bioihbjkbjnl/mcl2 huggingface dataset:
Turkish Version of The Upper Limb Hypermobility Assessment Tool
Condition: Hypermobility, Joint
MeSH terms: Joint Instability
Study type: Observational

Summary: 
      Hypermobility is more than normal joint laxity, mobility, and range of motion. It is
      characterized by increased laxity and fragility of connective tissues. Symptoms from
      hypermobility can begin at any age and affect women more than men. People are at higher risk
      than other people. It is stated that hypermobility is an important factor in orthopedic
      injuries and diseases. Individuals with hypermobility have more frequent orthopedic
      complaints and the problems are usually idiopathic and chronic. Studies have reported that
      proprioception and musculoskeletal reflex function may be affected independently of symptoms
      in hypermobile individuals. Therefore, evaluating hypermobility is very important in
      preventing hypermobility-related problems and injuries and developing appropriate treatment
      methods. Although the Beighton score is the most commonly used scoring method to determine
      hypermobility, it may be insufficient to determine hypermobility of the upper extremities.
      The Upper Limb Hypermobility Assessment Tool (ULHAT) has been reported to be one of the most
      appropriate scoring methods for assessing upper extremity hypermobility in the literature.
      The aim of this study is to adapt ULHAT to Turkish and measure its validity and reliability.
    


Intervention name(s): Turkish validity and reliability
Intervention type(s): Other
Intervention description(s): Explanation of the Turkish version of the scale.
Translating the Turkish version of the scale into English to ensure consistency with the original scale.
First application of scales to participants by two examiners separately.
Second application of the scales to the participants by one examiner.
Statistical analysis and scaling
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        - The study will be carried out by young adults and adults in the Kutahya Health Science
        University
Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation
Condition: Myocardial Blood Flow Reserve
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the consistency of quantitative peak stress
      myocardial blood flow and myocardial blood flow reserve following a 10 second, 1 minute, 2
      minute or 4 minute delay in beginning the rubidium-82 infusion post-Lexiscan (regadenoson)
      injection. It is anticipated that there will be no or minimal difference between the four
      delay times.
    


Intervention name(s): Regadenoson; Rubidium-82
Intervention type(s): Drug; Radiation
Intervention description(s): Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.; Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Other intervention name(s): Lexiscan; Cardio-Gen82
Intervention MeSH terms: Regadenoson
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PET; Lexiscan; Regadenoson; Rubidium; Blood Flow Reserve; Myocardial Perfusion; Quantitated Myocardial Perfusion
Comparison of Different Preoperative Fasting Times in Pediatric Patients Undergoing Elective General Anaesthesia
Condition: Pulmonary Aspiration of Gastric Contents
MeSH terms: Respiratory Aspiration of Gastric Contents
Study type: Interventional

Summary: 
      Rationale of this study is to provide an evidence on minimal safe clear fluid fasting
      duration without the risk of aspiration of gastric contents during elective pediatric
      procedures under general anesthesia.
    

Detailed description: 
      Pre-operative fasting is a specific time period before a procedure in which participants will
      be advised not to take any liquid or solid by mouth. Nil per oral (NPO) is a universally
      accepted practice before elective general anesthesia in order to reduce gastric contents
      aspiration. In the period of chloroform anesthesia NPO was introduced because of vomiting and
      discomfort associated with anesthesia. Hence prevention from aspiration of gastric contents
      was a main focus during general anesthesia. With introduction of better anesthesia drugs
      recommendations were given to keep minimal fasting time before general anesthesia.

      Recent guidelines suggest six, four and two hours fasting for solids/ infant formula milk,
      breast milk and clear fluids respectively. It is common practice to keep children NPO for 6
      hours before surgery. But many times, children have to suffer excessive unnecessary fasting
      due to delayed surgery that lead to reduction in systolic blood pressure, induce catabolic
      state and behavioral effects. Moreover prolonged fasting increases insulin resistance and may
      increase the inflammatory response to surgery.
    

Intervention name(s): Nasogastric aspiration for measurement of Residual Gastric Volume; Nasogastric Aspiration for Measurement of Gastric pH
Intervention type(s): Procedure; Procedure
Intervention description(s): The patients enrolled in this study undergoing elective general anesthesia,their mean gastric residual volume will be measured by taking Nasogastric tube aspirate.; The patients enrolled in this study undergoing elective general anesthesia,their mean gastric gastric PH will be measured by taking Nasogastric tube aspirate.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Total 120 patients will be randomly allocated into two groups using computerized generated numbers (60 in each group). Group A with 6,4 and 2 hours NPO for solids/ formula milk, breast milk and clear fluid respectively. Group B with 6,4 and 1-hour NPO for solids/ formula milk, breast milk and clear fluid respectively
Masking: None (Open Label)
Primary purpose: Prevention
Screening for Early Pancreatic Neoplasia (Cancer of the Pancreas Screening or CAPS4 Study)
Condition: Early Pancreatic Neoplasia; Familial Pancreatic Neoplasia
MeSH terms: Neoplasms; Pancreatic Neoplasms
Study type: Observational

Summary: 
      CAPS4 is a study at Johns Hopkins Hospital to study the diagnosis and long-term outcomes of
      screening patients with an increased inherited risk for pancreatic cancer.
    

Detailed description: 
      Pancreatic cancer is a deadly disease and the only hope for improvement of survival is early
      detection. Certain genetic syndromes are associated with a high risk of pancreatic cancer and
      screening for pancreatic cancer has become a relatively new strategy for familial pancreatic
      cancer. . Our pancreatic cancer research group at Johns Hopkins and others have shown that
      screening with EUS and/or abdominal imaging tests such as CT/MRI can detect a relatively high
      number of significant pancreatic neoplasms (7-18%) in asymptomatic high risk individuals with
      an inherited predisposition for pancreatic ductal adenocarcinoma This is a clinical, early
      detection translational study that will directly influence patient care. This long term study
      follows the successful completion of single center Cancer of the Pancreas (CAPS) 1 and CAPS 2
      studies at Johns Hopkins, and the ongoing CAPS 3 multicenter study. GENERAL AIM: This is a
      study that aims to evaluate the diagnostic yield, quality of life, and clinical outcomes of a
      clinical screening and surveillance program for individuals at-risk for pancreatic cancer and
      to validate a candidate panel of biomarkers for early detection of pancreatic neoplasia. The
      3 specific groups to be screened and followed are individuals from familial pancreatic cancer
      kindreds (who have 2 or more affected relatives and have an estimated risk 16-57 times that
      of controls), patients with familial Peutz-Jeghers syndrome, patients with a known BRCA-2,
      BRCA-1, PALB2, PRSS or p16 germline mutation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        asymptomatic high risk patients
      
Biospecimen description: 
      blood, pancreatic juices
Green Tea Lozenges for the Management of Dry Mouth
Condition: Xerostomia; Sjogren Syndrome; Dry Mouth
MeSH terms: Sjogren's Syndrome; Xerostomia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of this proposal is to investigate the effectiveness of a Medical College of Georgia
      patent pending formulation of natural plant extracts on patients with xerostomia. The major
      component of this formulation is green tea extract with a defined composition of polyphenols.
      Epidemiological studies suggest that phytochemicals in green tea possess beneficial effects
      on autoimmune and inflammatory diseases. Thus far, there is little evidence to indicate any
      marked and direct immunomodulatory effect of green tea on T or B lymphocytes. However, there
      is considerable evidence for green tea polyphenols (GTPs), major phytochemicals found in
      green tea extract, having properties consistent with effects on cells of tissues that would
      be protective towards local inflammation.
    

Detailed description: 
      Patients with subjective complaints of xerostomia will be given a screening questionnaire to
      complete. If they meet the criteria on this screening form, the research coordinator will be
      notified and will meet with the patient either immediately or at a scheduled follow-up
      appointment. The research coordinator will review the information and then explain the
      details of the study to the patient and obtain informed consent. Once the patient has signed
      the informed consent, the research coordinator will collect the demographic, medical history,
      and contact information from the patient. Any information missing will be noted for follow-up
      investigation by the research coordinator. If a subject is of child bearing age, they will be
      asked to complete a urine pregnancy test prior to enrollment.[a] First appointment
      -Screening, consent. [b]Follow appointments- review, then Patients will do VAS questionnaire,
      QOL questionnaire, Sialometry will be done measuring unstimulated whole saliva and Stimulated
      whole saliva for 5 min each.
    

Intervention name(s): MighTeaFlow; Xylitol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4-6 times daily; 4-6 times daily
Other intervention name(s): Green Tea Lozenge; Aspartame
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Xerostomia; Sjogren syndrome; dry mouth
Taxotere®, Eloxatin® and Xeloda® (TEX) in Combination With Herceptin® as Treatment for HER2 Positive Non-resectable Cancer
Condition: Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional

Summary: 
      The primary aim of this dose-finding study is to determine the maximum tolerated dose of
      taxotere, eloxatin and capecitabine (TEX) in combination with herceptin given every third
      week as first-line treatment in patients with HER2-positive advanced gastro-esophageal
      cancer. Secondary end points are to evaluate progression-free survival and overall survival.
    

Detailed description: 
      Primary aim:

      To define the maximum tolerated dose of the combination of taxotere, eloxatin and
      capecitabine (TEX) in combination with herceptin given every third week as first- line
      treatment in patients with HER2-positive advanced gastro-esophageal cancer.

      Secondary aims:

      Estimating response-rate, progression free survival and overall survival

      Methods:

      This dose-finding study is planned to include 15 patients with HER2 positive
      gastro-esophageal cancer, adenocarcinoma. Patients will be included in cohorts of three at
      progressively higher dose levels.

      Chemotherapy will be repeated day 1 every third week to a maximum of eight cycles. Treatment
      with trastuzumab will continue until disease progression. Dose-limiting toxicity (DLT) will
      be evaluated after the first cycle. In case of DLT among one of the three patients during the
      first course of treatment additional three patients will be added at the respective dose
      level. Dose escalation is continued if 0/3 or 1/6 patients experience DLT.

      Patients will be evaluated with a ct- scan at baseline and after every three cycles to
      exclude progression and evaluate response. Response is assessed by investigators according to
      RECIST version 1.1.

      Blood counts regarding tumour biology will be collected at baseline before 2nd, 4th and 7th
      cycle and 4 weeks after ended treatment. After completion of treatment patients will be
      followed every third month until progression or death.
    

Intervention name(s): Docetaxel; Oxaliplatin; Capecitabine; Trastuzumab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 42, 51 or 60 mg/m² day 1 every 3. week; 100 mg/m² day 1 every 3. week; 1250 mg/² continuously; Trastuzumab 8 mg/kg day 1, cycle 1. Following cycles 6 mg/kg every 3. week
Other intervention name(s): Taxotere; Eloxatin; Xeloda; Herceptin
Intervention MeSH terms: Docetaxel; Capecitabine; Oxaliplatin; Trastuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adenocarcinoma of the gastro-esophageal; Her2; Dose finding; Taxotere (Docetaxel); Eloxatin (Oxaliplatin); Xeloda (Capecitabine); Herceptin (Trastuzumab)
Comparison Medications in the Treatment of Postmenopausal Women With Osteoporosis
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare in postmenopausal women with established osteoporosis the effect of treatment with
      teriparatide 20 micrograms/day subcutaneous with the effect of salmon calcitonin 100 IU/day
      subcutaneous on change in lumbar spine BMD.
    


Intervention name(s): teriparatide 20 micrograms/day subcutaneous; salmon calcitonin 100 IU/day subcutaneous
Intervention type(s): Drug; Drug
Other intervention name(s): LY333334
Intervention MeSH terms: Teriparatide; Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics of KD101 in Healthy Male Subjects
Condition: Drug Toxicity
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 1

Summary: 
      To Evaluate the safety and tolerability after KD101 single oral dosing in healthy male
      subjects

      To Evaluate the pharmacokinetic property after KD101 single oral dosing in healthy male
      subjects

      To Evaluate the effect of food on bioavailability after KD101 single oral dosing in healthy
      male subjects
    

Detailed description: 
      This clinical trial is a dose block-randomized, double-blinded, placebo controlled, single
      ascending dose, food interaction study. AEs, PE, Vital signs, ECGs and clinical lab tests
      will be assessed to evaluate the safety and tolerability, and blood and urine will be
      collected to evaluate the pharmacokinetic parameters.

      This single ascending dose, food interaction study will be conducted with the KD101 dose of
      200, 600, 1000 and 1400 mg. After evaluating the safety and pharmacokinetic parameters in the
      single dose KD101 group of 200mg, next higher dose of KD101 will be administered and
      evaluated and food interaction will be evaluated in the KD101 group of 600mg.
    

Intervention name(s): KD101; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200mg (1casule), 600mg (3 capsule), 1000mg (5 capsule), 1400mg (7 capsule) PO, once in the morning; PO, once in the morning
Other intervention name(s): KD101 soft capsule 200mg; KD101 placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: KD101; Anti-obesity Agents
Study Investigating the Pharmacokinetic Properties of the Drug Lu AF35700 in Subjects With Liver Impairment and in Healthy Subjects
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the impact of mild to moderate hepatic impairment on
      the pharmacokinetics of a single oral dose of Lu AF35700
    


Intervention name(s): Lu AF35700
Intervention type(s): Drug
Intervention description(s): Single oral dose of 10 mg Lu AF35700
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Metformin Versus Vildagliptin for Diabetic Hypertensive Patients
Condition: Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a controlled study to measure the efficacy of using metformin or vildagliptin for
      type 2 diabetic patients who suffers from hypertension to reduce cardiovascular risk
      resulting from both diabetes and hypertension using different parameters measuring
    

Detailed description: 
      Several studies indicated that type 2 diabetes mellitus and hypertension are associated with
      increased cardiovascular complications. Recently, studies suggest that metformin and
      vildagliptin can reduce cardiovascular complications in diabetic patients with unclear
      mechanisms. This work aimed to determine the effect of metformin and vildagliptin on
      diabetic-hypertensive patients. Patients were allocated into four groups: groupI: healthy
      volunteers, groupII: patients recently diagnosed with their hypertension and diabetes,
      groupIII: patients treated with captopril (25mg once daily) for their hypertension in
      addition to metformin (1000mg bid) groupIV: patients treated with captopril (25mg bid) for
      hypertension in addition to vildagliptin (50mg bid). At the end of the therapeutic period,
      then total cholesterol, LDL,serum Creatinine level, blood pressure and vascular endothelial
      growth factor (VEGF) levels in serum will be measured for different groups to estimate the
      benefits of one drug over the other one in protecting against cardiovascular risks for
      diabetic hypertensive patients..
    

Intervention name(s): Metformin Pill; Vildagliptin 50 mg
Intervention type(s): Drug; Drug
Intervention description(s): a biguanide used as an insulin sensitizer for patients suffering from type 2 diabetes mellitus; Dpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus
Intervention MeSH terms: Metformin; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: diabetes; Metformin; vildagliptin; hypertension; cardiovascular risk
A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants
Condition: Gram-negative Bacterial Infections
MeSH terms: Bacterial Infections; Gram-Negative Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the intrapulmonary penetration of nacubactam in
      healthy volunteers. Nacubactam is a novel non-beta-lactam beta-lactamase inhibitor being
      developed as a combination therapy with the beta-lactam meropenem for the treatment of
      serious gram-negative bacterial infections. Adult male and female healthy participants will
      receive a single intravenous infusion of nacubactam co-administered with meropenem and then
      undergo a bronchoalveolar lavage (BAL) procedure to collect lung epithelial lining fluid
      (ELF) for measurement of intrapulmonary concentrations of nacubactam and meropenem.
    


Intervention name(s): nacubactam; meropenem
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single 2000 milligram (mg) intravenous (IV) infusion of nacubactam over 1.5 hours.; Participants will receive a single 2000 mg IV infusion of meropenem over 1.5 hours.
Other intervention name(s): RO7079901; Merrem
Intervention MeSH terms: Meropenem
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      -  A Pilot study

        -  Randomized and Double-blinded

        -  Placebo controlled

        -  In 2 parallel group (JOINS 200mg:Placebo = 1:1)

        -  Overall 24 months treatment (JOINS:Placebo comparison up to 12 months, Additional
           follow-up assessment up to 24 months)

        -  Provide rescue medicine throughout whole clinical trial period.
    

Detailed description: 
      1. Assessment of Efficacy

             1. Knee MRI(Magnetic resonance imaging):

                  -  Assessment of cartilage volume, thickness in target knee

                  -  GAG(glycosaminoglycan) concentration of target knee

                  -  Assessment of Whole-Organ Magnetic Resonance Imaging Score (WORMS) of target
                     knee

             2. Knee radiography:

                  -  Assessment of changes in minimal medial JSW(Joint Space Width) of target knee.

             3. Knee pain(VAS)

                  -  Assessment changes of pain in target knee.

             4. K-WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index for Korean)

                  -  Assessment score change for pain(5 questions), stiffness(2 questions) and
                     physical function(17 questions).

                  -  The questionnaire is self-administered by the patients.

             5. Used frequency of rescue medicine.

             6. Biochemical cartilage and bone markers

                  -  Blood and urine sample will be collected all through the morning after a night
                     fasting period since 10 pm the previous day to avoid the variations.

        2. Assessment of Safety

             1. Adverse event

             2. Laboratory assessment

             3. Vital sign

             4. 12-lead ECG

             5. Physical examination

        3. Enrollment: 76
    

Intervention name(s): JOINS 200mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet at each time, 3 times a day; placebo of Joins 200mg
Other intervention name(s): JOINS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cartilage; knee osteoarthritis; protective effect