bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot study is designed to explore the optimal concentration and method of Ginkgolides
      Meglumine Injection skin testing and to evaluate the value of skin test in predicting any
      possible allergic reactions to Ginkgolides Meglumine Injection.
    

Detailed description: 
      Subjects will be enrolled in one of three groups with different doses to receive skin prick
      testing. Then they may be arranged to receive intradermal, subcutaneous injection or
      intravenous tests with different doses.
    

Intervention name(s): 0.1mg/ml Ginkgolides Meglumine Injection; 1mg/ml Ginkgolides Meglumine Injection; 5mg/ml Ginkgolides Meglumine Injection
Intervention type(s): Drug; Drug; Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Allergy; Skin test; Ginkgolides Meglumine Injection
A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006 Tablets in Healthy Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics,
      Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of
      RLD2001-2 and RLD2006 Tablets in Healthy Subjects
    


Intervention name(s): HCP1904-1; RLD2006; RLD2001-2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Take it once per period.; Take it once per period.; Take it once per period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Group Cognitive Behavioral Therapy (CBT) Intervention for Women With Mild to Moderate Depression
Condition: Depression; Anxiety
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to develop a structured CBT group intervention for women with
      depression of mild or moderate severity and to pilot a randomized controlled trial to compare
      this intervention with usual care in socially deprived areas in Bristol, incorporating
      qualitative methods to assess acceptability.
    


Intervention name(s): Brief CBT Group therapy
Intervention type(s): Behavioral
Intervention description(s): CBT based therapy also expert patient programme
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Behavioral Therapy; expert patient programme; deprived population; women
Effects of Physical Activity on Weight Loss and Weight Maintenance in Obese Adults - Three Year Follow-up Study
Condition: Obesity; Weight Loss; Physical Activity; Healthy Obesity, Metabolically
MeSH terms: Obesity; Obesity, Metabolically Benign; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      Objective To study if exercise added to weight loss treatment at the beginning of the weight
      loss intervention or at 6 months could sustain the weight loss achieved or give extra boost
      for weight reduction.

      Design 36-month, 4-group parallel, randomized trial.

      Setting Oulu, Finland.

      Participants 120 obese adults (body mass index ≥ 30).

      Intervention Participants were randomly assigned to behavioural modification (iBM) (n = 30),
      behavioural modification + exercise from 0 to 3 months (CWT1) (n = 30), behavioural
      modification + exercise from 6 to 9 months (CWT2) (n = 30), and a control group (CON) (n =
      30). Questionnaires and measurements were performed at baseline, 3,9,4 and 36 months. The
      intervention consisted of an intensified weight loss period (1-12 months) followed by a
      weight maintenance period (13-36 months). Intensified behavioural modification included 14
      individual face to face meetings, eleven times with a personal therapist (qualified nurse)
      and three times with a nutritionist. Weight maintenance period included six individual
      meetings with personal therapist. Twelve weeks supervised exercise was offered three times a
      week, 40 minutes at a time. In the CWT1 group supervised exercise was offered at months 1-3
      and in the CWT2 group at months 4-6.

      Measurements Body weight (primary outcome) and waist circumference (secondary outcome)
    


Intervention name(s): Lifestyle modification
Intervention type(s): Behavioral
Other intervention name(s): Lifestyle modification and exercise 1; Lifestyle modification and exercise 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Weight loss; Weight maintenance; Physical activity; Fitness
Study of Freeze-dried Black Raspberry in Maintenance of Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is about adding Black Raspberry powder to the treatment regimen of
      patients with ulcerative colitis who are currently in remission and doing well.
    


Intervention name(s): Freeze-dried black raspberry powder
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stress Reactivity as a Determinant in Co-occurring Alcohol Use and Anxiety Disorder: Diagnosis and Alcohol Use Outcomes
Condition: Alcohol Use Disorder; Anxiety Disorder/Anxiety State; Stress Disorder; Hypothalamic Pituitary Adrenal; Drinking to Cope
MeSH terms: Alcoholism; Anxiety Disorders; Alcohol Drinking
Study type: Observational

Summary: 
      Alcohol dependence is among the most common and costly public health problems affecting the
      nation. Among individuals with alcohol use disorder (AUD), those with (vs. without) a
      co-occurring anxiety disorder (AnxD) are as much as twice as likely to relapse in the months
      following AUD treatment. Dysregulation of biological stress-mood systems predict and
      correlate with AUD relapse and AnxD symptomatology. In contrast, stress system re-regulation
      correlates with improved AUD treatment outcomes but has not been examined with respect to AUD
      recovery and relapse in co-occurring AUD+AnxD.
    

Detailed description: 
      The objectives of the proposed research are to 1) evaluate the effect of co-occurring AnxD on
      the severity of biological stress-mood system dysregulations in AUD inpatients at
      pre-treatment, 2) evaluate the effect of co-occurring AnxD on the persistence of stress-mood
      system dysregulations in AUD inpatients in the months following treatment, 3) evaluate the
      effects of treatment on biological stress-mood system re-regulation among AUD patients with
      co-occurring AnxD, and 4) evaluate the effect of re-regulation change in biological
      stress-mood system function on AUD clinical outcomes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of 1) inpatients receiving treatment for an alcohol use
        disorder 2) healthy controls recruited from the community.
Real Time Myocardial Contrast Echocardiography and Dobutamine Stress Perfusion Magnetic Resonance Imaging
Condition: Kawasaki Disease; Heart Disease
MeSH terms: Heart Diseases; Mucocutaneous Lymph Node Syndrome
Study type: Observational

Summary: 
      The present study is designed to:

        1. investigate the safety and efficacy of Real time myocardial echocardiography (RT-MCE) in
           adolescents and adults ages 12-50 with congenital and acquired congenital heart disease

        2. compare RT-MCE with dobutamine stress perfusion MR for determination of coronary flow
           reserve and ventricular wall motion

        3. assess regional myocardial mechanics using myocardial speckle tracking and MR tagging.

        4. evaluate RV volume and function for a subset of subjects using novel reconstruction
           software
    

Detailed description: 
      Individuals will be identified from the cardiology database and consented during their
      routine follow up visits. Exercise stress, transthoracic echocardiography and cardiac MR are
      part of standard medical care in the follow up evaluation of adolescents and adults with
      repaired congenital heart disease. The use of contrast (with transthoracic echocardiography)
      and dobutamine stress testing (with the cardiac MR) will be performed as part of the research
      study. After signing consent/ assent, a study subject will have pertinent medical history
      (e.g. past palliation and operative repair dates and type, current medications, review of
      systems) and physical exam findings extracted from the medical record, especially the
      recording of the most recent clinic visit. If the subject is a female of child bearing age, a
      serum pregnancy test will be done at this time. This data will be recorded using standardized
      case report forms for history and physical exam. The study patients will complete a
      standardized interview to determine their exercise tolerance according to New York Heart
      Association (NYHA) classification. All patients who consent to the additional testing will
      require an additional 1 hour of time to the regular Echo and CMR testing.

      Each patient will have the protocol supine bicycle stress with contrast echocardiogram
      performed at UNMC Echo lab.. The study subject will then have the clinically indicated CMR
      study (Philips Achieva 1.5T magnet), scheduled and performed by a qualified CMR technologist,
      working with a pediatric or adult cardiologist. An attempt will be made to have CMR and Echo
      performed on the same day to minimize physiologic variability, but will at least be done
      within 1 week each other. Further post-processing (wall motion analyses, speckle tracking and
      myocardial tagging) and image analyses will be performed by the principal investigators on
      standard workstations.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ages 12-50 with congenital and acquired congenital heart disease.
A Study of a Long-Acting r-Factor 7a (Factor VIIa) in Adult Men With Hemophilia A or B
Condition: Hemophilia A; Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the current Phase 1/2a single dose, dose-escalating study is to evaluate the
      acute safety, pharmacokinetics (PK) and pharmacodynamics (PD) properties of MOD-5014 in adult
      subjects with moderate/severe congenital hemophilia A or B. This will be a single-dose, open
      label, dose-escalating study. Each dose cohort will be concluded by a safety review,
      following which escalation to the next dose cohort will be approved.
    


