bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Effect of a Soluble Fiber Consumption on Immunity Response
Condition: Immune Response
Study type: Interventional

Summary: 
      At European level, the European Food Safety Agency has recognized two claims relating to the
      effects of prebiotics on the gastrointestinal sphere and on the immune system. In subjects
      aged 45-63, it was shown that a pre- and post-vaccination inulin consumption of 8g/day
      significantly increased the titer of antibodies directed against the H3N2 viral strain. The
      increase in bifidobacteria in the faeces confirmed that this effect was related to prebiotic
      capacities. The effect of prebiotics and probiotics on the immune response to influenza virus
      vaccination has been studied in two systematic reviews and meta-analyses. The authors show
      that the consumption of prebiotic fibers such as FOS, GOS, inulin, was also effective on the
      H3N2 strain, as on the H1N1 and B strains (antibody titers of 19.5%, 20.0% and 13.6% higher,
      respectively, compared to placebo).

      The soluble fiber under study is a resistant dextrin meeting the definition of a prebiotic
      fibre. The prebiotic properties have been demonstrated in humans in several studies for doses
      ranging from 10 to 20 g/day. Similarly, studies show that the effects on immune functions are
      favorably impacted by a consumption of 10 g/day for 8 weeks . These results confirm those of
      a preclinical study conducted in mini-pigs.

      The main objective of these study is to demonstrate that these prebiotic properties could
      help stimulate the post-vaccination immune response, and more specifically the production of
      antibodies directed against seasonal influenza viruses (following vaccination), and modulate
      the pro- and anti-inflammatory responses.
    

Detailed description: 
      Screened participants who met the eligibility criteria are randomized either in the control
      or test (soluble fiber) group.

      They are asked to ingest placebo or test product at 15 g/d dosing for 60 days (2 months) . At
      the end of the first month (30 days) they get vaccinated against influenza virus. The effect
      of soluble fiber on immune response is assessed by the comparison of HI titration 30 days
      after vaccination between groups.
    

Intervention name(s): Soluble fiber; Placebo
Intervention type(s): Other; Other
Intervention description(s): 15g/day during 2 months; Maltodextrin 15g/day during 2 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Evaluation of PCR Using DNA Extract From Slides and Filter Paper for the Detection of Tuberculosis and MDR-tuberculosis
Condition: Tuberculosis; Multi Drug Resistant Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Multidrug-Resistant
Study type: Observational

Summary: 
      Specimen transport from peripheral health structures to the National TB reference laboratory
      for MDR-TB identification presents a big challenge in term of sample management, safety,
      contamination and delays. Thus a system that allows specimen to be collected and shipped in a
      safely manner while reducing the possibilities of contamination, the cost of shipment and
      especially the time for detection of MDR-TB by using molecular methods would be very useful.
      Whereas the some studies show promising results for the development and standardization of
      simple specimen collection and transportation methods for molecular DST, more data is needed
      before these can be used in routine.

      The study described here aims at identifying a suitable method, in terms of adapted sample
      support (s) (slide, filter paper (FTA, Genocard ...)) and DNA extraction method. If one or
      several methods are found to give satisfying results, then a larger patient based evaluation
      of this (these) method(s) for molecular DST will be performed in a second phase. The protocol
      for the second phase will be prepared separately.
    

Detailed description: 
      The main objective of this study is to evaluate the performance of PCR in identification and
      detection of tuberculosis using DNA extracts from stained slides (Ziehl Neelsen and
      Fluorescence) and Filter paper (FTA card and Genocard).

      The secondary objectives of this study are to assess the MTB extraction yield from
      smear-negative, low and high bacilli load specimens on slides, filter paper ( Genocardand
      FTA), to determine the amount of sample required to make a detectable PCR reaction and to
      assess the feasibility of storage and extraction methods.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study will take place in the Mbarara Regional Referral Hospital (MRRH) located in
        Mbarara Municipality, Mbarara District, and south-west of Uganda.

        Patients suspected of TB are evaluated in the outpatient facility at the hospital or in the
        medical ward when admitted.

        Some samples will be collected from The Aid Support Organisation (TASO) Mbarara. TASO is
        located in the neighbourhood of MRRH and EMRB.
      
Keywords: Tuberculosis; TB; MDR-TB; LIPA; filter paper; slides; MTBDR Plus
Pre- Versus Post-Incisional Epidural Morphine: Higher Postoperative Pain Perception and Extra Morphine Consumption
Condition: Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Background and Objectives: Neuraxial administration of morphine is an effective way of
      controlling postoperative pain and reducing analgesic consumption. Several animal models have
      demonstrated that preemptive administration of neuraxial narcotics reduced pain while others
      revealed the induction of post-incisional hypersensitivity. There have been no consistent
      results in clinical setting either. This double blind, randomized study compared the effects
      of PRE- vs. POST-incisional administration of neuraxial morphine on postoperative pain
      perception and analgesic requirements over 48 hours following laparotomy for open colectomy
      under standardized general anesthesia.

      Methods: Twenty patients received epidural morphine (3 mg) pre-incision and saline after
      wound closure (MO1 group), and 20 patients received epidural saline before incision and
      morphine after wound closure (MO2 group). Postoperatively, all patients received boluses of
      morphine (1.5 mg) via intravenous patient-controlled analgesia (IV-PCA), and rescue doses of
      intramuscular diclofenac (75 mg) every 6 hours, as needed.
    


Intervention name(s): normal saline 3 ml, morphine 3mg
Intervention type(s): Drug
Intervention description(s): On the day of surgery, patients were brought to the operating room (OR) where routine monitors were placed and an epidural catheter was inserted at the level of L3-4 to a distance of 10 cm. All patients received two injections via the catheter: one injection contained 3 mg morphine (MO), and the other contained normal saline (NS) of the same volume. Patients were randomized to receive either NS preoperatively and MO postoperatively or vice versa. The first injection was administered 40 minutes before initiation of surgery, and the second one was given 15 minutes after surgery ended. All epidural catheters were removed before the patients were discharged from the post-anesthesia care unit (PACU).
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Epidural; Morphine; Preoperative; Postoperative; Analgesia; Tolerance; Preoperative, Postoperative Analgesia
Fear of Falling in Patients With Chronic Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of the study is to evaluate whether combining cognitive-behavioral therapy (CBT) with
      task-oriented balance training (TOBT) is more effective than general health education (GHE)
      together with TOBT in promoting fear of falling and reducing activity avoidance behavior.
    

Detailed description: 
      The null hypothesis of this study will be that no significant difference in the efficacy of
      the two treatments (CBT + TOBT; GHE + TOBT) in promoting fear of falling and reducing fear
      avoidance behavior, and thus no significant difference in improving balance ability, reducing
      fall risks, improving health-related quality of life and community reintegration of people
      with stroke.
    

Intervention name(s): GHE + TOBT training; CBT + TOBT training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): All subjects will receive 45 minutes of GHE, followed by 45 minutes of TOBT program twice a week for 8 weeks.; All subjects will receive 45 minutes of CBT, followed by 45 minutes of TOBT program twice a week for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Fear of falling; Fear avoidance behavior; cognitive behavioral therapy; Rehabilitation
Alterations in Bioelectric Activity at Acupuncture Points Following CV4 Cranial Manipulation
Condition: Autonomic Imbalance
Study type: Interventional

Summary: 
      By measuring specific electrical parameters at acupuncture points that have been shown to
      correlate with ANS activity, the objectives of this study were to: 1) determine if CV4 has
      any influence on the bioelectric properties of the acupuncture meridian system, and 2)
      determine if CV4 affects the ANS.
    

Detailed description: 
      This study is designed to measure bioelectrical activity at acupuncture Ting (Jing-Well)
      points immediately before and after employing a specific Osteopathic Cranial Manipulative
      Medicine (OCMM) technique called CV4 (Compression of the 4th Ventricle) vs. a Sham treatment.

      Ting (Jing-Well) points are acupuncture points located at the proximal edges of the finger-
      and toenails that represent the beginning and end of 14 acupuncture meridians as described in
      Traditional Chinese Medicine and Japanese systems. Measurement of electrical activity at Ting
      points is performed by a physicist who has extensive experience using a device known as the
      Apparatus for Meridian Identification (AMI). Data collected and analyzed by the AMI for both
      CV4 and Sham groups is compared statistically for significant differences in before vs. after
      electrical activity and specific acupuncture meridians affected. One particular analysis of
      After Polarization (AP) potentials correlates with changes in autonomic nervous system
      activity.
    

Intervention name(s): Osteopathic cranial manipulative medicine; Sham
Intervention type(s): Other; Other
Intervention description(s): Osteopathic cranial manipulative medicine technique using compression of 4th ventricle technique; Touch only, no osteopathic cranial manipulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants randomized to sham group or osteopathic cranial manipulative medicine treatment group
Masking: Single (Participant)
Primary purpose: Other
Acute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      The investigators hypothesize that Acute Thai traditional massage will yield beneficial
      effects on cerebrovascular reactivity in ischemic stroke patients.
    


Intervention name(s): Thai traditional massage; No massage
Intervention type(s): Other; Other
Intervention description(s): Thai traditional massage treatment based on original Thai traditional massage at Wat Po was use in this study. The participants will be assigned to receive one time of Thai traditional massage one time. Thai traditional massage techniques consists of petrissage, friction, and passive stretching on head, neck, shoulders, arms, back and legs for 60 minutes.; The participants will be asked to lie down in relaxant position on bed without sleep for 60 minutes.
Other intervention name(s): Thai massage
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ischemic stroke; Thai traditional massage; Vascular function; Cerebral blood flow; Cerebrovascular reactivity
Evaluation of Sinetrol® Xpur in Fat Mass Reduction on Overweight and Obese Subjects
Condition: Change in Total Body Fat Mass Percentage Loss Versus Body Weight
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      This study aims to evaluate effects of a 16-week supplementation with a polyphenol rich
      extract, Sinetrol® Xpur, on fat mass accumulation and body weight management
      improvement.Subjects were overweight or obese and received polyphenol supplement or placebo.
      A 4-week follow-up as performed to evaluate its effect after supplementation stop.
    


Intervention name(s): Placebo; Sinetrol® Xpur
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
This Study is Designed to Evaluate PD/PK and Safety of Replagal Manufactured by Two Different Processes.
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate safety and PK/PD in Canadian Fabry patients.
    

Detailed description: 
      In 2008, a change in the agalsidase alfa drug substance manufacturing process was made. There
      are no changes to the drug product formulation, manufacturing site, manufacturing process, or
      container closure.

      An agalsidase alfa bioreactor manufacturing process (agalAF1) utilizing animal component-free
      media replaced the previous roller bottle (RB) process.

      This study is designed to provide PD/PK and safety data. The assessment schedule is designed
      to capture the PK profile of drug uptake in the blood as well the pharmacologic effect which
      manifests over the course of weeks. Each patient will serve as his own control.
    

Intervention name(s): agalsidase alfa
Intervention type(s): Biological
Other intervention name(s): Replagal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Replagal
A Phase 3 Study of NI-071 in Participants With Rheumatoid Arthritis (RADIANCE)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to demonstrate similarity of NI-071 (proposed biosimilar to
      infliximab) to US REMICADE® (reference product) in terms of safety and efficacy in
      participants with rheumatoid arthritis (RA) not adequately responding to methotrexate (MTX).
    


Intervention name(s): NI-071; Remicade
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion.; IV infusion.
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Sexuality in Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to evaluate the different aspects of sexual function among adults
      with Parkinson Disease to develop a treatment and address sexual problems as a routine part
      of diagnostic workup and therapeutic planning.
    

Detailed description: 
      Because there is limited literature on sexual function in Parkinson disease, in this study,
      we examined sexual functioning in a large groups of patients with idiopathic Parkinson
      Disease compared with healthy subjects in the Italian community. To assess sexual function in
      PD we used the Brief Index of Sexual Functioning [(BISF-M for man; BISF-W for woman), the
      International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI).
      Participants were also assessed by the Beck Depression Inventory (BDI).

      This study aimed to provide a thorough epidemiological description of sexual dysfunction in
      Parkinson's disease. The knowledge of sexual function in PD might help to plan effective
      interventionist measures and ultimately to optimize patient's and the partner's quality of
      life.

      Parkinson patients (aged 40-80) and 123 healthy controls (aged 40-80) will be recruited from
      four Italian Movement Disorders Clinics.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed as having idiopathic PD were recruited from four Italian Movement
        Disorders Clinics
      
Keywords: Sexuality; Parkinson Disease; BISF; IIEF; FSFI
Study Evaluating the Safety of FXR-450 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to evaluate the safety of FXR-450 in healthy subjects.
      This study will also evaluate pharmacokinetics (PK) of FXR-450 in healthy subjects.
    


Intervention name(s): FXR 450; placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsule, single oral doses from 10 mg to 450 mg; capsule similar to active drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: healthy subjects
Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as
      compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).
    


Intervention name(s): Laquinimod; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Laquinimod 0.6 mg capsule, oral, once daily; oral, once daily, capsule
Other intervention name(s): TV-5600
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Relapsing; Remitting
Effects of Oral Pre-loads on Subsequent Energy Intake
Condition: Energy Intake; Gastrointestinal Hormones; Glycemic Control; Appetite; Satiation
Study type: Interventional

Summary: 
      The aim of this project is to investigate the effect of erythritol (given as pre-load),
      compared to sucrose, sucralose, and water on energy intake during a subsequent ad libitum
      test meal in healthy participants.

      Furthermore, the release of GI hormones, glycemic control, appetite-related sensations, GI
      tolerance, sweetness and liking in response to the pre-loads will be investigated.
    

Detailed description: 
      The subjects will participate in four study days. The screening will last 60 minutes, the
      study days about 4.5 hours each. After a simple-carbohydrate standard dinner, the subjects
      have to do an overnight fast until the next morning. Subjects will receive fixed equisweet
      doses of sucrose (33.5g), erythritol (50g), sucralose (0.0558g), or water as oral pre-loads
      in a blinded, randomized (counterbalanced) fashion (t = -15 min). Fifteen minutes after the
      administration (t = 0 min), a standard solid test meal will be presented and ad libitum
      calorie intake will be measured. The end of the test meal will be after 20 minutes or as soon
      as the subject stops eating for more than 5 minutes. Blood samples (to measure: glycemic
      control and GI hormones) will be collected at t = -16, t = -1, t = 15, t = 30, t = 60, t =
      90, t = 120, t = 150, t = 180 min and appetite-related sensation rating will be collected at
      t = -16, t = -1, t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 min. GI symptoms
      and nausea are assessed at t = -16, -1, 30, 60, 120 and 180 min. At t = -10 min subjects are
      asked to rate the perceived sweetness and liking of the pre-load and at t = 180 min the
      perceived liking of the test meal.
    

Intervention name(s): Erythritol; Sucrose; Sucralose; Water
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 50g erythritol dissolved in 300mL tap water.; 33.5g sucrose dissolved in 300mL tap water.; 0.0558g sucralose dissolved in 300mL tap water.; 300mL tap water.
Other intervention name(s): E968-Erythritol; Saccharose; E955-Sucralose
Intervention MeSH terms: Erythritol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Clinical Evaluation of dCELL® ACL Scaffold for Reconstruction of the Anterior Cruciate Ligament
Condition: Knee Injuries
MeSH terms: Knee Injuries
Study type: Interventional

Summary: 
      The safety and performance of dCELL® ACL Scaffold will be evaluated in 40 patients who have
      been implanted with the investigational product following a ruptured anterior cruciate
      ligament (ACL) of the knee.
    

Detailed description: 
      The dCELL® ACL Scaffold is a novel device manufactured from porcine tissue using a patented
      variation of Tissue Regenix's platform technology to render the tissue biocompatible and free
      from cellular material, providing a biological scaffold that is safe for human implantation
      whilst preserving the biomechanical properties.

      The device is used to reconstruct traumatic ACL tears to help restore normal knee function
      and therefore prevent further wear of the cartilage and future damage.
    

Intervention name(s): dCELL® ACL Scaffold
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial of Tolerability, Reactogenicity, Safety and Immunogenicity of Flu-M [Inactivated Split Influenza Vaccine] in Pregnant Women
Condition: Influenza, Human; Vaccination; Infection; Vaccines
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Comparative study of tolerability, reactogenicity, safety and immunogenicity Flu-M
      [Inactivated Split Influenza Vaccine] vs. the Ultrix® vaccine for the prevention of influenza
      in pregnant women in the 2nd-3rd trimesters of pregnancy
    

Detailed description: 
      This is a randomized, double-blind, comparative, controlled trial. A design with a control
      group treated with Ultrix®, inactivated influenza vaccine, was chosen to obtain objective
      findings.Trial population: healthy women aged 18 to 35 years during the 2nd and 3rd
      trimesters of pregnancy. Subjects were randomized into 4 groups in a ratio of 1:1:1:1, 50
      subjects per group.
    

Intervention name(s): Flu-M, Inactivated split influenza vaccine; Ultrix®, Inactivated Split Influenza Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): solution for intramuscular injection, 0.5 ml; solution for intramuscular injection, 0.5 ml
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza; Flu; Vaccine; FLU-M; SPbSRIVS; Ultrix