bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to gather scientific information about the
      effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult
      subjects with atopic dermatitis.
    


Intervention name(s): 5 mg ASB17061; Placebo; 10 mg ASB17061; 20 mg ASB17061
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral administration of 5 mg ASB17061 taken once daily for 28 consecutive days.; Oral administration of placebo taken once daily for 28 consecutive days.; Oral administration of 10 mg ASB17061 taken once daily for 28 consecutive days.; Oral administration of 20 mg ASB17061 taken once daily for 28 consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; eczema
A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients
Condition: Lupus; Psoriatic Arthritis
MeSH terms: Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate effects of BMS-986165 on blood levels of
      methotrexate given as a single dose in healthy male patients.
    


Intervention name(s): Methotrexate; Leucovorin; BMS-986165
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Other intervention name(s): MTX; LEU
Intervention MeSH terms: Leucovorin; Methotrexate; Deucravacitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intestinal Microbiome and Chemotherapy
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Observational

Summary: 
      Chemotherapy is commonly used as myeloablative conditioning treatment to prepare patients for
      haematopoietic stem cell transplantation (HSCT). Chemotherapy leads to several side effects,
      with gastrointestinal (GI) mucositis being one of the most frequent. Current models of GI
      mucositis pathophysiology are generally silent on the role of the intestinal microbiome.

      The aim of the study is to identify functional mechanisms by which the intestinal microbiome
      may play a key role in the pathophysiology of GI mucositis, the investigators applied high
      throughput DNA-sequencing analysis to identify microbes and microbial functions that are
      modulated following chemotherapy.
    


Intervention name(s): patients stool collection
Intervention type(s): Other
Intervention description(s): patients stool collection
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients, men and women, 18 to 65, who receive intravenous antibiotics broad spectrum
        (Tazocilline (piperacillin tazobactam) and Amiklin (amikacin)) in support of the context of
        febrile neutropenia following a autologous stem cells.
      
Biospecimen description: 
      stool of patients for bacterial analysis
    
Keywords: post-antibiotic diarrhea; intestinal microbiome
A Phase 3 Lot-consistency Clinical Trial of Live Attenuated Varicella Vaccine
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate consistency, immunogenicity and safety of live
      attenuated varicella vaccines manufactured at commercialized scale in aged 1-3 years
      children.
    

Detailed description: 
      The study is a single-center, double-blind, randomized, bridging clinical trial. The purpose
      of this study is to evaluate the consistency between each two lots of live attenuated
      varicella vaccines, to evaluate the non-inferiority of the immunogenicity of live attenuated
      varicella vaccines manufactured at commercialized scale compared to trial-scale, and to
      evaluate the safety of live attenuated varicella vaccines. 1197 healthy Chinese children aged
      1 to 3 years old were randomly assigned into four groups in the ratio 2:2:2:1. Children in
      the first three groups were administered with one dose of live attenuated varicella vaccines
      manufactured at commercialized scale, and children in the last group were administered with
      one dose of live attenuated varicella vaccines manufactured at trial-scale .
    

Intervention name(s): Vaccine manufactured at commercialized scale; Vaccine manufactured at trial-scale
Intervention type(s): Biological; Biological
Intervention description(s): Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0; Single subcutaneous injection of the control live attenuated varicella vaccine (0.5 ml) on Day 0
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: live attenuated varicella vaccine; consistency; immunogenicity; safety; children
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy Volunteers
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This double-blind, placebo-controlled, multiple ascending dose study is designed to evaluate
      the safety, tolerability, and pharmacokinetics (PK) of SKI-O-703 in healthy volunteers.
    

Detailed description: 
      This is a double-blind, placebo-controlled study in healthy adult volunteers, to evaluate the
      safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses of SKI-O-703. A
      total of 24 subjects are planned to participate in 3 cohorts (8 subjects each). In each
      cohort, 6 subjects will be randomly assigned to receive SKI-O-703 and 2 subjects will be
      randomly assigned to matching placebo. Dosing will be initiated with a 200 mg once daily (QD)
      dose cohort and escalated to 400 mg QD, under fasting conditions, for 7 days. In the third
      cohort, a 200 mg twice daily (BID) dose will be studied for 7 days. Evening dosing will occur
      12 hours after the morning dose and will be preceded by fasting for at least 3 hours. After
      all 8 subjects in each cohort have received the study drug and been monitored, the decision
      to escalate to the next dose cohort will be made.
    

Intervention name(s): SKI-O-703 capsule; Placebo capsule
Intervention type(s): Drug; Drug
Intervention description(s): SKI-O-703 200 mg capsule with no inactive excipients.; Placebo 180 mg capsule filled with microcrystalline cellulose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: rheumatoid arthritis; healthy volunteers; moderate to severe
Impact de la Marge de résection Sur la Survie à Long Terme et le Taux de récidive Des Patients Atteints de Cancers Colorectaux opérés au CHUS Entre 2006 et 2016 Pour Des métastases hépatiques
Condition: Colorectal Cancer Stage IV
MeSH terms: Neoplasm Metastasis
Study type: Observational

Summary: 
      We retrospectively looks at the impact of the margin status and its size in mm on the
      recurrence rate in colo-rectal liver metastasis surgery.
    

Detailed description: 
      Main objective : evaluation the margin status (<1mm, 1-4mm, 5-9mm, >10mm) on the survival and
      recurrence in colo-rectal liver metastases surgery.

      Secondary objectives include :

      Evaluate potentiel effects of neo-adjuvant chemotherapy, portal embolisation, and evaluate
      potentiel bias such as size and number of liver metastases, TNM status of original tumor,
      timing between primary and metastasis, and extra-hepatic disease.

      Methods :

      A retrospective cohort study is built where all patients undergoing liver surgery for
      colorectal liver metastases between 2011 and 2015 are analysed. Subjects are separated in
      groups according to their margin status. The local and distal recurrence rates are measured
      and well as survival. Data is obtained through our hospital data management system. Inclusion
      criterias include age over 18, primary colorectal cancer metastatic to the liver, having
      undergone surgery between 2011 and 2015, available pathology reports with required data,
      available radiologic follow-up. Exclusion criterias include repeat liver resection,
      documented grossly positive margins (R2 resection), and unavailable pathologic information
      and follow-up. Using survival as primary outcome (Kaplan Meier) and considering 25% potential
      loss to follow-up, we calculated a sample size. Since this a retrospective study, no patient
      is directly contacted. Data will is handled by the surgery resident responsible for the
      project as well as by research assistants. Statistical analysis are performed accordingly.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with colorectal liver metastases undergoing liver resection at our institution
        during the defined time-frame.
      
Keywords: liver surgery; Colorectal liver metastasis
Mass Balance Study of TS-142 in Healthy Adult Subjects.
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites
      of TS-142 after single oral dose of [14C] TS-142 in Japanese healthy male subjects.

      To assess the safety of single oral dose of [14C] TS-142 in Japanese healthy male subjects.
    


Intervention name(s): [14C] TS-142
Intervention type(s): Drug
Intervention description(s): Subjects received single dose of 7.5 mg of TS-142 containing 20 kBq [14C]TS-142 as an oral solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Single Oral Dose BIRB 796 BS on Endotoxin-induced Inflammatory Responses in Healthy Human Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the effect of a single dose BIRB 796 BS on systemic inflammatory responses
      induced by endotoxin in healthy humans
    


Intervention name(s): BIBR 796 BS, low dose; BIBR 796 BS, high dose; Placebo; Lipopolysaccharide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lipopolysaccharide (LPS) for endotoxin challenge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI TRIAL
Condition: Arrhythmias, Cardiac; Venous Puncture; Implantable Defibrillator User; Pacemaker Complication; Vascular Access Complication; Fluoroscopy; Adverse Effect
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      Single center, randomized trial (1:1 fashion) to asses the safety and the feasibility of the
      ultrasound guided venous puncture vs standard fluoroscopic technique in patients undergoing
      pacemaker or implantable cardioverter-defibrillator implantations.
    

Detailed description: 
      Rationale: axillary, cephalic and subclavian venous accesses are commonly used in pacemaker
      and implantable cardioverter defibrillator implantations. Axillary puncture and cephalic vein
      surgical cutdown are both recommended in international guidelines due to low risk of
      pneumothorax and chronic lead complications. Sometimes cephalic vein is not available. Today
      axillary puncture is performed under fluoroscopic view and some complications still exist
      with this venous access as pneumothorax and arterial puncture. Axillary vein direct
      visualization can be obtained with standard venography or with ultrasound. With direct
      visualization and puncture of the axillary vein under ultrasound guidance venography with
      radiocontrast could be avoided. Less radiation exposure for patient and operator and direct
      visualization of the needle are possible with lower periprocedural complications using
      ultrasound. Despite the great interest for ultrasound guided axillary puncture up today we
      have few data on its feasibility. Our hypothesis is that ultrasound guided axillary access is
      more safe and more feasible than the standard fluoroscopic technique.

      We decided to enroll all the patients undergoing standard transvenous pacemaker or
      cardioverter implantable defibrillator. We randomize the patients with 1:1 fashion to
      axillary venous access under fluoroscopic guidance or to ultrasound guided axillary venous
      access.

      Obiectives: to asses safety, feasibility of the ultrasound guided venous puncture.

      Main Endpoint: composite of pneumothorax, pocket hematoma, arterial puncture, pocket or
      device infection, hemothorax at 30 days.
    

Intervention name(s): Ultrasound Guided Axillary Venous Access; Fluoroscopy-Guided Axillary Venous Access
Intervention type(s): Procedure; Procedure
Intervention description(s): Direct visualization of axillary vein will be obtained with ultrasound sterile linear probe.; Fluoroscopic landmarks will be used and axillary venous puncture will be performed without ultrasound
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pacemaker; ICD; arrhythmias; Cardiac Implantable Electronic Device; Vascular access; Venous puncture; Ultrasound; Fluoroscopy
A Study of Cephalexin Suspension in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare two different preparations of an antibiotic called
      cephalexin to determine if they are essentially the same. The study has two periods.
      Participants will receive one preparation of cephalexin in each period. At least 7 hours will
      pass between the study periods. The study is expected to last about 2 days for each
      participant, not including screening or follow-up.
    


Intervention name(s): Cephalexin
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): Keflex®
Intervention MeSH terms: Cephalexin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Inhaled Apocynin Decreases Reactive Oxygen Species Concentrations in Exhaled Breath Condensate in Mild Asthmatics
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to investigate the effect of inhaled apocynin on ROS (reactive oxygen
      species) and NOS (reactive nitrogen species) synthesis in 10 nonsmoking mild asthmatics.
      Effects of nebulized apocynin (0.5 mg/ml, 6 ml) are assessed in exhaled breath condensate
      (EBC) after 30, 60 and 120 minutes.
    

Detailed description: 
      The study had a double-blind, placebo-controlled, cross-over design, consisted of 2 visits,
      separated 30 ± 10 days. If during the first visit the drug was used, in the second visit -
      placebo or vice versa. Before and after procedure, safety measures (arterial blood pressure,
      heart rate value, and cough scale) were performed. The effect of a possible inhibitor of ROS
      formation was performed using corticosteroid-naive asthmatic subjects, which are more prone
      to oxidative stress than healthy non-smoking subjects. The study protocol was approved by the
      Ethics Committee of Medical University of Lodz (no. RNN/12/08/KE) and written consent was
      obtained from every subject prior to the study.

      EBC was collected using a modification of the method described previously by Doniec et
      al.2005. The subjects breathed spontaneously through a mouthpiece for 20 min. Each subject
      wore a nose clip during this procedure. Approximately 2 ml of condensate was collected and
      immediately stored at -80°C until the procedure of H2O2, NO2- and NO3- measurement.

      6 ml of apocynin of total dose 3 mg (0.5 mg/ml) has been nebulized through the mouthpiece
      with using of a nose clip.

      The H2O2 concentration in EBC was measured according to the method applied previously by
      Nowak et al.2001. Determination of NO2- and NO3- with Griess solution was performed by
      micromethod, carried out in 96-well plates, according to Griess' method, modified the method
      described by Dziedzic et al.2003.
    

Intervention name(s): Apocynin nebulization
Intervention type(s): Drug
Intervention description(s): 6 ml of apocynin of total dose 3 mg (0.5 mg/ml dissolved in sterile 0.9% NaCl as the study drug) has been nebulized for 15-20 min through the mouthpiece with using of a nose clip. A nebulizer Pulmo Aide AP-50 (DeVilbiss; Richmond, VA) was used (mass median aerosol diameter 3.1 mm, output 0.3 ml/min.)
Other intervention name(s): 4-hydroxy-3-methoxyacetophenone,; acetovanillone
Intervention MeSH terms: Acetovanillone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: apocynin; asthma
Benefits of Dry Needling in Trigger Points on Autonomic Nervous System and Corporal Composition in Patients With Fibromyalgia Syndrome
Condition: Fibromyalgia; Trigger Points
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      This study evaluates the benefits of dry needling in trigger points on autonomic nervous
      system, photoelectric plethysmography, body composition in patients with fibromyalgia
      syndrome.
    

Detailed description: 
      Dru needling can be developed on active trigger points. Myofascial trigger points can be
      active or latent. An active myofascial trigger point pain causes giving a specific
      pathological picture. We will conduct a location of myofascial trigger points following the
      illustrations location myofascial trigger points that indicate Travell and Simons both
      left-sided and right.
    

Intervention name(s): Dry Needling Therapy; Electrical Stimulation Therapy
Intervention type(s): Other; Other
Intervention description(s): The dry needling therapy will be applied on active trigger points in occipital muscle, splenius capitis, sternocleidomastoid muscle, scalene muscles, trapezius, supraspinatus, infraspinatus muscle, latissimus dorsi, iliocostalis muscle, multifidus muscles, and quadratus lumbourm muscles.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Body Composition; Autonomic Nervous System; Oxygen; Randomized Controlled Trial
Lottery Incentives for Moving
Condition: Obesity; Sedentary Lifestyle
Study type: Interventional

Summary: 
      The purpose of the study is to learn more about effective ways to motivate people to increase
      their non-exercise energy expenditure exercise. This is an important research question
      because obesity and weight-related issues are increasingly becoming a problem in America.
      This project will address this research question by testing the effect of two different
      incentive schemes in motivating employees who are predominantly sedentary to use Walkstations
      at work. The Walkstations are treadmills that move at a very slow rate (maximum 2miles /
      hour) and are attached to a work station (i.e. with computer and telephone); they therefore
      are designed to increase energy spent not through heavy exercise, but through small changes
      in posture and movement associated with routines in daily life (called nonexercise activity
      thermogenesis or NEAT).

      Subjects will be employees of Blue Cross Blue Shield of Massachusetts (BCBSMA). Subjects will
      be the control participants from the previous Walkstation study we ran with BCBSMA. All 120
      control participants from this previous study will be told that they can now participate in a
      study that involves the Walkstations (up until now, they have not been given access to the
      Walkstations). These participants from the previous study will be sent an email informing
      them that they are eligible to participate in this new Walkstation pilot. Those who are
      interested in participating will then be invited to sign up for an enrollment session. There
      will be no incentives for participating in the initial enrollment session. For the 2 month
      follow-up session, participants will have a chance to win 1 of 3 prizes (1 * $100, 2 * $50)
      for completing the follow-up.
    


Intervention name(s): Incentive to exercise
Intervention type(s): Behavioral
Intervention description(s): Participants who attain their walkstation goal will be entered into a draw every two weeks. We are testing the effect of different prizes on walkstation usage.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science