Inclusion Criteria (Co-enrolled communication partner):

1. 18+ years of age
2. English as primary language used in daily communication activities (by self-report)
3. Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
4. Able to pass technology screening\* and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)

Exclusion Criteria:

* A dementia diagnosis other than Primary Progressive Aphasia
* Participation is co-enrolled in an outside speech language therapy program during the study course.
* Communication partners will be excluded if they have a pre-existing communication impairment that would affect study participation (e.g., aphasia, dementia) Medical records will be requested and reviewed to determine eligibility