louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06570265: RES-SAFE (Resorption, Safety, and Efficacy of Absorbable Collagen Membrane)
Official title: Evaluation of Resorption, Safety, and Efficacy of Absorbable Collagen Membrane in Preventing Significant Bone Loss Following GBR (Guided Bone Regeneration) Procedure.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Guided Bone Regeneration
Lead sponsor: Hyundai Bioland Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 50
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: The clinical study aims to assess the long-term safety and efficacy of the interventional medical device. The clinical study will enrol up to 50 patients aged 18 years and older, who meet specific inclusion and exclusion criteria designed to ensure patient safety and reliable data collection.


Eligibility criteria: Inclusion Criteria (among others):

* Patients over 18 years old (both sex) with full legal capacity who understand the treatment and sign the informed consent and who are medically healthy, except treated condition.

Exclusion Criteria (among others):

* Patients with dental diseases or conditions (except treated condition);
* Patients with unsatisfactory oral hygiene;
* Patients with alcohol, substance abuse, smoking habits, known allergy to collagen;
* Patients with severe or chronic diseases or with systemic inflammation and all patients classified as unhealthy;
* Pregnant or breast feeding women.

Primary outcomes:
measure: Assessment of collagen membrane's - efficacy and safety.
timeFrame: 6 months after intervention
Secondary outcomes:
measure: Complication rate
timeFrame: 7 days and 6 months after intervention
measure: Change in bone dimensions
timeFrame: Baseline, 6 and 12 months after intervention
measure: VAS scale
timeFrame: On the day of intervention and after 1, 2, 3 days. Satisfaction - on the day of intervention.
measure: Assessment of collagen membrane's - safety.
timeFrame: From the beginning till the end.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00839865: Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer
Official title: Phase 1 Study of Herb Yuyang Ointment That Expressed Good Effect in Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetic Foot Ulcer
Keywords: Evidence-based evaluation
Multi-center randomized controlled clinical trials
Traditional Chinese Medicine
therapy
diabetic foot ulcer
clinical trails
Lead sponsor: Guiyang No.1 People's Hospital
Sponsor class: OTHER
Collaborators: name: Beijing University of Chinese Medicine
name: Third Military Medical University
First posted: 2009-02-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
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 determine if dressing change with a kind of herb Yuyang ointment is clinically more efficacious and safer than Conventional treatment in the treatment of diabetic foot ulcers.

Detailed description: 1. Developing a Document Retrieval strategy for clinical trials of Chinese medicine treatment of diabetic foot ulcer according to the research program(finished)
2. Selecting and Evaluating the above trials,developing a methodological quality evaluation criteria(finished)
3. extract information, verification, meta-analysis, sensitivity analysis and sub-group analysis(finished)
4. comprehensive evaluating the pros and cons evidences of traditional Chinese medicine, acupuncture and Chinese and Western combined medicine with the treatment of diabetic foot of (finished)
5. we find dress change with a certain kind of herb ointment is very effective and safe to diabetic foot ulcers.The following step is randomized controlled multicenter clinical trial to verify it's efficacy and safety

Eligibility criteria: Inclusion Criteria:

* In-patient or out-patient patients diagnosed with diabetic foot ulcers
* Gangrene or ulceration occurred more than 3 weeks
* Over 18 years of age
* Gender-open
* The type of diabetes (type 1 or type 2) open
* Patients receive a written informed consent to participate in the trial

Exclusion Criteria:

* Serious complications of heart, liver, lung, kidney damage
* Malignant tumors
* Allergy for Chinese medicine used
* Pregnant women and breast-feeding women

Primary outcomes:
measure: The primary objective is to determine the effect of this ointment on the incidence of complete wound closure.
timeFrame: 6 months
Secondary outcomes:
measure: Secondary objectives include: evaluating the acceleration of ulcer closure or facilitation of surgical closure, reduction of ulcer surface area over time, reduction in complications, the quality of life and it's safety.
timeFrame: 6 months
Other outcomes:
Locations:
city: Guiyang
country: China
facility: endocrinology unit,No.1 people's hospital of Guiyang City
state: Guizhou
Study officials:
name: Li Shufa, doctor
role: STUDY_CHAIR
References:
citation: Leung PC, Wong MW, Wong WC. Limb salvage in extensive diabetic foot ulceration: an extended study using a herbal supplement. Hong Kong Med J. 2008 Feb;14(1):29-33.
Clinical trial NCT05118165: Influence of Preoperative Nutritional Status on Perioperative Period in Cardiac Surgery in Patients With Frailty
Official title: Influence of Optimization of Preoperative Nutritional Status on Perioperative Period in Cardiac Surgery in Patients With Frailty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malnutrition; Protein
Frail Elderly Syndrome
Keywords: preoperative malnutrition
frailty
cardiac surgery
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 176
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to determine whether the optimisation of the preoperative nutritional status affects the course of the perioperative period in patients with frailty.

Subjects: Patients 65 and over years of age with frailty or risk of it, with suboptimal nutritional status who are prescribed to elective cardiac surgery .

Research methods: Edmonton Crispness Scale, a Mini Nutritional Assessment (MNA-SF) test will be used to select subjects. Body composition will be examined by bioelectrical impedance analysis (BIA) to determine the degree of phase angle. Changes in laboratory blood tests will be recorded and evaluated The subjects randomly will be divided into control and study groups.

The diet of the patients in the study group will be optimised by protein supplements before elective heart surgery.

The benefits of optimising nutritional status will be evaluated comparing laboratory blood tests, changes in organ function, adverse outcomes, the need for vasoactive drugs, artificial lung ventilation time and length of hospitalisation between the groups.


Eligibility criteria: Inclusion Criteria:

* Patients 65 years of age and older.
* Patients for whom cardiac surgery will be performed on a scheduled basis.
* Patients able to move without the help of others except for an aid: a stick, a walker.
* Patients who speak and understand Lithuanian perfectly.
* Patients who have read the informed consent form and confirmed their consent to participate in the study in writing.

Exclusion Criteria:

* Patiens younger than 65 years.
* No written consent of a person to participate in a biomedical research has been obtained;
* Patients with a history of mental illness or central nervous system disorders that interfere with the perception and proper assessment of their health and the meaning and content of the questionnaire / tasks.
* Patients with amputated lower extremities.
* Patients with hepatic insufficiency, one or more of viral hepatitis.
* It is not possible to perform a qualitative physical examination for other reasons (hearing, vision, etc.)
* Allergy to B vitamins.

Primary outcomes:
measure: Postoperative outcomes
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03939065: Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management
Official title: Sensor Augmented Pump (SAP) Therapy for Inpatient Cystic Fibrosis Related Diabetes (CFRD) Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cystic Fibrosis-related Diabetes
Cystic Fibrosis Pulmonary Exacerbation
Cystic Fibrosis in Children
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2019-05-06
Enrollment: 1
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research proposes a pilot study using the combination of continuous glucose monitor (CGM) and insulin pump therapy, also known as sensor augmented pump (SAP) therapy, for cystic fibrosis related diabetes (CFRD) management in the inpatient setting, with the aim of improving glycemic control.


Eligibility criteria: Inclusion Criteria:

1. Age ≥8 years
2. Confirmed diagnosis of CF by consensus guidelines \[50\]
3. Diagnosis of CFRD based on American Diabetes Association and CFF criteria \[51\]
4. Admission for pulmonary exacerbation

Exclusion Criteria:

1. Known type 1 or type 2 diabetes, monogenic diabetes (MODY)
2. Critical illness requiring admission to the intensive care unit
3. Admission for indications other than pulmonary exacerbation (ex. Distal intestinal obstructive syndrome, surgery)
4. Pregnancy

Primary outcomes:
measure: Differences in CGM percent time over 140 mg/dl
timeFrame: through study completion, up to 3 weeks
Secondary outcomes:
measure: Change in Pulmonary Function
timeFrame: baseline and 1 week
measure: Circulatory markers of inflammation
timeFrame: baseline and 1 week
measure: Weight change
timeFrame: baseline and 1 week
measure: Statstrip glucose
timeFrame: through study completion, up to 3 weeks
Other outcomes:
measure: beta-cell function
timeFrame: within 24 hours of admission
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado, University of Colorado Denver
state: Colorado
Study officials:
affiliation: christinel.chan@childrenscolorado.org
name: Christine Chan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toner A, McCloy A, Dyce P, Nazareth D, Frost F. Continuous glucose monitoring systems for monitoring cystic fibrosis-related diabetes. Cochrane Database Syst Rev. 2021 Nov 29;11(11):CD013755. doi: 10.1002/14651858.CD013755.pub2.
Clinical trial NCT02134665: Unexpected Pharmacokinetics of Vancomycin in Patients With Severe Acute Pancreatitis Compared With Pneumonia
Official title: Unexpected Pharmacokinetics of Vancomycin in Patients With Severe Acute Pancreatitis Compared With Pneumonia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arbitrary Restriction Polymorphism 1
Keywords: Vancomycin
severe acute pancreatitis
Creatinine clearance
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who used vancomycin and who had diagnosed as severe acute pancreatitis (SAP group), and patients who had diagnosed as pneumonia (pneumonia group) . meanwhile, the fluorescence polarization immunoassay method was used to measure vancomycin serum trough concentrations in these patients 30 min before the next administration.

Brief summary: The purpose of this study was to evaluate the influence of severe acute pancreatitis on the serum level of vancomycin, a glycopeptide antibacterial agent.

Detailed description: The purpose of this study was to evaluate the influence of severe acute pancreatitis on the serum level of vancomycin, a glycopeptide antibacterial agent.

After reviewing more than 6000 clinical charts of patients who received vancomycin therapy and whose serum vancomycin level was monitored between January 2010 and December 2013, we identified 212 patients who also had diagnosed as severe acute pancreatitis (SAP group), and 98 patients who also had diagnosed as pneumonia (pneumonia group) at that time. The fluorescence polarization immunoassay method was used to measure vancomycin serum trough concentrations in these patients 30 min before the next administration. Using these measurements, we calculated the pharmacokinetic parameters using the Bayesian estimator.

Eligibility criteria: Inclusion Criteria:

* age 18-85years old
* vancomycin use ≥ 3days

Exclusion Criteria:

* age \<18years old or \>85 years old
* vancomycin use \< 3days

Primary outcomes:
measure: vancomycin serum trough concentrations in these patients just prior to the next vancomycin serum trough concentrations was measured
timeFrame: patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes:
measure: the pharmacokinetic parameters was calculated using the Bayesian estimator.
timeFrame: patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Wan-Hua Yang, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04752865: Effects of Cytotoxic Chemotherapy and PARP Inhibition on the Genomic Contexture of Ovarian Cancer
Official title: Effects of Cytotoxic Chemotherapy and PARP Inhibition on the Genomic Contexture of Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women with ovarian cancer eligible for neoadjuvant chemotherapy. The investigators examined changes in tissue molecular profile. The investigators examine tissue molecular profile at diagnosis and after the end of neoadjuvant chemotherapy

Brief summary: EFFECTS OF CYTOTOXIC CHEMOTHERAPY AND PARP INHIBITION ON THE GENOMIC CONTEXTURE OF OVARIAN CANCER: TR_NACT_OV/17 In order to approach the above open questions, ultimately aiming in understanding the effects of cancer drugs on tumor biology and hence in selecting the proper drugs for the patients in the context of Precision Medicine, the objective of this study is to study the genomic characteristics of ovarian tumors before and after treatment with classic neoadjuvant chemotherapy (NACT) and with the more recently approved PARP inhibitor olaparib.


Eligibility criteria: Inclusion Criteria:

* ovarian cancer eligible for neoadjuvant chemotherapy

Exclusion Criteria:

-

Primary outcomes:
measure: assesment of genomic characteristics of ovarian tumors at the diagnosis
timeFrame: 4 years
measure: assesment of genomic characteristics of ovarian tumors after treatment with neoadjuvant platinum-based chemotherapy
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Adamantia Nikolaidi
Study officials:
affiliation: HECOG
name: Adamantia Nikolaidi
role: STUDY_CHAIR
References:
Clinical trial NCT01545765: Anesthetic Effect Duration Assessment
Official title: Anesthetic Effect Duration Produced by Lidocaine 7% + Tetracaine 7% Cream on 2 Different Body Areas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the duration of anesthetic effect produced , Lidocaine7% + Tetracaine 7% cream when applied with 2 different application times on the face and thigh.

Detailed description: Subjects will have 4 target zones defined; 2 on the face and 2 on the anterior thighs. Upon inclusion into the study, subjects will have the study drug applied with a different application time to one side of the face and anterior thigh according to the randomization. After the completion of the application process, study drug on both sides of the face and on both anterior thighs will be removed by peeling.

After drug removal, the duration of anesthetic effect of the study drug will be tested using a pinprick test. Five (5) pinpricks using a 21-gauge needle will be performed at the 4 target zones (each side of the face and both anterior thighs). The pinprick test will be repeated up to 8 hours after drug removal. There will be a total of 20 post drug removal pinprick test completed.

Eligibility criteria: Inclusion Criteria:

* Healthy male of female subjects aged 18 or older with a normal not excessive hairy skin,

Exclusion Criteria:

* Female subjects who are pregnant or breast-feeding; or plan to become pregnant,
* Subjects who have a known allergy to one of the components of the test drug lidocaine, tetracaine or other local anesthetics,
* Subjects who are at risk in terms of precautions, warnings, and contra-indication with the study product.

Primary outcomes:
measure: Duration of Anesthesia(Minutes)
timeFrame: From T0 (product removal) up to T8 hours after product removal
Secondary outcomes:
measure: Adverse Events
timeFrame: During the study
Other outcomes:
Locations:
city: Rochelle Park
country: United States
facility: Galderma Investigational center
state: New Jersey
Study officials:
affiliation: Galderma investigational center
name: Regina YAVEL, MD- Dermatologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00833365: Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure
Official title: Early vs. Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure and Pain/Stress Reduction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patent Ductus Arteriosus
Prematurity
Keywords: premature infants
PDA
ibuprofen
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2009-02-02
Enrollment: 15
Sex: ALL
Maximum age (years): 96
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of Ibu. Early use is defined as medication given before the infant reaches 96 hrs old. Late use is defined as medication given when infant is more than 96 hrs old.

Detailed description: Infants with birth weight at \<1200gm and/or \<28 weeks gestation who have been diagnosed with a Patent Ductus Arteriosus (PDA) qualify for the study if there are no contraindications to treatment. Infants are randomized into treatment arms of \<96 hrs old and \>96 hrs old. Ibuprofen is given in the dosage of 10 mg/kg on initial dose, followed 24 hours later by 5 mg/kg dose and then 24 hours later another dose of 5 mg/kg. An echocardiogram will be done prior to treatment and then within 48 hours after treatment.

Eligibility criteria: Inclusion Criteria:

* Birth weight less than 1200gm
* Less than 28 weeks gestational age
* Confirmed Patent Ductus Arteriosus (PDA) via echocardiogram and clinical exam

Exclusion Criteria:

* Active Bleeding
* Currently being treated for Persistent Pulmonary Hypertension (PPHN)
* Cardiac anomalies
* Chromosomal abnormalities
* Endocrine, metabolic, renal, or hepatic disorders

Primary outcomes:
measure: Number of PDA Closures Related to Treatment With Ibuprofen
timeFrame: Within 48 hrs of ibuprofen round
Secondary outcomes:
measure: Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration
timeFrame: 1 and 6 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Gary Chan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04924465: Evaluation of Interstitial Lung Disease Severity in Patients With Antisynthetase Syndrome According to Specific Autoantibodies Profile
Official title: Evaluation of Interstitial Lung Disease Severity in Patients With Antisynthetase Syndrome According to Specific Antisynthetase Antibodies Types
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antisynthetase Syndrome
Keywords: Interstitial lung disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with antisynthetase syndrome

Brief summary: Antisynthetase syndrome (ASS) is an overlap connective tissue disease characterized by the presence of myositis-specific autoantibodies directed against tRNA-synthetases. Clinical manifestations are myositis, interstitial lung disease (ILD), Raynaud's phenomenon, mechanic's hands and polyarthritis. Clinical presentation varies between ASS patients. ASS is potentially life threatening due to lung involvement, especially in rapidly progressive forms. Anti-histidyl-tRNA synthetase (anti-Jo1) antibodies are the most frequently detected antibodies in ASS (60 % of patients). Anti-threonyl-tRNA synthetase (anti-PL7) and alanyl-tRNA synthetase (anti-PL12) antibodies are each detected in 10 % of patients approximatively. Anti-tRNA-synthetases antibodies are mutually exclusive.

Clinical heterogeneity of ASS patients appears to be associated with specific autoantibodies profile. Patients with anti-Jo1 antibodies have a more systemic presentation (especially with muscle involvement), whereas patients with anti-PL7 or anti-PL12 antibodies have more frequent and isolated ILD. If anti-PL7 and anti-PL12 antibodies are associated with more severe ILD and poorer survival is still matter of debate.

Aims of this study were to compare ILD severity at diagnosis and clinical course in patients with ASS according to antisynthetase autoantibodies types.


Eligibility criteria: Inclusion Criteria:

* Patients with antisynthetase syndrome according to Connors criteria

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of patients of rapidly progressive (RP)- ILD
timeFrame: 3 months
measure: Number of patients with severe ILD
timeFrame: Baseline
Secondary outcomes:
measure: Number of patients with ILD relapse
timeFrame: 3 years and 5 years
measure: Number of patients with chronic respiratory failure
timeFrame: 3 years and 5 years
measure: Rate of patients without death or lung transplant
timeFrame: 3 years and 5 years
Other outcomes:
Locations:
Study officials:
References: