cyrilzakka/clinical-trials huggingface dataset:
Comparative Effects of Play Based Therapy and Functional Communication Training in Speech-language Delayed Children

The purpose of this study is to compare the play based therapy and functional communication training in speech-language delayed children 2-6 years old. This study will highlight the most effective intervention or therapy for Speech \& Language Delayed Children. The Randomized clinical trial study will be conducted in clinic, sehat medical complex, with children who will have the diagnosis of speech and language delay. These individual will be diagnose by a speech therapist (more than 2 years experience in the field) with PORTAGE guide to early education . A group of children will be given play based therapy and the other group of children will be given functional communication training. Participants' assessments of SLD will be made using the Portage Guide to Early Education. It will take three months of sessions 5 days in a week, lasting 20 to 30 minutes. The Progress of both therapies will be seen and assessed through structured questionnaire that which technique is more effective. The individual will be assess through Speech Questionnaire on base line and after 3 months session program.

Speech is the verbal production of language, whereas language is the conceptual processing of communication. Language includes receptive language (understanding) and expressive language (the ability to convey information, feelings, thoughts, and ideas). Language is commonly thought of in its spoken form, but may also include a visual form, such as American Sign Language. Speech and language delay in children is associated with increased difficulty with reading, writing, attention, and socialization. In children not meeting the expected milestones for speech and language, a comprehensive developmental evaluation is essential, because atypical language development can be a secondary characteristic of other physical and developmental problems that may first manifest as language problems.

Eligibility Criteria:
Inclusion Criteria:

* Participants with comorbidity of behavioral disorder, Autism \& ADHD

Exclusion Criteria:

* Patient with comorbidity of syndromes ( downs syndrome, treacher Collin syndrome, hunter syndrome , Williams Syndrome, kabuki syndrome etc )
High Power vs Standard Power RF Ablation of Atrial Fibrillation in Conscious Patients

High RF energy ablation of atrial fibrillation is fast, safe, less painful and effective procedure.

Atrial fibrillation (AF) ablation is the most commonly performed radiofrequency (RF) ablation and is usually associated with a long procedural time and sensation of pain in conscious patients. Prolonged radiation exposure during the procedure puts the patient and the operator at risk of malignancy and genetic abnormalities. Complications such as asymptomatic cerebral lesions, tamponade, perforation, and also arrhythmia recurrence were associated with longer ablation time.

High-power, shorter-duration radiofrequency ablation (HPSDRFA) appears to be a novel concept for atrial fibrillation (AF) but there are scarce data in conscious patients. The lesion side index (LSI) value has been associated with durability of pulmonary vein isolation (PVI) lesions.

We hypothesised that HPSDRFA applications based on the lesion side index (LSI; its has been associated with durability of pulmonary vein isolation (PVI) lesions) which were not inferior to standard approach regarding safety and effectiveness with shorten procedure time and being less painful for a patient.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic patients with non-valvular AF,
* aged:18-85, first procedure in left atrium,
* exclusion of thrombus in left atrium and left atrium appendage,
* left ventricle ejection fraction \>55%

Exclusion Criteria:

* age below 18 or above 85 years,
* left ventricle ejection fraction\<55%,
* previous procedure in left atrium,
* valvular AF
CoCo: Colour Coded Blood Pressure Control

Insufficient blood pressure control is a frequent problem despite the existence of effective treatment. One of the causes is insufficient self-monitoring and a lack of adherence to therapy. Blood pressure self-measurement at home (Home Blood Pressure Measurement, HBPM) has positive effects on treatment adherence and is helpful in achieving the target blood pressure.

Only a few studies have investigated whether the adherence for HBPM can be improved through simple measures and better blood pressure monitoring can be achieved.

Objective Improvement of self-monitoring by means of blood pressure self-measurement and improved blood pressure control by using a new colour-coded blood pressure diary


Eligibility Criteria:
Inclusion criteria:

* Age \>18 years
* BP \> 140/90 mmHg Two consecutive measurements carried out in the practice (measured by the general practitioner at the start of the study).
* Unchanged anti-hypertension treatment for one month before inclusion
* Patient able to measure blood pressure at home
* Written informed consent

Exclusion criteria: • Blood pressure reading over 180 mmHg systolic and/or 110 mmHg diastolic.

* Serious general or psychological illness (malignant tumor, serious depressive episodes or evidence of dementia).
* Insufficient knowledge of the German language for instruction and blood pressure recording with a booklet.
CVD 37000: Immunity and Microbiome Studies At Intestinal and Systemic Sites in Ty21a Vaccinated Adults

This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever affect the normal immune system and bacteria in the intestine. Patients having standard-of-care colonoscopies will be divided into 3 groups:

Group 1: Vivotif typhoid vaccination then colonoscopy; Group 2: Colonoscopy, then Vivotif typhoid vaccination, then follow-up colonoscopy; Group 3: Colonoscopy without vaccination.

The Vivotif typhoid vaccine used in this study is licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Undergoing colonoscopy for screening or surveillance for colorectal cancer at the University of Maryland
* Provide written informed consent prior to initiation of any study procedures
* Healthy, as defined by considered fit to undergo outpatient elective colonoscopy by the referring health care provider

Exclusion Criteria:

* Pregnancy or nursing mother
* Known coagulopathy or bleeding disorder preventing mucosal biopsy
* History of Crohn's disease or ulcerative colitis
* Surgical removal of the ileocecal valve or any part of the small or large intestine
* Allergic reaction to oral typhoid vaccine in the past
* Immunosuppression from illness or treatment, including

  * immune-deficiency disorders such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
  * leukemia, lymphoma, or cancers
  * immune suppressive medications or treatments, such as corticosteroids or radiation
* Receipt of any other vaccine two weeks prior to receipt of Ty21a
* Positive urine pregnancy test (HCG) prior to colonoscopy or vaccination
The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes

The aim of this project is to explore whether the extinction of cue-reactivity following a cue-exposure based intervention in volunteers with an alcohol dependence is facilitated by drugs that increase NMDA-receptor function.

It is hypothesised that targeted treatment with D-Cycloserine prior to each extinction training session enhances the effects on cue-reactivity.

Further, a significant correlation between the reduction of cue-reactivity and both reduced craving and relapse probability is expected.


Eligibility Criteria:
Inclusion Criteria:

* current DSM-IV/ ICD-10 diagnosis of alcohol dependence
* controlled abstinence for a period of 5 to 21 days following admission to inpatient detoxification or day-clinic care
* women (in childbearing age): use of a highly effective method of contraception
* normal or corrected-to-normal vision
* ability to provide written informed consent

Exclusion Criteria:

* diagnosis of additional axis I or II disorders (according to DSM-IV( ICD- 10 criteria) either currently or within the past 12 months (except nicotine dependence)
* positive drug screening
* current medication with anti-convulsive or psychotropic drugs
* MRI ineligibility
* sensitivity to study medication as evidenced by a history of adverse drug experience
* severe withdrawal symptoms (e.g. convulsions, delirium)
* disposition towards experiencing convulsions/ epilepsy
* history of schizophrenic disorders/ affective psychosis
* neurological diseases that might affect the dopaminergic, limbic and frontal cortices or extrapyramidal motor functioning
* major diseases (e.g. diabetes, liver cirrhosis, heart disease)
* physical illness interfering with study procedures or affecting study outcomes
* pregnancy (positive test results)/ lactation period
* suicidal tendencies/ increased risk that others might be harmed -
Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

The purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged ≥12 years from the date of informed consent
* Confirmed diagnosis of CF at screening
* Confirmed EPI by historical (within past 12 months) CFA \<70% without use of PERTs or current fecal elastase \<50 µg/g stool at screening
* Currently receiving PERT with a commercially available pancreatic enzyme
* Currently on stable treatment with proton pump inhibitors or H2 receptor antagonists
* Clinically stable condition without evidence of acute respiratory disease or any other acute condition

Exclusion Criteria:

* History of fibrosing colonopathy
* History of significant bowel resection, in the opinion of the investigator, or solid organ transplant
* History of being refractory to pancreatic enzyme replacement
* Current diagnosis or history of distal intestinal obstruction syndrome
* Current diagnosis of small intestinal bacterial overgrowth, ileus or acute abdomen
* A body mass index percentile \<10%
Clinical Comparision of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal

* Objective: To compare clinical results of three types of manual tooth brushes on gingivitis and plaque removal efficacy.
* Material and Methods: This study is a single blind randomized trial with crossover design which involved 30 periodontally healthy individuals. At baseline professional plaque removal and oral hygiene instruction are performed for all the students, then they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores are measured using plaque and gingival indices (PI and GI). Then subjects are instructed to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed again. After passing one-week period for wash out, subjects don't brush for 1-2 days and indices are recorded again. The same procedure are done for Cross action, and Butler 411 tooth brushes respectively.

This study is a single blind randomized trial with crossover design which involved 30 periodontally healthy individuals. At baseline professional plaque removal and oral hygiene instruction are performed for all the students, then they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores are measured using plaque and gingival indices (PI and GI). Then subjects are instructed to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed again. After passing one-week period for wash out, subjects don't brush for 1-2 days and indices are recorded again. The same procedure are done for Cross action, and Butler 411 tooth brushes respectively.

Eligibility Criteria:
Inclusion Criteria:

* having at least five teeth in each quadrant;
* no partial denture;
* no orthodontic banding or retention wires;
* no oral lesions or sites with probing pockets depth ≥ 5 mm;
* routine use of a manual toothbrush.

Exclusion Criteria:

* having any systematic disease which would influence the course of periodontal diseases or the response to the treatment
* smoking
A Feasibility Study Evaluating the Use of a Non-invasive Ventilation Mask

Evaluate the clinicians assessment of the use of an oro-nasal mask during non-invasive ventilation (non-intubated) with a feasibility study.


Eligibility Criteria:
Inclusion Criteria:

* patient requiring non-invasive ventilation in an intensive care unit

Exclusion Criteria:

* patient not stable for non-invasive ventilation
* patient with unprotected airway
* excessive secretions
* patient with facial surgery
* agitated patient
Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate the efficacy of Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium Bromide Administered Via Dry Powder Inhaler in COPD


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults (40 ≤ age ≤ 85 years) with a diagnosis of COPD;
* Current smokers or ex-smokers;
* A Post-bronchodilator FEV1 ≥30% and \<80% of the predicted normal value and FEV1/FVC (Forced Vital Capacity) \< 0.7;
* Patients' COPD therapy (stable regimen at least 30 days before screening) with either:

  * Inhaled corticosteroids/long-acting β2-agonist/long-acting muscarinic antagonist (free or fixed) combination
  * Inhaled corticosteroids/long-acting β2-agonist (free or fixed) combination
  * Inhaled long-acting β2-agonist/long-acting muscarinic antagonist (free or fixed) combination
  * Inhaled long-acting muscarinic antagonist alone.

Exclusion Criteria:

* Pregnant and lactating women;
* Diagnosis of asthma;
* Known respiratory disorders other than COPD;
* Patients treated for a moderate or severe COPD exacerbation within 6 weeks prior to screening or during the run-in period;
* Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia;
* Patients who have clinically significant cardiovascular condition;
A Phase I Study of QLP2117 in Subjects With Advanced Solid Tumors

This is the first in human study of QLP2117. To evaluate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
2. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Ia dose escalation only requires at least one assessable lesion)
3. Eastern Cooperative Oncology Group Performance Status of 0 or 1
4. Agree to provide archived tumor tissue samples of primary or metastatic lesions.
5. Have adequate organ function as described in the protocol.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding
2. HBsAg/HBcAb positive and HBV-DNA\>1000 copy/mL;HCV-Ab positive and detection of HCV-RNA suggested viral replication
3. Is currently participating and receiving study medication in another study within 4 week prior to the first dose of study treatment
4. Has an active autoimmune disease that has required systemic treatment in past 2 years.
5. Has an active infection requiring systemic therapy
6. Has received a live vaccine wihtin 30 days of planned start of study treatment
7. Has know history of, or any evidence of interstitial lung disease
A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects

The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to meals in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 and ≤55 years of age
* Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mm Hg; diastolic blood pressure, 50-90 mm Hg; heart rate, 50-100 bpm
* Body mass index (BMI) ≥18 and ≤35 kg/sq m
* Able to provide written informed consent

Exclusion Criteria:

* Use of any medication (prescription, over-the-counter, herbal tea, or supplements) within 5 days of dosing
* Use of any investigational agent or study treatment within 30 days of Day 1
* Use of any protein or antibody-based therapeutic agents within 3 months of Screening
* Prior exposure to any SGLT inhibitor
* Use of cigarettes or any tobacco products within 6 weeks prior to Screening and while participating in the study
* History of bariatric surgery or any other gastrointestinal surgery that may induce malabsorption
* History of any major surgery within 6 months of Screening
* History of any hypersensitivity to the inactive components of LX4211
* History of renal disease or significantly abnormal kidney function tests
* History of hepatic disease or significantly abnormal liver function tests
* History of any active infection within 30 days of Day 1
* History of alcohol or substance abuse within 2 years prior to Day 1
* Positive urine glucose at Screening
* Positive pregnancy test at Screening
* Inability or difficulty swallowing whole tablets or capsules
* Unable or unwilling to communicate or cooperate with the Investigator.
A Phase III Study of Brimonidine Tartrate Ophthalmic Solution, 0.15% in Patients With Open-Angle Glaucoma or Ocular Hypertension

The primary objective of this study is to compare the safety and efficacy of Brimonidine Tartrate Ophthalmic Solution, 0.15% in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
* Patients of any race
* two (2) years of age or older
* of either sex
* diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)or ocular hypertension
Resveratrol for the Prevention of Bone Loss in Postmenopausal Women

The purpose of this study is to examine whether daily supplementation of resveratrol would improve bone health in postmenopausal women.

We plan to enroll and screen 68 women, with an estimated 34 qualifying women will be randomly assigned to two groups: 1) the placebo group and 2) the resveratrol group. The resveratrol group will receive 500 mg resveratrol daily for 24 weeks, and placebo group will receive placebo pills. Both groups will receive 500 mg calcium plus 400 IU vitamin D daily.

Blood and urinary biomarkers of bone metabolism will be assessed at baseline and after 12 and 24 weeks intervention. Bone mineral density will be assessed using dual-energy X-ray absorptiometry at baseline and after 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

1 to 10 years postmenopausal women with low bone mass

Exclusion Criteria:

* Osteoporosis
* Taking blood thinners, endocrine, or neuroactive drugs
* Hormone therapy
* Diagnosed: Metabolic bone disease, renal disease, kidney stones, cancer, cardiovascular disease, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease
* Severe menopausal symptoms, serious mood alterations, sleep disturbances
* Abnormal uterine bleeding, endometriosis, pelvic inflammatory disease
* Endometrial polyps, and significant uterine fibroids
* Smokers (≥ 20 cigarettes per day)
* BMI \<20 and \> 30 kg/m2
* Intolerance or allergic reaction to resveratrol, microcrystalline cellulose, grapes, red wine, or blueberries
Bihar Family Health Initiative (Ananya)

Ananya was funded by BMGF to reduce maternal, newborn, and child mortality; fertility; and child undernutrition in Bihar, India. Ananya involved multi-level interventions designed to build front line health worker (FLW) capacities and reach to communities and households, as well as to strengthen public health facilities and quality of care to increase maternal and neonatal care and health behaviors, and thus survival. From 2012 to 2014, eight focal districts in western and central Bihar.received Ananya, while 30 districts did not. Data were collected from mothers of infants 0-11 months at baseline and mothers of infants 0-23 months at 2 year follow-up, from comparable public health blocks in Ananya and Control districts to assess Ananya effects on quality and quantity of FLW home visits, postnatal health behaviors, and among older infants/toddlers, complementary feeding and vaccination. Difference in difference analyses were used to assess Ananya outcome effects in this quasi experimental study.


Eligibility Criteria:
Inclusion Criteria:

* Mothers of infants 0-23 months residing in the catchment area of the subcenters (public health facilities) included in this study.
Seek, Test, Treat, Retain: An Integrated Jail-Prison-Community Model for Illinois

Aim-1: Evaluate opt-out versus opt-in testing for the human immunodeficiency virus (HIV) at the Cook County jail and the Illinois Department of Corrections Northern Intake facilities. Outcomes of interest include a) uptake of each HIV testing strategy, b) comparative effectiveness of identifying HIV-positive cases, new cases and undisclosed cases, and c) predictors of HIV testing.

Aim-2: Evaluate two case management strategies - "correctional case management" and "transitional case management" - designed to improve linkage and adherence to appropriate medical care after release from incarceration. Correctional case management is a longer-term, more intense approach while transitional case management seeks to meet the clients' immediate needs, link them to Ryan White case management, and then support the Ryan White case manager in assisting these clients. Correctional case management will be compared to the standard of care for jail detainees, and to transitional case management for persons leaving prison. Outcomes of interest include, (a) HIV viral load and CD4 cell counts over time, (b) adherence to medication, and (c) visits to medical providers.

Aim-3: Evaluate the impact of an incentive for HIV-positive detainees released from jail to visit an HIV service organization where they can be linked to medical care and case management. Outcomes of interest are essentially the same as Aim-2.

Aim-4: Assess university-based telemedicine as means to improve care of state prison inmates living with HIV. Outcomes of interest include medication regimens, HIV viral load and CD4 cell counts, and associated health conditions.

Aim-5: Assess the uptake of partner notification and social network HIV counseling and testing involving HIV-positive persons released from jail and prison as a means to extend the reach of the 'seek, test, treat and retain' (STTR) model into the community.


Eligibility Criteria:
Inclusion Criteria:

* For assessing opt-out and opt-in HIV testing: all detainees in Cook County Jail and all prisoners in the Northern Intake facilities of the Illinois Department of Corrections (IDOC)
* For assessing telemedicine: all HIV-positive IDOC prisoners who have received treatment for HIV. -- For assessing case management: all IDOC HIV telemedicine patients who have been released from prison and returned to Chicago in the past 60 days, and all known HIV-positive jail detainees likely to be returning the community (Chicago) within 60 days of contact with the jail's HIV clinic
* For assessing a post-release incentive to visit an HIV service organization, and uptake of post-release partner notification and social network HIV testing: all former detainees participating in the case management evaluation

Exclusion Criteria:

* Less than 18 years old
* Unable to speak English or Spanish
* Incapable of providing informed consent
* For jail detainees: being under extradition to a locale outside Cook County or a high likelihood of being sent to prison rather than being released to the community
* For prison inmates: being under extradition to a locale outside Illinois