bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Parecoxib on the Change of Shoulder Pain Threshold After Gynecological Laparoscopies
Condition: Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective, double blind, placebo-controlled, parallel group study will be conducted in
      the first affiliated hospital of Sun yat-sen university in Guangzhou, China. Patients aged
      18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general anesthesia
      will be involved in this study. According to previous studies and our pilot trial, estimated
      120 patients will be involved in this study. All eligible patients will be randomly assigned
      to two groups. In group P, patients will receive parecoxib 40mg intravenously 30min before
      intubation, 8h and 20h after the surgery,respectively. In Group C, patients will receive
      normal saline at the same time points. The shoulder pressure pain thresholds will be measured
      with a pressure algometer by an independent doctor blinding to medication and grouping at the
      day before surgery, 24h and 48h after surgery. Moreover, the intensity of shoulder pain and
      side effects will be evaluated by another independent doctor at 24h and 48h after surgery. At
      the end of the observation, the intensity of the maximal shoulder pain will be assessed.
    


Intervention name(s): Parecoxib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Parecoxib 40mg will be intravenously infused.; Normal saline 5ml will be intravenously infused.
Intervention MeSH terms: Parecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: NSAIDs; Hyperalgesia; Postlaparoscopic shoulder pain
Effects of Progressive Muscle Relaxation Training With Music Therapy on Sleep Quality and Trait Anger/Anger Expression Style of Patients at Community Mental Health Center
Condition: Sleep; Anger; Psychiatric Disorder
MeSH terms: Mental Disorders; Problem Behavior
Study type: Interventional

Summary: 
      Aim: The aim of the study was to examine the effects of progressive muscle relaxation
      training with music therapy on sleep quality, trait anger, and anger expression style of
      patients at the community mental health center.

      Method: The study is conducted as the pretest-posttest control group design. The study
      population consisted of chronic psychiatric patients who continue in a Community Mental
      Health Center located in southeastern Turkey. The days when the participants came to the
      Community Mental Health Center were selected and the participants divided into two groups as
      an intervention and control group.
    


Intervention name(s): Progressive Muscle Relaxation Training and Music Therapy
Intervention type(s): Other
Intervention description(s): Progressive Muscle Relaxation Training and Music Therapy have applied to the participants two sessions for a week during two months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: sleep quality; Anger; Psychiatric Disorder; therapy
A Dose Ranging Study Evaluating Efficacy and Safety of NI-03
Condition: Chronic Pancreatitis
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of NI-03.
    

Detailed description: 
      The primary objective of the Single-Dose Phase is to assess the pharmacokinetics (PK) and
      safety of single doses of NI-03 when administered at doses of 100 mg, 200 mg or 300 mg to
      subjects with chronic pancreatitis.

      The primary objective of the Double-Blind Phase of the study is to determine the efficacy, PK
      and safety of three doses of NI-03 (100 mg, 200 mg and 300 mg) as compared to placebo when
      administered three times daily (TID) for 28 consecutive days in subjects with chronic
      pancreatitis.
    

Intervention name(s): NI-03; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Testing a Digital Intervention for Adolescents
Condition: Rumination; Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      Teen participants (ages 13-17) will be randomly assigned to either an experimental (the
      Happify Teens digital platform), or a waitlist control group. The study includes an 8-week
      intervention period and a 1-month follow up period.
    

Detailed description: 
      Teen participants (ages 13-17) will be randomly assigned to either the experimental group in
      which participants receive access to Happify Teens, a digital platform rooted in several
      therapeutic traditions that aims to improve wellbeing, or a waitlist control group. Both
      group conditions last 8 weeks. Participants assigned to the Happify Teens platform will have
      full access to the intervention, with featured tracks that focus on dealing with stress,
      worries and building skills for greater happiness. Participants assigned to the waitlist
      (control) condition will not have access to the Happify Teens platform for the full study
      period (12 weeks total). Participants in the waitlist control will receive access to Happify
      Teens after the full study period is complete (12 weeks). Perceived stress, rumination, and
      optimism will be assessed via self-report at baseline, end of the 8-week intervention, and at
      1 month post intervention.
    

Intervention name(s): Happify Teens
Intervention type(s): Behavioral
Intervention description(s): An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
Masking: None (Open Label)
Primary purpose: Other
Evaluation of a Balance-recovery Specific Falls Prevention Exercise Program
Condition: Accidental Falls
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to investigate the potential to train compensatory stepping and grasping
      reactions for the prevention of falls.
    

Detailed description: 
      Physical activity and exercise have been shown to prevent falling in older adults, although
      the exact mechanisms by which exercise prevents falls is unclear. Compensatory stepping and
      grasping reactions are frequently used to prevent a fall to the ground following a loss of
      balance. Age-related impairment in these reactions may be related to an increased risk of
      falling. Therefore, the purpose of this study is to investigate means for reversing
      age-related impairment in compensatory stepping and grasping reactions. A training program
      involving perturbation-evoked reactions will be evaluated.

      Comparison(s): Balance recovery ability before and after a 6-week training program will be
      assessed. Performance of the training group will be compared to a control group not receiving
      stepping and grasping training.
    

Intervention name(s): Balance training (exercise); Flexibility and relaxation exercise
Intervention type(s): Behavioral; Other
Intervention description(s): Perturbation-based balance training. 30-minute sessions three times per week for six weeks.; 30-minute sessions, three times per week for six weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Rehabilitation; Postural Balance; Accidental Falls; Geriatrics
The Effect of Central Insulin on Insulin Sensitivity and Energy Metabolism
Condition: Diabetes
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      Insulin has a direct effect on the energy metabolism of the brain under basal conditions and
      has an effect on the hepatic glucose production, lipid metabolism and the secretion of
      various hormone. The effect of intranasal insulin on peripheral metabolism in humans
      supposedly is mediated by the vagus nerve.

      The purpose of this study is to determine whether central insulin influences the human
      peripheral insulin sensitivity of liver and muscle and whether vagus nerve stimulation can
      mimick this effect.
    

Detailed description: 
      Insulin has a direct effect on the energy metabolism of the brain under basal conditions and
      has an effect on the hepatic glucose production, lipid metabolism in the mouse model.

      The purpose of this study is to determine whether central insulin influences the human
      peripheral insulin sensitivity of liver and muscle and energy metabolism. Intranasal insulin
      can be used in humans to deliver insulin to the brain and studies have shown that intranasal
      insulin might reduce food intake, lower body weight and modulate muscle glucose and adipose
      tissue lipid metabolism in himans. These effects are likely mediated by the vagus nerve as
      skeletal muscle insulin sensitization after intranasal insulin relates to parasympathetic
      tone activity (Heni et al. Diabetes 2014). Transcutaneous auricular vagus nerve stimulation
      (taVNS) activates non-invasively the sensory branches of the vagus nerve and is applied in
      humans as adjuvant treatment in drug-resistant epilepsy (Frangos et al. 2015). Thereby it can
      be used to examine whether the vagus nerve indeed mediates brain insulin signals to the
      periphery.

      Here we aim to investigate the effects of intranasal insulin on hepatic glucose, lipid and
      energy metabolism. We further aim to test whether taVNS can mimick intranasal insulin effects
      on peripheral metabolism in humans.
    

Intervention name(s): intransal insulin; Placebo; taVNS; sham stimulation
Intervention type(s): Drug; Drug; Device; Device
Intervention description(s): 4x 40mU intranasal insulin
Other intervention name(s): intranasal insulin; intranasal placebo spray; transcutaneous auricular vagus nerve stimulation; sham stimulation in the ear lobe
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: central insulin; insulin resistance; energy metabolism
Evaluation of Efficacy and Safety of Highly Purified Urofollitropin for Ovulation Induction in Chinese Females
Condition: Anovulation
MeSH terms: Anovulation
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to
      Recombinant Human Follitropin Alfa for Injection for Ovulation Induction in Chinese females
    


Intervention name(s): Highly Purified Urofollitropin; Recombinant Human Follitropin Alfa
Intervention type(s): Drug; Drug
Intervention description(s): for Injection; for Injection
Other intervention name(s): Bravelle®; Gonal-F®
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy,
      safety, and tolerability of fixed-dose brexpiprazole + sertraline combination treatment in
      adult subjects with post-traumatic stress disorder.
    


Intervention name(s): Brexpiprazole; Sertraline; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Up to 3 mg pill; Up to 150 mg pill; Pill
Other intervention name(s): Rexulti; Zoloft
Intervention MeSH terms: Sertraline; Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PTSD
Study of Gardasil in Mid-Adult Males (MAM)
Condition: Human Papillomavirus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effectiveness of the research study vaccine,
      Gardasil, in men ages 27-45 who have completed 4 years of observation in The Human
      Papillomavirus [HPV] infection in men (HIM) Study.
    

Detailed description: 
      The MAM Study is a prospective pilot intervention trial to investigate patterns of human
      papillomavirus (HPV) vaccine immunogenicity in men, aged 27-45 years, in which the men will
      receive Gardasil. Gardasil was administered at 0, 2, and 6 months. Blood was drawn at 0 and 7
      months to provide a quadrivalent HPV antibody serologic profile. Participants also completed
      surveys via computer-assisted interviews (CASI) at Day 1 and Month 7 to record sexual
      behavior.

      Our overall goal is to test the efficacy of Gardasil to reduce HPV 6, 11, 16, 18 persistent
      infection among men at the external genital epithelium, anal canal, and oral cavity, and to
      reduce lesions caused by these HPV types at the external genital epithelium and anal canal.
      The purpose of this Phase II trial is to establish the immunogenicity of Gardasil among
      mid-adult men and to establish the infrastructure with which to build the larger Phase III
      trial in the future.
    

Intervention name(s): Gardasil
Intervention type(s): Biological
Intervention description(s): The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3).
Other intervention name(s): HPV vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HPV
ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of ADX48621 in
      Parkinson's disease patients following four weeks of dosing.

      The secondary objectives of the study include the evaluation of the efficacy of ADX48621
      compared with placebo in reducing levodopa induced dyskinesia in patients with Parkinson's;
      the evaluation of the effect of ADX48621 on symptoms of Parkinson's disease and patient
      ability to function, and the evaluation of the effect of coadministration of ADX48621 on
      L-dopa efficacy.
    

Detailed description: 
      First study of ADX48621 in male and female Parkinson's disease patients with levodopa-induced
      dyskinesia. Four weeks, double-blind, placebo-controlled dose titration from 50 mg once daily
      up to 100 mg three times daily, at the start of week 4. Safety and tolerability assessed by
      adverse events enquiry, heart rate and blood pressure, 12-lead ECG, haematology and
      biochemistry. Efficacy assessments include Abnormal Involuntary Movement Scale (AIMS),
      Unified Parkinson's Disease rating Scale (UPDRS) patient PD symptom diaries, Hospital Anxiety
      Depression Scale (HADS), patient and clinician global impression of change in PD and
      dyskinesia (PGIC and CGIC).
    

Intervention name(s): ADX48621; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral administration; oral administration
Other intervention name(s): Dipraglurant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dyskinesia; Parkinson's disease
Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa; Acne Inversa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Hidradenitis suppurativa is a disease involving skin folds, causing swelling of the skin and
      surrounding tissues, pain, and foul-smelling discharges. Effective treatment options are
      lacking. Recently, clinical trials conducted in our lab found Brodalumab was an effective
      drug for this disease. Weekly dosing achieved superior therapeutic outcomes compared to a
      dosing given once in every other week. Brodalumab was safe in both regimens, but blood and
      tissue studies to better understand this response are still needed. By performing this small
      pilot study and collecting blood and tissue samples from participants treated with Brodalumab
      once weekly we would like to better characterize the molecular response to this treatment,
      identify blood and tissue markers reflecting disease severity, and better understand disease
      mechanisms.
    


Intervention name(s): Brodalumab
Intervention type(s): Drug
Intervention description(s): Subcutaneously Brodalumab/Siliq, 210mg/1.5ml once a week
Other intervention name(s): Siliq
Intervention MeSH terms: Brodalumab
Intervention model: Single Group Assignment
Intervention model description: Open label
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hidradenitis Suppurativa; Acne Inversa; Brodalumab
Cereals as a Source of Iron for Breastfed Infants
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      The purpose of this research study is to determine whether the type of iron in infant cereals
      makes a differance in how well the cereal helps infants remain free of iron deficiency.
    


Intervention name(s): electrolytic iron; ferrous fumarate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1/4 a cup of cereal fortified with electrolytic iron per day between the ages of 112 days and 280 days of age; 1/4 cup of cereal fortified with ferrous fumarate to be fed per day between ages of 112 days and 280 days of age
Intervention MeSH terms: Ferrous fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy
Condition: Type 2 Diabetes; Overt Diabetic Nephropathy
MeSH terms: Kidney Diseases; Renal Insufficiency; Diabetic Nephropathies; Proteinuria; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Objective:

      To evaluate how rosiglitazone does influence the renal plasma flow, the glomerular filtration
      rate and the degree of proteinuria in type 2 diabetic patients with renal insufficiency due
      to overt diabetic nephropathy.

      Background:

      Diabetic nephropathy is a world wide public health concern of increasing proportions. It has
      become the most common single cause of end-stage renal disease in the United States and in
      Europe. Previous studies have already found agents modifying the renin-angiotensin-system
      (ACE inhibitors and angiotensin receptor blocker) to retard diabetic nephropathy. These
      agents are likely to exert multiple effects in the kidney. One of them appear to be their
      known ability to improve endothelial function and to change renal glomerular hemodynamics.

      In a previous study we demonstrated an improvement of renal endothelial dysfunction in type 2
      diabetic patients without end organ damage after treatment with rosiglitazone. In that study,
      rosiglitazone significantly reduced glomerular hyperfiltration. This was associated with a
      reduction of urinary albumin excretion. The observed effects are potentially important in the
      context of renal protection, provided that a similar beneficial effect of rosiglitazone is
      demonstrable in overt diabetic nephropathy (renal insufficiency, hypertension, proteinuria).

      Hypothesis Rosiglitazone decreases proteinuria and improves renal hemodynamic function in
      patients with chronic renal insufficiency due to overt diabetic nephropathy.
    


Intervention name(s): Rosiglitazone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4 mg tablets, bid, 12 months; 2 tablets per day
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 2 diabetes,; glomerular filtration rate,; renal plasma flow,; endothelial dysfunction,; proteinuria,; diabetic nephropathy
Comparison of Transdermal and Oral Estrogens in Adolescent Girls With Ovarian Failure
Condition: Ovarian Failure, Premature
MeSH terms: Primary Ovarian Insufficiency
Study type: Interventional

Summary: 
      To directly compare the safety (by laboratory evaluation) and efficacy (feminization and
      growth) of three commonly used estrogen preparations in adolescent patients with ovarian
      failure, either due to congenital causes (Turner syndrome) or medical therapies. We
      hypothesize that transdermal estrogen will have equivalent efficacy and a more favorable
      safety profile in comparison with conventional oral estrogen replacement.
    

Detailed description: 
      Treatment with transdermal 17beta(17β) estradiol resulted in higher estradiol levels and more
      effective feminization compared to oral conjugated equine estrogen but did not result in an
      otherwise different biochemical profile in this limited number of heterogeneous patients. OBE
      (oral beta estradiol) and TBE (transdermal beta estradiol) provide safe and effective
      alternatives to OCEE (oral conjugated equine estrogen) to induce puberty in girls, but larger
      prospective randomized trials are required.
    

Intervention name(s): 17beta Estradiol; Conjugated estrogens; 17Beta Estradiol - transdermal; Progesterone, micronized
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral pill given daily at increasing doses every 6 months for 18 months.; Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months; Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months; Given starting at 18 months
Other intervention name(s): Estrace; Premarin; Vivelle-Dot; Prometrium
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Estrogens; Estrogens, Conjugated (USP); Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment