bioihbjkbjnl/mcl2 huggingface dataset:
Survival Study of Docetaxel and Carboplatin as Neo-Adjuvant Vs Adjuvant Chemotherapy in Early Stage NSLC
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the trial is to determine whether 3 cycles of TP (docetaxel plus cisplatin)
      after complete operation will improve survival when compared with 3 cycles of TP prior to
      complete resection for NSCLC.
    

Detailed description: 
      Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of lung cancers diagnosed
      worldwide. Surgical resection offers the best chance for cure for those patients diagnosed
      with early-stage disease, however, the vast majority of patients experience eventually
      relapse or metastasis. The rationale of neoadjuvant or adjuvant chemotherapy for early stage
      NSCLC lies in the possibility of eradicating micro-metastasis disease, so it appears to
      improve survival by reducing the occurrence of distant metastases. Meta analysis, CALGB 9633,
      JBR 10 and ANITA trials have shown postoperative (adjuvant) CT after complete resection will
      prolong survival. On the other hand, Depierre et al had conducted a trial to demonstrate
      preoperative (neoadjuvant ) chemotherapy in early stage NSCLC appears to improve survival. We
      need a head to head trial to comparing neoadjuvant with adjuvant chemotherapy to answer which
      treatment model is better to early stager NSCLC. Based on proven activity and survival
      benefit in advance NSCLC, docetaxel has been introduced into neoadjuvant therapy, even as a
      potential option in adjuvant setting.

      Comparison: 3 cycles of TP after complete operation compared to 3 cycles of TP prior to
      complete resection for NSCLC.
    

Intervention name(s): Chemotherapy+Surgery
Intervention type(s): Procedure
Intervention description(s): Docetaxel:75mg/m2 on D1 cycle,3 cycles Carboplatin:AUC=5 on D1 cycle,3 cycles
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-small cell lung cancer; Chemotherapy; surgery; neo-adjuvant; adjuvant; RCT
A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to assess the efficacy on joint damage and safety in RA patients
      treated with DMARDs in a double blind, placebo controlled study.
    


Intervention name(s): tacrolimus; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Prograf; FK506
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tacrolimus; Rheumatoid Arthritis; Tacrolimus anhydrous
A Clinical Study of Chinese Domestic Surgical Robot
Condition: Gallstone; Cholecystitis
MeSH terms: Cholecystitis; Gallstones
Study type: Interventional

Summary: 
      This is a prospective, multi-center, randomized, single-blind, parallel-controlled clinical
      trial to evaluate the safety and efficacy of the Chinese domestic endoscopic instrument
      control system in clinical treatment.
    

Detailed description: 
      To evaluate the safety and efficacy of the Chinese domestic endoscopic instrument control
      system in clinical treatment.This clinical trial is a prospective, multi-center, randomized,
      single-blind, parallel-controlled study. The system used in the experimental group is the
      endoscopic instrument control system developed by WEGO Surgical Robot Co., Ltd., and the
      system used in the control group is the da Vinci endoscopic instrument control system
      developed by Intuitive Surgical. Before patients are enrolled in this clinical study, the
      researchers will do a detailed screening of the subjects based on the inclusion criteria and
      the exclusion criteria to determine if the patients are appropriate for the clinical study.
      Patients who meet the conditions of the study will be required to sign an informed consent
      form. Then they will be randomly assigned to the experimental group or the control group. To
      evaluate the primary outcome measures and secondary outcome measures and to observe the
      incidence of organ and vascular injury. Finally, we evaluate the safety and efficacy of the
      test product through the comparison of the data obtained from the experimental group and the
      control group during the treatment.
    

Intervention name(s): the MicroHand S endoscopic instrument control system; the da Vinci endoscopic instrument control system
Intervention type(s): Device; Device
Intervention description(s): Using the MicroHand S endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.; Using the da Vinci endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism
Condition: Reactive Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether sitagliptin is effective in the treatment
      of reactive hypoglycemia by dysinsulinism.
    

Detailed description: 
      Symptomatic reactive hypoglycemia is an abnormal glucose decrease after meal ingestion.
      Patients with this abnormality as an early manifestation of glucose intolerance are at higher
      risk of type 2 diabetes. The pathophysiology of this abnormality appears to be related with
      delayed first phase insulin release. Improvement of first phase insulin secretion and delay
      in gastric emptying induced by sitagliptin phosphate could have favorable effects in patients
      in whom delayed insulin secretion is associated with reactive hypoglycemia.
    

Intervention name(s): Sitagliptin phosphate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin phosphate 100 mg per day per 2 weeks; Placebo 1 tablet per day per 2 weeks
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Reactive hypoglycemia; Sitagliptin; Glucagon-Like Peptide 1; Incretins; Prediabetes
Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome; Hyperphagia
MeSH terms: Prader-Willi Syndrome; Syndrome; Hyperphagia
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators propose a randomized double-blind 8 week treatment trial of intranasal
      oxytocin (IN-OXT) vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess
      IN-OXT's affect on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3)
      Salivary OXT levels.
    

Detailed description: 
      The investigators propose to conduct a treatment study of intranasal oxytocin (IN-OXT) vs.
      placebo in children and adolescents with Prader-Willi Syndrome (PWS). OXT has already been
      proven safe and effective in a treatment study of socialization and disruptive behavior in
      adults with PWS and is being used in infants with PWS in an ongoing clinical trial. The
      investigators hypothesize that OXT will be superior to placebo and have a positive effect on
      child and adolescent PWS eating and repetitive behaviors. Additional knowledge of OXT's
      ability to reduce overeating could lead to improvement of patient's quality of life and
      physical health and reduction in familial stress.

      The investigators propose a randomized double-blind 8 week treatment trial of intranasal OXT
      vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect on
      (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3) Salivary OXT levels. If
      superior to placebo, this data will add to the current knowledge that OXT is an effective
      treatment for hyperphagia as well as other problematic symptomatology of PWS.
    

Intervention name(s): Intranasal Oxytocin (IN-OXT); Matched Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).; Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prader-Willi Syndrome (PWS); Hyperphagia
Sleep in Cluster Headache: Sleep Parameters in- and Outside a Cluster Bout
Condition: Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Observational

Summary: 
      Sleep study in episodic cluster headache patients.
    

Detailed description: 
      This is an explorative study that aims to describe the sleep in 30 episodic cluster headache
      patients in- and outside of cluster using polysomnography. Data will be compared to a group
      of healthy controls.
    

Intervention name(s): Polysomnography
Intervention type(s): Other
Intervention description(s): Participants will be admitted for 1 night at the Danish Center of Sleep Medicine for polysomnography.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Episodic cluster headache patients diagnosed according to International Classification of
        Headache disorders III beta (ICHD III beta)
      
Keywords: cluster headache; sleep disturbances
A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
Condition: Diabetes Mellitus; Obesity
MeSH terms: Obesity; Weight Loss
Study type: Interventional

Summary: 
      This study compares two types of diet interventions: a low carbohydrate ketogenic diet
      (Atkins) and a low-fat diet combined with a medication (Orlistat).
    

Detailed description: 
      Overweight and obesity are increasingly prevalent in the veteran population as well as the
      general public. For patients with obesity-associated illnesses, there are few effective
      treatment options available after failed attempts at diet and exercise, even though weight
      loss has been shown to alleviate these conditions. The purpose of this study is to compare
      the tolerability, safety, and efficacy of a low-carbohydrate ketogenic diet (Atkins) with a
      combination of a low-fat diet and Orlistat. The outcomes examined over a 48 week duration
      will include body weight, risk factors for heart disease (e.g., lipid profiles), and blood
      sugar. This is a randomized, parallel-intervention trial. Subjects (n=150) will be recruited
      from the Durham VAMC Ambulatory Care Clinics. All patients receive one of the two intensive
      weight loss interventions.
    

Intervention name(s): Low carbohydrate ketogenic diet; Orlistat; Low-fat diet
Intervention type(s): Behavioral; Drug; Behavioral
Intervention description(s): A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat.; In addition to the low fat diet, Orlistat is taken 3 times daily.; Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake
Other intervention name(s): Xenical
Intervention MeSH terms: Orlistat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anti-obesity agents; diet therapy; diet, reducing; obesity; overweight; risk factors; weight loss
Tandem Control-IQ Evaluation Regarding Glucose Metrics, Sleep, and Health Economics
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      To evaluate Tandem Control-IQ compared with rtCGM and insulin pen respectively rtCGM and
      insulin pump treatment in children and adolescents regarding glucose control, sleep and
      health economics for 18 months.
    

Detailed description: 
      In this obesrvational study, the investigators assessed glycemic outcomes, sleep and health
      economics associated with AID treatment (Tandem Control-IQ) compared with multiple daily
      insulin injections with rtCGM (MDI+rtCGM) and a standalone insulin pump with rtCGM
      (CSII+rtCGM). Participants from two clinical sites in Sweden who continuously used one of the
      three modalities for at least six months were included in the analysis. Inclusion required
      all participants to use the Dexcom G6 rtCGM sensor for glucose monitoring, which meant only
      insulin treatment differentiated the three groups. Comparisons were conducted regarding
      Hemoglobon A1c (HbA1c) at the start of the study and rtCGM-generated glycemic metrics from 1
      month before the study started until 18 months. Sleep quality and quantity were assessed
      using a questionnaire for the persons with diabetes and the caretakers. Indirect and direct
      costs in all healthcare systems and additional information on sick leaves were collected from
      the Swedish Social Insurance Agency. Comparisons were then made between the three treatment
      alternatives.
    

Intervention name(s): Tandem Control-IQ
Intervention type(s): Device
Intervention description(s): AID-system
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals diagnosed with Type 1 diabetes at two different pediatric diabetes centres.
Patient Tolerability Study of GSK163090
Condition: Depressive Disorder, Major; Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of a new drug,
      GSK163090, which is being developed for the treatment of depression and anxiety disorders.
    


Intervention name(s): GSK163090
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: 163090; placebo-controlled; MDD; Depression; Tolerability; MDE
Apical Patency and Postoperative Pain.
Condition: Pain Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether maintaining an apical patency causes
      postoperative pain in posterior teeth with necrotic pulp and apical periodontitis.
    

Detailed description: 
      Apical patency (AP) is a procedure that prevents accumulation of soft and hard tissue debris
      within the cement canal. However, some RCTs indicate that maintaining an AP causes
      postoperative pain, whilst some RCTs pointed out there is no difference in terms of pain when
      AP has been performed. We, therefore, would like to conduct a RCT to increase the sample size
      of the previously performed RCTs to do an systematic review.
    

Intervention name(s): APICAL PATENCY
Intervention type(s): Procedure
Intervention description(s): After determining the working length, a small and flexible size 10 K-file was inserted 1 mm beyond the WL.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: apical patency; root canal treatment
To Assess the Effect of Rifampicin on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers
Condition: Solid Tumours
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the effect of Rifampicin on the pharmacokinetics of Selumetinib (AZD6244;
      ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers
    

Detailed description: 
      A Open-label, Single-center Study to Assess the Effect of the CYP3A4 inducer Rifampicin on
      the Pharmacokinetics of a 75 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142886)
      (Hyd-Sulfate) in Healthy Volunteers
    

Intervention name(s): selumetinib; rifampicin; selumetinib; rifampicin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Volunteers will receive a single oral dose of 75 mg selumetinib on day 1 (Treatment A).; Volunteers will receive single, daily, oral doses of 600 mg rifampicin on Days 4 to 11 (Treatment B).; On day 12 volunteers will receive a single oral dose of 75 mg selumetinib (Treatment C).; On day 12 volunteers will receive a single oral dose of 600 mg rifampicin. Once daily rifampicin administrations will continue through to Day 14 (Treatment C).
Other intervention name(s): AZD6244; AZD6244
Intervention MeSH terms: Rifampin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I, healthy, pharmacokinetics,
Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      The aim of our study is to determine the efficacy of Ketoprofen with or without vaginal
      isonicotinic acid hydrazide on the pain scores during HSG.
    

Detailed description: 
      hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to
      grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions
      including measuring uterine depth, inserting the cannula; and injection of the dye
    

Intervention name(s): Ketoprofen + INH; Ketoprofen + placebo
Intervention type(s): Drug; Drug
Intervention description(s): patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure; patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table placebo by the patient 12 hours before the procedure
Intervention MeSH terms: Ketoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blind placebo randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Trial of AXS-05 in Patients With Major Depressive Disorder
Condition: Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in
      patients with major depressive disorder (MDD).
    

Detailed description: 
      This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in
      patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with
      AXS-05 or placebo for 6 weeks.
    

Intervention name(s): AXS-05; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral AXS-05 tablets, taken daily for 6 weeks.; Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depressive Disorder; Depressive Disorder, Major; Bupropion; Dextromethorphan; MDD; Dopamine Reuptake Inhibitor; AXS-05; NMDA Receptor Antagonist; Central Nervous System; CNS; Sigma-1 Receptor Agonist; Nicotinic Acetylcholine Receptor Antagonist; Norepinephrine Reuptake Inhibitor; Glutamate Modulator; Axsome Therapeutics; GEMINI; Serotonin Reuptake Inhibitor
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation
Condition: Acute Myelogenous Leukemia; Graft Versus Host Disease; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Myelodysplastic Syndromes; Non-Hodgkin's Lymphoma; Hodgkin's Disease
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Hodgkin Disease; Myelodysplastic Syndromes; Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus
      host disease (GVHD) in patients following stem cell transplant from an unrelated donor. This
      trial is designed to test the hypothesis that elimination of methotrexate in the unrelated
      donor group would lead to less transplant-related toxicity while still preserving the
      effective control of GVHD.
    

Detailed description: 
      -  Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and
           sirolimus orally once daily starting 3 days before stem cell infusion. This will take
           place in the hospital where the patient will remain for the duration of the transplant.

        -  Sirolimus will continue for approximately 100 days at a stable dose, then it will be
           tapered slowly over the course of weeks to months to prevent a flare in GVHD.

        -  Patients will be seen in the clinic weekly for the first 2 months after discharge from
           the hospital. If GVHD is present, tapering schedule will be slower and based on the
           patient's clinical condition.

        -  Tacrolimus will also be given orally after the patient is discharged and will be tapered
           on the same schedule as sirolimus.

        -  During the year following stem cell transplant, blood tests will be performed to
           evaluate the immune system and graft versus host disease.
    

Intervention name(s): sirolimus; tacrolimus
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sirolimus; Tacrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Graft versus Host Disease; GVHD; sirolimus; tacrolimus; Stem cell transplant