bioihbjkbjnl/mcl2 huggingface dataset:
Measuring Effects of Prebiotics on Human Behavior and Cognition
Condition: Prebiotics and Human Behavior and Cognition
Study type: Interventional

Summary: 
      This study is designed to test the effects of prebiotics on cognition, behavior and
      physiology in healthy volunteers.
    

Detailed description: 
      The purpose of this study is to determine the effects of dietary carbohydrate supplements
      (prebiotics) on cognition, behavior and physiology in healthy individuals.

      This study will be separated into one pre-study visit + three consecutive weeks: Baseline
      (week 1), Intervention (week 2) and Assessment (week 3). For these three weeks, participants
      will be asked to take diet surveys and make in-person visits to complete online cognitive
      assessments and provide samples of blood and saliva to assess levels of serotonin and
      cortisol in addition to other basic metabolites. During the Intervention week, participants
      will be given snack bars that they will be asked to eat twice a day, for five days in a row.
      There will be two treatment groups that participants will be randomly assigned to, which vary
      according to the carbohydrate makeup of snack bars. For the entire three-week study period,
      participants will also be asked to collect samples of their stool at home every Tuesday and
      Friday. They will also be provided with wearable devices (a watch) to track their daily heart
      rate and activity level (including sleep) for the entirety of the study. Participants will be
      compensated for their time for each stage of the study, once in-person visits begin.

      The greatest risks of this study include the possibility of infection while sampling your own
      stool, and momentary discomfort and/or bruising associated with blood draws. Discomfort as a
      result of consuming the bars is possible in the form of flatulence, bloating, constipation,
      diarrhea, or borborygmi (stomach rumbling). Participants weighing less than 140 pounds may be
      more likely to develop diarrhea than those weighing more. Should any such discomfort occur,
      it can be alleviated simply by discontinuing consumption of the prebiotic. Infection,
      fainting, and excess bleeding/clotting, though highly unlikely, are also possible.
      Participants also face risks associated with the loss of confidentiality.
    

Intervention name(s): Inulin; Placebo (maltodextrin)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 9 grams of food grade inulin added to custom made fiber bars.; 9 grams of food grade maltodextrin - replaces inulin in fiber bars.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty
Condition: Knee Osteoarthritis; Arthropathy of Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Joint Diseases
Study type: Interventional

Summary: 
      Rehabilitation after total knee arthroplasty (TKA) should consider control of postoperative
      pain and swelling, protection of the healing graft, restoration of full range of motion
      symmetric to the contralateral knee, strengthening of the muscles that stabilize the knee,
      hip, and trunk, enhancing neuromuscular control, and a gradual progression to functional
      activities that are required for return to the normal daily life. The effects of concomitant
      injuries and surgical procedures must also be considered in planning an individualized
      rehabilitation program. However, it is still unclear regarding the optimal exercise
      prescription after TKA. In the current study, the investigators plan to develop an exercise
      protocol and evaluate the result in a multidisciplinary approach, i.e. bone mineral density
      assessment. The exercise prescription consisted of cyclic exercise, aerobic exercise and
      resistant training exercise for first, second and third year, respectively. Cyclic exercise
      is advantaged safety and effectiveness of hydraulic resistance equipment, as well as the
      exercise can be quantitatively determined. Aerobic exercise is privileged by the
      cardiopulmonary endurance improvement, along with muscle strengthening in the associated
      muscle groups. Resistance exercise is specified for the indicated muscle groups, especially
      knee extensors, flexors, ankle plantar flexor and dorsi flexor in TKA reconstructed patients.
      The investigators hypothesis that using this cyclic exercise process can improve the body
      composition, muscle strength, bone mass density, level of oxidative damage indicators, gait
      performance, quality of life, knee joint range of motion, function of cardiopulmonary and
      fitness. This project will establish the scientific basis for rehabilitation protocol
      involving knee surgery.
    


Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): cyclic exercise, aerobic exercise and resistant training exercise
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
DBPC Trial to Evaluate the Safety, Tolerability and Efficacy of Oral Litoxetine in Subjects With Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will explore the safety, tolerability and efficacy of litoxetine in men and women
      who suffer from urinary incontinence
    

Detailed description: 
      This is a double blind randomized placebo controlled study which will explore the safety,
      tolerability and efficacy of oral litoxetine, a highly selective SSRI, provided by dose
      titration to subjects suffering from urinary incontinence
    

Intervention name(s): Litoxetine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral study medication provided in a dose titration manner; placebo medication provided in a dose titration manner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: urinary incontinence, SSRI
Online Cognitive Behavioral Intervention Program for Hong Kong People With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to develop a culturally and linguistically appropriate online
      cognitive behavioral intervention program-- with therapist guidance -- for Hong Kong Chinese
      adults suffering from major depressive disorder with mild to moderate depressive symptoms,
      and examine the effectiveness of this program in reducing their depressive symptoms and
      improving their mental health. The 3- and 6-month maintenance effect after 3 months and 6
      months will also be tested.
    

Detailed description: 
      Previous studies have demonstrated that online cognitive behavioral therapy can significantly
      reduce depressive symptoms and improve mental health for people with depression. This project
      will develop an online cognitive behavioral intervention program (including both an online
      platform and a smartphone application) for Hong Kong people with depression. Blended mode
      will be delivered service, which include 8-week online program, 2 face-to-face sessions and 2
      telephone follow-ups by a clinical psychologist. The program will be evaluated in its
      effectiveness in reducing depressive and anxiety symptoms, psychological distress, negative
      thoughts and negative emotions and increasing positive thoughts and positive emotions.
    

Intervention name(s): Confront and Navigate Depression Online (CANDO)
Intervention type(s): Other
Intervention description(s): This study adopts a blended mode of service delivery, which included both online and offline intervention. The online intervention includes 8 weekly online model, animation briefing and debriefing, case demonstration video, exercise, forum, internal messaging, reminder, online assessment, session review and online booking system. The offline intervention includes two face-to-face sessions and two telephone follow-ups.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: online cognitive behavioral intervention; Hong Kong Chinese; depression
PENG and LFCN Block Versus FIC Block for Multimodal Analgesia After Total Hip Replacement Surgery: a Retrospective Analysis
Condition: Regional Anesthesia Morbidity; Arthropathy of Hip; Hip Arthropathy
MeSH terms: Joint Diseases
Study type: Observational

Summary: 
      Background: Optimal pain control with limited muscle weakness is paramount for a swift
      initiation of physical therapy and ambulation. Fascia iliaca compartment block (FICB) has
      been recommended since it offers the best pain control with low risk of motor block.
      Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve (LFCN) block has
      been proposed as an effective alternative to FICB that offers similar pain control with a
      considerably lower risk of motor block. This study aimed to compare the afore mentioned
      blocks and determine which one yielded the lowest NRS score.
    

Detailed description: 
      This single-center, retrospective investigation was conducted at ASST Nord Milano Bassini
      hospital. The study was approved by the ethics committee "Comitato Etico Milano Area 3". The
      main outcome of the study was the comparison of postoperative pain at 6, 12 and 24 hours,
      expressed as NRS (numeric rating scale), between PENG and LCFN . Secondary outcomes included
      total opioid consumption expressed as milligrams of morphine equivalents (MME), time to first
      opioid request, time to first postoperative ambulation.
    

Intervention name(s): Peripheral nerve blocks
Intervention type(s): Procedure
Intervention description(s): Peripheral nerve blocks provide intense, site-specific analgesia administring local anesthetics near the nerves.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        primary hip replacement surgery
      
Keywords: total hip replacement surgery; primary hip arthritis
A Study of the Effect of INCB013739 on Cortisone Reducing Enzyme Activity in Obese People Predisposed to Diabetes
Condition: Insulin Resistance; Obesity
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether the investigational drug INCB013739 has an
      effect on systemic and adipose tissue 11-HSD1 activity in obese, insulin resistant subjects.
    

Detailed description: 
      "Proprietary Information: Exploratory (Non-Confirmatory) Trial".
    

Intervention name(s): INCB13739
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia
Condition: Hyponatremia
MeSH terms: Hyponatremia
Study type: Interventional
Phase: Phase 3

Summary: 
      Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic
      hyponatremia
    


Intervention name(s): YM087 oral
Intervention type(s): Drug
Intervention MeSH terms: Conivaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: hyponatremia; hypervolemic; euvolemic; conivaptan
Psycometric Properties of Pushing Scale
Condition: Balance; Functionality
Study type: Observational

Summary: 
      Psycometric properties of a scale
    

Detailed description: 
      After a period of training in the administration of the CPS, a pilot will be conducted with
      10 patients who meet the inclusion-exclusion criteria and after signing the informed consent
      document, in which the 4 researchers will administer the CPS during two sessions on
      consecutive days, with the objective of evaluating the test-retest and intra-observer
      reliability, minimize the differences of criteria in its application and, if necessary, write
      an instruction manual.

      Once each patient has signed the informed consent document and it has been verified that the
      inclusion criteria are met, it will be assigned an Identification Number (ID) that will
      relate it to your Medical Record (IDHC) by simple coding; The custody of the file with the
      relation of each ID with its HC will be borne by the principal investigator. Likewise, each
      observer will be assigned an identification number in order to blind the researcher who
      performs the statistical analysis. The patients included in the study will be evaluated,
      through the Spanish version of the CPS, by two of the researchers with an interval of 10
      minutes between each evaluation, repeating this same procedure the next day. These evaluation
      sessions will be carried out throughout the treatment period, repeating on days 1, 15 and 28
      of the period of admission of the included patients. Two researchers will evaluate the
      patients treated in the morning shift and the other two those treated in the afternoon shift
      of the Physiotherapy Service of the Guadarrama Hospital.
    

Intervention name(s): Management of the Contraversive Pushing Scale
Intervention type(s): Diagnostic Test
Intervention description(s): Scale of evaluation of trunk control and pushing behavior in patients with stroke.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with the diagnosis of stroke who enter the Guadarrama Hospital, meet the inclusion
        / exclusion criteria and agree to participate in the study after signing the informed
        consent.
The Bioavailability of Mycoprotein
Condition: Availability of Mycoprotein
Study type: Interventional

Summary: 
      To evaluate the bioavailability of mycoprotein, compared with a reference animal based
      protein, in a dose-response manner.
    


Intervention name(s): Mycoprotein ingestion
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Study of [14C]IBI351 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the mass balance of single oral dose of [14C] IBI351 in healthy
      subjects. Six to eight healthy male subjects were planned to be enrolled. After passing the
      screening, subjects were admitted to hospital and received training on medication, urine and
      feces collection and other procedures to ensure that they could perform relevant operations
      according to the protocol and SOP requirements. On the evening before medication, the patient
      had standard meals, and fasted uniformly overnight. On D1, the suspension containing
      recommended dose of [14C] IBI351 was administered in the morning on an empty stomach.
      Subjects have standardized meal during the trial and blood, urine, and feces samples were
      collected and safety laboratory tests were performed as scheduled.
    


Intervention name(s): [14C] IBI351
Intervention type(s): Drug
Intervention description(s): The oral formulation of [14C] IBI351 was formulated as a suspension for subjects to take orally in drinking water under fasting conditions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KRP-A218 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-in-human study has three parts. In Parts A and B, the safety, tolerability, and
      pharmacokinetics (PK) will be evaluated following administration of single and multiple doses
      of KRP-A218, including food-effect. In Part C, the drug-drug interaction (DDI) with
      itraconazole will be evaluated.
    


Intervention name(s): KRP-A218; Placebo; itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): KRP-A218 tablet; Placebo tablet; 10 mg/mL oral solution
Other intervention name(s): Sporanox
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse
Condition: Alcoholism
MeSH terms: Recurrence; Alcoholism
Study type: Interventional

Summary: 
      Alcohol-dependence is a medical condition that can lead to the occurrence of an alcohol
      withdrawal syndrome (AWS) in case of alcohol drinking cessation. Diazepam is the reference
      medication for preventing or treating AWS. The recommended average diazepam treatment
      duration is usually around one week, and this duration is generally not considered to impact
      the subsequent relapse rate in alcohol drinking.

      However, several previous studies have found that patients experienced frequent anxious
      symptoms during the weeks following detoxification. Such symptoms may foster early relapse in
      alcohol drinking. Furthermore, it has been suggested that this anxiety could pertain to late
      withdrawal symptoms.

      The DIAMA study hypothesizes that extending the diazepam detoxification treatment to one
      month can significantly reduce the cumulated relapse rate in alcohol drinking over the three
      following months.
    

Detailed description: 
      -  inclusion at Day 5 of the outpatient alcohol detoxification procedure

        -  randomization in two arms: 1) "10 day - diazepam"; and 2) "30 day - diazepam"

        -  tapering of diazepam over the 10 days following the beginning of the detoxification
           procedure in the first arm; tapering of diazepam over the 30 days following the
           beginning of the detoxification procedure in the second arm.

        -  3-month-long follow-up after detoxification. Objective of maintaining abstinence from
           alcohol. No use of additional anticraving drug. Standardised psychotherapeutic support
           based on the BRENDA model.

        -  Longitudinal recording of alcohol consumption using the Alcohol Timeline Follow-Back
           method.

        -  Assessment of craving (Obsessive-Compulsive Drinking Scale) and anxiety (State-Trait
           Anxiety Inventory; Hamilton Anxiety Rating Scale) at Days 5 (baseline), 15, 30, 60 and
           90 (final assessment).
    

Intervention name(s): Diazepam
Intervention type(s): Drug
Intervention description(s): 40 mg per day.
Intervention MeSH terms: Diazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcohol-dependence; Relapse; Detoxification; Diazepam; Benzodiazepines; Anxiety
Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study
Condition: Smoking Reduction; Smoking Behaviors; Smoking, Tobacco; Smoking Cessation
Study type: Interventional

Summary: 
      Prospective open label, single center study enrolling up to 220 participants to evaluate the
      effect of the Pivot Breath Sensor on a user's attitudes towards quitting smoking and smoking
      behavior.
    

Detailed description: 
      Study to collect the following data during and after use of a personal carbon monoxide breath
      sensor (Pivot Breath Sensor):

        -  Change in attitudes towards quitting smoking

        -  Change in smoking behavior

        -  Participant feedback
    

Intervention name(s): Pivot Breath Sensor
Intervention type(s): Device
Intervention description(s): The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
tDCS and Aphasia Treatment
Condition: Aphasia
MeSH terms: Aphasia
Study type: Interventional

Summary: 
      This project will investigate the use of noninvasive brain stimulation in the form of tDCS
      (transcranial direct current stimulation) in conjunction with speech-language therapy, for
      the improvement of language production in stroke survivors with aphasia. The hypothesis is
      that anodal tDCS and speech-language therapy will facilitate improved outcomes compared to
      speech therapy alone.
    

Detailed description: 
      Aphasia, commonly defined as impairment or loss of language functions, is a frequent and
      often chronic consequence of stroke, with detrimental effects on patient autonomy and
      health-related quality of life (HRQOL). Although beneficial in some cases, the effectiveness
      of behavioral therapy is often limited, and therefore new complementary treatments must be
      developed in order to improve rehabilitation of post-stroke aphasia.

      In most individuals, language areas in the brain are localized in the left hemisphere. After
      stroke, there is evidence that the brain reorganizes such that either areas close to damaged
      language areas in the Left Hemisphere, or anatomically similar areas in the Right Hemisphere,
      are recruited to perform language tasks.

      Recently, studies have begun to examine the effects of non-invasive brain stimulation on
      aphasia rehabilitation. One such technique is transcranial direct current stimulation (tDCS),
      which involves administering weak electrical currents through surface electrodes on the
      scalp. The effects can either stimulate an area, or inhibit an area of the brain. The main
      hypothesis is that stimulating language areas in the Left Hemisphere in conjunction with
      speech language therapy will facilitate reorganization of language-relevant areas of the
      brain, and improve expression.

      The proposed study will compare the effects of transcranial direct current stimulation (tDCS)
      activating language centers in the Left Hemisphere and sham tDCS, in right-handed individuals
      with chronic post-stroke aphasia. This study will provide information on the effects of tDCS,
      in conjunction with speech-language therapy, on aphasia rehabilitation.
    

Intervention name(s): Soterix 1x1 tDCS
Intervention type(s): Device
Intervention description(s): Anodal and sham tDCS will be administered. All of the participants will also receive behavioral speech-language therapy.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: aphasia; therapy; stroke; language; naming; quality of life; tDCS; treatment
Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite
Condition: Cellulite
MeSH terms: Cellulite
Study type: Interventional

Summary: 
      To evaluate the safety, and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the
      temporary improvement in the appearance of cellulite.
    

Detailed description: 
      Multi-site clinical study to evaluate the safety, efficacy and tolerability of Soliton's
      Rapid Acoustic Pulse (RAP) device fo the temporary improvement in the appearance of
      cellulite.
    

Intervention name(s): Soliton's Rapid Acoustic Pulse (RAP)
Intervention type(s): Device
Intervention description(s): Treatment for the temporary improvement in the appearance of cellulite.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment