bioihbjkbjnl/mcl2 huggingface dataset:
Regulation of Immunological Cytokines by Qiliqiangxin Capsule in Dilated Cardiomyopathy Patients
Condition: Congestive Heart Failure
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Observational

Summary: 
      Purpose :Research into the impact of Qiliqiangxin capsule on IFN-γ，IL-4，NT-proBNP in dilated
      cardiomyopathy patients with heart failure.

      Methods :Data were collected from the patients with idiopathic dilated cardiomyopathy (
      cardiac function NYHA Ⅱ-Ⅳ) in the first affiliated hospital of Harbin Medical University from
      May 2012 to April 2014. These 30 cases were treated under the recommendations of normal
      diagnosis and treatment in cardiomyopathy. This experiment was randomized double-blinded，the
      experimental interferences were avoided and patients were divided into the experimental group
      and the placebo group. The patients in experimental group received the relevant tests and
      inspections before the beginning of experiment，signed the informed consent. Then the
      investigators get the venous blood centrifugalization and cryopreservation. The patients take
      the medicine qiliqiangxin three times per day，four tablets at a time. Afrer a month，the
      investigators evaluated the symptoms，the function of heart，blood pressure，heart rate and keep
      blood specimens. Three and six month later，electrocardiogram and echocardiography were taken
      and the determination of the NT - proBNP was done. The placebo group was followed up in the
      same way.
    


Intervention name(s): Qiliqiangxin Capsule
Intervention type(s): Drug
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        congestive heart failure.
Randomized-controlled Trial of Yoga for Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention
      compared to self-care on quality of life, stress, psychological health, and physiological
      parameters in 77 patients with ulcerative colitis.
    


Intervention name(s): Yoga; Self-care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12-week Hatha Yoga intervention 90 minutes once a week; Self-care books are provided for self-directed use
Other intervention name(s): Self-care book
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Colitis, ulcerative; Yoga
To Evaluate Pharmacokinetics and Pharmacodynamics of Z-215 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetics and pharmacodynamics of Z-215 (10
      mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium (10 mg, 20 mg ) in Healthy Male
      Subjects. And to evaluate food-effect in Healthy Male Subjects administrated Z-215 20 mg.
    


Intervention name(s): Z-215 10mg; Z-215 20mg; Rabeprazole Sodium 10mg; Rabeprazole Sodium 20mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Z-215 10mg, capsules; Z-215 20mg, capsules; Rabeprazole Sodium 10mg tablets; Rabeprazole Sodium 20mg tablets
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Male Subjects
Pramlintide in Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin
      immediately prior to meals can significantly reduce post-prandial glucose concentrations
      compared with mealtime insulin alone in children with type 1 diabetes.

      This is a 36 day, randomized, two-arm, open-label study with a treatment arm (taking
      pramlintide before all meals) and a control arm (diabetes regimen as usual).
    

Detailed description: 
      Participants aged 13-17 years who have been diagnosed with type 1 diabetes for more than 1
      year will be invited to participate.Other inclusion factors are:

        -  HbA1c level between 7.5 and 10% inclusive

        -  Currently using carbohydrate to insulin ratio

        -  Acceptable form of birth control

      Exclusion factors:

        -  Oral hyperglycemic agents or medications which might affect blood sugar levels

        -  Recurrent severe hypoglycemia requiring assistance in previous 6 months

        -  Diagnosis of gastroparesis and/or require use of drugs that stimulate gastrointestinal
           motility

        -  Previous use of pramlintide

      The study consists of 2 overnight stays at the CTRC where a continuous glucose monitoring
      system will be worn for twenty-four hours. Blood will be drawn 15 minutes prior to start of
      each meal and for three hours following each meal. Meals will be controlled for carbohydrate,
      fat and protein content. Meals will be identical at each CTRC visit.

      After a baseline visit for all participants, randomization will occur to either Treatment or
      Control.Bolus insulin will be adjusted for participants when beginning pramlintide and will
      likely remain at a reduced rate throughout the trial. All participants will have access to
      staff to assist with insulin dosing. There will be six mandatory phone visits over the 36
      days to ensure the safety of participants in this study.

      Insulin, glucose and glucagon levels will be assessed as well as pramlintide levels at final
      visit of the study. Hypoglycemic events will be tracked, as well as any other adverse events.
    

Intervention name(s): pramlintide
Intervention type(s): Drug
Intervention description(s): subcutaneous injection (15 mcg initial dose)prior to meals
Other intervention name(s): Symlin
Intervention MeSH terms: Pramlintide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: type 1 diabetes; adolescents; post prandial glucose
The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder
Condition: Depression, Anxiety
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will measure the effects of MET-2 on symptoms of depression and anxiety using pre-
      and post-treatment scores for overall depression and anxiety and other symptoms of
      depression, such as sleep and anhedonia.
    

Detailed description: 
      This study will measure the effects of MET-2 on symptoms of depression and anxiety using pre-
      and post-treatment scores for overall depression and anxiety and other symptoms of
      depression, such as sleep and anhedonia.
    

Intervention name(s): MET-2
Intervention type(s): Biological
Intervention description(s): Subjects will take study medication once daily for the duration of the study
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This is an open label study with one arm for subjects diagnosed with major depression disorder and one arm for subjects diagnosed with generalized anxiety disorder
Masking: None (Open Label)
Primary purpose: Treatment
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
Condition: Chronic Kidney Disease (CKD); Hyperkalemia (HK)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperkalemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the efficacy and safety of patiromer
      (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study
      also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic
      treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer
      treatment was also evaluated.
    

Detailed description: 
      There were two parts in the study, Part A and Part B.

      Part A was an assessment of 4 weeks of dosing with patiromer in the treatment of
      hyperkalemia; Part B was a randomized, placebo-controlled, 8-week assessment of the
      withdrawal of patiromer in participants with a baseline serum potassium at the beginning of
      Part A ≥ 5.5 mEq/L who responded to the 4 weeks of treatment with patiromer during Part A.

      All participants received patiromer during Part A; Part B participants were randomized to
      continue patiromer or switch to placebo. Total study participation was up to 14 weeks
      (including up to 2 weeks of follow up).

      The dose of patiromer could be titrated based on participant's serum potassium response.
    

Intervention name(s): Patiromer; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): RLY5016 for Oral Suspension; Veltassa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Chronic Kidney Disease; Treatment of Hyperkalemia; Hyperkalemia
Comparison of the Short-term Outcomes of Using DST and PPH Staplers in the Treatment of Grade III and IV Hemorrhoids
Condition: Bleeding; Stricture
MeSH terms: Constriction, Pathologic
Study type: Observational

Summary: 
      The hemorrhoidal disease affects approximately 4.4%-36% of the general population, and it has
      been estimated that >50% of the population aged >50 years experiences hemorrhoidal problems .
      Traditional hemorrhoidectomy, including Milligan-Morgan, Ferguson, and Whitehead procedures ,
      are known to cause significant postoperative pain and discomfort and result in a poor quality
      of life after operation. Since the first introduction of the novel procedure hemorrhoidopexy
      by Longo in 1998, it has been considered as a safe procedure causing less postoperative pain
      and resulting in earlier recovery; furthermore, the patients are able to resume their normal
      daily life and work. The PPH stapler (Ethicon Endo-Surgery, Inc. Cincinnati, OH, USA) was
      also first introduced in 1998 as a device to perform this procedure. Subsequently, a new
      device, the DST stapler (Covidien, Mansfield, MA, USA), was introduced in 2008 with some
      structural differences, including a detachable anvil, three anchor points over different
      levels, a larger case, and different agraffe sizes.

      However, the majority of current studies have been focusing on the use of PPH stapler for
      hemorrhoidopexy, and comparison with the DST stapler has been rarely discussed. One
      randomized controlled trial that compared between the PPH stapler and the DST stapler
      reported that the DST stapler demonstrated a better hemostatic ability and allowed the
      resection of a larger area of mucosal prolapse; however, that trial focused only on bleeding
      among the postoperative complications. Currently, only a limited number of studies have
      compared these two devices in terms of pain, complications, and anorectal stricture incidence
      rate. The present investigation is a matched cohort-control study aimed to compare the
      postoperative short-term outcomes among patients with grade III and IV hemorrhoids who were
      treated with either the PPH or the DST stapler. The specimen surface area and the
      relationships with complications were also analyzed.
    


Intervention name(s): Hemorrhoidopexy
Intervention type(s): Device
Intervention description(s): stapled hemorrhoidopexy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with grade III and IV hemorrhoid underwent stapled hemorrhoidopexy
      
Biospecimen description: 
      After the surgery, the ring of the excised anorectal mucosa was cut open and flattened on a
      surgical towel as shown in Figure 2. The presence of muscle in the specimen was confirmed
      grossly and photographed. The entire surface area of the mucosa, muscle and the muscle/mucosa
      ratio were measured using the ImageJ software (National Institutes of Health, Bethesda, MD,
      USA).
A Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1018-1 and BR1018-2 in Healthy Adult Subjects
Condition: Hypertension; Hyperlipidemia (E.G., Hypercholesterolemia)
MeSH terms: Hypercholesterolemia; Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic characteristics and compare the
      safety and tolerability after repeated separate or combined administrations of BR1018-1 and
      BR1018-2 in healthy adults.
    

Detailed description: 
      A total of 36 subjects will be randomized into 6 sequence groups, 6 subjects per sequence
      group. The Investigational Products wil be according to the treatment group (A,B,C) assigned
      to each sequence group in Period 1, Period 2 and Period 3.
    

Intervention name(s): BR1018-1; BR1018-2
Intervention type(s): Drug; Drug
Intervention description(s): Treatment group A : One tablet of BR1018-1 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.; Treatment group B : One tablet of BR1018-2 administered alone once daily for 9 days.
Treatment group C : One tablet each of BR1018-1 and BR1018-2 administered in combination once daily for 9 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis
Condition: Varicose Veins
MeSH terms: Varicose Veins
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare two therapeutic procedures in the treatment of
      isolated varicosis of the anterior accessory great saphenous vein (AAGSV): crossectomy and
      avulsion of the varicose AAGSV versus foam sclerotherapy of the AAGSV.
    


Intervention name(s): surgery; sclerotherapy with aethoxysclerol foam
Intervention type(s): Procedure; Drug
Intervention description(s): crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia; foam sclerotherapy with aethoxysclerol foam
Intervention MeSH terms: Polidocanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: varicosis; foam sclerotherapy; surgery
Platelet Function in Patients With Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      Abnormalities in the gene encoding Factor VIII (FVIII) results in hemophilia A, an X-linked
      recessive bleeding disorder with a prevalence of 1 in 5000 males. Hemophilia A patients are
      classified into 3 different categories based on residual FVIII activity compared to normal:
      mild (6-40%), moderate (1-5%) and severe (<1%). This categorization correlates to some degree
      with bleeding phenotype, but does not completely define it. Some patients with hemophilia A
      bleed less often than others despite identical plasma FVIII levels. The cause(s) of this
      phenotype heterogeneity in hemophilia A remains largely unknown, despite a number of studies
      of possible factors.

      Activated platelets, in addition to their role in primary hemostasis, play a major role in
      secondary hemostasis (coagulation) by providing a phospholipid surface to which coagulation
      factors bind. A role for platelets in the hemorrhagic propensity of hemophilia A has been
      suggested in the past, but only a small number of studies have been performed with
      limitations in assays performed and numbers of patients. The purpose of the present study is
      to determine whether platelet reactivity in severe hemophilia A patients is associated with
      past bleeding frequency and/or predicts future bleeding frequency.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with severe hemophilia A who do not have inhibitors against FVIII and who have a
        bleeding history of at least 6 months.
      
Biospecimen description: 
      whole blood
    
Keywords: severe hemophilia A; coated platelets; bleeding
Spine Angle Comparison in Adult Seating Posture With Immediate Feedback
Condition: Spinal Curvatures; Feedback, Psychological; Sitting Position
MeSH terms: Spinal Curvatures
Study type: Interventional

Summary: 
      1. Background: In modern society, people are spending more time sitting due to the
           increased use of IT devices. Prolonged sitting with incorrect posture can lead to spinal
           deformities and an increase in spinal diseases. Common deformities include turtle neck
           posture, flat back, straight neck, and bent back. Misalignment of the spine is
           considered an important factor in causing spinal diseases, such as pain, arthritis, and
           degeneration. To address these issues, researchers have developed pillows and chairs
           that are ergonomically designed for everyday use and have been found to be effective.

        2. Purpose: This study aims to investigate whether portable equipment can help individuals
           recognize and maintain correct sitting posture on their own.

        3. Design: This study has a cross-sectional study design. Each condition is divided into
           three different sitting conditions. By using post-evaluation data, the intention is to
           compare the effects. (Condition A: sitting on a standard chair wearing an immediately
           feedback device, Condition B: sitting on a gym-ball, Condition C: sitting on standard
           chair)

        4. Subject : Twenty-eight subjects were recruited as healthy students attending S
           University located in Nowon-gu, Seoul.

        5. Result: The study found that maintaining a sitting posture immediately resulted in a
           statistically significant lower angle over time at the Cervicothoracic angle compared to
           other interventions. Similarly, a sitting posture immediately maintained a lower angle
           over time at the Thoracic angle compared to other sitting postures . However, the lumbar
           angle showed a significant increase over time.
    


Intervention name(s): immediately feedback device; Unstable chair; Standard chair
Intervention type(s): Device; Device; Other
Intervention description(s): Sitting in a standard chair with immediate feedback device; sitting in an unstable chair; Sitting in a standard chair
Other intervention name(s): gym-ball; Control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa for Ovarian Stimulation in Donors
Condition: Controlled Ovaria Stimulation
Study type: Observational

Summary: 
      Currently, controlled ovarian stimulation (COS) in oocyte donors is performed by daily
      injections of gonadotropins( recombinant FSH) plus a GnRH Antagonist usually form 5th-6th
      stimulation day until ovulation induction with a bolus of another injection of a
      gonadotropin-releasing hormone (GnRH) Agonist. Injections of the GnRH Antagonist avoid
      untimely luteinizing hormone (LH) surge and spontaneous ovulation prior to follicular
      aspiration. There is a preparation of long-acting recombinant follicle stimulating hormone
      (rFSH= (corifollitropin alfa (FSH-CTP), Elonva®, MSD), that allows that a single subcutaneous
      injection substitutes the first 7 days of daily gonadotropin injections. On the other hand, a
      contraceptive oral progesterone only( Desogestrel, DSG) is available for contraception,
      avoiding the LH surge.

      In donors, by administering a single injection of FSH-CTP and oral desogestrel since the
      first menstruation day, the total number of injections administered is reduced and less
      discomfort is experienced without adverse impact on ovarian response.

      Other authors have reported good results using similar synthetic progestins
      (Medroxyprogesterone, dihydrogesterone, and natural progesterone).

      No description of the hormonal and ovarian response under this protocol has been published.
      Direct comparison between this novel protocol and the classical GnRH- antagonist plus daily
      gonadotropins has not been reported.
    


Intervention name(s): Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa
Intervention type(s): Drug
Intervention MeSH terms: Desogestrel
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        - Population: donors (18-35 ) from candidates of Donor program
      
Keywords: Oocyte donors; Ovarian stimulation; Desogestrel; Corifolitropina alfa; Gonadotropins
Safety and Relative Bioavailability of BIBF 1120 Soft Gelatine Capsules Charge 1, BIBF 1120 Soft Gelatine Capsules Charge 2 and BIBF 1120 Drinking Solution in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess pharmacokinetics and the relative bioavailability of a single dose of BIBF 1120
      soft gelatine capsule charge 1 vs. BIBF 1120 soft gelatine capsule charge 2 vs BIBF 1120
      drinking solution in healthy male subjects respectively. To establish an in-vitro-in-vivo
      correlation (IVIVC) for oral soft gelatine capsules with 150 mg BIBF 1120 in healthy male
      volunteers (if feasible)
    


Intervention name(s): BIBF 1120 capsules charge 1; BIBF 1120 capsules charge 2; BIBF 1120 drinking solution
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Nintedanib
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tool for Sibling and Children of Someone With Suicidal Thoughts
Condition: Suicide
MeSH terms: Suicide; Suicidal Ideation
Study type: Interventional

Summary: 
      This study aims to investigate to what extent a website developed for siblings and children
      (16-25 years old) of someone with suicidal thoughts and/or behaviors is effective in
      improving perceived pressure, knowledge, attitudes, self-confidence and hopelessness.
      Moreover, it aims to examine how participants evaluate the website.
    


Intervention name(s): Website (www.mee-leven.be)
Intervention type(s): Behavioral
Intervention description(s): The tool is a website aimed siblings and children of someone who has suicidal thoughts and/or behaviors. The intended objectives of the tool are 1) to contribute to knowledge about suicide and health care options, 2) to increase perceived competences in dealing with suicidality of a family member, 3) to reduce perceived pressure and negative feelings such as hopelessness and 4) to be accessible and user-friendly.
These objectives are achieved by providing the following content: 1) concerning the sibling/child themselves (primary objective) : information about the potential impact of having a suicidal family member, own needs, informal and formal (self) care, dealing with the suicidal family member, dealing with other family members 2) concerning the suicidal family member (Secondary objective): information about the suicidal process, signal recognition, how to provide support/create a safe environment for suicidal loved ones , help available for suicidal relatives
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention