cyrilzakka/clinical-trials huggingface dataset:
White Matter Pathology in Parkinson's Disease (PD)

The relationship between WM lesions (WM) and Postural Instability Gait Disorders (PIGD-PD)in Parkinson's disease patients is largely unknown. We hypothesize that sub-clinical WM pathology may be a major contributing factor to PIGD-PD. We will compare two groups of patients with Parkinson's disease (PD): those with PIGD and patients with dominant tremor (n=120)to assess the role of brain WM changes.

To compare brain WM burden using MRI in PD patients with and without PIGD. Diffusion tensor imaging (DTI) analysis techniques will be applied.We will quantify PIGD-related symptoms including cognitive function, balance and gait and their associations with MRI findings.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic PD, as defined by the UK Brain Bank criteria
2. Age between 50 and 80 years
3. Hoehn and Yahr stage II-III
4. On anti-parkinsonian medications
5. Mini-Mental State Exam score ≥ 25

Exclusion Criteria:

1. Brain surgery in the past including implanted Deep Brain Stimulation
2. Clinically significant co-morbidities likely to affect gait e.g., acute illness, significant rheumatic, orthopedic disease, dementia, or major depression
3. Unable to walk independently
4. Inability to comply with the protocol
Oral Health Promotion Vs. Standard Care in Egyptian Pregnant Women

The research question: In pregnant women, does participation in a comprehensive oral health promotion program, compared to standard care, improve maternal oral health, knowledge, attitudes, and practices? This study aims to evaluate the impact of a comprehensive oral health promotion program, compared to standard care, on improving maternal oral health, knowledge, attitudes, and practices among pregnant women. Null hypothesis: There is no significant difference in maternal oral health, knowledge, attitudes, and practices between the group of Egyptian pregnant women who receive the comprehensive oral health promotion program and those who receive standard care. The study population will be pregnant women aged 20 to 45 years. The participants will be categorized into two groups: Intervention will be offered Comprehensive Program and will Include educational workshops, Videos, pamphlets, and support sessions and group chat; and Comparator group will receive Standard care (Limited to oral health sessions only). The study will evaluate three outcomes. Primary outcome The participants will undergo a caries assessment test using The DMFT Index. Secondary outcome The Oral Hygiene Assessment will include the participants using the Simplified Oral Hygiene Index (OHI-S).

Tertiary outcome

1. The knowledge, attitude, and practice (KAP) assessment for pregnant women regarding the Comprehensive Oral Health Promotion Program will be carried out through a prestructured questionnaire. The response data will be collected as frequency and percentage.
2. The nutritional assessment for all participants will be performed using a prestructured questionnaire. The response data will be recorded as frequency and percentage.


Eligibility Criteria:
Inclusion Criteria:

* Mothers willing to participate.
* Pregnant women from 20 to 45 years
* Participants can understand and communicate

Exclusion Criteria:

* Pre-existing systemic conditions such as diabetes or cardiovascular diseases.
* Participants with a high risk of non-compliance with study requirements
Traumatic Brain Injury and Yoga

This long-term goal of this project was to advance best practices in occupational therapy in conjunction with yoga. To address the long-term goal, this research team developed a pilot yoga intervention. The intervention was designed to focus on balance, balance confidence, body responsiveness, pain, physical ability and quality of life. Assessments were then chosen to address these areas pre and post yoga intervention. A manual and protocol were developed for the intervention and then the intervention was implemented with a group of individuals with chronic traumatic brain injury.

This was an 8-week yoga intervention, focused on demonstrating the preliminary feasibility and efficacy of yoga for individuals with chronic traumatic brain injury. The study was a mixed-methods longitudinal study. Assessments were conducted 8 weeks prior to the yoga intervention and then just following the 8 week yoga intervention. The objectives of this feasibility and efficacy study was to 1) further develop, standardize, and manualize the yoga for the traumatic brain injury intervention and 2) assess change in balance, balance confidence, body responsiveness, pain, physical ability, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* chronic TBI (\>6 months)
* greater than or equal to 18 years of age
* no consistent practice of yoga in the last year

Exclusion Criteria:

* inability to provide informed consent
* less than 18 years of age
* self-report of exercise restriction
* consistent yoga practice within the last year
* inability to attend sessions based on transportation restrictions
Components Study of REAL Essentials

The Components Study of REAL Essentials (REA) is a descriptive implementation and outcome study. This study aims to identify the components that matter most for promoting positive health behaviors and outcomes among adolescents. The study will examine a variety of components to determine which are most influential in predicting participant outcomes. In addition, the study will measure youth engagement in programming from various perspectives and examine the role of engagement as an intermediary factor to achieving youth outcomes.

Sites participating in the study used the REA relationship education curriculum, a popular program among federal Teen Pregnancy Prevention (TPP) and Sexual Risk Avoidance Education (SRAE) grantees. The program is intentionally flexible, and each participating school selected a subset of the 87available lessons to meet the needs of the population it serves; the selected lessons comprised the site-specific scope and implementation sequence. Schools offered different lessons and total dosage, and facilitators had various levels of experience with the curriculum, and various backgrounds and facilitation quality. The variation in program delivery, coupled with diverse participant backgrounds, created different REA experiences for participating youth. The study capitalized on this variation to examine which program components were most predictive of variation in participant outcomes.

The study enrolled 1,301 youth across 27 schools in Spring 2022 and Fall 2022. The study collected youth outcome surveys at baseline and at program exit. The immediate follow-up survey enabled the study to explore how variation in components influences outcomes proximal to the REA content, which largely included antecedents to sexual behavior and optimal health. A six-month follow-up survey enabled the study to explore how program components influenced distal behavioral and optimal health outcomes.

In addition to the outcome data, the study collected extensive implementation data. Program facilitators completed logs after delivering each class to enable the study to determine whether facilitators delivered program content and activities, whether they adapted lessons, and the extent to which youth appeared engaged in the lesson. Facilitators also documented attendance at each class session to provide detailed dosage data for youth. Study staff independently observed a subset of classes and REA trainings and interviewed and hold focus groups with facilitators and youth.

The study measured youth engagement through brief exit tickets with youth (surveys administered after each class); facilitators' reports of perceived engagement; independent in-person observations; and in a small number of sites, video recordings of youth faces coded with artificial intelligence to determine how strongly the measures of youth engagement correlate with each other and which was most predictive of youth outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in a school recruited for the study, in a classroom/grade prioritized by school leadership
* Provided consent for data collection

Exclusion Criteria:

* None
Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)

Apixaban is a direct anticoagulant, which inhibits the factor Xa. Its clinical efficiency in prevention of stroke and systemic embolism in adult patients with NVAF (non/valvular atrial fibrillation) was demonstrated as well as has shown better safety profile compared with warfarin. A Drug Utilization study will evaluate whether this drug has been used in accordance with the approved indication and recommendations described in the summary of product characteristics (SmPC) and estimate possible misuse or overuse apixaban.

The primary research question is to evaluate the apixaban utilization according to the approved SPAF indication and recommendations by EMA.

In addition a comparison with a cohort of NVAF patients treated with VKA, dabigatran and rivaroxaban for the SPAF indication will also be performed.

Objective 1: To characterize patients using apixaban according to demographics, comorbidity, risk of thromboembolic events (CHADS2 and CHA2DS2-Vasc scores), risk of bleeding events (HAS-BLED score), comedications and compare it with the profile of patients treated with VKA, dabigatran and rivaroxaban.

Objective 2: Describe the level of appropriate usage according to the posology recommended in the apixaban SmPC.

Objective 3: Describe the potential interactions with other drugs prescribed concomintatly according with the SmPC recommendations.

Objective 4: Estimate the level of apixaban adherence by the medication possession ratio (MPR) and discontinuation rates and compare it with VKA, dabigatran and rivaroxaban cohort.

Objective 5: To analyze INR (International Normalized Ratio) values during the last 12 months and to obtain TTR (Time in Therapeutic Range) values in patients previously treated with VKA, and during the whole study period for those in the cohort treated with VKA.

Eligibility Criteria:
Inclusion Criteria:

1. Patients more than 18 years-old.
2. Patients diagnosed with NVAF registered in primary care according to ICD-10.
3. Patients initiating apixaban (naïve or VKA experienced), VKA (naïve or VKA experienced), dabigatran or rivaroxaban for the SPAF indication.
4. Continuous enrolment in the 12 months pre-index.

Exclusion Criteria:

1. Patients with valvular heart disease (ICD 10: I05.0-I05.09, I08.0-I08.9) including patients with mitral prosthetic valves.
2. Lost to follow-up (e.g. transfer to primary care center non-ICS).
PBMT Associated With MCE for Chronic Non- Specific Low Back Pain

Non-specific low back pain (LBP) is a very prevalent health condition and is highly associated with disability worldwide. There is evidence that patients with non-specific LBP may have impairments in the control of postural muscles. In this way, motor control exercises (MCE) may be an interesting alternative in the treatment of patients with non-specific LBP. In addition, the association of MCE and photobiomodulation therapy (PBMT) may potentiate its benefits, since PBMT has ergogenic effects. Therefore, the aim of this study is to evaluate the ergogenic effects of PBMT, using low-level laser therapy, when associated with MCE in patients with chronic non-specific low back pain.

This is a randomized, triple-blind (patients, therapists, outcome assessors), placebo-controlled trial, with voluntary patients with chronic non-specific low back pain. One hundred and forty-eight patients will be randomly allocated to two treatment groups: Placebo PBMT associated with MCE or Active PBMT associated with MCE. Treatment will be performed twice a week (on non-consecutive days), for 6 weeks, yielding 12 treatment sessions. Placebo PBMT or Active PBMT will be applied before the MCE protocol.

The clinical outcomes will be obtained at the end of treatment (6 weeks), one month after the end of treatment, 3, 6 and 12 months after randomization. The biochemical outcome will be obtained only after the end of treatment. The remaining outcomes will be obtained after the end of treatment, one month after the end of treatment, 3, 6 and 12 months after randomization.

The data will be collected by a blinded assessor. The statistical analysis will follow the intention-to-treat principles and the between-group differences will be calculated using two-way repeated measures ANOVA.

The project was also approved by the Research Ethics Committee from Universidade Nove de Julho, under the number 5.289.714.

Board Affiliation: Comissão Nacional de Ética em Pesquisa (CONEP) Phone: +55113385-9010 - Email: comitedeetica@uninove.br Address: Vergueiro nº 235/249. Liberdade, Sao Paulo, Sao Paulo, Brazil

Eligibility Criteria:
Inclusion Criteria:

* patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 month);
* with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale;
* aged between 18 and 65 years;
* able to read Portuguese.

Exclusion Criteria:

* evidence of nerve root compromise (i.e. one or more of motor, reflex or sensation deficit);
* serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases);
* patients with severe skin diseases (eg, skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);
* decompensated severe cardiovascular and metabolic diseases;
* previous back surgery;
* patients with cancer;
* body mass index (BMI) ≥ 30.
* pregnancy.
Gallium Ga 68-DOTATATE PET/CT in Predicting Tumor Growth in Patients With Meningiomas

This phase I trial studies how well gallium Ga 68-DOTATATE positron emission tomography (PET)/computed tomography (CT) works in predicting tumor growth in patients with meningiomas. Giving Gallium Ga 68-DOTATATE before PET/CT scan may work better in predicting tumor growth in patients with meningiomas.

PRIMARY OBJECTIVES:

I. To assess the ability of imaging with gallium Ga 68-DOTATATE (68Ga-DOTATATE) positron emission tomography/computed tomography (PET/CT).

II. To assess a metabolic response to radiation therapy in meningiomas as measured by a reduction in the tumor to background ratio of the maximum standardized uptake values (SUV) of the tumor compared to background brain parenchyma.

OUTLINE:

Patients receive gallium Ga 68-DOTATATE intravenously (IV) over a few minutes and, after 60 minutes, undergo a PET/CT scan over 5-10 minutes 14 days before starting scheduled radiation therapy and 6 weeks after completion of radiation treatment.

Eligibility Criteria:
Inclusion Criteria:

* Any meningioma with at least 10 mm measurable residual disease.
* Age 18 years or older.
* Planned radiation therapy for meningioma.
* Ability to understand and the willingness to sign a IRB approved written informed consent document in accordance with regulatory and institutional guidelines before study entry.
* No restriction based on language that would prohibit enrollment of the participant. IRB approved VTPS form will be utilized when non-English Speaking patient is enrolled

Exclusion Criteria:

* Neurofibromatosis type 1 or 2.
* Children.
* Pregnant.
* Contraindication to MR imaging.
* Body weight greater than 400 lbs (181.4kg).
A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)

This study will investigate and compare the pharmacokinetics of a single 25-mg dose of MK-3102 in participants with moderate hepatic impairment and matched healthy participants. The primary hypothesis is that in participants with moderately impaired hepatic function, the area under the concentration-time curve from time zero to infinity (AUC0-∞) is similar to that observed in healthy matched control participants following a single 25 mg oral dose of MK-3102. Specifically, the true ratio (moderately impaired hepatic function patients/healthy matched control subjects) of geometric means for AUC0-∞ is no greater than 2.


Eligibility Criteria:
Inclusion Criteria:

Impaired Hepatic Function Participants:

* A diagnosis of:

  1. Chronic (\> 6 months) hepatic insufficiency
  2. Stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology
* Score on the Child-Pugh Scale of 7 to 9 (moderate hepatic insufficiency)
* Estimated creatinine clearance (CLCr) \> 60 mL/min or glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m\^2

Both Impaired Hepatic Function and Healthy Participants:

* In general good health
* Continuous non-smokers or moderate smokers for at least 3 months prior to study start
* Body Mass Index ≤39 kg/m\^2
* Females of reproductive potential must have a negative pregnancy test and agree to use acceptable birth control method(s) or remain sexually inactive throughout study
* Non-vasectomized male patients must agree to use acceptable birth control method(s) or abstain from sexual intercourse during the trial and for 3 months after the study

Exclusion Criteria:

Healthy Participants:

* History or presence of alcoholism within the past 2 years
* Presence of hepatitis B virus (HBV) or hepatitis virus C (HVC)

Both Impaired Hepatic Function and Healthy Participants:

* History or presence of drug abuse within the past 2 years
* History or presence of human immunodeficiency virus (HIV)
* History or presence of significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (other than hepatic impairment), endocrine, immunologic, dermatologic, or neurological disease
* Use of any medication or substance (including prescription or over the counter, health supplements, natural or herbal supplements) which cannot be

discontinued at least 14 days prior to the study start and throughout the study

* Has been on a special diet within 28 days prior to the study start
* Blood donation within 56 days or plasma donation within 7 days prior to study start
* Participation in another clinical trial within 28 days of study start
* Women who are pregnant or nursing
Effects of Early Home-based Strength and Sensory-motor Training After THA on Functional Outcome and Patient Satisfaction

A prospective multicentre randomised clinical trial of 250 selected patients with THA, who will be randomly assigned to intervention (IG) or control group (CG). Both will have standard physiotherapy during hospitalisation, IG will additionally learn strength and sensory-motor training exercises. Follow up will be performed with physical tests, maximal voluntary isometric contractions and outcome assessment questionnaires at baseline and 1, 3 and 12 months after surgery.

This study is a prospective multicentre randomised clinical trial to be conducted in orthopaedic departments of two Slovenian hospitals. In each hospital 125 patients aged 60 or older with unilateral osteoarthritis, ASA score 1-3, signed informed consent, access to watching USB videos and without terminal illnesses disabling rehabilitation participation, will be randomly assigned to intervention (IG) or control group (CG). Total hip arthroplasty with anterior approach will be performed. All patients will get current standard physiotherapy during hospitalisation. Patients in IG will additionally learn strength and sensory-motor training exercises. Patients in both groups will get USB drives with exercise videos, written exercise instructions and training diary. Physiotherapists will perform measurements (physical tests and maximal voluntary isometric contractions) and patients will fill in outcome assessment questionnaires (Harris Hip Score and 36-Item Short Form Health Survey) at baseline and 1, 3 and 12 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing elective primary unilateral THA for OA.
2. Patients older than 60 years at the time of surgery.
3. Ability to watch exercise videos on USB drive.
4. American Society of Anaesthesiologists (ASA) Classification 1-3.
5. Patients are able to consent and willing to comply with the study protocol.

Exclusion Criteria:

1. Primary THA for a diagnosis other than OA (aseptic femoral head necrosis, dysplastic hip...) or revision THA.
2. Patients having previous hip interventions (osteosynthesis, osteotomy...)
3. Discharge to rehabilitation units or nursing homes.
4. Patients unable to consent and comply with the study protocol (diagnosed with dementia, mental disorders, poor preoperative physical status - neurological disorders, amputations, trouble walking with walkers or wheelchairs, painful hip or knee prosthesis in other joints).
Effects of Low LH Serum Levels on Ovarian Pick-up Outcome

Luteinizing hormone (LH) plays a key role for normal follicular development and oocyte maturation in controlled ovarian stimulation. In particular, LH stimulates the proliferation and differentiation of theca cells for the secretion of androgens, which synergistically increase the production of estrogen. This study aimed to investigate the effects of low LH concentrations on oocyte retrieval, fertilization and embryo development in patients undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI). Patients undergoing IVF/ICSI were prospectively analyzed, subdividing them into three groups according to their age. Serum LH levels were evaluated at day 3, during stimulation (day 10) and before ovulation induction (day 12).


Eligibility Criteria:
Inclusion Criteria:

age between 18 and 40 years, body mass index 18-29 kg/m 2 , regular menstrual cycles, normal uterine cavity assess by hysteroscopy, normal uterus and ovaries at transvaginal sonography,

Exclusion Criteria:

abnormal cervical cytology, affected by any other endocrinological, metabolic, autoimmune, and gynecological disease.
Prognostic Interest of Leucocyte Immunophenotyping During the Acute Phase of Sepsis

Septic shock is still a major cause of death in ICU. Sepsis diagnosis is linked with many clinical, hemodynamic and biological criteria which have a low sensitivity and specificity if they are considered separately. The extensive experimental data which have been published contrast with the hematological data collected by the physician at patient's bedside especially regarding neutrophils and platelets levels. When there is no obvious clinical sign, a biological tool reflecting the patient's immune status could be useful to understand the physiopathology of Sepsis and to predict the progression of the disease in the patient. On the long-term it could also help to define management strategies.


Eligibility Criteria:
Inclusion Criteria:

* patient older than 18 years old
* Patient with two criteria of systemic inflammatory response syndrome and a progressive infection which is clinically or microbiologically documented

Exclusion Criteria:

* Pregnancy,
* progressive solid cancer,
* HIV infection,
* history of blood or inflammatory disease,
* long-term immunosuppressive treatment