bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility of Ayurveda in Patients With Mild-to-Moderate COVID-19: A Community-Based Participatory Research
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Innovative strategies are required to manage COVID-19 in the communities. Back to Roots
      community based project was a collaborative, pilot intervention program in British Asian
      community to assess the efficacy and safety of Ayurveda intervention in relieving symptoms of
      mild-to-moderate COVID-19.
    


Intervention name(s): Ayurveda
Intervention type(s): Other
Intervention description(s): Dosage was used in common range (Ashwagandha: Doses range from 250 mg to 5 g; Giloy: range from 500mg to 1g; Tulsi: 500mg-1g) Dosage were altered based on age, weight and severity of symptoms.
Intervention model: Single Group Assignment
Intervention model description: Community Based Participatory Research
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Ayurveda Intervention, Community Based Participatory Research
The Acute Effects of Low Temperature for Long Time Heat Treatment of Pork Semitendinosus on Satiety
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      Cooking meat at low temperatures for prolonged times is widely used among chefs and in food
      service due to the possibility to obtain a consistent and appealing eating quality. The
      method is generally termed low-temperature long-time (LTLT) cooking. In LTLT cooking, meat is
      vacuum-packed and heated at temperatures between 50°C and 65°C in a water bath for several
      hours. LTLT has several benefits - improved tenderness and juiciness, less cooking loss,
      better vitamin retention and uncompromised food safety.

      A recent PhD thesis concluded that one of the mechanisms behind the changes in eating quality
      during LTLT cooking was due to the proteolytic degradation in the muscle tissue. The activity
      of proteolytic enzymes has shown to be dependent on heating temperature and time where the
      cathepsins were found to remain active during heat treatment. At 58°C the cathepsin B+L
      activity is increased compared to 48°C and 53°C and at 55°C compared to 25°C, 40°C and 70°C.
      A prolonged heating time of 17 hours at 58°C has also shown to increase cathepsin B+L
      activity. The proteolytic degradation results in the occurrence of peptides and amino acids
      such as tryptophan, tyrosine, leucine and histidine which could lead to a faster degree of
      satiety when consumed.

      According to the aminostatic hypothesis by Mellinkoff, a rise in plasma amino acids elicited
      by protein ingestion could assist in the suppression of food intake and the onset of satiety.

      The investigators therefore hypothesize that the ingestion of LTLT cooked pork would induce a
      faster satiety response due to the higher availability of peptides and amino acids prior to
      digestion. An acute meal study will elucidate this. LTLT cooking will be performed by the
      "cook-chill" method to mimic real life where meat is rapidly chilled after heat treatment,
      stored at 0-2°C and reheated and browned prior to serving.
    


Intervention name(s): Pork
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2a study is designed to evaluate the safety and tolerability of multiple
      subcutaneous (SC) doses of BG9924, administered in a cohort dose-escalation fashion, in
      patients with active rheumatoid arthritis (RA) who have had an inadequate response to therapy
      with disease-modifying anti rheumatic drugs (DMARDs) and who may have undergone anti-TNF
      therapy. This study will assist with dose selection for further planned Phase 2 studies.
    


Intervention name(s): BG9924
Intervention type(s): Drug
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthritis, Rheumatoid; Methotrexate; Antirheumatic Agents
The Potential Effects and Mechanisms of Flax Lignans on Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes; Hypercholesterolemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to improving the lipid profile and glucose control in type 2
      diabetic patients with supplementation of flax lignans. We hypothesize that flax lignans
      supplement will improve the cholesterol profile and glucose control in type 2 diabetic
      patients.
    

Detailed description: 
      The prevalence of type 2 diabetes is increasing dramatically in the last decade in China.
      Hyperlipidemia is a comorbid condition in type 2 diabetes and increase the adverse health
      outcomes. Flax lignans, a phytoestrogen found in flaxseed is thought to be the compound
      responsible for cholesterol-lowering effect of flaxseed. Our purpose is to improving the
      lipid profile in type 2 diabetic patients with supplementation of flax lignans.
    

Intervention name(s): flax lignans
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: type 2 diabetes; lignans; flaxseed; cholesterol
A Trial to Evaluate Safety of Firmagon® (Degarelix) in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate
      long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced
      hormone-dependent prostate cancer requiring androgen deprivation therapy.
    


Intervention name(s): Degarelix
Intervention type(s): Drug
Other intervention name(s): Firmagon®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad35.RSV.FA2 Regimens Boosted With Ad26.RSV.FA2 in Healthy Adult Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of intramuscular
      homologous and heterologous prime-boost regimens of Ad35.RSV.FA2 (human adenovirus-vectored
      vaccine candidate) and Ad26.RSV.FA2 in healthy participants.
    

Detailed description: 
      This is a single-center, randomized (study medication assigned to participants by chance),
      placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is
      compared in a clinical trial with a drug to test if the drug has a real effect), double-blind
      (neither the researchers nor the participants know what treatment the participant is
      receiving) and Phase 1 study in healthy participants. The study comprises a 4-week screening
      period; vaccination for each participant on Days 1, 85, and, 169; a 28-day follow-up period
      performed after each vaccination and a final visit at Day 323 or 351. Participants will be
      randomly assigned to one of the 4 treatment groups (Group 1/2/3/4) to receive either
      Ad35.RSV.FA2 or Ad26.RSV.FA2 or placebo. The study duration will be approximately 52 weeks.
      Blood samples for immunogenicity will be collected. Participant's safety will be evaluated
      throughout the study.
    

Intervention name(s): Ad35.RSV.FA2; Ad26.RSV.FA2; Placebo
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10^11) virus particles on Day 1 and 85 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10^11) virus particles on Day 1 and 169 in Group 2. Intramuscular injection of Ad35.RSV.FA2 (1x10^11) virus particles on Day 1 in Group 3.; Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on Day 169 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10^10) virus particles on Day 169 in Group 3. Intramuscular injection of Ad26.RSV.FA2 (5x10^10) virus particles on Day 169 in Group 4.; Participants will receive intramuscular injection of placebo (sterile formulation buffer) on Day 85 in Group 2. One intramuscular injections of placebo on Day 85 in Group 3. Two intramuscular injections of placebo on Day 1, and Day 85 in Group 4.
Other intervention name(s): JNJ-61187191-AAA; JNJ-61187165-AAA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Healthy Participants; Ad35.RSV.FA2; JNJ-61187191
24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate benefits and risks of lixisenatide (AVE0010), in
      comparison to sitagliptin, as an add-on treatment to metformin, in obese (body mass index
      [BMI] greater than or equal to 30 kilogram per square meter [kg/m^2]) type 2 diabetic
      patients less than 50 years of age, over a period of 24 weeks of treatment.

      The primary objective of this study is to assess the efficacy of lixisenatide, in comparison
      to sitagliptin, as an add-on treatment to metformin on a composite endpoint of glycemic
      control in terms of glycosylated hemoglobin (HbA1c) and body weight, at Week 24.

      Secondary objectives are to assess the effects of lixisenatide, in comparison to sitagliptin,
      as an add-on treatment to metformin on absolute changes in HbA1c values and body weight;
      fasting plasma glucose (FPG); plasma glucose, insulin, C-peptide, glucagon, and proinsulin
      during a 2-hour standardized meal test; insulin resistance assessed by homeostatic model
      assessment of insulin resistance (HOMA-IR); beta cell function assessed by homeostatic model
      assessment of beta-cell function (HOMA-beta); to evaluate safety, tolerability, and
      anti-lixisenatide antibody development.
    


Intervention name(s): Lixisenatide (AVE0010); Lixisenatide Placebo; Pen auto-injector; Sitagliptin; Sitagliptin Placebo; Metformin
Intervention type(s): Drug; Drug; Device; Drug; Drug; Drug
Intervention description(s): Self-administered by subcutaneous injections once daily within the hour preceding breakfast.; Self-administered by subcutaneous injections once daily within the hour preceding breakfast.; Administered orally once a day in the morning with or without food at approximately the same time each day.; Administered orally once a day in the morning with or without food at approximately the same time each day.; Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.
Other intervention name(s): OptiClik®; Januvia®
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Lixisenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Bowel Preparation Status on the Polyp Missing Rate
Condition: Colorectal Polyps; Colonoscopy; Bowel Preparation; Polyp Missing Rate
MeSH terms: Polyps
Study type: Observational

Summary: 
      High quality bowel cleaning preparation was most important prerequisites of a accurate
      colonoscopy, because even a small amount of residual fecal matter can obscure small polyps
      and increase unnecessary procedure time. Until now, several studies evaluated the impact of
      bowel preparation on the quality of colonoscopy using comparison of the polyp detection rate
      in patients with adequate bowel preparation status to that in patients with inadequate bowel
      preparation status during colonoscopy. However, there was no direct measurement the effect
      bowel preparation status on the polyp missing rate, the quality of colonoscopy, using tandem
      colonoscopic evaluation in prospective setting.
    

Detailed description: 
      1. Study flow

        1. All patients perform Colonoscopy

             -  record the polyp size, shape, location and number

             -  record the factors affecting polyp missing rate

                  -  Patients' age / gender

                  -  Indication of colonoscopy

                  -  colonoscopist career

                  -  colonoscopy withdrawal time

                  -  bowel preparation status according to scale of U.S. Multi-Society Task Force
                     on colorectal cancer, Aronchick's scale and Ottawa bowel preparation quality
                     scale

        2. the patients needed or wanted to 2nd stage colonoscopic polypectomy (2nd stage
           polypectomy was performed within 6 month)

             -  record additionally detected polyp - size, shape, location and number
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients underwent colonoscopy and 2nd stage colonoscopic polypectomy at Konkuk
        University Medical Center
Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Objectives: THN102 is a new combination between modafinil and flecainide low-dose, a
      documented glial connexin inhibitor. Efficacy of THN102 was compared to modafinil and to
      placebo on parameters impaired by total sleep deprivation (SD, lasting 40h).

      Methods: 20 healthy male subjects participated in a double-blind, randomised,
      incomplete-block 3-period cross-over trial involving 5 treatments (n=12 per group): placebo
      (PBO), modafinil 100 mg (MOD), and combinations THN102 (modafinil 100 mg and 1, 3 or 9 mg
      flecainide as THN1, THN3 and THN9), as 3 oral doses over 18h.
    


Intervention name(s): Placebo; Modafinil; THN102
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: modafinil; connexin; sleep deprivation; cognitive performance
Investigation of the Effect of Geriatric Massage
Condition: Nursing Caries
Study type: Interventional

Summary: 
      There is no study has been found to examine the effect of geriatric massage applied to the
      elderly with type 2 diabetes on diabetes symptoms and blood parameters. This study was
      planned as a pretest-posttest randomized controlled single-center study to examine the effect
      of geriatric massage on diabetes symptoms and blood parameters in the elderly with type 2
      diabetes. 60 elderly people who type 2 diabetes who applied to the Internal Medicine
      Polyclinic of Bayburt State Hospital in the city center of Bayburt will the diagnosis of Type
      2 diabetes will form the sample of the study. The sample will consist of two groups, the
      geriatric massage group and the control group. Data will be collected with the "Elderly
      Information Form", "Standardized Mini-Mental Test", "Diabetes Symptoms Checklist Scale",
      "Blood Parameters Monitoring Form". "Geriatric Massage" will be applied as an intervention.
      The geriatric massage group will receive 20 minutes (10 minutes on each foot) foot massage
      and 10 minutes back massage, two days a week for eight weeks. The control group will receive
      the institution's standard of care. Frequency, number, mean, Student's t test and/or
      Mann-Whitney U test, ANOVA and/or Kruskal-Wallis test, Chi-square test and/or Correlation and
      Regression Analysis will be used in the analysis of the data. As a result of this study, it
      is anticipated that the effects of geriatric massage on diabetes symptoms and blood
      parameters in the elderly with Type 2 diabetes will be determined and these effects will be
      included in evidence-based guidelines.
    


Intervention name(s): Feet and Back Massage
Intervention type(s): Other
Intervention description(s): Foot massage: Feet are the most neglected organs of people and therefore cause many complaints. Foot massage is a massage applied to the back of the foot, toes, soles of the feet, the muscles between the thumb and little fingers, and the heel, where the muscles between the metatarsal bones are located.
Back massage: Back massage is a non-invasive nursing intervention that can be easily applied by nurses. In back massage application; A 10-minute back massage program applied by Çınar and Eşer (2012) will be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The research was planned as a pre test-post test randomized controlled single-center study.
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Blood parameters; Elderly; Geriatric massage; Symptom; Type 2 Diabetes
Octreotide in the Prevention of Postoperative Complications After Pancreaticoduodenectomy
Condition: Periampullary Carcinoma Resectable
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      pancreaticoduodenectomy (PD) is the standard operation for treatment of patients with benign
      and malignant pancreatic and periampullary diseases. Despite improved surgical technique and
      postoperative care, the mortality rate after PD is high reaching up to 30%, due to high
      incidence of postoperative complications . Pancreatic fistula (PF) is the one of the most
      frequent complications of PD and the major contributor to postoperative morbidity The aim of
      this study to evaluate the effect of the perioperative octreotide use after PD for prevention
      of the postoperative pancreatic fistula. The secondary outcomes are overall postoperative
      complications, mortality and the cost benefit relationship of the use of the perioperative
      octreotide.
    

Detailed description: 
      This study will be a prospective randomized controlled trial for perioperative use of
      octreotide in patients after PD for pancreatic and periampullary tumours from May 2014 to
      April 2017 in Gastroenterology surgical center, Mansoura University, Egypt.

      The primary outcome of the study is the effect of perioperative use of octreotide on the rate
      of development of postoperative pancreatic fistula in patients after PD for pancreatic and
      periampullary tumours. The secondary outcome is postoperative overall complications,
      mortality, duration of the hospital length of stay and cost-benefit relationship of
      perioperative use of octreotide.

      Enrolled patients will be randomized to either the octreotide or the placebo group. The
      randomization process will be done using closed envelop method and will be withdrawn by a
      nurse after pancreaticoduodenectomy . Patients in the octreotide group will receive
      sandostatin 100ug SC every 8 hours daily staring from the day of operation to the
      postoperative day 7. Patients in the placebo group will receive saline administered in a
      similar manner.
    

Intervention name(s): Octreotide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Octreotide will be given after PD; Octreotide will NOT be given after PD
Other intervention name(s): sandostatin; Normal saline
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Pharmacokinetic Properties and Effect of Food on Pharmacokinetic Properties of the Oral Lafutidine Tablets
Condition: Chronic Gastritis
MeSH terms: Gastritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was to evaluate the pharmacokinetics of single and multiple doses of oral
      lafutidine tablets and the effect of food on pharmacokinetics in healthy Chinese subjects.
      The tolerability and the effect of sex on the pharmacokinetic properties were also evaluated
      to acquire more pharmacokinetic information.
    

Detailed description: 
      The study of single-dose was randomized, three-period, crossover. And in this study, 12
      subjects were randomly assigned to 3 dose groups and received a single dose of 10mg, 20mg and
      40mg lafutidine tablets. The washout period was 7 calendar days. In the multiple-dose, 12
      subjects took lafutidine tablets of 10 mg twice a day for 6 consecutive days. In the
      food-effect study, 12 subjects were randomly assigned to 2 groups. One group received a
      single dose of 10mg lafutidine tablets under fasted condition, while the other were in fed
      condition. The drug administrations were separated by a wash-out period of seven calendar
      days. In each study group, the male and the female are both in half of the subjects. Using a
      liquid chromatography tandem mass spectrometry (LC/MS/MS) method to determine the plasma
      concentration of lafutidine. Pharmacokinetic parameters were calculated using the single
      compartment model.
    

Intervention name(s): lafutidine
Intervention type(s): Drug
Intervention description(s): comparison of different doses, sex and medication conditions
Intervention MeSH terms: Lafutidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: lafutidine tablet; pharmacokinetics; food; safety; healthy subjects
Are Dental Neglect and the Siblings Risk Factors in Children
Condition: Behavior, Child; Caries,Dental; Neglect, Child; Anxiety
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      Neglect insidiously affects a child's overall health in all aspects. The aim of this study
      was to determine whether the presence of siblings caused dental neglect, and whether there
      was a relationship between dental neglect and anxiety.
    

Detailed description: 
      Dental neglect is an intentional failure of parents or caregivers to take precautions and
      fulfil necessary dental treatment, and has a close relationship with dental caries and
      anxiety. Oral health status of the children was evaluated using the DMFT/dmft, PUFA/pufa, and
      OHI-S indices. In addition, the parents completed the Dental Neglect Scale (DNS) and a
      questionnaire, and the Modified Child Dental Anxiety Scale (MCDASf) was administered to the
      children to assess their dental anxiety.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        children who presented for the first time to the Faculty of Dentistry in Rize
      
Keywords: anxiety; siblings; dental caries; oral health; child abuse