bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Arginine as a Treatment for Sickle Cell Anemia
Condition: Anemia, Sickle Cell
MeSH terms: Anemia; Anemia, Sickle Cell
Intervention: Arginine; Placebo
Intervention description: Depending on the weight of the child or adult, the patients took any where between 4-10 capsules 2 times a day. Patients weighing less than 45 kilograms were on the low dose active (or placebo) so the capsules were smaller. Patients greater than or equal to 45 kgs were on the high dose active or placebo, so these capsules were larger.; Depending on the weight of the child or adult, the patients took any where between 4-10 capsules 2 times a day. Patients weighing less than 45 kilograms were on the low dose active (or placebo) so the capsules were smaller. Patients greater than or equal to 45 kgs were on the high dose active or placebo, so these capsules were larger.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: No
Keywords: Sickle Cell Disease; Anemia; Nitric Oxide; Vaso Occlusive Events; Arginine Supplementation

Summary:

      Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited genetic disease
      that can cause intense pain episodes. This study will evaluate the effectiveness of the
      nutritional supplement arginine at improving blood cell function and disease symptoms in
      people with SCD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Established diagnosis of H SS or S-beta thalassemia

          -  History of at least one vaso-occlusive pain event in the 12 months prior to study
             entry

          -  Regular compliance with comprehensive medical care

          -  In a steady disease state and not in the midst of any acute complication due to SCD at
             study entry

        Exclusion Criteria:

          -  Inability to take or tolerate oral medications

          -  Liver dysfunction (i.e., SGPT level greater than or equal to two times the normal
             limit and albumin level less than or equal to 3.2 g/dL)

          -  Kidney dysfunction ( i.e., creatinine level greater than or equal to 1.2 mg/dL for
             children and greater than or equal to 1.4 mg/dL for adults)

          -  Allergy to arginine

          -  Pregnant

          -  Received a blood transfusion within the 90 days prior to study entry

          -  More than 10 hospital admissions for pain in the 12 months prior to study entry

          -  Daily use of opioids and experiencing unstable pain that interferes with work or daily
             routine

          -  Required more than 3 hospital admissions and more than 10 emergency department/day
             hospital visits in the 12 months prior to study entry

          -  Received treatment with hydroxyurea within the 90 days prior to study entry

          -  Received treatment with any investigational drug in the 90 days prior to study entry
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
Condition: Urinary Incontinence; Overactive Bladder With Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive
Intervention: OnabotulinumtoxinA and Hydrogel admixture; Placebo and Hydrogel admixture
Intervention description: BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation; Placebo and Hydrogel admixture administered as a single intravesical instillation
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 383.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in
      participants with overactive bladder and urinary incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months

          -  Inadequate response or limiting side effects with pharmacotherapy for the treatment of
             OAB

        Exclusion Criteria:

          -  Overactive Bladder caused by neurological condition

          -  Patient has predominance of stress incontinence

          -  History or evidence of pelvic or urological abnormality

          -  Prior use of BOTOX for any urological condition
Hypofractionated Radiation Therapy in Treating Participants With Breast Cancer Before Surgery
Condition: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8
MeSH terms: Breast Neoplasms
Intervention: Hypofractionated Radiation Therapy
Intervention description: Undergo hypofractionated radiation therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well hypofractionated radiation therapy works in treating
      participants with breast cancer before surgery. Hypofractionated radiation therapy delivers
      higher doses of radiation therapy over a shorter period of time and may kill more tumor cells
      and have fewer side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological confirmation of breast cancer

          -  Clinical stage T0-T2 N0 M0

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2

          -  Able to and provides Institutional Review Board (IRB) approved study specific written
             informed consent

          -  Study entry must be within 120 days of last biopsy (breast)

          -  Able to complete all mandatory tests

          -  Willing to return to enrolling institution for follow-up (during the active monitoring
             phase of the study)

          -  Planned breast surgery and indications for whole breast radiotherapy

        Exclusion Criteria:

          -  Medical contraindication to receipt of radiotherapy

          -  Severe active co-morbid systemic illnesses or other severe concurrent disease which,
             in the judgment of the investigator, would make the patient inappropriate for entry
             into this study or interfere significantly with the proper assessment of safety and
             toxicity of the prescribed regimens

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements or providing informed consent

          -  Active systemic lupus or scleroderma

          -  Pregnancy

          -  Women of childbearing potential who are unwilling to employ adequate contraception

          -  Prior receipt of ipsilateral breast or chest wall radiation

          -  Recurrent breast cancer

          -  Indications for comprehensive regional nodal irradiation

          -  No neo-adjuvant therapy
Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: QGE031; Omalizumab; Placebo
Intervention MeSH terms: Omalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 382.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: QGE031; ligelizumab; omalizumab; chronic; spontaneous; urticaria; adults; CSU

Summary:

      This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and
      safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic
      Spontaneous Urticaria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic spontaneous urticaria for at least 6 months

          -  Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of
             randomization

        Exclusion Criteria:

          -  Clearly defined underlying etiology for chronic urticaria other than chronic
             spontaneous urticaria

          -  Evidence of parasitic infection

          -  Any other skin disease with chronic itching

          -  Previous treatment with omalizumab or QGE031

          -  Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or
             epinephrine

          -  History of anaphylaxis

          -  History or current diagnosis of ECG abnormalities indicating significant risk of
             safety for patients participating in the study

          -  History of hypersensitivity to any of the study drugs or its components of similar
             chemical classes

          -  Pregnant or nursing (lactating) women

        Other protocol defined inclusion/exclusion criteria may apply.
Enemas Before Elective Cesarean Section
Condition: Complications After Cesarean Section
Intervention: enema
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Cesarean Section,; Enema

Summary:

      Enemas are not anymore used routinely before vaginal deliveries.The intention of this study
      is to elucidate whether there is a benefit in routine use of enema before cesarean section.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cesarean Section, Elective
A Study to Assess Sorafenib Alone and in Combination With Low-Dose Interferon Following Unsuccessful Treatment With Sunitinib in Patients With Advanced Renal Cell Cancer.
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Sorafenib (Nexavar, BAY43-9006); Sorafenib (Nexavar, BAY43-9006) + Interferon
Intervention description: Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously; Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously. IFN alpha-2a 3MIU FIW s.c., from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
Intervention MeSH terms: Interferons; Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal Cell Cancer; Interferon

Summary:

      This study is to assess sorafenib as second treatment for patients that have previously
      received only sunitinib as first-line treatment for advanced renal cell cancer, and who
      either responded and then progressed with sunitinib or were intolerant to sunitinib. This
      study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose
      interferon (3 million international unit (MIU) five times a week) can treat kidney cancer
      more effectively than the current approved dose alone and if it is safe. In addition, for
      patients that respond to treatment with sorafenib alone or in combination with interferon
      before progressing, patients may receive sorafenib alone at an increased dose of 300mg
      twice-daily, provided that toxicities are acceptable and at the discretion of the
      investigator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Disease progression as defined by Response Evaluation Criteria in Solid Tumors
             (RECIST) criteria following documented stable disease or better after at least 8 weeks
             of sunitinib as first-line treatment (or two cycles of 4 weeks on and 2 weeks off
             treatment)

          -  And/or patients who have discontinued sunitinib treatment at any point due to toxicity

          -  Study entry at least 2 weeks after treatment with sunitinib but up to a maximum of 8
             weeks

          -  Memorial Sloane Kettering Cancer Centre (MSKCC) prognostic score low or intermediate

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

          -  Patient must have histologically confirmed metastatic renal cell carcinoma with
             predominant clear cell histology (clear cell component more than 50%).

        Exclusion Criteria:

          -  Patient should be excluded if they have unresolved chronic toxicity grade

          -  > 1 and related to prior therapy with sunitinib.
Phase II Study for Robot Assisted Distal Gastrectomy
Condition: Early Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Robot assisted distal gastrectomy (DaVinci)
Intervention description: patients who received robot assisted distal gastrectomy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: DaVinci; Robot assisted surgery; Gastrectomy; Safety; Gastric Cancer

Summary:

      The aim of this study is to clarify safety of robot assisted distal gastrectomy with lymph
      node dissection in patients with stage Ia early gastric cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Biopsy specimen from the primary lesion shows adenocarcinoma

          2. Diagnosed as Stage IA early gastric cancer according to the preoperative
             esophagogastroduodenoscopy and computer tomography

          3. Endoscopic submucosal dissection is not indicated

          4. Tumor was located within lower two thirds of stomach

          5. Not having duodenal invasion

          6. Eastern clinical oncology group performance status is 0 or 1

          7. Body mass index is lower than 30

          8. No prior laparotomy

          9. No prior chemotherapy or radiation including those for other cancers

         10. Fulfil all following conditions WBC > 3,000/mm3 Plt > 100,000/mm3 AST < 100 IU/L ALT <
             100IU/L T.Bil < 2.0 g/dl Cre < 1.5mg/dl

        Exclusion Criteria:

          1. Having other active cancers

          2. Possibly pregnant, or breast feeding woman

          3. with psychiatric disorder

          4. Receiving steroids

          5. With Acute myocardial infarction in 6 months or with unstable angina

          6. With uncontrolled hypertension

          7. With uncontrolled diabetes mellitus

          8. With pulmonary disease which require continuous oxygen therapy
Abatacept in the Treatment of Uveitis
Condition: Uveitis
MeSH terms: Uveitis
Intervention: Abatacept
Intervention description: Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then be randomized to receive either 5 mg/kg or 10 mg/kg.
Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years.
Intervention MeSH terms: Abatacept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of abatacept in the treatment
      of uveitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with vision-threatening autoimmune uveitis

          -  failure to respond to prednisone and at least one other systemic immunosuppressive, or
             intolerance to such medications due to side effects

        Exclusion Criteria:

          -  serious concomitant illness that could interfere with the subject's participation
Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy
Condition: Pain
Intervention: pain pump containing ropivacaine; saline pain pump with injectable medication; ropivacaine, ketorolac , morphine sulfate
Intervention description: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour; 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Morphine; Ropivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Hypothesis: Ropivacaine, morphine and ketorolac injected after knee arthroscopy is as
      effective as this solution plus ropivacaine administered intra-articularly for twenty-four
      hours.

      Three groups were assigned random patients, each group provided a different method of pain
      medication in order to determine the effectiveness of each treatment.
    

Eligibility criteria:

        Inclusion Criteria: All subjects who underwent:

          -  knee arthroscopy + synovectomy

          -  knee arthroscopy + partial or complete meniscectomy

          -  knee arthroscopy + chondroplasty

          -  knee arthroscopy + microfracture

          -  knee arthroscopy + autologous osteoarticular transplantation

        Exclusion Criteria:

          -  A surgical procedure that required an incision other then an arthroscopic portal

          -  A surgical procedure within the same joint within ninety days

          -  A acute or chronic knee infection

          -  Any diagnosis of complex regional pain syndrome

          -  A known allergy to one of the study drugs

          -  A documented history of narcotic use

          -  A score of less than two standard deviation on the SF-12 mental component

          -  Any major systemic or cardiac illness (heart failure, uncontrolled angina,
             bifascicular blocks, renal insufficiency, or liver disease)

          -  Under the age of eighteen years
High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation
Condition: Hematopoietic Stem Cell Transplantation; Delirium; Thiamine Deficiency
MeSH terms: Delirium; Thiamine Deficiency; Beriberi
Intervention: Thiamine; Normal saline
Intervention description: 200 mg IV three times daily for seven days; Normal saline IV three times daily for seven days
Intervention MeSH terms: Thiamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Purpose: To conduct a randomized controlled pilot study investigating the use of high dose
      intravenous (IV) thiamine to prevent delirium and mitigate the long-term effects of delirium,
      including health-related quality of life (HRQOL), functional status, and neuropsychiatric
      outcomes, in patients admitted to University of North Carolina (UNC) Hospital for allogeneic
      hematopoietic stem cell transplant (HSCT).

      Participants: 60 adult inpatients admitted to the UNC Bone Marrow Transplant Unit for
      allogeneic stem cell transplant.

      Procedures (methods): Participants will be admitted for allogeneic HSCT and on the day after
      transplant randomized to seven days of high dose IV thiamine or placebo. Thiamine levels will
      be measured weekly and participants will be assessed for evidence of delirium using validated
      measures. Validated measures will also be used to assess cognitive function, depression,
      post-traumatic stress symptoms, functional status, and HRQOL prior to hospitalization and at
      one, three, and six months after transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admission to the UNC Hospital Bone Marrow Transplant Unit for allogeneic stem cell
             transplant

          -  At least 18 years of age

          -  Able to speak English

          -  Able to provide informed consent

        Exclusion Criteria:

          -  A history of adverse reaction to IV thiamine

          -  Pregnancy, confirmed by a negative pregnancy test within 30 days of study enrollment
Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Teeth
Condition: Periapical Diseases
MeSH terms: Periapical Diseases
Intervention: ProRoot MTA; MTA+ Cerkamed
Intervention description: Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA).; Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland).
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: periapical diseases; dental injuries; MTA

Summary:

      Traumatic tooth injuries are common in children and adolescents, and often result in pulpal
      necrosis and the development of periapical lesions. Treatment of traumatized teeth with
      endodontic complications depends on the type of injury, number of injured teeth, root
      development and patient cooperation, which altogether will create a challenge and dictate the
      treatment plan for the dentist. The purpose of this study was to assess the effectiveness of
      non-surgical root canal procedures in traumatized permanent teeth with necrotic pulps and
      chronic periapical lesions using a tri-antibiotic paste and calcium-hydroxide as intracanal
      medications and two different mineral trioxide aggregate (MTA) products for definitive
      obturation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy patient

          -  Non-vital tooth with chronic periapical lesions

          -  Restorable tooth

          -  No horizontal or vertical root fractures

          -  No root resorption

        Exclusion Criteria:

          -  Unrestorable tooth

          -  Horizontal or vertical root fractures

          -  Root resorption