bioihbjkbjnl/mcl2 huggingface dataset:
INVSENSOR00027 Fall Detection Clinical Performance Study
Condition: Healthy
Study type: Interventional

Summary: 
      This study assesses INVSENSOR00027's clinical performance for fall detection.
    


Intervention name(s): INVSENSOR00027
Intervention type(s): Device
Intervention description(s): Investigational, noninvasive sensor that will be placed on the subject's chest. INVSENSOR00027 detects falls for each subject.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Specificity Trial of the Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional

Summary: 
      The aim of this study is to test the recombinant tuberculosis skin test in the previously BCG
      vaccinated healthy adults with low risk of TB development, to determine the test specificity.
    

Detailed description: 
      Recombinant tuberculosis allergen (RTA) is a recombinant fusion protein CFP10-ESAT6 produced
      by the prokaryotic cell line. The test is widely used in Russian Federation and CIS countries
      for the latent TB diagnosis in adults and children over 8 years old. The current clinical
      study is a prospective, multicenter, open-label study in the cohort of healthy adults, not
      classified as at risk of tuberculosis, with no clinical symptoms of the disease, with a
      negative T-SPOT.TB test results, to evaluate the specificity of the RTA test in 72 hours
      following administration of the product at a dose of 0.2 μg/0.1 mL.
    

Intervention name(s): Recombinant tuberculosis allergen (RTA)
Intervention type(s): Diagnostic Test
Intervention description(s): Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm
Other intervention name(s): Diaskintest
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Tuberculosis; TB diagnosis; Tuberculosis skin test; CFP10; ESAT6
Hemangioma Growth During the First 6 Months of Life
Condition: Hemangiomas of Infancy
MeSH terms: Hemangioma
Study type: Observational

Summary: 
      One of the most important and unique characteristics of infantile hemangiomas is their
      dramatic growth during early infancy. Most hemangiomas are either absent at birth or barely
      evident as a small scratch or bruise-like area. A recent study emphasized how early
      hemangioma growth occurs. In this study by 3 months of age, hemangiomas had reached 80% of
      their final size, and by 5 months of age, 80% had already stopped growing. Unfortunately the
      average age when most infants are seen by specialists is often at 5 months of age or later, a
      time when most growth is already completed.

      Researchers at the University of California, San Francisco, the Medical College of Wisconsin,
      and at the Mayo Clinic are interested in studying hemangioma growth at even earlier ages,
      before 3 months of age, which is before most patients are ever seen by dermatologists or
      other specialists. For this study are requesting that parents of children older than 3 months
      of age with hemangiomas send us a series of photographs of their child which demonstrates
      this early growth. Ideally the photographs would show your child (including the area of the
      hemangioma of course) at weekly or every other week intervals up until age least 3 to 6
      months of age. This will probably not be difficult if the hemangioma is on the face but we
      would be interested in other body locations as well, if available.

      We are using these photographs to analyze early hemangioma growth patterns, to see if there
      is a period of especially rapid growth, and to help determine if there is a specific time
      before which specialty referral should occur. We are interested in all sizes of hemangiomas,
      from small to large. Of greatest importance is that the photos be at frequent intervals
      (every 1 to 2 weeks is ideal) and of sufficient quality to be able to evaluate the appearance
      of the hemangioma.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): We are only asking for photographs from parents.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients are being recruited from a national hemangioma support website (NOVA)and from
        community clinics atthe University of California, San Francisco. We hope to reach more
        interested parents through registering our protocol.
      
Keywords: Infantile hemangioma
Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
Condition: Diabetes, Hyperlipidemia, Mixed Dyslipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous
      evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from
      baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with
      hyperlipidemia or mixed dyslipidemia.
    


Intervention name(s): Evolocumab; Atorvastatin; Placebo
Intervention type(s): Biological; Drug; Other
Intervention description(s): Administered by subcutaneous injection; Administered orally once a day; Placebo to evolocumab administered by subcutaneous injection
Other intervention name(s): AMG 145; Repatha; Lipitor
Intervention MeSH terms: Atorvastatin; Evolocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Functional Dairy Products Enriched With Dietary Fibers on Human Health and Gut Microbiota
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this dietary intervention is to study the effects of dietary fibers on the gut
      microbiota and use yoghurt as the carrier.

      Hypothesis 1: Intake of dietary fibers improves the blood lipid profile of the participants.

      Hypothesis 2: Intake of dietary fibers stabilizes the gut microbiome (e.g., low diversity) of
      the participants, improves gut health and normalizes gastrointestinal function and bowel
      habits.
    

Detailed description: 
      The study design is a parallel randomized, prospective, pre-post intervention trial. The main
      goal of this study is to investigate the effect of the dietary fibers in an unsweetened
      yoghurt. Fermented dairy products have naturally a very low dietary fiber content, but such
      products can be supplemented with variety of dietary fibers and promote the growth of
      beneficial gut bacteria. Also, as fermented milk products contain live bacteria, it is
      possible that prebiotic fibers could support the growth of the starter-culture based strains
      in the human gut.

      PRE-STUDY EVALUATION AND TESTING

        1. Complete pre-study questionnaire

        2. Complete orientation to the study and provide voluntary consent to join the study

        3. Collection of coded intervention products, sampling supplies, and instructional
           materials 0-WEEK QUESTIONNAIRE AND LABORATORY VISIT

      1. Record food intake and gastrointestinal function for 3 days 2. Collect health data and
      provide a 3-day food frequency questionnaire 3. Provide a stool and blood sample at the
      laboratory 2-WEEK QUESTIONNAIRE AND LABORATORY VISIT

        1. Record food intake and gastrointestinal symptoms for 3 days

        2. Collect health data and provide a 3-day food frequency questionnaire

        3. Provide a stool and blood sample at the laboratory BLOOD SAMPLE ANALYSES

      1. Provide the blood sample at the laboratory in the morning in an overnight fasted state.

      DIETARY INTERVENTION

      1. Daily intake of a test or control product for two weeks.
    

Intervention name(s): Test product; Control product
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 200 g/day of unsweetened yogurt supplemented with a dietary fiber blend; 200 g/day of unsweetened yogurt
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: microbiome; bifidobacteria; fermented dairy product
Water-soluble Ubiquinol Supplementation on Blood Glucose, Lipids, Oxidative Stress, and Inflammation in Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Inflammation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Diabetes is considered an oxidative stress and a chronic inflammatory disease. Coenzyme Q10
      (ubiquinone) is recognized as a lipid soluble antioxidant. Ubiquinol is a reduced form of
      coenzyme Q10 in our body after food or supplements intakes. Studies have indicated that the
      water-soluble ubiquinol had better antioxidant activity and absorption than lipid-soluble.
      The purpose of this study was to investigate the effects of a water-soluble ubiquinol
      supplement (100 mg/d) on antioxidation and anti-inflammation in diabetes patients.
    

Detailed description: 
      The patients with type 2 diabetes will recruit as subjects (n = 50) and randomly assign to
      the placebo (n = 25) or coenzyme Q10 groups (n = 25). The intervention will administer for 12
      weeks. The concentrations of coenzyme Q10, oxidative stress marker (malondialdehyde),
      antioxidant enzymes activities (superoxide dismutase, catalase, and glutathione peroxidase),
      inflammatory markers [C-reactive protein (CRP), and interleukin-6 (IL-6)], and biochemical
      parameters (fasting glucose, A1C, insulin, C-peptide, and lipid profiles), and blood pressure
      will measure. Hopefully, the results of this study could provide the information of
      water-soluble ubiquinol supplement for clinical doctors and dietitians recommend that
      diabetes patients deserve to know whether the use of coenzyme Q10 supplement.
    

Intervention name(s): water-soluble ubiquinol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 100 mg/d; glycerin.soy-lecithin, and water
Other intervention name(s): water-soluble coenzyme Q10
Intervention MeSH terms: Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Antioxidation; Anti-inflammation; Blood glucose; Blood lipids
Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome
Condition: Sleep Apnea; Stroke; Cardiovascular Disease
MeSH terms: Apnea; Sleep Apnea Syndromes; Stroke; Cardiovascular Diseases
Study type: Interventional

Summary: 
      MAIN AIMS: to analyze the efficacy of nasal CPAP treatment in patients with ischemic
      first-ever stroke and Sleep Apnea Syndrome (SAS) in terms of: early neurological outcome,
      functional recovery, quality of life influence, stroke recurrence and survival.

      SECONDARY AIMS: to evaluate the feasibility of the treatment in this type of patients at
      short and long time.

      DESIGN: clinical randomized case-control study.

      PATIENTS: younger than 75 years with a First-Ever stroke with at least one of the following
      criteria: snoring, observed apnea, Hypertension or Ischemic Cardiopathy.

      MEASUREMENTS: protocol to define subtype stroke and parenchymatous and vascular location;
      sleep questionnaire (including Epworth Sleepiness Scale); Respiratory Polysomnography (RPSG).
      If RPSG shows an AHI > 20, with predominant obstructive events, patients will be randomized
      in a CONTROL GROUP (conventional treatment) and a TREATMENT GROUP (with Nasal CPAP). Follow
      up for both groups at 1, 3, 12 and 24 months will include: early neurological outcome, body
      mass index (BMI), blood pressure (BP), functional recovery (Barthel Index/Canadian Scale),
      quality of life (SF36), recurrences, vital status. Nasal CPAP titration will be performed by
      means of an automatic system (Autoset Portable ST). Compliance will be recorded. If a
      negative RPSG is obtained (AHI < 10) (NO SAS GROUP) or with AHI < 20 (mild SAS) the usual
      treatment and the same follow up protocol will be established.

      STATISTICS: the sample size is initially calculated in 10 patients for each group,
      considering this is part of a multicenter study including 8 centers. If no differences are
      found, depending on the statistical power the investigators will consider including more
      patients. The different groups will be compared for the analyzed variables with the
      corresponding tests.
    


Intervention name(s): Nasal CPAP (Continuous Positive Airway Pressure)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lidocaine Spray Plus Oral Celecoxib for Pain Control During Hysterosalpingography
Condition: IUCD Complication
Study type: Interventional

Summary: 
      our aims to investigate the effectiveness of10% Lidocaine Spray plus oral celecoxib for Pain
      Control During Hysterosalpingography
    

Detailed description: 
      hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to
      grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions
      including measuring uterine depth, inserting the cannula; and injection of the dye
    

Intervention name(s): celecoxib plus lidocaine; Celecoxib; lidocaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Celecoxib 200 mg (Celebrex® 200, Pﬁzer,USA) administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure; Celecoxib 200 mg (Celebrex® 200, Pﬁzer,USA) administered orally 2 h before the procedure +Sterile water 4 puffs during the procedure; placebo to celecoxib administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure
Other intervention name(s): experimental; Active Comparator; Active Comparato
Intervention MeSH terms: Celecoxib; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Single (Participant)
Primary purpose: Prevention
Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA)
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the safety and tolerability of BOSWELAN in subjects with multiple sclerosis or
      clinically isolated syndrome and to describe the effect of Boswellic acids on the disease
      activity as assessed by monthly MRI measures.
    

Detailed description: 
      Boswellic acids (BAs), the main biologically active compound of frankincense, are orally
      available and known to exhibit anti-inflammatory activities. This is a Phase IIa bicentric
      baseline-to-treatment study with the standardized frankincense extract Boswelan to test the
      safety, tolerability and efficacy of BAs in RR-MS patients. Following a 3-month screening
      phase, patients received an individualized dose finding identifying the highest well
      tolerated BOSWELAN dose for each patient. The primary outcome in the treatment phase (Stage
      3) will first compare mean Gd-enhancing lesion number occurring during the 4 month baseline
      to mean Gd-enhancing lesion number occurring months 5, 6, 7, 8 on treatment in patients
      treated with a dose of at least 800 mg t.i.d.
    

Intervention name(s): Boswellic acids (BOSWELAN)
Intervention type(s): Drug
Intervention description(s): 8 months of treatment at a t.i.d. (Ter In Die (Latin: Three Times A Day) dose of between 400-1600 mg Boswelan
Other intervention name(s): BOSWELAN
Intervention MeSH terms: Boswellic acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Yhteispeli - Effectiveness Study on Promoting Childrens' Socio-emotional Skills in School
Condition: Children's Socio-emotional Skills and Psychiatric Symptoms
Study type: Interventional

Summary: 
      The purpose of this cluster randomised trial is to investigate whether the Yhteispeli whole
      school programme is effective in improving children's socio-emotional skills and mental
      health and socio-emotional skills.

      All Finnish elementary schools and their classes in 1-3 grades were invited to participate in
      the study. The schools were randomly allocated to receive either Yhteispeli programme or two
      lectures
    


Intervention name(s): Yhteispeli, whole school programme; Two theoretical lectures
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Children; socio-emotional; socio-emotional skills; psychiatric symptoms; SDQ; Finland; School; School community; Teacher; Whole school approach; Intervention; Effectiveness study; Cluster randomised trial
A Study to Evaluate the Tolerability, Safety and Pharmacokinetic Characteristics of DA-3803
Condition: Infertility; Induction of Ovulation
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-blind, randomized, comparative, phase I study to evaluate the tolerability,
      safety and pharmacokinetic characteristics of human chorionic gonadotropin between two
      recombinant hCG products named DA-3803 injection and ovidrel liquid injection, in healthy
      subjects. The subjects will injected with these two injections at the the 21day-interval of
      time and their conditions including vital signs, blood, clinical examination will be
      carefully observed.
    


Intervention name(s): T-R (Test-Reference drug); R-T (Reference-Test drug)
Intervention type(s): Drug; Drug
Other intervention name(s): Drug: DA-3803 (Test drug); Drug: Ovidrel liquid injection (Referecne drug); Drug: Ovidrel liquid injection (Referecne drug); Drug: DA-3803 (Test drug)
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
To Compare the Safety and Efficacy of "HG-102" With Botox® in the Improvement of Moderate to Severe Glabellar Lines.
Condition: Glabellar Lines
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the safety and efficacy of "HG-102" with Botox® in the improvement of moderate to
      severe glabellar lines.
    

Detailed description: 
      Double-blinded, Randomized, Active control, Single center-designed, Phase I clinical trial to
      evaluate the safety and efficacy for improvement of Glabellar Lines of "HG-102" compared to
      Botox® in subjects with moderate to severe Glabellar Lines
    

Intervention name(s): Botulinum Toxin Type A Injection [Botox]; Botulinum toxin type A injection [HG-102]
Intervention type(s): Drug; Drug
Intervention description(s): Single administration, Day 0, 20 units; Single administration, Day 0, 20 units
Other intervention name(s): Botox®; HG-102
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Drug Interaction Between Daclatasvir/Asunaprevir/BMS-791325 and Rosuvastatin
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose is to assess the effect of Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325
      combination therapy on the exposure of Rosuvastatin.
    

Detailed description: 
      IND Number: 79,599/101,943

      Primary Purpose: Other - Phase 1 Clinical Pharmacology drug interaction study in healthy
      subjects
    

Intervention name(s): Daclatasvir, Asunaprevir and BMS-791325 FDC; BMS-791325; Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Crestor®
Intervention MeSH terms: Rosuvastatin Calcium; Asunaprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Isolated Thoracic Perfusion (ITP-F) for MPM
Condition: Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Study type: Observational

Summary: 
      This is an observational study of isolated thoracic perfusion with subsequent hemofiltration
      to lower the concentration of the cytotoxic drugs as a locoregional therapeutic strategy in
      malignant pleural mesothelioma.
    

Detailed description: 
      Treatment of patients with progressive malignant pleural mesothelioma (MPM) after multimodal
      therapy is a therapeutic challenge. Survival of the patients is low and the treatment options
      are sparse. This is an observational study of isolated thoracic perfusion with subsequent
      hemofiltration as a locoregional therapeutic strategy in this situation.

      23 pts. with epithelioid MPM were included in this phase II study after informed consent. All
      patients had progressive disease after multiple therapies and were recommended BSC of a MDT.
      Following insertion of a venous and arterial 21 ch. stop flow catheter via a femoral access,
      the inferior vena cava was blocked beneath the right atrium, the arterial catheter was
      blocked in the aorta at the diaphragm. The upper arms were blocked by pneumatic cuffs.
      Chemotherapy was given via the arterial catheter. Chemotherapy consisted of 60mg/m2
      cisplatinum and 15mg/m2 mitoxantrone q for 3 weeks until progress. After administration of
      chemotherapy, thoracic perfusion with blocked stop-flow catheters was maintained for 15
      minutes. After de-blocking of the catheters, hemofiltration was performed for 45 min. with 5l
      filtrate. The endpoint of the study was overall survival.Secondary endpoint was toxicity.
    

Intervention name(s): Chemotherapy
Intervention type(s): Drug
Intervention description(s): intraarterial infusion of cisplatin and mithoxantrone
Other intervention name(s): CDDP; Mitoxantrone
Intervention MeSH terms: Mitoxantrone
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with progressive malignant mesothelioma after failure of convetional multimodal
        therapy including resection
      
Keywords: Mesothelioma, malignant; Chemotherapy