bioihbjkbjnl/mcl2 huggingface dataset:
MRD-directed Donor Lymphocyte Infusion for Reduce of Relapse After Allo-HSCT
Condition: Minimal Residual Disease; Donor Lymphocyte Infusion; Hematopoietic Stem Cell Transplantation; Relapse
MeSH terms: Neoplasm, Residual; Recurrence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute
      leukemia, but relapse remains an important problem. Therapy options for relapse include
      stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI),
      and another transplantation used alone or in combination. However, the efficacy of these
      interventions is limited. One approach to the relapse problem is to intervene before
      hematologic or pathologic relapse occurs based on minimal residual disease (MRD). In this
      study, the efficacy of MRD-directed DLI on transplantation outcomes will be evaluated in
      patients with acute leukemia receiving allo-HSCT.
    

Detailed description: 
      Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute
      leukemia, but relapse remains an important problem. Therapy options for relapse include
      stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI),
      and another transplantation used alone or in combination. However, the efficacy of these
      interventions is limited. One approach to the relapse problem is to intervene before
      hematologic or pathologic relapse occurs based on minimal residual disease (MRD) using immune
      or molecular techniques.DLI is an effective post-transplantation therapy for prophylaxis of
      leukemia relapse, but is associated with a substantial risk of GVHD. Whether MRD-directed DLI
      could improve outcomes remains unclear. In this study, the efficacy of MRD-directed DLI on
      transplantation outcomes will be evaluated in patients with acute leukemia receiving
      allo-HSCT.
    

Intervention name(s): donor lymphocyte infusion
Intervention type(s): Biological
Intervention description(s): DLI was administered at a median dose of 1.0 (range 0.7-1.4) ×10*8 mononuclear cells/kg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Acupuncture Treatment for Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      The purpose of this study is to observe the efficacy and safety of acupuncture and
      moxibustion for Crohn's disease and the regulation mechanism of intestinal microbiota and
      peripheral immunity.
    

Detailed description: 
      1. A randomized controlled trial.

        2. Acupuncture and moxibustion treatment, placebo control.

        3. To observe the efficacy and safety of acupuncture and moxibustion treatment versus
           placebo controlled for Crohn's disease.

        4. To observe the effect on the regulation of intestinal microbiota in Crohn's disease.

        5. To observe the effect on the regulation of peripheral immunity in Crohn's disease.

        6. To observe the effect on the regulation of brain function and structure in Crohn's
           disease.
    

Intervention name(s): Acupuncture and moxibustion; Sham acupuncture and moxibustion
Intervention type(s): Device; Device
Intervention description(s): Acupuncture acupoints: CV12, bilateral ST36, ST37, SP6, SP9, SP4, LR3 and LI3. Disposable acupuncture auxiliary device and 0.30*40mm or 0.30*25mm acupuncture needles (hwato, suzhou medical supplies factory co., LTD.) were used. The needles were directly inserted 20-30mm into the skin and elicited a de-qi sensation. The needle was kept for 30 min.
Moxibustion acupoints: bilateral ST25 and ST36. Using mild-warm moxibustion, The surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint. Moxibustion and acupuncture were performed at the same time, once every other day, three times a week, a total of 12 weeks of treatment. After the treatment, subjects were followed up in the weeks 24, 36 and 48.; The acupoints used are same to the experimental group. Same disposable acupuncture auxiliary device and 0.35 * 40mm acupuncture needle (flat and blunt needle tip, Hwato, Suzhou Medical Supplies Factory Co., Ltd.) was selected. When the needle was pricked to the acupoint, it did not penetrating into the skin. The subject only felt slight pain and do not have the de-qi sensation.
Sham moxibustion : by using the same moxa stick, The surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint. Sham acupuncture and sham moxibustion were performed at the same time. They were treated once every other day, three times a week, a total of 12 weeks. After the treatment, subjects were followed up in the weeks 24, 36 and 48.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acupuncture; moxibustion; intestinal microbiota; Peripheral immunity; Brain functional and structural changes
Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting
Condition: Gastroenteritis
MeSH terms: Gastroenteritis; Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to give children with gastroenteritis with persistent vomiting
      flavored intravenous ondansetron orally. The investigators test the palatability of the drug
      and check the serum level of ondansetron at 4 hours .
    

Detailed description: 
      This is a prospective pilot study for children,3-8 years of age presented to the Pediatric
      Emergency Department in the state of Qatar between September 2014 and January 2015, with
      acute gastroenteritis with mild to moderate dehydration, more than 2 episodes of vomiting in
      the last 24 hours, and who had failed oral rehydration trial in the department as per the
      department oral hydration protocol. Acute gastroenteritis was defined as diarrhea and
      vomiting for less than a week period.

      Hydration level was assessed for all patients on arrival, and eligible patients were enrolled
      after obtaining an informed written consent.Enrolled patients received intravenous
      ondansetron form orally after being flavored 1:1 with ORA-sweet, the dose of ondansetron was
      determined based on the patient presenting weight. Palatability was evaluated by the primary
      investigator within one minute fom drug administration applying taste scores for children and
      recorded according to a specific scoring system. All patients were kept nil per oral for 30
      minutes and then oral rehydration trial was started as per the department rehydration
      protocol. If the drug was vomited within 30 min of administration, a similar second dose was
      given. Blood level for ondansetron was collected 4 hours after the successful drug
      administration and was sent to the department laboratory within 5 min. Patients were sent
      home when they were ready for discharge as per the treating physician discretion. All
      patients were followed by a telephone call after 24 hours to assess the safety and efficacy
      of the orally taken ondansetron.
    

Intervention name(s): Ondansetron with1:1 ORA - sweet.
Intervention type(s): Drug
Intervention description(s): single dose of intravenous ondansetron form orally after being flavored with 1:1 ORA-sweet, the dose of ondansetron was determined based on the patient presenting weight.
Other intervention name(s): Zofran
Intervention MeSH terms: Ondansetron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ondansetron; palatability; vomiting
Vitamin D Increases Serum Levels of the Soluble Receptor for Advanced Glycation End Products in Women With PCOS
Condition: Polycystic Ovary Syndrome; Vitamin D Deficiency
MeSH terms: Polycystic Ovary Syndrome; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the mechanism that explain the beneficial
      clinical effect of vitamin D treatment in women with PCOS.
    

Detailed description: 
      Seventy-nine women with (n=22) or without (control; n=57) PCOS who were diagnosed with
      vitamin D deficiency were enrolled. Sixty-three women were treated with oral vit D3 for 8
      weeks (16 with PCOS and 47 controls) and 16 women were not treated (6 with PCOS and 10
      controls). Serum 25 hydroxy-vitamin D (25 OH-D), sRAGE, and AMH concentrations were measured
      at baseline and after vit D3 supplementation in the treated group, and 8 weeks apart in the
      non-treated group. Paired t-test, Wilcoxon signed-rank test, and Pearson correlation were
      used as appropriate.

      Main outcome measure: Changes in AMH concentrations following vit D3 replacement.
    

Intervention name(s): Vitamin D3
Intervention type(s): Drug
Intervention description(s): Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.
Other intervention name(s): Vitamin
Intervention MeSH terms: Vitamin D; Cholecalciferol; Vitamins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome; Vitamin D; Anti Mullerian Hormone; Soluble receptor for Advanced Glycation End Products
Evaluation of the Media Detective Program for Elementary School-Aged Children to Prevention Substance Use
Condition: Alcohol Drinking; Tobacco Smoking
MeSH terms: Substance-Related Disorders; Alcohol Drinking
Study type: Interventional

Summary: 
      The purpose of this study was to determine whether a media literacy education program taught
      be teacher to late elementary school students (grades 3-5) positively affected students'
      critical thinking skills and substance use-related health outcomes.
    

Detailed description: 
      Media Detective is a 10-lesson elementary school, substance abuse prevention program
      developed based upon the Message Interpretation Processing model designed to increase
      children's critical thinking skills about media messages and reduce intent to use tobacco and
      alcohol products. The purpose of this study was to conduct a short-term randomized controlled
      trial study to evaluate the effectiveness of Media Detective for achieving these goals.
    

Intervention name(s): Media Detective
Intervention type(s): Behavioral
Intervention description(s): 10-lesson elementary school, media literacy education, substance use prevention program. Each lesson takes approximately 45 minutes to teach and was taught every school day for 2 weeks.
Other intervention name(s): Media literacy education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006
Condition: Asthma; Bronchospasm; Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Asthma; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bronchial Spasm
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic
      profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active
      control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in
      escalating and cumulative-doses up to 1440 mcg, eight (8) times of the proposed clinical
      dose.
    


Intervention name(s): A006; Placebo DPI; Proventil-HFA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Albuterol DPI with 180 mcg Albuterol/inhalation; Placebo DPI with 0 mcg Albuterol/inhalation; Albuterol MDI with 90 mcg Albuterol/inhalation
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma; bronchospasm; COPD; reversibility; efficacy
Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy
Condition: Pain; Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine
      are effective in the treatment of pain of diabetic neuropathy.
    


Intervention name(s): Neurodex
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: distal symmetrical; pain; lower extremities; dextromethorphan
Remission Rate of Newly Diagnosed Type 2 Diabetes Outpatients Treated With Short-term Intensive Insulin Therapy
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the long-term remission rate of short-term intensive insulin (STII) therapy in
      newly diagnosed type 2 diabetes outpatients and investigate the predictors contributing to
      the remission rate.
    


Intervention name(s): Novolin 30R;Pioglitazone;Metformin
Intervention type(s): Drug
Intervention description(s): Insulin (Novolin 30R) was titrated according to the level of blood glucose until reached euglycemia (FPG≤6.1mmol/L and/or P2hBG≤8.0mmol/L and/or HbA1c ≤6.5%). After glucose was well controlled within these targets for 4 weeks, insulin dosage was gradually decreased until discontinued;
Pioglitazone hydrochloride was discontinued if the glucose was well controlled at the 6th week after the cessation of insulin;
Metformin was the last drug that to be discontinued if the glucose was still well controlled at the 4th week after the cessation of pioglitazone.
Intervention MeSH terms: Metformin; Pioglitazone; Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes; remission; short-term intensive insulin therapy
Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception
Condition: Contraception
Study type: Interventional

Summary: 
      Prospective, multi-center, pilot study evaluating the safety of the FemBloc® Permanent
      Contraceptive System for female sterilization in preventing pregnancy.
    

Detailed description: 
      Prospective, multi-center, pilot study of subjects undergoing the FemBloc Permanent
      Contraceptive System procedure conducted at 5 sites in the U.S. following 49 subjects total.
      The objective of the trial is to evaluate the safety of the FemBloc Permanent Contraceptive
      System for female sterilization in preventing pregnancy through the 3-month confirmation test
      visit. Femasys also intends to continue follow-up of pilot subjects for safety a total
      duration of approximately 68 months after the FemBloc treatment procedure.
    

Intervention name(s): FemBloc® Permanent Contraceptive System
Intervention type(s): Device
Intervention description(s): The FemBloc Permanent Contraceptive System consists of treatment with a Delivery System and Biopolymer, and a confirmation test with the FemChec® Tubal Occlusion Confirmation device as part of a sonographic hysterosalpingogram (Sono HSG).
Intervention MeSH terms: Contraceptive Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Permanent contraception; Birth control
Sugammadex and Brain Waves
Condition: Anaesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      According to our experience, electroencephalogram-based indices of anaesthetic state show
      elevated numbers after administration of sugammadex (new reversal of neuromuscular blockade).
      This can be due to altered anaesthetic state, or some kind of artefact. In this study, the
      phenomenon is evaluated in detail.
    

Detailed description: 
      Rocuronium-induced neuromuscular blockade is antagonized with sugammadex or neostigmine. BIS,
      Entropy and the biosignal collected from the Entropy strip are collected on computer. The
      behaviour of these parameters before, during and after reversal on neuromuscular blockade
      will be analyzed in detail.
    

Intervention name(s): Sugammadex; Neostigmine and glycopyrrolate
Intervention type(s): Drug; Drug
Intervention description(s): Sugammadex 200 mg iv, single dose, bolus.; Neostigmine 2.5 mg and glycopyrrolate 0,5 mg, iv, single dose, bolus, diluted in 2 ml volume with saline
Other intervention name(s): Bridion; Glycostigmin.
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Electroencephalogram; Electromyogram; Entropy Index; Bispectral Index; Reversal of neuromuscular blockade
Study of Different Concentrations of Epidural Bupivacaine for the Effects on Vasodilatation and Sensory Block
Condition: Intraoperative Complications
MeSH terms: Intraoperative Complications
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to compare human subjects receiving epidural bupivacaine local anesthetic at
      different doses and concentrations and to assess the effect on vasodilatation
      (sympathectomy), sensory and motor block.

      The hypothesis is that the drug concentration is more important than drug dose in the
      determination of the extent and intensity of differential sympathetic, sensory and motor
      block following epidural local anesthetic.
    

Detailed description: 
      There is controversy regarding the factors that determine the extent and intensity of
      epidural drug action. Most studies have focused on the inter-related triad of dose,
      concentration and volume.

      We compare three groups: group A: 10ml of 0.5% bupivacaine; group B: 10ml of 0.25%
      bupivacaine and group C: 40ml of 0.0625% bupivacaine. When comparing these groups, groups A &
      B have the same volume of epidural drug, and groups B & C have the same total dose.

      In particular this study compares different methods of assessing the sympathetic block
      (causing vasodilatation). These methods include skin temperature changes, hemodynamic changes
      and photoplethysmography.
    

Intervention name(s): Epidural bupivacaine (dose/concentration/volume ranging)
Intervention type(s): Drug
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Anesthesia, Epidural; Pharmacology; Dose-Response Relationship, Drug; Sympathectomy; Photoplethysmography
Dose Finding Study for Depigoid Birch: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma
Condition: Allergic Rhinitis and/or Rhinoconjunctivitis +- Asthma; Immunotherapy, Allergen
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Conjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Specific immunotherapy for subcutaneous application: Dose finding study to evaluate the
      correct dose.

      4 concentrations of a birch pollen allergen extract are applied in this study. Duration of
      therapy 20 weeks. Primary criterion is the Conjunctival Provocation Test (CPT), i.e.
      comparison between treatment arms of increased amount of quantities of allergen to provoke a
      positive CPT at the end of treatment.
    

Detailed description: 
      This is a dose finding study and no therapeutic study. Patients will receive in 4-weekly
      intervals 5x injections of 0,5 ml of a solution of modified birch pollen extract outside the
      pollen season. The primary endpoint therefore is not the therapeutic effect of the specific
      immunotherapy (effect on symptoms of allergy during the birch pollen season) but the effect
      on the CPT. Acc. to the EMEA "Guideline on clinical development of products for specific
      immunotherapy for the treatment of allergic diseases" provocation tests are accepted as
      primary outcomes for dose-finding studies.

      For the CPT increasing doses of birch pollen solutions are applied to the eye and
      characteristic symptoms (eye redness, weeping, itching or burning and nose dripping/blockage)
      are assessed: 0 = absent, 1=mild, 2=moderate, 3=severe). At a score value of >=
      5/concentration the test is considered positive and finished.

      It is expected that at the end of the study higher doses are necessary to provoke a positive
      CPT.

      Furthermore comparative evaluation of the safety data (AEs) in the different dosage groups is
      a very important parameter for the evaluation of the outcome of the study.
    

Intervention name(s): Allergoid, allergenic extract of 100% Birch
Intervention type(s): Biological
Intervention description(s): Subcutaneous injections Build-up = 1 day: 0,1mL + 0,2mL + 0,2mL s.c. in intervals on 30 minutes; Maintenance = 5 x single injection of 0,5 mL s.c. every 4 weeks
Other intervention name(s): Depigoid (R); Depigmented, glutaraldehyd-polymerized allergenic extract of
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic Rhinitis +- intermittent asthma; Allergic Rhinoconjunctivitis +- intermittent asthma; Specific Immunotherapy