louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03425721: Histological and Microbiological Evaluation of Late Occurring Nodules With Hyaluronic Acid Dermal Fillers
Official title: Histological and Microbiological Evaluation of Late Occurring Nodules With Hyaluronic Acid Dermal Fillers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermal Nodule
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-02-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who present with late occurring nodules, occurring more than 4 weeks but less than 2 years after the latest injection of any HA soft tissue filler.

Brief summary: This study will determine if HA dermal filler late occurring (\> 4 weeks and \<2 years) nodules are associated with bacterial contamination (independent of filler type) and to characterize the histological response.


Eligibility criteria: Inclusion Criteria:

* Have only received HA fillers (no limitation on the brand(s)/product(s) of HA filler used; multiple product use is allowed).
* Present with an unresolved nodule (inflammatory or non-inflammatory) which was first observed \> 4 weeks and \> 2 years after most recent HA filler treatment and is determined to be greater than 3 millimeters (mm) in diameter by palpation

Exclusion Criteria:

* Have received non-HA fillers (e.g. polyacrylamide, calcium hydroxyapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene, collagen) including mixes with HA fillers anywhere in the face.
* Are currently enrolled in a dermal filler clinical trial or previously enrolled in a dermal filler clinical trial with randomized treatment in which the type of dermal filler is unknown (i.e. non-HA filler arm of study).
* Have history of keloid or hypertrophic scarring
* Have received intralesional intervention for the nodule (e.g. hyaluronidase, corticosteroids, antibiotics, 5-fluorouracil).
* Are pregnant

Primary outcomes:
measure: Histological Sampling
timeFrame: 12 Weeks
measure: Microbiological Sampling
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: West Hollywood
country: United States
facility: Skin Care and Laser Physicians (SCLP) of Beverly Hills
state: California
city: New York
country: United States
facility: Assure Surgical, P.C.
state: New York
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01237002: Pringle Time Exceeding 120 Min in Liver Resection
Official title: Safety of Intermittent Pringle Maneuver Cumulative Time Exceeding 120 Min in Liver Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tolerance of the Liver
Keywords: Liver ischemia; Pringle time
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 189
Sex: ALL
Minimum age (years): 29
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Among 426 consecutive patients who underwent hepatectomy, we retrospectively selected 189 patients with clamping time exceeded 60 minutes: 117 having intermittent Pringle maneuver less 120 minutes and 72 having clamping time exceeding 120 minutes were analysed.

Brief summary: Intermittent Pringle's maneuver is widely used to limit blood loss during hepatectomy, without an established time-limit. However, many authors claims its danger for patients' outcome. The investigators check the short term outcome of a consecutive cohort of patients who underwent hepatectomy with intermittent clamping exceeding 120 minutes.


Eligibility criteria: Inclusion Criteria:

* patients in whom total cumulative clamping time exceeded 60 minutes.

Exclusion Criteria:

* patients in whom total cumulative clamping time was less than 60 minutes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
state: Milan
Study officials:
affiliation: IRCCS Istituto Clinico Humanitas
name: Guido Torzilli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belghiti J, Noun R, Malafosse R, Jagot P, Sauvanet A, Pierangeli F, Marty J, Farges O. Continuous versus intermittent portal triad clamping for liver resection: a controlled study. Ann Surg. 1999 Mar;229(3):369-75. doi: 10.1097/00000658-199903000-00010.
citation: Elias D, Desruennes E, Lasser P. Prolonged intermittent clamping of the portal triad during hepatectomy. Br J Surg. 1991 Jan;78(1):42-4. doi: 10.1002/bjs.1800780115.
citation: Torzilli G, Procopio F, Donadon M, Del Fabbro D, Cimino M, Montorsi M. Safety of intermittent Pringle maneuver cumulative time exceeding 120 minutes in liver resection: a further step in favor of the "radical but conservative" policy. Ann Surg. 2012 Feb;255(2):270-80. doi: 10.1097/SLA.0b013e318232b375.
Clinical trial NCT00357721: Atazanavir Twice Daily
Official title: Randomized, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics of Atazanavir Administered Twice-Daily in Health Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Protease Inhibitor
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-07-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg, given once daily.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects between the ages of 18 to 45 years old with a BMI of 18 to 30 kg/m2

Primary outcomes:
measure: Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily.
Secondary outcomes:
measure: Assess the dose proportionality and the diurnal variation in the PK of atazanavir given BID
measure: Assess the effect of atazanavir BID on bilirubin values and explore the relationship between bilirubin and atazanavir dose level/exposure by UGT1A1 genetic isoform
measure: Assess the effect of atazanavir BID on metabolic parameters
measure: Assess the safety and tolerability of atazanavir when administered BID
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06927921: Assessement of the Knoweldge ,Attitudes,Practices of Diabetic Kidney Disease Among Diabetic Patients
Official title: Assessemnt of the Knoweldge ,Attitudes and Practices of Diabetic Kidney Disease Among Diabetic Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetic Nephropathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Across sectional study take anumber of diabetic patients either type 1or 2DM with age above 18yrs old to evaluate the level of knoweldge,attitudes and practices of diabetic kidney disease.

Brief summary: This research aims to evaluate the levels of knowledge , attitudes and practices, of diabetic kidney disease among diabetic patients.

Detailed description: Diabetic kidney disease is defined as patients with diabetes mellitus who have persistent proteinuria for at least three consecutive measurements per year, or a decrease in GFR (\<90 ml/min/1.73m²) .Diabetic kidney disease is a severe microvascular complication frequently associated with both type 1 and type 2 diabetes mellitus, is a leading cause of renal failure. The condition can also lead to accelerated cardiovascular disease and macrovascular complications.

In Egypt, DM is a dilemma and a fast-expanding concern. According to the International Diabetes Federation (IDF), the prevalence of DM among Egyptian adults is 15.2%, which may be an underestimation.Public awareness, knowledge, and preventive practices are crucial in mitigating the onset and progression of diabetic nephropathy. Gaining insights into the general population's awareness, knowledge, attitudes, and practices (A-KAP) pertaining to this condition is crucial for the development of effective educational campaigns and preventative strategies.

Eligibility criteria: Inclusion Criteria:

* • Diabetic patients (either type 1or 2 DM ) with age above 18yrs old.

Exclusion Criteria:

* • CKD patients due to cause other than diabetes.

  * Patients who refuse participation in the study.

Primary outcomes:
measure: evaluation of the knowledge, attitude and practice of chronic kidney disease among the diabetic patients through a questionnaire
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit university
country: Egypt
facility: Assuit university
city: Assuit
country: Egypt
facility: Assuit university
Study officials:
affiliation: Assiut University
name: Salah Abdelazeem Ahmed Seleem, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kato M, Natarajan R. Diabetic nephropathy--emerging epigenetic mechanisms. Nat Rev Nephrol. 2014 Sep;10(9):517-30. doi: 10.1038/nrneph.2014.116. Epub 2014 Jul 8.
Clinical trial NCT00395421: Study to Evaluate Drug-drug Interaction Between Valopicitabine and Ribavirin
Official title: A Partially-blinded, Randomized, Parallel-group Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between Valopicitabine and Ribavirin When Administered in Combination With Pegylated Interferon Alfa-2a in Treatment-naive Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: treatment-naive
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Novartis Pharmaceuticals
First posted: 2006-11-02
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to see if the investigational medication, valopicitabine, is safe to use in combination with ribavirin, a drug approved by the FDA for treating hepatitis C infection.


Eligibility criteria: Inclusion Criteria:

* Documented clinical history compatible with chronic hepatitis C and compensated liver disease
* Has not previously received anti-viral therapy for hepatitis C infection

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient is co-infected with hepatitis B virus and/or HIV

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
state: Georgia
city: Fairfax
country: United States
state: Virginia
Study officials:
References:
Clinical trial NCT05955521: Exosome as the Prognostic and Predictive Biomarker in EBC Patients
Official title: Development of a Prognostic and Predictive Biomarker for Locally Advanced Breast Cancer Patients Treated With Neoadjuvant Chemotherapy Using Exosome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Triple Negative Breast Cancer
HER2-positive Breast Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study is the experimental study for serial ctDNA and exosome evaluation in EBC patients


Eligibility criteria: Inclusion Criteria:

* Early breast cancer
* Planned neoadjuvant chemotherapy
* Triple negative breast cancer or HER2-positive breast cancer

Exclusion Criteria:

* Stage IV breast cancer
* Hormone receptor positive breast cancer

Primary outcomes:
measure: Prognostic biomarker for EBC
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ji-Yeon Kim
Study officials:
References:
Clinical trial NCT00659321: Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome
Official title: Placebokontrollierte Untersuchung Zur Wirkung Von Nikotinsäure Auf Die Dyslipidämie Bei Metabolischem Syndrom Und Das Arterioskleroserisiko (Placebo Controlled Investigation of Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome and the Risk of Atherosclerosis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolic Syndrome
Dyslipidaemia
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
Collaborators: name: Technische Universität Dresden
name: University of Regensburg
First posted: 2008-04-16
Enrollment: 68
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome. Nicotine acid decreases postprandial hyperlipidaemia in patients with metabolic syndrome which reduces the low-grade inflammation and the risk of atherosclerosis.


Eligibility criteria: Inclusion Criteria:

* dyslipidemia (triglycerides \>= 150 mg/dl and/or decreased levels of HDL-cholesterol \<40 mg/dl in men or \< 50 mg/dl in women)
* further components of the metabolic syndrome: Hypertension: blood pressure \>= 130/85 mmHg or/and Hyperglycemia: fasting plasma glucose \>= 100 mg/dl or/and 2 hour plasma glucose after 75g glucose load (OGTT) \>= 140 mg/dl or/and Obesity: waist circumferences \> 102 cm in men or \>88 cm in women

Exclusion Criteria:

* Contraindication and incompatibility of nicotine acid
* Patients with ulcus ventriculi or ulcus duodeni
* Intake of lipid lowering drugs \< 6 weeks before randomization
* therapy of type 2 diabetes with insulin, glitazones, acarbose or more than one antidiabetic drug (only mono-therapy with metformin or sulfonyl urea is permit) - no acceptable therapy of diabetes with levels of HbA1C\>=8.0%
* cardiovascular events in the last 6 months
* chronic inflammatory diseases (lupus erythematodes, arthritis, morbus Crohn or colitis ulcerosa)
* ALAT elevation 2.5 times more than the normal limit
* pregnancy

Primary outcomes:
measure: Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome
timeFrame: after 16 weeks treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: GWT-TUD GmbH, Centre for Clinical Studies
Study officials:
affiliation: GWT-TUD GmbH
name: Markolf Hanefeld, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00232921: The Effect of Caudal Volumes on the Anatomical Spread of Caudals in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asa 1 and 2 Patients for Elective Surgery Requiring Caudal as Part of Their Care
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2005-10-05
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Radiological study into the anatomical spread of caudal local anaesthetic in children age 1-7


Eligibility criteria: Inclusion Criteria:

* Asa 1 and 2 patients

Exclusion Criteria:

-

Primary outcomes:
measure: The radiographic height of the block post injection
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
Study officials:
affiliation: Great Ormond Street Hospital
name: Mark Thomas, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01540721: Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol® Extend
Official title: A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Different Sustained Released Paracetamol Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: paracetamol
pharmacokinetics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-02-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study will evaluate the pharmacokinetic profiles of experimental formulations of paracetamol.


Eligibility criteria: Inclusion Criteria:

* Good health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination

Exclusion Criteria:

* Current (within 14 days of screening) or regular use of any prescription, over the counter (OTC) drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism, excluding prescription birth control, if applicable.

Primary outcomes:
measure: Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state
timeFrame: baseline to 12 hours
measure: Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax
timeFrame: baseline to 12 hours
Secondary outcomes:
measure: To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC)
timeFrame: baseline to 12 hours
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: MDS Pharma Services NEBRASKA
state: Nebraska
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05739721: ZOOM First Impressions
Official title: Effects of Video Conferencing on First Impressions and Attractiveness
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Attractiveness
Self Esteem
First Impressions
Lead sponsor: DeNova Research
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Participants (random) will have a conversation with each other over zoom initially with their cameras off and then rate each other on attractiveness, first impressions, and self-esteem. Then both participants will turn their cameras back on and have another conversion and then again rate each other. The ratings are confidential and will not be shared with the other person.

Two months later the participants will come to the study clinic office and have an in-person conversation with someone new and rate each other.


Eligibility criteria: Inclusion Criteria:

1. Males and females of ages 21-39.
2. Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit.
3. Subjects must all be able to speak English fluently.
4. Subjects must have access to video camera technology.
5. Fully Vaccinated against covid-19

Exclusion Criteria:

1. Participants younger than 21 or older than 40 will not be included.
2. Subjects who are pregnant or nursing.
3. Imprisoned populations.
4. Subjects who are unable to travel to the clinic.
5. Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required virtual session and follow-up visit will also be excluded.
6. Any subject that is not fully vaccinated against covid-19

Primary outcomes:
measure: First Impressions
timeFrame: 8 weeks
measure: Trustworthiness scale
timeFrame: 8 weeks
measure: Overall Attractiveness
timeFrame: 8 weeks
Secondary outcomes:
measure: Self-Esteem
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
References:
Clinical trial NCT06567821: Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy
Official title: Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Chronic Maxillary Rhinosinusitis
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective randomized single blinded study. A block randomization will be performed to randomize each candidate to determine which side will receive a balloon sinusotomy without navigation and which side will receive balloon sinusotomy with the assistance of navigation. Each person has a set of sinuses on the right side and a set of sinuses on the left side. One side will be randomized to the balloon dilation with navigation while the other side will be performed with balloon dilation without navigation.
Primary purpose: OTHER

Brief summary: The purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis.

Detailed description: The purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis. Adult patients (18 and over) with a confirmed diagnosis of chronic maxillary rhinosinusitis without nasal polyposis (CRSwNP) will undergo maxillary balloon sinusotomy. Block randomization will be performed to determine which side will receive balloon sinusotomy with navigation and which will have balloon sinusotomy using traditional anatomic landmarks. Participants will be followed for approximately 1 month post-procedure for a total study participation time of approximately 3 months.

Eligibility criteria: Inclusion Criteria:

* Adults 18 years of age or older
* Candidate for primary endoscopic sinus surgery (ESS) for chronic maxillary rhinosinusitis without nasal polyposis (CRSwNP)
* Failed medical (non-surgical) therapy

Exclusion Criteria:

* History of previous sinus surgery
* Presence of nasal polyps
* Extensive sinonasal osteogeneis
* Cystic fibrosis
* Presence of sinonasal tumors
* Any records flagged "break the glass" or "research opt out."
* Any additional finding which in the opinion of the investigator precludes patient from participating in the study

Primary outcomes:
measure: Success Rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
Study officials:
References: