bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of vortioxetine, once daily (QD),
      compared with placebo in adults with major depressive disorder.
    

Detailed description: 
      The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested
      to treat depression in adults who have major depressive disorder (MDD). This study looked at
      MDD relief in people who took varying dosages of vortioxetine.

      The study enrolled 462 patients. Participants were randomly assigned (by chance, like
      flipping a coin) to one of the three treatment groups-which remained undisclosed to the
      patient and study doctor during the study (unless there was an urgent medical need):

        -  Vortioxetine 10 mg

        -  Vortioxetine 20 mg

        -  Placebo (dummy inactive capsule) - this was a capsule that looked like the study drug
           but had no active ingredient.

      All participants were asked to take one capsule at the same time each day throughout the
      study.

      This multi-center trial was conducted in the United States. The overall time to participate
      in this study was up to 13 weeks. Participants made 9 visits to the clinic, and were
      contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): Vortioxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Encapsulated vortioxetine immediate release tablets; Vortioxetine placebo-matching capsules
Other intervention name(s): Lu AA21004; Brintellix®
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression; Melancholia; Drug Therapy
Impact of Exenatide on Sleep Duration
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study investigates the effect of exenatide, a FDA approved medication for the treatment
      of type 2 diabetes on sleep duration and quality. Individuals with type 2 diabetes will be
      studied before and during treatment with Exenatide.

      Enrolled individuals will be asked to come to the University of Chicago for 3-4 outpatient
      visits over the course of 3-4 months.
    


Intervention name(s): Exenatide
Intervention type(s): Drug
Intervention description(s): Exenatide is started for the treatment of type 2 diabetes as determined by the patients regular physician. The dose will be 5-10 micrograms twice daily which is the standard dose. The medication is given by self-administered subcutaneous injection. The medication may continue for the treatment of the type 2 diabetes after the study is completed after 3 months.
Other intervention name(s): The brand name of exenatide is Byetta.
Intervention MeSH terms: Exenatide
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Convenience Sample
Controlling and Lowering Blood Pressure With The MOBIUS HD™ (CALM-FIM_EUR)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      To evaluate the safety and performance of the MobiusHD system in subjects with resistant
      hypertension.
    

Detailed description: 
      This is an open-label, multicenter, first-in-man clinical trial to be conducted in Europe.
      Eligible subjects with stage 2 resistant systemic arterial hypertension currently being
      treated with a minimum of three (3) anti-hypertensive drugs, who consent to study
      participation will be assigned to treatment with the MobiusHD system.

      Potential study participants will be consented and then screened at two (2) baseline visits
      beginning at least 30 days prior to MobiusHD placement. Qualified patients will undergo
      placement of the MobiusHD under angiographic visualization, and will then be followed for 36
      months.
    

Intervention name(s): MobiusHD
Intervention type(s): Device
Intervention description(s): Implant that is placed in the carotid sinus to control hypertension.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension
Effects of 650nm Low Energy Light on Human Retina and Choroid Microcirculation
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This project is a single-center, prospective, self-controlled clinical study. It intends to
      select patients with simple medium and low degree myopia as subjects, and apply 650nm
      low-energy red light irradiation to the retina to observe its effect on macular
      microcirculation.
    

Detailed description: 
      A total of 120 subjects are planned to be recruited and divided into 4 groups according to
      age and intervention, including 30 in the juvenile intervention group, 30 in the juvenile
      control group, 30 in the adult intervention group and 30 in the adult control group. Two
      intervention groups received 650nm low-energy red light irradiation treatment with a 650nm
      low-energy light emitter, twice a day for 3 minutes each time, The subjects were treated and
      followed up for 3 months. The control group was not treated and followed up for 3 months too.
      All subjects were followed up before treatment, at the end of the 1st month and at the end of
      3rd month. Angio-oct was used as the main examination to observe and record the vascular
      density and blood perfusion in macular area. Axial length, diopter and OCT were used as
      secondary observation indexes. At the end of the experiment, the data of the intervention
      group and the control group were compared
    

Intervention name(s): photobiomodulation
Intervention type(s): Radiation
Intervention description(s): 650nm low energy red light eye irradiation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: photobiomodulation,macular microcirculation,,myopia
Efficacy of Aquatic Physiotherapy in the Treatment of Upper Limb Lymphedema in Women With Breast Cancer.
Condition: Breast Cancer Lymphedema
MeSH terms: Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
Study type: Interventional

Summary: 
      This study aims to evaluate the effectiveness of Aquatic Therapeutic Exercise by providing a
      set of exercises in the reduction and / or control the volume of secondary lymphedema
      treatment of breast cancer in patients who are in the maintenance phase of conventional
      treatment. It is an experimental, randomized, unifactorial, and intersubjective study. The
      intervention group will be treated by guided underwater exercises while the control group
      will receive the same set of exercises out-of-water. The research will be based on comparing
      the difference on the volume of lymphedema obtained by the exercises provided aquatic
      environment and out-of-water exercises. The study population will be obtained from
      rehabilitation service Bellvitge Hospital. The goal is to evaluate the volume of lymphedema
      and the quality of life related to the health of patients will be evaluated before starting
      the treatment, at the end of the 20 sessions, when the treatment reaches 3 months and when
      patient is discharged.
    

Detailed description: 
      A randomized controlled experimental study has been carried out where two work groups were
      compared, experimental N: 43 that carried out an exercise regimen designed in the aquatic
      environment and control N: 47 that carried out the same regimen of exercises in a
      physiotherapy room. Both groups did 20 treatment sessions of 45 minutes duration with a
      frequency of 2 or 3 days per week. Lymphedema changes, quality of life and adherence to
      treatment were evaluated. The evaluations were 3 days prior to the start of the program, at
      the end of the 20 sessions, and at 3 months.
    

Intervention name(s): Exercise guideline
Intervention type(s): Other
Intervention description(s): The experimental group underwent 20 sessions with an aquatic exercise plan in the pool at the rehabilitation department. The control group did the same exercises in one of the rooms in the rehabilitation department, with the same number of sessions. Both groups were guided by a physiotherapist. The main outcome variables were assessed at the start of the study, at the end of the 20 sessions, and at 3 months after completing the sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental study randomized controlled
Masking: Single (Investigator)
Primary purpose: Treatment
A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder
Condition: Autism Spectrum Disorder; Pervasive Developmental Disorder; ASD; PDD
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Developmental Disabilities
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is an 8-week pilot trial with oxytocin nasal spray (Syntocinon) as a treatment for
      social impairment in children and adults with high functioning autism spectrum disorders
      (ASD). The investigators hypothesize that oxytocin will be safe, tolerable, and effective in
      improving social deficits in individuals with ASD.
    


Intervention name(s): Intranasal Oxytocin
Intervention type(s): Drug
Intervention description(s): This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD).
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorders; Pervasive Developmental Disorder; ASD; PDD; Oxytocin; Syntocinon; Social Impairment; Treatment
Staccato Alprazolam Abuse Liability
Condition: Abuse Liability of Staccato Alprazolam
Study type: Interventional
Phase: Phase 1

Summary: 
      Compare the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and
      Staccato Placebo.
    

Detailed description: 
      The Phase 1 clinical study compared the abuse liabilities of Staccato Alprazolam, oral
      immediate-release alprazolam, and Staccato Placebo in 14 subjects with a history of sedative
      abuse. Subjects who met the inclusion/exclusion criteria received 2 mg of oral alprazolam and
      matching placebo over 2 sessions. Those who demonstrated greater liking for alprazolam versus
      placebo were eligible to participate in the study.
    

Intervention name(s): Inhaled placebo + oral placebo; Inhaled alprazolam 0.5 mg; Inhaled alprazolam 1 mg; Inhaled alprazolam 2 mg; Oral alprazolam 1 mg; Oral alprazolam 2 mg; Oral alprazolam 4 m; Oral alprazolam 2 mg qualifying session; Oral placebo qualifying session
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Inhaled Staccato placebo + oral placebo; Inhaled Staccato alprazolam 0.5 mg + oral placebo; Inhaled Staccato alprazolam 1 mg + oral placebo; Inhaled Staccato alprazolam 2 mg + oral placebo; Oral alprazolam 1 mg + Inhaled placebo; Oral alprazolam 2 mg + Inhaled placebo; Oral alprazolam 4 mg + Inhaled placebo; Qualifying session (2 mg oral alprazolam); Qualifying control session (oral placebo)
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The crossover schedule is planned according to a 7-treatment, 7-period Latin Square design due to E.J. Williams (1949), which is balanced for first-order carryover effects (Fleiss, 1986). Each subject will receive all treatments in this 7-treatment, 7- period Williams Square crossover design as suggested by Chen & Tsong (2007). This Williams Square will include one replication by 1 subject of each of the 14 sequences
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Safety and Efficacy of Inhaled PT001 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of inhaled PT001 compared to
      placebo and tiotropium in patients with mild to moderate chronic obstructive pulmonary
      disease (COPD).
    


Intervention name(s): Inhaled PT001; Inhaled Placebo; Tiotropium Handihaler
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose, inhaled; single dose, inhaled; single dose, tiotropium 18 mcg administered via the Handihaler
Other intervention name(s): Spiriva
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; obstructive lung diseases; Tiotropium
Effects of PNF Patterns Training on Trunk Balance, and Gait in Chronic Stroke Patients
Condition: Stroke, Ischemic
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional

Summary: 
      To determine the effects of PNF patterns Training on trunk balance and gait in chronic stroke
      patients.
    

Detailed description: 
      This study will be conducted to investigate the effects of PNF patterns training on the trunk
      control, balance, and gait ability of chronic stroke patients. Data will be collected from
      stroke patients from Government Mian Munshi hospital (DHQ) and Riphah Rehabilitation center.
      A consecutive sampling technique will be use which is based on 6 months' time period. TIS
      (Trunk Impairment Scale), BBS (Berg Balance Scale), 10 MWT (Meter Walk Test) will be used as
      a tool to collect the data. SPSS 21 version will be used for data entry and analysis.

      This study will provide the effects of PNF patterns training on the trunk control, balance,
      and gait ability in chronic stroke patients. All possible patients will be taken using random
      sampling. Single plane training and diagonal pattern training will use. The subjects will
      randomly assign to the experiment group (diagonal pattern training) and the control group
      (single plane training). Diagonal pattern training will modified with proprioceptive
      neuromuscular facilitation technique's chopping and lifting pattern to create 10 movements.

      Informed consent will be taken from all patients.
    

Intervention name(s): diagonal pattern training; single plane training
Intervention type(s): Other; Other
Intervention description(s): patients will receive proprioceptive neuromuscular facilitation technique's chopping and lifting pattern to create 10 movements.; patients will receive single plane training of proprioceptive neuromuscular facilitation in control group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: total 30 subjects will be randomly assigned to the experiment group (diagonal pattern training) and the control group (single plane training).Diagonal pattern training will be modified with proprioceptive neuromuscular facilitation technique's chopping and lifting pattern to create 10 movements.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; Gait Disorder; Balance; Disorder,
Turkish Version of the Chalder Fatigue Scale: An Investigation of Its Psychometric Properties in Healthy Young Adults
Condition: Fatigue; Healthy
MeSH terms: Fatigue
Study type: Observational

Summary: 
      The aim of this study was to adapt the Chalder Fatigue Scale to Turkish and to examine its
      psychometric properties in young adults. Within the scope of the study, firstly the Turkish
      version of the scale will be developed and then its reliability and validity will be examined
      in healthy young adults in Turkey.
    

Detailed description: 
      Fatigue is a subjective experience that can affect all individuals. It is a protective
      symptom against physical or psychological stress for healthy individuals. However, it can
      negatively affect the performance of individuals in activities of daily living. In the
      clinic, fatigue is assessed by self-reported scales. Different fatigue scales have some
      advantages and disadvantages compared to each other. Moreover, it is stated that only one
      scale cannot fully measure the fatigue of individuals in different health status, therefore
      different scales have been developed.Chalder Fatigue Scale (CFS) is an easy-to-understand,
      short, fast and useful fatigue scale that evaluates fatigue with two dimensions (physical and
      mental) and enable individuals to express perceived fatigue clearly. Psychometric properties
      of CFS have been investigated in general population and different disease groups but not in
      only healthy young adults.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample: The sample of the study consisted of healthy young adults, who could be
        announced / informed about the study and volunteered to participate in the study.
      
Keywords: fatigue; assessment; reliability; validity; Chalder Fatigue Scale; Turkish version; healthy young adults
The Value of Traction in the Treatment of Cervical Radiculopathy
Condition: Radiculopathy; Neck Pain; Spinal Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Intervertebral Disk Displacement
MeSH terms: Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Displacement; Radiculopathy; Neuromuscular Diseases; Neck Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effectiveness of adding mechanical traction to
      standard physical therapy treatments for patients with neck and arm pain.
    

Detailed description: 
      Cervical traction is an intervention frequently recommended for the treatment of patients
      with neck pain. Systematic reviews have not endorsed the use of mechanical traction for
      patients with neck pain, however these reviews note the poor methodological quality of
      available research. Trials that have been performed have examined heterogeneous samples of
      patients with neck pain. It may be that cervical traction has not shown to be effective
      because only a specific subgroup may benefit from it. Most experts believe that traction is
      most beneficial for individuals with neck pain extending into the upper extremity who have
      signs of nerve root compression. Randomized clinical trials examining the effectiveness of
      traction for patients with these specific characteristics have not been performed.
      Preliminary studies support the hypothesis that there exists a specific subgroup of patients
      with neck pain likely to benefit from traction

      The current study will address 3 important questions:

        1. Will the existence of a more specific subgroup of patients who benefit from traction
           along with a standard exercise program be validated in a second sample of patients?

        2. Is cervical traction a critical component of the treatment necessary to maximize
           outcomes for patients in this subgroup?

        3. Do two commonly used traction protocols differ in their effectiveness for patients in
           this subgroup? (Specifically, we study will compare supine mechanical traction to
           over-the-door traction.)
    

Intervention name(s): Physical therapy rehabilitation; Physical therapy rehabilitation; Physical therapy rehabilitation
Intervention type(s): Other; Other; Other
Intervention description(s): Mechanical cervical traction will be applied at a moderate force and adjusted based on symptom relief. In addition, subjects will be trained in cervical and postural exercises.; Subjects will be instructed in use of an over-the-door traction unit utilizing weights up to 20 pounds in sitting. In addition, subjects will be trained in neck and postural exercises.; Subjects will be instructed in neck and postural exercises.
Other intervention name(s): Saunders 3D Active Trac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Radiculopathy; Neck pain; Physical therapy modalities; Rehabilitation
NOV-002, Doxorubicin, Cyclophosphamide, and Docetaxel in Women With Newly Diagnosed Stage II or IIIC Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Oxidized glutathione (NOV-002) may stimulate the immune system in different ways
      and stop tumor cells from growing. Drugs used in chemotherapy, such as doxorubicin,
      cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells,
      either by killing the cells or by stopping them from dividing. Giving more than one drug
      (combination chemotherapy) may kill more tumor cells. Giving NOV-002 together with
      chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue
      that needs to be removed.

      PURPOSE: This phase II trial is studying how well giving oxidized glutathione (NOV-002)
      together with doxorubicin and cyclophosphamide followed by docetaxel works in treating women
      with newly diagnosed stage II or stage III breast cancer.
    

Detailed description: 
      OUTLINE: This is a multicenter study.

      Patients receive oxidized glutathione (NOV-002) IV twice on day -1 of course 1 and once on
      day 1 of courses 2-8. Patients receive NOV-002 subcutaneously once daily on days 2-21 of
      courses 1-8. Patients also receive chemotherapy comprising doxorubicin hydrochloride IV and
      cyclophosphamide IV on day 1 of courses 1-4 followed by docetaxel IV on day 1 of courses 5-8.
      Treatment repeats every 21 days in the absence of disease progression or unacceptable
      toxicity.

      Patients undergo definitive surgery 3-6 weeks after completion of neoadjuvant therapy.

      Blood samples are obtained at baseline and periodically during study to measure serum and
      plasma protein glutathionlylation. Additional blood samples are collected from some patients
      for immunological correlative studies.

      After completion of study therapy, patients are followed at 30 days.
    

Intervention name(s): Cyclophosphamide; Docetaxel; Doxorubicin; NOV 002
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Cytoxan; Cytoxan; Adriamycin; Oxidized glutathione
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II breast cancer; stage IIIC breast cancer; inflammatory breast cancer