bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Topical Minoxidil 5% in Ethanol Plus Propylene Glycol Versus Minoxidil 5% in Ethanol Alone in Treatment of Women With Female Pattern Hair Loss
Condition: Female Pattern Hair Loss
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will be included 60 women with FPHL. The diagnosis of FPHL will be established by
      clinical (Ludwig classification) and trichoscopic evaluation of frontal and occipital regions
      of the scalp.
    

Detailed description: 
      Enrolled women will be randomly assigned into 3 treatment groups: group A will apply topical
      minoxidil 5% in 90% ethanol and 5% propylene glycol, group B will apply topical minoxidil 5%
      in pure ethanol alone and group C will apply pure ethanol (placebo) twice daily.

      The treatment will be continued for six months with regular visits at 3 months intervals.

      The medications will be provided in bottles which were identical in shape and color, and were
      coded by a third party.

      Both patients and investigator will be blinded to the medication. Disclosure of the codes
      will be done, by a third party, at the end of the study.
    

Intervention name(s): Topical minoxidil 5% in 90% ethanol and 5% propylene glycol; Topical minoxidil 5% in pure ethanol alone; Placebo (Ethanol)
Intervention type(s): Drug; Drug; Other
Intervention description(s): The treatment will be continued twice daily.for six months with regular visits at 3 months intervals.; The treatment will be continued twice daily.for six months with regular visits at 3 months intervals.
Other intervention name(s): Topical minoxidil 5% with 90% ethanol and 5% propylene glycol; Topical minoxidil 5%
Intervention MeSH terms: Ethanol; Minoxidil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be to compare the efficacy of topical minoxidil 5% solution in ethanol plus 5% propylene glycol (PG), as a vehicle, versus 5% minoxidil in ethanol alone in treatment of women with FPHL.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Female pattern hair loss; Minoxidil.
A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During Infancy
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the long-term persistence of immunity to hepatitis B
      in adolescents aged 14-15 years who were vaccinated with four doses of Infanrix™-Hexa in the
      first two years of life and to assess the anamnestic response, immunogenicity, safety and
      reactogenicity of a single challenge dose of the hepatitis B vaccine Engerix™-B Kinder.
    


Intervention name(s): Engerix-B Kinder
Intervention type(s): Biological
Intervention description(s): Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 14-15 years of age.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B antibodies; Safety; Challenge dose; Persistence; Engerix B Kinder; Infanrix hexa; Immunogenicity; Adolescents
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 1356 BS in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BI
      1356 as formulation for intravenous administration
    


Intervention name(s): BI 1356 BS - intravenous; BI 1356 BS - Tablet; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Validation of a Scale of Self-assessment of Fear Faces in Children 4 to 12 Years
Condition: Fear
Study type: Observational

Summary: 
      Since the 2000s, the experiences of children and especially their fear during a consultation,
      a treatment or examination is food for thought in our establishment. There is no tool
      validated self-assessment of fear to 6 faces. It therefore appeared necessary to us to create
      this tool. The scale self-assessment of the fear that we have developed consists of six faces
      representing a gradual level of fear: the child can easily describe their level of fear,
      which allows for appropriate care.
    


Intervention name(s): Placing a scale self-assessment of fear
Intervention type(s): Other
Intervention description(s): Children spend a self-assessment scale of fear
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participating in the study of children aged 4 to 12 years. In this study, participation of
        school children and hospitalized children
      
Keywords: scary scale
Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults
Condition: Virus Diseases; RNA Virus Infections; Respiratory Tract Diseases; Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Respiratory Tract Infections; RNA Virus Infections; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to assess the safety and tolerability of two consecutive doses of
      plant-based H5 VLP, (H5N1) pandemic influenza vaccine combined with Alhydrogel®, given 21
      days apart, at three dose levels: 5µg, 10µg and 20µg., compared to the placebo, and combined
      with Alhydrogel®.
    


Intervention name(s): H5 VLP pandemic influenza vaccine 5 µg; H5 VLP pandemic influenza vaccine 10 µg; H5 VLP pandemic influenza vaccine 20 µg; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, IM, 2 injections 21 days apart; 0.5 mL, IM, 2 injections 21 days apart; 0.5 mL, IM, two injections 21 days apart; 0.5 mL, IM, two injections 21 days apart
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pandemic vaccine; influenza; H5N1; Virus Like Particle (VLP)
The Effect of Dexmedetomidine on Postoperative Analgesia
Condition: Colon Cancer, Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether additional Dexmedetomidine to patient
      controlled analgesia can reduce fentanyl consumption.
    


Intervention name(s): Fentanyl; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): Fentanyl 2500mcg+NS50ml; Fentanyl 2500mcg+Dexmedetomidine 500mcg + NS 45ml
Intervention MeSH terms: Fentanyl; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to assess the effect of the combination treatment on
      C-reactive protein and inflammatory markers as well as the safety and tolerability in a
      Spanish population
    


Intervention name(s): fluvastatin, ezetimibe
Intervention type(s): Drug
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dyslipidemia, ezetimibe, inflammatory markers, fluvastatin
The Role of Serum Anticholinergic Activity in ACVB Patients
Condition: Acetylcholine; Cognition; BIS-EEG
Study type: Observational

Summary: 
      Drugs with anticholinergic potential increase the risk of postoperative transient and
      persistent cognitive dysfunction especially in cardiac patients. The investigators main goal
      is to identify preoperative risk factors and to monitor postoperative patients' state in
      relation to SAA activity and bilateral BIS-EEG changes.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ACVB patients:

        Ages Eligible for Study: 55 years to 90 years Genders Eligible for Study: Both Accepts
        Healthy Volunteers: No
Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus Block in Patients With Paroxysmal Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus (CTI) Block
      in Patients with Paroxysmal Atrial Fibrillation (PAF) will be performed. Study will be
      composed with two arms including 4 pulmonary vein isolation and pulmonary vein isolation with
      CTI block. After that all patients will be followed up by HRS(Heart Rhythm Society) 2010
      expert consensus guideline.
    


Intervention name(s): PVI, CTI block; PVI
Intervention type(s): Procedure; Procedure
Intervention description(s): PVI (pulmonary isolation)
Catheter ablation of cavo-tricuspid isthmus line for treatment of atrial fibrillation
Catheter is inserted into inferior venacava (IVC) and right atrium (RA) via femoral vein. And the procedure is to block bidirectionally between inferior venacava (IVC) and the annulus of tricuspid valve (TV) by using electrical energy of catheter tip.; PVI (pulmonary isolation)
Other intervention name(s): radiofrequency catheter ablation (RFCA), Catheter ablation of cavo-tricuspid isthmus line for treatment of atrial flutter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: atrial fibrillation; atrial flutter; catheter ablation; cavo-tricuspid isthmus block
Prostaglandin F2alpha in a Human Headache Model
Condition: Headache
MeSH terms: Headache
Study type: Interventional

Summary: 
      The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of
      brain vessels.
    


Intervention name(s): Prostaglandin F2alpha; Isoton sodium chloride
Intervention type(s): Drug; Drug
Intervention description(s): intravenous injection; intravenous injection
Other intervention name(s): Dinoprost; placebo
Intervention MeSH terms: Dinoprost; Dinoprost tromethamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Immunohistochemistry Role in Better Prognosis of Endometrial Carcinoma Patients
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional

Summary: 
      The incidence of endometrial cancer (EC) is increasing .Different risk classifications are
      used to direct the primary and adjuvant therapy. The European Society for Medical Oncology -
      European Society of Gynaecological Oncology -European Society for Radiotherapy & Oncology
      (ESMO-ESGO- ESTRO) could guide the need for lymph node surgery pre-operatively, and also
      post-operatively to determine adjuvant treatment.

      Low-risk patients are managed with surgery alone, while higher-risk group patients undergo
      more aggressive surgical options. So, it is important to identify new prognostic markers for
      better stratification of patients to avoid under- or over treatment of EC patients.
    


Intervention name(s): Tissue Biopsy
Intervention type(s): Diagnostic Test
Intervention description(s): The Post-hysterectomy tissue biopsy was analyzed immunohistochemically for detection of estrogen and progesterone receptors, P53 and L1CAM
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Therapeutic Education in Very Young Children With Diabetes Mellitus
Condition: Type 1 Diabetes; Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      DIAB-EDUC tests in a group of young diabetic patients (less than 6 years old) a specific
      educational tool in order to assess its impact on glycemic control, quality of life,
      knowledge about the disease and its daily management, over a period of 2 years. The
      investigators plan to include 300 type 1 diabetic children in 10 french hospitals.
    

Detailed description: 
      General frame : 1 inclusion / randomization visit and delivery of the educational tool for
      patients of the "Therapeutic Education" arm, then follow-up visits every 6 months during 24
      months.

      V0 - Inclusion / randomization visit - Verification of eligibility - Clinical examination and
      data report - Blood samples for lab tests (HbA1c assay)- Collection of signed consent form-
      DIAB-EDUC questionnaire (diabetes knowledge, treatment, quality of life, hypoglycaemia and
      emergency situations, parental stress)- Randomization - Education tool explanation and
      delivery by the physicians to parents randomized in " Experimental " arm

      M6 - Visit at 6 months- Clinical examination and data report- Blood samples for lab tests
      (HbA1c assay)

      M12 - Visit at 12 months- Clinical examination and data report- Blood samples for lab tests
      (HbA1c assay)- DIAB-EDUC questionnaire

      M18 - Visit at 18 months- Clinical examination and data report- Blood samples for lab tests
      (HbA1c assay)

      M24 - Visit at 24 months- Clinical examination and data report- Blood samples for lab tests
      (HbA1c assay)- DIAB-EDUC questionnaire
    

Intervention name(s): Educational tool
Intervention type(s): Other
Intervention description(s): Specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management
Other intervention name(s): Experimental
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Diabetes; Children; Disease management; Ketosis; Hypoglycemia; Parents; Education
A Randomized Controlled HD-tDCS Trial: Effects on Tinnitus Severity and Cognition
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      This randomized, placebo-controlled study will compare the effects of HD-tDCS (a non-invasive
      neuromodulation technique) with a sham stimulation. In the sham situation, patients will
      undergo an identical treatment but no stimulation will be applied, allowing to control for
      placebo effects. This study will assess the effects of HD-tDCS on chronic, non-pulsatile
      tinnitus in a reliable way, as confounding factors such as anxiety, depression, hearing
      impairment, tinnitus gradation, age, and sex will be controlled for. Ultimately, this study
      will result in final recommendations for a standardised protocol for the use of HD-tDCS in
      tinnitus patients. When accurate, individualised, and effective therapy is available for the
      patient, the total cost (both economical and personal) will decrease significantly. The
      investigation's findings will be relevant for all caretakers dealing with tinnitus patients
      (psychologists, psychiatrists, manual therapists, general practitioners, ENT specialists,
      audiologists, etc.).
    


Intervention name(s): tDCS; sham tDCS
Intervention type(s): Device; Device
Intervention description(s): Transcranial direct current stimulation; Sham transcranial direct current stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tinnitus; tdcs; neuromodulation; RCT
The Effect of Allergen Inhalation on Sputum Myeloid and Plasmacytoid Dendritic Cells in Mild Atopic Asthmatics
Condition: Asthma
MeSH terms: Asthma; Respiratory Aspiration
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Summary:

      A picture is emerging of dendritic cells migrating through the blood to the airways following
      allergen inhalation in atopic asthmatics. Although the Koh and McCarthy articles present
      novel findings, both do not provide a comprehensive view of sputum DCs following allergen
      challenge. Therefore, the proposed study will examine the kinetics of mDCs and pDCs in the
      induced sputum of atopic asthmatics following inhalation of allergen.

      Hypothesis:

      Following allergen challenge, sputum myeloid and plasmacytoid DCs will migrate into the
      airway lumen in atopic asthmatics during the timeframe of the late asthmatic response.

      Objective:

      The objective of this study is to examine the kinetics of dendritic cells in induced sputum
      following allergen challenge in atopic asthmatic subjects.
    

Detailed description: 
      Subjects will be put through two study periods. Each study period will consist of four visits
      and will be separated by 2-4 weeks. On the first visit, subjects will undergo screening
      procedures, including complete history and physical examination. In addition, methacholine
      inhalation challenge and skin-prick testing will be preformed to assess airway
      hyper-responsiveness and determine atopic status respectively. Lastly, sputum will be induced
      before challenge (0 hrs) and peripheral blood will be collected. On the second visit,
      subjects will inhale diluent or allergen and sputum will be collected 7 hours following
      inhalation challenge. Next, on the third visit, subjects will return 24 hours following
      inhalation challenge and sputum will be induced. On the final visit, subjects will return 72
      hours following inhalation challenge and sputum will be collected, along with peripheral
      blood.

      Before the next study period begins, there will be a washout period of 2-4 weeks. On the
      first visit of the second study period, a methacholine challenge will be performed to ensure
      the return of PC20 to within one doubling dose of baseline values. Also, sputum will be
      induced before challenge (0hrs) and peripheral blood will be collected. On the second visit,
      subjects will inhale diluent or allergen and sputum will be collected 7hrs following
      inhalation challenge. Next, on the third visit, subjects will return 24 hours following
      inhalation challenge and sputum will be induced. On the final visit, subjects will return 72
      hours following inhalation challenge and sputum will be collected, along with peripheral
      blood.
    

Intervention name(s): Aeroallergen
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: asthma; atopy; allergen challenge; sputum myeloid and plasmacytoid dendritic cells
CEGIR 7808: Use of Unsedated Transnasal Esophagoscopy (TNE) to Monitor Dietary Management of Eosinophilic Esophagitis in Children
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness of utilizing Transnasal Esophagoscopy
      as a means of monitoring Eosinophilic Esophagitis patients.
    

Detailed description: 
      A participant with an established diagnosis of EoE who is undergoing Standard of Care
      treatment with a four or less food elimination diet (not including or counting foods
      restricted at time of EoE diagnosis) OR is on topical swallowed steroid therapy with any
      number of foods eliminated from the diet, is in histological remission, and has been
      recommended as part of Standard of Care to start a single new food introduction OR remove the
      swallowed steroid treatment by the subject's clinical allergist or gastroenterologist will be
      enrolled in the study. 14-17 days after the introduction of the clinically recommended single
      food antigen, a TNE will be performed to assess the esophageal mucosa. TNE will be performed
      every 2 weeks for six weeks (3 total TNE) to evaluate recurrence time of mucosal eosinophilia
      (>15 eos/HPF), other histological changes, and patient tolerance to serial TNE. At week 6 a
      sedated esophagoscopy will be offered as an alternative choice to TNE if the participant
      chooses.
    

Intervention name(s): Transnasal esophagoscopy
Intervention type(s): Other
Intervention description(s): single food antigen introduction OR removal of topical swallowed steroid therapy followed by surveillance utilizing TNE
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
Condition: Malaria
MeSH terms: Malaria; Malaria, Vivax
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria
      patients with P. vivax or P. falciparum infection after 3 day dosing with KAE609 at 30 mg/day
    


Intervention name(s): KAE609
Intervention type(s): Drug
Intervention description(s): KAE609 was supplied as capsules for oral use.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute malaria; KAE609
LOIS: Long-Term Follow-Up in INSITE/SIFI
Condition: Degenerative Sacroilitis; Sacroiliac Joint Disruption
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the long term safety and effectiveness of SI joint
      fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or
      sacroiliac joint disruptions (SD).

      Study Design: This study is extended follow-up from two ongoing multicenter prospective US
      clinical trials. All participants have already undergone the surgical procedure of interest
      (SI joint fusion with iFuse Implant System). The two ongoing trials are:

        -  SIFI:( Sacroiliac Joint Fusion with iFuse Implant System) a single-arm trial of patients
           with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse
           placement, and

        -  INSITE(Investigation of Sacroiliac Fusion Treatment): a randomized clinical trial of the
           same patient population who underwent either non-surgical treatment or iFuse placement
    


Intervention name(s): Pelvic CT at 5 years post-op
Intervention type(s): Radiation
Intervention description(s): Pelvic CT at 5 years post-op
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse
        placement.
      
Keywords: si joint; si joint injury; si joint treatment; si joint inflammation; si joint problems; si joint symptoms; hypermobile joint; si joint arthritis; si joint pain treatment; inflamed si joint; si joint sclerosis; locked si joint; si joint injuries; si joint disease; si joint infection; sacroiliac joint pelvic pain; sacroiliac joint arthritis treatment; si joint pain; si joint injections