bioihbjkbjnl/mcl2 huggingface dataset:
LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis
Condition: Lumbar Spine Degeneration; Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      Lateral lumbar interbody fusion (LLIF), as a minimally invasive technique, is an indirect
      decompression technique, and its decompression effect is not as thorough as traditional
      posterior decompression surgery. For certain patients with severe lumbar stenosis, additional
      posterior decompression is required. However, whether additional posterior decompression is
      necessary for these patients is unknown. Radiographic predictors of failed indirect
      decompression via LLIF is unknown. In current randomized, controlled trial , the
      investigators compare the clinical outcomes of patients with severe lumbar stenosis who
      received LLIF plus posterior decompression and those without posterior decompression.
    

Detailed description: 
      The current randomized controlled trial consists of two groups. Patients included in the
      study are with Schizas's stenosis grades C. Patients in one group received transpsoas lateral
      lumbar interbody fusion. Patients in the other group received transpsoas lateral lumbar
      interbody fusion plus posterior decompression. Patients will be followed for one year.
      Clinical outcomes of the two groups will be compared. And radiographic predictors of failed
      indirect decompression via LLIF will be analyzed.
    

Intervention name(s): Lateral lumbar interbody fusion
Intervention type(s): Procedure
Intervention description(s): LLIF is an indirect decompression technique, and does not directly remove the disc or osteophyte protruding into the spinal canal. Its decompression effect is not as thorough as traditional posterior decompression surgery. Usually, posterior decompression is required for patients who have unsuccessful indirect decompression.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients included in this study are with degenerative lumbar stenosis and Schizas's stenosis grades C. Patients who suffered from significant lumbar scoliosis, grade 2 spondylolisthesis, lumbar fracture and prior lumbar surgery are excluded from this study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: indirect decompression; lateral interbody fusion; lumbar; direct decompression
Rituximab,Methotrexate and Lenalidomide in Newly Diagnosed Primary Central Nervous System Lymphoma
Condition: Primary Central Nervous System Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      It is a single arm, multicenter, phase 2 study to explore the efficacy and safety study of
      R2-MTX chemotherapy（Lenalidomide, Rituximab and Methotrexate）as first-line regimens in the
      treatment of newly diagnosed primary central nervous system lymphoma. Objective response rate
      is the primary endpoint.
    

Detailed description: 
      This is a single arm, multicenter, phase 2 study designed to evaluate the efficacy and safety
      of rituximab, methotrexate and lenalidomide as first-line regimens in the treatment of newly
      primary central nervous system lymphoma. A total of 40 patients plan to participate in this
      study to receive a total 6 cycles of induction chemotherapy followed by 4 cycles of
      maintenance chemotherapy. Follow-ups should be taken up to the first 3 years. The primary
      endpoint is objective response rate (ORR) and secondary endpoint includes Progression free
      survival (PFS), overall survival (OS), and adverse events.
    

Intervention name(s): Rituximab; Lenalidomide; Methotrexate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 375mg/m2 intravenous infusion d1, every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy. 375mg/m2 intravenous infusion d1, every 8 weeks for 1 cycle, 4 cycles will be prescribed for maintenance therapy.; 25mg orally d1-10 every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy. 25mg orally d1-14,d29-42 every 8 weeks for 1 cycle, 4 cycles will be prescribed for maintenance therapy.; 3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle, 6 cycles will be prescribed.
Intervention MeSH terms: Rituximab; Methotrexate; Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS
Condition: Infertility Poly Cystic Ovary
MeSH terms: Infertility
Study type: Interventional

Summary: 
      the aim of the study is to compare between the step-up and conventional protocols in
      ovulation induction in infertile women with PCOS
    

Detailed description: 
      The current study was conducted in private outpatient clinic after being approved by the
      medical ethics committee. The study is a prospective randomized study consisting of 90
      Egyptian patients diagnosed as having infertility with pcos .

      Sample size determination:

      Group sample sizes of 42 and 42 achieve 80% power based on study finding carried out by
      (Galal et al., 2014) to detect a difference of 0.7 between the null hypothesis that both
      group means are 2.2 and the alternative hypothesis that the mean of group 2 is 1.5 with known
      group standard deviations of 1.5 and 0.6 and with a significance level (alpha) of 0.05000
      using a two-sided Mann-Whitney test assuming that the actual distribution is uniform.

      Sample size was calculated by PASS 11 Computer program for sample size calculation.

      Taking into consideration 10% drop out rate, the sample size will be increased to 45 patients
      in group I and another 45 patients in group II.

      Patients were divided into two groups with randomization sheet:

      Group (I): includes 45 females taking Letrozole (old regimen).

      Group (II): includes 45 females taking Letrozole 5 mg tab in a step-up protocol (new
      regimen).
    

Intervention name(s): Letrozole
Intervention type(s): Drug
Intervention description(s): Letrozole is a third generation inhibitor that is emerging as a new oral agent for induction of ovulation.
Intervention MeSH terms: Letrozole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Spirituality, Experience of Disease and Quality of Life in Cancer Patients
Condition: Psychology and Cancer
Study type: Interventional

Summary: 
      The general aim of research is to identify and analyze the impact and role of spirituality
      (as a search for meaning and understanding of the meaning of existence) in the experience of
      cancer. For this purpose, the main objective of this study is to measure the "existential"
      component in the trajectory of the disease. It is a question of observing its potential
      contribution to the improvement of the quality of life of the patients and to define if this
      variable can be translated into a strategy of adjustment for the patients. This research has
      a double interest: (a) clinical interest in better managing patients' needs; (B) an interest
      in research in the field of health by combining a measure of spirituality with other
      psycho-social variables.

      The project is a prospective non-randomized mono-centric study by questionnaire and research
      interview. It is a study that seeks to identify the role of spirituality in the experience of
      illness (i.e. representations, adjustments, emotional distress) and as a determinant of the
      quality of life of subjects with cancer pathology.

      The interviews will be conducted by a psychologist to qualitatively collect the elements of
      the lived experience of the disease in connection with the spiritual elements of the "quest
      for meaning" type.

      The population covered by the project is in and out patients coming to the Department of
      Medical Oncology and Palliative Care at the CHU de la Timone.

      The realization of this project will allow investigators to explore the specificity of the
      existential / spiritual dimensions of patients confronted with cancer, to assess the
      patients' needs for this type of approach within the hospital, to link the existential
      component / Spiritual with psycho-social variables
    


Intervention name(s): Questionnaire and interview
Intervention type(s): Behavioral
Intervention description(s): Cancer patients will answer questionnaires and will be interviewed by a pshychologist to assess their spirituality and quality of life toward their disease
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Efficacy of Computerized Cognitive Training in Adults With ADHD: Change in ADHD Symptoms, Executive Functions and Quality of Life Following Three Months of Training.
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The study group of Adults with ADHD who will receive cognitive (executive attention)
      computerized training will show significant improvement in ADHD
      symptomatology,neuropsychological measures,daily functioning and quality of life.

      A significant difference will be found between the study group and the control group (adults
      with ADHD that will receive a simplified cognitive training program that does not challenge
      their executive functions)on the above measures.
    


Intervention name(s): cognitive computerized training; simple cognitive computerized training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): cognitive computerized training utilizing executive attention tasks; simple computerized cognitive program utilising simple reaction time tasks that do not challenge executive attention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Executive functions; Quality of life
Effect of Adding Dexamethasone to Intrathecal Bupivacaine on Blood Sugar of Patients Undergoing Diabetic Foot Surgeries
Condition: Diabetic Foot
MeSH terms: Diabetic Foot
Study type: Interventional

Summary: 
      effect of intrathecal dexamethasone on blood sugar of dietetic patients
    


Intervention name(s): Bupivacaine with dexamethasone; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): bupivacaine with dexamethasone; bupivacaine
Intervention MeSH terms: Dexamethasone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Adjunct Immunotherapy With Immunoxel in Patients With TB and TB/HIV
Condition: Tuberculosis; HIV
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Dzherelo (Immunoxel) is an oral immunomodulating botanical agent available over-the-counter
      in Ukraine. After many years of laboratory and clinical testing the formulation was approved
      in 1997 by the Ministry of Health of Ukraine as a dietary herbal supplement, which enhances
      immunity against viral and infectious diseases. The goal of this study is to conduct
      confirmatory clinical trial in Ukraine and Mongolia for TB indications.
    

Detailed description: 
      Phase III, placebo-controlled trial, aimed to seek the therapeutic benefit of Immunoxel in
      combination with standard of care anti-TB therapy (ATT) at the end of the 1-month period
      (p<0.05) among subjects with sputum-positive pulmonary TB. The results will be compared to
      standard ATT therapy + placebo. The trial will consist of one stage with laboratory
      evaluation after one month. Two cohorts or arms of at least 150 subjects each (total 300)
      with pulmonary TB positive for sputum AFB smear will be randomized in a 1:1 ratio to receive
      once-daily, honey lozenge of Immunoxel in combination with standard ATT for 1 month. Patients
      who receive standard ATT + placebo preparation will be used as a group of comparison.
    

Intervention name(s): Immunoxel; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 1 lozenge once per day; 1 lozenge once per day
Other intervention name(s): Immunoxel honey lozenges; Placebo lozenge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TB; MDR-TB; XDR-TB; TB/HIV
A Study to Evaluate the Pharmacokinetics，Safety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of the study are to evaluate the Pharmacokinetics，Safety and
      tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
      (FRSW117) in patients with severe hemophilia A.

      The secondary objectives are to monitor anti-durg antibodies and anti-PEG antibodies levels
      in patients with severe hemophilia A
    


Intervention name(s): ADVATE; FRSW117
Intervention type(s): Drug; Drug
Intervention description(s): a single dose.; a single dose.
Other intervention name(s): PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Intervention MeSH terms: Factor VIII
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: severe Hemophilia A; PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection; Pharmacokinetics; Efficacy and tolerability; Phase I
Development and Testing of Adolescent Twelve-Step Facilitation
Condition: Alcohol Abuse; Alcohol Dependence; Drug Abuse; Drug Dependence
MeSH terms: Alcoholism; Substance-Related Disorders
Study type: Interventional

Summary: 
      This study is the first to develop and test in a randomized experimental design the efficacy
      of an integrated 12-step facilitation intervention tailored for young people. In the first
      phase of the study, the investigators are developing and revising a preliminary manual for
      the two sessions individually-delivered Motivational Enhancement Therapy (MET) component and
      subsequent 8 session group-delivered Cognitive-Behavioral Therapy (CBT) component which will
      integrate Twelve-step Facilitation (TSF). Forty adolescents each will complete the
      preliminary integrated TSF protocol. In the second phase of the study, the investigators will
      compare integrated TSF (iTSF) to standard treatment (MET/CBT) in a randomized experimental
      design for adolescent substance use disorder with 60 adolescents. As a result, the
      investigators will examine potential mechanisms that may underlie the efficacy of iTSF in
      improving alcohol and other drug use outcomes. The investigators will test group differences
      on potential mechanisms of change (e.g., Alcoholics Anonymous/Narcotics Anonymous attendance
      and involvement) and whether these variables are associated with substance use outcomes.
    


Intervention name(s): Integrated Twelve-Step Facilitation; Cognitive Behavioral Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The iTSF condition will include review of treatment goals and overall review of progress, coping skills, real life practices, emotions/mood management, how to make changes in one's social network and discussions about how 12-step meetings can be helpful in one's recovery efforts. In addition, speakers from 12-step fellowships such as Alcoholics Anonymous (AA) and Narcotics Anonymous (NA) will be invited to share their experiences and discuss myths and facts related to attendance at 12-step meetings as well as answer any questions participants have about these fellowships.; The CBT condition will include review of progress, coping skills, group exercises, real life practice, and emotions/mood management.
Other intervention name(s): iTSF; CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents; Alcohol Abuse; Alcohol Dependence; Drug Abuse; Drug Dependence; Substance Use Disorder; Alcoholics Anonymous; Motivational Enhancement Therapy; Cognitive Behavioral Therapy
Peak Flow Monitoring in Older Adults With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Evaluate the incremental effectiveness of peak flow monitoring ove symptom monitoring as a
      management tool to enhance asthma control in adults >= 50 years with moderate-severe asthma.
    

Detailed description: 
      BACKGROUND:

      We propose a five-year Demonstration and Education project to assess the incremental value of
      peak flow monitoring (PFM) over symptom monitoring (SM) as a management tool for asthma
      control in adults greater than or equal to 50 years with moderate-severe asthma. We will
      develop three parallel asthma education programs for older adults using as our base an
      existing asthma education program (AIR/Kaiser Adult Education Program) of demonstrated
      efficacy for adults ,50 years of age.

      DESIGN NARRATIVE:

      Primary outcome Frequency and cost of health care utilization for asthma, and asthma-specific
      quality of life

      Key secondary outcomes Prebronchodilator FEV1; diurnal variability in PEF

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): Peak Flow Monitoring
Intervention type(s): Behavioral
Allocation: Randomized
Diffusion MRI for Pancreatic Adenocarcinoma
Condition: Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional

Summary: 
      The detection of small liver metastases represents a major challenge during the staging
      process of patients with pancreatic adenocarcinoma. Currently, thoraco-abdominopelvic CT
      represents the established imaging modality for selecting patients with pancreatic
      adenocarcinoma for curative surgery. However, despite its performance, 13% to 23% of patients
      undergoing a surgical procedure are finally found to have an unresectable disease because of
      arterial involvement, peritoneal carcinomatosis, or the existence liver metastasis that had
      not been detected by preoperative workup. Compared to CT, diffusion-weighted MRI provides a
      better contrast resolution for soft tissue and liver imaging, and thus leads to a better
      detection of focal liver lesions. Hence, it could be hypothesized that the use of DW-MRI in
      patients with potentially resectable PA may improve the selection process of candidates for
      curative pancreatic resection by increasing the detection of LM undiagnosed by traditional
      preoperative work-up
    


Intervention name(s): Diffusion-weighted nuclear magnetic resonance imaging
Intervention type(s): Radiation
Intervention description(s): All MRI examinations will be carried out using a Siemens Magnetom Avanto syngo MR B15 1.5 Tesla (Erlangen, Germany) or a Philips Intera 1.5 Tesla (Eindhoven, The Netherlands) and will include the following sequences: (i) T2 fat sat, with a FOV of 350 x 262, and a matrix of 384 x 207; slices, 30 per sequence, 6 mm thick; (ii) T1 in-phase and out-of-phase with a FOV of 380 x 262, and a matrix of 256 x 158; slices, 30 per sequence, 6 mm thick; (iii) T1 water excitation (= T1 ProSat), with a FOV of 300 x 300, and a matrix of 320 x 220; obtaining 20 slices of 4 mm; (iv) VIBE and THRIVE (dynamic T1 axial 3D EG after injection, during the arterial, portal venous, and late phases, in an axial plane, and optionally in a coronal plane during the portal venous phase), with a FOV of 400 x 312, a matrix of 384 x 192, and with fat suppression and breath-hold; slices 3 mm thick, with liver and pancreatic coverage. Contrast agent: gadobenate dimeglumine (MultiHance, Bracco Imaging, France).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Changes of Diet, Physical Activity and Sleep Pattern and Their Effects on Glycemic and Weight Control in Hong Kong Chinese Obese Patients With Type 2 Diabetes After Bariatric Surgery Compared to Telephone Intensive Lifestyle Counselling
Condition: Diabetes Mellitus Type 2 in Obese
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Nutrition therapy is recognized as one of the crucial components for the standard treatment
      of diabetes along with physical activity and drug therapy. Of note, dietary habits are
      culture specific and hence understanding the dietary intake, eating behavior and physical
      activity level of the local population is important to formulate effective nutrition and
      lifestyle strategies. Weight control is a major therapeutic challenge because many
      conventionally used anti-diabetic agents, such as sulphonylurea and insulin, can cause weight
      gain, thus setting up a vicious cycle with increasing insulin resistance due to increasing
      levels of free fatty acids from adipose tissues . Although intensive face-to-face lifestyle
      intervention program has showed that even modest weight loss in people with Type 2 diabetes
      (T2DM) who were overweight or obese was associated with improvements in glycemic control and
      associated conditions, it may not be feasible in public hospital setting in Hong Kong due to
      factors such as limited resources, scheduling, patient's employment and willingness for
      frequent travel to the clinic. Hence, alternative strategies such as a combination of face-
      to-face individual dietary and lifestyle consultation together with telephone intensive
      lifestyle reinforcement program will likely to be an useful strategy to engage those obese
      T2DM patients through frequent individual contacts. On the other hand, bariatric surgery has
      emerged as an impressive therapeutic option for poorly control obese T2DM patients.

      Realizing there is a knowledge gap in understanding the lifestyle factors in the Hong Kong
      Chinese obese T2DM patients, we therefore propose to conduct a 1-year prospective clinical
      trial with two main objectives:

        1. To study and compare the glycemic and weight improvement after bariatric surgery versus
           a telephone intensive lifestyle intervention program for 1 year in Hong Kong Chinese
           obese patients with type 2 diabetes.

        2. To investigate the effect of lifestyle factors including dietary intake, eating
           behaviors and physical activity level on the glycemic and weight control of Hong Kong
           Chinese obese patients with type 2 diabetes.
    


Intervention name(s): Bariatric surgery; Telephone Intensive Lifestyle Counselling
Intervention type(s): Procedure; Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment