bioihbjkbjnl/mcl2 huggingface dataset:
Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma; Diffuse Large Cell Lymphoma; Mantle Cell Lymphoma; Transformed Lymphoma; Other Subtypes of B-cell Lymphoma; Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas,
      but is limited by relapse occurs in 40 to 50% of subjects.

      This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose
      therapy increases the event-free survival in diffuse aggressive lymphomas and low grade
      lymphomas, as an alternative to the limitations of conventional therapy.

      Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about
      50% with very little toxicity. Rituximab is hypothesized to be a candidate for
      post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen;
      rituximab has impressive independent anti-tumor activity; and the antibody has little
      toxicity outside of the acute administration.
    

Detailed description: 
      The first 4 subjects received rituximab weekly for 4 weeks at the standard dose of 375 mg/m2,
      starting 6 weeks after ASCT transplant.

      After an observation period to assess acute and late toxicity for the first 4 subjects,
      subsequent subjects received induction as above followed by an additional 4 week course at
      6-months post-ASCT.
    

Intervention name(s): Rituximab 375 mg/m2
Intervention type(s): Drug
Other intervention name(s): Rituxan; MabThera; Zytux; IDEC-C2B8; chimeric anti-CD20
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-Hodgkin's lymphoma; diffuse large cell lymphoma; mantle cell lymphoma; transformed lymphoma; other subtypes of B cell lymphoma; recurrent lymphoma
The Effect of a Smartphone Application Self-management Programme on Clinical Health Outcomes in Patients With Chronic Obstructive Pulmonary Disease.
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic Obstructive Pulmonary Disease (COPD) has a significant impact on one's quality and
      quantity of life resulting in increased morbidity and mortality. In Ireland, COPD has the
      highest hospital admissions in comparison to other countries within the organisation for
      economic cooperation and development (OECD). There is a need to improve knowledge and
      self-management behaviour in order to improve recognition of early signs of an exacerbation
      thereby seeking early treatment from the general practitioner (GP) thus reducing hospital
      admissions among this cohort . There are limited studies pertaining to the use of a
      comprehensive self-management programme via a smartphone app for people with COPD on a
      longitudinal basis.The aim of this study is to investigate the effectiveness of a smartphone
      application self-management programme on clinical health outcomes in patients with COPD.
    


Intervention name(s): Smartphone application self-management programme
Intervention type(s): Behavioral
Intervention description(s): The intervention in this trial is a self-management programme via a smartphone app. This self-management programme measures lung function (FEV1), oxygen saturation (SP02), dyspnoea score (m MRC) and step count. It also provides educational videos such as recognising symptoms of an exacerbation and physical activity. The smartphone app self-management programme will provide real time data monitoring resulting in baseline trends in patient's disease pattern. Additionally, it also provides subjective data that will allow the clinician to develop an understanding of the patient's quality of life.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single centre feasibility three-arm parallel randomised control trial (RCT) study. The trial consists of three groups which are, Group A, Arm 1 (standard respiratory outpatient care with a smartphone app self-management programme with follow up monthly phone calls), Group B, Arm 2 (standard respiratory outpatient care with a smartphone app and Group C, control group (standard respiratory outpatient care).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Pilot Study of Strength Testing in Overweight Women With or Without Insulin Resistance
Condition: Obesity
MeSH terms: Overweight; Insulin Resistance
Study type: Observational

Summary: 
      Background:

      - Some people who are obese may have decreased muscle strength. They may have greater muscle
      mass shown in scans, but they show poor results in exercise tests. Poor muscle strength might
      cause some of the difficulty with exercise performance. Researchers want to test muscle
      strength in the arms and legs of overweight women. They will also see how insulin resistance
      affects muscle strength in these women.

      Objectives:

        -  To test muscle strength in overweight women.

        -  To see if insulin resistance affects muscle strength.

      Eligibility:

      - Women at least 18 years of age who are overweight (body mass index greater than 25 kg/m2).

      Design:

        -  Participants will be asked to fast before having an initial blood test to measure
           glucose and insulin levels.

        -  On a different day, they will have the strength testing. The first test will measure leg
           muscle strength by testing the quadriceps and the hamstrings. The second test will
           measure arm muscle strength by testing the biceps and triceps. The final test will
           measure hand muscle (grip) strength.

        -  All the tests should take about an hour.
    

Detailed description: 
      We have observed in our protocol (08-H-0108: Effects of Worksite Wellness Interventions on
      Vascular Function, Insulin Sensitivity and High-Density Lipoprotein in Overweight or Obese
      Women) that despite increased lean (muscle) mass in the extremities as measured by dual x-ray
      absorptiometry, obese women have poorer exercise tolerance than overweight women who have
      less muscle mass.1 Exercise testing, however, is an integrated function of cardiopulmonary
      capacity, in addition to muscle strength and endurance. We propose to determine whether
      muscle strength of elbow flexors and knee extensor muscle groups correlates with muscle mass
      of these groups in overweight and obese women selected for normal or abnormal insulin
      sensitivity. Our hypothesis is that subjects with impaired insulin sensitivity and high
      insulin levels will have greater muscle mass but lower muscle strength than subjects with
      normal insulin sensitivity and normal insulin levels. This is a feasibility study to be
      conducted in 10 non-diabetic women (5 with insulin resistance, 5 with normal insulin
      sensitivity) who previously participated in 08-H-0108, the outcome of which will provide data
      for planning a larger study of muscle mass and strength which may be important to achieving
      exercise goals important to successful weight loss.
    

Time perspective: Prospective
Keywords: Obesity; Insulin; Skeletal Muscle; Strength Testing
The 2-stage Approach for Reducing Posterior Wall Puncture During the Internal Jugular Vein Catheterization
Condition: Hematoma
MeSH terms: Hematoma
Study type: Interventional

Summary: 
      To evaluate the effect of a 2-stage approach to the internal jugular vein when performing a
      central venous catheterization compared to the traditional one stage approach on the
      incidence of hematoma formation and success rate.
    


Intervention name(s): Central venous catheterization; Central venous catheterization
Intervention type(s): Procedure; Procedure
Intervention description(s): Approach the internal jugular vein in a traditional one stage fashion during central venous catheterization; Approach the internal jugular vein in a 2 stage fashion during central venous catheterization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hematoma formation; success rate
Inguinal Hernia Repair and Male Fertility
Condition: Inguinal Hernia Bilateral
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      General objective: To evaluate the fertility of adult men submitted to bilateral
      herniorrhaphy with mesh placement by the Lichtenstein and laparoscopic approaches
    

Detailed description: 
      Specific objectives: To correlate pre and postoperative data (90 and 180 days) of adult men,
      according to biochemistry parameters (hemogram and CRP), autoimmune (anti-sperm antibodies),
      hormonal (FSH, LH and testosterone), perfusion and volume testicular (USG of testicles with
      Doppler), spermogram, sexual changes, pain and quality of life (standard questionnaires).
    

Intervention name(s): Bilateral hernioplasty
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial with two groups, in according to hernioplasty correction approach
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inguinal hernia; Infertility; Laparoscopy
The Effect of Ear Plug and Eye Mask on Sleeping Quality in Critically Ill Patients
Condition: Sleep
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Sleep is a complex physiologic and behavioral process essential for rest, repair, well-being,
      and survival. Sleep is defined as a periodic, reversible state of cognitive and sensory
      disengagement from the external environment. Critically ill patients experience poor sleep
      quality. Surveys of ICU survivors have shown that sleep disruption, pain and intubation for
      mechanical ventilation are the major sources of anxiety and stress during the ICU stay. Many
      physiological, psychological and environmental factors contribute to the incidence of sleep
      disruption for the ICU patients. The primary physiologic factors documented in the literature
      are pain, medications and illness.The primary psychological factors documented in the
      literature are stress and worry. Environmental factors include noise, patient care activities
      and therapeutic modalities as mechanical ventilation. Our research aim will be the impact of
      effective interventions like use of ear plugs and eye mask on decreasing light exposure and
      promoting sleep in ICU patients.
    

Detailed description: 
      50 patients in the age range 18- 60 years admitted to ICU of Assiut university hospitals will
      be randomly allocated into into two groups (control group and intervention group).
    

Intervention name(s): ear plug; eye mask
Intervention type(s): Other; Other
Intervention description(s): The patients will receive the intervention (ear plug) in the third night (N3) from 9 pm to 6 am.; The patients will receive the intervention (eye mask) in the second night (N2) from 9 pm to 6 am.
Other intervention name(s): eastnova ear plug; Sleeping mask
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Delirium; Ear Plug; Eye Mask; Mechanical ventilation; Sleep
A Safety and Tolerability Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Acute Lymphoblastic Leukemia (ALL)
Condition: Lymphoblastic Leukemia, Acute, Childhood
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase,
      and Vincristine to assess this 5-drug treatment's safety and tolerability in pediatric
      patients with first relapse Acute Lymphoblastic Leukemia (ALL).
    

Detailed description: 
      The trial is a Phase 1, open-label study to assess the safety and tolerability of
      incorporating clofarabine into an intensive chemotherapy regimen of etoposide,
      cyclophosphamide, PEG-asparaginase, and vincristine. Patients enrolled in this study will
      receive a maximum of 2 cycles of the 5-drug regimen, then will be treated according to
      investigator discretion. After the study treatment period, all patients will be followed for
      a minimum of 4 months beyond the final study visit. This study will include a maximum of 12
      evaluable patients.
    

Intervention name(s): Clofarabine incorporated into a 5-drug regimen
Intervention type(s): Drug
Intervention description(s): Clofarabine (IV) 40mg/m2 into an intensive chemotherapy regimen of etoposide, cyclophosphamide, PEG-asparaginas, and vincristine
Other intervention name(s): Clolar; VP-16; Cytoxan; PEGaspar-aginase; Oncovin
Intervention MeSH terms: Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ticagrelor in Comparison to Prasugrel for Early Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
Condition: Platelet Reactivity
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-center, randomized, single-blind, investigator-initiated, pharmacodynamic
      study with a parallel design. Patients with ST elevation myocardial infarction, undergoing
      primary percutaneous coronary intervention will be randomized after informed consent, in a
      1:1 ratio to the following treatment groups:

      Group Α: Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose
      (MD)starting 12±6 hours post LD, until Day 5 (5 days after randomization) Group Β: Prasugrel
      60 mg LD followed by 10mg x1 MD starting 24 hours post LD, until Day 5 (5 days after
      randomization).

      Platelet reactivity assessment will be performed at randomization (Hour 0) and at 1, 2, 6, 24
      hours after randomization, and on Day 5. Documentation of major adverse cardiac events
      (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and
      serious adverse events (bleeding, other adverse events)will be performed until Day 5.
    


Intervention name(s): Prasugrel; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Prasugrel 60mg LD followed by 10mg x1 MD starting post 24 hours; Ticagrelor 180mg LD followed by 90mg x2 MD starting after 12±6 hours
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Platelet reactivity; Ticagrelor; Prasugrel
Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain
Condition: Cancer Survivor; Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this quasi-experimental study is to explore the impact of a therapeutic
      horticulture program as an occupation-based intervention to address chronic pain symptoms for
      cancer survivors. The main objectives are to assess participants' perceptions of pain,
      physical and psychosocial wellness, stress management, and quality of life at pre-, post-,
      and 3-month follow-up. Quantitative and qualitative data will be synthesized and analyzed to
      explore this phenomenon.
    


Intervention name(s): Horticultural activity
Intervention type(s): Behavioral
Intervention description(s): Therapeutic horticulture activities are plant-related activities that include but not limited to digging, watering, planting, weeding, trimming, fertilizing, mulching, harvesting, learning about organic farming, and exploring options to incorporate horticulture into daily activities
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy.
Condition: Acute-On-Chronic Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure
Study type: Interventional

Summary: 
      In this study, all patients with ACLF (Acute on Chronic Liver Failure) with grade III/IV HE
      (Hepatic Encephalopathy) getting admitted in our institute will be enrolled after the
      fulfilment of inclusion/exclusion criteria and consent of the patient's attendants.
      Investigation of the patient (as mentioned in the proforma) will be done.

      Intervention step 1:

      liq Lactulose 100 mL stat followed by 30 mL/ hourly through NG/NJ route + Lactulose enema 3rd
      hourly - till 4 time soft stool is passed, then 30 mL through enteral route 6th hourly (If
      patient has no bowel sounds, only enema will be given)

      Intervention step 2:

      (after 24 hours of introduction of step 1, if no rapid reduction in ammonia to <70mcg/dL)
      Randomization to L or R arm R Arm (Addition of Rifaximin) Continuation of Lactulose +
      addition of Rifaximin 400 mg 8th hourly through enteral route L Arm (Lactulose only)
      Continuation of Lactulose therapy for further 48 hours.
    


Intervention name(s): Lactulose + Rifaximin; Lactulose
Intervention type(s): Drug; Drug
Intervention description(s): Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route; Continuation of Lactulose therapy for further 48 hours.
Intervention MeSH terms: Rifaximin; Lactulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cholic Acid for Hepatic Steatosis in Lipodystrophy
Condition: Hepatic Steatosis
MeSH terms: Fatty Liver; Lipodystrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and safety of cholic acid therapy in treating lipodystrophy patients
      with hepatic steatosis. This is a randomized, double-blind, placebo-controlled cross-over
      study.
    

Detailed description: 
      Lipodystrophies are rare disorders characterized by selective loss of adipose tissue and
      predisposition to develop insulin resistance and its associated metabolic complications such
      as dyslipidemia, diabetes mellitus and hepatic steatosis. Nonalcoholic hepatic steatosis or
      steatohepatitis caused by excessive accumulation of triglycerides in hepatocytes, in fact, is
      a common feature of these disorders. Often a cause for significant morbidity and even
      mortality in lipodystrophic patients, hepatic steatosis poses a significant therapeutic
      challenge. Recent insight into the role of primary bile acids, cholic acid and
      chenodeoxycholic acid, which are endogenous ligands for the farnesoid X receptor (FXR), in
      regulating hepatic triglyceride homeostasis offers new treatment options for hepatic
      steatosis. Cholic acid was shown to inhibit hepatic triglyceride accumulation by more than
      50% in a mouse model of hepatic steatosis and hypertriglyceridemia. Cholic acid has been
      previously used to treat inborn errors of bile acid synthesis in children without any side
      effects. In other studies in adults, cholic acid has been reported to be well tolerated.
      Therefore, we propose to investigate a potentially safe therapeutic option for its efficacy
      in reducing hepatic steatosis in patients with lipodystrophies.
    

Intervention name(s): Cholic Acid
Intervention type(s): Drug
Intervention description(s): Capsules of active Cholic Acid or matching placebo, total dose is 15 mg/kg per day, maximum dose of 1500 mg per day, taken PO, BID.
Intervention MeSH terms: Cholic Acids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: lipodystrophy
Calcium and Vitamin D Intakes in Children
Condition: Hypocalcemia; Hypovitaminosis D
MeSH terms: Rickets; Hypocalcemia; Avitaminosis; Vitamin D Deficiency
Study type: Interventional

Summary: 
      Calcium (Ca2+) and vitamin D (VitD) play an important role in child health. Aims. The
      investigators evaluated the daily intake of Ca2+ and VitD in healthy children; and the
      efficacy of Ca2+ and VitD supplementation. Daily Ca2 + and VitD intake was evaluated in
      consecutive healthy children through a validated questionnaire. Subjects with a daily Ca2 +
      and VitD intake < 70% of dietary reference intakes (DRIs) were invited to participate in
      prospective randomized trial with 2 groups of nutritional intervention: group 1, dietary
      counseling aiming to optimize daily Ca2+ and VitD intake plus administration of a
      commercially available Ca2 + and VitD supplementation product (Colecalcium®, Humana, Milan,
      Italy); group 2, dietary counseling alone. At the enrollment (T0) and after 4 months (T1)
      serum VitD levels were assessed.
    


Intervention name(s): Colecalcium supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Daily Ca2+ and VitD intake was determined using a previously validated written dietary questionnaire, filled by the parents with the help of a registered dietitian. Eventual assumption of Ca2+ and/or VitD supplements or fortified foods was also registered. All questionnaires were collected and analyzed using a specific software based on the Italian food composition tables (Winfood, Medimatica SRL, Martinsicuro, Teramo, Italy). All data were recorded in a specific clinical chart before statistical analysis. All subjects with less than 70% of the DRIs were invited to participate in a randomized trial aiming to investigate the efficacy of different nutritional interventions. The dietitian gave information to the parents on how to improve the consumption of foods rich in Ca2+ and VitD according to DRIs. No nutritional support products were prescribed in children enrolled in group 2.
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 25-Hydroxyvitamin D; dietary counseling; pediatrics; allergy; bone metabolism
Dentoskeletal Effects of Two Different Fixed Functional Appliances for Correction of Class II Malocclusion: A Comparative Clinical Study
Condition: Class II Malocclusion
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      Fixed Functional Appliances comparisons in treatment of orthodontic class II malocclusion
      cases
    

Detailed description: 
      Comparison between two types of fixed functional appliances, the first one is the Mandibular
      Protraction Appliances, while the second one was the PowerScope Appliance.

      the treatment duration was 6 months the patients age was considered according to Baccetti et
      al, CVMI 3,4
    

Intervention name(s): Mandibular Protraction Appliance; PowerScope Appliance
Intervention type(s): Device; Device
Intervention description(s): Mandibular Protraction Appliance was installed on fixed orthodontic appliance; PowerScope Appliance was installed on fixed orthodontic appliance
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 treatment groups, both have class II malocclusion
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PowerScope; Mandibular Protraction Appliance