bioihbjkbjnl/mcl2 huggingface dataset:
Study of Debio 1450 for Bacterial Skin Infections
Condition: Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy of 2 different doses of
      intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in
      the treatment of patients with staphylococcal ABSSSI.
    


Intervention name(s): Debio 1450 IV; Debio 1450 Oral; Linezolid; Debio 1450 Oral Placebo; Linezolid Placebo; Vancomycin IV
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intravenous (IV) form of Debio 1450 will be supplied in vials containing 50 mg of active pharmaceutical ingredient (API). Intravenous infusions of Debio 1450 (160 mg and 80 mg) will be administered over a 2-hour period BID every 12 hours within a 2-hour window (12 ± 2 hours).; Oral forms of Debio 1450 will be provided as white, opaque, hard gelatin capsules containing 50 mg drug substance (equivalent to 40 mg of Debio 1450).; Linezolid for oral administration will be provided as 600-mg film-coated compressed tablets.; Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.; Linezolid placebo will be supplied as film-coated compressed tablets.; Vancomycin will be administered BID every 12 ± 2 hours at doses of 1 g or 15 mg/kg as specified in local protocols, with the infusion rate adjusted to 2 hours.
Intervention MeSH terms: Vancomycin; Linezolid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Studying DNA in Blood and Bone Marrow Samples From Young Patients With Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the
      laboratory may help doctors learn more about changes that occur in DNA and identify
      biomarkers related to cancer. It may also help doctors predict how well patients will respond
      to treatment.

      PURPOSE: This research study is looking at DNA in blood and bone marrow samples from young
      patients with acute lymphoblastic leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  To manage and oversee determination of genome-wide genotypes using common laboratory
           methodologies for young patients with newly diagnosed acute lymphoblastic leukemia
           (ALL).

        -  To provide a mechanism for storing, distributing, and tracking usage of blast and
           germline genomic information for approved projects.

        -  To facilitate research for childhood ALL using genome-wide germline and blast data to
           identify genetic variations associated with important phenotypes: treatment response
           (e.g., relapse risk, minimal residual disease status), adverse effects (e.g.,
           osteonecrosis, infection risk, neurotoxicity), risk of ALL, and risk of ALL subtypes
           (e.g., TEL/AML1, BCR/ABL, T-cell).

        -  To provide a data resource, that can be linked with additional tumor cell information,
           to better characterize the biology and subtypes of childhood ALL.

      OUTLINE: This is a multicenter study.

      DNA from previously collected and banked blood and bone marrow samples is utilized for
      genome-wide genotyping.

      Genotype data is only used to examine specific questions related to the epidemiology and
      etiology of leukemia, response of leukemia to treatment, risk of recurrence, risk for
      development of side effects, and complications related to treatment.
    

Intervention name(s): DNA analysis; biologic sample preservation procedure; laboratory biomarker analysis
Intervention type(s): Genetic; Other; Other
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Young Patients With Acute Lymphoblastic Leukemia
      
Biospecimen description: 
      Blood and Bone Marrow
    
Keywords: untreated childhood acute lymphoblastic leukemia; recurrent childhood acute lymphoblastic leukemia
Upper Limb Robotic Rehabilitation After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This is a single arm study aimed at evaluating the acute effects induced by a single session
      of robot-assisted passive hand mobilization on local perfusion and upper limb function in
      post-stroke hemiparetic patients. Twenty-three participants with subacute or chronic stroke
      received 20 min passive mobilization of the paretic hand with robotic assistance. After the
      intervention, significant improvements were found in forearm perfusion, muscle tone
      significantly decreased and subjects reported decreased upper limb heaviness, stiffness and
      pain. This study supports novel evidence that hand robotic assistance promotes local forearm
      circulation, may help in the management of spasticity and acutely alleviates reported
      symptoms of heaviness, stiffness and pain in subjects with post-stroke hemiparesis.
    


Intervention name(s): Robotic passive mobilization
Intervention type(s): Device
Intervention description(s): The intervention was performed using the Gloreha (Idrogenet, Italy) robotic system. The system consists of a soft exoskeleton similar to a glove. Passive hand joints mobilization is provided by a hydraulic system. Each patient underwent a session of 20 min passive mobilization of the paretic hand.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Feasibility Study: Compare the Effectiveness Between Two Pain Medications When Used Prior to Ultherapy™ Treatments
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      This study will compare the effectiveness of two pain medications for reducing discomfort
      during an Ultherapy treatment.
    

Detailed description: 
      This trial is a prospective, single-site, double-blinded, randomized trial. All study
      subjects will receive a full face and neck Ultherapy treatment. Subjects will be randomized
      to receive one of two pain medications prior to treatment. Each subject will be asked to rate
      the level of discomfort during the Ultherapy treatment. All study subjects will be followed
      for 90 days following treatment.
    

Intervention name(s): Advil; Lortab; Ulthera System Treatment
Intervention type(s): Drug; Drug; Device
Intervention description(s): One (1) tablet 800 mg Advil one hour prior to treatment.; One (1) tablet 10/500 mg of Lortab one hour prior to treatment.; Focused ultrasound energy delivered below the surface of the skin
Other intervention name(s): Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Study of TAK-925 in Participants With Obstructive Sleep Apnea (OSA) Who Are Experiencing Excessive Daytime Sleepiness (EDS) Despite Adequate Use of Continuous Positive Airway Pressure (CPAP)
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of administering a
      single intravenous (IV) infusion dose of TAK-925 to adults with obstructive sleep apnea (OSA)
      who are experiencing excessive daytime sleepiness (EDS) despite adequate use of CPAP as the
      primary OSA therapy.
    

Detailed description: 
      The drug being tested in this study is called TAK-925. TAK-925 is being tested to treat
      participants who have EDS due to OSA despite using CPAP. The study will evaluate the
      pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a single IV dose of
      TAK-925 in participants with OSA.

      The study will enroll approximately 42 patients. The study will utilize a three-way cross
      over design with a 24 hour wash-out between each treatment.

      On Day 1 of each treatment period, TAK-925 or placebo will be administered as a single 9-hour
      IV infusion.

      The multi-center study will be conducted in United States. The patient's participation in the
      study will last for up to 43 days and include an 8-day stay in the study clinic and a safety
      follow-up phone call 7 days after the end of treatment.
    

Intervention name(s): TAK-925; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-925 IV infusion; TAK-925 placebo-matching IV infusion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Total-Body Irradiation, Busulfan, and Interferon Alfa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in
      chemotherapy use different ways to stop cancer cells from dividing so they stop growing or
      die. Interferon alfa may interfere with the growth of cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of total-body irradiation, busulfan, and
      interferon alfa followed by peripheral stem cell or bone marrow transplantation in treating
      patients with multiple myeloma.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the effects of total marrow irradiation and busulfan followed by
      allogeneic peripheral blood stem cell or marrow transplantation on the outcomes of treatment
      related mortality, response, relapse, survival, and event free survival for patients with
      advanced multiple myeloma.

      OUTLINE: Peripheral blood stem cell (PBSC) or bone marrow (BM) collection and infusion are
      performed according to standard practice. Patients undergo total marrow irradiation (TMI) bid
      for 3 days. Busulfan is administered every 6 hours on days -6 to -3. PBSC or BM is infused on
      day 0. Interferon alfa is administered subcutaneously on Mondays, Wednesdays, and Fridays
      beginning on day 80. Interferon therapy may continue in the absence of graft versus host
      disease or disease progression. Patients are followed on days 56 and 84, then every 6 months
      for 2 years, and annually thereafter.

      PROJECTED ACCRUAL: A maximum of 30 patients will be accrued over 3 years.
    

Intervention name(s): recombinant interferon alfa; busulfan; allogeneic bone marrow transplantation; peripheral blood stem cell transplantation; radiation therapy
Intervention type(s): Biological; Drug; Procedure; Procedure; Radiation
Intervention MeSH terms: Interferons; Interferon-alpha; Busulfan
Primary purpose: Treatment
Keywords: refractory multiple myeloma; stage II multiple myeloma; stage III multiple myeloma
Safety and Efficacy of Bendamustine, Gemcitabine, Rituximab, Nivolumab (BeGeRN) in Patients With r/r DLBCL
Condition: Diffuse Large B Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Despite the current advances in clinical oncology, the prognosis of patients with resistant
      diffuse large B cell lymphoma or relapse after high dose chemotherapy is dismal. Therefore
      there is a need for the introduction of novel treatment regimens. This phase I/II trial
      evaluates the safety and efficacy of combination bendamustine, gemcitabine, nivolumab and
      rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. The safety
      of combination treatment will be evaluated with the determination of recommended dose
      schedule prior to expansion of enrollment to evaluate the antitumor activity of bendamustine,
      gemcitabine, rituximab, and nivolumab.
    


Intervention name(s): Bendamustine hydrochloride; Gemcitabine 500 mg; Gemcitabine 700 mg; Gemcitabine 1000 mg; Nivolumab; Rituximab
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 70 mg/m2 by intravenous (IV) infusion for up to 2 cycles; 500 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles; 700 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles; 1000 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles; 1 mg/kg by intravenous (IV) infusion on day 1,15 for up to 2 cycles; 375 mg/m2 by intravenous (IV) infusion on day 0 for up to 2 cycles
Other intervention name(s): Ribomustin; Gemzar; Gemzar; Gemzar; Opdivo
Intervention MeSH terms: Rituximab; Nivolumab; Gemcitabine; Bendamustine Hydrochloride
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: There will be 2 parts in this study. In Part 1, the safety of combination treatment will be evaluated prior to expansion of enrollment to evaluate treatment effect in Part 2. The arms in Part 1 include 3 different dosage regimens of gemcitabine (500 / 700 / 1000). Part 2 of the study will further characterize the safety and evaluate the antitumor activity of drug combination by enrolling patients at the recommended dose schedule determined in Part 1.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diffuse Large B-cell Lymphoma; Nivolumab; Bendamustine Hydrochloride; Gemcitabine; Rituximab
Variation in Anisotropy of the Spinal Cord in Patients With Hyperkyphosis
Condition: Hyperkyphosis
MeSH terms: Kyphosis
Study type: Observational

Summary: 
      Spinal cord compression is commonly seen in patients with severe kyphosis. However,
      conventional morphologic magnetic resonance imaging (MRI) was unable to detect the damage in
      microstructural integrity of the spinal cord around the apical vertebrae in these patients.
      The aim of the study was to evaluate the neuronal metrics/microstructure of the spinal cord
      around apical region in patients with hyperkyphosis using diffusion tensor imaging (DTI).
    

Detailed description: 
      Spinal cord compression is commonly seen in patients with severe kyphosis. However,
      conventional morphologic magnetic resonance imaging (MRI) was unable to detect the damage in
      microstructural integrity of the spinal cord around the apical vertebrae in these patients.
      The aim of the study was to evaluate the neuronal metrics/microstructure of the spinal cord
      around apical region in patients with hyperkyphosis using diffusion tensor imaging (DTI).

      Twenty-four patients with hyperkyphosis aged 46.1±22.8 years who underwent 3.0T MRI
      examination with DTI sequence were prospectively enrolled from July 2022 to January 2023.
      Patients were divided into three groups according to spinal cord/cerebrospinal fluid
      architecture (CSF) on sagittal-T2 MRI of the thoracic apex: Type A-circular cord with visible
      CSF, Type B-circular cord but no visible CSF at apical dorsal, and Type C-spinal cord
      deformed without intervening CSF. The Fractional Anisotropy (FA) values acquired from DTI
      were compared among different groups. Correlations between DTI parameters and global kyphosis
      (GK)/sagittal deformity angular ratio (SDAR) were evaluated using Pearson correlation
      coefficients.
    

Intervention name(s): Variation in anisotropy of the Spinal Cord using diffusion tensor imaging
Intervention type(s): Radiation
Intervention description(s): All examinations were performed on a 3.0-T MRI machine with a 12-channel spine special coil (Ingenia CX, Philips Healthcare, Best, the Netherlands). The multi-sequence MRI protocol included conventional T1-weighted (sag & tra), T2-weighted (sag & tra), and DTI sequence.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        24 patients with hyperkyphosis aged 46.1±22.8 years who underwent 3.0T magnetic resonance
        imaging (MRI) examination with DTI sequence were prospectively enrolled.
Systemic Erythropoietin Injection in Patients Having Optic Atrophy
Condition: Optic Atrophy
MeSH terms: Optic Atrophy; Atrophy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this treatment trial is to study the effect of systemic erythropoietin in
      patients having optic atrophy.
    

Detailed description: 
      The purpose of this treatment trial is to study the effect of systemic erythropoietin in
      patients having optic atrophy. The intervention is systemic erythropoietin injections (eprax
      10000 IU subcutaneous twice daily for three days).

      Follow up after one month and three months by recording visual acuity and electro
      physiological studies.
    

Intervention name(s): Systemic erythropoietin injection
Intervention type(s): Drug
Intervention description(s): Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).
Other intervention name(s): Eprax 10000
Intervention MeSH terms: Epoetin Alfa
Intervention model: Single Group Assignment
Intervention model description: The study included 10 patients diagnosed as post papilledemic optic atrophy that were attending Alexandria main university hospital. All patients underwent initially assessment of visual acuity, color vision, pupil reaction ,funduscopy and electrophysiological tests ( pattern visual evoked potential and pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control). Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days). Follow up after one month and three months by recording visual acuity and electro physiological studies.
Masking: None (Open Label)
Primary purpose: Treatment
Electro-acupuncture at Zusanli, Qihai, and Guanyuan Acupoints Regulate Immune Function in Patients With Sepsis
Condition: Sepsis; Immune Dysfunction
MeSH terms: Sepsis; Toxemia; Immune System Diseases
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the biochemical and clinical effects of
      electro-acupuncture in patients with sepsis.
    

Detailed description: 
      Patients were randomly divided into an electro-acupuncture (EA) group and a Western medicine
      group(WM group) using restricted block randomization (1:1 ratio).

      Patients in the Western medicine group received conventional treatment with Western medicine.
      According to the International Guidelines for Management of Sepsis and Septic Shock: 2016,
      conventional treatment includes antibiotics and other anti-infection measures, fluid
      management, mechanical ventilation, and nutritional support, but did not include the use of
      immunosuppressants or immune enhancers including hormones, gamma globulin, and thymosin.
      Patients in the electro-acupuncture group were treated with Western medicine and
      electro-acupuncture. Electro-acupuncture was given at the Zusanli (ST36), Guanyuan (CV4), and
      Qihai (CV6) acupoints, twice a day for 30 minutes, and for 5 days in total.

      The indicators of immune dysfunction including the percentage of T lymphocyte subsets,
      percentage of natural killer (NK) cells, and serum soluble programed cell death protein
      (sPD-1) level, and clinical effect including APACHE-II and SOFA score, whole blood analysis,
      levels of tumor necrosis factor-α (TNF-α) and C-reactive protein (CRP), were determined
      before treatment and after treatment for 5 days.
    

Intervention name(s): electro-acupuncture
Intervention type(s): Device
Intervention description(s): Electro-acupuncture was given at the Zusanli (ST36), Guanyuan (CV4), and Qihai (CV6) acupoints, twice a day for 30 minutes, and for 5 days in total.
Acupoints were selected as follows. (1) Zusanli (ST36) belongs to zuyangming stomach meridian. It is located on the anterolateral part of the lower leg 3 inches (4 horizontal fingers) below the eye of the external knee between the fibula and the tibia, and a horizontal finger (middle finger) width from the front edge of the tibia. (2) Guan yuan (CV4) is located 3 inches below the umbilicus, on the midline of the abdomen. (3) Qihai (CV6) is located 1.5 inches below the umbilicus on the midline.
Acupuncture and electro-acupuncture methods were performed as follows. Participants were in the supine position, and needles was inserted in the skin . After the participant has acid, numbness, swelling, pain or other feelings, the electro-acupuncture device was connect to the acupuncture needle, the frequency was set to continuous wave.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sepsis; Immune Dysfunction; Electro-acupuncture
Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT)
Condition: Treatment Resistant Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The main interest in this study is to investigate if it is possible to use strategies from
      Dialectical Behavior Therapy (DBT) to increase effectiveness of ordinary Cognitive Behavioral
      Therapy (CBT) for patients with anxiety disorders. For the patients included in this study,
      previous exposure-based treatment should have been unsuccessful (drop-out, relapse or lack of
      positive results after treatment).
    


Intervention name(s): DBT-inspired anxiety treatment
Intervention type(s): Behavioral
Intervention description(s): In short, the treatment is 24 sessions consisting of skills-training strategies and exposure strategies. The idea is that the patient during the treatment will learn and practice the skills needed to handle exposures.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dialectical behavior therapy; cognitive behavioral therapy; emotion regulation; emotion dysregulation; anxiety disorders; skills training
Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery
Condition: Pain Management Following Cardiopulmonary Bypass Surgery
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the safety and efficacy of ketorolac for post-operative pain management
      after heart surgery. Ketorolac appears to provide enhanced pain relief while also decreasing
      the requirements for morphine during the (immediate) 24-hour post-operative period.
    

Detailed description: 
      Current practice at this institution does not include routine use of ketorolac for
      post-operative pain management of patients undergoing cardiac surgery. The investigators
      hypothesize that using Ketorolac as an adjunct to IV morphine can positively impact patient
      outcomes and reduce the occurrence of possible side effects.
    

Intervention name(s): Ketorolac; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Intravenous ketorolac every 6 hours for 24 hours; Placebo Comparator
Other intervention name(s): Toradol
Intervention MeSH terms: Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ketorolac