bioihbjkbjnl/mcl2 huggingface dataset:
Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease
Condition: Gaucher's Disease; Osteopenia
MeSH terms: Bone Diseases, Metabolic; Gaucher Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES:

      I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone
      density and focal bone lesions) in patients with Gaucher's disease.
    

Detailed description: 
      PROTOCOL OUTLINE:

      This is a randomized, double blind, placebo controlled study.

      All patients receive oral calcium carbonate and cholecalciferol daily. Patients are
      randomized to receive oral alendronate sodium or placebo daily for 24 months.

      Patients are followed every 6 months for 2 years.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): alendronate sodium; calcium carbonate; cholecalciferol
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cholecalciferol; Vitamin D; Alendronate; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Gaucher's disease; inborn errors of metabolism; rare disease; sphingolipidoses
Comparison of Two Mechanical Ventilation Modes on Oxygenisation
Condition: Bariatric Surgery Candidate; Mechanical Ventilation; Hypoxia; Tissue Damage
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      Comparison the effect of two different mechanical ventilation modes on tissue oxygenization.
    

Detailed description: 
      Aim of the study is to evaluate and compare the effects of two different mechanical
      ventilation modes as Volume Controlled Mechanical Ventilation (VCV) and Pressure Controlled
      Mechanical Ventilation (PCV) on non invasive tissue oxygenization levels of patients who
      scheduled for bariatric surgery.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study population involves the elective bariatric surgery patients who have body mass index
        between 35 and 50 kg/m2.
      
Keywords: bariatric surgery, tissue oxygenization, ventilation
Validation of an Environmental Exposure Chamber for Inhalation Studies With House Dust Mite Allergen in Patients With Allergic Rhinitis
Condition: Allergy to House Dust Mite
MeSH terms: Rhinitis; Rhinitis, Allergic; Dust Mite Allergy
Study type: Interventional

Summary: 
      This clinical validation study is aimed at testing the efficacy of a new environmental
      challenge chamber (ECC) to induce symptoms of allergic rhinitis in patients allergic to house
      dust mite. The symptoms will be recorded on a validated symptom score as Total Nasal Symptom
      Score (TNSS), allowing for determine whether the challenge is dose dependent and
      reproducible.
    

Detailed description: 
      At Fraunhofer ITEM, a novel technique to create an atmosphere loaded with allergenic
      particles was recently developed. In brief, particles are produced in a combined process of
      nebulization and drying of a solution containing soluble allergenic extracts and lactose. The
      particle size distribution is regulated by the droplet size distribution and the lactose
      concentration in the solution, while the allergen content can be chosen independently. Thus,
      the Fraunhofer scientists have created a universal tool which provides them with the
      possibility to create atmospheres containing allergenic particles of arbitrary sizes
      containing a variety of different allergens. By choosing particle sizes preferentially
      depositing in the nose (above 10 µm) or the lungs (5 to 10 µm), and selecting allergen
      concentrations commonly found in the environment, it is possible to build up challenge
      atmospheres for a large variety of indications.

      The first clinical application of this new method will be to create an atmosphere simulating
      the natural exposure to house dust mite allergens. The challenge aerosol will be composed of
      lactose as carrier material and the two major allergens Der p1 and Der p2 of house dust mites
      originating from a licenced allergen extract for inhaled challenge.
    

Intervention name(s): Exposure to house dust mite
Intervention type(s): Procedure
Intervention description(s): 0 SQE/qm for 4 hours 250 SQE/qm for 4 hours 500 SQE/qm for 4 hours 1000 SQE/qm for 4 hours
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: allergen provocation; environmental challenge; allergen chamber; house dust mite; immunotherapy
A Study to Evaluate the Safety of H1N1 Monovalent Vaccine (MEDI3414) in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine the safety and descriptive immunogenicity of the
      H1N1 influenza vaccine in healthy adults.
    

Detailed description: 
      The primary objective of this study was to assess the safety and descriptive immunogenicity
      of a monovalent influenza virus vaccine containing a new 6:2 influenza virus reassortant in
      healthy adults.
    

Intervention name(s): MEDI3414 [Influenza A/H1N1 live attenuated, intranasal]; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 0.5 mL; (intranasal sprayer); (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer)
Other intervention name(s): MEDI3414
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Multicenter Trial to Assess the MIcrovascular Integrity and Left Ventricular Function Recovery After Clopidogrel or TicagrelOr Administration, in Patients With STEMI Treated With Thrombolysis - The 'MIRTOS' Study
Condition: Myocardial Infarction; ST Segment Elevation Myocardial Infarction (STEMI)
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective randomized study, which investigates the coronary microvascular
      function as assessed by coronary angiography after administration of ticagrelor compared with
      clopidogrel in patients with myocardial infarction and ST segment elevation after
      thrombolysis.
    


Intervention name(s): Ticagrelor; Clopidogrel; Percutaneous Coronary Intervention (PCI); Coronary Angiography
Intervention type(s): Drug; Drug; Procedure; Procedure
Other intervention name(s): Brilique; Plavix
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: undergoing thrombolysis
A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women
Condition: Hemostasis; Oral Contraceptive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive
      compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy
      women.
    


Intervention name(s): desogestrel/ethinyl estradiol and ethinyl estradiol; desogestrel/ethinyl estradiol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Desogestrel; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Contraception; Hemostasis; Blood Coagulation
Safety and Effect Study of SHR0532 (Drug Code) Tablets in Patients With Mild Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to evaluate the safety and efficacy and
      Pharmacokinetics/Pharmacodynamics of SHR0532 in subjects with mild hypertension for 4 weeks.
    

Detailed description: 
      This is a randomized, double-blind, multiple ascending dose, placebo- and
      Hydrochlorothiazide-controlled study to evaluate the safety and tolerability,
      Pharmacokinetics and Pharmacodynamics and effect on blood pressure of SHR0532 tablets in
      patients with mild hypertension.
    

Intervention name(s): SHR0532; SHR placebo; Hydrochlorothiazide 25 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): once daily(QD) for 4weeks; once daily(QD) for 4weeks; once daily(QD) for 4weeks
Intervention MeSH terms: Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
This Study in Healthy Men and Women Tests How the Body Takes up BI 409306
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the absolute bioavailability of BI
      409306. The secondary objective is the evaluation and comparison of several pharmacokinetic
      parameters for the different treatments.
    


Intervention name(s): BI 409306 (C-13/N-15); BI 409306
Intervention type(s): Drug; Drug
Intervention description(s): i.v solution; Film-coated tablet
Intervention MeSH terms: BI 409306
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cerebellar rTMS to Improve Gait Recovery
Condition: Stroke; Gait, Hemiplegic
MeSH terms: Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      The cerebellum is known to be strongly implicated in the functional reorganization of motor
      networks in stroke patients, especially for gait an balance functions. Repetitive
      transcranial magnetic stimulation of the cerebellum can be used to enhance these adaptive
      processes in stroke recovery. In this randomized, double blind, sham-controlled trial we aim
      to investigate the efficacy and safety of cerebellar intermittent theta burst stimulation
      coupled with intensive physical therapy in promoting gait recovery in hemiparetic patients
      due to recent stroke in the territory of the contralateral middle cerebral artery
    


Intervention name(s): REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION
Intervention type(s): Device
Intervention description(s): theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression (LTD) in animal models. Whereas continuous TBS (cTBS) induces long-lasting inhibition of cortical areas, iTBS exerts the opposite effect, increasing cerebellar excitability
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Optimal management of patients with locally advanced breast cancer remains a complex
      therapeutic problem. Newly diagnosed breast cancers in the United States with a higher
      incidence in medically underserved areas. The optimal intensity and duration of neoadjuvant
      chemotherapy still remains controversial due to the difficulty of evaluating response to
      therapy. The goal would be to prevent over and under treatment of patients with neoadjuvant
      chemotherapy.
    

Detailed description: 
      The Researcher developed a diagnostic device called Diffuse Optical Spectroscopy Imaging is a
      non-invasive optical technique that utilizes intensity-modulated, near-infrared light to
      quantitatively measure optical properties in thick tissues.

      Diffuse Optical Spectroscopy Imaging can images tissue hemoglobin , oxygen saturation, blood
      volume fraction, water content, fat content and cellular structure. The measurements provide
      quantitative optical property values that reflect changes in tissue perfusion, oxygen
      consumption, and cell/matrix development.

      There is no therapeutic benefit to the subject, especially none that might influence the
      indication for the diagnostic procedure as indicated. However, information obtained may lead
      to a new form of non-invasive imaging for the early detection of breast cancer.
    

Intervention name(s): Diffuse Optical Spectroscopy Imaging
Intervention type(s): Device
Intervention description(s): Diffuse Optical Spectroscopy Imaging
Intervention model: Single Group Assignment
Primary purpose: Device Feasibility
Keywords: Breast cancer receiving chemotherapy
Hemospray Versus the Combined Conventional Technique for Endoscopic Hemostasis of Bleeding Peptic Ulcers : A Pilot Study
Condition: Bleeding Peptic Ulcers
MeSH terms: Peptic Ulcer; Peptic Ulcer Hemorrhage; Ulcer; Hemorrhage
Study type: Interventional

Summary: 
      Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), a new adsorptive nanopowder
      hemostatic agent for endoscopic treatment of high-risk bleeding peptic ulcers, provides
      significant ease of administration compared to the combined conventional technique of
      saline-adrenaline injection with mechanical clip or heater probe applications. The Hemospray
      powder is easily applied on ulcers at difficult endoscopic positions and ulcers with fibrotic
      bases, where the combined conventional technique has limited efficacy. Building up on
      preliminary work from small single-arm studies, the investigators aim to establish the
      efficacy and safety of Hemospray in treating bleeding peptic ulcers in comparison with the
      combined conventional technique. The investigators propose a pilot study to establish our
      centre's feasibility of performing a prospective, randomized, parallel group trial, which
      compares the efficacy of Hemospray with the combined conventional technique, in the
      endoscopic treatment of high-risk bleeding peptic ulcers. Patients with high-risk bleeding
      peptic ulcers will be treated with Hemospray to determine its initial hemostasis rate
      (defined as endoscopically verified cessation of bleeding for at least 5 minutes after
      endoscopic treatment), rebleeding rate (recurrent hemorrhage during a 4-week period following
      the initial hemostasis) and its safety profile.
    


Intervention name(s): Hemospray; Combined Conventional Technique
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Influence of Injection Speed on Pain During Administration of Local Anaesthetic.
Condition: Needlestick Injuries
MeSH terms: Needlestick Injuries
Study type: Interventional

Summary: 
      This study will investigate the influence of injection speed on pain during injection of
      lidocaine. It is anticipated that a longer injection time will lead to less pain for the
      patient during the injection. This hypothesis will be tested on healthy volunteers, who will
      each receive three injections with the same amount of lidocaine subcutaneously on the
      abdomen. The injections will be given over 15, 30 and 45 seconds. After each injection, the
      subject will be asked to evaluate the pain on a Visual analog scale (0-100 mm). The aim of
      the study is to find a simple method for pain reduction that can be used in clinical
      practice.
    


Intervention name(s): Normal speed lidocaine injection; Slow lidocaine injection; Fast lidocaine injection
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 30 seconds; speed 45 seconds; speed 15 seconds
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Injections; Time factors; Pain; Healthy volunteers; Lidocaine
Study to Determine the Impact of Multiple Doses of Rifampin on Single-dose Pharmacokinetics of HCV-796
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, 2-period, sequential study to determine the impact of multiple doses of
      rifampin on single-dose pharmacokinetics of HCV-796
    


Intervention name(s): Rifampin
Intervention type(s): Drug
Intervention MeSH terms: Rifampin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Genetic Basis of Odor Discrimination
Condition: Non-smokers
Study type: Observational

Summary: 
      Prior to the main study we will perform a pilot study on 60 subjects. The purpose of the
      pilot study is to identify the range of odor concentrations that will be used in the main
      study and to optimize the tasks performed in the main study.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy volunteers
      
Biospecimen description: 
      Blood sample taken
    
Keywords: Odor Discrimination
Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      This study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the
      treatment of dentine hypersensitivity.
    


Intervention name(s): Mouthrinse (IQP-OLP-101)
Intervention type(s): Other
Intervention description(s): Rinse/gargle 10mL of Mouthrinse for 60 seconds after tooth brushing, twice a day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Intralesional Tranexamic Acid and Platelets Rich Plasma in the Treatment of Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional
Phase: Phase 1

Summary: 
      ABSTRACT Objective: To study the efficacy while comparing Intralesional tranexamic acid Vs
      Platelets rich plasma (PRP) in treatment of Melasma.

      Study design: Randomized-controlled trial (RCT). Study setting and duration: Dept of
      dermatology, CMH-Abbottabad, Nov-2022 /April-2023.

      Methodology: The sample size of 60 patients 20 to 40 years were calculated by using Openepi
      App. The informed consent was taken. The patients were randomly allocated to two groups:
      Group A (30 patients injected with Intradermal Tranexamic acid (4mg/ml) and Group B (30
      patients treated with PRP (1ml) intra-dermally, every fourth week for up to 12 weeks between
      both groups). The mMASI scale was used to evaluate all patients. The final evaluation was
      performed on the 24th week of follow-up. For analysis Statistical Package for the social
      sciences version-27 was used. To determine statistical significance a paired t-samples test
      with a p-value of < 0.05 was applied.
    


Intervention name(s): Tranexamic acid; Platelets rich plasma
Intervention type(s): Drug; Drug
Intervention description(s): Group A 30 patients treated with Intradermal Tranexamic acid injection (4mg/ml) for preparation an insulin syringe was used with a volume of 1ml containing 0.04 ml of TXA and the reminder being normal saline to ensure 4mg preparation in each insulin syringe; Group B 30 patients prescribed with PRP (1ml) intra-dermally PRP was obtained manually by a two-step procedure using a centrifuge machine. First spin was performed at 1500 RPM for 10 minutes. Second spin was performed at 4000 RPM for 10 minutes. Thus, obtaining a two-part plasma. Upper two third was platelet poor plasma and was discarded. Lower one third was platelets rich plasma. Before injection applying 0.1 ml calcium chloride was added for each 1 ml of PRP to activate the platelets. PRP was injected 1 ml by using 30 G needle (insulin syringe) in each cm2 of melasma.
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Sertraline on Brain Connectivity in Adolescents With OCD
Condition: OCD
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators will examine how treatment with sertraline for 12 weeks impacts
      frontal-striatal-thalamic circuitry (FSTC) in this OCD sample.
    

Detailed description: 
      To examine FSTC using advanced multi-modal imaging techniques, including resting-state
      functional magnetic resonance imaging (R-fMRI) and high angular resolution diffusion imaging
      (HARDI), in 25 medication-free adolescents youths with OCD (ages 8-17) in comparison with 25
      matched healthy controls.

      Hypotheses: (A) Based on the pilot data, adolescents youths with OCD will show lower
      functional connectivity in FSTC at baseline when compared with controls, and , lower
      functional connectivity in FSTC will correlate with greater severity on CY-BOCS. (B)
      Adolescents Youths with OCD will also show abnormalities in structural connectivity in FSTC
      at baseline when compared with controls, and structural and functional connectivity will be
      related. (C) The investigators will explore relations between OCD dimensions and functional
      connectivity measures, and predict that the repeating/ordering dimension will correlate with
      orbitofrontal cortex (OFC) connections, hoarding will correlate with rostral anterior
      cingulate cortex (ACC) connections, and forbidden thoughts will correlate with caudal ACC
      connections.

      To investigate how sertraline impacts functional connectivity in FSTC in adolescents with
      OCD.

      Hypothesis: After 12 weeks of sertraline treatment, functional connectivity measures within
      FSTC for the OCD group will (on average) increase compared to baseline and will no longer be
      significantly different when compared with controls. Non-responders may show a different
      pattern (i.e. failure to show these changes).
    

Intervention name(s): Sertraline; No Intervention
Intervention type(s): Drug; Other
Intervention description(s): Impact of sertraline on functional brain connectivity; Healthy control non-intervention
Other intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: OCD