bioihbjkbjnl/mcl2 huggingface dataset:
Food Effects on the Gut Microbiota
Condition: Gut Microbial Responses to Dietary Fiber
Study type: Interventional

Summary: 
      This is a small-scale study of the effects on microbes in the human gut of adding high-fiber
      snack foods to usual diet. The snack foods are being provided by Mondelez International, Inc.
      Eight pairs of dizygotic twins, discordant or concordant for obesity, will participate in the
      study. They will complete 3 successive experiments in which their regular diet is
      supplemented by consumption, over a 6-week period, of high-fiber snack foods. Each experiment
      will involve (i) two weeks consuming regular diet (fecal sample collected weekly); (ii) one
      week consuming one snack food per day (approximately 7 g fiber, collection of all fecal
      samples), (iii) one week consuming two snack foods per day (approximately 14 g fiber,
      collection of all fecal samples), (iv) four weeks consuming three snack foods per day
      (approximately 20 g fiber, collection of all fecal samples); and (v) two weeks consuming only
      regular diet (weekly collection of fecal sample). For each experiment, participants will also
      provide a fasting blood sample during the free diet phase at the end of the week just before
      initiation of snack consumption, and a fasting blood sample at the end of the last week of
      snack consumption. Participants will also collect one first morning urine sample weekly
      throughout the study. During week 2, participants will also collect first morning urine
      samples for 3 consecutive days. Similarly, they will collect first morning urine samples for
      the last 3 consecutive days of the last week of snack consumption. The study will test the
      effects of the different fiber-rich snacks on the composition and metabolic properties of the
      gut microbial community in lean and obese subjects.
    


Intervention name(s): high-fiber food type
Intervention type(s): Other
Intervention description(s): In 3 successive experiments, usual diet will be supplemented with snack foods containing fiber of plant, fruit or grain origin.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 4

Summary: 
      Study objective is to compare neuropsychiatric adverse events in subjects treated with
      varenicline or placebo in a controlled setting where both groups are experiencing nicotine
      withdrawal.
    


Intervention name(s): varenicline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days); 1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days)
Other intervention name(s): Chantix, Champix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: nicotine withdrawal, smoking cessation, varenicline
A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved
Condition: Eosinophilic Esophagitis (EoE)
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 3

Summary: 
      A study in adolescents and adults with eosinophilic esophagitis (EoE) to measure the
      histologic response and determine if any reduction in dysphagia is achieved.
    


Intervention name(s): Oral Budesonide Suspension (OBS); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Budesonide Suspension (OBS) 10 milliliter (ml) of 0.2 milligram per milliliter (mg/ml) twice daily up to 16 weeks.; Oral dose of 10 ml of placebo matched with the experimental drug.
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This study will use a rules-based expert system embedded in an electronic health record (EHR)
      to extract, interpret, and present salient facts and recommendations related to the
      healthcare of premature infants.
    

Detailed description: 
      Premature infants are a vulnerable population with multiple inter-related health problems
      that put them at risk for poor outcomes. Electronic health records capture large amounts of
      information that may help guide decisions, but existing alert and reminder-based clinical
      decision support (CDS) frameworks do not adequately apply multiple overlapping care
      guidelines to complex patient histories to produce coherent clinical recommendations.

      The primary objective of the study is to design and evaluate the usability of a CDS
      intervention to improve the quality of primary care for low birth weight (LBW) and very low
      birth weight (VLBW) premature infants from the time of intensive care nursery discharge
      through 24 months corrected gestational age
    

Intervention name(s): Clinical Decision Support Tool
Intervention type(s): Other
Intervention description(s): A clinical decision support tool embedded within Epic will appear for children with a history of prematurity at the intervention sites.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Phase 1 Study of TDM-105795 Topical Solution in Male Subjects With Androgenetic Alopecia (AGA)
Condition: Alopecia, Androgenetic
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 1

Summary: 
      Multi-center, fixed volume, randomized, double-blind, vehicle-controlled, parallel group,
      dose escalation comparison study of TDM-105795 in male subjects, 18 to 55 years old, with
      Androgenetic Alopecia (AGA).
    

Detailed description: 
      Protocol 239-11651-101 is a planned Phase 1 study entitled "A Randomized, Double-Blind,
      Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety,
      Tolerability, and Pharmacokinetics of TDM-105795 Following a Fixed-Volume Topical Single
      Administration in Healthy Male Subjects with Androgenetic Alopecia". Eligible subjects will
      be assigned to a sequential treatment cohort and will receive either one of the TDM-105795
      solutions or the Placebo. The assigned test article will be applied once onto the scalp in
      the hair loss area (e.g., top of head and temple areas). All subjects will be treated with 1
      mL of test article with application to the scalp focusing on the regions that are bald and
      thinning.
    

Intervention name(s): TDM-105795; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TDM-105795 topical solution; Placebo for TDM-105795 topical solution
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-105795 Following a Fixed-Volume Topical Single Administration in Healthy Male Subjects with Androgenetic Alopecia
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Four Interventions in the Management of Psychomotor Agitation, Safety and Efficacy Evaluation
Condition: Psychomotor Agitation
MeSH terms: Psychomotor Agitation
Study type: Interventional

Summary: 
      This study aims to evaluate the efficacy and safety of four options of medications in the
      management of acute psychomotor agitation,or violence and aggression situations in health
      services. All of the treatment options are already approved and currently used for this
      purpose. The options are: haloperidol plus midazolam, haloperidol plus promethazine,
      olanzapine and ziprasidone. The investigators hypothesized that all treatment options are
      effective in the treatment of acute agitation, but the combination haloperidol plus
      promethazine could elicit more adverse affects than the others.
    


Intervention name(s): haloperidol+promethazine; haloperidol + midazolam; olanzapine; Ziprasidone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): haloperidol, 2,5mg plus promethazine,25mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, in the 90 minutes period of observation; haloperidol, 2,5mg plus midazolam, 7,5 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation; olanzapine, 10mg, intramuscular injection, after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of observation; ziprasidone, 10 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation
Intervention MeSH terms: Promethazine; Diphenhydramine; Midazolam; Haloperidol; Olanzapine; Haloperidol decanoate; Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Violence; Aggression; Psychiatric emergencies; Psychomotor agitation; Violent patient
PF-04995274 and Emotional Processing in Treatment Resistant Depression
Condition: Depression, Unipolar; Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test whether seven days adjunctive administration of a serotonin receptor
      subtype 4 (5HT4) agonist called PF-04995274 has positive effects on emotional processing and
      non-emotional cognition in medicated, treatment-resistant depressed patients compared to
      placebo.
    

Detailed description: 
      This study uses a double-blind, placebo-controlled, randomised between-groups design to test
      if adjunctive administration of a serotonin receptor subtype 4 (5HT4) agonist called
      PF-04995274 has positive effects on emotional processing and neural activity in medicated
      treatment-resistant depressed patients. Participants are patients who fulfill criteria for
      current episode of Major Depressive Disorder (MDD) and have shown lack of response to
      antidepressant treatment, and they will be randomised to receive 7 days treatment with either
      PF-04995274 (15 mg daily) or a matched placebo. Participants will come for a Screening Visit,
      a First Dose Visit, and a Research Visit (including measures of emotional processing and
      non-emotion cognition).
    

Intervention name(s): PF-04995274; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): PF-04995274 tablets; Placebo tablet, identical appearance to experimental tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly allocated to one of two groups (PF-04995264 or placebo) and receive their allocated study medication for 7 days.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Treatment for Advanced B-Cell Lymphoma
Condition: Diffuse Large Cell Lymphoma; Burkitt's Lymphoma; High Grade B-cell Lymphoma
MeSH terms: Burkitt Lymphoma; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      To safely reduce the burden of therapy in children, adolescents and young adults with mature
      B-NHL by reducing the number of intrathecal (IT) injections by the introduction of IT
      Liposomal Cytarabine (L-ARA-C, [Depocyt®]) and reducing the dose of anthracycline
      (doxorubicin) in good risk patients with the addition of rituximab to the FAB chemotherapy
      backbone (Immunochemotherapy).
    


Intervention name(s): Rituximab; IT Cytarabine
Intervention type(s): Drug; Drug
Other intervention name(s): RITUXAN®, IDEC-C2B8) NSC #687451, IND #10385; DEPOCYT® (Cytarabine Liposome Injection)
Intervention MeSH terms: Cytarabine; Rituximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric; Lymphoma (NOT primary mediastinal B-cell lymphoma); B-Cell---Burkitt's like; Rituximab; Liposomal ARA-C
Physiotherapist Approach to Shoulder's Diseases, Differences Between Fascial Manipulation and Standard Exercises
Condition: Shoulder Pain; Manual Therapy
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      The study purpose is to compare the effects of Fascial Manipulation added to standard
      exercises protocol versus the simple exercises protocol.
    

Detailed description: 
      The shoulder degenerative diseases are recurring in hospital employees. The early approach,
      as we see in literature, has high probability to reduce the pain and the disfunction in the
      long term.

      In particular stretching and strengthening exercises are the standard protocol applied.

      The Fascial Manipulation is a manual therapy that works on the connective tissue, by
      increasing mobility and reducing pain.

      We have added the Fascial Manipulation to prove if it make a faster recovery and a pain
      reduction in the short and the middle term.
    

Intervention name(s): Fascial Manipulation; Standard exercises protocol
Intervention type(s): Other; Other
Intervention description(s): Fascial Manipulation is a manual therapy that focused on deep muscular fascial.; Stretching and strengthening exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study are evaluated in parallel against a control group.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Postoperative Pain Management After Total Knee Arthroplasty
Condition: Postoperative Pain; Knee Arthroplasty
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The study compares three different analgesic techniques in order to determine which one
      serves as the optimal method for postoperative pain management after Total Knee Arthroplasty
      in patients suffering from Osteoarthritis
    

Detailed description: 
      Prospective, randomized, controlled study. Approval of the study from the University Hospital
      of Patras Ethics Committee. The Total Knee Arthroplasty procedure is performed always from
      the same team of Orthopedic surgeons who follow the same technique in each patient for the
      arthroplasty and the placement of the intraarticular catheter as well. The same team of
      Anesthesiologists (two Anesthesiologists) performs always the same technique for each
      analgesic method and is responsible for the patients' perioperative condition concerning
      anesthesia and analgesia.

      Preoperatively, one hour prior to the surgery, all patients receive preemptive multimodal
      analgesia in the following way; 40mg Parecoxib (iv), 1gr Paracetamol (iv), 150mg Pregabalin
      (po), 8mg Dexamethasone (iv) και 50mg Ranitidine (iv).

      All patients receive subarachnoid anesthesia with Ropivacaine 0.75% (7,5mg/ml) in a dosage of
      2-3ml titrated according to patient's age and height.

      Three groups

        1. Continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg.

        2. Continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg.

        3. Continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg.

      All the catheters remain for 48 hours while the infusion rate is 2ml/h + PCA with 0,5ml/15min
      and lock-out maximum dose 4/h in total volume of 150ml.

      Postoperatively all patients also receive; Parecoxib, Paracetamol, Pregabalin, and Ranitidine
      up to the third postoperative day (doses titrated).

      Rescue analgesia: Tramadol Chloride 50-100mg x 2 /24h depending on patient's age and medical
      history.
    

Intervention name(s): Epidural analgesia - Group E; Femoral blockade - Group F; Intraarticular infusion - Group I
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Postoperative analgesia with continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min); Postoperative analgesia with continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min) .; Postoperative analgesia with continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: epidural analgesia; intra-articular infusion analgesia;; femoral nerve block; total knee arthroplasty
Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions
Condition: Seasonal Influenza Vaccination
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      The objective of this study was to assess the feasibility and effectiveness of using a
      statewide immunization information system (IIS) to send seasonal influenza vaccine reminders
      from Local Health Departments (LHDs), targeting children with high-risk conditions.
    


Intervention name(s): Mailed influenza vaccination reminder notice
Intervention type(s): Behavioral
Intervention description(s): Influenza vaccination reminder sent by postal mail
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: influenza; vaccine; reminder / recall; immunization registry; immunization information systems
Observational Program to Assess Use of Intermittent Adjuvant Deprivation Therapy With Leuprorelin (Lucrin Depot) in Patients With Advanced Prostate Cancer (PCa) in Russia
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      The objective of this study was to describe treatment patterns of leuprorelin over 2 years
      using an intermittent, adjuvant regimen in participants with advanced prostate cancer (PCa)
    

Detailed description: 
      Participants started hormone treatment with Leuprorelin 3.75 mg once every 28 days,
      subcutaneously (SC) or intramuscularly (IM). Duration of induction therapy was at least 6
      months (6-9 months) during which PSA and testosterone levels were measured every 3 months.
      When PSA decreased by greater than 90% from baseline (PSA less than 10 ng/ml) or became lower
      than 4.0 ng/ml (for 2 consecutive measurements made at least 2 weeks apart) the participants
      were included into intermittent hormone therapy regimen group (IAD). Participants with PSA
      decrease not achieved greater than 90% or less than or equal to 4.0 ng/ml were given either
      continuous hormone therapy (CAD) or chemotherapy.

      Therapy was stopped if participants had PSA decrease greater than 90% from baseline or values
      less than 4.0 ng/ml after 6-9 months of continuous hormone therapy. PSA and testosterone were
      measured every 4 weeks. If PSA became greater than or equal to 10.0 ng/ml, hormone therapy
      was resumed until PSA was less than 4.0 ng/ml for 2 consecutive measurements made at least 2
      weeks apart. Duration of hormonal therapy cycle was at least 3 months. Then intermittent
      treatment was performed according to a similar scheme. PSA and testosterone levels were
      determined every 12 weeks when hormone therapy was administered and every 4 weeks after it
      was stopped. The treatment was carried out for 2 years or until Hormone Refractory Prostate
      Cancer (HRPC) developed.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with advanced PCa
      
Keywords: Lucrin Depot; intermittent adjuvant regimen; advanced prostate cancer; Leuprorelin
Taima TB: 3HP Study
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This phase IV clinical study trial will be conducted among persons who require treatment for
      LTBI treatment in Iqaluit, Nunavut and Ottawa, Ontario. The primary objective of this study
      is to compare the proportion of people who complete directly observed prophylactic treatment
      (DOPT) using the new 3HP regimen to the current standard of 9 months INH.
    

Detailed description: 
      The treatment of latent tuberculosis infection (LTBI) is a vital component of the overall
      strategy to reduce TB in a population. Treatment prevents ongoing transmission in communities
      by preventing the development of active TB disease. The current international standard for
      the treatment of LTBI is 9 months of Isoniazid (INH). Adherence to this lengthy regimen is
      one of the greatest impediments to treatment. A recent multi-centered, multi-national
      randomized control non inferiority trial with approximately 4,000 patients per arm
      demonstrated that Rifapentine and INH (3HP) given once weekly for a total of 12 doses was as
      effective as 9 months (252 doses) of daily INH treatment for LTBI.(1) These findings were
      also replicated in the pediatric population through a pediatric cohort (n=905 eligible
      participants) nested within the multi-centered international randomized controlled trial with
      children between ages 2-17 treated with 3HP compared to the INH standard for LTBI.(2) The
      efficacy and safety of this new regimen have been established. Rifapentine was approved by
      the United States Food and Drug Administration (FDA) in December of 2014 for the treatment of
      LTBI but is not yet approved in Canada. The shortened treatment course could increase the
      number of people who complete LTBI treatment which could lead to a decrease in active TB
      cases.
    

Intervention name(s): 3HP
Intervention type(s): Drug
Intervention description(s): An interrupted time series study design will be used to determine if the introduction of the 3HP regimen will result in more people completing LTBI treatment compared to the standard of 9 months INH twice weekly.
Other intervention name(s): rifapentine, Priftin
Intervention MeSH terms: Rifapentine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention