bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Chlorella Supplementation on Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Diabetes is a chronic disease and the prevalence of diabetes mellitus is rapidly increasing
      as a result of population ageing, urbanization and associated lifestyle changes. Recently,
      the use of natural products in chronic diseases such as diabetes has gained more attention.
      Chlorella is a single-celled green algae that contains essential nutrients including amino
      acids and fatty acids as well as some vitamins and minerals. There have been some studies on
      the effects of chlorella supplementation in chronic diseases such as NAFLD, prediabetes and
      diabetic mice, but none of them examined the effects of chlorella in patients with type 2
      diabetes. Thus the present study designed to evaluate the effects of chlorella
      supplementation on glycemic control, lipid profile and anthropometric measurements in type 2
      diabetic patients.
    

Detailed description: 
      This study is a double-blind, randomized controlled trial. 84 patients with type 2 diabetes
      are recruited. After informing the patients about this study and filling the consent letters,
      they are randomly assigned into intervention group (n=42) or placebo group (n=42) receiving
      1500 mg chlorella Vulgaris or placebo daily for 8 weeks. Patients are asked not to change
      their regular physical activity, diet, medicine and dosage during the study. Anthropometric
      and blood pressure measurements are collected and 24-hour food intake recall, IPAQ physical
      activity, Pittsburgh Sleep Quality Assessment (PSQI) and Beck anxiety and depression
      questionnaires are filled by each patients at the beginning and end of the study. In
      addition, blood samples are collected at the beginning and end of the study to determine the
      changes of FBS, HbA1c, insulin concentration and insulin resistance (HOMA-IR) and lipid
      profile.
    

Intervention name(s): Chlorella Vulgaris; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Chlorella capsules 1500 mg/day; Starch 1500 mg
Other intervention name(s): Algomed
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly allocated into two groups; Chlorella and placebo groups.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Telephone Support for Dementia Caregivers
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      Caring for a patient with dementia is associated with increased feelings of burden and
      depression. The proposed study will examine the efficacy of Family Intervention: Telephone
      Tracking - Dementia (FITT-Dementia), a multi-component, family-based, telephone intervention,
      as a tool to reduce caregiver stress.
    

Detailed description: 
      A previous pilot study of this approach showed reduced burden and reaction to memory and
      behavior problems for dementia caregivers. This study will test the intervention in a larger
      group of caregivers and have a more detailed analysis of outcomes.

      The caregiver of a person with dementia will receive telephone support calls. They will
      receive telephone calls from a trained member of the research team. These calls will occur
      over a six-month period and will be scheduled at a time that is convenient for the caregiver.
      They will receive a total of 16 calls over 6 months. During each call, the support person
      will discuss their current caregiving situation and provide various forms of support.
    

Intervention name(s): Family Intervention:Telephone Tracking Support- Caregiver; Telephone Support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Family-based problem solving treatment; Supportive telephone counseling about caregiving
Other intervention name(s): FITT-C
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Dementia; Caregivers; Alzheimer's disease
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      Primary objective of the present study was to compare the single dose bioequivalence of
      Torrent's Quetiapine Fumarate Tablets 1 × 25 mg. Dosing periods of the study were separated
      by a washout period of 7 days.

      Study Design:

      Open label, Randomized, Two-Way, Crossover, Single-Dose Bioequivalence Study
    


Intervention name(s): Torrent's Quetiapine Fumarate Tablets
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Chiropractic Care, Medication, and Self-Care for Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the effectiveness of chiropractic care, medications, and self-care on
      neck pain, a very common condition. The broad, long-term objective of this study is to
      identify effective therapies for neck pain sufferers and to increase understanding of neck
      pain conditions.
    

Detailed description: 
      Neck pain is very common, with considerable socioeconomic consequences. Although some
      therapies appear promising, there are too few randomized clinical trials of sufficient
      quality to support the use of one therapy over another. This is especially true for
      acute/subacute neck pain. Although commonly treated with prescription medications, neck pain
      sufferers are increasingly seeking relief through complementary and alternative medicine
      therapies, such as chiropractic spinal manipulation. Little is known, however about the
      short- and long-term relative efficacy of these therapies and how they compare to giving
      patients simple advice on self-care.

      The broad, long-term objective of this research is to identify effective therapies for neck
      pain sufferers and to increase our understanding of neck pain conditions. This randomized,
      observer-blinded clinical trial is a unique collaborative effort by experienced chiropractic
      and medical researchers and will focus on patients with acute/subacute neck pain (<12 weeks
      duration). The study will determine the relative efficacy of chiropractic spinal
      manipulation, prescription medication, and self-care advice for neck pain in both the short
      term (after 6 weeks) and long term (after 52 weeks), using patient-rated neck pain as the
      main indicator of success.
    

Intervention name(s): Chiropractic spinal manipulation; Acetaminophen; Self-care; Non-Steroidal anti-inflammatory drugs (NSAIDS); Tylenol with codeine
Intervention type(s): Procedure; Drug; Behavioral; Drug; Drug
Intervention MeSH terms: Acetaminophen; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Codeine
Primary purpose: Treatment
Assessing the Feasibility of a Prevention m-Health App Intervention for Informal Caregivers of Outpatients
Condition: Telemedicine; Caregivers; Pressure Ulcer
MeSH terms: Pressure Ulcer; Ulcer
Study type: Interventional

Summary: 
      The present quasi-experimental study aims to compare the level of preventive behaviours
      amongst caregivers who will be instructed to operating one mHealth App or given a relevant
      instruction manual. To achieve this, a comparison between the behavior of caregivers before
      and after the intervention and a comparison between the two groups (intervention group with
      the control group) will be performed. Specifically, data within the two groups will be
      collected via an online questionnaire consisting of three parts: prior to the intervention
      (baseline), two (2) and four (4) months after the intervention. The self-administered
      questionnaire consists of fifty-two (52) questions and uses three valid and reliable scales
      with a part that was developed via a bibliography research and consultations from experienced
      specialists. The questionnaire scales have been translated from the English language to
      Greek.
    


Intervention name(s): mHealth App
Intervention type(s): Device
Intervention description(s): In short, mHA contains three main functions for the user: a) a reminder for switching the patient position, b) training for preventive care habits and c) the possibility for patient evaluation in order to determine the need for the use of support surfaces.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pressure Ulcer Prevention, mHealth, quasi-experimental
A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
Condition: Progressive Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the safety and tolerability of GZ402668 after a single subcutaneous (SC) dose in
      men and women with progressive multiple sclerosis.

      Secondary Objectives:

      To assess in men and women with progressive multiple sclerosis:

        -  The pharmacokinetic (PK) parameters of GZ402668 after a single SC dose.

        -  The pharmacodynamic (PD) response to GZ402668 after a single SC dose.
    

Detailed description: 
      The total study duration from screening for a patient can be approximately up to 8 weeks.
      Upon completion of this trial, patients treated with GZ402668 will be required to enroll in a
      4 year safety follow-up study for continued safety observation.
    

Intervention name(s): GZ402668; Placebo; Acyclovir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: tablet
Route of administration: oral
Intervention MeSH terms: Acyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic Amyloidosis
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Amyloidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study in patients needing treatment for AL amyloidosis is to see how well
      treatment with IV melphalan works and then, if some clonal plasma cells are still present
      about 2 to 3 months after melphalan treatment, to see how well treatment with bortezomib and
      dexamethasone works to reduce the rest of the clonal plasma cell disease.
    


Intervention name(s): bortezomib; dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Given IV; Given orally
Intervention MeSH terms: Dexamethasone; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary systemic amyloidosis
Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature
Condition: Idiopathic Short Stature (ISS)
MeSH terms: Dwarfism
Study type: Interventional
Phase: Phase 3

Summary: 
      The present randomized trial was initially intended to study the benefits of a combined
      treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for
      pubertal children with idiopathic short stature. However, treatments were stopped in January
      2012 at the request of the French drug agency. Therefore, a protocol amendment divided the
      study in two study periods.

      Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with
      somatropin alone. Participants from France who participated in this Period 1 of the study
      were asked to participate in a long term safety follow up defined as a Period 2 of the study.
      Participants from the Netherlands were offered participation in Genetics and
      Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov
      Identifier: NCT01088412) for long term safety follow up independent of this study.
    


Intervention name(s): somatropin; leuprorelin
Intervention type(s): Drug; Drug
Intervention description(s): 0.05 mg/kg/day; 11.25 mg/3 months
Other intervention name(s): LY137998; Humatrope
Intervention MeSH terms: Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Single Dose Intranasal Insulin On Cognitive Function
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to find out how a small dose of insulin might affect memory, the
      ability to concentrate, and improve your daily functioning in patients with schizophrenia and
      schizoaffective disorders. Insulin is not being used to treat diabetes in this study. The
      investigators propose a single dose, double-blinded, placebo-controlled trial of intranasal
      insulin in 40 subjects with schizophrenia or schizoaffective disorder to examine insulin's
      effect on cognition. The specific aims include:

        1. Examine the effects of single doses of 40 IU intranasal insulin compared to placebo on
           cognitive functioning, including attention and memory.

        2. Examine whether single dose of intranasal insulin administration will raise serum
           insulin level and decrease plasma glucose level

      Insulin will be delivered through an air spray pump into your nose. The investigators will be
      comparing one dose of insulin (40 International Units) with placebo, an inactive liquid.
    

Detailed description: 
      Insulin signaling in the brain is associated with improved cognitive function in both animal
      and human studies. Intranasal administration of insulin, which is non-invasive and minimizes
      the risk of hypoglycemia, may represent a new intervention approach with the potential to
      improve cognition and real life functioning in this patient with schizophrenia.
    

Intervention name(s): Placebo; Insulin (Humulin)
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; 40 IU Intranasal Insulin will be administered once
Other intervention name(s): Humulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Memory; Concentration; Insulin
Effect of the Nasal Gel "Nascum®-Plus" on Allergic Symptoms
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      The aim of this study is to assess if a physical barrier, created by the nasal gel Nascum®-
      Plus, is able to prevent or minimize the induction of nasal symptoms during allergen
      challenge in the Fraunhofer Allergen Challenge Chamber (ACC). Furthermore, the effect on
      soluble and cellular inflammatory markers induced by the allergic reaction will be assessed.
      Nascum®-Plus contains no active pharmaceutical ingredient, only monographed pharmaceutical
      excipients.
    


Intervention name(s): Nascum Plus; ACC
Intervention type(s): Drug; Other
Intervention description(s): nasal application of nascum plus; 4 hours challenge to grass pollen in the allergen challenge chamber (ACC)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Virtual Reality on Balance and Gait Speed With Alzheimer's Dementia
Condition: Alzheimer's Dementia
MeSH terms: Dementia; Alzheimer Disease
Study type: Interventional

Summary: 
      The aim of study is to investigate the effect of virtual reality application on balance and
      gait speed in individuals with Alzheimer's Dementia.
    

Detailed description: 
      The aim of study is to investigate the effect of virtual reality application on balance and
      gait speed in individuals with Alzheimer's Dementia. The study consisted of 32 subjects,
      which were diagnosed as mild or moderate AD by the neurologist. The balance, fall risks and
      gait speed were assessed. Training group was trained with games selected from different
      categories such as balance and aerobic exercises with Nintendo Wii virtual reality device for
      6 weeks, 1 session 30 min, 2 times a week.
    

Intervention name(s): Exercises with Nintendo Wii virtual reality device
Intervention type(s): Other
Intervention description(s): In the first session, each Nintendo Wii components were introduced to each individual. The selected games and how they were played were taught to each individual by the physiotherapist and practically taught. The games were played with the help of physiotherapists in the first session so that individuals could transfer the correct weight on the Nintendo Wii balance board and to use the game console's control. The patient was supported with verbal and physical feedback when the patient played incorrectly during the games in the next sessions. Games that require serious balance and coordination were considered as a difficult activity for the patient and were not used in this study. The difficulty of the games was set to the simplest level for each patient. As the patients were successful the games' difficulty level was upgraded. The difficulty of the games has been increased according to the classification determined by the Nintendo Wii device.
Other intervention name(s): Virtual reality game
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study consisted of 32 subjects, which were diagnosed as mild or moderate AD by the neurologist. The balance, fall risks and gait speed were assessed. Training group was trained with games selected from different categories such as balance and aerobic exercises with Nintendo Wii virtual reality device for 6 weeks, 1 session 30 min, 2 times a week.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's Dementia; Balance; Gait Speed; Virtual Reality
Dose-Ranging Study for Prolonged Postoperative Analgesia in Subject Undergoing Total Knee Arthroplasty
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee
      arthroplasty
    

Detailed description: 
      This is a phase 2, multicenter, parallel-group, active-control, randomized, double-blind,
      dose-ranging study conducted to evaluate three dose levels of SKY0402 compared with 150 mg of
      bupivacaine HCl.
    

Intervention name(s): Bupivacaine HCl; SKY0402
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg Bupivacaine HCl; 600 mg SKY0402 (study drug)
Other intervention name(s): Bupivacaine HCl (Marcaine 0.25% with epinephrine 1:200,000); EXPAREL
Intervention MeSH terms: Epinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pain; postoperative; total knee arthroplasty; analgesia
Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The study objective is to explore the efficacy, safety and tolerability of STX209 for
      treatment of irritability in subjects with FSX. We hypothesize that STX209 will improve
      irritability and other typical problem behaviors associated with fragile X syndrome. We also
      hypothesize that STX209 will be safe and well tolerated.
    


Intervention name(s): STX209; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Variable dose from 1 mg bid to 10 mg tid, Capsule, Oral, 4 weeks; variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks
Other intervention name(s): arbaclofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fragile X syndrome; irritability; behavior problems
Reducing Children's Distress Towards Flu Vaccinations
Condition: Children's Distress During Flu Vaccination
Study type: Observational

Summary: 
      Millions of children in North America receive an annual flu vaccination, many of whom are at
      risk of experiencing severe distress. Children frequently use technologically advanced
      devices such as computers and cell phones. Based on this familiarity, the investigators
      introduced another sophisticated device - a humanoid robot to- interact with children during
      their vaccination. The investigators hypothesized that these children would experience less
      distress than children who did not have this interaction.
    

Detailed description: 
      57 children (30 male; age, mean + SD: 6.87 + 1.34 years) were randomly assigned to a
      vaccination session with a nurse who used standard administration procedures, or with a robot
      who was programmed to use cognitive-behavioral strategies with them while a nurse
      administered the vaccination. Measures of distress were completed by children, parents,
      nurses, and researchers.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children in the general public and from hospital ages 5-9 years
      
Keywords: Pain management; vaccination; immunization; pediatric; robotics; human-robot interaction
Growth Hormone Treatment in Infants Aged 1 to 2 Years With Chronic Renal Insufficiency (CRI) and Growth Retardation.
Condition: Chronic Kidney Disease; Chronic Renal Insufficiency
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Europe. Objective(s): To evaluate the effect of human growth
      hormone on infants aged 1 to 2 years with chronic renal insufficiency (CRI) and growth
      retardation despite an adequate dietary intake.

      Trial Design: This is an open, parallel group clinical trial with a duration of one year, in
      which period 50% of patients will receive GH treatment and the other 50% will act as a
      control group, without treatment.

      Trial Population: The trial will involve a total of 16 infants aged from 12±3 to 24 months
      suffering chronic renal insufficiency (Glomerular Filtration Rate less than 60 ml/min/1.73
      m2), and growth failure and undergoing conservative treatment or peritoneal dialysis. Include
      the key inclusion and exclusion criteria.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment