bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Relaxation Response Mind-body Intervention in Patients With IBS and IBD
Condition: Irritable Bowel Syndrome; Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      In this pilot study, the investigators examined whether a relaxation response mind-body
      intervention could be effectively delivered to mixed groups of IBS and IBD patients and
      determined the effects of the intervention on quality of life, inflammatory markers, and gene
      expression using transcriptional profiling.
    


Intervention name(s): Relaxation Response Mind-Body Intervention
Intervention type(s): Behavioral
Intervention description(s): The Relaxation Response Mind-Body Intervention (RR-MBI) involved a 9-week group program conducted by a nurse practitioner or psychologist skilled in MBI, which included a GI-specific session conducted by a physician. The groups met once weekly for 1.5 hours. Three consecutive, mixed-disorder groups, ranging in size from 10 to 18 participants each. The program was multidimensional and included daily elicitation of the RR using a variety of methods (including breath focus, single-pointed focus, imagery, contemplation, yoga, and mindful awareness); cognitive reappraisal skills, health enhancing behaviors, and the promotion of optimism and acceptance. Throughout the course of treatment, participants were asked to elicit the RR at home each day for 15-20 minutes.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Inflammatory Bowel Disease; mind body; intervention; group; Relaxation Response; genomic effects
Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      Goals of the study:

      Systemic Therapy was approved in 2008 by the Scientific Advisory Board on Psychotherapy
      (Wissenschaftlicher Beirat Psychotherapie: WBP) for a variety of disorders which, at the
      time, did not include anxiety disorders. According to the 2007 joint methods paper of the WBP
      and the Mutual Federal Committee (Gemeinsamen Bundesausschuss: G-Ba), there must be three
      randomized-controlled trials (RCT) for anxiety disorders. These studies are available now but
      lack explicit details about the clinical significance of the reductions they show in social
      anxiety symptoms. This project is funded by the German Association for Systemic Therapy,
      Counseling and Family Therapy (Deutsche Gesellschaft für Systemische Therapie, Beratung und
      Familientherapie: DGSF).

      Study design:

      The study is planned as a mono-centric, balanced pilot RCT. It investigates the feasibility
      of an RCT comparing Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety
      Disorders (SAD) in 32 patients.
    


Intervention name(s): Systemic Therapy for Social Anxiety Disorder; Cognitive Behavioral Therapy for Social Anxiety Disorder
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immune Modulation From Trichuris Trichiura
Condition: Crohn Disease; Colitis, Ulcerative; Intestinal Helminthiasis
MeSH terms: Helminthiasis; Crohn Disease; Colitis, Ulcerative
Study type: Observational

Summary: 
      Mucosal immunology during helminth infection
    

Detailed description: 
      The present study investigates the effects of Trichuris trichiura on human mucosal and
      systemic immunity in a single self-infected individual.
    

Intervention name(s): Trichuris trichiura eggs
Intervention type(s): Biological
Intervention description(s): Live eggs from human whipworm, Trichuris trichiura
Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        A single healthy volunteer
      
Biospecimen description: 
      Blood cell and intestinal biopsies
Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a research study comparing the safety and efficacy of two active study medications
      for the treatment of bipolar I disorder.
    


Intervention name(s): olanzapine; risperidone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine; Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bipolar I Disorder
Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With Long QT2 Syndrome
Condition: LQT2 Syndrome
MeSH terms: Long QT Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the effect of oral eleclazine (formerly
      GS-6615) on corrected QT (QTc) interval in participants with long QT2 syndrome.
    


Intervention name(s): Eleclazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets administered orally in a single dose; Placebo to match tablets administered orally in a single dose
Other intervention name(s): GS-6615
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Congenital Long QT Syndrome; LQTS; Sudden Cardiac Death
Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries .
Condition: Anesthesia
Study type: Interventional

Summary: 
      The purpose of this study is to compare addition of dexamethasone to bupivacaine versus
      bupivacaine alone for trans-incisional bilateral paravertebral block for postoperative
      analgesia in elective lumbar spine surgeries.
    


Intervention name(s): Dexamethasone+ Bupivacaine; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.; Bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.
Intervention MeSH terms: Dexamethasone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cameroon Mobile Phone SMS Trial
Condition: Adherence; HIV
Study type: Interventional

Summary: 
      The investigators hypothesize that sending weekly motivational text messages to people
      infected with HIV will encourage them to take their medication, compared to usual care.
    


Intervention name(s): Mobile phone text message; Usual care
Intervention type(s): Other; Other
Intervention description(s): Weekly message with motivational content; Usual care provided at clinic
Other intervention name(s): SMS; Texto; Text message; Routine care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: compliance; observance; mobile phone; SMS; text message; ARV; HAART; AIDS
Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension
Condition: Adverse Anesthesia Outcome
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypotension following spinal anesthesia for cesarean section is a serious problem. In this
      study we investigated the effect of the vasopressors phenylephrine and noradrenaline on
      postspinal hypotension.
    

Detailed description: 
      On arrival to the operating room, an 18g cannula will be inserted and monitors will be
      applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor).
      Patients will receive spinal anesthesia with 500 ml rapid crystalloid co-load. Ten milligrams
      heavy bupivacaine in addition to 20 mcg fentanyl will be injected in L3-L4 or L4-L5
      interspace using 25 g spinal needle in the sitting position.

      After spinal block, patients will be randomly allocated into one of two groups:

        -  Phenylephrine group (n=100)

        -  Norepinephrine group (n=100)

      Patients who shows SBP above 140 mmHg or heart rate below 55 bpm after the first vasopressor
      dose will not receive the infusion. The infusion will stop if the SBP was above 140 mmHg or
      if the heart rate was below 55 bpm. Patients will be positioned in the supine position with
      left lateral tilt. Block success will be assessed using pinprick, patients with failed block
      will be excluded from the study. The highest sensory block level will be assessed after 5
      minutes from intrathecal injection. Co-hydration will be continued till maximum of 1.5
      litres.
    

Intervention name(s): phenylephrine; Norepinephrine; Bupivacaine; Fentanyl; Placebo (normal saline)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): - phenylephrine; a vasopressor drug given to prevent post spinal hypotension; - norepinephrine; a vasopressor drug given to prevent post spinal hypotension; intrathecal bupivacaine 10 mg will be given in both groups; intrathecal fentanyl 20 mcg will be given in both groups
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Norepinephrine; Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetics and Pharacodynamics of GW642444 in Paedetric Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the effect of dosing paedeatric asthmatic subjects with GW642444,
      an orally inhaled long-acting agonist of the β2-adrenoceptor.
    

Detailed description: 
      This study will investigate the effect of dosing with 25 μg GW642444, an orally inhaled
      long-acting agonist of the β2-adrenoceptor, in asthmatic subjects aged 5 to 11. GW642444 is
      currently under development as the long-acting beta-agonist component of a combination
      product containing an inhaled corticosteroid and a longacting beta-agonist.

      Subjects will receive a single dose via a novel dry powder inhaler, then 7 days once-daily
      repeat dosing following a washout period. The study will be a randomized two-way crossover,
      with a placebo control. Approximately 26 subjects will be recruited to this study, with the
      aim that 20 will complete the study. Safety, tolerability, pharmacokinetics and glucose and
      potassium levels will be investigated.
    

Intervention name(s): GW642444; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GW642444 25 μg; Novel dry powder inhaler; Matching placebo; Novel dry powder inhaler
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Tolerability; Safety; Pharmacokinetics; GW642444
Evaluation of On-eye Optical Performances of the RMY-100 Lens
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a two-arm parallel, non-masked, bilateral, non-dispensing study with one Test arm and
      one concurrent, non-randomized Control arm to evaluate the one-eye optical performances of
      the test soft contact lens and compare with eyes treated with orthokeratology.
    


Intervention name(s): etafilcon A; Habitual Orthokeratology Lenses
Intervention type(s): Device; Device
Intervention description(s): Test Soft Contact Lens; CONTROL
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Food Additives on Phosphorus Metabolism
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of the study is to learn more about how phosphorus-based food additives affect
      phosphorus metabolism in people with normal kidney function.
    

Detailed description: 
      Phosphorus is a mineral that is found in foods such as dairy products, nuts, and meat, and is
      important for strengthening the bones. However, too much phosphorus in the blood may be bad
      for the health of your heart and blood vessels. The kidneys keep the blood levels of
      phosphorus normal by getting rid of extra phosphorus in the urine. New research has found
      that common forms of food additives that are high in phosphorus may increase blood phosphorus
      levels in individuals with kidney disease. In addition, these food additives may increase
      blood levels of hormones that control phosphorus such as parathyroid hormone (PTH) and
      fibroblast growth factor 23 (FGF23). Like high blood phosphorus levels, high levels of PTH
      and FGF23 in the blood may also be bad for the health of your heart and blood vessels. In
      this study, the investigators would like to examine the effects of food additives on blood
      levels of phosphorus, PTH and FGF23 in individuals with normal kidney function.
    

Intervention name(s): Research diet
Intervention type(s): Other
Intervention description(s): Participants will be provided specially prepared meals to eat at home for two weeks. During the first week, participants will eat foods that do not have any phosphorus-based food additives in them (this is called the control diet). During the second week, participants will eat foods that all have phosphorus-based food additives in them (called the intervention diet).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: phosphorus-based food additives; phosphorus metabolism
A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared
      with exenatide in patients with type 2 diabetes mellitus inadequately controlled with
      metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive
      taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly)
      or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in
      a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either
      alone or in combination. The anticipated time on study treatment is 3+ years, and the target
      sample size is >500 individuals.
    


Intervention name(s): exenatide; taspoglutide; taspoglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5mg twice daily for 4 weeks followed by 10mg twice daily; 10mg once weekly; 10mg once weekly for 4 weeks followed by 20mg once weekly
Intervention MeSH terms: Exenatide; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pulsed Radiofrequency of Lateral Femoral Cutaneous Nerve
Condition: Meralgia Paresthetica
MeSH terms: Femoral Neuropathy
Study type: Observational

Summary: 
      In the current retrospective cohort study, conducted by both pain specialists and
      neurophysiologists, primary outcome was to search the efficacy and predictors of PRF of LFCN
      in refractory MP for 6 months. Secondary outcomes were to identify the clinical and
      diagnostic features of the MP.
    

Detailed description: 
      In the current retrospective cohort study, conducted by both pain specialists and
      neurophysiologists, primary outcome was to search the efficacy and predictors of PRF of LFCN
      in refractory MP for 6 months. Secondary outcomes were to identify the clinical and
      diagnostic features of the MP.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients older than 18 years treated with PRF neuromodulation of LFCN for MP and followed
        up at least 6 months in the pain clinic of the tertiary hospital between January 2020 and
        August 2023.
      
Keywords: meralgia parestetica; pulsed radiofrequency; predictors
Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults
Condition: Systemic Proinflammatory State
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of mineralocorticoid receptor (MR)
      blockade in healthy participants in a systemic proinflammatory state after a meal high in fat
      and glucose, which is associated with the pathogenesis of atherosclerosis.

      Participants will include normal-weight, healthy males (Body Mass Index (BMI) ≤ 25 kg/m^2)
      between the ages of 18-45, without hypertension and clinical evidence of metabolic,
      cardiovascular or any other kind of diseases. After a 12-hour (h) fast, participants will be
      assigned to a combination of oral fat-loading test (OFLT) and oral glucose tolerance test
      (OGTT) (day 1), followed by a two-week treatment with 50 mg eplerenone. After two weeks,
      participants will receive the second OFLT/OGTT treatment (day 15). Starting 5 days prior to
      the first intervention (day1), the participant's usual diet (ad lib) will be supplemented
      with 2 bullion broths each day. Standardization of sodium intake is necessary as variations
      in dietary sodium intake may affect outcome measures. We will evaluate the following
      parameters at day 1 and day 15 of the study. Prior to OFLT/OGTT, and 2h, 4h thereafter, we
      will measure a parameter of vascular and systemic inflammation: interleukin-6 (IL-6).
    


Intervention name(s): Eplerenone
Intervention type(s): Drug
Intervention description(s): 50 mg daily for 14 days
Intervention MeSH terms: Eplerenone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Factors Related to Infection Prevention After Tension-free Inguinal Hernia Repair
Condition: INFECTION
MeSH terms: Infections
Study type: Observational

Summary: 
      The investigators conducted the study in 4 teaching hospitals and 2 non-teaching hospitals of
      Shaanxi Province. Surgeons, clinical pharmacists and nurses took part in patient collection,
      information registration, protocol performance.

      The investigators recruited 1200 patients with inguinal hernia undergoing inguinal
      hernioplasty in the six hospitals from January 2010 to July 2011. The patients were randomly
      allocated into control group, cefazolin group and levofloxacin group, with digital meter
      method , 400 in each group. The data such as age, sex, case number, length of hospital stay,
      antibiotic usage, post-operative infection, infection site, bacterial culture were filled in
      self-designed forms on computer.
    

Detailed description: 
      All of the patients received tension-free inguinal hernia repair with a mesh plug. The
      surgical-site infection (SSI) was diagnosed according to the criteria of the Centers for
      Disease Control and Prevention [5-6].

      We chose cefazolin sodium and levofloxacin sodium chloride injection as peri-operative
      antibiotics. Cefazolin sodium is an effective antibiotic with a short plasma elimination
      half-life against gram-positive cocci (GPC) except for enterococci and meticillin-resistant
      staphylococci. It is recommended as one of the prior antibacterial agents used for clearing
      cuts and preventing infection in many countries including China. Levofloxacin sodium chloride
      injection has a wide anti-bacterial spectrum composed of gram-negative bacteria and
      gram-positive anaerobic bacteria including anaerobic bacteria. It can remain a high
      concentration in urine, so it is recommended as an attractive antibiotic for urinary tract
      operation [5].

      In the control group, we gave normal saline as placebo by intravenous drip infusion for 30-60
      min before operation. Cefazolin group and levofloxacin group received intravenous
      administration of cefazolin sodium 1000 mg and levofloxacin sodium chloride injection 200 mg,
      respectively, for 30-60 min before operation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        e recruited 1200 patients with inguinal hernia undergoing inguinal hernioplasty in the six
        hospitals
      
Keywords: surgery; administration; infection
Effectiveness of Acupuncture for Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      What is the trend of changes in asthmatic patients' daily peak expiratory flow (PEF)
      variability, pulmonary function, and quality of life (QOL) with acupuncture treatment on
      specific acupoints (CV22 and bilateral LU5, ST40, BL13, EXB1) compared with minimal
      acupuncture treatment (sham control group) on non-acupoints, and no acupuncture treatment
      (waiting list control group)?
    


Intervention name(s): Disposable stainless steel acupuncture (0.2mmx4mm)
Intervention type(s): Device
Intervention description(s): For active acupuncture group, needles were inserted into nine acupoints (CV22 and bilateral LU5, ST40, BL13, EXB1)with De-qi three times a week for 4 weeks.
For sham acupuncture group, Nine non-acupoints corresponded with each active acupoint were treated with minimal penetration into skin three times a week for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Acupuncture; Pulmonary function; Quality of life
A Trial to Assess the Antipsychotic Efficacy of ITI-007
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will be conducted as a randomized, double-blind, parallel-group,
      placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an
      acute exacerbation of psychosis.
    


Intervention name(s): ITI-007; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.
Condition: Rubella; Mumps; Measles
MeSH terms: Measles; Rubella
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the safety and immunogenicity of GSK Biologicals' live attenuated MMR vaccine
      (Priorix) in a local population in Singapore. The vaccine was administered as a single dose
      to healthy children (12-18 months of age) and blood samples were collected at two time points
      (before vaccination and after vaccination).
    


Intervention name(s): MMR vaccine (Priorix)
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mumps; Singapore; Rubella; Measles