bioihbjkbjnl/mcl2 huggingface dataset:
Assessing Efficacy and Safety of Flexible Dosing With Vardenafil in Subjects With Erectile Dysfunction and Hyperlipidemia
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being conducted in US to obtain information on the efficacy, safety, and
      duration of erection of flexible-dose regime of vardenafil compared to placebo (dummy
      medication with no pharmacological activity), in patients with co-morbid factors associated
      with erectile dysfunction (also called impotence). The duration of erection endpoint will be
      assessed by patient utilized stopwatch timings during each attempt at sexual intercourse.
      Elevated levels of total cholesterol or low levels of HDL may result in atherosclerosis and
      induce erectile dysfunction. Vardenafil (Levitra) is approved by the Food and Drug
      Administration for the treatment of erectile dysfunction. While there is no intent to assess
      the effect vardenafil has on blood lipids, the study will provide prospective data on men
      diagnosed with both ED and dyslipidemia.
    


Intervention name(s): Levitra (Vardenafil, BAY38-9456); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10mg Vardenafil taken orally 1h prior to sexual intercourse; Matching placebo
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Male Erectile Dysfunction; Dyslipidemia; Vardenafil
PAHTCH Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure (Carvedilol)
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension; Heart Failure
Study type: Interventional

Summary: 
      Pulmonary arterial hypertension (PAH) is a progressive disease of the pulmonary vasculature
      leading to elevated pulmonary pressure and right ventricular (RV) dysfunction with heart
      failure. Measures of RV function are better predictors of mortality and long term outcomes
      than pulmonary vascular resistance. The interaction between RV function and the pulmonary
      circulation is not fully understood, but increased after load appears insufficient to explain
      right heart failure. Yet, all approved PAH therapies target vasodilation of the pulmonary
      vasculature to lower pressures
    

Detailed description: 
      Pulmonary arterial hypertension (PAH) is a serious condition characterized by endothelial
      dysfunction leading to pulmonary vascular constriction, smooth muscle and endothelial
      proliferation, and progressive right-sided heart failure. The severity of pulmonary
      hypertension is mostly determined by the response of the right ventricle (RV) to the
      increased afterload or pulmonary pressures, and RV failure is the leading cause of death in
      PAH. Most accepted therapies for PAH have been aimed at vasodilation of the pulmonary
      vasculature, and there has been little thought that PAH patients would benefit from
      traditional left heart failure treatments. A cornerstone therapy in left heart failure is
      £]-adrenergic receptor blockade because of its ability to reverse cardiac remodeling and
      improve clinical outcomes, despite decades of concern regarding its propensity to exacerbate
      heart failure. It has been reported to reduce mortality by about 30% in patients, and while
      the precise mechanisms that contribute to its beneficial effects remain to be elucidated,
      there is evidence that patients with underlying contractile reserve (i.e., via recruitment of
      viable myocardium with £]-adrenergic receptor stimulation) may experience greater recovery of
      their cardiac function. In a study using rats with pulmonary hypertension treated with £]
      blocker, RV function improved, and maladaptive myocardial remodeling was prevented.
    

Intervention name(s): Carvedilol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Group 1 will receive 3.125mg carvedilol twice daily for six months.Group 2 will receive carvedilol in a dose escalation scheme.; Placebo will be taken twice daily for 6 months
Other intervention name(s): low fixed dose, escalating dose
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate Safety and PK Profiles of OLX10010 in Healthy Subjects
Condition: Cicatrix, Hypertrophic
MeSH terms: Cicatrix; Cicatrix, Hypertrophic
Study type: Interventional
Phase: Phase 1

Summary: 
      The Study Drug is an investigational drug which is being developed by OliX Pharmaceuticals
      Inc., with an aim to help people who develop hypertrophic scars (a type of permanent scar) in
      the future. Hypertrophic scars are formed when a wound becomes red, raised, and itchy before
      it eventually heals. These scars tend to develop due to disease, surgical operations, or
      burns. Available physical treatment methods to remove scars include surgery or laser therapy;
      however these are often accompanied by further complications including pain and recurrence of
      the scar and can be costly. Similarly, therapeutic agents such as ointments or oral drugs
      have little to no effect in preventing or treating hypertrophic scars. The aims of this Study
      are to determine the safety of the Study Drug and any side effects that might be associated
      with it, and how much of the Study Drug gets into the bloodstream and how long it takes the
      body to remove it.

      The healthy adult subjects can participate in this study in the age between 18 and 60 years
      old in the UK.

      This study will be conducted in 2 parts, Part A and B. Part A will be a single subcutaneous
      or intradermal dose, dummy controlled study. Part B will be a multiple intradermal dose,
      dummy controlled study.
    

Detailed description: 
      The aims of this Study are to determine the safety of the Study Drug and any side effects
      that might be associated with it, and how much of the Study Drug gets into the bloodstream
      and how long it takes the body to remove it.

      As the selection criteria for the subjects, the healthy adult subjects can participate in
      this study in the age between 18 and 60 years old in the UK. Both female and male subjects
      can participate in this study.

      This study will be conducted in 2 parts, Part A and B. Part A will be a single subcutaneous
      dose (Groups A1 to A4) or intradermal dose (Groups A5 to A8), dummy controlled study.
      Overall, 32 subjects will be studied in 8 groups; 4 groups (Groups A1 to A4) of 4 subjects to
      assess OLX10010 administered subcutaneously and 4 groups (Groups A5 to A8) of 4 subjects to
      assess OLX10010 administered intradermally.

      Part B will be a multiple intradermal dose, dummy controlled study. Overall, 12 subjects will
      be studied as 3 groups (Groups B1 to B3) with each group consisting of 4 subjects. In each
      group, 3 subjects will receive OLX10010 and 1 subject will receive placebo.
    

Intervention name(s): OLX10010; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A cell penetrating asymmetric siRNA (cp asiRNA); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Study to Evaluate the Efficacy of an Over-the-counter (OTC) Sunscreen Lip Balm Product
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the 8-hour moisturization efficacy of OTC sunscreen
      lip balm after a single treatment application.
    

Detailed description: 
      A single-center, randomized, controlled, intra-individual comparison, open label clinical
      study to determine the 8-hour moisturization efficacy of a sunscreen lip balm. Skin hydration
      will be assessed before (Baseline) and after (2, 4, 6 and 8 hours post-treatment) a single
      treatment with test product, compared to 'no treatment' as control, using a corneometer.
      Study treatments will be randomly assigned to 2 test sites delineated on the skin of the
      participant's volar forearms (one test site on each arm). A 1-week conditioning phase will
      precede the test day, during which participants will use the soap provided for personal
      washing.
    

Intervention name(s): ChapStick Active Performance Unscented
Intervention type(s): Drug
Intervention description(s): Sunscreen lip balm.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Role of Suppression of Endometriosis With Progestins Before IVF-ET
Condition: IVF; Endometriosis; Pregnancy Rate; Progestins; GnRH-analogue
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression
      as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis
      pursuing IVF treatment.
    


Intervention name(s): Dienogest; leuprorelin acetate
Intervention type(s): Drug; Drug
Intervention description(s): Group B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF; Group A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol)
Intervention MeSH terms: Leuprolide; Dienogest
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive
      placebo in the treatment of the negative symptoms of schizophrenia
    


Intervention name(s): Pimavanserin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pimavanserin 34 mg, 20 mg, or 10 mg, taken as two tablets, once daily by mouth; Placebo, taken as two tablets, once daily by mouth
Intervention MeSH terms: Pimavanserin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Early Identification of Myocardial Impairment in PBC
Condition: Primary Biliary Cholangitis; Cardiovascular Abnormalities
MeSH terms: Cholangitis; Liver Cirrhosis, Biliary; Cardiovascular Abnormalities
Study type: Observational

Summary: 
      Primary biliary cholangitis (PBC) is a chronic inflammatory liver disease leading to
      cirrhosis. Researches reported patients with PBC may involve abnormalities on skeleton,
      thyroid and exocrine glands. However, whether this autoimmune disease would cause cardiac
      impairment is scarcely investigated. Cardiovascular Magnetic Resonance(CMR) is recently
      developed as a reliable modality to evaluate the cardiac tissue characteristics and
      functions. This study aims to investigate the cardiac status in PBC patients based on CMR.
    

Detailed description: 
      Primary biliary cholangitis (PBC) is a progressive and uncommon inflammatory autoimmune
      cholesteric liver disease，which will contribute to cirrhosis. Symptoms and course of primary
      biliary cholangitis can be diverse, wherefore the targets of the current treatment are
      focused on the prevention of end-stage liver disease. Researches reported patients with PBC
      may involve abnormalities on skeleton, thyroid and exocrine glands. However, whether this
      autoimmune disease would cause cardiac impairment is scarcely investigated. From our clinical
      practice, the cardiac structural abnormal can be found in certain patients with PBC detected
      by cardiovascular magnet resonance (CMR). CMR is the primary and emerging imaging modality
      for myocardial tissue characterisation, and it is recommended as a gold standard for
      functional imaging and assessment. This single-center, prospective observational study plans
      to identify the type and the severity of cardiac changes in PBC.
    

Intervention name(s): CMR examination
Intervention type(s): Diagnostic Test
Intervention description(s): After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive subjects were prospectively enrolled into 2 cohorts between September 2017 and
        December 2018. The cohorts were divided as follows: the PBC patients group and the control
        group.
      
Keywords: Primary Biliary Cholangitis; Cardiac impairment; Cardiovascular Magnetic Resonance
Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to assess the ability of clonidine to reduce the mean pulmonary
      artery pressure in patients with pulmonary hypertension subjected to cardiac surgery.
    

Detailed description: 
      Prospective, clinical-interventionist, randomized, and double-blind study. Patients with
      group 2 pulmonary hypertension will be included and subjected to cardiac surgery with
      extracorporeal circulation. Mean pulmonary artery pressure and the doses of dobutamine and
      sodium nitroprusside will be assessed four times: before (T0) administration of 2 μg/kg of
      intravenous clonidine or a placebo, 30 minutes after the onset of treatment (T1), immediately
      after extracorporeal circulation (T2), and 10 minutes after the injection of protamine (T3).
    

Intervention name(s): Clonidine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 2 μg/kg of intravenous clonidine; Injection of placebo solution.
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Clonidine; Hypertension Pulmonary; Cardiac Surgical Procedures
Safety, Efficacy, PK, and PD Characteristics of Orally Inhaled SB010 in Male Patients With Mild Asthma (Multiple Dose)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway
      hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent
      airway obstruction. One of the characteristics of the disease is an inflammatory reaction of
      the immune system caused by cytokine production. A substantial number of asthma patients do
      not satisfactorily respond to steroid therapy and consequently have an unmet medical need for
      novel targeted therapies with improved specificity, tolerability, and compliance.

      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting
      early disease-causing mechanisms are a promising approach for the treatment of asthma. The
      transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and
      has been shown to be necessary and sufficient for the production of cytokines interleukin
      (IL)-4, IL-5, and IL-13. The active drug substance of the investigational medicinal product
      SB010 is hgd40. SB010 belongs to a new class of antisense oligonucleotide therapeutics, the
      10-23 DNA (deoxyribonucleic acid)zymes (antisense oligonucleotide).

      DNAzymes are catalytically active nucleic acids that cleave complementary RNA (ribonucleic
      acid) molecules. By cleaving GATA-3 mRNA, hgd40 reduces specific cytokine production and
      thereby reduces key features of allergic airway inflammation. DNAzymes are generated
      completely by chemical synthesis and can be produced under Good Manufacturing Practice (GMP)
      controlled conditions. The DNAzymes are not biological drugs, i.e. they are not generated by
      use of any living organism including cell culture or bacteria. The molecules are highly
      water-soluble and will be applied as solution directly in their synthesized form.

      This proof-of-concept study will evaluate the safety, tolerability, efficacy,
      pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of inhaled SB010 in male
      patients with mild asthma.
    


Intervention name(s): SB010; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Treatment group (n=19), receiving the active drug substance.; Treatment group (n=19), receiving placebo.
Other intervention name(s): Active drug substance is hgd40; Phosphate-buffered saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antisense oligonucleotide; Asthma; Healthy subjects; Phase 1; Transcription factor GATA-3; Oral inhalation
Observational Feasibility Study of Home-based Training With Therabands in PAD-patients
Condition: Peripheral Artery Disease; Intermittent Claudication
MeSH terms: Peripheral Arterial Disease; Intermittent Claudication
Study type: Interventional

Summary: 
      The study is an observational feasibility study to evaluate the feasibility of a combined
      aerobic+resistance training program in patients with IC.
    


Intervention name(s): aerobic+resistance exercise training program
Intervention type(s): Behavioral
Intervention description(s): Personalized exercise program based on the inclusion testing and patient screening will be provided to the patient. The program will consist of a gradual walking program as well as a gradual resistance training program using therabands.
Intervention model: Single Group Assignment
Intervention model description: Patients enrolled in the study receive a novel physiotherapy program.
Masking: None (Open Label)
Primary purpose: Treatment
Effect Of Low Level Laser Therapy on the Rate of En- Masse Retraction: RCT
Condition: Bimaxillary Protrusion
Study type: Interventional

Summary: 
      There is scarcity in the literature regrading the effect of Low Level Laser Therapy (LLLT) on
      the rate of en-masse retraction. This study aims to investigate whether LLLT would affect the
      rate of en-masse retraction in females having bimaxillary dento-alveolar protrusion.
    

Detailed description: 
      Individuals having bimaxillary dentoalveolar protrusion are characterized by proclined upper
      and lower incisors and increased procumbency of the lips thus suffering from poor facial
      esthetics. The conventional management of these patients is the extraction of the first
      premolars and retraction of the anterior teeth.

      One of the treatment techniques is in the form of canine retraction followed by four incisors
      retraction. This conventional method takes tedious work and tremendous time, thus affecting
      the patients' satisfaction adversely. The other technique is retraction of the whole set of
      anterior teeth as one unit (Canine and incisors), which is referred to as "En-Masse
      retraction".

      Enhancing the rate of orthodontic tooth movement has always been a supreme goal of
      orthodontic research hoping to raise the level of care delivered to patients, hence, increase
      patients' satisfaction.

      One of the proposed modalities of increasing the rate of tooth movement is Low Level Laser
      Therapy (LLLT). Thus, the aim of the current consideration was to evaluate the impact of LLLT
      on the rate of en-masse retraction in adult females having bimaxillary dentoalveolar
      protrusion.
    

Intervention name(s): En- masse retraction and LLLT; En- masse retraction without LLLT
Intervention type(s): Procedure; Procedure
Intervention description(s): Retraction will start on a 0.019"x0.025" Stainless steel wire using NiTi closed coils (force applied will be 200 g per side) extending between the crimpable hooks and the TADs. LLLT will be applied on days 0,3,7,14 from extraction then repeated biweekly till the end of retraction.; Retraction will start on a 0.019"x0.025" Stainless steel wire using NiTi closed coils (force applied will be 200 g per side) extending between the crimpable hooks and the TADs.
Other intervention name(s): Laser group; Group A; No laser group; Group B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: En-masse retraction; Rate of tooth movement; Low Level Laser Therapy (LLLT); 3D
Applications Site Reactions After Injection of Insulin Detemir and Saline in Subjects With Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare application site reactions after superficial and deep subcutaneous and intradermal
      injections of insulin detemir and saline in patients with diabetes

      - The patient serves as his own control, n=100 patients with diabetes
    


Intervention name(s): insulin detemir; saline
Intervention type(s): Drug; Drug
Intervention description(s): 3 cutaneous injections; 3 cutaneous injections
Intervention MeSH terms: Insulin Detemir
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic