cyrilzakka/clinical-trials huggingface dataset:
Survey of Procedures and Resources for Initiating Treatment of HIV in Africa-South Africa

In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization called for rapid or same-day initiation of antiretroviral treatment (ART) for eligible patients testing positive for HIV. The South African National Department of Health adopted this recommendation in October 2017. Neither organization provided detailed guidance, however, on how to implement the recommendation.

In sub-Saharan Africa, where most HIV patients are located, studies continue to document high losses of treatment-eligible patients from care before they receive their first dose of antiretroviral medications (ARVs). Among facility-level reasons for these losses are treatment initiation protocols that require multiple clinic visits and long waiting times before a patient who tests positive for HIV is dispensed an initial supply of medications. There is very little published evidence on the practical details of the process and the extent to which it varies by facility, setting, or country. Without a robust baseline evidence base, it is challenging to identify opportunities for making improvements. The SPRINT (Survey of Procedures and Resources for Initiating Treatment of HIV in Africa) study will begin to develop this evidence base. SPRINT will combine a facility-level description of the standard of care with a retrospective record review of patients who recently initiated ART at the study sites. Data will be collected from 12 clinics across 3 provinces in South Africa (KwaZuluNatal Province, Gauteng Province, and Limpopo Province). The survey will elicit detailed information about current procedures through structured interviews with clinic staff. The record review for a retrospective cohort of patients eligible for ART will estimate actual numbers of clinic visits, services provided, and duration of the steps for treatment initiation from start to finish. SPRINT is expected to identify differences in approaches to treatment initiation and potential opportunities for improvement.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* HIV-positive

Exclusion Criteria:

* Pregnant
Inhaled Furosemide for Transient Tachypnea of Newborn

This is a randomized double blind clinical trial in which newborns with suspected Transient tachypnea of the newborn (TTN) will receive either furosemide or normal saline by nebulizer every 6 hours for 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* Neonates with 34+0-39+0 gestational age
* on the first day of life
* with the clinical diagnosis of Transient Tachypnoea
* need for CPAP \>6 hours to obtain the oxygen saturation \>92%

Exclusion Criteria:

* Systemic infection
* Intubation and mechanical ventilation before Inclusion in the trail
* Malformation and any other disease with disturb of respiratory system
Effect of a Physical Activity and Nutrition Education Intervention on Obesity Prevalence in Schoolchildren

Childhood obesity is a major global public health problem. Several strategies have been implemented to reduce the high prevalence, the most cost-effective of which were those that focused on the school environment. Although there is vast research that focus on interventions that address obesity through interventions to improve schoolchildren diets and physical activity level in many countries of the Latin American region, there is lack of evidence of the effectiveness of multicomponent interventions that aim to reduce the prevalence of obesity among schoolchildren in the Paraguayan context.

Nutritional education and physical activity. Interventions that promote healthy eating and lifelong physical activity in schoolchildren through school programs aim to equip children with knowledge, attitudes and behavioral skills to help them establish and maintain a healthy lifestyle.

Poor diet quality has been identified as one of the main factors contributing to the obesity epidemic. Research has shown that a diet that includes the recommended servings of fruits and vegetables (VF) reduces morbidity and mortality from non-communicable diseases (NCDs) and has also been linked to a lower risk of adiposity. Therefore, the need to promote the consumption of VF from an early age through effective programs.

The interventions in Physical Activity have shown effective results in the decrease of BMI, the thickness of the skin folds and the percentage of fat mass in school-age children. Taking into account that currently the schoolchildren have decreased the amount of time dedicated to games, sports or other types of movement and the hours of sedentary life and in front of the screens (computers, tablets, television, mobile phones, others) have increased.

It is necessary to promote the performance of physical activity in the school environment through permanent programs that contribute to improving the physical condition of children, complying with daily recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Being public or private schools of the 22 districts of Caaguazú Department
* Having a minimum of 100 students in each of the three grades of second level of basic school education during 2017 school year
* Having physical education teachers

Exclusion Criteria:

* Schools that had only one school shift
* Schools that expressed their refusal to participate
Balance Training After Stroke With REWIRE

The study will include 20 patients after stroke, randomly assigned to the experimental and control group (10 each). In both groups, the program with last for five days; walking and balance will be assessed before and after the program. Both groups will receive regular neurophysiotherapy; in addition, the experimental group will exercise each day by playing REWIRE games, while the control group will perform standing balance exercises.

Detailed inclusion and exclusion criteria are specified in the appropriate section. Both groups will perform the additional exercises for 15 minutes daily. In addition to the outcome measurement, informal feedback will be obtained from the patients and the therapists on the feasibility of the REWIRE system.

Eligibility Criteria:
Inclusion Criteria:

* first stroke
* first admission to inpatient rehabilitation

Exclusion Criteria:

* less than 25 points scored on the Mini-Mental State Examination
* inability to walk independently
Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With CAR-T Cell Therapy

Despite impressive outcomes in selected patients, significant heterogeneity in clinical response to CAR-T cell therapy remains. The gut microbiome (GM) has recently emerged as one of the key modifiable factors of prognosis and response to treatment in cancer patients, with high-diversity profiles rich in health-associated taxa while poor in pathobionts generally associated with better response and longer survival. Currently, it is unknown if GM also modulates anti-tumor responses to CAR-T cells and related toxicities in lymphomas.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Patients affected by histologically confirmed DLBCL.
3. Patients amenable for CAR-T cell therapy as for clinical approved indication (commercial products).
4. Patients must provide written informed consent.

Exclusion Criteria:

1. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
2. Concurrent second malignancy.
Rehabilitation Manometry Study

Oropharyngeal dysphagia, or difficulty swallowing, is a devastating condition that affects physiological and psychosocial functioning in 1 in 25 adults. Many dysphagia treatments exist, but our ability to adequately measure treatment outcomes is limited. Pharyngeal high-resolution manometry (pHRM) directly measures swallowing pressures, providing an objective measurement of physiology that characterizes the basic mechanisms of swallowing. pHRM is well-poised to measure outcomes of dysphagia treatments due to its direct, objective, and reproducible measures of swallowing function.

This proposed project will address a central hypotheses that objective swallowing measures (including (pHRM) will reveal treatment-mediated swallowing changes, will align with patient-reported outcome measures, and will be able to predict who will benefit from treatment. The investigators will follow a cohort of participants with oropharyngeal dysphagia as they undergo either pharyngeal strengthening therapy or relief of upper esophageal sphincter outlet obstruction at three time points: baseline, mid-treatment (4-6 weeks) and post-treatment (10-12 weeks). The investigators will compare participants to healthy controls using pHRM, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Pathological Group

  * Must have dysphagia as diagnosed by a licensed and certified otolaryngologist, gastroenterologist, or speech-language pathologist AND must have a dysphagia treatment plan that includes one of the following primary goals:

    * Therapy to strengthen oropharyngeal musculature
    * Medical or surgical management to relieve an obstruction at the upper esophageal sphincter
  * Must agree to comply with swallowing assessment, including interview and manometry
  * Must sign the Informed Consent form approved by the Health Sciences Institutional Review Board of the University of Wisconsin
* Normal Group

  * Having no swallowing disorders
  * Must agree to comply with swallowing assessment, including interview and manometry
  * Must sign the Informed Consent form approved by the Health Sciences Institutional Review Board of the University of Wisconsin.\\

Exclusion Criteria:

* Pathological Group

  * Therapeutic management plan already initiated prior to recruitment
  * Therapy goals including only improvement of swallowing coordination
  * Developmental disability, dementia, cognitive dysfunction, or difficulty comprehending instructions
  * Positive history of allergic response to topical anesthetic
  * Allergy to food relevant to study participation (e.g. lactose intolerance)
* Normal Group

  * Known swallowing disorder
  * Developmental disability, dementia, cognitive dysfunction, or difficulty comprehending instructions
  * Positive history of allergic response to topical anesthetic
  * Allergy to food relevant to study participation (e.g. lactose intolerance)
Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients

This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation-based individualized stimulation compared to conventional stimulation and sham stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral stroke patients
* Chronic patients over 6 months after onset
* Patients with motor evoked potential of the first dorsal interosseous muscle
* Patients with the movement of fingers

Exclusion Criteria:

* History of psychiatric disease
* Significant other neurological diseases except for stroke
* Difficult to perform this experiment
* Patients who are deemed difficult to participate in this research by the investigator
* Patients with metal implants and medical devices
* History of epilepsy
* Pregnancy
* Skin defect at the site of electrode attachment
Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine

This randomized controlled trial, compared postoperative pain score in patient undergoing cesarean delivery between bupivacaine peritoneal and subcutaneous infiltration and diclofenac intramuscular injection

Postoperative cesarean delivery was painful that can effect daily activity, resulted in poor quality of life and required morphine injection to relief pain which had both maternal and breastfeeding infancy side effect. So this study compare efficacy of diclofenac and bupivacaine by measured the pain score and requirement of morphine injection.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergo elective or urgency cesarean delivery at Rajavithi Hospital in 2016-2017

  * Urgency conditions: CPD, fail induction of labor, antepartum hemorrhage without hypovolemic shock, dystocia, previous cesarean section and active labor, malpresentation in labor, macrosomic presentation in labor
* Pregnant women more than 20 years of age
* Gestational age more than 37 week
* Cesarean section under regional or general anesthesia
* Ability to communicating, writing and reading Thai language

Exclusion Criteria:

* Inability to communicating or writing or reading Thai language
* Contraindicated to bupivacaine or diclofenac or morphine
* Pregnant women with emergency conditions
* Have one or more complication of pregnancy
* Intraoperative arrhythmia
* Pregnant women less than 20 years of age
* Regional anesthesia with morphine
Gallstones and Risk of Inflammatory Bowel Disease

The purpose of this study was to evaluate the association between gallstone disease and the risk of inflammatory bowel disease.

Crohn's disease and ulcerative colitis , collectively known as inflammatory bowel diseases , have increased substantially over the past few decades affecting nearly 6.8 million individuals worldwide. The etiology of IBD remains obscure, possibly involving a complex interaction between the genetic, environmental or microbial factors and the immune responses. Gallstone disease is one of the most common and costly gastroenterological disorders, with a prevalence of 10-20% in Europe and America. Considering that gallstones and IBD also share specific risk factors, such as obesity, inappropriate diet and metabolic hormone levels, and have the pathophysiologic linkage, such as changes in gut microbiota composition and bile acid profile, the investigators propose that the occurrence of gallstones may predict the subsequence risk of IBD. However, investigations concerning the association is lacking.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 90 years old
* IBD established by standard criteria, either Crohn's disease or ulcerative colitis

Exclusion Criteria:

* Pregnant or nursing woman;
* Prior abdominal surgery related to IBD, such as subtotal or total colectomy;
* HIV infection or any congenital immunodeficiency at the time of inclusion;
* Post organ transplant patients;
* Patients suffering from cancer currently or in the past;
* Patients suffering from significant cardiovascular disease;
* Patients suffering from significant respiratory diseases;
* Patients suffering from any other chronic severe diseases.
Safety, Tolerability, and Pharmacokinetics of XXB750 in Healthy Participants

This study was a randomized, participant and investigator-blinded, placebo-controlled, single-ascending dose study, consisting of 9 sequential dose cohorts (1 mg, 3 mg, 10 mg, 30 mg, 60 mg, 120 mg, 240 mg, 450 mg and 600 mg) and a Japanese ethnic sensitivity cohort (240 mg dose)

Eligible healthy participants with normal blood pressure (SBP: 110-139 mmHg; DBP: 70-89 mmHg) were randomized into dose cohorts 1 - 240 mg. Eligible healthy participants with elevated blood pressure (SBP: 139 - 159 mmHg; DBP: 75 - 95 mmHg) were randomized into dose cohorts 450 and 600 mg. Each participant received a subcutaneous single dose of either XXB750 or placebo. In total, the duration of the study was 151 days, including the full Screening period of up to 28 days, safety, pharmacokinetics and pharmacodynamics assessments over a period of 91 days, and a 30-day safety follow up call after the end of study visit.

Sentinel dosing will be applied in this FIH study at each new dose level to ensure participant's safety and minimize the number of participants that may experience symptomatic hypotension, especially for sustained periods of time attributing to the long acting nature of XXB750 and the sustained pharmacological effects on BP at higher doses. The 10-day safety monitoring for the sentinel cohort is considered sufficient based on the predicted mean Tmax (4.5 days) in humans.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants age 18 to 50 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
* Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 32 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
* For ethnic Japanese cohort: participants must be defined as being of first, second or third generation ethnic origin, with each set of parents qualifying as Japanese under the prior generation.

Exclusion Criteria:

* Any surgical or medical condition which significantly altered the distribution, metabolism, or excretion of drugs, or which jeopardized the participant's participation in the study.
* Known history or current clinically significant arrhythmias.
* Women of child-bearing potential were excluded from this study.
Oxygen Insufflation in Microlaryngoscopies

The purpose of this project is to evaluate the efficacy of oxygen insufflation (continuous oxygen flow) to keep oxygen saturation (oxygen levels measured with a pulse oximeter \[finger device used in medicine\]) at 90% or greater in adult patients undergoing microlaryngoscopy surgery.

High flow, low pressure oxygen will be supplied in microlaryngoscopy airway surgery. These procedures are usually performed with jet ventilation (UAB) or intermittent apnea (surgery centers). Jet ventilation provides oxygenation with limited ventilation but come with high risks, such as barotrauma, pneumothorax, mucosa drying, and even death in the most severe cases. Intermittent apnea is a nuisance for the surgeon in that surgical time is often interrupted with having to place the endotracheal tube whenever the patient's oxygen saturation levels fall. The solution is oxygen insufflation, which will give extended oxygenation times for the surgeon to operate without the inherent risks associated with jet ventilation. During the procedure, oxygen tubing will be connected to the surgeon's laryngoscope instead of the jet ventilation tubing. Oxygen flows of 15 L/min will be administered through the laryngoscope to the posterior oropharynx. Endotracheal tube will be placed if oxygenation deemed insufficient due to oxygen saturations of \<90%. Endotracheal tube will be intermittently placed to check and correct carbon dioxide levels.

Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing microlaryngoscopy surgery without a tracheostomy

Exclusion Criteria:

* patients who have a tracheostomy
Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients

This is a study designed to identify a dose of NIM811 that has a good safety profile, is well tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral load reduction compared to SOC alone. This information will be used to support doses selected for future studies.


Eligibility Criteria:
Inclusion criteria:

Patients eligible for inclusion in this study have to fulfill all of the following criteria:

* chronic hepatitis C genotype-1
* HCV-RNA should be ≥ 4 x 105 IU/mL at screening
* Recipient of prior long acting interferon and ribavirin treatment for at least 12 weeks, with documented negative serum HCV RNA on treatment, who subsequently becomes serum HCV RNA positive after stopping treatment ("relapser"). Patients must have been off all treatment for at least 3 months prior to start of study (Visit

Exclusion criteria:

* Use of any HCV treatment ≤ 3months prior to study start
* Prior receipt of any investigational anti-HCV therapy which is not IFN or RBV
* Women of child-bearing potential unless they are post-menopausal or use predefined acceptable methods of contraception
* Pregnant or breastfeeding women
* Evidence of cirrhosis, hepatic decompensation, other than HCV liver disease, HBV or HIV infection
* Specified abnormalities in lab values of amongst others hemoglobin, WBC, ANC, platelets
* History of treatment for depression
* Steroid/immunosuppression drug use 3 months prior to study start Other protocol-defined inclusion/exclusion criteria may apply
Drug Interactions Between Paracetamol and Setrons in Pain Management

The aim of this study is to demonstrate that the association paracetamol / ondansetron is not as effective as the association paracetamol / droperidol in the treatment of pain in children following tonsillectomy. The secondary objectives are to compare opioid consumption (morphine / codeine) and the cumulated incidence of nausea and vomiting between the two groups of patients in the first 24 hours after

Tonsillectomy is a common operation performed in children that is associated with marked pain and a high incidence of nausea and vomiting. Therefore, national and international guidelines have recommended the use of a setron as a prevention to nausea and vomiting and also the systematic administration of paracetamol to help in the control of postoperative pain. However, a potential interaction between setrons and paracetamol has been reported in different animal studies and in human volunteers although its existence has never been found in the clinic. Indeed, several hypotheses are proposed to explain the mechanism of action of paracetamol in the treatment of pain. However, a recent one involves the endocannabinoid system and spinal serotonin receptors. Serotonin receptors are also involved in the mechanism of action of antiemetics such as setrons. Indeed, these drugs are serotonin antagonists. Therefore, the investigators hypothesized that the concomitant administration of paracetamol and ondansetron leads to an interaction that will decrease the analgesic effect of paracetamol.

Patients aged 2-7 years old and scheduled for a tonsillectomy will be recruited. They will all receive intraoperatively intravenous paracetamol together with either ondansetron or droperidol. Pain scores using the CHEOPS scale will be recorded for 24 hours. Furthermore, patients will receive i.v. morphine during the operation and in the recovery room if necessary and a non-steroidal anti-inflammatory drug for postoperative pain; on the ward, oral codeine will be administered when needed. Pain scores will be recorded regularly for up to 24 hours together with opioid consumption and the incidence of nausea and vomiting in the same period. Any adverse event will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* tonsillectomy in a child 2-7 years old who is hospitalized for at least 24 hours ;
* informed consent from one parent at least

Exclusion Criteria:

* hospital stay of less than 24 hours ;
* patient already on pain medication ;
* allergic patient with a contra-indication to one of the study drugs.
Antacid Interaction Study

This study will assess the potential effects of calcium carbonate and aluminum/magnesium hydroxide-containing antacids on the pharmacokinetics (PK) and pharmacodynamics (PD) of lesinurad in healthy, adult male subjects.

In this study, lesinurad and antacid will be administered in the fed state, antacid doses will be attenuated to reflect the more commonly used doses, baseline PD assessments will be performed both in presence and absence of antacid treatment, and the sequence of treatments (lesinurad +/- antacid) will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2.
* Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment

Exclusion Criteria:

* Subject has a history or suspicion of kidney stones.
* Subject has undergone major surgery within 3 months prior to Screening.
* Subject donated blood or experienced significant blood loss (\>450 mL) within 12 weeks prior to Screening or gave a plasma donation within 4 weeks prior to Screening.
* Subject has inadequate venous access or unsuitable veins for repeated venipuncture.