cyrilzakka/clinical-trials huggingface dataset:
ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities: A Randomized CLinical Precision Public HealTh Intervention --The SCULPT-Job Study

This is an interventional research study about clinical, psychosocial, and behavioral factors that impact weight loss, weight maintenance, and cardiovascular disease in socially disadvantaged persons.

The purpose of this study is to understand whether the incorporation of social determinants of health into a weight loss/maintenance study, along with a known behavioral intervention will result in improved efficacy than the behavioral intervention by itself. This study will examine the role of psychosocial, clinical, and behavioral factors in the context of the intervention.

The entire duration of the study will be 18 months. Study activities will occur virtually or at YMCA locations in the city of San Francisco or at other community centers.

Eligibility Criteria:
Inclusion Criteria:

* Participants from disadvantaged backgrounds (average median household approximately $31,000 household income/ 4 people,
* participants in the federal Medicaid insurance program or Medical,
* age \> 18 years old,
* and BMI \> 25 kg/m2 (for Asian ethnicity BMI\> 22 kg/m2).

Exclusion Criteria:

* pregnancy or post-partum state (\< 12 months post-partum),
* history of diabetes (type 1 or 2),
* history of myocardial infarction, stroke or cardiac arrest in the prior 2 years,
* history of physician diagnosed cognitive, developmental or psychiatric conditions, recent orthopedic diagnosis or surgery (\< 6 months),
* and persons facing housing eviction or undergoing an active housing leasing process (e.g getting their credit report in shape for a potential lease, in the process of getting a new housing lease).
Facilitating Anemia Treatment Risk Communication for Patients With Kidney Disease: Decision Aid Trial

Anemia is a common complication of chronic kidney disease (CKD). In anemia of chronic kidney disease, patients suffer from low hemoglobin levels, which contribute to feelings of malaise and fatigue. The current accepted practice is often to administer erythropoietin-stimulating agents (ESAs), which act like the body's natural hormones to stimulate the production of red blood cells from bone marrow. Although ESAs are widely used in CKD, recent evidence suggests that they are not as safe as previously thought. In this study, we seek to test a decision aid to be used when a patient visits his or her nephrologist at Vanderbilt. The objective of the decision aid is to reduce patient confusion, improve their satisfaction with their care, improve their knowledge of kidney disease, and ultimately bring more clarity to patients about a controversial but ubiquitous drug.

The decision aid will be about 1 page long and will include questions and information that might help the patient be more active and informed regarding the choice of a course of ESA therapy. We will ask patients to answer questions before and after their clinic visits regarding their satisfaction and confidence in their treatment and their knowledge of kidney disease; we will ask some of the same questions 3 months after the clinic visit. We will compare patients who are counseled using the decision aid to patients who are not. We anticipate total experiment running time to be approximately 5 months to recruit and follow up on all patients.


Eligibility Criteria:
Inclusion Criteria:

* Has Chronic Kidney Disease or End Stage Renal Disease
* Over 18, under 80 years of age
* Currently receiving care in the Vanderbilt Nephrology or Dialysis Clinics
* Receiving ESAs for anemia
* Speaks and can read English (no previous use of interpreter services)
* No significant visual impairment documented in medical record

Exclusion Criteria:

* Diagnosed cognitive disability
* Stated inability to converse and read fluently in English, or prior use of translation services
* Poor visual acuity
Study of RTMS Analgesic Effect in Chronic Neuropathic Pain,

The purpose of this study is to compare the analgesic effectiveness of three modes of repetitive Transcranial Magnetic Stimulation (rTMS) in chronic neuropathic pain:

* Classical rTMS stimulation
* Deeper rTMS stimulation
* Sham rTMS stimulation

Conduct of study:

* Entry into the study: After informed consent, patients will be randomised. The physician responsible for conducting neurostimulation sessions will make the randomization via an interactive web response system (IWRS). Only this physician will have the knowledge of the group allocated to the patient.
* Baseline : Patients, will record on a diary form, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 week.
* Treatment sessions: after the baseline, sessions of neurostimulation will begin for seven weeks.
* After the end of neurostimulation sessions, patients will be followed for 2 weeks.
* Throughout their participation in the study, patients will plot on a diary form their daily VNS.

Eligibility Criteria:
Inclusion Criteria:

* Patient's written consent
* Affiliated with social security system
* Male or female, suffering for more than a year from unilateral refractory neuropathic pain: hemi-body, upper limb, lower limb and facial chronic pain.
* Patient whose analgesic treatment, is stable for at least 1 month.
* Patient not responding to conventional treatments
* Prescreening EVN \>3

Exclusion Criteria:

* History of drug addiction, epilepsy, cranial trauma
* History of psychiatric disorder
* Patients previously treated with rTMS
* Patient with intracranial ferromagnetic material or implanted stimulator
* New treatment for less than one month
* Pregnant or Breastfeeding woman
* Patient who does not understand the study protocol
* Persons who are protected under the act.
Color Adjusting Resin Composite in Anterior Tooth Restorations: Clinical and Subjective Evaluations

The ability of single-shade composite restorations to blend with adjacent tooth structure shades is called chameleon effect. This effect is enhanced using specially designed spherical particles in the composite material which will help diffuse light in a way that mimics the natural color and translucency of teeth making the restoration nearly imperceptible to the naked eye.

The hypotheses of the investigation are as follow:

* Single-shade RBC exhibits similar shade matching and optical behavior to conventional RBC across all anterior restorations.
* Patient satisfaction regarding color blending between the restoration and tooth structure is comparable regardless of the type of material used.
* Dentist satisfaction regarding color blending is similar for both single-shade RBC and conventional RBC materials.

Optimal shade matching in restorative dentistry is crucial for achieving aesthetic success, particularly in anterior restorations. This study aims to evaluate the shade-matching efficacy of single-shade resin-based composites (RBCs) in comparison to conventional multi-shade composite, using spectrophotometric analysis as an objective measurement tool. Additionally, the study assesses patient and clinician satisfactions with the color adaptability of single-shade composites across various restoration types, including Class V, III, IV, and diastema closures.

A sample of 240 teeth will be selected based on strict inclusion criteria and divided into two groups: a test group receiving single-shade RBCs and a control group receiving multi-shade composite. Each patient will receive at least one restoration from each treatment group, ensuring balanced comparison within subjects. Satisfaction levels regarding color adaptability and aesthetic integration will be evaluated using a Visual Analogue Scale (VAS) one-week post-treatment. The double-blind design will be employed as it maintains blinding for both patients and evaluating clinicians regarding the materials used in each restoration.

Eligibility Criteria:
Inclusion Criteria:

* Patients attending the dental clinics at JUST in Irbid or on the university campus.
* Patients aged 18 years and older.
* Patients with good oral hygiene.
* Patients with a positive attitude towards dental treatment.
* Patients require restorations on at least two anterior teeth.
* Patients with spaces between teeth that do not require orthodontic treatment for correction.
* Patients with healthy pulp or reversible pulpitis.
* Patients without any periapical lesions

Exclusion Criteria:

* Teeth with enamel or dentin deformations.
* Teeth affected by fluorosis or tetracycline staining.
* Teeth with severe discoloration.
* Primary teeth.
* Patients with gingival inflammation or periodontal disease.
* Patients undergoing active orthodontic treatment.
* Heavy smokers.
* Very deep or very shallow cavities.
* Class IV cavities where more than half of the tooth surface is lost.
* Traumatic Class IV cavities with pulp exposure.
* Class III cavities that do not open labially.
Focus on Function Study for Children With Cerebral Palsy

This study will compare two treatment approaches that are currently being used for children with cerebral palsy. Both treatments aim to improve a child's function. The two approaches being compared are: 1) improving function by working with the child to improve his/her skills and abilities ("child-focused" approach) and 2) improving function by changing/adapting the task and/or environment around the child to improve his/her skills and abilities ("context-focused" approach). It is hypothesized that the context-focused approach will significantly improve activity and participation outcomes while leading to no significant decreases in body function and structure outcomes.

Children with cerebral palsy commonly receive ongoing physical and occupational therapy to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. The primary objective of this project is to conduct a multi-site clinical trial to evaluate the efficacy of a context-focused approach in improving performance of functional tasks, mobility, participation in everyday activities and quality of life in 220 children 12 months to 5 years of age who have cerebral palsy. A randomized clinical trial research design will be used to examine the efficacy of the context-focused approach compared to a child-focused approach. 72 therapists in Ontario and Alberta will be randomly assigned to provide either context-focused or child-focused therapy. Therapists in both groups will participate in a training workshop and expert consultants will be available to support the therapists throughout the study. Children will receive either the context-focused or child-focused therapy intervention for a period of 6 months. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes will be measured across the domains of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion, spinal alignment), activities (performance of functional tasks, motor function), participation (involvement in formal and informal activities), and environment (parent perceptions of care, parental empowerment). The children's range of motion will also be evaluated by an independent, trained evaluator at baseline, 3, 6, and 9 months. We hypothesize that the context-focused approach will significantly improve activity and participation outcomes while leading to no significant decreases in body function and structure outcomes.

Eligibility Criteria:
Inclusion Criteria:

* children with cerebral palsy
* children classified as levels I-V on the Gross Motor Function Classification System
* children aged 12 months to 5 years, 11 months

Exclusion Criteria:

* children whose parents feel uncomfortable or unable to respond to interviews and questionnaires in English
* children with planned surgical or medication changes during the study period that may impact motor function
* parents and caregivers who state that they will not be able to comply with the treatment schedule
The Effect of Semaglutide on Cardiovascular Markers and Liver Function

Fifty patients with diabetes mellitus type 2 and non-alcoholic fatty liver disease (NAFLD) will be enrolled in the study.

25 patients will treated with semaglutide and 25 patients with dipeptidyl peptidase 4 (D-PP4) inhibitors.

At baseline, at four and at 12 months will evaluate the endothelial, cardiovascular and liver function.

The cardiovascular benefits of semaglutide are established; however, its effect on surrogate vascular markers and liver function is not known.The aim of our study is to investigate the effects of semaglutide on vascular,endothelial and liver function in patients with type 2 diabetes and non-alcoholic fatty liver disease.

A.Overall, 50 patients with diabetes mellitus type 2 and NAFLD will be studied at baseline ,at four and twelve months of treatment:

25 patients will be treated with semaglutide 25 patients will be treated with D-PP4 inhibitors. B. In all patients, the investigators will measure the pulse wave velocity (measured in m/s), pulse wave augmentation index \[which is calculated by the formula (P2-P1)/PP x 100, where P1 stands for peak systolic pressure, P2 stands for second peak systolic pressure due to wave reflection and PP stands for Pulse Pressure \], central systolic blood pressure (SBPao, measured in mm Hg) and central pulse pressure (PPao, measured ) with Arteriograph, Mobilograph and Complior, and perfused boundary region of sublingual vessels (5-25 μm in size) using a high-resolution camera with Sideview Darkfield Imaging technique (Microscan, Glucockeck). Perfused boundary region consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx. Increased Perfused boundary region is considered to be an accurate indicator of the reduction of endothelial glycocalyx thickness due to plasma penetration into the glycocalyx.Liver steatosis and stiffness will be measured using Fibroscan® Mini+ 430 (Echosens, Paris, Île-de-France). Controlled Attenuation Parameter (CAP) score will be used as an index of liver fat content, with normal values being \< 238 dB/m. E score will be used as an index of liver fibrosis, with normal values being 2- 6 kPa.

The examination will be carried out at the Laboratory of Preventive Cardiology of the 2nd Department of Cardiology of the University of Athens at "Attikon" Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus type 2
* NAFLD

Exclusion Criteria:

* malignancies
* chronic inflammatory disease
* chronic kidney disease (estimated glomerular filtration rate \<60 ml/min/m2 for a period of at least 90 days)
* peripheral vascular disease
* retinopathy
* previous therapy with a Glucagon-like peptide-1 agonist.
* None of the female patients was on hormone replacement treatment.
A Comparison of Land and Water Based Plyometric Training on Fitness of Field Hockey Players

Field hockey players, recruited from clubs in Jamaica, will be randomized to either a water training or land training groups. Persons will be exposed to 6 weeks of plyometric training with two sessions per week. Pre and post test measures will be done for lower limb power, flexibility and agility. Distance covered, pace, heart rates and exertion during a match will also be assessed.

Plyometric training has been used in a variety of sports to improve power. There is minimal research however regarding its use among hockey players and even less research exploring water based training. International field hockey competitions are played on wet turf and it is felt that water training may be beneficial to these players. The study will explore whether water based plyometrics will prove to have additional benefits compared to land based plyometrics for the Jamaican hockey athletes. The members of the Jamaica hockey clubs will be recruited to participate in this study. Recruitment will be done by the principal investigator Dr. Roopchand-Martin. A total of 34 persons will be recruited and they will be randomly allocated to aquatic or land based training. All training programmes will be conducted at the section of physical therapy and training will be done two times per week for 6 weeks. Baseline assessments will be done independent evaluators for lower limb power using the Standing Broad Jump and Vertical Jump Test, anaerobic power using the Running Anaerobic Sprint test, agility using the Illinois agility and T tests, flexibility using the Sit and Reach Test and performance during game play on wet artificial turf in relation to time-motion analysis for total distance covered, and total time, average and maximum pace, average and maximum heart rate, time in heart zones 1-5, and changes in rate of perceived exertion.

Eligibility Criteria:
Inclusion Criteria:

* All club hockey players over the age of 16 in Kingston and St. Andrew, Jamaica

Exclusion Criteria:

* Persons with musculoskeletal injuries of the hip or knee, who have undergone surgery or injections in the past 3 months, or who are under rehabilitation and not at the phase to undergo high intensity training will be excluded.
* Persons with skin diseases, open wounds and self-reported aqua phobia will also be excluded.
Early Stepping Verticalization in ICU for ABI Patients

Verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI) and to be safe in ICU. The investigators evaluated the effectiveness of a very early stepping verticalization protocol on the functional and neurological outcome of patients affected by disorder of consciousness due to ABI.

Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU on the third day after an ABI. They were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. Once stabilized, patients were transferred to a Neurorehabilitation unit for an individualized treatment. Outcome measures were assessed on the third day from the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2).


Eligibility Criteria:
Inclusion Criteria:

* Glasgow Coma Scale (GCS) ≤8 for ≥24h from the event;
* diagnosis of vegetative state or minimally conscious state on the third day after the injury;
* adequate pulmonary gas exchanging function;
* stable hemodynamics

Exclusion Criteria:

* sedation;
* unstable intracranial pressure (ICP);
* cerebral perfusion pressure (CPP) \<60 mmHg;
* fractures or skin lesions in thorax, abdomen or lower limbs;
* deep vein thrombosis;
* body weight \>130 kg; height \>210 cm.
Observational Prospective Study of the Predicted Value of Immature Thrombocytes Counts in Three Different Groups of Critically Ill Patients

Immature Platelet Fraction (IPF) is a new value in CBC blood tests Recent Studies showed that this value may be another prognostic factor in critically ill patients such as those admitted to ICU, or those with neutropenic Fever.

The purpose of the study is to check if the IPF may be used as a prognostic Factor in these patients

In this study we have 3 groups of patients

* Patients admitted to ICU
* Patients admitted with neutropenic fever
* Patients admitted with hip fractures it is a prospective study, not interventional, we'll take blood samples of these patients including CBC count eith IPF and other inflammation markers such as CRP and we'll compare CRP to IPF in addition to clinical follow-up of the patient till discharge.

At the end of this study we'll compare the efficacy of IPF as a prognostic Factor in these patients

Eligibility Criteria:
Inclusion Criteria:

- Admission to hospital blood sample is taken between 24:00 pm till 15:00 pm

Exclusion Criteria:

* blood sample is taken after 15:00 pm in the first day of admission during the week
* blood sample is taken on weekend: thursday 15:00 pm till saturday 24:00 pm
Evaluation of Seelens AF, an Aspheric Intra-ocular Lens

Senile cataract is managed by cataract extraction and intra-ocular lens (IOL) implantation. The purpose of this study is to evaluate the safety and efficacy of the SeeLens AF, an acrylic hydrophilic aspheric IOL. This lens was designed to reduce vision aberrations and secondary cataract formation rate.

Preoperative evaluation: Best corrected visual acuity, refraction, comprehensive slit lamp examination and biometry.

Surgical procedure: Cataract surgery using a clear corneal incision (1.8mm to2.4mm), phacoemulsification and implantation of the SeeLens AF to the capsular bag. IOL implantation parameters will be evaluated by the surgeon.

Postoperative follow up: Best corrected visual acuity, uncorrected visual acuity, refraction and comprehensive slit lamp examinations up to 3 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Senile Cataract
* Age \>18 years
* Cataract extraction using phacoemulsification
* Corneal incision less than 1.5 mm

Exclusion Criteria:

* Allergy/sensitivity to eye drops used during and after cataract surgery
* Amblyopia/ strabismus
* Ocular disease, other than cataract, diminishing visual acuity, such as corneal opacity, advanced glaucoma, diabetic retinopathy, exudative or moderate to severe non-exudative age-related macular degeneration, uveitis.
* previous ocular surgery or ocular trauma in the investigated eye
* Ocular anomaly, such as microphthalmos
* Keratometry values less than 40 diopters or more than 47 diopters.
* Ocular axial length less than 21.0 mm or longer than 25.0 mm
* Intra-operative complications prior to intraocular lens implantation, such as tear of the posterior capsule.
* posterior capsular scar
* visual acuity in the fellow eye less than 20/200
Solar Lighting to Reduce Indoor Air Pollution in Rural Uganda

This study evaluates the impact of a solar lighting system on kerosene lamp use, levels of indoor air pollution, and health in women living in rural Uganda. Half of the participants will receive the lighting systems immediately, while the other half will receive them after an 18 month delay.

One fifth of the global population relies on kerosene lamps for lighting, yet few studies have focused on kerosene lighting as a source of indoor air pollution. In our preliminary studies performed in Uganda, we show that homes using solar lighting have much lower levels of indoor air pollution compared to homes using kerosene lighting. The primary goal of this study is to determine the extent to which solar lighting will reduce kerosene use and indoor air pollution in rural Uganda, whether this intervention improves lung health, and to identify the role bacteria in our gut have on determining whether or not people will get sick from indoor air pollution.

Eligibility Criteria:
Inclusion Criteria:

* Women living in Nyakabare Parish, Uganda with no prior history of chronic lung disease

Exclusion Criteria:

* Current active tuberculosis in any family member