bioihbjkbjnl/mcl2 huggingface dataset:
Temporomandibular Dysfunction Affects Neck Disability, Headache, Anxiety, And Sleep Quality In Women: A Cross-Sectional Study
Condition: Temporomandibular Disorders; Headache; Neck Disorder; Anxiety; Sleep Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Sleep Wake Disorders; Headache; Anxiety Disorders
Study type: Observational

Summary: 
      The temporomandibular joint (TMJ), is the only movable joint between the joints in the head
      and neck system. It is a component of the chewing system and is involved in important
      functions such as speech, swallowing, taste and breathing. Temporomandibular dysfunction
      (TMD) is the general name given to various musculoskeletal problems seen in the
      stomatognathic system, mostly affecting the masticatory muscles and/or TMJ. TMD is the second
      most common musculoskeletal pain after chronic low back pain. Patients with TMD may also
      complain of other musculoskeletal problems, craniocervical problems, sleep problems, and
      anxiety disorders. The aim of this study is to investigate, compare and examine the
      relationship between neck dysfunction, headache and temporomandibular dysfunction severity,
      anxiety and sleep quality in female individuals.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        temporomandibular disorder and healthy women
Ropinirole 0.25 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the relative bioavailability of the test
      formulation of Ropinirole (TEVA Pharmaceuticals USA) with already marketed reference of
      Requip® (Manufactured by SmithKline Beecham Pharmaceuticals for GlaxoSmithKline) under
      fasting conditions in healthy, non-smoking, adult subjects.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA bioequivalence statistical methods
    

Intervention name(s): Ropinirole HCl 0.25 mg Tablets; Requip® 0.25 mg Tablets
Intervention type(s): Drug; Drug
Intervention description(s): 1 x 0.25 mg; 1 x 0.25 mg
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
Effect of Low Glycemic Index Diet on Biochemical Parameters and Body Image in Obesity With Insulin Resistance: A Randomized Clinical Trial
Condition: Obesity
MeSH terms: Obesity; Insulin Resistance
Study type: Interventional

Summary: 
      To examine how a low glycemic index diet (LGID) changes biochemical parameters, body
      measurements, and body image perception in obese individuals with insulin resistance. Obesity
      groups with insulin resistance who received a control diet (CD) and a LGID will be compared
      with each other in terms of biochemical parameters, body image perception and body
      measurements. In addition, each group will be compared with the start and end measurements
      over the same values.
    

Detailed description: 
      The main purpose of this study is to determine the effect of LGID on body image perception,
      biochemical parameters and body measurements in obese individuals with insulin resistance.

      Sub-objectives of the study;

      Determination of the effect of LGID on fasting blood glucose, fasting insulin level and
      HOMA-IR levels compared to CD.

      Determination of the effect of LGID on body weight, fat mass, muscle mass, body muscle ratio
      and body mass index (BMI) compared to CD.

      Determination of the effect of LGID on body image perception status compared to CD.
    

Intervention name(s): Low Glycemic Index Diet
Intervention type(s): Behavioral
Intervention description(s): Participants who came to the hospital for control and were interested in the study contacted the study researchers and eligibility was determined through face-to-face interviews. Potential participants were invited to a screening visit to verify eligibility.
The LGID program was initiated as an outpatient treatment in patients who applied to a dietitian. 3) Medium and high GI carbohydrates (GI > 55) were excluded from the diet and only low GI (GI < 50) foodstuffs were allowed. 4) A list of low glycemic index foods were given to the patients. In addition, a list of foods to avoid (medium and high glycemic index) is provided.
Other intervention name(s): LGID Group
Intervention model: Sequential Assignment
Intervention model description: Different nutrition programs were applied to obese individuals divided into control and experimental groups. While the experimental group was given a healthy/balanced nutrition program containing carbohydrates and aimed to lose weight, a nutritional program that was balanced and aimed to lose weight but did not make any classification was applied to the control group. At the end of 8 weeks, biochemical parameters and scales were compared.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low Glycemic Load Diet; Obesity
Expressiona and Diagnostic Potential of miRNAs in NSCLC
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      Its to explore the expression pattern, diagnostic and prognostic potentials of miRs (106b-5p,
      601 and 760) in serum of NSCLC patients
    

Detailed description: 
      A retrospective observational study on NSCLC patients, to determine the serum expression
      levels if some miRNAs in NSCLC patients and to find if having proper diagnostic and
      prognostic values in early disease detection, and/or staging.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Case-control
TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease
Condition: Keratoconjunctivitis Sicca
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Keratoconjunctivitis
Study type: Observational

Summary: 
      This is a prospective, observational case series to determine the clinical utility of tear
      osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to
      establish referent values for objective tests of the disease.
    

Detailed description: 
      This is a prospective, observational case series to determine the clinical utility of tear
      osmolarity, tear film breakup time, corneal fluorescein staining, conjunctival lissamine
      green staining, Schirmer's test without anesthesia, Bron/Foulks meibomian glan grading and
      the ocular surface disease index to diagnose dry eye disease, as well as to establish
      referent values for objective tests of the disease. Patients were recruited across sites in
      the EU and US from the general clinical population.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ophthalmology and Optometry Clinics
      
Keywords: Dry Eye Disease; Dry Eye Syndrome; Dry Eye
Interpersonal and Social Rhythm Therapy Enter the Brief Title for Protocol IRB 09-003781>
Condition: Bipolar Disorder, Depressed
MeSH terms: Bipolar Disorder; Depression
Study type: Interventional

Summary: 
      In patients with bipolar disorder referred for psychotherapy, is interpersonal and social
      rhythm therapy delivered in a group psychotherapy format over 2-3 weeks feasible? This
      project will help determine if interpersonal social rhythm therapy can be delivered in the
      programmatic format being considered for the outpatient mood program.
    


Intervention name(s): Interpersonal and Social Rhythm Therapy
Intervention type(s): Behavioral
Intervention description(s): Interpersonal and Social Rhythm Therapy delivered in two individual therapy sessions and six group therapy sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar; Depressed
A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      PPI-383 is an antiviral agent (an inhibitor of the hepatitis C virus NS5B polymerase) that is
      being developed as a potential treatment for hepatitis C virus infection. This study is being
      done to assess the dose-related safety and tolerance of PPI-383 when given to healthy
      volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3
      days (Part II). In addition, the study will assess how much PPI-383 is absorbed into the
      bloodstream. In Part II, the dose-related effect of PPI-383 on the amount of hepatitis C
      virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.
    


Intervention name(s): PPI-383; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: NS5B polymerase inhibitor; Phase 1; Genotype 1
Accuracy of Endometrial Volume Measured by VOCAL Versus Office Hysteroscopy for Diagnosis of Endometrial Polyps
Condition: Premenopausal; Metrorrhagia
MeSH terms: Metrorrhagia
Study type: Observational

Summary: 
      Endometrial volume will be assessed by 3DUS and VOCAL and compared to the results of office
      hysterscopy to measure the abilty of this technique to diagnose endometrial polyps in women
      complaining of abnormal uterine bleeding.

      The safety of both procedures will be compared .
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Premenopausal women complaining of irregular vaginal bleeding
      
Keywords: Endometrial volume , VOCAL , Endometrial , Metrorrhagia
Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study
Condition: Acne Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 4

Summary: 
      The pilot study will investigate whether combination treatment of Finacea 15% Gel and
      Brimonidine 0.33% Gel could be more effective than Brimonidine 0.33% Gel monotherapy in
      treating both the papules/pustules and erythema associated with rosacea.
    

Detailed description: 
      Acne rosacea is a chronic inflammatory disease with different components including
      inflammatory lesions (papules/pustules), erythema and telangiectasia. Brimonidine 0.33% Gel
      primarily affects the erythematous components of rosacea. As such, combination treatment with
      a standard rosacea treatment, such as Finacea 15% Gel, may provide additional relief for the
      inflammatory component of rosacea.
    

Intervention name(s): Azelaic acid 15%; Brimonidine 0.33%
Intervention type(s): Drug; Drug
Intervention description(s): Applied to the face each AM and PM; Applied to the face each AM 30 minutes after the application of Azelaic acid 15%
Other intervention name(s): Finacea; Miravaso
Intervention MeSH terms: Azelaic acid; Brimonidine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Efficiency of Home-Based Pulmonary Rehabilitation in Adults With Asthma
Condition: Pulmonary Rehabilitation; Asthma; Home-based Pulmonary Rehabilitation
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Asthma is a serious global health problem affecting people of all ages in every country in
      the world. Despite the presence of effective medications, many studies have reported poor
      asthma control in patients. Therefore, new approaches are needed to improve asthma control.
      Pulmonary rehabilitation is recommended as an alternative approach in patients with chronic
      lung disease including asthma. Also, home-based type of pulmonary rehabilitation can be
      preferred because it is more cost-effective and patients can spend more time with their
      families. There are a limited number of studies in the literature evaluating the efficacy of
      home-based pulmonary rehabilitation in asthmatic patients. The aim of this study was to
      investigate the efficacy of home-based pulmonary rehabilitation program with simple equipment
      in asthmatic patients.
    


Intervention name(s): Home-based Pulmonary Rehabilitation; Education and Recommendations
Intervention type(s): Other; Other
Intervention description(s): Patients will admit a home-based pulmonary rehabilitation program for 8 weeks, with a minimum of 3 days per week and one session of this is under the supervision of a physiotherapist. The pulmonary rehabilitation program includes stretching exercises, strengthening exercises for upper and lower extremities, breathing exercises and aerobic exercises (walking). All of these exercises will be equipped with equipment that the patients can easily provide at home. In addition, patients will be provided with a pedometer and exercise diary.; The control group will be given a training session on the course of the disease and the correct inhaler use and will be given booklets on breathing exercises, aerobic exercises (walking) and physical activity recommendations for a minimum of 2-3 days per week for 8 weeks. Patients will be given a pedometer and exercise diary.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; pulmonary rehabilitation; home-based pulmonary rehabilitation; home-based rehabilitation
Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Some patients have respiratory depression (decreased breaths per minute) after surgery.
      Acetaminophen, an FDA approved pain medication, may prevent this problem. The purpose of this
      study is to determine if acetaminophen decreases respiratory depression after surgery. The
      investigators will also evaluate the cost effectiveness of acetaminophen.

      Patients having elective major abdominal surgery are being asked to participate in this
      research study. If eligible, a patient will have their baseline tidal volume (amount of air
      moved into or out of the lungs) and vital capacity (how much air the lungs are capable of
      holding) measured using a spirometer (apparatus for measuring the volume of air inspired and
      expired by the lungs) measured before surgery. Three questionnaires will also need to be
      completed before surgery.

      The patient will then be randomized, like flipping a coin, to receive either Acetaminophen or
      placebo (inactive substance) as an infusion throughout surgery and for the first two days
      thereafter. Neither the patient nor his or her physician will know if the patient is assigned
      to study drug or placebo. Regardless of study assignment, both groups will receive standard
      pain management medications and sedation.

      After surgery, the patient's blood pressure, activity, posture, respiratory rate, the
      electrical activity of the heart, oxygen saturation, tidal volume, minute ventilation and
      respiratory rate will be continuously monitored and recorded for 48 hours using a wireless
      pulse-oximeter and a respiratory volume monitor.

      48 hours after surgery the patient will be asked to complete a patient satisfaction
      questionnaire, which will allow the patient to rate the satisfaction with the treatment
      received for pain. The patient will also be asked to complete a questionnaire about recovery.

      At discharge, the patient will be given two questionnaires about pain and quality of life.
    


Intervention name(s): Intravenous Acetaminophen
Intervention type(s): Drug
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of LY2801653 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This type of study is called a radiolabeled study. For this study, LY2801653 (study drug) has
      been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally
      occurring radioactive form of the element, carbon. This study will increase understanding
      about how the drug appears in the blood, urine, and stool after it is administered to healthy
      people. Information about any side effects that may occur will also be collected. This study
      will last up to 15 days for each participant, not including screening. Screening is required
      within 28 days prior to enrollment.
    


Intervention name(s): [^14C]-LY2801653
Intervention type(s): Drug
Intervention description(s): Administered orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Acupuncture With Deqi And Psychological Effects in Treatment of Bell's Palsy
Condition: Bell's Palsy
MeSH terms: Bell Palsy; Facial Paralysis; Paralysis
Study type: Interventional

Summary: 
      The purpose of this study is to observe the influence of Deqi and neuropsychological factors
      on effects of acupuncture treatment for Bell's Palsy.
    

Detailed description: 
      Through long-term clinical practice，acupuncture treatment on facial paralysis has been
      generally proved effective；the large number of ancient and modern medical literature also
      have suggested that acupuncture is beneficial for facial paralysis. However,a scientific
      basis is still needed to be established to make sure the efficacy of acupuncture be
      recognized internationally.This study will adopt a series of international practice scales
      ,such as House Brackmann Scale,Facial Disability Index(FDI),World Health Organization Quality
      of Life-BREF (WHOQOL-BREF), Cattell Personality Factors (16PF),and Cancellation test to
      evaluate the role of deqi and neuropsychological factors in the acupuncture treatment for
      Bell's Palsy.
    

Intervention name(s): acupuncture, deqi; acupuncture Non-manipulation
Intervention type(s): Device; Device
Intervention description(s): Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the deqi sensation.; After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.
Other intervention name(s): Manipulation; Non-Manipulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bell's palsy，deqi，acupuncture, neuropsychology
Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of s-1 plus Albumin
      Bound Paclitaxel as first-line therapy in the treatment of patients with advanced gastric
      cancer.
    

Detailed description: 
      As the first phase II clinical trial of fluoropyrimidines plus Nab-PTX in AGC patientsphase
      II trial, this study aimed to evaluate the efficacy and safety of S-1 plus Nab-PTX as a
      first-line treatment for patients with metastatic gastric cancer. All patients were orally
      treated with S-1 in doses of 40 mg (BSA<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg
      (BSA≥1.50 m2) b.i.d. on days 1-14 in combination with Nab-PTX (240 mg/m2, divided on days 1
      and 8, intravenously for 30 minutes) of each 21-day cycle. Treatment was planned for 6 cycles
      or until progression, unacceptable toxicity, or patient refusal.
    

Intervention name(s): Albumin Bound Paclitaxel; S-1
Intervention type(s): Drug; Drug
Intervention description(s): 120 mg/m2, D1,D8,every 3 weeks until disease progress or intolerable toxicity.; 40mg QD D1-D14,every 3 weeks,for BSA<1.25 m2, 50mg QD D1-D14,every 3 weeks,for BSA=1.25～1.5m2, 60mg QD D1-D14,every 3 weeks,for BSA>1.5m2,until disease progress or intolerable toxicity.
Other intervention name(s): abraxane
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric Cancer; Albumin Bound Paclitaxel; S-1; First Line
First-in-Human Study With GNbAC1 in Healthy Volunteers
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of single ascending doses
      of GNbAC1 in healthy male subjects.
    

Detailed description: 
      Scientific research has shown that the expression of genes of a virus which is integrated in
      the Human genetic material, the Multiple Sclerosis associated RetroVirus (MSRV) could play a
      critical role in the causation of multiple sclerosis. GNbAC1 is an experimental medication,
      which neutralizes (i.e. inactivates) a protein of MSRV that might contribute to the
      development or deterioration of multiple sclerosis.
    

Intervention name(s): GNbAC1; GNbAC1 placebo
Intervention type(s): Biological; Biological
Intervention description(s): Single dose intravenous (IV) GNbAC1 of 0.0025mg/kg, 0.025mg/kg, 0.15mg/kg, 0.60mg/kg, 2.00mg/kg or 6.00mg/kg; Single dose intravenous (IV) GNbAC1 placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple sclerosis; GNbAC1; Monoclonal antibody; Multiple Sclerosis Associated Retrovirus (MSRV); Temelimab
Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      It has been shown in previous study that progressive glycemic deterioration was associated
      with progressive loss of b-cell function, measured by the decrease in plasma insulin levels,
      irrespective of the therapy used (diet, sulfonylureas or metformin).There is growing evidence
      that thiazolidinediones could have a positive action on the b-cell function. But it has not
      yet been demonstrated that they could protect from a deterioration in insulin secretion in
      the long term. So, it appears interesting to study the long term evolution of the b-cell
      function and the possible protection with rosiglitazone in patients with type 2 diabetes
      showing evidence of loss of b-cell function with metformin alone.
    


Intervention name(s): rosiglitazone-metformin; Metformin; metformin+ gliclazide
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): rosiglitazone-metformin; Metformin
Intervention MeSH terms: Metformin; Rosiglitazone; Gliclazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Beta cell function; Type 2 diabetes; Combination treatment