cyrilzakka/clinical-trials huggingface dataset:
Impact of New Tools of Simulation-enhanced Peer Learning on Neonatal and Maternal Mortality

In the vast majority of developing nations, frontline birth attendants are often the only care providers responsible for newborn care including newborn resuscitation, thermal care, feeding and administration of medications. These midwives need knowledge and skills to provide all these newborn clinical care needs. However, frontline birth attendants in these circumstances are seldom exposed to the training and decision support tools that would empower them to holistically assess, decide and manage newborn babies in their care. Current training opportunities are fragmented and need to be administered as a comprehensive package.

A combination approach to training, skills retention, and the use of decision support tools such as Protecting Infants Remotely by SMS (PRISMS) and Augmented Infant Resuscitator (AIR) may provide a comprehensive package for the acquisition and retention of knowledge and skills on newborn care and empower birth attendants to provide effective, timely interventions.

The investigators will implement the Sim for Life Impart, Retain, Empower and Monitor (IREM) module at the University of Jos teaching Hospital and 4 high volume health facilities in Tanzania in addition to the Uganda sites. We propose to implement the program with all its components for each of the partner institutions.

The Sim for Life IREM module combines four strategies: Impart skills using Helping Babies Survive (HBS)/Helping Mothers Survive (HMS) courses, Retain skills (Simulation), Empower birth attendants (PRISMS and AIR) and Monitor progress objectively. The simulation sessions for health facilities will be conducted using the peer to peer learning methodology which equips participants with the skills to facilitate simulation scenarios in their health facilities. The scenarios will be provided by the Sim for life team. The topics for the scenarios will be based on common maternal and newborn illnesses like post-partum hemorrhage, pre-eclampsia, birth asphyxia, neonatal sepsis and prematurity.

All health facilities in this study will require smart phones for the PRISMS application, resuscitation practice tables, source of electricity to charge a phone, practice manikins / associated practice supplies and peer learning cards.

Eligibility Criteria:
Inclusion Criteria:

* Newborns babies
* Mothers delivering at participating health facilities
* Health workers providing maternal and newborn care services at participating health facilities

Exclusion Criteria:

* Health care workers not providing maternal and newborn care services
* Male patients
* Non pregnant female patients seeking care at participating health facilities
Detection and Metabolic Characterization in DOPA PET/CT of Brain Metastases

About 20 to 30% of patients treated for cancer will have brain metastases. These brain metastases are found more frequently in patients with lung cancer, breast cancer or melanoma. The prognosis of these patients is unfavorable but prolonged survival can be obtained with the local and systemic treatments currently available.

Brain MRI is the gold standard for evaluating brain metastases but has limitations in therapeutic evaluation, partially offset by PET imaging of amino acid metabolism.

Our work aims to compare the performance of PET-DOPA with standard MRI for the detection of brain metastases (≥ 5mm) in lung cancer, breast cancer and melanoma; and to characterize these lesions using dynamic acquisitions obtained with a digital PET camera with high spatial resolution. Having better knowledge of the metabolic characteristics of newly discovered brain metastases, the objective of subsequent studies will be to better assess the per- or post-therapeutic efficacy of radiotherapy and the various systemic therapies available (chemotherapy, targeted therapy, immunotherapy).


Eligibility Criteria:
Inclusion Criteria:

* Primitive cancer (brest cancer, lung cancer, melanoma) proven histologically
* Presence of brain metastasis visualized on MRI, of which at least one measures 5 mm
* Age \> 18 years
* Patient has valid health insurance
* Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations

Exclusion Criteria:

* History of irradiation cerebral
* History of brain surgery for brain metastasis or glial tumor
* Systemic therapy (chemotherapy, targeted therapy, immunotherapy) modified in the 6 weeks preceding the realization of DOPA PET/CT,
* New anti-tumor treatment started between the discovery of brain metastases and the performance of DOPA PET/CT
* Other concomitant cancer, or history of cancer in the 5 years preceding the performance of DOPA PET/CT
* Pregnant or lactating females
* Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.

Disorder precluding understanding of trial information or informed consent.
Preoperative Tamsulosin to Prevent Postoperative Urinary Retention After Surgery For Pelvic Floor Disorders

Our hypothesis is that patients receiving preoperative Tamsulosin will have decrease rates of postoperative urinary retention (POUR) after surgery in females for pelvic floor disorders.

This study is a prospective randomized control trial. Patients undergoing pelvic surgery will randomized into two groups. The study group will receive one oral dose of .4mg of Tamsulosin preoperatively.The control group will receive one placebo pill preoperatively. Success or failure of initial voiding trial in postoperative period will be measured. Patients who fail the voiding trial will be discharged home with Foley catheter as is standard protocol at our institution.

Eligibility Criteria:
Inclusion Criteria:

i. Patient undergoing surgery for prolapse with or without mid-urethral sling procedure.

ii. Specific surgical procedures include all vaginal, laparoscopic and robotic reconstructive or obliterative surgeries including the use of mid-urethral slings

Exclusion Criteria:

i. Diagnosis of urinary retention preoperatively (post void residual \>150ml)

ii. Malignancy

iii. History of neurological disease

iv. History of spinal cord injuries

v. Allergy to Tamsulosin

vi. Perioperative complications requiring prolonged postoperative bladder drainage

vii. Incontinence procedures other than mid-urethral slings
7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients

Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis (PEP) is estimated to be 10% to 15% in high-risk patients. Current guidelines recommend using pancreatic duct stent (PDS) for PEP prevention in high-risk patients, but it is not clear whether stent length will affect the effect of PEP prevention. The longer PDS will remain in the pancreatic duct for a longer period of time, thereby ensuring prolonged decompression with subsequent lowering of the risk for PEP. Findings from two retrospective studies showed that longer PDS was more effective in reducing the risk of post-ERCP hyperamylasemia and the frequency of PEP compared with the shorter PDS. We conducted this trial to test whether 7cm PDS was superior to 5cm PDS in PEP prevention in high-risk patients.


Eligibility Criteria:
Inclusion Criteria:

1. Un-intentional pancreatic duct cannulation:

   * 2 or more times;
   * 1 time with more than 10 minutes cannulation.
2. Double-wire technique;
3. High-risk patients:

met at least 1 of the major criteria

* Clinical suspicion of sphincter of Oddi dysfunction;
* Pancreatic sphincterotomy
* Delayed precut sphincterotomy
* ≥ 8 cannulation attempts
* Pneumatic dilatation of an intact biliary sphincter
* Ampullectomy

or met at least 2 or more of the minor criteria

* Age \< 50;
* Female;
* Normal TBIL;
* ≥ 3 injections of contrast into the pancreatic duct with ≥ 1 injection to the tail of the pancreas;

Exclusion Criteria:

* Therapeutic PDS;
* Acute pancreatitis within 3 days;
* With a history of pancreatic surgery or biliary-enteric anastomosis;
* Pregnant or breastfeeding women;
* unwilling or inability to provide consent.
A Bilateral Interconnected DIEP Flap Based on One Vessel Pedicle for Breast Reconstruction

Bilateral DIEP flap needs two groups of vessel pedicles. We suppose that the bilateral DIEP flap may survive on one vessel pedicle by means of interconnection of bilateral DIEA. This study is aimed to build a interconnected vessel system of bilateral DIEP flap based on one vessel pedicle and observe its survival in breast reconstruction.

The DIEP flap have become the most common and primary choice in autogenous tissue breast reconstruction nowadays. In cases with inadequate abdominal soft-tissue volume or abdominal midline scar, the bilateral DIEP flap is needed.However, it need two groups of recipient vessels. So it is unavailable in cases short of two groups of recipient vessels after radiotherapy. This study is aimed to solve the problems by interconnecting one of the branches of DIEA each side. The MDCT will be used to predict the branches and perforators of DIEA both sides. According to the branches of DIEAs, one branch will be anastomosed with that on contralateral side with only one vessel pedicle preserved on one side. We believe that the whole flap can be completely nourished with only one vessel pedicle by means of vessel interconnection.

Eligibility Criteria:
Inclusion Criteria:

* Breast lost after mastectomy
* With good general condition
* No pregnancy demand
* With additional soft tissue needed for reconstruction

Exclusion Criteria:

* With bad general condition
* DIEA damaged by previous surgery
* Limited abdominal tissue
Brain and Peripheral Electrical Stimulation in Chronic Low Back Pain: a Factorial Design

The purpose of this study is to evaluate the efficacy of brain and peripheral electrical stimulation on chronic non-specific low back pain patients.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged \> 18 years and \<65 years
* Complaining of back pain for more than three months
* Presence of a chronic pain measurable with the number rating scale (NRS 0-10) not less than 4 during a 1 week daily NRS monitoring
* Seeking care for low back pain

Exclusion Criteria:

* Previous surgery on the spine, spondylolisthesis
* Previous treatment with TENS \<6 months
* Previous treatment with tDCS
* Disc herniation with nerve compression
* Neurological, psychiatric and rheumatologic diseases
* Impaired sensibility
* Use of pacemakers or other implanted devices
* Pregnancy
A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults

The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young adults, and the comparative immunogenicity among the three groups will be measured at 1 mon post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore, the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged between 16 and 25 as established by medical history and clinical examination
* Written informed consent will be obtained from each subject before the serum screening of HBV markers
* Seronegative for HBsAg, anti-HBs antibody, anti-HBc antibody
* Have never been immunized with HBV vaccine before

Exclusion Criteria:

* Subject has a medical history of allergic to any ingredient of vaccine
* Family history of seizures or progressive neurological disease
* Autoimmune disease or immunodeficiency
* Women with pregnant
* Bleeding disorder diagnosed by a doctor
* Chronic diseases: hepatitis, tumor, tuberculosis,et.al
* Any prior administration of immunoglobulins or blood products in the last 3 mon before recruitment
* Subjects had a medical history of serious adverse reactions to vaccines
Reducing AIR Pollution Exposure to Lower Blood PRESSURE Among New York City Public Housing Residents

Fine particulate matter \<2.5 µm (PM2.5) air pollution is the fifth leading risk factor for global mortality, with the largest portion of deaths due to cardiovascular disease (CVD). While several mechanisms are responsible, PM2.5-induced elevations in blood pressure (BP) may be relevant. Indoor portable air cleaners (PACs) are a novel approach to reduce exposure to PM2.5 and potentially lower blood pressure. The current study is being conducted to provide evidence that PACs reduce PM2.5 exposure and lower systolic blood pressure (SBP) in key patient populations.


Eligibility Criteria:
Inclusion Criteria:

* self-reported nonsmokers living in a nonsmoking household.
* adults living with hypertension (HTN) from NYC public housing.

Exclusion Criteria:

* History of major known arrhythmias (e.g. atrial flutter or fibrillation, ventricular tachycardia).
* Screening systolic BP ≥160 mm Hg or diastolic BP ≥100 mm Hg (i.e. severe hypertension by the 2017 ACC/AHA BP guideline).
* A change in drug regimen in the prior 2 weeks or a planned change in drug regimen during the first 30 days for those taking antihypertensive medication.
* Current smoking or living with an active smoker who smokes indoors
* Planned travel out of NYC for ≥2 weeks in next 6 months
* Incarcerated
* Pregnant
* Unable/unwilling to consent
* Established cardiovascular disease
* End-stage renal disease (chronic kidney disease stage IV or on dialysis)
* Barrier to technology use (e.g., visual or hearing impairment)
* Lung disease requiring oxygen
* Cancer receiving treatment
A Study to Compare Eutropin Formulations in Healthy Volunteers for Bioavailability, Safety, and Tolerability

A randomized, Open Label, Single Subcutaneous Dose, 2x2 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability among Different Eutropin Formulations in Healthy Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 19 to 40years at screening.
* Voluntarily decide to participate and provide written informed consent.
* Able to receive the investigational product (IP) and pre-treatment drugs.
* Wiliing and able to comply with study requirements, including follow-up visits and blood/urine sampling.

Exclusion Criteria:

* History of conditions contraindicating somatropin or pre-treatment drugs.
* Clinically significant medical history.
* Participation in another clinical trial and receipt of an investigational product within 80 days prior to the first IP administration.
Synchronizing Blastocyst in Frozen Embryo Transfer

The aim of the present study is to determine if implantation rate could be increased in women undergoing frozen embryo transfer cycles in case of adjusting their embryo development at hatching stage.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who will agree to participate and assign an informed consent form
2. Only blastocyst transfer FET cycles
3. Patients undergoing FET after their 1st IVF or ICSI cycle with no pregnancy at the fresh transfer
4. Freeze-all cycles due to OHSS
5. Freeze-all cycles due to poor endometrium
6. Age 19-33 at the time of randomization.
7. Their frozen blastocysts are 3 or less grade of expansion.
8. Female with a ≥12 AFCs
9. Endometrial thickness ≥ 8mm at the time of ovulation
10. Women with their male partners will give only fresh semen
11. Women who have no uterine abnormality by ultrasound
12. BMI ≤ 31

Exclusion Criteria:

1. Cycles undergoing preimplantation genetic diagnosis.
2. Women who have previous two cycles of implantation failure at fresh transfer
3. Women who have previous two FET failed cycles
4. Any uterine pathology (myomas, adenomyosis, endocrinopathies, thrombophilia, chronic pathologies, acquired or congenital uterine abnormalities)
5. Patients with severe endometriosis
6. Presence of uni- or bilateral hydrosalpinx
7. Recurrent pregnancy loss.
8. Any medical condition that affect fertility.
Garcinia Mangostana L Rind and Solanum Lycopersicum Fructus Trial to Prevent Exercise-induced Oxidative Stress

Treatments are an administration of a mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) and placebo control.

Double-blinded Randomized Clinical Trial

The population of study will involve sedentary men, the student in Universitas Negeri Semarang aged 18-25 years old, targetted populations are 30 subjects consist of 15 treatment group and the rest 15 placebo-control group. Voluntary sampling will be conducted. Information to the candidates delivered directly, leaflets, and social media broadcasting.

Two arm treatment to be given is an administration of a mixture extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) and placebo control.

The administration of extract treatment and placebo will be given for four weeks.

The primary effect that will be observed is the changes in malondialdehyde (MDA) and high-sensitivity Cardiac-Troponin I (hs-cTnI) level after an ergo-cycle exercise test.

The secondary effect of the treatment that will be observed is the baseline and post-treatment parameters of MDA levels.

Eligibility Criteria:
Inclusion Criteria:

* sedentary lifestyle
* apparently healthy person
* willing to use the smart-phone application for diet and physical activity monitoring

Exclusion Criteria:

* pathological appearance in ECG
Sensorimotor Training for Adults With Diabetic Peripheral Neuropathy

Adults with diabetic peripheral neuropathy tend to fall more frequently than healthy population as a consequence of multiple sensorimotor and cognitive damages. In this protocol study, a randomized controlled trial is proposed using a sensorimotor intervention based on Feldenkrais method to improve somatosensory aspects and, therefore, postural control of participants.

Among all the systems suffering damage due to hyperglucemia toxicity in diabetes, somatosensory system, composed by proprioception and skin sensory receptors has a key role since it is in charge of the faster body reaction when a postural control response is needed. Despite of it, few studies have focused on this issue. This randomized controlled trial proposed a safe and easy training adapted to adults and old people with diabetic peripheral neuropathy. Pressure, touch, proprioception and graphesthesia sensibility were measured, as well as functionality in daily basis, quality of life and fear of falling.

Eligibility Criteria:
Inclusion Criteria: having peripheral neuropathy and history of falls or risk factors for it. Current ulcer -

Exclusion Criteria: amputation and cognitive or mental issues

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Clinical Trial to Evaluate the Efficacy of Metadoxine as a Therapy for Patients With Non-alcoholic Steatohepatitis

The aim of this study is to evaluate the efficacy of metadoxine as a therapy for patients with biopsy-proven non-alcoholic steatohepatitis.

Type and design of the study: A randomized, placebo-controlled, double-blind, clinical trial to evaluate the efficacy of metadoxine as a therapy in patients with biopsy-proven nonalcoholic steatohepatitis.

Population: Non-diabetic patients with nonalcoholic steatohepatitis diagnosed by liver biopsy through the "nonalcoholic fatty liver disease activity score" (NAS)\> 3.

Sample size: Considering a difference of at least 30% between groups, a confidence level of 95% (two-sided, significance 0.05), a statistical power of 80%, and an additional 20% for possible losses, we need 54 patients per group.

Variables:

Independent: Treatment group (metadoxine / placebo).

Dependents:

* "Nonalcoholic fatty liver disease activity score" (NAS):0 a 8
* Degree of liver steatosis: 0 a 3
* Degree of lobular inflammation: 0 a 3
* Degree of ballooning: 0 a 2
* Degree of fibrosis: 0 a 2
* Weight: Kg
* Body mass index: Kg/m2
* Waist circumference: cm
* Serum alanine aminotransferase: U/L
* Serum aspartate aminotransferase: U/L

Methods:

Those meeting the selection criteria will be invited to participate in this study, those who agree to participate must sign the consent form and will be randomized to placebo or metadoxine group. The duration of the therapy will be 6 months and after this period a second liver biopsy will be performed to assessed the improvement on liver histology.

Eligibility Criteria:
Inclusion Criteria:

* Non-diabetic patients,
* Overweight or with obesity degrees I, II or III according to WHO criteria (BMI ≥ 25),
* With evidence of liver steatosis in the ultrasonography,
* With biopsy-proven nonalcoholic steatohepatitis, with ≥ 3 in the NAS score (at least 1 point for liver steatosis, at least 1 point for lobular inflammation, and at least 1 point for ballooning),
* With or without fibrosis in the liver biopsy, but if it is present must be ≤ 2 on a scale of 4, where 4 is equivalent to cirrhosis.

Exclusion Criteria:

* Cirrhosis,
* Diabetes,
* Heavy alcohol intake ( ≥ 20 g / day), ≥ 8 points in the "Alcohol Use Disorders Identification Test" (AUDIT),
* Acute or chronic hepatitis C,
* Acute or chronic hepatitis B,
* Immunodeficiency acquired syndrome
* Pregnant women,
* In the last year, history of herbal consumption, total parenteral nutrition, amiodarone, methotrexate, hormonal contraceptives, steroids, tamoxifen, valproic acid or any other drug associated with the development of liver steatosis.
* Uncontrolled hypothyroidism or hyperthyroidism,
* Any uncontrolled chronic disease.
Articaine and Bupivacaine in Impacted Tooth Surgery

Articaine is a common local anesthetic used in oral surgery and belongs to the amide group of it has fast onset with little side effects. Bupivacaine is preferred in prolonged surgical procedures with its long duration of action and residual analgesic effect.

The aim of this study was to evaluate the anesthetic, analgesic, hemodynamic effects of 4% articaine and 0.5% bupivacaine in extraction of impacted mandibular third molar teeth in intraoperative and postoperative periods. Hemodynamic parameters, onset of anesthetic action, total amount, intraoperative comfort, intraoperative bleeding, duration of postoperative anesthesia and analgesia, rescue analgesic use, maximum incisal opening and postoperative pain at 6th, 12th, 24th, 48th and 72th hours and 7th day using a visual analogue scale be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years of age with bilaterally symmetric, impacted or partially impacted mandibular third molar and patients classified in American Society of Anesthesiologists (ASA) 1 group.

Exclusion Criteria:

* Patients with the presence of any systemic diseases, patients allergic to articaine and bupivacaine or any other NSAIDs and patients with analgesic or anti-inflammatory drugs usage in 15 days before to the surgery.