bioihbjkbjnl/mcl2 huggingface dataset:
Study of Naltrexone for Methamphetamine Addiction
Condition: Methamphetamine Dependence
MeSH terms: Behavior, Addictive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether methamphetamine-dependent individuals will
      use less methamphetamine when treated with naltrexone. The study will also investigate
      whether individuals with the mu opioid receptor gene variant A118G will use less
      methamphetamine than individuals without A118G.
    


Intervention name(s): Naltrexone
Intervention type(s): Drug
Intervention description(s): 380mg extended-release, given once by intramuscular gluteal injection
Other intervention name(s): Vivitrol; Vivitrex
Intervention MeSH terms: Naltrexone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meth; Methamphetamine Addiction; Methamphetamine Treatment; Naltrexone; Vivitrol; A118G; OPRM1
Sleepiness and the Effects of CPAP on Salivary Cortisol and Alpha-Amylase Levels in Patients With Sleep Apnea
Condition: Sleep Apnea; Sleep Disordered Breathing
MeSH terms: Apnea; Sleep Apnea Syndromes; Respiratory Aspiration; Sleepiness
Study type: Interventional

Summary: 
      Patients with Obstructive Sleep Apnea Syndrome (OSAS) will evidence higher levels of salivary
      cortisol and alpha-amylase levels prior to use of placebo and continuous positive airway
      pressure (CPAP) and will evidence a decrease in these levels after consistent use of
      continuous positive airway pressure (CPAP) therapy as compared to placebo. Their level of
      sleepiness will also decrease with the use of CPAP therapy and will correlate with the levels
      of salivary cortisol and alpha-amylase in relation to their subjective sleepiness scale,
      Psychomotor Vigilance Test (PVT), and pupillometry.
    

Detailed description: 
      It has been shown that there is an inconsistent response in serum cortisol levels in patients
      with Obstructive Sleep Apnea Syndrome (OSAS), but it is undetermined whether a change in
      hormone level was not seen due to compliance issues in these long-term studies. These
      investigators will be employing compliance monitoring continuous positive airway pressure
      (CPAP) machines and also assessing "sleepiness" before and after therapy. Sleepiness is the
      dependent variable in our study and will be measured subjectively using sleepiness scales and
      objectively using Psychomotor Vigilance Test (PVT) and an autonomic measure using
      pupillometry prior, during and after treatment.
    

Intervention name(s): 14 days of placebo therapy; 14 days of CPAP therapy
Intervention type(s): Device; Device
Intervention description(s): 14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation; 14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
Other intervention name(s): placebo arm, non-CPAP arm; CPAP arm
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: automatic positive airway pressure (APAP); continuous positive airway pressure (CPAP); Salivary Cortisol; Apnea; Sleep Apnea and/or any Sleep Disordered Breathing
Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Resectable Esophageal Squamous Cell Carcinoma
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to evaluate the efficacy and safety of preoperative treatment with durvalumab
      combined with neoajuvant therapy (carboplatin, paclitaxel with/without radiation) in locally
      advanced resectable oesophageal squamous carcinoma.
    

Detailed description: 
      The primary objective of the study is to assess the tumor response (by irRECIST) and
      pathological response of preoperative treatment with durvalumab combined with neoadjuvant
      therapy (carboplatin, paclitaxel with/without radiation).

      Secondary objectives are:

      To assess completion of treatment with durvalumab combined with chemotherapy with/without
      radiation treatment.

      To assess toxicities of durvalumab in combination with chemoradiation. [Time Frame: up to 1
      year] To assess completion of chemotherapy with/without radiation treatment. To assess
      withdrawal rate from surgery. To assess delay rate from surgery. To assess R0 resection rate.
      To assess post-operative complications. Progression Free Survival. [ Time Frame: up to 24
      months ] Overall Survival. [ Time Frame: up to 24 months ]
    

Intervention name(s): Durvalumab; Carboplatin; Paclitaxel; Radiotherapy 23 x 1.8 Gy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention description(s): Durvalumab 1500mg i.v. day 1-22-43-64; Chemotherapy; Chemotherapy; Radiotherapy 23 x 1.8 Gy
Other intervention name(s): Chemotherapy; Chemotherapy; Radiotherapy
Intervention MeSH terms: Paclitaxel; Carboplatin; Durvalumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Clinical Pharmacology of p38 MAP Kinase Inhibitor, VX-745, in Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the effects of VX-745 on markers of disease in the central nervous
      system of patients with MCI due to AD or with mild AD. The study will also evaluate the
      safety and tolerability of VX-745 in these patients during 6 weeks of dosing, as well as the
      plasma and cerebrospinal fluid concentrations of VX-745 during dosing.
    


Intervention name(s): VX-745
Intervention type(s): Drug
Intervention description(s): Orally-active P38 MAP kinase alpha-selective inhibitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy, Safety, Tolerability of AXA1125 in Fatigue After COVID-19 Infection
Condition: Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
MeSH terms: Infections; Communicable Diseases; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the effects of AXA1125, an orally active mixture of amino acids,
      compared to placebo, on improving muscle function (metabolism) following moderate exercise in
      subjects with fatigue-Predominant Post-Acute Sequelae of SARS-CoV-2 as well as the safety and
      tolerability of AXA1125. Subjects will take one dose of AXA1125 or a placebo twice daily for
      28 days.
    


Intervention name(s): AXA1125; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AXA1125 administered BID with or without food; Matching Placebo administered BID with or without food
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Long COVID; Long-haul COVID; Muscle weakness; COVID; PASC; Fatigue; Amino acids; Bioenergetics; Mitochondrial dysfunction; Phosphocreatine recovery; Exertional fatigue; Phospho magnetic resonance spectroscopy; Skeletal muscle
Comparison of the DANA to the ANAM in the Evaluation of Cognitive Changes After Concussion
Condition: Traumatic Brain Injury; Brain Concussion
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      The Defense Automated Neurobehavioral Assessment (DANA) was recently developed as a durable,
      portable, and "field-hardened" NeuroCognitive Assessment Tool. The purpose of this study is
      to compare the sensitivity of the DANA Brief exam with the Automated Neuropsychological
      Assessment Metrics (ANAM) battery currently used by the military after concussion. The
      primary hypothesis is that the DANA Brief exam will be more sensitive for detecting continued
      impaired cognitive performance than the ANAM during recovery after a concussion.
    

Detailed description: 
      Among active duty military personnel deployed to combat theaters, blast injury is a leading
      cause of traumatic brain injury (TBI). Service members with TBI can experience notable
      neurological impairments-e.g., attention disturbances, memory and language deficits, and
      delayed reaction time. Cognitive performance can still be impaired 2-4 weeks after concussion
      with no overt physical symptoms. Thus, there is a critical need to have an efficient means to
      determine the incidence of cognitive deficits in service members exposed to or injured by
      blasts. To that end, this study plans to evaluate the ANAM and the DANA to determine which
      neurocognitive test more reliably and accurately detects cognitive impairments during the
      recovery period from a concussion.
    

Intervention name(s): DANA Brief; ANAM
Intervention type(s): Device; Other
Intervention description(s): The DANA Brief is a newly-developed neurocognitive test administered on a handheld computer that tests simple reaction time, procedural reaction time, code substitution, and spatial processing. The test also includes subtests for depression/distress, PTSD, and insomnia.; The ANAM is a currently used test by military health care providers in evaluating cognitive performance after concussion.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: DANA; ANAM; Concussion; mild traumatic brain injury
A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the effect of single doses of daridorexant on electrocardiogram parameters
      in healthy subjects
    


Intervention name(s): Daridorexant; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Daridorexant (ACT-541468) administered as film-coated tablets for oral use.; Placebo administered as tablets for oral use.; Moxifloxacin administered as film-coated tablets for oral use.
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-center, randomized, double-blind, placebo- and moxifloxacin-controlled, Phase 1 study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Insulin Resistance; Hypersensitivity; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Amla has demonstrated promising effects in the treatment of obesity, dyslipidemia,
      hypertension, insulin secretion, among others. The above mentioned findings show that Amla
      has an excellent potential for the prevention and treatment of metabolic syndrome.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled clinical trial will be conducted in 28
      patients, 30-59 years old, with diagnosis of Metabolic Syndrome according with modified
      International Diabetes Federation criteria. Patients will be randomly assigned to receive
      Amla (500mg) or homologated placebo orally twice daily, for 90 days. Before and after the
      intervention, the components of Metabolic Syndrome will be evaluated, waist circumference,
      blood pressure, levels of fasting glucose, triglycerides, cholesterol high density
      lipoprotein (C-HDL), total insulin secretion (Insulinogenic index), first phase of insulin
      secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
    

Intervention name(s): Amla; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days; Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days
Other intervention name(s): Emblica Officinalis; Calcined Magnesia
Intervention MeSH terms: Magnesium Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Amla; Emblica officinalis; Metabolic Syndrome; Insulin Secretion; Insulin Sensitivity
Improving Neuropathy and Mobility in People With Early Diabetes
Condition: Diabetes; Physical Activity
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to determine if an individually tailored diet and physical
      enhancement program can improve mobility, physical activity, and neuropathy in people with
      early diabetes.
    

Detailed description: 
      Neuropathy is the most common complication of diabetes mellitus. Impaired glucose regulation
      (IGR) is associated with development of peripheral neuropathy coupled with gait and mobility
      impairment that may be disabling for the patient. Recent novel data from the investigators'
      group indicates that improved diet and exercise can significantly improve and even reverse
      neuropathy associated with IGR, however this has not been tested as a specific intervention
      in a controlled diabetes complications trial. IGR includes patients with early type 2
      diabetes mellitus (T2DM), impaired glucose tolerance (IGT), and impaired fasting glucose
      (IFG) based on standardized criteria for the diagnosis of T2DM. The investigators hypothesize
      that, compared to IGR participants advised to follow the current standard care
      recommendations on diet and exercise (Standard Care or "SC"), IGR participants undergoing a
      Tailored Diet and Physical Activity (TDPA) enhancement program will show greater improvement
      in the 6 minute walk test (6MW) and will show a greater reduction in markers of neuropathy
      progression e.g. intraepidermal nerve fiber density (IEFND). Furthermore, the investigators
      will test the hypothesis that improvement in measures of neuropathy, mobility function and
      physical activity (PA) will correlate strongly with each other and with improvement in
      specific measures of metabolic function, and weight loss. This proposal will permit us to
      determine if TDPA can improve mobility and induce nerve regeneration in subjects with early
      diabetes.
    

Intervention name(s): Tailored Diet and Physical Activity; Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will receive an individually tailored diet and physical activity enhancement program; Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel treatments
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Neuropathy; diabetes
Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers.
    


Intervention name(s): CHF5074 1x; CHF5074 2x; CHF5074 3x; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral tablet, 1x, once a day in the morning for 14 days; oral tablet, 2x, once a day in the morning for 14 days; oral tablet, 3x, once a day in the morning for 14 days; oral tablet, placebo, once a day in the morning for 14 days
Intervention MeSH terms: 1-(3',4'-dichloro-2-fluoro(1,1'-biphenyl)-4-yl)cyclopropanecarboxylic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sugar-replacement Sweeteners, and Blood Sugar Control
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Several sugar-replacement sweeteners are currently on the market, including saccharine (ex.
      Sweet'N Low), aspartame (ex. Equal), and sucralose (ex. Splenda). The purpose of this study
      is to examine wether non caloric sweeteners affects how well the body works to control blood
      sugar. The study includes detailed blood sugar testing after drinking liquids that may
      contain sucralose. The investigators hypothesize that drinking liquids with sucralose will
      effect the amounts of specific appetite-affecting substances naturally produced by the body.
    


Intervention name(s): Water; Sucralose
Intervention type(s): Other; Other
Intervention description(s): 60 ml of water were drank 10 min before doing a OGTT; 60 ml of 2 millimolar sucralose were drank 10 min before doing a OGTT
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: obesity; diabetes; artificial sweeteners
The Effect of Air Pollution on Lung Health Among Children Living in Haifa Bay Region, Israel
Condition: Bronchial Asthma; Signs and Symptoms, Respiratory; Allergy
MeSH terms: Asthma; Signs and Symptoms, Respiratory
Study type: Interventional

Summary: 
      Haifa bay region is located close to a major industrial zone. The aim of the study is to
      evaluate the health status of children living in Haifa bay region.

      The health status will be evaluated using health questionnaires and spirometry.
    

Detailed description: 
      Haifa bay is located close to a major industrial zone. The aim of the study is to evaluate
      the health status of children living in Haifa bay region.

      The health status will be evaluated while using health questionnaires and spirometry.

      Objective: To evaluate the respiratory health of Haifa bay region children with comparatives,
      with respect to local air pollution levels.

      Material and Methods: Children from Haifa bay region from 10 different communities (1200
      children) will be included in the study, after both parents and the children (above 12 years
      of age) will sign an informed consent form.

      First step: A health questionnaire (based on Hebrew version of ISAAC questionnaire) will be
      filled in by the parents.

      Second step: Spirometry checking of the children. In parallel, air pollution levels will be
      measured and provided by a network of ground monitoring stations maintained by the Haifa
      District Municipality Association for the Environment (HDMAE). The station provides
      half-hourly measurement of mean concentrations of gaseous (NOX, SO2, O3) and particular (PM
      10) pollutants over the entire investigation window. Additional meteorological data are also
      collected.

      Risk maps: Using a GIS platform, we are developing a multi-layer risk mapping procedure which
      accounts for ambient concentrations of selected pollutants and the heterogenic spatial
      distribution of several demographic and socio-economic indexes in the region.

      The prevalence of pulmonary disease will be evaluated according to the risk maps The health
      status of the children will be documented from the children's primary clinic files as well.
    

Intervention name(s): Spirometry (Pony spirometer)
Intervention type(s): Device
Intervention description(s): Spirometry at rest
Other intervention name(s): Pony spirometer, Cosmed, Italy.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Asthma; Allergy; Respiratory; Pollution; Children; Air pollution
Psychophysiological Correlates of Mindfulness Based Cognitive Therapy (MBCT) in Recurrent Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The study investigates cognitive attention, rumination and psychophysiological (EEG)
      processes in healthy subjects and remitted patients with at least three previous depressive
      episodes. The investigators expect that Mindfulness Based Cognitive Therapy prevents future
      depressive episodes and has influence on cognitive and psychophysiological measures.
    


Intervention name(s): Mindfulness Based Cognitive Therapy; Waiting List Control
Intervention type(s): Behavioral; Other
Intervention description(s): Group treatment over 8 weeks with training in meditation, stress regulation, shift attention, stay present, in addition with cognitive and behavioral strategies (following Williams et al. Manual 2002); Patients receive MBCT with a delay of 6 months.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: recurrent depression,; mindfulness training; attention; Evoked EEG potentials; Relapse prevention in recurrent depression
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride
      and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met® (pioglitazone
      hydrochloride and metformin hydrochloride) Tablets 15 mg/850 mg of Takeda Pharmaceuticals
      America, Inc. USA. Dosing periods of studies were separated by a washout period of 14 days.

      Study Design:

      Randomized, Two-Way Crossover, Single-Dose, and Open-Label
    


Intervention name(s): Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Pioglitazone
Pregabalin Compared to Gabapentin for Pain Control in Lumbar Disc Surgery
Condition: Intervertebral Disc Prolapse
MeSH terms: Intervertebral Disc Displacement; Prolapse
Study type: Interventional
Phase: Phase 3

Summary: 
      Pregabalin is claimed to have superior analgesic effect at lower doses and better
      pharmacological profile as compared to gabapentin esp. in perioperative pain control after
      major surgeries like intervertebral disc surgery.

      The investigators found that pregabalin is equivalent to gabapentin for relief of
      post-operative pain at a lower dose in patients undergoing intervertebral disc surgery.
    


Intervention name(s): Pregabalin; Gabapentin
Intervention type(s): Drug; Drug
Intervention description(s): Pregablin 75 mg per oral two times a day; Gabapentin 200 mg twice daily per oral
Intervention MeSH terms: Pregabalin; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pregabalin; gabapentin; microdiscectomy; pain