bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars
Condition: Scar; Surgical Scar; Cicatrix; Cicatrix, Hypertrophic; Keloid
MeSH terms: Keloid; Cicatrix; Hypertrophy; Cicatrix, Hypertrophic
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium
      titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the
      treatment of fresh surgical scars.
    

Detailed description: 
      Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment
      of Fresh Surgical Scars. This is a single-center prospective, randomized, open-label, pilot
      study of a novel 532 nm KTP Laser in comparison with the 595nm pulsed-dye laser (PDL) in up
      to 20 subjects who have had a fresh surgical scar acquired within one to twelve months of the
      screening visit.
    

Intervention name(s): 532nm KTP; 595nm PDL
Intervention type(s): Device; Device
Intervention description(s): up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.; up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.
Other intervention name(s): ExcelV laser; Cutera ExcelV; Excel V; Cynosure Cynergy; Cynergy laser
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Scar; Scars; Surgical Scar; Surgical Scars; Cicatrix; Hypertrophic Cicatrix; Keloid; Hypertrophic Scar; Surgical Incision; Scarring; Abdominoplasty; Tummy Tuck; Augmentation Mammoplasty; Breast Augmentation; Thyroidectomy
Safety and Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine
Condition: Condylomata Acuminata
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I clinical study was designed to evaluate the safety and immunogenicity of the
      novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO.,
      LTD., in healthy volunteers aged over 18-55 years of age at enrollment. The study volunteers
      will receive the 3 different formulations of the novel HPV vaccine or placebo administered
      intramuscularly according to a 0-1-6 month schedule.
    


Intervention name(s): low dosage HPV Vaccine; medium dosage HPV Vaccine; high dosage HPV Vaccine; Aluminium Adjuvant
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Participants would intramuscularly receive low dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.; Participants would intramuscularly receive medium dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.; Participants would intramuscularly receive high dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.; Participants would intramuscularly receive aluminium adjuvant at 0, 1, 6 month for 3 doses.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: human papillomavirus vaccine; condylomata acuminata
Evaluating the Clinical Efficacy and Safety of Colflex
Condition: Personal Satisfaction
Study type: Observational

Summary: 
      This study is designed to test the safety and efficacy of Colflex, an oral spray created by
      Innotech Nutrition, on human subjects to measure changes on frequency/duration of colds and
      sore throats, as well as dental and oral health changes.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Residents in town
      
Keywords: Oral health; Mouth health; Halitosis; Oral bacteria; Sore throat; Colds
Effect of Lifestyle and/or Metformin Intervention on Pregnancy Outcome, A Pilot Randomized Controlled Trial
Condition: Infertility, Female; Obesity; Insulin Resistance
MeSH terms: Infertility; Infertility, Female; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of pilot trial is to compare the efficacy of lifestyle intervention, metformin
      intervention, lifestyle combined with metformin intervention in improving assisted
      reproductive technology in non-polycystic ovary syndrome(pcos) patients with
      overweight/obesity and insulin resistance compared with conventional clinical education.
      Subjects who meet the inclusion criteria will be randomized to four groups: lifestyle
      intervention group, metformin intervention group, lifestyle combined with metformin
      intervention group, and routine clinical education group. Subjects of above three
      intervention group will start ovulation stimulation treatment after reach the aim or duration
      of intervention and routine clinical education group has no intervention. All subjects are
      treated with the same procedures, including a long ovarian stimulation regimen, oocyte
      retrieval, and fertilization, followed by a planned transfer of two day-3 embryos. The
      primary outcome is ongoing pregnancy rate.
    


Intervention name(s): weight loss intervention; metformin intervention
Intervention type(s): Behavioral; Drug
Intervention description(s): weight loss intervention under the guidance of a dietitian, including: restricted energy balanced diet, aerobic exercise, etc.; metformin intervention with a starting dose of 0.5g bid, and the dose will be adjusted by doctors according to the patient's insulin level and adverse events.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of Immunosuppressive Drugs in Heart Transplant Patients
Condition: Heart Transplant
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective is to develop pharmacokinetic methods for individual dose adjustment of
      the global immunosuppressive treatment (cyclosporine, tacrolimus, mycophenolate mofetil and
      everolimus, taking into account the pharmacokinetic interactions), in order to optimise the
      efficiency and reduce the potentially severe sides effects of these drugs.

      Forty five heart-transplant patients are to be included in this phase IV study to obtain a
      minimum of 10 patients treated with tacrolimus-mycophenolate, 10 with
      cyclosporine-mycophenolate and 20 with everolimus-cyclosporine.

      Ten to 11 blood samples will be collected within the 8 to 12 hours post-dose in each patient
      and the immunosuppressive drug concentrations will be measured by LC-MS/MS.

      The pharmacokinetic models and Bayesian estimators thus developed will provide tools for
      individual dose adjustment of immunosuppressive drugs simultaneously, at different
      post-transplant periods, using the area under the concentration-time curve (AUC) estimated
      using a limited number of time-points (2 or 3).
    

Detailed description: 
      For each heart transplant patient, 10 to 11 blood samples (5 mL each) will be collected
      following dosing of he immunosuppressive drugs (at T0, T20', T40', T60', T90', T2h, T3h, T4h,
      T6h, T8h and T10h + T12h for inpatients), at several post-transplant periods (7 to 15 days, 1
      month, 3 month and 1 year after transplantation). One more blood sample will be taken at
      D7-14 for pharmacogenetic analyses.
    

Intervention name(s): cyclosporine, tacrolimus, mycophenolate mofetil and everolimus (immunosuppressive drugs)
Intervention type(s): Drug
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Tacrolimus; Cyclosporins; Immunosuppressive Agents
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: heart transplantation; immunosuppressive drugs; individual dose adjustment; harmacokinetics; modelling
Genetic Etiology in Premature Ovarian Insufficiency
Condition: Primary Ovarian Insufficiency; Genetic Predisposition to Disease
MeSH terms: Premature Birth; Menopause, Premature; Primary Ovarian Insufficiency; Genetic Predisposition to Disease
Study type: Observational [Patient Registry]

Summary: 
      Premature Ovarian Insufficiency (POI), first described by Albright in 1942, is defined as an
      increase in Follicle Stimulating Hormone (FSH), an insufficiency of the ovarian function
      leading to an early menopause (<40 years of age).Today, only 35% of POI's etiology can be
      explained. Causes enlightening POI may be enumerated as follows, according to their
      frequency: genetic mutations, autoimmune defects and abnormalities detected on the X
      chromosome.The purpose of the study is to determine the frequency of the genetic
      abnormalities and polymorphisms described above in the POI Turkish population
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        patients who are admitted to obstetrics and gynecology department
      
Biospecimen description: 
      4ml whole blood sample
    
Keywords: Premature Ovarian Insufficiency (POI)
An Open-Label Phase I/II Study of Recombinant Granulocyte Colony Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)
Condition: HIV Infections
MeSH terms: HIV Infections; AIDS-Related Complex; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerance, and biological activity of filgrastim (recombinant
      granulocyte colony stimulating factor; G-CSF) given by daily subcutaneous injection prior to
      and concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or
      severe ARC. To evaluate the safety, tolerance, and biological activity of recombinant EPO
      given three times weekly by subcutaneous injection concomitantly with G-CSF and prior to and
      concomitantly with AZT in patients with AIDS or severe ARC. To study the safety and tolerance
      of three dose levels of AZT given concomitantly with G-CSF and EPO in patients with AIDS or
      severe ARC. To study the effects of G-CSF on neutrophil function and number in patients with
      AIDS or severe ARC. To study the effect of G-CSF alone and in combination with EPO on HIV
      replication in vivo as measured by circulating HIV p24 antigen, plasma HIV viremia, and
      semiquantitative HIV cocultures.
    


Intervention name(s): Filgrastim; Epoetin alfa; Zidovudine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Zidovudine; Epoetin Alfa
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Erythropoietin; Granulocyte Colony-Stimulating Factor; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine
Efficacy of a Once Daily Calcium and Vitamin D Fortified Food Product to Improve Bone Microarchitecture
Condition: Bone Alteration; Dietary Modification
Study type: Interventional

Summary: 
      The primary objective of this randomized, double-blind, placebo controlled trial is to
      determine the efficacy of a once per day calcium (1000mg) and vitamin D (1000IU) fortified
      food product on bone turnover markers, including parathyroid hormone (PTH) and
      microarchitecture during Army basic military training (BCT). The investigators hypothesize
      that consumption of a once daily calcium and vitamin D fortified food product will stabilize
      PTH and contribute to improved bone microarchitecture compared to placebo. The results will
      determine the efficacy of daily supplementation with calcium and vitamin D on bone turnover
      markers as well as provide novel data regarding microarchitectural changes during BCT as
      assessed by high resolution peripheral computed tomography (HRpQCT) scanning.
    

Detailed description: 
      Stress fractures may affect up to 2-5% of male and 8-21% of female Soldiers during training,
      resulting in attrition in up to 60% of affected personnel. A recent report indicates that
      supplemental calcium (2000mg) and vitamin D (800-1000IU) stabilizes PTH, increases tibia
      volumetric bone mineral density in male and female recruits undergoing Army BCT, and reduces
      stress fracture incidence by up to 20% in female Nacy recruits. Bone macroarchitecture has
      been measured in response to basic training however, the resolution of standard peripheral
      quantitative computed tomography (pQCT) is insufficient for assessment of microarchitectural
      changes, which may underlie the pathophysiology of stress fracture. With the use of HRpQCT
      this study will allow the investigators to evaluate microarchitectural changes within the
      bone tissue and assess the efficacy of a moderate daily dose of calcium and vitamin D to
      support bone health during BCT.
    

Intervention name(s): Calcium/Vitamin D; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily, calcium and vitamin D fortified snack bar
Intervention MeSH terms: Vitamin D; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Calcium; Vitamin D; Parathyroid Hormone; Bone; Microarchitecture
Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Micro Hole Zone Catheter
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence
Study type: Interventional

Summary: 
      This investigation is a randomized, single-blinded, parallel, single-center investigation. In
      total, up to 50 subjects (40 completers) will be included and each subject will have two test
      visits overseen by the Principal Investigator (PI), or designee. Each subject will be
      enrolled in the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same
      day). The subjects will be randomly assigned to test either the test product or the
      comparator product, with at least 20 subjects assigned to each product.
    

Detailed description: 
      This investigation is a randomized, single-blinded, parallel, single-center investigation. Up
      to 50 subjects (40 completers) will be included and each subject will have two test visits
      overseen by the Principal Investigator (PI), or designee. Each subject will be enrolled in
      the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same day). The
      subjects will be randomly assigned to test either the test product or the comparator product,
      with at least 20 subjects assigned to each product. The subjects will undergo cystoscopy and
      catheterization.
    

Intervention name(s): Nautilus Catheter; Comparator
Intervention type(s): Device; Device
Intervention description(s): The test product is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.; The comparator is a urinary catheter for bladder drainage through the urethra.
Other intervention name(s): Infyna Chic - Hollister
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Curcumin Supplementation in Patients With Chronic Kidney Disease on Peritoneal Dialysis
Condition: Chronic Kidney Diseases; Peritoneal Dialysis; Hemodialysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The objective of this study is to assess whether supplementation with curcumin could modulate
      the intestinal microbiota, reducing levels of inflammatory markers of oxidative stress,
      uremic toxins and inflammasome, in patients with chronic kidney disease in peritoneal
      dialysis.
    

Detailed description: 
      Curcumin is a chemical compound of the curcuminoids class found in the root of Curcuma
      (Curcuma longa), and due to its potential antioxidant and anti-inflammatory, has been
      suggested as a nutritional strategy to reduce oxidative stress and inflammation present in
      several chronic diseases. Although it is a promising therapy, there are no studies evaluating
      the effects of curcumin in patients with chronic kidney disease (CKD) in peritoneal dialysis
      (PD). The aim of this study is to evaluate the effect of curcumin supplementation on
      inflammatory markers and oxidative stress in patients with CKD in PD. Methods: This is a
      longitudinal randomized clinical double-blind crossover study, with a washout period and
      placebo-controlled, where patients will be randomized into two groups: Turmeric and Placebo.
      After the 12-week supplementation period, a washout (12 weeks) will be performed for
      subsequent crossover of the patients. Mononuclear cells will be extracted from whole blood
      and the expression of m ribonucleic acid from transcription factors (Nrf2 and NF-kB),
      antioxidant enzymes (NQO1, HO-1), as well as NLRP3 inflammasome will be analyzed by real-time
      Polymerase Chain Reaction and protein expression by western blotting. Inflammatory cytokine
      levels will be assessed by ELISA, also, plasma levels of TBARS, routine laboratory
      parameters, as well as food intake and nutritional status.
    

Intervention name(s): Curcumin supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): The patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks
Other intervention name(s): Dietary Supplement; Placebo
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: chronic kidney disease; peritoneal dialysis; curcumin; hemodialysis
US Inhaled Insulin Therapeutic Choice Questionnaire Study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a questionnaire based study (no study drug is involved) that asks if more patients
      with uncontrolled type 2 diabetes on diabetes pills will choose insulin as the next treatment
      choice if inhaled insulin were available in addition to all currently available treatments,
      compared with if inhaled insulin was not available as part of currently available treatments.

      This study will also ask if patients with uncontrolled type 2 diabetes currently managed on
      diabetes pills + once daily insulin will choose as the next treatment choice to take insulin
      multiple times a day if inhaled insulin were available in addition to all currently available
      treatments, compared with if inhaled insulin was not available as part of currently available
      treatments.
    


Intervention name(s): Educational Materials
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Educational/Counseling/Training
TROPHY - Candesartan Cilexetil Long-term Hypertension Prevention Trial
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effectiveness of candesartan cilexetil in
      preventing hypertension in people with high normal blood pressure. Patients will be
      randomized to either Candesartan or placebo for an initial 2-year period followed by a second
      2-year period of placebo for all patients.
    


Intervention name(s): ATACAND
Intervention type(s): Drug
Intervention MeSH terms: Candesartan cilexetil
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Atlas of Human Milk Nutrients
Condition: Breastfeeding Mothers
Study type: Observational

Summary: 
      The main objective of this clinical trial is to collect human milk samples from 0 to 4 months
      after delivery in order to characterize human milk components. The secondary objectives of
      this study are:

        1. To assess whether there is a correlation between human milk composition and mothers'
           diet

        2. To assess whether there is a correlation between human milk composition and maternal
           clinical parameters

        3. To assess whether there is a correlation between human milk composition and mother and
           infant clinical parameters
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy mothers of any ethnicity having decided to exclusively breast-feed their new born
        baby from birth up to 4 months of age will be eligible to participate in the study.
      
Biospecimen description: 
      1. Mother milk

        2. Umbilical cord blood

        3. Mother blood

        4. Adipose tissue
Therapeutic Effect of Crizotinib for Rearrangement-negative, High Phosphorylated ALK Patients
Condition: ALK Phosphorylation
Study type: Interventional

Summary: 
      Patients with histologically or cytologically confirmed stage IIIB or IV ALK-negative
      non-small-cell lung cancer (NSCLC) participated in this study following the failure of
      initial treatments. The ALK phosphorylation expression was detected in histologic samples of
      patients. patients with positive ALK phosphorylation expression were treated with crizotinib
      .
    

Detailed description: 
      Some patients with histologically or cytologically confirmed stage IIIB or IV ALK-negative
      non-small-cell lung cancer (NSCLC) participated in this study following the failure of
      initial treatments. The ALK phosphorylation expression was detected in histologic samples of
      patients. patients with positive ALK phosphorylation expression were treated with crizotinib
      250 mg/day orally. A treatment cycle was defined as 30 days of once-daily crizotinib
      treatment.
    

Intervention name(s): crizotinib for rearrangement-negative, high phosphorylated ALK patients
Intervention type(s): Drug
Intervention description(s): Patients with positive ALK phosphorylation expression were treated with crizotinib 250 mg/day orally. A treatment cycle was defined as 30 days of once-daily crizotinib treatment. Treatment with crizotinib continued until the patient experienced unacceptable toxicity, was pregnant, or started new cancer therapy.
Intervention MeSH terms: Crizotinib
Intervention model: Single Group Assignment
Intervention model description: Some patients with histologically or cytologically confirmed stage IIIB or IV ALK-negative non-small-cell lung cancer (NSCLC) participated in this study following the failure of initial treatments. The ALK phosphorylation expression was detected in histologic samples of patients.
Masking: None (Open Label)
Primary purpose: Treatment