bioihbjkbjnl/mcl2 huggingface dataset:
Telerehabilitation and Face-to-face Rehabilitation on COVID-19 Survivors
Condition: Covid19; Exercise Tolerance; Quality of Life; Lung Function; Fatigue Intensity
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      INTRODUCTION: As this is a new disease, the short- and long-term consequences for patients
      with COVID-19 are still unclear. The use of sedatives, as well as prolonged rest, can lead to
      musculoskeletal damage, including decreased muscle strength and physical function. Thus,
      rehabilitation after this disease is a key component in continuing patient care. OBJECTIVE:
      To verify the effects of face-to-face cardiac rehabilitation and telerehabilitation on
      tolerance to the maximum and submaximal exercise, lung function, fatigue intensity and
      quality of life of COVID-19 survivors. METHODS: This is a longitudinal, intervention study.
      Primary outcomes will be maximum and submaximal functional capacity, intensity and impact of
      fatigue, while secondary outcomes will be lung function and quality of life. EXPECTED
      RESULTS: This work will bring important information to the scientific community and health
      professionals, about the best forms of intervention and its repercussions on the surviving
      individuals of COVID-19.
    


Intervention name(s): Face-to-face rehabilitation; Telerehabilitation
Intervention type(s): Other; Other
Intervention description(s): Aerobic training will be performed with 60% to 80% of the maximum VO2 obtained through the CPET. The exercise will be performed on the treadmill, with a total time of 40 minutes, with 5 minutes of warm-up, 30 minutes of conditioning, 5 minutes of cooling down. Resistance training will be performed for upper and lower limbs and the load used in the exercises will be 60% of the maximum repetition test (1RM), with load progression every six sessions. The exercises are performed in three series of 12 repetitions.; The telerehabilitation protocol will consist of stretching the muscles of the upper and lower limbs and accessory muscles of breathing. The conditioning phase will consist of stationary walking, side running, jumping jump and stationary running, 3 times of 40 seconds with a 30-second passive rest interval between them. Resistance training will be applied to the muscles of the upper limbs and lower limbs, with specific exercises for each musculature, using elastic bands as resistance.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Proteiomic Fingerprints of Gastric Juice
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      No accurate, inexpensive and non-invasive test for gastric cancer screening is currently
      available. The investigators' recent study identified a1-antitrypsin and other proteins as
      potential biomarkers of gastric cancer in gastric juice. The aim of this study was to develop
      a novel non-invasive modality for detecting gastric cancer by measurement of biomarkers in
      gastric juice.
    

Detailed description: 
      Patients and methods: The study consisted of two parts: (1) investigating the differences in
      gastric juice biomarker concentrations between gastric cancer patients and controls, and (2)
      screening gastric cancer using string test to obtain gastric juice followed by immunoassay
      for biomarker concentration.
    

Intervention name(s): normal subject; gastric cancer
Intervention type(s): Other; Other
Intervention description(s): biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA; biomarker in gastric juice, e.g., alpha 1-antitrypsin
Other intervention name(s): biomarker in gastric juice; biomarker in gastric juice
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: gastric cancer; proteomics; gastric juice
Single and Multiple Ascending Dose Study of AMG 133 in Participants With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to assess the safety and tolerability of AMG 133 as single and multiple doses
      in participants with obesity
    


Intervention name(s): AMG 133; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Participants will receive AMG 133 as a single dose in Part A and multiple doses in Part B and C.; Participants will receive placebo as a single dose in Part A and multiple doses in Part B.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography
Condition: Pain Relief
Study type: Interventional
Phase: Phase 2

Summary: 
      hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and
      considered to be the traditional and the gold standard in the assessment of the patency of
      the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study
      reported the patients complained of moderate to severe pain during the procedure. It is
      reported that some patients undergoing hysterosalpingography was more stressful and anxiety
      and effect on pain scores.
    


Intervention name(s): oral hyoscine butyl bromide tablets plus lidocaine cream; oral placebo tablets plus placebo cream
Intervention type(s): Drug; Drug
Intervention description(s): patients will take oral hyoscine butyl bromide 30 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before the procedure; patients will take oral placebo 30 minutes before the procedure plus placebo cream placed into their cervix immediately before the procedure
Intervention MeSH terms: Lidocaine; Scopolamine; Bromides; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the potential for a PK drug-drug interaction when
      IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination.
      Safety and tolerability will also be assessed.
    


Intervention name(s): IDX719; Simeprevir; TMC647055; RTV
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): IDX719 will be supplied as a 50 mg tablet for oral administration.; Simeprevir will be supplied as 75 mg capsules for oral administration.; TMC647055 will be supplied as 150 mg capsules for oral administration.; RTV will be supplied as 80 mg/mL solution for oral administration.
Other intervention name(s): Olysio™; Norvir™
Intervention MeSH terms: Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis C; Hepatitis C virus; HCV
Investigating the Microstructural and Functional Alterations of Brain in Parkinson's Disease Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this protocol is to investigate the microstructural alterations and
      monoaminergic function in Parkinson's disease patients with impulse control disorders and
      cognitive impairment by multimodal MRI and 18F-DTBZ PET imaging.
    

Detailed description: 
      Study duration is expected to be completed in a period of 4 year. This study will compare the
      microstructural integrity by multimodal MRI imaging and monoaminergic function by18F- DTBZ
      PET in 35 PD patients without dementia/ICD (PD group), 35 patients with mild cognitive
      impairment (PD-MCI), 35 PD patients with dementia (PDD group), and 35 patients with impulse
      control disorders (PD-ICD group).
    

Intervention name(s): 18-FDTBZ
Intervention type(s): Drug
Intervention description(s): During this study, participants will receive a single i.v. administration of approximately 370MBq (10 mCi) 18F- DTBZ immediately prior to imaging. The dosage of DTBZ is 10 nmole. The effective dose in human body is about 5.6 mSV.
The proposed dose for this study is based on the investigators' phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG (Lin 2010).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
Condition: Menopause
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment
      of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence
      of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on
      changes from baseline in weight, breast pain, and health outcomes indicators.
    


Intervention name(s): DVS-233
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Menopause
Magnetic Resonance Imaging (MRI) for Early Diagnosis of Cystic Fibrosis (CF)
Condition: Cystic Fibrosis; Lung Disease
MeSH terms: Cystic Fibrosis; Lung Diseases; Fibrosis
Study type: Observational

Summary: 
      In patients with Cystic Fibrosis (CF) the clinical course of lung disease is crucial for
      individual prognosis and life expectancy.

      Imaging modalities are important in the assessment of follow up of structural lung changes
      and monitoring of pulmonary complications in CF. Although high resolution computed tomography
      (HRCT) is the accepted gold standard for evaluation of morphological lung changes in CF,
      chest-X-ray is widely used as standard imaging procedure for assessment and follow up in
      these young patients due to less radiation exposure.

      Magnetic resonance imaging (MRI) has not been used for lung imaging in CF so far. Studies
      from the 80's and early 90's were not able to show any impact for the use of MRI in CF. Due
      to recent technical developments MRI of the lung became possible.

      Our study group was able to show that MRI is a competitive imaging modality for evaluating
      changes of the CF-lung in comparison to the gold standard (HRCT).

      So far only patients from the age of 6-7 years were examined. According to recent studies CF
      is a disease which starts in utero. Therefore it can lead to extensive pulmonary changes even
      in infants and young children. In this age group lung function testing is difficult and not
      broadly available. An early optimized therapy is crucial for the long term course and outcome
      of the pulmonary disease.

      The aim of this study is to evaluate morphological and functional MRI for early diagnosis of
      lung changes in children (0-6 years) with CF.
    

Detailed description: 
      Month 1-2: Protocol adaptation for infants and small children Month 3-14: Patient
      examinations (20 Patients with sedation) Month 15-18: Data evaluation
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Diagnosed CF-patients (male/female), age 0-6 years
      
Keywords: cystic fibrosis,; lung disease,; MRI,; morphology,; function; morphological MRI; functional MRI; correlation to clinical data
Women Underwent TRAM Surgery: Its Influence on Abdominal Muscle Function and the Effects of Therapeutic Exercises
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The unilateral transverse rectus abdominis musculocutaneous (TRAM) flap is a major operation
      widely used for breast reconstruction. It is hypothesized that this surgery has the potential
      risk of weakening the abdominal wall because it disrupts the integrity of the rectus
      abdominis muscle (RA), therefore, alters the insertion of the oblique muscles and the
      biomechanical relationship between the RA muscle and adjacent structures. The purposes of
      this study were to examine the effects of the TRAM flap surgery on muscle size of abdominal
      muscles, strength and endurance of trunk muscles, strength and endurance of core stability,
      as well as the effects of therapeutic exercises on it in post-mastectomy women underwent TRAM
      surgery.
    

Detailed description: 
      This first year of the proposed study was aimed to understand the impacts on abdominal muscle
      functions. We design a case-control, cross-sectional study. There were 46 women who have
      undergone TRAM flap and 36 age-matched healthy women. We recorded the biomechanic and
      electromyographic responses during voluntary limb movements and elicited by unexpected
      support surface translations and tilts in standing. A six-camera Qualisys motion system was
      used. Ground reaction forces and moments were acquired by one Kisler force plate. Surface
      electromyography electrodes were used to record the activity of selected trunk and limb
      muscles. The second year was aimed to evaluate the effects on abdominal muscle functions
      after 12 weeks abdominal muscle training in the TRAM women. Outcome measures were the
      clinical tests for trunk muscle strength, endurance and one-leg standing was also used to
      exam the abdominal muscle function.
    

Intervention name(s): Abdominal muscle training
Intervention type(s): Behavioral
Intervention description(s): Participants will receive 12-week, 60 minutes, 36-session abdominal muscle training in the TRAM women. Aimed to evaluate the effects on abdominal muscle functions after 12 weeks abdominal muscle training in the TRAM women. Outcome measures were the clinical tests for trunk muscle strength, endurance and one-leg standing was also used to exam the abdominal muscle function.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Xbox in the Rehabilitation of Chronic Traumatic Brain Injury
Condition: Traumatic Brain Injury; Balance Disorders; Attention Deficits
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Traumatic brain injury is an extremely common disease, it counts 50.000 deaths and 235.000
      hospitalizations every year. Functional consequences of an acquired brain injury have a
      considerable impact on quality of lives of patients and care-givers with direct effects on
      balance, mobility and on psycho-social functions. Attention deficits are one of the most
      frequent and disabling consequences of severe brain injury. Within the wide spectrum of
      attentive problems, patients with traumatic brain injury frequently have shown difficulties
      in divided attention. Patients, care-givers and professionals frequently refer difficulties
      also in selective attention and vigilance as consequence of the trauma. It has been shown how
      these difficulties are tightly related with the missed return to work after two years from
      the injury.

      The hypothesis of this study is to investigate the feasibility of a rehabilitative protocol
      on gaming using the console Xbox and its efficacy in improving balance, mobility, risk of
      falling, attentive functions (selective and divided attention) in subjects which have had a
      traumatic brain injury at least 12 months before.
    

Detailed description: 
      Inclusion Criteria:

      Chronic traumatic brain injury (>12 months) Age>18, <70 years old Presence of a moderate
      balance deficit identified by CB&M with a score < 65 or presence of a selective attention and
      shifting attention deficit identified by the TEA computerized battery (Tau<37).
    

Intervention name(s): gaming therapy (Xbox); Dynamic balance platform (Biodex)
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: traumatic brain injury (TBI); balance disorders; attention deficits; x-box; gaming; virtual reality
The Anabolic and Catabolic Effect of Loaded and Unloaded Exercise on Articular Cartilage Health
Condition: Healthy
Study type: Interventional

Summary: 
      The serum concentration of cartilage oligomeric matrix protein (sCOMP) has been considered a
      mechano-sensitive biomarker of articular cartilage turnover, and N-propeptide of type II
      collagen (PIIANP) is a proposed biomarker of type II collagen synthesis. Few studies have
      investigated both the anabolic and turnover response of articular cartilage as a result of
      acute changes in body weight mass during exercise. Using a repeated measures cross-over
      design, fifteen healthy adults (age 18-30 years) performed three, 30-minute bouts of
      treadmill walking exercise under 3 loading conditions: (1) control (no alteration to body
      mass); (2) loaded (12% increase in body mass using a weighted vest); and (3) unloaded (12%
      decrease in body mass using lower body positive pressure). Venous blood was collected before,
      immediately after, and 15 and 30 minutes after exercise to investigate cartilage turnover
      (sCOMP) and anabolism (PIIANP).
    


Intervention name(s): Control Condition; +12% Body Mass; -12% Body Mass
Intervention type(s): Other; Other; Other
Intervention description(s): Control (no alteration to body mass).; Loaded walking exercise (12% increase in body mass using a weighted vest).; Unloaded walking exercise (12% decrease in body mass using lower body positive pressure).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: articular cartilage; walking exercise; sCOMP; PIIANP
Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder
Condition: Autistic Disorder; Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      We aim to study the efficacy of Acupuncture versus sham acupuncture in children with ASD.
    

Detailed description: 
      In Traditional Chinese Medicine (TCM) philosophy, the approach to Autistic Spectrum Disorder
      (ASD) is a holistic one. The objective is to study the efficacy of a short intensive course
      of Acupuncture versus sham acupuncture in improving the overall functional status of children
      with autism. A single-blind randomized control trial was conducted in 50 children. These
      children were randomly assigned to Treatment group with Tongue Acupuncture (40 sessions over
      8 weeks) or Control group (Sham Tongue Acupuncture to non-acupoints in the tongue).
    

Intervention name(s): Tongue Acupuncture (Procedure)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Alternative Medicine (AM); Traditional Chinese Medicine; Tongue Acupuncture; Autistic Spectrum Disorder; Autism; Children
Drug-Drug Interaction Study With Rifampin
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine if the concomitant administration of rifampin with
      BMS-708163 will affect the Pharmacokinetics of BMS-708163 and to assess safety and
      tolerability of co-administration BMS-708163 and rifampin
    


Intervention name(s): BMS-708163; Rifampin; Rifampin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsule, Oral, 125 mg, Once daily, 1 day; Capsule, Oral, 600 mg, Once daily, 7 days; Capsule, Oral, 600 mg, Once daily, 6 days
Intervention MeSH terms: Rifampin; BMS 708163
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A relative bioavailability study of commercial palbociclib free base hard capsules to the
      isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different
      fasting conditions.
    


Intervention name(s): palbociclib isethionate (phase 1 and 2 studies); palbociclib isethionate (phase 1 and 2 studies); palbociclib commercial free base capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 125 mg palbociclib isethionate salt under overnight fasting conditions; 125 mg palbociclib isethionate salt under minimal fasting conditions (1 hr before palbociclib administration and 2 hrs post dose); 125 mg palbociclib commercial free base capsule under fed conditions ( moderate fat meal)
Intervention MeSH terms: Palbociclib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioavailability; bioequivalence; AUC; Cmax
Safety of and Immune Response to an HIV-1 Vaccine Boost (VRC-HIVADV014-00-VP) in HIV Uninfected Adults Who Participated in HVTN 052
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine,
      VRC-HIVADV014-00-VP, when given as a vaccine booster to HIV uninfected adults who
      participated in HVTN 052.
    

Detailed description: 
      The worldwide HIV epidemic highlights the importance of developing an affordable, globally
      successful vaccine for HIV prevention. The VRC-HIVADV014-00-VP adenoviral vector vaccine used
      in this study was developed to stimulate strong virus-specific CD8 cytotoxic T-lymphocyte
      (CTL) responses thought to be crucial in an effective preventive HIV vaccine. The purpose of
      this study is to determine the safety and immunogenicity of a VRC-HIVADV014-00-VP vaccine
      boost given to healthy, HIV uninfected individuals who participated in HVTN 052, which
      evaluated the VRC-HIVDNA009-00-VP DNA plasmid vaccine. In that study, participants received
      either 3 injections of vaccine, 2 injections of vaccine and 1 injection of placebo, or 3
      injections of placebo over a 2-month period.

      This study will last one year. Participants will be randomly assigned to receive vaccine
      boost or placebo by intramuscular injection. The injections will be given 6 to 9 months after
      each participant's first HVTN 052 study injection, preferably as close to 6 months after the
      first HVTN 052 injection as possible. After a screening visit, study visits will occur at
      enrollment (when the injection will be given), at Week 2, and at Months 1, 3, 6, and 12.
      Blood collection, physical exam, and medication assessment will occur at every study visit;
      urine collection will occur at selected visits.
    

Intervention name(s): VRC-HIVADV014-00-VP
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine