bioihbjkbjnl/mcl2 huggingface dataset:
Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this trial is to investigate the effect of 6 weeks treatment with
      tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and
      exercise tolerance in patients with COPD
    


Intervention name(s): Placebo; Tiotropium; Olodaterol; tiotropium + olodaterol; Tiotropium + Olodaterol; Respimat
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Device
Intervention description(s): placebo matching tiotropium + olodaterol FDC; Tiotropium 5 mcg once daily; Olodaterol 5 mcg once daily; tiotropium + olodaterol 5 mcg once daily; Tiotropium 2.5 mcg + Olodaterol 5 mcg once daily; Respimat inhaler
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
A Study in Older Subject to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Rivaroxaban
Condition: Bleeding
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the ability of Andexanet Alfa to reverse the
      anticoagulation effect of Rivaroxaban.
    


Intervention name(s): Andexanet; Placebo
Intervention type(s): Biological; Other
Other intervention name(s): Andexanet alpha; PRT4445
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Andexanet alpha; Anticoagulation; Antidote; Rivaroxaban; Anti-fXa inhibitor; PRT4445; Xarelto; Reversal agent
Clinical Assessment Of GW815SF Salmeterol/Fluticasone Propionate(HFA MDI) In Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the long-term (24-week) safety and efficacy of GW815SF
      Salmeterol/fluticasone propionate(HFA MDI) 50/100mcg(administered as 2 inhalations of
      25/50mcg) bid in pediatric patients with bronchial asthma.
    


Intervention name(s): GW815SF Salmeterol/Fluticasone propionate(HFA MDI)
Intervention type(s): Drug
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: salmeterol/fluticasone propionate combination; pediatric bronchial asthma
A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis; Medial Compartment Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2a, multicenter, randomized, double-blind, parallel group, placebo-controlled study
      to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic effect of
      ABT-981 in patients with symptomatic, radiographic, and inflammatory knee osteoarthritis.
    


Intervention name(s): ABT-981; Placebo
Intervention type(s): Biological; Other
Other intervention name(s): Lutikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Synovitis; Knee; Pain
Moxifloxacin in Situ Gel to Treat Periodontal Pocket.
Condition: Chronic Generalized Periodontitis
MeSH terms: Periodontitis; Periodontal Pocket
Study type: Interventional
Phase: Phase 4

Summary: 
      In this Randomized clinical trial locally delivered moxifloxacin in situ gel was evaluated as
      an adjunct to scaling and root planing for efficacy in the treatment of chronic periodontitis
      and for short-term effects on the periodontal microflora.
    

Detailed description: 
      Moxifloxacin exerts excellent antibacterial activity against a wide range of putative
      periodontal pathogens, including Porphyromonas gingivalis, Tannerella forsythia, Prevotella
      species, Fusobacterium nucleatum, Actinomyces species, Peptostreptococcus species,
      Campylobacter rectus, and Actinobacillus actinomycetemcomitans. Moxifloxacin penetrates well
      into soft tissues and is effective against intracellular periodontal pathogens when used in
      the treatment of periodontitis as an adjunct to scaling and root planning (SRP). Systemic
      administration of moxifloxacin has provided superior outcomes compared with SRP in
      conjunction with systemic administration of doxycycline, or SRP alone. We hypothesized
      similar benefits with local drug delivery of Moxifloxacin in the treatment of chronic
      periodontitis. To the best of our knowledge, there is no published literature on in situ gel
      using moxifloxacin employing gellan gum as the vehicle, for direct placement in the
      periodontal pocket for the treatment of chronic periodontitis.

      Among various drug delivery systems for treating periodontitis, gel formulations have some
      advantages. Despite a relatively faster release of the drug, gels can be more easily prepared
      and administered. Moreover, they possess a higher bio compatibility and bio adhesivity, by
      allowing adhesion to the mucosa in the dental pocket and by decreasing the risk of dilution
      of the material by saliva.

      Keeping the above facts in mind, the goals of this study were to (1) evaluate in situ gel as
      a vehicle in a local drug delivery system, (2) evaluate the efficacy of moxifloxacin for
      local drug delivery, (3) evaluate the efficacy of gellan gum for in situ gelation of
      moxifloxacin, and (4) evaluate and compare the clinical and microbiological parameters of
      moxifloxacin with those of the gold standard, chlorhexidine di gluconate.
    

Intervention name(s): Moxifloxacin
Intervention type(s): Drug
Intervention description(s): TO ASSESS THE EFFICACY OF MOXIFLOXACIN IN SITU GEL IN THE TREATMENT OF PERIODONTAL POCKET.
Other intervention name(s): Avelox
Intervention MeSH terms: Moxifloxacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Moxifloxacin; Chlorhexidine; In situ gel; Chronic periodontitis
Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer
Condition: Basal Cell Carcinomas
MeSH terms: Carcinoma, Basal Cell; Skin Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Human Basal Cell Carcinomas (BCCs) can be ablated by treating them with nanosecond pulsed
      electric fields (nsPEF)
    

Detailed description: 
      The purpose of this study is to determine if low energy, non-thermal, 100 ns pulses can
      ablate BCCs. The investigators consider this a non-significant risk study because our
      PulseCure system only applies 0.4 watts to the skin compared to the 40 watts applied by the
      currently used electrosurgical unit to remove skin lesions, the Hyfrecator. Since the
      PulseCure applies 1/100 of the energy and does not even heat the skin significantly, it
      represents a non-significant risk to the patient. Our study will provide the first data on
      the response of BCCs to these 100 ns pulses. The investigators will first treat three BCCs on
      BCNS patients with different pulse numbers to determine the pulse number needed to ablate.
      Once the investigators have the optimal pulse number, the investigators will use it to treat
      20 normal patients with sporadic BCCs on their trunks. This should provide sufficient data to
      conclude whether or not nsPEF can ablate BCCs on normal individuals.
    

Intervention name(s): PulseCure pulse generator and Derm-pulse electrode
Intervention type(s): Device
Intervention description(s): PulseCure 100 ns pulse generator: generates 30 kV/cm electric pulses 100 ns long to trigger apoptosis in cells between the electrodes.
NanoBlate: Delivery device to treat 5 mm wide skin lesions with 100 ns pulses from PulseCure
Other intervention name(s): BioElectroMed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: basal cell carcinoma; Basal Cell Nevus Syndrome; Electric Field; Nanosecond pulse
Safety, Tolerability, PK, and Pharmacodynamics(PD) of IONIS APOCIII-LRx in Healthy Volunteers With Elevated Triglycerides
Condition: Elevated Triglycerides (TG)
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      IONIS APOC-III-LRx given to healthy volunteer subjects.
    


Intervention name(s): APOC-III-L-Rx; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): Ascending single and multiple doses of IONIS-APOC-III-LRx by subcutaneous (SC) injection; Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Family Communication and Support in the Pediatric Intensive Care Unit
Condition: Reducing Post Traumatic Stress
Study type: Interventional

Summary: 
      This project is evaluating the effect of a standardized communication intervention in the
      pediatric intensive care unit (PICU) on long-term distress of family members of children in
      the PICU for 5 days or longer. The study hypothesis is that intervention families will have
      lower (better) acute stress disorder scores when their child is discharged from the PICU and
      lower (better) post-traumatic stress disorder scores at 3-month follow-up, as compared to the
      control group families. The investigators will recruit 220 families (110 in each of the
      control and intervention groups). Families who are randomized to the intervention group will
      receive routine visits from members of the PACT (palliative care) team at least three
      times/week to address psychosocial needs, keep families informed about their child's health
      status, and offer emotional and instrumental support and resources. Families in the control
      group will receive usual care in the PICU. The intervention will end whenever the child is
      discharged from the PICU, which usually happens within 3 weeks of enrollment. The
      investigators will assess family outcomes at discharge from the PICU and 90 days after study
      enrollment. The investigators will conduct two additional activities to learn more about the
      processes of care for those in both the intervention and control groups. First, during the
      intervention, the investigators will recruit 30 families (15 in each group) and ask
      permission to audio-record the family care conferences to assess communication styles and
      gain greater insight into the differences in practice with or without the participation of
      the intervention team. The investigators will obtain additional consent from participants in
      these family conferences who are not otherwise enrolled in the study. Second, after
      completion of the 3-month follow-up interview, a sub-sample of a different 30 families
      (again, 15 in each group) will be invited to participate in qualitative interviews to debrief
      about their experience in the study and the intervention (for those in that group). This will
      be a one-time interview scheduled within 60 days of recruitment for this part of the project.
    


Intervention name(s): Assigned to palliative care team; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Communication and Support through the palliative care team assigned to intervention participants.; usual hospital care, not assigned to palliative care team
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Effect of Udenafil on Spermatogenesis
Condition: Spermatogenesis; Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      Study of udenafil daily in subjects with mild or no erectile dysfunction to evaluate effects
      on semen characteristics.
    

Detailed description: 
      Safety Study in male subjects with no or mild ED (erectile dysfunction)
    

Intervention name(s): Placebo; Udenafil
Intervention type(s): Drug; Drug
Intervention description(s): Daily, oral tablet; Daily tablet
Intervention MeSH terms: Udenafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Semen characteristics; Erectile Dysfunction
Safety, Tolerability, and Effect of LY2405319 After Multiple Injections in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study intends to evaluate how safe and well tolerated the LY2405319 compound is when
      given to people for 7 days (in Part 1) and 28 days (in Part 2). This study intends to also
      determine if there is a positive effect on lowering the level of glucose in people with type
      2 diabetes.
    

Detailed description: 
      Subjects in Part 1 will be randomized to receive LY2405319 or placebo over 7 days in one of 4
      dose level groups, in ascending order: 1 mg, 3 mg, 10 mg, or 20 mg.

      Subjects in Part 2 will be randomized to receive LY2405319 or placebo over 28 days, and will
      receive the dose level determined to be the most well tolerated in Part 1.
    

Intervention name(s): LY2405319; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Preparing Children for Anesthesia With an Educational Pop-Up Book
Condition: Pediatric Preoperative Anxiety, Pediatric Coping
Study type: Interventional

Summary: 
      The study evaluated an educational pop-up book about general anesthesia induction as an
      interactive, child-focused preoperative education resource for pediatric patients undergoing
      outpatient surgery. The study's objectives were to evaluate the book as an educational tool
      and to understand the book's effects on patient and caregiver perceptions of the surgical
      experience. The study's hypotheses were that preoperative education from the pop-up book,
      compared to standard care, would more effectively reduce children's fear and expected pain,
      facilitate more positive views of the procedure and preoperative explanations, encourage
      adaptive coping strategies, reduce behavioral anxiety at anesthesia induction, and increase
      caregiver satisfaction with the surgical experience.
    


Intervention name(s): Pop-Up Book
Intervention type(s): Other
Intervention description(s): Patients spent 5-10 minutes reading an illustrated pop-up book that promoted active learning about the process of general anesthesia induction.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were allocated via a block-randomized list to either the intervention arm (the educational pop-up book) or the control arm (standard care).
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Preoperative education; Patient education; Preoperative anxiety; Pediatric outpatient surgery; Pediatric anesthesia
Efficacy and Tolerability of a Bilberry Extract in Volunteers With Impaired Twilight and Night Vision
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to determine the efficacy of Anthocyan to improve impaired twilight and night vision
      and to test its tolerability and safety.
    


Intervention name(s): Anthocyan capsules; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Incretin Physiology Associated With Steroid Hormone Treatment
Condition: Type 2 Diabetes Mellitus; Steroids
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether the reduced incretin effect and the
      paradoxical glucagon responses during oral glucose ingestion and isoglycaemic iv glucose
      infusion observed in patients with type 2 diabetes are causes (non-inducible in lean healthy
      subjects without family history of diabetes) or consequences (inducible) of the diabetic
      state.
    

Detailed description: 
      The incretin effect is severely reduced in patients with type 2 diabetes. This
      pathophysiological trait is accompanied by an almost abolished insulinotropic effect of the
      incretin hormone glucose-dependent insulinotropic polypeptide (GIP) and a reduced
      insulinotropic potency of the other incretin hormone glucagon-like peptide-1 (GLP-1).
      Furthermore, recent studies suggest that hypersecretion of glucagon during oral glucose
      ingestion, as opposed to a normal suppression of glucagon during isoglycaemic intravenous
      (iv) administered glucose, further attenuates the incretin effect in patients with type 2
      diabetes.

      However, it remains unclear whether the severely reduced incretin effect and its accompanying
      pathophysiological traits characterizing patients with type 2 diabetes can be induced
      temporarily in healthy subjects by a short period of glucose homeostatic dysregulation.

      In this study the incretin effect will be measured using 50-g oral glucose tolerance test and
      isoglycaemic iv glucose infusion and meal test in 10 healthy Caucasian subjects without
      family history of diabetes before and after dysregulation of glucose homeostasis using high
      calorie diet, physical inactivity and administration of adrenocortical steroids
    

Intervention name(s): Oral glucose test (OGTT); isoglycaemic iv. clamp; liquid meal test; Gastric Emptying Rate; Prednisolone; Paracetamol
Intervention type(s): Other
Intervention description(s): OGTT: The test is performed with 50 g of glucose deluded in 300 ml. of water. Isoglycaemic iv. clamp: Iv glucose infusion mimicking the glucose response curve of the OGTT.
Liquid Meal Test: The test is performed with 100g of formula milk in 300 ml. of water.
Gastric Emptying Rate: Paracetamol absorption test. Adrenocortical Steroids: Use of 37,5 mg./day of prednisolone during 10 days
Other intervention name(s): Prednisolone; Paracetamol
Intervention MeSH terms: Acetaminophen; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Incretin Effect; Steroids; Glucagon-Like Peptide 1; Gastric Inhibitory Peptide; Glucose-dependent Insulinotropic Polypeptide; Insulin; C-peptide; Glucagon
BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333)
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage
      during a 3 months treatment.
    


Intervention name(s): losartan potassium (+) hydrochlorothiazide; Comparator: Valsartan (+) Hydrochlorothiazide
Intervention type(s): Drug; Drug
Intervention description(s): losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide; Valsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide
Intervention MeSH terms: Losartan; Valsartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevalence of Circulating Parvovirus Genome in Recently Diagnosed Graves' Disease: a Case-control Study
Condition: Graves Disease
MeSH terms: Parvoviridae Infections; Graves Disease
Study type: Interventional

Summary: 
      Lymphocytic thyroiditis is the most common autoimmune disease, usually affecting young women.
      Although the aetiology and pathogenesis remain obscure, the most widely accepted hypothesis
      is an interaction between a genetic predisposition and an environmental trigger factor such
      as viral infection. Parvovirus infections have been proposed as trigger factors for
      Hashimoto's thyroiditis and Graves' disease.
    


Intervention name(s): serodiagnosis
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: parvovirus genome
GF-GS 01: Comparing Conventional Axillary Dissection Versus Sentinel Node Resection in Clinically Node-negative Operable Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Sentinel node resection appears as a promising advancement in the surgical treatment of
      breast cancer.

      The GF-GS 01 study, sponsored by a National Hospital Research Program, compares this new
      surgical method with a classical method in patients having a negative sentinel node.

      The duration of the follow-up is 5 years.
    


Intervention name(s): Sentinel Node Resection; Conventional Axillary Dissection
Intervention type(s): Procedure; Procedure
Intervention description(s): Sentinel Node Resection; Conventional Axillary Dissection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; sentinel node resection; survival; Breast cancer unifocal N0