bioihbjkbjnl/mcl2 huggingface dataset:
Study to Compare (COPD) Assessment Test in COPD Stage III and IV in a Prophylactic Treatment
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The study will assess the treatment of patients with Chronic Obstructive Pulmonary Disease
      (COPD) stage III and IV who will self administer the AlphaCore stimulation three times a day
      over a course of 2 months. Patients will either receive an active AlphaCore device or a Sham
      device during these two months while not knowing which device they have been provided. At the
      end of the two months, all patients will be asked to continue in the study for another 2
      months to self administer with the active AlphaCore device. Subjects will complete diaries at
      home on their breathing and quality of life and will return to the clinic monthly for
      assessment by the investigator.
    

Detailed description: 
      PERFORMANCE AND SAFETY VARIABLES:

      The primary efficacy endpoint for this study is the total Chronic obstructive pulmonary
      disease (COPD) Assessment Test (CAT) score change from baseline to the 8 week follow-up
      period comparing the two device groups.

      Secondary efficacy endpoints will be the mean difference from baseline to the 8 week
      follow-up for the following assessments: Medical Research Council (MRC) dyspnoea scale, 6
      minutes walking test and Forced Expiratory Volume in one second (FEV1)

      Safety Variables:

      Each subject will be assessed throughout the study for Adverse Events and at the last visit
      (4 months) subjects will undergo another physical examination including vital signs and blood
      pressure.
    

Intervention name(s): AlphaCore device
Intervention type(s): Device
Intervention description(s): Each study group will go under the same treatment regimen and assessments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: COPD; vagus nerve stimulation; vagal nerve stimulation; nVNS; VNS; non invasive; gammacore
5% Sodium L-Ascorbyl-2-Phosphate Lotion for the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      12-week study to compare the efficacy and safety of a course of a twice daily treatment with
      APS in the form of a lotion to its vehicle for the treatment of acne.
    


Intervention name(s): APS Topical Lotion; Placebo
Intervention type(s): Other; Other
Safety and Efficacy Study of CVD 1208S, a Live, Attenuated Oral Vaccine to Prevent Shigella Infection Using cGMP
Condition: Shigella
MeSH terms: Dysentery, Bacillary
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral
      vaccine) is safe and effective in the prevention of Shigella infection.
    

Detailed description: 
      There are two purposes for conducting this Vaccine Study to evaluate an experimental vaccine
      called CVD 1208S (Center for Vaccine Development 1208S): 1) to learn whether CVD 1208S causes
      side effects, and 2) to learn whether the CVD 1208S gives people immunity to Shigella.
    

Intervention name(s): CVD 1208S, a Shigella flexneri 2a live, oral vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): The vaccine is mixed with salt water and given by mouth.; Corn starch and baking soda are mixed with salt water and given by mouth.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Shigella; Vaccine; Mucosal immunity
Ultrasonographic Fetal Soft Markers and Aneuploidy
Condition: Soft Markers
MeSH terms: Aneuploidy
Study type: Observational

Summary: 
      The purpose of this study is to investigate the prevalence of soft markers which will be
      identified during a second trimester ultrasound. Secondary aims were to estimate the
      association between the soft markers and trisomies 13, 18 and 21 as well as the effect on the
      number of invasive tests will be performed.
    


Intervention name(s): Midtrimester anomaly scan; Fetal Karyotyping
Intervention type(s): Device; Genetic
Intervention description(s): A detailed anomaly scan to detect soft markers at 16 to 24 weeks pregnancy; Fetal karyotyping after birth to confirm chromosomal anomaly diagnosed clinically
Other intervention name(s): 2nd trimester anomaly scan
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant Women at (16-24) weeks of gestation for mid trimester anomaly scan with one
        sonographic fetal soft marker or more
      
Biospecimen description: 
      Fetal karyotyping
    
Keywords: Anomaly scan; Anuploidy
Safety, Pharmacokinetics and Potential Activity of HE3286 in Obese Adult Subjects
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to evaluate the safety, tolerance and pharmacokinetics of
      HE3286 when administered daily for 28 days to obese adult subjects and to assess potential
      activity of HE3286 to decrease insulin resistance. An open-label cohort of 6 patients with
      type II diabetes mellitus will be treated at 10 mg (5 mg BID).
    

Detailed description: 
      HE3286 has a potentially new mechanism of action that may improve the current therapeutic
      options available to patients with metabolic disorders, inflammatory and autoimmune diseases.
      In preclinical experiments, HE3286 has shown to have anti-inflammatory activity associated
      with corticosteroids but without the side effects known with corticosteroid use, such as
      immune suppression and bone loss. HE3286 has demonstrated glucose-lowering and
      insulin-enhancing effects in several preclinical mouse and rat models of insulin resistance.
      In these experiments, HE3286 lowered blood glucose levels and prevented progression of
      hyperglycemia and HE3286 appeared to enhance insulin sensitivity.
    

Intervention name(s): HE3286
Intervention type(s): Drug
Intervention description(s): Dose escalating cohort driven study. 6 planned cohorts.
HE3286 5 mg or placebo QD for 28 days;
HE3286 10 mg (5 mg BID) or placebo BID for 28 days
HE3286 20 mg (10 mg BID) or placebo BID for 28 days
HE3286 40 mg (20 mg BID) or placebo BID for 28 days
HE3286 4 mg (2 mg BID), 20 mg (10 mg BID) or placebo BID for 28 days
HE3286 10mg (5 mg BID) for 28 days (open-label cohort in patients with T2DM)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: phase I; safety; tolerance; insulin resistance; obese; pharmacokinetics
Prebiotics as a Means to Modulate Gut Fermentation, Metabolism, Appetite and Cognition
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study aims at investigating the impact of colonic fermentation of intrinsic indigestible
      carbohydrates in cereal whole kernels after three days consumption, on metabolic variables
      and cognition. The study is performed in healthy, normal to slightly over-weight test
      subjects.
    


Intervention name(s): test meal; reference meal
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
The Foley's Catheter Balloon to the Bleeding From Placenta Previa
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Placenta Previa; Hemorrhage
Study type: Interventional

Summary: 
      Post-partum haemorrhage due to placenta previa is usually from the placental bed at the lower
      uterine segment and it occurs after the placenta separation. Although, nowadays the
      obstetrician can diagnose placenta previa before delivery, it is still one of the important
      causes of maternal mortality . Hysterectomy can be the only effective action to take,
      although it carries many morbidities for the women especially those with low parity.

      Uterine packing considers as a line of treatment before performing surgical procedures in
      postpartum hemorrhage resulting from placental site bleeding. It can save life, avoid
      laparotomy and save uterus.

      Nowadays, the use of intrauterine balloons have been developed and become effective for the
      control of placental site bleeding not responding to medical treatment. The 2-way Foley's
      Cather has many advantages over the gauze packing; First, it allows drainage of blood so no
      occult bleeding could be accumulated inside the uterus as in uterine gauze, second the
      removal of the Foley's Cather balloon is easy and not a painful, third, the removal of 2-way
      Foley's Cather could be gradually as a test of its effectiveness before complete removal .
    


Intervention name(s): Foley's cather ballon
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Drug Levels of [14C]CC-99677 in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to characterize the absorption, distribution, metabolism and
      excretion (ADME) of a single oral dose of [14C] CC-99677.
    


Intervention name(s): CC-99677
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CC-99677; Healthy Male Participants; Pharmacokinetics; Absorption; Distribution; Metabolism; Excretion
Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabis
Condition: Cannabis
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      Few studies have been conducted to assess the pharmacokinetic and pharmacodynamic effects of
      orally consumed intact cannabis (e.g., cannabis-containing brownies). Careful analysis of
      oral cannabis dose effects on these parameters is required to determine the level and
      duration of biological cannabinoid exposure and associated subjective, cardiovascular and
      cognitive effects. In the present study we evaluated the detection of cannabinoids in oral
      fluid, plasma, hair, and urine for up to 9 days following consumption of oral cannabis (10mg,
      25mg, or 50mg THC). The outcomes of the study will extend scientific knowledge about the
      behavioral pharmacology and toxicology of oral cannabis administration and can inform
      policies regarding clinical, workplace and roadside drug testing programs.
    


Intervention name(s): Oral cannabis
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cannabis; toxicology; intoxication
TMC435350-TiDP16-C106: A Phase I Trial to Compare the Bioavailability and Plasma Pharmacokinetics After a Single Oral Dose of TMC435350 of 2 Different Solid Formulations Relative to a Powder Blend Capsule
Condition: Hepatitis C; HCV
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives are: to compare the oral bioavailability and plasma pharmacokinetics of
      TMC435350 for 2 different solid formulations to those of TMC435350 formulated as a powder
      blend in a capsule, after a single oral dose of 200 mg in healthy volunteers; to determine
      the short term safety and tolerability of TMC435350 after a single oral dose of 200 mg
      formulated in capsules with 2 different formulations and as a tablet in healthy volunteers
    

Detailed description: 
      This is a Phase I, open-label, 3-way crossover trial in 12 healthy adult volunteers to
      compare the oral bioavailability of a single 200 mg intake of TMC435350 salt, formulated as 2
      different solid formulations (a tablet and a capsule) to that of a single 200 mg intake of
      TMC435350 salt, formulated as a powder blend in a capsule. TMC435350 is a protease inhibitor
      in development for treatment of chronic hepatitis C virus (HCV) infection. During 3 sessions,
      each volunteer will receive 3 treatments according to a classical 6-sequence, 3-period
      Williams design.The treatments administered are: Treatment A: single dose of 200 mg TMC435350
      salt, formulated as a powder blend filled in a capsule. Treatment B: single dose of 200 mg
      TMC435350 salt, formulated in a tablet. Treatment C: single dose of 200 mg. MC435350 salt,
      formulated in beads filled in a capsule. All medication intakes will be oral and under fed
      conditions. There will be a washout period of at least 7 days between medication intakes in
      subsequent treatment sessions. Full pharmacokinetic profiles of TMC435350 will be determined
      up to 72 hours after administration in each session. Safety and tolerability will be
      monitored continuously throughout the trial. Treatments A, B and C: TMC435350 200mg on Day 1
      of each session.Intakes will be oral and in fed conditions.
    

Intervention name(s): TMC435350
Intervention type(s): Drug
Intervention MeSH terms: Simeprevir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC435350-TiDP16-C106; TMC435350-C106; Bioavailability; Pharmacokinetics
Phase II Study of Pallidotomy for Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES:

      I. Evaluate the safety and efficacy of pallidotomy immediately following 3 preoperative
      assessments vs. delayed pallidotomy following 6 months of standard medical therapy in
      patients with Parkinson disease.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized study. One group of patients undergoes the surgical
      procedure pallidotomy, a precise lesioning of brain cells in the globus pallidus.

      The other group receives standard medical care for 6 months followed by a pallidotomy.
    

Intervention name(s): pallidotomy
Intervention type(s): Procedure
Allocation: Randomized
Primary purpose: Treatment
Keywords: Parkinson disease; neurologic and psychiatric disorders; rare disease
Efficacy of DA-5204 on Gastroesophageal Reflux Disease
Condition: Esophageal Disease
MeSH terms: Gastroesophageal Reflux; Esophageal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled clinical Study to
      evaluate the efficacy of DA-5204 and proton pump inhibitor combination therapy compared with
      proton pump inhibitor alone therapy in patients with gastroesophageal reflux Disease.
    

Detailed description: 
      Gastroesophageal reflux disease is a condition in which reflux of stomach contents into the
      esophagus causes troublesome symptoms, such as heartburn and acid regurgitation.

      Proton pump inhibitors, as acid suppressor, are the agents recommended as the first-line
      treatment for gastroesophageal reflux disease. However, approximately 20-30% of patients have
      insufficient effect on this therapy alone.

      DA-5204 is a medicine based on Artemisia asiatica 95% ethanol extract. DA-5204 has been
      administered to treat gastritis and gastric ulcers with antioxidative and cytoprotective
      actions on gastric mucosal damage. Therefore, we expect DA-5204 to be effective in reflux
      esophagitis (esophageal mucosal injury).
    

Intervention name(s): Pantoprazole; DA-5204; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pantoprazole 40mg tablet; DA-5204 tablet; Film-coated tablet manufactured to mimic DA-5204
Other intervention name(s): Pantoline; Stillen 2X®; Placebo (for DA-5204)
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux; Esophagitis, Peptic
Study to Assess Safety and Effect of a Prebiotic Fiber Meal Replacement Shake in Individuals With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study is a double-blind, randomized, trial of a commercially available meal-replacement
      shake versus a placebo control designed to evaluate the impact on quality of life, safety,
      and tolerability. It also includes a randomized, non-blinded third arm consisting of only
      dietary guidelines.
    

Detailed description: 
      A total of 147 participants will be recruited for the study following screening, with the
      expectation that approximately 131 participants will complete the trial. The 147 participants
      will be randomized to the three different study arms in a 2:1:1 ratio with the commercially
      available meal-replacement shake group being the one favored, i.e., 73 participants in that
      arm and 37 in the other two arms.

      The trial will be mostly virtual, with in-person visits to a laboratory facility for blood
      draws, as well as standardized BMI calculations, waist circumference, and blood pressure
      readings. A technology platform will be utilized to screen, enroll and capture study data of
      the participants.
    

Intervention name(s): Supergut; Placebo; Dietary guidelines
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Meal replacement shake; Placebo; Dietary guidelines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a 3-arm randomized, double-blinded (for the two meal replacement arms), placebo-controlled study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Diabetes; Microbiome; Fiber; Prebiotic
Life Quality of Children in Cancer Remission During School Reintegration
Condition: Cancer Remission
Study type: Interventional

Summary: 
      Few data about the evaluation of consequences of past life with cancer on life quality of
      children in school reintegration are available in literature. Nevertheless, some of these
      studies show that the reintegration impairs life quality of these children (school
      difficulties, conflictual relations with peers…). The hypothesis is that children with past
      life with cancer have more chances to have school integration difficulties with a consequent
      life quality degradation compared to healthy children.

      The main objective of this project is to study the relation between the satisfaction of
      school reintegration of children in cancer remission and the evolution of life quality in the
      medium term (after getting back to school). More exactly, it is the question if the
      satisfaction of school reintegration influences life goals and priorities of these children.

      The secondary objective is to study the role of psychological status of these children
      (anxiety, depressive symptoms) on satisfaction-life quality relation.

      A group of children with cancer history sent to ordinary school is compared to a control
      group of children sent to school in the same conditions (sex and age matched). Data are
      collected with questionnaires some months to several years after school reintegration and
      same questionnaires 1 year later.

      If the study hypothesis is confirmed, this study will show the necessity of a long term
      follow up of children in cancer remission and not only medical care, but also psychological
      and social care, in order to support a better school reintegration.
    


Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): SPP questionnaire (Self Perception Profile for Children), Systemic inventory of life quality for children (ISQV-E), Anxiety questionnaire (STAI-C), Depression questionnaire (CDI)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: children; life quality; school reintegration
ILMA Fastrach Versus I-gel for Fiberoptic Tracheal Intubation
Condition: Tracheal Intubation
Study type: Interventional

Summary: 
      We evaluate feasibility of fiberoptic intubation through the "ILMA Fastrach" vs the "i-gel".
      Both are airway devices to be introduced in the mouth we the possibility to ventilate the
      patient and furthermore to be a guide to introduce a tracheal tube. We first insert either
      the ILMA or the i-gel. In a second step, we will introduce a tube through the device, all
      guided visually through a fiberoptic tool which works as a railroad for the tracheal tube.
    

Detailed description: 
      The ILMA Fastrach™ is a widely accepted and intensively investigated supraglottic airway
      device that is inserted blindly. It may be used to facilitate intubation and secure the
      airway in routine practice, in difficult airway scenarios or in emergency situations.
      Endotracheal tube insertion may be blind or fiberoptic scope guided, the latter raises the
      success rate. The i-gel™ is a newly developed supraglottic airway device and is also
      introduced blindly. Insertion of an endotracheal tube may be blind or fiberoptically guided.

      So far, prospective randomized controlled trials comparing their performance are not yet
      published. There are case reports about intubating over the i-gel.

      In this prospective, randomized, controlled trial, we are going to evaluate the performance
      of intubation through both devices. In 250 patients undergoing elective surgery, we will
      place either the ILMA or the i-gel according to randomization and then intubate with the help
      of a fiberoptic scope, using the specific ILMA tracheal tube or a normal tracheal tube for
      the i-gel. In order to remove the supraglottic airway devices, we will use the ILMA
      stabilizer rod.
    

Intervention name(s): i-gel; ILMA
Intervention type(s): Device; Device
Intervention description(s): insertion after induction of anaesthesia. Afterwards, intubation over the device fiberoptically; Insertion after Induction. Insertion of tracheal tube over device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: i-gel; Fastrach; intubation; fiberoptic; difficult airway; Patients undergoing elective surgery requiring tracheal intubation; Presenting at least one sign of difficult intubation
A Study of MDT-10013 in the Treatment of Acute Postoperative Pain Following Bunionectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of MDT-10013 in men and
      women 18 to 80 years of age who are undergoing bunionectomy. The primary objective is to
      determine the analgesic efficacy of MDT-10013 compared with standard of care in the treatment
      of acute postoperative pain after subjects undergo bunionectomy.
    


Intervention name(s): MDT-10013; Standard of care for pain
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment