bioihbjkbjnl/mcl2 huggingface dataset:
PK and DPK of Lidocaine Dermal Products
Condition: Heat Effect
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a bioequivalence study to compare lidocaine release between a brand name and generic
      skin patches in healthy adults.
    

Detailed description: 
      This research study is intended to determine the effect of heat on lidocaine patches. This
      study will use lidocaine patches (brand name and generic patches) that have been approved by
      the Food and Drug Administration (FDA) and are already sold to customers in the United
      States, and will not include any placebos.
    

Intervention name(s): Lidocaine patch
Intervention type(s): Drug
Intervention description(s): lidocaine patch
Other intervention name(s): skin patch
Intervention MeSH terms: Lidocaine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The 3-Dimensional Printed Guide in Endodontic Microsurgery
Condition: Endodontic Disease; Endodontic Re-treatment Failure
MeSH terms: Dental Pulp Diseases
Study type: Interventional

Summary: 
      In recent years, there was a great interest in employing the surgical guide in dentistry due
      to the development occurred in the 3D printing which became available widely.

      Cone beam computed tomography (CBCT) is necessary and crucial in planning for endodontic
      surgery, but the procedure still depends on how the surgeon reflect the 3D images on the
      anatomical structures accurately, which may leave room for error.

      This study is to compare the clinical and radiographic outcomes using guided endodontic
      microsurgery versus conventional endodontic microsurgery in critical anatomical structures.
    

Detailed description: 
      Endodontic microsurgery in critical anatomical structures is considered as a serious
      challenge for the endodontist.

      Major advances have been made to the techniques used in endodontic surgery to make the
      procedure easier to perform, safer and more predictable.

      Several case reports that used surgical guide in endodontic microsurgery found that the
      procedure was more accurate in control of depth, diameter and angle of osteotomy.

      The aim of this study is to compare the clinical and radiographic outcomes using guided
      endodontic microsurgery versus conventional endodontic microsurgery in critical anatomical
      structures.

      Patients will be selected that they are indicated for endodontic surgery. Upper and lower
      teeth will be selected close to critical anatomy such as; maxillary sinus, nasal fossa,
      mental foramen and mandibular canal. medical and dental history will be obtained from all
      selected patients. Patients will be randomly distributed to either guided micro-surgery group
      or conventional micro-surgery group. All steps of the surgical procedure will be performed
      under microscopic magnification. Bioceramic putty will be used as a root-end filling
      material. Post-surgical instructions will be given to patients. The time of the surgery will
      be recorded from the first incision to the last suturing. Success and failure will be
      assessed using radiographic and clinical evaluation at 6 and 12 months.
    

Intervention name(s): 3-D printed Guide; Conventional Endodontic Micro-Surgery
Intervention type(s): Device; Other
Intervention description(s): Guided Endodontic micro-surgery; Free-hand endodontic micro-surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Apicoectomy; Guided Endodontic Surgery; Micro-Surgery; Surgical Guide; 3-Dimensional Printed; Critical Structures
JAYDESS Drug Utilization Study in Sweden
Condition: Contraception
Study type: Observational

Summary: 
      -  To describe characteristics (demographic, clinical, social) of first time users of
           Jaydess

        -  To estimate the duration of use of Jaydess

        -  To study switching patterns, e.g. what are the hormonal contraceptive methods used
           before and what are the methods after discontinuing Jaydess

        -  To study off-label use of Jaydess
    


Intervention name(s): Levonorgestrel (Jaydess, Skyla, BAY86-5028)
Intervention type(s): Drug
Intervention description(s): Women use Levonorgestrel (Jaydess, BAY86-5028) .
Intervention MeSH terms: Levonorgestrel
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women in Sweden
      
Keywords: Drug Utilization Study
Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline
Condition: Improvement of Jawline Contour
Study type: Interventional

Summary: 
      To demonstrate the effectiveness and safety of Radiesse (+) following deep (subdermal and/or
      supraperiosteal) injection to improve the contour of jawline by adding volume to the jawline.
    


Intervention name(s): Radiesse (+)
Intervention type(s): Device
Intervention description(s): Radiesse (+) for jawlines.
Other intervention name(s): Radiesse (+) Injectable Dermal Filler with Lidocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 2

Summary: 
      To Evaluate the efficacy of Z-338 in subjects with Functional Dyspepsia, focusing on the
      assessment of subjective symptoms in order to further determine the optimal dosage and
      efficacy parameters for PhaseIII clinical trials.
    


Intervention name(s): Z-338
Intervention type(s): Drug
Intervention MeSH terms: Z 338
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia
Condition: Apoptotic Signal Pathways in Endometrial Hyperplasia
MeSH terms: Endometrial Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine apoptotic signaling pathways such as Survivin,
      Bcl-2, Bax, c-Myc and caspase-9 expression levels in rats model with iatrogenic endometrial
      hyperplasia after metformin and medroxyprogesterone acetate administration.
    


Intervention name(s): 17β estradiol hemihydrate; Metformin; medroxyprogesterone acetate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 4mg/kg/day for 20 days; 50 mg/kg/day last 10 days; 1mg/kg/day last 10 days
Intervention MeSH terms: Metformin; Medroxyprogesterone Acetate; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Medroxyprogesterone; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Apoptotic signal pathway; Survivin; Bcl-2; Bax; c-Myc; Caspase-9; endometrial hyperplasia; endometrium cancer
Curve of Spee: Speed of Leveling Using Different Orthodontic Archwires
Condition: Orthodontic Treatment
Study type: Interventional

Summary: 
      The objectives if this study was to evaluate the efficacy of 3 different rectangular
      archwires in the correction of the curve of Spee (COS), to record the time needed to level
      excessive COS in the mandibular arch using the 3 archwire sizes, to investigate the changes
      in intercanine and intermolar widths and arch length during leveling, to measure the
      arterio-posterior and vertical movement for the lower incisors and lower molars, to record
      pulpal blood flow and to detect the root resorption in the lower anterior teeth associated
      with leveling excessive COS using the 3 different archwires.
    

Detailed description: 
      Fifty one subjects with an excessive COS were included in this study. The subjects will be
      randomly divided into three groups; Group one (17 patients): leveling of COS using
      0.017X0.025-inch stainless steel archwire. Group two (17 patients): leveling of COS using
      0.019X0.025-inch stainless steel archwire. Group three (17 patients): leveling of COS using
      0.021X0.025-inch Titanium molybdenum archwire.

      In the three groups, a 5mm depth reverse COS will be inserted. Records consisted of lateral
      cephalograms (pre-treatment, at T0 and post-treatment), peri-apical radiographs (at T0 and at
      T5), study casts (pre-treatment and at each time point during the tudy). Patients will be
      followed up on monthly visits without removing leveling archwires where alginate impressions
      were taken for the lower arch. Pain scores during the first week of leveling will be recorded
      using visual analogue scale (VAS).The amount of COS correction in mm, changes in intercanine
      in mm, intermolar and arch length in mm, pain scores and lower incisors root resorptions in
      mm will be measured.
    

Intervention name(s): 0.017X0.025 Stainless steel; 0.019X0.025 Stainless steel; 0.021X0.025 B-Titanium archwire
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Leveling curve of Sppe using 0.017X0.025 SS archwire; Leveling curve of Sppe using 0.019X0.025 Stainless steel archwire; Leveling curve of Sppe using 0.019X0.025 B-Titanium archwire
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Leveling of the curve of Spee
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: root resorption; pain; pulpal blood flow
GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigates if Celebrex has a lower incident of Gastrointestinal Events than
      other NSAIDS in subjects with osteoarthritis.
    


Intervention name(s): Celecoxib; Any commercially available NSAID with the indication for osteoarthritis
Intervention type(s): Drug; Drug
Intervention description(s): open-label; dosing as per USPI label related to the chosen commercially marketed NSAID
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GI events in patients with moderate GI risk treated with NSAIDS
Pharmacokinetics of HCP1305 and Co-administration of HCP0605, HGP0816 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetics and safety/tolerability after administration of HCP1305
      and co-administration of HCP0605, HGP0816 in healthy male volunteers
    

Detailed description: 
      The purpose of this study is to investigate the pharmacokinetics and safety/tolerability
      after administration of HCP1305 and co-administration of HCP0605, HGP0816 in healthy male
      volunteers
    

Intervention name(s): HCP0605 + HGP0816; HCP1305
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Skeletal Muscle Protein Synthetic Response to Amino Acid and Peptides
Condition: Protein Metabolism
Study type: Interventional

Summary: 
      Skeletal muscle quality is an important determinant of exercise performance and overall
      health. It is vital for not just movement, but also metabolizing nutrients. Protein from the
      diet can promote muscle protein synthesis for muscle recovery and growth. More importantly,
      doing so shifts net protein balance positively (e.g. protein synthesis is greater than
      protein breakdown) and promotes greater rates of muscle protein turnover. Leucine is an amino
      acid required to build muscle, but it also acts as a signaling molecule informing the muscle
      to start protein synthesis. Before reaching skeletal muscle, dietary protein is digested into
      small peptides and free amino acids. Rate of absorption from the intestine to the blood
      stream is significantly faster for peptides compared to amino acids. As amino acid
      availability in the blood is a precursor for muscle protein synthesis, our objective is to
      determine if the different absorption rates between free amino acid and peptides influence
      muscle protein synthetic and breakdown rates.
    


Intervention name(s): Resistance Exercise; No Resistance Exercise; Leucine; Dileucine
Intervention type(s): Behavioral; Behavioral; Dietary Supplement; Dietary Supplement
Intervention description(s): Prior to protein consumption participants will perform an acute bout of resistance exercise. They will warm up with two sets of 10 repetitions at 35-75% working load respectively, then perform four working sets of 10-12 repetitions at 65-70% of 1-RM. 1 min, 30 sec rest periods will be implemented between each set.; Participants allocated to this group will not perform exercise prior to the administration of the nutritional intervention. Participants will remain at rest throughout the trial.; Participants will be given 2g of leucine dissolved in 250mL of water. Drink will be consumed immediately after exercise or equivalent time point for non-exercise group.; Participants will be given 2g of dileucine dissolved in 250mL of water. Drink will be consumed immediately after exercise or equivalent time point for non-exercise group.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Metabolism; Amino Acid Peptides; Muscle Protein Synthesis; Muscle Protein Breakdown
Influence of Chemotherapy on Postural Control in Women With Cancer
Condition: Cancer, Breast; Cancer, Gynecologic
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The aim of this study is to understand the strategies for adapting postural control in
      patients who have received chemotherapy treatment for gynaecological cancer.
    

Detailed description: 
      Chemotherapy can cause many side effects, including peripheral neuropathies. Chemotherapy
      induced peripheral neuropathies (CIPN) are primarily sensory impairments that can alter the
      signals for somatosensory feedback and thus affect the postural control in the standing
      position. The objective of this study is to evaluate the impact of chemotherapy and
      peripheral neuropathies on postural control in the standing position. As balance maintenance
      is a complex construct involving different systems, this study will evaluate maintenance
      strategies during sensory disturbances in order to better understand post-chemotherapy coping
      strategies. These sensory disturbances concern vision (eyes closed) and the alteration of the
      somatosensory system (foam under the feet and vibration system). In addition, this study will
      evaluate balance in double task situations and dynamic stability. Given the consequent impact
      of chemotherapy and peripheral neuropathies on quality of life, a quality of life
      questionnaire will also be administered.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will consist of 31 women between the ages of 18 and 65 consulting at
        the University Hospitals for their oncological disease.
      
Keywords: postural control; balance; chemotherapy induced peripheral neuropathy; quality of life
A Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties of Biochaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period
      cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin
      treatment. Each subject will be randomly allocated to a treatment sequence and will be
      administered single subcutaneous doses of 0.8 U/kg Biochaperone® Combo, 0.8 U/kg Humalog®
      Mix25 or simultaneous subcutaneous injections of 0.2 U/kg Humalog® and 0.6 U/kg Lantus®
      during three separate dosing visits.
    


Intervention name(s): Biochaperone Combo; Humalog Mix25; Humalog; Lantus; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Injection of BioChaperone Combo; Injection of Humalog Mix25; Injection of Humalog; Injection of Lantus; Injection of saline 0.9% solution
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Clinical Trial to Evaluate the Tolerability and Efficacy of Microencapsulated Calcium Carbonate
Condition: Hypocalcemia; Dietary
MeSH terms: Hypocalcemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Interventional Clinical trial with food supplement, randomized, double-blind, comparative
      between microencapsulated calcium, calcium carbonate salts standardized and calcium citrate,
      in a population of postmenopausal women, lasting 1 month.
    


Intervention name(s): Calcium supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Calcium supplement for low contribution of elemental calcium in the daily diet
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Levetiracetam 750 mg Tablets Under Non-Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the rate and extent of absorption of a test
      formulation of Levetiracetam tablets versus the reference Keppra® administered as a 1 x 750
      mg tablet under fed conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA bioequivalence statistical methods
    

Intervention name(s): Levetiracetam; Keppra®
Intervention type(s): Drug; Drug
Intervention description(s): 750 mg Tablet; 750 mg Tablet
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
Sexual Timing in Couples Actively Trying to Conceive
Condition: Conception
Study type: Interventional

Summary: 
      This study will asses the effectiveness of two strategies for timed intercourse in couples
      actively trying to conceive
    


Intervention name(s): health educational video
Intervention type(s): Other
Intervention description(s): visualization of health educational video
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: marital relationship
Safety and Tolerability of Multiple Inhaled NVA237 Doses in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetics, pharmacodynamics and safety of multiple doses
      of the NVA237 in mild and moderate COPD patients .
    


Intervention name(s): NVA237; NVA237; NVA237; NVA237; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Glycopyrrolate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: multiple inhaled, NVA237, COPD
Acamprosate Treatment: Mechanisms of Action
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine whether pretreatment with two doses of acamprosate for seven days
      prior to abstinence lessens the intensity of acute withdrawal from alcohol compared with a
      placebo. Subjects will be randomly assigned to receive either one of two doses of acamprosate
      or placebo for seven days. This will be followed by a four- day inpatient period when
      withdrawal will be monitored. Additional drinking information will be obtained at a three
      month followup interview.
    


Intervention name(s): acamprosate (Campral)
Intervention type(s): Drug
Intervention MeSH terms: Acamprosate
Allocation: Randomized
Primary purpose: Treatment
Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single
      rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI
      425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral
      drinking solution fasted compared to BI 425809 tablet fasted and tablet fed
    


Intervention name(s): BI 425809 PfOS; Placebo; Placebo; BI 425809 tablet; BI 425809 PfOS
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): BI 425809 PfOS; Placebo; Placebo; BI 425809 tablet; BI 425809 PfOS
Intervention MeSH terms: BI 425809
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
A Phase # Clinical Study Trial of Felbinac Trometamol Injection in China
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      A multi-center, randomized, double-blind, placebo parallel controlled phase Ⅲ clinical trial
      on the efficacy and safety of felbinac trometamol Injection in the treatment of postoperative
      pain in gynecology.main purpose is to evaluate the efficacy of Felbinac Trometamol Injection
      in the treatment of moderate and severe pain after surgery.Secondary purpose is to evaluation
      the safety of Felbinac Trometamol Injection in the treatment of moderate and severe pain
      after surgery
    


Intervention name(s): Felbinac Trometamol Injection; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Felbinac Trometamol Injection diluted to 100 ml with 0.9% sodium chloride injection.Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min)..
One dose at 8h and 16h after the start of the first dose,the first intravenous infusion was started at 30±5 minutes before the end of the operation (Skin suture completes the last stitch).The drug was given 3 times,3 times/day, once every 8 hours.; Placebo diluted to 100 ml with 0.9% sodium chloride injection. Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min).
One dose at 8h and 16h after the start of the first dose, the first intravenous infusion was started at 30±5 minutes before the end of the operation (Skin suture completes the last stitch).The drug was given 3 times,3 times/day, once every 8 hours.
Other intervention name(s): 4-Biphenylacetic Acid Trishydroxymettiylaminometnane; Normal saline
Intervention MeSH terms: Biphenylylacetic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment