cyrilzakka/clinical-trials huggingface dataset:
Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis

This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Females and males 18 to 75 years of age
* History of type I or type II diabetes mellitus for more than 3 years
* History of upper gastrointestinal symptoms consistent with diabetic gastroparesis
* Hemoglobin A1c \< 9.5%
* Delayed gastric emptying

Exclusion Criteria:

* Abnormal endoscopy finding that can explain the presence of gastroparesis symptoms
* Medical conditions affecting gastric emptying
* A clinically significant medical condition that would interfere with the patient completing the trial
* Clinically significant abnormal creatinine level
* Known allergies to the same class of drug and/or allergies to eggs
* Severe obesity

Other protocol-defined inclusion/exclusion criteria may apply.
Prediction of Hemodynamic Response to Intubation by ANI Variation During Standardized Stimulation

The objective : to investigate a correlation between ANI following a standardized nociceptive stimulus and hemodynamic or somatic reactions during orotracheal intubation.

Piloted study. ANI and hemodynamic and somatic parameters response associated tetanus stimulation followed by orotracheal intubation were collected.

Background: The Analgesia Nociception Index reflects the balance between analgesia and nociception and allows early detection of a defect in analgesia. Orotracheal intubation is responsible for a sometimes deleterious hemodynamic reaction. The Analgesia Nociception Index could allow an individual adjustment of the investigator's anesthetic inductions during this period.

Objective: The objective of this study is to investigate if there is a correlation between variations in the ANI following a standardized nociceptive stimulus and the occurrence of hemodynamic or somatic reactions during orotracheal intubation without muscle relaxation.

Materials and Methods: Prospective, interventional, analytical, monocentric, piloted study carried out in the operating theatre after obtaining patient's informed consent between January 2014 and November 2014. Under steady state total intravenous anaesthesia with propofol and remifentanil at constant dosage (entropy between 40 and 60) tetanus stimulation of the ulnar nerve was performed followed by orotracheal intubation. The variation of ANI and hemodynamic parameters as well as the somatic response associated with both maneuvers were collected.

Eligibility Criteria:
Inclusion Criteria:

* Any patient requiring general anaesthesia with tracheal intubation by direct laryngoscopy
* Intubation Difficulty Assessment Score \< 7
* BMI between 17 and 30 Kg/m2
* Socially insured patient
* Patient 18 years of age or older
* Patient with signed consent
* Patient with a sinus heart rhythm

Exclusion Criteria:

* Patient refusing to participate in the study
* Pregnant woman
* Patient with a pace maker (any mode)
* Patient treated with Beta Blocker
* Known Dysautonomia
* Diabetes
* Spontaneous ventilation anaesthesia
* Allergy to any of the required medications
Intralesional Vitamin D3 Versus Intralesional Acyclovir in Treatment of Plantar Warts

To evaluate and compare the efficacy and safety of intralesional acyclovir versus intralesional vitamin D3 in the treatment of plantar warts

Introduction Warts are common epidermal growths caused by various strains of human papillomavirus (HPV) affecting all age groups. They have an unsightly appearance and are mostly asymptomatic but sometimes may be painful as in the case of palmoplantar warts . Plantar warts is a clinical variant that occur on sole of the foot, most frequently over pressure points .

It is estimated that 40% of population is infected with HPV, and in 7% to 12%, a wart develops . Plantar warts exhibit an annual incidence of 14% in the general population . Sixty-five percent to 78% of cutaneous warts have been shown to regress within 2 years . In persons older than 12 years, the rate of spontaneous regression significantly decreases .

Variable therapeutic options are available for treating warts, with none considered a gold standard. Primary treatments include topical salicylic acid, topical imiquimod, topical 5-fluorouracil, cryotherapy, excision, electrocautry and laser vaporization .

Vitamin D is a fat-soluble steroid prohormone that has wide range of biological actions e.g. inhibition of cellular proliferation, induction of terminal differentiation, and inhibition of angiogenesis. It also stimulates macrophages and cathelicidin production . Recently, several studies have demonstrated the efficacy of intralesional vitamin D in treatment of warts, as well as recalcitrant lesions, with clearance rates of 72.5%-90% .

Acyclovir is a synthetic purine nucleoside analogue with activity against some viruses as herpes simplex and varicella-zoster virus. Acyclovir uses viral thymidine kinase to convert to its active form, acyclovir triphosphate. Through this mechanism of utilizing viral thymidine kinase, acyclovir specifically targets viral DNA preventing its replication in the host.

Previously, few studies and case reports documented the clearance of warts, some were unresponsive to prior treatment, with both topical and oral use of acyclovir .

A recent study has evaluated the efficacy of intralesional acyclovir versus intralesional saline in treatment of warts and reported complete clearance rate of 52.6% and a partial response of 16.7% for acyclovir with a statistically significant difference from saline (0% complete clearance) .

Eligibility Criteria:
Inclusion Criteria:

* Adult participants of both sex with plantar warts will be included in the study

Exclusion Criteria:

* - Children \< 12 years.
* Pregnant and lactating women.
* Receiving any treatment for warts within 1 month before the study.
* Systemic antiviral medication.
* Previous history of vitamin D or acyclovir hypersensitivity.
* Vitamin D supplementation.
* Concurrent other skin disorders.
* Immunosuppressive disorders or receiving immunosuppressive drugs.
* Receiving drugs that may alter vitamin D level including prednisone, orlistat, phenytoin and thiazide diuretics.
CAR T-CELL Therapy Educational Video Trial

The purpose of this study is to test a new educational video to help patients and doctors talk about CAR-T cell therapy, a treatment being used in cancer.

- Educational video tool for patients receiving CAR-T cell therapy.

This research study is a Feasibility Study, which is the first-time investigators are examining this educational video tool for patients receiving CAR-T cell therapy.

The research study procedures include screening for eligibility, randomization and a series of questionnaires

Participants will be randomized to one of 2 groups:

* Group A: Educational video tool
* Group B: Standard care

Participants will be in the research study for a month after consent

It is expected that about 80 participants will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or age or older
* Established diagnosis of a hematologic malignancy
* Under consideration for CAR T-cell therapy at Massachusetts General Hospital

Exclusion Criteria:

* Significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary oncologist believes prohibits informed consent or participation in the study
* Undergoing CAR T-cell therapy for solid tumor malignancy
* Inability to comprehend English, as the video is currently only available in English at this time
Screening and Intervention of MASLD in Children

Non-alcoholic fatty liver disease (NAFLD) in children and adolescents has recently been renamed metabolic dysfunction-associated steatotic liver disease (MASLD). It has become one of the leading chronic liver diseases in children. The prevalence of MASLD is 6.3% among the general pediatric population and 40.4% among overweight and obese children, with an increasing trend each year. MASLD increases the risk of various metabolic diseases and can eventually lead to liver fibrosis or hepatocellular carcinoma, contributing to the disease burden.

Previous work by our project team using machine learning methods has identified that fasting insulin, alanine aminotransferase (ALT), and waist-to-height ratio (WHtR) have good predictive value in overweight and obese children, with a recommendation that children with a WHtR ≥ 0.48 should undergo further screening. However, external validation is still required to improve the effectiveness and cost-efficiency of this screening approach.

Till now, there are no approved drug treatments for paediatric MASLD, and lifestyle interventions (such as restricting energy intake and increasing physical activity) are the main therapeutic strategies. However, existing studies face limitations, such as small sample sizes, diverse intervention methods, lack of standardization, and short intervention durations, which hinder their clinical application. Therefore, it is essential to explore effective health lifestyle intervention models tailored to children.

This study aims to: First, optimizing the screening and treatment pathway, assess the cost-effectiveness and applicability of WHtR as a screening tool, and develop a tiered screening system suitable for Chinese children; Second, integrating school, clinic, family, and community resources to establish a multifacted lifestyle intervention model and evaluate its efficacy.


Eligibility Criteria:
Inclusion Criteria:

* parents agree and support their children's weight loss, and students and parents have informed consent;
* students in two to four grade aged 7 and 11 years old;
* students with WHtR \> 0.48.

Exclusion Criteria:

* medical history of heart disease, hypertension, diabetes, tuberculosis, asthma, virus hepatitis or nephritis;
* obesity caused by endocrine diseases or side effects of drugs;
* abnormal physical development like dwarfism or gigantism;
* physical deformity such as severe scoliosis, pectus carinatum, limp, obvious O-leg or X-leg;
* inability to participate in school sport activities;
* a loss in weight by vomiting or taking drugs during the past 3 months.
Supporting Adolescent Adherence in Vietnam (SAAV)

The small RCT will assess feasibility, acceptability, and impact of a real-time intervention on ART adherence and clinical outcomes for HIV-positive adolescents. All subjects will use a wireless pill container (WPC) to monitor adherence. Intervention subjects will receive a personalized triggered reminder (cellphone message/call or bottle-based flash/alarm) when they miss a dose, and engage in monthly counseling sessions informed by their adherence data. Comparison subjects will receive usual care and an offer of counseling at monthly clinic visits.

A major priority in HIV care and treatment is identifying effective interventions for adolescent patients, including those that make use of new technologies, to help them achieve and maintain high levels of adherence to antiretroviral treatment (ART), particularly as they take responsibility for their own medication-taking in the transition to adult care. The research planned here will contribute to the scientific evidence base on approaches to support ART adherence effectively among youth by 1) conducting formative research on adherence challenges among adolescents and refining options for a personalized adherence intervention package; and 2) implementing a small randomized controlled trial (RCT) to assess the feasibility, acceptability, and efficacy of a novel real-time feedback intervention that permits adolescent patients to tailor intervention features to suit their individual preferences.

Eligibility Criteria:
Inclusion Criteria:

* currently a patient at the Infectious Disease (ID) clinic at National Hospital for Pediatrics (NHP) in Hanoi, Vietnam
* between 12 and 17 years old of age AND
* expected to remain in care at the NHP for 7 months minimum
* currently on ART
* live in the clinic catchment area
* willing to provide informed assent, caregiver willing to provide consent
* identified ás having adherence challenges (CD4, detectable VL, and/or clinician suggestion)

Exclusion Criteria:

* below the age of 12 years or above the age of 18
* not currently on ART
* live outside the clinic catchment area
* not willing to provide informed assent, caregiver not willing to provide consent
The Effect of Upper Extremity Telerehabilitation on Balance and Gait

Parkinson's Disease (PD) is a disease that affects the upper extremity functional skills with clinical findings such as bradykinesia, rigidity, and hypokinesia and causes limitations in the daily living activities of the patients. The influence of fine dexterity, reaching, and grasping movements greatly affects the daily living activities of the patients. Medical treatment and surgical approaches are frequently used among the treatment options for PD today. Physiotherapy and rehabilitation approaches for progressive functional loss in PD, together with optimal medical and surgical treatment, form the basis of PD treatment. Recently, it has been stated that intensive and task-specific rehabilitation interventions in the field of physiotherapy and rehabilitation will be more effective than traditional rehabilitation approaches. On the other hand, telerehabilitation approaches, the use of which has increased rapidly due to technological developments in recent times, enables the delivery of rehabilitation services to patients in distant places by using communication technologies. For this purpose, it is highly valuable to implement a task-oriented training (TOT) program based on motor learning-based principles, which consists of intense exercise content, through telerehabilitation. Although there are very few studies investigating the effectiveness of telerehabilitation-based TOT in PD, these studies have shown that upper extremity motor performance, activities of daily living, and quality of life are improved. On the other hand, no study has been found showing the effect of upper extremity TOT applied through telerehabilitation on balance and walking. Therefore, there is a need to investigate the effectiveness of telerehabilitation-based TOT exercises on balance and walking.

