bioihbjkbjnl/mcl2 huggingface dataset:
Muco Smartphone Exacerbation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity.
      Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship
      between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments present
      health costs burden leading to important physical psychological and social impact. Preventing
      exacerbation and early detection of these exacerbations may decrease intensity and freqauency
      of exacerbation leading to increase clinical status and QoLwith a decreased health cost.

      Patients actually follow in CRCM track exacerbations when visits out patient clinic and
      during phone call. If patients did not call or did not present regularly to out patient
      clinic, exacerbation detection came later and so increasde the burden and therapeutic
      pressure.

      The objective of our study is to identify earlier the potential exacerbations and so
      decreased the health costs and increased the patient's QoL. Forthis purpose we propose to use
      modern technologiessuch as smartphone in order to create alert when patients report weekly
      health satatus. We will compra patients randomize in control group with standart follow-up to
      patients randomize in the smartphone group.Moreover we will study the compliance and
      satisfactory degree of the use of this device in the interventional arm.
    

Detailed description: 
      Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity.
      Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship
      between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments present
      health costs burden leading to important physical psychological and social impact. Preventing
      exacerbation and early detection of these exacerbations may decrease intensity and freqauency
      of exacerbation leading to increase clinical status and QoLwith a decreased health cost.
    

Intervention name(s): Application of Smartphone; No application Smartphone
Intervention type(s): Device; Other
Intervention description(s): Weekly questionnaire on smartphone; No weekly questionnaire on smartphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Exacerbation, QoL
Characterization of Metabolic and Brain Effects of Rising Glucagon During an Oral Glucose Challenge
Condition: Metabolic Syndrome; Diabetes
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The investigators previously characterized a phenotype with non-suppressed glucagon at 120
      minutes after standardized oral glucose load. This phenotype is associated with healthy
      metabolic traits such as lower BMI, higher insulin sensitivity and lower liver fat content.
      Glucagon is a pleiotropic hormone that, besides its main action on increasing endogenous
      glucose production, also reduces appetite and increases basal energy expenditure. The aims of
      this study are to i. detect functional differences in the appetite-related central nervous
      system (CNS) areas between the suppressed and non-suppressed glucagon phenotype ii. mimick
      the non-suppressed glucagon phenotype in those participants who suppress glucagon by
      administering a very-low-dose glucagon infusion and retest them.
    


Intervention name(s): Intravenous glucagon; Intravenous saline
Intervention type(s): Drug; Drug
Intervention description(s): Randomized application of glucagon or saline during oral glucose tolerance test; Randomized application of glucagon or saline during oral glucose tolerance test
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effectiveness of Trephination With Platelet Rich Plasma or Placebo in a Primary Meniscal Tear Treatment
Condition: Meniscus Lesion
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will compare meniscal healing augmented or without augmentation with platelet rich
      plasma in primary meniscal tear treatment (prolotherapy). The assessments will include
      validated, disease specific, patient oriented outcome measures. Results of this study will
      help ascertain whether platelet rich plasma may improve meniscal healing rates.
    

Detailed description: 
      The role of meniscal in the knee integrity is pivotal and lack or partial role of the
      meniscus increases rate of joint degeneration. Partial meniscal removal is the most popular
      procedure and meniscal repair remain in minority of arthroscopic surgeries. As criteria of
      inclusion to meniscal repair are very rough, still success rates of meniscal repair remain in
      the 60-80% range for isolated repairs. This rate is greater when performed with ACL
      reconstruction. The investigators believe that augmentation with platelet rich plasma as
      prolotherapy ill induce healing without the need for arthroscopy.
    

Intervention name(s): trephination with placebo; trephination with platelet rich plasma
Intervention type(s): Biological; Biological
Intervention description(s): trephination under US guidance and placebo injection; trephination under US guidance and platelet rich plasma injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: meniscus repair; platelet rich plasma
Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%
Condition: Primary Immunodeficiency
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics
      (PK) of ProMetic's Immune Globulin Intravenous (Human) 10%, the investigational medicinal
      product [IMP]), in Adults and Children with Primary Immunodeficiency Diseases (PIDD).
    

Detailed description: 
      This is a pivotal Phase 3, open-label, single-arm, multicenter study to assess the
      tolerability, safety, efficacy, and Pharmacokinetics of the Investigational Medicinal Product
      in adults and children with Primary Immunodeficiency Diseases (PIDD). A total of
      approximately 75 subjects aged 2-80 years will be enrolled in the study. Subjects who switch
      from an investigational immune globulin or subcutaneous immune globulin (IGSC) are required
      to receive a stable dose of commercial product (CP), which is a licensed commercially
      available immune globulin intravenous (IGIV) product for at least 3 cycles before they can be
      given the Investigational Medicinal Product . This study schema will result in the Commercial
      Product Treatment Period and Investigational Medicinal Product Treatment Period. All subjects
      will be treated on an outpatient basis with the Investigational Medicinal Product for
      approximately 1 year, with the dose and schedule based on their previous IGIV treatment
      regimen (21-day or 28-day dosing interval). A subset of subjects will participate in a
      Pharmacokinetics sub-study.

      The primary objective of the study is to examine the rate of clinically documented serious
      bacterial infections (SBIs) in subjects treated with the Investigational Medicinal Product to
      achieve a rate of less than one SBI per year.
    

Intervention name(s): Immune Globulin Intravenous; Prometic's Immune Globulin Intravenous 10%
Intervention type(s): Biological; Biological
Intervention description(s): Gammargard, Gammaplex,Gamunex, or Octogam IGIV Product; Liquid formulation of Prometic Immune Globulin Intravenous 10% (human) in 50 mL vials containing 100 mg/mL of immunoglobulin G (IgG)
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bone Height Changes In Three Implants Retained Mandibular Overdenture
Condition: Bone Loss; Implant Site Reaction
Study type: Interventional

Summary: 
      this study was to compare the bone height changes around three implant telescopic, locator,
      and ball retained mandibular overdentures. radiographic changes in peri-implant tissue in
      three groups were evaluated
    

Detailed description: 
      Twenty-four completely edentulous patients were recruited from the outpatient clinic of
      Removable Prosthodontics Cairo University. All patients recruited were seeking to install
      implants in their lower jaw, and have to meet the following inclusion criteria: age ranging
      from 50 to 69 years old, patients should have no contra-indication for implant installation,
      all patients should perform a glycosylated hemoglobin analysis and only up to 8 were included
      in the study. All patients had to sign an informed consent before the start of the study, and
      have to comply with the assigned follow-ups. Patients with any contraindications for implant
      placement or those who didn't comply with the follow ups were excluded from the study.

      All patients included had maxillary and mandibular complete dentures fabricated following the
      conventional steps, after a period of 6 weeks adaptation, all patients were ready for implant
      installation. The lower denture was duplicated into a radiographic stent, having radio-opaque
      markers in the areas of implant installation. All patients had a CBCT x ray wearing the
      radiographic stent, to allow for proper implant planning and to visualize the height and
      width of the osteotomy site. The radiographic stent was then modified to a surgical stent by
      making a tunnel corresponding to the site of implant installation. All Patients in this study
      received three implants in the lower jaw at the premolar-canine area bilaterally and one
      implant in the midline at the central incisor area.
    

Intervention name(s): ball attachment to retain mandibular over denture; locator attachment to retain mandibular over denture; telescopic attachment to retain mandibular over denture
Intervention type(s): Other; Other; Other
Intervention description(s): each patient in group receive 3 locator attachment for over denture retention; each patient in group receive 3 locator attachment for over denture retention; each patient in group receive 3 telescopic attachment for over denture retention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: implant - over denture - bone height changes - attachment
Amlodipine on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients
Condition: Female Infertility Associated With Anovulation
MeSH terms: Infertility; Infertility, Female; Anovulation
Study type: Interventional

Summary: 
      On the basis of the current study, amlodipine seems to be a promising drug on improving
      uterine, ovarian blood flow, size of pre-ovulatory follicle, midluteal progesterone level and
      pregnancy outcome in patients with pco.
    

Detailed description: 
      To know if amlodipine has vasodilator effect on ovarian ar. In pco patient.
    

Intervention name(s): Clomifene citrate ( clomid 50 mg ); Amlodipine
Intervention type(s): Drug; Drug
Other intervention name(s): clomid ( 50 mg ); Norvasc 5mg
Intervention MeSH terms: Amlodipine; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pco; Amlodipine
Insulin Titration System Based on Deep Learning
Condition: Diabetes Mellitus Type 2 - Insulin-Treated
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This is an open-labeled, one-arm intervention trial to access the effect and safety of the
      Insulin Titration System Based on Deep Learning in patients with Type 2 Diabetes Mellitus.
    

Detailed description: 
      The study enrolls 13 patients with Type 2 Diabetes in Zhongshan Hospital who are on treatment
      with insulin. After screening for the inclusion and exclusion criteria, eligible patients
      will receive insulin dosage titration set by the Insulin Titration System Based on Deep
      Learning in the intervention trial. The goal of insulin therapy was to achieve preprandial
      capillary blood glucose between 5.6-7.8 mmol/L and postprandial capillary glucose less than
      10.0mmol/L. All patients are studied for 5 consecutive days or untill hospital discharge. For
      each patient, capillary glucose concentration was measured at 7 time points of fasting, after
      breakfast, before and after lunch, before and after dinner, and before bedtime a day using
      Glucometer (Glupad, Sinomedisite, China). Capillary glucose measurements were performed by
      the nurse staff according to standard procedures with a point-of-care testing device, which
      is integrated into the HIS system. And continuous glucose monitoring (CGM) was performed
      using flash glucose monitoring (Abbott Freestyle Libre, USA) placed on the upper left arm.
      This study will be conducted in the Department of Endocrinology, Zhongshan Hospital,Fudan
      University.
    

Intervention name(s): Insulin Titration System
Intervention type(s): Device
Intervention description(s): A noval insulin titration system, which is based on deep learning
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study Evaluating Efficacy and Safety of T3D-959 in Mild-to-moderate AD Subjects
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Evaluate the Safety and
      Efficacy of Three Dose Strengths of T3D-959 in Subjects with Mild-to-Moderate Alzheimer's
      Disease.
    

Detailed description: 
      Study Design & Methods: Phase 2 multi-center, randomized, double blind, placebo-controlled
      study of T3D959 15 mg, 30 mg, 45 mg, or matching placebo administered orally once daily for
      24 weeks. There will be equal allocation of subject numbers across the four groups.
      Stratified randomization will be conducted on the basis of ApoE4 genotype so that subjects
      are randomized into one of the four dose groups within each stratum of ApoE4 status:
      ApoE4-positive (at least one E4 allele) vs ApoE4-negative (no E4 alleles).

      Following informed consent, subjects will enter the screening phase of the study.

      Once eligibility is confirmed and before the start of the first dose of study drug, subjects
      will be randomized on a 1:1:1:1 basis to placebo or T3D959 treatment (15mg, 30mg, 45mg) for
      the 24-week treatment period. Investigators, subjects, and caregivers will be blinded to the
      treatment assignment.

      Study schedule visits: screening, baseline, weeks 4, 8, 16, 24 and 28 (F/U visit)
    

Intervention name(s): 15mg T3D-959; 30 mg T3D-959; 45 mg T3D-959; Placebos
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral administration once daily in the morning; Oral administration once daily in the morning; Oral administration once daily in the morning; Oral administration once daily in the morning
Other intervention name(s): T3D-959; T3D-959; T3D-959; T3D-959 Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double-blind, placebo-controlled design evaluating three dose levels (15 mg, 30 mg, 45 mg) of T3D-959 in subjects with mild-to-moderate Alzheimer's Disease. Subjects will be stratified by ApoE4 genotype and assigned to one of four dose groups (1:1:1:1 ratio) in a randomized fashion.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mild-to-moderate Alzheimer Disease
Russia/Ukraine Suppression of Ovarian Activity Study
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to look into the effectiveness of a new investigational
      medication applied as a transdermal patch. The patch is applied on the skin with study
      medication that is absorbed through the skin suppressing ovarian activity and therefore
      preventing an egg from leaving an ovary (ovulation). The study will look into the study
      drug's safety and how well it is tolerated and its absorption, breakdown and elimination in
      the body. It describes how the body affects a specific drug after administration.
    


Intervention name(s): Gestodene/EE Patch (BAY86-5016)
Intervention type(s): Drug
Intervention description(s): 7 day patch containing 0.55 mg ethinyl estradiol and 2.1 gestodene in a 21 day regimen.
Intervention MeSH terms: Gestodene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception; Transdermal contraceptive patch; Safety; Efficacy; Pharmacokinetic
Stimulation of the Cervical Sympathetic Ganglion for Treatment of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate if stimulating the nerve involved with airway
      constriction, while undergoing procedures that are known to cause asthma exacerbations,
      decreases the level of asthma attack experienced.
    

Detailed description: 
      Asthma is a chronic inflammatory disorder of the airways characterized by shortness of
      breath, wheezing, cough, and fatigue. Some people suffer from sudden worsening of asthma
      symptoms despite being treated with medications. When people have asthma attacks the muscle
      tissue in the airway contracts causing the airway to narrow and decreasing the ability for
      the person to breathe.

      Neurological pacemakers are FDA approved devices that stimulate nerves in the body and have
      been used for the treatment of many disorders such as Parkinson's, epilepsy, chronic pain and
      urinary incontinence. Recent animal studies have shown that stimulating (activating a nerve)
      the carotid sheath area (located in the neck) can cause the rapid relaxation of the muscles
      which contract during an asthma attack. This approach has also been successfully used in
      patients at an emergency room when they came in with a severe asthma attack.
    

Intervention name(s): Neurostimulation of stellate ganglion
Intervention type(s): Procedure
Intervention description(s): An electrical nuerostimulation of the stellate ganglion up to 60 minutes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Milk on the Vaccination Response
Condition: Infection
Study type: Interventional

Summary: 
      Rationale: Oral vaccination is known to induce a systemic immune response as well as an
      immune response in mucosal tissues, and can therefore serve as a model to study systemic and
      mucosal immunity. In this study, the oral cholera vaccine Dukoral® was chosen as model
      vaccine. The kinetics of the immune response and the interaction with a raw milk matrix have
      been evaluated in a previous, pilot study (NL49042.081.14). Based on the outcomes of this
      pilot, in this study oral cholera vaccination will be applied to study the support of
      immunity by raw milk, compared to heat-treated milk. The study design has been optimised
      based on previous results: study duration is extended and sample size is based on relevant
      change and known variation in the primary outcome parameters.

      Infections are an important worldwide cause of death, both in elderly and young children.
      Therefore, support of immunity could help to reduce the incidence of infections. To screen
      the potential of specific foods or food ingredients to support immunity, oral vaccination can
      serve as a model. In a previous study, this model was developed using oral cholera
      vaccination in human adult volunteers. In that study, raw milk was shown to support the
      immune response to vaccination. In this follow-up study, the effect of raw milk will be
      compared with pasteurized and ultra-heat treated (UHT) milk.

      Objective: To investigate whether pasteurized milk and/or UHT milk are able to enhance the
      immune response as induced by oral cholera vaccination, in comparison to raw milk and to
      regular vaccination.

      Study design: The study is designed as a single-blind randomized controlled trial of 6 weeks.

      Study population: Healthy subjects of 18-50 years of age.

      Interventions: 1) Raw milk, obtained from farms that comply to the high quality requirements
      for production of raw milk, and that has been screened according to the safety criteria for
      raw milk; 2) commercially available full-fat UHT milk; 3) commercially available full-fat
      pasteurized milk.
    


Intervention name(s): cholera vaccination; raw milk; pasteurized milk; UHT milk
Intervention type(s): Biological; Other; Other; Other
Intervention description(s): Oral cholera vaccination on day 0 and day 14; raw milk; pasteurized milk; UHT milk
Other intervention name(s): Dukoral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: immunity; vaccination; milk
Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)
Condition: Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333
      doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain
      taking opioids.
    


Intervention name(s): SP-333 1 mg; SP-333 3 mg; SP-333 6 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Tablet; Tablet
Intervention MeSH terms: Dolcanatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Constipation; Opioid; GC C Agonist; Pain