bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate OPTI-BIOME™ Bacillus Subtilis MB40 on Abdominal Discomfort, Gas and Bloating in a Healthy Population
Condition: Bloating
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effects of OPTI-BIOME™ (Bacillus subtilis
      MB40), a probiotic supplement, on bloating, gas and abdominal discomfort symptoms in
      otherwise healthy adults.
    


Intervention name(s): OPTI-BIOME™ Bacillus subtilis MB40; Placebo
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Healthy; Bloating; Abdominal Discomfort; Gas; Probiotic; Bacillus Subtillis
Study to Investigate the Potential Drug-Drug Interaction Between ZSP1273 and Oseltamivir
Condition: Drug-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the drug-drug interaction between ZSP1273 and oseltamivir, the pharmacokinetic
      characteristics and safety of ZSP1273 and oseltamivir in healthy subjects, so as to provide a
      basis for the design of administration regimen in subsequent clinical trials.
    


Intervention name(s): ZSP1273; Oseltamivir
Intervention type(s): Drug; Drug
Intervention description(s): ZSP1273 tablets 600mg administered orally once daily; Oseltamivir 75mg administered orally twice daily
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)
Condition: Intracerebral Hemorrhage; Cerebral Hemorrhage; Intracerebral Haemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      This is a multicenter, randomized, adaptive clinical trial comparing standard medical
      management to early (<24 hours) surgical hematoma evacuation using minimally invasive
      parafascicular surgery (MIPS) in the treatment of acute spontaneous supratentorial
      intracerebral hemorrhage.
    

Detailed description: 
      The ENRICH trial will compare the outcomes between early surgical intervention using the
      BrainPath® Approach (i.e., MIPS) and a medically managed cohort. The integrated surgical
      approach includes a combination of available technologies, including the FDA-cleared NICO
      BrainPath® for non-disruptive access and NICO Myriad® to achieve the goal of maximum clot
      evacuation. The medically managed cohort will be treated according the Clinical
      Standardization Guidelines (CSG) as adapted by Emory University from the 2015 AHA/ASA
      Guidelines for the Management of Spontaneous Intracerebral Hemorrhage. Clinical efficacy will
      be determined by demonstrating an improvement in functional outcome, as determined by a
      blinded-assessment of the 180-day utility-weighted modified Rankin Scale (mRS).

      Data suggests improved mortality rates and potential functional benefits of surgical ICH
      evacuation. The methodology proposed for this trial was tested in a preliminary series of 39
      patients treated for supratentorial spontaneous ICH and retrospectively reviewed (Labib et
      al.). These results were replicated in a single center retrospective series of 18 patients
      (Bauer et al.). Despite positive results of both studies and the widely accepted benefit of
      the BrainPath Approach (i.e., MIPS) for subcortical lesions, stronger evidence supporting the
      use of these techniques in ICH is needed for the technique to become universally validated.

      CONTACTS:

      Sponsor - Primary: Penny Sekerak, MBA, BA, RN (317) 569-1229, Penny.Sekerak@niconeuro.com

      Sponsor - Backup: Jennifer Carroll, (317) 709-2466, Jennifer.Carroll@niconeuro.com
    

Intervention name(s): Early Surgical Hematoma Evacuation
Intervention type(s): Procedure
Intervention description(s): Early Minimally Invasive Parafascicular Surgery (MIPS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Subcortical Intracerebral Hemorrhage; Intracerebral Hemorrhage; Intracranial Hemorrhages; ICH; Hemorrhage; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; MIPS; Minimally Invasive Parafascicular Surgery; Neurosurgery; Medical Economic; Hospital Economics
Activity of NCO-48 Fumarate in Treatment-Naive Adults With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study evaluating multiple doses of NCO-48 Fumarate versus tenofovir
      alafenamide (TAF).
    

Detailed description: 
      This is a randomized, open-label, active comparator, multiple oral dose study to evaluate the
      safety, tolerability, pharmacokinetics, and anti-hepatitis B virus (HBV) activity of NCO-48
      Fumarate in treatment-naive adults with chronic HBV infection. This study will evaluate the
      safety, viral kinetics, and antiviral activity of 2 different doses of NCO-48 Fumarate over
      28 days of therapy. In addition, the study will evaluate the antiviral activity of an optimal
      dose of NCO-48 Fumarate versus 25 mg tenofovir alafenamide (TAF) over 28 days of therapy.
    

Intervention name(s): NCO-48 Fumarate 4 mg; NCO-48 Fumarate 20 mg; Tenofovir Alafenamide 25 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 x 2mg NCO-48 Fumarate over 28 days of therapy; 2 x 10 mg NCO-48 Fumarate over 28 days of therapy; 25 mg over 28 days of therapy
Other intervention name(s): Vemlidy ®
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After Screening procedures, eligible subjects will be randomized 1:1:1 to receive either open-label NCO-48 Fumarate 4 mg (2 x 2 mg) or 20 mg (2 x 10 mg), or open-label TAF 25 mg for 28 days.
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia
Condition: Bacterial Pneumonia
MeSH terms: Pneumonia; Pneumonia, Bacterial
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy and safety of the tigecycline regimen with that of the
      imipenem/cilastatin regimen in subjects with nosocomial pneumonia.
    


Intervention name(s): Tigecycline; Imipenem; Cilastatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Imipenem; Tigecycline; Cilastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pneumonia
The Impact of the Practice of Touch-massage on the Anxiety of Patients With Hematological Disorders Hospitalized in a Protective Environment, a Randomized, Controlled Study
Condition: Hematologic Diseases
MeSH terms: Hematologic Diseases
Study type: Interventional

Summary: 
      Each year, 17000 cases of severe hematological diseases are diagnosed in France, with more
      than 6,000 of these requiring hospitalization in a protective, sterile environment. New
      methods, such as touch massage, have emerged in response to anxiety symptoms observed in
      patients in such sterile and isolated surroundings. We hypothesize that during the period of
      isolation, touch massage becomes a nursing care which can help the patient.
    

Detailed description: 
      Patients with hematologic diseases (leukaemia, myeloma, lymphoma) hospitalized in a sterile
      area of a hematology unit for at least 3 weeks 18 to 65 years female or male Not having met
      the nurse, who is providing the touch-massage
    

Intervention name(s): Touch-massage
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Touch-massage; anxiety; leukemia; haematology; cancerology; supportive care; complementary therapy
Vascular Healing After Deployment of Titanium-nitride-oxide-coated OPTIMAX™ Stent and PROMUS-ELEMENT™ Everolimus-Eluting Stent
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare vascular healing of the stented segment after
      deployment of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent stent and
      Promus-Element™ everolimus-eluting stent in patients with acute coronary syndromes requiring
      percutaneous coronary intervention.

        1. Comparison of OCT and CFR findings of titanium-nitride-oxide coated cobalt-chromium
           Optimax™-stent and Promus-Element™ everolimus-eluting stent at two months after the
           index procedure.

        2. Comparison of intravascular coronary flow reserve measurement to non-invasive
           transthoracic echocardiography-derived coronary flow reserve measurement.

        3. Comparison of epicardial vasodilation to coronary microcirculatory vasodilation
    


Intervention name(s): Stenting using Optimax™; Stenting using PROMUS Element™ Plus
Intervention type(s): Procedure; Procedure
Intervention MeSH terms: Tryptophan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: titanium-nitride-oxide-coated stent; everolimus-eluting stent; optical coherence tomography; strut coverage
Preemptive and Preventive Use of Paracetamol for Pain Relief After Cesarean Section
Condition: Cesarean Section; Dehiscence
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators designed a prospective randomized study to investigate the efficacy of
      intravenous (IV) preemptive versus preventive paracetamol on postoperative pain scores,
      patient satisfaction, total morphine consumption and the incidence of morphine-related side
      effects in patients undergoing cesarean section.
    


Intervention name(s): Paracetamol was given intravenously in both group at different times
Intervention type(s): Drug
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Effects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache.
Condition: Cervicogenic Headache; Headache
MeSH terms: Post-Traumatic Headache; Headache
Study type: Interventional

Summary: 
      Cervicogenic headache is defined as unilateral headache associated with neck pain. Effect of
      manual translatoric therapy of the upper cervical spine associated with cervical exercises in
      these patients is currently unknown. Our aim was to determine if adding manual therapy to an
      exercise and home-exercise program improved effects on symptoms and function in short- and
      mid-term in patients with cervicogenic headache.

      A randomized controlled study will be conducted with 40 subjects with cervicogenic headache.
      Each group will receive four 20-minute sessions weekly and a home-exercise program. Upper
      cervical flexion, flexion-rotation test, Impact Headache Test-6 (HIT-6), headache intensity,
      craniocervical flexion test, pain pressure thresholds and Global Rating of Change
      (GROC)-Scale will be assessed at end of the intervention, at 3- and at 6-month follow-ups.
    


Intervention name(s): Manual Therapy and Exercises; Exercise
Intervention type(s): Other; Other
Intervention description(s): Combination of physiotherapy (manual therapy) techniques and exercises for cervicogenic headache; Exercises for cervicogenic headache
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cervicogenic headache; exercise; manual therapy; upper cervical spine
Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will evaluate the effectiveness and safety of the experimental compound OP2000
      (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study
      will have received (and will continue to receive) stable doses of aminosalicylates (oral,
      enema and/or suppository), if tolerated. OP2000 is an ultra low molecular weight heparin with
      anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the
      treatment of ulcerative colitis.
    

Detailed description: 
      This is a double-blind, placebo-controlled, research study to evaluate the effectiveness and
      safety of the experimental compound OP2000 (deligoparin) in patients with active ulcerative
      colitis. Patients eligible for this study will have received (and will continue to receive)
      stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. OP2000 is an
      ultra low molecular weight heparin with anticoagulant (blood thinning) and anti-inflammatory
      actions that may be of benefit for the treatment of ulcerative colitis. Patients will be
      randomized (assigned by chance like the toss of a coin) to receive 75 mg OP2000, 125 mg
      OP2000, or placebo once daily for 6 weeks. Study drug will be administered by subcutaneous
      (under the skin) injection and patients will be taught how to self-administer these
      injections. Following an initial Screening Visit, eligible patients will return to the clinic
      for initiation of study treatment and then again for follow-up visits after 1, 2, 4 and 6
      weeks of treatment. A follow-up telephone call will be scheduled 2 months (and possibly also
      4 and 6 months) after completing study treatment. Study procedures will include a flexible
      sigmoidoscopy at the Screening Visit and at the Week 6 visit.
    

Intervention name(s): deligoparin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Effects of the Novel Unloading Device "HEPHAISTOS" on Bone, Muscles and Vessels
Condition: Muscle; Atrophy, General
MeSH terms: Muscular Atrophy; Atrophy
Study type: Interventional

Summary: 
      11 healthy men used the HEPHAISTOS unloading orthosis in an ambulatory 8 week intervention
      study.

      It greatly reduces calf muscle forces without reducing ground reaction forces.
    

Detailed description: 
      The 56day unloading intervention with HEPHAISTOS had the following key objectives:

        1. Primary objective: Assessment and evaluation of bone adaptation.

        2. Secondary objective: Assessment and evaluation of functional and structural muscular
           adaptations.

        3. Third objective: Assessment and evaluation of functional and structural vascular
           adaptations.

        4. Fourth objective: Assessment and evaluation if the present findings deviate from
           findings observed in established unloading models.
    

Intervention name(s): Hephaistos unloading orthosis
Intervention type(s): Device
Intervention description(s): The Hephaistos unloading orthosis greatly reduces plantarflexor muscle torque and plantarflexor muscle activation during any gait activity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: weight bearing; muscle unloading; bone loss; arterial adaptation; muscular adaptation
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
Condition: Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary:

      • To compare the safety profile of a single intravenous administration of AVP-21D9 as
      compared with Placebo

      Secondary:

        -  To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9

        -  To evaluate the immunogenicity of AVP-21D9
    

Detailed description: 
      This is a sequential, dose-escalating healthy volunteer study of the safety and
      pharmacokinetics of intravenously-infused AVP-21D9.
    

Intervention name(s): AVP-21D9; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): intravenously, single dose; Placebo comparator
Other intervention name(s): Placebo comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Quantitative Sensory Testing in Subjects With Sensitive Skin or Not
Condition: Sensitive Skin
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Sensitive skin is a common problem, with 50% of women and 30% of men in Europe feel they have
      sensitive skin.

      The Quantitative sensory testing (QST) is a physico-psychic method that uses gradients
      stimuli of different modalities to measure a subjective somatosensory response. This allows
      to characterize sensory dysfunction by assessing the participation of small and large nerve
      fibers.

      The aim of this project is to characterize the presence or absence of a neurological disorder
      in patients with sensitive skin. This discovery would be a decisive argument to reinforce the
      suspicion that sensitive skins is linked to a small fiber neuropathy.
    

Detailed description: 
      Sensitive skin is a common problem, with 50% of women and 30% of men in Europe feel they have
      sensitive skin. A sensitive skin is characterized by the occurrence of tingling sensations,
      tightness, heat, burning, itching or pain triggered by non pathogenic factors such as wind,
      heat, cold, water , cosmetics, toiletries, stress...

      The Quantitative sensory testing (QST) is a physico-psychic method that uses gradients
      stimuli of different modalities to measure a subjective somatosensory response. This allows
      to characterize sensory dysfunction by assessing the participation of small and large nerve
      fibers.

      The aim of this project is to characterize the presence or absence of a neurological disorder
      in patients with sensitive skin. This discovery would be a decisive argument to reinforce the
      suspicion that sensitive skins is linked to a small fiber neuropathy.
    

Intervention name(s): Quantitative Sensory Testing
Intervention type(s): Device
Intervention description(s): Study of detection thresholds of vibration, cold and pain related to the heat in the dominant hand of the subjects through the QST.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sensitive skin; Quantitative Sensory Testing
The Effects of Cinnamon on Postprandial Blood Glucose, and Insulin in Subjects With Impaired Glucose Tolerance
Condition: Diabetes
MeSH terms: Glucose Intolerance
Study type: Observational

Summary: 
      To study the effect of cinnamon on postprandial blood glucose, and plasma concentrations of
      insulin in subjects with impaired glucose tolerance.
    

Detailed description: 
      Ten subjects with impaired glucose tolerance were assessed in a crossover trial. A standard
      75 g oral glucose tolerance test (OGTT) was served with placebo or cinnamon capsules.
      Finger-prick capillary and venous blood samples were taken before and 15, 30, 45, 60, 90,
      120, 150, and 180 min after the start of the OGTT to measure glucose, and insulin.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All subjects were recruited from the population in southern Sweden.
Transplanting Hepatitis C Lungs Into Negative Lung Recipients
Condition: Lung Diseases
MeSH terms: Hepatitis C; Hepatitis; Lung Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is being conducted to determine safety and effectiveness of transplanting lungs
      from Hepatitis C-positive donors into Hepatitis C-negative patients on the lung transplant
      waitlist, who will then be treated with appropriate direct-acting antiviral (DAA) after
      transplantation.
    

Detailed description: 
      Open-labelled pilot clinical trial of Zepatier (Grazoprevir + Elbasvir), Epclusa (Sofosbuvir
      + Velpatasvir), or another appropriate DAA in at least 10 HCV-negative subjects receiving a
      lung transplant from a hepatitis C (HCV)-positive donor. Eligible subjects will receive a
      lung transplant from a deceased-donor, and then will receive treatment after lung
      transplantation when infection with HCV is confirmed in these lung transplant recipients.
      Treatment will be complete after 12 weeks for most subjects.
    

Intervention name(s): Zepatier; Epclusa
Intervention type(s): Drug; Drug
Intervention description(s): Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.; Epclusa (sofosbuvir 400mg and velpatasvir 100mg once daily) is taken by mouth for 12 weeks. Study subjects with treatment failure will be provided an alternative DAA + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
Intervention MeSH terms: Sofosbuvir-velpatasvir drug combination; Elbasvir-grazoprevir drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung Disease
Ramipril in Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The present study is designed to evaluate the hypothesis that the Angiotensin-Converting
      Enzyme (ACE) inhibitor Ramipril improves vascular function and reduces markers of low-grade
      chronic inflammation and oxidative stress in patients with Rheumatoid Arthritis.
    

Detailed description: 
      The effect of an 8-week treatment with either ramipril or placebo is studied using a
      randomized, double-blind, and crossover protocol. After given written informed consent,
      baseline characteristics including physical examination, ECG, blood sample and a noninvasive
      assessment of endothelial function are obtained. The patients are randomly assigned to
      receive either ramipril 10mg (up-titration-scheme: starting with 2.5mg in Week1, then 5mg in
      Week2 followed by 2-5mg for the final 6 weeks) followed by placebo or vice versa.The
      individual disease-modifying antirheumatic drug therapy is continued throughout the study.
      The examinations are repeated after 8 weeks treatment of the first and 8 weeks after the
      second study drug. At week 1 and 2 in each treatment period a safety visit is scheduled.
    

Intervention name(s): Ramipril
Intervention type(s): Drug
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment