bioihbjkbjnl/mcl2 huggingface dataset:
A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Liver Cirrhosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To explore the effective dose and safety of the effect of hydronidone and entecavir on
      hepatic fibrosis in chronic viral hepatitis B.
    

Detailed description: 
      Primary observation indexes:

      Hepatic fibrosis Ishak score after treatment decreases by the proportion not less than 1
      compared with that before treatment.

      Secondary observation indexes :

        1. Negative conversion ratio of HBV DNA after treatment (HBV DNA<1×103copies/mL) and
           falling range.

        2. The falling proportion of Fibrocan Kpa value after treatment compared with that before
           treatment.

        3. The falling proportion that decreases not less than 1 level and progression-free
           fibrosis after treatment compared with that before treatment.

        4. The improvement of ALT of liver function.
    

Intervention name(s): Hydronidone; Placebo; Entecavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The investigational products in the test groups and control group shall be orally taken 30 minutes before meals for 52 continuous weeks. There are respectively 60 cases in the test group I, II, III and the control group, totally 240 cases.
Other intervention name(s): F351
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of the Symbiotic Fermented Milk in Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study evaluates the effect of a symbiotic fermented milk on health-related quality of
      life and irritable bowel syndrome (IBS) symptoms in patients with constipation-predominant
      IBS.
    

Detailed description: 
      Irritable bowel syndrome (IBS) is one of the most common digestive disorders in the developed
      world which. It is associated to numerous symptoms, of which the most characteristic are
      recurrent pain or discomfort in the abdominal region, changes and difficulties related to
      bowel movements, and bloating. Although not dangerous, the disease may significantly impair
      the patients' quality of life. Treatment is symptomatic, but currently not very efficient.
      The use of probiotics in the treatment of IBS is a promising approach and has been the
      subject of much research in the last two decades.

      The purpose of this randomized, placebo-controlled study is to assess changes in
      health-related quality of life in patients with constipation-predominant IBS after regular
      consumption of symbiotic fermented milk (containing probiotics and dietary fibres) and to
      assess its effects on some symptoms, like abdominal pain or discomfort, bloating, and chronic
      constipation.
    

Intervention name(s): LCA symbiotic fermented milk; heat-treated fermented milk
Intervention type(s): Other; Other
Intervention description(s): LCA symbiotic fermented milk with the probiotic cultures Lactobacillus acidophilus La-5® and Bifidobacterium animalis ssp. lactis BB-12® and the Beneo dietary fibers.; heat-treated fermented milk without probiotic cultures and dietary fibres
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Performance Study to Evaluate Access to Pulmonary Veins for Treatment of Paroxysmal AF
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The study is intended to assess the safety and performance of the Vado™ Steerable Sheath in
      facilitating ease of access to the pulmonary veins (PV) for the treatment of paroxysmal
      atrial fibrillation and persistent atrial fibrillation (AF). The study will be a prospective,
      single-center, non-randomized investigation.
    

Detailed description: 
      The design for this study involves the sequential enrollment of patients with documented
      paroxysmal atrial fibrillation who have had two (2) or more AF episodes for at least 30
      seconds in length within six (6) months prior to enrollment. Target population shall be
      selected from the treatable AF population that meets both inclusion/exclusion criteria.It is
      intended that the Vado Steerable Sheath will be used as part of standard clinical workflow
      procedures, with no procedural deviations relative to other procedures requiring steerable
      sheaths. Individual subjects will be studied during mapping and ablation procedures and
      followed until release from hospital post procedure per institutional standard of care.
    

Intervention name(s): Steerable Sheath System
Intervention type(s): Device
Intervention description(s): The Vado™ Steerable Sheath consists of a dilator and steerable sheath which are designed to provide intracardiac access and flexible catheter positioning in the cardiac anatomy.
Other intervention name(s): Vado Steerable Sheath
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese
      and non-Japanese participants. The secondary objective is to evaluate the safety and
      tolerability of multiple, oral doses of BIIB104 administered BID for 9 days, with an
      additional dose occurring in the morning on Day 10 in healthy Japanese and non-Japanese
      participants.
    


Intervention name(s): BIIB104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Other intervention name(s): PF-04958242
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Does Abatacept Induce Regulatory B Cells in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      Abatacept disrupts T-cell coactivation signals in rheumatoid arthritis (RA). Its potential
      effects on B cells are not well described. This study will assess the effects of abatacept
      therapy on the phenotype and function of peripheral blood B cells in patients with RA.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with RA fulfilling ACR/EULAR criteria, in whom abatacept is started as part of
        their usual clinical care
      
Biospecimen description: 
      Serum
The Effectiveness of Vibrational Applications on Orthodontic Treatment
Condition: Control Group; Acceledent Group
Study type: Interventional

Summary: 
      The aim of this study is to determine whether vibrational applications, as an adjunct to
      orthodontic forces, increases the rate of tooth movement in patients with fixed orthodontic
      appliances.
    

Detailed description: 
      Nineteen patients who had class 2 division 1 malocclusion or severe crowding and needed first
      premolar extractions as a treatment modality were included to the study. The patients were
      divided into two groups, 8 in control and 11 in the study. The subjects assigned to study
      group were applied suplementary vibrational forces for 20 min/daily. 3-dimensional digital
      models were generated just before canine distalization and after space closure by 3Shape
      TRİOS R700 (3Shape Inc., Copenhagen, Denmark) device. The linear measurements between molars
      and canines were evaluated. The results were assessed with SPSS 23.0 programme (lBM SPSS
      Statistics for Windows, NY, USA). The amount of tooth movement for all samples were measured
      twice by the responsible investigator at one week interval. Interclass correlation
      coefficient-ICC was used to asses intraobserver accuracy and reliability.Mann- Whitney U test
      was used to assess treatment effect in terms of time to reach canine distalization.
      Correlation between measurements were described with Spearman Correlation Coefficient.
      Interclass correlation was 95%, which is in the range of excellent measurement agreement.
    

Intervention name(s): Acceledent
Intervention type(s): Device
Intervention description(s): Device for accelerating tooth movement
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects were randomly allocated to either the AcceleDent group or the control group. The randomization was achieved by coin-tossing by one investigator. This method is equivalent to tossing a coin for each subject that enters a trial, such as Heads = control group, Tails = AcceleDent group.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Tooth movement; AcceleDent; distalizing
Wharton´s Jelly Derived Mesenchymal Stromal Cell Treatment of Adult Patients Diagnosed With Type I Diabetes
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To investigate the safety and tolerance after allogeneic infusion of WJMSCs intravenously in
      adult patients diagnosed with type 1 diabetes.
    

Detailed description: 
      This is a combined phase I and phase II study, where the first part is an open, dose
      escalating study consisting of 9 male patients, 18-40 years of age. The second part is a
      randomized, double-blinded, placebo-controlled, phase I/II study in parallel design comparing
      allogeneic WJMSC treatment to placebo in adult patients diagnosed with type 1 diabetes.
      Besides safety, preservation of endogenous insulin production (measured as C-peptide
      concentrations) together with metabolic control, diabetes treatment satisfaction and
      immunological profile will be assessed.

      A total number of 24 patients will be enrolled in the study and followed for one year after
      WJMSC/placebo treatment. Patients 18-40 years of age, both male and female, diagnosed for
      type 1 diabetes will be eligible. Providing informed consent and fulfillment of inclusion
      criteria and no exclusion criteria, they will within two years of diagnosis be randomized.
    

Intervention name(s): ProTrans: Allogeneic transplantation with WJMSCs; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): The drug is a cell suspension with allogeneic mesenchymal stromal cells derived from umbilical cord tissue.; Placebo treatment
Other intervention name(s): Protrans; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216)
Condition: Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in
      pediatric subjects (ages 2 to 5 years old) with plaque psoriasis:
    


Intervention name(s): ARQ-151 cream 0.3%
Intervention type(s): Drug
Intervention description(s): ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks
Other intervention name(s): Topical roflumilast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial of Nonpharmacologic Interventions in Elderly (TONE)
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Vascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To test the efficacy of weight loss and sodium restriction, alone and combined, in
      maintaining the normotensive state following withdrawal of antihypertensive medications in an
      elderly cohort. Conducted in collaboration with the National Institute on Aging.
    

Detailed description: 
      BACKGROUND:

      An estimated 30 to 40 percent of elderly persons are treated with blood pressure medications.
      The efficacy of blood pressure drug therapy in older patients with diastolic or combined
      diastolic/systolic hypertension is well proven, but such therapy can adversely affect quality
      of life and biochemical profile. In 1992 when the study started, there was a compelling
      rationale to identify what proportion of medicated, well-controlled elderly hypertensives
      could be maintained long-term or greater than 30 months in the normotensive state following
      withdrawal of blood pressure medications. There was also a need to determine whether
      nonpharmacologic therapy could significantly increase the proportion with a successful
      outcome.

      DESIGN NARRATIVE:

      Randomized. A total of 585 overweight subjects were assigned in a 2 x 2 factorial design to
      weight loss, sodium reduction, combined weight loss and sodium reduction, or usual life-style
      control. The remaining 390 subjects of normal weight were assigned in a 2-armed design to a
      sodium reduction or an attention control group. The control groups were engaged in a series
      of non-blood pressure related health encounters designed to control for non-specific effects
      of groups contacts. Withdrawal of antihypertensive medication was attempted following three
      months of intervention. The primary endpoint was a blood pressure of 150/90 mm Hg or greater,
      resumption of antihypertensive drug therapy, or the occurrence of a blood pressure-related
      clinical complication during two to three years of follow-up. Recruitment ended in June,
      1994. Follow-up ended in December, 1995. NHLBI support for the trial ended in March, 1997.
      The NIA supported the Coordinating Center and two clinical centers through February 1998.

      The study completion date listed in this record was obtained from the "Completed Date"
      entered from the old format in the Protocol Registration and Results System (PRS).
    

Intervention name(s): diet, reducing; diet, sodium-restricted
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Primary purpose: Treatment
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Metastatic Kidney Cancer
Condition: Kidney Cancer; Melanoma (Skin)
MeSH terms: Melanoma; Carcinoma, Renal Cell; Kidney Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Peripheral stem cell transplantation may be able to replace immune
      cells that were destroyed by chemotherapy used to kill tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell
      transplantation in treating patients who have metastatic kidney cancer or melanoma.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the safety of nonmyeloablative chemotherapy followed by allogeneic peripheral
           blood stem cell transplantation in patients with metastatic renal cell carcinoma or
           melanoma.

        -  Determine the incidence and severity of all adverse events related to this treatment
           regimen in this patient population.

        -  Determine the efficacy of this treatment regimen in terms of tumor regression, response
           duration, progression free survival, and overall survival in these patients.

        -  Measure the resulting chimerism and immune reconstitution in these patients after this
           treatment regimen and correlate with clinical response.

      OUTLINE: Patients receive fludarabine IV over 30 minutes on days -8 through -4 and
      cyclophosphamide IV over 1 hour on days -3 and -2. Immediately following each daily donor
      leukapheresis, patients receive allogeneic peripheral blood stem cells (PBSC) IV over 15
      minutes beginning on day 0 and continuing until the target cells are collected. Patients
      receive filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until blood
      counts recover.

      If no graft versus host disease has developed within 4 weeks of allogeneic PBSC
      transplantation, patients with disease progression or recurrence who have residual donor
      hematopoiesis on chimerism analysis may receive donor T lymphocytes IV over 30 minutes.
      Patients may receive an additional course of donor T lymphocytes at the investigator's
      discretion.

      Patients are followed at days 30 and 100, and then every 3 months thereafter.

      PROJECTED ACCRUAL: A total of 10-38 patients will be accrued for this study within 2.5 years.
    

Intervention name(s): filgrastim; therapeutic allogeneic lymphocytes; cyclophosphamide; fludarabine phosphate; peripheral blood stem cell transplantation
Intervention type(s): Biological; Biological; Drug; Drug; Procedure
Intervention MeSH terms: Cyclophosphamide; Fludarabine; Fludarabine phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV renal cell cancer; recurrent renal cell cancer; stage IV melanoma; recurrent melanoma
intrathecaم Ketamine, Morphine and Both for Lower Abdominal Cancer Surgery Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      this study investigates the analgesic efficacy and other possible effects of ketamine,
      morphine, and both together when administered intrathecally for control of postoperative pain
      following lower abdominal cancer surgeries.
    


Intervention name(s): intrathecal morphine; intrathecal ketamine; intrathecal morphine + ketamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg intrathecal morphine1 ml volume.; patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg intrathecal ketamine in 1ml volume.; patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and intrathecal morphine + ketamine 0.3 mg and 0.1 mg/kg respectively in 1 ml volume.
Intervention MeSH terms: Ketamine; Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This dose-escalating study is to evaluate the efficacy and the safety of different doses of a
      new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection
      (PEG-IFN-SA) and Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been
      previously treated with Interferon(IFN) by exploring the dose-effect relationship, while
      identity the optimal dose for phase Ⅲ study. In addition, population pharmacokinetic method
      is adopted to assess the pharmacokinetic behavior, individuals / intra-individual
      variability, and the possible factors for further study.
    

Detailed description: 
      Total 200 subjects will be randomized and enrolled into four groups proportionally receiving
      experimental drug of high dose, middle dose, low dose and positive-control drug. Treatment
      duration will be 24 or 48 weeks corresponding to different HCV genotype, genotype 2,3 and
      non-genotype2,3.
    

Intervention name(s): PEG-IFN-SA /RBV low dose; PEG-IFN-SA /RBV middle dose; PEG-IFN-SA /RBV high dose; Pegasys /RBV
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3; 24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3; 24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3; 24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
Intervention MeSH terms: Peginterferon alfa-2a; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: interferon; ribavirin; virological response
Specific Lp(a) Apheresis for Regression of Coronary and Carotid Atherosclerosis
Condition: Atherosclerosis; Coronary Disease; Carotid Artery Diseases
MeSH terms: Carotid Artery Diseases; Atherosclerosis; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate whether specific lipoprotein(a) apheresis on the top of optimal medical therapy
      could affect atherosclerotic disease burden in coronary and carotid arteries of coronary
      heart disease patients with elevated Lp(a) levels.
    

Detailed description: 
      Following the hypothesis that if Lp(a) excess has a pathogenic role in atherogenesis, then
      specific elimination of circulating Lp(a) should affect plaque growth and stability, we
      evaluated the efficacy of Lp(a) apheresis on changes in coronary plaque volume and
      composition and carotid intima-media thickness in patients with CHD on the background of
      optimal medical treatment.
    

Intervention name(s): Specific Lp(a) apheresis
Intervention type(s): Procedure
Intervention description(s): Specific Lp(a) apheresis procedures were carried out weekly with "Lp(a) Lipopak" columns (POCARD Ltd., Moscow, Russia) according to the standard protocol
Other intervention name(s): "Lp(a) Lipopak" immunoadsorption columns
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lipoprotein(a);; Lp(a) immunoadsorption;; Apheresis;; Coronary atherosclerosis;; Carotid Atherosclerosis;; Intima-media thickness;; Regression;; Quantitative Coronary Angiography;; Intravascular Ultrasound;; Virtual Histology;; Plaque;; Atorvastatin;