This study is a randomized controlled study. The patients will be randomly divided into two groups exercise and control. Balance and walking exercises consisting of 3 days a week for 6 weeks will be given to both groups as a home program. In addition, the exercise group will receive Task-oriented Training (TOT) based telerehabilitation via video conferencing 3 days a week for 6 weeks. TOT will be formed from daily life activities such as reaching out, grasping, writing, and manual skills, which are frequently used in daily life. As the outcome measures, disease severity, and disability, balance, and gait will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 40- 80 years of age
* Having diagnosed with "Parkinson's Disease" by a specialist physician
* Having between 1-3 stages according to the Hoehn and Yahr Scale
* Mini-Mental Test score more than or equal 24

Exclusion Criteria:

- Any orthopedic, vision, hearing, cardiovascular, or perception problems that may affect the research results
Comparative Study of Static and Dynamic Hand Grip Endurance in Pregnancy

Background: Physiology of the mother, changes constantly during pregnancy including reduced HGS that is require for carrying the child after delivery. Activities of daily living require manual gripping tasks that require dynamic and static contractions. Predictor of upper extremity function is Hand Grip Strength and handgrip endurance. Screening of hand grip strength during antenatal care is still uncommon.

Objectives: To compare static and dynamic hand grip endurance in pregnant females and to find its correlation with deep breathing.

Material and Methods: The study recruited 40 participants of primi-gravida of 1st and 2nd trimester, between ages 20 and 35 years from SHALAMAR GYNAE OPD. The participants assigned to the groups (Group 1: with DB, Group 2: without DB) based on their trimester and gravidity. Static and dynamic endurance assessed using hand held dynamometer.

Key words: Pregnancy, deep breathing, trimester, endurance, peak grip endurance


Eligibility Criteria:
Inclusion Criteria:

* primigravida

Exclusion Criteria:

* multigravida
* Cardiac patients
Kidney Cancer DNA Registry

This registry will help us develop better methods of:

* Preventing these cancers
* Diagnosing these cancers
* Treating these cancers


Eligibility Criteria:
Inclusion Criteria:

Kidney Cancer Case Cohort:

* Must be ≥ 18 years of age AND
* Must be an English-speaker AND
* Must have a diagnosis or suspicion of kidney cancer

Family Member Cohort:

* Must be ≥ 18 years of age AND
* Must be an English-speaker AND
* Must be a blood relative of the proband. Family members of probands including mother, father, sisters, brothers, half-sisters, half-brothers, daughters, sons, grandmothers, grandfathers, as well as aunts and uncles are eligible. These individuals need not have kidney cancer, as they will be used for segregation analysis of suspected variants found in the proband; requesting DNA from relatives is required.

Control Cohort:

* Must be ≥ 18 years of age AND
* Must be an English-speaker AND
* Must not have a personal history of cancer, with the exception of nonmelanoma skin cancer, AND
* Must not be a blood relative of any cases or controls enrolled in this study

Exclusion Criteria:

* Patients who, in the opinion of the primary MSKCC clinician or the investigator, have a condition that precludes their ability to provide an informed consent
Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections

Study is planned to evaluate safety and efficacy of Levolet in patients with complicated UTI

A complicated urinary tract infection is a urinary infection occurring in a patient with a structural or functional abnormality of the genitourinary tract.

Fluoroquinolones have been recommended as the antimicrobials of choice for the empirical treatment of complicated urinary tract. Levofloxacin is a broad spectrum agent, which is known to demonstrate good clinical efficacy against urinary tract infection (UTI).

There is no published evidence available on the empirical use of Levofloxacin 500 mg OD and its optimal duration of therapy in patients with Complicated Urinary Tract Infections (cUTI). The present study evaluates the efficacy and safety, and optimal duration of therapy of levofloxacin 500 mg OD in patients with complicated UTI.

Eligibility Criteria:
Inclusion Criteria:

* Men or non-pregnant women over 18 years of age with cUTI in
* One or more clinical symptoms and signs of a lower UTI: fever (\> 38°C, orally), chills, frequency of micturition, dysuria, urge sensation.
* One or more of the following underlying conditions suggestive of cUTI:
* Indwelling urinary catheter.
* Neurogenic bladder.
* Obstructive uropathy due to lithiasis, tumor or fibrosis.
* Acute urinary retention in men

Exclusion Criteria:

* History of allergy to quinolones
* Are unable to take oral medication
* Have an intractable infection requiring \> 14 days of therapy
* Have a requirement for concomitant administration of sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminum or calcium
* Have prostatitis or epididymitis
* Have had a renal transplant
* Have ileal loop or vesica- urethral reflux
* Have significant liver or kidney impairment
* Have a history of tendinopathy associated with fluoroquinolones
* Are pregnant, nursing
* Have a history of convulsions or CNS disorders
A Registry Based Study Evaluating Overall Survival and Treatment Length in mCRPC Patients Treated With Enzalutamide in Sweden

The purpose of this study is to provide real world data on treatment with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) patients.

The primary purpose is to evaluate overall survival (OS) in mCRPC patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel) (post chemo patients).

This study will also evaluate treatment duration with enzalutamide in patients pre- and post-chemo.

The data source in this study is a local hospital registry created from a patient follow up of prostate cancer patients.

Eligibility Criteria:
Inclusion criteria:

* Chemo naïve mCRPC patients treated with enzalutamide and ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration).
* mCRPC patients treated with enzalutamide and ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration) post chemo.

Exclusion Criteria

* mCRPC patients previously exposed to Radium-223, abiraterone acetate and/or cabazitaxel for mCRPC (pre- and post chemotherapy).
* Patients previously exposed to chemotherapy or abiraterone acetate+prednisolone in combination with GnRH analogue for hormone sensitive prostate cancer (HSPC).
Comparison of Static Air Support Devices (Repose®) and Alternating-Pressure Devices in the Prevention of Pressure Ulcers

Maintaining and improving skin health are major goals in acute and long-term care. Patients at the extremes of age, the critically ill, medically compromised and those with immobility are at risk for developing several skin disorders, with pressure ulcers (PUs) as one of the most common and mostly preventable ones. Prevalence figures of PUs vary between 6.4% and 31.4%. PUs are described as localised injuries to the skin and/or underlying tissue, usually over a bony prominence, as a result of pressure or pressure combined with shear. Prevention of PUs is internationally seen to be a key quality indicator of care. To prevent PUs, reducing both the amount and the duration of pressure and shear at the pressure points of the body is strongly recommended. One of the interventions to achieving this, is the use of pressure-reducing devices (mattresses, cushions, etc.). Studies that compare the (cost-) effectiveness of different pressure-reducing devices are needed.

The primary aim of this study is to compare the (cost-) effectiveness of pressure ulcer prevention in high risk patients using static air support devices (Repose®) versus alternating-pressure devices. The second aim is to get insight in patients' experiences and perceptions of comfort using static air support devices and alternating-pressure devices. The third aim is to get insight in caretakers' perceptions of barriers and facilitators of the use of static air support devices and alternating-pressure devices and to reveal how these perceptions influence the readiness to use the products in clinical practice.

This randomized controlled trial will be performed in ca. 25 nursing homes in a random sample of 306 residents who are at high risk of developing pressure ulcers. Residents will be included in the study for a period of 14 days. Skin assessment and risk factor registration will be done on a daily basis by the nurses. Reliability checks and time measurements will be completed by the researcher.


Eligibility Criteria:
Inclusion Criteria:

* High risk of pressure ulcers (Braden score \< 12) and/or pressure ulcer category 1
* Currently using alternating-pressure devices
* Bedbound (\> 8 hours in bed) or chair bound (\> 8 hours in chair)
* Aged \> 65 years

Exclusion Criteria:

* Pressure ulcer category 2,3,4, deep tissue injury (DTI) or unstageable pressure ulcer
* Expected length of stay \< 2 weeks
* End of life care
* Medical contraindication for use of static air support devices