bioihbjkbjnl/mcl2 huggingface dataset:
Berberine on the Secretion of Incretin
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Berberine (BBR) is the main active ingredient of the ancient Chinese herb medicine Coptis.
      The hypoglycemic effect of BBR has been demonstrated in numerous studies. Although BBR is
      safe and effective in the treatment of diabetes, its exact hypoglycemic mechanism is still
      unclear. Jin-Kui Yang found that BBR can promote GLP-1 secretion from intestinal L cells in
      mice in vitro and in vivo, thereby achieving the effect of lowering blood glucose, but it is
      still unknown whether BBR can promote incretin secretion in humans. In this study,
      investigators plan to examine the effect of BBR on secretion of incretin in human.
    


Intervention name(s): Berberine Chloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Traditional Chinese medicine; Placebo control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Osteoporosis in Children With ALL
Condition: Leukemia, Lymphocytic, Acute, L1
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Osteoporosis
Study type: Observational

Summary: 
      Hypothesis:

      Pediatric patients with acute lymphoblastic leukemia, treated with chronic glucocorticoids as
      a part of the leukemia treatment protocol, will have an increased incidence and severity of
      osteoporosis.
    

Detailed description: 
      Osteoporosis is a disease characterized by low bone mass and microarchitectural deterioration
      of bone tissue. Osteoporosis is a devastating disorder with significant physical,
      psychosocial and financial consequences. Intensive chemotherapy and radiotherapy have led to
      significant improvements in long term, disease-free survival of children with malignancies.
      Unfortunately, there are many deleterious side effects associated with this therapy. Little
      is known about the longitudinal changes in bone mass accumulation and bone metabolism in
      these patients.

      The purpose of this study is to evaluate the timing and severity of changes in bone mineral
      metabolism for children treated for childhood leukemia. Data will be used to establish
      treatment protocols with the goal of preventing severe fractures and pain in the acute
      treatment stage and severe osteoporosis and related pathology in the chronic stage.
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: Osteoporosis; Childhood acute lymphoblastic leukemia
Computational Cognitive Training To Boost Reward Responsiveness In Anhedonic Patients
Condition: Anhedonia; Depression
MeSH terms: Anhedonia
Study type: Interventional

Summary: 
      Anhedonia, i.e., reduced positive mood and decreased sensitivity to rewards, is observed in
      many psychiatric illnesses, particularly depression and anxiety disorders. Untreated
      anhedonia predicts worse clinical outcomes and poorer response to treatment, yet cognitive
      behavioral treatment approaches to target anhedonia are fraught with poor patient compliance
      in real-life settings. The proposed study aims to address this gap by 1) testing the
      usefulness of a non-invasive, computationally informed, cognitive training in boosting reward
      sensitivity and reducing anhedonia in depressed and anxious patients, and 2) delineating the
      neurocomputational mechanisms of change associated with such intervention. In other words,
      can we train the brain to obtain rewards and boost positive mood among depressed and anxious
      individuals? This project will help to develop a computational training protocol aimed at
      reducing anhedonia and improving existing interventions for psychiatric conditions
      characterized by reward processing deficits. Long-term goals include expanding this framework
      to a broader range of appetitive and social stimuli to develop precise cognitive training
      tools to treat anhedonia.
    


Intervention name(s): High Reward - High Variance; High Reward - Low Variance
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Computerized reward learning task designed to increase reward responsiveness; Computerized reward learning task designed to have minimal effect on reward responsiveness
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Fasted Exercise in People With Type 1 Diabetes
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study aims to compare the effect of a bout of high-intensity interval training (HIT)
      with a bout of moderate-intensity continuous training (MICT) on glucose concentrations over
      the subsequent 24h period.
    

Detailed description: 
      This study aims to compare the effect of a bout of high-intensity interval training (HIT)
      with a bout of moderate-intensity continuous training (MICT) on glucose concentrations over
      the subsequent 24h period. Fourteen people with type 1 diabetes (duration of type 1 diabetes
      8.2±1.4 years), all on basal-bolus regimen, completed a randomised, counterbalanced,
      crossover study. Continuous glucose monitoring was used to assess glycaemic control following
      a single bout of HIT (6 x 1min intervals) and 30 mins of moderate-intensity continuous
      training (MICT) on separate days, compared to a non-exercise control day (CON). Exercise was
      undertaken following an overnight fast with omission of short-acting insulin. Capillary blood
      glucose samples were recorded pre and post-exercise to assess the acute changes in glycaemia
      during HIT and MICT.
    

Intervention name(s): Effects of the type of exercise on blood glucose concentrations
Intervention type(s): Behavioral
Intervention description(s): glucose concentrations were assessed over the 24 hour periods following no exercise, a single bout of high intensity interval training and a single bout of moderate intensity continuous training
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour
Condition: Pregnancy; Induced Labor
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the blood loss in induced vaginal delivery by
      misoprostol and caesarians section with induction attempt.
    

Detailed description: 
      Methods: it was a study achieved with 101 pregnant women with indication to induced delivery
      labor that were evaluated by the hemoglobin dosage pre and post delivery for estimate the
      blood loss at delivery. Patients were submitted to transabdominal obstetric ultrasound and
      basal cardiotocography. Procedures were taken for induced labor delivery with misoprostol
      25mcg, by vaginal rout. The pills were administered each 6 hours in a maximum number of six.
      The control group was formed by 30 patients that began an spontaneously labor and 30 patients
      that achieved caesarians electively. The study of hemoglobin before and after delivery was
      evaluated through ANOVA to repeated measures, where it was verified the time effect (pre and
      post delivery) and the effect of the group (with and without use of misoprostol).
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): Procedures were taken for induced labor delivery with misoprostol 25mcg, by vaginal rout. The pills were administered each 6 hours in a maximum number of six.
Other intervention name(s): Citotec
Intervention MeSH terms: Misoprostol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Induced labor; Misoprostol; Postpartum blood; Erythrocyte indices; Vaginal delivery
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating
      acute pain after a bunionectomy.
    


Intervention name(s): VX-548; HB/APAP; Placebo (matched to VX-548); Placebo (matched to HB/APAP)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets for oral administration.; Capsules for oral administration.; Placebo matched to VX-548 for oral administration.; Placebo matched to HB/APAP for oral administration.
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants.
Condition: Malocclusion, Angle Class II
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      The study aimed to evaluate the influence of a 635nm diode laser on the stability of
      orthodontic mini-implants in vitro, as well as mini-implants failure rate (mini-implant loss)
      and patients pain level after the treatment. A randomized clinical split-mouth trial was
      concluded with 22 subjects (14 women, 8 men), 44 orthodontic mini-implants with a diameter
      1.4mm and length of 10mm. Mini-implants were placed between teeth 3 and 4; and 13 and 14
      (Universal Numbering System), in the area of the attached gingiva, 2 mm below mucogingival
      junction.
    


Intervention name(s): Irradiation of implants with 808nm laser
Intervention type(s): Procedure
Intervention description(s): Irradiation of implants with 808nm laser
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Acellular Dermal Matrix Graft In Root Coverage of Gingival Recessions With Previously Restored Cervical Lesions
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      Patients with high standards of oral hygiene frequently search for buccal gingival recession
      (GR) treatment due to cervical wear, root sensitivity and compromising aesthetics. The
      cervical lesion (NCCL) is commonly produced by improper toothbrushing techniques, sharing the
      same etiology of GR. Many different surgical approaches have been described. The association
      of a graft to the coronally advanced flap had demonstrated the best long-term outcome for
      root coverage. But, substitutes for the autogenous graft must be studied. Therefore, the aim
      of this clinical trial was to investigate the effectiveness of the acellular dermal matrix
      graft (ADMG) in root coverage associated with a previous restored cervical lesion or not.

      Material and methods: Seventeen individuals with bilateral GR were included in the study. At
      one side, the GR must present a previously restored cervical lesion, as the test group (TG).
      The contralateral arch, must present GR with an intact root surface (CG). All patients were
      treated with the extended flap technique associated with the ADMG. All clinical parameters
      were assessed at baseline and 6-months postoperative.
    


Intervention name(s): Root coverage with extended flap technique and acelular dermal matrix
Intervention type(s): Procedure
Intervention description(s): At one side, the root coverage have been done with a extended flap technique and acellular dermal matrix and there was no cervical lesion. At the other side, the same technique was performed, but the gingival recession was associated with a noncarious cervical lesion.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Controlled Split-mouth clinical trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acellular dermal matrix graft; Clinical Trial; Root coverage; Noncarious cervical lesion
Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis
Condition: Knee Osteoarthritis; Pes Anserine Bursitis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Bursitis
Study type: Interventional

Summary: 
      A randomized control trial will be conducted at the outpatient department of Dow Institute of
      Physical Medicine and Rehabilitation. A sample size of 80 is calculated using PASS version 11
      software. The subjects will be first screened and those who fulfill the inclusion criteria,
      will be asked to fill the consent form. After selection, the participants will be randomly
      allocated by the help of computer generated randomization sheet, into two groups i.e.
      experimental and the control group. The group A will be provided with the myofascial release
      along with the neuromuscular training whereas the group B will only receive the neuromuscular
      training. Cold pack will be applied to both the groups. The neuromuscular training consists
      of warm-up phase, lunges, sideways exercises, wall squats, weight transfer exercises, step up
      and down and the cool down phase. Total 12 sessions of 35 minutes each will be given to all
      the participants for about 4 weeks on alternate days. Outcome measures will be analyzed by
      visual analogue scale (VAS) for pain assessment, goniometry for range of motion and the Knee
      injury and Osteoarthritis Outcome Score (KOOS) to evaluate the functional assessment of the
      patients at the baseline and the post intervention.
    


Intervention name(s): Myofascial release; Neuromuscular exercises; Cold pack
Intervention type(s): Other; Other; Other
Intervention description(s): It is a type of physical therapy often used to treat myofascial pain syndrome with pressure.; Exercises commonly utilized in neuromuscular training programs to improve strength, balance , speed and agility. It will comprised of Warm-up, Lunges, Sideways exercises, Wall squats, Weight transfer exercise, Step up & down, Cool-down; Application of cold pack around the patient's body, and covered with dry towel
Other intervention name(s): Cold pack therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Weight Management for Improved Pregnancy Outcomes
Condition: Obesity; Pregnancy
Study type: Interventional

Summary: 
      This study will examine the safety and effectiveness of a dietary intervention in pregnant
      women. Women who are obese will be invited to participate. The control arm will receive
      routine prenatal care and one in-person nutritional and dietary counseling session to promote
      healthy eating during their pregnancy. The intervention arm will receive a more intensive
      dietary program that will include in-person counseling and group support sessions. The goal
      of the intervention will be weight maintenance (weight at 2 weeks after delivery should be
      within 3% of baseline weight) and avoidance of postpartum weight retention
    


Intervention name(s): Weight Management; Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy; Standard nutrition counseling from Health Plan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: obese; pregnant; large for gestational age; large for gestational age baby
Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with
      glioblastoma multiforme.
    


Intervention name(s): ABT-414; Temozolomide; Whole Brain Radiation
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): ABT-414 will be administered by intravenous infusion; Temozolomide will be administered per label and local prescribing regulations.; Whole Brain radiation will be administered in 30 fractions.
Other intervention name(s): Depatuxizumab Mafodotin
Intervention MeSH terms: Temozolomide; ABT-414
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GBM
Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      24 week open-labeled extension study to continue monitoring the same group of patients in the
      previous MRA230TW phase IIIb trial in order to evaluate the long term efficacy and safety of
      tocilizumab.
    


Intervention name(s): Tocilizumab+Methotrexate(MTX)
Intervention type(s): Drug
Intervention description(s): Tocilizumab: 8 mg/kg every 4 weeks, IV infusion Methotrexate: 10-20 mg/week
Intervention MeSH terms: Methotrexate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RA
Timing of Meals for Weight Loss
Condition: Overweight; Obesity; Weight Loss
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      While eating the majority of energy earlier in the day appears to have a positive effect on
      weight and cardiometabolic outcomes, it is not clear how eating earlier in the day influences
      other behaviors that have a circadian rhythm (sleep), other energy balance behaviors
      important for weight loss (physical activity), and self-reported feelings of appetite control
      (hunger and fullness). Thus the purpose of this study is to examine the influence of timing
      of eating on sleep patterns, physical activity, and self-reported feelings of appetite
      control. It is hypothesized that those who eat the majority of their calories earlier in the
      day will have greater weight loss than those who eat the majority later in the day.
    

Detailed description: 
      Thirty adults will be provided an 8-week standard lifestyle intervention, that includes a
      1200-1500 kcal/day, < 30% energy from fat dietary prescription, and a physical activity goal
      of 200 minutes/week. Participants will be randomized to one of two conditions differing in
      timing of energy consumed during eating bouts. Both conditions will limit the number of
      eating bouts/day to three. Participants will be instructed to eat their first eating bout
      within one hour of awakening and to consume their second and third eating bouts within five
      or six hours of their previous bout. Participants will be discouraged from eating at least
      one hour prior to going to sleep. During the intervention, participants will be instructed to
      self-monitor the time they wake up, the time of the start of each eating bout, and time they
      go to bed, as well as foods and beverages, and portion sizes, consumed. One condition will
      consume more energy earlier in the day (MORNING), thus energy intake will be split amongst
      the three eating bouts with 50% in the first bout, 30% in the second bout, and 20% in the
      last bout. The second condition will consume more energy later in the day (EVENING), thus
      energy intake will be split amongst the three eating bouts with 20% in the first bout, 30% in
      the second bout, and 50% in the last bout.
    

Intervention name(s): Eat majority of calories in the morning; Eat the majority of calories in the evening
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Meal Time; Weight Loss; Circadian Rhythm
PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label, proof of concept (PoC) study of Cenicriviroc (CVC) in adult
      participants with Primary Sclerosing Cholangitis (PSC). The main objective of this PoC study
      is to assess changes in alkaline phosphatase (ALP) both individually and as a group, over 24
      weeks of treatment with CVC.
    


Intervention name(s): Cenicriviroc 150 mg
Intervention type(s): Drug
Intervention description(s): One tablet of CVC 150 mg once daily taken with food in the morning.
Other intervention name(s): CVC 150 mg
Intervention MeSH terms: Cenicriviroc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary Sclerosing Cholangitis
Analgesic Effectiveness of Three Different Doses of a New Formulation of Lamaline in a Model of Painful Knee (Gonarthrosis)
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to assess the analgesic effectiveness and safety of three different doses of
      a new formulation of Lamaline® versus Dafalgan® Codeine after 10 days administration in
      subjects with painful gonarthrosis
    


Intervention name(s): Lamaline® , 3 different doses, Dafalgan codeine
Intervention type(s): Drug
Intervention MeSH terms: Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: osteoarthritis, pain
Double-blind Clinical Trials of Probiotic Products in Oral Health.
Condition: Probiotics; Oral Health; Probiotic Metabolites
Study type: Interventional

Summary: 
      In order to evaluate the effects of supplementary probiotics and their metabolites on oral
      environment and oral microbiota, Taiwan FDA No. 88037803 will be used to evaluate the effects
      of oral probiotic candidate strains from previous research results and develop oral probiotic
      products.
    


Intervention name(s): Combined probiotics (1); Combined probiotics (2); Combined heat-killed probiotics (1); Combined heat-killed probiotics (2); Probiotic metabolites; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects used one oral combined probiotics (1) tablet each morning, noon, and evening for 4 weeks.; Subjects used one oral combined probiotics (2) tablet each morning, noon, and evening for 4 weeks.; Subjects used one oral combined heat-killed probiotics (1) tablet each morning, noon, and evening for 4 weeks.; Subjects used one oral combined heat-killed probiotics (2) tablet each morning, noon, and evening for 4 weeks.; Subjects used one oral probiotic metabolites tablet each morning, noon, and evening for 4 weeks.; Subjects used one oral placebo tablet each morning, noon, and evening for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention