bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents
Condition: Acute Lymphoblastic Leukemia; Relapsed Pediatric ALL; Refractory Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I clinical study to evaluate the safety and tolerability of pCAR-19B in
      patients with relapsed or refractory B-ALL, and to obtain the maximum tolerated dose of
      pCAR-19B and phase II Recommended dose.
    

Detailed description: 
      This is a single-center, single-arm, open-label study. The study plans to set up 3 dose
      groups, adopting a dose-escalating 3+3 design, and plan to recruit about 9-18 subjects with
      relapsed or refractory B-ALL.pCAR-19B will be infused to the subject by intravenous infusion.
    

Intervention name(s): pCAR-19B cells
Intervention type(s): Biological
Intervention description(s): Drug: pCAR-19B cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CAR-T; CD19; B-ALL
Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate that CHF 1535 in pressurized metered dose inhaler
      (pMDI) is non-inferior to the corresponding dose of free combination of Beclomethasone (BDP)
      and Formoterol Fumarate (FF) and superior to the corresponding dose of BDP in terms of lung
      functions in asthmatic children patients.
    


Intervention name(s): CHF 1535; Beclomethasone (BDP); Beclomethasone (BDP) + Formoterol Fumarate (FF)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CHF 1535 (BDP/FF) for 12 weeks; Beclomethasone (BDP) for 12 weeks; free combo Beclomethasone (BDP) + FF for 12 weeks
Intervention MeSH terms: Beclomethasone; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; children; chronic treatment
Safety, Tolerability, and Pharmacokinetics of Andecaliximab in Adults With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the safety and tolerability of multiple
      infusions of andecaliximab (formerly GS-5745) in participants with chronic obstructive
      pulmonary disease (COPD) as assessed by adverse events (AEs) and laboratory abnormalities.
    


Intervention name(s): Andecaliximab; Placebo to match Andecaliximab
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg andecaliximab administered intravenously; Placebo to match andecaliximab administered intravenously
Other intervention name(s): GS-5745
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD, chronic obstructive pulmonary disease; Safety, Pharmacokinetics
A Study to Access the Safety/Efficacy of Thalidomide in the Treatment of Anemia in Patients With Myelodysplastic Syndromes
Condition: Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to determine the efficacy of thalidomide for the
      treatment of anemia in patients with myelodysplastic syndromes (MDS).
    


Intervention name(s): thalidomide
Intervention type(s): Drug
Intervention MeSH terms: Thalidomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Gastric Emptying Ultrasound Research Study
Condition: Gastric Emptying
Study type: Interventional

Summary: 
      The proposed study will use this technology to observe emptying of the stomach of a protein
      and carbohydrate rich clear liquid sports/nutrition drink.
    

Detailed description: 
      In order to ensure safety for elective anesthesia, standard practice requires pre-operative
      fasting to ensure that the stomach is empty prior to induction. The question of timing of
      pre-operative consumption of oral fluids remains vexed, and challenges anesthesiologists on a
      frequent basis. In the past few years, a new controversy in pre-operative fasting has arisen:
      clear drinks with increased content of protein and carbohydrate have been introduced to the
      market. Families and professionals alike are confused whether to regard these products as
      clear liquids (2 hours fasting) or as solids (at least 6 hours).

      Ultrasound is now considered an accepted tool in the anesthesia literature as a surrogate for
      aspiration risk with different materials and in different disease states.
    

Intervention name(s): Ultrasound; 2% milk; apple juice; ensure clear
Intervention type(s): Procedure; Other; Other; Other
Intervention description(s): Baseline ultrasound is performed upon arrival. Ultrasound is performed when beverage is consumed and then every 30 minutes thereafter until stomach is empty.; 16 participants will drink 10 ounces of 2% milk; 16 participants will drink 10 ounces of apple juice; 16 participants will drink 10 ounces of ensure clear
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
A Bioequivalence Study of L04TD1 Compared to Administration of L04RD1 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to
      evaluate bioequivalence after administration of L04RD1 or administration of L04TD1 in healthy
      volunteers.
    


Intervention name(s): L04RD1; L04TD1; L04TD1; L04RD1
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 tablet of L04RD1; 1 tablet of L04TD1; 1 tablet of L04TD1; 1 tablet of L04RD1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Manual Lymphatic Drainage
Condition: Venous Leg Ulcer; Venous Insufficiency; Lymphatic Disease
MeSH terms: Varicose Ulcer; Venous Insufficiency; Lymphatic Diseases; Leg Ulcer
Study type: Interventional

Summary: 
      In venous ulcer, venous insufficiency is accompanied by lymphatic insufficiency. Manual
      lymphatic drainage (mld) technique cause to increase contraction rate of lymphatic collector
      and venous flow. It is known that Manual lymphatic drainage accelerates microcirculation,
      enabling nutrients and oxygen to reach tissues and at the same time removing residual
      substances from the tissue. We hypothesis that if we inrease to lypmhatic activity with MLD,
      we could stimulate healing of ulcer. The aim of this study to investigate the effect of
      manual lymphatic drainage on venous ulcer healing.
    


Intervention name(s): Manual Lymphatic drainage (MLD); Skin Care; Exercise; Shame Manual Lymphatic drainage
Intervention type(s): Other; Other; Other; Other
Intervention description(s): MLD vith vodder technique was applied to leg; Wound was cleaned with salin and covered by dressing without including active products; breathing and foot pump exercise was prescribed; manual lymphatic drainage was applied with light touch instead of real mld techniques
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
RISK FACTORS OF GALL BLADDER STONE
Condition: Gall Stone
MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis; Urinary Bladder Calculi
Study type: Observational

Summary: 
      Gallbladder disease is a significant health burden in the developed world and its prevalence
      has risen by more than 20% in the past three decades In the United States, 20-25 million
      individuals are affected by gallbladder disease, resulting in an average annual treatment
      cost of $6.2 billion Obesity, diet, rapid weight loss, metabolic syndrome, and conditions
      such as cirrhosis, Crohn's disease, irritable bowel syndrome, and gallbladder stasis increase
      the risk of gallstone formation Surgical removal of the gallbladder, cholecystectomy, is the
      most recommended treatment for gallbladder disease; however, the procedure increases the risk
      of non-alcoholic fatty liver disease, cirrhosis and metabolic effects
    

Detailed description: 
      Gallbladder disease is a significant health burden in the developed world and its prevalence
      has risen by more than 20% in the past three decades .

      In the United States, 20-25 million individuals are affected by gallbladder disease,
      resulting in an average annual treatment cost of $6.2 billion Obesity, diet, rapid weight
      loss, metabolic syndrome, and conditions such as cirrhosis, Crohn's disease, irritable bowel
      syndrome, and gallbladder stasis increase the risk of gallstone formation .

      Surgical removal of the gallbladder, cholecystectomy, is the most recommended treatment for
      gallbladder disease; however, the procedure increases the risk of non-alcoholic fatty liver
      disease, cirrhosis and metabolic effects .

      Oral dissolution therapy using ursodeoxycholic acid is currently one of the leading
      non-invasive alternative treatments for gallstones. Ursodeoxycholic acid dissolves small
      cholesterol gallstones by decreasing hepatic secretion of cholesterol and lowering the
      chances of unsaturated gallbladder bile formation Although oral dissolution therapy has
      proven to be a safe alternative to cholecystectomy, it has a gallstone recurrence rate of
      50%-70% at 12 years post-treatment .

      The high incidence rate and treatment cost associated with gallbladder disease have
      encouraged the search for preventative strategies. In approximately 75% of cases, impaired
      gallbladder motility results from the accumulation of cholesterol gallstones. Therefore,
      agents that reduce lipid concentrations or improve gallbladder motility may reduce the need
      for surgical interventions and/or the use of potentially harmful pharmaceutical products .
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study will include all adult patients with gallstones admitted to Tropical Medicine
        Department, Sohage University Hospital.
      
Keywords: Risk factors ,gallbladder stone
Effect of Salicylate on Glucose Metabolism in Insulin Resistance States
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Data supports diet induced obesity leads to activation of the IKK/NF-kB inflamatory pathway
      and that chronic inflammation leads to insulin resistance and diabetes. In rodents,
      salicylates inhibit IKK/NF-kB and may improve insulin sensitivity. We will study if this is
      true in people.
    

Detailed description: 
      Please see the following review articles on this topic:

      Shoelson SE, Lee J, Goldfine AB. (2006) Inflammation in insulin resistance. J. Clin. Invest.
      116, 1793-1801.

      Goldfine AB, Fonseca V and Shoelson SE (2010) Therapeutic approaches to target inflammation
      in type 2 diabetes. Clin Chem. 57, 162-167.

      Donath MY and Shoelson SE (2011) Type 2 diabetes as an inflammatory disease. Nat Rev Immunol.
      11, 98-107.

      Goldfine AB and Shoelson SE (2017) Therapeutic approaches targeting inflammation for diabetes
      and associated cardiovascular risk. J Clin Invest. 127, 83-93.
    

Intervention name(s): Salsalate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active; Placebo for salslate, used only in the third trial
Other intervention name(s): Disalcid
Intervention MeSH terms: Salicylsalicylic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay
Condition: Smoking Cessation; Pregnancy
Study type: Interventional

Summary: 
      Argentina and Uruguay are among the countries with the highest proportion of pregnant women
      who smoke. The implementation of an effective smoking cessation intervention would have a
      significant impact on the health of mothers and children. The "5 A's" (Ask, Advise, Assess,
      Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15
      minutes delivered by a trained provider, which is considered the standard of care worldwide.
      However, it is under used in Argentina and Uruguay. We will conduct a two-arm, parallel
      cluster randomized controlled trial of an implementation intervention in 20 prenatal clinics
      in Argentina and Uruguay. Our primary hypothesis is that the intervention is feasible in
      prenatal clinics in Argentina and Uruguay and will increase the frequency of women receiving
      tobacco use cessation counseling during pregnancy. Our secondary hypothesis is that the
      intervention will decrease the frequency of women who smoke by the end of their pregnancies.
      Prenatal clinics will be randomly allocated to either an intervention or a control group
      after a baseline data collection period. Midwife facilitators in the ten intervention clinics
      will be identified and trained to deliver the "5 A's" to pregnant women and will then
      disseminate and implement the program. The ten clinics in the control group will continue
      with their standard in-service activities. A follow-up data collection will be conducted
      immediately after delivery. The intervention will be tailored by formative research to be
      readily applicable to local prenatal care services at busy maternity hospitals, as well as to
      be acceptable to local pregnant women and health providers. The study will be conducted in 48
      months.
    


Intervention name(s): Training in smoking cessation counseling
Intervention type(s): Behavioral
Intervention description(s): Midwife facilitators in the intervention clinics will be identified and trained to deliver the "5 A's" to pregnant women and will then disseminate and implement the program. The "5 A's" (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15 minutes delivered by a trained provider, which is considered the standard of care worldwide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Smoking Cessation; Pregnancy; Implementation; Knowledge translation
PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Approximately 25 subjects will be enrolled and receive a standard WHO adult potency BCG
      immunization (1cc/50mg live mycobacilli) in the deltoid. Following a wait period after BCG
      vaccination, patients will then receive standard strength BCG intravesical therapy once a
      week for a total of 6 weeks. The BCG is instilled and held in the bladder for approximately 2
      hours. While the BCG is retained in the bladder the patient should be repositioned every 30
      minutes to maximize bladder surface exposure to the agent. Patients will undergo a cystoscopy
      every 3 months following most recent TURBT. Study duration last approximately 6 months.
    

Detailed description: 
      Approximately 25 subjects will receive a standard WHO adult potency BCG immunization
      (1cc/50mg live mycobacilli) in the deltoid. Following a wait period after BCG vaccination,
      patients will then receive standard strength BCG intravesical therapy once a week for a total
      of 6 weeks. The BCG is instilled and held in the bladder for approximately 2 hours. While the
      BCG is retained in the bladder the patient should be repositioned every 30 minutes to
      maximize bladder surface exposure to the agent. Patients will undergo a cystoscopy every 3
      months following most recent TURBT. Study duration last approximately 6 months.
    

Intervention name(s): Bacillus Calmette-Guerin (BCG)
Intervention type(s): Drug
Intervention description(s): Intravesical instillation for non-muscle invasive bladder cancer
Other intervention name(s): Tice BCG
Intervention MeSH terms: BCG Vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis
Condition: Arsenical Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional

Summary: 
      Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized,
      double-blind, placebo-control trial
    

Detailed description: 
      The objective of this study is to evaluate the effectiveness of topical administration of the
      Leaf of Azadirachta indica in the treatment of palmer arsenical keratosis. Fifty patients of
      moderate palmer arsenical keratosis patients from an arsenic affected area will be recruited
      on the basis of inclusion and exclusion criteria and had been drinking arsenic contaminated
      water for more than six months. They will be divided into two groups each will consist of
      twenty five members. One group will be provided A. indica plus 6% salicylic acid ointment to
      apply on palm overnight daily for 12 weeks. Another group will be provided 6% salicylic acid
      ointment . Water and nail sample will be collected before starting recruitment to confirm
      diagnosis. Then again nail sample will be collected before and after the study to see the
      level of arsenic in skin. Effects will be observed after every two weeks and change will be
      detected as nil, mild reduction, moderate reduction and fully cured.
    

Intervention name(s): Leaf extract of A. indica; Salicylic Acid (6%); Petroleum jelly
Intervention type(s): Other; Drug; Other
Intervention description(s): Leaf extract of A. indica plus 6% salicylic acid will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.; Salicylic acid (6%) will be applied on palmer keratotic lesion once daily on bedtime for 12 weeks.; Petroleum jelly will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.
Intervention MeSH terms: Salicylic Acid; Salicylates; Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Palm; Arsenic; Keratosis; Salicylic acid; Azadirachta indica; Neem
A Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene
Condition: Acquired Hypogonadotropic Hypogonadism; Obesity
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the effects of 12 months of treatment with
      enclomiphene 12.5 mg, 25 mg, or placebo capsules on body composition and metabolic parameters
      in overweight men with acquired hypogonadotropic hypogonadism [confirmed morning testosterone
      (T) ≤300 ng/dL] following a 6 month diet and 15 month exercise program.
    

Detailed description: 
      To compare the effects of 12 months of treatment with enclomiphene 12.5 mg, 25 mg, or placebo
      capsules on body composition and metabolic parameters in overweight men with acquired
      hypogonadotropic hypogonadism (confirmed morning T≤300 ng/dL) following a 6 month diet and 15
      month exercise program. Participants must not have been treated with testosterone products in
      the 6 months prior to the study and must not ever have used testosterone products for a year
      or longer.
    

Intervention name(s): Placebo; Enclomiphene
Intervention type(s): Drug; Drug
Intervention description(s): One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months.; Enclomiphene capsule daily in the morning with approximately 8 ounces of water for up to 12 months.
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of 25-hydroxy Vitamin D Level in Caucasian Women Receiving Vitamin D Supplementation and Not Receiving Supplementation: a Randomized Controlled Trial.
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The objective of this study is to assess whether vitamin D supplements are sufficient to
      increase females who are deficient or borderline deficient in vitamin D levels to normal
      levels.
    


Intervention name(s): vitamin D; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Subject will receive vitamin d supplements; Subject will receive a placebo.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules.
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be conducted as a Phase 1, open-label, single-dose, randomized, 2- or 3
      period, cross over design in a single cohort.
    


Intervention name(s): PF-06651600
Intervention type(s): Drug
Intervention description(s): PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Dichloroacetate Kinetics, Metabolism and Toxicology
Condition: Lactic Acidosis
MeSH terms: Acidosis; Acidosis, Lactic
Study type: Observational

Summary: 
      Dichloroacetate (DCA) is a product of water chlorination and a metabolite of certain
      industrial solvents, thus making it a chemical of environmental concern. However, DCA is also
      used as an investigational drug for treating various diseases of adults and children, at
      doses far greater than those to which humans are normally exposed in the environment. Our
      research involves how DCA is metabolized by healthy adults and by children with a fatal
      genetic disease, congenital lactic acidosis (CLA) who are treated with DCA.
    


Intervention name(s): Dichloroacetate
Intervention type(s): Drug
Observational model: Defined Population
Time perspective: Prospective
Keywords: Dichloroacetate; Chlorinated hydrocarbons; Genetic disease; Toxicology; Biotransformation