bioihbjkbjnl/mcl2 huggingface dataset:
Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)
Condition: Acute Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      The first step in treating patients with acute pancreatitis is to provide pain relief and
      intravenous fluids to keep them comfortable. As the pain subsides and patient starts to feel
      better food and fluids by mouth are restarted. This is done to rest the pancreas which is the
      organ that has been inflamed.

      In some patients when food by mouth restarts they have pain and as a consequence they have a
      longer stay in hospital. It is thought that patients who have little pain and are within 24
      hours of admission to hospital do well if they control their own food intake. This is in
      contrast to the usual treatment where the treating team advise when eating should restart.
    


Intervention name(s): Patient-controlled oral refeeding
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
Keywords: Acute pancreatitis, nutrition
Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients
Condition: Parkinson's Disease; L-dopa Induced Dyskinesia
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of administration of AFQ056 in combination
      with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease
      patients.
    


Intervention name(s): AFQ056; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's; L-dopa; dyskinesia
RCT of Russian IDU Peer Network HIV Prevention Intervention - 1
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to conduct a randomized controlled trial to assess the efficacy
      of a peer-educator intervention focused on injection drug users and their drug and sexual
      networks. We expect that participants who receive the intervention will demonstrate a
      reduction in the rate of HIV infection and HIV risk behaviors and members of their risk
      network will also demonstrate reductions in risk behaviors compared to those in the control
      group.
    

Detailed description: 
      Intravenous drug use (IDU) is driving the HIV epidemic in Russia; over 90% of all HIV-1
      infections have occurred within communities of IDUs. In St. Petersburg (population 5
      million), the prevalence of HIV infection in IDUs (estimated population 100,000) leapt from
      4% in 1999 to 12% in 2000. At present there are an estimated 5-7 million IDUs, a four-fold
      increase since the end of the Soviet Union. In St. Petersburg, there has been a three-fold
      increase in regular IDUs and a nine-fold increase in teenage IDUs during the past five years.

      The intervention to be tested in this study draws upon theoretical and empirical evidence
      suggesting that peer educator programs can have significant effects on the risk-related
      behaviors of both the educators and the peers whom they educate. Providing peer educator
      training to IDUs may efficiently cultivate sustainable protective behavioral norms related to
      injection and sexual risk among the IDU educators' social networks. Prior studies have
      demonstrated that peer educator programs can realize such normative changes, and it is
      hypothesized in this study that these normative changes will be reflected in significant
      reductions in the rates of HIV transmission among the peer educators and the members of their
      social networks.

      Comparison condition: Informed by the Centers for Disease Control model of best practice"
      standard of care of HIV testing and counseling, participants in the comparison condition will
      receive risk reduction education and motivational counseling to reduce their risk behaviors.
    

Intervention name(s): Peer mentor intervention
Intervention type(s): Behavioral
Intervention description(s): groups sessions, 8
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV; injection drug use; social networks
Bowen Technique and Post Isometric Relaxation in Knee Osteoarthritis Patients
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The Hamstring muscles are present at the posterior surface of the thigh. The muscles start in
      the gluteal region and run back of the thigh and insert into the popliteal fossa. The
      function of hamstring muscles flexes the knee and extension of the thigh. In degenerative
      joint disease, muscles tightness of the lower extremity leads to a decrease in joint
      flexibility. In knee joint osteoarthritis, hamstring muscles are more prone to tightness. The
      objective of this study is to compare the effects of the Bowen technique and Post Isometric
      Relaxation on pain, range of motion, and hamstring flexibility in knee osteoarthritis
      patients.
    

Detailed description: 
      This study will be a randomized clinical trial and will be conducted at Al- Mustafa Medical
      and Physiotherapy Center. The study will be completed within the time duration of six months.
      For data collection, a convenient sampling technique will be used. The Population will be
      diagnosed with osteoarthritis patients. A sample size of total 24 patients will be taken in
      this study. The measurement tool will be Active knee extension test, Goniometer and Numeric
      pain rating scale. The pre-test and post-test outcome measurement will be taken. Patients
      will be divided into two groups. Group A will receive the Bowen technique intervention and
      Group B will receive the Post Isometric Relaxation technique. The interventions groups will
      receive three sessions per week for 4 weeks.
    

Intervention name(s): Bowen Technique; Post Isometric Relaxation
Intervention type(s): Other; Other
Intervention description(s): A Bowen moves challenges the muscles for several seconds by the application of a gentle lateral pressure applied by the therapist thumb, against its medial edge. The muscle fibres and its fascia are disturbed from their neutral position and they are slightly stretched. The therapist apply gentle pressure towards the muscles using the skin slack available, and then rolls the thumb across the muscles and gently compressing it, the muscle will bounce back to its original position.; Post Isometric Relaxation is performed in supine position on treatment table. The therapist passively flexed the hip and knee at the 90 degrees and then passively extends the knee until the point of tissue resistance. Patient placed their leg on therapist shoulder and contracts his hamstring muscles by pushing down on the therapist shoulder for 10 seconds. After the contraction, patient is asked to relax, then therapist passively stretch to gain new range of muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post Isometric Relaxation; Bowen Technique; Hamstring muscle flexibility; Knee Osteoarthritis
Traditional Chinese Medicine(TCM) Syndrome Classification of Idiopathic Pulmonary Fibrosis(IPF) and Metabolomics
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The pathogenesis of idiopathic pulmonary interstitial fibrosis is complex, and there is no
      specific biomarkers, the treatment effect is not such useful. Currently, it is discovered
      that Chinese medicine treatment may be effective. The investigators select patients with
      idiopathic pulmonary interstitial fibrosis and healthy controls, use metabolomics to study
      the biological characteristics of idiopathic pulmonary interstitial fibrosis, screen
      biomarkers of IPF, and label different TCM syndromes of IPF, explore the biological nature of
      IPF TCM syndromes, find the biological changes that occur during the development and
      progression of IPF and explore the metabolite marker clusters of IPF. Furthermore, the
      results of this study may find its diagnostic significance for IPF and Looking for potential
      targets for future treatment of IPF.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        IPF patients in XUZHOU
      
Biospecimen description: 
      blood
    
Keywords: Idiopathic Pulmonary Fibrosis; Metabolomics; Chinese medicine
A Study of LY3540378 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of the study drug
      known as LY3540378 in healthy participants following single and multiple doses (Parts A and
      B) and multiple doses in Japanese (Part C) and Chinese (Part D) healthy participants. Blood
      tests will be performed to check how much LY3540378 gets into the bloodstream and how long it
      takes the body to eliminate it. This is a 4-part study and may last up to 70, 113, 113 and
      113 days for each participant in Parts A, B, C, and D respectively.
    


Intervention name(s): LY3540378; Placebo; LY3540378
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered IV or SC.; Administered IV or SC.; Administered SC.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System
Condition: Intracranial Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Observational

Summary: 
      The objective of the registry is to evaluate the real world safety and performance of the
      CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate
      endovascular coil embolization of intracranial aneurysms.
    

Detailed description: 
      The data will be collected in consecutive subjects treated with the commercially available
      product and following standard clinical practice. This registry will be limited to subjects
      who have received only the CORDIS ENTERPRISE™ VRD during the index procedure. While only
      limited inclusion or exclusion criteria are specified, uniform, complete and accurate data
      will be collected peri-procedurally, during the index hospitalization, and during follow-up
      up to 6 months. All subjects should be treated according to the Instruction For Use (IFU)
      including conduct of the VRD placement, coiling procedure, application of antiplatelet
      medication and any other medical therapy to be provided according to local usual practice.
    

Intervention name(s): Vascular Reconstruction Device
Intervention type(s): Device
Intervention description(s): CORDIS ENTERPRISE™ VRD
Other intervention name(s): ENTERPRISE; Codman ENTERPRISE; Codman VRD
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering of an intracranial aneurysm and necessitating an endovascular treatment.

        Patients who meet all of the general inclusion criteria and none of the exclusion criteria
        and who agree to voluntarily sign a informed consent form will be enrolled into the study.
Physical Activity Scale in Individuals With Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      The aim of this study was to improve the cultural adaptation and Turkish version of the The
      Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) and to
      investigate the validity and reliability of the Turkish version of PASIPD in individuals with
      spinal cord injury. PASIPD, which consists of 13 questions, will be adapted to Turkish by
      translation and back translation method. The study included 47 wheelchair-dependent patients
      over the age of 18 who were able to read and write Turkish (26 females, 21 males). In order
      to determine the reliability and internal consistency of PASIPD, item-total correlation, if
      item deleted cronbach alpha coefficient and cronbach alpha coefficient of the whole scale
      will be calculated. Test-retest method will be used for the stability of the scale. In the
      test-retest method, the scale will be re-applied to the same people with 7-day intervals.
      Pearson correlation analysis will be performed between the first test and the second test
      total and sub-parameters after 1 week. Test-retest reliability will be determined using the
      intraclass correlation coefficient (ICC). In the validity test of PASIPD; construct validity
      and criterion validity will be used. Test of construct validity; factor analysis and
      convergent and discriminant validity methods. The Barthel Index of Activities of Daily Living
      and Functional Independence Measure (FIM); World Health Organization Quality of Life Scale
      Abbreviated Version (WHOQOL-BREF), Nottingham Health Profile (NHP) and Craig Handicap
      Assessment and Reporting Technique (CHART-SF) will be used to convergent and discriminant
      validity. Manual Wheelchair Propulsion Tests will be used to demonstrate criterion validity.
    


Intervention name(s): Assessment
Intervention type(s): Other
Intervention description(s): Evaluation forms will be applied to the patients who meet the inclusion criteria by face to face interview method.The sociodemographic information of the patients and the time taken to answer the questions in the questionnaires will vary according to each patient, but will take approximately 45 minutes. The second interview will be conducted with the patients for test-retest application at 1 week intervals.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Our study will be made on Turkey Spinal Cord Injury Association in ages ranging from ages
        18-75 enrolled 47 volunteers.
A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to evaluate the anti-plaque efficacy of the Anacor prototype
      dentrifice as compared to commercial control products following a single use of the
      dentrifice.
    

Detailed description: 
      The widespread successful use of triclosan as an anti-inflammatory and anti-bacterial agent
      is well documented. The standard dentrifice has demonstrated a robust anti-plaque and
      anti-inflammatory effect providing multiple benefits. There is a clear value to identify
      additional agents with the same dual action with a comparable or an enhanced level of
      efficacy. This study examined the anti-plaque efficacy following a single use of the
      prototype dentifrice.
    

Intervention name(s): Negative Control (Regular Toothpaste); Positive Control (anti-plaque/anti-bacterial toothpaste); Prototype (AN0128 Toothpaste)
Intervention type(s): Other; Other; Drug
Intervention description(s): Regular Toothpaste; Standard anti-plaque and anti-bacterial toothpaste; AN0128 Toothpaste
Intervention MeSH terms: Anti-Bacterial Agents
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dental Plaque
Anticholium® Per Se
Condition: Shock, Septic; Sepsis; Perioperative Period
MeSH terms: Sepsis; Shock, Septic
Study type: Interventional

Summary: 
      Anticholium® per Se is a randomized, double-blind, placebo-controlled, monocentric trial to
      assess whether the CAP can be transferred from bench to bedside. In this pilot study, 20
      patients with perioperative sepsis and septic shock as a result of intra-abdominal infection
      are enrolled. According to randomization, participants are treated with physostigmine
      salicylate (verum group) or 0.9% sodium chloride (placebo group) for up to 5 days. The mean
      Sequential Organ Failure Assessment (SOFA) score during treatment and subsequent intensive
      care of up to 14 days is used as surrogate outcome (primary endpoint). Secondary outcome
      measures include 30- and 90-day mortality. An embedded pharmacokinetics and pharmacodynamics
      study investigates plasma concentrations of physostigmine and its metabolite eseroline.
      Further analyses will contribute to the understanding of the role of various cytokines in the
      pathophysiology of human sepsis. A computer-generated list is used for blocked randomization.
    


Intervention name(s): Physostigmine; Isotonic Saline
Intervention type(s): Drug; Drug
Other intervention name(s): Anticholium
Intervention MeSH terms: Physostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Toddler Milk Containing L.Reuteri, Galacto-oligosaccharides and Palm-Oil Free Fat Blend
Condition: Toddlers Bone Metabolism
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of experimental growing up milk (EXPL)
      as compared to traditional children's fortified milk (CTRL) fed for 6 months on bone mass
      index.
    

Detailed description: 
      A randomized, double-blind controlled clinical trial was chosen to study the effects of
      toddler milk containing L. reuteri and GOS (4g/L) and a low sn-1, -3 fat blend when compared
      to a control formula. There is an additional unblinded habitual intake reference group (REF)
      for "real-world" comparison (including 58% non-dairy drinkers according to observational
      data).
    

Intervention name(s): Traditional cow's milk; Experimental milk; Habitual diet
Intervention type(s): Other; Other; Other
Intervention description(s): Fortified cow's milk; Milk with synbiotics and fat blend; Habitual diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Tulip Study: Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:

      The primary objective of this trial is:

        -  To evaluate the efficacy of initiating Lantus in combination with oral antidiabetics
           drugs compared to oral antidiabetic treatment optimised by enhancing hygienic and
           dietary measures in type 2 diabetics whose blood glucose control is acceptable but not
           optimal on maximum oral treatment, based on the number of patients achieving a HbA1c
           value < 7% at the end of treatment.

      Secondary objectives:

      The secondary objectives of this trial are to compare between the two treatment groups:

        -  The variation in HbA1c between baseline and end of trial.

        -  The frequency of episodes of symptomatic hypoglycaemia (diurnal and nocturnal), severe
           hypoglycaemia (diurnal and nocturnal) and asymptomatic hypoglycaemia.

        -  Mean blood glucose levels at different times of the day.

        -  The variation in weight and lipid in each group between baseline and end of trial.

        -  The incidence of adverse events.
    


Intervention name(s): Insulin Glargine
Intervention type(s): Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of GRT6005 in Painful Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the trial is to determine whether GRT6005 is effective in patients with pain
      due to osteoarthritis of the knee.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, tolerability and efficacy of 3 doses of
      GRT6005 taken once daily for 4 weeks in outpatients with moderate-to-severe painful
      osteoarthritis of the knee.
    

Intervention name(s): Matching Placebo; GRT6005; GRT6005; GRT6005
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 capsules of matching placebo once a day, in the morning, for a total of 28 days; 2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days; 2 capsules containing a total of 200 µg GRT6005 once a day, in the morning, for a total of 28 days; 2 capsules containing a total of 400 µg GRT6005 once a day, in the morning, for a total of 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis, knee; Analgesia; Pain; Painful
Levoketoconazole Food Effect Study in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, randomized, open-label, single-dose, two-period, two-sequence crossover
      study in healthy male and female subjects to evaluate the effect of food on the PK of
      levoketoconazole.
    

Detailed description: 
      In each period of the randomized, two period crossover study, levoketoconazole will be
      administered orally as a single dose of 600 mg levoketoconazole to subjects in the fasted
      state or fed (at 30 minutes after beginning consumption of a standardized high-fat meal).
      Subjects assigned to one treatment in Period 1 will be assigned to the opposite treatment in
      Period 2.
    

Intervention name(s): levoketoconazole
Intervention type(s): Drug
Intervention description(s): food effect
Other intervention name(s): COR-003
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other