bioihbjkbjnl/mcl2 huggingface dataset:
Low-dose IL-2( Interleukin-2) Treatment in SLE
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      This clinical study will test the efficacy and safety of low dose IL-2 treatment in Systemic
      lupus erythematosus.
    

Detailed description: 
      Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various organs.
      While available therapies, such as corticosteroids and immunosuppressive agents have improved
      the outcome of patients, there remains a significant unmet need for safe and more effective
      treatments. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune
      diseases, which can be promoted by interleukin-2 (IL-2). We hypothesized that low-dose IL-2
      could be a novel therapy in active SLE patients.

      This is a single center, uncontrolled, open-label study to assess the efficacy/safety of low
      dose IL-2 plus standard therapy in active SLE.

      Methods: Each SLE patients (n=40) with Scores>=8 on the Safety of Estrogens in Lupus
      Erythematosus National Assessment (AELENA) version of the SLE Disease Activity Index (SLEDAI)
      that was refractory or relaps to glucocorticoid therapy received low-dose IL-2 (1 million
      units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After
      a 14-day rest, another cycle started) for 3-6 cycles according to the situation of the
      disease. The end points were safety and clinical and immunologic response.

      Expected Results: This trail will define low-dose IL-2 plus standard therapy is efficacy and
      safety with active lupus patients, which could be relevant to the amelioration the abnormity
      of T help cells in SLE patients.
    

Intervention name(s): Interleukin-2
Intervention type(s): Drug
Intervention description(s): Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 courses according to the situation of the disease.
Other intervention name(s): Recombinant Human Interleukin-2,125Ala, SL Pharm
Intervention MeSH terms: Interleukin-2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SLE, IL-2
GRASPA (Erythrocytes Encapsulating L-asparaginase) in Patients With Relapse of Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia, in Relapse
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Recurrence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by
      toxicities including hypersensitivity. Clinical allergy is associated with inactivation of
      asparaginase by antibodies (A-Abs), which can also neutralize asparaginase without any
      clinical signs of hypersensitivity (silent inactivation). GRASPA improves pharmacokinetics,
      tolerability and maintain circulating asparaginase activity due to the protective barrier of
      the erythrocyte membrane.

      This study is run to confirm the benefit/risk profile of GRASPA at 150 IU/kg in combination
      with the COOPRALL regimen in adults and children patients with relapsed ALL, with or without
      known hypersensitivity to L-asparaginase.
    

Detailed description: 
      This open, randomized international Phase 2/3 study will enrol patients with relapsed ALL.
      The co-primary endpoints were the duration of asparagine depletion < 2µmol/L and the
      incidence of asparaginase hypersensitivity during induction. Key secondary endpoints are
      complete remission (CR), minimal residual disease (MRD), event free survival (EFS) and
      overall survival (OS).The study was powered to detect 3-fold difference in the incidence of
      allergic reactions between treatments. patients will be randomized to GRASPA or to Reference
      L-asparaginase. Patients with history of hypersensitivity to previous L-asparaginase
      treatment will be treated with GRASPA (exploratory arm)
    

Intervention name(s): GRASPA; L-asparaginase
Intervention type(s): Drug; Drug
Intervention description(s): one injection of GRASPA 150 IU/kg at each cycle of chemotherapy; 3 to 4 Injections of Native E.coli asparaginase 10000IU/m² (every 3 days) at each cycle of chemotherapy
Other intervention name(s): ERY001; KIDROLASE
Intervention MeSH terms: Asparaginase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute lymphoblastic leukemia; relapse; asparaginase
My Type 2 Diabetes: Person-centred Health Care
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The T2D project is a research and innovation project that will create a new comprehensive,
      participant-centered service model for interaction, increased physical activity,
      self-management, distance monitoring and lifestyle change for patients with type 2 diabetes
      (T2D). Central to the degree of innovation is a new model for interaction and use of
      technology for distance monitoring and coping.
    

Detailed description: 
      Type 2 diabetes is both physically and mentally stressful. At the same time, it requires a
      high individual effort, which can be demanding. Good mental health is necessary to be able to
      manage and control diabetes in a healthy and effective way. Therefore, we want to create an
      offer that takes care of the whole person, and physically as well as mentally.

      Personal follow-up Based on surveys and conversations, the study participant and a contact
      person will prepare a 12-week plan that will be implemented with self-measurements and
      follow-up from the contact person. The plan will consist of the activities that best suit the
      participant's needs. It can be physical activity, diet course, health competence, motivation
      and psychosocial intervention that will be useful for the participant. After 12 weeks, the
      implementation will be evaluated.

      Several new technological solutions are developed and will be used during the project period.
      A digital tool for mapping of the individuals needs will be an important part of the survey
      that is done during start-up. Activity clocks will be used for measuring steps, heart rate,
      and number of PAI. An online portal for communication and interaction will make information
      easily accessible to users, simplify distance follow-up and communication flow.

      The intervention will take place at two Healthy Life Centres (HLC). A HLC is an
      interdisciplinary primary health care service which offers effective, knowledge-based
      measures for people with, or in high risk of disease, who need support in health behaviour
      change and in coping health problems and chronic disease.

      The HLC is part of the public health care service in the municipality. HLC programs have a
      patient centred approach and aim at strengthening the individual's control of his or her own
      health.

      The intervention study starts in two municipalities in Møre og Romsdal, and the goal is to
      make the offer national.
    

Intervention name(s): Person centred care
Intervention type(s): Other
Intervention description(s): physical activity, nutrition, motivation, health competence, psychosocial.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physiological Effects of Yogurt With Bb12 in Subjects With GI Symptoms Strointestinal Symptoms
Condition: Non-diarrhea Functional Bowel Symptoms
Study type: Interventional

Summary: 
      Hypothesis:

        -  Daily consumption of yogurt containing probiotic bacteria (Bb12) and inulin will
           significantly decrease whole gut and intestinal segmental transit time

        -  The effect of accelerating intestinal transit will be associated with other GI
           physiology parameters including stool frequency and stool consistency.
    

Detailed description: 
      In previous preliminary study we have shown that daily consumption of a probiotic yogurt
      drink containing probiotic bacteria (Bifidobacterium lactis Bb12) and inulin significantly
      accelerate colonic transit time in non-patients population with functional bowel symptoms. In
      this study we investigate the physiologic effect(s) of yogurt with the same bacteria and
      inulin on gastrointestinal function by assessing its effect on the whole gut and segmental
      transit time using SmartPill™ - a recently introduced device of measuring intestinal transit
      time. The proposed study will provide additional information on the effect on the whole gut
      transit as well as on other segments of the GI tract (stomach and small bowel). Assessment of
      transit time in the proposed study will be done following 10 to 14 days of the probiotic
      yogurt consumption.
    

Intervention name(s): A probiotic yogurt with inulin; Acidified dairy snack
Intervention type(s): Other; Other
Intervention description(s): A 4 oz. cup with a probiotic yogurt containing Streptococcus thermophilus and Lactobacillus bulgaricus (at least 1x10^8 cfu/g); the probiotic bacteria Bifidobacterium lactis (Bb12) (5x10^7 cfu/g; 5x10^9 cfu/serving) and Inulin (3gr/serving), once daily.; A 4 oz. cup of acidified dairy snack, once daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: non-patients; non-diarrhea functional bowel symptoms
S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to examine S.endotoxins , inflammatory mediators and Magnetic
      Resonance Spectroscopy (MRS) before and after treatment in patients of cirrhosis and minimal
      hepatic encephalopathy.
    

Detailed description: 
      60 patients of cirrhosis with Minimal Hepatic Encephalopathy (MHE) who fulfills the inclusion
      & exclusion criteria will be the part of study. Study patients will be divided in to two
      groups ( n=30 in each group).

      Group L patients will receive lactulose therapy while Group NL will receive placebo. After 3
      months , S.endotoxins , inflammatory mediators and MRS will be repeated in each group.
    

Intervention name(s): placebo; Lactulose
Intervention type(s): Drug; Drug
Intervention description(s): Syrup, 30 ml BD for 3 months in Gr. NL; Syrup 30 ml BD for 12 weeks
Other intervention name(s): Duphalac , Looz
Intervention MeSH terms: Lactulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endotoxins HE
Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
Condition: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of PF-04856883
      (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.
    


Intervention name(s): Placebo; PF-04856883; PF-04856883; PF-04856883; Placebo; PF-04856883; PF-04856883; PF-04856883; Placebo; PF-04856883; PF-04856883; PF-04856883; PF-04856883
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Single subcutaneous injection of placebo; Single subcutaneous injection of PF-04856883; Single subcutaneous injection of PF-04856883; Single subcutaneous injection of PF-04856883; Single subcutaneous injection of placebo; Single subcutaneous injection of PF-04856883; Single subcutaneous injection of PF-04856883; Single subcutaneous injection of PF-04856883; Multiple weekly subcutaneous injections of placebo for 3 weeks; Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks; Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks; Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks; Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Other intervention name(s): CVX-096; CVX-096; CVX-096; CVX-096; CVX-096; CVX-096; CVX-096; CVX-096; CVX-096; CVX-096; CVX-096
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phase 1; Type 2 Diabetes; CVX-096
UNDISTORT Correction of Distortions in Diffusion MRI V1.0
Condition: MR Image Distortion Correction; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      This is a three-year project funded by a Cancer Research UK Multidisciplinary Award and
      brings together a team from UCL Division of Medicine, Computer Science and University College
      London Hospital. The aim is to develop Magnetic Resonance (MR) sequences and mathematical
      algorithms to reduce the distortions in MR images, especially of the prostate.
    

Detailed description: 
      This is a three-year project funded by a Cancer Research UK Multidisciplinary Award and
      brings together a team from UCL Division of Medicine, Computer Science and University College
      London Hospital. The aim is to develop Magnetic Resonance (MR) sequences and mathematical
      algorithms to reduce the distortions in MR images, especially of the prostate. Current NICE
      guidelines include a type of MR imaging called Diffusion Weighted MRI for the detection of
      tumour within the prostate, and for active surveillance of low risk confirmed disease.
      However, approximately 40% of prostate diffusion images suffer from severe localised
      distortions and this is most marked in the peripheral zone of the prostate where 75% of
      prostate cancers occur. The source of these distortions is magnetic field imperfections due
      to the presence of rectal gas or metallic hip implants.

      The research study will ask both healthy volunteers and patients to undergo research MR scans
      and use the acquired data for analysis. For patients, the scans may be either additional
      sequences acquired during an extended clinical session, or a separate additional session
      entirely for research.

      The output from the research will be modified ways to run an MR scanner and compute the final
      images.

      The work should lead to improved diagnostic accuracy and a reduced number of non-diagnostic
      studies. It will have broader impact through application to diffusion imaging of other body
      sites, including whole-body diffusion MRI and non-cancer applications. If successful, the
      results would provide evidence for a larger trial with the eventual outcome being
      manufacturers incorporating modified MR sequences and data processing into clinical systems
      worldwide.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will recruit patients within the UCLH imaging pathway and healthy participants
        for research Magnetic Resonance imaging. There is no requirement for participants to be
        imaged more than once for this study. Following the MR scan, no further involvement is
        required from the participants. This is a single-centre study and all imaging will take
        place at UCLH. The de-identified data will be processed by members of the study team within
        UCL.
      
Keywords: MRI; distortion correction; Magnetic Resonance Imaging; prostheses
Quetiapine SR and Divalproex Sodium ER in the Treatment of Anxiety in Bipolar Disorder With Panic Disorder and/or GAD
Condition: Bipolar Disorder; Panic Disorder; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders; Bipolar Disorder; Panic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The specific aim of this study is to evaluate the efficacy, tolerability, and safety of
      quetiapine SR monotherapy and divalproex sodium ER monotherapy in comparison to placebo in
      the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or
      generalized anxiety disorder and current at least moderately severe anxiety.
    

Detailed description: 
      This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of
      quetiapine SR monotherapy compared to divalproex sodium ER monotherapy in outpatient subjects
      with a lifetime bipolar I, II, or not otherwsise specified (NOS) disorder, a lifetime panic
      or generalized anxiety disorder, and current diagnosis at least moderately severe anxiety
      symptoms. Approximately 180 subjects will be randomized to obtain 90 subjects who complete
      the 8-week trial (30 completers per treatment group). This calculation is based on drop out
      rates in a similar patient population carried out by this group of collaborators. Subjects
      will be randomized to quetiapine SR or divalproex sodium ER or placebo in a 1:1:1 ratio. No
      concomitant psychotropic medication will be allowed throughout the study except for prn
      lorazepam during the first two weeks for the management of affective and anxiety symptoms,
      prn zolpidem and zaleplon for the management of insomnia and benztropine for the management
      of extrapyramidal side effects (EPS). Throughout the study, psychiatric scales will be used
      to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be
      monitored and recorded.
    

Intervention name(s): quetiapine SR; divalproex sodium ER; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): flexible dosing, 50 mg up to a maximum of 300 mg per day for 8 weeks; Flexible dosing, 500 mg up to a maximum of 3000 mg per day for 8 weeks; placebo
Intervention MeSH terms: Valproic Acid; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Randomized; Double-Blind; Placebo-Controlled; Quetiapine; DivalproexSodiumER; Bipolar; Anxiety; Panic; GAD
Efficacy and Tolerability of Sensoril® in Improving Immunity and Thereby Reducing Incidence of Upper Respiratory Tract Infections
Condition: Immune Health
MeSH terms: Respiratory Tract Infections
Study type: Interventional

Summary: 
      to assess the efficacy and safety of a standardized Withania somnifera extract (Sensoril®) as
      an immunomodulator in individuals suffering from recurrent URTIs. The study population will
      be administered with this unique blend of WS extract for 12 weeks and will be assessed as per
      the study designated efficacy and safety variables.
    


Intervention name(s): Aqueous extract of roots plus leaves of Withania somnifera 125 mg; Aqueous extract of roots plus leaves of Withania somnifera 250 mg; Microcrystalline Cellulose
Intervention type(s): Other; Other; Other
Intervention description(s): One capsule before breakfast for 84 days; One capsule before breakfast for 84 days; One capsule before breakfast for 84 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study to Evaluate the Effect of JNJ-28431754 (Canagliflozin) on Post-Meal Glucose in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of canagliflozin on post-meal glucose
      blood levels in patients with Type 2 Diabetes Mellitus.
    

Detailed description: 
      This is a double-blind (neither study staff or the patient will know the identity of the
      treatment assigned) study of canagliflozin in patients with Type 2 Diabetes Mellitus (T2DM)
      who are currently taking metformin at a stable dose of >=1500 mg/day. Patients will
      participate in the study for up to approximately 16 weeks. During the study, patients will
      receive 4 treatments (A, B, C, and D); each treatment will be administered during a 3-day
      treatment period. Patients will receive 1 dose of study medication in the morning of Day 1
      and Day 2 of each treatment period and treatment periods will be separated by approximately 2
      weeks. Treatments will consist of placebo (A), canagliflozin 300 mg and placebo (B),
      canagliflozin 300mg (C), and canagliflozin 300mg and canagliflozin 150mg (D).
    

Intervention name(s): Placebo; Canagliflozin 300mg/Placebo; Canagliflozin 300mg/Canagliflozin 150mg; Canagliflozin 300mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment A: Form=capsule, route=oral administration. Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.; Treatment B: Type=1, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods.
Form=capsule, route=oral administration. Capsule is taken once on Day 2 in 1 of 4 treatment periods.; Treatment D: Type=1, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods.
Type=1, unit=mg, number=150, form=capsule, route=oral use. Capsule is taken once on Day 2 in 1 of 4 treatment periods.; Treatment C: Type=1, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Canagliflozin; Placebo; Type 2 diabetes mellitus
Citalopram for Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine
      dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent
      patients will be assigned equally to one of three medication conditions: placebo or the
      Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or
      40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase
      periods of sustained abstinence substantially more than placebo. Performance on a set of
      behavioral tasks of impulsivity will be analyzed as potential predictors of treatment
      response.
    


Intervention name(s): Citalopram; Citalopram; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg once per day for 9 weeks; 40 mg per day for 9 weeks; 0 mg per day for 9 weeks
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cocaine; citalopram; treatment; serotonin