bioihbjkbjnl/mcl2 huggingface dataset:
Management of Cervical Intraepithelial Neoplasia Grade 2
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to compare two management options for CIN 2. This randomized
      clinical trial performed between 2003 and 2006. A series of 90 Brazilian women diagnosed as
      CIN2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women
      subjected to follow-up at 3-month intervals for 12 months.
    

Detailed description: 
      Pap smear and colposcopy were performed at every follow-up visit and all lesions were
      completely visible at colposcopy.

      The researchers purpose was to make some comments about the over treatment and the
      misclassification of CIN 2.
    

Intervention name(s): Excision of the lesion; Follow-up for spontaneous regression of the lesion
Intervention type(s): Procedure; Other
Intervention description(s): Surgery with Large Loop Excision of Transformation Zone (LLETZ); Follow-up at last 12 months
Other intervention name(s): LEETZ; conservative managment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: CIN2; management
Effect of Liraglutide on Blood Glucose Control in Japanese Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Japan. The aim of this research trial is to evaluate the effect of
      treatment with liraglutide or placebo on blood glucose control after 14 weeks in Japanese
      subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily
      in the evening. The trial is a multi-national trial with treatment concealed to participating
      subjects, investigators and the sponsor. Treatment allocation is random with equal chance of
      being assigned to each group.
    


Intervention name(s): liraglutide
Intervention type(s): Drug
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Clinical Study of Making the Evidence With Application of Da Vinci-Robot Assisted Low Anterior Resection in Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      The clinical study of making the evidence with application of Da vinci-Robot assisted low
      anterior resection in rectal cancer
    


Intervention name(s): surgery(robot versus laparoscopy)
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients who visit Severance Hospital for rectal cancer
Enriched Canned Tuna With Fibre or Polyphenols on Satiety
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the satiating effects of different canned tuna
      preserved in olive oil enriched with soluble fiber or polyphenols on overweight subjects (BMI
      ≥25 and <30 kg / m2).

      Some studies have shown the contribution of high-fiber foods in the reduction of the
      cardiovascular risk.
    

Detailed description: 
      A randomized, cross-over and double-blind pilot study with 3 study arms is being performed to
      evaluate the satiating properties of different canned tuna preserved in olive oil enriched
      with soluble fiber or polyphenols on overweight subjects.

      The investigators included 12 participants (6 men and 6 women) between 18 and 55 years (BMI
      ≥25 and <30 kg / m2). All volunteers will be randomized into 3 study groups, and participants
      will receive the 3 different study products in order during the 3 experimental phases.
    

Intervention name(s): Control Canned Tuna; Enriched Canned Tuna Variety 1; Enriched Canned Tuna Variety 2
Intervention type(s): Other; Other; Other
Intervention description(s): 210 g/day; 210 g/day; 210 g/day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Satiety; Polyphenols; Fibre; Visual Analogue Scale; Cross-over; Tuna
Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the safety and efficacy of Padagis' product to an FDA approved product for the
      treatment of plaque psoriasis
    


Intervention name(s): roflumilast cream 0.3%; Zoryve; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): test product; RLD product; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old
Condition: Ear Infection; Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the safety and performance of the Hummingbird® for
      the placement of ear tubes in children undergoing tympanostomy tube placement in an
      otolaryngology clinic using local anesthetic.
    

Detailed description: 
      The Hummingbird Tympanostomy Tube System (H-TTS) is intended to deliver a tympanostomy tube
      (also referred to as a ventilation tube) through the tympanic membrane of the patient and is
      indicated to be used in office settings for children. The H-TTS is intended to deliver a
      tympanostomy tube through the tympanic membrane (TM) of the patient. It combines the separate
      functions of creating a myringotomy, and positioning and placing a ventilation tube across
      the TM.

      The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to
      deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a
      tympanostomy tube placement procedure. More than 1,000,000 ear tubes are inserted annually in
      the US, making it one of the most common surgical procedures performed in children.

      Preceptis Medical, Inc. has developed the H-TTS to reduce trauma, pain, and risk to the
      patient while reducing the overall surgical procedure time. The H-TTS integrates the multiple
      surgical instruments necessary for current surgical procedure into a single, one-pass device.
      The H-TTS creates an incision in the tympanic membrane ("ear drum") and inserts a
      tympanostomy tube with the push of a lever. Thus, the H-TTS allows placement of a
      tympanostomy tube with a single pass down the ear canal. The ear tube used with the H-TTS is
      a standard, commercially available tympanostomy tube.
    

Intervention name(s): Hummingbird Tympanostomy Tube System (H-TTS)
Intervention type(s): Device
Intervention description(s): The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.
Other intervention name(s): H-TTS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Paraffin Bath Therapy for Chronic Hand Eczema
Condition: Eczema
MeSH terms: Eczema
Study type: Interventional

Summary: 
      Objective: Chronic Hand eczema (CHE) is a common inflammatory skin disease has a major
      medical psychological and socio-economic implications that affect quality of life (QoL)and
      work ability. This study, the first randomized controlled trial that will be conducted to
      evaluate the effect of paraffin bath therapy (PBT) in the treatment of CHE.
    

Detailed description: 
      Design: The study design is a randomized controlled trial with measures at pre-and
      post-intervention.

      Subjects: Sixty patients with moderate to severe Chronic Hand eczema (CHE) will participate
      in the study. They will be classified randomly into two groups of equal number; paraffin
      group and the control group.

      Interventions: Paraffin group will receive Paraffin bath therapy for 5 days per week for 12
      weeks in addition to routine skin care program while the control group will receive routine
      skin care program.

      Outcome Measures:

      Objective SCORing Atopic Dermatitis, subjective item score and dermatology life quality index
      (DLQI) will be assessed before, at 6th week and at 12th week of treatment.
    

Intervention name(s): Paraffin baths therapy
Intervention type(s): Other
Intervention description(s): Patients in treatment group will receive paraffin wax baths for five days per week for 12 weeks. Prepare the paraffin device and blocks of paraffin wax. Put the paraffin wax blocks inside the tank and set the thermostat 35 to 40◦C. Melting paraffin was taken from 90 to 120 minutes. Adjust the suitable temperature for each patient before immersion of patient's hand. Submerge patient's hand completely for three to four seconds then withdraw it
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sixty patients with moderate to severe Chronic Hand eczema (CHE) will participate in the study. They will be classified randomly into two groups of equal number; paraffin group and the control group.
Interventions: Paraffin group will receive Paraffin Therapy for 5 days per week for 12 weeks in addition to routine skin care program while the control group will received routine skin care program
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Paraffin bath therapy, Hand Eczema, SCORAD, DLQI, Itching
Signature Diagnostic of Non-alcoholic Steatohepatitis (NASH) by Infrared Light Spectroscopy
Condition: Obesity
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Obesity
Study type: Interventional

Summary: 
      Evaluation of the diagnostic performance of an algorithm developed to detect metabolic
      profiles specific of non-alcoholic steatohepatitis NASH and based on the reading of a blood
      sample's infrared spectra
    

Detailed description: 
      The study is aimed at patients suffering from severe or morbid obesity and engaged in a
      bariatric surgery course. An additional blood sample will be taken upstream of the surgical
      procedure in the fasted subject. The metabolic fingerprint of the patient will be analyzed on
      serum from spectral data measured at most two hours after collection. The spectra obtained by
      the spectroscopy platform will be processed by algorithmic analysis to build the diagnostic
      test.

      During the surgical procedure, a liver biopsy will be performed. The sample will be sent to
      the pathology laboratory for preparation and the slides will then be anonymized to be sent to
      a specialized laboratory for centralized reading by an expert pathologist. This expert will
      determine the diagnosis of non-alcoholic steatohepatitis (NASH) or non-NASH after microscopic
      analysis of the sample without having any information about the patient.

      The two results obtained by the spectroscopic test and by means of the biopsy will then be
      compared to determine the diagnostic performance of the developped test (NASHMIR test).
    

Intervention name(s): NASHMIR
Intervention type(s): Diagnostic Test
Intervention description(s): An additional blood sample will be taken upstream of the surgical procedure and a liver biopsy will be performed in all included patients. The two results obtained by the spectroscopic test and by means of the biopsy will then be compared to determine the diagnostic performance of the developped test (NASHMIR test).
Intervention model: Single Group Assignment
Intervention model description: The study is aimed at patients suffering from severe or morbid obesity and engaged in a bariatric surgery course. An additional blood sample will be taken upstream of the surgical procedure in the fasted subject. During the surgical procedure, a liver biopsy will be performed. The two diagnosis determined by the spectroscopic test and by means of the biopsy will then be compared to determine the diagnostic performance of the developped test (NASHMIR test).
Masking: None (Open Label)
Primary purpose: Screening
Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Study Objectives :

        -  To demonstrate the reduction in office Blood Pressure following a 8-week regimen of
           irbesartan / hydrochlorothiazide using irbesartan as a reference.

        -  To demonstrate the reduction in office Blood Pressure after 4-week regimen of irbesartan
           / hydrochlorothiazide using irbesartan as a reference.

        -  To compare the response rate (defined as office Systolic Blood Pressure/Diastolic Blood
           Pressure reduce more than 10mmHg from Week 0) of patients after 4-week and 8-week
           regimen of irbesartan / hydrochlorothiazide versus irbesartan.

        -  To compare the proportion of patients requiring titration after 4-week regimen of
           irbesartan/hydrochlorothiazide versus irbesartan

        -  To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus
           irbesartan when administered once daily
    


Intervention name(s): Irbesartan/hydrochlorothiazide; Irbesartan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Hydrochlorothiazide; Irbesartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic Technique
Condition: Hemorrhage
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      This is a prospective, open-label, exploratory clinical trial designed to investigate the
      safety and efficacy of HLBLS-200 (an investigational hemostatic agent). The study will
      recruit approximately 8 subjects.
    

Detailed description: 
      Patients scheduled for hepatic resection who voluntarily agree to participate the study will
      be recruited for the screening procedures.

      Patients who meet the eligibility criteria will be assigned to the study. Subjects will
      receive HLBLS-200 as a supplementary hemostatic technique for oozing hemorrhage which can be
      occurred during hepatic resection.

      A dose of HLBLS-200 based on the area of liver resection will be applied and time to
      hemostasis of blood oozing will be evaluated.

      Patients will be followed for 12 weeks after application of HLBLS-200 to monitor any adverse
      event.

      Study objective:

        1. To investigate the safety of HLBLS-200 application.

        2. To explore hemostatic function of HLBLS-200 in patients receiving hepatectomy.
    

Intervention name(s): HLBLS-200
Intervention type(s): Device
Intervention description(s): The amount of HLBLS-200 applied will be determined by the investigator based on the resection area.
Intervention model: Single Group Assignment
Intervention model description: Single Arm, Open Label, Single Center Exploratory Clinical Trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hemostatic; Blood oozing; Absorbent hemostatic; Liver resection; Intraperitoneal surgery
A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and efficacy of ABT-652 in combination with a Non-steroidal
      Anti-inflammatory Drug (NSAID) compared to NSAID alone in adults with osteoarthritis (OA) of
      the knee.
    

Detailed description: 
      This is a randomized withdrawal design study, containing a 4 week open-label period followed
      by a 6 week double-blind period. The total treatment period will be 10 weeks.
    

Intervention name(s): ABT-652 NSAID; Placebo NSAID
Intervention type(s): Drug; Drug
Intervention description(s): ABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed; Placebo - 2 placebo capsules twice daily NSAID- as prescribed
Intervention MeSH terms: Anti-Inflammatory Agents, Non-Steroidal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis of the knee
Increased Salt Sensitivity of Ambulatory Blood Pressure in Women With a History of Severe Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Interventional

Summary: 
      Cardiovascular diseases are the principal cause of death in women in developed and developing
      countries and are importantly promoted by hypertension. Salt sensitivity of the blood
      pressure is considered as an important cardiovascular risk factor at any blood pressure
      level. Severe preeclampsia is a hypertensive disorder of the pregnancy that also arises as a
      risk factor for cardiovascular and renal diseases.

      The major aim of this study is to examine the salt sensitivity of the ambulatory blood
      pressure in women with a history of severe preeclampsia (< 34 weeks gestation) compared with
      women with no history of pregnancy-related hypertensive complications. We plan to recruit 20
      non-menopausal women with a history of severe preeclampsia, and 20 age, parity, race- matched
      premenopausal women as controls. The study has a case control randomized design. The salt
      sensitivity of the ambulatory blood pressure is defined as an increase of ≥4 mmHg in 24h
      ambulatory blood pressure on a high sodium diet. The high sodium diet is obtained by adding
      capsules of 6gr of NaCl/ day in the usual diet.

      The participants are identified as women discharged from the Maternity of University Hospital
      of Geneva between 1999 and 2001 with a preeclampsia coding. Fetal and maternal data will be
      carefully recovered from hospital records to identify severe preeclampsia (PE), based on
      International Society for the Study of Hypertension in Pregnancy criteria. These criteria are
      systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥110 mmHg with severe
      proteinuria (≥ 5g /24h or 3+ dipstick) and one or more signs of multisystem disease
      developing after 20 weeks of gestation in previously normotensive women. Severe preeclampsia
      was also defined as occurring before 34wk of gestation. Women with a history of hypertension,
      diabetes mellitus, renal or cardiac impairment, polycystic ovary syndrome will be excluded.
      Other exclusion criteria are anti-inflammatory drugs, diuretics, aspirin, oral contraceptives
      and hormonal replacement therapy. The protocol is approved by the University Hospital Ethical
      Committee and written informed consent will be obtained from each individual in accordance
      with the declaration of Helsinki. The study is conducted between 2009 and 2012 at the
      University Hospitals of Geneva, Switzerland.
    


Intervention name(s): high sodium diet; low-salt diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The high-sodium diet was obtained by adding 6g of sodium chloride to the individual's regular diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Integrated Treatment for Youth With Mood Disorders
Condition: Mood Disorders in Children and Adolescents
MeSH terms: Mood Disorders
Study type: Interventional

Summary: 
      In an effort to understand the effects of evidence-based interventions on children and
      adolescents, the aims of this study are to:

        1. evaluate the feasibility of utilizing wearable devices to track health information
           (i.e., sleep, physical activity);

        2. evaluate the effectiveness of evidence-based intervention components on mood and
           interpersonal functioning, family engagement, and sleep and physical activity level
           outcomes.
    


Intervention name(s): Family-based treatment
Intervention type(s): Behavioral
Intervention description(s): 2-week family-based treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; bipolar; caregivers; children; adolescents; treatment; parents
Evaluation of the Vasoconstriction Properties of MC2-01 Cream
Condition: Vasoconstriction
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this trial is to compare the vasoconstriction potential
    

Detailed description: 
      The objective of this trial is to compare the vasoconstriction potential (skin blanching
      effect) of MC2-01 cream with 5 comparators and MC2-01 vehicle using the human skin blanching
      test (McKenzie-Stoughton's test).
    

Intervention name(s): MC2-01 Cream; Clobetasol Propionate 0.05% Lotion; Betamethasone Dipropionate 0.05% Cream; Triamcinolone Acetonide 0.1% Cream; Hydrocortisone Butyrate 0.1% Cream; Desonide 0.05% Cream; Vehicle
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation; Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation; Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation; Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation; Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation; Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation; Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
Other intervention name(s): Calcipotriol + Betamethasone dipropionate cream; Clobex; Betamethasone Dipropionate; Triamcinolone acetonide; Locoid® cream; Desowen® cream; Vehicle cream
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Hydrocortisone; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Clobetasol; Desonide; Hydrocortisone-17-butyrate; Betamethasone sodium phosphate; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single application, intra individual comparison on mini-test sites (n=7)
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment