bioihbjkbjnl/mcl2 huggingface dataset:
A Study Comparing Protected Early Weightbearing Versus Non-Weightbearing After Surgery for Achilles Tendon Rupture
Condition: Achilles Tendon Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effect of protected early weightbearing (PEWB)
      compared to non-weightbearing (NWB) after surgery for an Achilles tendon rupture (ATR) on
      health related quality of life (HRQL) in the initial six week period after surgery,
      functional recovery over time, return to work and activity and complications. We hypothesized
      that PEWB following ATR repair would result in: i) improved HRQL in the initial postoperative
      period, ii), a quicker recovery of HRQL, strength and endurance, iii) earlier return to work
      and sport, and iv) no increase in complications, such as re-rupture compared to NWB.
    

Detailed description: 
      Achilles tendon rupture (ATR) is commonly treated with open surgical repair. Following
      surgical repair, there are a variety of protocols, ranging from complete immobilization to
      immediate postoperative mobilization with early weightbearing. However, no clear consensus
      regarding the optimal postoperative rehabilitation protocol for ATRs exists. Early
      rehabilitation after ATR has been shown to be beneficial in animal and human studies. Human
      prospective studies and randomized controlled trials have shown that early postoperative
      mobilization do not pose additional risks compared to cast immobilization, with a trend
      toward a reduction in lost work days and an earlier return to sport. However, these trials
      define early postoperative mobilization differently (i.e. use different combinations of
      weightbearing and range of motion). This makes it difficult to determine which factor in the
      early rehabilitation process plays an important role in optimizing recovery. An important
      component of early rehabilitation is weightbearing.

      Comparison: Patients weightbearing in the early rehabilitation period after surgical repair
      of the Achilles tendon compared to patients non-weightbearing after the surgical repair of
      the Achilles tendon repair. With the exception of weightbearing status, both groups performed
      the same rehabilitation program.
    

Intervention name(s): Protected early weightbearing/Achilles tendon surgery
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Achilles tendon rupture; Open surgical repair; Early functional mobilization; Weightbearing; Rehabilitation
The Natriuretic Peptide Response to Saline Infusion
Condition: Obesity
Study type: Interventional

Summary: 
      The primary objective is to evaluate the overarching hypothesis that obese and black
      individuals have relatively lower circulating natriuretic peptide levels compared with lean
      and white individuals. Conventional clinical assays for measurement of circulating
      natriuretic peptides display substantial overlap, precluding determination of the basis of
      the relative natriuretic peptide deficiency previously observed in these groups. We will
      study lean or obese, black or white, healthy adult subjects with intravenous (IV) saline
      infusion as a stimulus for natriuretic peptide production and release. We will measure
      circulating levels of natriuretic peptide isoforms using mass spectrometry that allows the
      specific identification of proBNP 1-108 and its cleavage product BNP 1-32.
    


Intervention name(s): Normal Saline 0.9% Infusion Solution Bag
Intervention type(s): Drug
Intervention description(s): Participants will receive a normal saline infusion at a rate of 10ml per unit of body surface area per minute for 120 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis
Condition: Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective was to describe the safety and tolerability of up to 10 years or 7
      years denosumab administration as measured by adverse event monitoring, immunogenicity and
      safety laboratory parameters in participants who previously received denosumab or placebo,
      respectively.
    


Intervention name(s): Denosumab
Intervention type(s): Biological
Intervention description(s): Administered by subcutaneous injection once every 6 months.
Other intervention name(s): AMG 162; Prolia
Intervention MeSH terms: Denosumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: postmenopausal osteoporosis; low bone density; fractures; low bone mass
Comparison of IPACK and Adductor Canal Block Combination Versus Epidural Analgesia for Total Knee Arthroplasty
Condition: Knee Injuries
MeSH terms: Knee Injuries
Study type: Observational [Patient Registry]

Summary: 
      To compare the efficacy and complications of IPACK and adductor canal block combination and
      epidural block in patients who will be operated for knee arthroscopy under spinal anesthesia.
    

Detailed description: 
      Between 15.08.2022 and 15.04.2023, the patients who will be operated on for knee surgery
      under spinal anesthesia, older than 18 years of age were included in the study. Demographic
      characteristics of the patients, comorbidities, ASA scores, mobilization time, amount of
      postoperative analgesic use, and postoperative pain scores of the 1. 8. 24. hours will be
      observed. The vas score at the 3rd month was learned over the phone.
    

Intervention name(s): ipack+adduktor kanal
Intervention type(s): Procedure
Intervention description(s): nerve block
Other intervention name(s): kombine epidural
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        80 people
Autoantibody Specificity and Response to IVIG in ITP
Condition: Immune Thrombocytopenia (ITP)
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Observational

Summary: 
      The objective of this human study was to evaluate the association between the specificity of
      anti-platelet autoantibodies and response to IVIG treatment.
    

Detailed description: 
      Immune thrombocytopenia (ITP) is a common autoimmune bleeding disorder, in which platelet
      surface GPIIb/IIIa and GPIb/IX are the two most frequently targeted autoantigens. Our
      previous studies in animal models of ITP demonstrated that intravenous immunoglobulin G
      (IVIG) could protect against anti-GPIIb/IIIa-mediated thrombocytopenia but failed to
      ameliorate ITP induced by most anti-GPIb/IX antibodies. The objective of this human study was
      to evaluate the association between the specificity of anti-platelet autoantibodies and
      response to IVIG treatment.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        adult patients with severe ITP who underwent IVIG therapy and had platelet autoantibodies
        assayed
Lifestyle Intervention Using Mobile Technology in Patients With High Cardiovascular Risk
Condition: Primary Prevention; Digital Health; Lifestyle Risk Reduction
Study type: Interventional

Summary: 
      In the present study, investigators aim to compare intervention using mobile technology (IMT)
      plus usual care with only usual care in patients with a high risk for cardiovascular diseases
      (CVD). Investigators hypothesize that IMT plus usual care reduces the CVD risk and improves
      the secondary outcomes in this population through 12 months of follow-up period. Patients
      presented to the outpatient clinics in a tertiary hospital (Dr. Siyami Ersek Thoracic and
      Cardiovascular Surgery Research and Training Hospital, Istanbul, Turkey) who were considered
      to be eligible according to inclusion and exclusion criteria will be enrolled to the study.
      The eligibility criteria is; Patients between 20 to 79 years old who are in high risk for CVD
      (10 years ASCVD risk ≥ 7.5%). Patients with prior CVD events (myocardial infarction,
      percutaneous coronary intervention, coronary artery by-pass grafting operation, stroke and
      peripheral artery disease), pregnancy, communication problems, severe neuropsychiatric
      problems and chronic kidney disease are excluded from the study. In addition, patients that
      are unable to use smartphone phone are also excluded.
    


Intervention name(s): Intervention using mobile technology
Intervention type(s): Behavioral
Intervention description(s): Each study patients that are randomized to IMT plus usual care group will receive a group of smart devices including mobile phone (Vestel Venus e2) (Vestel, Manisa, Turkey), wristband (Xiaomi band 2) (Beijing Xiaomi Technology Co., Beijing, China), weight scale (Bluecat, Yongkang Tiansheng Electronic Co., Zhejiang, China) and blood pressure monitor (Clever Chek TD-3250) (TaiDoc Technology Co., Taipei County, Taiwan)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients that are randomized to usual care group will receive guideline-standardized medications and lifestyle recommendations. Cardiovascular risk management and compliance to medication and lifestyle recommendation will be assessed and controlled by three cardiologists in clinical visits performed at 6 and 12 months. For the necessary cases counseling to other specialities will be performed for smoke cessation and weight management.
Each study patients that are randomized to IMT plus usual care group will receive a group of smart devices including mobile phone (Vestel Venus e2) (Vestel, Manisa, Turkey), wristband (Xiaomi band 2) (Beijing Xiaomi Technology Co., Beijing, China), weight scale (Bluecat, Yongkang Tiansheng Electronic Co., Zhejiang, China) and blood pressure monitor (Clever Chek TD-3250) (TaiDoc Technology Co., Taipei County, Taiwan).
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Primary prevention; Lifestyle intervention; Digital health; Cardiovascular disease prevention
A Clinical Study to Evaluate Efficacy and Safety of HSK21542 for Postoperative Analgesia of Subjects Undergoing Elective Laparoscopic Surgery Under General Anesthesia
Condition: Postoperative Analgesia
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multi-center, randomized, double-blind, placebo-controlled study. A total of
      276 subjects undergoing elective laparoscopic surgery under general anesthesia are planned to
      be enrolled and randomized into 2 groups, i.e., the HSK21542 group (138 subjects) and the
      placebo group (138 subjects).
    


Intervention name(s): HSK21542; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HSK21542：1 µg/kg; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML)
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to assess the pharmacokinetic profile of a new paracetamol formulation
      (paracetamol Uniflash 125mg/1.25mL) for buccal use after single dose.
    


Intervention name(s): paracetamol Uniflash (125 mg/ 1.25 mL)
Intervention type(s): Drug
Intervention description(s): Oromucosal solution (125 mg/ 1.25 mL) for buccal route
Intervention MeSH terms: Acetaminophen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History
Condition: Moderate to Very Severe Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in
      symptomatic patients with moderate to very severe COPD who are receiving standard of care
      therapies
    


Intervention name(s): Benralizumab Arm A; Benralizumab Arm B; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Benralizumab subcutaneously on study week 0 until study week 48 inclusive; Benralizumab subcutaneously on study week 0 until study week 48 inclusive; Placebo subcutaneously on study week 0 until study week 48 inclusive
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Obstructive Lung Diseases; Chronic Obstructive Pulmonary Disease; Lung Disease; Bronchial Diseases; COPD Exacerbation; Respiratory Tract Diseases
Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole
Condition: Hyperprolactinemia; Prolactinoma
MeSH terms: Prolactinoma; Hyperprolactinemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the use of the non-ergoline dopamine agonist
      ropinirole for the treatment of hyperprolactinemia in patients with idiopathic
      hyperprolactinemia and prolactinomas.
    

Detailed description: 
      Treatment of prolactin secreting pituitary tumors with traditional ergot dopamine agonist
      drugs can be limited by medication side effects, pharmacologic resistance, and by concerns
      regarding the potential risk of cardiac valve disease. The overall goal of this project is
      therefore to evaluate, for the first time, the efficacy and tolerability of the selective
      D2/D3 receptor non-ergot dopamine agonist ropinirole for the treatment of prolactinomas. This
      proposal will establish the pharmacologic profile of this medication when used to treat
      hyperprolactinemia in patients with prolactinomas and will determine the impact of long-term
      ropinirole administration on critical clinical parameters including serum prolactin levels,
      gonadal function, and tumor regression, in order to establish ropinirole's utility as a new,
      clinically efficacious, safer and more tolerable therapeutic option for the treatment of
      prolactinomas that may prove particularly useful in patients with underlying cardiac valve
      disease and in those with resistance or intolerance to ergot dopamine agonists.
    

Intervention name(s): Ropinirole
Intervention type(s): Drug
Intervention description(s): 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole
Other intervention name(s): ROP therapy
Intervention MeSH terms: Ropinirole
Intervention model: Single Group Assignment
Intervention model description: 1) Forced titration dose response PKPD study and 2) A prospective open-label outpatient dose escalation trial of ropinirole for treatment of prolactinomas and hyperprolactinemia.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ropinirole; hyperprolactinemia; prolactin
A Study of Evacetrapib and Rifampin in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine how much evacetrapib gets into the blood
      stream and how long it takes the body to get rid of it when given with rifampin. The safety
      and tolerability of the two drugs, given together, will also be evaluated. The study will
      also look at blood cholesterol levels and levels of a hormone called cortisol before and
      after taking rifampin. Information about any side effects that may occur will also be
      collected.

      For each participant, this study will include 2 periods in fixed order. The study will last
      approximately 29 days.
    


Intervention name(s): Evacetrapib; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY2484595
Intervention MeSH terms: Rifampin; Evacetrapib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Long-term Study of Cariprazine in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the long-term safety, tolerability, and
      pharmacokinetics of cariprazine in patients with schizophrenia.
    


Intervention name(s): Cariprazine
Intervention type(s): Drug
Intervention description(s): Cariprazine was supplied in capsules.
Other intervention name(s): RGH-188
Intervention MeSH terms: Cariprazine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Acute schizophrenia; Psychotropic drugs; Antipsychotic agents; Mental disorders; Dopamine agents; Central nervous system agents
Results at 10 to 14 Years After Microfracture in the Knee
Condition: Articular Chondral Defect
MeSH terms: Fractures, Stress
Study type: Observational

Summary: 
      Articular cartilage lesions are commonly occurring. In a prospective study of 1,000 knee
      arthroscopies focal chondral or osteochondral defects were found in 19% of the patients
      (Hjelle 2002). Chronic articular cartilage defects do not heal spontaneously. However, acute
      traumatic osteochondral lesions or surgically inflicted lesions extending into subchondral
      bone, e.g. by drilling (Pridie 1959), spongialization, abrasion or microfracture with an
      angled awl (Rodrigo 1994) causing the release of pluripotent mesenchymal stem cells from the
      bone marrow, may heal with repair tissue consisting of fibrous tissue, fibrocartilage or
      hyaline-like cartilage. The microfracture technique causes little damage to the subchondral
      bone plate and the risk of heat necroses caused by drilling or abrasion is eliminated. The
      quality of the repair tissue after these bone marrow stimulating techniques depends on
      various factors including the species and age of the individual, the size and localization of
      the defect, the surgical technique, e.g., how the subchondral bone plate is treated, and the
      postoperative rehabilitation protocol. Microfracture has been used in small traumatic defects
      in young sporting individuals (Steadman 2003) as well as in larger osteoarthritic lesions in
      older patients (Miller 2004, Steadman 2007). The purpose of the present study was to
      investigate the long-term clinical outcome 10 to 14 years after microfracture of articular
      cartilage defects in the knee and possible predictors of good and poor outcomes.
    


Intervention name(s): Microfracture
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All patients operated with a microfracture of articular chondral defects in the knee at the
        Deaconess University Hospital from 1999 to 2002.
      
Keywords: chondral defect; microfracture; arthroscopy; cartilage repair; outcome study; Lysholm score
Effects of Yoga on Heart Rate Variability and Mood in Women
Condition: Heart Rate Variability
Study type: Interventional

Summary: 
      Background: Women are more likely to suffer from depression and anxiety, which have been
      linked to reduced heart rate variability (HRV) and increased cardiovascular morbidity and
      mortality. The purpose of this study was to examine the effects of an 8-week yoga program on
      HRV and mood in generally healthy women. The investigators hypothesized that there would be
      improvements in HRV and reductions in perceived stress and symptoms of depression and anxiety
      after the yoga intervention.

      Methods: Fifty-two healthy women were randomized to either a yoga group or a control group.
      Participants in the yoga group completed an 8-week yoga program, which comprised a 60-minute
      session, twice a week. Each session consisted of breathing exercises, yoga pose practice, and
      supine meditation/relaxation. Participants' HRV, perceived stress, depressive symptoms, and
      state and trait anxiety were assessed at baseline and week 9.
    


Intervention name(s): Yoga
Intervention type(s): Other
Intervention description(s): Yoga program was 60 min per session, twice per week for 8 weeks. Led by an experienced yoga instructor.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Yoga, heart rate variability, stress, mood, women
Visual Reconstitution Therapy After Optic Neuritis
Condition: Optic Neuritis; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Neuritis; Optic Neuritis
Study type: Interventional
Phase: Phase 2

Summary: 
      Incomplete remission after an optic neuritis attack is not uncommon. Visual reconstitution
      therapy is a software-based approach that has been shown to substantially improve residual
      visual field deficits in patients with pre- and postchiasmatic lesions.

      The primary hypothesis of this randomized, controlled clinical trial is, that visual
      reconstitution therapy is superior to active comparator treatment in improving the visual
      field after optic neuritis.
    

Detailed description: 
      Patients with an acute optic neuritis (between 60 and 180 days before screening) or with
      residual visual deficits after a past optic neuritis are randomized in two treatment groups.
      Group A is instructed to perform software-based visual reconstitution therapy on a home PC
      daily and regularly for 30 minutes over a period of six month. Group B will perform a
      similarly, also software-based training program, developed to improve saccadic eye movements
      rather than visual fields. Patients are blinded to the respective treatment.
    

Intervention name(s): Visual Reconstitutions Therapy; Saccadic Eye Movement Training
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: History of; Patients; acute