bioihbjkbjnl/mcl2 huggingface dataset:
A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate
      the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) of the Knee
    

Detailed description: 
      This is a multicenter, randomized, double-blind, and placebo-controlled phase 2 study
      evaluating 2 formulations of HP-5000 in subjects with OA of the knee. The study will consist
      of up to 28-day Screening Phase that will include a Washout Period of current prescription
      and over the counter (OTC) analgesics, a 4-week double-blind Treatment Phase, and a 1-week
      safety Follow-up Period.
    

Intervention name(s): Diclofenac Sodium Active Topical Patch 1; Diclofenac Sodium Active Topical Patch 2; Placebo patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HP-5000 Active Topical Patch 1 were applied on subjects with Osteoarthritis of the knee(s); HP-5000 Active Topical Patch 2 were applied on subjects with Osteoarthritis of the knee(s); Topical placebo patches were applied on subjects with Osteoarthritis of the knee(s)
Other intervention name(s): HP-5000; HP-5000; Placebo treatment
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Methadone-Dolutegravir (DTG - GSK1349572) Drug Interaction Study.
Condition: Infections, Human Immunodeficiency Virus and Hepatitis
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3
      clinical development for the treatment of HIV infection. As HIV-infected subjects may also be
      receiving methadone for opioid dependence, an evaluation of the potential interaction between
      DTG and methadone is warranted. The primary objective of this study is to determine whether
      concomitant administration of DTG can affect the pharmacokinetics (PK) of methadone. As a
      secondary endpoint, the PK of DTG will be compared to historical data. This study will be
      open-label with subjects receiving DTG and stable doses of methadone. The study will be
      conducted at one center in Canada in adult male and female subjects.
    

Detailed description: 
      The study is an open label methadone- doltegravir (DTG, GSK1349572) drug interaction study
      consist of 2 periods. Subjects must be opiate-dependent and are HIV sero-negative and are on
      stable dose of methadone 14 days prior to pre-screening. After meeting all eligible
      criterions, subjects will remain on their individual methadone dose for 3 days in period 1.
      In period 2, subjects will continue on their individual stable dose of methadone and will
      receive 50 mg DTG every 12 hours for 5 days. Pharmacokinetics will be collected on Day 3 of
      period 1 and Day 5 of period 2. Safety measurements will be routine chemistry, haematology
      and urinalysis. Pharmacodynamic parameters for pupillometry and opioid symptom questionnaire
      will be collected at the same timepoints as for the pharmacokinetics. Subjects will be
      discharged after the last PK sample has been collected. A follow-up visit will occur 7-14
      days after the last dose of study drug. This study will be conducted at one centre in Canada.
    

Intervention name(s): Dolutegravir; Methadone
Intervention type(s): Drug; Drug
Intervention description(s): Dolutegravir is an experimental drug in the integrase inhibitor class for the treatment of HIV. Dose of 50mg every 12 hours for 5 days.; Methadone is a synthetic opioid used in the treatment of opioid dependence. Subjects will be on individualize stabe dose for 8 days.
Intervention MeSH terms: Dolutegravir; Methadone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: methadone; Opiate-dependent
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are
      effective in the treatment of vaginal atrophy.
    


Intervention name(s): Bazedoxifene/Conjugated Estrogen
Intervention type(s): Drug
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Vaginal Atrophy; Postmenopause
Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.
Condition: Asthma
MeSH terms: Asthma; Emergencies
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED
      patients with refractory acute asthma helps improve forced expiratory volume at one second
      (FEV1) and decrease the need for hospitalization.
    

Detailed description: 
      This is a randomized clinical trial studying the effect of nebulized budesonide (Pulmicort)
      in acutely ill adults presenting to the Emergency Department with severe asthma. Budesonide
      is an inhaled steroid FDA approved for the treatment of pediatric chronic asthma. ED entry
      criteria include hyporesponsiveness to nebulized beta-agonists and an FEV1<50% predicted. The
      trial will evaluate the efficacy of multiple doses of nebulized budesonide as an adjunct to a
      highly regimented standardized treatment protocol; standard care consists of bronchodilators
      (beta-agonists/anticholinergics), systemic steroids, and intravenous magnesium sulfate (if
      the FEV1<25% predicted). The primary efficacy endpoint will be the FEV1 4 hours after
      administration of the study intervention. An additional safety and efficacy endpoint will
      take place at 5 hours after study intervention. The treatments will be coupled with a
      protocol-defined assessment regimen, with endpoints measured before each treatment and on ED
      disposition (at 5 hours after study intervention).
    

Intervention name(s): Budesonide; albuterol; Ipratropium bromide; Prednisone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2mg/dose by nebulizer, four doses over 3 hours; 2.5mg/dose by nebulizer, 7 doses over 6 hours; 2.5 mg, one dose; 60mg PO
Other intervention name(s): Pulmicort Respules; proventil; proair; ventolin; salbutamol; Atrovent; deltasone
Intervention MeSH terms: Prednisone; Budesonide; Bromides; Albuterol; Ipratropium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: acute, emergency department
Safety Study of Gene Therapy for Ischemic Heart Disease in Korea
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of VM202RY direct injection into the
      cardiac muscles of the coronary artery territory where complete revascularization could not
      be done even through Coronary Artery Bypass Graft.
    

Detailed description: 
      All the patients expected to undergo Coronary Artery Bypass Graft will screen for the
      participation in the clinical study. Subjects who signed the informed consent will receive
      all the screening tests within 21 days before surgery (Day 0). VM202RY will be injected into
      4 sites or 8 sites on the coronary artery where complete revascularization was not done since
      vascular anastomosis could not be performed due to the bad vascular condition during surgery.
      VM202RY will be administered to Group1 (0.5mg), Group 2 (1mg) and Group 3 (2mg) at different
      concentrations. Subjects will be scheduled to get inpatient treatment during the gene therapy
      period (7 days) and follow-up tests at Week 2, 4, 8, 12 and 24 based on surgery day (Day 0).
      Adverse events and concomitant drugs will be checked.
    

Intervention name(s): VM202RY; VM202RY; VM202RY
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5mg intramuscular injection; 1mg intramuscular injection; 2mg intramuscular injection
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Addition of Nitrous Oxide and Its Effects on Depth of Anesthesia
Condition: Deep Sedation; Anesthesia, General
Study type: Interventional

Summary: 
      The study hypothesizes that adding 60% nitrous oxide to a steady state sevoflurance or
      propofol anesthetic will lead to a decrease in both BIS and Entropy indices during a constant
      level of surgical stimulus
    

Detailed description: 
      Nitrous oxide is a widely used general anesthetic pas. It is often used in addition to a
      second, more potent agent. BIS and Entropy are depth of anesthesia monitors in clinical use.
      There are conflicting reports about the usefulness of these monitors when nitrous oxide is
      used as a part of the anesthetic regimen. While some studies demonstrate a decrease in BIS
      and Entropy, this study aims to investigate the effects of adding nitrous oxide to a
      sevoflurane or a propofol based anesthetic on BIS and Entropy indices.
    

Intervention name(s): Sevoflurane group; Propofol group
Intervention type(s): Drug; Drug
Intervention description(s): Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.; Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.
Other intervention name(s): nitrous oxide; nitrous oxide
Intervention MeSH terms: Nitrous Oxide; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: depth of sedation; nitrous oxide; general anesthesia; anesthesia indices
The Effect of Corticotomy in En-mass Retraction
Condition: Accelerate Tooth Movement
Study type: Interventional

Summary: 
      -  To compare patients who will undergo orthodontics treatment involving upper premolar
           extraction for space of time whether with or without corticotomy by Piezotome.

        -  Assess the safety of both methods of retraction in regard to the quality of the
           surrounding periodontium and roots of anterior teeth.

        -  Monitor postoperative pain.
    


Intervention name(s): piezotome assisted orthodontic tooth movement
Intervention type(s): Procedure
Intervention description(s): Surgical procedure
After local anesthesia, vertical interproximal incisions will be done under the interdental papilla, on the labial aspect of upper arch using a blade No. 15.
The incisions will be kept minimal.
The incisions go though the periosteum, which permit the blade to reach to the alveolar bone.
A Piezo surgical knife will be used to make the cortical alveolar incision through the gingival incisions to a depth of approximately 3mm.
As we will not use bone graft so we don't need use suturing after cortication.
We give patient antibiotic and analgesic cover.
Other intervention name(s): corticotomy assisted tooth movement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: corticotomy; enmass retraction; mini implant
A Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the effect of a cytochrome P450 3A4 (CYP3A4)
      inhibitor (itraconazole) and CYP3A4 inducer (carbamazepine) on the single dose
      pharmacokinetics (PK) of DC-806 coadministered with itraconazole or carbamazepine in healthy
      male and female participants.
    


Intervention name(s): DC-806; Itraconazole; Carbamazepine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablets; Oral capsules; Oral tablets
Intervention MeSH terms: Itraconazole; Carbamazepine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: DC-806; Drug-Drug Interaction; Itraconazole; Carbamazepine
Bevacizumab for Treatment of Recurrent Respiratory Papillomatosis (RRP)
Condition: Recurrent Respiratory Papillomatosis
MeSH terms: Respiratory Tract Infections; Papillomavirus Infections; Papilloma; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I single center open labeled study is planned to assess the safety and
      tolerability of bevacizumab for treating patients with bilateral Recurrent Respiratory
      Papillomatosis (RRP). Approximately 20 patients will receive bevacizumab directly injected
      into the vocal folds. Patients who enroll in the protocol will be injected with bevacizumab
      in one vocal fold that represents the more diseased of the two folds. A sham injection with
      saline will be administered to the other vocal fold as the control. This therapy will be
      administered once every 6 ± 1 week for 6 months, with the same vocal fold selected for the
      initial treatment always getting the drug injection. The investigator will also treat lesions
      by laser photoangiolysis of both vocal folds using the 532 nm potassium-titanyl-phosphate
      (KTP) laser.
    


Intervention name(s): Avastin® (bevacizumab); Saline
Intervention type(s): Drug; Drug
Intervention description(s): Bevacizumab injections (~7.5-12.5mg in 0.3 - 0.5 c.c.) into diseased vocal folds in conjunction with 532 nm pulsed-KTP laser photoangiolysis, administered every 6 ±1 weeks, for a total of 5 treatments. No patient will have an injection volume exceed 0.5 cc. for any single treatment. If initial results indicate a benefit, as described below, an extension of the active treatment period will be permitted up to a total treatment duration of 18 months.; A sham injection with saline (0.3-0.5 cc) has been administered to the other vocal fold as the control. This therapy will be administered once every 6 ± 1 week for 6 months, with the same vocal fold selected for the initial treatment always getting the drug injection.
Other intervention name(s): Avastin®
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Frozen Blastocyst Transfer in Natural Cycle
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The rational of the study is to assess the pregnancy rate after the transfer of frozen
      blastocyst in natural cycle controlled by external administration of hCG.
    


Intervention name(s): hCG
Intervention type(s): Drug
Intervention description(s): 5000IU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FET; Blastocyst; natural cycle; hCG; Spontaneous LH pic
Sleep, Physical Activity and Multiple Sclerosis Symptoms in Pediatric Multiple Sclerosis
Condition: Pediatric Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Most youth with MS experience symptoms such as depression and fatigue. In addition, cognitive
      issues, especially with attention and memory occur frequently. However, little is known about
      interventions that might work to improve these symptoms. In other work, the investigators
      have shown that higher levels of physical activity are associated with lower levels of
      depression and fatigue. Importantly, sleep problems are frequently encountered in youth with
      MS, and were seen in 60% of surveyed youth with MS in the investigators preliminary work.
      Modifiable lifestyle factors such as sleep and physical activity (PA) may play a key role in
      ameliorating common symptoms in pediatric MS. However, sleep has not been objectively
      described in pediatric MS, and the relationship between PA and sleep is poorly understood.
      This study aims to address these gaps.
    


Intervention name(s): Actigraphy
Intervention type(s): Device
Intervention description(s): Actiwatch Spectrum Plus will be worn on the non-dominant wrist 24 hours/day for seven days. Actigraphy is a valid and reliable objective measure of sleep patterns, including sleep quality, duration, and timing when compared to polysomnography (PSG).
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        There will be a total of 60 participants in this study. The study population consists of
        both patient participants (pediatric multiple sclerosis patients) and non-patient
        participants (healthy volunteers).
A Specialized Diet for the Unique Metabolic Characteristics of Peripubertal African American Girls
Condition: Obesity; Type 2 Diabetes
MeSH terms: Obesity
Study type: Interventional

Summary: 
      A diet (42% carbohydrate) specialized to the unique metabolic characteristics of peripubertal
      African AMerican girls (hyperinsulinemic, low insulin sensitive) will be more effective in
      maintaining glucose and insulin homeostasis compared to a standard diet (55% carbohydrate)
    


Intervention name(s): Dietary
Intervention type(s): Other
Intervention description(s): modification of macronutrient content
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: obesity, puberty, diabetes,insulin dynamics
The Changes of Body Fat Distribution in Obese Patients With PCOS After LSG
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to
      15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation
      disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other
      metabolic abnormalities. Abdominal fat accumulation, overweightness and obesity are
      frequently present in patients with PCOS . Visceral adipose tissue (VAT) plays an important
      role in the pathogenesis of PCOS.Therefore，this study aim to investigate the changes of body
      fat distribution in obese women with PCOS after laparoscopic sleeve gastrectomy (LSG), and to
      explore the factors that may predict the changes in body fat distribution in PCOS patients
      after LSG.
    

Detailed description: 
      This study consecutively enrolled 153 patients with obesity aged 18-45 years (83 with PCOS
      and 70 control patients) who underwent LSG from May 2013 to September 2020 at the Department
      of Endocrinology, Shanghai Tenth People's Hospital, with a 12-month follow-up. Dual-energy
      X-ray absorptiometry (DEXA) was used to assess body fat distribution.
    

Intervention name(s): laparoscopic sleeve gastrectomy (LSG)
Intervention type(s): Procedure
Intervention description(s): Multiple studies have indicated that laparoscopic sleeve gastrectomy (LSG) was superior to nonsurgical approaches for the treatment of obese PCOS patients over both the short and long term
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laparoscopic Sleeve Gastrectomy; Body fat distribution; Dual-energy X-ray absorptiometry; Visceral adipose tissue
Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis
Condition: Pharyngitis
MeSH terms: Pharyngitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to investigate efficacy and tolerability of lozenges containing
      20 mg a mbroxol hydrochloride (Mucoangin?) relative to lozenges containing placebo and
      lozenges containing 3 mg benzocaine in relieving pain of sore throat in patients suffering
      from acute viral pharyngitis.
    

Detailed description: 
      This is a randomised, double-blind, placebo- and active-controlled parallel group study in
      adult pat ients, suffering from acute viral pharyngitis and throat pain of at least moderate
      intensity.

      The whole study will last for up to 4 days, on each of test days patients will take one
      lozenge cont aining Ambroxol hydrochlorid 20 mg/ or placebo/ or benzocaine lozenge 3 mg up to
      6 lozenges per day.

      Using Patient Diaries the assessment of tolerability and efficacy by the patient will be
      obtained.

      Study Hypothesis:

      The primary hypothesis to be tested is the test of superiority of ambroxol 20 mg in
      comparison to placebo. If and only if the corresponding test of superiority to placebo is
      statistically significant, the hypothesis of non-inferiority of am broxol 20 mg in comparison
      to benzocaine 3 mg will be tested.

      Comparison(s):

      For the primary comparison the placebo lozenges will be used, for the secondary comparison
      the benzocaine 3 mg lozenges will be used.
    

Intervention name(s): Ambroxol hydrochloride (Mucoangin?); benzocaine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Benzocaine; Ambroxol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
Condition: ADHD; Stimulant-Induced Euphoria
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to a) assess the efficacy of naltrexone in preventing
      stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere
      with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether
      naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We
      predict that naltrexone will successfully prevent stimulant-induced euphoria without
      interfering with the ability of stimulants to effectively treat ADHD in adults. This study
      will be an 8 -week trial with young adults (18-24) with ADHD.
    


Intervention name(s): SODAS MPH; Naltrexone
Intervention type(s): Drug; Drug
Intervention description(s): Adults with ADHD will receive open-label SODAS MPH; Subjects randomized to the "active" double-blind group will receive Naltrexone HCl
Other intervention name(s): Ritalin LA; Naltrexone HCl
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ADHD; Naltrexone; SODAS MPH; Stimulant-Induced Euphoria; Substance Abuse; Adults