louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04856319: The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success
Official title: The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tooth Loss
Keywords: Dental Implants
Antibiotic Prophylaxis
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is no consensus on antibiotic prophylaxis in dental implant applications, and its necessity is controversial. Current reports on antibiotic use are insufficient. Also, other than antibiotic prophylaxis, data that may affect the post-operative situation such as the patient's gender, age, smoking, duration of surgery, length of the operation field, flap design have not been evaluated comprehensively.

This study aims to evaluate post-operative complications, implant success, and implant stability in 50 individuals: preoperative single dose of 2 g amoxicillin + clavulanic acid (25) and placebo (25).


Eligibility criteria: Inclusion Criteria:

* Tooth loss

Exclusion Criteria:

* Systemic disease
* Lactation/pregnancy

Primary outcomes:
measure: Baseline implant stability / osseointegration
timeFrame: Baseline
measure: 10th day implant stability / osseointegration
timeFrame: 10th day
measure: 1st month implant stability / osseointegration
timeFrame: 1st month
measure: Final implant stability / osseointegration
timeFrame: 3rd month
measure: Radiographic bone loss
timeFrame: 3rd month
measure: Early healing index (Wachtel et al)
timeFrame: 10th day
measure: Early healing index (Wachtel et al)
timeFrame: 1st month
Secondary outcomes:
measure: Operation duration
timeFrame: Baseline
measure: Painkiller (0-3 days)
timeFrame: Baseline - 3rd day
measure: Painkiller (3-10 days)
timeFrame: 3rd day - 10th day
measure: Operation zone length
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
affiliation: Biruni University, assistant professor
name: Mustafa Yılmaz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00253019: A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods
Official title: A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods (Oral Contraceptive Pills, Depo Provera and Ortho Evra) Among Women Seeking First Trimester Abortion.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: birth control
continuation
abortion
contraception
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-11-15
Enrollment: 321
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were recruited from a indigent, urban, African American population.

Brief summary: This study will assess the continuation rates among women using oral contraceptive pills, Depo-Provera and Ortho Evra following a first trimester abortion.

Detailed description: Unintended pregnancy rates among women in the United States continue to surpass that of the rest of the developed world at great cost to society. Contraceptive failure has been attributed to poor compliance with contraceptive methods and results in unintended pregnancies. This study will evaluate the 3-month continuation rates among women using the oral contraceptive pill and Depo-Provera. It will also assess the continuation rates of Ortho Evra®, which has not previously been studied in the adolescent population. This study will provide information with regard to pregnancy rates and 3-month patterns of use of contraception among women seeking first-trimester abortion. It will also assess other factors contributing to successful contraception such as the use of emergency contraception and concomitant condom use. The results of this study will be used to inform the practice of providers who provide reproductive health care to women and add to the sparse body of literature available comparing the success of different contraceptive methods used by women.

Eligibility criteria: Inclusion Criteria:

* Age 13-45 women presenting at the ambulatory surgery at Grady Memorial Hospital who want to use either oral contraceptive pills, ortho evra or depo provera?

Exclusion Criteria:

* Leaving the Atlanta area within 6 months?
* Desires pregnancy within the next 6 months?
* Unable to provide contact information?
* Contraindications to hormonal contraceptive?

Primary outcomes:
measure: Continuation Rates
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Carrie Cwiak, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00240019: Maximizing the Benefit of Renin-Angiotensin Blocking Drugs in Diabetic Renal Disease.
Official title: Maximizing the Benefit of RAS Blockade in Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Nephropathy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The angiotensin converting enzyme inhibitor drugs are now standard therapy for patients with diabetic nephropathy. The hypothesis of this study is that adding a diuretic agent (furosemide) will decrease the urine protein, which is a sign of disease, more than an angiotensin converting enzyme inhibitor alone.


Eligibility criteria: Inclusion Criteria:

proteinuria greater than 1 gram/day serum creatinine \< 2.6 for men, \< 2.0 for women

Exclusion Criteria:

blood pressure which cannot be controlled without a diuretic renal diseases other than diabetic nephropathy other disease which would alter renal function during 6 months

Primary outcomes:
measure: The amount of protein in the urine after 8 weeks of treatment.
Secondary outcomes:
measure: The estimated glomerular filtration rate after 8 weeks of treatment.
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Kaiser Permanente of Northern California, Santa Clara and San Jose
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Timothy W Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02964819: Influence of Interferential Current Therapy in the Treatment of Individuals With Shoulder Impact Syndrome: A Randomized, Placebo Controlled Clinical Trial.
Official title: Influence of Interferential Current Therapy in the Treatment of Individuals With Shoulder Impact Syndrome: A Randomized, Placebo Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project will analyze the influence of interferential current therapy in an exercise program for individuals with a unilateral impact syndrome diagnosis. To that end, volunteers of both genders, aged 18-59 years, had an unilateral, unilateral pain in the shoulder with more than 3 months duration, at least grade 4 pain by the numerical scale of pain assessment, positivity In at least 2 of 3 orthopedic tests for impact syndrome, will be randomized into the following groups: exercise group, exercise + ultrasound group, exercise group + interferential current. Sixteen consecutive treatment sessions will be performed, and the volunteers will be evaluated before and after, by means of the following instruments: Numerical scale of evaluation of pain, Shoulder pain and disability index (SPADI), Pain-Related Catastrophizing Thoughts Scale, being applied the Numerical scale of evaluation of pain at the end of Each session and one month after the end of treatment.


Eligibility criteria: Inclusion Criteria:

* History of anterolateral, unilateral pain in the shoulder with more than 3 months duration.
* Medical diagnosis,
* minimal grade 4 pain by numerical scale of pain assessment,
* positivity in at least 2 of 3 orthopedic tests for impact syndrome: Neer, Hawkins or Jobe.

Exclusion Criteria:

* Fibromyalgia diagnosis,
* pregnancy,
* numbness or tingling in the upper limb
* History of shoulder trauma, other shoulder related diseases,
* ruptured tendons, ligament laxity,
* symptoms of numbness and / or Tingling in the upper limbs, history of shoulder and / or cervical surgery
* use of corticosteroid injection in the shoulder, and analgesic, anti-inflammatory or muscle relaxant use and have or have undergone physiotherapeutic treatment in the last 6 months.

Primary outcomes:
measure: physical function and pain
timeFrame: 10 months
Secondary outcomes:
measure: pain
timeFrame: 10 months
measure: Catastrophizing of the Pain
timeFrame: 10 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Nove de Julho
state: São Paulo
Study officials:
References:
Clinical trial NCT02759419: A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension.
Official title: An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypertension, Pulmonary
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-05-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To provide riociguat therapy to eligible patients with PAH originating from Bayer-sponsored trials with BAY63-2521/ Riociguat / Adempas® who are currently or recently treated in these trials until lack of patient benefit as assessed by investigator, or commercial availability and reimbursement.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Pulmonary Arterial Hypertension (PAH) participating or having participated in the Bayer-sponsored studies 12935, 16719 or 18588, who have completed the main study phase and are still being treated with riociguat (either while still being on treatment with the respective study drug or by commercial means with Adempas) and who, in the opinion of the investigator, are expected to continue to have an overall positive benefit/risk from continuing treatment.
* Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and 30 days after the last administration of study drug.

Exclusion Criteria:

* Ongoing serious adverse event (SAE) from originating study that is assessed as related to riociguat
* Pregnant women or breast-feeding women
* Any contra-indication to Adempas treatment listed in the BAY63-2521 / Riociguat Investigators's Brochure
* Concomitant participation in another clinical study with the study drug
* Patients with pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)

Primary outcomes:
measure: Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerability
timeFrame: Up to approx. 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
city: Brest
country: France
city: Le Kremlin-bicetre
country: France
city: Lille Cedex
country: France
city: Rouen
country: France
city: Roma
country: Italy
state: Lazio
city: Pavia
country: Italy
state: Lombardia
city: Seoul
country: Korea, Republic of
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Otwock
country: Poland
city: Wroclaw
country: Poland
city: Bangkok
country: Thailand
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03391219: Combined Intravitreal Injection of Bevacizumab and Fasudil Versus Bevacizumab Alone for Macular Edema Secondary to Retinal Vein Occlusion in Previously Treated Patients
Official title: Combined Intravitreal Injection of Bevacizumab and Fasudil Versus Bevacizumab Alone for Macular Edema Secondary to Retinal Vein Occlusion in Previously Treated Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Retinal Vein Occlusion
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to compare the effect of combined intravitreal Bevacizumab and Fasudil injection with Bevacizumab only injection in patients with persistant macular edema secondary to ratinal vein occlusion.

Methods:

In this study patients with retinal vein occlusion patient who had at least three or more intravitreal AntiVEGF injection with persistence of macular edema at funduscopic examination is recruited. The eligible patients in randomized in two groups "Bevacizumab" and "Bavacizumab + Fasudil" and in injected intravitreally for 3 times monthly. In "Bevacizumab+Fasudil" group patients receive two injections at each session Bavacizumab and Fasudil. In "Bevacizumab" group patients receive only Bevacizumab. The patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. Baseline ancillary exams include Fluorescein Angiography and OCT-Angiography which is performed at the final exam as well. Patients needing any therapeutic intervention is addressed during the 6 month follow up period.


Eligibility criteria: Inclusion Criteria:

* Branch retinal vein or central retinal vein occlusion Previous at least 3 intravitreal antiVEGF injection Macular edema in SD-OCT CMT = \>250 microns BCVA equal or lesd than 20/40

Exclusion Criteria:

* Moderate or severe corneal opacity Significant cataract obscuring retinal exam or OCT Glaucoma History of vitreoretinal surgery Diabetic retinopathy Macular disease (AMD,ERM,VMT Kidney or Liver disease Uncontrolled or moderate or severe Anemia Uncontrolled hypertention

Primary outcomes:
measure: Measure Macular Thickness
timeFrame: 9 month
Secondary outcomes:
measure: Measure Visual acuity
timeFrame: 9 month
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT02473419: Neurobiological Basis of Response to Vayarin in Adults With ADHD: an fMRI Study of Brain Activation Pre and Post Treatment
Official title: Neurobiological Basis of Response to Vayarin in Adults With ADHD: an fMRI Study of Brain Activation Pre and Post Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ADHD
Keywords: Medical food
ADHD
Vayarin
Fish Oil
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: New York University
name: Enzymotec
name: The Medical Research Network
First posted: 2015-06-16
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be subjects participating in a Vayarin clinical trial being conducted at NYU and The Medical Research Network in NYC.

Brief summary: The objective of this research is to use functional magnetic resonance imaging (fMRI) with a neuropsychological task to test the prefrontal mechanism of action of the medical food Vayarin.

Detailed description: The investigators prior research suggests that effective non-stimulant treatments for ADHD act through key prefrontal regions that subserve inhibitory and executive functions, although different medications may achieve these effects via distinct mechanisms. The objective of this research is to use functional magnetic resonance imaging (fMRI) with a face go/no-go task to test the prefrontal mechanism of action of the medical food Vayarin. Participants are not treated at the Icahn School of Medicine, but instead will be recruited from trials of Vayarin that are enrolling and treating participants at New York University and The Medical Research Network.

Eligibility criteria: Inclusion Criteria:

* Subjects eligible to enroll in the Vayarin clinical study according to screening visit will be asked to participate in the fMRI study.
* Must be willing and able to perform fMRI scanning
* Must maintain compliance to their trials' protocols

Exclusion Criteria:

* pre-existing medical or psychological condition that precludes scanning (e.g., claustrophobia, morbid obesity)
* implanted medical device (e.g., pacemaker)
* metal in the body that cannot be removed (e.g., braces)
* pregnancy
* concomitant use of anti-hypertensives or any other medications affecting the blood oxygenation level-dependent (BOLD) signal

Primary outcomes:
measure: Change in the emotional go/no-go task
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Change in the resting state fMRI
timeFrame: Baseline and 16 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jeffrey Newcorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02217319: Cardioprotection by Sevoflurane Preconditioning in Noncardiac Thoracic Surgery
Official title: Does a Sevoflurane Preconditioning Have Cardioprotective Properties in Noncardiac Thoracic Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Sensitive Troponin T Release
Keywords: Volatile Anesthetic
Cardioprotection
Lung surgery
non cardiac surgery
Lead sponsor: Dr. Horst Schmidt Klinik GmbH
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It has been shown that the use of volatile anaesthetics, that are usually used to perform a general anesthesia, have cardioprotective properties. This has been shown in animal studies and in patients that underwent cardiac surgery. The aim of our study is to examine if Sevoflurane, a volatile anaesthetic, has this properties in patients undergoing lung surgery.


Eligibility criteria: Inclusion Criteria:

* Lung surgery
* ASA (American Society of Anesthesiologists) physical status 1-3

Exclusion Criteria:

* Disposition for malignant hyperthermia
* Medication with ß-blocking drugs
* Use of clonidin

Primary outcomes:
measure: Troponin T
timeFrame: change of Troponin T levels preoperative and postoperative up to 40 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: Dr Horst Schmidt Klinik
Study officials:
References:
Clinical trial NCT02026219: Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in ST-Segment Elevation Myocardial Infarction
Official title: Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in Acute Coronary Syndrome Patients: The Index of MIcrocirculatory Resistance After PCI in STEMI Patients (TIME Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-ST Segment Elevation Myocardial Infarction
ST Segment Elevation Myocardial Infarction
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ticagrelor is a non-thienophyridine, direct P2Y12 blocker that is more potent than clopidogrel and is associated with less interindividual variability. In the PLATO trial, it was found to be superior to clopidogrel with respect to cardiovascular outcomes and total mortality without increasing the risk of bleedings.

More potent and reversible receptor bindings are possible explanation for the superior outcomes. Beside the potent effect on inhibition of antiplatelet function, ticagrelor has previously been demonstrated to increase adenosine levels by inhibiting adenosine re-uptake in tissue level and can induce adenosine triphosphate (ATP) release from human red cells, which both stimulate vasodilation of in red blood cells.


Eligibility criteria: * Inclusion Criteria:

  * Males and Females
  * between the ages of 18 and 75 years
  * STEMI patients treated with percutaneous coronary intervention
  * Able to provide informed consent
* Exclusion Criteria:

  * History of stroke or transient ischemic attack
  * Platelet count \< 100 000/μL
  * Known Bleeding Diathesis
  * Hematocrit \<30% or \>52%
  * Severe Liver Dysfunction
  * Renal Insufficiency (Creatinine Clearance \< 30ml/min)
  * Pregnant females
  * Cardiogenic shock or symptomatic hypotension or sitting SBP \< 95 mmHg

Primary outcomes:
measure: Index of microcirculatory resistance (IMR) measured after successful coronary intervention
timeFrame: IMR will be immediately assessed after successful PCI patients within 48hr from admission
Secondary outcomes:
measure: wall motion score index on three month later TTE from index PCI
timeFrame: TTE will be assessed in all enrolled patients 3 month later from index PCI
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
References:
citation: Park SD, Baek YS, Woo SI, Kim SH, Shin SH, Kim DH, Kwan J, Park KS. Comparing the effect of clopidogrel versus ticagrelor on coronary microvascular dysfunction in acute coronary syndrome patients (TIME trial): study protocol for a randomized controlled trial. Trials. 2014 May 1;15:151. doi: 10.1186/1745-6215-15-151.