Intervention name(s): MOD-5014
Intervention type(s): Drug
Intervention description(s): Long Acting Factor VIIa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemophilia; Factor VII; Factor VIIa; Inhibitors; Long Acting
Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem
Condition: Primary Total Hip Arthroplasty
Study type: Observational

Summary: 
      Summary from initial protocol

      Goal: Validation of the uncoated SL-PLUS® MIA stem within an observation study

      Study design: prospective, single-center, observational, non-comparative study

      Study population: 135 consecutive cases (uncoated SL-PLUS® MIA implants)

      Intervention (if applicable): Implantation of a total hip endoprosthesis

      Main goals/endpoints: Radiological: radiolucent lines, osteolysis, hypo- and hypertrophy of
      the cortex, loosening of the implant or migration; clinical: Harris Hip Score,
      implant-related complications, revisions; patient questionnaire (WOMAC)

      Type and extent of the risks associated with the study participation as well as benefits for
      the patient: All patients will benefit from the hip prostheses without exception. There are
      no increased risks for the patients participating in the study compared to patients who do
      not participate. Normal, necessary follow-up exams will be performed over the course of 10
      years. These follow-up exams will then be quantitatively evaluated within the scope of the
      study in accordance with a standardized protocol. Accordingly, the benefit for the patients
      from the participation in the study is currently not yet foreseeable.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        135 consecutive cases (uncoated SL-PLUS® MIA implants)
      
Keywords: Uncoated SL PLUS® MIA stem
Percutaneous Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of irreversible
      electroportion in unresectable liver cancer close to diaphragmatic dome.
    

Detailed description: 
      Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation
      (IRE) as the sole treatment of liver cancer close to diaphragmatic dome.

      This pilot study was designed to study the feasibility and safety of treatment as an
      alternative therapeutic IRE in the treatment of neoplastic nodules in the liver, with
      particular reference to close to diaphragmatic dome, where the current therapeutic arsenal is
      inadequate or counter-indicated.

      To perform the IRE procedure the IRE NanoKnife™ System (AngioDynamics) will be used.
    

Intervention name(s): Irreversible electroporation (IRE)
Intervention type(s): Device
Intervention description(s): Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels,bile ducts and diaphragmatic dome.
Other intervention name(s): NanoKnife
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Lymph Node Mapping in Patients With Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional

Summary: 
      This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph
      node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer
      staging and treatment.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To estimate the negative predictive value of pelvic sentinel lymph node (SLN) in
      endometrial cancer to predict nodal metastasis.

      SECONDARY OBJECTIVE:

      II. To examine the ability of sentinel lymph nodes to increase the detection of metastatic
      disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC
      results and standard hematoxylin and eosin (H&E) results.

      OUTLINE:

      Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine
      green solution and isosulfan blue and sentinel lymph node biopsy and detection of sentinel
      lymph nodes is noted in the within 30 minutes of injection of the dye, followed by full
      pelvic lymph node dissection and aortic lymph node dissection as indicated, and standard
      hysterectomy and salpingo-oophorectomy.

      After completion of study treatment, patients are followed up every 3 months for 2 years,
      every 6 months for 3 years for a total of 5 years according to the standard surveillance
      guidelines for endometrial cancer.
    

Intervention name(s): sentinel lymph node detection; indocyanine green solution; isosulfan blue; sentinel lymph node biopsy
Intervention type(s): Procedure; Drug; Drug; Procedure
Intervention description(s): Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue; Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue; Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue; Undergo sentinel lymph node biopsy
Other intervention name(s): IC-GREEN; ICG solution; Lymphazurin; N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide; sentinel node biopsy
Intervention MeSH terms: Pharmaceutical Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Endometrial Cancer; Robotic-Assisted Staging
A Second Study of NicVAX/Placebo as an Aid for Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term
      abstinence.
    


Intervention name(s): NicVAX Vaccine; Placebo Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): NicVAX vaccine given 6 times over 6 months; Placebo vaccine given 6 times over 6 months
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking Cessation; NicVAX; Smoking Vaccine; Smoking Abstinence; Smoking; Tobacco Cessation
MicroRNA-126 and Its Target VCAM-1Dermatitis to Nickel
Condition: Allergic Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
Study type: Observational [Patient Registry]

Summary: 
      Background. Allergic Contact Dermatitis (ACD) is an inflammatory skin disease mediated by
      direct contact with allergens as nickel, the most common allergen, that may be related with
      epigenetic changes.

      Objective. Evaluate the miR-126 expression and its target VCAM-1, in the skin of patients
      with ACD to nickel.

      Methods. Fifteen patients with positive patch test to nickel were included, and the
      expression of miR-126 and VCAM-1 was evaluated by RT-qPCR.
    

Detailed description: 
      Patients that went to the dermatology and outpatient department of the Central Hospital "Dr.
      Ignacio Morones Prieto ", with a suspected diagnosis of nickel allergic contact dermatitis,
      were invited to participate in this study. Later, the objective and methodology of the study
      were explained to them, as well as the advantages of participating and the possible
      undesirable effects. All patients signed the informed consent previous perfom the medical
      history. After, the epicutaneous patch test was performed, and patients were divided
      according to the result them. Finally, under local anesthesia, two 3-mm punch biopsies, from
      lesional (positive parch test site) and adjacent non lesional skin, 10 cm apart, were
      performed. Tissues for reverse transcriptase real-time polymerase chain reaction (RT-qPCR)
      analyses were stored frozen in sterile tubes at 80ºC until processing
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female and male patients with allergic contact dermatitis for more than one year
      
Biospecimen description: 
      skin biopsies
    
Keywords: allergic contact dermatitis; nickel; microRNAs; VCAM-1
Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome
Condition: Down Syndrome; Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Many individuals with Down syndrome (DS) have breathing problems during sleep. This is called
      obstructive sleep apnea syndrome (OSAS). OSAS is very common in individuals with Down
      syndrome because of the shape of their face and tongue and because of their low muscle tone.
      OSAS can cause a lot of health problems including behavioral and learning problems as well as
      heart problems.

      The purpose of this research study is to look at the effects of treating OSAS in individuals
      with Down syndrome with a machine called Continuous Positive Airway Pressure (CPAP). The
      investigators want to see if treatment of OSAS improves learning, behavior and heart
      problems.
    

Detailed description: 
      All individuals participating in the study will be evaluated for obstructive sleep apnea
      syndrome (OSAS) with a baseline sleep study. Based on the results of the sleep
      study,individuals with OSAS will be randomly assigned into two groups. One group will receive
      continuous positive airway pressure (CPAP) and the other intervention group will receive sham
      CPAP(placebo) for four months. CPAP is a machine with a mask that fits over the nose, is worn
      during sleep and helps keep the airway open. Sham CPAP (placebo) is a machine that looks and
      sounds like a CPAP machine but does not give pressure so it does not treat OSAS. Individuals
      with normal breathing during the sleep study will not receive a machine, and will serve as
      controls.

      Individuals will also have baseline tests including blood tests, an echocardiogram (pictures
      of the heart), a walking test and learning tests. After 4 months, the baseline tests will be
      repeated in all participants. At the end of the study, all individuals with OSAS will get
      treatment.
    

Intervention name(s): Continuous positive airway pressure; Sham or placebo continuous positive airway pressure
Intervention type(s): Device; Device
Intervention description(s): Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open.; Sham or placebo CPAP is a machine used instead of therapeutic CPAP. This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS.
Other intervention name(s): CPAP; Sham or placebo CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Down syndrome; Obstructive sleep apnea syndrome; Continuous positive airway pressure; sham or placebo CPAP