louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06602284: A Full Face Study to Evaluate the Efficacy of Dermapen 4™ Microneedling Device in Addition with MG-CLR Serum for Acne Treatment Over 12 Weeks.
Official title: A Full Face, Baseline Controlled Study to Evaluate the Efficacy of Dermapen 4™ Microneedling Device in Conjunction with MG-CLR Serum for Acne Treatment Over 12 Weeks.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acne
Keywords: dermapen, microneedling, acne
Lead sponsor: Equipmed USA LLC
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is conducted to check how well the Dermapen 4™ microneedling device works with MG-CLR serum for treating acne over 12 weeks.


Eligibility criteria: Inclusion Criteria:

1. Female subjects aged between 18-45 years (both ages inclusive)
2. Fitzpatrick skin phototype I to VI.
3. Subjects having IGA score of 2 and 3.
4. Subjects who have not received any kind of treatment for acne 1 month before the start of the study.
5. Subject free of excessive hair, cuts, abrasions, fissures, wounds, lacerations, or any other skin conditions on the face.
6. Subjects who agree not to use any other product/treatment/home remedy/ except the provided products on their face during the study period

Exclusion Criteria:

1. Subjects with known skin condition that may impact the assessment.
2. Subjects with active Herpes labialis infection.
3. Subjects known to have bleeding and clotting disorders (self-declared).
4. Subjects known to have connective tissue disorders.
5. Subjects with any other signs of significant local irritation or skin disease.
6. Subjects currently taking any medication, which the investigator believes may influence the interpretation of the data.

Primary outcomes:
measure: Acne severity
timeFrame: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Skin Wellness Dermatology
state: Alabama
Study officials:
References:
Clinical trial NCT05069584: TransPERineal Fusion Biopsy Versus transrECTal
Official title: Efficacy and Safety of Prostate Biopsies by Transperineal Versus Transrectal Route: Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 270
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of the efficacy and safety of 2 types of prostatic biopsies: transperineal biopsy versus transrectal biopsy.

Detailed description: Interventional, comparative, randomized, controlled study in 2 parallel groups, open-label, longitudinal, multicenter, aimed at demonstrating the non-inferiority of targeted transperineal biopsies compared to targeted transrectal biopsies in terms of diagnostic efficiency.

Eligibility criteria: Inclusion Criteria:

* Patient having had a multiparametric prostatic MRI with the realization of 3 sequences (T2, diffusion, perfusion) interpreted by a local referent radiologist in prostate MRI or whose PI-RADS score is confirmed by rereading by a local referent radiologist in prostate MRI in case prostate MRI performed outside the center;
* Patient with at least one PI-RADS 4-5 lesion on MRI;
* Patient eligible for prostate, transperineal and transrectal biopsies, targeted and systematized;
* Patient with negative pre-biopsy antibacteriological urine examination ;
* Patient with prostate specific antigen (PSA) level ≤ 20 ng / mL;
* Patient capable of understanding the information related to the study, answering questionnaires in French, reading the instructions and having expressed their consent to participate in the study.

Exclusion Criteria:

* Patient who has already had a prostate biopsy;
* Patient with stage ≥ cT3a prostate cancer according to TNM classification version 8
* Patient with negative MRI or whose lesions have a PI-RADS score \<4;
* Patient with impassable rectal stenosis;
* Patient with a dermatological disease preventing perineal access;
* Patient with rectal amputation;
* Patient presenting with a urinary tract infection;
* Patient on anticoagulant treatment at an effective oral dose, not relayed;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial

Primary outcomes:
measure: Efficacy of the targeted biopsy in terms of detection of significant cancers.
timeFrame: Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Quint-Fonsegrives
country: France
facility: Clinique La Croix Sud
Study officials:
References:
Clinical trial NCT03265184: Green Coffee Extract Supplementation and Oxidative Stress, Systemic and Vascular Inflammation
Official title: Effects of Green Coffee Extract Supplementation on Oxidative Stress, Systemic and Vascular Inflammation in Patients With Metabolic Syndrome: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Metabolic syndrome (Mets) is defined as the collection of risk factors contributing to type 2 diabetes mellitus and cardiovascular disease. Mets is accompanied by oxidative stress and low-grade inflammation. Green coffee is rich in polyphenols called chlorogenic acids (CGA) which possess anti-inflammatory and anti-oxidative characteristics. Thus, we carried out this trial to examine green coffee extract (GCE) effects on oxidative stress, systemic and vascular inflammation in patients having Mets


Eligibility criteria: Inclusion Criteria:

* body mass index of over 25, waist circumference \>102 cm in men or \>88 cm in women,Fasting blood glucose \>100 mg/dL, Triglycerides (TG) \> 150 mg/dL, High density lipoprotein cholesterol (HDL-C) \<50 in women or \<40 in men, Systolic blood pressure (SBP) \>130 mmHg and diastolic blood pressure (DBP) \>85mmHg

Exclusion Criteria:

* insulin administration for diabetes control, having hypo- or hyperthyroidism, renal failure or other chronic diseases, regular coffee consumption, pregnancy, breastfeeding, taking estrogen, progesterone, corticosteroids, weight loss supplements and obeying unusual weight loss plans

Primary outcomes:
measure: intercellular adhesion molecule-1 (ICAM-1)
timeFrame: 8 weeks
measure: interleukin-6 (IL-6)
timeFrame: 8 weeks
measure: high sensitivity C-reactive protein (hs-CRP)
timeFrame: 8 weeks
measure: malondialdehyde (MDA)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03080584: Effect of 12 Weeks of Acupuncture on AMH and COH in Low Responder Patients
Official title: Effect of 12 Weeks of Acupuncture on AMH and Ovarian Reserve in Women With Low Ovarian Reserve. A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypogonadism; Ovarian
Female Infertility
Keywords: acupuncture
IVF
AMH
ovarian reserve
Lead sponsor: Dansk Fertilitetsklinik
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: comparison of AMH and ovarian response before and after acupuncture
Primary purpose: TREATMENT

Brief summary: the investigators want to study whether 12 weeks of acupuncture has any effect on AMH and the ovarian reserve in women with low ovarian reserve (low responders). AMH is measured before and after 12 weeks of acupuncture and the clinical response to controlled ovarian hyperstimulation before and after the acupuncture is compared.

Detailed description: AMH is measured cycle day 2 or 3 before and after 12 weeks of acupuncture and the levels are compared. Furthermore, secondary outcomes from IVF treatments before and after the intervention are compared.

Eligibility criteria: Inclusion Criteria:

* IVF/ICSI treatment
* 18-40 years
* AMH measured \< or = 10 pmol/l
* maximum of 8 oocytes collected at last treatment before inclusion-

Exclusion Criteria:

* (use of testicular sperm)
* more than 4 acupuncture treatments within the last 3 months before inclusion -

Primary outcomes:
measure: AMH
timeFrame: chance from baseline after 12 weeks of acupuncture
Secondary outcomes:
measure: No. of oocytes aspirated
timeFrame: change from baseline treatment and after 12 weeks of acupunture
measure: FSH dose/oocyte collected
timeFrame: change from baseline treatment and after 12 weeks of acupuncture
measure: TQE 44 hours after fertilisation
timeFrame: change from baseline treatment and after 12 weeks of acupuncture
measure: biobank with blood plasma
timeFrame: 2 years after treatment completion
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Dansk Fertilitetsklinik
Study officials:
affiliation: Dansk Fertilitetsklinik
name: Ursula Bentin-Ley, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02184884: Effect of Perioperative Clopidogrel Responsiveness on Ischemic Outcome in Patients With Acute Coronary Syndrome Undergoing Off-pump Coronary Artery Bypass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome (ACS)
Keywords: off-pump coronary artery bypass surgery, clopidogrel responsiveness, ischemic outcome
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 195
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with acute coronary syndrome (ACS) undergoing off-pump coronary artery bypass surgery

Brief summary: The whole blood Thrombelastograph (TEG®) Platelet Mapping™ assay measures clot strength, maximal amplitude (MA), reflecting maximal platelet function, and detects the reduction in platelet function, presented as percentage inhibition, by both aspirin and clopidogrel. A study reported that the TEG® can be used as routine monitoring of the variability in ADP receptor inhibition and of antiplatelet therapy. Therefore, using TEG Platelet Mapping assay, we could find out the perioperative clopidogrel responsiveness of the patients with ACS undergoing OPCAB.

The purpose of this study is to determine whether the rate of the major adverse cardiac events (MACE, a combined endpoint of MI, revascularization and cardiac death) is higher in the patients with high degree of clopidogrel resistance, who are scheduled to undergo the OPCAB due to ACS.


Eligibility criteria: Inclusion Criteria:

1. the patients with ACS undergoing OPCAB
2. the patients over 20 years of age
3. the patient who have been taking \[100 mg of Aspirin\] and \[75 mg of clopidogrel or 180 mg of ticagrelor\] for more than one week and who continue within 3 to 5 days prior to surgery

Exclusion Criteria:

1. re-operation or emergency operation
2. the patients with bleeding tendency of decreased liver function
3. Left ventricular ejection fraction \< 40% by echo
4. preoperative hematocrit \< 33% or platelet count \< 100,000/mm3 or creatinine \> 1.4 mg/dL
5. abnormal preoperative prothrombin time or activated partial thromboplastin time
6. preoperative use of other PO antiplatelet drugs or PO anticoagulants

Primary outcomes:
measure: Rate of the major adverse cardiac events
timeFrame: at 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine
Study officials:
References:
citation: Soh S, Shin YR, Song JW, Choi JH, Kwak YL, Shim JK. Platelet Reactivity and Outcomes after Off-Pump Coronary Surgery in Acute Coronary Syndrome Patients. J Clin Med. 2022 Jun 8;11(12):3285. doi: 10.3390/jcm11123285.
Clinical trial NCT06483984: Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout
Official title: Physiological Effects of Novel Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout in Patients With Hypercapnic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Insufficiency
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (Nivairo, Visairo, Optiniv) in patients with acute hypercapnic respiratory failure


Eligibility criteria: Inclusion Criteria:

Acute respiratory failure with

* PaCO2 ≥ 45 mmHg;
* Arterial pH \< 7.35;
* Signed written informed consent

Exclusion Criteria:

* Respiratory rate \< 12 bpm;
* Immediate need for intubation;
* Haemodynamic instability (Systolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg) and/or lactic acidosis (lactate \>5 mmol/L) and/or clinically diagnosed shock;
* Metabolic Acidosis;
* Recent head surgery or anatomy that prevent the application of facemasks;
* Any contraindications to oesophageal balloon insertion and/or electrical impedance tomography (EIT) belt placement.
* Any contraindications to facemask noninvasive ventilation.

Primary outcomes:
measure: Metabolic work of breathing
timeFrame: 45 minutes
Secondary outcomes:
measure: Normalized metabolic work of breathing
timeFrame: 45 minutes
measure: Inspiratory effort, expressed in cmH2O
timeFrame: 45 minutes
measure: Corrected minute ventilation
timeFrame: 45 minutes
measure: Dyspnea
timeFrame: 45 minutes
measure: Discomfort
timeFrame: 45 minutes
measure: End-expiratory lung volume
timeFrame: 45 minutes
measure: Regional End-expiratory lung volume
timeFrame: 45 minutes
measure: Arterial carbon dioxide, expressed in mmHg
timeFrame: 45 minutes
measure: Arterial acid-base state
timeFrame: 45 minutes
measure: Recuitment of expiratory muscles, expressed in cmH2O of gastric pressure
timeFrame: 45 minutes
measure: Tidal volume distribution
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Roma
country: Italy
facility: General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS
city: Rome
country: Italy
facility: Fondazione Policlinico Universitaro A. Gemelli IRCCS
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Massimo Antonelli, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00376584: Effect of an Investigational Compound on Tolerability of Extended Release Niacin (0524A-023)(COMPLETED)
Official title: A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Study to Evaluate the Efficacy of MK0524 to Improve Tolerability of Extended Release Niacin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesteremia
Hyperlipidemia
Keywords: Primary Hypercholesteremia
Mixed Hyperlipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-09-15
Enrollment: 825
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of MK0524 to improve the tolerability of extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms.


Eligibility criteria: Inclusion Criteria:

* Patient is appropriate candidate for niacin therapy
* Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C \<130 mg/dL at V1
* Patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have LDL-C \<130 mg/dL at V1
* Non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have LDL-C \<160 mg/dL at V1
* Patient has TG \<500 mg/dL (5.65 mmol/L) at V1
* A patients historic serum or plasma lipid values measured within 6 months from Visit 1 may be used to meet lipid inclusion criteria
* ALL OTHER PATIENTS DO NOT REQUIRE SPECIFIC LIPID ENTRY CRITERIA

Exclusion Criteria:

* Patients with unstable doses of medications
* Pregnant or lactating women, or women intending to become pregnant are excluded
* Patients with diabetes mellitus that is poorly controlled, unstable or newly diagnosed
* Patients with: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year)

Primary outcomes:
measure: Global Flushing Severity Score (GFSS) during 7 days of treatment
timeFrame: during 7 days of treatment
Secondary outcomes:
measure: Percentage of Participants Who Experience at Least 1 Adverse Event
timeFrame: up to 10 weeks
measure: Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event
timeFrame: up to 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01829984: Verbal and Written Instruction Versus Verbal and Written Plus Simulation in Patients With Breast Cancer and Their Caregivers
Official title: A Comparison of Strategies for Injection Teaching: Verbal and Written Instruction Versus Verbal and Written Plus Simulation in Patients With Breast Cancer and Their Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Injection Teaching
13-057
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All breast cancer medical oncology clinics at MSKCC will serve as recruitment clinics for the proposed study. Nurses will notify the PI of any patient due to start adjuvantadjuvant or neoadjuvant treatment when the regimen includes pegfilgrastim.

Brief summary: The purpose of this study is to compare two different ways of teaching people how to give injections at home. The first is what we do now, which is teaching patients and/or their caregivers verbally and by giving written instructions. The second is what we do now (verbal and written instructions) along with a demonstration and practice using a needle and an injection pad that feels similar to skin and fat. This is being done to find the best method for teaching people to give an injection at home.


Eligibility criteria: Inclusion Criteria:

* English speaking
* Over 18 years of age
* No history of performing injections
* Patient must be receiving pegfilgrastim during adjuvant or neoadjuvant chemotherapy
* Patient will have the pegfilgrastim administered at home either by self administering or by a caregiver.

Exclusion Criteria:

* Patient or caregiver desire to inject (with saline) during or immediately following the injection teaching
* Prior self-injection or injection administration experience of any type
* Patients with history of anaphylaxis or other severe reactions to latex
* Patients that required pegfilgrastim injection be administered in clinic

Primary outcomes:
measure: compare verbal and written teaching for injection teaching
timeFrame: 1 year
Secondary outcomes:
measure: Assess for changes in patient self-reported
timeFrame: 1 year
measure: Compare nurses' perceptions of patient/caregiver confidence levels
timeFrame: 1 year
measure: Compare the amount of nurses' time spent teaching
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Erica Fischer-Cartlidge, RN, MSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01148784: Comparison of Doubled Quadrupled Versus Quadrupled Allograft Tissue Constructs for Anterior Cruciate Ligament (ACL) Reconstruction
Official title: A Prospective Randomized Comparison of Doubled Versus Quadrupled Allogenic Tissue Constructs for Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament
Injury
Keywords: anterior cruciate ligament tear
ACL
ligament
knee
allograft
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two different soft tissue allografts, double bundle tibialis anterior allograft or quadruple bundle hamstring allograft, used in repairing a torn anterior cruciate ligament (ACL) of the knee.


Eligibility criteria: Inclusion Criteria:

* ACL injury is the primary limitation to activities of daily living.

Exclusion Criteria:

* Multiple current ligamentous injuries to the knee.
* Revision reconstruction of the ACL.
* Uncorrected instability of the ACL on the opposite knee.

Primary outcomes:
measure: Knee outcome scores
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Dennis C Crawford, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: