bioihbjkbjnl/mcl2 huggingface dataset:
Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention
Condition: Multiple Drug Use
Study type: Interventional

Summary: 
      The proposed study will examine brain mechanisms of a brief mindfulness intervention - IBMT
      on ATC reduction.
    

Detailed description: 
      The R61 phase of the proposed study will examine brain mechanisms of a brief mindfulness
      intervention - IBMT that targets at self-control networks in the brain, and test IBMT effects
      on ATC reduction.
    

Intervention name(s): IBMT; RT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): mindful presence in a non-judgmental way; progressive muscle relaxation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The bariatric surgery is widely used to treat obesity. Roux-en-Y gastric bypass is one of the
      most frequently surgical methods performed and combines restrictive and malabsorptive
      procedures. Different data suggest that this surgery may modify drug absorption and we think
      it would be clinically relevant to describe the consequences of gastric bypass on drug
      systemic exposure in obese patients, since no data on the comparison between the
      pharmacokinetics (PK) of a drug before and after surgery are available and help to predict
      the drugs posology.The investigators decided to study the morphine because there is a lack of
      information about the PK, pharmacodynamics (PD) et pharmacogenetics (PG) of morphine in obese
      subjects, in contrary with anaesthetic drugs. This is a drug with a narrow therapeutic range
      frequently prescribed in obese patients.
    


Intervention name(s): gastric bypass
Intervention type(s): Procedure
Intervention description(s): gastric bypass combines restrictive and malabsorptive procedures
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: obesity; gastric bypass; morphine; pharmacokinetic; absorption
Evaluation of the Efficacy and Safety of Inhaled Nitric Oxide as Adjunctive Treatment for Cerebral Malaria in Children
Condition: Malaria, Cerebral
MeSH terms: Malaria; Malaria, Cerebral
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess if adding inhaled Nitric Oxide to other malaria
      treatments can improve the outcome of cerebral malaria in children aged 2months to 12 years.
    

Detailed description: 
      Despite very effective antimalarial treatment, there is a residual and unacceptable high
      mortality rate of malaria, especially amongst young children. Recent progress has been made
      in understanding the role of Nitric Oxide (NO) in severe malaria, indicating that NO
      supplementation is likely to have a beneficial action in severe malaria possibly through
      down-regulation of inflammatory cytokines like TNF. Of the various ways to supplement NO, iNO
      appears to be the safest since it is very well studied in critically ill patients and does
      not cause systemic vasodilation. The safety of NO inhalation has been clearly demonstrated
      through its wide use in the treatment of persistent pulmonary hypertension in neonates and
      pulmonary hypertension in children and adults. Extensive data on its safety has been
      collected. This study is a phase 2 clinical trial that aims at demonstrating the efficacy of
      iNO when added to antimalarial treatment to treat cerebral malaria. This study will also
      provide a better understanding of the pathophysiological mechanisms involved in severe
      malaria.
    

Intervention name(s): inhaled nitric oxide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study drug will be administered using an INOpulse delivery system that delivers small pulses of study drug to the patient via a nasal cannula. Subjects randomized to the intervention arm will receive a dose equivalent to 80 ppm iNO in air for 24 hours per day for a minimum of two days and until clinical improvement (coma recovery), death or a maximum of 5 days.; The placebo will be administered using an INOpulse delivery system that delivers small pulses of study drug to the patient via a nasal cannula. Subjects randomized to the placebo arm will receive nitrogen in air for 24 hours per day for a minimum of two days and until clinical improvement (coma recovery), death or a maximum of 5 days.
Other intervention name(s): INOmax (nitric oxide) for inhalation; Nitrogen in air
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: severe malaria; children; adjunctive treatment
Quantifying and Developing Countermeasures for the Effect of Fatigue-Related Stressors on Automation Use and Trust During Robotic Supervisory Control
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      This project proposes to both develop and test adaptive automation countermeasures for the
      effects of stressors such as sleep deprivation (SD) on human performance related to robotic
      tasks, and investigate the relationship between human trust and appropriate use of these
      countermeasures.
    


Intervention name(s): Sleep deprivation
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Ultrasound-Assessed Diaphragmatic Dysfunction as a Predictor of Weaning Outcome
Condition: Weaning Failure; Sepsis
MeSH terms: Sepsis
Study type: Observational [Patient Registry]

Summary: 
      This study aims to assess whether the degree of diaphragm excursion and diaphragm thickening
      measured by ultrasound during a weaning trial may be used to predict successful weaning from
      mechanical ventilation in patients with sepsis in intensive care unit
    

Detailed description: 
      After being informed about the study and giving written informed consent, Intubated and
      mechanically ventilated patients with sepsis on admission and fulfilling criteria of weaning
      from mechanical ventilation (MV), will undergo diaphragm ultrasound during spontaneous
      breathing trial on T-piece. We will measure diaphragm excursion (DE), diaphragm thickness
      (DT) and calculate diaphragm thickness fraction (DTF):

      DT during inspiration - DT during expiration / DT during expiration

      According to weaning outcome, patients will be divided into 2 groups:

        -  Successful weaning group

        -  Weaning failure group

      By statistical analysis we will define the cut off value and area under curve (AUC) for DE
      and DTF and we can confirm if DE and DTF using ultrasound can be used as predictors for
      weaning from MV or not
    

Intervention name(s): Ultrasound
Intervention type(s): Device
Intervention description(s): Diaphragm ultrasound will be done while patient is supine on T-piece during SBT 30 minutes after disconnecting mechanical ventilation. The measurements will be done by placing the transducer in the eighth or ninth intercostal space, between the anterior axillary and the mid-axillary lines.
Diaphragmatic excursion (DE) will be measured in M-mode using a 1- to 5- Megahertz (MHz) ultrasound curved transducer during maximal breathing. The amplitude of diaphragmatic excursion will be measured as the point of maximal height of the diaphragm to the base line.
Diaphragmatic thickness (DT) will be measured at both end of maximal inspiration and end of maximal expiration using a high frequency 7-11 MHz ultrasound linear transducer in M-mode. The diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients will be intubated (for 2 - 7 days) and ready for weaning process. They will
        undergo diaphragmatic ultrasound on spontaneous breathing pattern on T-piece connected to
        8L/min O2 with subsequent outcome either successful weaning or failed weaning
      
Keywords: Diaphragm ultrasound; Weaning predictor
Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess potential interactions between intravenous (i.v.)
      cocaine and atomoxetine (Strattera) administered orally in four escalating doses.
    


Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cocaine Dependence
FIRM as a Stand-alone Procedure in the Treatment of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The FIRM Study Oslo will in two sequential within-patient trials investigate the efficacy of
      focal impulse and rotor modulation (FIRM) as a stand-alone procedure in the treatment of
      paroxysmal and persistent atrial fibrillation, evaluated by continuous pre- and
      post-procedural heart rhythm monitoring.
    

Detailed description: 
      After a pilot/implementation study consisting of 10 patients with paroxysmal atrial
      fibrillation (AF); 20 patients with paroxysmal AF will be included in a within-patient trial.
      This study will be followed by a similar comparison in 20 patients with persistent or
      longstanding persistent AF.

      The AF driving sources will be visualized by a novel sequential bi-atrial panoramic contact
      mapping technique. Unipolar signals will be recorded by a 64-polar basket catheter (FIRMap®,
      Topera. Inc.), then processed and the activation patterns visualized (RhythmView® 3D
      Electrophysiologic Mapping System, Topera, Inc.).

      Focal impulse and rotor modulation (FIRM) will then be performed with standard irrigated
      radio frequency catheter ablation until rotor or focal impulse elimination is confirmed by
      repeat FIRM mapping.

      Treatment efficacy will be assessed with continuous heart rhythm monitors (Reveal XT®,
      Medtronic, Minneapolis, USA) implanted 3 months prior to ablation, and freedom from AF
      defined as AF burden <1% at follow-up at 12, 24 and 30 months.
    

Intervention name(s): FIRM ablation
Intervention type(s): Procedure
Intervention description(s): Radiofrequency catheter ablation of atrial fibrillation driving sources detected by sequential bi-atrial panoramic contact mapping.
Other intervention name(s): Atrial fibrillation; Rotors; Mapping; Radiofrequency ablation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial fibrillation; Arrhythmias, Cardiac; Heart diseases; Cardiovascular diseases; Pathological processes
Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy
Condition: Liver Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to show that everolimus initiation together with reduction and
      thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal
      function in de novo liver transplant recipients as compared to continuation of CNI-based
      treatment.
    


Intervention name(s): everolimus; basiliximab; CNI
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Start dose of everolimus was 1.5 mg in the morning followed by 1.5 mg in the evening. After one week, the dose was adjusted to achieve trough levels between 5-12 ng/mL. Once trough levels were above 5ng/mL, the CNI dose was reduced to 70%. At week 8 post-baseline (latest at week 16 post baseline), CNI was completely discontinued. For patients receiving Ciclosporin A (CiA) as CNI, the everolimus dosage was adjusted to achieve a trough level of 8-12 ng/mL, prior to discontinuation of CiA. After discontinuation of CNI, everolimus was maintained at a trough level of 5-12 ng/mL.; All patients who met the eligibility criteria were treated with 2 doses of basiliximab on Day 0 (transplantation) and Day 4.; Patients who met the screening eligibility received CNI-based immunosuppressive therapy for 1 month. Then at week 4 (or week 8 at maximum), patients randomized to the CNI arm continued on CNI-based immunosuppressive therapy.
Other intervention name(s): certican; simulect
Intervention MeSH terms: Everolimus; Basiliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver transplantation, everolimus, CNI
Brighter Bites - Access, Continuity and Education With Fruits and Vegetables
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of the research is to find out how well a new nutrition program works for
      elementary school students and their families. This program is called Brighter Bites.
      Brighter Bites is a school-based program that teaches students and their parents about the
      importance of eating fresh fruits and vegetables and how to prepare them in tasty, healthy
      ways. This project is being carried out at six elementary schools in Houston, Texas. Up to
      600 first grade students and their parents/guardians are expected to join this project.
    


Intervention name(s): Brighter Bites; CATCH
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The comparison schools received training in implementing the Coordinated Approach to Child Health (CATCH) school-based health promotion program
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections
Condition: Moderate Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in
      patients who have moderate Clostridium difficile infections.
    


Intervention name(s): LFF571; Vancomycin (POC)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vancomycin; LFF571
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clostridium difficile,; C. difficile,; CDI,; Clostridium difficile-associated disease,; CDAD,; pseudomembranous colitis,; PMC,; antibiotic-associated diarrhea
Effect of Exercise on Sex Hormones in Postmenopausal Women
Condition: Breast Cancer Prevention
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goals of the study are to examine the effect in postmenopausal women of a one-year
      moderate intensity exercise intervention, as compared with a sedentary pattern (low-level
      stretching program), on: serum estrogens, androgens, sex hormone binding globulin, insulin,
      triglycerides, glucose, aromatase, FSH, LH, as well as parameters of body fat mass.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Moderate intensity exercise, 5 days per week, 45 min per session, 50-70% max HR, divided into a 3-month individualized and 9-month maintenance period.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Personal FET in RIF Patients According to Histological Dating of Endometrial of Natural/ Hormone Replacement Cycle
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      At present, the evaluation criterion of endometrial receptivity is controversial. The
      development of a molecular diagnostic tool, the endometrial receptivity array (ERA) for
      diagnosis of endometrial receptivity . But use of this test in patients with RIF has shown
      that the window of implantation (WOI) is displaced in only a quarter of these patients and
      use of a personalized embryo transfer (pET) on the day designated by ERA improves
      reproductive performance with higher cost .what is known to the others'population? The
      morphological changes observed on histology for each specific day after ovulation were
      described by Noyes and his colleagues in 1950 . An endometrial biopsy that shows a difference
      of more than 2 days between the histologic dating and actual day after ovulation is
      considered to be ''out of phase''. But such pET studies according to the Noyes criterion are
      lacking . The aim of this study is to explore the Personal frozen-thawed embryo transfer in
      unexplained RIF patients according to the blinded histological dating of endometrial biopsies
      .
    


Intervention name(s): personal embryo transfer
Intervention type(s): Procedure
Intervention description(s): According to the histological dating of endometrium of natural/hormone replacement cycle in control group, to explore the effectiveness of intervention by advanced or delayed personal embryo transfer .
The establishment of standard control group: Frozen embryo transfer patients according to the inclusion and exclusion criteria were evaluated for histological dating by endometrial biopsy on 7 days after ovulation/P+7. After routine time transfer in the frozen embryo transfer cycle, the standard of histological dating were determined according to the pregnancy outcome of the FET cycle .
pET in RIF patients was delayed one(ovulation +4/P+4, OV/P+4) / two days(OV/P+3) or advanced one day(OV/P+9). Day 5 blastocysts were transferred with this strategy in natural cycles.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics of EVP-0962 and Effects of EVP-0962 on Cerebral Spinal Fluid Amyloid Concentrations in Healthy Subjects and in Subjects With Mild Cognitive Impairment or Early Alzheimer's Disease
Condition: Mild Cognitive Impairment; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to determine the safety, tolerability, pharmacokinetics, and
      effects of EVP-0962 on cerebral spinal fluid Amyloid concentrations in healthy subjects and
      in subjects with mild cognitive impairment or early Alzheimer's disease.
    

Detailed description: 
      This is a randomized, double-blind, sequential escalating repeat daily dose study conducted
      in two parts. The first part is being conducted in healthy subjects and will evaluate safety,
      tolerability, and pharmacokinetics and pharmacodynamics of escalating EVP-0962 doses (10, 50
      100 and 200 mg) or matching placebo following once-daily administration for 14 days. The
      second part will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics
      of EVP-0962 following once-daily administration for 14 days in patients with mild cognitive
      impairment or early Alzheimer's disease at the dose level selected based on the available
      safety, pharmacokinetics and pharmacodynamics observations in the first part.
    

Intervention name(s): EVP-0962; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Arms: 1,2,3,4; Arm 5
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Therapeutic Strategy in Postmenopausal Women Using Osteoporotic Diagnostic Kits
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      The frequency of osteoporosis in Japan is increasing. Also, the frequency of
      osteoporosis-based fractures in postmenopausal women is increasing. Therefore, it is urgently
      required to improve osteoporosis. Life expectancy in Nagano prefecture is the longest in
      Japan, however, healthy life expectancy in Nagano is not very long in Japan. There are
      several problems in this issue from the medical site and the patient site. The aim of this
      study is, from the patient site, to increase the motivation of postmenopausal women for
      osteoporosis using osteoporotic diagnostic kit.
    


Intervention name(s): diagnostic osteoporotic kit ( including 7 genes and 4 life styles)
Intervention type(s): Device
Intervention description(s): Most osteoporotic patients want to know what kinds of life styles they should take care of. The device will help it.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who are over 20 years old
      
Keywords: To decrease; number; osteoporotic; patients in; Kami-Ina area; Nagano prefecture
Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive
Condition: Diabetes Mellitus, Type 2
MeSH terms: Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      to determine safety, efficacy and tolerability of BI 1356 versus placebo
    


Intervention name(s): BI 1356; placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 1356 dosed once daily; placebo matching BI 1356 taken once daily
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study To Asses Mass Balance And Absolute Bioavailability Of 14C PF-06826647 In Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the metabolism and excretion following a single oral
      administration of 14C-PF-06826647-LR (14C labelled PF-06826647 with lower radioactivity per
      mass unit) in fed conditions. This information will enable assessment of clearance mechanisms
      of PF-06826647 as well as identify metabolites. In addition, this study will determine
      absolute bioavailability of PF-06826647 and understand intravenous (IV) pharmacokinetic (PK).
    


Intervention name(s): 14C-PF-06826647-LR 600 mg PO; PF-06826647 600 mg PO; 14C-PF-06826647 100 ug IV
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 14C-PF-06826647-LR 600 mg with 300 nCi orally as extemp prep; Unlabeled PF-06826647 600 mg; 14C-PF-06826647 100 ug IV
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ADME, Mass Balance, Absolute Bioavailability, AMS