bioihbjkbjnl/mcl2 huggingface dataset:
CapsoCam® Colon Capsule Endoscope (CCE) Compared to Colonoscopy (OC)
Condition: Colonoscopy
Study type: Interventional

Summary: 
      This non-significant risk pilot study is designed to evaluate safety and performance of the
      CapsoCam® Colon capsule endoscope in patients who meet the eligibility criteria and are
      scheduled for colonoscopy.
    


Intervention name(s): CapsoCam Colon Capsule Endoscopy
Intervention type(s): Device
Intervention description(s): CapsoCam® Colon is intended to provide visualization of the colon and the detection of colon polyps in adults.
Intervention model: Single Group Assignment
Intervention model description: Multi-Center; Prospective, Open Label, Non-Significant Risk, Pilot Study
Masking: None (Open Label)
Primary purpose: Diagnostic
Radiation Dose Escalation Study for Advanced Liver Cancer
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of
      3-dimensional conformal radiation therapy (3-DCRT)/intensity modulated radiation therapy
      (IMRT) for locally advanced hepatocellular carcinoma (HCC).
    


Intervention name(s): 3DCRT/IMRT; 3DCRT/IMRT
Intervention type(s): Radiation; Radiation
Intervention description(s): The starting radiation doses were the total tumor doses of 46 Gy in 2 Gy per fractions for arm I . Escalation was achieved by increasing the tumor dose of each cohort in increments of 4.0 Gy. Subsequent cohorts received higher doses up to a chosen maximum of 62 Gy for arm I.; The starting radiation doses were the total tumor doses of 40 Gy in 2 Gy per fractions for arm II. Escalation was achieved by increasing the tumor dose of each cohort in increments of 4.0 Gy. Subsequent cohorts received higher doses up to a chosen maximum of 52 Gy for arm II.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; radiation therapy; 3-dimensional conformal radiation therapy (3-DCRT); intensity modulated radiation therapy (IMRT); active breathing control
Treatment of Thromboangiitis Obliterans (Buerguer's Disease) With Bosentan
Condition: Thromboangiitis Obliterans
MeSH terms: Thromboangiitis Obliterans
Study type: Observational

Summary: 
      This study assessed the effectiveness and safety of bosentan when administered to
      thromboangiitis obliterans (Buerger's disease)patients. A clinical pilot study was
      designed,included in which patients with ulcer and/or pain at rest were treated with bosentan
      p.o at a dose of 62,5 mg twice daily during the first month, which each thereafter uptitrated
      to 125 mg twice daily. Study endpoints were clinical improvement rate, major or minor
      amputation rate, hemodynamic changes, changes in endothelial function and angiographic
      changes.

      12 patients were included were current smokers. With bosentan treatment, no new ischemic
      lesions were observed in all but one patient. Overall, clinical improvement was observed in
      12 of the 13 extremities (92%). Only two of 13 extremities underwent amputation after
      bosentan treatment. As assessed by digital arteriography with subtraction or angio-magnetic
      resonance image an increase of distal flow was observed in 10 out of the 12 patients. All
      patients experienced a statistically significant improvement in their BAFMD values (means:1.8
      at baseline;6.6 at the end of the treatment;12.7 three months after the end of the
      treatment;p<0.01). In conclusion: Bosentan treatment may result in an improvement of
      clinical, angiographic, hemodynamic and endothelial function outcome. Bosentan deserves
      further investigation in the management TAO patients.
    


Intervention name(s): Bosentan
Intervention type(s): Drug
Intervention description(s): Bosentan therapy consisted of a month's treatment with 62.5 mg bid orally administered. Dose doubled to 125 mg bid after the first month. The full-dose regimen (125 mg/12h) was maintained for the following months or until total healing fo the ulcers.
Intervention MeSH terms: Bosentan
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering from Buerger's disease
      
Keywords: Bosentan; Buerguer disease
Study to Evaluate the QTC Interval in Healthy Volunteers Dosed With Dexpramipexole (QTC = Electrocardiogram (ECG) Interval Measured From the Onset of the QRS Complex to the End of the T Wave Corrected for Heart Rate)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate whether dexpramipexole prolongs the QTc interval when orally administered to
      healthy volunteers.
    

Detailed description: 
      This is a Phase I, single-center, blinded (with respect to dexpramipexole administration),
      randomized, placebo- and active-controlled, 4-period crossover study in approximately 68
      healthy volunteers. This thorough QT/QTc study will be conducted to formally evaluate the
      effect of dexpramipexole on QT prolongation.
    

Intervention name(s): Dexpramipexole; Dexpramipexole; Dexpramipexole Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 300 mg - Oral Tablets; 600 mg Oral Tablets; Placebo - Oral Tablet; 400 mg - Oral Tablet
Intervention MeSH terms: Moxifloxacin; Pramipexole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Effectiveness and Safety of Korean Herbal Medicine for Post-accident Syndromes After Acute Phase
Condition: Traffic Accident; Whiplash Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      This study is a single blind, randomized controlled trail. condition/disease: Post-accident
      syndromes after acute phase treatment/intervention: herbal medicine treatment strategy
    

Detailed description: 
      The Korean herbal medicine is a complex extract of medicinal herbs prescribed by a Korean
      medicine doctor who has completed specialized education to diagnose the health condition and
      symptoms of patients with post-traffic accident syndromes. This treatment is known to relieve
      the post-accident syndromes and improve health. However, there are no studies examining the
      efficacy of Korean herbal medicine alone.

      So, the investigators will conduct a randomized controlled trials to verify the efficacy and
      safety of Korean herbal medicine. From July, 2021 to May, 2022, the investigators recruited
      40 patients who are suffered from post-accident syndromes with the numeric rating scale(NRS)
      over 5. For experimental group(the Korean herbal medicine treatment group, n=20), the
      investigators conducted Korean medicine treatment for 4 weeks(28 days), and for control
      group(the Non-Korean herbal medicine treatment group, n=20), just Korean medical
      treatment(acupuncture, pharmacoacupuncture, cupping, and chuna) has been conducted. For these
      two groups, the investigators compared NRS, Impact of Event Scale-Revised-Korean(IES-R-K),
      5-level EuroQol 5-dimension(EQ-5D-5L), Short-Form-12 Health Survey version2(SF-12 v2), and
      Patient Global Impression of Change(PGIC).
    

Intervention name(s): Korean herbal medicine treatment; Non-Korean herbal medicine treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Korean herbal medicine treatment is a treatment using complex extract of medicinal herbs prescribed by a Korean medicine doctor who has completed specialized education to diagnose the health condition and symptoms of patients with post-traffic accident syndromes.; acupuncture, pharmacoacupuncture, cupping, chuna
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of JNJ-77242113 in Healthy Japanese and Chinese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)
      of JNJ-77242113 after single ascending oral dose administration as an immediate-release (IR)
      tablet formulation in healthy Japanese participants and after single oral dose administration
      as an IR tablet formulation in healthy Chinese participants; and as a delayed release (DR)
      tablet formulation in healthy Japanese participants.
    


Intervention name(s): JNJ-77242113; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-77242113 will be administered as an oral tablet.; Matching placebo will be administered as an oral tablet.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Two Modes of Respiratory Physiotherapy in Cardio-thoracic Surgical Patients
Condition: Postoperative; Dysfunction Following Cardiac Surgery; Postoperative; Dysfunction Following Lung Surgery
Study type: Interventional

Summary: 
      Two forms of pre and postoperative physiotherapy are compared in three cohorts of patients
      undergoing cardio-thoracic surgery: Minor thoracic surgery (biopsy), major thoracic surgery
      (lobectomy etc, open or VATS) and cardiac surgery
    

Detailed description: 
      Inspiratory force calibrated training is applied in a controlled randomized trial
    

Intervention name(s): Chest Physiotherapy; Post-therapy lung volume measurements
Intervention type(s): Other; Device
Intervention description(s): In both intervention groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers
Condition: Healthy
Study type: Interventional

Summary: 
      Research suggests dietary fiber may play a role in weight management, and fiber consumption
      is inversely associated with body weight, body fat, and BMI in cross-sectional studies. These
      effects may be mediated by increased satiety, reduced food intake, or changes in blood levels
      of glucose, insulin, and gut hormones.

      The purpose of this study is to determine the satiety, glycemic, hormonal, and
      gastrointestinal responses of novel fiber supplements.
    


Intervention name(s): Placebo; Resistant Starch; Resistant starch + soluble fiber; Fiber made from corn starch; Fiber made from corn starch + soluble fiber
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Low fiber muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase); 25 g resistant starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase); 25 g fiber as resistant starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase); 25 g fiber made from corn starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase); 25 g fiber as a fiber made from corn starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: satiety; fiber; food intake; gut hormones; visual analog scales; microflora
Endotracheal Intubation in Prehospital Scenario
Condition: Endotracheal Intubation
Study type: Interventional

Summary: 
      We therefore designed this randomized crossover study to compare C-MAC with Macintosh
      laryngoscope in emergency intubation performed by paramedics according to three different
      intubator positions.
    


Intervention name(s): C-MAC laryngoscope; Macintosh laryngoscope
Intervention type(s): Device; Device
Intervention description(s): Intubation performed using C-MAC laryngoscope; Intubation performed using laryngoscope with Macintosh blade
Other intervention name(s): C-MAC; C-MAC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Extended Administration of Polyethylene Glycol (PEG) Interferon Alfa-2b in Participants With Solid Tumors (C/I97-349/MK-4031-009)
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an extension study to base study protocol C/I97-188 (MK-4031-006). Its primary
      purpose is to assess the safety and tolerability of extended administration of polyethylene
      glycol (PEG) interferon alfa-2b in participants with solid tumors.
    


Intervention name(s): PEG Interferon Alfa-2b; Acetaminophen
Intervention type(s): Drug; Drug
Intervention description(s): Participants receive PEG interferon alfa-2b administered by SC injection, in doses ranging from 0.75 mcg/kg OW up to 7.5 mcg/kg OW, for up to 40 weeks of treatment.; Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg.
Other intervention name(s): MK-4031; SCH 54031; PEG Intron®; Tylenol®
Intervention MeSH terms: Acetaminophen; Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
HFCWO in Hospitalized Asthmatic Children
Condition: Bronchial Asthma; Asthma; Status Asthmaticus
MeSH terms: Asthma; Status Asthmaticus
Study type: Interventional

Summary: 
      To determine whether or not high frequency chest wall oscillation (in the form of the VestTM)
      is superior to regular asthma therapy in the management of children hospitalized with
      moderate to severe asthma.
    

Detailed description: 
      A historically controlled pilot study was conducted in pediatric patients 18 months to 18
      years of age hospitalized with a diagnosis of asthma or reactive airway disease and admitted
      to the pediatric intensive care unit. Upon receiving informed consent, patients were treated
      with HFCWO therapy via the VEST. The primary endpoint was time to readiness for discharge,
      lack of need for continued supportive care (e.g., intravenous fluid or oxygen), and
      bronchodilator treatments spaced at least four hours apart.
    

Intervention name(s): VEST
Intervention type(s): Device
Intervention description(s): 15 minutes of HFCWO via the Vest 2-3 times daily
Other intervention name(s): Hill-Rom Vest(tm)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Bronchial Disease; Status Asthmaticus; High Frequency Chest Wall Oscillation; the Vest; HFCWO
the Efficiency of Thalidomide for Recurrent Small Intestinal Bleeding Due to Gastrointestinal Vascular Malformation
Condition: Gastrointestinal Vascular Malformation
MeSH terms: Vascular Malformations; Congenital Abnormalities; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      Gastrointestinal vascular malformation (GIVM), which is an important cause of acute or
      chronic gastrointestinal bleeding, currently lacks of effective treatment. The investigators'
      previous study first confirmed thalidomide treatment of GIVM bleeding was safe and effective.
      This prospective multi-center randomized controlled clinical trial intends to investigate the
      efficacy of thalidomide to the recurrent small intestinal hemorrhage due to GIVM.
    

Detailed description: 
      This multi-institutional clinical trial investigates the efficacy of thalidomide to the
      recurrent small intestinal hemorrhage due to GIVM. Patients with annual average bleeding 4
      times or more and lesions located in the small intestine which are not suitable for
      endoscopic therapy will be randomly assigned to receive A(25mg,Thalidomide，qid), B(25mg,
      Thalidomide, bid& placebo bid ) or placebo(deferred treatment group) for 4 months. The
      primary endpoints were the effective response of patients with ≥50% reduction of numbers of
      bleeding episodes, followed by rate of cases with cessation of bleedin, the difference in
      blood transfusion, hospitalization, transfusion volume of red cell, average bleeding
      duration, average hemoglobin level, yearly hospitalization times, average hospital stay and
      yearly bleeding episodes. This study will be done at 10 centers in China.
    

Intervention name(s): Thalidomide (100mg); Thalidomide (50mg); placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients were randomly assigned to receive a 120-days course of 100 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China).; Patients were randomly assigned to receive a 120-days course of 50 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China).; Patients were randomly assigned to receive a 120-days course of placebo (Pharmaceutical Co., Ltd. of ChangZhou, China).
Other intervention name(s): Group 1; Group 2; Group 3
Intervention MeSH terms: Thalidomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gastrointestinal vascular malformation; thalidomide; Small intestinal bleeding
A Potential Novel Marker for Liver Fibrosis in NASH: the Soluble Secreted Form of the Human Asialoglycoprotein Receptor
Condition: Liver Fibrosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Observational

Summary: 
      Soluble secreted proteins that are expressed uniquely in specific organs and whose formation
      of secretion is regulated by disease states are excellent markers for the disease. This is
      because the disease can be diagnosed by simply measuring the levels of the secreted protein
      in serum. A soluble form of the asialoglycoprotein receptor could be a promising candidate
      for such marker in the case of liver fibrosis secondary to steatohepatitis for which the
      existing markers are not satisfactory. The human asialoglycoprotein receptor (ASGPR) is
      expressed only in hepatocytes. The H2a alternatively spliced variant of the ASGPR H2 subunit
      differs from H2b variant only by the presence of an extra pentapeptide. EGHRG, in the
      exoplasmic domain next to the membrane-spanning segment. H2a is rapidly cleaved to a36 kDa
      fragment, comprising the entire ectodomain, which is secreted. H2a does not participate in a
      membrane bound receptor complex with H1 as in the case for H2b and thus it is not a subunit
      of the receptor but a precursor for a soluble secreted form of the protein (sH2a). Although
      H2a is a type II transmembrane protein, signal peptidase is probably responsible for the
      cleavage to the soluble form.

      The objective in this research proposal is to study the association between the level of
      sH2a. in the serum and the severity of fibrosis in steatohepatitis in patients undergoing
      bariatric surgery due to morbid obesity.

      The existence of sH2a in normal human serum is at very constant levels. On the other hand the
      membrane ASGPR (expressed exclusively in hepatocytes) is profoundly down - regulated in liver
      cancer and cirrhosis. The investigators will analyze the levels of sH2a in serum from
      patients with steatohepatitis in different stages of fibrosis and compare with healthy
      subjects. A possible early down-regulation of sH2a in fibrosis may prove to be a valuable
      diagnostic tool.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients who are scheduled to bariatric surgery will be enrolled.
      
Keywords: human asialoglycoprotein receptor (ASGPR); hepatocytes; bariatric surgery
Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of two
      HIV-1 pDNA vaccines: p24CE1/2 pDNA and p55^gag pDNA administered with IL-12 pDNA adjuvant,
      given by intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected
      adults.
    

Detailed description: 
      This study will evaluate the safety, tolerability, and immunogenicity of two HIV-1 pDNA
      vaccines: p24CE1/2 pDNA and p55^gag pDNA administered with IL-12 pDNA adjuvant, given by
      intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.

      Participants will be randomly assigned to one of four groups: Group 1 Treatment, Group 1
      Control, Group 2 Treatment, or Group 2 Control.

      Participants in Group 1 Treatment will receive p24CE1/2 pDNA and IL-12 pDNA at Day 0 and
      Month 1, then p24CE1/2 pDNA plus p55^gag pDNA and IL-12 pDNA at Months 3 and 6. Participants
      in Group 1 Control will receive placebo (sodium chloride for injection) at Day 0 and Months
      1, 3, and 6.

      Participants in Group 2 Treatment will receive p55^gag pDNA and IL-12 pDNA at Day 0 and
      Months 1, 3, and 6. Participants in Group 2 Control will receive placebo (sodium chloride for
      injection) at Day 0 and Months 1, 3, and 6.

      Study visits will occur at Day 0, Week 2, and Months 1, 1.25, 1.5, 3, 3.5, 6, 6.25, 6.5, 9,
      and 12. Visits may include physical examinations and clinical assessments, blood and urine
      collection, optional stool collection, HIV testing, risk reduction counseling, and
      interviews/questionnaires. At Month 18, study staff will contact participants for follow-up
      health monitoring.
    

Intervention name(s): p24CE1/2 pDNA Vaccine; p55^gag pDNA Vaccine; IL-12 pDNA Adjuvant; Placebo; Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device
Intervention type(s): Biological; Biological; Biological; Biological; Device
Intervention description(s): Administered bilaterally using the Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device; Administered bilaterally using the TDS-IM EP device; Administered bilaterally using the TDS-IM EP device; Administered bilaterally using the TDS-IM EP device; The TDS-IM EP device will be used to administer study product(s).
Other intervention name(s): p24CE1/2; p55^gag; GENEVAX® IL-12 DNA Plasmid; TDS-IM EP device
Intervention MeSH terms: Interleukin-12; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV vaccine; DNA vaccine; IL-12; Electroporation; p24; Gag; Adjuvant; Healthy