cyrilzakka/clinical-trials huggingface dataset:
Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)

The goal of this study is to perform the first fracture reduction clinical trial with a potent antiresorptive agent (intravenous zoledronic acid) in the most vulnerable long-term care population.

Although close to 85% of frail women in long-term care (LTC) facilities have osteoporosis and the risk of osteoporotic fractures is nearly 10 times that of community dwelling elderly, few are treated and studies are scarce. It is postulated that in frail, LTC women an annual infusion of zoledronic acid, an antiresorptive therapy for osteoporosis, will:

1. be effective demonstrated by fracture reduction;
2. be safe.

To address these hypotheses, up to 1000 female LTC residents age 65 and older will be screened in order to enroll 310 eligible for randomization in a 3 year, randomized, double-blind, calcium and vitamin D controlled trial with the antiresorptive agent zoledronic acid. Use of an intravenous, once yearly agent avoids concerns of oral bisphosphonate side effects, poor absorption and burden on staff. Participants will reside in the long-term care settings associated with the Division of Geriatric Medicine, University of Pittsburgh and will include women with multiple comorbid conditions, functional and cognitive impairment, and limited mobility.

Eligibility Criteria:
Inclusion Criteria:

* women age ≥65 years including those using assistive devices to maximize generalizability if they:

  1. Reside in long-term care (LTC);
  2. Have:

     * osteoporosis by axial bone density (spine, hip or forearm bone mineral density (BMD) T-score ≤ -2.5 SD); or
     * a previous adult fragility fracture of the spine or hip; or,
     * would be treated based on FRAX National Osteoporosis Foundation (NOF) treatment thresholds of a 10 year risk of ≥ 20% for a major osteoporotic fracture or ≥ 3% for hip fracture using femoral neck BMD.

Exclusion Criteria:

* Men because osteoporosis is less common in men and our initial ZEST 1 study only included women.
* Institutionalized women with subacute illnesses surviving or discharged in \< 3 years.
* Women currently on bisphosphonate, denosumab, or teriparatide therapy or who have been on a bisphosphonate for greater than 1 year during the previous 2 years because bisphosphonates are long acting.
* Patients with a calculated creatinine clearance \< 35 ml/min or who have a contraindication for bisphosphonates (allergy, hypocalcemia).
Naltrexone, Craving, and Drinking

This 5-week study will examine the effects of naltrexone on alcohol craving, drinking rates, and reaction to drinking-related triggers, or cues, in participants' everyday environment and in laboratory sessions. Participants will monitor and record their daily desires to drink, environmental circumstances in which urges occur, and drinking behavior using a palm top computer. Participants will receive naltrexone or a placebo. One week after receiving medication, all participants will be asked to respond to alcohol-related cues that may or may not arouse the desire to drink.


Eligibility Criteria:
Inclusion Criteria:

* Drink at least 4 days per week with 2 heavy drinking days (more than 6 standard drinks for men, more than 5 drinks for women) per week on average during the month prior to the study.

Exclusion Criteria:

* Current interest in treatment or a history of treatment for alcohol problems.
* History of liver disease or current liver function tests greater than five times normal.
* Opiate abuse or dependence, any opiate use two weeks before the study or a urine test screen that is positive for opiates.
* Females, who are pregnant, nursing, or not using reliable birth control method.
* Daily use of acetaminophen.
* Living with someone who participated in this study.
Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia

This study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* ACR criteria for fibromyalgia
* A score of more or equal to 40 mm on the Pain VAS
* An average score more or equal to 4 on 4 daily pain diaries

Exclusion Criteria:

* Patients with other severe pain conditions
* Patients with severe depression
* Patients taking excluded medications
* Patients with suicidality
Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments

Strong Teens for Healthy Schools (STHS) is a school-based, civic engagement program that empowers middle school students to improve their physical activity and healthy eating behaviors, improve their cardiovascular disease outcomes, and create positive change in their school health environments.

The investigators will conduct a cluster-randomized controlled trial to evaluate the impact of the Strong Teens for Healthy Schools (STHS) program on cardiovascular disease-related outcomes. STHS is a multi-level, theory-based civic engagement program to catalyze positive food and physical activity environmental change and improve cardiovascular disease-related health (CVD) outcomes among 6th and 7th-grade students.

Title 1 middle schools in Texas (n=20) with \> 40% Hispanic and Black students will be randomized at baseline to the intervention condition (STHS program) or control condition (will continue with usual care, as they will not be asked to add or remove any of their current, physical activity, healthy eating, or positive youth development programming) (n=20-25 students per school).

The investigators hypothesize that students who participate in STHS will have reduced MetS risk, improved positive youth developmental outcomes, and improved social and environmental outcomes immediately post-intervention and one year after study completion compared to students in a control condition.

Eligibility Criteria:
School Inclusion Criteria:

* \> 50 6th and 7th grade students
* \> 40% economically disadvantaged students
* \> 40% Black and Hispanic students

School Exclusion Criteria:

Student Inclusion Criteria:

* 6th or 7th grade student
* Attend a Title 1 middle school that is participating in the STHS intervention
* Read and understand English

Student Exclusion Criteria:

* Participation in a weight loss program in the past 3 months
* Presence of a condition that prevents participation in physical activity
Effectiveness of Manual Therapy and Strengthening Exercises in Hemophilic Arthropathy of the Elbow Joint

Manual treatment involves techniques based on the principles of moving the joint faces and separating the joint gap, and soft tissues mobilization techniques. The use of manual therapy in hemophilia is gradually increasing although it previously described as a contraindication. The utility and use of strengthening exercises in hemophilia has been going on for a long time. In this study, the effect of manual therapy and strengthening exercises joint was investigated in hemophilic arthropathy of the elbow.

The aim of this study was to investigate the effects of strengthening exercises and manual therapy on bleeding frequency, pain, range of motion, muscle strength, arm circumference, joint health, functionality and quality of life in the physiotherapy and rehabilitation of hemophilic arthropathy of the elbow. Seventeen adolescent and young adult hemophilic individuals aged 12-30 years with elbow arthropathy were included in the study. The individuals were divided into the two groups via simple randomisation as Manuel Therapy and Exercise Group (MTEG) and Home Exercise Group (HEG). The individuals in HEG were given strengthening exercises as a home program. Those in the MTEG were applied manual therapy by the physiotherapist and were given supervised strengthening exercises. All treatments were performed 3 times a week for 5 weeks totally 15 sessions. Frequency of bleeding was evaluated with number of bleeding in the last 5 weeks. Numerical Pain Scale was used for activity and resting pain. Range of motion and muscle strength were measured with universal goniometer and digital dynamometer, respectively. The Quick-DASH questionnaire and Oxford Elbow Score were used for the functionality of the upper extremity and quality of life, respectively. The joint health status was evaluated with Hemophilia Joint Health Score-Elbow Point and Hospital for Special Surgery-Elbow Scoring System. Evaluations were made by the same physiotherapist before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Having signs of hemophilic arthropathy in one or both elbow joints, Being between the ages of 12-30 (Adolescent and young adult), Receiving prophylactic factor replacement therapy.

Exclusion Criteria:

* Having undergone any surgical procedure for elbow arthropathy, Having an orthopedic problem, such as a fracture, ligament or tendon injury, related to the upper limb in the past year, Receiving physiotherapy and rehabilitation for the elbow joint in the last 6 months
Effects of Universal Exercise Unit Therapy With Task-oriented Training in CP Children

Cerebral palsy is a problem that affects the development and motor skills caused by early non-progressive central nervous system damage. Muscle rigidity, spasticity, fragility, uncontrolled movement, or a combination of these abnormalities characterized it. Therapeutic usage of the universal exercise unit is common. Also called a spider cage or monkey cage. This device helps people with motor problems, especially cerebral palsy. This metal 3-dimensional contraption uses wires, rubber bands, pulleys, weights, and belts. The goal is to engage the vestibular and proprioceptive systems, which are necessary for balance, coordination, and awareness.

A Randomized Clinical Trial (RCT) design will be employed, conducted at the Sialkot Medical and Physiotherapy Center over 10 months following synopsis approval. The anticipated sample size, accounting for a 20% attrition rate, will be 34 participants in each of the two study groups. Group A will undergo Universal Exercise Unit (UEU) therapy along with task oriented training, while Group B will receive task-oriented training for gross motor functioning. The sampling technique will be Non-probability convenience sampling, with inclusion criteria comprising children aged 5-15 diagnosed with spastic cerebral palsy, of both genders and in stable health condition. The data collection tools include the Gross Motor Function Measure 88 (GMFM 88), Trunk Impairment Scale (TIS) and pediatric balance scale. The analysis will be conducted using SPSS for Windows software version 25. Training sessions, lasting 6 weeks, will be conducted twice a week, and data will be collected before and after each session. The UEU therapy will focus on various movements facilitated by the equipment, while the task-oriented training will be personalized, targeting specific functional limitations through activities simulating daily tasks.

Eligibility Criteria:
Inclusion Criteria:

* Children who were spastic and able to understand and follow commands. Children aged 5-15 years old. Gross Motor Function Classification System (GMFCS) level I-III. Youngsters are capable of walking and standing on their own.

Exclusion Criteria:

* Children with severe physical limitations and disabilities. Children with planned surgeries in the next 6 months. Any musculoskeletal or orthopedic conditions limiting participation in exercise programs.

Kids with planned surgical or medical surgeries during the study period. Children with impaired cognition. Children with hearing impairment and visual impairment.
Telerehabilitation Using Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation.

The overall aim of this randomized controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and daily activities compared to traditional mirror therapy and sensomotor exercises without a mirror in patients following lower limb amputation.

Up to 75% of patients after amputation of an arm or leg suffer from chronic phantom limb pain that still is perceived in the missing limb, leading to limitations in daily activities and quality of life. The treatment of phantom limb pain is still challenging. Despite many different pharmacological interventions, the outcomes on the longer-term are in many cases not satisfying. Alternative, non-pharmacological interventions, such as mirror therapy, are gaining increased recognition in the treatment of phantom limb pain. In this context, telerehabilitation plays an important role to support long-term self-management and autonomy of these patients.

In the developmental phase of the project, a user-centred design is applied. Patients as well as physical and occupational therapists are interviewed concerning their preferences and needs with respect to the design and content of the telerehabilitation. Additionally, two focus groups with each five participants will be conducted. Subsequently, a prototype of the telerehabilitation will be developed based on user preferences, available evidence, expert opinion and already existing systems. This prototype will be tested on its usability and technical performance in phase three using the thinking-aloud-method and data logging. Accordingly, a multicenter, randomized controlled trial will be conducted to evaluate the cost-effectiveness of the telerehabilitation.

Eligibility Criteria:
Inclusion Criteria:

1. Lower limb amputation
2. At least since one week constant or intermittent phantom limb pain (PLP) with an average intensity of at least score 3 on the 11-point NRS and a minimum frequency of one episode of PLP per week.
3. Sufficient cognitive, communicative and motor functions to be able to use the telerehabilitation service, to concentrate for at least 15 minutes on the mirror image and to follow instructions and questionnaires; this is based on clinical judgment of recruiting physicians or therapists.

   Exclusion Criteria:
4. Duration of inpatient rehabilitation not long enough to ensure the 4-week clinical intervention phase.
5. Bilateral amputation, severe co-morbidity (e.g. stroke) or pain affecting the intact limb; this prevents engagement in the prescribed exercise programs of the study.
6. Severe psychiatric disorders that preclude patients from participating in the trial.
7. Intensive course of mirror therapy in the past (\> 6 treatments during the last three months).
Comparison of Two Spinal Manipulation Treatments in Patients With Chronic Mechanical Neck Pain

There is enough evidence to suggest that the spinal manipulation of the upper cervical spine and cervicothoracic spine are effective in decreasing neck pain. Therefore, the purpose of this randomized controlled trial is to compare the effects of an isolated application of upper cervical spine thrust joint manipulation with the application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation on neck pain, disability and cervical range of motion in individuals with chronic mechanical neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Symptom persistence for more than 12 weeks.
* Age from 18 to 55 years.
* Localized pain in the cervical spine.
* Symptoms are caused by cervical movement or sustained postures.

Exclusion Criteria:

* Stage acute of symptoms.
* Any contraindication to cervical spinal manipulation (fracture, osteoporosis, joint infections or vertebrobasilar insufficiency).
* Patients with previous neck trauma or cervical spine surgery.
* Patients diagnosed with cervical radiculopathy.
* Patients diagnosed with fibromyalgia.
* Have been treated with manual therapy in the last 3 months.
* Receiving other treatment during the course of the study.
Multicenter Study of Safety and Efficacy of Prolgolimab in Patients With Advanced Melanoma in Routine Clinical Practice

Describe the safety, tolerability, efficacy and approaches to prescribing prolgolimab in the standard dosing regimen of 1 mg / kg every 2 weeks in patients with advanced melanoma in routine practice.

Prolgolimab (Forteca, formerly BCD 100) is an IgG1 anti-PD-1 (programmed cell death protein 1) monoclonal antibody containing the Fc-silencing 'LALA' mutation.

Describe the safety and tolerability of using Prolgolimab at a standard dosage regimen of 1 mg / kg every 2 weeks.

Describe the efficacy of prolgolimab 1 mg / kg every 2 weeks in patients with metastatic or inoperable melanoma in routine practice, based on the following indicators: Progression-free survival (time from first dose of prolgolimab to disease progression or death for any reason); Overall survival (time from receiving the first dose of prolgolimab to death for any reason); Objective response rate (proportion of patients with a complete or partial response to prolgolimab therapy).

Eligibility Criteria:
Inclusion Criteria:

Histological confirmed melanoma Advanced stage (unresectable III or metastatic IV) Treated by at least one therapy line including prolgolimab in routine practice -

Exclusion Criteria:

- Patient participation in any interventional clinical study.
Understanding the Physiological Implications of Scanning Kelvin Probe Measurements

The purpose of this study is to evaluate the effects of skin thickness, skin moisture, and sweat gland density on Scanning Kelvin Probe measurements.

The Scanning Kelvin Probe measures the electrical potential of material surfaces without actually touching it. Although this technology has been applied to non-living materials (e.g. metal and semiconductors) before, it has not been effectively applied to biological materials, much less to live human skin . This project aims to evaluate the use of Scanning Kelvin Probe to live human skin by investigating the effects of skin thickness, skin moisture, and sweat glands on Kelvin Probe measurements of electrical potential. Testing will be performed on the arms and hands of twenty four healthy individuals under different study conditions.

Eligibility Criteria:
Inclusion Criteria:

* "Healthy" is defined as not having a chronic medical condition requiring daily medications (hypertension, diabetes, hypothyroidism, etc)

Exclusion Criteria:

* autonomic disorders (sweating irregularities), skin disorders, extensive burns/scars on the hand, tremors, neuromuscular conditions, restless leg syndrome, movement disorders, and implanted cardiac defibrillator/pacemaker
Laser Treatment of the Crystalline Lens

The use of a femtosecond laser in cataract surgery that gives equivalent or improved results comapred to conventional phaco-emulsification surgery.

The objective of this study is to evaluate the feasibility of the LensAR laser system to surgically intervene within the crystalline lens. The primary goal of this initial study is to establish safety parameters as compared with conventional phacoemulsification procedures, and to evaluate the ability to provide an accurate and consistent anterior capsular opening (capsulotomy).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must sign and be given a copy of the written informed consent form.
* Subjects must have elected to undergo lens extraction and foldable monofocal IOL implantation (ideally of the same type), and then elect to have the LensAR laser surgery.
* Subjects must be willing and able to return for scheduled follow-up examinations for a minimum of 12 months after surgery.
* Central 8 mm of clear cornea without vascularization.

Exclusion Criteria:

* Subjects with prior anterior segment or vitreo-retinal surgical intervention in the eye to be treated.
* Subjects with lenticular cataracts with nuclear grading greater than Grade 4 on the LOCS III scale.
* Subjects who cannot attain ocular dilation of 7.0 mm.
* Subjects with anterior segment pathology in the eye to be treated that is not directly improved by lens extraction and IOL implantation.
* Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease or any corneal abnormalities (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the eye to be treated.
* Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in the eye to be treated.
* Subjects with a history of severe dry eye not responding to therapy.
* Subjects with macular degeneration, history of retinal detachment, or any other fundus findings that would pose a risk to safety or an acceptable visual outcome in the eye to be treated.
* Subjects with a history of herpes zoster or herpes simplex keratitis.
* Subjects who have a history of steroid-responsive rise in intraocular pressure, glaucoma, or are a glaucoma suspect.
* Subjects with diabetic retinopathy, autoimmune disease, connective tissue disease, pseudoexfoliation syndrome, or clinically significant atopic syndrome.
* Subjects on chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immuno-compromised subjects.
* Subjects who are using ophthalmic medication(s) other than artificial tears for treatment of ocular pathology including ocular allergy.
* Subjects using systemic medications with significant ocular side effects.
* Subjects who are pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.
* Subjects with known sensitivity to planned study concomitant medications.
* Subjects who are participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
Impact of Positive & Negative Lens-Induced Defocus on Contrast-Sensitivity in Myopic & Non-Myopic Adults

examines the influence of lens-induced defocus on contrast sensitivity-a crucial aspect of visual performance.Each participant experiences both positive and negative defocus through different lenses, with measurements taken for contrast sensitivity using the Pelli-Robson chart. Outcomes are evaluated at baseline, 2 weeks, and 4 weeks to understand the effect of defocus over time.

Additional data on symptoms like visual fatigue and computer vision syndrome are gathered using the Visual Fatigue Questionnaire (VFQ) and the Computer Vision Syndrome Questionnaire (CVS-Q), respectively. This study's findings could be instrumental in refining optical treatments, offering insights into how defocus impacts visual function across refractive conditions. Results may ultimately benefit optometric practices by guiding lens prescriptions for improved contrast sensitivity and quality of life for myopic and non-myopic individuals alike.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 50 years.
* Participants with a confirmed diagnosis of myopia or non-myopia.
* Best corrected visual acuity of 20/30 or better.
* No history of ocular surgery or significant ocular disease.
* Informed consent was obtained.

Exclusion Criteria:

* Individuals with a history of systemic diseases affecting vision (e.g., diabetes, hypertension).
* Presence of binocular vision anomalies or strabismus.
* Pregnant or nursing women.
* Any current use of medications affecting visual function (e.g., medications causing visual side effects).