bioihbjkbjnl/mcl2 huggingface dataset:
COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation (COOL-COS) Associated With Corifollitropin Alfa: a Pilot Study
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled
      ovarian stimulation using clomiphene citrate, letrozole, and Corifollitropin Alfa on the
      number of oocytes retrieved.
    


Intervention name(s): COOL-COS
Intervention type(s): Drug
Intervention description(s): Controlled ovarian stimulation will start on the second or third day of a menstrual cycle: Oral clomiphene citrate: 100 mg/day until the day of the triggering. Oral letrozole: 7.5 mg/day during the first 5 days of the controlled ovarian stimulation.
Corifollitropin Alfa: 100 mcg on the 3rd day of the controlled ovarian stimulation.
The triggering will be performed using leuprorelin 1 mg (subcutaneous).
Other intervention name(s): Friendly COS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Dose-response Study of Dietary Resveratrol on Lipid Metabolism Disorder
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      In order to study the effect of resveratrol on the improvement of lipid and uric acid
      metabolism, randomized intervention trials were conducted to compare the effects of
      resveratrol on the improvement of lipid and uric acid metabolism in different dose groups. To
      explore the best dose of resveratrol for the prevention and treatment of metabolic diseases
      provide an important scientific basis.
    

Detailed description: 
      In order to study the effect of resveratrol on the improvement of lipid and uric acid
      metabolism, randomized controlled trials were conducted to enrolled 160 patients with
      dyslipidemia. The subjects were divided into 0 mg / d, 100 mg / d, 300 mg / d, 600 mg/ d four
      dose groups, intervention for 8 weeks, comparing different doses of resveratrol on lipid and
      uric acid metabolism. To explore the best dose of resveratrol for the prevention and
      treatment of metabolic diseases provide an important scientific basis.
    

Intervention name(s): Mega Resveratrol® capsules; Mega Resveratrol® Placebo capsules
Intervention type(s): Drug; Drug
Intervention description(s): Subjects were orally administered Mega Resveratrol® capsules daily for 8 weeks.; Mega Resveratrol® Placebo capsules
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe
      and advanced ankylosing spondylitis.
    


Intervention name(s): Etanercept (Enbrel); Placebo
Intervention type(s): Drug; Other
Intervention description(s): 50 mg injection once weekly; placebo
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Axial Ankylosing Spondylitis; Adult
Visceral Lymphatic Mapping Using Isosulfan Blue in Patients With Cancer of the Pancreas, Colon, Stomach, Small Intestine, or Gallbladder
Condition: Colorectal Cancer; Gallbladder Cancer; Gastric Cancer; Pancreatic Cancer; Small Intestine Cancer
MeSH terms: Pancreatic Neoplasms; Stomach Neoplasms; Gallbladder Neoplasms; Intestinal Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Diagnostic procedures, such as visceral lymphatic mapping using isosulfan blue,
      may help find cancer of the pancreas, colon, stomach, small intestine, or gallbladder and
      find out how far the disease has spread.

      PURPOSE: This clinical trial is studying the side effects and how well visceral lymphatic
      mapping using isosulfan blue works in patients with cancer of the pancreas, colon, stomach,
      small intestine, or gallbladder.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the safety and feasibility of visceral lymphatic mapping using isosulfan blue
           in patients with adenocarcinoma of the pancreas, colon, stomach, small bowel, or
           gallbladder.

        -  Evaluate the ability of surgically defined sentinel lymph nodes to predict whether other
           lymph nodes in the basin are involved with the tumor in these patients.

      Secondary

        -  Compare the results obtained from the sentinel lymph node (i.e., positive or negative
           for metastatic disease) with the results obtained from the other nodes in these
           patients.

        -  Compare immunohistochemical analysis with standard analysis of the sentinel lymph nodes
           in these patients.

        -  Evaluate the value of intraoperative touch prep analysis of sentinel lymph nodes in
           these patients.

      OUTLINE: This is a pilot study.

      During surgical resection of the primary tumor, patients receive isosulfan blue
      subcutaneously 5 minutes before undergoing sentinel lymph node identification/excision and
      radical lymphadenectomy. Tissue samples are analyzed by IHC for cytokeratins and CEA.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with gastrointestinal cancer
      
Keywords: adenocarcinoma of the gallbladder; stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer; stage I colon cancer; stage II colon cancer; stage III colon cancer; stage IV colon cancer; stage I gastric cancer; stage II gastric cancer; stage III gastric cancer; stage IV gastric cancer; localized gallbladder cancer; small intestine adenocarcinoma; adenocarcinoma of the colon; adenocarcinoma of the pancreas; adenocarcinoma of the stomach
A Study of TY-9591 in Advanced Non-small Cell Lung Cancer(NSCLC) Patients With EGFR Positive Mutation
Condition: NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of TY-9591,
      with dose-escalation stage and dose-expansion stage.
    

Detailed description: 
      -  To define the maximum tolerated dose(MTD) and the recommended phase 2 dose (RP2D)

        -  To investigate the pharmacokinetic profile of TY-9591 and its metabolites after single
           then multiple doses of TY-9591 administered orally once daily

        -  To evaluate the anti-cancer activity of TY-9591 in NSCLC patients with EGFR
           mutation(ORR、PFS、DoR、DCR、and CBR)
    

Intervention name(s): TY-9591(10mg,40mg) qd. po
Intervention type(s): Drug
Intervention description(s): Increased dose cohorts from low dose to MTD(20mg Cohort1, 40mg Cohort2, 80mg Cohort3,120mg Cohort4, 160mg Cohort5, 200mg Cohort6)
Other intervention name(s): TY-9591
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of a Supplement Containing Fucoidan on Basal Body Temperature
Condition: Low Basal Body Temperature
Study type: Interventional

Summary: 
      We aim to determine whether a supplement containing fucoidan isolated from Mekabu (sporophyll
      of Undaria pinnatifida), EPA, and DHA has effects of elevating basal body temperature in
      subjects with low basal body temperature.
    


Intervention name(s): Supplement containing fucoidan, EPA, and DHA; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 75 mg fucoidan per day, for 8 weeks; for 8 weeks
Intervention MeSH terms: Fucoidan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
EMERALD: Effects of Metformin on Cardiovascular Function in Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      Diabetes is increasingly common among youth, forecasting early complications. Type 1 (T1D)
      cause early heart disease, shortening lifespan despite modern improvements in control of
      blood sugars and other risk factors for heart disease. Poor insulin action, otherwise known
      as insulin resistance (IR), is the main factor causing heart disease in type 2 diabetes
      (T2D), but the cause of increased heart disease in T1D is unclear. IR may contribute to heart
      disease in T1D as in T2D, as the investigators and others have found the presence of IR in
      T1D. Much less is known about IR in T1D, but a better understanding of its role in T1D is
      critical to understanding causes of heart disease in T1D. The investigators long-term goal is
      to understand the early causes of heart disease in diabetes so that we can prevent it. The
      investigators unique initial findings suggest that even reasonably well-controlled, normal
      weight, T1D youth are IR. The IR appears directly related to the heart, blood vessel, and
      exercise defects, but in a pattern that appears very different from T2D. The goals of this
      study are to determine the unique heart, blood vessel and insulin sensitivity abnormalities
      in T1D youth, and determine whether metformin improves these abnormalities. A clear
      understanding of these factors will help determine the causes, and what treatments could help
      each abnormality.

      Hypothesis 1: Metformin will improve insulin function and mitochondrial function in T1D.

      Hypothesis 2: Metformin will improve vascular and cardiac function in T1D.

      All measures will be performed twice, before and after a 3-month randomized,
      placebo-controlled design where subjects are randomized to either metformin or placebo. The
      independent impact of insulin action as well as glucose levels, BMI, T1D duration, and gender
      on baseline outcomes and the impact of changes in insulin action, glucose levels and BMI on
      response to metformin will also be examined to help customize future strategies to prevent
      heart disease in T1D. This study will advance the field by providing new information about
      the role of poor insulin action in the heart disease of T1D, and whether improving insulin
      action in T1D is helpful. If a focus on directly improving insulin action in T1D youth is
      supported by our studies, the clinical approach to T1D management may significantly change.
    


Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescent; Youth; Diabetes; Insulin Resistance; Cardiovascular; Metformin
The Effect High Velocity Low Amplitude Hip Mobilization on Strength in Subjects With Lower Extremity Pathology
Condition: Hip Joint; Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      Introduction: Lower extremity weakness associated with musculoskeletal pathology can cause
      activity limitations. Physical therapy intervention in the form of exercise is commonly
      directed at improving muscular performance, however, neuromuscular adaptations may limit the
      effectiveness of traditional strengthening exercises. Manual therapy techniques have been
      used as a disinhibitory intervention to increase muscle activation and strength before
      participating in strengthening exercises or performing functional tasks While there is recent
      evidence to support joint mobilization as a valuable manual therapy disinhibitory
      intervention Currently, there is no evidence to substantiate anecdotal experience that a
      HVLAT hip distraction mobilization improves muscle performance in subjects with lower
      extremity pathology and lower extremity weakness. The purpose of this study was to determine
      if a HVLAT hip distraction mobilization would result in an immediate change of maximal force
      output of the quadriceps, gluteus maximus and gluteus medius.

      Methods: Forty individuals with a lower extremity pathology volunteered for this study.
      Inclusion criteria were having a unilateral musculoskeletal pathology, being greater than 18
      years of age, 10% decrease in muscle strength in symptomatic side compared to healthy side,
      and absence of medical precautions that would prevent a maximal effort strength test and
      exclusion criteria included individuals with a history lower extremity recent muscle or
      tendon ruptures (within the past 6 months) and postoperative knee, hip and ankle surgery.
      Demographic data, including diagnosis from referring physician were collected. All subjects
      completed the Lower extremity function scale (LEFS). A single evaluator blinded to the
      involved extremity was responsible for quadriceps, gluteus medius and maximus strength
      analysis pre and post mobilization of both symptomatic and non-symptomatic sides. The subject
      underwent the HVLAT hip distraction mobilization of the symptomatic side, and an immediate
      re-assessment of strength of both symptomatic and non-symptomatic sides followed the
      mobilization.
    


Intervention name(s): Hip mobilization; Hip manipulation simulation
Intervention type(s): Other; Other
Intervention description(s): High velocity low amplitude hip mobilization of the experimental group; Hip manipulation simulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Intrabronchial Airway Pressures in Intubated Patients During Bronchoscopy
Condition: Acute Respiratory Distress Syndrome; Acute Lung Injury (ALI)
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
Study type: Observational

Summary: 
      The purpose of this study is to examine changes in ventilation and airway pressures during
      conventional bronchoscopy of intubated patients.
    

Detailed description: 
      Mechanically ventilated patients often need bronchoscopy as a diagnostic procedure or for
      visually directed elimination of secretions. Partial endotracheal tube occlusion by the
      bronchoscope increases airflow resistance. Inhibition of inspiratory flow may be compensated
      for by augmented inspiratory pressure. Reduced expiratory flow however, cannot be compensated
      for by most ventilators and could lead to higher airway - and intrathoracic pressures that
      are not detected by pressure transducers in the ventilator tubing. In this study we compare
      changes in ventilation, airway pressures, ventilator pressures and blood gases during
      bronchoscopy of intubated patients in both volume controlled and pressure controlled
      ventilation. Our hypothesis are that 1) increased resistance in the tube during bronchoscopy
      leads to high intrabronchial airway pressures when the ventilator is in volume controlled
      mode, and 2) when the ventilator is in pressure controlled mode, increased resistance in the
      tube during bronchoscopy leads to reduced Tidal Volume and moderately increased paCO2.
    

Intervention name(s): Bronchoscopy
Intervention type(s): Other
Intervention description(s): Airway pressures, ventilation changes and blood gas changes are recorded in a group of intubated patients on mechanical ventilation before and after bronchoscope insertion. The registration is done immediately before a therapeutic/diagnostic bronchoscopy requested by a staff physician not involved n the study.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ARDS/ALI patients on mechanical ventilation where a therapeutic or diagnostic bronchoscopy
        has been requested by the staff physician.
      
Biospecimen description: 
      Arterial blood gases
Assessment of the Relative Increase in Bioavailability of (Non-) Nutrients From a Mixed Salad by Adding Fat Containing Dressing
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The hypothesis will be tested that fat can also increase absorption of (non)-nutrients from a
      salad. Therefore we designed the current study to show an increase in relative absorption
      (bioavailability) of (non-) nutrients from a mixed salad by adding fat containing dressing.
    


Intervention name(s): Test product: Salad with a high dosage fat; Control product: Salad with low dosage fat
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
A Study of Zomacton in Children With Growth Hormone Deficiency
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone
      deficiency in children. The children will be treated for 1 year. Half of the patients will be
      treated with Genotropin and half with Zomacton. During this time they will be dosed every day
      by themselves or their parents at home in the evening. There will be 138 patients in the
      trial from age 3 to age 11. The patients cannot have been treated before with growth hormone
      and the patients must have a proven growth hormone deficiency, this will be shown by a
      specific test that will be performed before the trial in the local clinic and once during the
      trial. During the time of the treatment the patients will come to visit the clinic every 3
      months. At these visits their heights will be measured, blood samples will be taken, physical
      examinations will be performed and questions about their health will be asked. At 2 times in
      the trial they will have a hand x-ray taken to measure the bone age. At the end of the trial
      the patients will stop the treatment and continue on one of the marketed products available
      to treat growth hormone deficiency.
    


Intervention name(s): Genotropin; Zomacton
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase III Clinical Study of KW-2246 for Breakthrough Pain in Cancer Patients
Condition: Pain, Cancer
MeSH terms: Breakthrough Pain; Cancer Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to determine whether KW-2246 is superior to placebo and not inferior
      to immediate-release morphine for the relief of breakthrough pain in cancer patients.
    


Intervention name(s): Placebo; KW-2246 (fentanyl citrate)
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; KW-2246 (fentanyl citrate)
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pain, cancer
The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women
Condition: Obesity; Metabolic Syndrome
MeSH terms: Overweight; Metabolic Syndrome
Study type: Interventional

Summary: 
      The benefits of weight-loss programs on mood state and cognitive and motor behavior remain
      unclear and are largely limited to those of calorie restriction (CR) or physical exercise
      alone. Our aim was to investigate the effect of a combined CR and aerobic exercise program on
      mood state, cognition-related brain activity, and cognitive and motor behavior in overweight
      and obese women. Twenty-six overweight or obese women were randomized to either a control
      group (no intervention) or an experimental group (aerobic exercise + 12.5% energy-intake
      reduction). Brain-derived neurotrophic factor (BDNF) levels, mood, prefrontal cortex
      activity, cognitive performance, and learning of a speed-accuracy task were evaluated before
      and 6 months after the beginning of the program. Confusion and depression increased in the
      control group (P < 0.05), whereas tension decreased in the experimental group (P < 0.05).
      BDNF level and learning of a speed-accuracy task remained unchanged. Although PFC activity
      and executive functions were not affected, the reaction time of visual scanning and
      associative learning were improved in the experimental group (P < 0.05). An improvement in
      reaction time during the speed-accuracy task was observed (P < 0.05). In conclusion, a
      6-month combined CR and aerobic exercise intervention improved the psychosocial mental state
      of overweight and obese women. Although it improved motor planning during the speed-accuracy
      task, it had little impact on cognition and no effect on brain activity and learning of the
      speed-accuracy task.
    


Intervention name(s): aerobic exercise plus calorie restriction
Intervention type(s): Procedure
Intervention description(s): both a 6-month aerobic exercise program (moderate intensity) and caloric restriction (12.5% energy deficit)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: brain activity; cognitive function; diet; exercise; motor behavior; psychosocial state