bioihbjkbjnl/mcl2 huggingface dataset:
Enhancing Connections Program in Improving Communication Between Patients With Incurable Cancer and Their Children
Condition: Advanced Malignant Neoplasm
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      This pilot clinical trial studies the use of the Enhancing Connections Program in improving
      communication between patients with incurable cancer and their children. The Enhancing
      Connections Program is an educational program that may provide patients with new competencies
      to improve communication with their children and help them to cope with their parent's
      incurable cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To test the feasibility of the study protocol in advanced cancer patients
      (recruitment/retention, dosage and fidelity of the intervention; program acceptability of
      program; and logistics).

      II. To evaluate the short-term impact of the program on the diagnosed parents' and children's
      adjustment using a within group design (pre- and post-test design).

      III. To compare outcomes from the Enhancing Connections Program with outcomes obtained from
      the completed Phase III trial (between group design).

      OUTLINE:

      Patients participate in Enhancing Connections Program comprising of anchoring patients to
      help their child, adding to listening skills, building on listening skills, being a detective
      of their child's coping, and celebrating success for 5 sessions. Patients also receive
      workbook which includes text from the sessions, handouts, and at-home assignments to be
      completed between sessions.
    

Intervention name(s): Educational Intervention; Questionnaire Administration
Intervention type(s): Other; Other
Intervention description(s): Receive Enhancing Connections Program; Ancillary studies
Other intervention name(s): Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence
Condition: Pelvic Organ Prolapse; Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      To evaluate the impact of Burch colposuspension (BC), as an anti-incontinence measure, in
      patients with urinary incontinence (UI) undergoing abdominal surgery for pelvic organ
      prolapse (POP) repair
    

Detailed description: 
      Forty-seven women suffering from POP and UI were randomly assigned to abdominal POP repair
      and concomitant BC ( 24 patients; group A) or POP repair alone without any anti-incontinence
      procedure ( 23 patients.; group B). They were followed-up at 3, 6, and 9 months after surgery
      and then annually. The primary outcome measures were anatomical outcome and changes in
      incontinence status as indicated by a bladder diary, the number of daily pads and the stress
      test. Secondary endpoints were changes in subjective symptoms and Quality of Life (QoL) as
      measured by the Urogenital Distress Inventory (UDI-6) and the Impact Incontinence Quality of
      Life (IIQ-7) questionnaires.
    

Intervention name(s): Pelvic organ prolapse repair and Burch colposuspension
Intervention type(s): Procedure
Intervention description(s): Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pelvic organ prolapse, Urinary incontinence, Burch colposuspension, surgery
Investigation of Psycho-Physiological Parameters in Adolescent Inpatients With Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      A study to assess changes in mental and physical symptoms in adolescent inpatients with
      anorexia nervosa, a severe eating disorder.
    

Detailed description: 
      This is a prospective controlled trial to assess changes in psycho-physiological parameters,
      including eating disorder features (drive for thinness, body dissatisfaction) and comorbid
      symptoms such as anxiety, depression and quality of life as well as heart rate variability,
      body warmth and BMI in adolescent inpatients with anorexia nervosa. Parameters were assessed
      at admission, six weeks after admission and three months thereafter and compared to reference
      values of healthy controls.
    

Intervention name(s): Integrative medicine-based multimodal treatment
Intervention type(s): Other
Intervention description(s): Multimodal inpatient treatment program based on anthroposophic medicine, including individual and group psychotherapy, family therapy, art therapies and specific nursing applications such as embrocations, rhythmical massage and oil dispersion baths.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescent patients with Anorexia Nervosa who are admitted to the Filderklinik's ward for
        eating disorders to attend a specific inpatient treatment program based on anthroposophic
        medicine
      
Keywords: Anorexia nervosa; Eating disorder; Adolescents; Inpatient treatment; Integrative medicine; Anthroposophic medicine; Heart rate variability; Thermography
Effect of Heat on Rivastigmine TDS Products
Condition: Bioavailability
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This research study is designed to measure the amount of medicine in blood over time after
      the patch is placed on the skin with and without external heat application.
    


Intervention name(s): Rivastigmine (RLD) transdermal patch; Rivastigmine (generic) transdermal patch
Intervention type(s): Drug; Drug
Intervention description(s): brand name patch; generic patch
Other intervention name(s): brand name patch; generic patch
Intervention MeSH terms: Rivastigmine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: The same healthy subjects are assigned to all four treatments.
Masking: None (Open Label)
Primary purpose: Other
Durom(R) Hip Resurfacing System Multicenter Trial
Condition: Advanced Hip Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to gather clinical information on the safety and efficacy of the
      resurfacing devices in the young, active patient with advanced hip disease. Study enrollment
      has been temporarily suspended due to a change in the surgical technique.
    

Detailed description: 
      Safety will be evaluated based on the frequency and incidence of any device related adverse
      events or unanticipated adverse device events. The efficacy will be measured by comparing the
      overall functional performance based on the Harris Hip Score, implant survivorship, and
      radiographic parameters, including radiolucencies, osteolysis, stem subsidence, cup
      migration, and change in cup angle and a change in the femoral shaft angle.
    

Intervention name(s): Durom Hip Resurfacing System
Intervention type(s): Device
Intervention description(s): Hip resurfacing devices in the young, active patient with advanced hip disease instead of traditional total hip arthroplasty.
Other intervention name(s): Hip Reserfacing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Total Hip Arthroplasty,; Acetabular Cup,; Hip Resurfacing; Young,; active; patients
Outcomes 8 Years After Minimal Invasive THA
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      There exists only limited scientific evidence concerning medium- to long-term benefits
      concerning minimally invasive (MI) total hip arthroplasty (THA). The investigators examined
      in a randomized study design 157 patients 8 years after THA, which were performed via 3
      different surgical approaches.
    

Detailed description: 
      In contrast to reported short-term advantages of minimally invasive (MI) total hip
      arthroplasty (THA) there exists only limited scientific evidence concerning medium- to
      long-term benefits.

      The investigators therefore sought to answer the following questions: Is the functional
      medium-term outcome in THA patients with MI-anterior(MI-A) and MI-anterolateral (MI-AL)
      approach superior to those treated by direct lateral approach (DLA)? Is the level of life
      quality increased by MI-THA? Is patient satisfaction higher by MI-THA? Is the revision rate
      reduced by MI-THA?
    

Intervention name(s): surgical approach
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-center prospective randomized study design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Total Hip Arthroplasty; minimally invasive; Patient-relevant outcomes
Treatment of Anxiety/Depression and Pain Through Relaxation Yoga for Patient With Cystic Fibrosis (CF)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators research question is whether or not yoga effectively alleviates symptoms of
      pain, sleep disturbance, anxiety and depression in children with cystic fibrosis. If yoga
      does prove to be effective, the investigators will educate our CF population about the
      benefits they may experience if they choose to incorporate yoga into their CF therapy. The
      investigators will also go on to do further research of other complementary alternative
      medicine therapies.

      This is a pre/post-test study with 20 subjects. The subjects will serve as their own
      controls. Each subject will participate in six yoga sessions over a ten week period.
      Subjects' symptoms will be evaluated with the use of questionnaires. The investigators will
      also test cortisol levels on weeks -2, -1, 1, 6, 7, 8. Cortisol is a hormone that is affected
      by stress. Testing of cortisol throughout the study will help us determine the subjects'
      stress level throughout the study.
    

Detailed description: 
      H1: The implementation of a yoga therapy program decreases symptoms of pain within our CF
      population.

      H2: The implementation of a yoga therapy program decreases symptoms of sleep disturbance
      within our CF population.

      H3: The implementation of a yoga therapy program decreases symptoms of anxiety within our CF
      population.

      H4: The implementation of a yoga therapy program decreases symptoms of depression within our
      CF population.
    

Intervention name(s): Yoga treatment program
Intervention type(s): Other
Intervention description(s): yoga program designed specifically for the patient with CF
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CF
Bleeding Time Study With AZD6482, Clopidogrel and ASA
Condition: Antiplatelet Effect
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the effect of AZD6482 and clopidogrel on
      bleeding time when taken together with low-dose ASA.
    


Intervention name(s): AZD6482; Clopidogrel; ASA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single intravenous infusion during a maximum of 5 hours; Oral doses given once daily during 7 days. 300 mg on day 1 and 75 mg on day 2 to 7.; 75 mg orally once daily during 7 days in each treatment arm
Other intervention name(s): Plavix®; Trombyl®
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antiplatelet
A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1
Condition: Hepatorenal Syndrome Type 1
MeSH terms: Hepatorenal Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open-label, multi-center study, investigating the efficacy and safety of
      terlipressin in Japanese patients with hepatorenal syndrome type 1.
    


Intervention name(s): Terlipressin
Intervention type(s): Drug
Intervention MeSH terms: Terlipressin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of L-Citrulline Supplementation on NAFLD in Adolescents With Obesity
Condition: Non-Alcoholic Fatty Liver Disease; Obesity
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Obesity
Study type: Interventional

Summary: 
      One of the comorbidities of obesity is nonalcoholic fatty liver disease (NAFLD). L-citrulline
      is a non-protein amino acid that has shown positive effects on the degree of fat retention
      and metabolic profile in NAFLD. The objective is to assess the effect of oral L-citrulline
      supplementation on liver function and nonalcoholic fatty liver in adolescents with obesity. A
      clinical study will be carried out in 40 adolescents (15-19 years) with obesity, they will be
      divided into a control group that will receive a placebo and an experimental group that will
      receive 6 g of l-citrulline per day for eight weeks.
    

Detailed description: 
      It is hypothesized that l-citrulline supplementation decreases liver enzymes and the degree
      of hepatic steatosis in adolescents with obesity. The aim of the study is to assess the
      effect of oral L-citrulline supplementation on liver function and nonalcoholic fatty liver in
      adolescents with obesity. A prospective randomized, double-blind clinical study will be
      carried out in 40 adolescents (15-19 years) with obesity, they will be divided into a control
      group that will receive a placebo (carboxymethyl cellulose) and an experimental group that
      will receive 6 g of pure l-citrulline per day per eight weeks. At the beginning and end of
      the intervention, anthropometric, biochemical and metabolic data will be evaluated, as well
      as tests of function and degree of hepatic steatosis.
    

Intervention name(s): L-Citrulline supplement; Carboxymethyl cellulose supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The intervention will consist of oral supplementation of six grams of pure l-citrulline for eight weeks.; The intervention will consist of oral carboxymethyl cellulose supplementation as a placebo.
Intervention MeSH terms: Carboxymethylcellulose Sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The intervention consists of the oral administration of placebo or l-citrulline as follows:
Group Placebo: Carboxymethyl cellulose will be used for the placebo group. Four capsules will be taken in the morning before the first meal and four capsules at night before going to sleep for eight weeks.
Group Citrulline: a dose of 6 g of citrulline will be used per day, distributed as 3 g (4 capsules) in the morning before the first meal and 3 g (4 capsules) in the evening before sleep, for eight weeks. Each capsule contains 750 mg of pure citrulline.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NAFLD; Obesity; Adolescents; L-citrulline supplementation
Dietary Biomarkers 2.0: From Potential Towards Implementation.
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this project is to fill a gap in the translation of dietary biomarkers as unbiased
      measures of food intake from high-end academic research into a methodology that ca be easily
      applied across academic, public and private health sector to objectively assess specific
      dietary intakes at group and individuals' level to a) improve understanding of diet and
      health relationships b) address compliance in dietary intervention studies and c) assess
      individuals' dietary intakes to guide their eating towards improved health. The study will be
      carried out as a three-way cross-over design with three different meal compositions (A, B, C)
      where each meal is provided 3 times per day during four days per meal. A wash-out period of 7
      days where participants consume their habitual diet is implemented and a 3-day run-in before
      the study meal intervention. The first day of study meal intervention includes postprandial
      measurements during 8 hours.
    


Intervention name(s): Diet
Intervention type(s): Other
Intervention description(s): All intervention meals consist of five different food groups including fruits, vegetables, legumes, dairy products, and whole grains. Differences in the proportion of these foods in Meal A-C is tested.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Phase 1 Safety, Tolerability and Pharmacokinetics (PK) Study of FP-025 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo controlled, single and multiple ascending dose study to assess
      the safety and tolerability and pharmacokinetics of FP-025 in healthy subjects.

      Note: Dosing in the SAD phase was completed, and the planned MAD portion of the study was not
      conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No.
      FP02C-17-001).
    

Detailed description: 
      In the SAD part of the study the investigational drug will be administered once in a dose
      escalation manner starting from 200 mg in Cohort 1 to 2000 mg in Cohort 6. The study drug
      will be orally taken as capsules. In the MAD part of the study the investigational drug will
      be administrated twice daily for 5 days depending on the half-life of FP-025, as determined
      in the SAD part of the study. Study subjects will be randomized in a 1:3 ratio to either
      placebo or FP-025 in every cohort of the SAD and MAD part of the study.

      Note: Dosing in the SAD phase was completed, and the planned MAD portion of the study was not
      conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No.
      FP02C-17-001).
    

Intervention name(s): FP-025; Placebo; FP-025; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive single doses of 200 to up to 800 mg of FP-025 (API-in-capsule) in a dose escalation format (cohorts 1-3). Subjects will receive single doses of 50 to up to 450 mg of FP-025 (ASD-in-capsule) in a dose escalation format (cohorts 4-8).; Subjects will receive single doses of FP-025 matching placebo (capsule) in a dose escalation format.; Subjects will receive doses of FP-025 (capsule) twice daily for 5 days.; Subjects will receive FP-025 matching placebo (capsule) twice daily for 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phase I; Safety and tolerability; Pharmacokinetic; Randomized; Double Blind; Placebo-Controlled; Single- & Multiple Dose Escalation; FP-025; MMP-12 inhibitor
A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of paliperidone
      palmitate in schizophrenic inpatients who have experienced recent exacerbation of acute
      schizophrenia (that is within past 4 weeks).
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), prospective
      (looking forward using periodic observations collected predominantly following participant
      enrollment), non-comparative and multicenter study to evaluate the effectiveness and safety
      of paliperidone palmitate in acute schizophrenic participants. This study consists of a
      screening phase (up to 7 days), treatment phase (13 weeks), and a study completion or early
      withdrawal visit. Safety evaluations will include adverse events, clinical laboratory tests,
      concomitant medications, physical examination, and vital signs, which will be monitored
      throughout the study. The total duration of study participation for each participant will be
      approximately 13 weeks.
    

Intervention name(s): Paliperidone palmitate
Intervention type(s): Drug
Intervention description(s): Participants will receive 1 intramuscular (into muscle) injection of 150 milligram (mg) on Day 1 and 1 injection of 100 mg on Day 8. Participants will also receive the last 2 paliperidone intramuscular injections between 50 - 150 mg (based on effectiveness and safety profile), on Day 36 and Day 64.
Other intervention name(s): Sustenna
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Antipsychotics; Paliperidone Palmitate; Paliperidone; Invega; Sustenna; Psychotic disorder; Psychosis
Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Patients With Step Length Asymmetry After Stroke
Condition: Stroke; Hemiplegic Gait
MeSH terms: Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      To investigate the effect of anteroposterior weight shifting training with visual biofeedback
      on step length asymmetry. Reduced speed and asymmetry of stepping is a specific
      characteristic of hemiplegic gait. Asymmetry of stepping is characterized by shorter step
      length of the unaffected limb compared to the affected limb. Causes of this phenomenon are
      difficulty in weight bearing at the affected limb, weak propulsive force of the affected
      limb, and decreased strength of hip extensors. To correct these factors. we have developed an
      anteroposterior weight shifting training system with visual feedback and studied its effects.
    


Intervention name(s): AP shifting training; Gait training
Intervention type(s): Procedure; Procedure
Intervention description(s): AP shifting training in addition to gait training 3 times a week for 6 weeks; Gait training only for 3 times a week for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: anterioposterior; weight; shifting; training; patient