bioihbjkbjnl/mcl2 huggingface dataset:
Nursing Management of Irritable Bowel Syndrome:Improving Outcomes
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is 1) to determine whether a comprehensive self-management
      intervention is effective in a sample that includes men and women with irritable bowel
      syndrome, and 2) to determine whether the comprehensive self-management intervention is as
      effective when delivered over the telephone as compared to a face-to-face approach.
    

Detailed description: 
      Randomization and Intervention Phase. Upon completing the baseline assessment phase,
      participants will be randomized to one of 3 treatment groups. A customized computer program
      will be used to do the randomization in an adaptive manner that ensures the 3 groups remain
      fairly balanced with respect to possible important predictors of outcomes: age, sex,
      predominant stool pattern (alternating, constipation-predominant or diarrhea-predominant),
      and severity of IBS symptoms and psychological symptoms at baseline. When each new
      participant is randomized, the program will adjust the probabilities of assignment to the
      three groups so that there is a higher probability of assignment to the group that results in
      the best balance.

      Intervention Groups. Face-to-Face Individualized Comprehensive Self-Management (CSM-FF)
      Group. Participants in the individualized CSM-FF group will be scheduled for 9 weekly
      sessions with the nurse therapist followed by post-intervention follow-up assessment.

      Telephone Individualized Comprehensive Self-Management (CSM-TEL) Group. Participants in the
      individualized CSM-TEL group will initially have 2 face-to-face meetings with the nurse
      therapist, 6 sessions over the phone and the final session face-to-face at 9 weeks.

      Usual Care Control Group (UC). Following randomization the participants in the control group
      will no receive any contacts during the comparable 9-week intervention in the treatment
      groups.

      Follow-up Phase. Participants in all 3 groups will be reassessed at 3-mo, 6-mo, and 12-mo
      post randomization. At this time the participants will complete questionnaires, a 4 week
      diary and collect 4 urines.
    

Intervention name(s): cognitive-behavioral
Intervention type(s): Behavioral
Intervention description(s): Cognitive-behavioral over 9 weeks
Other intervention name(s): Usual care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Cognitive-behavioral intervention; Psychological distress; Quality of life
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic
      (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the
      investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) in subjects
      with type 1 diabetes.
    


Intervention name(s): Faster-acting insulin aspart; insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): A single dose will be administered subcutaneously (under the skin) in the abdomen.
Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days.; A single dose will be administered subcutaneously (under the skin)) in the abdomen.
Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the clinical efficacy of once daily treatment for 4
      weeks with Xamiol® gel (calcipotriol plus betamethasone) with twice daily treatment for 4
      weeks with Calcipotriol Scalp Solution in patients with scalp psoriasis.
    


Intervention name(s): Xamiol® gel; Calcipotriol scalp solution
Intervention type(s): Drug; Drug
Intervention description(s): Once daily application; Twice daily application
Intervention MeSH terms: Calcipotriene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
[18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
Condition: Prostate Cancer; Localized Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the ability of a new PET scan radiotracer, called FDHT
      (stands for [18F] Dihydro-Testosterone), to better find and monitor prostate cancer.
      Radiotracers are a type of drug that carries small amounts of radioactivity that can be seen
      by the PET scanner. FDHT is a radiotracer that looks for a protein which is present in almost
      all prostate cancer cells. The investigators want to find out if we can find and monitor
      changes in cancer using a FDHT PET scan.
    


Intervention name(s): [18F] DIHYDRO-TESTOSTERONE; PET scan; MRI; Blood draw
Intervention type(s): Drug; Device; Device; Other
Intervention MeSH terms: Testosterone; Dihydrotestosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: [18F] Dihydro-testosterone; PET Scan; MRI; 14-185
Radiation Biodosimetry in Children Undergoing Total Body Irradiation
Condition: Total-body Irradiation; Hematopoietic Stem Cell Transplant
Study type: Observational

Summary: 
      The purpose of this study is to develop fecal tests that will determine the extent of
      radiation exposure in patients undergoing radiation treatment for cancer. This project will
      determine whether fecal biomarkers can be used to diagnose exposure to radiation.
    

Detailed description: 
      Patients undergoing TBI as part of a hematopoietic stem cell transplant (HSCT) will have
      feces collected for use in the validation and refinement of new methods for rapid radiation
      biodosimetry. The stool samples will be collected before, and at defined times after TBI.
      Stool sampling will occur in the same manner that it does during routine patient care during
      HSCT.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing Total Body Irradiation (TBI) preceding hematopoietic stem cell
        transplantation.
      
Biospecimen description: 
      Stool
    
Keywords: Fecal biomarkers; Radiation biodosimetry; Total-body irradiation (TBI); Hematopoietic stem cell transplantation; Gene expression profiles; Fecal metabolites
Evaluating the Impact of B Vitamin Supplementation (Soloways™) on Homocysteine and LDL-C Levels in Patients With MTHFR, MTR, and MTRR Polymorphisms.
Condition: Hyperhomocysteinemia; Hyperlipoproteinemias
MeSH terms: Hyperhomocysteinemia; Hyperlipoproteinemias; Hyperlipidemias
Study type: Interventional

Summary: 
      This randomized, double-blind, placebo-controlled trial will evaluate the impact of
      methylfolate, pyridoxal-5'-phosphate (P5P), and methylcobalamin supplementation on
      homocysteine and LDL-C levels in individuals with low to medium cardiac risk and MTHFR, MTR,
      and MTRR gene polymorphisms. The study aims to explore the efficacy of these vitamins in
      reducing homocysteine levels, a critical risk factor for cardiovascular disease (CVD), while
      also monitoring LDL-C levels. The findings will offer valuable insights into personalized CVD
      prevention and management, emphasizing the significance of genetic factors in nutritional
      therapy.
    

Detailed description: 
      Design: Participants with specific genetic polymorphisms and homocysteine levels above 15
      µmol/L, without a history of severe CVD or other exclusion criteria, will be enrolled and
      randomized into two groups: one receiving methylfolate, P5P, and methylcobalamin, and the
      other a placebo. The study, adhering to ethical standards and informed consent, will involve
      54 patients divided equally between the treatment and placebo groups. The primary endpoint
      will be the percent change in homocysteine levels over six months, with secondary endpoints
      including changes in LDL-C and other lipid profile components.

      Intervention: Participants will receive either the active treatment (L-methylfolate, P5P, and
      Methylcobalamin) or a placebo, with both groups taking two capsules daily for 180 days.
      Fasting measurements of lipid profiles and homocysteine levels will be conducted at the
      start, midpoint, and end of the study.
    

Intervention name(s): Vitamin B; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): MTHFR, MTR, and MTRR polymorphysm based L-methylfolate (1 mg), P5P (pyridoxal-5-phosphate, 50 mg), and Methylcobalamin (500 mcg) prescription; MTHFR, MTR, and MTRR polymorphysm based placebo prescription
Intervention MeSH terms: Vitamins; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Methylfolate; Homocysteine; Genetic Polymorphisms (MTHFR, MTR, MTRR); Cardiovascular Risk; Methylcobalamin; LDL-C; Cholesterol; Low-Density Lipoprotein
Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis
Condition: Acute Adenoviral Keratoconjunctivitis
MeSH terms: Keratoconjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study objective is to evaluate the efficacy and the safety of GV 550 in comparison to
      placebo in patients with acute adenoviral keratoconjuncivitis.
    


Intervention name(s): GV550; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ganciclovir 1.5 mg/g, 1 drop 10 times daily at D0 and D1 and 1 drop 5 times daily from D2 to D9 + additionnal treatment (Hyabak® eye drops: 5 times daily from D10 to D30); 1 drop 10 times daily at D0 and D1 and 1 drop 5 times daily from D2 to D9 + additionnal treatment (Hyabak® eye drops: 5 times daily from D10 to D30)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GV550; Acute adenoviral keratoconjunctivitis
Diet Study on Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      The primary purpose of this study is to determine the effectiveness of a low-fat or standard
      American diet (high in fat) in helping people with ulcerative colitis improve their symptoms
      and the signs of inflammation in blood tests and in bowel biopsies.
    


