bioihbjkbjnl/mcl2 huggingface dataset:
Exendin-9,39 and Satiety After Bariatric Surgery
Condition: Obesity
Study type: Interventional

Summary: 
      The overall aim of the application is to determine the contribution of the elevated incretin
      hormone concentrations seen after certain types of bariatric surgery to the regulation of
      food intake and satiety.
    

Detailed description: 
      Both Sleeve Gastrectomy (SG) and Roux-en-Y Gastric Bypass (RYGB) increase GLP-1
      concentrations, although this is of lesser magnitude in SG compared to RYGB. Data suggests
      that endogenous GLP-1 is at least partially responsible for reducing free-choice caloric
      intake after RYGB, providing a mechanism underlying differences between procedures.
      Inhibition of GLP-1 action with Exendin-9,39 after RYGB accelerates gastric emptying. These
      observations suggest that factors other than anatomy regulate the upper gastrointestinal
      response to food ingestion. It is therefore reasonable to consider that the postprandial rise
      in GLP-1 might affect feeding behavior after RYGB, and to a lesser extent SG, where the
      increase in GLP-1 is less marked.
    

Intervention name(s): Saline; Exendin-9,39
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be studied on 2 occasions, in random order. During the saline study they will be infused with saline.; Subjects will be studied on 2 occasions, in random order. During the Exendin-9,39 study day they will be infused with Exendin-9,39. Exendin-9,39 blocks the actions of specific hormones called incretins, that are produced in the gut in health and in larger quantities after gastric bypass surgery.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sleeve Gastrectomy; Roux-en-Y Gastric Bypass
A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to
      placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus
      (SLE) with an inadequate response to standard of care treatment for SLE.
    

Detailed description: 
      This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo controlled,
      parallel-group study to evaluate the efficacy and safety of 2 intravenous (IV) treatment
      regimens in adult participants with chronic, moderately-to-severely active SLE with an
      inadequate response to SOC SLE. The investigational product (anifrolumab or placebo) will be
      administered as a fixed dose every 4 weeks (28 days) for a total of 13 doses.
    

Intervention name(s): Anifrolumab 300 mg; Anifrolumab 1000 mg; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): Participants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.; Participants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.; Participants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
Other intervention name(s): MEDI-546; MEDI-546
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MEDI-546; Anifrolumab; Systemic Lupus Erythematosus
Boric Acid in Degree 2 Furcation Defect
Condition: Chronic Periodontitis With Mandibular Degree 2 Furcation Defects
MeSH terms: Periodontitis; Chronic Periodontitis; Furcation Defects
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this double-masked, randomized, controlled clinical trial was to evaluate the
      effects of subgingival delivery of boric acid gel as an adjunct to scaling and root planing
      (SRP) on clinical and radiographic parameters and compare this method with SRP plus placebo
      gel alone in patients with chronic periodontitis (CP).
    

Detailed description: 
      Background: The purpose of this double-masked, randomized, controlled clinical trial was to
      evaluate the effects of subgingival delivery of boric acid gel as an adjunct to scaling and
      root planing (SRP) on clinical and radiographic parameters and compare this method with SRP
      plus placebo gel alone in patients with chronic periodontitis (CP).

      Methods:FORTY EIGHT systemically healthy patients with CP are included in this study. They
      were divided into two groups: 1) SRP + 0.75% Boric acid gel (BA group); 2) SRP + Placebo gel
      (Placebo group). At baseline, 3 month, and 6 months after treatment, clinical measurements,
      including plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD),
      clinical attachment level (CAL) and radiographic parameters intrabony defect depth (IBD),
      percentage change in radiographic defect depth reduction (DDR%) were assessed.
    

Intervention name(s): 0.75 % Boric Acid; placebo
Intervention type(s): Drug; Drug
Intervention description(s): After Scaling and Root Planing placement of 0.75% Boric Acid gel in Mandibular degree 2 Furcation defect.; After Scaling and Root Planing placement of Placebo gel in Mandibular degree 2 Furcation defect.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Diflunisal on Familial Amyloidosis
Condition: Familial Amyloid Polyneuropathy; Familial Amyloidosis
MeSH terms: Polyneuropathies; Amyloid Neuropathies; Amyloid Neuropathies, Familial; Amyloidosis, Familial; Amyloidosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine if diflunisal can prevent progressive lower leg
      nerve damage in patients with familial amyloidosis polyneuropathy.

      Funding Source - FDA Office of Orphan Products Development (OOPD); National Institute of
      Neurological Disorders and Stroke (NINDS)
    

Detailed description: 
      Familial amyloidosis polyneuropathy (FAP) is a rare, lethal, autosomal dominant,
      neurodegenerative disease characterized by misfolding of variant transthyretin tetramer (TTR)
      - a transport protein produced by the liver. The disease causes TTR to become unstable,
      triggering amyloid fibrils to form and leading to peripheral and autonomic nerve dysfunction.

      Currently, the only treatment for FAP is a liver transplant, which is expensive and
      risk-filled. Medicines are needed to treat this disease. Previous in vitro (in a test tube)
      studies have shown that a common anti-inflammatory drug called diflunisal stabilizes TTR,
      preventing the formation of amyloid fibrils.

      The goal of this 2-year randomized, double-blind, placebo-controlled research study is to
      establish whether diflunisal can stop the nerve damage, or peripheral neuropathy, resulting
      from amyloid production in patients with FAP. Scientists already know that diflunisal
      prevents formation of amyloid in the test tube. This study will determine if the drug can
      block amyloid production in FAP patients.

      Participants will be randomly chosen to receive either diflunisal or an inactive (placebo)
      pill twice daily for 24 months. Participants will be carefully monitored through 7 follow-up
      visits, either at the study center or with individual primary care physicians. Participating
      in the study does not preclude patients from being listed for liver transplantation.
    

Intervention name(s): diflunisal; placebo
Intervention type(s): Drug; Other
Intervention description(s): given twice daily for 24 months; an inactive substance given twice daily for 24 months
Intervention MeSH terms: Diflunisal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: familial amyloid polyneuropathy; familial amyloidosis; diflunisal; amyloidosis; transthyretin; peripheral neuropathy; autonomic neuropathy; amyloid cardiomyopathy
Drug Interaction Study of Isavuconazole and Methadone
Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Methadone; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the effect of multiple doses of isavuconazole
      on the pharmacokinetics (PK) of methadone after single dose administration. The secondary
      purpose is to assess the safety and tolerability of isavuconazole alone and in combination
      with methadone.
    


Intervention name(s): Isavuconazole; Methadone
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): BAL8557; BAL4815; Dolopine
Intervention MeSH terms: Isavuconazole; Methadone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: isavuconazole; methadone; Healthy Volunteers; BAL8557
The Effects of Laxative-probiotic Sequential Treatment in the Irritable Bowel Syndrome Patients
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      the laxative-probiotic sequential treatment might reduce the symptoms of IBS and alter the
      fecal microbiota of the patients in a more robust manner .
    

Detailed description: 
      Probiotics can regulate intestinal immunity, repair mucosal barrier, and reportedly exert
      therapeutic effects on IBS patients. The laxatives could also alter the gut microflora
      significantly, thus the laxative-probiotic sequential treatment might affect the symptoms and
      the composition of fecal microbiota in the IBS patients in a more robust manner .
    

Intervention name(s): Probiotic Clostridium Butyricum; Laxative Polyethylene Glycol
Intervention type(s): Drug; Drug
Intervention description(s): probiotic:2 tablets/ times, 3 times / day for 2 weeks; laxative：2000 ml.
Other intervention name(s): Clostridium Butyricum Tablets; Polyethylene Glycol Electrolytes Powder.
Intervention MeSH terms: Laxatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fecal microflora; IBS; Sequential treatment; Probiotic; Laxative
Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study
Condition: IgE Mediated Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional

Summary: 
      Peanut allergy is increasingly common, especially in countries such as UK and Australia.
      There is currently no accepted routine clinical therapy to cure peanut allergy. Recently
      studies have looked at desensitising people with peanut allergy by giving them small daily
      doses of roasted peanut. Although this therapy works for some people, its effects are not
      generally long lasting and it is associated with many side effects during protocol, resulting
      in a significant rate of drop-outs.

      Pilot data suggests that boiled peanut is less immunogenic than roasted peanut, and may
      therefore provide a safer way of inducing desensitisation in patients who are allergic to
      roasted peanut, by first inducing tolerance to boiled peanut.

      Study hypothesis: Increasing doses of boiled peanut can induce desensitisation to roasted
      peanut, in peanut-allergic individuals.
    


Intervention name(s): Desensitisation using boiled peanut; Desensitisation using boiled peanut (deferred start)
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peanut allergy; Desensitisation; Safety
OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women
Condition: Skin Diseases; Skin Disorder; Melanoma (Skin)
MeSH terms: Skin Diseases; Melanosis
Study type: Interventional

Summary: 
      OneDoc Picopulse™ is a radiopulse technology beauty grade device invented for treating
      melasma.
    

Detailed description: 
      This is a new attempt to evaluate the effectiveness of OneDoc PicopulseTM in treating melasma
      among women of childbearing age in Klang Valley, Malaysia. This pilot feasibility study
      protocol is to access feasibility of the OneDoc Picopulse™ in the future definitive trial.
      The findings of this study would justify OneDoc Picopulse™ as one of the promising
      alternative treatment for melasma.
    

Intervention name(s): OneDoc Picopulse
Intervention type(s): Device
Intervention description(s): Eligible patients will proceed to receive skin cleansing prior to OneDoc Picopulse treatment. After the cleansing, the patients will receive OneDoc Picopulse treatment for 15 mins. Patients will receive ten picopulse treatments for bi-monthly.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melasma; Skin treatment; Picopulse; Malaysian women
Examining the Effectiveness of an Early Psychological Intervention to Prevent Post-Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the use of prolonged exposure therapy on people who have recently
      experienced a trauma to prevent them from developing post-traumatic stress disorder.
    

Detailed description: 
      Post-traumatic stress disorder (PTSD) is a disorder that forms in response to a traumatic
      event. The symptoms of PTSD, such as hyper-arousal and re-experiencing the traumatic event,
      are common in all people who have recently experienced a trauma, but those who develop PTSD
      continue to have these symptoms more than a month after the trauma. Some researchers believe
      that developing PTSD is the result of a failure to adequately recover from the trauma. This
      study will determine whether providing a common form of treatment for PTSD, prolonged
      exposure (PE) therapy, to people who have recently experienced trauma will prevent them from
      developing PTSD. The study will also seek to identify predictive markers, such as hormone
      levels and genes, for developing PTSD.

      Participation in this study will last 3 months. Participants will first undergo an evaluation
      session that will include an interview, questionnaires, and a medical chart review for blood
      pressure and heart rate measurements taken after their trauma. They will then be randomly
      assigned to receive either PE therapy or assessments only. Participants receiving PE therapy
      will complete three weekly treatment sessions, with the first occurring immediately after the
      evaluation session. Treatment will involve reviewing memories of a recent trauma out loud
      with a therapist and audio-recording these discussions for review at home. All participants
      will undergo assessments 1 and 3 months after the initial evaluation session. The 1-month
      assessment will involve an interview and questionnaires similar to the evaluation session,
      and the 3-month session will involve only a brief phone interview. Some participants will
      also be asked to complete an optional part of the study in which they provide two saliva
      samples to researchers: one to measure stress hormones and one to test for genetic bases of
      trauma response.
    

Intervention name(s): Prolonged Exposure (PE) Therapy
Intervention type(s): Behavioral
Intervention description(s): Three PE sessions lasting 1 hour each, delivered 1 week apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: PTSD
Clinical, Genetic and Epigenetic Characterization of Patients With FSHD Type 1 and FSHD Type 2
Condition: Muscular Dystrophy, Facioscapulohumeral
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Facioscapulohumeral
Study type: Interventional

Summary: 
      The aim of the study was to compare the severity of illness between groups of patients
      (Facio-Scapulo-Humeral Dystrophy = FHSD1, FSHD2 and patients both FSHD1 and FSHD2).

      Despite advances in research on the subject, answers are still needed on these diseases.

      We also aim to determine whether the chromosomal genetic abnormality is involved in other
      diseases and the frequency of this mutation in the population of patients FSHD.

      This study will increase our knowledge of the two forms of FSHD who present a common
      pathophysiological mechanism and may occur together in the same family with a worsening of
      the clinical phenotype worsening . In addition, epigenetic differences between FSHD type 1
      and type 2 seems to have clinical consequences requiring appropriate management
    


Intervention name(s): Blood test
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Acceptability of a New Paediatric Formulation of Hydroxycarbamide in Children With Sickle Cell Disease.
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, interventional, phase II, open-label, multicentre, national,
      non-comparative study of a single administration of the new dispersible form of
      hydroxycarbamide at the usual dose in children with sickle cell disease who are already
      treated with the current form of hydroxycarbamide (Siklos® 100 mg and/or 1000 mg film-coated
      tablets).
    


Intervention name(s): Hydroxycarbamide
Intervention type(s): Drug
Intervention description(s): Single administration of the new dispersible form of hydroxycarbamide at the usual dose in children with sickle cell disease who are already treated with the current form of hydroxycarbamide.
Intervention MeSH terms: Hydroxyurea
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hydroxycarbamide; pediatric; acceptability
Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, the investigators will use P-HDFL, a regimen with high tumor remission rate (~
      60-70%) and with only modest treatment-associated toxicities, as induction chemotherapy for
      patients with non-resectable gastric cancer. For those patients who have achieved complete
      response (CR) or partial response (PR), DI will be used to "consolidate" the remission. For
      those patients who fail to achieve remission by P-HDFL, DI will be used as salvage
      chemotherapy. The efficacy and toxicities of DI in these two settings will be evaluated in
      this prospective study.
    

Detailed description: 
      1. To evaluate if weekly Docetaxel-Irinotecan,a potentially non-cross-resistant regimen,can
           prolong the overall survival (OS) or the duration of remission in those patients who
           have achieved CR or PR by P-HDFL regimen

        2. To evaluate the efficacy of weekly Docetaxel-Irinotecan combination as salvage regimen
           for those patients who have either failed to achieve remission or have recurred from
           P-HDFL chemotherapy

        3. To find out the optimal doses for docetaxel and irinotecan in a weekly dosing schedule
           for gastric cancer patients

        4. To evaluate the toxicities of weekly Docetaxel-Irinotecan regimen in inoperable gastric
           cancers
    

Intervention name(s): Docetaxel-Irinotecan
Intervention type(s): Drug
Intervention description(s): Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks
Other intervention name(s): Docetaxel (taxotere); Irinotecan (campto, CPT-11)
Intervention MeSH terms: Docetaxel; Irinotecan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Combination, Chemotherapy, Inoperable Gastric Cancer
Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents
Condition: Cannabis Use; Cognitive Change; Adolescent Behavior
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      This study will use a randomized controlled design to test whether 30 days of cannabis
      abstinence, compared to 30 days of monitoring, is associated with improvements in cognitive
      functioning. Non-using controls will also be enrolled to determine the clinical significance
      of any cognitive improvements with abstinence.
    

Detailed description: 
      This is a 5-year randomized, longitudinal trial of cannabis abstinence designed to determine
      (1) if performance improves with abstinence beyond that observed with continued cannabis use,
      and if so, (2) when during abstinence cognitive improvement occurs, and (3) whether
      performance in abstinent individuals "returns" to performance levels observed in non-using
      peers. We hypothesized that abstinent adolescent cannabis users would have more
      neurocognitive improvement over four weeks compared to non-abstinent cannabis users, and
      performance would continuously improve throughout four weeks of abstinence. We will recruit
      210 adolescents with and without regular cannabis use. Eligible cannabis users will be
      randomized to either a contingency management intervention which will incentivize 4 weeks of
      cannabis abstinence (n = 70), or non-contingent monitoring with no abstinence requirement (n
      = 70). All participants (including non-users; n = 70) will complete cognitive assessments,
      toxicology testing, self-report questionnaires and semi-structured mood and substance use
      interviews during the 4-week study as well as one 30-day follow-up visit. Abstinence will be
      indexed by decreasing levels of cannabis metabolites in urine.
    

Intervention name(s): Abstinence
Intervention type(s): Behavioral
Intervention description(s): Cannabis users randomized to this condition will be enrolled in a contingency management intervention for 30 days of cannabis abstinence.
Other intervention name(s): Contingency Management
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cannabis users are randomized either to 30 days of cannabis abstinence or 30 days of monitoring with no abstinence requirement. Non-users are not randomized.
Masking: None (Open Label)
Primary purpose: Other