bioihbjkbjnl/mcl2 huggingface dataset:
PET and CT Scans in Patients With Locally Advanced Primary Rectal Cancer That Can Be Removed During Surgery
Condition: Colorectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Diagnostic procedures, such as PET and CT scans, may improve the ability to detect
      the extent of locally advanced primary rectal cancer and may also help to measure a patient's
      response to treatment.

      PURPOSE: This clinical trial is studying how well PET and CT scans detect residual or
      metastatic disease in patients with locally advanced primary rectal cancer that can be
      removed during surgery.
    

Detailed description: 
      OBJECTIVES:

        -  Determine if fludeoxyglucose F 18 positron emission tomography (FDG-PET) is superior to
           CT scan at monitoring rectal cancer response to radiation and chemotherapy by
           identifying residual rectal cancer in the rectal wall or pelvic lymph nodes in order to
           optimize selection of patients suitable for a sphincter preserving rectal cancer
           resection or a local excision.

        -  Determine the accuracy of FDG-PET in detecting extrapelvic metastatic disease in primary
           rectal cancer patients considered operable on the basis of currently accepted diagnostic
           work-up, including abdominal CT scan and chest x-ray.

      OUTLINE: This is a diagnostic study conducted concurrently with multimodality management.

      Within 1-2 weeks prior to starting preoperative radiotherapy/chemotherapy, patients undergo
      baseline positron emission tomography (PET) imaging of the thorax, abdomen, and pelvis.
      Patients receive fludeoxyglucose F 18 (FDG) IV followed 45 minutes later by PET imaging.
      Patients also undergo baseline CT imaging of the abdomen and pelvis. A CT scan of the chest
      is obtained if the prestudy chest x-ray is abnormal.

      Patients receive preoperative radiotherapy/chemotherapy. Within 4-6 weeks of completion of
      radiotherapy/chemotherapy, patients undergo repeat FDG-PET imaging and CT scan. Patients
      undergo surgical resection 1-2 weeks later.

      PROJECTED ACCRUAL: A total of 125 patients will be accrued for this study within 3 years.
    

Intervention name(s): chemotherapy; computed tomography; conventional surgery; neoadjuvant therapy; positron emission tomography; radionuclide imaging; fludeoxyglucose F 18; radiation therapy
Intervention type(s): Drug; Procedure; Procedure; Procedure; Procedure; Procedure; Radiation; Radiation
Intervention MeSH terms: Fluorodeoxyglucose F18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: stage II rectal cancer; stage III rectal cancer; stage IV rectal cancer
Validity and Reliability of the 2-minute Step Test in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational [Patient Registry]

Summary: 
      The objective of this study was twofold: first, to assess the validity and reliability of the
      2 Minute Step Test (2MST) in patients with fibromyalgia; and second, to explore its
      relationship with objective assessment methods, specifically the 2 Minute Walk Test (2MWT)
      and the 6 Minute Walk Test (6MWT). Additionally, the study aimed to investigate the
      correlation between the 2MST and quality of life as well as chronic fatigue levels using the
      Fibromyalgia Impact Questionnaire (FIQ) and the Fatigue Severity Scale (FSS).
    

Detailed description: 
      This cross-sectional study will include 55 female patients aged 18-65 who will be diagnosed
      with fibromyalgia according to the American College of Rheumatology 2010 Diagnostic Criteria.
      Demographic characteristics of the patients will be documented. The extent of impact on
      patients' quality of life will be evaluated using the Fibromyalgia Impact Questionnaire
      (FIQ), while the severity of chronic fatigue will be measured using the Fatigue Severity
      Scale (FSS). The intensity of chronic pain experienced by patients will be expressed using
      the Visual Analogue Scale (VAS). All patients will undergo an initial assessment using the
      2-Minute Step Test (2MST), 2-Minute Walk Test (2MWT), and 6-Minute Walk Test (6MWT). To
      assess test-retest reliability, the 2MST will be repeated with a 7-day interval between
      assessments.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        -  Having been diagnosed with fibromyalgia according to the American College of
             Rheumatology 2010 Diagnostic Criteria

          -  Female patients aged 18-65

          -  The absence of any pathological condition that would hinder walking
      
Keywords: Fibromyalgia; Exercise test; Physical fitness
Correlation Between Five Asthma Control Questionnaires
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This observational study aims to assess the correlation between many questionnaires designed
      to assess the level of control of asthma. The five questionnaires will be submitted, at the
      same time and in a random order, to asthma patients. Some other parameters will be recorded
      (e.g. lung function, epidemiological data). The hypothesis is that the results of the
      questionnaires will be the same. If not, we will try to understand why.

      The investigators will include 100 patients, stratified with relation to their level of
      asthma severity (25 patients for each level of severity - described by the GINA guidelines).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients seen at the consultation of pulmonology of a tertiary hospital.
      
Keywords: Asthma; Questionnaires
Calcium Retention as Influenced by Dietary Components That Induce an Acid Load
Condition: Healthy
Study type: Interventional

Summary: 
      The impact of protein sources such as beef as part of Western diet on calcium retention
      remains controversial. We propose to test the hypothesis that the positive effect of high
      protein intake (especially from meat protein) can offset the negative effect of
      protein-induced net acid load on bone metabolism and the retention of body calcium. Healthy
      postmenopausal women recruited from the community will consume two diets differing in meat
      protein and acid load for 7 weeks. Calcium retention from diets will be determined using a
      highly sensitive measurement of whole body retention of a calcium isotope added to the diet.
    


Intervention name(s): High Meat - High Potential Renal Acid Load (PRAL) diet; Low Protein - Low Potential Renal Acid Load (PRAL) diet
Intervention type(s): Other; Other
Intervention description(s): Menu high in meat protein; Menu low in meat protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meat protein; acid load; calcium retention; postmenopausal women
"Hepafast" in Non-alcoholic Fatty Liver Disease (NAFLD)
Condition: Non-alcoholic Fatty Liver Disease (NAFLD); Obesity
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether a weight reduction with "Hepafast" in
      combination with raw food and vegetables for two weeks followed by a meal substitution with
      "Hepafast" and a calorie restriction in accordance with the Low Glycemic and Insulinemic Diet
      (LOGI) for 10 weeks is superior regarding improvement of non-alcoholic Fatty Liver Disease
      (NAFLD) compared to a conventional weight reduction in accordance with the LOGI diet without
      use of "Hepafast" for 12 weeks.
    


Intervention name(s): Hepafast; LOGI diet
Intervention type(s): Other; Other
Intervention description(s): Two weeks of Hepafast three times a day and additionally 200 kcal followed by 10 weeks of Hepafast two times a day and a meal according to LOGI diet; For twelve weeks, this group eats meals according to the Low Glycemic and Insulinemic Diet (LOGI).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-alcoholic fatty liver disease (NAFLD); Obesity; Hepafast
The Effect Of Proprioceptive Neuromuscular Facilitation Techniqueson in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The aim of this study is to examine the effects of PNF techniques on pain, motor function,
      fatigue and quality of life.
    


Intervention name(s): PNF Group; Control Group
Intervention type(s): Other; Other
Intervention description(s): Exercise training and PNF training; Exercise training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Proprioceptive Neuromuscular Facilitation; Pain; Motor Function; Fatigue; Quality of Life
Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Can perioperative administration of intra-peritoneal local anaesthetics further reduce
      postoperative pain, inflammation and outcome in patients undergoing major abdominal surgery
      (cytoreductive surgery) and managed with thoracic epidural analgesia? - Multicenter study.
    

Detailed description: 
      The aim of this study is to measure the efficacy of local anesthetics (LA) administered into
      the intra-peritoneal cavity compared to placebo. Our hypothesis is that the injection of
      local LAs intra-peritoneally would reduce post-operative pain and the inflammatory process
      caused by the massive release of cytokines during extensive cytoreductive surgery. The study
      is a controlled, parallel group, double blind, prospective, randomized and performed at
      Sahlgrenska University Hospital in Goteborg, Sweden . Twenty mL of ropivacaine or saline
      would be injected every hour by an automatic pump via the intra-peritoneal catheter into the
      abdomen according to group randomization in order to double blind patients and all personnel
      involved in the study.

      The parameters that would be evaluated are inflammatory markers, postoperative morbidity,
      pain intensity, consumption of morphine, cognitive function and progression-free survival.
    

Intervention name(s): Ropivacaine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Active Group; Placebo Comparator
Other intervention name(s): Narop; Sodium Chloride
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesia; Local infiltration analgesia; Pain, relief; Pain, Postoperative; Intra-peritoneal analgesia; Ropivacaine; Saline; Therapeutic Uses; Analgesics, Non-Narcotic; Analgesics; Opioids; Morphine; Pain; Postoperative Complications; Physiological Effects of Drugs; Anesthetics, Local; Anesthetic; Cytoreductive; Surgery; Cancer
A Study Investigating the Effect of Patient Pelvic Positioning and Method of Acetabular Component Insertion on Acetabular Component Inclination During Total Hip Arthroplasty (THA)
Condition: Total Hip Arthroplasty; Total Hip Replacement; THA; THR
Study type: Interventional

Summary: 
      Total Hip Arthroplasty (THA) is one of the most commonly performed orthopaedic operations
      worldwide. The main aim is overall improvement in levels of patient pain and mobility. Such
      surgery involves implantation of both an acetabular and femoral component. With the patient
      in the lateral decubitus position, the Orthopaedic Surgeon assumes that the pelvis is in a
      neutral position with respect to all three body planes at the time of acetabular component
      implantation.

      With regard to THA, the current orthopaedic literature demonstrates a clear relationship
      between acetabular component positioning, polyethylene wear and risk of dislocation. Problems
      with edge loading, stripe wear and squeaking are also associated with higher acetabular
      inclination angles, particularly in hard-on-hard bearing implants.

      The important parameters of acetabular component positioning are depth, height, version and
      inclination.

      Control of acetabular component inclination, particularly in the lateral decubitus position,
      is difficult and remains a challenge for the Orthopaedic Surgeon.

      Accurate implantation of the acetabular component within the 'safe zone' of radiological
      inclination is dependent on:

        -  Operative version

        -  Operative inclination

        -  Pelvic position (Primarily, but not exclusively, abduction / adduction.)

      This study aims to investigate the effect of patient pelvic positioning and method of
      acetabular component insertion on acetabular component inclination during Total Hip
      Arthroplasty (THA).
    


Intervention name(s): Operating table position 0° head down (Horizontal); Operating table position 7° head down.; Operating table position Y° head down; Standard straight acetabular component introducer without alignment guide.; Modified 35° acetabular component introducer.; Inclinometer-assisted acetabular component introducer.
Intervention type(s): Procedure; Procedure; Procedure; Device; Device; Device
Intervention description(s): Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Keywords: Acetabular component inclination
Diet and Well-being of Young Danish Children Born by Obese Mothers
Condition: Growth; Overweight; Metabolic Syndrome; Obesity
MeSH terms: Overweight; Metabolic Syndrome
Study type: Observational

Summary: 
      The overall aim is to provide a detailed description of growth, development and risk factors
      for later disease, especially obesity and metabolic disease in infants born by obese mothers
      and to compare them with a group of infants born by mothers without any restriction in
      prepregnancy BMI (SKOT I).
    

Detailed description: 
      The SKOT II is a prospective cohort study that includes children of obese mothers with a body
      mass index over 30 kg/m2. These mothers were invited to SKOT II while participating in a
      randomised study at Hvidovre Hospital, Copenhagen. The families were invited to three
      examinations, when the children were 9, 18 and 36 months of age. A total of 184 children were
      included in 2010. The examinations and the collecting of data are designed in the same way as
      SKOT I, a study of healthy children born by non-obese mother. The examinations takes place at
      Department of Nutrition, Exercise and Sports, Frederiksberg, Denmark. Following data were
      collected during the examinations: Anthropometry (weight, height, age- and sex specific Z
      scores for body composition, triceps- and subscapularis skinfolds), background interview
      (e.g. infant feeding, household income, the parent's educational level, allergy and chronic
      diseases), blood pressure (systolic, diastolic and mean arterial pressure), faeces- and urine
      samples, blood samples (at 9 and 36 months of age), bio impedance (at 36 months of age), 4
      day diet registration, general questionnaire (e.g. sleep, daycare, attendance and use of
      screen devices), psychomotor questionnaire (motoric development) and 7 day physical activity
      monitoring (at 36 months of age).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy young Danish infants born by obese morthers, who during pregnancy were part of a
        intervention study at Hvidovre Hospital. In the intervention at Hvidovre Hospital study the
        mothers were asked to join SKOT II,
      
Biospecimen description: 
      Urine, faeces, white cells, plama/serum
    
Keywords: growth,; infancy,; children,; diet,; breastfeeding; complementary feeding; early life programming; tracking; physical activity
Effects of Stretch-shortening Cycle Exercises Postural Control in Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      To investigate the effect of a 3-month, trampoline-based stretch-shortening cycle (SSC)
      exercises on muscle strength and postural control in children with Down syndrome.
    

Detailed description: 
      a variety of physical therapy techniques are being used to improve lower limb muscle strength
      and postural control in children with Down syndrome including, but not limited to,
      progressive resistance training, hippotherapy, aquatic therapy, and isokinetic strength
      training. Stretch-shortening (SSC) exercises-also referred to as plyometric exercises, is a
      traditional form of resistance training that involves three-phase muscle contraction during
      dynamic movements (like jumping and hopping), where the muscle moves rapidly through the
      eccentric, isometric, and concentric phases.
    

Intervention name(s): Standard physical therapy; trampoline-based stretch-shortening cycle exercises
Intervention type(s): Other; Other
Intervention description(s): building strength, enhancing developmental skills, boosting balance, coordination, and postural control; muscle strength
Other intervention name(s): physical fitness; postural control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Addressing Psychosocial Comorbidities in HIV Treatment and Prevention
Condition: Human Immunodeficiency Virus; Depression; Mental Health
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      Project AProaCH is an open pilot trial of a cognitive behavioral therapy (CBT) for
      individuals with HIV with various psychological comorbidities, which the investigators call
      "syndemics". Syndemics are co-occurring psychosocial problems that interact with each other
      and with health behavior such as HIV sexual transmission risk behavior and adherence to self
      care.
    


Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Integrating CBT for mental health and substance issues concern with CBT for health behavior change
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Young Adult Hypertension Feasibility Study
Condition: Health Behavior; Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study was designed to evaluate the feasibility of a telephone-based health coach
      self-management intervention for young adults.
    

Detailed description: 
      To address the unmet need for hypertension care in young adults, MyHEART (My Hypertension
      Education and Reaching Target), a multi-component hypertension intervention was developed.
      Eligible patients were identified via the healthcare system's electronic health record.

      Inclusion criteria included:

        1. 18-39 years old at the start of the study,

        2. previous hypertension ICD-9 coded office visits and

        3. uncontrolled hypertension (≥140/90 mmHg) based on the last ambulatory blood pressure
           reading.

      Exclusion criteria included a pre-defined list of co-morbidities, in addition to planned or
      current pregnancy, any health condition that limits physical activity or dietary changes,
      current participation in another study, and planning to leave the area in the next three
      months. During the feasibility study, all participants continued to receive usual
      hypertension care from their primary care provider. The intervention involved health coach
      calls over a 3-month period using self-management modules. The order of the modules was
      guided by the participant's choice. All encounters were documented in the electronic health
      record. Patient acceptability and home blood pressure monitoring survey data was acquired.
    

Intervention name(s): Coaching
Intervention type(s): Behavioral
Intervention description(s): Self-management education
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: young adult
Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of
      oral brexpipirazole in adolescent subjects with schizophrenia or Other Related Psychiatric
      Disorders.
    

Detailed description: 
      Schizophrenia is a severely delibitating mental illness that affects approximately 1% of the
      world population. The onset of schizophrenia symptoms typically peaks in late adolescence and
      early adulthood. In a minority of cases, the initial episode may occur during childhood or
      early adolescence. Patients who experience this "early-onset schizophrenia" exhibit symptoms
      that are more severe and follow a more chronic course; adolescents with schizophrenia may
      never achieve full remission of the initial episode. The prognosis for early-onset
      schizophrenia tends to be poor, and cognitive impairment is greater compared with individuals
      whose onset of schizophrenia occurs later in life. Several antipsychotics have been
      investigated for the treatment of adolescent schizophrenia, however, there is a particular
      challenge because developing bodies are more sensitive to side effects of antipsychotics,
      particularly with respect to weight gain. In order to enroll a population that includes the
      younger ages, adolescents with other related psychiatric disorders are also included in this
      study.
    

Intervention name(s): Brexpiprazole (OPC-34712)
Intervention type(s): Drug
Intervention description(s): Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.
Intervention MeSH terms: Brexpiprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescent; Otsuka,; Brexpiprazole