bioihbjkbjnl/mcl2 huggingface dataset:
Post-Infectious Irritable Bowel Syndrome (PI-IBS)
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Communicable Diseases; Infections; Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Observational

Summary: 
      Purpose:

        -  identification of factors predisposing for Post-Infectious Irritable Bowel Syndrome
           (PI-IBS) development after an episode of traveler's diarrhea

        -  identification of systemic (serum) and local (biopsy) changes in infectious and
           immunological activity during infection and correlation with Irritable Bowel Syndrome
           (IBS) symptoms, persisting after traveler's diarrhea

      Design:

        -  4 study visits: before traveling, 2 weeks after traveling, 6 months after traveling, 12
           months after traveling

        -  at each study visit following investigations: blood collection, stool collection,
           questionnaires, rectal biopsy
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Travelers to tropical destinations visiting the outpatient clinic for vaccinations in a
        tertiary care hospital.
      
Biospecimen description: 
      whole blood, blood plasma, feces, rectal biopsy
    
Keywords: Post-Infectious Irritable Bowel Syndrome; PI-IBS
EPO906 Therapy in Patients With Advanced Kidney Cancer
Condition: Kidney Neoplasms
MeSH terms: Kidney Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine whether the investigational drug EPO906, given by intravenous
      infusion (IV directly into the vein), is effective in shrinking tumors and preventing the
      growth of cells that cause kidney cancer.
    


Intervention name(s): epothilone b
Intervention type(s): Drug
Intervention description(s): EPO906 administered intravenously at 2.5 mg/m2 as a 5 minute bolus infusion repeated every week for three weeks followed by one week off The final tables and data is not in yet, so I cannot give you info on safety issues.
Intervention MeSH terms: Epothilones; Epothilone B
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: kidney cancer; renal cancer; cancer; tumor; tumour; neoplasm; carcinoma; clear cell; sarcomatoid; papillary; medullary; collecting duct; chromophobe; intravenous; epothilone
VasQ External Support for Arteriovenous Fistula
Condition: Arterio-Venous Fistula; ESRD; Steal Syndrome; Aneurysm; Renal Failure; Renal Disease; Diabetes Mellitus; Kidney Failure
MeSH terms: Renal Insufficiency; Aneurysm; Arteriovenous Fistula; Fistula
Study type: Interventional

Summary: 
      This is a prospective clinical study of the VasQ external support for arteriovenous fistulas.
      The device is designed to improve fistula outcomes by optimizing the geometrical
      configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote
      laminar flow.

      All patients will be implanted with the VasQ device and will be followed up for a duration of
      24 months.
    


Intervention name(s): VasQ
Intervention type(s): Device
Intervention description(s): An external support device for AV fistula
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety And Efficacy Study Of Orally Administered Epeleuton In Patients With NAFLD
Condition: Non Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to
      assess the safety and efficacy of orally administered Epeleuton capsules versus placebo in
      the treatment of adult patients with Non Alcoholic Fatty Liver Disease (NAFLD)
    


Intervention name(s): Placebo capsules; Epeleuton
Intervention type(s): Other; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Cranial Electrical Stimulation (CES) for Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to see if using Cranial Electrical Stimulation (CES) helps
      improve symptoms of major depressive disorder (MDD). The investigators are studying the
      device's effectiveness in treating depression, as well as its safety. This is a pilot study.

      Eligible participants will be randomly assigned to receive either active CES or sham CES,
      every weekday for 3 weeks. During the visits, subjects will receive CES or sham CES treatment
      for 20 minutes.

      The primary outcome measure will be change in score on the HAM-D 17. The secondary outcome
      measure will be change in patient-reported sleep score.
    

Detailed description: 
      We examined efficacy and safety of one specific cranial electrical stimulator (CES) device at
      a fixed setting in subjects with treatment-resistant major depressive disorder (MDD). Thirty
      subjects with MDD and inadequate response to standard antidepressants were randomized to 3
      weeks of treatment with CES (15/500/15000 Hz, symmetrical rectangular biphasic current of 1-4
      mAmp, 40 Volts) or sham CES (device off) for 20 minutes, 5 days per week. The primary outcome
      measure was improvement in the 17-item Hamilton Depression Rating Scale (HAM-D-17). Adverse
      effects (AEs) were assessed using the Patient Related Inventory of Side Effects (PRISE). We
      hypothesized that subjects who received active as opposed to sham CES would have a
      significantly greater improvement in their depression symptoms. Due to the small sample, we
      could not hypothesize an effect size, but would calculate one to determine signal strength to
      guide the design of a larger, more rigorous study. As an exploratory aim, we also examined
      whether CES would benefit sleep.
    

Intervention name(s): Active CES; Sham CES
Intervention type(s): Device; Device
Intervention description(s): CES current; Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks.
Other intervention name(s): FW-100 Fisher Wallace Cranial Stimulator; Formerly known as: Liss Cranial Stimulator Model SBL202-B; FW-100 Fisher Wallace Cranial Stimulator (sham setting); Formerly known as: Liss Cranial Stimulator Model SBL202-B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: depression; Major Depressive Disorder; MDD; Cranial Electrical Stimulation; CES
Cognitive Stimulation Program in AIDS
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      There has been little success in treating the cognitive (thinking) problems associated with
      HIV/AIDS using medications. The purpose of this study is to determine whether an
      internet-based cognitive "stimulation" program might help HIV-infected individuals think more
      clearly. If this is true, then it means that people with mild forms of cognitive impairment
      may be able to help themselves to get better.
    

Detailed description: 
      The neurocognitive manifestations of HIV/AIDS have long been recognized as important for the
      management, survival, and quality of life of affected patients and their families. Following
      the advent of Highly active anti-retroviral therapy (HAART) the incidence of HIV-associated
      dementia (HAD) has fallen, but the prevalence of the milder forms of HIV-related cognitive
      disorders has risen. This is important because alterations in cognitive function can have
      significant impact on work and social activities, mood, and perceived quality of life. To
      date, pharmacological management of HIV-associated cognitive disorders - apart from HAART -
      have met with limited success (e.g., Peptide T, Ritalin). Therefore, it appears reasonable to
      ask whether the use of non-pharmacological tools might help alleviate or ameliorate the
      symptoms of the milder forms of cognitive impairment, and thus improve mood and activities of
      daily living. The purpose of this application is to request funds to allow us to complete a
      feasibility/pilot study of the merits of using an internet-based cognitive stimulation
      program (CSP) to improve the cognitive functions and quality of life of individuals with
      HIV/AIDS, and, secondarily, to detect such changes using a computerized assessment tool
      designed for use in a health care practitioner's office (Computer-Based Assessment of Mild
      Cognitive Impairment (CAMCI)).
    

Intervention name(s): Smartbrain
Intervention type(s): Behavioral
Intervention description(s): The initial session will be set for 10 minutes, with weekly increases (of 10 minutes) to a maximum of 30 minutes per day, 7 days a week. Each subject will be trained using the same modules of the Smartbrain protocol, with an emphasis on speed of information processing.
Other intervention name(s): Cognitive stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognition; Rehabilitation; Cognitive Stimulation; Human Immunodeficiency Virus; AIDS
Long-Term Effects of Sublingual Grass Therapy
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to investigate whether sublingual immunotherapy (SLIT,
      grass pollen tablets under the tongue) has long term effects in severe hay fever.
    

Detailed description: 
      This is a randomized, double-blind, single-center, placebo-controlled, three-arm study
      comparing SLIT with placebo and SCIT with placebo. The main comparison will be between SLIT
      and placebo.

      Individuals with severe grass pollen hay fever, with or without associated seasonal asthma,
      will be recruited during the pollen season of March through September 2011. Eligible
      participants will be randomized to one of the following three treatment arms administered in
      a double-blind (masked), double-dummy fashion in a 1:1:1 ratio:

        -  SLIT + SCIT placebo

        -  SCIT + SLIT placebo

        -  SLIT placebo + SCIT placebo

      Participants will receive treatment over a 2-year period followed by a 1-year blinded
      (masked) withdrawal phase. Participants will be provided with anti-allergic rescue
      medications (antihistamine, topical intranasal corticosteroids, and short-acting beta
      agonists) throughout the study. Clinical endpoint assessments will be performed at prior to
      initiating their assigned treatment, after 1 and 2 years of treatment, and after the 1-year
      withdrawal period at 3 years.
    

Intervention name(s): Sublingual immunotherapy (SLIT); Subcutaneous immunotherapy (SCIT); Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): Participants randomized to receive sublingual allergen tablet immunotherapy with placebo injections.; Participants randomized to receive subcutaneous injection immunotherapy with placebo tablets. Subcutaneous immunotherapy was included as a positive control.; Participants randomized to double-placebo tablets and injections. This group was included as a negative control.
Other intervention name(s): Grazax®; Alutard SQ Grass Pollen®
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sublingual immunotherapy; subcutaneous immunotherapy
Efficacy, Safety and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and to compare efficacy and safety of BI 695501 versus Humira in
      patients with moderate to severe chronic plaque psoriasis.
    


Intervention name(s): BI 695501; Humira
Intervention type(s): Drug; Drug
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety of single oral doses of 1592U89 (abacavir succinate, ABC) administered
      to HIV-positive individuals. To determine the pharmacokinetics of 1592U89 after single oral
      doses. To determine the effects of food on the bioavailability of 1592U89.
    

Detailed description: 
      Patients are randomized in a double-blinded manner, with 12 patients entering the treatment
      arm and 6 patients entering the control arm. Patients in the treatment arm receive 6 single
      escalating doses of 1592U89 separated by at least a 6-day washout period. Patients in the
      control arm receive 6 single oral doses of placebo at least 6 days apart. The second and
      third doses of 1592U89 are equivalent. During these doses, investigators study the effects of
      food on the pharmacokinetics of 1592U89 by giving half of the patients the second dose with a
      standardized, high-fat breakfast and giving the other half the dose in a fasted state. During
      the third dose, patients are crossed over so that patients who received the second dose with
      a meal now receive it in a fasted state, and vice versa. Following the sixth dose,
      investigators break the blind. Patients who received 1592U89 take a seventh dose in solution
      form and return for follow-up at least 7 days later; patients who received placebo receive no
      further treatment or follow-up. Serial blood and urine samples are collected before and after
      each administration of 1592U89 (or placebo) for determination of plasma and urine
      concentrations of 1592U89, and investigators monitor patients closely for adverse events or
      abnormal laboratory test findings.
    

Intervention name(s): Abacavir sulfate
Intervention type(s): Drug
Intervention MeSH terms: Abacavir
Masking: Double
Primary purpose: Treatment
Keywords: Biological Availability; Reverse Transcriptase Inhibitors; Food-Drug Interactions; abacavir
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The Revita™ System is being investigated to assess the ability to improve glycemic control in
      conjunction with diet and exercise in patients with Type 2 diabetes who are inadequately
      controlled with oral anti-diabetic medications. The purpose of this study is to demonstrate
      the safety and effectiveness of the Fractyl DMR Procedure using the Revita™ System compared
      to a sham procedure. At 24 weeks, subjects randomized to the DMR procedure be continued to be
      followed per protocol till 48 Weeks and the Sham treatment arm will be offered to cross over
      to receive the DMR treatment and will be followed per protocol for 24 weeks post treatment.
    

Detailed description: 
      The study is a randomized, double-blind sham-controlled prospective multi-center clinical
      investigation of subjects with T2D sub-optimally controlled on two oral anti-diabetic
      medications, one of which must be metformin, comparing the Fractyl DMR procedure using the
      Revita™ System to a sham procedure. All subjects will participate in a 4 week oral
      anti-diabetic medication run-in period before the procedure to confirm inadequate blood
      glucose control in conjunction with medication compliance and nutritional counseling.
      Subjects who meet all criteria after screening are randomized 2:1 (DMR to sham), with double
      blinding (subject and endocrinologist/Sponsor). The endoscopist is not blinded.
    

Intervention name(s): Duodenal Mucosal Resurfacing (DMR); Duodenal Mucosal Resurfacing Sham (Sham)
Intervention type(s): Device; Device
Intervention description(s): The Fractyl DMR procedure utilizes the Revita™ Catheter to perform hydrothermal ablation of the duodenum. The catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DRM treatment are followed for 48 weeks while Sham subjects who cross over and undergo the DMR procedure at 24 weeks are followed for further 24 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.; The Sham procedure consists of placing the Revita™ Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Type 2 diabetes; Diabetes Mellitus; Noninsulin-Dependent Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Revita System; Anti-diabetic medications; Duodenal Mucosal Resurfacing
Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD)
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Obsessive-compulsive disorder is a disabling and frequent disorder. In some patients, the
      medical treatment is ineffective. The pathophysiology of this disease is still unknown. Some
      data suggest that basal ganglia dysfunction could participate in the occurrence of OCD. The
      aim of this study is to evaluate the efficacy of subthalamic nucleus high-frequency
      stimulation in patients with severe OCD.
    


Intervention name(s): deep brain stimulation; No stimulation
Intervention type(s): Procedure; Procedure
Intervention description(s): Stimulator on followed by off; Stimulator off followed by on
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obsessive compulsive disorder; deep brain stimulation; subthalamic nucleus
Mechanisms of Acupuncture Analgesia on Experimental Dental Pain - A Psychophysical Study (Phase1)
Condition: Experimental Dental Pain
MeSH terms: Toothache
Study type: Interventional

Summary: 
      The investigators will assess the effects of manual acupuncture on experimental dental pain
      in 36 healthy subjects by means of subjective pain intensity ratings and pain-specific
      autonomic nervous system (ANS) reactions.
    

Detailed description: 
      This psychophysical and -physiological study is the first part of a two-phase project which
      pursues to explore how acupuncture-induced pain modulation interacts with pain-specific brain
      processing patterns by means of functional magnetic resonance imaging (fMRI) and by using an
      experimental dental pain model.

      In this preceding study, the characterization of manual acupuncture effects on the
      experimental dental pain model will be tested under laboratory conditions and without
      restrictions of an fMRI-measurement in order to provide a sound foundation for the following
      fMRI-experiment. Pain modulating effects of the manual acupuncture intervention (4 points:
      needle manipulation of bilateral large-intestine 4 (LI4), stomach 6 and 7 (ST6, ST7)
      ipsilateral to the stimulated tooth) will be compared to sham-acupuncture (insertion and
      manipulation of 4 non-acupuncture points) and a control intervention (no acupuncture) which
      will each be performed at 3 different days in a randomized order. Intervention effects on
      experimental dental pain will be assessed by testing of 36 healthy volunteers by means of
      subjective pain intensity ratings and pain-specific ANS reactions such as electrodermal
      activity and heart rate/respiratory changes. Besides laying the groundwork for the following
      fMRI experiment, this study could provide valuable basic insights into the dynamics of the
      tested manual acupuncture effects and further provide important knowledge for the planning of
      future clinical studies encompassing dental conditions and development of acupuncture
      treatments.
    

Intervention name(s): Acupuncture; Sham-Acupuncture; No Acupuncture
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Needle insertion and manipulation at 4 acupuncture points (bilateral LI4, right ST6 and ST7).; Needle insertion and manipulation at 4 non-acupoints; Control intervention: No needle insertion and manipulation
Other intervention name(s): Verum Acupuncture
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Manual acupuncture; Experimental dental pain; Psychophysics; Autonomic nervous system; Subjective pain ratings
Impact of an Educational Personalized Clinical Support Device Preventive and a Referent Nurse in Surgery for Obesity
Condition: Dumping Syndrome
MeSH terms: Dumping Syndrome; Syndrome
Study type: Interventional

Summary: 
      The postprandial dumping syndrome is a frequent consequence of Roux-en-Y Gastric ByPass due
      to the rapid emptying of the stomach remnant in to the intestinal lumen. Dumping-related
      symptoms occur very early after eating (within 30 minutes), are not associated with
      concurrent hypoglycemia, and are most prominent in the early postoperative period. This
      syndrome very debilitating for the patient can be improved by dietary and nutritional
      recommendations. We hypothesize that a personalized approach based on dietary and nutritional
      recommendations conducted by a nurse would likely to decrease the frequency of dumping
      syndrome and improve the postoperative quality of life of patients in the early postoperative
      period.
    

Detailed description: 
      The Roux-en-Y Gastric ByPass is considered the gold standard of weight loss surgery and is
      the most commonly performed bariatric procedure worldwide.The postprandial dumping syndrome
      is a frequent consequence of gastrojejunal anastomosis due to the rapid emptying of the
      stomach remnant in to the intestinal lumen. Dumping-related symptoms occur very early after
      eating (within 30 minutes), are not associated with concurrent hypoglycemia, and are most
      prominent in the early postoperative period. The symptoms of dumping syndrome include nausea,
      abdominal cramps, diarrhea, dizzy spells, weakness and cold sweats either with or after
      eating.This syndrome very debilitating for the patient can be improved by dietary and
      nutritional recommendations. We hypothesize that an individualized approach based on dietary
      and nutritional recommendations and monitoring of patients conducted by a nurse in the first
      three months after surgery would likely to decrease these problems and improve the
      postoperative quality of life of patients.
    

Intervention name(s): Dietary and nutritional recommendations conducted by a nurse
Intervention type(s): Behavioral
Intervention description(s): Supplementary dietary and nutritional education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Roux-en-Y Gastric ByPass