bioihbjkbjnl/mcl2 huggingface dataset:
Double Blind, Crossover Study of Fish Oil [EPA and DHA] for Intractable Partial Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if Omega-3 fatty acids reduce seizures and modify
      cardiac risk factors in people with epilepsy.
    

Detailed description: 
      Epilepsy is a common and disabling condition, characterized by recurrent seizures. Sudden
      unexpected death (SUDEP) is a major cause of mortality in people with epilepsy. SUDEP
      accounts for up to 20% of all cause mortality, and is most common in younger people,
      especially in their 20's to 40's year olds. In those with drug resistant epilepsy, SUDEP is
      five times more common than in well-controlled epilepsy. Likely causes of death include
      cardiac arrhythmias due to impaired autonomic regulation and reduced heart rate variability.
      Similarly, patients with recent myocardial infarction and congestive heart failure are at
      higher risk for sudden death, and manifest markedly reduced heart rate variability. Clinical
      studies of heart disease indicate that n-3 fatty acids, prevent cardiac arrhythmias, reduce
      mortality after myocardial infarction, and reduce the risk of sudden cardiac death. The
      mechanism by which EPA and DHA exert their anti-arrhythmia effect is due to inactivation of
      high frequency sodium and L-type calcium channels in the heart. In addition, n-3 fatty acids
      improve HRV in cardiac patients, and this reduction in HRV is postulated to be a marker of
      the anti-arrhythmic effect of n-3 fatty acids. Preliminary data from our group indicates that
      n-3 fatty acids improve HRV in people with epilepsy, especially those with low HRV (SDNN <
      50). The commonality between n-3 fatty acids and improvement in HRV in patients with heart
      disease and epilepsy serves as a basis for our hypothesis that n-3 fatty acids may reduce the
      risk of SUDEP in epilepsy. The purpose of this proposal is to determine if n-3 fatty acids
      reduce seizures and modify cardiac risk in people with epilepsy who are at risk of SUDEP.
    

Intervention name(s): Placebo; High Dose Fish Oil; Low Dose Fish Oil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): corn oil (n-6 fatty acids); n-3 fatty acids, 1060 mg EPA + DHA; n-3 fatty acids, 2160 mg EPA + DHA
Other intervention name(s): Corn Oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: epilepsy; cardiac risk factors; memory; cognition; n-3 fatty acids; fish oil; EPA; DHA; seizures
Progesterone for Postpartum Cocaine Relapse
Condition: Cocaine Abuse; Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional

Summary: 
      The investigators propose a placebo-controlled, randomized clinical trial that would enroll
      50 postpartum women with a history of cocaine abuse or dependence to assess whether
      progesterone (100mgs twice daily) decreases postpartum cocaine use.
    

Detailed description: 
      Specific Aim 1: To evaluate whether postpartum women with a history of cocaine abuse or
      dependence use less cocaine if they are randomized to progesterone than placebo.

      Hypothesis 1: Compared to women who are randomized to placebo, those assigned to progesterone
      will use less cocaine as measured by urine toxicology results and self-reported days of use.

      Specific aim 2: To obtain information about the safety and tolerability of progesterone
      treatment in the postpartum period.

      Hypothesis 2: Side effects for progesterone will be similar to those of placebo.
    

Intervention name(s): Progesterone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 100mgs progesterone twice daily; Matched placebo pills to be taken twice daily
Other intervention name(s): prometrium
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cocaine abuse; cocaine dependence; postpartum period
Use of Near Infrared Spectroscopy to Measure Intracranial ScvO2
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether analysis of near infrared absorbance
      signals that occur at different frequencies might provide information about the difference in
      oxygen saturation between arterial and venous blood.
    


Intervention name(s): Use of impedance threshold device during spontaneous ventilation
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: volunteers
Study of BHV-4157 in Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Preclinical models suggest that riluzole, the active metabolite of BHV-4157, may protect from
      AD-related pathology and cognitive dysfunction. Titrated dose of BHV-4157 to 280 mg, or
      placebo, were administered orally once daily. Duration of treatment is 48 weeks in
      double-blind phase. There is also a screening period of up to 42 days; and a 4-week
      post-treatment observation period. Eligible participants who completed the double-blind
      treatment phase had the opportunity to receive open-label troriluzole for up to 48 weeks in
      an open-label extension (OLE) phase.
    


Intervention name(s): troriluzole; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Oral BHV-4157 will be given daily for up to 48 weeks; Oral matching placebo will be given daily for up to 48 weeks
Other intervention name(s): BHV-4157
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Merozoite Surface Protein 1 Antibody Response in Asymptomatic Human Malaria Infection
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      The main purpose of this trial is to study whether a certain blood test can reliably identify
      the presence of malaria in people who have been infected with, but who do not have symptoms
      of malaria.
    

Detailed description: 
      In this study, two groups of volunteers will be exposed to malaria through the bites of
      infected mosquitoes. In one group, volunteers will be given several doses of a drug called
      mefloquine, known to prevent the development of malaria symptoms. The other group will not be
      treated with any drug that could prevent symptoms or infection. After exposure, both groups
      will be monitored for a period of approximately 6 months to see if they develop symptoms of
      malaria. Any subjects who do so will be treated with appropriate medications. Subjects in
      both groups will have their blood checked regularly during this period for the presence of a
      certain malaria antibody called Merozoite Surface Protein 1, or Anti-MSP-1 for short, using a
      special blood test (also known as an assay). At the completion of the study, the results of
      all assays will be analyzed to determine if this test can be used to diagnose malaria
      infection in persons without symptoms.
    

Intervention name(s): Mefloquine; Control
Intervention type(s): Drug; Other
Intervention description(s): To determine the seroconversion rate (sensitivity) to Plasmodium falciparum Merozoite Surface Protein 1 (Pf MSP-1) antigen by ELISA assay in the infectivity control and mefloquine cohorts as part of a larger project to support the qualification of anti-MSP-1 antigen-specific antibody assays as valid surrogate endpoints for malaria infection.; No Intervention
Other intervention name(s): Lariam
Intervention MeSH terms: Mefloquine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Malaria; Diagnosis; Biomarker
Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal
Condition: Epiretinal Membrane
MeSH terms: Epiretinal Membrane
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the changes in visual acuity, metamorphopsia, and
      thickness of retinal layers after epiretinal membrane removal and to investigate factors
      associated with visual function.
    

Detailed description: 
      Eyes with idiopathic Epiretinal Membrane Removal (ERM) scheduled to underwent ERM removal
      were included. Changes in visual acuity, metamorphopsia score (M-score) using M-chart, and
      parafoveal thickness of each retinal layer were evaluated preoperatively and at 2-month and
      6-month postoperative follow-up visits. Factors associated with visual acuity and M-score
      were investigated.
    

Intervention name(s): Pars plana vitrectomy and removal of epiretinal membrane
Intervention type(s): Procedure
Intervention description(s): A three-port standard pars plana vitrectomy was performed by a single surgeon using a 23-gauge vitrectomy system, either Associate®(Dutch Ophthalmic Research Center. Inc., Zuidland, The Netherlands) or Accurus®(Alcon Laboratories Inc., Fort Worth, USA), with one step scleral tunnel incision. Visualization of the fundus was achieved using a wide-angle viewing system. After core vitrectomy, induction of a posterior vitreous detachment was conducted using a 23-gauge angulated dissecting needle in cases without presence of a posterior vitreous detachment. The epiretinal membrane and internal limiting membrane was removed in all eyes. In most cases, internal limiting membrane was removed without the assistance of staining dye. Indocyanine green dye was used to facilitate the removal of internal limiting membrane in some of the cases.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: epiretinal membrane; visual acuity; metamorphopsia; thickness of retinal layers; spectral domain optical coherence tomography
Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia; Cachexia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Cachexia
Study type: Interventional

Summary: 
      This cohort study aims to investigate the composition and activity of the gut microbiota of
      patients newly diagnosed for acute myeloid leukemia (AML), in relationship with their food
      habits and cachectic hallmarks. The recruitment for this study is currently ongoing with the
      help of clinicians, nurses and data managers at the Saint-Luc clinics, University Hospital
      Leuven (Campus Gasthuisberg) and University Hospital Gent.

      Primary Objective

      •To assess the composition and activity of the gut microbiota in patients with acute myeloid
      leukemia (AML) compared to matched control subjects.

      Secondary Objectives

        -  To investigate correlations between the gut microbiota, cachectic hallmarks and gut
           microbiota-related markers in the blood (gut permeability markers, microbial compounds,
           microbial metabolites).

        -  To characterize the changes in the gut microbial ecosystem that are induced by
           chemotherapy and associated with colitis.

        -  To assess whether the composition of the gut microbiota can predict the severity of
           chemotherapy-related colitis.

      Study Design

      This is an academic multi-centric prospective study. The study is composed of two cohorts
      (Fig. 1). In Cohort A, patients are included before any chemotherapy. Biological samples
      (urine, feces, blood) are collected, alongside information on nutritional habits, appetite
      and medical records. Muscle strength and body composition are also measured. Only patients
      receiving a standard chemotherapy are included in Cohort B. In Cohort B, biological samples
      are collected and body composition, muscle strength and appetite are evaluated at 2 different
      time points, at the end of the chemotherapy (T1) and at discharge (T4).
    


Intervention name(s): collection of clinical data and biological samples
Intervention type(s): Other
Intervention description(s): nutritional assessement
cachexia symptoms
urine, feces and blood samples
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Protein Concentration on Human Embryo Development
Condition: Human Embryo Culture
Study type: Interventional

Summary: 
      Protein Concentration in Human Embryo Culture Media remains assigned to the manufacturers
      with no clear evidence on which concentration is ideal.
    


Intervention name(s): Effect of Protein on Blastocyst Development
Intervention type(s): Other
Intervention description(s): Embryo Development Related to The Protein Concentration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the long-term safety, tolerability, and
      efficacy of upadacitinib in adults with rheumatoid arthritis (RA) who have completed a
      preceding randomized controlled trial with upadacitinib.
    

Detailed description: 
      This is an open-label extension study to assess the long-term safety, tolerability, and
      efficacy of upadacitinib in adults with RA who have completed Study M13-550 (NCT01960855) or
      Study M13-537 (NCT02066389) Phase 2 randomized controlled trial (RCT) with upadacitinib.

      All participants received treatment with 6 mg upadacitinib twice a day at the start of the
      study. Participants may have been up-titrated to 12 mg BID based on protocol-specified
      criteria. In Protocol Amendment 2 (January 2016) the study treatment was changed to a once
      daily (QD) formulation. Participants receiving 6 mg BID were transitioned to 15 mg QD and
      participants receiving 12 mg BID were transitioned to 30 mg QD dosing.

      An optional 12-week vaccine sub-study was added in Protocol Amendment 3 (November 2017) to
      assess the impact of upadacitinib treatment (15 mg QD and 30 mg QD) with background
      methotrexate on immunological responses to pneumococcal 13-valent conjugate vaccine (PCV-13;
      Prevnar 13®) in RA patients. The vaccine substudy included 111 participants who were enrolled
      in the main study, the first participant was enrolled on 13 February 2018 and the the last
      participant completed the sub-study on 9 April 2020.

      In Protocol Amendment 5 (December 2019), the protocol was revised to allow a decrease in
      upadacitinib dosing from 30 mg QD to 15 mg QD, as appropriate, based on investigator's
      medical decision or for safety/tolerability concerns.
    

Intervention name(s): Upadacitinib; Pneumococcal 13-valent conjugate vaccine (PCV-13)
Intervention type(s): Drug; Biological
Intervention description(s): Tablet taken orally; Administered by intramuscular injection
Other intervention name(s): ABT-494; RINVOQ®; Prevnar 13®
Intervention MeSH terms: Upadacitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Musculoskeletal Disease; Arthritis; Joint Diseases; Anti-inflammatory Agents; Antirheumatic agents
Nicotine Uptake, Measures of Abuse Liability, and Puffing Topography With Use of RELX ENDS Products by Smokers
Condition: Electronic Cigarette Use
Study type: Interventional

Summary: 
      This study is being conducted to evaluate nicotine uptake and exposure, the abuse liability,
      and puffing topography associated with the use of an electronic nicotine delivery system ENDS
      with tobacco- and menthol-flavored e-liquids in current smokers.
    


Intervention name(s): RELX ENDS Tobacco Flavor; RELX ENDS Menthol Flavor; Usual Brand Cigarette; Nicorette White Ice Mint nicotine polacrilex gum
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Ad libitum use of RELX ENDS tobacco flavor product during 8-hour and 5-minute use sessions; Ad libitum use of RELX ENDS Menthol flavor product during 8-hour and 5-minute use sessions; Ad libitum use of subjects usual brand product during 8-hour and single cigarette use sessions; Ad libitum use of Nicorette White Ice Mint nicotine polacrilex gum product during 8-hour and 30-minute use sessions
Intervention MeSH terms: Menthol; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Electronic Nicotine Delivery System; Nicotine; Pharmacokinetics; Abuse Liability; Topography; E-cigarette
Team PLAY (Positive Lifestyles for Active Youngsters)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether an intense family-centered program to help
      children, 4 to 7 years old, control their weight is more effective than the advise and
      referrals their health provider gives in the primary care office.
    

Detailed description: 
      This randomized controlled trial is designed to determine whether an intense 6 month
      family-centered intervention to increase physical activity and health eating patterns,
      primarily directed at parents, followed by a 6 month maintenance period, will be
      significantly more successful in controlling weight in overweight/obese children, ages 4-7
      years, than usual standard care, at 2 years after enrollment. The intervention group (180
      children with a BMI > 85% percentile) will receive standard of care, as well as, additional
      parental counseling. Parents will receive intense counseling regarding developmentally
      appropriate physical activity, strategies for reducing sedentary behaviors, nutritional
      counseling, and behavioral counseling including a self-management program to use with their
      children at home. The group will meet once a week for the initial 8 weeks, biweekly for 8
      weeks, and monthly for 2 months. Following this period (the next 6 months), a case manager
      will call the family on a monthly basis and the family will be sent educational and support
      information by mail. The control group (60 children with a BMI > 85% percentile) will receive
      standard care provided by their primary care provider and be offered a six week optional
      parenting class. All children will have a medical history, physical examination, and
      anthropometric measures, nutritional assessment, measurement of physical activity, and
      behavioral/psycho-social measures provided by study personnel. Outcome measurements will be
      done at baseline, 6, 12, 18, and 24 months.
    

Intervention name(s): Team PLAY
Intervention type(s): Behavioral
Intervention description(s): Parents will receive intense counseling regarding developmentally appropriate physical activity, strategies for reducing sedentary behaviors, nutritional counseling, and behavioral counseling, including a self-management program to use with their children at home. The group will meet once a week for the initial 8 weeks, bi-weekly for 8 weeks, and monthly for 2 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: children; overweight; obesity; family; intervention; control; randomized; physical activity; diet; nutrition; behavior; body mass index
Patient Education Before Orthognathic Surgery
Condition: Malocclusion; Anxiety; Micrognathism; Prognathism
MeSH terms: Prognathism; Micrognathism; Malocclusion
Study type: Interventional

Summary: 
      To evaluate the effectiveness in the use of an educational material through: Assessment of
      knowledge about post-operative orthognathic surgery; assessing levels of anxiety with the
      survey of Anxiety Inventory-STATE-TRAIT; clinical evaluation of self-care in the management
      of postoperative signs and symptoms
    

Detailed description: 
      It is a clinical randomized controlled trial being developed from February 2013 to September
      2015, divided into two phases: a pilot study without randomization for impact testing and
      evaluation of intervention and, in the second time, the clinical randomized study with
      possible changes after the pilot study.

      Will be entered in the study patients undergoing maxillofacial surgery originating at
      outpatient clinic located in the municipality of São Paulo. The study aims to evaluate the
      effects of educational material in postoperative education orthognathic surgery, with
      intervals between pre and postoperative serials.

      Recruitment plan of patients: the patients seen in oral and maxillofacial surgery and
      traumatology clinic located in the municipality of São Paulo with indication for orthognathic
      surgery will be covered by personally and invited to participate in intervention research. To
      control the bias will be included in the study patients of the same surgical team, to ensure
      the same surgical technique and postoperative guidance conduct by the surgeon.

      Study variables: it is intended to analyse the socio-demographic variables: sex, age, level
      of education; independent variables: surgical technique, recovery time, difficulties
      experienced during the postoperative period, possible surgical complications; dependent
      variables: signs and symptoms postoperatively (presence or absence) and monitoring of care
      during the postoperative period; level of knowledge about the post-op of orthognathic surgery
      and anxiety levels (State-trait anxiety inventory-IDATE).
    

Intervention name(s): Booklet - Preoperative Educational
Intervention type(s): Other
Intervention description(s): the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Anxiety; Orthognathic surgery; Patient educational as topic; Patient educational handout; Pamphlets
To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      To examine the lung when people with diabetes take an inhaled form of insulin, compared to
      subcutaneous insulin.
    


Intervention name(s): Inhaled insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment