bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Evaluation of Herbal and Allopathic Drugs for the Treatment of Chronic Diarrhea
Condition: Chronic Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Revival of significance and the emergent market of herbal medicinal products necessitate
      strong commitment by the stakeholders to safeguard the end users. The variability in the
      concentrations of constituents of plant material, coupled with the variety of extraction
      techniques and processing steps used by different manufacturers, results in distinct
      inconsistency in the quality of herbal products. The present study will be directed to a
      polyherbal formulation Entoban which integrates an outstanding blend of herbs that have been
      used for decades to eradicate microorganisms and worms from gastrointestinal tract. It is the
      combination of Holarrhena antidysenterica, Berberis aristata, Symplocos racemosa, Querecus
      infectoria and Helicteres isora. The current study would target the chemical assessment,
      pharmacological and comparative clinical evaluation of Entoban to assure its safety and
      efficacy.
    

Detailed description: 
      The study will be adopted to compare the efficacy, tolerability, and safety of Entoban using
      Metronidazole DS as a comparator. The study was carried out in XYZ hospital from Jan 2015 to
      Dec 2015. The participants will be selected on the basis of inclusion and exclusive criteria.
    

Intervention name(s): Metronidazole; Entoban
Intervention type(s): Drug; Drug
Intervention description(s): The data will be recorded for physical examination including gender , age, height, weight, temperature, heart rate ,respiratory rate and blood pressure of the subject, number of stool per day, stool with or without mucus or mixed with blood along with abdominal cramps, dehydration, nausea, vomiting and related clinical information will be carefully recorded. Statistical tools and tabulated results will be used to identify the similarities and differences in safety, efficacy and tolerability of treatment.; To evaluate the safety and efficacy of coded herbal formulation (Entoban) through randomized clinical study and compared with Metronidazole DS for treatment of gastrointestinal infections for improving the health of the community with due regard to the prevalence of disease and the feasibility of using alternative treatments.
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: safety; efficacy
Arthroscopic Treatment of Partial Rotator Cuff Tears in Shoulder Joint
Condition: Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Observational

Summary: 
      A retrospective analysis was performed on patients with partial-thickness rotator cuff tendon
      tears who underwent arthroscopic surgery from August 2006 to December 2011. To evaluate
      functional outcomes and tendon healing after arthroscopy.
    

Detailed description: 
      To study the surgical method and clinical effect of arthroscopic treatment of rotator cuff
      tendon tear. Retrospective analysis was performed on patients with rotator cuff tendon tears
      who underwent arthroscopic surgery from August 2006 to December 2011. Preoperative X-ray and
      MRI were performed. Rotator cuff repair was performed during the operation. UCLA shoulder
      scoring scale was used to evaluate the shoulder joint at preoperative and final follow-up.
    

Intervention name(s): shoulder arthroscopy
Intervention type(s): Procedure
Intervention description(s): Patients underwent ubacromial bursectomy and acromioplasty , cuff debridement and cuff repair, side to side suture of rotator cuff combined with suture anchor.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with partial-thickness rotator cuff tendon tears. Partial rotator cuff
        tears can be divided into three categories, bursa side tears, tendon tears and joint side
        tears. Studies have found that rotator cuff tendon tears account for 55% of partial tears,
        compared to the other two types of partial tears, there has been very little research on
        partial-thickness rotator cuff tendon tears, which has no consensus on diagnosis and
        treatment.
The Effects of a Pre-packaged, Portion Controlled Meal Plan on Type 2 Diabetes and Glycemic Control: A Comparison Study
Condition: Obesity
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this research study to find out whether a pre-packaged, portion controlled
      diet with a group behavior modification program or group diabetes support and education, is a
      safe and effective way for people with type 2 diabetes to lose weight and manage their
      diabetes.
    

Detailed description: 
      Eligible volunteers are randomly assigned to a treatment group consisting of a pre-packaged,
      portion controlled meal plan plus a group behavior modification program or to a control group
      that consists of a group diabetes support and education (DSE) program. Random assignment will
      be stratified by whether or not a subject is taking insulin at baseline, which will be
      included as a covariate in all subsequent analyses. Treatment assignments are unmasked. At
      the end of 24 weeks both groups will have completed 9 group sessions (weeks 0, 1, 2, 4, 8,
      12, 16, 20 and 24). At week 16, each participant will meet individually with the study
      physician to review their progress to date. These meetings will take place at the week 16
      group visit. The PCD program is aimed at achieving and maintaining a decrease in weight and
      providing a group behavior modification program from 0-24 weeks. The DSE program is aimed at
      providing diabetes support and education from weeks 0-24. A Certified Diabetes Educator (CDE)
      will review the effects of diet and weight loss, exercise, and medications on blood glucose
      levels among all participants at the individual session before any changes in dietary intake
      or exercise are prescribed. Participants will be counseled on strategies to prevent
      hypoglycemia and will be given a blood glucose meter and strips and instructed to measure
      their blood glucose at least two times per day while participating in the study. In addition,
      the causes, symptoms and treatment of hypoglycemia will be reviewed including when to contact
      their health care provider.
    

Intervention name(s): Portion controlled diet; Diabetes Support and Education
Intervention type(s): Behavioral; Other
Intervention description(s): Participants learn skills for changing nutritional and lifestyle habits and diabetes management follow a program that includes eating a pre-packaged, portion controlled meal for weight loss in addition to attending the behavior modification groups; The DSE groups will consist of educational sessions offered for diabetes support and education which will include sessions on diet/nutrition, exercise, foot care and living with diabetes.
Other intervention name(s): PCD; DSE
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight loss; Type 2 Diabetes; Behavior Modification; portion control
The Maintenance Treatment of UFT in Advanced 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 efficacy and tolerability of the maintenance
      treatment of tegafur-uracil (UFT) after the standard first-line chemotherapy in advanced
      gastric cancer.
    


Intervention name(s): UFT
Intervention type(s): Drug
Intervention description(s): UFT 360mg/m2 qd po d1-14, q3w
Other intervention name(s): Uracil and Tegafur
Intervention MeSH terms: Tegafur
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: disease control survival
Evaluation of Efficiency for Three Different Aligning Archwires During Initial Orthodontic Leveling
Condition: Dental Malocclusion; Dental Crowding
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The present prospective clinical study was directed to evaluate the efficiency of three
      different aligning archwires during initial orthodontic leveling.
    

Detailed description: 
      The present prospective clinical study was directed to evaluate efficiency of three different
      aligning arch wires during initial orthodontic leveling.

      The sample of present study included 30 patients, 15 females and 15 males; with a mean age
      was 17.81 ± 1.96 years. They were randomly allocated into three equal groups, according to
      the type of the aligning arch wire as follows:

        1. Group A: in which 10 patients, with a mean age was 17.27 ± 1.95 years, were treated with
           conventional singlestrand NiTi arch wires.

        2. Group B: in which 10 patients, with a mean age was 17.33 ± 2.42 years, were treated with
           Niobium-titanium-tantalum-Zirconium (Gummetal) arch wires.

        3. Group C: in which 10 patients, with a mean age was 18.70 ± 1.49 years, were treated with
           multistrand NiTi arch wires.

      Mandibular orthodontic study models were taken every 4 weeks and laser scanned to obtain 3D
      digital models during the 3 months observation period of the study. The changes in LII were
      determined at every 4 weeks observation intervals. Moreover, the changes in inter-canine,
      inter-1st premolar and inter-molar widths before and after three months were evaluated and
      compared among the three groups of aligning arch wires.

      Data were collected and statistically analyzed via Statistical Package for Social Science
      (SPSS, version 23). One Way ANOVA and Kruskall-Wallis tests were used to assess the
      difference among the three studied groups and paired t-test was used to assess the difference
      and percent of changes within each group before and after three months observation period.
    

Intervention name(s): fixed orthodontic appliance and arch wires
Intervention type(s): Device
Intervention description(s): leveling and aligning stages in orthodontics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Orthodontic arch wire; alignment; Gummetal arch wire; multistrand arch wire
Effect of COVID-19 Pandemic on Perceived Stress, Anxiety, Mood, and Training Quality in Elite Athletes.
Condition: COVID-19; Life Satisfaction; Anxiety; Mental Health Wellness 1; Athlete; Stress
MeSH terms: COVID-19; Anxiety Disorders
Study type: Observational

Summary: 
      In this study, the investigator aims to measure stress, anxiety, mood, life satisfaction
      measures among elite athletes during COVID-19 and measure the relationship between these
      measures and the changes in training characteristics in elite athletes during the COVID-19
      pandemic.
    

Detailed description: 
      On 11 March 2020, the World Health Organization declared the COVID-19 outbreak as a pandemic.
      On the same day, the first COVID-19 case reported in Turkey and nationwide quarantine
      regulations started after a spike in case numbers. In the world of sports, the effects of the
      COVID-19 pandemic started with staging games without spectators, gradually all sports events
      and team practices were postponed. Soon later, athletes advised to quarantine at home and
      continue training individually. Similar to previous study results, the COVID-19 outbreak
      expected to cause a profound and wide range of psychosocial impacts on people during
      outbreaks of infection. In fact, preliminary results from a study in China showed a moderate
      to severe degree psychological impact on more than half of the respondents. However, the
      effect of COVID-19 on mental health symptoms in elite athletes has not been investigated.

      In this study, the investigator aims to investigate stress, anxiety, mood, life satisfaction
      measures among elite athletes during COVID-19 and explore the potential relationship between
      these measures and the changes in training characteristics during the COVID-19 pandemic.
    

Intervention name(s): Online Survey
Intervention type(s): Other
Intervention description(s): Online Survey
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Elite Athletes
      
Keywords: COVID-19; Athlete; Mental Health
A Crossover Study to Evaluate the Efficacy of Simvastatin in Elevating HDL-C Levels in Patients With Type 2 Diabetes (0733-216)(COMPLETED)
Condition: HDL Cholesterol
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see how well simvastatin raises HDL levels in patients with
      Type 2 Diabetes.
    


Intervention name(s): MK0733 / Duration of Treatment: 18 Weeks; Comparator: placebo (unspecified) / Duration of Treatment: 18 Weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxymetazoline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass
Condition: Gastroesophageal Reflux Disease; Morbid Obesity
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Obesity; Obesity, Morbid
Study type: Observational

Summary: 
      The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal
      reflux disease (GERD) in morbidly obese patients.
    

Detailed description: 
      The investigators studied the impact of this surgical procedure on GERD in patients with
      morbid obesity.

      Esophageal syndromes were evaluated according to the Montreal Consensus, where troublesome
      symptoms were defined as score ≥ 2 on a validated questionnaire of symptoms for Portuguese
      language along with esophageal syndromes with injury assessed through upper endoscopy.

      Esophageal acid exposure was determined through 24h pH monitoring. Increased acid exposure
      was characterized when total esophageal pH < 4 for at least 4% of the total monitoring time.
    

Intervention name(s): Gastric bypass
Intervention type(s): Procedure
Intervention description(s): Open Silastic® ring Roux-en Y gastric bypass was performed through an upper midline incision. A gastric pouch was created by dividing the stomach with a 10-cm stapler from the lesser curvature (7 cm vertically from the cardia) to 1 cm to the left of the Hiss angle. The estimated volume of the gastric pouch was 20 to 30 ml that was banded with a 6.5 cm long Silastic® ring. A gastrojejunal anastomosis was performed with two-layers hand sewn absorbable suture over a 1.2 cm bougie distal to the ring, keeping an alimentary limb with 100 cm in length, and a biliopancreatic limb ranging 60 and 80 cm.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic patients
      
Keywords: GERD; Gastric bypass
Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations
Condition: Post Dental Restoration; Caries, Dental
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      To minimize the effects of polymerization shrinkage in the restorative treatment, there are
      new composites called Bulk- Fill which the companies has developed this composites for
      example Tetric N Ceram(Ivoclar-Vivadent) and Filtek ( 3M ESPE). Its decreased polymerization
      shrinkage and properties allow the material to be inserted in one layer being quickly than
      traditional composite. This clinical study is designed to compare the clinical performance of
      the bulk fill composite resin in Class I (one-surface posterior), II (two-surface posterior)
      and V (cervical-surface posterior) fillings.
    

Detailed description: 
      A patients with 3 caries lesions class one either two or five will be divided into 3 groups ,
      cavities will be incrementally layered with resin composite and each increment will be cured
      as directed by the manufacturer with the light curing unit (Bluephase Style
      Ivoclar-Vivadent), with an energy 1,100 mW/cm² (±50 mw/cm²) and others group of cavities will
      be restored by bulk fill composite (3M ESPE) and other bulk fill composite (
      IVOCLAR-VIVADENT) as one increment then will be cured as directed by the manufacturer with
      the light curing unit.

      The study will investigate the clinical performance and efficacy of a bulk-filled composite
      resin restorative material for a period of 5 years
    

Intervention name(s): Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite; Z 350 Xt Composite
Intervention type(s): Device; Device
Intervention description(s): Restorative cavities one, two and five with material Filtek Bulk Fill Composite; Restorative cavities one, two and five with material Z 350 XT Composite
Intervention MeSH terms: Z 350
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention: Bulk full composite (3M) bulk fill composite in posterior class one cavities bulk fill composite in posterior class two cavities bulk fill composite in posterior class five cavities
Intervention:Bulk full composite (Ivoclar-Vivadent) bulk fill composite in posterior class one cavities bulk fill composite in posterior class two cavities bulk fill composite in posterior class five cavities Other: bulk fill composite Intervention Control: Nano resin composite (K Z350 xt) Restoration in class one cavities Restoration in class Two cavities Restoration in class five cavities
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the relative bioavailability of Lansoprazole DR
      Capsules 30 mg with Prevacid® Capsules 30 mg under fasting conditions in healthy adult human
      subjects.
    

Detailed description: 
      open label, randomized, two-treatment, three-period, three-sequence, partial replicate oral
      bioequivalence study of Lansoprazole 30 mg DR Capsules of Dr.Reddy's Laboratories Limited,
      India comparing with that of PREVACID® (containing Lansoprazole) 30 mg DR Capsules of TAP
      Pharmaceuticals Inc. USA, in healthy, adult, human subjects under fasting conditions. 48
      healthy, adult, human subjects were enrolled in the study and 42 subjects were completed the
      study.
    

Intervention name(s): Lansoprazole
Intervention type(s): Drug
Intervention description(s): Lansoprazole DR Capsules 30 mg
Other intervention name(s): Prevacid
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; two way crossover
Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will assess the safety, tolerability of a single 1500 mg dose of famciclovir in 50
      adolescents with recurrent herpes labialis. Eight of the 50 adolescents will also participate
      in the pharmacokinetics (PK) assessment of famciclovir single 1500 mg dose
    

Detailed description: 
      Uncontrolled study
    

Intervention name(s): Famciclovir
Intervention type(s): Drug
Intervention description(s): Famciclovir 1500 mg (3 x 500 mg tablets) oral as a single dose.
Intervention MeSH terms: Famciclovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Herpes labialis; cold sores; herpes simplex type 1
A Study of Baricitinib and Rifampicin in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to look at what effect multiple doses of rifampicin have on a
      single dose of baricitinib and to look at the safety and tolerability of these drugs. Side
      effects will be documented. The study will last approximately 31 days from the first dose to
      the end of the study.
    


Intervention name(s): Baricitinib; Rifampicin
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY3009104
Intervention MeSH terms: Rifampin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluate the Safety, Tolerability and PK of Different Formulations of Orally Administered Solabegron in Healthy Male Subjects
Condition: Healthy Subjects, Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      different formulations of orally administered solabegron in healthy male subjects.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      different formulations of orally administered solabegron in healthy male subjects. Eligible
      male subjects will be enrolled into 2 cohorts of 12 subjects each conducted in parallel. The
      study is a single blind (subjects), randomized, cross-over design in 3 study periods.
    

Intervention name(s): Formulation 1 solabegron; Formulation 2 solabegron
Intervention type(s): Drug; Drug
Intervention MeSH terms: Solabegron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Overactive bladder, Incontinence