bioihbjkbjnl/mcl2 huggingface dataset:
[11C]NOP-1A and Cocaine Use Disorders
Condition: Cocaine Use Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of this study is to compared [C-11]NOP-1A binding in recently abstinent cocaine use
      disorders and controls.
    

Detailed description: 
      This will allow for understanding brain stress and anti-stress mechanisms that underlie abuse
      of cocaine in humans.
    

Intervention name(s): [C-11]; NOP-1A
Intervention type(s): Radiation; Drug
Intervention description(s): Radiolabel; Tracer
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: [C-11]NOP-1A
Masking: None (Open Label)
Primary purpose: Basic Science
Comprehensive Lifestyle Modification for Patients With Hypertension and Metabolic Syndrome: a Multicenter Randomized Controlled Trial
Condition: Hypertension; Metabolic Syndrome
MeSH terms: Hypertension; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Different forms of diet, e.g. Mediterranean diet, DASH diet, or fasting, have demonstrated
      efficacy in reducing elevated blood pressure. Moreover, Mediterranean diet, and fasting seem
      to be effective in improving insulin sensitivity in type 2 diabetes. Further, studies on
      meditation or mindfulness-based interventions have shown positive effects in patients with
      hypertension and/or type 2 diabetes. Comprehensive Lifestyle Modification, this is a
      combination of diet, exercise, and stress management, have improved coronary atherosclerosis.
      However, no studies have yet investigated the effects of Comprehensive Lifestyle Modification
      in patients with metabolic syndrome and/or in combination with fasting therapy.

      This study is supported by a grant from the Corona-Foundation, Germany.
    


Intervention name(s): Comprehensive Lifestyle Modification; Standard Lifestyle Modification / modified DASH
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Fasting (1st week), followed by:
Vegetarian and modified DASH diet (plant-based, low-salt)
Aerobic exercise
Stress reduction techniques: progressive muscle relaxation, meditation, yoga; Modified DASH (vegetarian focused, plant-based, low-salt)
Aerobic exercise
Stress reduction techniques: progressive muscle relaxation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Early or Late Cord Clamping in the Depressed Neonate
Condition: Neonatal Disorder; Asphyxia Neonatorum
MeSH terms: Asphyxia Neonatorum; Infant, Newborn, Diseases; Asphyxia
Study type: Interventional

Summary: 
      This study evaluates the hypothesis that delayed compared to early umbilical cord clamping
      will improve neonatal transition in terms of circulation and breathing during resuscitation.
    

Detailed description: 
      At the time of birth, the infant is still attached to the placenta via the umbilical cord.
      The infant is usually separated from the placenta by clamping the cord with two clamps. Early
      cord clamping has been generally advised to be carried out in the first 30 seconds after
      birth, regardless of whether the cord pulsation has ceased. However, arguments against early
      cord clamping include the reduction in the amount of placental transfusion and any associated
      benefits of extra blood volume, as delayed clamping allows time for a transfer of the fetal
      blood in the placenta to the infant at the time of birth.

      The study will evaluate the effect of early versus delayed cord clamping in a low-income
      setting in children that do not spontaneously start to breathe. The randomized controlled
      trial will be carried out at Paropakar Maternity and Women's Hospital (PMWH) in Kathmandu.

      The trial will fill several important gaps in relation to early and delayed cord clamping and
      results.
    

Intervention name(s): Early (≤ 60 seconds) cord clamping; Delayed (≥ 180 seconds) cord clamping
Intervention type(s): Procedure; Procedure
Intervention description(s): If the infant don't breathe, the umbilical cord is clamped (≤ 60 seconds) and cut and resuscitation will be provided at a resuscitation table; If the infant don't breathe, the umbilical cord is not clamped and cut until after 180 seconds. Initial resuscitation will be provided bedside to the mother
Other intervention name(s): Immediate clamping; Late cord clamping; Deferred cord clamping; Optimal cord clamping
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Resuscitation; Cord clamping
A Comparative Analysis Between College Park Sidekick Feet and Conventional Stubby Prosthesis
Condition: Amputation Stumps
Study type: Interventional

Summary: 
      The purpose of this study is to compare the College Park Sidekicks to conventional stubby
      prosthetics to investigate their effects on bilateral above-knee-amputee gait velocity,
      exertion, and balance. The investigators aim to demonstrate that: (i) greater balance will be
      observed and reported on a level and gravel surface with the Sidekicks; (ii) time to complete
      the 10-meter walk test will be decreased wearing Sidekicks compared to the conventional
      stubby prosthesis; and (iii) subjects will report feeling less exerted with the sidekicks.
    


Intervention name(s): Sidekick Stubbies
Intervention type(s): Device
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Effect of Shock Wave Therapy on Upper Trapezius Trigger Points in Patients With Cervicogenic Headache. a Randomized Controlled Trial
Condition: Cervicogenic Headache
MeSH terms: Post-Traumatic Headache; Headache
Study type: Interventional

Summary: 
      Control group will receive US, TENS, IR and exercises. The treatment group will receive the
      same program in addition to shock waves therapy. Patients will receive 3 sessions per week
      for 4 weeks.
    

Detailed description: 
      Control group will receive US, TENS, IR and exercises. The treatment group will receive the
      same program in addition to shock waves therapy. Patients will receive 3 sessions per week
      for 4 weeks.
    

Intervention name(s): Shock Wave Therapy; US, TENS, IR and exercises.
Intervention type(s): Other; Other
Intervention description(s): Receiving Shock wave therapy + US, TENS, IR and exercises.; Receiving US, TENS, IR and exercises only.
Other intervention name(s): US, TENS, IR and exercises.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Shock wave therapy; Trapezius trigger points; Cervicogenic headache
A Study of the Safety, Blood Levels and Biological Effects of GBT440 in Healthy Subjects and Subjects With Sickle Cell Disease
Condition: Healthy Subjects; Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and
      pharmacodynamic effects of GBT440 compared with placebo in healthy subjects and subjects with
      sickle cell disease (SCD).
    


Intervention name(s): GBT440; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GBT440 will be administered as oral capsules; Matching placebo will be administered as oral capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Evaluation of Gynecological Acceptability of 3 Health Care Products
Condition: Atrophic Vaginitis; Vaginal Disease
MeSH terms: Vaginitis; Atrophic Vaginitis; Vaginal Diseases
Study type: Interventional

Summary: 
      The research was conduct with 3 different products for use in the intimate region in up to 70
      research participants, that use the investigational product by 35 ± 2 days. The subjects were
      follow up throughout the study by a gynecologist for verification of safety, effectiveness
      and possible adverse events.
    

Detailed description: 
      At this study, 70 female participants, 18 to 70 years, healthy with complaints of vaginal
      dryness used the 3 investigational product, each one by 9 days. Between the changes of
      product use, there were 4 days of wash out. At the 9th day, the participants answered
      assessment questionnaire.
    

Intervention name(s): Hyaluronic acid - Research product 1; Hyaluronic acid - Research product 2; Hyaluronic acid - Comparator product
Intervention type(s): Other; Other; Other
Intervention description(s): Health care product (intimate gel); Health care product (intimate gel); Health care product (intimate gel)
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clinical trial, triple arm, randomized
Masking: Single (Participant)
Primary purpose: Treatment
Possible Role of Gingival Crevicular Fluid Levels of Chemerin and Fibroblast Growth Factor 21 as Biomarkers of Periodontal Disease in Diabetic and Non-diabetic Patients
Condition: Periodontal Disease (Diagnosis); Diabetes Mellitus, Type 2
MeSH terms: Periodontal Diseases; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The current study aims to spot the light on the possible role of gingival crevicular fluid
      (GCF) level of Chemerin and FGF21 to study their potential role as biomarkers of periodontal
      disease and to understand their role in the link between periodontitis and diabetes .

      The study will be conducted on three groups; group (A) include fifteen controlled T2 DM
      patients suffering from periodontitis, group (B) include fifteen patients suffering from
      periodontitis alone, and group C) include fifteen periodontally and medically healthy
      individuals. GCF samples will be collected from all participants for assessment of Chemerin
      and FGF 21. Samples will be analysed using ELISA technique.
    


Intervention name(s): gingival crevicular fluid level
Intervention type(s): Diagnostic Test
Intervention description(s): gingival crevicular fluid collection
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        forty five individuals (ranging in age from 35-60 years) recruited from the outpatient
        clinic of Oral Medicine, and Periodontology Department, Faculty of Dentistry, Cairo
        University

        The participants were divided into the following three groups:

        Group (1): 15 patients with periodontitis and controlled t2DM and no other systemic
        disease.

        Group (2): 15 systemically healthy individuals having periodontitis. Group (3): 15
        periodontally and systemically healthy individuals.
Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy
Condition: Surgical Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double blinded, placebo-controlled trial on the routine use of
      preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy
      of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI)
      in patients undergoing modified radical mastectomy (MRM) for breast care.
    

Detailed description: 
      A randomized, double blinded, placebo-controlled trial on the routine use of preoperative
      antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy of
      preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI) in
      patients undergoing modified radical mastectomy (MRM) for breast care.

      Women with breast cancer who will undergo elective MRM were recruited for the study. Excluded
      were patients with significant co-morbid factors, for simultaneous breast reconstruction or
      bilateral oophorectomy, with intake of antibiotics within one week, with known allergy to
      cephalosporins, and those with local infection. Patients were randomized to receive either
      transvenous cefazolin 1 gram or sterile water only within 30 minutes prior to skin incision.
      Standard skin preparation and operative technique for MRM were carried out. Wounds were
      assessed for the presence of SSI and other complications weekly for 30 days.
    

Intervention name(s): Cefazolin; Sterile water
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients received intravenous cefazolin 1 gram within 30 minutes prior to skin incision;; Patients received sterile water only within 30 minutes prior to skin incision
Intervention MeSH terms: Cefazolin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Antibiotic prophylaxis; surgical site infection; modified radical mastectomy; Prevention of surgical site infection (SSI) in patients undergoing MRM for breast cancer
Analysis of Injectate Spread During Erector Spinae Block
Condition: Pain; Cervical
Study type: Interventional

Summary: 
      The primary purpose of this study was to identify the ESPB spread level in the craniocaudal
      direction when performed at the T2 level. The secondary purpose was to determine the
      incidence of spread into epidural, paravertebral, intercostal, and intravascular injections
      with ESPB
    

Detailed description: 
      The ESPB requires ultrasound guidance which enables visible local anesthetic spread
      underneath the erector spinae muscles. The spinalis, longissimus thoracis, and iliocostalis
      muscles comprise the ES muscles, which run vertically along both sides of the vertebral
      column from the sacrum up to the skull base. The ESPB can be performed in the cervical,
      thoracic, and lumbar regions. Among them, upper or mid thoracic ESPB has been used more
      widely compared to cervical and lumbar regions. Previous cadaveric studies on the ESPB at the
      T5 level using computed tomography (CT) reconstruction or direct dissection demonstrated the
      extensive craniocaudal distribution of methylene blue ranging from T1 to T8 vertebral
      segments deep to the ES muscles and variable involvement of epidural, paravertebral, and
      intercostal spaces. The ESPB performed at the T2 level of the cadaver demonstrated an
      injected dye distribution ranging from C4 to T10. Also, 36% of cadavers showed the spread of
      an injected dye to the ventral, dorsal ramus, paravertebral space, and even the contralateral
      side. The exact mechanism of action of ESPB remains unclear. A recent study suggested that
      the analgesic effect of ESPB could be obtained by blocking the ventral and dorsal ramus of
      the spinal nerves by passing through the costotransverse foramen. However, in clinical
      practice, we can encounter highly variable clinical outcomes or sensory block after the ESPB.
      The study of the physical spread of the injected agent can be used to predict the clinical
      result and elucidate the possible mechanism of action of ESPB.
    

Intervention name(s): Erector spinae plane block
Intervention type(s): Procedure
Intervention description(s): fascial plane injection using ultrasound and fluoroscopic guidance
Other intervention name(s): ESP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Cervical; Spread
Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the PK properties in fed and fasted men and women.
    


Intervention name(s): Lorcaserin 10mg
Intervention type(s): Drug
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study Comparing the Efficacy of Two Ibuprofen Formulations
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study of healthy volunteers to compare how quickly different ibuprofen products
      relieve dental pain.
    


Intervention name(s): placebo; ibuprofen Formulation 1; ibuprofen Formulation 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 placebo gels capsules delivered as a single dose.; 2 marketed ibuprofen gels; 2 marketed ibuprofen gels
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Dental pain analgesia
Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)
Condition: Anxious Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine if a highly selective enkephalinergic receptor modulator is
      effective in the treatment of anxious major depressive disorder.
    


Intervention name(s): AZD2327; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet, Oral, Daily; Tablet, Oral, Daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anxious Major Depressive Disorder
Bronchoreversibility Test in Asthmatic Children and Correlation With Diagnostic Criteria Proposed by the GINA Guidelines
Condition: Pediatric Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Since 2015, GINA (Global INitiative on Asthma) guidelines were modified and adapted to better
      fit the pediatric population. Asthma diagnosis is mainly based on the results of PFT
      (Pulmonary Function Tests) and broncho-reversibility test in adult. GINA guidelines modified
      the requirements to reach a diagnosis of Asthma in children, based on the reversibility test.
      GINA guideline propose an increase of 12% of the FEV1 is considered as the diagnostic
      criterium for asthma in pediatrics.

      Nevertheless, in clinical practice, most physicians base their diagnosis of asthma in
      children on the clinical signs presented by the patient and on the efficacy of the prescribed
      therapy. Also, the spirometric criterium is not sufficiently corroborated by clinical
      studies. No research has ever looked for the results of bronchoreversibility test in patients
      receiving a clinical diagnosis of asthma. For this reason, in children with a clinical
      diagnosis of asthma, the investigators want to look for the results of the
      bronchoreversibility test and validate that an increase of 12% of the FEV1 correlate with a
      physician-driven diagnosis of asthma in pediatrics. For further analysis the
      investigatorswill evaluate also the reversibility of small airways (FEF25-75) and the z-score
      of the results of the PFT in these children.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Children with a physician-base diagnosis of asthma, undergoing a bronchodilation test
      
Keywords: Bronchodilation test; GINA; Reversibility criteria
BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity
Condition: Muscle Spasticity
MeSH terms: Muscle Spasticity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult
      post-stroke lower limb spasticity.
    


Intervention name(s): botulinum toxin Type A; Normal Saline
Intervention type(s): Biological; Drug
Intervention description(s): Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.; Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles.
Other intervention name(s): BOTOX®; onabotulinumtoxin A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Randomized Trial: Changing Behavior in Post-Angioplasty Patients
Condition: Angioplasty Patients
Study type: Interventional

Summary: 
      The long-term objective of this study is to determine whether a positive affect and
      self-affirmation condition added to an empirically demonstrated approach for motivating
      behavior change is more effective than a standard approach in reducing risk factor behavior
      among a high-risk group of patients with coronary artery disease. Thus, the goal of the
      project is to refine and improve strategies for long-term maintenance of physical activity
      among patients post-angioplasty or stent.
    

Detailed description: 
      Among coronary artery disease patients who have just had either angioplasty or stents, the
      objective of this randomized trial is to evaluate whether a novel behavioral intervention
      that employs induced positive affect and self-affirmation is more effective than an
      intervention without positive affect in increasing the maintenance of newly initiated
      physical activity post-procedure.

      Secondary objectives:

        -  To determine whether more patients who receive the positive affect and self-affirmation
           intervention initiate more multiple behavior changes (e.g., changes in more health
           behaviors directed to their risk-factor profile) than those in the control group at one
           year.

        -  To determine whether the positive affect and self-affirmation intervention increases
           physical activity among patients who have depressive symptoms.

        -  To determine whether patients who are successful in increasing physical activity are
           more successful at changing other health behaviors.
    

Intervention name(s): Intervention Group
Intervention type(s): Behavioral
Intervention description(s): During the physical activity goal setting process, subjects were randomly assigned to either the control or the intervention group. The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their physical activity level. Patient also received small token gifts to remind them of their participation in the study and to induce positive affect. The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.
Other intervention name(s): Postivie affect and self-affirmation induction vs. control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Angioplasty patients; Behavior change; Physical activity; Risk reduction