bioihbjkbjnl/mcl2 huggingface dataset:
A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine,
      prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer
      cells from dividing so they stop growing or die. Combining more than one chemotherapy drug
      may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating
      older patients with previously untreated Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy and toxicity of vinblastine, cyclophosphamide, procarbazine,
           prednisolone, etoposide, mitoxantrone, and bleomycin in older patients with Hodgkin's
           lymphoma.

        -  Determine whether the application of the Hasenclever prognostic index is valid in these
           patients at diagnosis.

      OUTLINE: This is an open-label, multicenter study.

        -  Chemotherapy: Patients receive vinblastine IV and cyclophosphamide IV on day 1; oral
           procarbazine and oral prednisolone on days 1-5; oral etoposide on days 15-19; and
           mitoxantrone IV and bleomycin IV on day 15. Treatment repeats every 28 days, in the
           absence of disease progression or unacceptable toxicity, for a total of 3 courses in
           patients with early (stage IA or IIA) disease or 6 courses in patients with advanced
           (stage IB or IIB-IV) disease.

        -  Radiotherapy: Patients with early stage disease receive involved-field radiotherapy.
           Patients with advanced stage disease receive radiotherapy limited to sites of initial
           bulky disease or residual disease. Radiotherapy begins 4 weeks after the completion of
           chemotherapy.

      Patients are followed monthly for 3 months, every 3 months for 6 months, and then annually
      thereafter.

      Peer Reviewed and Funded or Endorsed by Cancer Research UK

      PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 36 months.
    

Intervention name(s): bleomycin sulfate; cyclophosphamide; etoposide; mitoxantrone hydrochloride; prednisolone; procarbazine hydrochloride; vinblastine sulfate
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Treatment; Treatment; Treatment; Treatment; Treatment; Treatment; Treatment
Other intervention name(s): Blenoxane; Cytoxan; Eposin; Etopophos; Vepesid; Novantrone; Flo-Pred; Pediapred; Orapred; Matulane; Vincristine
Intervention MeSH terms: Prednisolone; Cyclophosphamide; Etoposide; Vincristine; Mitoxantrone; Bleomycin; Vinblastine; Procarbazine; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma
Virtual Reality Distraction During Arteriovenous Fistula Puncture
Condition: Pain Management; Hemodialysis; Virtual Reality
MeSH terms: Arteriovenous Fistula; Fistula
Study type: Interventional

Summary: 
      The cannulation of arteriovenous fistula is a painful procedure in hemodialysis patients.
      Previous studies have shown the effectiveness of virtual reality in reducing pain during
      needle-related procedures
    

Detailed description: 
      Patients undergoing hemodialysis experience anxiety and pain related to the insertion of
      hemodialysis needles, estimated 320 times in total per year. The pain experienced is mostly
      caused by needle insertion into a fistula. Pain control is one of the main nursing tasks.
      Pain relief leads to the acceptance of the procedure and ultimately enhances the patients'
      quality of life. The use of virtual reality to reduce pain and anxiety during the
      arteriovenous fistula cannulation procedure is based on the concept that the perception of
      pain can be controlled because an individual is able to process only a limited amount of
      information at once. As such, the use of virtual reality during painful procedures may serve
      as a distraction.
    

Intervention name(s): virtual reality distraction
Intervention type(s): Procedure
Intervention description(s): study group patients will view VR scene for 6 minutes before puncture .It involves a soothing nature experience and calming background music. Patients in intervention group will not able to see the puncture procedure due to the VR glasses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Postpartum Thyroid Measures and Mood
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression
Study type: Observational

Summary: 
      Women with abnormal serum thyroid antibody levels or abnormal TSH and/or T4 values are more
      likely than their normal counterparts to have higher scores on a common postpartum depression
      screening test.
    

Detailed description: 
      This small pilot study was an attempt to corroborate a relationship between quantified mood
      and thyroid measures, using the numerical scores obtained from a common depression screen,
      the Edinburgh Postnatal Depression Scale (EPDS), as a continuum. Mood scores were compared
      with presence of thyroid autoantibodies and plasma concentrations of free T4 and TSH.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects were patients from two Oklahoma State University Center for Health Sciences
        (OSUCHS) clinics in Tulsa, Oklahoma.
      
Keywords: postpartum depression; thyroxine; thyroid antibodies; thyroid stimulating hormone; Edinburgh Postnatal Depression Scale (EPDS)
Does the Mode of Anesthesia Affect the Feto-maternal Outcome in Category-1 Caesarean Section
Condition: Anesthesia; Adverse Effect; Newborn Morbidity
Study type: Observational

Summary: 
      Spinal anesthesia (SA) has become the standard technique in elective cesarean section (CS) as
      it results in less maternal and neonatal morbidity than general anesthesia (GA) (Grade-A
      recommendation, NICE). For women requiring emergency CS, rapid sequence general anesthesia
      (RSGA) is commonly used because this technique is faster to perform than SA. Though several
      randomized trials have compared the maternal and fetal outcome between these two anesthetic
      techniques, the studies with respect to category 1 CS (emergent conditions that hold
      immediate threat to life of the woman or fetus) are limited.
    

Detailed description: 
      Full term pregnant females will be included in this study. They will be allocated into two
      groups:

      (Group G): will receive rapid sequence general anesthesia, and (Group S): will receive spinal
      anesthesia. After preoperative assessment and investigations by the attending
      anesthesiologist, the decision of the anesthetic approach will be decided by the attending
      anesthesiologist according to indications for CS.

      Before induction of anesthesia intravenous (IV) ranitidine 50 mg will be administered after
      establishing an IV access. On the operating table, vital signs will be monitored for all
      parturients throughout the surgery according to the standard departmental protocol.

      fetal well being will be assessed after delivery by using 1 minute and 5 min APGAR score and
      umbilical cord PH . in addition to maternal vital signs intra-operative then follow up any
      complications that may occur to the mother post-operative.
    

Intervention name(s): anesthesia of emergency cesarean section
Intervention type(s): Procedure
Intervention description(s): compare General versus spinal anesthesia
Intervention MeSH terms: Anesthetics
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        full term pregnant women from 18-40 years old
      
Keywords: emergency cesarean section; general anesthesia; spinal; feto-maternal
Effectiveness of the Just Right Challenge Food Club for Decreasing Food Selectivity and Increasing Mealtime Quality
Condition: Food Selectivity
Study type: Interventional

Summary: 
      This single subject study tested the effectiveness of the Just Right Challenge Food Club for
      decreasing food selectivity and increasing mealtime qualify for children with developmental
      disabilities.
    

Detailed description: 
      This study used a single subject design to test the effectiveness of the Just Right Challenge
      Food Club for decreasing food selectivity and increasing mealtime quality for children with
      developmental disabilities. Baseline data was collected during the time that participants
      spent on the wait list for treatment. Treatment data was collected each week during treatment
      session. This protocol produced a significant change in both the number of foods the children
      in the study ate as well as the parents perception of mealtime quality.
    

Intervention name(s): Just Right Challenge Food Club
Intervention type(s): Behavioral
Intervention description(s): Systematic desensitization, positive reinforcement and escape extinction at a level of just right challenge.
Intervention model: Single Group Assignment
Intervention model description: This was a single-subject (time series design).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Avoidant Restrictive Food Intake Disorder
Fetal Alcohol Syndrome/ARND Research Consortion
Condition: Fetal Alcohol Syndrome
MeSH terms: Fetal Alcohol Spectrum Disorders; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Children will receive comprehensive evaluations through the UOHSC ABC program The assessment
      for the child will include: medical issues (including medication), dysmorphic examination,
      intellectual assessment, academic achievement, language, and motor skills. This program will
      provide appropriate non-study services and referrals. Eligible families will be randomly
      assigned to treatment group or control group. Treatment group will receive Parent Child
      Interaction Therapy (PCIT). The Control group will receive standard referrals and services
      through the ABC program and the parent education/advocacy component of the project.
    

Detailed description: 
      PCIT has been adapted by the applicant for group administration. The intervention will
      consist of 90-minute sessions of PCIT once a week for 14 weeks. During PCIT sessions parents
      and children will participate in activities that promote interactions. A behavior specialist
      who will be observing through a two-way mirror assists parents in development of appropriate
      behaviors and interaction techniques. Parents will be prompted by use of in-ear devices
      (i.e., bug in the ear). This intervention has been shown to be effective in other
      populations. For each family, individualized goals for parent-child interactions will be set
      and reviewed each session. Homework assignments also will be given.

      Parent Component: Three 90-minute sessions conducted in a group format. Topics will include:
      FAS/ARND education, impact of FAS/ARND on families, specific development of a child with
      FAS/ARND, and FAS/ARND social skills and deficits.

      Evaluation Plan: Treatment and control groups will be compared using pre- and post-tests
      measures. Post-tests will be at the conclusion of the intervention and at a 6, 12, and
      18-month follow-ups. Process (e.g., parent satisfaction, compliance, etc) and outcome (e.g.,
      behavior, family functioning, etc) measures will be evaluated.
    

Intervention name(s): Parent-child Interaction Therapy (PCIT)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Keywords: treatment; control
Lamellar Body Counts on Gastric Aspirate in Healthy Term Newborns
Condition: Infant, Newborn, Diseases
MeSH terms: Infant, Newborn, Diseases
Study type: Observational

Summary: 
      The aim of this study to determine the reference ranges of LBC on gastric aspirate in healthy
      term newborns.
    

Detailed description: 
      Lamellar bodies represent the storage form of lung surfactant. Surfactant is produced in
      alveolar type II cells and transported to the alveolar surface as lamellar bodies. Lamellar
      bodies are present in the amniotic fluid and also gastric aspirate.It has become a preferred
      test for determine fetal lung maturity, because of the rapid, inexpensive, easily accessible
      and easily applicable method.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy newborns
      
Biospecimen description: 
      gastric aspiration fluid
Effects Of Latissimus Dorsi Stretching On Functional Disability Related To Chronic Low Back Pain
Condition: Mechanical Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The main objective of the study is to determine effects of latissimus dorsi stretching on
      functional disability related to chronic low back pain
    

Detailed description: 
      A single-blinded,randomized clinical trial will be conducted in /multiple rehabilitation
      centers of Rawalpindi and Islamabad, after taking approval from ERB/IRB respective centers.
      The study duration will be 3 months. the study participants will be having mechanical low
      back pain.

      The intervention will be included latissmus dorsi stretching along with spinal stabilization
      exercises in one group and in comparative group spinal stabilization exercises alone.
      Oswestry Disability Index (ODI) will be used to measure the disability related to the chronic
      low back pain.
    

Intervention name(s): Spinal Stabilization Exercises (SSE); Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)
Intervention type(s): Other; Other
Intervention description(s): Spinal stabilization exercises (SSE) including bridging, planks and tummy tuck-in will be performed. Each participant received a total 7 session thrice a week sessions in two weeks, . Each session had lasted for 30-40 minutes. Spinal stabilization exercises were repeated 5-15 times depending on the endurance of patients.
Home exercise plan will also be given e.g. postural care, precautions in lifting and carrying weights etc.; In experimental group in addition SSE group interventions, participants will receive the latissimus dorsi stretching (LDS). Each participant received a total 7 session thrice a week sessions in two weeks. Each session had lasted for 30-40 minutes. each stretch of latissimus dorsi was of 20-30 seconds with 10-20 repetitions in each session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Vaccinia Virus Vaccine (APSV) in Vaccinia- Naive Subjects: PILOT
Condition: Smallpox
MeSH terms: Vaccinia; Smallpox
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To define the safety of vaccination with APSV as determined by the reactogenicity of the
      vaccine and the development of expected and un-expected adverse events associated with
      vaccination.

      To assess the proportion of individuals who respond to vaccination with a "take" (those who
      form a visible lesion at the injection site) 6 to 8 days after the vaccination.
    

Detailed description: 
      The study will be a four-center, randomized, dose finding trial to evaluate safety,
      preliminary efficacy, and immunogenicity of Aventis Pasteur smallpox vaccine (APSV) in
      healthy, vaccinia-naive adults. Four concentrations of APSV, derived from 2 lots of vaccine,
      will be tested; ranging from 10 (exponent 6 pfu per ml) to 10 (exponent 7.5 pfu per ml). Four
      concentrations of Dryvax (ranging from 10 exp 6 per ml to 10 exp 8 per ml) will be evaluated
      as a positive control. This study is designed to assess the feasibility of the use of APSV
      and dilutions of APSV in an emergency vaccination scenario. The study will be conducted in
      two phases. The initial phase will consist of a single-center, randomized, open-label study
      in 45 subjects to evaluate the safety and approximate the take rate of undiluted APSV (two
      lots APSV plus a Dryvax control arm: n=15 per arm). A 14 day post vaccination safety
      follow-up will be completed for all subjects vaccinated in the initial phase prior to
      initiation of the second phase of the study with an additional 285 subjects. All subjects
      will be followed for 56 days post vaccination with a clinic visit at day 180 for stage 1
      subjects and a follow-up phone call at day 180 for stage 2 subjects. The expansion phase of
      the study will be conducted at three additional sites.
    

Intervention name(s): Wetvax (APSV)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Smallpox; APSV; Aventis Pasteur Smallpox Vaccine; vaccinia-naive
Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Effects of a plant based ingredient on blood glucose in Type II diabetes patients.
    

Detailed description: 
      The study is designed to determine the extend to which a plant based ingredient in a food
      format affects blood glucose responses in untreated Type II diabetes patients.
    

Intervention name(s): Low dose plant based ingredient; High dose plant based ingredient; Reference food format
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Reference food with low dose of plant based ingredient; Reference food with high dose of plant based ingredient; Reference food without plant-based ingredient
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Cilostazol in Acute Ischemic Stroke Treatment (CAIST)
Condition: Cerebral Infarction
MeSH terms: Ischemic Stroke; Cerebral Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to study efficacy and safety of cilostazol use in patients with
      acute ischemic stroke.
    

Detailed description: 
      Stroke is a leading cause of death and elderly disability in developed countries. However,
      treatment of acute stroke is limited except thrombolytic therapy in hyperacute stroke within
      several hours. Currently, aspirin is widely used in spite of its small benefit compared to
      bleeding complications.

      Cilostazol will be compared to aspirin in acute stroke patients in terms of functional
      outcome at 3 months, efficacy to prevent stroke recurrence, and safety for bleeding
      complications.
    

Intervention name(s): Cilostazol; Aspirin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin; Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cilostazol; aspirin; cerebral infarction
Unsupported Upper Extremity Exercise Test in Chronic Neck Pain
Condition: Neck Pain; Upper Extremity Dysfunction
MeSH terms: Neck Pain
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study was to examine the validity and test-retest reliability of unsupported
      upper extremity exercise test (UULEX) in individuals with chronic neck pain.

      Patients with neck pain lasting at least 3 months will be included in the study. It is
      planned to examine the validity and test-retest reliability of the UULEX test in that patient
      groups.
    

Detailed description: 
      Persons with chronic neck pain may limit the functional use of their upper extremities. It is
      recommended to determine appropriate upper extremity measurement methods in patients with
      chronic neck pain. Therefore the aim of this study was to examine the validity and
      test-retest reliability of unsupported upper extremity exercise test (UULEX) in individuals
      with chronic neck pain.

      Six Minute Pegboard Ring Test, 30-Second Push-Up Test and Arm, Shoulder and Hand Injury
      Questionnaire (DASH), Visual Analog Scale, Neck Disability Index, New York Posture Rating
      Chart and Short Form-36 Health Survey were used to evaluate the validity of the test. For
      test-retest reliability, the unsupported upper extremity test was repeated 1 week later by
      the same investigator.
    

Intervention name(s): Performance Tests
Intervention type(s): Other
Intervention description(s): Performance tests consist of Six Minute Pegboard Ring Test, 30-Second Push-Up Test and Arm, Shoulder and Hand Injury Questionnaire (DASH), Neck Disability Index, New York Posture Rating Chart and Short Form-36 Health Survey.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        44 patients with neck pain lasting at least 3 months and being volunteer to participate in
        our study
      
Keywords: chronic neck pain; upper extremity test; validity; reliability
Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density
Condition: Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to provide information on the safety, tolerability, pharmacokinetics
      (PK) and bone biomarker response following multiple BPS804 administration in multiple dosing
      regimens. This information will permit a comparison of the possible risks and benefits of
      different dosing regimens of the study drug to enable optimal doses and dose intervals to be
      tested in subsequent studies.
    

Detailed description: 
      This study was conducted and previously posted by Novartis. The record was transferred to
      Ultragenyx in February 2021.
    

Intervention name(s): BPS804 20mg/Kg; Placebo to 20mg/Kg BPS804
Intervention type(s): Drug; Drug
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteopenia; osteoporosis; low bone mineral density
Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
    

Detailed description: 
      Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
    

Intervention name(s): Drug:OP0201; Drug: Placebo
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Drug: OP0201; Drug: Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other