bioihbjkbjnl/mcl2 huggingface dataset:
Repetitive Transcranial Magnetic Stimulation in Postpartum Depression
Condition: Depression, Postpartum
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Several factors characterize repetitive transcranial magnetic stimulation (rTMS) as a
      strategic aid in the treatment of postpartum depression.

      However, up to current days there have been no studies evaluating the effects of rTMS on
      neurocognitive and social performance of women suffering from the disorder.

      The present study evaluates the impacts of rTMS in clinical, cognitive and social
      performance.
    

Detailed description: 
      Transcranial magnetic stimulation is a noninvasive technique that can influence specific
      areas of the brain and has very few side effects.

      The treatment with transcranial magnetic stimulation requires attendance to hospital daily
      sessions for 4 consecutive weeks. Each session lasts up to 30 minutes.

      Side effects include scalp discomfort and mild headache. No anesthesia is required.

      Stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat
      depression symptoms with positive results.

      The present technique has never been employed in previous studies, but risks are
      insignificant.
    

Intervention name(s): repetitive transcranial magnetic stimulation (rTMS)
Intervention type(s): Procedure
Intervention description(s): 20 daily sessions: each with 25 trains of 10 seconds at 5Hz, with a 20 second inter-train interval, at an intensity of 120% of motor threshold.
Site: Left Dorsolateral Prefrontal Cortex
Other intervention name(s): TMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Magnetic Stimulation;; Postpartum Depression;; Clinical Performance;; Cognitive Performance;; Social Performance
A Phase 1 Study to Assess the Safety of NLY01 in Healthy Subjects
Condition: Safety and Tolerability in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, first-in-human study designed to assess the safety, tolerability, and
      pharmacokinetics of NLY01, a PEGylated form of exenatide, in healthy volunteers. NLY01 is
      being developed as a potential treatment for neurodegenerative disorders including
      Parkinson's disease. This study is intended to identify the appropriate dose-range for
      evaluation in Parkinson's disease patients.
    

Detailed description: 
      This is a Phase 1, first-in-human, double-blind, randomized, placebo-controlled, single and
      multiple-dose study to assess the safety, tolerability, and PK of NLY01, a PEGylated form of
      the anti-diabetic peptide exenatide, when administered by SC injection in healthy subjects.

      In Part A of the study, 5 ascending-dose cohorts will be sequentially enrolled with an
      evaluation of safety and tolerability prior to each dose-escalation. Subjects in each cohort
      will be randomized to receive NLY01 or placebo. Each dose escalation and selection of doses
      for Part B will be conducted with oversight by an independently-chaired Safety Review
      Committee.

      In Part B, subjects will receive once-weekly subcutaneous doses of NLY01 or placebo for 4
      weeks. Three ascending-dose cohorts will be sequentially-enrolled with a safety review prior
      to each dose-escalation. Subjects in all Part B cohorts will receive fixed doses of NLY01 (or
      placebo) once-weekly for 4 weeks.
    

Intervention name(s): NLY01
Intervention type(s): Drug
Intervention description(s): NLY01, a PEGylated form of the anti-diabetic peptide exenatide
Other intervention name(s): Placebo; normal saline
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: A Phase 1, first-in-human, double-blind, randomized, placebo-controlled, single-ascending followed by multiple-dose study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis
Condition: Progressive Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a is a small scale open phase two interventional study to assess long-term
      stabilising effects of on neurological symptoms by regular intrathecal administered
      monoclonal antibodies in progressive multiple sclerosis.
    

Detailed description: 
      There is presently no efficient therapy available in progressive MS, especially if there is
      no clear evidence of active inflammatory lesions or exacerbations as part of the disease.
      There are, however, evidence that some treatment protocols using cytotoxic drugs may to some
      extent slow down the progressive course. One specific feature of long-standing MS is that
      inflammatory cells accumulate in the central nervous system(CNS) compartment in the
      subarachnoid and perivascular spaces and may therefore be hard to reach via standard drug
      delivery through systemic administration. Administration of substances via the Intrathecal
      (IT) route, however, have shown to efficiently distribute in the subarachnoid spaces and may
      therefore be an attractive route of drug delivery
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): 25 mg rituximab is injected intrathecally via an Ommaya reservoir once a week for 3 weeks. Patients are then followed for one year.
Other intervention name(s): Mabthera
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Progressive multiple sclerosis; Monoclonal antibodies; Mabthera; Intrathecal treatment
An Open-labelled Clinical Trial of Live Attenuated Varicella Vaccines to Evaluate the Immunity Persistence After Primary Immunization and Safety and Immunogenicity After the Booster Immunization
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-labelled clinical trial of live attenuated varicella vaccines manufactured by
      Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the
      immunity persistence of the single-dose primary immunization of live attenuated varicella
      vaccine on different time points ,and the safety and immunogenicity after the booster
      immunization
    

Detailed description: 
      This study is an open-labelled phase Ⅲ clinical trial.The experimental vaccine manufactured
      by Sinovac(Dalian) Vaccine Technology Co., Ltd.A total of 1195 subjects who received vaccine
      in the phase Ⅲ lot-consistency clinical trial were be enrolled .All subjects except C0243 and
      C0556 were divided into 3 groups according to the order of study number.Subjects in 3 groups
      received a booster immunization of live attenuated varicella vaccines 1 year,2 years and 3
      years after primary immunization,respectively.About 3.0ml of venous blood was collected from
      each enrolled subject at pre-booster immunization,30 days after booster immunization and the
      serum was separated for neutralizing antibody detection.The antibody levels were used to
      evaluate the immunity persistence and immunogenicity after booster immunization of live
      attenuated varicella vaccines .
    

Intervention name(s): Investigational live attenuated varicella vaccine
Intervention type(s): Biological
Intervention description(s): The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.And the live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of FLUTIFORM® VS Seretide® in Paediatric Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Study compares the efficacy and safety of FLUTIFORM® with Seretide® in the treatment of mild
      to moderate persistent asthma in pediatric subjects.
    

Detailed description: 
      This is a study involving a 12 week treatment phase followed by a 6 month extension phase.
      During the treatment phase subjects receive FLUTIFORM® or Seretide®. In the extension phase
      all subjects receive FLUTIFORM®. Efficacy will be assessed by lung function tests and asthma
      symptoms, sleep disturbance. Safety will be assessed by adverse events, vital signs, lab
      tests and ECGs.
    

Intervention name(s): FLUTIFORM® (Formoterol fumarate / Fluticasone propionate)
Intervention type(s): Drug
Intervention MeSH terms: Fluticasone; Xhance; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Paediatric subjects with asthma
Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and
      pharmacodynamics (PD), of ivacaftor in children with cystic fibrosis (CF) who are 2 through 5
      years of age and have a CF Transmembrane Conductance Regulator (CFTR) gating mutation in at
      least 1 allele.

      Part A is designed to evaluate the safety and PK of multiple-dose administration of ivacaftor
      in participants 2 through 5 years of age and to confirm the doses for Part B. Part B is
      designed to evaluate the safety, PK, PD, and efficacy of ivacaftor in participants 2 through
      5 years of age.
    


Intervention name(s): Ivacaftor
Intervention type(s): Drug
Other intervention name(s): Kalydeco; VX-770
Intervention MeSH terms: Ivacaftor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis
Effect of Functional Electrical Stimulation on Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      Objective: The aim of this study is to evaluate the FES effect on erectile function in men
      with erectile dysfunction.

      Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.
    

Detailed description: 
      Introduction: Erectile dysfunction (ED) affects approximately 150 million men worldwide. The
      application of functional electrical stimulation (FES) has been used due to the high
      regenerative capacity of smooth muscle cells. This approach can be beneficial in the
      treatment of which usually has the ultimate causes cavernous smooth muscle degeneration.

      Objective: The aim of this study is to evaluate the FES effect on erectile function in men
      with erectile dysfunction.

      Methods: Randomized Clinical Trial will be selected in which 30 patients with erectile
      dysfunction. The men included will be randomized into two groups. The intervention group will
      conduct therapy with FES (50Hz / 500us) for 15 minutes with intensity below the motor
      threshold and the control group will use FES placebo. Two sessions will be held weekly for
      four weeks. Erectile function will be assessed using the validated questionnaire IIEF-5. The
      instrument will be completed by blinded researcher and the technique is randomized and the
      treatment done randomly.

      Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.
    

Intervention name(s): Functional Electrical Stimulation (FES); FES- Sham
Intervention type(s): Device; Device
Intervention description(s): FES (50Hz / 500us)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Electrical Stimulation During Immobilization
Condition: Disuse Atrophy; Immobilization; Neuromuscular Electrical Stimulation
MeSH terms: Muscular Disorders, Atrophic
Study type: Interventional

Summary: 
      In the present study, the effects of 5 days of lower limb immobilization with or without
      daily neuromuscular electrical stimulation on muscle mass and muscle fiber characteristics
      will be determined.
    


Intervention name(s): immobilization
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Postpartum Screening of Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Gestational diabetes mellitus (GDM) complicates 5 to 30 % of pregnancies. GDM is defined as
      hyperglycemia with onset or first recognition during pregnancy. Because it is a forerunner of
      type 2 diabetes mellitus (T2DM), professional associations recommend T2DM postpartum
      screening (T2DM-pPS) at 6 weeks/6 months post delivery, using a 75g oral glucose tolerance
      test (OGTT).

      However, less than a quarter of these women are screened. This recommendation has failed for
      multiple reasons; the most important being that busy new mothers must deal with the major
      inconveniences of returning to a sampling center for a 2h testing session, bringing baby
      along or paying for a sitter, transportation, parking… A mother-friendly solution is direly
      needed.

      The investigators hypothesize that, in these women, results of an OGTT performed after
      delivery on the last day of their hospital stay (OGTT-1) will predict results of the
      recommended OGTT (OGTT-2) at 6 weeks/6 months postpartum.

      The main aim of our project is to determine the optimal cut-off value for the 2h glucose
      result during OGTT-1 in order to predict abnormal glucose tolerance status at OGTT-2 (the
      gold standard), in the same woman.
    


Intervention name(s): oral glucose tolerance test 2 days post-partum
Intervention type(s): Procedure
Intervention description(s): Screening for type 2 diabetes after gestational diabetes mellitus.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: postpartum screening; type 2 diabetes
Effect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia
Condition: Gastric Cancer
MeSH terms: Pneumoperitoneum
Study type: Interventional

Summary: 
      The primary purpose of this study is to investigate the effect of pneumoperitoneum on
      remifentanil requirements in the surgical pleth index-guided analgesia for laparoscopic
      gastrectomy.
    


Intervention name(s): High end-tidal CO2; Low CO2 group
Intervention type(s): Other; Other
Intervention description(s): maintaining of end-tidal CO2 with the range of 40-45 mmHg; maintaining of end-tidal CO2 with the range of 30-35 mmHg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
AeroEclipse II Agreement
Condition: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Traditional, continuous-mode nebulizers such as the English-Wright nebulizer are designed to
      operate continuously with tidal breathing. As inhalation accounts for only about one-third of
      the respiratory cycle, two-thirds of the continuously produced aerosol is lost to the
      environment possibly posing a hazard any fellow-patients, family members, or health-care
      workers in the vicinity. The English-Wright has been the only American Thoracic Society
      (ATS)recommended device available on the market. Recently Roxon Medi-Tech has announced the
      discontinuation of the English-Wright nebulizer. For these reasons it is necessary to review
      the use of other nebulizers such as the AeroEclipse II breath-actuated nebulizer and further
      validate their performance.

      The investigators expect to show equivalence between the AeroEclipse II and the
      English-Wright nebulizers.
    

Detailed description: 
      This study would like to determine if the use of the Aeroeclipse II breath actuated nebulizer
      for the delivery of methacholine chloride bronchoprovocation agent to the lungs results in
      the same Provocation Concentration PC20 (provocation concentration, or dose that causes a 20%
      decrease in Forced Expiratory Volume in 1 sec or FEV1) as using the English-Wright nebulizer
      for the delivery of methacholine chloride bronchoprovocation agent to the lungs.
    

Intervention name(s): AeroEclipse II breath-actuated nebulizer; English-Wright continuous-mode nebulizer
Intervention type(s): Device; Device
Intervention description(s): The AeroEclipse II (Trudell Medicinal International, London, ON, Canada) is a breath-actuated nebulizer that allows for the creation of aerosol only in response to the patient's inspiratory flow, resulting in virtually no drug loss to the environment and providing a safer healthcare and patient environment by significantly reducing second-hand drug exposure and the possibility for transmission of viral airborne pathogens.; The English-Wright is a continuous-mode nebulizer, designed to operate continuously with tidal breathing, producing an aerosol which is lost to the environment possibly posing a hazard to any fellow-patients, family members, or health-care workers in the vicinity. It is the only device recommended by the American Thoracic Society guidelines that is available on the market and it has recently been discontinued. For these reasons it is necessary to review the use of other nebulizers and validate their performance.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Methacholine challenge; nebulizer; English-Wright; AeroEclipse II
Study About High Fat Meal and Postprandial Lipemia
Condition: Obesity
Study type: Interventional

Summary: 
      The hypothesis of the proposed project is that after a fat overload, the postprandial
      response is different in both groups, suggesting that the LPP will present the most
      significant damage in endothelial vasomotion in obese individuals, especially those with GI
      and T2DM. After the fat overload, we hypothesized that there will be a worsening of
      endothelial function and microvascular reactivity in OB/DM2 and OB group compared to C, but
      also find lower concentrations of incretins in OB/DM2 group compared to other groups.

      These hypotheses may be confirmed by techniques for evaluating microvascular function, the
      use of DFT skin for vasomotion evaluation and finally analysis of analytes through metabolic
      and cardiovascular read by Multiplex kit.
    

Detailed description: 
      Will be recruited 60 women aged 19-40 years, with a diagnosis of obesity (BMI ≥ 30 kg/m2)
      treated at the obesity clinic at the State University of Rio de Janeiro (UERJ)at Brazil.

      Microcirculation parameters and blood tests will be assessed at baseline and after this, the
      women will receive a high-fat meal containing croissant, salami, whole milk and cheddar
      cheese. After 30, 60, 120 and 180 minutes this meal the microcirculation will be evaluated as
      well as blood collection.
    

Intervention name(s): High fat meal
Intervention type(s): Dietary Supplement
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: glucose intolerance (20); Control (20)
SNS to Increase HIV Testing Uptake and Linkage to Double Cascade Services Among Adolescent MSM and TGW in Thailand
Condition: Social Network Strategy; HIV Self Testing; Men Who Have Sex With Men
Study type: Interventional

Summary: 
      UNAIDS aims to end AIDS by 2030 using "90-90-90" diagnosis-treatment-viral suppression
      targets. Thailand has achieved elimination of HIV mother-to-child transmission, but continues
      to see new infections among adolescent men who have sex with men (YMSM) and transgender women
      (YTGW). Reaching and engagement of key populations to HIV services remains a major challenge,
      with differentiated care needed to address this. Investigators propose a study on outreach
      for HIV at-risk adolescents using peer-led social network strategies (SNS), linkage to
      facility-based HIV self-testing, and same day HIV prevention or treatment. The study will
      focus on the 15-19 year age group who have the highest HIV incidence in Thailand (6.9-10 per
      100 person years, PY), but will also include young adults aged 20- 24 years of age, due to
      their frequently intertwining sex networks and very similar HIV incidence of 4.9-7.2 per 100
      PY.

      Eight hundred adolescent and young adult (AYA) MSM and TGW aged between 15-24 years will be
      recruited into a double HIV cascade care system. AYA aged between 15-24 years will be trained
      as recruiters to approach and refer their peers, 'network members' (NMs) to our adolescent
      clinic. NMs will be offered a choice of either blood-based or oral fluid-based HIV
      self-testing. HIV positive cases will be offered same-day antiretroviral therapy (SDART) and
      high-risk adolescents will be offered same day preexposure prophylaxis (PrEP). The project
      will be conducted at adolescent differentiated care services previously established by CIPHER
      grants in Thailand, located at King Chulalongkorn Memorial Hospital (KCMH), Bangkok. It will
      inform both Thailand and other Asia-Pacific region countries with similar epidemic patterns
      through an implementation research lens on strategies to engage YMSM and YTGW into HIV
      services, which investigators believe will make high-impact contributions to our collective
      ultimate goal of ending AIDS.
    


Intervention name(s): Social network strategy (SNS)
Intervention type(s): Other
Intervention description(s): SNS utilizes peers to reach and recruit their network members into HIV services, therefore having the advantage that recruiters with different behavioral risks and HIV statuses are likely to have access to a wide variety of HIV at risk populations
Intervention model: Single Group Assignment
Intervention model description: Potential recruiters will be approached in routine adolescent HIV treatment and services and those enrolled will approach peers to become network members who then come in for HIV testing
Masking: None (Open Label)
Primary purpose: Health Services Research