bioihbjkbjnl/mcl2 huggingface dataset:
Long Term Follow up of Failed Back Surgery Syndrome(FBSS)
Condition: Failed Back Surgery Syndrome; Integrative Medicine; Medicine, Korean Traditional
MeSH terms: Syndrome; Failed Back Surgery Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to reveal the effectiveness and satisfaction of integrative
      Korean medicine for Failed Back Surgery Syndrome(FBSS) by observation patients treated with
      integrative Korean medicine.

      This study is a prospective observational study. The subjects for study are patients
      diagnosed with Failed Back Surgery Syndrome(FBSS) and who have been admitted to Gangnam
      Jaseng Hospital of Korean medicine and Bucheon Jaseng Hospital of Korean medicine for
      2011.11-2014.09.

      Medical records of selected patients will be analyzed, and telephone surveys will be
      conducted for each patient. The survey questions are Numeric rating scale (NRS), Oswestry
      disability index (ODI), quality of life, and Patient Global Impression of Change (PGIC), etc.
    


Intervention name(s): phone survey
Intervention type(s): Other
Intervention description(s): A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone for patients.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects for study are patients diagnosed with Failed Back Surgery Syndrome and who
        have been admitted to two Jaseng Hospital of Korean medicine (Gangnam, Bucheon) for
        2011.11-2014.09
      
Keywords: integrative Korean medicine
Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults.
Condition: Antibiotic-associated Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this study was to investigate the efficacy and safety of LRG-002 investigational
      medicinal product, capsules (Lek d.d., Slovenia) in comparison with placebo, as an adjunct
      treatment for prophylaxis of antibiotic-associated diarrhea (AAD) in patients with acute
      respiratory diseases (ARDs) receiving a standard antimicrobial therapy.
    

Detailed description: 
      This study was the prospective, multi-centered, double-blinded, randomized, parallel-group
      clinical study. The study investigated the efficacy and safety of LRG-002 investigational
      medicinal product, capsules (Lek d.d., Slovenia) in comparison with placebo, as an adjunct
      treatment for prophylaxis of antibiotic-associated diarrhea (AAD) in patients with acute
      respiratory diseases (ARDs) receiving a standard antimicrobial therapy.

      The study comprised the following periods:

      Study Periods Visit 1 (Day 1): Screening + randomization + initiation of treatment

      Patients started participating in the study after signing the Informed Consent Form. Having
      completed screening tests, eligible patients were randomized on the same day to receive
      either LRG-002 or matching placebo capsules, each as an adjunct to the prescribed antibiotic.
      The treatment group was determined by randomization at a center ratio. Study subjects were
      supplied with the patient diary and blinded investigational product (investigational
      medicinal product or placebo) depending on the assigned treatment group. Patients could start
      study treatment only after receiving appropriate training. On Day 1, the study started in
      both groups from randomization and administration of the first dose of the investigational
      product depending on the assigned group after randomization:

      Group T, treated with LRG-002: a single dose of 1 oral hard capsule taken during meals with
      some water; the product was to be taken orally 2 times per day for 14 days.

      Group R, provided with placebo:a single dose of 1 oral hard capsule taken during meals with
      some water; the product is to be taken orally 2 times per day for 14 days.

      Visit 2 (Day 7): Intermediate Follow-up Visit

      Visit 3 (Day 15) : Visit 3 was scheduled at Day 15 when a patient was to come to the study
      site bringing along the completed diary, unused laboratory kit, unused product and empty
      packages.
    

Intervention name(s): LRG-002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules containing live lyophilized probiotic bacteria of Lactobacillus genus; Capsules containing placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diarrhea
Urban Health Study II
Condition: HIV
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will test an intervention to help HIV-positive people achieve consistency of HIV
      care while transitioning in and out of jail.
    

Detailed description: 
      The study has two research objectives: (1) to expand access and options for HIV testing with
      individuals in the criminal justice system, by focusing on high-risk intravenous drug users
      (IDUs) and crack cocaine smokers in community settings; and (2) to improve access and
      maintenance of highly active antiretroviral treatment (HAART) among HIV-positive persons in
      this population, by implementing a promising intervention focused on continuity of HIV care,
      and evaluating it using a rigorous experimental design.

      HIV-positive persons will be identified through the testing activities described in Objective
      1. They will then be offered enrollment in a randomized controlled trial (RCT) of an
      intervention designed to engage and maintain HIV-positive people with criminal justice
      involvement in medical care. The intervention, Project Bridge, has shown great promise but
      has not yet been rigorously evaluated. The RCT will assess the efficacy of Project Bridge
      compared with a Usual Care arm. Our hypotheses are that, at quarterly data collection visits:
      (1) Intervention participants will have lower HIV viral load than usual care participants 2b:
      (2) Intervention participants will be more likely to be in HIV care than usual care
      participants (3) Intervention participants will be more likely to be on HAART than usual care
      participants.

      The study design was changed from a randomized controlled trial to a quasi-experimental
      comparison group design. This change was approved by the NIMH Program Officer and the RTI IRB
      in June, 2012.
    

Intervention name(s): Standard Referral; Project Bridge
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants randomized to this arm will be referred to local HIV care resources; Arm 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Drug users; criminal justice; HIV care; HAART; incarceration
Hands on vs Hands Off for Perineal Laceration
Condition: Perineal Tear
MeSH terms: Lacerations
Study type: Interventional

Summary: 
      Perineal trauma at the time of vaginal delivery is common, and when the anal sphincter is
      included, these injuries can be associated with additional morbidity including incontinence,
      pelvic pain and sexual dysfunction. Techniques studied include hands-on vs hands-off,
      perineal massage, warm compresses, Ritgen maneuver, and others. It is unclear if a hands-on
      technique decreases the incidence of perineal trauma compared to a hands-off technique
    

Detailed description: 
      Different strategies have been adopted in the late first and/or second stage of labor to
      decrease the incidence of perineal lacerations. These strategies include not only the
      hands-on technique, but also warm compresses, perineal massage, the use of oil or jelly, the
      Ritgen maneuver and a new perineal protection device. The review by Aasheim reported a
      decreased risk of third- and fourth-degree lacerations in the perineal massage group (two
      studies, RR 0.52, 95% CI 0.29 to 0.94).4 This review also showed a similar reduction in
      third- and fourth-degree lacerations with warm compresses (two studies, RR 0.48, 95% CI 0.28
      to 0.84), but no significant changes with use of a Ritgen maneuver. Additional reviews have
      evaluated delayed versus immediate pushing, with no significant difference in perineal
      trauma.

      Regarding how the interventions may work, initially the hands-on technique was hypothesized
      to control the velocity of the crowning process and therefore decrease perineal trauma. Given
      the fact that the hands-on approach has been found to be possibly associated with more
      perineal lacerations instead of less, some have proposed that the harm may be caused by the
      hands-on approach's additional pressure resulting in some perineal ischemia. Moreover, using
      one intervention (e.g. hands-on) may predispose to use other interventions (e.g. episiotomy),
      which have themselves been proven to increase perineal trauma.

      Perhaps a combination of perineal interventions, such as massage or compresses, with a
      hands-off approach and avoidance of episiotomy, will prove to show improved perineal
      outcomes. Larger studies, including evaluation specific for nulliparous subjects, are
      required to make definitive recommendations for management.
    

Intervention name(s): hands on
Intervention type(s): Procedure
Intervention description(s): Hands-on was defined as involving one hand on the fetal head, applying pressure to control expulsion, with the other hand applying pressure on the maternal perineum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
RESTOR-MV: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve
Condition: Mitral Valve Regurgitation; Left Ventricular Dysfunction; Heart Failure
MeSH terms: Heart Failure; Ventricular Dysfunction; Ventricular Dysfunction, Left; Mitral Valve Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this prospective, randomized, multi-center, pivotal trial is to compare the
      safety and effectiveness of the off-pump, closed heart Coapsys System (Myocor, Inc.) to open
      surgical repair of the mitral valve using an annuloplasty ring or band in patients with
      moderate to severe functional mitral regurgitation.
    

Detailed description: 
      Patient clinical evaluations will consist of 3-month, 6-month, and 12-month follow up of the
      primary endpoints. Additional follow up of 18-month, 24-month, and annually thereafter will
      also be included.
    

Intervention name(s): Less invasive mitral valve repair
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Functional Mitral Regurgitation (FMR); Ischemic Mitral Regurgitation; Less invasive repair; Surgical MV repair; Mitral Valve Repair; Heart Failure; Left Ventricular Dysfunction
Antioxidant and Immunomodulator Properties of Viusid in 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 3

Summary: 
      The pathogenesis of chronic hepatitis C (CHC) is associated to severe oxidative stress and
      non-selective immunological disturbance that leads to necro-inflammation and progression of
      fibrosis. Previous trials suggested that antioxidant and inmunostimulant therapies may have a
      beneficial effect. The purpose of the study is to evaluate whether Viusid, a nutritional
      supplement with hepatoprotective properties, could ameliorate the oxidative stress and
      modulate the immune response in patients with CHC and non-responders to pegylated interferon
      plus ribavirin, during 24 weeks of treatment.
    


Intervention name(s): Viusid; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Viusid, three oral sachets daily during 24 weeks; Placebo three oral sachets daily during 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic hepatitis C; Oxidative stress; Antioxidant; Cytokines; Nutritional supplement
Cause and Consequence of Neural Fatigue
Condition: Cognitive Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      While the scientific community understands quite well why muscles ache after prolonged
      exercise, the origins of mental fatigue remain totally mysterious. Existing theories remain
      at a psychological level, with scarce supporting evidence. Mental fatigue typically occurs
      after long episodes during which humans exert control on motor or cognitive processes,
      instead of executing routine or stimulus-driven behaviours. However, work organization
      (especially in risky job like airplane control or medical profession) and pathologies due to
      an overload of work (like burn-out) seems to be directly linked to neural fatigue. One of the
      consequences of neural fatigue is to alter decision-making. As an example, the choice between
      an immediate monetary reward and a larger but delayed monetary reward (the so called
      intertemporal choices) are susceptible to fatigue state of its underpinning neural network.

      The investigators are proposing an exploratory study of neural fatigue, induced either in a
      natural way (by performing cognitive tasks for hours) or by transcranial stimulation, using
      three main physiological measures (Electro-encephalography to measure neural activity,
      indirect calorimetry to measure the metabolic cost of a cognitive effort, and pupillometry to
      measure cognitive effort).

      This study should allow to better understand the consequences of neural fatigue on cognitive
      functions like decision making as well as the associated physiological variables.
    


Intervention name(s): Natural Fatigue; tDCS; TMS
Intervention type(s): Behavioral; Device; Device
Intervention description(s): Experimental: EEG Indirect Calorimetry Pupillometry; Experimental: EEG Indirect Calorimetry Pupillometry; Experimental: EEG Indirect Calorimetry Pupillometry
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of Two Different Formulations of LY3502970 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in
      the bloodstream when administered as two different formulations in healthy participants. The
      study will also evaluate the safety and tolerability of LY3502970. The study will last up to
      13 weeks excluding the screening period.
    


Intervention name(s): LY3502970
Intervention type(s): Drug
Intervention description(s): Administered orally.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Tidal Model's Effects on Emotion Regulation and Recovery
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effectiveness of Tidal Model-based emotion
      regulation interventions on recovery in individuals diagnosed with depression and nursing
      diagnosis of impaired mood regulation. The research was designed as a randomized controlled
      trial.

      The main hypothesis; After nursing interventions for emotion regulation based on the Tidal
      Model, there is a significant difference between the recovery, difficulty in emotion
      regulation, depression levels and nursing outcome criteria of individuals in the intervention
      and control groups.
    

Detailed description: 
      The research carried out with patients followed in psychiatry outpatient clinics. As a result
      of the G-power analysis, the sample consisted of 23 interventions and 23 control groups. In
      the study, while the control group received only routine treatment, in the intervention
      group, Tidal Model-based nursing interventions were applied in addition to the routine
      treatment. Pre-tests administered before individuals were randomly assigned to the
      intervention and control groups. Randomization was created using the website randomizer.org.
      After this randomization was created, it was hidden from the physician who made the diagnosis
      of depression and from the researcher who conducted the interviews (allocation concealment).
      After the pre-tests were completed, the researcher (consulting faculty member) who knew the
      random assignment order was reached and the individuals were randomly assigned to the control
      or intervention group. Tidal Model-based nursing interventions were structured as 8 sessions
      in total. Each individual in the intervention group participated in a session for a total of
      8 weeks, one session per week. In the eighth session, post-tests were applied to the
      individuals in the intervention group. Individuals in the control group were asked to come
      back 8 weeks after the first interviews and post-tests were applied. All interviews were
      conducted face to face. Recovery Assessment Scale (RAS), Difficulties in Emotion Regulation
      Scale (DERS), and Nursing Outcomes Criteria (NOC) were used.
    

Intervention name(s): Tidal Model Based Emotion Regulation Interventions
Intervention type(s): Other
Intervention description(s): The Tidal Model is a nursing model and was developed by Phil Barker. It is an important model for psychiatric nursing care. In the research, nursing interventions for emotion regulation were structured by using the Tidal Model.At each session, emotion regulation interventions were applied within the Tidal Model care domains.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Emotional Regulation; Psychiatric Nursing; Tidal Model; Recovery
Open Label Study of Long Term Evaluation Against LDL-C Trial
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be
      safe and well tolerated in adults with hypercholesterolemia.
    


Intervention name(s): Evolocumab; Standard of care
Intervention type(s): Biological; Other
Intervention description(s): Administered by subcutaneous injection; Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Other intervention name(s): AMG 145; Repatha
Intervention MeSH terms: Evolocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High cholesterol; Raised cholesterol; Cholesterol; Elevated Cholesterol
Adjuvant Growth Therapy in in Vitro Fertilization
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      In an In Vitro Fertilization (IVF) cycle super ovulating drugs (gonadotropins) are usually
      taken to stimulate the ovaries to produce more than one egg. In Vitro Fertilization protocols
      are constantly under review in order to improve the recruitment of the follicles, which
      contain the eggs, whilst minimizing the doses of gonadotrophins required, with the ultimate
      aim of increasing the live birth rate.
    

Detailed description: 
      The addition of growth hormone, which is a biological hormone that can be synthetically
      produced, as a supplement to gonadotrophins in an In Vitro Fertilization cycle has been
      suggested as a way in which In Vitro Fertilization pregnancy rates may be increased.Growth
      hormone has been shown, in animal and human studies, to be important in the recruitment of
      follicles.However, to date, only a limited number of clinical studies have been performed in
      order to assess whether the addition of growth hormone can improve the probability of
      pregnancy in women undergoing ovarian stimulation for In Vitro Fertilization. As the total
      number of patients analysed in these studies was small it has not been possible to determine
      whether if there is any improvement the outcome of an In Vitro Fertilization cycle when a
      woman is given growth hormone therapy as a supplement during her treatment.

      This goal of this study is to determine the effectiveness of using growth hormone therapy as
      a supplement to the administration of gonadotropins in an antagonist In Vitro Fertilization
      protocol.
    

Intervention name(s): Adjuvant Growth Hormon
Intervention type(s): Drug
Intervention description(s): The treatment group will receive 2.5 mg of Saizen daily via subcutaneous injections, from the beginning of the ovarian reserve stimulation until the day of the ovulation triggering
Other intervention name(s): Saizen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: In vitro fertilization; Antagonist protocol; Growth Hormone
MK0524 Asthma POC Study (0524-008)(COMPLETED)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to demonstrate the benefit of MK0524 compared to placebo in
      patients with chronic asthma.
    


Intervention name(s): Comparator: MK0524 + placebo; Comparator: MK0524 + montelukast; Comparator: placebo + montelukast; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Two 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks; Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks; Two placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks; During the double-blind treatment periods, patients receive either two placebo tablets in the matching image of MK0524 150 mg or one placebo tablet in the matching image of montelukast 10 mg in a crossover manner. During the washout period before the crossover to the opposite treatment sequence, patients receive two placebo tablets in the matching image of MK0524 150 mg and one placebo tablet in the matching image of montelukast 10 mg once daily for two weeks.
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Asthma