bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia, Pediatric
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Assessment of of the biological effects of curcumin on microbiota in children with acute
      lymphoblastic leukemia
    

Detailed description: 
      Assessment of the safety of curcumin, which is the most active constituent of the ground
      rhizome of the Curcuma longa plant, in children with acute lymphoblastic leukemia patients
      (ALL) in maintenance phase of chemotherapy through the assessment of the any reported adverse
      event (AE). And assessment of the curcumin effect on health by eliminating intestinal
      microflora dysbiosis
    

Intervention name(s): Curcumin; Standard of Care
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Tumeric curcumin 500 mg per oral capsule of Puritans Pride company supplement; As per institution protocol for Standard of nutritional Care
Other intervention name(s): Tumeric curcumin
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Curcumin; Ain Shams University; Egypt; Acute Lymphoblastic Leukemia; Children
Histological Modifications of Postmenopausal Vaginal Mucosa After Repeated Carbon Dioxide (CO2) Laser Treatment
Condition: Vaginal Atrophy; Breast Cancer Female; Dyspareunia
MeSH terms: Dyspareunia
Study type: Interventional

Summary: 
      To assess the long-term histological and clinical efficacy of MonaLisa Touch procedure for
      the management of the Genitourinary Syndrome of Menopause (GSM) in postmenopausal female
      patients.
    

Detailed description: 
      The investigator propose a prospective case series of 15 postmenopausal women with bothersome
      symptoms of GSM treated with MonaLisa Touch CO2 laser. The investigator hypothesize that even
      in the long term MonaLisa Touch will significantly improve GSM histologically and clinically
      from baseline.

      The primary outcome objective of the study is to evaluate the histological modifications of
      the vaginal mucosa after repeated CO2 Monalisa Touch laser treatment. The investigator shall
      evaluate the role of this treatment by calculating the difference in vaginal epithelial
      thickness between the biopsy obtained before the start of laser treatment and the biopsy
      obtained after treatment. In addition, the study will analyze the safety of repeated laser
      treatments verifying the absence of fibrosis formation in the vaginal mucosa. Secondary
      objectives of the study will include an evaluation of the clinical effects associated with
      repeated Monalisa Touch CO2 laser treatments using validated questionnaires.

      All participants will be screened to ensure inclusion/exclusion criteria are met. A biopsy
      will be taken from each patient one month before the first laser treatment and one month
      after the last laser treatment. The MonaLisa treatment will be performed monthly for 3
      months. MonaLisa treatment with fractional microablative laser system. For subjects with
      concomitant vulvar symptoms, vulvar treatment will be done. Biopsy samples will be analyzed
      with Hematoxylin- Eosin and Trichrome staining, Periodic acid-Schiff (PAS) reaction for
      glycogen and immunohistochemistry for CD34, a vessel marker. All clinical questionnaires will
      be assessed at baseline and at one month after the last session.
    

Intervention name(s): SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy
Intervention type(s): Device
Intervention description(s): SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy; MonaLisa Touch CO2 fractionated laser
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the safety and tolerability of repeated doses of
      HM11260C when given different regimens in subjects with type 2 diabetes mellitus (T2DM) on
      stable metformin monotherapy.
    


Intervention name(s): HM11260C; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1, 2, and 4 mg for 8 weekly subcutaneous injections for cohorts W1, W2 and W3. 8, 12 and 16 mg for 3 monthly subcutaneous injections for cohorts M1, M2 and M3; Placebo for 8 weekly subcutaneous injections for cohorts W1, W2 and W3. Placebo for 3 monthly subcutaneous injections for for cohorts M1, M2 and M3
Other intervention name(s): LAPS-Exendin4
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Children's Healthy Living Community Randomized Trial
Condition: Obesity; Acanthosis Nigricans; Central Obesity
MeSH terms: Acanthosis Nigricans; Obesity; Obesity, Abdominal
Study type: Interventional

Summary: 
      The goal is to build social/cultural, political/economic, and physical/built environments
      that will promote active play and intake of healthy food to prevent young child obesity in
      the Pacific Region. Our methods will support local culture in order to achieve this goal in
      these remote, underserved native populations. CHL will engage the community, and focus on
      capacity building and sustainable environmental change.

      The focus of the CHL community-based program is to promote healthy eating and to increase
      physical activity. In order to demonstrate effectiveness, the investigators will recruit and
      measure children in six communities selected in each of our jurisdictions in the Pacific.
      These represent intervention communities, comparison communities, and temporal communities.
    

Detailed description: 
      The specific objectives of our study are as follows.

      Objective. Decrease the prevalence of young child overweight and obesity; and its functional
      outcomes (decrease acanthosis nigricans, and increase sleep ; increase moderate to vigorous
      physical activity and decrease sedentary behavior (screen time); increase healthy eating
      (fruit and vegetable intake, water intake; decrease sweetened beverage intake, through
      community-based primary prevention environmental interventions in the Pacific region.

      Objective. Measure 2-8-year-old children at baseline and 24 months in selected communities to
      track behaviors and anthropometry that indicate healthy eating, physical activity, and BMI.
    

Intervention name(s): CHL program; Delayed Optimized CHL program
Intervention type(s): Other; Other
Intervention description(s): Multiple component environmentally focused program designed with community engagement.; CHL programs with fewer component and shorter duration.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Community randomized intervention for child obesity prevention with multiple levels and components (policy, environment, messaging, and capacity)
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Child; Food; Physical Activity; Pacific
Point-of-Care System for Determination of Bilirubin Capacity in Neonates
Condition: Jaundice, Neonatal; Hyperbilirubinemia; Bilirubin-Induced Neurological Dysfunction (BIND)
MeSH terms: Jaundice, Neonatal; Jaundice; Hyperbilirubinemia
Study type: Observational

Summary: 
      The aims of this observational bench project are to validate the performance of the
      miniaturized and modernized hematofluorometer that measures bilirubin capacity into a product
      and is suitable for operation in various point of care environments w in the management of
      preterm neonates.
    

Detailed description: 
      The status of bilirubin binding to albumin (Alb) is central to personalized management of
      unconjugated newborn hyperbilirubinemia, especially those at risk of bilirubin-induced
      neurologic dysfunction (BIND) (1). Our objectives were to validate the Aviv Bili-4
      Hematofluorometer in the context of its usefulness and ease of use based on ad hoc clinical
      studies and surveys of end-users. In addition, we continued our efforts to validate the
      Bili-4 device in order to facilitate Aviv, Inc. in their development of claims of the most
      appropriate use of bilirubin binding capacity (BBC) information in the management of
      neonates. Neonatal blood samples were obtained from newborns born at Stanford University's
      LPCH with gestational ages (GA) ranging from 22-40 wks. Total bilirubin (TB), Alb and
      apparent serum unbound bilirubin (UB) concentrations were measured or calculated. Ratios of
      bound bilirubin (BB) to reserve Alb binding capacity for bilirubin (RABC) were also
      determined. Bilirubin binding capacity (BBC) by hematofluorometry (Hmf) was compared to the
      calculated BBC (or 8.8 × Alb) using Alb levels as measured by the clinical laboratory. We
      report the progress of this inquiry at the Stanford University (1).
    

Intervention name(s): Bilirubin Binding Capacity by Hematofluorometry Validation
Intervention type(s): Device
Intervention description(s): Observation study
Intervention MeSH terms: Bilirubin
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of preterm (≥ 24 wks GA, BW≥500g) as well as sick or
        unstable late-term newborns (infants ≥ 35 wks GA, BW≥2500g).
      
Keywords: Bilirubin Binding Capacity Preterm Neonates and Jaundice
Does Emotional Support Decrease In Vitro Fertilization Stress?
Condition: In Vitro Fertilization; Psychological Stress
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      In vitro fertilization for infertility has been associated with a significant amount of
      treatment related stress for patients. In addition,stress levels increase between embryo
      transfer and pregnancy test, during this waiting period. The investigators evaluated whether
      or not brief interventions by phone by trained social workers influenced stress levels. Our
      data showed that these interventions did not change levels, but confirmed that stress did
      increase during this time and that patients report wanting additional emotional support to
      improve stress during this period.
    


Intervention name(s): Phone calls
Intervention type(s): Behavioral
Intervention description(s): Phone calls to offer emotional support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: IVF; Stress; Infertility
Revival of Stem Cells in Addison's Study
Condition: Adrenal Failure
MeSH terms: Adrenal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Autoimmune Addison's disease (AAD) is a rare and debilitating disease in which an autoimmune
      attack progressively destroys the adrenal cortex. Untreated it is universally fatal and
      treated people are absolutely dependent upon steroid medications lifelong, with a consequent
      excess in morbidity and mortality. A key feature of the adrenal cortex is that its cells are
      responsive to changes in circulating adrenocorticotrophic hormone (ACTH) concentration. This
      study aims to regenerate adrenocortical steroidogenic cell function in patients with
      established autoimmune Addison's disease (AAD) by stimulating proliferation and
      differentiation of their progenitor cells, the adrenocortical stem cells (ACSCs) (1,2). Using
      daily subcutaneous ACTH, administered according to two different regimens over 20 weeks, we
      will investigate whether regeneration of adrenal steroidogenic function through revival of
      ACSC activity is a realistic possibility.
    


Intervention name(s): depot tetracosactide
Intervention type(s): Drug
Intervention description(s): 1mg, 3x weekly by sc injection
Intervention MeSH terms: Cosyntropin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Traditional Greek Meals on Glycemic Responses
Condition: Potential Abnormality of Glucose Tolerance; Appetitive Behavior
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      This study investigated the effects of Greek traditional meals in dehydrated form consumed
      after reconstitution with water on glycemic responses
    

Detailed description: 
      This study aimed at 1. to determined the glycemic index and glycemic load of three mixed
      meals and 2. to investigate the effects of these mixed meals on postprandial glycemic
      response in healthy subjects
    

Intervention name(s): Glucose as reference food; Lentils and lupins mixed meal; Trahanas with tomato sauce mixed meal; Halva with currants mixed meal
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.; Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from lentils and lupins mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.; Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from trahanas with tomato sauce mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.; Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from halva with currants mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: blood glucose; lentils; trahanas; halva; glycemic index
Lidocaine-prilocaine Cream on IUD Insertion Pain
Condition: IUD Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the investigators' study was to evaluate whether cervical lidocaine-Prilocaine
      cream will improve pain scores compared to placebo. The investigators hypothesized that
      lidocaine-Prilocaine cream will reduce the insertion pain.
    

Detailed description: 
      IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix
      and straighten the uterus for proper insertion; trans-cervical actions including measuring
      uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the
      device in the uterus.

      To minimize the discomfort and the hazards of an IUD insertion, several measures have been
      proposed including NSAIDs, anxiolytics, and local anesthetics in the form of intracervical
      gel, cervical and para-cervical block, but there have not done enough studies about their
      effectiveness. According to the review published in the Cochrane, non-steroidal
      anti-inflammatory drugs and misoprostol are not effective on reducing an IUD insertion pain.
      Many trials have been done about effectiveness of lidocaine gel in reducing pain during IUD
      insertion and only one of those trials showed positive effect of 2% lidocaine gel, while
      others failed.

      Lidocaine 2.5% and Prilocaine 2.5% Cream, is an emulsion in which the oil phase is a eutectic
      mixture of Lidocaine and Prilocaine cream in a ratio of 1:1 by weight. This eutectic mixture
      has a melting point below room temperature and therefore both local anesthetics exist as
      liquid oil rather than as crystals. Its absorption of from the genital mucosa is more rapid
      and onset time is shorter (5 to 10 minutes) than after application to intact skin. After a 5
      to 10 minute application of Lidocaine-Prilocaine cream to female genital mucosa, the average
      duration of effective analgesia was 15 to 20 minutes.
    

Intervention name(s): lidocaine-Prilocaine cream; placebo cream
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Healthy Infants
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This purpose of the study is to assess the safety and immunogenicity of a GSK Biologicals'
      candidate tuberculosis vaccine (692342) when administered concomitantly with or after the
      Expanded Programme of Immunisation vaccines regimen to healthy infants aged between and
      including 2 and 7 months, living in a tuberculosis endemic region.
    


Intervention name(s): GSK's investigational vaccine 692342; Tritanrix™ HB+Hib; Prevnar™; Polio Sabin™; Menjugate™
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular, 1 or 2 doses; Intramuscular, 3 doses; Intramuscular, 3 doses; Oral, 3 doses; Intramuscular, 3 doses
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tuberculosis vaccine
A Bioequivalence Study of Two Azithromycin Tablet Formulations in Indonesian Healthy Subjects
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to assess the bioequivalence of 500 mg Azithromycin FC tablets
      (Azivol) produced by PT. Novell Pharmaceutical Laboratories, compared to the reference
      product Zithromax 500 mg FC tablet produced by Pfizer Australia Pty, Ltd
    


Intervention name(s): Azithromycin; Azithromycin
Intervention type(s): Drug; Drug
Intervention description(s): Single dose 500 mg of film coated tablet; Single dose 500 mg of film coated tablet
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Bariatric Scalable Internet Treatments
Condition: Bariatric Surgery; Weight Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of the study is to conduct a randomized clinical trial examining the feasibility
      and effectiveness of two guided self-help behavioral weight loss (gshBWL) treatments
      delivered via the internet for individuals struggling with weight loss one year following
      bariatric surgery. The two treatments will consist of 1) gshBWL delivered through the
      internet only (gshBWL-I) and 2) gshBWL delivered via the internet with additional
      complementary phone sessions (gshBWL-IP).
    


Intervention name(s): Guided Self-Help Behavioral Weight Loss
Intervention type(s): Behavioral
Intervention description(s): Participants will be provided with patient-focused materials and worksheets that contain all the necessary information, procedures, and techniques of the behavioral weight loss program. For 12 weeks, treatment will be provided over the internet. This therapy focuses on making gradual and modest lifestyle changes with goals of normalizing eating patterns, decreasing caloric intake, building coping skills, and increasing physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The proposed study is designed to evaluate (i) the effects of saxagliptin, with or without
      acarbose, on gastric emptying, postprandial glycaemia, and plasma intact GLP-1, insulin,
      C-peptide and glucagon after a high carbohydrate meal, and (ii) whether the magnitude of the
      effects of saxagliptin and/or acarbose is related to the rate of gastric emptying, in
      patients with type 2 diabetes.
    


Intervention name(s): Saxagliptin; Acarbose
Intervention type(s): Drug; Drug
Other intervention name(s): Onglyza; Glucobay
Intervention MeSH terms: Saxagliptin; Acarbose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment