bioihbjkbjnl/mcl2 huggingface dataset:
Correlation Between Cytokines and the Severity of Meningococcal Disease
Condition: Meningococcemia
MeSH terms: Meningococcal Infections
Study type: Observational

Summary: 
      Objectives:

      Meningococcal disease (MD) is a complex catastrophic phenomenon that can converge rapidly to
      irreversible septic shock, myocardial dysfunction, and profound coagulopathy. During
      meningococcal sepsis and meningitis, a myriad of cells release cytokines within the
      intravascular environment and subarachnoid space. Cytokines are key molecular messengers that
      play key roles in orchestrating and mediating the metabolic, endocrine and coagulation
      responses to meningococcal infection. The aim of the present study is to determine the
      profile of different cytokines in serum and cerebrospinal fluid during MD, as well as relate
      the level of these cytokines to severity of MD.

      Design:

      Prospective, nonrandomized study.

      Setting:

      Tertiary referral intensive care unit.

      Patients:

      Children and adults admitted with a clinical diagnosis of MD. Interventions: Blood and
      cerebrospinal fluid will sample from children and adults with MD.
    

Detailed description: 
      Meningococcal disease (MD) is a complex catastrophic phenomenon that can converge rapidly to
      irreversible septic shock, myocardial dysfunction, and profound coagulopathy. During
      meningococcal sepsis and meningitis, a myriad of cells release cytokines within the
      intravascular environment and subarachnoid space. Cytokines are key molecular messengers that
      play key roles in orchestrating and mediating the metabolic, endocrine and coagulation
      responses to meningococcal infection. The aim of the present study is to determine the
      profile of different cytokines in serum and cerebrospinal fluid during MD:

      IL -4; IL-6; IL-10 and interferon alfa, as well as relate the level of these cytokines to
      severity of MD, evaluated by occurrence of shock, acute renal failure, disseminated
      intravascular coagulation and survival.

      Design: Prospective, nonrandomized study. Setting: Tertiary referral intensive care unit.
      Patients: Children and adults admitted with a clinical diagnosis of MD. Interventions: Blood
      and cerebrospinal fluid will sample from children and adults with MD.

      Measurements and Main Results: in process Conclusions: in process
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted at the Intensive Care Unit of the Instituto de Infectologia Emílio Ribas
      
Biospecimen description: 
      blood sample cerebral spinal fluid
    
Keywords: meningococcal disease; cytokines
Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Gymnema sylvestre has demonstrated promising effects in the treatment of obesity,
      dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings
      show that Gymnema sylvestre has an excellent potential for the prevention and treatment of
      metabolic syndrome.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients
      with a diagnosis of metabolic syndrome in accordance with the modify International Diabetes
      Federation criteria. The patients received 300 mg capsules of Gymnema sylvestre or placebo,
      two times daily before breakfast and dinner for 90 days. Before and after intervention the
      investigators evaluated: The components of metabolic syndrome (waist circumference,
      triglycerides, high-density lipoprotein, fasting glucose and blood pressure), body weight,
      body mass index, total cholesterol, low-density lipoprotein, very-low-density lipoprotein,
      creatinine, aspartate transaminase and alanine transaminase.

      Were calculated: Areas under the curve of glucose and insulin were calculated with de
      Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and
      the insulin sensitivity was estimated using the Matsuda index.
    

Intervention name(s): Placebo; Gymnema Sylvestre
Intervention type(s): Drug; Drug
Intervention description(s): Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.; Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Other intervention name(s): Calcined Magnesia; Gurmar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gymnema Sylvestre; Insulin Secretion; Insulin Sensitivity; Central Obesity
Study of Arm and Putter Movement in Golfers With Golfer's Cramp
Condition: Occupational; Cramp(s)
MeSH terms: Muscle Cramp; Spasm
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators will investigate golfers with visual evidence of an involuntary movement
      while putting before and after treatment with a low dose of propranolol.
    

Detailed description: 
      Dystonia affecting athletes has received little research attention and there has been a lack
      of awareness or interest among both physicians and athletes. Task-specific dystonias or
      occupational cramps affect people while writing, typing, and or playing a musical instrument.
      Our group has previously shown that a subset of golfers who complain of the yips appear to
      have a task-specific dystonia or golfer's cramp. The yips are characterized by an inability
      to appropriately complete a golf stroke, most often putting and chipping strokes. Most
      individuals with the yips describe a jerking or shaking movement that interrupts their swing.
      In many cases the yips are disabling and the golfer, including professional tour players,
      give up golfing.

      Golfers who have evidence of golfer's cramp will putt a series of putts during which they
      will be monitored for arm movements and putter movements. They will then be treated with a
      low dose of propranolol to see if there is a change in these parameters.
    

Intervention name(s): Propranolol; Opal Device; Science and Motion PuttLab (SAM); Surface Electromyography EMG
Intervention type(s): Drug; Device; Procedure; Device
Intervention description(s): Single oral dose of 10 mg propranolol; The Opal Device (APDM, Inc.) will be used to measure wrist movement.; The SAM will be used to study putter stroke movement and ball movement.; The surface EMG will be used to evaluate co-contraction of the wrist flexor/extensor muscle groups and the wrist pronator/supinator muscle groups.
Other intervention name(s): Inderal
Intervention MeSH terms: Propranolol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Occupational; Cramp(s)
Intra-individual Stability in Electroencephalography (EEG) Parameters
Condition: Stability of EEG Features in Humans
Study type: Observational

Summary: 
      The main objective is to evaluate the stability of EEG features on an individual level.
    


Intervention name(s): EEG recording
Intervention type(s): Other
Intervention description(s): A short EEG recording is performed 10 times over the span of three months.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        15 individuals in the age range of 50 - 90 years.
      
Keywords: Intra-individual stability, EEG
Effect of High Frequency Electrical Currents in Healthy Subjects.
Condition: High Frequency Current
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the transcutaneous application of
      unmodulated high frequency alternating currents could produce a quickly conduction block of
      peripheral nerve.
    

Detailed description: 
      In the last years several animal experimental studies have evidenced that high frequency
      unmodulated currents about 5 KHz can cause a peripheral nerve block. However electric
      currents with these high frequencies that are usually used for the treatment of pain in
      humans are interrupted or modulated (i.e. interferential currents).

      It has show that the diameter of the nerve it is related with the frequency to produce the
      conduction block. For this reason we decided to applied 30KHz to observe the effects on pain
      in patients with whiplash and to compare versus sham stimulation.

      Only one study has applied 5KHz on experimental pain and they have demonstrated changes in
      somatosensory thresholds.
    

Intervention name(s): High-Frequency; Sham Stimulation
Intervention type(s): Device; Device
Intervention description(s): high-Frequency electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands); Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Electric current; Nerve block; somatosensory evaluation
Study of Aripiprazole in Subjects With Alcoholism
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this clinical research study is to learn whether subjects treated with
      aripiprazole are able to abstain from alcohol use for a greater number of days than subjects
      treated with placebo. The safety of using aripiprazole will also be studied.
    


Intervention name(s): Aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 2-30mg, Once daily, 12 weeks.; Tablets, Oral, Once daily, 12 weeks.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Transversalis Fascia Plane Block in Caesarean Section Patients
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Transversalis fascia plane block is a regional anesthesia technique described ten years ago.
      Its use for many indications has been identified by case reports in the literature. As the
      investigators have considered that transversalis fascia plane block could be efficacious for
      providing postoperative analgesia in the cesarean section, the investigators have implemented
      the application of this blockade into practice at the clinic. The main purpose of this study
      is to evaluate the analgesic effect of ultrasound-guided bilateral transversalis fascia plane
      block in cesarean section.
    


Intervention name(s): transversalis fascia plane block
Intervention type(s): Other
Intervention description(s): patient controlled analgesia devices with tramadol
Other intervention name(s): patient controlled analgesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Human AME Study for Omaveloxolone
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetics (PK), mass balance, metabolite profiles, and
      rates and routes of elimination of [14C] omaveloxolone and derived metabolites following
      administration as a single 150 mg (containing approximately 90 µCi) dose to healthy male
      subjects.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): [14C]-Omaveloxolone
Intervention type(s): Drug
Intervention description(s): [14C]-Omaveloxolone 50 mg capsules
Other intervention name(s): [14C]-RTA 408
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RTA 408; RTA 408 capsules; omaveloxolone; omaveloxolone capsules; AME; mass balance; metabolite identification
Clinical Trial on the Effects of Bifidobacterium Infantis in Active Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional

Summary: 
      This exploratory study has been designed to determine the effect of the probiotic
      Bifidobacterium infantis vs. placebo orally administered over a period of 3 weeks on clinical
      features, Quality of Life parameters (QoL), intestinal permeability and inflammatory markers
      of patients having positive serological evidences of Celiac Disease.
    

Detailed description: 
      Objective: This exploratory study has been designed to determine the effect of the probiotic
      Bifidobacterium infantis vs. placebo orally administered over a period of 3 weeks on clinical
      features, Quality of Life parameters (QoL), intestinal permeability and inflammatory markers
      of patients having serological evidences of CD (positive serological markers). The testing
      period will be approximately three weeks between the results of serological testing and
      before the intestinal biopsy procedure during which time subjects are consuming a
      gluten-containing diet.

      Study Design: A 3-weeks duration, placebo-controlled, double-blind, randomized study plan in
      ambulatory (non-hospitalized outpatients) patients, with 2 parallel groups. Treatment arms
      will be as follows:

      A). Placebo 2 capsules 3 times daily (morning, evening and night).

      B). Probiotics (Bifidobacterium infantis) 2 capsules 3 times per day (morning, evening and
      night).
    

Intervention name(s): Probiotic
Intervention type(s): Dietary Supplement
Intervention description(s): Bifidobacterium infantis, 2 capsules (2.0E+9 CFU/capsule) 3 times/day for a total of 1.2E+10 CFU/day for 21 days.
Other intervention name(s): Natren Inc.; Life Start Two; Bifidobacterium infantis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Inflammatory Bowel Disease; Coeliac Disease
An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients
Condition: Cytomegalovirus Retinitis; HIV Infections
MeSH terms: Infections; Cytomegalovirus Retinitis; Retinitis
Study type: Interventional

Summary: 
      To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS
      patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the
      safety and efficacy of three different foscarnet maintenance therapy regimens. To determine
      the pharmacokinetics of intermittent administration of foscarnet with or without concomitant
      administration of zidovudine (AZT).
    


Intervention name(s): Foscarnet sodium
Intervention type(s): Drug
Intervention MeSH terms: Foscarnet; Phosphonoacetic Acid
Primary purpose: Treatment
Keywords: Retinitis; AIDS-Related Opportunistic Infections; Drug Therapy, Combination; Foscarnet; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome; Antiviral Agents; Zidovudine
Role of Three Dimensional Ultrasound in the Diagnosis of Septate Uterus
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      Congenital uterine anomalies are found in 8% of infertile women and 24.5% of infertile women
      with a history of recurrent miscarriage, with septate and sub-septate uterus being the most
      common anomalies in these women, Also, septate uterus is the commonest anomaly found in
      infertile women requiring assisted reproductive technology.

      Published data showed improved Cumulative pregnancy rate and live birth rate, and a
      significant reduction in Miscarriage rate in In Vitro Fertilization women after hysteroscopic
      metroplasty of both small and large septate compared to non-operated women.

      Investigators hypothesized that trans-vaginal three Dimensional Ultrasound will be superior
      to Hystro-salpingography for the differentiation between arcuate and septate uterus in
      infertile women scheduled for In Vitro Fertilization.
    


Intervention name(s): Three dimensional ultrasound
Intervention type(s): Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effectiveness of Cognitive Behavior Therapy for Persons With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This was a randomized controlled clinical trial (RCT) carried out in three different
      hospitals in Dhaka city, Bangladesh.
    

Detailed description: 
      This was a randomized controlled trial, conducted to determine the effectiveness of CBT for
      depression delivered by trained therapists with an adapted Bengali CBT (BaCBT) manual, as
      compared to a control group. The main objective of the current study was to examine the
      efficacy of CBT for persons with major depression in Bangladesh.
    

Intervention name(s): cognitive behavior therapy
Intervention type(s): Other
Intervention description(s): Psycho-therapeutic intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Observational [Patient Registry]

Summary: 
      The rate of serious complications are relatively low in bariatric surgery today, but still
      3-4 % will suffer from a serious complication. There are factors known before the surgery or
      during the operation that are likely to increase the risk for a serious complication. If the
      investigators are aware of these we can optimize the patients risk factors prior to the
      operation or at least increase the awareness of the increased risk in some patients given the
      presence of risk factors.
    

Detailed description: 
      Data is collected prospectively to the Scandinavian Obesity Surgery Registry. Today all 44
      clinics performing bariatric surgery in Sweden submits data on baseline characteristics,
      operational data and data from a 30 days, 1 year, 2 years and 5 years follow up for all
      patients. The database is compared annually to the Swedish civil registry to cover all
      mortality.

      From the database we will identify patients who underwent a bariatric procedure between May
      1st 2007 and September 30th 2012. Patients undergoing other bariatric procedures than
      laparoscopic gastric bypass or revisional surgery will be excluded.

      The data will be analyzed with "Chi-2" test, logarithmic regression, linear regression or
      t-test when appropriate. Odds ratio will be calculated.
    

Intervention name(s): laparoscopic gastric bypass surgery
Intervention type(s): Procedure
Intervention description(s): laparoscopic gastric bypass surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing bariatric surgery in Sweden
      
Keywords: bariatric surgery; postoperative complications
Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1)
Condition: Rheumatoid Arthritis Interstitial Lung Disease
MeSH terms: Arthritis; Arthritis, Rheumatoid; Lung Diseases; Lung Diseases, Interstitial
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to to assess the safety and tolerability of pirfenidone 2403
      mg/day for the treatment of RA-associated interstitial lung disease.
    

Detailed description: 
      This is a phase 2, randomized, double blind, placebo controlled trial of pirfenidone for the
      treatment of RA associated interstitial lung disease. Approximately 270 subjects will be
      randomized to receive Pirfenidone 2403 mg per day or placebo in a 1:1 ratio. The primary
      outcome of this study is to assess the efficacy of pirfenidone 2403 mg/day versus placebo in
      patients with RA associated interstitial lung disease, as defined by progression free
      survival over the 52 weeks of treatment. Patients will receive blinded study treatment from
      the time of randomization until the Week 52 Visit.

      Eligible patients aged 18 to 85 years must meet 2010 ACR/EULAR criteria for RA (Aletaha,
      Neogi et al. 2010) as well as RA-associated ILD, as determined by imaging and, when
      available, lung biopsy. Patients will be required to have a % predicted FVC ≥40 and %
      predicted DLCO or TLCO ≥30 at screening.

      The dose of study treatment will be titrated over 14 days. Patients will receive a telephone
      assessment at Weeks 1 and 2, and visit the clinic at Weeks 4, 8, 13, 19, 26, 39, and 52.
      Subjects will have a follow up phone call 28 days after completion of the study drug.
      Patients should complete a compliance diary between visits. If patients discontinue study
      treatment for any reason before the end of the study, they should continue with all scheduled
      study procedures through Week 52. If subjects are unable to complete the study visits as
      scheduled, all efforts should be made to complete an early termination visit.

      The primary outcome variable of this study will be progression free survival, defined as
      progression free from decline in FVC of 10% or greater during the 52 week study period.

      More information can be found at www.ralung.org.
    

Intervention name(s): Pirfenidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pirfenidone three times daily (2403 mg) for 52 weeks; Placebo three times daily for 52 weeks
Other intervention name(s): Esbriet
Intervention MeSH terms: Pirfenidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: TRAIL1; TRAIL; Pirfenidone
Text Message Intervention to Improve Adherence in Adolescents and Young Adults With Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional

Summary: 
      This is a prospective randomized controlled trial investigating the impact of educational
      bidirectional text message reminders on gluten free diet adherence among adolescents and
      young adults with celiac disease age 12-24. Participants will complete a series of online
      questionnaires assessing quality of life, patient activation, celiac symptoms, and self
      reported dietary adherence at the beginning and end of the study. Participants will also have
      their blood drawn to measure Tissue Transglutaminase IgA (TTG IgA) antibody and Deamidated
      Gliadin Peptide IgA (DGP IgA) at the beginning and end of the study. Lab draws can be done
      locally, and are at no cost to the participant. Patients are randomized to the intervention
      or control group based on enrollment TTG IgA. Intervention group receives 45 unique text
      messages over the 3 month study. A gift card is provided for participation in the study.
    


Intervention name(s): Educational Text Message Reminders
Intervention type(s): Behavioral
Intervention description(s): 45 unique text messages designed by the Stanford Pediatric Gastroenterology physicians and nutritionists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)