bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Hyaluronic Acid and Platelet-rich Plasma Injections
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This study aims to compare the effects of hyaluronic acid injection and platelet rich plasma
      injection in terms of pain, physical function and femoral cartilage thickness in short term
      treatment in patients with knee osteoarthritis.
    

Detailed description: 
      Platelet-rich plasma and hyaluronic acid injections are both popular treatments and commonly
      used for treatment of knee osteoarthritis. Even though there are many studies investigating
      the effectiveness of these treatments, the results are mostly qualitative. Also there are a
      few studies comparing these two treatment modalities. In this study the investigators aim to
      compare these modalities both for self-reported data (pain, physical function) and objective
      measurement data (femoral cartilage thickness via ultrasonography). Patients with unilateral
      osteoarthritis/unilateral complaint will be included in the study. Unaffected side will be
      controls for each group.
    

Intervention name(s): Hyaluronic acid injection; Platelet-rich plasma injection
Intervention type(s): Biological; Biological
Intervention description(s): Hyaluronic acid 48 mg 2.0% in 2.4 ml solution; Platelet-rich plasma injection 5ml
Other intervention name(s): Reviscon Mono
Intervention MeSH terms: Hyaluronic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis; Hyaluronic acid; Platelet-rich plasma; Injection
A Study to Evaluate the DDI of HSK7653 With Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single center, open-label, single arm, drug-drug interaction study of
      HSK7653 and metformin in Healthy Subjects.
    


Intervention name(s): HSK7653; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Part 1: Day 1 to Day 4, not take; Part 2: Day 6 - Take HSK7653 35 mg; HSK7653 25 mg on day 13, day 20, day 27, and day 34; Part 3: Day 41 - Take HSK7653 25 mg; Part 1: Day 1 to Day 4, 1000mg BID; Part 2: Not take; Part 3: Day 38- day 47, 1000mg BID
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?
Condition: Agitated; State, Acute Reaction to Stress
MeSH terms: Psychomotor Agitation; Stress Disorders, Traumatic, Acute
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, the investigators aimed to compare postanesthetic agitation in patients
      undergoing laparotomic gynecological surgery under general anesthesia using sevoflurane at a
      fresh gas flow rate of 2 L / min with fresh gas flow rate of 0.5 L / min.
    

Detailed description: 
      Emergence agitation is a temporary state of mental anxiety that occurs during general
      anesthesia recovery. It is characterized by emergence agitation, hallucination, excitation,
      delusion and confusion. Increased hemorrhage due to hypertension may cause serious
      complications such as injury to the surgical site, patients' self-removal of surgical drains
      and catheters, and self-extubation. Due to these, emergence agitation results need for
      additional treatment, psychological stress and increased medical workload for patients and
      their families.

      Emergence agitation after general anesthesia in adult patients was reported up to 20%.
      However, the ratios are very wide.

      In our operating room, the investigators observed that patients with low flow anesthesia were
      less agitated in the recovery phase than patients with normal flow anesthesia. In our
      researches, the investigators have not found any studies on the agitation values of patients
      who underwent low flow anesthesia in the literature.
    

Intervention name(s): Analgesics; Antiemetics
Intervention type(s): Drug; Drug
Intervention description(s): while patients are in the PACU after general anesthesia, if patients' VAS scores are higher than 3, we will give them 50 mg of deksketoprofen as analgesic.; while patients are in the PACU after general anesthesia, if patient' Nausea and vomiting scores are higher than 1, we will give them 4 mg of ondansetron
Intervention MeSH terms: Analgesics; Antiemetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Screening
Keywords: postanesthesia agitation; general anesthesia; low-flow anesthesia
Selected Aspects of Mental Health of Athletes
Condition: Mental Health Disorder
MeSH terms: Mental Disorders
Study type: Observational

Summary: 
      The study will assess the prevalence of mental health problems among different athletes. The
      study is based on the application of the battery of psychodiagnostic questionnaires, which
      were chosen aiming at investigating the prevalence of different symptoms related to problems
      in mental health or disorders.

      This descriptive cross-sectional study will undertake sample with athletes categorized by the
      quality of their achievement.
    

Detailed description: 
      In the field of sports, there is a lot of knowledge about sports injuries, nutrition and
      regeneration. Much less is known about mental health among athletes. The investigators often
      think that the incidence of mental problems is low among top athletes. As the main cause of
      this misconception, the authors attribute the idealization of sports and athletes. Both the
      professional and the lay public are often of the opinion that only mentally strong
      individuals can be successful, which of course means that there is no place in the highest
      level for individuals with mental problems and disorders.

      The clinical study will be performed with 400-500 athletes of both genders aged 18 to 40,
      from Slovenia. The investigators will invite all athletes who have been categorized in the
      current year and classified into the membership category, i.e. national, international, world
      or Olympic class (there were 500 at the last categorization) and they compete in various
      sports disciplines. The study will be designed as a cross-sectional study. For the purpose of
      the research, the investigators will use a battery of psychodiagnostic questionnaires
      consisting of five parts: demographics and sport characteristic, depression symptomatic,
      anxiety symptomatic, eating problems, alcohol use and abuse and resilience characteristics of
      individual athlete.
    

Intervention name(s): Psychodiagnostic
Intervention type(s): Diagnostic Test
Intervention description(s): Intensity and frequency of specific symptoms, signs of problems in mental health
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Atletes at a competitive level, coming from different sports.
Multivariable Recovery After Exercise-induced Muscle Pain in the Forearm Muscles
Condition: Musculoskeletal Pain; Healthy; Delayed Onset Muscle Soreness
MeSH terms: Musculoskeletal Pain; Myalgia
Study type: Observational [Patient Registry]

Summary: 
      This study investigates the evolution of sensory, motor and tissue variables following
      exercise-induced pain in wrist extensor muscles in healthy subjects.
    

Detailed description: 
      The aim of this study is to determine how is the normalization process of sensory (pressure
      pain thresholds, subjective pain sensation, self-recovery perception), motor (maximal
      isometric strength, active range of motion, manual dexterity) and tissue (myotonometer)
      variables after an experimental pain model in the extensor forearms muscles, by delayed onset
      muscle soreness after an eccentric exercise in healthy subjects. This way will be possible to
      establish 1) if there are differences in the time of normalization for each variable; 2) if
      there is a correlation between each variable and self-recovery perception.

      Seven assessment sessions are performed in a 14-days period. Day 0 (baseline assessment 1),
      Day 7 (baseline assessment 2, pre exercise), Day 7 (post exercise), Day 8 (24-hours post
      exercise), Day 9 (48-hours post exercise), Day 10 (72-hours post exercise), Day 14 (1-week
      post exercise).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy young-adults free of pain or disease and without history of severe injury.
      
Keywords: Musculoskeletal pain; Delayed Onset Muscle Soreness; Pain mechanisms; Pressure Pain Threshold; Myotonometer; Maximal isometric strength; Manual dexterity
The Effects of Core Stabilization Exercises in Addition to Balance Exercises in Adult Hemophilia Patients on Balance, Quality of Life, Lower Limb Muscle Strength and Functional Level
Condition: Hemophilia
MeSH terms: Hemophilia A
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of core stabilization exercises in
      addition to balance exercises on balance, quality of life, lower extremity muscle strength
      and functional level in adult hemophilic patients.
    

Detailed description: 
      The aim of this study is to investigate the effects of core stabilization exercises in
      addition to balance exercises on balance, quality of life, lower extremity muscle strength
      and functional level in adult hemophilic patients.
    

Intervention name(s): Balance exercises; Core Stabilization exercises
Intervention type(s): Other; Other
Intervention description(s): Balance Exercises; Core Stabilization exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
The Effects of Contact Lenses With UV/HEV-Filter on Visual Function
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a 2-phase, single-site, non-dispensing, randomized, controlled, double-masked, 2x2
      crossover study to objectively measure potential benefits of a new UV/HEV filter using
      psychophysical testing techniques.
    


Intervention name(s): ACUVUE OASYS 1-Day; ACUVUE OASYS MAX 1-Day; ACUVUE OASYS Multifocal; ACUVUE OASYS MAX 1-Day Multifocal; ACUVUE OASYS 1-Day for Astigmatism; senofilcon A based contact lens (toric) with new UV/HEV filter
Intervention type(s): Device; Device; Device; Device; Device; Device
Intervention description(s): Sphere CONTROL; Sphere TEST; Multifocal CONTROL; Multifocal TEST; Toric CONTROL; Toric TEST
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      Injection Site Tolerability

      Secondary Objectives:

        -  To assess the safety profile of alirocumab SAR236553 (REGN727)

        -  To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553
           (REGN727)
    

Detailed description: 
      Total duration for each subject (not including screening) will be approximately 85 days.
    

Intervention name(s): alirocumab SAR236553 (REGN727)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:solution Route of administration: subcutaneous
Intervention MeSH terms: Alirocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Performance of 13C Mannitol for in Vivo Measurement of Small Intestinal Permeability
Condition: Impaired Small Intestinal Permeability
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators' overall objective with this study is to determine performance
      characteristics of small intestine permeability measurement using 13C mannitol and 12C
      (regular) mannitol.
    

Detailed description: 
      An impaired intestinal permeability is implicated in the pathophysiology of a number of
      disorders such as celiac disease, environmental enteropathy, inflammatory bowel disease,
      obesity, and HIV. Current measurements of intestinal permeability rely on urinary excretion
      of naturally available, orally ingested, non-absorbable sugars (e.g. lactulose, mannitol).
      However, dietary intake of these sugars limits interpretation from these assays.

      Subjects will have an esophagogastroduodenoscopy (EGD) with biopsies and provide a baseline
      urine sample. They will be asked to ingest 3 saccharides (12C mannitol 100 mg,13C mannitol
      100 mg and lactulose 1 g) in 250 ml of water. Urine samples will be obtained every 30 min. in
      the Clinical Research and Trials Unit (CRTU) for 0-2 hours. Subjects will collect 2-8 hour
      sample in provided container. Another container will be provided to collect the 8-24 hour
      urine which will be returned the following morning. Subjects will undergo an Indomethacin
      challenge intervention. They will be instructed to take three 25 mg capsules 8 hours before
      their next visit (just before fasting). They will take 3 additional 25 mg capsules 30 min.
      before the repeat in vivo permeability testing. Repeat EGD with duodenal biopsies will be
      done. Long term follow-up will be done within 4-6 weeks of previous testing, where subjects
      will once again be asked to complete the in vivo permeability testing.
    

Intervention name(s): 12C mannitol; Indomethacin; 13C mannitol; Lactulose
Intervention type(s): Dietary Supplement; Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): 12C mannitol 100 mg; Subjects will receive six 25 mg capsules of Indomethacin (immediate release). The subjects will take 3 capsules 8 hours before the timing of visit 5 (before fasting), and 3 additional capsules 30 minutes before visit 5.; 13C mannitol 100 mg; lactulose 1 g
Other intervention name(s): Indocin
Intervention MeSH terms: Indomethacin; Mannitol; Lactulose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Ketogenic Diet Survey in Patients With McArdle Disease (GSDV)
Condition: McArdle Disease
MeSH terms: Glycogen Storage Disease Type V
Study type: Observational

Summary: 
      The purpose of this survey is to report experiences with variants of a ketogenic diet in a
      group of individuals diagnosed with McArdle disease (glycogen storage disease type V).
      Further more the survey will report on physical activity, fatigue, sleep and quality of life
      in this cohort.
    

Detailed description: 
      Currently, there is no satisfactory treatment for McArdle disease. The limitation in people
      with McArdle disease is due to a limited availability of energy in the muscle due to affected
      carbohydrate metabolism. A key element in improving muscle function is therefore to introduce
      alternative energy sources. Ketone bodies are a well-known source of energy for both brain
      and muscle. Ketone bodies are produced during fasting or when following a ketogenic diet. A
      ketogenic diet is a diet high in fat and low in carbohydrates. The classic ketogenic diet
      contains up to 90% fat, but there are several alternative diets with less fat, including a
      modified ketogenic diet, Atkins diet, LCHF (low carb high fat), OMAD (one meal a day) and
      more. This survey will collect information on all variations. The rationale for a ketogenic
      diet for persons with McArdle disease makes good sense in theory, as the diet would
      contribute with a new source of energy (ketone bodies) independent of the affected
      carbohydrate breakdown. However, evidence is sparse on whether the diet actually works. The
      primary purpose of this survey is to report experiences with variants of the ketogenic diet
      in a group of individuals diagnosed with McArdle disease. Secondarily this survey will
      collect information on physical activity, fatigue, sleep and quality of life in this cohort
    

Intervention name(s): There is no intervention, as this is a survey study
Intervention type(s): Other
Intervention description(s): Survey
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        McArdle disease
Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) +
      corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the
      introduction of MMF in de novo renal allograft recipients.
    


Intervention name(s): CsA+Rapamune+CS; CsA+MMF+CS
Intervention type(s): Drug; Drug
Intervention description(s): Part 1: Rapamune will be given as a loading dose of 6 mg once followed by maintenance dose of 2 mg to achieve a target trough level of 8-15 ng/ml. Part 2: Rapamune dose will be adjusted to achieve a target trough level of 10-15ng/ml through 6 months; The control arm is the standard local practice (official protocol) in Iran:
Cyclosporine + MMF + Corticosteroid. The time period is from pre-study screening / baseline evaluation up to 12 months for patients who are maintained on CsA + MMF + CS.
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Saline Lubrication on Post-intubation Complications
Condition: Postoperative Sore Throat
MeSH terms: Pharyngitis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the influence of none-lubricated dry tube on the
      incidence of Postoperative Sore Throat (POST) after general anesthesia with endotracheal
      intubation.
    


Intervention name(s): Saline group; Dry group
Intervention type(s): Procedure; Procedure
Intervention description(s): After anesthetic induction, patients will be intubated with endotracheal tube which was immersed in normal saline before intubation.; After anesthetic induction, patients will be intubated with endotracheal tube which was not immersed in normal saline.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Bortezomib in Treating Patients With Mantle Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary
      for cancer cell growth.

      PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who
      have previously untreated or relapsed mantle cell lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of bortezomib, in terms of response rate, in patients with
           previously untreated or relapsed mantle cell lymphoma.

        -  Determine the toxicity of this drug in these patients.

        -  Correlate suppression of 20S proteasome levels with toxicity of and response to this
           drug in these patients.

        -  Determine the time to progression and response duration in patients treated with this
           drug.

      OUTLINE: This is a nonrandomized, multicenter study.

      Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every
      3 weeks in the absence of disease progression or unacceptable toxicity. Patients with
      complete response (CR) receive 2 courses beyond documentation of CR. Patients with stable
      disease receive a maximum of 4 courses. Patients with partial response (PR) continue therapy
      until disease progression or for 2 courses beyond documentation of stable PR.

      Patients are followed at 4 weeks and then every 3 months until disease progression.

      PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 18-24
      months.
    

Intervention name(s): bortezomib
Intervention type(s): Drug
Intervention MeSH terms: Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I mantle cell lymphoma; contiguous stage II mantle cell lymphoma; noncontiguous stage II mantle cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; recurrent mantle cell lymphoma
Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep
Condition: Breast Cancer; Memory Disorders
MeSH terms: Breast Neoplasms; Memory Disorders
Study type: Interventional

Summary: 
      The results of this study will contribute to a better understanding of prospective memory
      deficit processes in breast cancer in relation to sleep disorders frequently reported in this
      pathology. In the long term, a better understanding will make it possible to envisage
      appropriate treatments to compensate for these memory difficulties and to improve the
      autonomy of the patients.
    


Intervention name(s): Neuropsychological, psycho-pathological and quality of life assessments; Hormonotherapy
Intervention type(s): Other; Drug
Intervention description(s): Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests; Adjuvant hormone therapy
Other intervention name(s): sleep tests
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 50 patients including:
25 patients being treated with adjuvant hormone therapy (Group A)
25 patients not receiving adjuvant hormone therapy (Group B)
25 healthy volunteers
Masking: None (Open Label)
Primary purpose: Other
Safety Evaluation of Telmisartan Plus Hydrochlorothiazide in Patients With Mild-to-Moderate Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to assess the safety of six month of open-label, treatment with the fixed dose
      combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg in a subset of patients
      with mild-to-moderate hypertension who completed the eight week randomized, double blind
      502.261 study.
    


Intervention name(s): Telmisartan/hydrochlorothiazide
Intervention type(s): Drug
Intervention MeSH terms: Hydrochlorothiazide; Telmisartan; Telmisartan, hydrochlorothiazide drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment