bioihbjkbjnl/mcl2 huggingface dataset:
Omega 3 Fatty Acids in Patients With Chronic Renal Disease
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      To study the tolerance and efficacy of an omega 3 fatty acids supplement on renal and
      vascular function and inflammatory parameters in patients with chronic renal disease
    

Detailed description: 
      In a double blind trial in patients with chronic renal disease, the effects of a 3.7 g
      supplement of docosahexanoic and eicosapentanoic acids or a supplement of a similar dose of
      corn oil during 12 weeks, will be assessed on the following parameters:

        1. Urine albumin excretion

        2. Renal function measured with serum creatinine, cystatin C and beta-2 microglobulin

        3. Carotid intima media thickness and pulse wave velocity

        4. Inflammation status assessed measuring serum levels of C reactive protein and
           interleukin 6

        5. Metabolic control of diabetes

        6. Serum lipid levels
    

Intervention name(s): Omega 3 fatty acids; Corn oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids; Corn oil will be the placebo comparator for omega 3 fatty acids supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly selected to receive 3.7 g of a supplement containing docosahexanoic and eicosapentanoic acids or a supplement containing corn oil. The supplements will be provided for 12 weeks
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Albuminuria; Carotid Intima-Media Thickness; Pulse Wave Velocity; Inflammation
Fatigue Test With an XCo
Condition: Fatigue
MeSH terms: Fatigue
Study type: Observational

Summary: 
      The reliability of the Xco endurance test will be assessed in sedentary adults and in
      overhead athletes. The experimentation will be divided into two sessions. During the
      sessions, the impact of the test on rotators strength and throwing performance will be
      explored.
    

Detailed description: 
      At first, the reliability of the Xco endurance test will be assessed in sedentary adults.
      Then, the reliability of the test will be assessed in overhead athletes. The experimentation
      will include two sessions. During those sessions, the impact of fatigue (induced by the test)
      on rotator cuff muscles strength and on functional test performance (Single Arm Medicine Ball
      Throw) will be assessed. A time of 7 to 10 days will be provided between the two sessions.

      To perform the XCo endurance test, the participant will be seated on a chair, arm at 90° of
      abduction (in frontal plane), elbow flexed at 90 degrees and positioned on a wooden support.
      From a 90 degrees of abduction and a neutral position of rotation, the participants will be
      asked to realise an external rotation movement of 90 degrees and then to go back to the
      starting position as many times as possible at a speed of 140 bpm. Mechanical stops (the wall
      and an adjustable height table) will be added to make sure that the participants respected
      the entire range of motion. After adjusting the position, it will be asked to the
      participants to perform 2 repetitions of 5 movements at 140 bpm (in eccentric and concentric)
      to get familiar to the rhythm. Thirty seconds of rest will be provided between the 2
      repetitions to avoid the appearance of fatigue before the test.

      Then, the participants will begin the test. The objective of the test will be to perform the
      movement as long as possible. The test will be stopped if the volunteers is not able to
      maintain the rhythm or to do the movement anymore. The Modified Borg Scale will be used to be
      sure that each subject was really exhausted when the test was stopped. For that purpose, each
      of them will have to quantify their level of exhaustion on the scale (maximum score = 10)
      every 30 seconds.
    

Intervention name(s): Performing Xco endurance test
Intervention type(s): Other
Intervention description(s): The subjects will perform the test two times, with 7-10 days between the two sessions
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population will be divided into two groups : sedentary adults and overhead athletes
Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome
Condition: Amplified Musculoskeletal Pain Syndrome; Reflex Sympathetic Dystrophy; Complex Regional Pain Syndromes
MeSH terms: Musculoskeletal Pain; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Chronic Pain; Somatoform Disorders
Study type: Interventional

Summary: 
      A pilot randomized controlled trial to assess feasibility, acceptability and generate outcome
      domains for a future RCT testing the efficacy of immersive virtual reality on pain intensity
      in pediatric amplified musculoskeletal pain syndrome.
    

Detailed description: 
      Adolescents with amplified musculoskeletal pain syndrome (AMPS) are invited to take part in
      this research project that studies two different audio-visual relaxation technologies in
      reducing amplified musculoskeletal pain. In addition, the investigators are interested in
      studying if they have an effect on some of the ways adolescents think about their pain and
      cope with it. Both of these technologies provide the user with a similar natural environment
      designed to have a calming effect, along with guided relaxation and soothing music. The
      adolescents will be assigned to use one of these for a total duration of about 10 minutes.
      Pain related outcomes including pain intensity, pain catastrophizing and self-efficacy to
      manage pain will be collected before and after the relaxation session.
    

Intervention name(s): Oculus GO VR HMD, application Happy Place (© Mimerse); iPad, application Happy Place (© Mimerse)
Intervention type(s): Device; Device
Intervention description(s): The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).; The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators propose a parallel-group pilot randomized controlled trial with a stratified block randomization and an equal allocation ratio of 1:1. The participants will be randomly allocated to Group A (VR/intervention group) or Group B (iPad/control group). The relaxation session will last for 10 minutes in each group using the same application Happy Place (© Mimerse) played on VR headsets (Oculus GO) versus iPad (Apple Inc. Cupertino CA). The randomization will be stratified on the basis of pain score on the day of intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Cardiorespiratory Fitness Using Electrically Assisted Bicycles
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study aimed to examine cycling time and distance when inactive subjects were provided
      with electrically assisted bicycles, and secondly, to examine changes in cardiorespiratory
      fitness.
    

Detailed description: 
      Method: Inactive employees in a selection of public and private corporations in three
      Norwegian cities were invited to participate. Inclusion criteria were: a desire to cycle to
      work, residence more than 3km from the workplace, and not physically active according to
      guidelines. There were 25 participants in the study and we provided them all with
      electrically assisted bicycles fitted with GPS bike computers to record usage. The
      participants were followed for three to eight months, 226 days on average. Measures of
      maximal oxygen uptake were performed before and after the intervention. Demographic
      characteristics and prior transportation habits were reported in a questionnaire at baseline.
    

Intervention name(s): Commuting with electrically assisted bicycles
Intervention type(s): Behavioral
Intervention description(s): 25 participants were provided with electrically assisted bicycles fitted with GPS bike computers to record usage
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Inactive employees in a selection of public and private corporations in three Norwegian cities were invited to participate. Inclusion criteria were: a desire to cycle to work, residence more than 3km from the workplace, and not physically active according to guidelines. There were 25 participants in the study and we provided them all with electrically assisted bicycles fitted with GPS bike computers to record usage. The participants were followed for three to eight months, 226 days on average
Masking: None (Open Label)
Primary purpose: Prevention
A Weight Loss RCT Comparing Keyto vs Weight Watchers
Condition: Overweight and Obesity; Ketogenic Diet
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      Very low-carbohydrate ketogenic diet may have beneficial metabolic and weight loss effects,
      however, adhering to this diet may be challenging. Keyto is a self-monitoring and
      app-enhanced intervention to help individuals learn about and monitor their breath acetone (a
      measure of ketosis) levels to promote dietary change and weight loss. The purpose of this
      research is to test the Keyto self-monitoring + app intervention against a "standard of care"
      weight loss dietary app (Weight Watchers). 144 participants will be recruited through
      Facebook ads, provide online consent, and will be randomized to one of the two conditions.
      Weight loss after 12 weeks will be assessed as the primary outcome, with weight loss at 24
      and 48 weeks being secondary outcomes. Blood samples will be collected at baseline and 12
      weeks with optional blood samples at 48 weeks follow up.
    


Intervention name(s): Keyto device + app; Weight Watchers app
Intervention type(s): Device; Other
Intervention description(s): Keyto is a self-monitoring and app-enhanced intervention to help individuals learn about and monitor their breath acetone (a measure of ketosis) levels to promote a very low carbohydrate diet and weight loss.; The Weight Watchers app helps people to monitor their food intake, track points and provides recipe ideas to support weight loss.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diet; weight loss; ketogenic diet; low carbohydrate
A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to evaluate the efficacy and safety of DBPR108 tablets in combination with
      metformin hydrochloride in the treatment of type 2 diabetes mellitus. A total of 210 subjects
      will be randomly assigned in a ratio of 2:1 to receive metformin hydrochloride plus DBPR108
      or metformin hydrochloride plus placebo.
    


Intervention name(s): DBPR108; metformin hydrochloride; placepo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DBPR108: 100 mg, once daily for 24 weeks.; metformin hydrochloride: 500 mg, 1-3 times daily for 24 weeks.; placebo:100 mg, once daily for 24 weeks.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DBPR108; Dipeptidyl peptidase-4 (DPP4) inhibitors; metformin hydrochloride
Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare and evaluate the single-dose oral bioavailability and
      to monitor the safety of subjects.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-way crossover oral
      bioequivalence' study of Atorvastatin Calcium 80 mg Tablets of Dr. Reddy's and Lipitor 80 mg
      Tablets of Pfizer Ireland Pharmaceuticals in healthy adult, human subjects under fed
      conditions.
    

Intervention name(s): Atorvastatin Calcium Tablets, 80 mg
Intervention type(s): Drug
Intervention description(s): Atorvastatin Calcium Tablets, 80 of Dr. Reddy's Laboratories Limited
Other intervention name(s): Lipitor 80 mg Tablets
Intervention MeSH terms: Atorvastatin; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Atorvastatin calcium; crossover
Bioavailability Study of MLDL1278A After Subcutaneous and Intravenous Administration in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study in healthy volunteers designed to investigate the PK following intravenous
      and subcutaneous administration of MLDL1278A (also known as BI-204). The bioavalialbility of
      MLDL1278A after subcutaneous administration will be determined.
    


Intervention name(s): MLDL1278A; MLDL1278A
Intervention type(s): Drug; Drug
Intervention description(s): Single intravenous dose of 360 mg MLDL1278A followed by a single subcutaneous dose of 360 mg MLDL1278A.; Single subcutaneous dose of 360 mg MLDL1278A.
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Minimal Invasive Surgery for Gastric Subepithelial Tumor
Condition: Gastric Subepithelial Tumor
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      The investigators conducted a retrospective study of those patients with gastric SETs
      receiving ER or LR at the operative theater in the single institution from January 2013 to
      December 2021. Medical records were retrospectively reviewed to define patient/tumor
      characteristics and operative outcomes.
    


Intervention name(s): Endoscopic resection
Intervention type(s): Procedure
Intervention description(s): Complete resection of gastric SETs was recommended if the tumor size was >2 cm, presence of malignant features, or if the patient was symptomatic, declined periodical surveillance, and preferred to undergo diagnostic and therapeutic resection.
Other intervention name(s): Laparoscopic resection
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients with gastric SETs who underwent ER or LR at the operative theater in our
        institution
      
Keywords: gastric subepithelial tumors; endoscopic resection; laparoscopic resection
Using Stable Isotopes to Assess the Effectiveness of Vitamin A Supplementation in Cameroon
Condition: Vitamin A Deficiency
MeSH terms: Night Blindness; Vitamin A Deficiency
Study type: Interventional

Summary: 
      This is a study to evaluate the effects of vitamin A supplementation program on the vitamin A
      status of preschool children. All children aged 3-5 years who do not have severe illness and
      are not planning to move from the study area are eligible. Children whose caregivers agree to
      sign the consent form will be enrolled in their community and submitted to a longitudinal
      evaluation of vitamin A status before and after vitamin A supplementation campaign.

      Vitamin A status will be assessed by measuring serum retinol, retinol binding protein and
      vitamin A total body pool size using stable isotope dilution methodology.
    

Detailed description: 
      Five months after the last supplementation (day 0), an oral dose (2 mg retinol equivalents)
      of label vitamin A ([2H8]-retinyl acetate) in oil will be administered to 80 eligible
      children together with a low vitamin A high-fat snack. Fasting venous blood samples (about 7
      ml) will be collected into evacuated foil-wrapped blood collection tubes specifically
      designed for the collection of serum (containing no anticoagulant and metal free) on the
      mornings of days 0 before the administration of the dose and on day 14 for quantitative
      estimation of initial vitamin A pool size and determination of potential confounding
      parameters (CRP, AGP, iron, zinc, malaria, carotenoids and retinoids). About six months after
      the last supplementation (day 30), each child will received the vitamin A supplement. After
      30 days and 90 days, two groups of 40 children (Grp1, Grp2) will respectively received a
      second dose of labeled vitamin A ([2H4]-retinyl acetate); fasting venous blood samples will
      be obtained before the administration of the dose and 14 days after dosing for quantitative
      estimation of final vitamin A pool size and determination of potential confounding
      parameters.
    

Intervention name(s): vitamin A supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): Each child received one capsule of 200,000 IU of vitamin A
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: n subjects received the treatment and then randomly divided in two groups for outcome evaluation after one and three months respectively
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Depression and Bipolar Disorder
Condition: Mood Disorders
MeSH terms: Depression; Bipolar Disorder; Mood Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Depression and bipolar disorder (mania and depression) may be related to problems with nerve
      cells not being regenerated as fast as normal and are accompanied by cognitive difficulties
      including memory, attention and planning problems. There is thus a need for better, more
      efficient treatments with effects on cognitive function. Erythropoietin (Epo) is involved in
      brain repair and may be a candidate for future treatment strategies. The investigators have
      demonstrated that a single dose of Epo improves mood and reduces the processing of negative
      emotional information in healthy volunteers similar to effects seen with antidepressants.
      With the current study the investigators aim to build upon this discovery by investigating
      whether repeated Epo administration has antidepressant effects and is able to reverse
      cognitive difficulties in patients with depression or bipolar disorder. It is hypothesized
      that Epo will improve mood in treatment-resistant depression and improve cognitive function
      in this group and in patients with bipolar disorder in remission. If the study reveals
      beneficial effects of Epo, this would highlight Epo as a candidate compound for future
      treatment of depression and bipolar disorder, with the potential to directly promote brain
      repair mechanisms.
    


Intervention name(s): Erythropoietin
Intervention type(s): Drug
Intervention description(s): 40.000 IU/ml epoetin alfa is administered as intravenous infusions over 15 min weekly for 8 weeks.
Other intervention name(s): Eprex; Epo
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erythropoietin; Epo; depression; bipolar disorder; cognition; cognitive function; antidepressant
Use of Copeptin Measurement After Arginine Infusion for the Differential Diagnosis of Diabetes Insipidus - the CARGOx Study
Condition: Diabetes Insipidus; Polydipsia, Primary
MeSH terms: Diabetes Insipidus; Diabetes Mellitus; Polydipsia; Polydipsia, Psychogenic
Study type: Interventional

Summary: 
      The differential diagnosis of central diabetes insipidus (cDI) is difficult and the current
      test with the highest diagnostic accuracy is copeptin measurement after hypertonic saline
      infusion (HIS). Although the HIS improved diagnostic accuracy compared to the standard water
      deprivation test used for decades before, it still comprises great discomfort for patients
      due to the rise in serum sodium levels above 149mmol/l and requires the presence of medical
      staff at all times to guarantee safety of the test.

      The arginine stimulation test is routinely used to stimulate growth hormone. Own data in 52
      patients with polyuria / polydipsia syndrome showed that arginine infusion is a potent
      stimulator of the neurohypophysis and provides a new diagnostic tool in the differential
      diagnosis of cDI. Copeptin measurements upon arginine stimulation (CAS) discriminated
      patients with diabetes insipidus vs. patients with primary polydipsia with a high diagnostic
      accuracy of 94%.

      To validate these results and to compare them against the HIS a large multicenter trial is
      needed, where the diagnostic accuracy of the CAS is compared to the HIS.
    


Intervention name(s): Arginine infusion; Hypertonic saline infusion
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Intravenous Infusion of Arginine is given, copeptin measurement will be collected before and 60minutes after start of infusion; Intravenous Infusion of hypertonic Saline is given, copeptin measurement will be collected before and once Plasma sodium rises above 149mmol/l
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Observational randomized cross-over diagnostic international multicenter study
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Copeptin