bioihbjkbjnl/mcl2 huggingface dataset:
GnRH Agonist as Luteal Support in FET Cycles
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      Back ground: A single dose of GnRH analogue in the luteal phase is reported to improve the
      outcome of IVF/ICSI treatments but the effect in FET cycles has not been reported.

      Aim: To compare the results of frozen thawed embryo transfers with and without GnRHa analogue
      support Primary end point: IR, PR, on going PR Secondary end point: hCH, E2 and progesterone
      levels 14 days after thawing
    


Intervention name(s): Natural cycle: Triptorelin acetate 0.1 mg; Hormone replacement cycle and triptorelin acetate 0.1 mg
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of triptorelin acetate 0.1 s.c. was giwen when the age of the transferred embryo was six days in additon to standard micronized progesterone 400 mg vaginally; A single dose of triptorelin acetate 0.1 s.c. was giwen when the age of the transferred embryo was six days in addition to standard Estradiol and progesterone support
Intervention MeSH terms: Triptorelin Pamoate; Hormones
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections
Condition: Skin Infection; Bacterial Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Cellulitis; Skin Diseases, Infectious
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of three different dosing
      regimens of brilacidin compared to daptomycin for the treatment of serious skin infections.
      This study will aid in selecting the appropriate dose of brilacidin for later stage studies.
    

Detailed description: 
      This is a randomized, multi-center, double-blind study to evaluate the efficacy and safety of
      three regimens of brilacidin compared to an active control, daptomycin, in subjects with
      ABSSSI. Subjects must have infections that warrant intravenous therapy but may be treated as
      either inpatients or outpatients.

      Eligible subjects will be randomized to one of 4 treatment groups in a 1:1:1:1 ratio.
      Subjects randomized to brilacidin will receive either a single intravenous infusion (0.6
      mg/kg or 0.8 mg/kg) followed by six days of once daily placebo, or a three day regimen (0.6
      mg/kg on Day 1 followed by 0.3 mg/kg on Days 2 and 3) followed by 4 days of once daily
      placebo. Subjects randomized to daptomycin will receive 7 days of treatment. Subjects will be
      assessed for both clinical and microbiologic efficacy 48-72 hours after the first dose of
      study drug. After an assessment at Day 7-8, subjects will be again be evaluated for efficacy
      at Day 10-14 and via a phone contact at Day 21-28.

      Approximately 200 subjects randomized in a 1:1:1:1 ratio to receive one of the three
      brilacidin regimens or daptomycin will be evaluable. The primary efficacy outcome, early
      clinical response 48-72 hours after the first dose of study drug, will be determined in the
      Intent-to treat (ITT) population. Additional efficacy and safety analyses will be performed.
    

Intervention name(s): Daptomycin; Brilacidin
Intervention type(s): Drug; Drug
Intervention description(s): Active Comparator; Experimental Drug
Other intervention name(s): Cubicin; PMX63
Intervention MeSH terms: Daptomycin; Brilacidin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Skin Infection; Staph aureus; MRSA; MSSA; Cellulitis/Erysipelas; Wound Infection; Abscess
The Effect of The Walking Exercise Training Given According to Transtheoretical Model, and Follow-Up on Improving Exercise Behavior and Metabolic Control in Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      OBJECTIVE This study aims to find out the effects of walking exercise training, which is
      given according to Transtheoretical Model (TTM), and follow-up on improving exercise behavior
      and metabolic control in type 2 diabetic patients.

      RESEARCH DESIGN AND METHODS The study was conducted as a pre-test, post-test experimental
      model with 76 intervention (INT) groups and 76 control (CON) groups adult type 2 diabetic
      patients providing the criteria of the study and followed-up by the diabetes polyclinic of
      Adıyaman Education and Research Hospital. Patient introduction form (PIF), TTM scales and
      pedometer were used to collect the data. TTM based training was given to the intervention
      group according to the patients' change stages at hospital 10 weeks once per every 2 weeks.
      PIF, TTM scales were applied after the training. PIF, TTM scales were applied to the groups 9
      months after the pre-test again.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Other intervention name(s): THE WALKING EXERCISE TRAINING GIVEN ACCORDING TO TRANSTHEORETICAL MODEL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Type 2 Diabetes Mellitus; Metabolic Control; Walking Exercise; Transtheoretical Model; Nurse
Behavioral Interventions for Chronic Pain and Opioid-Related Problems
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of Mindfulness-Oriented Recovery
      Enhancement versus a social support group (supportive counseling) intervention for chronic
      pain patients receiving long-term opioid pharmacotherapy for pain.
    


Intervention name(s): Mindfulness-Oriented Recovery Enhancement; Supportive Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention led by a therapist that combines training in mindfulness, cognitive reappraisal, and savoring skills.; A support group led by a therapist will allow participants to express emotions, share experiences, and receive social support.
Other intervention name(s): MORE; Support Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Insertion of an Intrauterine Device (IUD) After Medical Abortion
Condition: Intrauterine Device Expulsion; Medical Abortion; Induced Abortion
MeSH terms: Abortion, Spontaneous
Study type: Interventional

Summary: 
      The purpose of this study is to determine the expulsion and continuation rate of an
      intruterine device (IUD) placed immediately after medical abortion.

      Our hypothesis is that immediate-placement of an IUD after completed medical abortion will
      have a similar expulsion and continuation rate to traditional placement (4-6 weeks after
      pregnancy).
    

Detailed description: 
      Women who seek abortion care often desire more effective or longer- lasting contraception.
      Intrauterine devices are as efficacious as tubal ligation, require no on-going effort on the
      woman's part to protect her from pregnancy, and are underutilized in the US. We are
      interested in determining whether placement of an intreatuereine device (IUD) at the time of
      confirming the completion of a medical abortion may have similar expulsion and continuation
      rates as IUDs placed after pregnancy (usually a 4-6 week time period). If this is the case,
      women may save the time and effort of yet another clinic visit, as well as have immediate
      protection against pregnancy after their abortion. FDA labeling does not specify or restrict
      time of insertion and therefore this study is in compliance with FDA labeling.
    

Intervention name(s): IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]
Intervention type(s): Device
Intervention description(s): When a subject has chosen a method of intra-uterine contraception and has agreed to participate in the study, she will have the intra-uterine device of her choice inserted according to the Food and Druga Administration (FDA) instructions.
Other intervention name(s): IUD insertion icludes the insertion of either the Copper T-380A or Levonorgestrel (intrauterine system) IUS
Intervention MeSH terms: Copper; Levonorgestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intrauterine Device; Induced Abortion; Medical Abortion
Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Healthy Subjects.
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard
      to its total and to its maximum serum insulin concentrations.
    

Detailed description: 
      The purpose of this study is the comparative evaluation of the Pharmacodynamics and
      Pharmacokinetics of two recombinant regular human insulin injections administered
      intravenously in healthy volunteers under the conditions of euglycemic clamp.
    

Intervention name(s): Wosulin R; Actrapid
Intervention type(s): Biological; Biological
Intervention description(s): Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.; Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Diabetes, Healthy Volunteers
Platelet Rich Fibrin Combined With Simvastatin for Treatment of Intrabony Defect in Chronic Periodontitis
Condition: Three Wall Intrabony Defects in Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the present study was to investigate the efficacy of autologous Platelet rich
      fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment
      of three wall intrabony defects in comparison to OFD alone.
    

Detailed description: 
      90 systemically healthy subjects were divided randomly into three groups (30 subjects in each
      group, per subject one site). Control group consisted of the sites treated with OFD and test
      groups sites were treated with OFD with autologous PRF or PRF with SMV. Site-specific plaque
      index (PI), sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL)
      and intrabony defect (IBD) depth reduction was measured at baseline and 9 month after
      surgery.
    

Intervention name(s): Platelet rich fibrin and simvastatin; Platelet rich fibrin; Open Flap Debridement alone
Intervention type(s): Drug; Biological; Procedure
Intervention description(s): Three wall intrabony defect sites treated with Open Flap Debridement. 0.1 mL prepared SMV gel (1.2 mg/0.1 mL) was mixed with PRF. The PRF - SMV mixture was delivered to the defect.; Three wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect.; Three wall intrabony defect sites treated with Open Flap Debridement only. No PRF or SMV was delivered to the defect.
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety Study of BMS-823778 in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects
      on fasting plasma glucose (FPG).
    


Intervention name(s): BMS-823778; BMS-823778; BMS-823778; Placebo; Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsules, Oral, 2 mg, once daily, 28 days; Capsules, Oral, 10 mg, once daily, 28 days; Capsules, Oral, 20 mg, once daily, 28 days; Capsules, Oral, 0 mg, once daily, 28 days; Capsules, Oral, ≥ 1500 mg, once daily, 28 days
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study of the Efficacy and Safety of SCH 486757 in Subjects With Chronic Cough (Study P04887)
Condition: Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, crossover, single center study of SCH
      486757 in subjects with chronic cough. Subjects will be randomized to receive SCH 486757 or
      placebo for 14 days. After a 2-week washout period, subjects will be crossed over to the
      other treatment. The primary objective is to evaluate the effectiveness of SCH 486757 in
      reducing cough reflex sensitivity as determined by a challenge with capsaicin, an agent that
      induces cough.
    


Intervention name(s): SCH 486757; Placebo Dose 1
Intervention type(s): Drug; Drug
Intervention description(s): SCH 486757 2 x 50-mg capsule twice daily orally for 2 weeks followed by a 2-week washout period and 2 weeks of crossover treatment; Matching placebo capsules twice daily orally for 2 weeks followed by a 2 week washout period and 2 weeks of crossover treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19
Condition: Covid19; Critical Illness; Critical Illness Polyneuromyopathy; Early Mobilization; Rehabilitation; Robotics
MeSH terms: COVID-19; Critical Illness
Study type: Interventional

Summary: 
      Feasibility trial investigating the potential higher frequency of robotic assisted early
      mobilization in intubated COVID19 patients on the ICU.
    


Intervention name(s): Robotic assisted early mobilization
Intervention type(s): Device
Intervention description(s): Robotic assisted early mobilization Robotic assisted early mobilization started within 72 hours of ICU admission.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled, parallel-group, open label pilot trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID19; Early mobilization; robotics; Vemo
Towards a Post-exposition Pharmacological Prophylaxis for Post-traumatic Stress Disorder
Condition: Intrusive Thought; Psychological Trauma; Inflammatory Response; Physiological Stress
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Psychological Trauma
Study type: Interventional

Summary: 
      In this study, we investigate the role that deep sleep plays in the prevention of
      posttraumatic stress disorder after someone has been exposed to a trauma by boosting deep
      sleep with two drug conditions compared to placebo condition. Each volunteer in the study
      goes through all three conditions. The quantity of intrusive memories of the trauma will be
      compared between the three conditions.
    

Detailed description: 
      The present study seeks to investigate the potential to pharmacologically modulate slow-wave
      sleep in the acute aftermath of an experimentally-induced trauma in the interest of
      developing a secondary prevention of posttraumatic stress disorder. The effects of a
      GABAergic compound will be compared with that of a noradrenergic compound. Memory, sleep and
      stress-related immune response factors will be quantified and compared across drug
      conditions.
    

Intervention name(s): Dexmedetomidine; Gamma-Hydroxybutyrate; Placebo; Experimental Model Trauma Film
Intervention type(s): Drug; Drug; Drug; Behavioral
Intervention description(s): Volunteers receive a single dose of dexmedetomidine sublingually at scheduled bedrest in the sleep laboratory; Volunteers receive a single oral dose of gamma-hydroxybutyrate at scheduled bedrest in the sleep laboratory; Volunteers receive an oral (saline) or sublingual (orodispersible tablet) at scheduled bedrest in the sleep laboratory; Each volunteer views experimental model trauma film before scheduled bedrest in the sleep laboratory. This video is ca. 15 minutes in duration and is composed of short (a few seconds to a few minutes) individual and unrelated scenes of violent death and injury of varying description. Six versions of the film without re-occurring scenes will be presented in balanced order across drug order conditions.
Other intervention name(s): Dexdor; Xyrem
Intervention MeSH terms: Sodium Oxybate; Dexmedetomidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effect of Oxytocin Nasal Inhalation on Empathy Analgesia
Condition: Oxytocin; Pain; Empathy; Social Familiarity; Analgesia
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study recruited healthy volunteers and randomly divided them into four groups. They
      inhaled oxytocin or saline, and watched a pain test video with photos of acquaintances or
      strangers, respectively, to test whether their feelings of the same thermal pain stimulus had
      changed.
    


Intervention name(s): Oxytocin nasal spray; Placebo; Stranger; Acquaintance
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): Volunteers inhale 24 units of oxytocin spray; Volunteers inhale 24 units of placebo spray; Volunteers watch a video of a pain test and attach a photo of a stranger; Volunteers watch a video of a pain test and attach a photo of an acquaintance
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CBT for Pediatric OCD: Community Training Pilot
Condition: Obsessive Compulsive Disorder
MeSH terms: Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      This study examines a training program for clinicians who work in mental health clinics that
      serve children with OCD. We will provide clinician training in conducting exposure-based
      treatments for children with OCD. The purpose of the project is to test the use of a new tool
      to enhance training in exposure-based treatments for clinicians. Therapists will receive
      training and oversight from the researchers regarding the treatment procedures and use of the
      new tool. All children enrolled in the study will receive treatment by clinicians who are
      participating in this study. Therapists and youth will be recruited separately for the study
      and will be assigned to work together.
    


Intervention name(s): Behavioral Checklist
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Zilretta Injection
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the pre-post effects of a single ZILRETTA knee
      injection on physiological measures of self-reported pain and disability, physical
      performance, and physical activity in individuals with knee osteoarthritis (OA). The
      investigators will recruit 35 symptomatic knee OA patients for this study. All data will be
      collected prior to injection (baseline), as well as at 4 (post 1) and 8-week follow-ups (post
      2).
    

Detailed description: 
      Individuals with knee osteoarthritis (OA) demonstrate significant physical disability which
      leads to diminished physical activity, a lesser quality of life, as well as a higher risk of
      inactivity related comorbidities including mortality. This is thought to be caused by an
      inability to voluntarily activate your quadriceps muscle due, in part, to knee joint swelling
      and joint-related pain. Incomplete muscle activation causes quadriceps weakness.

      Individuals with quadriceps weakness exhibit changes in their walking biomechanics which is
      associated with diminished physical function and lesser physical activity in those with knee
      OA. Therefore, it is critical to develop interventions that target mechanisms causing
      decreased quadriceps activation in order to restore optimal walking biomechanics and improve
      physical activity.

      The ZILRETTA knee injection is an FDA approved, extended release corticosteroid for in
      patients with knee osteoarthritis and has been shown to reduced knee pain for 3 months in
      approximately 70% of patients. Currently, there are no studies that have examined ZILRETTA's
      objective effectiveness on physical activity, biomechanics, and performance tests in patients
      who have received an injection.

      The overall purpose of the current study is to examine the effect of a ZILRETTA knee
      injection on functional and performance tests including quadriceps neuromuscular activation,
      quadriceps strength, walking gait biomechanics, and a battery of physical performance
      outcomes at 4 and 8-weeks following injection in 35 individuals with knee OA.
    

Intervention name(s): Triamcinolone Acetonide Extended-Release Injectable Suspension
Intervention type(s): Drug
Intervention description(s): A single ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) intra-articular knee injection.
Other intervention name(s): Zilretta Injectable Product
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
First-line Gefitinib Versus Chemotherapy for Lung Adenocarcinoma in Never Smoker
Condition: Lung Cancer
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators will conduct the randomized trial to determine the role of Gefitinib
      monotherapy as first-line setting in adenocarcinoma patients with no history of smoking, as
      compared with the standard combination chemotherapy.

      This is a randomized, open label, parallel group, phase III study in never-smokers with
      advanced or metastatic adenocarcinoma of lung.

      After stratification by gender, performance status, and disease stage, patients will be
      randomized to one of the two treatment arms to receive either gefitinib or standard
      chemotherapy until clinical or objective disease progression, unacceptable toxicity or
      patient's refusal, whichever is sooner. The chemotherapy will be administered for no more
      than nine cycles.
    

Detailed description: 
      Gefitinib (Iressa TM) Arm - Gefitinib administration 250mg tablet once daily every 3 weeks

      standard chemotherapy arm - gemcitabine (1,250mg/m2 for 30 minutes on day 1 and 8 of a 3 week
      cycle) plus cisplatin (80mg/m2 on day 1 of a 3 week cycle)
    

Intervention name(s): Gefitinib; chemotherapy
Intervention type(s): Drug; Procedure
Intervention description(s): gefitinib 250mg tablet/ QD daily until Progression; gemcitabine(1250mg/m2 iv on D1 & 8) plus Cisplatin (80mg/m2 iv on D1) every 3 weeks, maximum 9 cycles
Other intervention name(s): Treamtment Arm; standard chemotherapy arm
Intervention MeSH terms: Gefitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adenocarcinoma; NSCLC; gemcitabine; Cisplatin; Gefitinib; Never smoker