cyrilzakka/clinical-trials huggingface dataset:
The Added Value of Telephone Follow Up and Home Visits in Helping Children to Grow Up Healthy

Leading medical organizations have called on primary care pediatricians to take a central role in the prevention of childhood obesity. Weight counseling typically has not been incorporated into routine pediatric practice due to time and training constraints. Brief interventions with simple behavior change messages are needed to reach high-risk children, particularly Latino and Black children who are disproportionately affected by obesity and related comorbidities. Steps to Growing Up Healthy (Added Value) is a randomized controlled trial testing the efficacy of brief motivational counseling (BMC) delivered by primary care clinicians and the added value of supplementing BMC with monthly contact by community health workers (CHW) in the prevention/reversal of obesity in Latino and Black children ages 2-4 years old. Mother-child dyads (targeted n=150) are recruited for this 12-month randomized trial at an inner-city pediatric primary care clinic and randomized to: 1) BMC delivered by clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic behaviors (BMC); 2) BMC plus monthly phone calls by a CHW (BMC+Phone); or 3) BMC plus monthly home visits by a CHW (BMC+Home). During BMC, the medical team facilitates the selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the mother and teaches the mother simple behavioral strategies. Monthly contacts with CHWs are designed to identify and overcome barriers to goal progress. Dyads are assessed at baseline and 12 months and the primary outcome is change in the child's BMI percentile. We hypothesize that BMC+Phone and BMC+Home will produce greater reductions in BMI percentiles than BMC alone and that BMC+Home will produce greater reductions in BMI percentiles than BMC+Phone.


Eligibility Criteria:
Inclusion Criteria:

* Child is 2-4 years old
* Latino or Black descent by maternal report
* Receiving services through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)

Exclusion Criteria:

* Mother is younger than 18 years old
* Dad does not live in the Greater Hartford area or if they have plans to move out of the area in the next 12 months
* Child or mother has special needs (dietary, physical, and/or emotional) that would make the intervention inappropriate (e.g. failure to thrive, type 1 diabetes, cystic fibrosis)
Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm

Aim:

To adapt and develop a culturally appropriate psychological intervention and test its feasibility, and acceptability for the patients presenting to general hospital following self-harm in Karachi Pakistan.

Primary hypothesis:

Patients who receive cognitive behavioral therapy will show significant decrease in suicidal ideation as compared to patients with treatment as usual.

Design:

Randomized Control Trial

Setting:

Medical Departments of General Hospitals in Karachi.

Participants:

A total of 200 self harm patients will be randomized to psychological intervention and treatment as usual arm.

Intervention:

Culturally Adapted Cognitive Behavioral Therapy (CBT)

Outcome measure:

Beck Suicidal Ideation Scale

Culturally Adapted manualised Cognitive Behavioral Therapy (CBT) will be a brief problem focused therapy comprising of 6 sessions within three months after a self-harm episode. The adapted therapy/training will be delivered by therapists/trained counselors at the hospital. Sessions will be offered weekly in the first two weeks and than fortnightly and will last 50 minutes. During each session the therapists will assess the risk of suicide and will liaise with the research supervisor and patient's treating clinician.

The areas covered by the manual which has been adapted include an evaluation of the self-harm attempt, crisis skills, problem solving, and basic cognitive techniques to manage emotions and negative thinking and relapse prevention strategies. The treatment will be structured around patient's current problems with the relevant sections of the manual helping the patient to deal with specific problems leading to the self-harm act. Between the sessions the manual can be used for homework tasks by the patient.

Eligibility Criteria:
Inclusion Criteria:

* An episode of self harm within 48 hours before being admitted at the department;

  * age of 16 to 64 years;
  * Resident in the trial site catchments area,
  * Ability to complete a baseline assessment;
  * Ability to provide at least 2 verifiable contacts to improve tracking for subsequent assessments; and ability to understand and provide informed consent.

Exclusion Criteria:

* • A medical disorder that would prevent participation in an outpatient clinical trial.

  * Temporary resident unlikely to be available for follow up.
  * Diagnosis of Alcohol and other drug dependence, schizophrenia or Bipolar Disorders.
Advisa MRI Clinical Study

The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body including the chest).

The Advisa MRI IPG is a dual chamber, multi-programmable IPG. The IPG is indicated to restore heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The IPG is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity and has been modified for use during an MRI exam.

Subjects will have required follow-up visits after implant, at 2 months, 9-12 weeks, 3 months, 4 months, 6 months and every 6 months thereafter until the study ends. The MR scans will occur at the 9-12 weeks visit.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have a Class I or II indication for implantation of a dual chamber pacemaker according to the American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines
* Subjects who are able to undergo a pectoral implant
* Subjects who are able and willing to undergo elective magnetic resonance (MR) scanning without sedation
* Subjects who are geographically stable and available for follow-up at the study center for the length of the study

Exclusion Criteria:

* Subjects with a mechanical tricuspid heart valve
* Subjects with a history of significant tricuspid valvular disease
* Subjects for whom a single dose of 1.0 milligram (mg) dexamethasone acetate may be contraindicated
* Subjects who require a legally authorized representative to obtain consent
* Subjects who have a previously implanted pacemaker or implantable cardioverter defibrillator (ICD) (abandoned pacemaker and/or defibrillator leads are not permitted; however subjects with complete system explants are not excluded)
* Subjects who are immediate candidates for an ICD
* Subjects who require an indicated MR scan, other than those specifically described in the study, before the 4 months follow-up
* Subjects with previously implanted active medical devices
* Subjects with a non-MRI compatible device (such as ICDs or neurostimulators) or material implant (e.g. non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys)
* Subjects with medical conditions that preclude the testing required by the protocol or limit study participation
* Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during this clinical study
* Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control
* Subjects with exclusion criteria required by local law (e.g. age, breastfeeding)
Comparison Between Two Different High Power Ablative Lasers in the Treatment of Oral Leukoplakia

Oral leukoplakia is a precancerous lesion with relatively high malignant transformation potential. They are often treated by wide surgical excisions or conservative retinoids therapy. The use of high power ablative lasers has been proposed as an effective way of treating these lesions safely. The aim of this study was to evaluate efficiency Er:YAG and Er,Cr:YSGG laser, in the treatment of oral leukoplakia.

The purpose of this research was to determine the effectiveness of two high-power ablative lasers in the treatment of oral leukoplakia. Furthermore, the purpose was to compare reciprocally and evaluate the subjective and objective postoperative parameters for two different tested ablative lasers, Er: YAG and Er, Cr: YSGG.

All the patients were referred to the Department of Oral Medicine or Oral Surgery where a biopsy and measuring the size of lesion that meet the criteria of the histopathological diagnosis of leukoplakia was performed. Patients who met the conditions of pathohistological diagnosis of leukoplakia and clinical criteria for diagnosis of non-homogeneous leukoplakia, were included in the research.

The patients were randomly allocated into one of the two test groups. In the first group of patients leukoplakia lesion were removed using high-power ablative laser Er: YAG and to those in the second group using high power ablative Er, Cr: YSGG laser.

The patients were monitored one year and six months after treatment to evaluate subjective and objective parameters focused on life quality after treatment and in case of eventual relapse. Criteria of effectiveness for lasers were appearance of relaps in one year and six months following.

Eligibility Criteria:
Inclusion Criteria:

* based clinically diagnosed non homogeneous leukoplakia

Exclusion Criteria:

* immunocompromised patients
* HIV positive patients
* patients on suppressive therapy
Evaluation of Post Operative Pain and Success Rate After Pulpotomy

The aim of this randomized controlled trial is to assess the post-operative pain as primary outcome and the success rate as secondary outcome after pulpotomy using different calcium silicate based materials in mature permanent teeth diagnosed with irreversible pulpitis.

Setting and location :

Out-patients clinic of Endodontic Department, Faculty of Dentistry, Ain Shams University

Patient allocation:

Using computer generated randomization (www.randome.org), the participants will allocated randomly into three groups .

The sequentially numbers that will be generated, will be placed in opaque envelope until the intervention and each participant will be asked to select an envelope that determine which group of intervention he will be assigned.

Patient Classification:

Patients will be randomly divided into three groups according to material used in pulpotomy Group (1) Biodentine (n=20) Group (2) theracal PT (n=20) Group (3) Neoputty (n=20)

Procedural steps:

* Pain scale chart will be given to each patient to rate his /her pain level before endodontic treatment as preoperative reading on a visual analogue scale (VAS)
* Tooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000.
* Rubber dam isolation of tooth
* Tooth surface disinfection using guaze soaked in 5.25% sodium hypochlorite
* Access cavity will be performed using a carbide steel round bur and tapered diamond stone until complete deroofing.
* Using a sterile excavator, the coronal pulp tissue will be excavated14
* Cotton pellets soaked in 2.5 % sodium hypochlorite will be used to achieve hemostasis for 2-3 minutes
* Once hemostasis will be achieved one of the three materials will be placed according to the manufacturer's instructions
* Final restoration will be placed

Methods of evaluation

1. Post operative pain
2. Pulpotomy success rate

Eligibility Criteria:
Inclusion Criteria:

* Patients age between 20 and 40 years old.

  * Teeth diagnosed with symptomatic irreversible pulpitis.
  * Normal periapical condition confirmed by normal periapical radiograph or that with minimal widening of the PDL space.
  * The teeth are restorable.
  * Teeth probing depth and mobility should be within normal limits.

Exclusion Criteria:

* Teeth with immature roots

  * Non restorable teeth
  * Bleeding could not be controlled after pulpotomy in 10 minutes.
  * Medically compromised patients with systemic complication that would alter the treatment.
A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers

The purpose of this study is to determine whether a new cerebral oxygen monitoring device is effective and comparatively similar to the current approved devices.

Cerebral oxygenation monitoring is an innovative way to monitoring cardiac surgery patients intraoperatively to reduce the incidence of postoperative hypoxic side effects. There are a number of approved devices already in the market that have proved their effectivity.

Eligibility Criteria:
INCLUSION CRITERIA:

* Healthy male or Female Volunteers
* 18 years old or older
* Capable and willing to operate a bicycle
* Understand enough about the risks and benefits of the study to be able to make an informed decision before agreeing to be in the study

EXLUSION CRITERIA:

* History of Cerebrovascular Disease
* History of Skin Problems on Forehead (Skin Rashes, Acne, Allergies, etc.)
* Pregnancy
Observation of the Incidence and Natural History of MGUS in Patients Undergoing Weight Reduction Surgery

Screening study to determine incidence of MGUS in this patient population

This study is designed to observe the incidence of monoclonal gammopathy of undetermined significance (MGUS) among obese patients planning to have weight reduction surgery or planning to enter into a physician monitored weight loss program and to follow the regression or progression of MGUS following surgery or the initiation of the weight loss program.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients 30 years or older planning to undergo weight reduction surgery or planning to enter into a physician monitored weight loss program
2. Patients must be obese, defined as a BMI ≥ 30 as calculated by the formula:

   weight in pounds / height squared x 703 = BMI
3. Subject consent and authorization for the release of health information must be obtained according to local institutional guidelines.
4. To remain in the study for the follow-up phase, the baseline screening test must indicate that a patient has MGUS.

Exclusion Criteria:

1. No history of any malignancy except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years.
2. No concurrent or planned participation in randomized trials of weight loss.
3. A patient will be excluded from the follow-up phase if the baseline screening test indicates they do not have MGUS
Herbal Treatment for Perennial Allergic Rhinitis

Allergic rhinitis(AR) is one of the most common allergic disorders throughout the world.The conventional therapies are effective in alleviating symptoms but the efficacy are limited and not persistent. Furthermonre, the cost and side-effect are known defects. A classical Chinese herbal formula, has been used for AR for centries. Our study purpose is to evaluate the clinical efficacy and safety of this formula verus placebo in perennial allergic rhinitis (PAR).

Hypothesis: the classical herbal formula would improve the symptoms of PAR patients and change some immunological parameters in the peripheral blood when comparing with the placebo.

It is a randomized, double-blind, placebo-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 65 years old
* Have typical symotoms of PAR including rhinirrhea, sneezing, nasal obstruction and itching in nose and eyes for at least 2 previous consecutive years.
* Postive skin prick test(SPT) to hose dust mite, mold, animal dander and cockcroach with regular AR medications withould for 3 days prior to the test

Exclusion Criteria:

* Pregnant women and women at risk of conception
* Received allergen injections in previous 2 years
* Regular medications for AR or cold and other allergic disorder
* Seasonal allergic rhinitis, vasomotor rhinitis and rhinitis medicamentosa
* Nasal structure deformities, nasal polyps and hypertrophic rhinitis
* Systematic cortisosteroid used within recent 3 months or nasal cortisosteroid with 15 days
* Other active respiratory disorders
* Active medical disorders: cancer, infection, hematology, renal, hepatic, cardiovascular, metabolic and gastrointestinal diseases
Map of Unwanted Loneliness

Creating a map of the magnitude of the problem and the response of primary care to unwanted loneliness among the elderly, stratifying different needs based on place of residence and proximity to available assistance programs to address this issue, which, due to its scale, calls for collaboration among various institutions, disciplines, and experiences.


Eligibility Criteria:
Inclusion Criteria:

* Population aged 65 or older.
* Registration of medical records related to unanticipated loneliness.
* Patients with diagnoses of anxiety disorders (CIE-10 F41.1, F41.2, F41.8, F41.9, F43.2, F45, F48) or insomnia (CIE-10 F51) or affective disorders (CIE-10 F34.1) or somatization (CIE-10 F45.0) or pathological grief (CIE-10 Z63.4) or those referred to mental health or social worker services.

Exclusion Criteria:

* None
A Retrospective Cohort Study of HFRS

The goal of this retrospective cohort study is to learn about the clinial characteristics of HFRS patients, explore the risk factors of the occurrence and death of HFRS, and build a risk prediction model for HFRS.

HFRS remains an important public health issue in China, which not only poses a threat to people's physical health and safety, but also has a serious impact on social and economic development. At present, there is no unified standard for clinical prediction of the occurrence and death of HFRS. In order to better prevent and treat HFRS, this multicenter retrospective clinical study is designed to include HFRS inpatients, and collect their demographics, epidemiological history, hospitalization information, clinical manifestation, laboratory results, imaging results, treatment plan and outcome.

Eligibility Criteria:
Inclusion Criteria:

The patients must meet all of the following criteria:

* Inpatient with clinical diagnosis of Haemorrhagic Fever with Renal Syndrome

Exclusion Criteria:

Exclude patients who meet any of the following criteria:

* Patients with previous chronic kidney disease
* Pregnant or perinatal patients
* Patients unsuitable for inclusion by investigators' evaluation
Bikram Yoga and Asthma

Cold and dry air induce exercise induced asthma. Yoga training may improve lung function tests. Bikram Yoga (heat 39 degree Celsius and humidity 60%)training may improve both lung function tests and bronchial hyperreactivity (to exercise and adenosine 5'monophosphate).

15 young adults with exercise induced asthma and 10 healthy young adults will participate in 2 months taining of Bikram Yoga in Tel Aviv. They will perform sessions of 90 minutes training at least 5 times a week. Lung function tests, bronchial challenges (exercise and AMP) and progressive exercise test will be performed before and after the 2 month training at Hadassah University Hospital in Jerusalem in the asthmatic patients. Healthy adults will perform only lung function tsts and progressive exercise before and after training.

Eligibility Criteria:
Inclusion Criteria:

* controlled asthma
* age 18-30 years

Exclusion Criteria:

* heart,
* hypertension,
* kidney disease,
* chronic lung disease,
* oxygen dependence
The Investigation of Effect on Blood Lipid Parameters With Walnut Addition of Diet

Introduction There is a strong relationship between eating habits and diseases of the cardiovascular system. It is known that walnut consumption has positive effects on cardiovascular system diseases. However, its effect on small dense LDL (sdLDL) is discussed. Therefore in this study, you participated the effects of walnut consumption on the serum lipids values, especially sdLDL values of healthy volunteers.

Methods Volunteers participating in this study were offered 30 grams of walnuts per day for 21 days. Walnuts were consumed on empty stomach or with breakfast every morning for 21 days. The blood values of subjects were measured at the beginning and the end of the study. The serum was obtained from the taken blood and blood lipid/hemoglobin parameters were measured on routine blood work. Food consumption records and surveys were taken from individuals.


Eligibility Criteria:
Inclusion Criteria:

* Do not consume any products such as nuts and walnuts (the frequency of consumption should not be more than once a week)
* Have no allergies to foods such as nuts and walnuts
* Do not take drugs on a daily and continuous basis

Exclusion Criteria:

* Obesity
* Diabetes Mellitus
* Acoholic and chronic diseases such as kidney
* Thyroid
* Hepatitis
* Cancer etc.
Tilted Gaze Target Test in the Examination of Children With Superior Oblique Muscle Palsy

This study is a prospective, randomized, double-blind cohort study aimed at assessing the accuracy of the preoperative tilted gaze target test in predicting the degree of improvement in compensatory head position after surgery in children with superior oblique muscle palsy.

This is a prospective, randomized, double-blind cohort study conducted from May 2023 to April 2024. The study aims to evaluate the effectiveness of a non-human contact gaze tilt test in the diagnosis of children with superior oblique Muscle Palsy. Patients who met the inclusion criteria for outpatient and inpatient ophthalmic surgery for strabismus and pediatric ophthalmology were enrolled after signing a written informed consent. The gaze tilt test was added to the normal treatment process and performed by a professional ophthalmologist who was not involved in the treatment process. The test involved playing a small animated video with a visual mobile device at a distance of 33 cm and 3 m, respectively, to determine the optimal angle of head position improvement and the spatial tilt angle of the screen relative to the orthostatic position. A third-party analysis of the data was performed to identify myotonic and oculocutaneous tilts and compared with the results of the conventional test. The study aims to clarify the authenticity, reliability, and practicality of the gaze object tilt test in diagnosing and treating oculocutaneous squint.

Eligibility Criteria:
Inclusion Criteria:

* Age between 1 and 8 years old.
* History of torticollis less than 5 years.
* Ability to cooperate with basic examinations at the Tianjin Ophthalmology Strabismus and Pediatric Ophthalmology Clinic.
* Complete clinical information available.
* Signed informed consent.

Exclusion Criteria:

* Both eyes cannot look at the same time or alternately
* Children with ocular disease other than oculomotor eye disease.
* Clearly defined systemic developmental abnormalities: Down syndrome, microcephaly, autism, Leber syndrome, central visual impairment, etc.
* Children who cannot cooperate with the examination due to age or other reasons.