bioihbjkbjnl/mcl2 huggingface dataset:
Phase I of Infusion of Selected Donor NK Cells After Allogeneic Stem Cell Transplantation
Condition: Hematological Malignancy
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of our study will be to determine the clinical and biological safety of infusing
      immuno-selected NK (Natural Killer) CD3-/CD56+ cells, early after allogeneic transplantation
      with colony stimulating factor (G-CSF) mobilized peripheral blood stem cells and Reduced
      Intensity Conditioning (RIC), as a potential substitute to usual "Donor Lymphocyte Infusion"
      (DLI), that contain the whole range of immune effectors. The trial will include several
      progressive steps: dose escalation up to a level compatible with the cost-effectiveness
      potential of the device and clinical situation and recombinant interleukin-2 (r-IL2)
      activation of selected NK cells in vitro prior to re-infusion.
    

Detailed description: 
      In the mid 90's, it has been shown that donor lymphocyte infusions (DLI), when given for
      Chronic Myelocytic Leukemia (CML) that has relapsed after conventional allogeneic stem cell
      transplantation (SCT), result in a high incidence of durable cytogenetic and molecular
      remissions. However, regular documented effects are the occurrence of secondary aplasia
      and/or graft-versus-host disease (GVHD) including the post RIC situation. These effects are
      related to the high content of cytotoxic T cells in the DLI. Attempts to deplete CD8+ T-cells
      from DLI have been conducted with promising results but are not totally satisfactory.

      More recently the infusion of r-IL2 ex-vivo activated autologous or allogeneic NK-selected
      cells have been studied and the safety established in patients presenting various
      malignancies.

      Indeed, NK are thoroughly characterized in terms of genotype, phenotype and function.
      Although a handful of clinical-grade reagents and devices exist that give access to the human
      NK cell compartment, an immuno-selection device exists that allows for the selection of NK
      cells from various types of hematopoietic cell collections in view of clinical applications:
      the process produces CD3-/CD56+ cells in two steps and have been used in the previous
      experiences.
    

Intervention name(s): NK Cell infusion
Intervention type(s): Biological
Intervention description(s): level 1: 1 x 10e6 NK cells /kg;
level 2: 5 x 10e6 NK cells /kg;
level 3: > 5.10e6 and ≤ 5.10e7 cellules NK/kg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hematological malignancy; stem cell transplantation
Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The purpose of the study is:

        -  to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety
           (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series
           of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or
           AcrySof Natural Monofocal (Model SN60AT)

        -  to assess patient satisfaction before and after implant
    


Intervention name(s): Acrysof Natural ReSTOR SN60D3; Acrysof Natural Monofocal SN60AT
Intervention type(s): Device; Device
Intervention description(s): Bilateral implantation with the AcrySof Natural ReSTOR Intraocular Lens (IOL) SN60D3 following cataract removal.; Bilateral implantation with the AcrySof Natural Intraocular Lens (IOL) Model SN60AT following cataract removal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Electronic Cigarettes in Daily Dependent Smokers
Condition: Substance Withdrawal Syndrome; Nicotine Dependence
MeSH terms: Tobacco Use Disorder; Substance Withdrawal Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to measure nicotine cue- and withdrawal-induced craving in current
      smokers under four distinct conditions: after smoking a conventional cigarette, an electronic
      cigarette (e-Cigarette) containing nicotine, an e-Cigarette without nicotine, and after
      taking a nicotine lozenge. Participants will be asked to attend four morning study visits
      after overnight smoking abstinence. Standardized questionnaires will be used to assess
      changes under each condition, allowing for the investigation of the efficacy of e-Cigarettes
      in reducing craving by replacing the behavioral component of smoking with minimal risk of
      adverse effects.
    

Detailed description: 
      Many addiction models postulate stimuli to be linked with nicotine intake and reward after
      prolonged use. As such, smoking becomes more heavily based in habit, initiated by cues.
      Craving has been found to be a crucial component of continued smoking and relapse in response
      to various environmental and behavioral cues. Electronic Cigarettes (e-Cigarettes) are new
      smoking products emerging in consumer markets that often mimic conventional tobacco
      cigarettes. E-Cigarettes commonly include a cartridge, a heating element, a puff sensor, and
      a battery. When a user draws on the device, the heating element is activated and the
      cartridge fluid is vaporized. Users then inhale the aerosol containing droplets of the
      vaporized fluid. This study will empirically assess the efficacy of e-Cigarettes in
      alleviating craving by replacing the behavioral component of smoking. Using standardized
      questionnaires, intra-subject changes in cue- and withdrawal-induced craving after smoking an
      e-Cigarette without nicotine will be compared with that after either smoking a conventional
      cigarette, an e-Cigarette with nicotine, or taking a 4mg lozenge.
    

Intervention name(s): Nicotine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): E-Cigarette with nicotine cartridge; E-Cigarette with 0mg nicotine cartridge
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Electronic Cigarettes; Lozenge; Nicotine; Tobacco; Dependence; Withdrawal
Stress Neuroadaptation in Tobacco Dependence
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the current study is to evaluate the validity of the No Shock, Predictable
      Shock, Unpredictable Shock (NPU) stressor task for use as a surrogate endpoint to predict
      short-term clinical outcomes among smokers during a smoking cessation attempt.
    

Detailed description: 
      Smokers recruited for this study are randomly assigned at a screening session to complete the
      NPU stressor task pre-quit or post-quit (i.e., nicotine deprived or non-deprived).
      Participants are also randomized to receive either placebo or active combination nicotine
      replacement therapy (NRT; patches and lozenges) for a two week smoking cessation period. The
      NPU stressor task measures stressor reactivity to predictable and unpredictable stressors
      (i.e., electric shock). Startle potentiation during predictable and unpredictable stressors
      (relative to no-shock) provides the primary measures of stressor reactivity in this task.
      Predictable and unpredictable startle potentiation are used to calculate overall stressor
      reactivity and selective unpredictable stressor reactivity. Further detail on these
      reactivity measures is provided in the Independent Variables section. Detail on the
      quantification of startle potentiation is provided at the end of this registration.

      Smokers provide three weeks (1 week pre-quit, 2 weeks post-quit) of brief 4x daily, real-time
      web-survey reports of recent cigarette use, NRT use, and other measures not relevant to this
      study's purpose on the participants' smartphones. At two weeks post-quit, smokers are
      scheduled for a laboratory visit where participants provide an additional report via staff
      interview of any smoking during the two-week smoking cessation period.

      The stressor reactivity measures from the NPU task will be tested as predictors of clinical
      outcome (i.e., continuous abstinence during the two-week cessation period) to evaluate the
      validity of each as surrogate endpoints for use in research on stress mechanisms in smoking
      relapse. Deprivation status at the time of the NPU stressor task will be examined as a
      moderator of the effect of stressor reactivity to determine if the surrogate endpoints
      predict clinical outcome generally or only as deprivation increases.
    

Intervention name(s): nicotine; placebo
Intervention type(s): Combination Product; Other
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Risperidone Maintenance Treatment in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study set out to determine the duration of maintenance treatment with therapeutic
      risperidone dose in schizophrenia. In a multi-center, open label, randomized, controlled
      study design, patients with schizophrenia who were clinically stabilized following an acute
      episode were randomly assigned to a 'maintenance group' (optimal therapeutic doses continued
      for at least 1 year), a 4-week group (optimal therapeutic doses continued for 4 weeks
      followed by a 50% dose reduction that was maintained for at least 11 months) or a 26-week
      group (optimal therapeutic doses continued for 26 weeks followed by a 50% dose reduction for
      at least another 6 months).
    

Detailed description: 
      Prevention of relapse is the crucial task in the maintenance treatment of schizophrenia. This
      study set out to determine the duration of maintenance treatment with therapeutic risperidone
      dose in schizophrenia. In a multi-center, open label, randomized, controlled study design,
      patients with schizophrenia who were clinically stabilized following an acute episode were
      randomly assigned to a 'maintenance group' (optimal therapeutic doses continued for at least
      1 year), a 4-week group (optimal therapeutic doses continued for 4 weeks followed by a 50%
      dose reduction that was maintained for at least 11 months) or a 26-week group (optimal
      therapeutic doses continued for 26 weeks followed by a 50% dose reduction for at least
      another 6 months).
    

Intervention name(s): risperidone
Intervention type(s): Drug
Intervention description(s): Patients with schizophrenia who were clinically stabilized following an acute episode were randomly assigned to a 'maintenance group' (optimal therapeutic doses continued for at least 1 year), a 4-week group (optimal therapeutic doses continued for 4 weeks followed by a 50% dose reduction that was maintained for at least 11 months) or a 26-week group (optimal therapeutic doses continued for 26 weeks followed by a 50% dose reduction for at least another 6 months)
Other intervention name(s): Risperdal
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Schizophrenia; Risperidone; Maintenance treatment; Relapse
A Study of LY3209590 in Healthy Participants and Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted to evaluate the safety of a study drug given by injection under the
      skin to healthy participants and participants with type 2 diabetes. It will also investigate
      how the body processes the study drug and the effect of the study drug on blood sugar levels.
      Information about any side effects and tolerability will be documented. This study is
      approximately 30 days for each participant, not including screening. Screening is required
      within 28 days prior to the start of the study.
    


Intervention name(s): LY3209590; Placebo; Insulin Glargine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Isovolumetric and Isocaloric Preloads of Various Types of Milk on Food Intake, Subjective Appetite and Glycemic Response
Condition: Diabetes Prevention; Obesity Prevention
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this protocol is to study the effects of fluid milk products on satiety, food
      intake, and glucose metabolism in healthy young men and women. Experiment 1: The specific
      objective is to investigate isovolumetric amounts of milk (2% M.F.), chocolate milk (1%
      M.F.), a soy beverage, cow's milk-based infant formula, and water (control) on satiety and
      food intake and on blood glucose before and after a meal. A fixed volume approach is based on
      the commercially available serving size. Experiment 2 will examine equicaloric amounts of
      milk (2% M.F.), chocolate milk (1% M.F.), a soy beverage, cow's milk-based infant formula, a
      glucose drink and water (control) the treatments in order to investigate macronutrient
      composition on satiety and food intake and on blood glucose before and after the meal.
    


Intervention name(s): Dietary intervention
Intervention type(s): Other
Intervention description(s): Dietary treatments with beverages
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Food intake; Blood glucose; Milk
Recombinant Endostatin Combined With Vinorelbine and Cisplatin in Patients With Advanced Non-small Cell Lung Cancer
Condition: Advanced Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      The main object of this trial is to offer treatment of recombinant endostatin ( Sulijia)
      combined with Vinorelbine and Cisplatin (NP) plus maintenance therapy with Sulijia for
      advanced Non-small Cell Lung Cancer, expecting to improve progression free survival (PFS) ,
      disease control rate(DCR) , objective response rate(ORR) and Overall survival (OS) compared
      with chemotherapy alone, and evaluate the efficacy and safety of Sulijia.
    

Detailed description: 
      Recombinant endostatin injection Sulijia is a new type of recombinant protein drugs
      inhibiting tumor angiogenesis developed by a group of Chinese scientists and clinician. It is
      expressed in E. coli which Consists of 184 amino acids. It appears to be better than NP
      chemotherapy alone in terms of efficacy in phase I/II trials for advanced NSCLC. In this
      study, a randomized, double-blind, Placebo plus NP as control, multi-center phase III trial
      was designed to evaluate the safety and efficacy of Sulijia plus NP in the treatment of
      advanced NSCLC patients. PFS (progress free survival) is the primary end-point with OS
      (overall survival), ORR (objective response), DCR (disease control rate) and safety as the
      secondary end-point. A total of 560 patients have been recruited.
    

Intervention name(s): Placebos; Sulijia
Intervention type(s): Drug; Drug
Intervention description(s): Drug 1:
Placebo(Sodium Chloride Injection),7.5mg/m2 on d1-d14 in each 21-day cycle（stop interventing until the disease progress）
Drug 2:
Vinorelbine-Cisplatin:
Vinorelbine, 25mg/m2, iv, on d1 and d8 in each 21-day cycle (no more than 4 cycles); Cisplatin,75mg/m2, iv, on d1 in each 21-day cycle(no more than 4 cycles); Drug 1:
Sulijia(Recombinant Endostatin Injection) Sulijia, 7.5mg/m2 on d1-d14 in each 21-day cycle（stop interventing until the disease progress）
Drug 2:
Vinorelbine-Cisplatin:
Vinorelbine, 25mg/m2, iv, on d1 and d8 in each 21-day cycle (no more than 4 cycles); Cisplatin,75mg/m2, iv, on d1 in each 21-day cycle(no more than 4 cycles)
Other intervention name(s): Sodium Chloride Injection; Recombinant endostatin injection
Intervention MeSH terms: Endostatins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-small Cell Lung Cancer; Sulijia; Recombinant endostatin; Vinorelbine; Cisplatin
Revlimid, Endoxan, Prednison Evaluation After Prior Revlimid Treatment (REPEAT)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Study Phase: phase 1 and phase 2

      Objective: Evaluation of the effect of lenalidomide, cyclophophamide and prednisone (REP) in
      patients with relapsed multiple myeloma previously treated with lenalidomide

      Study design: prospective, multicenter, non-randomized
    

Detailed description: 
      The REPEAT-study is a prospective, multicenter, non-randomized phase 1 and phase 2 study in
      which we evaluate the effect of lenalidomide, cyclophosphamide and prednisone (REP-therapy)
      in patients with relapsed multiple myeloma, previously treated with lenalidomide and
      refractory to lenalidomide monotherapy.
    

Intervention name(s): Lenalidomide, endoxan, prednisone; lenalidomide, endoxan, prednisone
Intervention type(s): Drug; Drug
Intervention description(s): dose-finding; oral therapy with lenalidomide 25mg a day during 3 of 4 week cycles. Number of Cycles: until progression or unacceptable toxicity develops.
Other intervention name(s): revlimid combined with endoxan and prednisone; revlimid combined with cyclophosphamide and prednisone
Intervention MeSH terms: Prednisone; Cyclophosphamide; Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: REPEAT; multiple myeloma; revlimid; lenalidomide; cyclophosphamide; endoxan; prednisone; lenalidomide refractory
Climate Friendly and Ecological Food on Microbiota
Condition: Sustainability; Microbiota; Pesticides; Organic Food
Study type: Interventional

Summary: 
      The aim of this study is to investigate changes in nutrient intake, the human gut microbiota
      and pesticide excretion in urine when shifting from conventional food habits to sustainable
      food habits.
    


Intervention name(s): Climate friendly diet; Organic diet; Climate friendly and organic diet; Control group (Control diet)
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants in the 'Climate friendly' group will be assigned a diet generating low emissions of greenhouse gases. The target is to reduce the participants' diet-related carbon dioxide equivalents (CO2e) to 2.5 kg per person and day, which is approximately a reduction by 50% compared the average CO2e, according to a previous study on diet-related CO2e in Sweden. The participants will be instructed to reduce their consumption of beef and dairy products and increase their consumption of plant-foods i.e. fruits, vegetables, legumes and whole-grain cereals.; Participants in the 'Organic group' will be assigned an organic diet with very low, or no, content of pesticides. The participants will be instructed to replace at least 50% of their food intake with organic foods.; The participants in the 'Climate friendly and organic diet group' will be assigned a combination of a climate friendly and organic diet generating low emissions of greenhouse gas and having very low levels of pesticides. The target is to reduce the participants' diet-related CO2e to 2.5 kg per person and day. The participants will be instructed to replace at least 50% of their food intake with organic products.; A conventional diet according to the Nordic Nutrition Recommendations (NNR). The participants will get information about the present dietary guidelines and how they can adhere to the guidelines, for example, by implementing the "plate model" for meals and learning about recommended levels of intake of macronutrients, micronutrients, fiber and energy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Electronic Feedback on Diabetic Care to General Practitioners
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      The aim of this study is to determine whether electronic feedback to general practitioners on
      quality of Type 2-Diabetes care increases the quality of care measured on process and outcome
      measures contained in the national guidelines. Effect evaluation will be performed using a
      mixed method design.
    

Detailed description: 
      Background: In an effort to optimize diabetes care in general practice, an electronical
      feedback system has been developed. The system will be evaluated both quantitative and
      qualitative.

      Method: The general practitioners (GP´s) of the Region of Southern Denmark have been
      randomised to either admission or no admission to the electronic feedback system. The system
      was launched 1/3-2007 and ran for one year prior to evaluation.

      Quantitative evaluation by assessment of the following end-points: Patients Hba1c-level,
      number of patients who have had their hba1c-level measured within the last year,
      cholesterol-level and number of patients who have had an eye examination within the last
      year.

      Qualitative evaluation by interviewing GP´s who have had admission to the system.

      Qualitative data have been collected through interviews with intervention GPs, designed to
      uncover motivational factors as well as barriers concerning the use of feedback on chronic
      care in general practice. Data are being analyzed.

      Quantitative data are being gathered. Perspective: This project will shed light on the value
      of electronic feedback systems within chronic care in general practice.

      Based on this project it will be possible to set up a system for automatic electronic
      monitoring and feedback of the quality of care in general practice, taking motivational
      factors of the GP s into account during implementation.
    

Intervention name(s): Electronic feedback system on diabetes care
Intervention type(s): Device
Intervention description(s): An electronic feedback system was introduced in randomized primary care clinics providing an overview of quality of care. The intervention ran for 15 months.
Other intervention name(s): Electronic feedback system; Decission support system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Quality of care; General Practice; Electronic Feedback System