bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Hydration on Gut Health and Thinking
Condition: Dehydration; Cognitive Change; Gastrointestinal Microbiota
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      The central hypothesis is that improving hydration through increased water consumption will
      change the relative abundance of mucolytic bacteria found in the stool. Therefore the
      specific aims are 1) to quantify intervention effects on fecal microbiota relative abundance
      and plasma lipopolysaccharide binding protein, 2) observe the effects of the intervention on
      bowel frequency and signs/symptoms of gastrointestinal stress, and 3) to investigate
      relations between executive function and hydration status.
    

Detailed description: 
      A single arm 3-week hydration intervention will be employed where participants increase their
      water consumption to 2 (F) or 2.5(M) liters per day which is approximately 70% of the AI for
      daily water consumption. Pre-test and follow-up measures of fecal microbiota, urinary
      hydration status, cognitive function, circulating markers, and dietary intake will be
      assessed at baseline and at 3-week follow up via laboratory visits.
    

Intervention name(s): Water Intake
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will increase plain water consumption to at least 70% of the daily adequate intake for Americans depending on their sex.
Intervention model: Single Group Assignment
Intervention model description: Single arm hydration water intake intervention with a baseline urine concentration threshold for eligibility
Masking: None (Open Label)
Primary purpose: Prevention
Active Immunotherapy CEA Vaccine in Patients With Malignancies Expressing CEA
Condition: Colon Cancer; Lung Cancer; Breast Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to find out what effects (good and bad) that a cancer vaccine
      has on you and your cancer. The cancer vaccine is called Ad5 [E1-, E2b-]-CEA(6D)or ETBX-011
      and is made by Etubics. This vaccine is based on a virus called an adenovirus but it has been
      changed to express the protein CEA that is found on some cancer cells. Therefore, the vaccine
      can tell the immune system to attack cancer cells which make CEA. The investigators are
      trying to determine whether giving this virus is safe and whether this causes a strong immune
      system attack on the cancer. ETBX-011 is an investigational drug.
    

Detailed description: 
      This is a phase I/II study with the primary purpose to determine the safety of immunization
      with Ad5 [E1-, E2B-]-CEA(6D), in patients with advanced or metastatic CEA-expressing
      malignancies. The secondary objectives are to evaluate CEA-specific immune responses to the
      immunizations and to obtain preliminary data on clinical response rate. The study population
      consists of patients with a histologically confirmed diagnosis of metastatic malignancy that
      is CEA positive who were previously treated with standard therapy known to have a possible
      survival benefit or refused such therapy. The study will determine the safety of three dosage
      levels of Ad5 [E1-, E2B-]-CEA(6D) vaccine (phase I component), and the maximally tolerated
      dose of Ad5 [E1-, E2B-]-CEA(6D) vaccine (phase II component). The study drug is Ad5 [E1-,
      E2B-]-CEA(6D) given by subcutaneous (SQ) injection every 3 weeks for 3 immunizations. We will
      evaluate safety in each cohort at least 3 weeks after the last patient in the previous cohort
      has received their first injection. A dosing scheme will be considered safe if <33% of
      patients treated at a dosage level experience DLT (e.g., 0 of 3, ≤1 of 6, ≤3 of 12 or ≤5 of
      18 patients).
    

Intervention name(s): AD5 CEA Vaccine
Intervention type(s): Biological
Intervention description(s): AD5[E1-, E2b-]-CEA Vector Vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colon Cancer; Lung Cancer; Breast Cancer; CEA
Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is a multi-center, open-label, randomized, parallel group trial in adult patients
      with T1DM comparing the efficacy and safety of GP40071 (insulin aspart, GEROPHARM) with that
      of NovoRapid®.
    


Intervention name(s): GP40071; NovoRapid® Penfill®
Intervention type(s): Drug; Drug
Intervention description(s): GP40071, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake.; NovoRapid® Penfill®, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake.
Other intervention name(s): Insulin aspart; Insulin aspart
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin; Insulin aspart; Aspart
Efficacy and Tolerance of Formula 609613 37 in Acneic Patients
Condition: Acne
Study type: Interventional

Summary: 
      Acne affects most adolescents and young adults with varying severity and presentation. For
      early or localized forms, the first-line treatment is usually local. The available treatments
      often lead to local irritation, particularly during the first few weeks of use. This is why
      creams containing exfoliating agents have long been used in acne, as they are considered to
      allow a faster disappearance of superficial lesions.

      The objective of this 6-month double-blind study is to demonstrate in 100 acneic patients the
      interest of an anti-acne face cream as an adjunct to and in addition to a 5% benzoyl peroxide
      gel.
    

Detailed description: 
      The study is conducted in accordance with the protocol and the legislative and regulatory
      provisions in force (after obtaining authorization of the French health authorities and the
      favorable opinion of the ethics committee).

      Regarding the statistical analysis, two different analysis are performed:

        -  Descriptive analysis: quantitative variables are described by the mean and standard
           deviation and qualitative variables by the raw number of each modality and the
           corresponding percentage.

        -  Comparative analysis: for quantitative variables, inter-group comparisons are made by a
           Student's T-test or a non parametric Mann-Whitney test if necessary. For qualitative
           variables, comparisons are made using a Chi-square test, if the expected number of
           participants is less than 5, Fischer's exact test on a 4-box contingency tables is used.

      A significant level of p <0.05 is considered as significant. A double-data entry is carried
      out then a comparison of the two databases is performed. Finally internal and external
      consistency tests are planned. Missing data are described and possibly analyzed.
    

Intervention name(s): moisturizing cream and 5% benzoyl peroxide gel; anti-acne face cream and 5% benzoyl peroxide gel
Intervention type(s): Other; Other
Intervention description(s): Group A: Eclaran 5% every evening and formula 609567 49 every morning, for 3 months.
Then the group is divided: Group A1/ formula 609613 37 and Group A2/ formula 609567 49 every morning, for the next 3 months; Group B: Eclaran 5% every other night and 609613 37 every morning, for 3 months.
Then the group is divided: Group B1/ 609613 37 and Group B2/ formula 609567 49 every morning, for the next 3 months
Intervention MeSH terms: Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acne; lipohydroxyacid; salicylic acid; benzoyl peroxide; dermocosmetic
The Health Effects of Small-sided Team Handball
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of the project was to examine the fitness and health effects of participation in
      recreational Team Handball for untrained 20-30 year old healthy men and women.
    

Detailed description: 
      Fitness and health effects of 12 weeks of recreational team handball in untrained adult men
      and women aged 20-30 years"

      Adult men and women aged 20-30 years will be recruited to take part in a 12-week intervention
      with recreational team handball. Half of the participants are men (n=32), who are randomly
      assigned to a group playing recreational team handball (n=16) and an inactive control group
      (n=16). The women (n=40) are also divided and assigned to a group with regular participation
      in recreational team handball (n=20) and an inactive control group (n=20). The training
      sessions will be offered 2-3 times weekly for 70 minutes per session by a supervised trainer.
      The sessions involves an injury preventive warm-up and ball exercises for 15 minutes followed
      by recreational handball on small pitches such as 4 vs 4. A comprehensive testing protocol is
      conducted before and after the training period. The measurements includes body composition
      and bone mineralization, blood pressure, resting heart rate, fasting blood sugar, insulin,
      cholesterol and bone markers. In addition, a number of physical tests which involves fitness
      level (VO2max), intermittent work, muscle strength and balance will further be conducted. The
      testing takes place at the University of Copenhagen. The training sessions will also take
      place at the University of Copenhagen or in a handball club near the University. The study
      will be approved by the local ethical committee of Copenhagen.
    

Intervention name(s): Recreational handball; Control
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Evidence-Based Practice: Proposed Application of Facilitating Tools for Clinical Nurses
Condition: Evidence-Based Practice
Study type: Interventional

Summary: 
      Randomized study of educational intervention, comparative and prospective about Evidence
      Based Practice (EBP) and its application by clinical nurses in the implementation of EBP
      projects in search of best practice in nursing processes.
    

Detailed description: 
      Evidence Based Practice (EBP) has become an important issue in nursing. It is considered a
      process consisting of sequential steps. Multiple barriers are found, among them, time
      restriction, lack of personal motivation, professional resistance to research and inadequate
      knowledge. The proposal of this study is to provide Brazilian clinical nurses with tools to
      be used as a guide, with a structured process in stages as a facilitator of the
      implementation of EBP projects in search of best practice in nursing processes, for this the
      investigators will verify the adequacy of authorized translation of the Portuguese version of
      the Johns Hopkins Center for Evidence-Based Practice guide tools and whether these tools are
      facilitators in structuring and describing an EBP project from the perspective of the
      clinical nurse, in addition to verifying whether the EBP project met the requirements of
      preparation from the perspective of the researcher.
    

Intervention name(s): Educational Workshop; Educational Workshop plus J. H. N. EBP Guide Tools
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The workshop proposes a review of all stages of EBP which includes approaches to clinical care based on science and the quality of evidence, with the ultimate goal of promoting safe and quality care.
The workshops comprise one for each group with a total workload of six (6) hours divided into two days, lasting three hours each day. The first day will be a theoretical approach and the second day a practical approach.
The workshops with theoretical content and practical classes will be held in rooms of Albert Einstein Hospital.
All participants of both educational strategies will answer the same questionnaires.; In addition to the workshop. It will follow the same molds as the case of group "Educational Workshop" plus the Johns Hopkins Nursing Evidence-based Practice guide tools since the beginning of this practical class, when the participant will receive a description of a problem as a basis for elaborating their clinical question, and thus, move on to the next stage.
The tools will be offered in the case of this group: question development, evidence level and quality guide, research evidence assessment tool, individual evidence tool, evidence synthesis and recommendation tool, action planning tool and tool dissemination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Evidence-Based Practice; Evidence-Based Nursing; Education; Nursing
Reliability and Validity of the Spinal Cord Injury Secondary Conditions Scale
Condition: Spinal Cord Injuries; Reliability; Validity
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      People living with spinal cord injury (SCI) experience a range of secondary health conditions
      that impact their quality of lives. The Spinal Cord Injury Secondary Conditions Scale
      (SCI-SCS) is a 16-item questionnaire that assess secondary health conditions in persons with
      SCI. The total score of SCI-SCS range from 0 to 48 and is derived by adding the scores for
      each item. Higher scores indicate greater problems with secondary conditions. The
      investigators aimed to determine the reliability and cross-cultural validation of the Turkish
      translation of the SCI-SCS.
    

Detailed description: 
      After translation and back translation of the SCI-SCS, 93 patients between the ages of 18 and
      78 years with SCI, American Spinal Injury Association impairment scale grades from A to D and
      at least 6 months after injury were assessed. Participants rated the SCI-SCS 2-3 day apart,
      and test-retest agreement was investigated. Factor analysis was done and convergent validity
      was investigated by correlating the SCI-SCS with the Spinal Cord Injury Spasticity Evaluation
      Tool (SCI-SET), Functional Ambulation Categories (FAC), 36-Item Short Form Health Survey
      (SF-36), and Spinal Cord Independence Measure III (SCIM-III).
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between the ages of 18 and 80 years with SCI, American Spinal Injury Association
        impairment scale grades from A to D and at least 6 months after injury who volunteered to
        participate in the study were recruited from the inpatient and outpatient rehabilitation
        unit of an education and research hospital.
Basal Androgens and LH Needing for Ovarian Stimulation for in Vitro Fertilization
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      Basing the investigators study on the evidence that basal serum androgens decrease with age,
      the investigators hypothesize that women with serum androgens below a certain level could be
      the population obtaining a benefit of Luteinizing Hormone (LH) supplementation. The objective
      of the present study is to explore the relationship between basal serum androgen levels and
      the need of LH for Controlled Ovarian Stimulation (COS) in IVF.
    

Detailed description: 
      Design: Single centre, open label, randomized controlled trial.

        -  Population: Patients with indication of In Vitro Fertilization (IVF) with the following
           criteria:

        -  Protocol: All patients are tested on day 3-5 of cycle for total Testosterone (Te),
           Dehydroepiandrosetnodione sulphate (DHEAS) and Androstenodione (Δ4). Samples are frozen
           and stored at -20ºC for later analysis. FSH, LH, E2, PRL and TSH are also determined.
           All patients follow Controlled Ovarian Stimulation for IVF with a GnRH agonist long
           protocol. They are randomized to receive recombinant (r) FSH alone (225 IU/day) or r-FSH
           + r-LH (225+75 IU/day).

        -  Sample size calculation: To detect a difference from 40 to 60% (Relative risk: 1.50) on
           pregnancy rate (PR) between patients with low and high androgen levels with respect to
           the mean of each COS protocol, with a confidence level of 95% (error α=0.05) and 80% of
           power (error β=0.2), 97 patients per arm were needed. (n=388 patients). Rounding up, 400
           patients are to be recruited.
    

Intervention name(s): FSH+LH; FSH+LH
Intervention type(s): Drug; Drug
Intervention description(s): 75 IU of LH will be given from stimulation day 1; 75 IU of LH will be given from stimulation day 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
480 STUDY: Phase 2b Study of Locteron Plus Ribavirin to Treat Hepatitis C Virus (HCV)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this 12-week study was to assess in subjects with chronic hepatitis C
      (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the early virologic
      response to the 480 ug dose level of Locteron™, dosed every 2 weeks, in comparison with 1.5
      ug/kg PEG-Intron™ dosed weekly.
    

Detailed description: 
      The aim of the 480 STUDY was to compare efficacy and safety of 480ug Locteron dosed every
      other week to 1.5 ug/kg PegIntron dosed weekly in treatment-naïve genotype-1 chronic HCV
      subjects treated with weight-based ribavirin. This 12-week study was comprised of two panels
      (Panel A and Panel B). The designs of both panels were identical. HCV RNA was measured weekly
      for three weeks and then every other week. Adverse events including flu-like events and
      depression were collected during weekly clinic visits for 12 weeks. Flu-like events were also
      collected daily for 12 weeks by subject self-report using the internet (ePRO). Beck
      Depression Inventory (BDI) and Short Form-36 scores were measured at baseline and monthly
      through Week 12.

      In Panel A of 480 STUDY, 42 treatment-naïve subjects with chronic genotype-1 HCV in Bulgaria
      and Romania were randomized and dosed with either Locteron q2weeks or weekly PegIntron, both
      in combination with weight-based ribavirin (13). In Panel A, 19 subjects received 480ug
      Locteron and 23 subjects received PegIntron.

      In Panel B of 480 STUDY, 32 treatment-naïve subjects with genotype-1 HCV in Israel were
      randomized and dosed with either Locteron q2weeks or weekly PegIntron, both in combination
      with weight-based ribavirin (13). In Panel B, 16 subjects received 480ug Locteron and 16
      subjects received PegIntron.
    

Intervention name(s): ribavirin
Intervention type(s): Drug
Intervention description(s): Ribavirin - oral administration Subjects with body weight < 65 kg: 800 mg/day Subjects with body weight 65-85 kg: 1000 mg/day Subjects with body weight 86-105 kg: 1200 mg/day Subjects with body weight > 105 kg: 1400 mg/day
Other intervention name(s): Ribasphere
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treatment naive
Single Dose Mass Balance Study With [14C]Iruplinalkib (WX-0593) In Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single dose, mass balance and biotransformation study conducted at 1
      study center in China. This study will evaluate the absorption, distribution, metabolism, and
      elimination (ADME), mass balance, safety, and tolerability of a single dose of intravenously
      administered [14C]Iruplinalkib (WX-0593) in Chinese healthy male volunteers.
    


Intervention name(s): [14C]Iruplinalkib (WX-0593)
Intervention type(s): Drug
Intervention description(s): Volunteer will receive a single oral dose of 120 mg [14C]Iruplinalkib (WX-0593) as a solution on Day 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the long-term efficacy and safety of the subjects during the third year after
      priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the
      primary vaccination study (102247). The Rotarix vaccine was administered in the primary
      vaccination study. There was no vaccine/intervention in this long-term efficacy study.
    


Intervention name(s): Rotarix (primary vaccination study); Placebo (primary vaccination study)
Intervention type(s): Biological; Biological
Intervention description(s): GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.; Two liquid oral doses of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Intussusception; Gastroenteritis; Finland
Clinical Trial on Pharmacokinetic and Tolerability of AP701
Condition: Pharmacokinetic; Tolerability; Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to investigate the uptake of AP701, a preparation from cannabis flowers, into
      the bloodstream after in single administration in healthy volunteers.
    

Detailed description: 
      Pharmacokinetic parameters and tolerability of AP701 is studied over 30 hours after single
      dose administration in healthy volunteers in a prospective and open-label manner at a single
      study center.
    

Intervention name(s): AP701
Intervention type(s): Drug
Intervention description(s): Preparation of Cannabis flowers (Cannabis flos)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cannabis; Cannabis based medicine; THC; Tetrahydrocannbinol