bioihbjkbjnl/mcl2 huggingface dataset:
Gut Transit Effect on Enterohepatic Circulation
Condition: Intestinal Transit
Study type: Interventional

Summary: 
      A study to determine the influence of changing intestinal transit time of the enterohepatic
      recirculation of bile acids.
    

Detailed description: 
      The digestion of food by human body starts from oral cavity and continues until its excreted
      as faeces. There are different factors affecting this process. Important factors are movement
      through the GI Tract, breakdown of food material and absorption by the body to produce
      energy. The unabsorbed waste material is then excreted by the body.

      Different enzymes are produced by human body which are responsible for digestion of food. One
      important chemical is bile which is produced in the gall bladder. It is important in
      digestion of fatty foods but affects the movement of food material as well. There are
      numerous bacteria present in human GI tract especially in mouth and large bowel which also
      play an important role in process of digestion of food.

      Different conditions of health and disease can affect how food moves through the GI tract
      (known as intestinal transit). It also affects the activity of different digestive enzymes
      and chemicals in body. The bacterial population in the body is also affected by changes
      described above. The purpose of this study is to observe how these different processes
      especially the intestinal transit, bile salts and gut bacteria affect each other. This will
      help to identify mechanisms responsible for different disorders of human gut like irritable
      bowel syndrome. The study is part of an effort to identify new and future treatment of these
      conditions.
    

Intervention name(s): Loperamide; Senna
Intervention type(s): Drug; Drug
Intervention description(s): Alters intestinal transit time.; Alters intestinal transit time.
Intervention MeSH terms: Loperamide; Antidiarrheals
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised cross-over study. Volunteers will be assessed at baseline, then after either taking loperamide or senna at the maximally tolerated dose for 2 days prior to the 'assessment period' then during the assessment period (5-7 days). After a washout period of at least 21 days, volunteers will then repeat the same assessments but cross over to take the second drug either loperamide or senna.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Intestinal Transit, Bile Salts, Gut Bacteria, Volatile Organic Compounds
Endodontic Treatment of Primary Teeth Using Mineral Trioxide Aggregate Paste
Condition: Teeth, Endodontically-Treated
MeSH terms: Tooth, Nonvital
Study type: Interventional
Phase: Phase 2

Summary: 
      The maintenance of primary teeth until their exfoliation has been one of the main purposes of
      Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of the
      permanent dentition. Often, injuries or extensive dental caries reach the pulp of deciduous
      teeth making maintenance on these dependent endodontic treatment arc. Thus, this study was to
      conduct a randomized clinical trial is to evaluate the performance of endodontic treatment in
      primary teeth using MTA paste, comparing to Vitapex.
    

Detailed description: 
      After approval by the ethics committee of the patients Faculty of Dentistry, University of
      São Paulo that having root canal filling of primary teeth will be invited to participate in
      the study. A clinical examination and prior radiographic diagnosis will be-held. The patient
      will be randomized to one of two groups and will be made the endodontics by a dentist. The
      patient will be accompanied with periods of one week, one month and three months by a blinded
      evaluator. The outcome will be the success or failure of endodontic treatments evaluated
      through permanent tooth in the arch on clinical and radiographic conditions of normality. The
      longevity of the treatments will be evaluated by estimating survival rates by Kaplan-Meier.
      The differences between the survival rates according to the type of proposed endodontic
      treatment will be analyzed using the log-rank test with a minimum significance level of 5%.
    

Intervention name(s): Endodontic treatment using Vitapex; Endodontic treatment using MTA paste
Intervention type(s): Drug; Drug
Intervention description(s): Endodontic treatment using Vitapex; Endodontic treatment using MTA paste
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Brexpiprazole Orally Disintegrating Tablets (ODT) 2mg
Condition: Healthy Adult Male
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional
      tablet 2 mg
    


Intervention name(s): Brexpiprazole ODT 2mg with water; Brexpiprazole ODT 2mg without water; Brexpiprazole conventional tablet 2mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Brexpiprazole ODT 2mg is administered with water.; Brexpiprazole ODT 2mg is administered without water.; Brexpiprazole conventional tablet 2mg is administered with water.
Other intervention name(s): OPC-34712 OD; OPC-34712 OD; OPC-34712 conventional tablet
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brief Behavioral Insomnia Treatment Study
Condition: Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a brief, behavioral treatment for insomnia
      is effective in addressing social and occupational functioning and overall health among
      Veterans with insomnia disorder.
    

Detailed description: 
      This study is a randomized, controlled trial of a telephone-based, brief insomnia treatment
      in primary care in order to accomplish the goal of improving psychosocial functioning in
      Veterans who meet criteria for Insomnia Disorder. The primary outcome for the trial will be
      psychosocial functioning, with insomnia severity serving as the secondary outcome. Additional
      goals include evaluating durability of treatment gains and obtaining feedback from
      participants about the utility and feasibility of the proposed insomnia treatment.
    

Intervention name(s): Brief Behavioral Treatment for Insomnia; Progressive Muscle Relaxation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.; Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Veteran; Insomnia; Primary Healthcare
Identifying Genetic Determinants of Eczema Herpeticum and Other Viral Infections in Individuals With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Kaposi Varicelliform Eruption; Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      People with atopic dermatitis (AD), or eczema, are susceptible to skin infections and
      inflammations. Some individuals with AD develop a condition known as eczema herpeticum (EH)
      following exposure to the herpes simplex virus (HSV). The purpose of this study is to
      identify the genetic determinants that lead people with AD to develop EH and similar
      conditions caused by other viruses.
    

Detailed description: 
      AD is a chronic inflammatory skin disorder characterized by recurrent viral skin infections.
      However, people with AD do not all develop the same infections. For example, some people with
      AD who receive the smallpox vaccine develop a life-threatening condition known as eczema
      vaccinatum (EV). This study focuses on individuals with AD who also have a history of eczema
      herpeticum (ADEH+), a condition similar to EV. It is unlikely that the differences in the
      development of skin infections are due to differences in viral exposure, and instead due to
      differences in each individual's response to viruses. The purpose of this study is to
      determine the genetic pathways which are responsible for the development of viral skin
      infections in people with AD.

      Participants in this study will also be enrolled in the ADVN Biomarker Registry Study. There
      will be only one clinical visit for this study at which blood and/or skin samples may be
      collected. The samples will then have high-throughput genotyping to define genetic markers in
      individuals susceptible to viral infections.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        African-American, Caucasian, and Non-Hispanic people ages 8 months to 80 years
      
Biospecimen description: 
      Skin scrapings and blood collection may occur
    
Keywords: Atopic Dermatitis; Eczema; Eczema Herpeticum; Molluscum Contagiousum; Herpes Simplex; Vaccinia
The Role of Computerized Training in Post-Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether a computerized training, "Cognitive Bias
      Modification" targetting appraisals (CBM-App), can reduce dysfunctional appraisals of trauma
      in patients with Post-Traumatic Stress Disorder (PTSD), compared to a control condition.
      Other outcomes measured include symptoms of PTSD and trauma-relevant dysfunctional
      cognitions. Participants are recruited from inpatients with PTSD admitted to the Clinic for
      Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum.
    


Intervention name(s): Cognitive Bias Modification of Appraisals (CBM-App); Peripheral Vision Task (control condition)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Post-Operative Pain Control Following Shoulder Surgery
Condition: Shoulder Pain
MeSH terms: Shoulder Pain; Pain, Postoperative
Study type: Interventional

Summary: 
      This study will evaluate overall opioid and non-narcotic analgesic use following surgical
      treatment for shoulder pathology, and recommend evidence based guidelines for standardized
      postoperative pain management.
    

Detailed description: 
      There is currently very limited information in the literature regarding postoperative pain
      medication consumption following orthopedic shoulder surgery. To fill this knowledge gap,
      this study will evaluate overall opioid consumption in morphine milligram equivalents
      following surgical treatment for shoulder pathology.
    

Intervention name(s): Tylenol and NSAIDS (Ibuprofen, diclofenac)
Intervention type(s): Other
Intervention description(s): This study will assess an aspect of perioperative care relating to pain control. Subjects will not be aware of which aspect is randomized, but will be given a list of possible aspects which will include the intervention (listed below):
Agents used in nerve block (lidocaine vs ropivacaine)
Location of injection for analgesic
Use of over-the-counter pain management (including but not limited to acetaminophen, ibuprofen, naproxen, etc.)
Type of initial opioid prescribed (including but not limited to oxycodone, tramadol, hydrocodone, etc.)
Number of pills in the initial opioid prescription
Instructions for sling wear (duration of use or type of sling)
Ice usage (duration of use and frequency of use)
Blinding the participant to the randomized aspect of this study will help prevent bias in patient responses for outcome scores and medication usage.
Intervention MeSH terms: Acetaminophen; Ibuprofen; Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants undergoing shoulder surgery will be randomized into one of the three study arms.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome
Condition: Primary Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of
      multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary
      Sjögren's syndrome(pSS)
    


Intervention name(s): CFZ533 active - Cohort 1; CFZ533 placebo- Cohort 1; CFZ533 active - Cohort 2; CFZ533 placebo - Cohort 2; CFZ533 active -Cohort 3; CFZ533 active - Cohort 3
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): multiple doses of CFZ533 s.c. injection; multiple doses of placebo s.c. injection; multiple doses of CFZ533 intravenous infusion; multiple doses of placebo intravenous infusion; multiple doses of CFZ533 s.c. injection; Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Sjögren's syndrome, CFZ533, ESSDAI
Transversus Abdominis Plane Block Versus Local Anesthetic Infiltration for Pain Control in the Abdominal Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Postoperative analgesia is an important part of the anesthetic care. According to the recent
      studies, multimodal analgesia can provide better analgesia & patient satisfaction with fewer
      side effect. For example, combining intravenous, intramuscular or oral analgesics with
      transversus abdominis plane (TAP) block or local anesthetic (LA) infiltration as the
      multimodal analgesia, can furnish a more effective pain control after the abdominal surgery.

      For abdominal surgery, both local infiltration and TAP block target on relieving somatic
      pain. Local anesthetic wound infiltration is easy to perform with low risk. As the
      advancement of ultrasound technology, performing the TAP block also becomes easier, safer and
      more accurate. But whether LA infiltration or TAP block is better for the multimodal
      analgesia regimen remains unclear.

      This study is to compare the postoperative pain score, opioid consumption, side effects, and
      quality of recovery between these two analgesic methods in patients undergoing abdominal
      surgery. The investigators hypothesized that TAP block may be more effective than LA
      infiltration as a part of the multimodal analgesia, and can improve the recovery after the
      abdominal surgery.
    


Intervention name(s): transversus abdominis plane block; local infiltration; Patient controlled analgesia
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia; local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure; postoperative analgesia with intravenous patient controlled analgesia with morphine
Other intervention name(s): local anesthetics infiltration
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: transversus abdominis plane block; local infiltration; ropivacaine; heart rate variability; postoperative analgesia
A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)
Condition: Functional Constipation in Children Ages 6-17 Years
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate dose response of the safety and efficacy of
      linaclotide for the treatment of functional constipation (FC), in children age 6-17 years.
      This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period.
      Participants age 6-11 years will receive oral liquid formulation and participants 12-17 years
      will receive solid oral capsule or liquid oral solution.

      Children ages 6-11 years meeting the entry criteria will be randomized to 1 of 3 doses of
      linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will
      be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks.

      This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well
      as other bowel symptoms of FC.
    


Intervention name(s): Placebo; LIN Dose A; LIN Dose B; LIN Dose C; LIN 145 µg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants received matching placebo LIN liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.; Participants received LIN 9 or 18 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.; Participants received LIN 18 or 36 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.; Participants received LIN 36 or 72 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.; Participants received LIN 145 µg, liquid solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
Other intervention name(s): LINZESS; LINZESS; LINZESS; LINZESS
Intervention MeSH terms: Linaclotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Functional constipation in children; LINZESS
Bioequivalence Study of Capsule and Tablet Formulations of TA-8995
Condition: Dyslipidaemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics of capsule and tablet
      formulations of TA-8995 in healthy male subjects aged 18 to 55 years.
    


Intervention name(s): TA-8995; TA-8995
Intervention type(s): Drug; Drug
Intervention description(s): Capsule; Tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multiple Ascending Dose Study of TRN-157 in Stable Mild and Moderate Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This multiple ascending dose study is to determine the safety and bronchodilator activity of
      TRN-157 in 59 mild and moderate asthmatics.
    


Intervention name(s): TRN-157; Placebo; Tiotropium
Intervention type(s): Drug; Other; Drug
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy Study of RX-10100 to Treat Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this Phase IIa trial is to determine the effective dose and
      treatment period for an upcoming RX-10100 Phase IIb trial in subjects with major depression
      disorder (MDD). The secondary objectives of this trial are to evaluate the safety and quality
      of life in subjects with MDD receiving RX-10100 treatment.
    


Intervention name(s): RX-10100
Intervention type(s): Drug
Intervention description(s): Extended-release tablet, 5~15mg, twice day (morning & evening) at least 30 min before meal, 8 weeks
Other intervention name(s): Serdaxin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major Depressive Disorder (MDD); Serdaxin; Rexahn
AANCART Research Project on Lay Health Workers and Asian Americans
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This is a behavioral research study to evaluate the effectiveness of a type of health
      education, lay health worker (LHWs), on increasing the use of a routine health behavior,
      colorectal cancer (CRC) screening, among Asian Americans, who underutilize such screening.
      Using quantitative and qualitative methods and a community-based participatory research
      (CBPR) approach, the project will develop and implement a group randomized controlled trial
      to evaluate LHW effectiveness in promoting CRC screening among Asian Americans age 50 to 75.
      The investigators will conduct focus groups and individual interviews with community
      participants to revise training and survey materials developed in prior projects. The
      investigators will recruit LHWs to be randomly assigned to the intervention arm and to the
      comparison arm. The LHWs will each recruit 15 participants from their social network.
      Intervention LHWs will be taught to teach their participants about CRC screening through 2
      outreach sessions and 2 telephone calls aimed at increasing their CRC screening receipt. LHWs
      and participants in the comparison group will receive a bilingual CRC brochure as well as 2
      lectures on healthy nutrition for cardiovascular health delivered by a health educator and an
      optional post- intervention LHW outreach session on CRC screening. Effectiveness of the
      intervention will be measured by pre-intervention and post-intervention surveys of community
      participants' CRC screening behaviors. The investigators will also conduct ethnographic
      observations of LHWs and their participants during the small group sessions and post-
      intervention focus groups to understand how such a health education approach may work.
    


Intervention name(s): CRC Prevention and Screening Education; Nutrition Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Refer to Arm Description; Refer to Arm Description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Asian Americans; colorectal cancer screening; cancer prevention; Filipinos Americans; Hmong Americans; Korean Americans; Randomized Controlled Trials