bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Fruit and Vegetable Consumption on Immune Function in the Elderly
Condition: Immune Function
Study type: Interventional

Summary: 
      The immune system undergoes a range of changes as individuals become elderly. These may
      manifest as an increasing susceptibility to infection or a tendency to develop autoimmune or
      malignant disease. Multiple underlying factors contribute to this phenomenon of immunological
      aging, and in this study the investigators will examine the possibility that inadequate diet
      may be one such contributing factor. Fruit and vegetable intake, which can be low in the
      elderly, is associated with reduced chronic disease risk. This proposal will test the
      hypothesis that increased fruit and vegetable intake may positively affect clinically
      relevant measures of immune function. One hundred healthy volunteers aged 65-85 years
      following a low fruit and vegetable diet (<=2 portions/d) will be recruited and randomised to
      continue following their normal diet, or to consume at least 5 portions of fruit and
      vegetables daily for 16 weeks. Immune function and biochemical markers of nutritional status
      will be assessed before and after the intervention period.
    


Intervention name(s): 5 portions; 2 portions
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects randomised to the intervention group will be provided with a selection of fruit and vegetables once a week (from a local supermarket) and will be asked to consume 5 portions of fruit and vegetables per day. For the purposes of this study, a portion will be as defined by the Food Standards Agency, i.e. an 80 g serving (one apple, orange or banana, or 3 heaped tablespoons of vegetables).; Subjects randomised to the control group will be provided with a selection of fruit and vegetables once a week (from a local supermarket) and will be asked to consume 2 portions of fruit and vegetables per day. For the purposes of this study, a portion will be as defined by the Food Standards Agency, i.e. an 80 g serving (one apple, orange or banana, or 3 heaped tablespoons of vegetables).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Natural killer cell cytotoxicity; Antibody response; Tetanus toxoid vaccination; Pneumovax II vaccination; Total serum immunoglobulins; IgG subclasses
Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury
Condition: Neonatal Brachial Plexus Palsy
MeSH terms: Neonatal Brachial Plexus Palsy
Study type: Interventional

Summary: 
      This study evaluates the addition of constraint-induced movement therapy (CIMT) to usual care
      occupational therapy in children with perinatal brachial plexus injury. Participants are
      randomized to receive either the intervention (CIMT) or control first, then cross over to
      receive the other one.
    

Detailed description: 
      Children with perinatal brachial plexus injury routinely receive occupational therapy
      intervention to improve strength and function in their weak or paralyzed arm.

      Constraint-induced movement therapy (CIMT) is known to increase upper extremity function in
      children with weakness or disuse as a result of cerebral palsy. However, it is unknown if
      this therapy is effective for treating arm weakness or disuse as a result of perinatal
      brachial plexus injury. The addition of CIMT to usual and standard occupational therapy care
      is evaluated in this trial.
    

Intervention name(s): Constrain-induced Movement Therapy; Usual Occupational Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8-week therapy program utilizing constraint of the unaffected arm; 8-week therapy program without constraint of the unaffected arm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of Dry Needling on Trunk Muscle Function in Low Back Pain Patients
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The study will establish data on the function of trunk muscles in healthy and low back pain
      patient's pre and post dry needling treatment. This will help in understanding the underlying
      mechanism of this treatment and reveal the effect of dry needling on muscle performance.

      Study hypothesis is that an improvement of back muscle function following dry needling
      procedure will be found.
    

Detailed description: 
      Dry needling of muscles is mainly used for the management of pain in musculoskeletal
      disorders. Yet, the association between dry needling and motor performance of muscles is
      still unclear.

      This study aims to investigate the immediate effect of dry needling on lumbar multifidus
      muscles' function in healthy and low back pain subjects.

      The sample will be divided into: low back pain group and control (healthy) group. Both groups
      will receive dry needling to the lumbar multifidus muscles using a deep insertion technique
      with 4 needles (2 on each side of the spine). The needles will be left in situ for 10
      minutes. Ultrasound imaging will be used to measure multifidus muscles' thickness, pre and
      post- procedure during rest in a prone position and during contralateral active straight leg
      extension.
    

Intervention name(s): dry needling
Intervention type(s): Other
Intervention description(s): Dry needling uses traditional acupuncture needles without injecting any liquid. Dry needling is based on traditional Western medicine whereby the needle insertion sites are located in known anatomical landmarks such as skeletal muscles, fascia and occasionally joints, tendons and bone/tendon junctions.
Other intervention name(s): acupuncture
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ultrasound imaging; acupuncture; back muscles; spine; muscle strength
Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the assay is to assess the safety and the efficacy of TRO19622 330 mg QD as
      add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, as
      compared to placebo, assessed by the 18-month survival rate.
    

Detailed description: 
      A stand alone treatment with TRO19622 is not acceptable for ethical reasons. Riluzole is an
      approved and widely used ALS treatment in the European community, in Japan and in the USA.

      Therefore, in this study, TRO19622 will be assessed as add-on to riluzole in patients
      suffering from ALS.

      At the start of the study, patients will be randomized to one of two groups : TRO19622 (330
      mg QD or placebo (once a day).

      Each treatment will be administered for 18 months under double-blind conditions. The product
      under evaluation will be administered to patients receiving the standard of care for ALS,
      including riluzole.

      Riluzole dosage (50 mg bid) must be stable and well tolerated for at least one month prior to
      inclusion into the study.

      After the double-blind period, open-label administration of TRO19622 will be allowed for
      safety and survival assessments and until efficacy results are available.

      A separate open-label protocol will be written 6 months after the randomization of the last
      patient into the study.
    

Intervention name(s): Olesoxime; Placebo Comparator; Riluzole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzol 50mg bid; 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid; Riluzole given as add-on therapy 50mg bid
Other intervention name(s): TRO19622; Placebo; Rilutek
Intervention MeSH terms: Riluzole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Amyotrophic Lateral Sclerosis; TRO19622; Trophos
Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma; Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to look at the safety aspects and effects of repeat inhaled doses of
      GW597901X in asthmatics to develop this drug for its use in asthma and Chronic Obstructive
      Pulmonary Disease(COPD).
    


Intervention name(s): GW597901X
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: GW597901X; Asthma; Crossover; dose ascending; repeat dose; inhaled
Serum Clozapine and Cognition
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      This study aim to investigate the relationship between serum levels of clozapine and
      cognitive performance in patients with ICD-10 Schizophrenia and treated with clozapine
      monotherapy. The hypothesis is that higher serum levels of clozapine are associated with
      cognitive dysfunctions. Furthermore, ECG changes and the relation to serum level of clozapine
      are studied. The design is cross-sectional.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        ICD-10 Schizophrenia (f20.0-3; F20.9) treated with clozapine
      
Keywords: clozapine; schizophrenia; cognition; t-wave morphology
Function-oriented Assistive Technology Indexing System Development and Promotion
Condition: Multiple Disability
Study type: Observational

Summary: 
      Appropriate assistive devices are important factors for the activity participation of the
      disabled. These devices should be prescribed by the specialists based on their functional
      needs. However, most individuals in need of assistive devices locate in the household,
      school, or nursing institute, in which the professional interventions are not always
      available on demand. Consequently most assistive devices are used without thorough
      evaluation, therefore do not necessarily meet the exact needs of the individual. Hence an
      easy-to-access and easy-to-use assistive technology device indexing system based on the
      functional needs of the subjects is necessary. The goals of this two-year study are twofold:
      assistive technology indexing system application(APP) development and promotion. First, the
      multidisciplinary research team, composed of specialists from assistive technology,
      rehabilitation, computer science, and special education fields, is going to integrate and
      refine the current resources and develop an assistive technology indexing system App based on
      the functional needs of the disabled. Second, in cooperation with the disabled community and
      special schools, the team is going to promote the use of the App and evaluate its usability
      via System Usability Scale. This App will be beneficial to the individuals in need of
      assistive device application. It can also be used as an assistive device manual for the
      specialists. The App will guide the individuals step by step to the proper assistive devices
      based on their functional capacities. The complete system will include details of each
      assistive device and link up with the related service resources. With its registering
      function, the statistics collected via user clicks can serve as references for further design
      adjustments and assistive device related policy modifications. All together this App can
      provide comprehensive services to the disabled in need of assistive devices.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        the disabled and their caregivers
      
Keywords: Assistive technology; functional needs; system usability
The Effect of Insulin-induced Hypoglycaemia on Gut-derived Glucagon Secretion (Px-Hypo)
Condition: Diabetes After Total Pancreatectomy
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      The overall objective of this study is to investigate whether hypoglycaemia (the most potent
      stimulus of pancreatic glucagon secretion) affects the secretion of gut-derived glucagon in
      totally pancreatectomized patients.
    

Detailed description: 
      The investigators want to assess the plasma glucagon response to insulin-induced
      hypoglycaemia in totally pancreatectomised patients and at the same time evaluate whether
      hypoglycaemia affects a range of other products from endocrine cells in the gastrointestinal
      tract including ghrelin, gastrin, cholecystokinin (CCK), glucose-dependent insulinotropic
      polypeptide (GIP), GLP-1, glucagon-like peptide-2 (GLP-2), oxyntomodulin and peptide YY
      (PYY). Furthermore the investigators will evaluate how hypoglycaemia in these patients
      affects other counter-regulatory mechanisms including plasma responses of the hormones
      adrenaline, noradrenaline, growth hormone and cortisol as well as the rate of gastric
      emptying rate (which under normal circumstances accelerates during hypoglycaemia) during an
      oral glucose tolerance test (OGTT).
    

Intervention name(s): Oral glucose tolerance test; Clamp experiment
Intervention type(s): Other; Other
Intervention description(s): 50 grams OGTT; insulin-induced hypoglycaemic clamp followed by an 50 grams OGTT
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 12 totally pancreatectomized patients and 12 healthy control subjects
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: glucagon
Feasibility of the Sinex Program for Shoulder Instability
Condition: Anterior Shoulder Dislocation
MeSH terms: Shoulder Dislocation
Study type: Interventional

Summary: 
      An optimal treatment for traumatic anterior shoulder instability (TASI) remains to be
      identified. A shoulder instability neuromuscular exercise (SINEX) program has been designed
      for patients with TASI, but has not yet been tested in patients eligible for surgery. The
      purpose of this study was to investigate and evaluate the feasibility and safety of the SINEX
      program for patients diagnosed with TASI and eligible for surgery.

      A feasibility study with an experimental, longitudinal design using both quantitative and
      qualitative research methods. Participants undergo the SINEX program, a twelve week exercise
      program including physiotherapist supervised sessions. Feasibility data on recruitment,
      retention, compliance, acceptability and safety was collected through observation and
      individual semi-structured interviews. Clinical tests and self-report questionnaires were
      completed at baseline and 12 weeks follow-up. Clinical assessments included apprehension and
      relocation tests, shoulder joint position sense (SJPS), shoulder sensorimotor control
      measured by center of pressure path length (COPL) on a force platform, isometric strength
      measured by Constant Score - Isometric Maximal Voluntary Contraction (CS-iMVC), self-report
      questionnaires included Western Ontario Shoulder Instability Index (WOSI), Tampa Scale of
      Kinesiophobia (TSK) and Global Perceived Effect questionnaire (GPE).
    


Intervention name(s): Sinex program (neuromuscular training program)
Intervention type(s): Other
Intervention description(s): The SINEX program is a three months neuromuscular training program aiming to increase neuromuscular stability of the shoulder
Intervention model: Single Group Assignment
Intervention model description: Feasibility study. One group before and after design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: shoulder instability; feasibility studies; neuromuscular exercise
LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Condition: Heavy Menstrual Bleeding; Uterine Fibroid
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a
      day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared
      with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
    

Detailed description: 
      This study is an international phase 3 randomized, double-blind, placebo-controlled efficacy
      and safety study to evaluate 24 weeks of oral daily relugolix 40 mg co-administered with
      low-dose E2 and NETA (Group A) and 12 weeks of daily oral relugolix 40 mg alone followed by
      12 weeks of daily oral relugolix 40 mg co-administered with low-dose E2 and NETA (Group B)
      compared with 24 weeks of placebo (Group C).

      All participants completing the Week 24 visit, including participants randomized to placebo,
      were offered the opportunity to enroll in an open-label extension study in which all eligible
      participants will receive relugolix co-administered with low-dose E2 and NETA. Participants
      who did not enroll into the extension study had a follow-up visit approximately 30 days after
      the end of treatment (that is, after the participant's last dose of study medication).

      Safety will be assessed throughout the study by monitoring adverse events, vital signs,
      physical examinations, clinical laboratory tests, 12-lead electrocardiograms, and assessments
      of bone mineral density.
    

Intervention name(s): Relugolix; Estradiol/norethindrone acetate; Relugolix placebo; Estradiol/norethindrone acetate placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Relugolix (40 mg) tablet administered orally once daily.; E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.; Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.; E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the capsule containing E2/NETA in size, shape, color, and odor.
Other intervention name(s): TAK-385; MVT-601; E2/NETA; low-dose hormonal add-back; E2/NETA placebo
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate; Relugolix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Uterine Fibroid; Heavy Menstrual Bleeding; Menstrual Blood Volume
SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation
Condition: SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is the first-in-human phase 1/2a trial of the inhaled administration of the
      SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and
      SARS-CoV-2-infected individuals. It will evaluate the safety, pharmacokinetic profile,
      immunogenicity, and antiviral activity of DZIF-10c.
    

Detailed description: 
      The phase 1 component of this trial consists of a single-inhalation open-label
      dose-escalation phase (Groups 1A-1C and Groups 2A-2C). Subsequently, the highest tolerated
      dose tested will be administered to an expansion cohort of SARS-CoV-2-infected individuals
      (Group 2D). In this randomized and blinded group, participants will receive DZIF-10c or
      placebo both by inhalation and intravenous infusion.
    

Intervention name(s): DZIF-10c; DZIF-10c; Placebo; Placebo
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): Inhaled administration of the human monoclonal antibody DZIF-10c; Intravenous administration of the human monoclonal antibody DZIF-10c; Inhalation of DZIF-10c diluent as placebo; Intravenous infusion of sterile normal saline (NaCl 0.9%) as placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study consists of an open-label dose escalation phase in both healthy volunteers (Groups 1A-1C) and SARS-CoV-2-infected participants (Groups 2A-2C).
After completion of the dose escalation phase, SARS-CoV-2-infected individuals will be enrolled into a randomized placebo-controlled expansion cohort (Group 2D).
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: SARS-CoV-2; Covid-19; Monoclonal Antibody; Inhalation
The Effects of the Water Drinking Test on Intraocular Pressure
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      This clinical trial is designed to investigate the efficacy profile of the SENSIMED
      Triggerfish® during 24-hour IOP monitoring in patients with glaucoma or ocular hypertension,
      done three times at monthly intervals under different therapeutic regimen. This trial will
      also evaluate the efficacy of SENSIMED Triggerfish® to detect changes in intraocular pressure
      (IOP) after the water drinking test (WDT) will be investigated.
    

Detailed description: 
      The investigation will recruit male and female patients 18-80 years old and diagnosed with
      glaucoma or ocular hypertension requiring hypotensive ocular treatment. Up to 100 subjects
      will be enrolled in the study to ensure a minimum of 80 completing three IOP fluctuation
      monitoring sessions. Patients will be considered enrolled in the study upon signature of
      informed consent. A screening visit and three 26-hour IOP fluctuation monitoring sessions are
      planned for each patient. IOP monitoring sessions will be carried out in ambulatory mode at 4
      week intervals (plus/minus 7 days). All subjects will be monitored during the same period of
      the day (± 1hr). The expected duration of participation for each patient is of 3.5 days over
      three to four months. Patients will be recruited over a 16-month period. The total expected
      study duration is 16 months.
    

Intervention name(s): SENSIMED Triggerfish
Intervention type(s): Device
Intervention description(s): Comparison of fluctuation of Intraocular pressures with different class of drugs
Other intervention name(s): bimatoprost (Lumigan); brinzolamide (azopt)
Intervention MeSH terms: Bimatoprost; Brinzolamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic