bioihbjkbjnl/mcl2 huggingface dataset:
The Safety and The Efficacy Evaluation of NEUROSTEM®-AD in Patients With Alzheimer's Disease
Condition: Dementia of the Alzheimer's Type
MeSH terms: Dementia; Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the safety and the tolerability of
      NEUROSTEM®-AD (Human Umbilical Cord Blood Derived Mesenchymal Stem Cells) and to assess the
      maximum tolerated dose (MTD). This study is also to investigate the efficacy of this study
      drug in patients with dementia of Alzheimer's type.
    

Detailed description: 
      Most of the treatments for Alzheimer disease are chemical drug that is designed to
      temporarily increase acetylcholine, based on the cholinergic hypothesis. These drugs can
      improve the symptoms but is not able to inhibit the disease progression. New drugs from the
      disease have been developed but they have not been successful yet.

      Mesenchymal stem cells (MSC) are capable of differentiating into various tissues. Due to the
      characteristics of the cells it has been widely investigated in tissue regeneration. In
      addition, the paracrine effect of MSC in microenvironment has been recently reported. MSC has
      been developed as an immunomodulation cell therapy product because it has been known that it
      does not cause immunological rejection in allo- and xeno-transplantation. Clinical studies
      showed that umbilical cord blood-derived MSC is immunologically stable and not toxic.

      This study is to evaluate the safety and the tolerability of NEUROSTEM®-AD (Human Umbilical
      Cord Blood Derived Mesenchymal Stem Cells) and to assess the maximum tolerated dose (MTD).
      This study is also to investigate the efficacy of this study drug in patients with dementia
      of Alzheimer's type.
    

Intervention name(s): Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells
Intervention type(s): Biological
Intervention description(s): DOSE A - 250,000 cells per 5 uL per 1 entry site, 3 million cells per brain DOSE B - 500,000 cells per 5 uL per 1 entry site, 6 million cells per brain
Other intervention name(s): NEUROSTEM®-AD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer, Mesenchymal Stem Cells, Umbilical Cord Blood
TevaGastrim for Stem Cell Mobilization Sibling Donors
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the efficacy of TevaGastrim which is a biosimilar
      version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem
      cells from normal sibling donors for allogeneic stem cell transplantation.
    


Intervention name(s): TevaGastrim
Intervention type(s): Drug
Intervention description(s): TevaGastrim 10 mg/kg SC will be administered in the evening for 4 days prior to apheresis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute myeloid leukemia; Myelodysplastic syndrome; Stem Cell Mobilization; Allogeneic Stem Cell Transplantation
A Pharmacokinetic Study of TRK-100STP in Japanese Patients With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The PK and safety profiles to be examined following a single oral administration of
      TRK-100STP (120 μg) under fasting conditions to patients with renal impairment and to
      subjects with normal renal function.
    


Intervention name(s): beraprost sodium(BPS)
Intervention type(s): Drug
Intervention MeSH terms: Beraprost
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: TRK-100STP; PK; beraprost sodium; Japanese males and females; Subjects with mild/moderate/severe patients; renal impairment
Evaluation of the Effect of Self-Assembling Peptide P11-4
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 1

Summary: 
      Dental caries is a biofilm-mediated, sugar-driven, multifactorial, dynamic disease that
      results in the phasic demineralization and remineralization of dental hard tissues.

      These tissues have poor regeneration capability because of the lack of both regenerative
      cells and vascularization.

      In the complex caries progression process involving dietary sugars, bacterial metabolism and
      demineralization, the collagenous organic matrix becomes exposed and destroyed by resident
      and bacterial proteases, allowing the lesion to expand
    

Detailed description: 
      It is possible to find numerous noninvasive or minimally invasive therapies for caries such
      as hygiene education, fluorides, Phosphopeptide compounds, xylitol and infiltrative resins.

      However, when caries progresses to the point of breaking down the dental tissues, composite
      restorations are imperative to preserve the tooth functionality.

      During the execution of routine dental restorations, the hybrid structure formed by the
      dental bonding procedure occurs through the interaction and subsequent polymerization of
      monomers around the demineralized collagen matrix.

      The oral cavity is a severe environment for the resin-dental bond to survive for a reasonable
      length of time, with thermomechanical changes, chemical attacks by acids and enzymes and
      other factors posing routine daily challenges. Therefore to achieve effective and stable
      bonding, the preservation of dentin collagen is critical, since collagen represents the major
      organic component of the dentin matrix.

      Based on today's understanding of the dental biomineralization process, new efforts have been
      made to develop synthetic analogues of non-collagenous proteins (NCPs), which are involved in
      the events of nucleation and growth of hydroxyapatite crystals in hard tissues Such analogues
      have been designed mirroring the amphiphilic characteristics of NCPs, with polar groups
      complexing inorganic ions and non-polar side chains governing the matrix-matrix interactions.
    

Intervention name(s): Peptide
Intervention type(s): Drug
Intervention description(s): it is about synthetic protein acting on tooth structure help information apatite crystals
Other intervention name(s): peptide P11-4
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To study the effect of self assembling-peptide P11-4 treatment on dentine remineralization, after removal of all infected dentine (Remineralization of caries affected dentin),
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of the Surfacer System Approach to Central Venous Access
Condition: Venous Occlusion
Study type: Interventional

Summary: 
      Pre-market Investigational device exemption study evaluating the safety and efficacy of the
      Surfacer System to facilitate stable upper body central venous access suitable for any
      conventional catheter.
    

Detailed description: 
      This prospective, single arm, multi-center study is to demonstrate the safety and efficacy of
      the Surfacer System. Safety will be evaluated based on the overall rate of acute
      complications using the study device as compared to historical rates of device/procedure
      related safety events using conventional central venous access methods. Efficacy will be
      evaluated by the rate of transient successful central venous accesses created by the study
      device. A total of 30 patients are planned to be enrolled, with 10 patients initially
      following review of safety data. Duration expected to be through 7 days. A minimum of 3 sites
      will participate in the study in the United States.
    

Intervention name(s): Central Venous Access Placement
Intervention type(s): Device
Intervention description(s): Device inserted into the femoral vein to insert a central venous access catheter
Intervention model: Single Group Assignment
Intervention model description: patients requiring venous access
Masking: None (Open Label)
Primary purpose: Treatment
Indocyangreen Elimination in Cirrhosis and Acute Liver Failure
Condition: Acute Liver Failure; Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Failure; Hepatic Insufficiency; Liver Failure, Acute; Fibrosis
Study type: Observational

Summary: 
      Indocyangreen (ICG)is totally biliary eliminated and corresponds to hepatocyte function and
      liver perfusion.

      The ICG-clearance will be evaluated as a prognostic marker in liver disease.
    

Detailed description: 
      patients with acute liver failure or advanced liver disease will be studied. ICG-clearance
      will be correlated with established clinical scores and outcome.
    

Intervention name(s): Indocyangreen (ICG) clearance
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Keywords: ICG clearance; liver cirrhosis; acute liver failure; prognosis
Hormonal Regulation of Body Weight Maintenance
Condition: Obesity; Weight Loss; Weight Gain; Hormone Disturbance; Adipose Tissue; Insulin Resistance; Skeletal Muscle
MeSH terms: Insulin Resistance; Endocrine System Diseases; Body Weight; Weight Loss; Weight Gain
Study type: Interventional

Summary: 
      The investigators here propose to perform a collaborative clinical research effort including
      a randomized controlled trial investigating the mechanisms of weight maintenance and their
      relation to a lifestyle intervention in children, adolescents and adults. The detailed
      investigation and analysis of the variability and dynamics of the endocrine circuits
      responding to a negative energy balance and weight loss will be accompanied and enhanced by
      specific clinical projects targeting peripheral and central-nervous aspects of hormonal
      counter-regulation after weight loss. Mechanisms of endocrine counter-regulation and
      potential therapeutic approaches will be studied.
    


Intervention name(s): multimodal lifestyle intervention; placebo
Intervention type(s): Behavioral; Behavioral
Intervention description(s): After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults; no intervention, only follow up
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight regain; endocrine counterregulation
A Research Study to Evaluate the Renal (Kidney) Protective Effects of Losartan in Patients With Non-insulin Dependent Diabetes (0954-147)(COMPLETED)
Condition: Type 2 Diabetes; Nephropathy
MeSH terms: Kidney Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the effect of Losartan in reducing kidney disease in patients with Non-insulin
      Dependent Diabetes and Nephropathy (kidney damage that usually accompanies late stage
      Diabetes Mellitus).
    


Intervention name(s): MK0954, losartan / Duration of Treatment: mean 3.4 years; Placebo / Duration of Treatment: mean 3.4 years
Intervention type(s): Drug; Drug
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis
Condition: Hand Dermatosis
MeSH terms: Dermatitis; Skin Diseases; Hand Dermatoses
Study type: Interventional

Summary: 
      The purpose of this study is to find out if the use of a hand cleanser that adds moisture to
      the skin will help improve skin rashes caused by frequent hand washing (hand dermatitis).
    

Detailed description: 
      The objective of this protocol is to evaluate compatibility and potential benefits of daily
      use of a marketed mild, moisturizing hand cleanser for subjects/patients who experience mild
      to moderate hand dermatitis induced by frequent cleansing.
    

Intervention name(s): Mild, moisturizing hand cleanser
Intervention type(s): Other
Intervention description(s): Hand cleanser ingredient list:
Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Cocamide MEA, PEG-5 Cocamide Cocamidopropyl Betaine Sodium Lauroyl Sarcosinate Glycerin Petrolatum Soybean Oil Sodium Hydroxypropyl Starch Phosphate Lauric Acid Lauryl Alcohol PEG-14M Guar hydroxypropyl trimonium chloride DMDM Hydantoin; Iodopropynyl Butylcarbamate Etidronic Acid Tetrasodium EDTA Titanium Dioxide Fragrance Sodium Hydroxide Water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Hand dermatitis
A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of the study is to evaluate the efficacy of a topical 5% minoxidil
      formulation in males for the treatment of pattern hair loss. The secondary purpose is to
      evaluate the safety of a topical 5% minoxidil formulation in males when used twice daily for
      the treatment of pattern hair loss and to obtain the safety data on the investigational
      product when used twice daily for up to one year.
    

Detailed description: 
      Male subjects with androgenetic alopecia were enrolled in this fourteen-center trial.
      Subjects were randomized to use either 5% minoxidil or placebo foam twice daily for 16 weeks.
      A total of 143 subjects continued use of the 5% minoxidil foam for 8 to 12 months in an
      open-label phase to obtain safety data on 5% minoxidil topical foam when used twice daily for
      up to one year.

      The 5% minoxidil foam was shown to be effective in the treatment of male androgenetic
      alopecia in a 16 week trial. It was statistically significantly superior to placebo foam in
      the primary efficacy measure of mean change in the non-vellus hair count in the target region
      between Baseline and Week 16, and the subject rating assessed an overall improvement from
      Baseline.

      The efficacy of 5% minoxidil compared to placebo was confirmed by the secondary efficacy
      endpoints of scores from the expert panel review of hair regrowth when comparing photographs
      obtained at Baseline with photographs obtained at Week 16, as well as the percent change from
      Baseline in non-vellus hair counts within a pre-specified area of clipped hair.

      The 5% minoxidil foam formulation was well tolerated, the incidence of adverse events was
      similar between groups, and no safety concerns were raised based on clinical laboratory test
      results, vital signs or scalp irritation scores.
    

Intervention name(s): minoxidil
Intervention type(s): Drug
Intervention description(s): Topical 5% minoxidil foam, BID, for sixteen weeks
Other intervention name(s): Formula # P902942A00 vs Placebo foam (Formula # P902943A00)
Intervention MeSH terms: Minoxidil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alopecia, Balding
Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval
Condition: Infertility, Female; Pain, Postoperative
MeSH terms: Infertility; Infertility, Female; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      In this research study we want to learn more about how effective certain medications are at
      reducing pain after oocyte (egg) retrieval surgery and how effective they are at reducing the
      time between the retrieval and discharge from the hospital. We will compare three types of
      pre-operative medications: intravenous (IV) acetaminophen, oral (PO) acetaminophen, and
      placebo (no medication), which is the current typical care.
    

Detailed description: 
      OBJECTIVE: To compare the efficacy of pre-operative IV acetaminophen, PO acetaminophen,
      versus placebo for adjunctive pain control in the setting of oocyte retrieval in an in vitro
      fertilization clinic setting.

      HYPOTHESIS: Our hypothesis is that patients receiving IV acetaminophen pre-operatively will
      have improved postoperative pain scores, lower overall opiate consumption, and shortened time
      to discharge from post analgesic recovery unit (PACU) or recovery than those receiving PO
      acetaminophen or placebo.

      Participants will be consented and enrolled in the study prior to their oocyte retrieval. The
      patient will then be randomized to one of three treatments:

      Group 1: In the pre-op suite, these patients will receive 1000mg IV acetaminophen and PO
      placebo, followed by standard protocol anesthesia and pain control as needed.

      Group 2: In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV
      placebo, followed by standard protocol anesthesia and pain control as needed.

      Group 3:

      In the pre-op suite, these patients will receive PO and IV placebo, followed by standard
      protocol anesthesia and pain control as needed.

      The patient and care team will be blinded to the treatment group.

      A member of the study staff will review participants' medical record to collect data
      regarding demographics, clinical history, cycle and pregnancy outcomes, up to 12 months
      following study completion.
    

Intervention name(s): IV Acetaminophen; PO Acetaminophen; Placebo IV Acetaminophen; Placebo PO Acetaminophen
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): IV Acetaminophen for pain control during procedure; PO Acetaminophen for pain control during procedure; Placebo IV Acetaminophen; Placebo PO Acetaminophen
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: in vitro fertilization; oocyte retrieval; acetaminophen; postoperative pain control
Autogenous Grafts for Anterior Maxillary Horizontal Ridge Augmentation
Condition: Alveolar Ridge Augmentation
Study type: Interventional

Summary: 
      The aim of the study was to compare efficacy of autogenous onlay and inlay grafts for
      anterior maxillary horizontal ridge augmentation.
    

Detailed description: 
      Autogenous block graft has been used as onlay thin cortical shell and cortico-cancellous
      particles. The thin cortical shell acts as an autogenous biological membrane that will resist
      resorption and stabilize the small pieces of particulate bone. The bone block is screwed-in
      at a distance from the recipient site by means of titanium bone screws, and then the free
      space under the shell is filled with the particulate bone.

      The resultant augmentation somehow resembles an iliac graft, with thick internal cancellous
      bone and a thin external cortical layer. This leads to an ideal graft, with a high
      regenerative capacity comparable to iliac bone and a stable regenerated volume with optimum
      osseointegration potential close to that of mandibular block grafts.

      Interpositional grafts have been successfully established in restoring vertical bone height .
      However much less evidence is present on its use for horizontal augmentation. It is the
      purpose of this study to assess the efficacy of autogenous onlay corticocancellous block
      grafts for anterior maxillary horizontal ridge augmentation as compared to onlay block
      grafts.
    

Intervention name(s): Horizontal ridge augmentation by symphyseal bone block placed and fixed buccally as onlay graft; Horizontal ridge augmentation by symphyseal bone block interpositioned in space created between buccal and lingual cortex as inlay graft
Intervention type(s): Procedure; Procedure
Intervention description(s): autogenous bone block harvested from chin area using piezosurgery and fixed buccally in deficient area with fixation screws; autogenous bone block harvested from chin area using piezosurgery and fixed in bone split created at deficient area with fixation screws
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: onlay grafting; inlay grafting
Randomized, Double Blind, Efficacy Study of Escitalopram in ENT Cancer Patients Suffering From Emotional Distress
Condition: ENT Cancer
Study type: Interventional
Phase: Phase 3

Summary: 
      Escitalopram is an antidepressant inhibitor of the serotonin reuptake. On the market in
      France since 2002.

      Prevalence of emotional distress in patients with cancer is 30-50%. this prevalence may vary
      regarding the tumor localisation, the population, intensity of the symptoms...

      Incidence of ENT cancer is highly significant in France, it is one of the most important in
      the world 37 out of 100 000. it is in patients with ENT cancer that the prevalence of
      depression is the most important (22%-57%).

      Researches appears necessary to assessed the efficacy of antidepressant treatments with as
      primary objective not only the decrease of depressive symptoms but also an ensemble of physic
      and psychological symptoms.
    


Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRA
Condition: Juvenile Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      2000 international units (IU) vitamin D, 1 gram (gm) calcium, or both given to children with
      Juvenile Rheumatoid Arthritis (JRA) may increase percent true calcium absorption, bone
      mineral turnover and/or bone mineralization.
    

Detailed description: 
      Supplementation With 2000 IU Vitamin D, 1 gm Calcium or Both on Calcium Absorption and Bone
      Mineralization in Children With Juvenile Rheumatoid Arthritis may increase percent true
      calcium absorption, bone mineral turnover and/or bone mineralization.
    

Intervention name(s): Cholecalciferol; Calcium; Calcium and cholecalciferol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): 2000IU Cholecalciferol P.O. Q.D.; 1 gm calcium as calcium carbonate; 2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months; Placebo
Intervention MeSH terms: Calcium, Dietary; Cholecalciferol; Vitamin D; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment