bioihbjkbjnl/mcl2 huggingface dataset:
The Study of Acupuncture on Vascular and Functional Neuroimaging in Parkinson's Disease Patients With Sleep Disorders
Condition: Acupuncture; Parkinson's Disease; Sleep Disorders; Neuroimaging
MeSH terms: Parkinson Disease; Sleep Wake Disorders; Parasomnias
Study type: Interventional

Summary: 
      The purpose of the study is to compare vascular and functional neurological changes of
      acupuncture in patients with Parkinson's Disease and Sleep Disorders. In the randomized
      controlled clinical trial study, patients meeting the criteria for inclusion will be randomly
      enrolled and divided into two groups in a 1:1 ratio: the acupuncture group and the sham
      acupuncture group. The intervention is going to be executed using the acupoints
      GV14（Dazhui）and GB20 (Fengchi).The acupuncture needles will be inserted to a depth of 0.8 to
      1 cm using GV14（Dazhui）and GB20 (Fengchi) in the acupuncture group. The sham acupuncture
      group's needles will be inserted to a depth of 0.1 to 0.2 cm with nonacupuncture points
      located 0.5 cm in lateral to the real acupoint or to the right for midline points.During the
      study, researchers will observe changes in cerebral blood vessels and neuroimaging before and
      after acupuncture in the two groups. Using multimodal fusion advanced vascular-neuronal
      imaging techniques could evaluate the effect of acupuncture on brain blood vessels and
      function in patients with Parkinson's disease and Sleep Disorders and provide an objective
      neuroimaging basis for assessing the effectiveness of acupuncture.
    

Detailed description: 
      Neuroimaging assessment:Subjects are keeping awake, resting flat on the examination table,
      using rubber earplugs to reduce noise, using foam headbands to fix head movement artifacts,
      closing eyes to calm breathing, fixing the head and minimizing head and other parts of the
      initiative and passive exercise.At the same time, it is required not to carry out any
      thinking activities. After the subject is familiar with the environment, it begins to scan
      and conduct a comprehensive MRI scan before and after the acupuncture needling.
    

Intervention name(s): Sterile acupuncture needles for single use
Intervention type(s): Device
Intervention description(s): Sterile acupuncture needles for single use are made by China Beijing Zhongyan Taihe Medical Instrument Limited Company.Acupuncture needles' specifications are 0.25mm*25mm.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Assess the Effect of Multiple-Dose Administration of JNJ-42847922 on Midazolam and Warfarin in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate effect of multiple-dose administration of
      JNJ-42847922 on the single-dose pharmacokinetics of oral midazolam and single-dose
      pharmacokinetics and pharmacodynamics of (R)- and (S)-warfarin after oral administration of
      racemic warfarin.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-center,
      fixed-sequence, study of JNJ-42847922 in healthy participants. The study consists of 3
      Phases: Screening Phase (28 Days), open-label treatment Phase (40 Days) and follow up visit
      (7 to 14 Days after last study procedure). The duration of participation in the study for
      each participant is approximately 82 Days. Participants' safety will be monitored throughout
      the study.
    

Intervention name(s): JNJ-42847922; Midazolam; Warfarin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-42847922 20 milligram (mg) tablet orally once daily from Day 1 to Day 9.; Participants will receive midazolam 4 milligram (mg) syrup orally once on Day 1 during treatment A and on Day 7 during treatment B.; Participants will receive warfarin 25 milligram (mg) tablet orally once on Day 3 during treatment A and on Day 9 during treatment B.
Intervention MeSH terms: Midazolam; Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-42847922; Midazolam; Warfarin; Pharmacokinetics
Assessment and Prevention of Acute Post-herniotomy Pain
Condition: Hernia
MeSH terms: Hernia
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is the assessment and management of Acute Post-herniotomy Pain using two
      different therapeutical protocols per os: ketorolac versus association of
      acetaminophene+tramadol.
    

Detailed description: 
      Persistent post-herniotomy pain (PPP) affects everyday activities in 5-10% of patients. Even
      brief intervals of acute pain can induce long-term neuronal remodeling and sensitization,
      chronic pain and lasting psychological distress. Chronic pain may be caused by intense acute
      PPP, intraoperative nerve injury and/or ongoing inflammation or mesh response with
      subsequence damage to nerve structures. The aim of our study is to analyze analgesic
      efficacy, safety and prevention of persistent postsurgical pain of two different
      pharmacological strategies.
    

Intervention name(s): Ketorolac postoperative; postoperative Patrol; intraoperative analgesia; intraoperative analgesia
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ketorolac 10mg 1cp x 3/die; acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die; ketorolac 30 mg iv; Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg
Other intervention name(s): Toradol; Patrol; Ketorolac; Tramadol
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Herniotomy
Efficacy and Safety of InSan Bamboo Salt on Improvement of Helicobacter Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Helicobacter Infections
Study type: Interventional

Summary: 
      The investigators performed a 4-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of InSan Bamboo Salt on improvement of Helicobacter
      pylori infection. The investigators measured improvement of Helicobacter pylori infection
      parameters , including 14C-UBT(Urea breath test), and subjects' symptoms, and monitored their
      blood pressure.
    


Intervention name(s): InSan Bamboo Salt; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): InSan Bamboo Salt (10g/day); Placebo (10g/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Sequential Dose-Escalation Study in Subjects With Mild Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to investigate the safety of administration of this
      drug by increasing doses to male and female adult subjects with mild asthma.
    

Detailed description: 
      The primary objective of this study is to investigate the safety of administration of
      BIW-8405/MEDI-563 in increasing doses to male and female adult subjects with mild asthma.
    

Intervention name(s): MEDI-563
Intervention type(s): Biological
Intervention description(s): BIW-8405/MEDI-563 administered at one of five dose levels:
0.03 mg/kg intravenous injection
0.1 mg/kg intravenous injection
0.3 mg/kg intravenous injection
1.0 mg/kg intravenous injection
3.0 mg/kg intravenous injection
Following the -3.0 mg/kg dose level,
BIW-8405/MEDI-563 administered at one of two lower dose levels:
0.003 mg/kg intravenous injection 0.0003 mg/kg intravenous injection
Intervention MeSH terms: Benralizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Comparison of Psychotherapy Programs to Treat Panic Disorder
Condition: Anxiety Disorders; Panic Disorder; Agoraphobia
MeSH terms: Anxiety Disorders; Panic Disorder; Agoraphobia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine the relative effectiveness of three psychotherapies in treating
      people with a panic disorder.
    

Detailed description: 
      Panic disorder (PD) is a debilitating anxiety disorder. It is characterized by unexpected and
      repeated episodes of intense fear, accompanied by serious physical symptoms, such as chest
      pain, heart palpitations, shortness of breath, dizziness, or abdominal stress. Available
      treatments for PD include medication therapy and cognitive behavioral therapy (CBT), a type
      of psychotherapy that teaches people how to view panic attacks differently and how to reduce
      anxiety. Approximately 30% of patients refuse medication, however, and nearly 50% do not
      achieve remission with CBT alone. Therefore, there is a pressing need for additional
      non-pharmacologic treatment methods. Panic-focused psychodynamic psychotherapy (PFPP) and
      applied relaxation training (ART) are among some of the other available treatments for PD.
      During ART, individuals are taught to relax their muscles while being exposed to increasingly
      frightening situations. PFPP combines elements of CBT with other, more extensive approaches
      aimed at determining the anxiety's origin and at finding ways to reduce it. This study will
      compare the effectiveness of PFPP, CBT, and ART in treating PD.

      Participants in this single blind study will be randomly assigned to receive PFPP, CBT, or
      ART for 12 weeks. All participants will attend between 19 and 24 treatment sessions over the
      course of the study. Upon completing the study, participants will attend monthly follow-up
      visits for an additional 12 months. Participants assigned to ART who have not responded by
      the end of treatment may opt to receive PFPP or CBT. Outcomes will be assessed using a
      variety of scales to determine depression and anxiety symptoms.
    

Intervention name(s): Cognitive behavioral therapy; Applied relaxation training (ART); Panic focused psychodynamic psychotherapy (PFPP)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): CBT for panic disorder will include 19 to 24 sessions over 12 weeks.; ART with exposure protocol will include 19 to 24 sessions over 12 weeks.; PFPP will include 19 to 24 sessions over 12 weeks.
Other intervention name(s): Panic control treatment; ART
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PD; CBT; PFPP
Skin Closure With Tissue Adhesives vs. Subcuticular Suture After Robotic Urogynecologic Procedures
Condition: Surgical Wound; Tissue Adhesion
MeSH terms: Tissue Adhesions; Surgical Wound
Study type: Interventional

Summary: 
      To compare skin closure via subcuticular suture versus tissue adhesive (Dermabond) in
      urogynecological robotic surgeries. The primary outcome is incision cosmesis at the 12 week
      follow up visit. Secondary outcome is the operative time between the two methods of closure.
    

Detailed description: 
      The purpose of this study is compare skin closure via suture versus tissue adhesive
      (Dermabond) in urogynecological robotic surgeries. The primary outcome is incision cosmesis.
      Therefore, if the tissue adhesive is cosmetically comparable to that of sutures, that will be
      reason to use tissue adhesives over traditional sutures. In these surgeries, there are five
      to six port sites (compared to fewer for usual laparoscopic procedures) and the procedures
      are lengthy procedures (average duration about 300 minutes as per recent AUGS/ACOG committee
      opinion), so if the investigators can show significant time reduction for closure, that
      should reduce operative time and costs. To the investigators' knowledge, this will be the
      first study of its kind to make this comparison for urogynecologic robotic procedures.
    

Intervention name(s): Subcuticular Skin Closure; Tissue Adhesives
Intervention type(s): Procedure; Device
Intervention description(s): We will only close the subcuticular layer with suture; No subcuticular closure will be done. Only tissue adhesives applied to the approximated skin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a randomized controlled trial comparing skin closure after robotic urogynecologic surgery with tissue adhesive versus subcuticular suture.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Efficacy Safety of a Combination Thiocolchicoside+Ketoprofen Compared to Thiocolchicoside Twice a Day for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective :

      To demonstrate the superiority of the oral fixed - combination of a muscle relaxant,
      thiocolchicoside (TCC) to a non steroidal anti-inflammatory drug, ketoprofen, over oral TCC,
      on average pain within the last 24 hours in adults suffering from acute non specific low back
      pain with an episode of recent onset

      Secondary Objective :

      To compare the safety of the oral combination to that of oral TCC alone
    


Intervention name(s): Thiocolchicoside+Ketoprofen; Thiocolchicoside
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d; 2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d
Intervention MeSH terms: Ketoprofen; Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Physical Effort in the Decision Making Process of Preadolescents With ADHD
Condition: ADHD
Study type: Observational

Summary: 
      In the current study we will examine a specific aspect of these processes that has yet to be
      studied. We will test the effect that a physically effortful assignment has on the choices
      that a preadolescent makes using a forced choice paradigm in which the participant will be
      asked to choose between and carry out either a high cost-high reward option (HR) or a low
      cost-low reward (LR) option. The HR option will demand a significant amount of physical
      effort and will be paired up with a large reward as opposed to the LR option which will be
      less demanding physically and paired up with a small reward. The assignment will be carried
      out using a hand held dynamometer which measures the power produced by the participants'
      upper extremity.

      We propose that a child with attention deficit hyperactivity disorder (ADHD) will choose a
      task that involves less effort despite the small reward tied to it compared to a control
      child who will choose the more demanding task and the larger reward.
    

Detailed description: 
      In the current study we will examine a specific aspect of these processes that has yet to be
      studied. We will test the effect that a physically effortful assignment has on the choices
      that a preadolescent makes using a forced choice paradigm in which the participant will be
      asked to choose between and carry out either a high cost-high reward option (HR) or a low
      cost-low reward (LR) option. The HR option will demand a significant amount of physical
      effort and will be paired up with a large reward as opposed to the LR option which will be
      less demanding physically and paired up with a small reward. The assignment will be carried
      out using a hand held dynamometer which measures the power produced by the participants'
      upper extremity.

      We propose that a child with ADHD will choose a task that involves less effort despite the
      small reward tied to it compared to a control child who will choose the more demanding task
      and the larger reward.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        residents of jerusalem
A Novel Dynamic Random-dot Stereopsis Assessment to Measure the Stereopsis in Intermittent Exotropia
Condition: Dynamic Stereopsis in Intermittent Exotropia Patients
MeSH terms: Exotropia
Study type: Observational

Summary: 
      A novel dynamic random-dot stereopsis test that included motion + disparity (MD), motion (M),
      and disparity (D), in which the disparity cues range from 200 to 1200 arc-seconds was used.
      The characteristics of preoperative dynamic stereopsis in 83 intermittent exotropia patients
      and its associations with clinical features were analysed, and the prognosis was followed up
      on the 1st day and 2nd, 6th and 12nd months postoperatively.
    


Intervention name(s): The dynamic stereopsis test
Intervention type(s): Diagnostic Test
Intervention description(s): The characteristics of preoperative dynamic stereopsis in 83 intermittent exotropia patients and its associations with clinical features were analysed, and the prognosis was followed up on the 1st day and 2nd, 6th and 12nd months postoperatively.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 83 cases X(T) patients and 50 normal subjects were enrolled in the study.
Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles
Condition: Wrinkle
Study type: Interventional

Summary: 
      This study will evaluate the clinical safety and the performance of the BTL-785F system
      equipped with BTL-785-2 applicator for non-invasive treatment of facial wrinkles.
    

Detailed description: 
      This study will evaluate the clinical safety and the performance of the BTL-785F system
      equipped with BTL-785-2 applicator for non-invasive treatment of facial wrinkles. The study
      is a multicenter single-arm, open-label, interventional study. The subjects will be enrolled
      and assigned into one experimental study arm. The subjects will be required to complete three
      (3) treatment visits and two follow-up visits. At every treatment visit after the first,
      prior to the procedure, the participants will be assessed for adverse effects resulting from
      the previous treatment(s) with the BTL-785F device.

      Safety measures will include documentation of adverse events (AE) during and after the
      procedures.

      Follow-ups visits at 3 months and 6 months after the final treatment will be held.
    

Intervention name(s): Non-invasive treatment of facial wrinkles
Intervention type(s): Device
Intervention description(s): Application of radiofrequency field which provides controlled heating to the skin.Therapeutic effect is observed when the tissue temperature reaches 40-45 degrees Celsius.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multiple Ascending Dose and Electroencephalography Trial of GATE-202 in Healthy Volunteers
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability, pharmacokinetics and EEG pharmacodynamics of single and
      multiple ascending doses of apimostinel in normal human volunteers
    

Detailed description: 
      Single ascending dose (SAD), multiple ascending dose (MAD), double-blind placebo-controlled
      study in normal human volunteers.

      Subjects will receive a single 25 mg IV dose of apimostinel or matching placebo, or 8
      consecutive days of 1, 5, 10, or 25 mg IV or matching placebo.
    

Intervention name(s): apimostinel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): N-methyl-D-aspartate (NMDA) receptor modulator; Placebo
Other intervention name(s): GATE-202
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: major depressive disorder; single ascending dose; multiple ascending dose; pharmacokinetics; EEG
Tolerability and Potential ECG Effects After a Single Oral Dose of Pentoxyverine Citrate in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial was to investigate the potential effects of pentoxyverine
      on the ECGs of healthy subjects. A secondary objective was the exploration of safety and
      tolerability. Pharmacokinetics (PK) were only to be investigated if necessary for the
      explanation of ECG effects.
    


Intervention name(s): pentoxyverine citrate; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Carbetapentane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Fluoxetine Tablets Under Fed Conditions
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and
      Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated
      by a washout period of 35 days.
    

Detailed description: 
      An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose
      Bioequivalence Study of Fluoxetine Tablets containing Fluoxetine 20 mg ( Test Formulation,
      Torrent Pharmaceutical Ltd., India) Versus Sarafem® 20 mg Tablets containing Fluoxetine 20 mg
      (Reference, Warner Chilcott LLC, USA) in Healthy Human Volunteers Under Fed Condition.
    

Intervention name(s): Torrent's Fluoxetine Tablets; Warner Chilcott LLC's Sarafem Tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment