bioihbjkbjnl/mcl2 huggingface dataset:
A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424, 13 Cycles
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this trial is to demonstrate the contraceptive efficacy of LPRI424,
      Additional goals of the trial are to demonstrate the safety and tolerability of LPRI424.
    

Detailed description: 
      This trial is a prospective, multicenter, open-label, non-controlled trial in postmenarcheal
      and premenopausal female subjects, including adolescents, between the ages of 13 and 45 who
      present to the clinic seeking contraception.

      At screening, informed consent will be obtained and the screening procedures will be
      performed. After confirmation of the subject's eligibility, the subject will be provided with
      the investigational product and trained in the use of an electronic diary. Afterwards, the
      subjects will visit the clinical site on Day 20±3 of the 1st, 3rd, 6th and 9th cycles and on
      Day 29+3 of the 13th cycle. The last clinical site visit will occur 10-14 days after the 13th
      cycle visit.

      The trial will include women who have never used hormonal contraceptives before consent
      (naïve users), women who have used hormonal contraceptives in the past but have had a
      contraceptive-free period before consent and a full menstrual cycle during the drug-free
      period (previous users) as well as women directly switching from another hormonal method
      (switchers).

      Adverse events and safety information will be collected throughout the study.
    

Intervention name(s): LPRI424 (dienogest/ethinylestradiol)
Intervention type(s): Drug
Intervention description(s): One LPRI424 tablet once per day for 24 days followed by 4 placebo tablets for 4 days equals one cycle.
Intervention MeSH terms: Dienogest; Ethinyl Estradiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: contraception; hormonal oral contraceptive agents; hormonal oral contraceptive; oral contraceptive
MAGE of Anagliptin Compared With Sitagliptin With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      An exploratory study to evaluate the Effect of Improving Glycemic Variability of Anagliptin
      Compared with Sitagliptin in Patients with Type 2 Diabetes Mellitus
    

Detailed description: 
      This clinical trial is an exploratory study, and does not calculate the subject number based
      on statistical assumptions, and enrolls 50 subjects per group and a total of 100 subjects are
      registered to evaluate the effect of improving blood glucose variability in type 2 patients
      with anagliptin 100 mg twice a day(BID) and sitagliptin 100 mg once a day(QD).
    

Intervention name(s): Anagliptin BID Treatment
Intervention type(s): Drug
Intervention description(s): Continuous Glucose Monitoring with Anagliptin 100mg BID or Sitagliptin 100mg QD treatment for 12 weeks
Other intervention name(s): Sitagliptin QD Treatment
Intervention MeSH terms: Sitagliptin Phosphate; Anagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Multi-center, Active controlled, Randomized, Double-blinded, Parallel Study
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Mucoadhesive Tacrolimus Patch on Caspase-3 Inducing Apoptosis in Oral Lichen Planus
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Interventional
Phase: Phase 4

Summary: 
      tacrolimus has been widely used as an immunosuppressant. the objective of this study was to
      evaluate the clinical efficacy of tacrolimus 0.1 % in muco adhesive patch compared to
      tacrolimus or corticosteroids in paste forms for symptomatic oral lichen planus, and to
      investigate the effect of topical tacrolimus or corticosteroids on the expression of
      caspase-3 in oral lichen planus as an early marker of apoptosis using immunohistochemically
      analysis
    

Detailed description: 
      thirty patients with erosive or atrophic OLP were randomly assigned into three equal groups
      to receive topical steroid ( triamcinolone acetonide 0.1%), four times per day ( Group 1),
      tacrolimus paste 0.1% four times per day ( Group 2) , and tacrolimus patch 2 times per day (
      Group 3). all groups are given treatment for 8 weeks and 4 weeks follow up period without
      treatment. Photographs of the most severe lesion were taken ( marker lesion ) in each patient
      and analyzed for total ulcerative area (TUA), total atrophic area (TAA). patients were also
      assessed using clinical scores (CS) and visual analogue scale (VAS). pre treatment and post
      treatment specimens were immunohistochemically stained to detect expression of caspase-3.
    

Intervention name(s): Corticosteroid Topical
Intervention type(s): Drug
Intervention description(s): topical tacrolimus and corticosteroids
Other intervention name(s): tacrolimus paste and patch topical
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: treatment of oral lichen planus
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
Condition: Advanced Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability
      and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with
      recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in
      subjects with advanced lung cancer.
    


Intervention name(s): IBI939; Sintilimab
Intervention type(s): Biological; Biological
Intervention description(s): IBI939 injection; Sintilimab injection
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The previous studies have shown that recovery after laparoscopic or vaginal hysterectomy is
      faster than after abdominal approach. The aim of this study is to evaluate postoperative pain
      after vaginal or laparoscopic hysterectomy. The primary outcome measurement is opioid
      consumption.
    


Intervention name(s): laparoscopy, laparoscopic hysterectomy; vaginal : vaginal hysterectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): laparoscopic hysterectomy; Vaginal hysterectomy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain, postoperative; hysterectomy, vaginal; surgery, gynecological
The Effect of Probiotics on Symptoms and Intestinal Flora in Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate benefit of a probiotic product in adults with irritable bowel syndrome.
    


Intervention name(s): Probiotics; Control placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared
      to placebo, in fibromyalgia out-patients
    


Intervention name(s): Milnacipran; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsules; capsules
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy
Condition: Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating
      ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This
      study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up
      to one year after the procedure.
    


Intervention name(s): intramyocardial bone marrow stem cells implantation
Intervention type(s): Procedure
Intervention description(s): Patients with previous diagnosis of non-ischemic dilated cardiomyopathy. were included. Bone-marrow was collected from in the antero-superior iliac crest and mononuclear stem-cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Surgical technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5 ml), in the anterior, lateral, posterior and apical faces of the left ventricle(average 9.6 ± 2.6 x 107 cells). After the procedure, the patients were kept in the post-operative intensive care unit for a minimum period of 24 hours. They were released from the hospital in a period that varied from five to seven days.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiomyopathy, stem cell, cardiac failure
The Effect of Circadian Timing Program on Obesity Management and Sleep Quality
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study, it was aimed to examine the effect of circadian timing program created for obese
      individuals with evening chronotype on obesity management and sleep quality.
    

Detailed description: 
      The importance of chronotype, which reflects individual preferences in sleep timing and other
      behaviors, for obesity is mostly unknown. Morning types are more successful in long-term
      weight control than evening type chronotypes. Those with a sleep preference in the evening
      and a long sleep time have a higher rate of being overweight / obese than those with a
      morning preference and sufficient sleep time. Evening-type circadian preferences are
      indirectly related to food addiction. Individuals with the evening chronotype tend to have
      higher BMI and unhealthy eating habits.

      Although a direct link between chronotype and obesity has not yet been demonstrated, based on
      the negative health consequences in evening chronotypes; In this study, it is assumed that
      success in obesity management will increase with well-timed circadian / sleep cycles,
      adequate sleep time and quality sleep in obese individuals with evening chronotype.

      Therefore, in this study, it was aimed to examine the effect of circadian timing program
      created for obese individuals with evening chronotype on obesity management and sleep
      quality.

      This study will be conducted in an experimental design, in a randomized controlled manner, in
      accordance with its purpose. The universe of the study will be obese individuals followed in
      Kocaeli University Hospital Obesity Outpatient Clinic. As a result of the power analysis
      performed to determine the sample size, the number of individuals in each group was
      determined as n = 18. The sample of the study will be 36 individuals in total. Participants
      will be selected to the intervention and control groups by simple randomization method.
    

Intervention name(s): Circadian Timing Program; Sleep Hygiene Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Sleep hygiene training will be provided to the participants. They will be asked to make lifestyle changes according to the "Circadian Timing Program" created by the researcher.; Sleep hygiene training will be given by the researcher. There will also be sleep hygiene training sections on the website.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: obese; chronotype; eveningness; circadian rhythm; sleep quality
Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
      yet known which combination chemotherapy regimen is more effective for treating non-small
      cell lung cancer.

      PURPOSE: Randomized phase II trial to compare the effectiveness of two combination
      chemotherapy regimens in treating patients who have non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare overall survival, response rate, and time to progression of patients with
           non-small cell lung cancer treated with paclitaxel and carboplatin versus gemcitabine
           and cisplatin.

        -  Compare the toxicities of each of these 2 regimens in this patient population.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight
      loss in the past 6 months (less than 5% vs at least 5%) and disease stage (stage IIIB with
      pleural or pericardial effusion or pleural implants vs stage IV/recurrent). Patients are
      randomized to one of two treatment arms.

        -  Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30
           minutes on day 1.

        -  Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by
           cisplatin IV over 1 hour on day 1 only.

      Treatment continues in both arms every 21 days for up to 6 courses in the absence of
      unacceptable toxicity or disease progression.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: Approximately 40-90 patients (20-45 per arm) will be accrued for this
      study within 12 months.
    

Intervention name(s): carboplatin; cisplatin; gemcitabine hydrochloride; paclitaxel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine
Allocation: Randomized
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; adenosquamous cell lung cancer; bronchoalveolar cell lung cancer
A Study of How Insulin Peglispro (LY2605541) and Insulin Glargine Affect the Breakdown of Fat and Sugar in Type 1 Diabetics
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-period study of participants with type 1 diabetes mellitus (T1DM). In each
      period, participants will receive once daily injections of stable dose LY2605541 or insulin
      glargine for 28 to 35 days followed by procedures to look at how the body uses or stores fats
      and sugars. Participants will continue to use meal time insulin throughout the study. Healthy
      participants will also enroll in the study. They will not receive any study medication.
    


Intervention name(s): LY2605541; Insulin Glargine
Intervention type(s): Biological; Biological
Intervention description(s): Administered SQ; Administered SQ
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Sandostatin LAR® Depot in Patients With Primary Insulin Hypersecretion (PIH) and at Least Moderate Obesity
Condition: Primary Insulin Hypersecretion; Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is in patients with at least moderate obesity (Body Mass Index [BMI] > 30 kg/m2 or
      approximately 30 or more pounds overweight) and who also produce too much insulin (insulin
      stores sugar as fat). Sandostatin LAR® Depot suppresses insulin, and is being developed to
      help with weight loss in people who find it hard to lose weight on their own because they
      produce too much insulin.

      The main purpose of the study is to find the lowest dose of Sandostatin LAR® Depot that
      safely helps overweight people lose weight. The study will also compare weight loss in obese
      patients who receive one of three different dosages of Sandostatin LAR Depot or placebo.
    


Intervention name(s): Sandostatin LAR Depot
Intervention type(s): Drug
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Primary Insulin Hypersecretion; PIH; Obesity
Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa (HS)
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Observational

Summary: 
      The objective of this study is to evaluate the long-term safety and effectiveness of Humira
      in patients with Hidradenitis Suppurativa (HS) in real-world clinical practice in Japan.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hidradenitis Suppurativa (HS)
      
Keywords: Hidradenitis Suppurativa (HS); Humira; Adalimumab
Within Subject Variability Study of ER Torsemide 20 mg Tablet in Healthy Subjects
Condition: Congestive Heart Failure; Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the within-subject variability of 20mg ER torsemide as compared to
      20mg IR torsemide (Demadex) in fully replicate double-crossover trial in healthy volunteers,
      who are consuming a high-salt diet (300 mmol/day). The study will also evaluate the effects
      of ER torsemide and IR torsemide on 24h sodium excretion and total urinary excretion.
    

Detailed description: 
      Immediate Release (IR) Torsemide is a highly effective natriuretic drug but its short
      duration of action is a major drawback, which allows significant post-dose sodium retention,
      and as consequence, limits salt loss in patients with heart failure, unless dietary salt
      intake is severely restricted. Extended Release (ER) torsemide is being developed to address
      the drawback by prolonging the duration of action to increase sodium excretion even in
      patients who consume high salt diet (300 mmol/day).

      In addition, IR torsemide induces large and abrupt urination that, in some patients, causes
      incontinence, and as a result, compliance becomes challenging. ER torsemide is formulated to
      cause robust but gradual urination over an extended period to reduce accidental wetting and
      improve compliance.

      In this study, ER torsemide is tested for within-subject variability in fully replicate
      design double-crossover trial in healthy volunteers who are on a 300 mmol/day sodium diet
      (high salt diet). The primary endpoint of the study is full pharmacokinetics measurements
      after a single dose of either ER torsemide or IR torsemide (Demadex). The secondary endpoints
      are 24h sodium excretion and total urinary excretion.
    

Intervention name(s): Demadex 20mg Tablet; ER Torsemide 20mg Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Immediate Release (IR) Torsemide; Extended Release Torsemide 20 mg tablet given once daily
Other intervention name(s): Torsemide; ER Torsemide
Intervention MeSH terms: Torsemide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Fully Replicate double-crossover
Masking: None (Open Label)
Primary purpose: Treatment
The Listening Project: Tuning Into Change
Condition: Auditory Perceptual Disorders; Stress Disorder
MeSH terms: Auditory Perceptual Disorders; Perceptual Disorders
Study type: Interventional

Summary: 
      A research project funded by the Australian Childhood Foundation (ACF) will be conducted in
      Australian facilities of the ACF to evaluate the effectiveness of the Listening Project
      Protocol (LPP) in children with a trauma history. The LPP is designed as a "neural exercise"
      to reduce auditory hypersensitivities, to improve auditory processing of speech, and to
      improve behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural
      regulation of the middle ear structures to rehabilitate and to normalize the acoustic
      transfer function of the middle ear structures. The current study is being conducted to
      evaluate efficacy and feasibility of the LPP and will use objective measures to evaluate
      changes in acoustic transfer function of the middle ears structures, auditory processing
      skills, physiological state regulation, and sensory symptoms.
    


Intervention name(s): Listening Project Protocol
Intervention type(s): Behavioral
Intervention description(s): The intervention will consist of listening to computer-altered acoustic stimulation, designed to modulate the frequency band of vocal music passed to the participant. The frequency characteristics of the acoustic stimulation are selected to emphasize the relative importance of specific frequencies in conveying the information embedded in human speech. Modulation of the acoustic energy within the frequencies of human voice, similar to an exaggerated vocal prosody, are hypothesized to recruit and modulate the neural regulation of the middle ear muscles and to functionally reduce sound hypersensitivities and improve auditory processing.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: autonomic nervous system; auditory processing disorder; social behavior