bioihbjkbjnl/mcl2 huggingface dataset:
Open Mesh Versus Suture Repair in Treatment of Abdominal Wall Hernias
Condition: Abdominal Hernia
MeSH terms: Hernia; Hernia, Abdominal; Internal Hernia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to:

        1. compare the long term results of mesh versus suture repair in treatment of abdominal
           wall defects;

        2. find the optimal location of implanted prosthesis, comparing the two most useful
           position of mesh in abdominal wall hernia surgery.
    

Detailed description: 
      To determine difference of operation time, applied materials of hernia operations; clinical
      complications, postoperative pain, hernia recurrence, recovery and normal activity time after
      surgery.
    

Intervention name(s): abdominal wall reconstruction
Intervention type(s): Procedure
Intervention description(s): suture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: position of the mesh; recurrence rate; surgical procedure; long time outcome
Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients
Condition: Advanced Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to Investigate the Absorption, Metabolism and Excretion of [14C]
      Anlotinib in Patients With Advanced Cancer patients.
    


Intervention name(s): Anlotinib and 14C-labeled Anlotinib
Intervention type(s): Drug
Intervention description(s): oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optimal Treatment Frequency of 308-Nm Excimer Laser for Vitiligo on the Face and Neck
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Observational

Summary: 
      To determine the optimal treatment frequency of 308-nm excimer laser for vitiligo and
      identify the key clinical variable(s) associated with the treatment efficiency under the
      optimal treatment frequency.

      Prospective, randomized, comparative study among groups of vitiligo patients treated with
      308-nm excimer laser, with the limitation of no follow-up.
    

Detailed description: 
      Vitiligo patients were treated with 308-nm excimer laser for 20 sessions at different
      frequencies (0.5×, 1.0×, 2.0× and 3.0× weekly). Treatment protocols adapted the dose to the
      lesions and not to the minimal erythemal dose. Treatment efficacy was blindly evaluated by 2
      independent physicians. Re-pigmentation rate was graded on a 6-point scale. The onset of
      re-pigmentation of vitiligo lesions was evaluated after 5 treatment sessions. The differences
      between Group 0.5×, 1.0×, 2.0× and 3.0× linking different clinical variables were assessed.
    

Intervention name(s): 308-nm excimer laser
Intervention type(s): Device
Time perspective: Prospective
Keywords: 308-nm excimer laser; vitiligo
Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age
Condition: Bacterial Infections; Intra-Abdominal Infection; Pneumonia, Bacterial; Skin Diseases, Bacterial; Skin Diseases, Infectious
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Intraabdominal Infections; Pneumonia, Bacterial; Skin Diseases, Infectious; Skin Diseases, Bacterial; Skin Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the pharmacokinetic profile and to evaluate the safety and tolerability of
      ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious
      infections; complicated intra-abdominal infections (cIAI), complicated skin and skin
      structure infections (cSSSI), or community-acquired pneumonia (CAP).
    


Intervention name(s): Tygacil
Intervention type(s): Drug
Intervention MeSH terms: Tigecycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cIAI; cSSSI; CAP; Child
The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to compare platelet reactivity between patients
      receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients
      receiving only a loading dose of prasugrel.
    

Detailed description: 
      This is a prospective, open-label, non-randomized trial of approximately 260 patients with
      Acute Coronary Syndrome (ACS) undergoing percutaneous coronary intervention (PCI). In order
      to compare platelet reactivity, as assessed by the VerifyNow P2Y12 assay, we plan to recruit
      two study groups of interest:

        1. Patients who have already received a 600 mg loading dose (LD) of clopidogrel in
           preparation for PCI will receive a loading dose of 60 mg of prasugrel.

        2. Patients who have not received a LD of clopidogrel will receive a 60 mg LD of prasugrel
           prior to PCI.

      A subset of 40 patients from each study group (80 patients total) will undergo additional
      platelet reactivity testing with the vasodilator stimulated phosphoprotein (VASP) assay.All
      patients will be followed throughout the duration of the hospital stay.
    

Intervention name(s): Prasugrel; Prasugrel
Intervention type(s): Drug; Drug
Intervention description(s): Patients who have received 600 mg loading dose of clopidogrel will receive a reloading dose of 60 mg prasugrel; Patients who have not received a loading dose of clopidogrel will receive a 60 mg loading dose of prasugrel.
Intervention MeSH terms: Prasugrel Hydrochloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Coronary Syndrome; Clopidogrel; Prasugrel
Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study
Condition: Infraorbital Hollows
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to determine the efficacy and longevity of the use of
      Restylane® and Perlane® in combination for the rejuvenation of the infraorbital hollows and
      to measure patient satisfaction with this treatment
    

Detailed description: 
      This study will examine the effectiveness of using Restylane® and Perlane® together in the
      treatment of the hollows in the under eye area. The combination of these treatments for use
      in the under eye area is considered investigational. An investigational therapy is a therapy
      that is not approved by the US Food and Drug Administration (FDA). Restylane® and Perlane®
      has been approved for treatment of moderate to severe facial wrinkles and folds, such as
      nasolabial folds by the FDA.
    

Intervention name(s): Restalyne; Perlane
Intervention type(s): Drug; Drug
Intervention description(s): one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.; One syringe of Perlane® (1.0cc) will be used total for both tear trough areas.
Other intervention name(s): Hyaluronan; Hyaluronate Sodium; Hyaluronic Acid; Hyaluronan; Hyaluronate Sodium; Hyaluronic Acid
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Life Skills Improved in Children With Down Syndrome After Using Assistive Technology
Condition: Down Syndrome; Adaptive Behavior; Quality of Life
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Enhancing independence and quality of life are key modifiable outcomes that are short- and
      long-term goals for children with Down syndrome (DS) and for their parents. The study
      investigated the efficacy of assistive technology in improving children with Down Syndrome's
      independence and quality of life. Using a commercially available assistive technology, the
      MapHabit system, the investigators implemented the software with participants' families for 4
      weeks. The investigators hypothesized that the assistive technology will improve adaptive
      behavioral skills and overall quality of life.
    


Intervention name(s): The MapHabit System
Intervention type(s): Device
Intervention description(s): The MapHabit System (MHS) is a commercially available visual mapping software application that utilize visual, audio, and text media to create step-by-step visual guides to assist individuals and their caregivers in structuring and accomplishing activities of daily living (ADLs). The goal of the application is to develop and facilitate habits and routines using structured visual and auditory stimuli that can be customized by the user and can include educational and lesson-based material in addition to ADLs. The application was made available to families through compatible smartphones and tablets.
The MHS is a general wellness product and there is no regulatory oversight of the MapHabit System mapping functionality. This functionality is not a regulated medical device.
Intervention model: Single Group Assignment
Intervention model description: This single-arm repeated measures design examined the effects of a software device as an intervention, permitting the participants to serve as their own controls.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Down syndrome; Assistive technology; Adaptive behavioral skills
At Home Placebo-controlled 8-week GOS Intervention on Emotion Behaviour and Cognition in Children (Age 6-14 Years).
Condition: Emotional Regulation
Study type: Interventional

Summary: 
      This study aims to investigate how GOS food supplement influences the gut-microbiome-brain
      axis to improve emotion regulation skills and cognition in a sample of children and
      adolescents (aged 6-14 years).
    


Intervention name(s): Galacto-oligosaccharide; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Single 7g dose daily for 28 days; Single 7g dose daily for 28 days
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Laser Therapy Versus Anterior Re-positioning Splint in the Treatment of Disc Displacement With Reduction
Condition: Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      comparing the effects of Laser therapy with anterior re-positioning splint and a placebo
      group on clinical signs and symptoms of temporo-mandibular dis-function and assessing
      articular disc morphology and configuration with magnetic resonance imaging.
    

Detailed description: 
      to compare the clinical effects of Laser therapy as assessed with research diagnostic
      criteria of temporo-mandibular disorders to a group that received anterior re-positioning
      splint therapy and a control group that received placebo Laser. Diagnosis for disc
      displacement with reduction was performed with magnetic resonance imaging before treatment.
      assessment of the clinical and MRI findings was again performed after a 3 months observation
      period.
    

Intervention name(s): Laser therapy; anterior re-positioning splint; inactive Laser therapy
Intervention type(s): Device; Device; Device
Intervention description(s): epic model biolase with an output of 4W, 1800 J wavelength with a continuous Laser mode.; hard acrylic anterior re-positioning splint; sham Laser, with inactive beam
Other intervention name(s): low-level Laser therapy; Biolase laser device; occlusal splint; TMD splint
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: laser therapy; anterior re-positioning splint
Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus
Condition: 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 alogliptin, once daily
      (QD), combined with pioglitazone in adults with type 2 diabetes mellitus
    

Detailed description: 
      There are approximately 19 million people in the United States who have been diagnosed with
      diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies
      among racial and ethnic populations and has been shown to correlate with age, obesity, family
      history, history of gestational diabetes, and physical inactivity. Over the next decade, a
      marked increase in the number of adults with diabetes mellitus is expected.

      Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients
      with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV
      enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of
      2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition
      of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2
      diabetes.

      The aim of the current study is to evaluate the efficacy of alogliptin in combination with
      pioglitazone in subjects who are inadequately controlled on a thiazolidinedione (pioglitazone
      or rosiglitazone) alone or in combination with metformin or a sulfonylurea. Individuals who
      participate in this study will be required to commit to a screening visit and up to 14
      additional visits at the study center. Study participation is anticipated to be about 34
      weeks (or 8.5 months).
    

Intervention name(s): Alogliptin and pioglitazone; Alogliptin and pioglitazone; Pioglitazone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks; Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks; Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks
Other intervention name(s): SYR110322; Alogliptin; AD-4833; Pioglitazone; Actos; SYR-322; SYR110322; Alogliptin; AD-4833; Pioglitazone; Actos; SYR-322; AD-4833; Actos
Intervention MeSH terms: Pioglitazone; Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus; Lipoatrophic; Dyslipidemia; Drug Therapy
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in
      Patients with Stage III Unresectable Non-Small Cell Lung Cancer.
    

Detailed description: 
      A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study
      of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small
      Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based,
      Concurrent Chemoradiation Therapy (PACIFIC)
    

Intervention name(s): MEDI4736; PLACEBO
Intervention type(s): Drug; Other
Intervention description(s): MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).; PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).
Intervention MeSH terms: Durvalumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Locally advanced; Unresectable Non-Small Cell Lung Cancer; MEDI4736; PD-L1; Stage III Non-Small Cell Lung Cancer; Chemoradiation; Immune-mediated cancer therapy
Safety, Tolerability and Pharmacodynamics of BIIX 1 XX in Healthy Young Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the present study is to obtain information about the safety and tolerability
      of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a
      methacholine challenge test and to obtain preliminary pharmacokinetic data
    


Intervention name(s): BIIX 1 XX - single rising dose; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      AC220 will be administered as a once daily oral solution given continuously as 28-day
      treatment cycles, without any rest periods, until disease progression, relapse, intolerance
      to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT).
    


Intervention name(s): Compound AC220
Intervention type(s): Drug
Intervention description(s): Precomplexed powder in bottle formulation supplied as 200 mg in a 60 cc polyethylene terephthalate (PET) plastic bottle. Requires reconstitution by a pharmacist, must be stored securely, and protected from light.
Other intervention name(s): AC010220 × 2HCl, oral powder for reconstitution
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; AC220; acute; FLT3; inhibitor; kinase; leukemia; leukaemia; myeloid; relapsed; refractory
Study of the Copper IUD or Oral Levonorgestrel and the Levonorgestrel IUD for Women Seeking Emergency Contraception
Condition: Emergency Contraception
MeSH terms: Emergencies
Study type: Observational

Summary: 
      The purpose of this study is to see how often women who come to a family planning clinic for
      emergency contraception, the morning after pill, are willing to use either the copper IUD or
      the levonorgestrel IUD. The investigators will also see if pregnancies occur in those
      choosing the levonorgestrel IUD and if people continue to use the IUD for 1 year.
    

Detailed description: 
      Widely available oral levonorgestrel (LNG) for emergency contraception (EC) has not reduced
      unplanned pregnancy rates. However, our study of the copper T380 IUD vs. oral LNG for EC
      showed lower pregnancy rates 12 months after presenting for EC in the copper IUD group.
      Because there is a strong preference for the LNG IUD among women offered the IUD, the
      objective of this research project is to initiate investigation into, and use of the LNG IUD
      in the setting of EC. Our experienced team of EC researchers proposes the following aims to
      provide needed information in this understudied area:

      Aim 1: To assess uptake of the LNG IUD vs. the copper IUD among women presenting for EC
      exposed to standardized counseling.

      Aim 2: Gather baseline data on one-year continuation and pregnancy rates from women
      initiating the LNG IUD vs. the copper T380 IUD when presenting for EC.

      Aim 3: Assess willingness of women presenting for EC to participate in a future randomized
      controlled trial comparing the LNG IUD vs. the copper T380 IUD for EC.

      The study aims will be accomplished with a prospective observational trial of women who
      choose either method of EC. The investigative team will recruit 180 women who present for EC
      at two participating family planning clinics and follow study participants for 12 months.
      This project will compare continuation and pregnancy rates between LNG and copper IUD users
      in the year following presentation for EC. This proposal is another aspect in our growing
      research program offering highly effective contraception at the time of EC presentation.
      Results of this project will direct future study in this area aimed at reducing population
      unplanned pregnancy rates among EC users with the potential to inform a future RCT of the LNG
      vs. copper IUD for EC.
    

Intervention name(s): Copper IUD; Levonorgestrel IUD
Intervention type(s): Drug; Drug
Other intervention name(s): Paragard IUD; Mirena IUD
Intervention MeSH terms: Copper; Levonorgestrel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women presenting for emergency contraception to family planning clinics in Salt Lake City,
        UT
      
Biospecimen description: 
      Urine to test for progesterone and/or pregnandiol
    
Keywords: Emergency contraception; Levonorgestrel IUD; Copper IUD; Oral Levonorgestrel
Gastric Tolerability and Pharmacokinetics of DMMET-01
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the gastric tolerability and the pharmacokinetics
      of a new drug for the treatment of type 2 diabetes, DMMET-01, in healthy volunteers.
    


Intervention name(s): DMMET-01
Intervention type(s): Drug
Intervention description(s): 1050.6 mg daily for 30 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Diabetes; gastric tolerability