bioihbjkbjnl/mcl2 huggingface dataset:
A Survey to Describe the Experience and Unmet Needs of Persons Living With Von Willebrand Disease (VWD) and Their Caregivers
Condition: Von Willebrand Disease (VWD)
MeSH terms: Von Willebrand Diseases
Study type: Observational

Summary: 
      The main aim of this study is to describe the experience and unmet needs of persons living
      with VWD and their caregivers in Canada.

      The survey is planned to be done in two phases: The first phase will be directed at adult
      participants; the second phase will focus on children and teenagers. At the end of the first
      phase the Sponsor will decide if the second phase will be started.

      Participants and their caregivers will be asked to answer a set of questions either using an
      online questionnaire or through interviews. The participant/caregiver's perception,
      experience, satisfaction, and unmet needs, and need for new treatments or new indications
      will be determined based on their responses to the questions.
    

Detailed description: 
      This study is a non-interventional, prospective, qualitative survey to know the unmet needs
      of participants living with VWD and their caregivers.

      The study will enroll approximately 49 patients, taking into scope both the participant's and
      caregiver's perspectives, and is planned to be conducted in two phases:

      Phase 1: Adult Participants Phase 2: Pediatric Participants The decision to proceed with
      Phase 2 will be determined at the completion of Phase 1.

      This multi-center trial will be conducted in Canada. The overall time for data collection in
      this study is approximately 9 months.
    

Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): As this is an observational study, no intervention will be administered.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants and caregivers of participants diagnosed with VWD in Canada.
      
Keywords: Drug Therapy
Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation
Condition: Healthy; Skin Manifestations
MeSH terms: Skin Manifestations
Study type: Interventional

Summary: 
      The goal of this double-blind randomized clinical trial is to investigate the effects on the
      skin from oral intake of probiotic supplements in healthy adult men and women. The main
      questions it aims to answer are: • Will probiotic supplementation result in beneficial
      changes to different skin parameters? • Will probiotic supplementation result in alterations
      in the skin microbiome? Participants will consume the study product daily for 8 weeks and
      come in for skin measurements at baseline and after 8 weeks.
    


Intervention name(s): Probiotic with niacin and berry extract; Probiotic without niacin and berry extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1 capsule daily of probiotic with niacin supplementation for 8 weeks; 1 capsule daily of probiotic without niacin supplementation for 8 weeks; 1 capsule daily of placebo supplementation for 8 weeks
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Use of Perfusion CT Derived Parameters as Early Acute Pancreatitis Severity Biomarker Compared to Clinico Biological Score
Condition: Acute Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      The investigators to establish whether early microvascular permeability parameter evaluated
      by perfusion-CT could be good biomarkers for severity in acute pancreatitis.

      Therefore the investigators want to compare 48 hours-clinico-biological systemic inflammatory
      response syndrome score to initial microvascular permeability parameters ( ktrans - capillary
      membrane permeability factor- and pancreatic blood flow ) calculated by OLEA software using
      inclusion perfusion CT.
    


Intervention name(s): Perfusion computed tomography.
Intervention type(s): Radiation
Intervention description(s): Using specific post treatment imaging software ( Olea® ) we will calculatell permeability parameters : the pancreatic blood flow and the k-trans, capillary membrane permeability factor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Pharmacodynamic Trial on Rocuronium in Obese Patients
Condition: Bariatric Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim: To optimize the use of rocuronium (a neuromuscular blocking agent) in obese patients
      undergoing gastric bypass or gastric banding.

      Background: During general anaesthesia, a neuromuscular blocking agent is needed to allow
      surgery and airway management. Optimal dosing is important in order to avoid inadequately
      muscle relaxation, but also to avoid overdosage, which can result in prolonged anaesthesia
      and respiratory complications.

      Main hypothesis: Rocuronium dosed according to ideal body weight results in shorter duration
      of action compared to rocuronium dosed according to corrected body weight without prolonged
      onset time or compromised airway management or surgical demands for muscle relaxation.
    


Intervention name(s): Rocuronium
Intervention type(s): Drug
Intervention description(s): 0.6 mg/kg given intravenously before intubation
Other intervention name(s): Esmeron (R)
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
TMC435 HPC1004 - Phase I Study Investigating the Pharmacokinetics of TMC435 in Healthy Chinese Volunteers
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics, safety and tolerability of
      single and multiple oral doses of TMC435 in Chinese healthy volunteers. Pharmacokinetics (PK)
      means how the drug is absorbed into the bloodstream, distributed in the body and eliminated
      from the body.
    

Detailed description: 
      TMC435 is being investigated for the treatment of chronic hepatitic C infection. The results
      of this study will provide dosing recommendations for the administration of TMC435 in Chinese
      HCV-infected patients. This is a Phase I, open label (both participant and investigator know
      the name of the medication given at certain moment), randomized (study medication is assigned
      by chance) study to investigate the pharmacokinetics, safety and tolerability of TMC435 after
      single and repeated intakes. Each participant will receive 2 treatments. First, participants
      will receive TMC435 as a single dose of 100 or 200 mg. Thereafter, in the multiple dose part,
      100 or 200 mg TMC435 will be administered during 5 consecutuve days every morning. Both
      treatments will be administered with food. There will be a washout period of at least 72
      hours between the 2 treatments. The main focus of the trial is the pharmacokinetic
      characteristics (level-profile of TMC435 over time in the blood stream). This evaluation
      requires multiple blood samples from Day 1 till Day 3 in the first session and from Day 1
      till Day 11 in the second session. Safety assessments (blood and urine tests, blood pressure,
      pulse, electrocardiogram, and physical examination) will follow a different schedule and will
      be performed during each treatment period, up to 4 weeks after the last. Each volunteer
      participate in 2 treatments, i.e., single dose period and multiple dose period. In the single
      dose part, planned doses will be 100 or 200 mg TMC435. In the multiple dose part, TMC435 will
      be administered during 5 consecutive days every morning.
    

Intervention name(s): TMC435; TMC435
Intervention type(s): Drug; Drug
Intervention description(s): 100 or 200 mg capsule, one single dose; 100 or 200 mg capsule, once daily for 5 days
Intervention MeSH terms: Simeprevir
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC435HPC1004; TMC435; HCV; Hepatitis C; Healthy Chinese volunteer
Impact of Chemo-induced Menopause on Quality of Life in Women <45 Years Old, Diagnosed With Non-metastatic Breast Cancer
Condition: BREAST CANCER
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Prospective multicenter study, Not on Health Products that evaluates up to 2 and a half years
      the impact of chemo-induced menopause (CIM) on the functional score of the QLQ-C30 quality of
      life questionnaire in young women of childbearing age, diagnosed with non-metastatic breast
      cancer.
    

Detailed description: 
      Approximately 20% of women with breast cancer are still of childbearing age and are likely to
      benefit from chemotherapy. Since Chemotherapy-Induced Menopause (CIM) may be one of its
      consequences, it seems important to study its impact on the quality of life of these young
      patients. It is within this framework that the Jean Perrin Center promoted the MENOCOR study,
      whose main objective is to assess the impact of the CIM on the quality of life through the
      QLQ-C30 functional score over a two-year period. The CIM incidence, its impact on quality of
      life (body image, anxiety, depression, physical activity and sleep quality) and the onset of
      climacteric signs, the onset of amenorrhea according to chemotherapy protocols and patient
      age and hormonal variations are among the secondary objectives of the study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        premenopausal women with age between 18 to 45 years. premenopausal women with
        non-metastatic breast cancer.
      
Biospecimen description: 
      Serum is collected in order to measure AMH (Anti-Müllerian Hormone) levels, before the start
      of chemotherapy and after the end of chemotherapy treatment
    
Keywords: breast cancer; Chemotherapy-induced menopause; quality of life
Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Gastric Cancer
Condition: Gastric Cancer; Peritoneal Carcinomatosis
MeSH terms: Stomach Neoplasms; Carcinoma; Peritoneal Neoplasms
Study type: Observational

Summary: 
      Gastric cancer associated peritoneal carcinomatosis has a poor prognosis with a median
      survival of less than one year. Systemic chemotherapy including targeted agents has not been
      found to significantly increase the survival in Gastric cancer associated peritoneal
      carcinomatosis. Since recurrent gastric cancer remains confined to the abdominal cavity in
      many patients, regional therapies like aggressive cytoreductive surgery and hyperthermic
      intraperitoneal chemotherapy have been investigated for Gastric cancer associated peritoneal
      carcinomatosis. Hyperthermic intraperitoneal chemotherapy has been used for three indications
      in Gastric Cancer- as an adjuvant therapy after a curative surgery, hyperthermic
      intraperitoneal chemotherapy has been shown to improve survival and reduce peritoneal
      recurrences in many randomised trials in Asian countries; as a definitive treatment in
      established PC, hyperthermic intraperitoneal chemotherapy along with cytoreductive surgery is
      the only therapeutic modality that has resulted in long-term survival in select groups of
      patients. While the results of randomised trials of adjuvant hyperthermic intraperitoneal
      chemotherapy from western centres are awaited, the role of hyperthermic intraperitoneal
      chemotherapy in the treatment of Gastric cancer associated peritoneal carcinomatosis is still
      evolving and needs larger studies before it is accepted as a standard of care.
    


Intervention name(s): Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure; Cytoreductive surgery alone
Intervention type(s): Procedure; Procedure
Intervention description(s): Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure; Exclusively Cytoreductive surgery approach
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with gastric peritoneal carcinomatosis. All patients received the current standard
        neoadjuvant treatment.
Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: The use of diindolylmethane, a substance found in cruciferous vegetables, may slow
      the growth of tumor cells.

      PURPOSE: This phase II trial is studying how well diindolylmethane works in treating patients
      with stage I or stage II prostate cancer undergoing radical prostatectomy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To measure the level of diindolylmethane in prostate tissue after treatment with oral
           microencapsulated diindolylmethane (B-DIM) in patients with stage I or II adenocarcinoma
           of the prostate undergoing radical prostatectomy.

      Secondary

        -  To measure serum biomarkers (e.g., total PSA, serum testosterone, and diindolylmethane
           levels) pre- and post-treatment with B-DIM.

        -  To measure tissue biomarkers (e.g., androgen receptor, NF-κB, and PSA) pre- and
           post-treatment with B-DIM.

      OUTLINE: This is a multicenter study.

      Patients receive oral microencapsulated diindolylmethane (B-DIM) twice daily for 14-72 days
      in the absence of disease progression or unacceptable toxicity. Patients then undergo radical
      prostatectomy 1 day after the last dose of B-DIM.

      Patients undergo blood and tissue sample collection for correlative laboratory studies. Blood
      samples are analyzed for serum PSA, testosterone, and diindolylmethane levels by high
      performance liquid chromatography and tandem mass spectrometry (LC-MS/MS). Tissue samples are
      analyzed for diindolylmethane concentration by LC-MS/MS and for androgen receptor, activated
      NF-κB (p65 antibody), and PSA expression by IHC.
    

Intervention name(s): B-Dim; Radical Prosatectomy
Intervention type(s): Drug; Procedure
Intervention description(s): B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
Other intervention name(s): 3,3'-Diindolylmethane; therapeutic conventional surgery
Intervention MeSH terms: 3,3'-diindolylmethane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer
A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Infants and Children Infected With or at Risk for HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      AMENDED: As of 10/19/90 only Children 0 to 3 months are being enrolled. Original design: To
      determine whether the experimental drug recombinant CD4 (rCD4), which is produced through
      genetic engineering technology, is safe and well-tolerated in children infected with or at
      risk for HIV infection.

      rCD4 may be an effective treatment for HIV infection, based on its ability to block infection
      of human cells by HIV in laboratory tests. However, the activity of rCD4 still needs to be
      confirmed in clinical trials. It is hoped that these tests will show that rCD4 is both safe
      and effective in treating children who are infected with or who are at risk for infection
      with HIV.
    

Detailed description: 
      rCD4 may be an effective treatment for HIV infection, based on its ability to block infection
      of human cells by HIV in laboratory tests. However, the activity of rCD4 still needs to be
      confirmed in clinical trials. It is hoped that these tests will show that rCD4 is both safe
      and effective in treating children who are infected with or who are at risk for infection
      with HIV.

      Children have preliminary testing and evaluation to determine eligibility and health. The
      dosage schedule varies with the dose. During the course of the study, children are monitored
      for safety through physical exams and blood tests. They have blood withdrawn to study the
      response to rCD4 and measure the activity of rCD4 in the body. Children may receive
      immunization of DPT (diphtheria, pertussis, tetanus) or DT and a polio vaccine to measure
      their antibody response. If the rCD4 is beneficial, children may continue treatment. The
      study is conducted in four parts:

        -  Part A: Children 13 to 18 years old.

        -  Part B: Children 3 months to less than 13 years old.

        -  Part C: Full-term infants over 3 months old.

        -  Part D: Preterm infants less than 3 months old. Parts C and D are not started until
           parts A and B have been completed.
    

Intervention name(s): CD4 Antigens
Intervention type(s): Drug
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recombinant Proteins; Acquired Immunodeficiency Syndrome; Antigens, CD4; Antiviral Agents
Manual Therapy in Haemophilic Arthropathy of the Knee
Condition: Patients With Haemophilia
MeSH terms: Joint Diseases; Hemophilia A
Study type: Interventional

Summary: 
      This study aims to assess the effectiveness of two Physiotherapy treatments: one with manual
      therapy using joint traction, passive muscle stretching, and isometric exercise, active
      resisted and proprioception exercises; and other treatment with educational sessions and home
      exercises to improve the ROM, muscle strength and proprioception in patients with haemophilia
      and arthropathy of the knee.
    

Detailed description: 
      Randomized trial with two treatment groups: one using joint traction, passive muscle
      stretching and isometric exercises, active resisted and proprioception exercises (group MT);
      and another with educational sessions and home exercises (group E); and a control group
      (group C).

      The intervention was carried out during twelve weeks, performing evaluation before and after
      treatment, and six months of finalizing this. The treatment in MT group consisted of two
      sessions per week for one hour each, and the treatment in group E consisted of a session of
      90 minute every two weeks, with exercises daily home. The control group (group C) did not
      receive any treatment. After the allocation to the groups, the composition was follows: MT
      group = 7; E group = 7; and control group = 7.
    

Intervention name(s): Manual Therapy; Educational Physiotherapy
Intervention type(s): Other; Other
Intervention description(s): 5 minutes. Thermotherapy shallow to 50 cm away from the knee. 15 minutes. Joint traction, grade I-II. Fixation of distal femur with cinch and manual fixation of proximal tibia. Patient in prone position and the traction is carried out in the submaximal ranges of flexion and extension.
10 minutes. Passive muscle stretching of quadriceps (within the limits of mobility), through compression muscle, passive muscle stretching and relaxation of muscle.
10 minutes. Isometric and resisted exercises of quadriceps, in submaximal ranges, of flexion and extension.
10 minutes. Proprioception exercises with unipodal support, with and without visual support, and posterior destabilization.
10 minutes. Local cryotherapy with ice pack.; Theory. Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of knee; Anatomy of ankle musculature; Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
Practice: exercises in favor of gravity; active exercises for mobility and pain management; knee proprioception exercises; isometric and isotonic exercises of quadriceps; swimming and cycling technique.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee; Joint disease; Haemophilia; Physiotherapy modalities
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Sweden
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is a Swedish, Multicentre, Observational Registry to study Adherence and Long Term
      Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth
      hormone treatment to assess the level of adherence of subject receiving SAIZEN® via Easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter longitudinal observational registry.
      Parents/subjects will provide their Informed Consent/assent to upload their data for
      population-based analyses and optionally to adhere to a patient adherence support program
      designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will
      be primarily derived from the Easypod™ device combined with physician data entry of outcome
      measures. Data will be collected retrospectively and prospectively. This will allow the
      establishment of adherence profiles and explore the hypothesis that patient adherence support
      programs improve adherence and subsequent clinical outcomes. Collected data will be also
      analyzed in a multinational pooled analysis of comparable national studies.

      Primary Objective:

      • To assess the level of adherence of subjects receiving SAIZEN® via Easypod™

      Secondary Objectives:

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via Easypod™

        -  To identify adherence subject profiling based on age, gender, self injection or not,
           time on treatment, medical history at time of enrollment

        -  To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above,
           below or within normal ranges)

      Other Objectives:

      • To assess the impact of adherence on average blood glucose (HbA1C)
    

Intervention name(s): easypod™
Intervention type(s): Device
Intervention description(s): Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™
Other intervention name(s): Somatotropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        Easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject