bioihbjkbjnl/mcl2 huggingface dataset:
A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
Condition: Attention Deficit Disorder; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated the efficacy, safety, and tolerability of centanafadine
      sustained-release tablets in adults with ADHD. Participants either received a twice-daily
      dose of centanafadine sustained-release tablets, or twice-daily placebo.
    

Detailed description: 
      Screening & Washout Period: up to 28 days Investigational Treatment Period: 49 days Follow-up
      Period : 7 days or 10 days
    

Intervention name(s): Centanafadine SR; Placebo; Centanafadine SR
Intervention type(s): Drug; Other; Drug
Intervention description(s): 100 mg, BID, oral tablets; BID, oral tablet; 200 mg, BID, oral tablets
Other intervention name(s): EB-1020; EB-1020
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Centanafadine; ADD; ADHD
Breast Cancer Risk Biomarkers in Premenopausal Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to gather information on how the prescription drug Lovaza™ which
      contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer.
      This drug is currently approved by the FDA for reducing blood levels of triglycerides.
    

Detailed description: 
      The central hypothesis is that 6 months of administration of high dose omega-3 fatty acid
      esters [eicosapentaenoic acid (EPA) 1860 mg, and docosahexaenoic acid (DHA) 1500 mg] daily in
      the form of a standard prescription strength dose of Lovaza™ (two 1 gram capsules twice
      daily) will have a favorable side effect profile and potential efficacy as demonstrated by
      favorable modulation of one or more blood and breast tissue risk biomarkers for breast cancer
      in premenopausal women.
    

Intervention name(s): Lovaza™
Intervention type(s): Drug
Intervention description(s): 4 capsules daily for 6 months
Other intervention name(s): esters of EPA and DHA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Primary Efficacy Evaluation of Traditional Chinese Medicine in Treating Older Infertile Women
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a preliminary evaluation of the efficacy of traditional Chinese medicine in the
      treatment of elderly infertile women.
    

Detailed description: 
      Research design: initial acceptance of 60 people, 30 in the no intervention group and 30 in
      the experimental group.

      The no intervention group no use Traditional Chinese medicine. The experimental group use
      Traditional Chinese medicine. Affect natural pregnancy and IVF success factors, the quality
      of ovarian function plays a very important role. Currently used to predict ovarian follicle
      inventory indicators, including: age, the total number of small sized ovarian follicles, the
      first three days of menstrual follicle-stimulating hormone, Anti-Mullerian hormone,
      inhibin-B.

      Research Analysis Chang Gung Memorial Hospital infertility patients using traditional Chinese
      medicine, more than 40-year-old infertility patients, the most commonly used compound is Zuo
      Gui Wan. Chinese medicine believes that elderly women with infertility ovulation poor, the
      main pathogenesis of kidney deficiency. The proportion of domestic infertility patients has
      increased year by year. Traditional Chinese medicine had become popular and acceptable, but
      the substantial evidence and treatment consensus of infertility are scanty.

      Due to the outbreak of the new crown pneumonia epidemic, which made it difficult to accept
      the case. Only 17 subjects in the experimental group completed the test. The average age of
      the subjects was 40.11 ±3.09 years old, and 9 of them were over 40 years old. The AMH before
      the test was all below 1.2. After three months of treatment with traditional Chinese
      medicine, 16 subjects had an increase in the number of small sized ovarian follicles. The
      average total number of small ovarian follicles before the test was 3.06±0.90, and the
      average increased to 4.53±1.46 after treatment. (P<0.05), which was statistically
      significant. Eleven subjects showed a decrease in follicle-stimulating hormone on the third
      day of menstruation after treatment, 9 subjects showed an increase in anti-Mullerian hormone
      (AMH) value after treatment, and 3 subjects had anti-Mullerian hormone (AMH) values higher
      than 1.2 after treatment, but they did not reach statistical significance.
    

Intervention name(s): traditional Chinese medicine: tonifying kidney Wan
Intervention type(s): Drug
Intervention description(s): traditional Chinese medicine : tonifying kidney Wan
Other intervention name(s): tonifying kidney Wan I: Zuo Gui Wan; tonifying kidney Wan II :Guilu Erxian
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anti-Mullerian hormone (AMH); Traditional Chinese Medicine(TCM); Infertility
Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain
Condition: Postcraniotomy Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The efficacy of codeine is dependent on its demethylation to morphine. This extent of
      demethylation has wide inter-individual variability, making codeine's efficacy as a analgesic
      variable. Oxycodone is a semi-synthetic opioid and is a weak agonist on mu opioid receptors.

      Codeine has been the mainstay of analgesia for patients after craniotomy for many years.
      Traditionally, craniotomies were not thought to be very painful procedures, hence the use of
      codeine, a moderately potent opioid (when compared to morphine).

      However, in recent years, it has been found that up to 70% of post-craniotomy patients have
      moderate to severe pain and codeine did not provide adequate analgesic relief. Many studies
      have compared codeine to other drugs such as PCA morphine, fentanyl and tramadol, and
      patients on these stronger opioids generally had lower pain scores and better satisfaction.

      No study has been conducted to determine the efficacy of analgesia of oral oxycodone to oral
      codeine.

      Hence, the hypothesis is that oxycodone is more effective than codeine in providing pain
      relief in post-craniotomy patients.
    


Intervention name(s): Oxycodone; Codeine
Intervention type(s): Drug; Drug
Intervention description(s): Oral Oxycodone 5mg 6hrly/prn; Oral Codeine 60mg 6hrly/prn
Other intervention name(s): Oxynorm Immediate Release; Codeine Phosphate
Intervention MeSH terms: Oxycodone; Codeine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: analgesic efficacy; oral codeine; oral oxycodone; postcraniotomy
Use Modular Medical Equipment Vehicle in Mobilization of Patient With Chest Tube
Condition: Mobility Limitation; Sleep Quality; Pain; Comfort; Time of the Removal Chest Tube
MeSH terms: Mobility Limitation
Study type: Interventional

Summary: 
      in this study, it was aimed to examine the effect of the modular carrying system on the
      outcomes of care in the mobilization of patients with a chest tube. The population of the
      study consisted of patients followed in Yedikule Chest Diseases, and Thoracic Surgery
      Training and Research Hospital between October 2019 and January 2021, and the sample
      consisted of 83 patients who met the inclusion criteria. The study was performed with the
      intervention group (n=37) mobilized with the Modular medical equipment carrying vehicle and
      the control group (n=46) mobilized with the routine application.
    

Detailed description: 
      Within the scope of the study, a Modular medical equipment carrying vehicle was developed by
      the researchers to ensure the safe and comfortable mobilization of patients with chest tube
      and additional medical equipment. This vehicle has been designed to maintain the level of the
      chest tube during mobilization and to prevent it from tipping over.Patients in the
      intervention group were mobilized with the help of this Modular medical equipment carrying
      vehicle for 20 minutes at least 6 times a day. Patients in the control group were mobilized
      at least 6 times a day for 20 minutes with clinical routine practice.
    

Intervention name(s): mobilization with moduler medical equipment carring vehicle
Intervention type(s): Other
Intervention description(s): Mobilization of the patients was carried out with the vehicle in their modular vehicle.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventional study with posttest control group
Masking: Single (Participant)
Primary purpose: Other
Keywords: care outcomes; mobilization; chest tube
Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis
Condition: Acute Appendicitis
MeSH terms: Appendicitis; Acute Disease
Study type: Interventional

Summary: 
      Several recent studies have examined the feasibility and benefits of nonoperative treatment
      of perforated appendicitis in children. One such study showed a trend toward longer operative
      times for patients randomized to immediate appendectomy, but no overall advantage. In another
      larger study, the costs of delayed appendectomy for perforated appendicitis were higher - in
      part related to readmissions in the interval (6-8 weeks). Nevertheless, these and other
      studies have demonstrated the safety of delaying appendectomy for perforated appendicitis.

      Emergency appendectomy is a well-established approach, and postoperative recovery in children
      is fast. Nevertheless, from the onset of symptoms through the hospital stay and the
      postoperative recovery, appendicitis causes a disruption of a family's normal routine
      (absence from school and work) of up to 1-2 weeks. Because this is an unplanned operation,
      patients have to wait until an operating room becomes available, or elective operations have
      to be placed on hold to accommodate the emergency operation. Each year, more than 250
      children undergo an appendectomy at HCH. This represents 250 episodes of emergency surgery,
      or about one emergency add-on operation per working day. If an initial trial of antibiotics
      is safe for the treatment of appendicitis, converting an emergency operation into an
      elective, scheduled outpatient procedure may reduce stress and disruption of routine for
      patients and their families - and may allow better operating room planning for health care
      professionals and hospitals.

      The investigators hypothesize that initial antibiotic treatment of acute (non-perforated)
      appendicitis, followed by scheduled outpatient appendectomy, reduces the overall cost of
      treating the disease and results in greater patient and family satisfaction.

      This pilot study aims to establish the safety and feasibility of treating acute appendicitis
      with intravenous antibiotics, followed by outpatient oral antibiotics. Patients and their
      families will be offered the possibility of initial nonoperative treatment and subsequent
      outpatient elective appendectomy in a nonrandomized, single arm study.
    


Intervention name(s): Piperacillin + Amoxicillin
Intervention type(s): Drug
Other intervention name(s): Zosyn®; Augmentin®
Intervention MeSH terms: Amoxicillin; Piperacillin; Amoxicillin-Potassium Clavulanate Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: appendicitis
Correlation Between Cardiopulmonary Metabolic Cost and Lower Limb Muscle Activity
Condition: Gait
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effect of lower extremity muscle activity on
      the increase of cardiopulmonary metabolic cost during inclined treadmill gait in the elderly.
    

Detailed description: 
      The purpose of this study was to determine the effect of lower extremity muscle activity on
      the increase of cardiopulmonary metabolic cost during inclined treadmill gait in the elderly.

      Metabolic energy expenditure and muscle activity are measured simultaneously.
    

Intervention name(s): Inclined treadmill gait
Intervention type(s): Other
Intervention description(s): All subjects underwent measurements of muscle activity and respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Muscle activity; Cardiopulmonary metabolic cost
The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
Condition: Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine how medications thought to attenuate the effects of
      alcohol (naltrexone) and smoking cessation medications (varenicline) affect the ability to
      resist smoking and also subsequent ad-lib smoking, following a low-dose alcohol priming
      drink, in non-treatment seeking alcohol-drinking daily smokers.
    


Intervention name(s): naltrexone; varenicline; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).; 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).; placebo
Other intervention name(s): Chantix
Intervention MeSH terms: Naltrexone; Varenicline
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking lapse behavior; smoking cessation; varenicline; naltrexone; medication effect on smoking lapse behavior
Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for Injection
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics and safety of Antihemophilic
      factor, recombinant, manufactured protein-free (rAHF-PFM) reconstituted in 2 mL sterile water
      for injection (SWFI) and compare with those of rAHF-PFM reconstituted in 5 mL of SWFI.
    


Intervention name(s): Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM). (Antihemophilic factor is also known as Factor VIII)
Intervention type(s): Biological
Intervention description(s): Subjects are randomized to receive an infusion of rAHF-PFM reconstituted in 2 mL sterile water for infusion (SWFI) followed (after a wash-out period) by rAHF-PFM reconstituted in 5 mL SWFI or in 5 mL then 2 mL SWFI(cross-over design). Each subject will receive 2 infusions.
Other intervention name(s): ADVATE
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Ex Vivo Transformation of White Adipose Tissue (WAT) Into Brown Adipose Tissue (BAT) in Morbidly Obese Patients Using the Ex Vivo Adipocyte Expansion (ExAdEx) Approach: Proof of Concept. From White to Brown Adipose Tissue
Condition: Obesity
Study type: Interventional

Summary: 
      Obesity and metabolic associated diseases such as type 2 diabetes, NASH, cardiovascular
      diseases, are the dysregulation of energy homeostasis associated with an imbalance between
      different types of adipose tissues (ATs). White AT (WAT) which stores energy and functions as
      a fat storage depot, is fibrotic whith chronic inflammation and is found in excess. On the
      other hand, brown and beige ATs (BATs), considered as the good ATs because they regulate
      energy expenditure, are almost undetectable in individuals with obesity. In addition, BAT and
      WAT produce different hormones that are involved in the control of energy homeostasis via
      central and peripheral actions. A promising emerging therapeutic approach is to restore BAT
      in patients with severe obesity in two ways, i) by stimulating BAT in individuals with
      obesity by pharmacological treatment, ii) by injecting BAT into individuals with obesity
      using a cell-based therapy approach. However, the development of these two proposals is
      limited both by the lack of in vitro preclinical BAT models relevant for the screening and
      validation stages of drug candidates, and by the lack of physiologically functional BAT
      compatible with tissue graft. The bottleneck is the absence of an unlimited source of human
      BAT.

      The ExAdEX technology makes possible in vitro to turn WAT derived from lean donors into BAT.
      This new technology offers the possibility of having in vitro predictive human 3D models
      suitable for the identification and characterization of compounds affecting AT biology, and
      paves the way for the production of BAT for cell-based therapy of obesity and associated
      metabolic diseases.

      The Primary objective of the study is addressed the effectiveness of the ExAdEx process to
      induce, ex vivo, the conversion of WAT from obese patients into TAB. The secondary objectives
      are 1) to compare the efficacy for conversion into BAT when WAT derived from either from
      visceral or from subcutaneous AT; 2) to investigate the capacity of the ExAdEX-BAT to produce
      the FGF21 and adiponectin batokines and to respond to insulin.
    


Intervention name(s): Sampling
Intervention type(s): Other
Intervention description(s): During thier bariatric surgery, samples of adipose tissue will be done
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo
Condition: Seizure Disorder; Hypogonadism; Erectile Dysfunction
MeSH terms: Epilepsy; Seizures; Erectile Dysfunction; Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if treatment using a medication
      (anastrozole/Arimidex), which lowers estrogen levels in the blood is better than placebo, a
      tablet that does not contain any active medication, when combined with testosterone
      replacement to treat reproductive and sexual dysfunction in men with epilepsy. Anastrozole,
      the medication that is currently under study, does not, at this time, have FDA approval for
      use for this indication.
    

Detailed description: 
      This is a three-month study where baseline information is collected at the first visit and
      then each patient is started on treatment with testosterone supplementation and either
      anastrozole or placebo. Lab tests, seizure frequency, sexual function and mood will be
      monitored on a monthly basis.
    

Intervention name(s): Anastrozole 1mg; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Other intervention name(s): Arimidex
Intervention MeSH terms: Anastrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Seizure; Epilepsy; Testosterone; Hormone; Sexual Dysfunction; Hypogonadism; Men
Radiation Therapy and Docetaxel With Either Fluorouracil or Cisplatin as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
      chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet
      known whether radiation therapy, docetaxel, and fluorouracil are more effective than
      radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic
      cancer.

      PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and
      fluorouracil to see how well they work as first-line therapy compared to radiation therapy,
      docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot
      be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the 6-month progression-free survival rate in patients with unresectable
           metastatic adenocarcinoma of the pancreas treated with radiotherapy and docetaxel in
           combination with either fluorouracil or cisplatin as first-line therapy.

      Secondary

        -  Compare the toxicity of these regimens in these patients.

        -  Compare the objective response rate in patients treated with these regimens.

        -  Compare overall survival of patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
      arms.

        -  Arm I: Patients undergo radiotherapy to the celiac area once daily 5 days a week for 6
           weeks. Patients also receive docetaxel IV weekly and fluorouracil IV daily for 6 weeks.

        -  Arm II: Patients undergo radiotherapy and receive docetaxel as in arm I. Patients also
           receive cisplatin IV weekly for 6 weeks.

      In both arms, patients experiencing disease progression after completion of chemoradiotherapy
      may receive additional courses of chemotherapy.

      PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this
      study within 3 years.
    

Intervention name(s): cisplatin; docetaxel; fluorouracil; radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention MeSH terms: Docetaxel; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the pancreas; stage IV pancreatic cancer