Intervention name(s): LFD; SAD
Intervention type(s): Other; Other
Intervention description(s): Participants will receive daily prepared food trays to achieve a diet with approximately 10% of total fat, 1-5% of calories from saturated fat, and 5-9% of MUFA and PUFA. This diet will contain an approximate ratio of 1:1 of omega-6/omega-3 fatty acids.; Participants will receive daily prepared food trays to achieve a diet with approximately 35-40% of calories from fat, 10-11% of saturated fats, and 25-29% would be mono-unsaturated (MUFA) and PUFA. This diet will contain a 20-30:1 ratio of omega-6/omega-3 fatty acids, representing the current SAD.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Inflammatory bowel disease; diet; low fat; UC; IBD
COMPARISON OF CORNEAL MEASUREMENTS IN NORMAL AND KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER
Condition: The Reliability of Corneal Topographic Measurements of Keratoconus Eyes
MeSH terms: Keratoconus
Study type: Observational [Patient Registry]

Summary: 
      The purpose of current study is to provide a comprehensive comparison of the reliability of
      corneal topographic measurements between Optovue AS- OCT and a combined Scheimpflug imaging
      using Wavelight Oculyzer Pentacam HR in normal and keratoconus eyes.
    


Intervention name(s): corneal topography
Intervention type(s): Diagnostic Test
Intervention description(s): In all patients, TCT will be measured first by WaveLight® Oculyzer™II Pentacam HR and second by The Optovue AS-OCT .
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        keratoconus patients
High-dose Cytarabine and Survival in AML
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Observational

Summary: 
      In adults with acute myeloid leukemia, especially those < 60 years of age, high-dose
      cytarabine consolidation therapy has been shown to influence survival, but the appropriate
      dose has not been defined.
    

Detailed description: 
      Background In adults with acute myeloid leukemia, especially those < 60 years of age,
      high-dose cytarabine consolidation therapy has been shown to influence survival. However, the
      appropriate dose has not been defined. We evaluated survival after cytarabine consolidation
      therapy at three different doses.

      Design and Methods We conducted a single-center, retrospective study involving 499 acute
      myeloid leukemia patients, aged 18-92 years, all evaluated between 1978 and 2007. Of those
      499 patients, 400 received curative treatment and 203 received cytarabine consolidation. The
      latter were divided into three groups: low-dose (receiving < 1.5 g/m2 of i.v. cytarabine,
      every 12 h, on 3 alternate days, for up to 4 cycles); medium-high-dose (< 45.45 g-the median
      dose-by the end of the cycles); and very-high-dose (≥ 45.45 g by the end of the cycles).

      Results Among the 400 patients receiving curative treatment, five-year survival was 22.8% (91
      patients). Cytarabine consolidation dose was an independent determinant of survival
      (significant differences were found among the groups), whereas age, karyotype, induction
      protocol, French-American-British classification and etiology were not. In comparison with
      the very-high-dose group, the risk of death was 3.871 times (95% CI, 1.043 to 14.370 times)
      higher in the high-dose group (p=0.043) and 9.775 times (95% CI, 2.493 to 38.320 times)
      higher in the low-dose group (p=0.001), assuming, in both cases, that age, karyotype,
      French-American-British classification and etiology of acute myeloid leukemia were constant.

      Conclusions Consolidation therapy with high-dose cytarabine appears to improve survival in
      patients with acute myeloid leukemia.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Acute myeloid leukemia in adults treated in the University of Sao Paulo between 1978 and
        2007
      
Keywords: acute myeloid leukemia; prognosis; cytarabine
A School-Based Osteoporosis Prevention Program for Adolescent Girls
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The Incorporating More Physical Activity and Calcium in Teens (IMPACT) study was a
      behaviorally-based middle school nutrition and physical activity program for the prevention
      of osteoporosis. The goal of IMPACT was to increase calcium intake and physical activity to
      help build bone mass in girls.
    

Detailed description: 
      Peak bone mass is achieved during the first twenty years of life, and dietary and activity
      patterns that contribute to the formation of peak bone mass are developed during childhood.
      The IMPACT intervention was designed to increase bone density and ultimately prevent
      osteoporosis during adulthood. IMPACT included physical education, food service, and
      classroom environmental and behavioral components and was delivered by physical education
      (PE) specialists, food service personnel, and classroom teachers.

      A group of 718 sixth grade girls (mean age 11.1) from twelve middle schools in central Texas
      participated in the study. The group was 72% non-Hispanic white, 12% Hispanic, 5% African
      American, and 11% other ethnicity. After baseline measurements were completed in the fall of
      2000, the twelve middle schools were pair-matched based on school characteristics (ethnicity,
      % economically disadvantaged, % girls in athletics) to a control (usual health education
      program) or the IMPACT program. The intervention was implemented for 18 months and consisted
      of three major components: a PE component, which emphasized daily weight-bearing activities
      (WBA); a health lessons component consisting of sixteen behaviorally-based lessons which
      emphasized WBA, calcium-rich foods, and osteoporosis prevention; and a food service
      component.

      Outcome measures included physical properties of the students' heel bones, calcium
      consumption, physical activity, and psychosocial factors believed to be precursors to these
      behaviors. Changes at the school environmental level, such as the number of calcium rich
      foods offered in the cafeteria and the number of opportunities offered for weight-bearing and
      aerobic activity, were also assessed.
    

Intervention name(s): Incorporating More Physical Activity and Calcium in Teens (IMPACT) Program
Intervention type(s): Behavioral
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Weight-bearing physical activity; Calcium intake; School-based health education; Adolescent girls; Child nutrition; Diet
High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Renal Cancer
Condition: Metastatic Clear Cell Renal Cell Carcinoma
MeSH terms: Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic
      radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky
      progressive disease, but also to provide antigen presentation and immune stimulation which is
      expected to act synergistically when immediately followed by the non-specific immune
      stimulation provided by treatment with HD IL-2 and thereby increase the response rate and
      complete response for metastatic clear cell renal cell cancer patients. Both HD IL-2 and SABR
      are FDA approved therapeutic cancer treatment
    


Intervention name(s): IL-2; Stereotactic Ablative Body Radiation Therapy
Intervention type(s): Drug; Radiation
Intervention description(s): HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions
Other intervention name(s): SABR, SBRT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: kidney cancer; metastatic cancer
Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This study proposes to evaluate the effects that a dose of oxytocin given by intramuscular
      (IM) injection (into the muscle) will have on an area of skin that has been exposed to
      ultraviolet (UV) light. The area of skin exposed to UV light will have a mild sun burn
      feeling.

      Sensory testing will be performed on the area of UV burn. The area will be evaluated for
      sensitivity in 3 methods: touch, vibratory
    

Detailed description: 
      This protocol aims to provide an estimate of effect size of intramuscular oxytocin on a test
      of Aβ and of Aδ fiber sensitivity in injured skin following ultraviolet B (UVB) burned skin.

      For the primary goal - to examine the effects of oxytocin peripheral nerves after tissue
      injury - the investigators chose the controlled ultraviolet sunburn model.

      The investigators propose a randomized, blinded, cross over design with treatment with
      oxytocin one day and placebo on another. Following baseline measures on each of the two study
      days, participants will receive an intramuscular injection of oxytocin (Pitocin®) in its
      indicated dose of 10 IU (17 μg) or an equivalent volume of saline.

      In order to determine the highest frequency that Aβ nerve fibers can respond to, the
      investigators will use a device that produces an oscillatory / vibratory stimulus which can
      be used on the hand.

      Pain threshold to punctate stimulation within the area of irradiation will be determined
      using calibrated von Frey filaments and an up-down sequential method which efficiently
      estimates median thresholds.

      Thermal heat testing will also be performed by the surface of the skin of the forearm or leg
      is heated to 45°C using a computer controlled thermode for a period of 5 minutes.
    

Intervention name(s): Oxytocin; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 10 IU oxytocin (Pitocin) for intramuscular injection; 1.5 ml preservative free saline for intramuscular injection
Other intervention name(s): Pitocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double blinded crossover treatment with oxytocin and placebo (saline)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study to Evaluate Safety and Immunogenicity of the GSK Bio CMV Vaccine in CMV-seronegative Healthy Male Adult Subjects
Condition: Infections, Cytomegalovirus
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be the first time in humans (FTIH) study with the GSK Bio recombinant gB antigen to
      evaluate safety and immunogenicity of this CMV candidate vaccine with a proprietary GSK
      adjuvant system. The vaccine will be administered to young male healthy subjects at 0, 1 and
      6 months. The trial will assess the safety and immunogenicity of the candidate CMV vaccine.
      An additional secondary objective of this trial is to identify and validate a test which will
      be able to differentiate between previous CMV infection and CMV vaccination. Subjects will be
      followed for a total of 2 years.
    

Detailed description: 
      The protocol posting has been amended to reflect changes as a consequence of an amendment to
      the protocol. The section impacted by the change is Key inclusion & exclusion criteria. The
      Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Intervention name(s): GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A
Intervention type(s): Biological
Intervention description(s): Intramuscular injection, 3 doses
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention