bioihbjkbjnl/mcl2 huggingface dataset:
NasoShield in Healthy Adults to Study Safety and Immunogenicity
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety for up to two doses of NasoShield, to
      determine if antibodies that protect against anthrax are formed after treatment with
      NasoShield, and to determine whether the formation of these antibodies are affected by
      different positions of administration.
    

Detailed description: 
      After being informed about the study and potential risks, all healthy volunteers that have
      given written informed consent will undergo screening to determine eligibility for study
      entry. If the healthy volunteer qualifies for the study, they will be randomly assigned to 1
      of 3 treatment groups. Within the treatment group, the participant will be randomized in a
      double-blind manner in a 5:2 ratio to NasoShield or placebo.

      The investigational drug (either NasoShield or placebo) will be administered on Days 1 and 29
      after qualifying into the study. The position of administration and the amount of time the
      subject will need to stay in the specified position will depend on the group to which the
      subject is assigned.

      Participants will return to the investigational site for multiple visits through Day 210
      (approximately 6 months after the second dose). At each visit, the participant will be asked
      about interim medical history and use of any medications, and safety and immunogenicity
      assessments will be performed.
    

Intervention name(s): NasoShield; Placebo
Intervention type(s): Biological; Other
Intervention description(s): NasoShield is an adenovirus-vectored anthrax vaccine; Normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 parallel groups defined by dosing position and number of doses
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Anthrax
Family Based Intervention in Childhood obesitY
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The study compares the effect on BMI of two different treatment options for obesity in
      childhood. Families with at least one obese child and parent are invited to join the project.
      The hypothesis is that family camp gives an additional reduction in BMI compared to a less
      intensive family lifestyle school.
    

Detailed description: 
      Participants are randomised to two intervention groups:

      A): Two weeks family camp and two years follow-up as a cooperation with primary health care,
      private rehabilitation center and specialist health care.

      B): Four days lifestyle school with two years follow-up as a cooperation with primary health
      care and specialist health care
    

Intervention name(s): Parent Management Training - Oregon (PMTO); Motivational interviewing; Dynamic group therapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Method to help parents and caregivers manage the behavior of the children they are responsible for.; Communication method to facilitate behavioral change and empower the parents.; Focuses on individual experiences within families and/or parents/children, and that the participants are their own experts.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Child; Parent; Family
Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients
Condition: Immunosuppression
Study type: Interventional

Summary: 
      The objective of this study is to determine the tolerability and safety of Myfortic in liver
      transplant patients. Patients receiving CellCept who have GI side effects will have CellCept
      discontinued and changed to Myfortic (Myfortic is a new drug similar to CellCept, except it
      is enteric-coated). Our hypothesis is that Myfortic has less GI side effects and will,
      therefore, be tolerated better than CellCept and also that Myfortic will have a comparable
      effectiveness to CellCept.
    

Detailed description: 
      This is a prospective, single center, open-label, safety and tolerability study on the use of
      Myfortic after liver transplantation. Adult liver transplant patients who are experiencing GI
      symptoms (nausea, vomiting, diarrhea, abdominal discomfort/pain, dyspepsia) attributable to
      CellCept are eligible to enter the study. CellCept will be discontinued and replaced with
      Myfortic. The duration of the study will be 3 months, and during this time, we will assess
      the incidence and severity of GI adverse events, the incidence and severity of bone marrow
      suppression (leukopenia), and the incidence of cytomegalovirus (CMV) infection or disease in
      patients receiving Myfortic.
    

Intervention name(s): Myfortic
Intervention type(s): Drug
Intervention description(s): Myfortic 360mg or 720 mg BID for 90 days.
Intervention MeSH terms: Mycophenolic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver transplantation; mycophenolate mofetil; gastrointestinal; adverse effects
Treatment for Subjects With Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      This multicenter, open-label, randomized, parallel study was designed to evaluate whether a
      single fixed-dose subcutaneous (SC) administration of pegfilgrastim or daily administration
      of Filgrastim for absolute neutrophil count (ANC) support would assist in allowing the
      planned dose-on-time (PDOT) of cyclophosphamide, doxorubicin, vincristine, prednisolone
      (CHOP) chemotherapy with Rituximab every 14 days in subjects with aggressive B-cell
      Non-Hodgkin's Lymphoma by reducing the duration of neutropenia and incidence of febrile
      neutropenia.
    


Intervention name(s): pegfilgrastim; Filgrastim
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-Hodgkin's lymphoma; R-CHOP-14; pegfilgrastim; neutropenia, clinical trial; haematopoietic growth factor
Cardiovascular Risk Factors, Maximal Oxygen Uptake and Sedentariness: an Observational Study
Condition: Aging
Study type: Observational

Summary: 
      This is a substudy of the Generation-100 study (NCT01666340). The aim of this study is to
      find critical values for (1) maximal oxygen uptake and (2) sedentary behavior, below which
      cardiovascular risk parameter clustering is apparent in an elderly Norwegian population.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        elderly, norwegian
      
Keywords: physical activity; maximal oxygen uptake
Computer-Assisted Provision of Reproductive Health Care
Condition: Contraception; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      This project seeks to demonstrate that computer kiosks in a clinic waiting room can improve
      access to hormonal contraception and screening for sexually transmitted infections. The study
      will be a randomized controlled trial which will evaluate the use of a computer kiosk module
      to compare the proportion of women of reproductive age who receive a prescription for
      hormonal contraception when computer-assisted provision of hormonal contraception is offered
      (intervention) to encounters when the study clinic provides standard contraceptive care
      (control). Subjects will be contacted approximately 3 months (range 2-4 months) after the
      clinic visit to complete a follow-up phone interview. The study population will include
      English and Spanish-speaking women ages 18-45 who seek care at this clinic. Our hypothesis is
      that computer-assisted provision of hormonal contraception (intervention)will increase the
      proportion of women of reproductive age who receive a prescription for hormonal contraception
      versus standard contraceptive care(control).
    

Detailed description: 
      Data collection has been completed
    

Intervention name(s): computer-assisted provision of hormonal contraception; STI module
Intervention type(s): Other; Other
Intervention description(s): a computer program available at a kiosk will offer women information about and a prescription for hormonal contraception that they can ask their clinician to sign.; computer module available at a kiosk that will encourage women to be screened for chlamydia
Other intervention name(s): Family planning kiosk; Chlamydia kiosk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Contraception; sexually transmitted diseases
Perceptions of Cervical Cancer Among Asian Americans
Condition: Epidemiology
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      The goal of this research study is to learn about the beliefs, practices, and knowledge about
      cervical cancer among Asian American young adults. Researchers want to develop materials that
      will educate Asian Americans about cervical cancer and encourage them to get screened for
      this disease.
    

Detailed description: 
      Survey:

      If you agree to take part in this study, you will complete a survey about your health
      practices and knowledge about cervical cancer and HPV. You will also be asked to provide some
      personal history on yourself such as your age, gender, birthplace, ethnicity, relationship
      status and educational level. Female participants will be asked to indicate if they have
      received an HPV test (also called a "Pap" test) within the last 3 years. The survey will take
      about 5-10 minutes to complete and will be filled out on the same day as the focus group.

      Focus Group:

      You will also take part in a discussion group called a "focus group." A trained focus group
      leader will guide you and 8-10 others through a series of questions. He/she will lead a
      discussion to hear comments, opinions, and observations on a brochure and poster about
      cervical cancer and HPV. Groups will be made up of participants of the same gender (that is,
      all male or all female) and ethnic group (Filipino, Korean, or Vietnamese). Each discussion
      group will last about 2 hours and may be audiotaped so that the discussion may be transcribed
      and analyzed. You will only be called by your first name and you are not required to use your
      real name during the focus group discussion. You will not be identified by the audiotape
      recordings.

      Length of Study:

      When the focus group discussion is over, you will be off-study.

      This is an investigational study. Up to 60 participants will be enrolled on this study. All
      will be enrolled at M. D. Anderson.
    

Intervention name(s): Focus Group; Questionnaire
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Focus groups each lasting about 2 hours.; Questionnaire relating to your health practices and knowledge about cervical cancer and HPV.
Other intervention name(s): Survey
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants that are self identified as Korean, Filipino, or Vietnamese.
      
Keywords: Epidemiology; Cervical Cancer; Human Papillomavirus; Focus Group; Questionnaire; Survey; HPV
Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters
Condition: Subjects With Abdominal Obesity
MeSH terms: Obesity, Abdominal
Study type: Interventional

Summary: 
      The aim of this is study is to evaluate the acute effect of grape and pomegranate polyphenols
      in the modulation of markers of metabolic syndrome. Most of the previous works about
      polyphenols have only considered a fraction of polyphenols, i.e., extractable polyphenols. As
      a consequence, an important amount of dietary polyphenols, the so-called non-extractable
      polyphenols are ignored. In contrast, the effect of both extractable and non-extractable
      polyphenols will be considered in this study. Furthermore, the effect of both polyphenols as
      present in the food matrix and metabolites derived from microbial fermentation will be
      evaluated.
    


Intervention name(s): Mixture of grape pomace and pomegranate pomace; Mixture of grape pomace and pomegranate pomace; Mixture of grape pomace and pomegranate pomace
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Oral Glucose Tolerance Test; Oral Glucose Tolerance Test right after taking the mixture of grape and pomegranate polyphenols; Oral Glucose Tolerance Test ten hours after taking the mixture of grape and pomegranate polyphenols
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Polyphenols; Grape; Pomegranate; Metabolic syndrome; Abdominal obesity; Postprandial glucose; Insulin resistance
Feasibility of Intraperitoneal Chemotherapy in the Surgical Treatment of Colon Cancer cT4
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      This is a randomised controlled study aims to determine the oncological effectiveness of
      adjuvant HIPEC, using intraperitoneal Mytomicin C following a curative resection of a cT4
      Colon cancer in preventing the development of peritoneal carcinomatosis in addition to the
      standard adjuvant systemic treatment.
    

Detailed description: 
      In the experimental group (50 patients) after laparotomy and revision of the abdominal cavity
      organs, peritoneal lavage will be performed followed by immunological examination. After
      performing the surgical intervention, the patient will undergo intraoperative intra-abdominal
      chemotherapy with mitomycin C. Further, lavage of the abdominal cavity will be repeated,
      followed by immunological examination.

      In the control group (40 patients), after laparotomy and revision, peritoneal lavage will
      also be performed, followed by immunological examination. Patients of this group will not
      receive intraoperative intra-abdominal chemotherapy. After performing the surgical
      intervention, the patient will perform irrigation of the abdominal cavity with physiological
      saline. Further, lavage of the abdominal cavity will be repeated, followed by immunological
      examination.
    

Intervention name(s): Experimental group; Control group
Intervention type(s): Procedure; Procedure
Intervention description(s): After performing the surgical intervention, the patient will undergo intraoperative intra-abdominal chemotherapy with mitomycin C. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.; In the control group (40 patients), after laparotomy and revision, peritoneal lavage will also be performed with subsequent immunological examination. Patients of this group will not receive intraperitoneal chemotherapy. After performing the surgical intervention, the patient will be irrigation of the abdominal cavity with physiological saline. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: intraperitoneal chemotherapy; Peritoneal Carcinomatosis; Colonic Diseases
High-Dose Melphalan Plus Peripheral Stem Cell Transplantation in Treating Patients With Primary Systemic Amyloidosis
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: High-dose chemotherapy may destroy the amyloid-producing cells in bone marrow.
      Peripheral stem cell transplantation

      PURPOSE: Phase II trial to study the effectiveness of high dose melphalan plus peripheral
      stem cell transplantation in treating patients who have primary systemic amyloidosis.
    

Detailed description: 
      OBJECTIVES: I. Assess the response rate and overall survival of patients with biopsy proven
      primary amyloidosis following treatment with myeloablative chemotherapy and hematopoietic
      stem cell reconstitution. II. Evaluate the toxicity of high dose melphalan in this patient
      population.

      OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 1 of the
      peripheral blood stem cell (PBSC) collection period and continuing until PBSC collection is
      completed. PBSC are collected beginning on day 5 of the collection period and continuing
      until the final target cell count is reached or for up to a maximum of 7 collections. If
      sufficient PBSCs are not harvested within a maximum of 7 collections, the patient is removed
      from the study. Within 30 days of PBSC collection, patients receive melphalan IV on day -1 of
      the infusion period and PBSC infusion on day 0. The infusion period continues until day 30.
      Patients receive G-CSF subcutaneously daily starting on day 1 and continuing until blood
      counts recover. Patients are followed every 3 months for 2 years, every 3 months for 3
      additional years, and yearly thereafter.

      PROJECTED ACCRUAL: A maximum of 33 patients will be accrued for this study over 2 years.
    

Intervention name(s): filgrastim; melphalan; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Procedure; Procedure
Intervention MeSH terms: Melphalan
Primary purpose: Treatment
Keywords: primary systemic amyloidosis
A Study of LY2216684 in Participants With Impaired Hepatic Function
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of liver function on how much of the
      study drug (LY2216684) gets into the blood stream and how long it takes the body to get rid
      of it. Information about any side effects that may occur will also be collected.

      The duration of participation in this study is approximately 12 days, not including the
      screening visit. This study requires 1 clinic confinement of 5 days/4 nights followed by 1
      out-patient follow-up visit. A screening visit is required within 30 days prior to the start
      of the study. This research study will be an open-label study.

      The study involves a single oral dose of 18 milligrams (mg) LY2216684 given as 2 tablets.
    


Intervention name(s): LY2216684
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): Edivoxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of KQ-791 in Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will consist of multiple ascending oral doses in up to 3 groups, for 29 days.
    


Intervention name(s): KQ-791; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules administered orally; Capsules administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Investigating the Pharmacokinetics of Subcutaneous Injections With 1 mg/mL, 3 mg/mL, and 10 mg/mL Semaglutide Strengths and the Absolute Bioavailability of Semaglutide
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the
      pharmacokinetics (the exposure of the trial drug in the body) of subcutaneous injections of
      three different strengths of semaglutide and the absolute bioavailability of semaglutide.
    


Intervention name(s): semaglutide; semaglutide
Intervention type(s): Drug; Drug
Intervention description(s): Semaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL).; Semaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL) or intravenously (i.v.) (1mg/mL).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      The Purpose of the study is to evaluate the 1440nm Laser Assisted Selective Photothermolysis
      vs. Botulinum Toxin or miraDry® Microwave Thermolysis For Treatment of Axillary
      Hyperhidrosis.
    


Intervention name(s): miraDry; Nd:YAG Laser; Botox®
Intervention type(s): Device; Device; Device
Intervention description(s): miraDry; Nd:YAG 1440 nm Laser; Botox®
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment