cyrilzakka/clinical-trials huggingface dataset:
District-based Mainstreaming Nutrition Project in Rural Pakistan

This study aims to provide evidence regarding the feasibility of integrating an enhanced maternal and child care health education package into the existing curricula of the National Program for Family Planning and Primary Health Care (LHW Program) and evaluating the feasibility of scaling-up as well as the impact on birth outcomes, nutritional status, morbidity patterns and overall survival patterns at the community level.

This project aims to do the following:

* To evaluate the operational feasibility of integrating an enhanced health education and nutrition package into the existing curriculum of the National Program for FP/PHC (LHW Program)
* Impact of the implementation of the full package of evidence-based nutrition interventions on the nutrition status, morbidity patterns and overall survival patterns in the district

Eligibility Criteria:
Inclusion Criteria:

* Live born infants and young children from all registered pregnancies within participating villages and catchment population
* pregnant women
* Consent given by at least one of the parents

Exclusion Criteria:

* Children born with congenital malformations or serious birth injury
* Suspected non-compliance (mobile and poorly motivated parents).
* Failure to give consent
Analysis of TU-LESS by 3D Laparoscopy in the Treatment of Infertility

This study intends to carry out a prospective, randomized controlled trial to compare the trans-umbilical laparoendoscopic single-site surgery by 3D laparoscopy with normal laparoendoscopic surgery in the treatment of infertility patient, so as to further clarify the safety and curative effect of TU-LESS by 3D laparoscopy and provide evidence-based basis for its application in infertility population.


Eligibility Criteria:
Inclusion Criteria:

1. Patients are younger than 36 and older than 24.
2. Clearly diagnosed with female Infertility.
3. Infertility within 1 to 10 years.
4. informed consent form signed

Exclusion Criteria:

1. Over the age of 35.
2. Indefinite diagnosis.
3. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
4. abdominal surgery history
5. Unwilling to comply with the research plan.
Simulation Training for Labor and Delivery Providers to Address HIV Stigma During Childbirth in Tanzania

This study will work in Tanzania to develop and pilot test a simulation and experiential learning intervention for labor and delivery providers, in order to address HIV stigma during childbirth. The primary endpoint will be patient-rated changes in respectful maternity care, comparing women who deliver in the pre-intervention time period and women who deliver in the post-intervention period.

The study will pilot test the MAMA intervention in six clinics in the Kilimanjaro Region. 60 L\&D providers will be enrolled across the sites. Patient level outcomes will be assessed using an interrupted time series design. Approximately 206 participants will be enrolled (103 in the pre-intervention period and 103 in the post-intervention period). The primary outcome will be patients' reported experiences of respectful maternity care (RMC). Secondary outcomes will be internalized HIV stigma, trust in health care, birth outcomes, HIV care engagements at 3 months, anticipated HIV stigma, and attitudes to long-term antiretroviral therapy. Our enrollment targets (103 per condition) will allow for detection of a medium effect of 0.4 in the change of RMC overall scores with 80% power and α=0.05. Pre- and post- surveys will be conducted for providers enrolled in the intervention, assessing outcomes related to practices of RMC, stigma toward WLHIV, self efficacy and clinical knowledge.

Eligibility Criteria:
Inclusion Criteria:

For labor and delivery providers:

* Over age 18
* Employed by a study clinic
* Work in the labor and delivery ward

For birthing women:

* Over age 18
* Gave birth in a study clinic
* Diagnosed with HIV

Exclusion Criteria:

For labor and delivery providers:

* Has not provided clinical care in the labor and delivery ward in past 6 months

For birthing women:

* Under age 18
* Unconfirmed HIV status
Beta-blockers in Pulmonary Arterial Hypertension

The investigators will conduct a, randomized, phase 2, placebo-controlled, double-blinded, crossover trial of carvedilol in 26 PAH patients with World Health Organization functional class II or III symptoms and RV ejection fraction (EF) \< 45% for 6 months.

Adult PAH patients on a stable dose of an approved PAH medication will undergo the following baseline assessments: cardiac magnetic resonance imaging (MRI), right heart catheterization (RHC), echocardiogram, 6-minute walk test (6-MWT), plasma NT-ProBNP (biomarkers of RV function) and serum catecholamine (measure of sympathetic activation), and quality of life. Patients will be randomized to carvedilol (3.125 mg bid and escalated to 9.375 mg bid, as tolerated, over 3 months) or placebo in a 1:1 fashion. After 6 months, testing is repeated and patients are crossed over to the alternate treatment. Testing is repeated at the end of the study (month 13).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* WHO category 1 pulmonary arterial hypertension (Nice 2013)
* WHO functional class II-III
* RVEF by cardiac MRI \< 45%
* Stable on PAH-specific therapy as defined by no change in PAH-specific treatment and functional class in the past 3 months. Patient can be on either mono or combination PAH-specific therapy

Exclusion Criteria:

* Subjects will be excluded from participation in the study if any of the following conditions exist:
* Significant persistent bradycardia (resting heart rate \< 60 bpm) without a permanent pacemaker
* Second or third degree AV block without a permanent pacemaker
* Significant sinus tachycardia (resting heart rate \> 110 bpm)
* Use of anti-arrhythmic drugs
* Hypotension defined as systolic blood pressure \< 100 mmHg at the time of enrollment
* Significant illness in the past 30 days requiring hospitalization
* Acute decompensated right heart failure within past 30 days
* Known allergy or intolerance to carvedilol or other β blockers
* Cardiac index \< 2 l/min/m2 or right atrial pressure \> 15 mm Hg by right heart catheterization within last 3 months
* Asthma
* Positive pregnancy test in patients of child bearing-potential
dbGaP Protocol: The Pediatric Cardiac Genetics Consortium (PCGC)

Background:

Researchers do not know much about the causes of congenital heart disease (CHD). They do know that many factors play a role. Some factors are environmental. Some are genetic. But few specific factors have been identified. And researchers do not know how many involve genes. They want to study data that has already been collected from people with CHD and their families.

Objectives:

To identify genetic variations related to CHD. To study molecules related to vascular disease in order to learn new ways to treat it.

Eligibility:

People who already participated in the Pediatric Cardiac Genomics Consortium (PCGC) study

Design:

Researchers will study data that was already collected in the PCGC. There will be no active participants.

Researchers will get access to the data through the coordinating center. They will not download data to local storage devices.

The data will have no personally identifying information....

Current understanding of the causes of congenital heart disease (CHD) is limited, but CHD is known to be multifactorial and affected by a combination of environmental, teratogenic, and genetic causes. Furthermore, both genetic and environmental factors have been proposed to act as disease modifiers, accounting for a wide variation in phenotypic expression and clinical outcomes of these disorders. To date however, few specific genetic or environmental causative factors have been identified, nor is it even known what proportion of cases involve genetic factors.

Eligibility Criteria:
* Retrospective Analysis Study. Data will be analyzed from subjects from cardiovascular disease databases.
Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy

This was a single site, three-arm, parallel group randomized clinical trial that compared the effect of three preoperative psychosocial interventions on knee and hip replacement patients' preoperative pain intensity and postoperative pain intensity, pain unpleasantness, and opioid use.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking males or females.
* 18 years old or older
* Patients within the University of Utah Hospital system
* Patients attending Joint Academy to prepare for either hip or knee replacement surgery

Exclusion Criteria:

* Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.
EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

The purpose of this study is to determine the safety of the drug EPO906 that could shrink tumors when used with radiation therapy in cancer patients.

* To determine the maximum tolerated dose (MTD) of EPO906 administered in combination with radiation therapy and establish a recommend phase II dose.
* To evaluate the safety and toxicity profile of EPO906 when administered concurrently with radiotherapy in three disease cohorts.
* To evaluate tumor response.

Eligibility Criteria:
Inclusion Criteria:

* Requires a minimum of 3 weeks of radiation therapy
* Solid tumors with advanced or recurrent disease for which there is no standard therapy or tumors have failed standard therapy
* World Health Organization (WHO) performance status equal to or less than 2
* Life expectancy equal to or greater than 3 months

Exclusion Criteria:

* Any peripheral neuropathy
* Unresolved diarrhea greater than grade 1
* Patients who received any other investigational compound within the past 28 days
* Severe cardiac insufficiency
* Patients on Coumadin
DVD-Based Training Program in Self-Hypnosis for Children

The proposed study is designed to utilize a self-hypnosis DVD home-training program for parents to use with their children to teach self-hypnosis techniques for inducing relaxation and hypnotic analgesia. These relaxation techniques can be employed to manage anticipatory anxiety, distress, and pain during an invasive medical procedure, for example, voiding cystourethrography (VCUG). The study will examine the efficacy of this intervention for children undergoing VCUG procedures.

Pediatric care professionals and parents seek safe ways to make invasive medical procedures less stressful and traumatic for children. However, for unpleasant procedures that require child cooperation, this task becomes difficult. Home-training in self-hypnotic relaxation may provide an inexpensive, yet systematic method for improving the overall medical care of children undergoing invasive medical procedures. The proposed study is designed to utilize a self-hypnosis DVD home-training program for parents to use with their children to teach self-hypnosis techniques for inducing relaxation and hypnotic analgesia. The study will examine the efficacy of this intervention for children undergoing urethral catheterization for VCUG procedures. Parents will be instructed to watch the DVD and practice the self-hypnosis exercises every day for a week with their child prior to the upcoming procedure. Parents are encouraged to practice self-hypnosis during their child's VCUG procedure. Both parents and children will be asked to complete a series of questionnaires before and following the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Child and participating parent have assented (child) or consented (parent) to participate
* Both child and parent are English-speaking
* Child has undergone at least one previous VCUG
* Child was at least 4 years of age at the time of the most recent VCUG
* Parent reports child experienced some difficulty (e.g., at least some crying, pain, or fear) during that earlier procedure.

Exclusion Criteria:

* Child and participating parent have not assented (child) or consented (parent) to participate
* Either child or parent are not English-speaking
* Child has not undergone at least one previous VCUG
* Child was under 4 years of age at the time of the most recent VCUG
* Parent reports child did not experience difficulty (e.g., at least some crying, pain, or fear) during that earlier procedure.
Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly

This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.


Eligibility Criteria:
Inclusion Criteria:

* A male or female between 12 and 16 weeks of age at the time of the first vaccination.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
* Administration of chronic immunosuppressants or immune-modifying drugs during the study period.
* Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose.
* Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases.
* History of/or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.
* Major congenital defects or serious chronic illness.
* Progressive neurological disorders.
* Administration of immunoglobulins and/or any blood products since birth and during the study period.
* Acute febrile illness at the time of planned vaccination.
Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical Practice in the Treatment of Relapsing-Remitting Multiple Sclerosis in MENA Region

The purpose of this observational study is to evaluate the effectiveness, safety and health related quality of life of Generic DMF (Sclera® or Marovarex ®, Hikma) in patients undergoing routine clinical care for RRMS in MENA Region

This is an observational, multi-center, prospective, cohort study, where no visits or intervention(s) additional to the daily practice will be performed. In the study sites, patients undergoing routine clinical care for RRMS and initiated treatment with Generic DMF (Sclera® or Marovarex ®, Hikma) in accordance with the approved SPC will be followed up and assessed for a total of 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who initiate treatment with Hikma Generic DMF at baseline in accordance with the approved Summary of Product Characteristics
2. Age ≥ 18 years
3. Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria who are :

   1. Newly diagnosed who had no prior DMT, or
   2. Switched patients who had ≥1 prior DMTs, other than DMF
4. Patients who agree to participate in the study and provide a written informed consent

Exclusion Criteria:

1. Patients with previous exposure to DMF other than (Sclera® or Marovarex ®-Hikma), Fumaderm (fumaric acid esters), or compounded fumarates.
2. Patients participating in other clinical studies
3. Patients who meet any of the contraindications to the administration of the Study drug according to the approved Summary of Product Characteristics
Pharmacokinetics and Safety Profiles After Administration of DA-5211 and Co-administration of DA-5211-R1 and DA-5211-R2 in Healthy Adult Volunteers

Pharmacokinetics and safety Profiles after administration of DA-5211 and co-administration of DA-5211-R1 and DA-5211-R2 in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* BMI between 18 and 30 kg/m2
* Body weight: Male≥50kg, Female≥45kg
* Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study

Exclusion Criteria:

* Subjects with allergy or drug hypersensitivity
* Subjects with clinically significant medical history
* Subjects with history of drug abuse or addicted
Evaluation of the Moments That Matter Program in Kenya

This cluster-randomized trial aims to evaluate the impact of the Moments That Matter® (MTM) Program on early child development and caregiving outcomes in two selected counties in western Kenya.

Approximately 43% of children under-5 are at risk of not attaining their developmental potential. Parenting interventions are recommended for improving early childhood development during the earliest years of life. However, there is limited evidence regarding the delivery and effectiveness of parenting interventions to promote early child development outcomes in Kenya specifically. This cluster-randomized trial aims to evaluate the effectiveness of the Moments That Matter® (MTM) Program on early child development and caregiving outcomes in two selected counties in western Kenya. The MTM Program will be implemented by the Anglican Church of Kenya Development Services - Nyanza (ADS-Nyanza), a faith-based organization focused on supporting integrated community-based programs to support the health, wellbeing, and development of the most vulnerable children and families. Various stakeholders - including community volunteers, faith leaders, and ECD committees - will be mobilized and trained to deliver nurturing care and ECD services over an 18-month program period. This trial will enroll primary caregivers of children 0-18 months of age and longitudinally follow the study cohort to ultimately compare changes in early child development and caregiving outcomes between the intervention and waitlist-control study arms. In addition to the impact evaluation, a qualitative implementation evaluation will be conducted to assess quality of delivery, identify factors that influence program effectiveness, and determine program potential for sustainability and scale-up.

Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver (parent or legal guardian) to a child aged 0-18 months
* Resides in a village selected into the research study
* Caregiver provides informed consent on behalf of both themself and the child to participate
Efficacy of Myofunctional Therapy in Class II Patients

Randomized clinical trial , with a sample of 60 children with atypical swallowing, class II and with SN1 orthopedic appliances these patients were randomly divided into, group 1: 30 patients with SN1 orthopedic appliances and myofunctional therapy and group 2: 30 patients with SN1 orthopedic appliances and without myofunctional therapy.

Randomized clinical trial with two parallel arms, on a sample of 60 children with atypical swallowing, class II and with SN1 orthopedic appliances, these patients were randomly divided into, group 1: 30 patients with SN1 orthopedic appliances and myofunctional therapy and group 2: 30 patients with SN1 orthopedic appliances and without myofunctional therapy for the study. Both groups carried out the evaluation of the protocol that included: 1) evaluation of the dental occlusion class and skeletal classification 2) swallowing function test using the Payne technique; 3) Mioscaner analysis to measure perioral forces, i.e. tongue extension force, lip pressure, masseter contraction force.

Eligibility Criteria:
Inclusion Criteria:

* the inclusion criteria the participants will be between

  * 8 and 10 years old
  * mixed dentition
  * canine class II diagnosis and 2 to 4 mm
  * molar according to Angle and overjet between 4 to 6 mm

Exclusion Criteria:

* Patients with systemic involvement

  * congenital malformations
  * facial deformities
  * Open bite
  * oral breathing
  * finger sucking habit will be excluded
Effectiveness and Safety of Sodium Bicarbonate Pleural Lavage in the Treatment of Complex Pleural Effusion

The goal of this clinical trial is to evaluate the safety and efficacy of sodium bicarbonate pleural lavage in treating complex pleural effusion in adult. The main questions it aims to answer are:

Will sodium bicarbonate pleural lavage reduce the failure rate of medical treatment (referral rate for surgery) for complicated pleural effusion？ Can sodium bicarbonate pleural lavage accelerating the rehabilitation of patients with complicated pleural effusion？ Will sodium bicarbonate pleural lavage improve the prognosis of patients with complicated pleural effusion?

Participants will will undergo catheter placement for continuous drainage of pleural effusion. Once at least 200 mL of pleural effusion has been drained:

Group A: Participants will receive a daily intrapleural injection of 200 mL of saline in 7 days; Group B: Participants will receive a daily intrapleural injection of 200 mL of 2.5% sodium bicarbonate in 7 days.

For patients with ultrasound evidence of pleural effusion loculations or drainage tube obstruction, intrapleural administration of urokinase may be performed at the discretion of the treating physician to ensure effective drainage.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients aged 18 to 80 years, inclusive.
* Patients fulfilling any one of the following three criteria for complicated pleural effusion: A. Pleural fluid pH \< 7.2; B. Pleural fluid glucose \< 2.2 mmol/L and LDH \> 1000 IU/L; C. Positive pleural fluid culture or smear for pathogens.
* Pleural effusion volume exceeding 300 mL, as determined by CT imaging using the formula D\^2 \* L (where D represents the maximum depth and L the maximum length), and for whom pleural effusion drainage is clinically indicated according to established guidelines or criteria.

Exclusion Criteria:

* Patients with known allergies to sodium bicarbonate or normal saline.
* Patients with severe coagulation disorders.
* Patients with severe heart or kidney failure.
* Pregnant or lactating women.
* Patients with pleural effusion caused by hospital-acquired interference, tuberculosis, fungal infections, or non-infectious causes.
* Patients unable to tolerate intrapleural administration.
* Patients with chronic lung diseases that may affect antibiotic efficacy, such as uncontrolled chronic obstructive pulmonary disease (COPD GOLD E group), bronchiectasis, or immunodeficiency.
* Patients who have experienced shock, major bleeding, trauma, or pulmonary surgery within the past 5 days.
* Patients with a history of lung or pleural surgery on the side of the pleural effusion.
* Patients who have recently had chest tubes placed due to pneumothorax, surgery, or pleural effusion.
* Patients currently enrolled in another drug or device clinical trial.
* Patients with poor compliance or difficulty in follow-up, or those with an expected survival of less than 3 months due to conditions other than pleural effusion.