cyrilzakka/clinical-trials huggingface dataset:
Developmental Screening and Nutritional Intervention of Severe Acute Malnourished Children in Southern Punjab, Pakistan

i. To examine the impact of malnutrition on development quotient of children

ii. To determine the effectiveness of Ready to Use Therapeutic Food (RUTF) in improving the development quotient of severe acute malnourished children under five year of age.

iii. To investigate the outcome of Vitamin D therapeutic doses intervention with RUTF rehabilitation on growth and development of malnourished children.

1. Research Instrument: For Development quotient Denver 2 screening form and tools will be used. Follow up of patients for three months and for recording of their weight Community management of acute malnutrition forms will be used. Denver screening tool will be used for child development quotient covering all areas of development, fine motor, gross motor, language and personal social contact.
2. Research Settings: The study will be conducted in Dera Ghazi Khan division at, Basic Health Units (BHU).
3. Study design: Randomized Controlled Trial.
4. Data Collection: Lady Health Visitors (LHWs) will screen the children aged 6 months to 59 months in their community and will refer the severely malnourished children to Outpatient Therapeutic Programs (OTPs).Two groups of malnourished children will be made one study and one control group; one group will be treated with RUTF and extra virgin olive oil as placebo. Other will with RUTF and two mega doses of Vitamin D randomly, first after 15 days of enrollment and second after 15 days of first dose.

Eligibility Criteria:
Inclusion Criteria

* All the selected children of Severe uncomplicated acute malnutrition of concerned age group whose parents or guardians have give written consent for the study
* Mid Upper Arm Circumference (MUAC) less than 11.5 cm or Weight For Height (WFH) less then minus 3 standard deviation.

Exclusion Criteria

* Children above the concerned age group
* Refusal of parents for taking part in the study.
* Child having Severe Acute Malnutrition (SAM) with complications have loss of appetite, lower respiratory tract infection indicated by chest in drawing, severe vomiting.
* Temperature greater then 39°C or hypothermia less then 35°C, very pale, oedema, unconsciousness.
Pushing and Manual Perineal Protection Techniques

Perineal trauma during vaginal delivery is very common, especially in countries with a high prevalence of episiotomy. Perineal traumas can range from tears limited to the skin, subcutaneous and vaginal mucosa to severe tears involving the anal sphincter and rectal mucosa. Perineal trauma is associated with short-term morbidities such as bleeding, infection, pain, edema. Besides, it may cause long-term morbidities such as urinary incontinence, fecal incontinence, dyspareunia, a decrease in quality of life, a need for surgery, and psychosocial problems. Moreover, it is associated with an increase in national healthcare costs and malpractice cases. For these reasons, some measures to reduce the frequency of perineal trauma have been discussed for many years. Pushing techniques applied in the second stage of labor and manual perineum protection techniques applied during fetal expulsion are among these. Current data are insufficient to make definitive recommendations. In this study, it was aimed to compare different pushing and perineal protection techniques in the second stage of labor.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparity
* 37-40 weeks of gestation
* Singleton pregnancy
* Vertex presentation
* Risk-free pregnancy
* Estimated fetal weight 2500-4000 g
* In the first stage of birth
* Amniotic membranes are intact
* Adequate knowledge of written and spoken Turkish

Exclusion Criteria:

* Cesarean delivery need
* Need for labor induction
* Need for operative delivery (vacuum, forceps)
* Need for obstetric analgesia
* Kristaller maneuver
* Perineal preparation during pregnancy (perineal massage in the last month of pregnancy, etc.)
* Vulvo-vaginal infection
* Vulvar severe varicose veins
* Postpartum atony
* Non-compliance with research follow-up criteria
* Covid-19 positivity
* Non-compliance with the procedure of the group involved
* Neuropsychiatric and other diseases that cause understanding, speech, and expression disorders
Effect of Osteopathic Manipulation on Postural Stability in the Elderly

Postural stability and balance are defined as the body's ability to return the body back to its equilibrium point when exposed to a perturbation. This exploratory project is based on the hypotheses that decreased balance (increased sway as measured by the center of pressure of the body during quiet standing) causes an increased risk of falls and osteopathic manipulative treatment can improve postural balance. To test these hypotheses, the investigators will investigate the kinematics (study of the way the body moves) of postural balance in two cohorts of healthy elders, those receiving manipulation and those not receiving manipulation. We hypothesize that OMT is effective to increase postural stability, balance.

Postural stability and balance are defined as the body's ability to return the body back to its equilibrium point when exposed to a perturbation. This exploratory project is based on the hypotheses that decreased balance(increased sway as measured by the center of pressure of the body during quiet standing) causes an increased risk of falls and osteopathic manipulative treatment can improve postural balance. To test these ideas, the investigators will investigate the kinematics(study of the way the body moves)of postural balance in two cohorts of healthy elders, those receiving manipulation and those not receiving manipulation. We hypothesize that OMT is effective to increase postural stability, balance.

Specific Aims Aim 1: To measure balance in a cohort of healthy elders(age 65 and over)using a force plate to measure center of pressure in the Anterior/posterior and medial-lateral directions during quiet standing with the eyes open, with the eyes closed and during a Romberg test.

Aim 2: To evaluate the effectiveness of OMT to improve balance in a healthy elderly population. We will observe the progression of improvement in balance in one group who will receive OMT for four weeks compared to the other who will not receive OMT.

Aim 3: To examine any potential impact and efficacy of OMT on cardiac and circulatory responses by measuring blood flow and circulation.

Eligibility Criteria:
Inclusion Criteria:

* 65 years ofage and older
* Healthy
* Male and Female

Exclusion Criteria:

* Self report of a condition that could impair balance, such as otoneurologic, musculoskeletal or neurological diseases.
* Under the age of 65
Cesarean Skin Incision Trial

The purpose of this study is to determine if there is a difference between Pfannenstiel and midline vertical skin incision at time of cesarean section in preventing wound complications in the morbidly obese patient. This is a comparative effectiveness study of two commonly-used skin incisions. The investigators plan to enroll morbidly obese obstetrical patients upon admission and randomize them to one of the above incision types in the operating room. The investigators will follow them for 6 weeks post-op to evaluate for wound complications. There is minimal risk to the participant as both incision types are acceptable in current obstetrical practice. There is no direct benefit to the patient.

Currently, there is no level I evidence to support either Pfannenstiel or midline vertical skin incision in the prevention of wound complications in the obese patient undergoing cesarean section. Therefore, current practice is for the surgeon to make the decision based on preference and weighing theoretic risks. Therefore, there is clinical equipoise. Cesarean section is a very common procedure, with a national rate of 32% of all live births in 2007. Not only does obesity increase the expectant mother's risk of a cesarean section, it is also a well recognized risk factor for wound complication. The cesarean wound complication rate in the morbidly obese population at the University Of Texas at Houston - Memorial Hermann Hospital Texas Medical Center in 2011 was roughly twenty times as high as the normal weight population, 28% compared to 1.4%. Results from this study could be extrapolated in the future to affect lower post-operative morbidity, higher patient satisfaction, less antibiotic use, shorter hospital stay, and overall lower health care costs.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women undergoing cesarean delivery for any indication, regardless of number of prior cesarean deliveries
2. Age 18-50 years
3. BMI of 40 kg/m2 or more

Exclusion Criteria:

1. Underlying infection such as chorioamnionitis
2. Rupture of membranes over 18 hours prior to cesarean section ,
Non- Vs Partial Controlled Weightbearing After Multiple Knee Ligament Reconstruction

This is a prospective randomized controlled trial with the purpose to determine if patients undergoing isolated posterior cruciate ligament (PCL) reconstruction, or isolated medial collateral ligament (MCL) reconstruction, or combined PCL, anterior cruciate ligament (ACL), fibular collateral ligament (FCL), posterolateral corner (PLC), and MCL reconstructions (or any combination of multiple ligaments) can safely begin partial controlled weightbearing for the first six weeks after surgery.

Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery:

1. non-weightbearing
2. partial weightbearing

An immobilizer brace in extension will be used from post-operative day 0 through 4 and a dynamic stabilizing posterior knee brace (Ossur) will be used from 5 days through 6 months post-surgery to protect against increased posterior translation forces due to gravity and while weightbearing for patients with PCL reconstructions.

Specific Aims

1. Primary Aim: To determine if there is clinical equivalence in millimeters of posterior tibial translation on posterior stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation.
2. Primary Aim: To determine if there is clinical equivalence in millimeters of valgus and/or varus compartment gapping on stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation.
3. Secondary Aim: To determine if there is a difference in pain, edema, range of motion, gait, and quadriceps strength between groups.

The current standard of care for posterior cruciate ligament reconstruction and multiligament reconstruction is non-weightbearing for the first six weeks after surgery.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 14 years old, \<60
* Reconstruction of PCL alone
* Reconstruction of MCL alone
* Reconstruction of combined multiligament injuries (PCL+ (FCL, PLC, ACL, MCL))
* Reconstruction of multiligament injuries (ACL+MCL)
* Males or females
* Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.

Exclusion Criteria:

* \< 14 years old
* \>60 years old
* Pregnant
* Revision PCL reconstructions
* Previous or concurrent vascular injury (vascular bypass procedure)
* Associated fractures requiring concurrent surgery
* Concurrent meniscal root or radial repair surgery
Mind Body Intervention for Chronic Migraine Headaches

The goal of this exploratory study is to test a mind-body interventional approach for the treatment of chronic migraines. The main goal is to obtain feasibility information on the protocol which has been used in other similar conditions. We will also evaluate multiple measurement tools in order to optimize a follow-up pilot study evaluating the impact of the protocol on migraines.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥ 18 years of age)
2. Previously diagnosed with migraine headache based on ICHD-3 beta criteria 91
3. A score of ≥ 50 on the Headache Impact Test-6 self-report survey (moderate impact) 92
4. Presence of migraine headaches at least 5 days per month
5. Willing to engage in a Mind-Body intervention
6. Willing/able to participate in remote sessions

Exclusion Criteria:

1. Known history or suspicion of headaches due to organic cause (e.g. cancer, sinus infection, head trauma, cerebrovascular disease)
2. Diagnosis of other chronic pain syndromes that may cloud assessments (e.g. fibromyalgia, chronic idiopathic neck pain)
3. Diagnosis of cognitive impairment or dementia
4. Active addiction disorder, e.g. cocaine or IV heroin use, that would interfere with study participation
5. Major psychiatric comorbidity (e.g., schizophrenia). Anxiety and mild-moderate depression are not considered exclusions.
Application of Artificial Intelligence for Early Diagnosis of Gastric Cancer During Optical Enhancement Magnifying Endoscopy

Previous prospective randomized controlled study demonstrated higher accuracy rate of diagnosing early gastric cancers by Magnifying image-enhanced endoscopy than conventional white-light endoscopy. Nevertheless, it is difficult to differentiate early gastric cancer from noncancerous lesions for beginner. we developed a new computer-aided system to assist endoscopists in identifying early gastric cancers in magnifying optical enhancement images.

Gastric cancer is the third most common cause of cancer-associated deaths worldwide especially in Asia.Early detection and treatment would cure the disease with 5-year survival rate greater than 90%.However, the sensitivity of conventional endoscopy with white-light imaging (C-WLI) in diagnosis of early gastric cancers (EGCs) is merely 40%. Magnifying image-enhanced endoscopy (IEE) techniques such as magnifying narrow band imaging (M-NBI) have been developed and 2 RCT report that white-light imaging combine with M-NBI can increase the sensitivity to 95%. The strategy that using white-light imaging to detect the suspicious lesion and using M-IEE techniques to make a diagnosis of early gastric cancer is recommend in screening endoscopy.

Optical enhancement (OE) which is one of the M-IEE techniques was developed by HOYA Co. (Tokyo, Japan) . This technology combines digital signal processing and optical filterers to clear display of mucosal microsurface (MS) and microvessel (MV). The advantage of OE is to overcome the darkness of NBI which leads to less usefulness for detect-ability in the full extended gastrointestinal lumen.Nevertheless, it is difficult to differentiate early gastric cancer from noncancerous lesions for beginner, and expertise with sub-optimal inter-observer agreement is essential for the use of M-IEE.

Nowadays, Artificial intelligence (AI) using deep machine learning has made a major breakthrough in gastroenterology, which using gradient descent method and backpropagation to automatically extract specific images features. The diagnostic accuracy in identifying upper gastrointestinal cancer was 0.955 in C-WLI . Polyps can be identified in real time with 96% accuracy in screening colonoscopy. AI show an outstanding application in detection and diagnosis.

This study aims to develop a M-OE assistance model in the diagnosis of EGCs by distinguishing cancer or not.

Eligibility Criteria:
Inclusion Criteria:

* patients receive optical magnifying OE endoscopy examination

Exclusion Criteria:

* Patients with advanced cancer, lymphoma,active stage of ulcer and artificial ulcer after ESD were excluded.
Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation

The best opioid for bronchoscopy is still unclear.This randomized double-blind prospective study was conducted on a total of 60 patients who were randomly allocated into 3 groups: Group S received sufentanil 0.1 mcg/kg, Group F received fentanyl 1 mcg/kg and Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml. Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2). Adverse events, patient tolerance and physician satisfaction were analized.


Eligibility Criteria:
Inclusion Criteria:

* ASA grade I-II

Exclusion Criteria:

1. psychological disorders
2. SpO2\<90% in ambient air
3. hypersensitivity or allergy to anaesthetic drugs or benzodiazepine
4. severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of predicted value, requirement for oxygen therapy)
5. unstable haemodynamic status
6. habitual alcohol consumption
7. asthmatic patients
High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure

All the children with acute liver failure who are candidates for transplant but have constraints for transplant will be randomized either to receive standard medical therapy or high volume plasma exchange along with standard medical therapy with the aim to assess the effect of high volume plasma exchange on transplant free survival.


Eligibility Criteria:
Inclusion Criteria:

- Children ≥ 10kg with ALF with INR ≥ 4 or INR ≥ 3 with Hepatic Encephalopathy.

Exclusion Criteria:

1. Evidence of active infection (Age specific neutrophilic leucocytosis (ANC) and procalcitonin ≥ 2 and/or focus of active infection
2. Refusal of consent or assent (annexure 3)
3. Liver resections with liver failure
4. Patients with clinical suspicion of irreversible brain injury
5. Patients with acute kidney injury
Effectiveness of 0.01% Atropine Sulfate Solution in Controlling of Myopia Progression in Children

Increasing number of myopic children and significant complications of high myopia enhance the necessity of effective control strategy. Instillations of low-dose atropine have been shown to reduce myopia progression in Asian populations but its effect in non-Asian populations is still unclear. This open prospective study with historical control is designed to investigate if 0.01% atropine can reduce myopia progression in Russian children, taking into account a change of difference between manifest and cycloplegic refraction, as well as, myopia progression rate at the time of recruitment.

The study is designed to test the following hypotheses:

* 0.01% atropine one drop nightly is safe and with no significant side effects.
* nightly instillations of 0.01% atropine does not influence tear production.
* 0.01% atropine one drop nightly reduces the progression of childhood myopia in Russian children.
* nightly instillations of 0.01% atropine decreases the manifest refraction and, consequently, difference between manifest and cycloplegic refractions.
* effectiveness of 0.01% atropine depends on the age and myopia progression rate at the time the therapy was started.

Eligibility Criteria:
Inclusion Criteria:

* myopia progression rate of 0.5D or more per year;
* myopia with astigmatism of 1.0D or less;
* axial length and cycloplegic refraction data obtained 6 months before recruiting or earlier
* signed informed consent.

Exclusion Criteria:

* congenital myopia;
* onset of myopia at 6 years old or earlier;
* allergic reactions to any eye drops in anamnesis;
* concomitant eye disorders, including strabismus.
Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions

The objective of this study was the bioequivalence of a potential generic 250 mg clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to clarithromycin or any other macrolide antibiotic.
Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants

An oral dose in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986165


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
* Body weight of at least 50 kilograms (110 pounds); body mass index (BMI) between 18 to 32 kg/m2.
* No evidence of acute infection or other significant problem as determined from a review of a chest x-ray, medical history, and physical examination

Exclusion Criteria:

* History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
* Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
* Participant with greater than Grade 2 acne.
* Participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.
Japan Statin Treatment Against Recurrent Stroke (J-STARS)

Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset
* Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days
* Able to visit outpatient department
* Informed consent on the form.

Exclusion Criteria:

* Ischemic stroke of other determined cause according to the TOAST classification
* Ischemic heart disease and necessary to use statin
* Hemorrhagic disorders
* Platelet count \<=100,000/ul within 3 months prior to study start
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\>= 100IU/L within 3 months prior to study start
* Serum creatinine \>=2.0mg/dl within 3 months prior to study start
* A scheduled operation
* The presence of malignant disorder