bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies
Condition: Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Non-Hodgkin's Lymphoma; Non-Hodgkin Lymphoma; Hodgkin Disease; Hodgkins Disease; Hodgkin's Disease; Multiple Myeloma; Myelodysplastic Syndrome; Myeloproliferative Neoplasm
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Hematologic Neoplasms; Hodgkin Disease; Myelodysplastic Syndromes; Myeloproliferative Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Current protocols use G-CSF to mobilize hematopoietic progenitor cells from matched sibling
      and volunteer unrelated donors. Unfortunately, this process requires four to six days of
      G-CSF injection and can be associated with side effects, most notably bone pain and rarely
      splenic rupture. BL-8040 is given as a single SC injection, and collection of cells occurs on
      the same day as BL-8040 administration. This study will evaluate the safety and efficacy of
      this novel agent for hematopoietic progenitor cell mobilization and allogeneic
      transplantation based on the following hypotheses:

        -  Healthy HLA-matched donors receiving one injection of BL-8040 will mobilize sufficient
           CD34+ cells (at least 2.0 x 10^6 CD34+ cells/kg recipient weight) following no more than
           two leukapheresis collections to support a hematopoietic cell transplant.

        -  The hematopoietic cells mobilized by SC BL-8040 will be functional and will result in
           prompt and durable hematopoietic engraftment following transplantation into
           HLA-identical siblings with advanced hematological malignancies using various
           non-myeloablative and myeloablative conditioning regimens and regimens for routine GVHD
           prophylaxis.

        -  If these hypotheses 1 and 2 are confirmed after an interim safety analysis of the data,
           then the study will continue and include recruitment of haploidentical donors.
    


Intervention name(s): BL-8040; Leukapheresis; Hematopoietic cell transplant
Intervention type(s): Drug; Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adult Dacryocystocele Among Patients With Epiphora
Condition: Lacrimal Passage Obstruction
MeSH terms: Lacrimal Apparatus Diseases
Study type: Interventional

Summary: 
      Patients with lacrimal dacryocystocele were chosen for the study. Dacryocystorhinostomy were
      done for them after their evaluation.
    

Detailed description: 
      Evaluation for lacrimal passage in the included patients using syringing, probing and dye
      disappearance test. Dacryocystorhinostomy were done for all patients and followed up for at
      least 6 months.
    

Intervention name(s): Dacryocystorhinostomy
Intervention type(s): Procedure
Intervention description(s): Anastomosis between lacrimal sac and nasal cavity
Intervention model: Single Group Assignment
Intervention model description: Adult Dacryocystocele
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Fluoxetine Tablet Under Fasting Conditions
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and
      Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated
      by a washout period of 35 days.
    

Detailed description: 
      An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose
      Bioequivalence Study of Fluoxetine Tablets containing Fluoxetine 20 mg ( Test Formulation,
      Torrent Pharmaceutical Ltd., India) Versus Sarafem® 20 mg Tablets containing Fluoxetine 20 mg
      (Reference , Warner Chilcott LLC, USA) in Healthy Human Volunteers Under Fasting Condition.
    

Intervention name(s): Torrent's Fluoxetine Tablets; Warner Chilcott LLC Sarafem Tablets
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the effect of favipiravir + SOC v. SOC on COVID-19 viral clearance.
    

Detailed description: 
      This is an open label, randomized, controlled, multicenter Phase 2 proof-of-concept study of
      favipiravir in hospitalized subjects with Corona Virus Disease (COVID) -19. Subjects will be
      randomized within their study site and stratified by the severity of their disease to receive
      either favipiravir + standard of care (SOC) or SOC alone.

      The dose regimen will be 1800 mg favipiravir bis in die (BID) plus SOC or SOC alone on Day 1
      followed by 1000 mg BID favipiravir (800 mg BID for subjects with Child-Pugh A liver
      impairment) plus SOC or SOC for the next 13 days.

      The study will have 14 days of treatment and 46 days of follow-up.

      Approximately 50 patients are planned to be enrolled in the trial at approximately 8 study
      sites in the US.
    

Intervention name(s): Favipiravir; Standard of Care
Intervention type(s): Drug; Other
Intervention description(s): Favipiravir to be administered as an oral tablet or made into a slurry for subjects who cannot swallow tablets; Standard of Care for individual study site as determined by each hospital's protocol
Intervention MeSH terms: Favipiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-label, randomized (1:1 ratio) to receive favipiravir plus standard of care or standard of care alone.
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for Episodic Treatment of Cold Sores
Condition: Recurrent Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if Merlin, a mixture of ethanol and glycolic acid,
      is safe and effective in the treatment of cold sores.

      Subjects who meet the requirements to participate in the study will be put randomly, and
      equally, into one of two groups: 1) a group receiving Merlin to treat their cold sore; or 2)a
      group receiving a placebo of just ethanol to treat their cold sore. Neither the subject nor
      the site will know which treatment they will be getting. Once the subject has been assigned
      to a treatment group, they will be given a kit containing a bottle of the treatment and
      special swabs to apply the liquid. The subject will be told to take the kit home and wait
      until they think they are starting to get a cold sore.

      Once a subject begins to see something that they think is the start of a cold sore, they are
      to immediately call the clinic. Once the clinic confirms that the subject is in fact starting
      to get a cold sore, the subject will be told to open the kit and begin treatment. From the
      start of treatment, there will be twelve (12) treatments, with either Merlin or placebo,
      applied six (6) hours apart, up to 3 per day, over the next 96 hours (4 days). Each treatment
      of Merlin or placebo is made up of three (3) applications given twenty (20) minutes apart,
      for a total of thirty-six (36) applications. For each application, the subject will use the
      special swab to put the Merlin or placebo solution on their cold sore.

      Subjects will need to report daily to the clinic for a minimum of 3 consecutive days, until
      either the cold sore is completely healed or 14 days from the start of treatment, whichever
      comes first. At each clinic visit the cold sore will be observed to determine at what stage
      it is at or if it has healed. The subject will also be asked how they are feeling.

      Subjects will also be told to record in a diary the time of each application of Merlin or
      placebo. They will also be asked to record the stage of their lesion and how much pain, if
      any, related to the cold sore, that they are feeling.
    


Intervention name(s): Merlin; Ethanol
Intervention type(s): Drug; Drug
Intervention description(s): glycolic acid/ethanol solution; Ethanol solution
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Herpes Labialis; Cold Sore
Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate structural changes effected by AD9668 in
      the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice
      Computed Tomography (MSCT)
    


Intervention name(s): AZD9668; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 x 30 mg oral tablets twice daily (bid) for 12 weeks; 2 x matched placebo to oral tablet twice daily (bid) for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic; obstructive; pulmonary; lung; respiratory disease; efficacy; placebo-controlled; COPD; FEV1; St Georges Respiratory Questionnaire; Computed Tomography; MSCT
Combined Therapy With Myo-inositol and Alpha-Lipoic Acid in PCOS Women
Condition: Polycystic Ovary Syndrome; Menstrual Pattern; Hyperandrogenism; Metabolic Features
MeSH terms: Polycystic Ovary Syndrome; Hyperandrogenism; Syndrome
Study type: Interventional

Summary: 
      The aim of our study is to investigate the effects of a combined treatment of alpha-lipoic
      acid and myoinositol on clinical, endocrine and metabolic features of women affected by PCOS.
      The study Group included 40 patients treated with a combined therapy of alpha-lipoic acid
      (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months. The
      investigation includes menstrual pattern, hirsutism score, hormonal assays, oral glucose
      tolerance test, lipidic profile at baseline and after six months of treatment.
    


Intervention name(s): myo-inositol,alpha-lipoic acid and folic acid
Intervention type(s): Drug
Intervention MeSH terms: Folic Acid; Thioctic Acid; Inositol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Renal Allograft Tolerance Through Mixed Chimerism
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will examine the safety and effectiveness of a combination kidney and bone marrow
      transplant from a haplo-identical related donor. An investigational medication and other
      treatments will be given prior to and after the transplant to help protect the transplanted
      kidney from being attacked by the body's immune system
    


Intervention name(s): MEDI-507; Rituximab; Total Body Irradiation; Thymic Irradiation
Intervention type(s): Drug; Drug; Radiation; Radiation
Intervention description(s): T-Cell Depleting Agent; B-Cell Depleting Agent; Bone Marrow Depletion
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: End Stage Renal Disease; Renal Transplant; Bone Marrow Transplant; Tolerance; Chimerism; ESRD
Perineal Physiotherapy in Postpartum
Condition: Post Partum
Study type: Interventional

Summary: 
      Objective: To find out the effectiveness of pelvic-perineal physiotherapy in prevention and
      treatment of postpartum pelvic floor dysfunction caused by vaginal delivery.
    

Detailed description: 
      Design: Randomized, controlled and single blinded clinical trial. Participants will be
      randomly assigned to one of these groups: Experimental group: pelvic-perineal physical
      therapy plus hypopressive exercises plus training in lifestyle advice; Experimental group II:
      hypopressive exercises plus training in lifestyle advice; Control group: just training in
      lifestyle advice. In the 3 groups several physical therapy assessments will be undertaken:
      1st before intervention, 2nd immediately after completing intervention; 3th, 4th, 5th and 6th
      after 3, 6, 12 and 24 months. Study subjects: Postnatal women (6 and 8 weeks after vaginal
      delivery), primiparous, whose vaginal delivery has occurred in the "PrÍncipe de Asturias"
      Hospital, which have not been already treated for pelvic floor dysfunction, and after
      reading, understanding and freely signing an informed consent form. Sample size: 240 subjects
      will be included (80 subjects per group). Allowing for 15% of drop-outs and taking into
      account that 17% of women in the intervention group may develop pelvic floor dysfunction
      (urinary incontinence) versus 40% in the control group, with an alpha risk of 0.05, a beta
      risk of 0.1 in a bilateral contrast using the arcsine approximation. Data analysis: A
      descriptive analysis will be done of all variables. A confidence level of 95% (p <0,05) will
      be established for all the cases. Effectiveness will be evaluated by comparing between the
      two groups of the change in outcome variables between visits.
    

Intervention name(s): PFM training; HE; Educational strategy
Intervention type(s): Other; Other; Behavioral
Intervention description(s): See information included in arm/group descriptions.; See information included in arm/group descriptions.; See information included in arm/group descriptions.
Other intervention name(s): Pelvic floor muscle training; Hypopressive exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 groups: 2 experimental groups and 1 control group
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Rhinological Outcomes in Endonasal Pituitary Surgery
Condition: Pituitary Neoplasm; Pituitary Adenoma; Prolactinoma; Cushings Disease; Acromegaly
MeSH terms: Adenoma; Pituitary Neoplasms; ACTH-Secreting Pituitary Adenoma; Prolactinoma; Acromegaly; Pituitary Diseases; Pituitary ACTH Hypersecretion
Study type: Observational

Summary: 
      This is a prospective, multi-center observational study designed to address patient-reported
      nasal outcomes in adults undergoing endoscopic and microscopic surgical removal of pituitary
      tumors. The primary objective of this study is to determine the difference in nasal outcomes
      by using the Anterior Skull Base (ASK) Nasal survey between patients treated with endoscopic
      surgical technique and those treated with microscopic surgical technique. Patients will be
      given the ASK Nasal survey to assess their nasal functioning and overall health before their
      surgery, and at post-operative visits 1-2 weeks, 3 months, and 6 months.
    

Detailed description: 
      The technical and patient factors that influence rhinological (nasal) outcomes following
      endonasal anterior skull base surgery and pituitary surgery are not well understood. Several
      timely and controversial topics, such as the influence of endoscopic techniques and the
      impact of underlying disease on nasal outcomes are in need of further study.

      The Anterior Skull Base (ASK) Nasal survey is a 24-item questionnaire designed to assess for
      common postoperative nasal complaints, such as crusting, nasal congestion, pain, sinusitis,
      sense of smell, and overall functioning. The survey is a brief and simple assessment that
      asks patients to score symptom severity on a five-point scale.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with pituitary lesions referred to our investigators for surgical management by
        either microscopic or endoscopic transspenoidal surgical resection.
      
Keywords: Pituitary surgery; Transsphenoidal surgery; Anterior skull base surgery; Endoscopic surgery; Patient survey; Nasal complications
The Safety and Feasibility of MONOFIX on Fascial Closure of Mid-line Wound After Minimally Invasive Colorectal Cancer Surgery
Condition: Colon Cancer; Rectal Cancer; Colon Adenocarcinoma; Rectal Adenocarcinoma
MeSH terms: Adenocarcinoma; Colonic Neoplasms
Study type: Interventional

Summary: 
      This clinical trial aims to evaluate the safety and feasibility of mid-line fascial suturing
      using MONOFIX sutures in patients undergoing minimally invasive surgery for colorectal
      cancer.
    


Intervention name(s): Monofix
Intervention type(s): Device
Intervention description(s): a new absorbable barbed suture device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: minimally invasive surgery; Barbed suture
HCV Virions Bound Proteins
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional

Summary: 
      The emergence of hepatocellular carcinoma (HCC) has prompted a search for a thorough
      understanding of the biology of one of its major causative agents, the hepatitis C virus
      (HCV). HCV particles acquire via budding and encapsidation cellular proteins. There is
      mounting evidence on several viral species that virion-bound proteins are prone to be
      involved either at the replication, budding/egress or entry/release steps of the viral cycle.

      Identifying such targets may yield ideal candidates for gaining insight on the dependence of
      HCV upon a restricted subset of host proteins, therefore providing refined sets of
      genetically stable targets for therapy. This project's goals are to set up adequate
      conditions for robust and reproducible purification of HCV virions in clinical samples,
      followed by the identification of their HCV-bound host proteins and the characterization of
      their functions. Proteomics profiling of HCV particles purified from clinical samples will be
      overlaid with proteins identified and characterized in cell culture grown HCV particles
      during my post-doctoral training, using clinical biomarker discovery grade criteria. Targets
      identified in both samples sets will be subjected to in vitro investigations using
      HCV-replicating cells. Conventional biochemical and imaging methods will be used in order to:
      (i) ascertain their physical association with HCV virions; (ii) define the modalities of
      their interaction with HCV proteins; (iii) decipher the topology and subcellular localization
      of their association with HCV proteins and virions; (iv) quantitatively assess their
      functional involvement in particle budding, egress or secretion and infectivity. A candidate
      that yielded satisfactory results in these experiments will be disclosed and further
      investigated at the level of structural biology, in collaborative research programs.
    


Intervention name(s): blood draw of 150ml, twice
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: HCV, liver
A Safety Study of Galcanezumab in Participants With Migraine, With or Without Aura
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to evaluate the longer term safety of the study drug known
      as galcanezumab in participants with episodic or chronic migraine.
    


Intervention name(s): Galcanezumab
Intervention type(s): Drug
Intervention description(s): Administered SC
Other intervention name(s): LY2951742
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prevention; prophylaxis; headache
A Single Dose Escalation Study In Healthy Volunteers To Determine The Pharmacokinetics, Safety And Tolerability Of PF-05089771 In Healthy Volunteers
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two part study. The purpose of the first part is primarily to determine the safety
      and toleration and pharmacokinetics of PF-05089771 following single escalating doses.
      Secondary objectives will be to investigate the PK of an alternative formulation of
      PF-05089771 and the effect of food on the PK of PF-05089771. The second part of the study
      will focus on investigation of the exploratory pharmacodynamics of PF-05089771 using novel
      biomarkers in healthy volunteers. The doses selected in Part B will have been administered
      previously in Part A of the study.
    


Intervention name(s): PF-05089771; PF-05089771; PF-05089771; PF-05089771; PF-05089771; PF-05089771
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive single ascending doses of PF-05089771 or placebo to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated.; Subjects will receive single ascending doses of PF-05089771 or placebo to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated.; Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur. In addition the exploratory pharmacodynamics of PF-05089771 will be investigated using novel biomarkers.; Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur.; Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur.; Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics Safety Tolerability Pharmacodynamics