bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Effect of Myopic Femtosecond Laser Assisted-LASIK on Anterior Chamber Flare Values and Corneal Endothelial Cells: A Prospective Before-and-After Study
Condition: Cornea; Refractive Surgery; Anterior Chamber Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      This study aimed to investigate whether femtosecond laser-assisted LASIK (FS-LASIK) surgery
      causes inflammation in the anterior chamber and to analyze its effect on endothelial cells.
    

Detailed description: 
      Since FS-LASIK surgery is applied using both an FS laser and an excimer laser, we aimed to
      determine the direct and indirect effects of these applications on the corneal endothelium,
      the intensity of the inflammation, and the blood-aqueous barrier in the anterior chamber. To
      the best of our knowledge, the effects of FS-LASIK on anterior chamber inflammation have not
      been previously investigated. Therefore, we evaluated these effects using objective
      measurement methods, such as specular microscopy and laser flare photometry.
    

Intervention name(s): Femtosecond laser assisted LASIK
Intervention type(s): Procedure
Intervention description(s): Refractive surgery
Intervention model: Single Group Assignment
Intervention model description: prospective, before-after study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Excimer laser Corneal Endothelium; Laser in situ keratomileusis (LASIK);; femtosecond assisted-LASIK; Anterior chamber flare; Endothelial cell densit; Corneal Endothelium
Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain
Condition: Post-operative Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen
      sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial
      naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg
      liquid gels capsules) and placebo in the dental pain model following third-molar extractions.
    

Detailed description: 
      This is a single-dose, randomized, double-blind, placebo- and active- controlled,
      parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of 440 mg
      of naproxen sodium administered as two Test NPX 220 mg tablets compared with two commercial
      products and placebo over a twelve-hour period after third-molar extractions. Subjects will
      undergo dental extraction of three or four third molars.
    

Intervention name(s): Test naproxen sodium tablet; Commercial naproxen sodium tablet; Commercial naproxen sodium liquid gels capsule; Placebo tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of 2 test naproxen sodium 220 mg tablets; Single dose of 2 naproxen sodium 220 mg tablets; Single dose of 2 naproxen sodium 220 mg liquid gel capsules; 2 placebo tablets
Other intervention name(s): Test NPX tablet; Commercial NPX tablet; Commercial NPX liquid gels capsule
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Post-operative dental pain following third molar extraction.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Single-dose Pharmacokinetics of Oral Nicotine Replacement Products
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      This is an explorative study comparing new prototypes of Nicotine Replacement Products with
      Nicorette® gum.
    

Detailed description: 
      This study included 40 subjects who were randomly assigned to one of eight treatment
      sequences. In four of the sequences, the three prototypes with the shorter dissolution time
      and the reference were used; in the remaining four sequences, the three prototypes with the
      longer dissolution time and the reference were used. Hence, half of the subjects received the
      Short prototypes and half received the Long prototypes. Subjects in both treatment groups
      (short and long) attended four treatment visits, each of 11 hours' duration, and periods of
      at least 36 hours' duration between treatment visits.
    

Intervention name(s): Nicotine; Nicotine Gum
Intervention type(s): Drug; Drug
Intervention description(s): Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day; Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes.
Other intervention name(s): Not yet marketed; Nicorette®
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Smoking Cessation; Nicotine pharmacokinetics
Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care
Condition: Illicit Opioid Drug Use
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether, for individuals in inpatient opioid
      detoxification, linking to outpatient Suboxone treatment increases treatment adherence and
      reduces relapse to illicit opioid use.
    

Detailed description: 
      In this randomized trial, consenting individuals seeking inpatient opioid detoxification will
      be assigned to one of two groups. The first group will receive a tapering schedule of
      buprenorphine during inpatient detoxification to alleviate acute withdrawal symptoms, and
      referral to a community medical and substance abuse treatment providers (DETOX). The second
      group will also receive buprenorphine to relieve withdrawal symptoms, but will maintain a
      stable dose of buprenorphine through inpatient discharge and linkage to an appointment with a
      primary care provider within a week of discharge (LINKAGE). All participants complete study
      assessments at baseline, 1-month, 3-months and 6-months post-enrollment.

      The SSTAR inpatient detoxification program based in Fall River, Massachusetts will serve as
      the recruitment site of this trial. SSTAR's program has 38 beds and is a 24-hour medically
      and psychiatrically supervised treatment facility that provides evaluation and withdrawal
      management. The SSTAR Family Healthcare Center is a 330 Federally Qualified facility also in
      Fall River that provides primary care and behavioral health services to residents of
      Community Health Network Area 25 (Fall River, Somerset, Swansea and Westport, Massachusetts).
      Dr. Bailey, Director of Research at SSTAR, will oversee the provision of buprenorphine
      treatment to study participants during detoxification and serve as liaison to the primary
      care providers at the Family Healthcare Center.
    

Intervention name(s): Linkage; Treatment as Usual
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: illicit opioid drug use; health service utilization
Immediate Implant With Different Filling Materials
Condition: Immediate Implant
Study type: Interventional

Summary: 
      36 patients, were included in this study. They were chosen from the Outpatient Clinic in the
      Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for
      replacement of non-restorable maxillary anterior and premolar teeth (esthetic zone) by
      immediate implant.
    


Intervention name(s): bone filling materials
Intervention type(s): Other
Intervention description(s): the buccal jumping gap was packed using PRF in group 1 the buccal jumping gap was packed using xenograft in group 2 the buccal jumping gap was packed using Alloplastic β-tricalcium phosphate in group 3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Capsimax Effect on Metabolic Rate, Satiety and Food Intake
Condition: Energy Metabolism; Eating; Hunger
Study type: Interventional

Summary: 
      Comparison of Capsimax™ 2mg and 4mg of capsicum extract vs. placebo on metabolic rate and
      satiety.
    

Detailed description: 
      Capsimax™ is a capsicum extract in a bead technology to avoid oral and gastric burning.
      Capsimax™ 2mg, Capsimax™ 4 mg and placebo was initially given as a single dose on an empty
      stomach with measures of metabolic rate, and satiety before and after and food intake at 1
      hour after Capsimax™.
    

Intervention name(s): Capsimax; Placebo; Meal
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Capsimax; Placebo; Meal
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 4 arm crossover trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: capsaicin; energy expenditure; satiety; food intake
Spleen Radiotherapy Decreases Severe CIT in Advanced NSCLC (SPLEENIR)
Condition: Chemotherapy in Non-Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      Chemotherapy is one of the main treatments for advanced NSCLC. However, chemotherapy induced
      thrombocytopenia (CIT) is one of the most important limitations for subsequent chemotherapy
      of cancer.

      Although platelet transfusion is the gold standard to treat severe CIT, its clinical
      application is limited due to many disadvantages, such as short time for storage, not easy to
      save, the risk of infection and immunological diseases. What's more, other cytokines
      including IL-11 and rhTPO, are not so useful in clinical work. It is necessary to explore a
      new therapeutic method to treat CIT.

      Researches show that spleen resection could improve the count of PLT. In this clinical trial,
      we design chemotherapy plus spleen radiotherapy to the subjects with advanced NSCLC,
      simultaneously, who underwent grade II or worse CIT. The primary endpoint is the incidence of
      severe CIT (≧grade III) in subsequent chemotherapy, the second endpoints are recovery time
      from bone marrow suppression and progression free survival, and the exploring index is the
      immulogical status.
    


Intervention name(s): spleen radiotherapy
Intervention type(s): Radiation
Intervention description(s): Radiation: spleen radiation In Experimental arm, combine spleen radiation with chemotherapy. In Chemotherapy alone arm, the subjects should also receive spleen radiation once there is a severe CIT (≧grade III) during chemotherapy after radomization.
Other intervention name(s): IMRT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spleen radiation; IMRT
Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function
Condition: Healthy
Study type: Interventional

Summary: 
      The knowledge of the health effects of CLA on the human body is limited. However, CLA
      supplements are sold over the counter in several countries and various techniques are used to
      increase the content of CLA in food.

      The CLAxon-study will be performed to investigate wether high doses of CLA can be safely
      given to healthy human volunteers.
    

Detailed description: 
      Each volunteer receives CLA enriched products for a total of 3 weeks containing approximately
      20g CLA per day. A control group is not needed. If three subjects or more show one or more
      blood values for liver and kidney function above predefined limits the study will be
      terminated.
    

Intervention name(s): consumption of CLA enriched food
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: CLA; liver; kidney
Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of co-administration of
      Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 weeks in Japanese
      patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and
      have inadequate glycemic control.
    


Intervention name(s): Teneligliptin; Canagliflozin; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Tenelia, MP-513; Canaglu, TA-7284
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MT-2412; MP-513; TA-7284; Teneligliptin; Canagliflozin
MT1013 Clinical TRIAL In Healthy Subject
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single ascending dose administration
      phase one clinical trial to evaluate the safety, tolerability, pharmacokinetics and
      preliminary pharmacodynamics of MT1013 injection in healthy subjects.
    

Detailed description: 
      This will be a single center, Phase 1, randomized, double-blind single-dose, sequential SAD
      study.

      This SAD study will consist of up to 5 cohorts (1 cohort per dose level). Each cohort will
      include 8 subjects (6 subjects receiving the active study drug and 2 subjects receiving
      matching placebo).

      A staggered dosing schedule will be used for each dose level administered under fasting
      conditions. Two (2) sentinel subjects (1 active and 1 placebo) will be dosed first (a minimum
      of 1 hour apart) and the remaining 6 subjects will be dosed no sooner than the next day (each
      dosed at least 15 minutes apart).

      Following completion of each dose level, a SRC will review the safety and tolerability data
      as well as the available PK data up to 48 hours in order to make decisions whether to
      escalate to the next dose level, decrease the next dose level, repeat a dose level, or to not
      evaluate any additional dose.
    

Intervention name(s): MT1013
Intervention type(s): Drug
Intervention description(s): bispecific peptide as a CaSR agonist and a functional OGP analogue
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Randomized, double-blind single-dose, sequential SAD
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain
Condition: Port-wine Stain
MeSH terms: Hemangioma, Capillary; Port-Wine Stain
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot study aims to evaluate the safety and efficacy of hemoporfin photodynamic therapy
      (PDT) with different light doses for port-wine stain (PWS）in 2-7 years old children. The
      pharmacokinetic behavior and pharmacokinetic parameters of hemoporfin in children will be
      investigated as well.
    


Intervention name(s): Hemoporfin PDT
Intervention type(s): Drug
Intervention description(s): Photodynamic therapy is performed using hemoporfin under general anesthesia. Hemoporfin（5mg/kg）is infused for 20 minutes, followed by light illumination at 10 minutes from the start of infusion. Different light dose of PDT is applied to the patients.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of Aliskiren on Endothelial Function in Pre-Diabetes and Diabetes
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Prediabetic State; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this research is to study and determine the effects of Aliskiren on blood
      vessels and blood flow. The primary hypothesis is that Aliskiren will increase endothelial
      function by 30% or more in comparison to the placebo group.
    


Intervention name(s): Placebo; Aliskiren
Intervention type(s): Drug; Drug
Intervention description(s): 0mg tablet, taken orally for 12 weeks daily; 150mg tablet, taken orally for 12 weeks daily
Other intervention name(s): Trade name: Tekturna
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Multi-center 12-week Study of HMS5552 in T2DM
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type
      2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will
      receive placebo.
    

Detailed description: 
      Glucokinase (GK, also called hexokinase IV or D) can phosphosphorylate glucose to
      glucose-6-phosphate (G-6-P) in pancreatic β-cells and liver cells, which represents the first
      step of glucose metabolism. GK also acts as a glucose sensor and exerts a key role in
      maintaining glucose homeostasis. HMS5552 is a 4th-generation GK agonist or activator (GKA),
      which was originally licensed from Roche and subsequently developed by Hua Medicine. HMS5552
      has been shown to activate GK in pancreatic beta cells, liver and intestinal epithelial
      cells. It regulates systemic blood glucose through a variety of mechanisms including directly
      enhancing insulin release (pancreas), inhibiting production of endogenous glucose (liver) and
      by indirectly promoting GLP-1 release (enteroendocrine L-cells).
    

Intervention name(s): HMS5552; HMS5552; HMS5552; HMS5552; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): 75mgQD; 100mgQD; 50mgBID; 75mgBID; QD/BID
Other intervention name(s): GKA; GKA; GKA; GKA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GKA,T2DM,HMS5552
A Study of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies
Condition: Chronic Lymphoid Leukemia; Lymphoid Malignancies; Non-Hodgkin's Lymphoma; Follicular Lymphoma; Mantle Cell Lymphoma; Peripheral T-cell Lymphoma
MeSH terms: Lymphoma; Neoplasms; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The Phase 1 portion of the study evaluated the pharmacokinetic profile and safety of ABT-263
      with the objective of defining the dose limiting toxicity and maximum tolerated dose in
      subjects with lymphoid malignancies. The Phase 2a portion of the study is evaluating ABT-263
      using a step-up dosing regimen and may be increased to the defined recommended Phase 2 dose
      to obtain additional safety information and a preliminary assessment of efficacy in subject
      with lymphoid malignancies. The Extension portion of the study is to allow Phase 2a subjects
      who remain active 1 year after the last subject enrolls or who have been on study
      approximately 1 year to continue receiving ABT-263 with less frequent study evaluations.
      Subjects in the Extension Study will continue receiving study drug for up to 7 years after
      the last subject transitions to the Extension Study, or until disease progression or toxicity
      that necessitates discontinuation (whichever comes first).
    

Detailed description: 
      Enrollment breakdown: Entered Study: Phase 1a: 39; Phase 1b: 19; Phase 2a: 33; Total: 91
      Entered Treatment: Phase 1a: 38; Phase 1b: 17; Phase 2a: 26; Total: 81
    

Intervention name(s): ABT-263
Intervention type(s): Drug
Intervention description(s): Oral solution
Phase 1 dosing was under two different schedules: 14 days on drug, 7 days off or 21 days continuous dosing.
Oral solution and tablets
Phase 2a dosing under 21 day continuous dosing.
- 150 mg lead-in dose for 7-14 days followed by a 325 mg continuous once daily dose.
Intervention MeSH terms: Navitoclax
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sezary syndrome; cutaneous T-cell lymphoma; follicular lymphoma; marginal zone lymphoma; indolent T-cell lymphoma; Navitoclax; Non-Hodgkin's lymphoma; peripheral T-cell lymphoma; ABT-263; lymphoid malignancies; chronic lymphoid leukemia; mycosis fungoides; mantle cell lymphoma
Multiple Ascending Doses of Rozibafusp Alfa (AMG 570) in Adults With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate safety and tolerability and characterize the pharmacokinetic (PK) profile
      of rozibafusp alfa following multiple dose administration in adults with rheumatoid arthritis
      (RA).
    


Intervention name(s): Rozibafusp Alfa; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection once every 2 weeks.; Administered by subcutaneous injection once every 2 weeks.
Other intervention name(s): AMG 570
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment