bioihbjkbjnl/mcl2 huggingface dataset:
Role of Myo-inositol and D-chiro Inositol on the Ovaric and Metabolic Functions
Condition: PCOS
Study type: Interventional
Phase: Phase 4

Summary: 
      Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of
      reproductive age and is characterized by menstrual abnormalities, clinical or biochemical
      hyperandrogenism, multiple abnormal cysts and enlarge ovaries. Women affected by PCOS often
      suffer of insulin resistance and of a compensatory hyperinsulinemia which put them at risk of
      developing several metabolic disorders. Inositol is a six-carbon polyol which has been
      characterized as an insulin sensitizer: it exists as nine different isomers and among them
      myo-inositol and D-chiroinositol are the most represented and studied in physiology and
      physiopathology. In particular, myo-inositol (MI) and D-chiro inositol (DCI) glycans
      administration has been reported to exert beneficial effects at metabolic, hormonal and
      ovarian levels.

      The aim of this randomized study is to evaluate the metabolic and ovaric effects of a
      six-month supplementation of myo-inositol and D-chiro-inositol on young women with PCOS and
      hyperinsulemia.
    


Intervention name(s): Myo-inositol + D-chiro-inositol + Folic acid; Folic acid
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Myo-inositol (550 mg) + D-chiro-inositol (13.8 mg) + Folic acid (200 mcg); 2 x die; Folic acid (200 mcg); 2 x die
Intervention MeSH terms: Folic Acid; Vitamin B Complex; Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: PCOS; Metabolic disorders; Ovarian functionality; Myo-inositol; D-chiro-inositol
Submacular Hemorrhage Associated With Retinal Arterial Macro Aneurysm
Condition: Submacular Hemorrhage; Ruptured Retinal Arterial Macro Aneurysms
MeSH terms: Retinal Arterial Macroaneurysm; Aneurysm; Hemorrhage
Study type: Interventional

Summary: 
      Evaluation of surgical outcome of vitrectomy with subretinal injection of recombinant
      tissue-plasminogen activator for submacular hemorrhage associated with retinal arterial
      macroanuerysms.
    


Intervention name(s): Vitrectomy for submacular hemorrhage; subretinal injection of tissue-plasminogen activator
Intervention type(s): Procedure; Drug
Intervention MeSH terms: Plasminogen; Tissue Plasminogen Activator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Submacular hemorrhage; Vitrectomy; tissue- plasminogen activator
How Reflux Medications Affect the Microbiome of Infants
Condition: GERD; Dysbiosis
MeSH terms: Dysbiosis
Study type: Observational

Summary: 
      The changes in the organisms making up the gut microbiota in infants who are taking anti-acid
      reflux medications (histamine 2 receptor antagonists) as compared to infants who are not
      taking these medications is not well-studied or understood. Whether these medications change
      the gut microbiota and microbiome, and what that change may imply for children on these
      medications, is the focus of this study.
    

Detailed description: 
      Gut microbiota dysbiosis is associated with diseases ranging from localized gastrointestinal
      disorders to neurologic, respiratory, metabolic, hepatic, and cardiovascular illnesses. The
      microbial colonization of the infant gut is known to play a key role in immunologic and
      metabolic pathways impacting on human health. Disruptions during the complex process of
      microbial colonization have been shown to increase disease susceptibility during life. A
      variety of factors are known to influence the gut microbiota, including mode of delivery of
      neonate, host genetic factors, hose immune response, diet, xenobiotics and other drugs,
      infections, and environmental microbial exposures.

      The diagnosis of gastroesophageal reflux disease in the infant population has increased
      during the past two decades. Acid suppression medications are used commonly in infants for
      gastroesophageal reflux disease and other acid-related conditions despite little evidence of
      their efficacy. Multiple studies have shown adverse effects in pediatric patients using
      either proton pump inhibitors or H2 receptor antagonists, the two classes of acid suppression
      medications that are most frequently used in children. Some of these adverse effects may
      result from alterations in the microbiome caused by these medications. Prior studies have
      demonstrated significant changes in microbial composition of both gastric and intestinal
      microbiota with proton pump inhibitor use (5), but to the investigators' knowledge, no prior
      studies have looked at the effect of H2 receptor antagonists on the microbiome in healthy,
      full term infants.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Infants must be healthy, male or female term infants (gestational age ≥37 weeks) who are at
        least 2 months old, on or off H2RA medication, who meet inclusion/exclusion criteria.
        Infants will be recruited from Nemours Children's Clinic and through local advertisements
        in the greater Wilmington / Northern Delaware area.
      
Keywords: Infant GERD; H2RA medication
Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus
Condition: T2DM (Type 2 Diabetes Mellitus); Hypogonadism
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypogonadism
Study type: Observational

Summary: 
      The purpose of the study is to get data of prevalence of testosterone deficiency in patient
      with T2DM in Russian Federation
    

Detailed description: 
      Clinical and Epidemiological Characteristics and Efficacy of Androgen Substitution for
      Hypogonadism in Men With Type 2 Diabetes Mellitus Under Routine Clinical Practice (DESTINY)
    

Intervention name(s): Laboratory tests
Intervention type(s): Diagnostic Test
Intervention description(s): Testosterone HSBG Hb1Ac LH
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Men with T2DM aged between 45-60 years old
Sciatic Perineural Versus Stump Catheter for Below Knee Amputation
Condition: Ischemia; Phantom Limb Pain; Vascular Disease; Chronic Pain
MeSH terms: Phantom Limb; Vascular Diseases; Chronic Pain; Ischemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of this study is to determine if pre-operative placement of the continuous
      peripheral nerve block by an anesthesiologist using ultrasound technology is more effective
      than a continuous peripheral nerve block placed during the surgery by a surgeon for patients
      undergoing a limb amputation
    

Detailed description: 
      We wish to determine the most effective site for the continuous infusion of local anesthetic
      for patients undergoing amputation of a limb. The information we obtain from this study will
      help to decide the most effective manner to provide pain relief for patients in the future.
      The primary outcome of interest is post-operative pain relief as measured by the amount of
      pain-relieving medications (opioids) required by patients prior to discharge home. The
      secondary outcomes of interest will be pain-relieving medications (opioid) requirements
      during the operation, length of stay in the hospital, time required for mobility, and patient
      satisfaction- measured by a survey given while in hospital and 3 months later.
    

Intervention name(s): Sciatic catheter; Stump catheter
Intervention type(s): Procedure; Procedure
Intervention description(s): presurgical sciatic catheter insertion; intraoperative placed stump catheter
Other intervention name(s): anesthesiologist placed catheter; surgeon placed catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sciatic catheter; stump catheter; below knee amputation
Effect of Galantamine on Smoking Abstinence
Condition: Nicotine Addiction
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a preliminary open-label study to determine whether a medication called galantamine
      (Brand Name: Razadyne) will help smokers quit and whether it reduces cognitive problems that
      smokers experience during a quit attempt.
    

Detailed description: 
      Galantamine, an FDA-approved treatment for Alzheimer's disease, is used to treat cognitive
      impairment by enhancing acetylcholine through inhibition of the enzyme, acetylcholinesterase.
      We propose an open-label pilot feasibility study of short-term (6 weeks) treatment with
      galantamine.

      Sixteen chronic smokers will undergo a validated procedure for screening new medications.
      Following an initial 4-week drug run-up phase (8mg daily of galantamine-ER), medication dose
      will be increased to 16 mg daily of galantamine-ER during the fifth and sixth weeks of the
      study. At the beginning of Week 6, smokers will receive brief counseling and make a 7-day
      quit attempt.

      Following completion of the study, participants will be offered standard smoking cessation
      treatment. Subjects will perform a working memory task (Visual/Spatial N-Back), a sustained
      attention task (Continuous Performance Task; CPT), a recall memory task (Word Recognition), a
      cognitive flexibility task (Wisconsin Card Sort Test), and a response inhibition task (Stop
      Signal Task). The primary outcome is the ability to remain abstinent during a 7-day quit
      attempt. Secondary outcomes include change in cognitive performance, adherence, and side
      effects.

      This pilot study will provide information about the role of the cholinergic system during
      brief abstinence and whether enhancing acetylcholine reduces abstinence-induced cognitive
      symptoms that promote smoking relapse. Information obtained in this study may further
      establish cognitive performance measures as endophenotypes for nicotine dependence.
    

Intervention name(s): Galantamine ER
Intervention type(s): Drug
Intervention description(s): The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.
Other intervention name(s): Razadyne ER
Intervention MeSH terms: Galantamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tobacco; Smoking; Galantamine
Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether the use of a lumbar plexus block for
      arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in
      treating pain. In addition, the study will examine whether lumbar plexus blocks reduce the
      total amount of pain medication needed, and therefore reduce the side effects of these
      medicines and increase patient satisfaction. It is hypothesized that addition of the lumbar
      plexus block will significantly reduce patients' postoperative pain.
    


Intervention name(s): Lumbar Plexus Blockade; Control
Intervention type(s): Procedure; Procedure
Intervention description(s): The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine; The control group will receive only a combined spinal-epidural.
Other intervention name(s): Marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dose-Escalation Study on Safety and Immunogenicity of VPM1002 in Comparison With BCG in Healthy Male Volunteers
Condition: Tuberculosis; Healthy
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing
      BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against TB for
      residents in endemic areas and persons at risk in non-endemic areas. The new live vaccine
      VPM1002 should be at least as potent as the currently used BCG vaccine and should cause fewer
      side effects (Kaufmann, 2007; Grode et al., 2005). It is formulated as lyophilised bacteria
      to be resuspended before intradermal injection. First application of VPM1002 in human male
      volunteers will evaluate its safety, local and systemic tolerability as well as its
      immunogenicity. The study has a dose-escalating sequential design with comparison to
      commercially available BCG. 80 volunteers in Germany will randomly be allocated to 4 groups
      each with 20 volunteers stratified for their history of BCG-vaccination.
    


Intervention name(s): VPM1002; BCG
Intervention type(s): Biological; Biological
Intervention description(s): live vaccine; commercially available live vaccine BCG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Safety; Immunogenicity; Tuberculosis; Vaccination; Vaccination against tuberculosis; Safety and immunogenicity of VPM1002 in comparison with BCG
Progenitor Cell Therapy in Dilative Cardiomyopathy
Condition: Heart Failure, Congestive; Cardiomyopathy, Dilated; Stem Cell Transplantation
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Intracoronary infusion of bone marrow derived progenitor cells into the LAD in patients with
      non ischemic dilated cardiomyopathy.
    

Detailed description: 
      Initial clinical pilot trials suggested that intracoronary infusion of bone marrow-derived
      progenitor cells (BMC) may enhance left ventricular functional recovery in patients with
      acute myocardial infarction. It is unknown, however, whether such a strategy might also be
      applicable to patients with non-ischemic dilated cardiomyopathy (DCM). Therefore, we
      initiated the TOPCARE-DCM - trial (Transplantation Of Progenitor Cells And Recovery of Left
      Ventricular Function in Patients with non ischemic Dilatative CardioMyopathy) aiming to
      regionally improve left ventricular contractility by selective infusion of BMC into the left
      anterior descending coronary artery.

      Patients will be randomized 2:1 (20/10) BMC Infusion versus standard medical therapy
    

Intervention name(s): intracoronary infusion of BMC
Intervention type(s): Procedure
Intervention description(s): catheter delivery of stem cells
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Buprenorphine Maintenance Treatment for Opioid Dependence in Primary Care
Condition: Heroin Dependence; Opioid-Related Disorders; Substance Abuse, Intravenous
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders; Heroin Dependence; Substance Abuse, Intravenous
Study type: Observational

Summary: 
      The purpose of this treatment research study is to assess the effectiveness of buprenorphine
      maintenance treatment for opioid dependence delivered in a primary care clinic setting. This
      study will determine whether buprenorphine treatment in primary care is effective in reducing
      cravings, reducing illicit opioid use, reducing addiction severity, and retaining patients in
      primary care treatment for opioid dependence.
    

Detailed description: 
      Buprenorphine maintenance treatment of opioid dependence in primary care may expand treatment
      access. Buprenorphine is a partial mu-opioid agonist approved for treatment of opioid
      dependence (dependence on heroin, prescription opioid pain medication, or methadone), which
      can be prescribed in primary care by authorized physicians. The purpose of this study is to
      assess the effectiveness of buprenorphine maintenance treatment in a primary care setting.
      Outcome measures include illicit opioid use during treatment, addiction severity scores from
      the Addiction Severity Index (ASI), patient craving ratings on a 100mm visual analog scale
      (VAS), and patient retention in treatment.

      This is a 6-month, prospective cohort study of adults aged 18-65 who are seeking
      buprenorphine maintenance treatment for opioid dependence. This study is observational, not
      experimental, and patients will be treated in a naturalistic condition according to their
      individual treatment needs. Clinic visits will occur weekly for the first 4 weeks (Induction
      and Stabilization Phases), and monthly for the remaining 20 weeks (Maintenance Phase), at
      which time up to a month of medication may be prescribed. Participation in ancillary
      psychosocial treatment is recommended but not required. Urine toxicology and craving ratings
      will be collected at each visit. Additionally, research visits will occur monthly to collect
      data assessing addiction severity, risk factors, general health, and psychiatric symptoms.
    

Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention description(s): Dose is determined according to the participants' individual need.
Intervention MeSH terms: Buprenorphine
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults aged 18-65 who are seeking buprenorphine maintenance treatment for opioid dependence
      
Keywords: Heroin Dependence; Opioid Dependence; Primary Care; Buprenorphine
Xenogeneic Collagen Matrix as an Alternative to Free Gingival Grafting for Oral Soft Tissue Augmentation
Condition: Gingival Diseases
MeSH terms: Gingival Diseases
Study type: Interventional

Summary: 
      A split-mouth study comparing soft tissue augmentation results using free gingival graft
      (FGG) versus xenogeneic collagen matrix (CM) for the generation of keratinized tissue (KT)
      around teeth with insufficient (< 2mm) KT.
    

Detailed description: 
      A single-blind, randomized, controlled, split-mouth study of 30 subjects with insufficient
      zones of KT (< 2mm). The study utilized a within subject treatment comparison design to
      establish non-inferiority of the test (CM) versus control (FGG) therapy. The primary efficacy
      endpoint was KT width at 6-months. Secondary endpoints included traditional periodontal
      measures, such as clinical attachment, recession and bleeding on probing. Patient reported
      pain, discomfort and esthetic satisfaction were also recorded. Biopsies were obtained at
      6-months.
    

Intervention name(s): Xenogeneic Collagen Matrix; Free Gingival Graft
Intervention type(s): Device; Device
Intervention description(s): A type I and III porcine collagen matrix, as cleared by FDA (K012423); Autogenous, full-thickness soft tissue graft harvested from patient's palate.
Other intervention name(s): Free Autogenous Graft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autologous; Collagen Matrix; Keratinized Tissue
The Long-term Study to Evaluate the Safety of Eplerenone in the Treatment of Hypertension in Children Aged 6 to 16 Years
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the long-term safety and toleration of eplerenone in the children aged 6 to 16
      years with high blood pressure. The study will last at least 1 year and about 140 patients
      will participate.
    


Intervention name(s): Eplerenone
Intervention type(s): Drug
Intervention MeSH terms: Eplerenone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare different ratios of
      explorative formulations, not similar to the proposed commercial formulation, of IDegAsp
      (co-formulation of insulin degludec/insulin aspart and insulin aspart) with separately
      injected, simultaneous doses of insulin degludec (insulin 454), and insulin aspart, compared
      with biphasic insulin aspart 30 in male subjects with type 1 and type 2 diabetes mellitus.

      Trial part 1 is a five-period cross-over trial with incomplete block-design in subjects with
      type 1 diabetes where each subject will be randomised to five out of the ten possible
      treatments. Each treatment consists of an injection of the insulin product followed by a
      euglycemic clamp with a washout period of 7-15 days between treatments.

      Trial part 2 is a three-period cross-over trial with complete blockdesign in subjects with
      type 2 diabetes. Each treatment consists of an injection of the insulin product followed by a
      euglycaemic clamp with a washout period of 7-15 days between treatments.
    


Intervention name(s): insulin degludec/insulin aspart 30; insulin degludec/insulin aspart 40; insulin degludec/insulin aspart 50; insulin degludec; insulin aspart; biphasic insulin aspart 30; insulin degludec/insulin aspart 40; insulin degludec/insulin aspart 50; biphasic insulin aspart 30
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose administrated subcutaneously (s.c., under the skin).; Single dose administrated subcutaneously (s.c., under the skin).; Single dose administrated subcutaneously (s.c., under the skin).; Single dose administrated subcutaneously (s.c., under the skin).; Single dose administrated subcutaneously (s.c., under the skin).; Single dose administrated subcutaneously (s.c., under the skin) as comparator.; Single dose administrated subcutaneously (s.c., under the skin).; Single dose administrated subcutaneously (s.c., under the skin).; Single dose administrated subcutaneously (s.c., under the skin).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin, Isophane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment