bioihbjkbjnl/mcl2 huggingface dataset:
Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI
Condition: Spinal Cord Injury; Sleep Disordered Breathing
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes; Spinal Cord Injuries
Intervention: Buspirone; Trazodone; Placebo
Intervention description: The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached.; 100 mg dose before bed-time; One placebo pill before bed-time
Intervention MeSH terms: Buspirone; Trazodone
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to look at the effect of exciting using drugs to target a
      specific pathway in the body, that relies on a natural chemical the body produces called
      'serotonin', in patients with spinal cord injury (SCI) during sleep. During this part of the
      study participants will be asked to take buspirone (Buspar) (15-50mg per day), trazodone
      (100mg per day) and a placebo in a random fashion, each for a 2 week period (drug period) of
      time followed by two weeks without drugs (washout period). The drugs will not be taken all at
      the same time, but each will be taken separately for two weeks followed by a night study to
      look at the effect the medication/placebo pill has on the way the body responds during sleep.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with SCI (>6months after spinal cord injury) at the T6 level/above

        Exclusion Criteria:

          -  Pregnant and lactating females

          -  Heart failure, vascular disease, or stroke

          -  Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic
             kidney disease

          -  BMI >38 kg/m2

          -  Mechanical ventilation dependence

          -  The following medications are not allowed (potential interaction with buspirone or
             inhibition of the CYP3A4 system):

               -  cimetidine

               -  ketoconazole

               -  ritonavir

               -  itraconazole

               -  erythromycin

               -  diltiazem

               -  verapamil

               -  Monoamine oxidase (MAO) inhibitors [such as Marplan, Nardil, Parmate, Emsam]

               -  Other prohibited concomitant medications include haloperidol, trazodone, or
                  triazolam
Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140)
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by
      independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in
      subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating
      agent.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Grade 1, 2, or 3a FL without pathologic evidence of transformation

          -  Male and female, ages 18 and above, with relapsed or refractory FL lymphoma after > or
             =2 prior treatment lines; each of the 2 prior treatment lines must include at least
             CD20 antibody and/or an alkylating agent

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1

        Exclusion Criteria:

          -  Known central nervous system lymphoma

          -  History of interstitial lung disease

          -  Subjects with active, known or suspected autoimmune disease

          -  Prior allogeneic stem cell transplant

          -  Prior autologous stem cell transplant ≤12 weeks prior to first dose of study drug
MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: MEDI7183 low dose; MEDI7183 medium dose; MEDI7183 high dose; Matching Placebo
Intervention description: MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8; MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8; MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8; Placebo will be administered by SC on Day 1, Week 2,4, and 8
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis, Japanese, subcutaneously

Summary:

      This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase
      II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with
      moderate to severe UC
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Diagnosis of UC established by clinical and endoscopic evidence and corroborated by a
             histopathology report

          -  Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with
             rectosigmoidoscopy score ≥ 2 during screening period

          -  Demonstrated an inadequate response to, loss of response to, or intolerance to at
             least one of immunomodulators or Anti- TNF-α agents. etc.

        Exclusion Criteria:

          -  Disease limited to the rectum

          -  Toxic megacolon

          -  Crohn's Disease

          -  History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch,
             Koch pouch, or ileostomy for UC

          -  Planned bowel surgery within 12 weeks from Visit 2

          -  Stool positive for C. difficile toxin at screening

          -  Primary Sclerosing Cholangitis

          -  History of gastrointestinal surgery within 8 weeks of Visit 2

          -  Any uncontrolled or clinically significant systemic disease

          -  Condition or disease that, in the opinion of the investigator would pose a risk to
             subject safety or interfere with study evaluation, procedures or completion

          -  Subjects with positive HBsAg, HBsAb, HBcAb or HCVAb serology at screening etc
In Vivo Preoperative Skin Preparation Persistence Evaluation
Condition: Bacterial Recovery of Skin Flora Post-product Application
Intervention: 3M CHG/IPA Prep; ChloraPrep
Intervention description: Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.; Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.
Intervention MeSH terms: Ethanol; Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evaluate persistent antimicrobial effectiveness of chlorhexidine gluconate containing
      products on abdominal and inguinal sites following a saline and wipe challenge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of any race

          -  Subjects in good health

          -  Minimum skin flora baseline requirements on abdomen and groin

        Exclusion Criteria:

          -  Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin
             disorders (including acne) on the applicable test area

          -  Topical antimicrobial exposure within 14 days prior to screening and treatment days

          -  Use of systemic or topical antibiotics, steroid medications, or any other products
             known to affect the normal microbial flora of the skin within 14 days prior to
             screening and treatment days
Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma
Condition: Peripheral T-cell Lymphoma; Cutaneous T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Intervention: E7777
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Peripheral T-cell lymphoma; Cutaneous T-cell lymphoma; E7777; Phase 2

Summary:

      The purpose of this study is to evaluate the objective response rate (ORR) of E7777 in
      participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous
      T-cell lymphoma (CTCL).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants who have histological diagnosis as peripheral T-cell lymphoma (PTCL) and
             cutaneous T-cell lymphoma (CTCL).

          2. Participant who have measurable disease.

          3. Participant who had previous systemic chemotherapy.

          4. Participant who had disease progression (PD) or did not have response (complete
             response (CR) or partial response (PR)) in systemic chemotherapy, or relapsed or
             progressed after systemic chemotherapy.

          5. Participant with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0
             or 1.

          6. Participant with adequate renal, liver and bone marrow function.

          7. Male and female participants ≥20 years of age at the time of informed consent.

          8. Participants who have provided written consent to participate in the study.

        Exclusion Criteria:

          1. Participant with serious complications or histories.

          2. Participant with history of hypersensitivity to protein therapeutics.

          3. Participant who is positive for Human immunodeficiency virus (HIV) antibody, Hepatitis
             C virus (HCV) antibody, or Hepatitis B Surface (HBs) antigen.

          4. Participant with malignancy of activity other than PTCL or CTCL within 36 months
             before informed consent.

          5. Women of childbearing potential or man of impregnate potential who don't agree to use
             a medically effective method for contraception.

          6. Woman who is pregnant or lactating.

          7. Participant with allogeneic stem cell transplantation.

          8. Participant who were decided as inappropriate to participate in the study by the
             investigator or sub-investigator.
Investigation of the Safety and Feasibility of AAV1/SERCA2a Gene Transfer in Patients With Chronic Heart Failure
Condition: Chronic Heart Failure; Patients That Have Received a Left Ventricular Assist Device
MeSH terms: Heart Failure
Intervention: AAV1/SERCA2a; Placebo
Intervention description: AAV1/SERCA2a will be delivered by a percutaneous method in the catheter laboratory. Dose: 1x 10^13 DRP (DNase resistant particles); Placebo aliquots will be of the same composition as the investigational medicinal product with the absence of the active ingredient and will be visually indistinguishable from the medicinal product. Placebo is prepared and handled exactly as above in a blinded fashion.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic Heart Failure

Summary:

      The aim of the study is to determine the safety and feasibility of giving an adeno-associated
      viral vector expressing the sarcoplasmic reticulum calcium ATPase (SERCA2a), driven by the
      CMV promoter (AAV1-CMV-SERCA2a), to heart failure patients that have received a left
      ventricular assist device (LVAD) for an accepted clinical indication.
    

Eligibility criteria:

        Inclusion criteria

          -  Patients that have had a left ventricular assist device (LVAD) implanted for chronic
             heart failure, where chronic heart failure is defined as at least 6 months

          -  Patients are clinically stable in the opinion of the clinical team looking after the
             patient

          -  Written informed consent

        Exclusion criteria

          -  <18 or >70 years of age at the time of consent

          -  Pregnancy or within 6 months of giving birth

          -  Women of child-bearing potential not using an effective method of contraception

          -  Men not using an effective method of contraception

          -  Suspected or active viral, fungal or parasitic infection within 48 hours prior to
             administration of IMP, in the opinion of the investigator*.

          -  Patients at a high risk of thrombosis in the opinion of the investigator

          -  Patients with a previous episode of LVAD thrombosis

          -  Patients with persistently raised lactate dehydrogenase (LDH >2.5 ULN)

          -  Patients requiring triple anticoagulation i.e. warfarin and dual anti-platelet

          -  Patients participating in another clinical trial

          -  Patients unable to comply with the protocol mandated procedures for social or other
             reasons, in the opinion of the investigator and primary care physician

               -  Eligible, enrolled and randomised patients who develop an infection will have
                  study treatment delayed until 7 or more days after the time point when infection
                  is no longer clinically evident.
Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; semaglutide; oral placebo
Intervention description: Once-daily oral administration as tablets.; Once-weekly,injected s.c./subcutaneously (under the skin) using a pen; Once-daily oral administration as tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 632.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to examine the dose range,
      escalation and efficacy of oral semaglutide in subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI above or equal to 25 and below or equal to 40 kg/m^2

          -  Subjects diagnosed with T2D (Type 2 diabetes) treated with diet and exercise and/or
             who have been on a stable dose of metformin for at least 30 days prior to screening

          -  HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive)

        Exclusion Criteria:

          -  Subjects on selected oral medication with a narrow therapeutic window, such as
             warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and
             anticonvulsants

          -  History of chronic pancreatitis or idiopathic acute pancreatitis

          -  Chronic malabsorption, regardless of aetiology

          -  History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease

          -  Treatment with glucose lowering agent(s) other than metformin as stated in the
             inclusion criteria in a period of 90 days before the screening visit
Inhibition of Gastric Acid is the Key to Satisfactory Relief of Symptoms With Esomeprazole in NUD Patients
Condition: Indigestion
MeSH terms: Dyspepsia
Intervention: Esomeprazole; Placebo
Intervention description: Esomeprazole 40 mg QD; Placebo
Intervention MeSH terms: Esomeprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Epigastric Pain; Non-Ulcer Dyspepsia (NUD)

Summary:

      Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in
      NUD patients
    

Eligibility criteria:

        Inclusion criteria:

        A. Males and females of age 18-55. B. A diagnosis of epigastric pain/discomfort (located in
        the upper abdomen) rated by the patient as moderate to severe in intensity (on a four-point
        categorical scale), which has been present at least 3 times per week for 12 weeks,
        unrelated to exercise.

        C. Patients may have other symptoms of NUD including heartburn, regurgitation, bloating
        (abdominal distension), early satiety (feeling of fullness), belching (burping), or nausea;
        however, the dominant symptom must be epigastric pain/discomfort.

        D. Capable of and willing to give informed consent and comply with all study requirements.

        Exclusion criteria:

        A. H. pylori positive serology. B. Regular use of NSAIDs or more than 100 mg of aspirin. C.
        Patients requiring chronic treatment with any medication inducing GI symptoms (e.g.,
        certain antibiotics, codeine, etc.).

        D. History or presence of endoscopic/radiological evidence of esophagitis. E. History or
        presence of chronic gastric or duodenal ulcer. F. History or presence of duodenal erosions.
        G. History or previous upper GI surgery. H. Presence of concomitant symptoms of irritable
        bowel syndrome (IBS) as assessed by three or more of the Manning or Rome criteria.

        I. History or presence of other known organic disease that might explain the dyspepsia
        symptoms (e.g., symptomatic gallstones).

        J. Pregnancy or lactation. K. Inadequate contraception. L. Regular consumption of greater
        than 2 fluid ounces of beverage alcohol (corresponding to 2 cocktails or 40 fluid ounces of
        beer or 16 fluid ounces of wine) per day.

        M. History of substance abuse. N. Unwillingness or expected inability to tolerate absence
        of antisecretory medications (antacids, H2 receptor antagonists or Proton pump inhibitors
        (PPIs) or other GI pharmacotherapy for a period of time of study protocol (16 weeks
        maximum).
Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)
Condition: IgG4-RD
MeSH terms: Immunoglobulin G4-Related Disease
Intervention: XmAb5871
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related
      Disease (RD) activity
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active IgG4-RD

          -  Compatible pattern of organ involvement consistent with IgG4-RD that cannot be
             attributed to other causes

          -  Histopathologically-proven diagnosis of IgG4-RD

          -  Peripheral blood plasmablast count >900 cells/mL and/or elevated IgG4-RD levels during
             screening

          -  Able and willing to complete the entire study according to the study schedule

          -  Able and willing to provide written informed consent

        Exclusion Criteria:

          -  History or evidence of a clinically unstable/uncontrolled disorder, condition or
             disease other than IgG4-RD that, in the opinion of the Investigator would pose a risk
             to the patient safety or interfere with the study evaluation, procedures or completion

          -  Malignancy within 5 years (except successfully treated in situ cervical cancer,
             resected squamous cell or basal cell carcinoma of the skin, or prostate cancer with no
             recurrence ≥3 years following prostatectomy)

          -  Presence of recurrent or chronic infections, defined as ≥3 infections requiring
             antimicrobials over the past 6 months prior to screening

          -  Active infection requiring hospitalization or treatment with parenteral antimicrobials
             within the 60 days prior to randomization or oral antimicrobials within the 21 days
             prior to enrollment

          -  Patient is taking >40 mg of prednisone QD

          -  Prior use of rituximab (or other B cell depleting agents) within 6 months of
             enrollment. Prior use of any B cell depleting agent greater than 6 months from
             enrollment is allowed if the CD19+ B cell count is within the normal reference range
             during screening

          -  Use of any investigational agent within 5 half-lives of the agent (or 6 months if the
             half-life is unknown) prior to enrollment

          -  Immunosuppressive agent use within the three months prior to enrollment

          -  Has received live vaccines within 2 months of enrollment

          -  Patient is pregnant or breast feeding, or planning to become pregnant while enrolled
             in the study, up to end-of-study visit

          -  Unable or unwilling to partake in the follow-up assessments or required protocol
             procedures