bioihbjkbjnl/mcl2 huggingface dataset:
Examination of Cognitive Function in Patients Treated With Subutex
Condition: Opiate Addiction
MeSH terms: Opioid-Related Disorders
Study type: Observational

Summary: 
      People who addicted to Heroin and other opiates suffer from a disease with approved genetic
      basis. It causes to a behavioral response as searching and using those drugs even though they
      know it causes severe damages as physiological, familiar and legal affairs.

      The popular treatment's goal is to "clean" the people from any drug. In a medical and
      pharmacological point of view there is no sense in this approach for all people. This point
      of view believes that Buprenorphine (Subutex) is a correct pharmacological treatment.

      The hypothesis of this research is that people using Buprenorphine have difficulties in
      gaining weight, in sexual and cognitive function (according to subjects' reports)
    

Detailed description: 
      People who addicted to Heroin and other opiates suffer from a disease with approved genetic
      basis. It causes to a behavioral response as searching and using those drugs even though they
      know it causes severe damages as physiological, familiar and legal affairs.

      The popular treatment's goal is to "clean" the people from any drug. In a medical and
      pharmacological point of view there is no sense in this approach for all people. This point
      of view believes that Buprenorphine (Subutex) is a correct pharmacological treatment.

      The hypothesis of this research is that people using Buprenorphine have difficulties in
      gaining weight, in sexual and cognitive function (according to subjects' reports) We examine
      people who stopped opiates and began Buprenorphine. Every participant in the study will have
      two visits: the first one before receiving Buprenorphine and the second one after 3 months of
      receiving Buprenorphine.
    

Intervention name(s): Sexual, cognitive functional tests and measurement weight
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        People who suffer from addiction problems (opiates) and willing to start Buprenorphine
        treatment
      
Keywords: Opiates; Subutex; Buprenorphine; Patients who addicted to opiates
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
    

Detailed description: 
      Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to
      RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris
    

Intervention name(s): Clindamycin Phosphate; Clindamycin Phosphate RLD; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A thin film of investigation product will be applied to the affected areas of the face once daily; A thin film of investigation product will be applied to the affected areas of the face once daily; A thin film of investigation product will be applied to the affected areas of the face once daily
Other intervention name(s): Lotion; Lotion; Vehicle
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether vitamin C is effective in the prophylaxis
      of post-operative atrial fibrillation in on-pump cardiac surgery
    

Detailed description: 
      Atrial fibrillation (AF) is the single most common post-operative complication after on-pump
      cardiac surgery, ranging from roughly 25% in CABG procedures, up to 65% in valve replacement
      procedures. The presence of AF in cardiac surgery patients doubles the morbidity amongst
      these patients, as well as raising the mortality rates. VitC is an electron donor for a
      number of enzymatic systems, reducing potentially harmful free radicals. In post-procedural
      AF, there is increased peroxynitrite concentration, which is a target for vitamin C. A
      randomized, double blind study will be conducted in order to establish the efficiency of
      vitamin C as prophylaxis for postoperative AF.
    

Intervention name(s): Vitamin C; L-Carnitine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days; L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Atrial fibrillation; Cardiac valve repair; Aneurysm repair; CABG; On-pump; Cardiac surgery; Vitamin C
Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The primary objective of the study is to assess the clinical utility of a genetic test for
      Type 2 diabetes risk in combination with standardized risk assessment compared with
      standardized risk assessment alone, and to measure whether changes in perceived risk
      following genetic testing for Type 2 diabetes risk are correlated with behavior change and
      increased concern about risk for Type 2 diabetes.
    

Detailed description: 
      One thousand outpatients will be enrolled over two years at two university-affiliated primary
      care clinics. Patients will be assigned to one of three study arms: those who want genetic
      testing for diabetes risk will be randomly assigned to either receive the testing in addition
      to the SRA (SRA+G) or to receive the SRA only (SRA-only). Those who do not wish to have
      genetic testing will receive the SRA only. All patients will be surveyed at baseline,
      immediately after going through the SRA (risk-counseling visit; 2-4 weeks after initial
      visit), at 3 months post risk counseling visit and at 12 months post risk counseling visit.
      BMI, waist circumference, fasting plasma glucose and insulin will be measured at baseline and
      12 months. Surveys will allow us to track patients' emotional responses to diabetes risk
      information and changing perceptions of personal risk for Type 2 diabetes over time, and to
      see if these correlate with subsequent diet and exercise behaviors.

      We will use a linear model to assess the effects of genetic testing among the three study
      groups, using HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR) and weight loss as
      the primary outcomes. We will use generalized linear ordinal regression models to fit the
      ordinal survey outcomes of risk perceptions to the continuous HOMA-IR and weight outcome
      variables.
    

Intervention name(s): Standardized Risk Assessment
Intervention type(s): Other
Intervention description(s): patients interested in genetic testing will be randomly assigned to either get testing for type 2 diabetes or not. All arms with receive standardized risk asessements. This study is evaluating behavior after receipt of genetic risk information and different types of counseling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: predictive genomics; personalized medicine; personal genomics; genetic knowledge; genetic attitudes; prevention; health outcomes; behavioral
Evaluate the Safety, Tolerability, Pharmacokinetics,and Clinical Activity of FB704A
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The cause of Rheumatoid Arthritis (RA) is not fully understood. However, one of the
      substances secreted by certain cells in the body, interleukin-6 (IL-6), is believed to play a
      major role in chronic inflammation that is typical in RA. This study investigates the drug
      FB704A, which is believed to lower the inflammation caused by IL-6. This study will be in 2
      sequential parts: a single increasing dose part (Part 1) and a multiple-increasing dose part
      (Part 2). Subjects will receive either active or placebo drug by IV infusion. Subjects in
      both parts will have a short stay in the clinic at the start of the study, then will return
      for outpatient visits.
    


Intervention name(s): FB704A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by IV infusion; Identical in appearance and same excipients as FB704A, but without active compound. Administered by IV infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Epidemiology of Pain in the Delivery Room
Condition: New Born Child Pain
Study type: Observational

Summary: 
      The nociceptif system of the newborn child is functional from 22 to 23 weeks of pregnancy.
      During the delivery the baby is exposed to multiple exterior factors and he is capable to
      memorize the pain .Recent epidemiologic studies showed that the coverage of pain was
      insuffcient and also an increase of analgesic means. Normally the pain coverage have to be
      managed and group every painful gesture. In fact all these recommandations are not followed
      by medical team.

      The aim of the study is to evaluate the prevalence of this type of pain as to set up an
      adequate coverage.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Newborn child been born after 24 weeks amenorrheas undergoing a painful gesture in delivery
        room
Cerebral Dynamic Perfusion Study With Spectral CT in Patients Suspected of Stroke
Condition: Stroke, Acute
MeSH terms: Stroke
Study type: Interventional

Summary: 
      -  Generate a dynamic mapping of the distribution of iodine within the cerebral parenchyma
           in the patient suspected of acute ischemic disorder with the CT spectral scanner.

        -  Correlate the anomalies of iodine mapping to the other parameters acquired during the
           classic dynamic infusion phase to define the ischemic area (MTT higher and rCBV normal)
           versus infarcted zone (MTT higher and rCBV decreased)
    


Intervention name(s): spectral CT
Intervention type(s): Radiation
Intervention description(s): Head spectral CT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
ERADICATE Hp2 - Treating Helicobacter Pylori With RHB-105 Compared to Active Comparator
Condition: Helicobacter Pylori Infection; Dyspepsia
MeSH terms: Infections; Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      The "test and treat" strategy for treating dyspeptic patients who are H. pylori positive is
      rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a
      new triple therapy to treat H. pylori infection in dyspeptic patients against an active
      comparator.
    

Detailed description: 
      This is a, randomized, double blind, active comparator-controlled study of RHB-105 in adult
      subjects complaining of epigastric discomfort that have been screened and found to be
      positive for H. pylori infection via 13C UBT and gastric biopsy.

      The biopsy samples will also be used to conduct H. pylori antibiotic
      susceptibility/resistance assessment.

      The study will be conducted at up to 65 sites in the USA. Eligible subjects will be
      randomized in a ratio of 1:1 between the RHB-105 arm (n=222) and the active comparator arm
      (n=222). Subjects will receive RHB-105 or active comparator for 14 consecutive days.
      Eradication of H. pylori infection will be determined at Visit 5 based on 13C UBT testing
      conducted between 43 and 71 days after initiation of study drug therapy.

      All subjects who meet inclusion and exclusion criteria and have positive13C UBT will undergo
      upper endoscopy with sampling for culture and sensitivity testing (to rifabutin, amoxicillin,
      clarithromycin, and metronidazole) prior to randomization. After test of cure at Visit 5, all
      H. pylori eradication failures will receive susceptibility directed Standard of Care therapy
      based on initial culture results for subjects, and undergo repeat upper endoscopy for post
      treatment antibiotic susceptibility/resistance assessment.
    

Intervention name(s): RHB-105; Active Comparator
Intervention type(s): Drug; Drug
Intervention description(s): The intended dose of RHB-105 (12.5 mg rifabutin, 250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, is equivalent to a total daily dose of:
Rifabutin 150 mg
Amoxicillin 3000 mg
Omeprazole 120 mg
One 50mg Riboflavin tablet to be taken once daily to maintain the blind.; The intended dose of the Active Comparator (250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, equivalent to a total daily dose of:
Amoxicillin 3000 mg
Omeprazole 120 mg
One 50mg Riboflavin tablet to be taken once daily to maintain the blind.
Other intervention name(s): Amoxicillin, Omeprazole and Rifabutin; Amoxicillin and Omeprazole
Intervention MeSH terms: Amoxicillin; Rifabutin; Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction
Condition: Emphysema; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous
      upper lobe emphysema.
    

Detailed description: 
      All subjects meeting the eligibility criteria and who provide written informed consent will
      be enrolled. Immediately prior to BTVA treatment, an initial bronchoscopy will be performed
      to evaluate the baseline condition of the airways and to confirm anatomy of the lung segments
      targeted for BTVA treatment. Up to 3 segments in either the right or left upper lobe will be
      treated with a vapor dose of 10 calories per gram of lung tissue (10 cal/g). Targeted lobe
      for treatment will be based on lobar disease severity.
    

Intervention name(s): BTVA System
Intervention type(s): Device
Intervention description(s): Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Emphysema; COPD; Lung Volume Reduction; BTVA
The Effect of N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis
Condition: Pulmonary Sarcoidosis
MeSH terms: Sarcoidosis, Pulmonary; Sarcoidosis
Study type: Interventional

Summary: 
      This is a pilot study investigating the effect of an antioxidant, N-Acetyl-L-Cysteine (NAC),
      on inflammation and oxidative stress in sarcoidosis.
    

Detailed description: 
      Sarcoidosis is a granulomatous lung disease predominantly affecting the lungs. Reactive
      oxidative species are produced secondary to oxidative stress and inflammation and can affect
      key cellular processes. The investigators have shown a role for oxidative stress in chronic
      beryllium disease (CBD), a granulomatous disease that resembles sarcoidosis, and have also
      shown that antioxidant therapy reduces inflammation in CBD. Oxidative stress also plays a
      role in sarcoidosis but the exact mechanism and potential effect of antioxidant therapy on
      sarcoidosis is unknown. The investigators propose conducting a pilot study investigating the
      effect of an antioxidant, N-Acetyl-L-Cysteine (NAC), on inflammation and oxidative stress in
      sarcoidosis. The investigators will measure and compare markers of inflammation and oxidative
      stress in the lungs of sarcoidosis patients before and after treatment with NAC. The results
      of this study will prepare the investigators for a larger study investigating the role of NAC
      as a therapy for sarcoidosis with changes in lung function and x-ray as our primary outcome.
      This will provide the investigators with a new non-toxic therapy for sarcoidosis that can be
      used on its own or to supplement other therapies minimizing their toxicity.
    

Intervention name(s): N-acetyl-cysteine; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 900mg three times daily for 8 weeks; Matching placebo three times daily for 8 weeks.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sarcoidosis; oxidative stress; anti-oxidant
Tailored Treatment of Permanent Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac
      Ablation System compared to medical therapy in the persistent and long-standing persistent
      atrial fibrillation population.
    


Intervention name(s): Medtronic Cardiac Ablation System; Class I or III Antiarrhythmic Medications
Intervention type(s): Procedure; Drug
Intervention description(s): Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium. Cardioversion could be used to restore sinus rhythm if needed.; Arm 2 (Medical Management): Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator.
Intervention MeSH terms: Anti-Arrhythmia Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial fibrillation
Pilot Study of Interpersonal and Social Rhythm Therapy for Subthreshold Bipolar
Condition: Bipolar Disorder NOS
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The investigators propose to conduct a 20 week open pilot study of Interpersonal and Social
      Rhythm Therapy (IPSRT) to treat individuals (n=18) with subthreshold bipolar (BP) who are
      currently depressed. The investigators will conduct a preliminary evaluation of sleep-wake
      and social rhythm patterns in study participants using questionnaires and actigraphy. Primary
      aims of this study are to evaluate feasibility of this treatment and assessment approach.
      Exploratory aims are to examine 1) sleep-wake and social rhythm patterns in subthreshold BP,
      2) impact of IPSRT on symptoms and functioning over time and 3) relationship between
      sleep-wake and social rhythm patterns and treatment outcomes.
    

Detailed description: 
      Subthreshold bipolar disorder (BP) is a common, understudied, illness associated with high
      levels of impairment. "Subthreshold" BP refers to individuals who have episodes of both
      depression and hypomania, but the episodes of hypomania do not last long enough or are
      characterized by too few symptoms to meet conventional criteria for "threshold" hypomania.
      Compared to individuals with episodes of depression only (major depressive disorder or MDD),
      individuals with subthreshold BP have higher rates of suicide, earlier onset of illness, more
      episodes of depression, and more co-occurring psychiatric disorders. Despite the severity of
      the disorder, virtually nothing is known about how to treat this illness.
    

Intervention name(s): Interpersonal and social rhythm therapy
Intervention type(s): Other
Intervention description(s): IPSRT Subjects will receive weekly 45 minute sessions of IPSRT for 20 weeks. IPSRT sessions focus on reducing symptoms by teaching patients to: a) increase regularity of social rhythms and regulate sleep-wake cycles; b) resolve interpersonal problems that contribute to mood symptoms (role dispute, role transition, grief, or interpersonal deficits); and c) recognize and accept the symptoms of subthreshold BP disorder (psychoeducation). Although we train therapists in techniques that are specific to each component, in practice, these strategies are administered flexibly and fluidly, without distinct boundaries between modalities. During the course of a session, therapists move seamlessly among the techniques, according to patients' needs.
Other intervention name(s): IPSRT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Bipolar NOS; Bipolar Depression
Efficacy and Safety of Sugammadex in Renal Diseased Patients
Condition: Kidney Failure, Chronic; Neuromuscular Blockade
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether sugammadex reverses a profound
      neuromuscular blockade induced by rocuronium in patients with end-stage renal disease just as
      effectively and safely as it does in patients with normal renal function.
    

Detailed description: 
      Sugammadex antagonizes rocuronium induced neuromuscular blockade by encapsulating the
      molecules of this agent in the plasma and originating a complex which is highly stable, and
      mainly eliminated by the kidneys. In patients with end stage renal disease, this complex
      remains in the circulation for days. Previous studies have shown that sugammadex adequately
      reverses the blockade induced by rocuronium in such patients, and no evidence of recurrence
      was observed after a dosis of 2 mg/Kg administered to reverse a moderate level of blockade.
      To our knowledge, nothing has been published so far on the reversal of profound blockade by
      sugammadex in patients with renal failure.

      The aim of our study was to evaluate the efficacy and safety of sugammadex in the reversal of
      profound neuromuscular block (NMB) induced by rocuronium in patients with end-stage renal
      failure and compare it to patients with normal renal function.
    

Intervention name(s): Sugammadex (4 mg/Kg)
Intervention type(s): Drug
Intervention description(s): Sugammadex administered at the end of surgical procedure, once skin suture had been finished, to reverse profound neuromuscular blockade induced and maintained with rocuronium
Other intervention name(s): Bridion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: complications, renal;; kidney, failure;; neuromuscular block, antagonism;; neuromuscular block, rocuronium;; safety, drug; sugammadex