bioihbjkbjnl/mcl2 huggingface dataset:
Study: Effects of Strawberries on Blood Pressure
Condition: Pre-hypertension
MeSH terms: Hypertension; Prehypertension
Study type: Interventional

Summary: 
      The specific aim of the study is to determine whether a freeze dried powder provided by the
      California Strawberries Commission, can reduce blood pressure in patients with
      pre-hypertension. The powder is prepared by the California Strawberry Commission (CSC).
    

Detailed description: 
      Primarily, we would like to find out whether freeze dried strawberry powder lowers blood
      pressure. In addition we would like to know if the strawberry alters the subject's blood
      cholesterol and the ability of the subject's blood vessels to relax.
    

Intervention name(s): Strawberry Beverage; Placebo
Intervention type(s): Other; Other
Intervention description(s): Beverage, daily for 8 weeks, 12g freeze-dried strawberry powder; Placebo beverage, 8 weeks
Other intervention name(s): Strawberry powder made from a mix of California strawberries.; Beverage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: blood pressure; strawberry; fruit phenolics; LDL oxidation; Flow mediated dilation (FMD)
Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM)
Condition: HIV/AIDS; HIV Prevention
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      ATN DREAM is an early phase-1, open label study to examine the safety, pharmacokinetics (PK),
      pharmacodynamics (PD), and acceptability of a one-dose tenofovir (TFV) medicated douche. The
      overall goal is to inform the design of an extended safety study of an on-demand and
      behaviorally congruent TFV douche to confer protection from HIV acquisition in an outpatient
      pre-RAI context
    

Detailed description: 
      On demand and behaviorally-congruent forms of HIV pre-exposure prophylaxis (PrEP) have long
      been demanded by communities at great risk of HIV, especially men who have sex with men
      (MSM). The DREAM Program is developing a tenofovir (TFV) douche for on demand PrEP use prior
      to receptive anal intercourse (RAI), given that the vast majority of MSM very commonly douche
      prior to RAI (behaviorally-congruent). This ATN protocol seeks to ensure the inclusion of
      adolescent and young adults' (age 15-24 years) perspectives as next generation biomedical
      prevention, specifically a rectal douche, is being developed for efficacy.

      ATN DREAM is an early phase 1, open label study to compare the safety, PK, PD, and
      acceptability of a TFV-medicated douche. Each participant will undergo a Screening Visit to
      evaluate eligibility. Baseline Visit will assess pre-dose safety, PK, PD, and behavioral
      points of reference. Safety, PK, PD, and behavioral readouts are assessed at specified times
      after the single dose. The TFV douche to be used consists of TFV 660 mg in 125 mL half-normal
      saline (TFV 5.28 mg/mL). Study objectives including safety, pharmacokinetics (PK),
      pharmacodynamics (PD), and acceptability of a single TFV douche, are essential to inform the
      design of an extended safety study of a TFV douche in outpatient pre-RAI contexts. The
      necessity of extending the testing of new HIV prevention modalities to this proposed
      adolescent population is motivated by anticipated behavioral differences, not biological
      ones.

      Participant accrual will take approximately 9 months and each participant will be on study
      for approximately 3 months. Total study duration is about 1 year.
    

Intervention name(s): Tenofovir Douche
Intervention type(s): Drug
Intervention description(s): 660 mg TFV in 125 mL hypo-osmolar solution
Intervention MeSH terms: Tenofovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tenofovir; Tenofovir Douche
Analysis of Sexual Bias in Type 2 Innate Lymphoid Cells (ILC2) in Asthmatic Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Asthma is more common in females than in males but the difference has not been explained yet.
      Group 2 innate lymphoid cells (ILC2) have recently emerged as critical players in the
      initiation of allergic responses but their implications in the difference between males and
      females in terms of asthma prevalence has not been fully studied. The aim of this project is
      to compare the proportion of ILC2 in blood between males and females with asthma.
    

Detailed description: 
      Asthma is more common in males until puberty but becomes more prevalent and more severe in
      females after puberty suggesting a protective action of male sex hormones. ILC2 have recently
      emerged as critical players in the initiation of allergic responses. The present team
      established that androgens, signaling through the nuclear receptor 3 C4 (NR3C4) androgen
      receptor (AR), negatively control ILC2 at steady state and during lung inflammation. Relevant
      to this application, females with asthma have more circulating ILC2 than males. The present
      hypothesis is that harnessing AR signaling in ILC2 may provide a new therapeutic approach to
      down regulate tissue resident ILC2. This project will analyze the sex bias in circulating
      ILC2 in female and male patients with moderate to severe asthma. In females with asthma, the
      team will purify circulating ILC2 from peripheral blood mononuclear cells (PBMC) and expand
      them in vitro using cytokines and stromal cells in the presence of AR antagonist or agonist
      ligands. Bulk ILC2 cultures at day 7 will used to measure the expression profile of various
      gene, including AR.
    

Intervention name(s): Blood sample collection (one tube); Blood sample collection (five tubes)
Intervention type(s): Biological; Biological
Intervention description(s): Collection of one tube of 7.5 ml blood in addition to a blood sample made in clinical practice; Collection of five tubes of 7.5 ml blood in addition to a blood sample made in clinical practice
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Asthma patients
      
Keywords: allergy; type 2 innate lymphoid cells
The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to verify the role of adding cisplatin chemotherapy to the
      intensity-modulated radiotherapy (IMRT) for stage II nasopharyngeal carcinoma.
    

Detailed description: 
      Clinical Stage II nasopharyngeal carcinoma consisted of T2N0M0, T1N1M0, T2N1M0 three
      subgroups, the data came from conventional radiotherapy era showed that the prognosis of this
      three subgroups were different, the N1 groups suffered more distant metastasis than N0 group,
      and some literature showed that combined chemotherapy with radiotherapy in stage II patients
      can improve the treatment results.

      Intensity-modulated radiotherapy (IMRT)now is an widely used technique in the treatment of
      nasopharyngeal carcinoma, the preliminary results showed that IMRT can improve the quality of
      life in nasopharyngeal through salivary gland preservation.

      Compared IMRT alone with IMRT plus cisplatin concurrent chemotherapy in the treatment of
      stageII nasopharyngeal carcinoma, we hope to confirm whether stage II (and which subgroup)
      nasopharyngeal carcinoma will be benefit from concurrent chemoradiotherapy.
    

Intervention name(s): cisplatin
Intervention type(s): Drug
Intervention description(s): in experimental arm, the eligibility patients will be received the same radiotherapy as radical radiotherapy alone group, and also will received concurrent chemotherapy with the regimen of cisplatin 40mg/m2, weekly,from week 1 to week 7
Other intervention name(s): DDP
Intervention MeSH terms: Cisplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasopharyngeal carcinoma; Stage II; Intensity-modulated radiotherapy; Concurrent chemoradiotherapy; Cisplatin
Live Feedback to Increase Adherence in Adolescents With Patellofemoral Pain
Condition: Patellofemoral Pain Syndrome; Musculoskeletal Disorders; Joint Diseases
MeSH terms: Patellofemoral Pain Syndrome; Joint Diseases; Musculoskeletal Diseases
Study type: Interventional

Summary: 
      This study investigates if live feedback during home-based exercises will improve the ability
      to perform the exercises with the prescribed time under tension (TUT) per repetition compared
      with no feedback among adolescents with patellofemoral pain. The hypothesis is that
      adolescents who receive live feedback from BandCizer™ will have a mean TUT that is
      significantly closer to the prescribed TUT compared to the group not receiving feedback
      during the course of the intervention.
    


Intervention name(s): Feedback on TUT; No feedback on TUT; Exercise
Intervention type(s): Other; Other; Other
Intervention description(s): Access to live visual and auditory feedback on TUT and pulling force from an application on an iPad.; Access only to live visual feedback on pulling force from an application on an iPad.; 3 exercises (knee extension, hip abduction and hip extension) using an elastic band with 3 sets of 10 repetitions at 10-12 RM 3 times a week for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Adolescent; Physical therapy modalities; Exercise intervention; Auditive feedback; Visual feedback
Comparing Diet and Exercise Approaches in Women
Condition: Diet Modification
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether following a Curves high protein/low fat
      diet (30% carbohydrate, 45% protein, 25% fat) for 30-days several times during 16 weeks of
      participating in the Curves fitness program promotes stepwise reductions in body weight,
      improvements in body composition and/or improvements in markers of fitness and health better
      than following the Weight Watchers Momentum Program for the same time period.
    

Detailed description: 
      The Curves International fitness and weight loss program has become a very popular means of
      promoting health and fitness among women. The program involves a 30-minute circuit training
      program and a weight management program involving periods of moderate caloric restriction
      (1,200 to 1,600 calories per day) followed by short periods of higher caloric intake (2,600
      calories per day). The program is designed to promote a gradual reduction in body fat while
      increasing strength and muscle mass/tone. Researchers in the Exercise and Sport Nutrition Lab
      at Texas A&M University have conducted an extensive study on the effectiveness and safety of
      the Curves fitness and diet program. Results of this initial study have shown that the
      program promotes weight loss, improves markers of health, and improves fitness. The Weight
      Watchers program is another popular weight loss program. It provides a systematic approach to
      diet and exercise throughout the weight-loss process. Consequently we are interested in
      comparing the efficacy of both programs to one another. The purpose of this study is to
      determine whether following a Curves high protein/low fat diet (30% carbohydrate, 45%
      protein, 25% fat) for 30-days several times during 16 weeks of participating in the Curves
      fitness program promotes stepwise reductions in body weight, improvements in body composition
      and/or improvements in markers of fitness and health better than following the Weight
      Watchers Momentum Program for the same time period.
    

Intervention name(s): Curves Circuit; Weight Watchers
Intervention type(s): Other; Other
Intervention description(s): The Curves Circuit consists performing 13 hydraulic resistance exercise machines that utilize bidirectional resistance that work all major muscle groups. These are interspersed with floor-based calisthenic exercises designed to maintain an elevated heart rate.; The Weight Watchers program encourages one to increase physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Exercise Intervention
IFM 2005-01: Velcade/Dexamethasone Versus Vincristine/Adriamycin (Doxorubicin)/Dexamethasone (VAD) for the Treatment of Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, multi-centre, randomised Phase III study, looking at a series of 480
      patients up to the age of 65 with newly diagnosed multiple myeloma (MM) not previously
      treated. They will receive VAD or Velcade®/dexamethasone combination as induction treatment
      plus/minus (±) dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) followed by
      autograft as first-line therapy, as the investigators try to compare the complete remission
      (CR) rate (with negative or positive immunofixation) at the end of their induction treatment.
    

Detailed description: 
      After their written informed consent has been obtained and their eligibility verified,
      patients are randomised between 4 treatment arms: A1 VAD (4 cycles); A2 VAD (4 cycles)
      followed by DCEP (2 cycles); B1 Velcade® + dexamethasone (4 cycles); B2 Velcade® +
      dexamethasone (4 cycles) followed by DCEP (2 cycles) A1, A2, B1, B2 + autograft.
      Randomisation will be stratified on the basis of the initial b2 microglobulin level (> or < 3
      mg/l) and the presence of chromosome 13 abnormalities identified by FISH analysis. VAD:
      Vincristine/Adriamycin/Dexamethasone; DCEP: Dexamethasone/Cyclophosphamide/
      Etoposide/Cisplatin.
    

Intervention name(s): Velcade
Intervention type(s): Drug
Intervention MeSH terms: Bortezomib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Secretory Multiple Myeloma; First line treatment; Velcade®; autograft; Newly diagnosed secretory Multiple Myeloma (MM)
Effects of Administration of L.Plantarum WCFS1, L.Plantarum CIP104448, L.Plantarum CIP104450 on Small Intestinal Mucosa
Condition: Gastro Intestinal Infection
Study type: Interventional

Summary: 
      The design of this study conforms to a randomized double-blind placebo-controlled cross-over
      design.

      The objective of the study is to assess the effect of three probiotics (Lactobacillus
      plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450) on
      intestinal epithelial permeability and the immune system, in at least 8 healthy subject.

      The effect of the three different probiotics and a placebo will be assessed on every subject
      in random sequence.

      Prior to the start of a 7-days supplementation period (one of the three probiotic supplements
      or placebo), blood samples will be obtained and small intestinal permeability will be
      assessed by measuring the urinary extraction ratios of ingested water-soluble, non-degradable
      test probes, with and without indomethacin challenge (to compromise the gut). After each
      supplementation period the gut will be stressed again by the indomethacin protocol, followed
      by measurement of small intestinal permeability, whereupon blood samples will be taken and
      duodenal tissue samples will be obtained by standard gastroduodenoscopy. Each supplementation
      period will start 1 month after finishing the pervious test episode, in randomized sequence.

      The primary objective of this study is to assess the effects of Lactobacillus plantarum
      WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450 on intestinal
      epithelial permeability. Secondary objectives are to assess the effects on immune modulation,
      gene expression of peripheral blood mononuclear cells, small intestine epithelial gene
      regulation and tight junction proteins modulation, infiltration of immune cells in intestinal
      mucosa and immune markers in blood plasma.

      The investigators hypothesize that Lactobacillus plantarum WCFS1, Lactobacillus plantarum
      CIP104448, and Lactobacillus plantarum CIP104450 will, each separately, significantly affect
      the innate immune system and intestinal permeability in humans.
    


Intervention name(s): Probiotics
Intervention type(s): Dietary Supplement
Intervention description(s): Bacterial supplements (Lactobacillus plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450) will be prepared in the food-grade pilot plant of NIZO food research. Exactly 1x10^11 life bacteria are consumed by each participant.
Consumption of this amount of life bacteria is in line with earlier human studies and routinely reached by the consumption of dairy. As a placebo, the same drink will be used without addition of bacterial cells.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix
Condition: Cancer of Cervix
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effectiveness of two methods of treating cancer
      of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing
      radiation therapy, followed by adjuvant gemcitabine and cisplatin and the other half will
      receive cisplatin along with radiation therapy without adjuvant therapy.
    


Intervention name(s): Gemcitabine; Cisplatin; Brachytherapy; Pelvic radiation
Intervention type(s): Drug; Drug; Radiation; Radiation
Intervention description(s): Brachytherapy, 30-35 Gy over 1 week; Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
Other intervention name(s): LY188011; Gemzar
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Modulation of Anaerobic Gut Bacteria of Arsenicosis Patients by Probiotics
Condition: Chronic Arsenic Poisoning
MeSH terms: Arsenic Poisoning; Poisoning
Study type: Interventional

Summary: 
      The role of anaerobic bacteria in the pathogenesis of palmer arsenical keratosis is not
      known. This can be evaluated by administering probiotics. Thirty patients from an arsenic
      affected area will be provided two probiotics capsules per day orally for 12 weeks and stool
      samples will be collected for qualitative and quantitative analysis of anaerobic bacteria.
      Similar number of arsenic exposed controls and healthy volunteers from the same area will be
      included with similar protocol for comparison. Like aerobic bacteria, anaerobic bacteria may
      be modulated by probiotics in arsenicosis patients.
    

Detailed description: 
      Recent study done by our laboratory shows that there are reduction in the number of E. coli
      in the gut of patients with arsenical keratosis which is increase by the administration of
      probiotics (manuscript is preparing). However, E.coli contribute only about 0.1% of the total
      gut bacteria. It is not known whether anaerobic bacteria play an important role in the
      pathogenesis of arsenical keratosis. This can be evaluated by administering probiotics.
      Thirty patients of moderate arsenical palmer keratosis from an arsenic affected area will be
      recruited on the basis of inclusion and exclusion criteria. They will be provided two
      probiotics capsules per day orally for 12 weeks. Water sample will be collected before
      starting the study for confirming the diagnosis. Stool samples will be collected twice
      (before and after completion of the study) for qualitative and quantitative analysis of
      anaerobic bacteria. Similar number of arsenic exposed controls (30) and healthy volunteers
      (30) from the same area will be included in this study and they will be provided probiotics
      capsules with similar dosage and duration. Like aerobic bacteria, anaerobic bacteria may be
      modulated by probiotics in arsenicosis patients.
    

Intervention name(s): Probiotic
Intervention type(s): Dietary Supplement
Intervention description(s): Each capsule Probiotics (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic arsenic poisoning; Palmer arsenical keratosis
Prevalence of Female Circumcision Among Young Women in Beni-Suef, Egypt
Condition: Woman Abuse
Study type: Observational

Summary: 
      Female circumcision (FC) is a deeply-rooted practice in Egypt with deblitating physical and
      psychological consequences, however the previous two decades witnessed sincere efforts to
      counterfight this practice. The objective of this study is to investigate the prevalence of
      circumcision among young women (12-25 years) in Beni-Suef , Egypt.
    

Detailed description: 
      This cross-sectional study was conducted on a total of 3353young women residing urban and
      rural quraters in Beni-Suef City. Data was collected usinga questionnaire that included
      information about the socio-demographic charcteristics of the women, their gynecological
      data, exposure to FC, and complaints associated with menses during the previous year.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The urban Metropolitan of Beni-Suef City was classified according to the socioeconomic
        level of its quarters to low, middle, and high levels. Out of each level, one quarter was
        selected randomly, by a card withdrawal, where households residing these quarters were
        chosen using a random start. For the rural villages surrounding the urban Metropolitan,
        three villages were selected randomly; one on the road to the North, one on the road to the
        West, and the last one on the road to the South. Each village was clustered roughly into
        two sites; one to the East of the water channel and one to the West of the same water
        channel.

        In both urban and rural areas, a trained team of data collectors visited the selected
        households. Householders were informed briefly of the study and the residing women aged
        between 12 and 25 years were invited to participate and then interviewed.
      
Keywords: Female circumcision, Young Women, Dysmenorrhea,Dysuria