bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Platelet Rich Plasma (PRP) on Mouth Opening and Pain After Surgical Extraction of Mandibular Third Molars.
Condition: Tooth Extraction
Study type: Interventional

Summary: 
      Wisdom tooth extraction is the most common surgical procedure being carried out in oral
      surgical departments. The complications carried by post operative period include pain and
      trismus and may affect patient's quality of life.

      PRP is an autologous concentrate of platelet in plasma and accelerate healing by production
      of growth factors. PRP is prepared from patient's own blood and later packed with gel sponge
      (Spongistone) in the experimental group immediately after surgical extraction of mandibular
      third molar teeth, followed by suture placement to close the surgical site.
    

Detailed description: 
      Wisdom tooth extraction is the most common surgical procedure being carried out in oral
      surgical departments. The complications carried by post operative period includes pain,
      swelling, trismus , along with disturbance in post extraction wound healing which may
      significantly affect patient's quality of life.

      PRP is an autologous concentrate of platelet suspended in plasma and accelerate healing by
      production of various growth factors. PRP is prepared from patient's own blood and later
      packed with gel sponge (Spongistone) in the experimental group immediately after surgical
      extraction of mandibular third molar teeth, followed by suture placement to close the
      surgical site. PRP speeds up healing by concentration of growth factors which can lessen the
      inflammation and decreases trismus and pain.
    

Intervention name(s): Platelet Rich Plasma (PRP); Surgical Extraction
Intervention type(s): Procedure; Procedure
Intervention description(s): PRP was prepared by withdrawing 8-10 ml of patients own blood (IV from antecubiodal area and collected in a vacuum tube coated with anticoagulant (Na citrate). For activation 1 ml of calcium chloride was added to Platelet Rich Plasma. This layer of approximately 2 ml of PRP was then taken into the residual bone cavity along with gel sponge to stimulate regeneration in wound healing after surgical extraction of mandibular third molar tooth followed by sutures; Surgical extraction procedure under Local anesthesia on dental chair, followed by spongstone (gel sponge) and suture placement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1 Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
Condition: N/A - Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics
      (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.
    


Intervention name(s): Apixaban; Atenolol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atenolol; Apixaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study
Condition: Hepatitis C Infection; HIV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the
      treatment of hepatitis c in patients taking stribild.
    

Detailed description: 
      The objective of this study is to evaluate the safety, efficacy and pharmacokinetics of
      sofosbuvir 400mg once daily plus ribavirin 1000-1200 mg daily in HIV-infected patients on
      fixed dose co-formulation emtricitabine/tenofovir/cobicistat/elvitegravir (Stribild).
    

Intervention name(s): Sofosbuvir, Ribavirin, and Stribild
Intervention type(s): Drug
Intervention MeSH terms: Ribavirin; Sofosbuvir; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; HCV; DAA
Atorvastatin in Active Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 2

Summary: 
      Condition:

      Non segmental and active vitiligo of adulthood.

      Main objective:

      To evaluate the efficacy of a daily treatment with atorvastatin 80mg/d combined to UVB
      compared to UVB alone in active vitiligo after 6 months of treatment.

      Methods:

      Prospective interventional bicentric study with evaluation blinded to the treatment received.

      Inclusion criteria:

      Patients from 18 to 75 year-old with active non segmental vitiligo. Active is defined by the
      apparition or the modification of vitiligo lesions with the past 3 months and under Wood's
      lamp examination hypochromic borders and/or spotty depigmentation.

      Interventions:

      After central randomization

        -  Arm A : atorvastatin 40mg/d for 1 months then 80mg/d for 5 months combined with twice
           weekly narrowband UVB treatment for 6 months.

        -  Arm B: with twice weekly narrowband UVB treatment for 6 months.

      Evaluation:

      Main criteria: Decrease of VASI score expressed in percentage Secondary criteria: Decrease of
      VETF score expressed in percentage. Variation of PGA and DLQI scores. Clinical and biological
      tolerance. Variation of CXCL10 levels in the serum.

      Length of the study:

      Inclusion period: 12 months. Length of treatment: 6 months. Statistical analyses and drafting
      the article: 6 months. Total length: 24 months.
    


Intervention name(s): Atorvastatin; UVB
Intervention type(s): Drug; Other
Intervention description(s): The patients will be treated with the combination of oral atorvastatin and NBUVB phototherapy twice a week for 6 months. The initial starting dose of the oral atorvastatin will be 40mg daily and after 1 month, if tolerated clinically and biologically following blood tests, the dose will be increased to 80mg daily.; The patients will be receiving only NB-UVB phototherapy twice a week for 6 months.
Other intervention name(s): UVB
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dermacyd PH_DESILSTY_FR (Lactic Acid) - Photo Evaluation - Stay on Frutal
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To demonstrate the absence of photoirritation and potential photosensitization of the product
      Dermacyd PHDESILSTYFR.
    


Intervention name(s): LACTIC ACID(ND)
Intervention type(s): Drug
Intervention description(s): Treatment duration 5 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects
Condition: Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy
      male subjects.
    

Detailed description: 
      A double-blind, randomized, placebo-controlled, two-centre, phase IIa pharmacodynamic
      cross-over study to assess the effect of AZD2516 on the total number of reflux episodes in
      healthy male volunteers.
    

Intervention name(s): AZD2516, 5 mg; AZD2516, 16 mg; AZD2516, 40 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsule, oral; Capsule, oral; Capsule, oral; Capsule, oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Pharmacodynamic effect; Reflux inhibition
Serum MIF in Acute Kidney Injury
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      Acute kidney injury (AKI) is a common complication in critical care patients. Currently no
      parameters are available for early prognosis of AKI. Macrophage migration inhibitory factor
      (MIF) has been associated with AKI in clinical studies. The aim of this study is to evaluate
      the time course of MIF concentrations in patients with AKI.
    


Intervention name(s): Blood draw for measurement of MIF
Intervention type(s): Other
Intervention description(s): Observational study, no intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Critical care patients
      
Biospecimen description: 
      Serum
A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the bioavailability of risankizumab new
      formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy
      volunteers. The study will also evaluate the bioavailability of risankizumab new formulation
      in auto-injector (AI) relative to PFS in healthy volunteers.
    


Intervention name(s): Risankizumab; Risankizumab
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous Injection via Prefilled Syringe (PFS); Subcutaneous Injection via Auto-Injector (AI)
Other intervention name(s): ABBV-066; SKYRIZI; ABBV-066; SKYRIZI
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study of Blood Samples From Older Patients at High Risk of Developing Prostate Cancer and From Healthy Male Participants
Condition: Precancerous Condition; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Precancerous Conditions
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood in the laboratory from patients who are at high risk of
      developing prostate cancer may help doctors identify biomarkers related to cancer.

      PURPOSE: This research study is looking at blood samples from patients at high risk of
      developing prostate cancer and from healthy male participants.
    

Detailed description: 
      OBJECTIVES:

        -  To determine whether there are any changes in pro-oxidant-antioxidant profiles in
           patients who are at high risk for developing prostate cancer.

        -  To compare the profiles of these patients with those of healthy controls.

      OUTLINE: Participants undergo blood sample collection. Samples are used to measure levels of
      antioxidant enzymes (i.e., glutathione, glutathione peroxidase, glutathione reductase,
      superoxide dismutase, and reduced glutathione) and biomarkers of oxidative stress and DNA
      damage in leukocytes (i.e., thiobarbituric acid reactive substances [TBARS] and
      8-hydroxydeoxyguanosine). Samples are analyzed via antioxidant enzyme assay, TBARS assay, and
      enzyme-linked immunosorbent assay.

      PROJECTED ACCRUAL: A total of 40 participants (20 at high risk for developing prostate cancer
      and 20 healthy controls) will be accrued for this study.
    

Intervention name(s): immunoenzyme technique; laboratory biomarker analysis
Intervention type(s): Other; Other
Intervention description(s): Participants undergo blood sample collection. Samples are used to measure levels of antioxidant enzymes (i.e., glutathione, glutathione peroxidase, glutathione reductase, superoxide dismutase, and reduced glutathione) and biomarkers of oxidative stress and DNA damage in leukocytes (i.e., thiobarbituric acid reactive substances [TBARS] and 8-hydroxydeoxyguanosine). Samples are analyzed via antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay.; Participants undergo blood sample collection. Samples are used to measure levels of antioxidant enzymes (i.e., glutathione, glutathione peroxidase, glutathione reductase, superoxide dismutase, and reduced glutathione) and biomarkers of oxidative stress and DNA damage in leukocytes (i.e., thiobarbituric acid reactive substances [TBARS] and 8-hydroxydeoxyguanosine). Samples are analyzed via antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary Care Clinic
      
Biospecimen description: 
      Blood samples from patients at high risk of developing prostate cancer and from healthy male
      participants.
    
Keywords: prostate cancer; high grade prostatic intraepithelial neoplasia
High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
Condition: Breast Cancer Female
MeSH terms: Breast Neoplasms; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this second pilot study is to extend the feasibility demonstrated in
      NCT02963740 that the intervention achieves high levels of moderate to vigorous physical
      activity (MVI PA) and modulates risk biomarkers for breast cancer and cardiovascular disease
      in older, obese sedentary breast cancer survivors who are undergoing moderate calorie
      restriction.
    

Detailed description: 
      All subjects participate in same intervention. Intervention consists of a 6-month structured
      weight loss program utilizing portion controlled meals and a prescribed level of graduated
      physical activity with an eventual goal of 200 minutes or more per week. The program will
      include twice weekly sessions with a trainer at a local YMCA, and weekly phone group sessions
      the first 3 months with transition to unsupervised exercise and less frequent group phone
      sessions the second 3 months.
    

Intervention name(s): Supervised Exercise; Home-based Exercise; Reduced Energy Diet; Group Phone Calls
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will take part in supervised exercise activities two times per week at a YMCA. Length of the activity will be increased during participation in study. Participants will start at 40 minutes per week and work their way up to 120 minutes per week.; Aerobic exercise activities to be completed at home. Participants will be asked to start out doing 60 minutes at home and work up to 180 minutes of purposeful aerobic home exercise per week.; Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.; Sessions are weekly months 1-3 and every other week months 4-6. The calls will discuss lifestyle changes specific to participants and cover the effects of diet, physical activity, and weight on breast cancer risk, as well as body image and emotional eating.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breast cancer survivor; weight loss program
Temozolomide Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma
Condition: Brain Tumor; Central Nervous System Tumor
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of temozolomide plus lomustine followed by
      radiation therapy in treating patients who have high-grade malignant glioma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of temozolomide when administered with lomustine in
           patients with high-grade malignant gliomas.

        -  Determine the dose-limiting toxic effects of this regimen in these patients.

        -  Evaluate the feasibility of radiotherapy after this treatment regimen in this patient
           population.

        -  Evaluate the radiographic responses in patients treated with this regimen.

      OUTLINE: This is a multicenter, dose-escalation study of temozolomide.

      Patients receive oral temozolomide on days 1-5 and oral lomustine on day 1. Treatment
      continues every 28 days, if blood counts have recovered, for 2 courses in the absence of
      disease progression or unacceptable toxicity. Patients then undergo radiotherapy on days 1-5
      weekly for 6 weeks. Patients continue the same chemotherapy regimen for up to 6 more courses
      beginning 4 weeks after completion of radiotherapy.

      Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity.

      Patients are followed for survival.

      PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.
    

Intervention name(s): lomustine; temozolomide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Temozolomide; Lomustine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: childhood high-grade cerebral astrocytoma
Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine the safety and efficacy of the addition of sitagliptin (MK-0431)
      compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic
      control who are taking pioglitazone and metformin.
    


Intervention name(s): Sitagliptin; Comparator: Placebo; Pioglitazone; Metformin; Glipizide
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Sitagliptin 100 mg tablet orally once daily for 26 weeks.; Placebo to sitagliptin 100 mg tablet orally once daily for 26 weeks.; Participants taking 30 mg or more pioglitazone oral tablet(s) daily at screening in combination with metformin will enter a 4-week dose-stable period followed by a 2-week single-blind run-in and a 26-week treatment period. Participants taking 4 mg or more rosiglitazone oral tablet(s) daily at screening in combination with metformin were to be switched to a corresponding dose of pioglitazone prior to starting a 4-week dose-stable period. Participants who are taking less than 30 mg/day or no pioglitazone at screening will be titrated to a stable dose of at least 30 mg pioglitazone once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period. Total treatment with pioglitazone will be up to 42 weeks.; Participants taking 1500 mg or more metformin oral tablet(s) and at least 30 mg pioglitazone or 4 mg rosiglitazone daily at screening will enter a 4-week dose-stable period followed by a 2-week single-blind placebo run-in, and a 26-week treatment period. Participants who are taking less than 1500 mg/day metformin at screening will be titrated to a stable dose of at least 1500 mg metformin once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period. Total treatment with metformin will be up to 42 weeks.; Participants not meeting specific glycemic controls during the 26-week treatment period will use glipizide oral tablets as rescue therapy. In countries where glipizide is not available, participants will receive a sulfonylurea marketed in that country.
Other intervention name(s): Januvia; MK-0431; Actos; Glucophage; Glucotrol
Intervention MeSH terms: Metformin; Pioglitazone; Sitagliptin Phosphate; Glipizide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Do Back School and/or supervised walking improve reported pain and spine flexibility in
      sedentary women with chronic low back pain (LBP)?
    

Detailed description: 
      From August 2002 to March 2004, one hundred nineteen volunteers sedentary women with chronic
      LBP and age ranging from 32 to 60 years old, randomly allocated to four groups of
      participants assigned as Back School (BS; N=28), Supervised Walking (W; N=32), Back School
      and Supervised Walking (BS+W; N=29), and Control Group (CG; N=30) were submitted to
      interventions once a week for 5 consecutive weeks and followed for up to 6 months. The groups
      BS, W, and BS+W received LBP-targeted lectures and on-place practical sessions of each
      respective intervention. CG received print information about LBP and 5 different lectures
      unrelated to LBP.
    

Intervention name(s): Back School Intervention; Supervised Walking Intervention; Back School and Walking; Control Group
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Patients were submitted once a week for 5 consecutive weeks to sessions of 45 minutes including: 15-minute lectures about basics of spine's anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, and spine preventive care; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); Patients were submitted once a week for 5 consecutive weeks to sessions of 45 minutes including: 15-minute lectures about basics of physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised walking in group.; Weekly sessions of 90 minutes including: 30-minute lectures about basics of spine's anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; Weekly sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention.; beside the 2-page folder content this group received no other information about LBP, BS or walking all along the follow-up.
Other intervention name(s): BS; W; BS+W; CG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Chronic low back pain; Back School; Walking; Physical activity