louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01895374: Clinical Efficacy of Bovine Freeze-dried Amniotic Membrane on Wound Healing in Laser Treatment
Official title: A Comparison of the Effects of Bovine Freeze-dried Amniotic Membrane and Hydrocolloid on Epithelialization After Laser Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biological Dressings
Keywords: Laser therapy
Biological dressing
Amniotic membrane
Hydrocolloid bandages
wound healing
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bovine amniotic membrane may show better efficacy than hydrocolloid dressing.

Detailed description: Bovine amniotic membrane as a biological dressing can be applicable to wound after laser treatments. Comparing with hydrocolloid dressing material, which is the most widely used after laser treatment now, amniotic membrane will show better efficacy. Thus, with amniotic membrane, epithelization time will shorten and redness which is usually left after laser will disappear quickly.

Eligibility criteria: Inclusion Criteria:

* Skin lesions treatable by ablative lasers
* More than two skin lesions of similar size at the same area
* Available during the study period (2 weeks)

Exclusion Criteria:

* Taking steroid or nonsteroidal antiinflammatory drug, isotretinoin
* underlying diabetes mellitus, keloid or any malignancy

Primary outcomes:
measure: Epithelization time
timeFrame: 2 weeks
Secondary outcomes:
measure: Epithelization Scale
timeFrame: 2 weeks
measure: Photometric measurements
timeFrame: 2 weeks
measure: Vancouver scar scale
timeFrame: 2 weeks
measure: Assessment by subjects
timeFrame: 2 weeks
measure: measurements of adverse effects
timeFrame: 2 weeks
measure: histopathologic analysis
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Dermatology, Seoul National University College of Medicine
Study officials:
affiliation: Department of Dermatology, Seoul National University College of Medicine
name: Dae Hun Suh, PhD
role: STUDY_CHAIR
affiliation: Department of Dermatology, Seoul National University College of Medicine
name: Seonguk Min, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh R, Chacharkar MP. Dried gamma-irradiated amniotic membrane as dressing in burn wound care. J Tissue Viability. 2011 May;20(2):49-54. doi: 10.1016/j.jtv.2010.06.001. Epub 2010 Jul 8.
Clinical trial NCT01272674: Adiponectin and Circulating Progenitor Cells (CPC) Function
Official title: Adiponectin Promotes the Migration of Circulating Progenitor Cells Through p38-mediated Induction of the CXCR4 Receptor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Artery Disease
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: Heart Center Leipzig - University Hospital
First posted: 2011-01-10
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Adiponectin and exercise training contribute to the maintenance of a normal vascular tone by influencing vascular NO bioavailability and concentration and function of endothelial progenitor cells. The molecular mechanisms are only partially understood. Therefore, aim of the present study is to elucidate the effects of Adiponectin on endothelial progenitor cell migration and the underlying signaling pathways. Furthermore, the impact of exercise training on adiponectin-mediated endothelial progenitor cell migration will be investigated.


Eligibility criteria: Inclusion Criteria:

* ≤ 75 years of age
* stable coronary artery disease
* preserved left ventricular function
* physical work capacity of ≥ 50
* successful elective percutaneous coronary intervention at study begin

Exclusion Criteria:

* diabetes mellitus
* hypercholesterolemia
* untreated hypertension
* smoking
* myocardial infarction within the last 4 weeks
* significant stenosis of the left main coronary artery

Primary outcomes:
measure: migratory capacity of endothelial progenitor cells towards an SDF-1 gradient
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig, Heart Center
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Axel Linke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04466774: A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
Official title: A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urine Detectable Acute and Chronic Diseases
Lead sponsor: Healthy.io Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-10
Enrollment: 429
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Dip Home-Based Dipstick Analyzer (henceforth HBDA) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance, including providing a urine sample and scanning the urine strip after placing it on the Color-Board.

The user will also complete a questionnaire to collect information regarding the use of the HBDA device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device. The use of the HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Men and women 18-80 years of age
* Subjects who are healthy or pregnant; or
* Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite
* Subject is capable and willing to provide informed consent.
* Subject has facility with both hands.
* Subject is capable and willing to adhere to the study procedures

Primary outcomes:
measure: Evaluation of the % agreement of the Dip HBDA, tested by the lay user, as compared to a comparator device, tested by a professional user.
timeFrame: 11 months
Secondary outcomes:
measure: Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions.
timeFrame: 11 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Methuen
country: United States
facility: Activmed Practices & Research, Inc.
state: Massachusetts
city: Garden City
country: United States
facility: AccuMed research associates
state: New York
Study officials:
References:
Clinical trial NCT00366574: Comparison of a Laser Keratome to a Mechanical Microkeratome
Official title: Comparison of INTRALASE® to AMADEUS™ Microkeratome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Myopic Astigmatism
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2006-08-21
Enrollment: 20
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 was to evaluate the performance of the INTRALASE®, a laser keratome which creates a corneal flap, and compare it to a mechanical microkeratome (Amadeus™). Our hypothesis is that there is no difference between the 2 devices.


Eligibility criteria: Inclusion Criteria:

* Candidate for bilateral wavefront-guided LASIK
* Myopia up to -7.00 D
* Astigmatism of 0.00 to -1.50 D

Exclusion Criteria:

* History of ocular pathology
* Previous ocular surgery
* Very large pupils (greater than 8mm diameter, infrared measurement)
* Thin corneas (preoperatively calculated minimal residual bed \< 250 um)
* Irregular astigmatism
* Asymmetric astigmatism
* Unstable refraction
* Any other criteria that precludes subject to undergo LASIK

Primary outcomes:
measure: Visual acuity
measure: Contrast sensitivity
measure: Induction of high order aberration
measure: Corneal sensation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Kerry D. Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03534674: Vitamin D3 Supplementation for AlloHSCT-RCT
Official title: Validating a Vitamin D3 Supplementation Regimen Among Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitamin D Deficiency
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 84
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: This study is to assess whether a single oral loading dose of 100,000 IU vitamin D3 prior to allogeneic hematopoietic stem cell transplant (aHSCT) can achieve optimal 25 hydroxy-vitamin D3(25-OH-D3) levels (\>75nmol/L) at one month post aHSCT, and maintain adequate levels for at least three months, compared to our standard practice of 2000 IU vitamin D3 daily. 25-OH-D3 levels will be measured prior to vitamin D3 supplementation, and 30 as well as 100 days post vitamin D supplementation. We hypothesize that the intervention will prevent vitamin D insufficiency or deficiency in aHSCT recipients, therefore benefit aHSCT-associated morbidity, including osteoporosis.

Detailed description: This is a randomized non-blinded single centre prospective clinical trial designed to validate whether a single oral loading dose of 100,000 IU vitamin D3 prior to allogeneic hematopoietic stem cell transplant (aHSCT) can achieve optimal 25 hydroxy-vitamin D3(25-OH-D3) levels (\>75nmol/L) at one month post aHSCT, and maintain adequate levels for at least three months, compared to our standard practice of 2000 IU vitamin D3 daily.

84 patients will be enrolled. Following completion of all baseline data collection, participants will be randomized 1:1 to the intervention group or the control group on the admission day for aHSCT

Patients in the intervention group will receive a single oral loading dose of 100,000 IU vitamin D3, with subsequent vitamin D3 2000 IU daily. Patients assigned to the control group will receive our current standard of care, 2000 IU vitamin D3 daily.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing allogeneic stem cell transplantation at the Leukemia/BMT Program of British Columbia.
2. Age greater than or equal to 18 years.
3. Able to provide written informed consent.

Exclusion Criteria:

1. Hypercalcemia, hypervitaminosis D, or allergic/ sensitive to vitamin D.
2. Not meeting eligibility criteria to proceed with allogeneic stem cell transplantation as per the Leukemia/BMT Program of BC.

Primary outcomes:
measure: To assess the efficacy of 100,000 IU vitamin D3 prior to aHSCT
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency
name: Raewyn Broady, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02870374: For a Better Interpretation of Quality of Life Scores of Kidney Transplant Patients: Determination of the Minimum Significant Change RetransQol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidneys Transplantation
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Kidneys transplanted patients

Brief summary: The project team developped and validated a French patient-based health-related quality of life instrument in kidney transplant: the QoL Retrans.

The aim of the study is to determine the minimum significant change of the valdiated tool: ReTransQol


Eligibility criteria: Inclusion Criteria:

* Patient with a transplant kidney

Exclusion Criteria:

* Patient not able to answer survey

Primary outcomes:
measure: Number of change in quality of life in kidneys transplantation patients using ReTransQol
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
affiliation: Assistance Publique Hôpitaux de Marseille
name: Stéphanie GENTILE, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04035174: Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa
Official title: Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Onchocerciasis
Loiasis
Diagnoses Disease
Neglected Diseases
Keywords: Health Public
Lead sponsor: Center for Research on Filariasis and Other Tropical Diseases, Cameroon
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Each participant will have both a LTS-2 patch applied on the skin and a skin snip performed.
Primary purpose: DIAGNOSTIC

Brief summary: This study aims at evaluating the diagnosis performances of the LTS-2 DEC patch for onchocerciasis compared to the gold standard which are the skin snips. This study will be conducted in Cameroon in two different areas : Ngog-Mapubi and Bafia Health Districts (one area only endemic for onchocerciasis, and one area endemic for both loiasis and onchocerciasis).


Eligibility criteria: Inclusion Criteria:

* All voluntary adults

Exclusion Criteria:

* General acute infection (temperature ≥ 38,5°C)
* Impaired general condition
* Ivermectin taken in the 6 last months
* Known allergies to one of the component of the patch
* Dermatological acute infection (bacterial, atopic, prurigo, or zona)

Primary outcomes:
measure: Tolerability of the patch
timeFrame: 24 hours
measure: Feasibility of the patch
timeFrame: 24 hours
Secondary outcomes:
measure: Diagnosis performances
timeFrame: 24 hours
measure: Loiasis and cross-reactivity assessment
timeFrame: 24 hours
measure: Semi-quantitative scoring of the LTS-2 DEC patch results
timeFrame: 24 hours
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: Centre de Recherche sur les filarioses et autres maladies tropicales (CRFilMT)
Study officials:
References:
Clinical trial NCT02332174: Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects
Official title: Pharmacokinetics and Tolerability of Rufinamide Following Single and Multiple Oral Doses and Effect of Food on Pharmacokinetics in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Seizures
Keywords: pharmacokinetics
food effect
sex effect
tolerability
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study was to determine the pharmacokinetic (PK) and safety profile of single and multiple doses of rufinamide. The effects of food and sex on the PK properties of rufinamide in these Chinese volunteers were also evaluated.

Detailed description: This single- and multiple-dose, randomized, open-label study was conducted in healthy Chinese subjects. In the single-dose study, volunteers were randomly assigned to 4 dose groups and received a single dose of 200, 400, 800, 1200 mg rufinamide tablets under fasted condition. An additional food effect study was performed in the 200-mg dose group by assessing changes in PK parameters after high-fat diet. In the multiple-dose study, 10 subjects were administered 200-mg rufinamide formulation twice daily for 6 consecutive days. LC-MS/MS method was applied to determine plasma concentration of rufinamide. Tolerability was assessed based on investigator inquiries, spontaneous reports, and clinical evaluations such as standard laboratory tests, vital signs, physical examinations and 12-lead electrocardiography.

Eligibility criteria: Inclusion Criteria:

* body mass index between19 and 24 kg/m2
* negative for HIV and hepatitis B
* had no clinicallyimportant findings on health tests
* thorax radiography and ECG with no abnormalities
* normal blood pressure values
* heart rate

Exclusion Criteria:

* any drug treatment within 2 weeks before starting the study
* participation in another clinical study within the previous 3 months
* alcoholism and smoking
* pregnancy
* breast-feeding
* hypocalcemia
* blood donation or participation in other clinical trials within 3 months before enrollment in the study
* sitting blood pressure \<80/50 mm Hg or \>140/100 mm Hg
* A ventricular rate \<60 beats/min or \>100 beats/min at rest

Primary outcomes:
measure: AUC
timeFrame: three days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Medical College, Huazhong University of Science and Technology
name: Weiyong Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01182974: Paracetamol Toxicity in Septic Patients
Official title: Paracetamol-induced Liver Toxicity in Septic Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Fever
Sepsis
Keywords: fever in severe sepsis
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
Collaborators: name: Hadassah Medical Organization
First posted: 2010-08-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators will examine the toxicity of therapeutic doses of paracetamol in patients in severe sepsis. Patients with fever and severe sepsis will be randomized to receive paracetamol or dypirone. The investigators will monitor blood glutathione and liver enzymes to look for potential toxicity.

Detailed description: Paracetamol is metabolized in liver using the glutathione system. This detoxification system is depressed during severe illness such as sepsis, trauma etc. The study will examine the toxicity of therapeutic doses of paracetamol in patients in severe sepsis. We believe that during sepsis, paracetamol metabolites are not fully detoxified and therefore are toxic to the patient.

Patients with fever and severe sepsis will be randomized to receive paracetamol or dypirone. The investigators will monitor blood glutathione (as a surrogate marker for liver glutathione), liver enzymes and various clinical data (such as length of hospitalization) to look for a potential toxicity.

Eligibility criteria: Inclusion Criteria:

* age\>18y
* hospitalized to int. med. dept. or ICU
* body temp\>38 and one or more from the following:

  1. pulse\>90 bpm
  2. resp. rate\>20/min or PaCO2\<32 mmHg
  3. WBC\>12000 or \<4000
* one of the following:

  1. hypotension
  2. disturbed end-organ perfusion (confusion, oliguria, lactic acidosis etc.)

Exclusion Criteria:

* acute / chronic liver disease
* acute CNS disorder
* current isoniazid treatment
* alcoholism
* active malignancy
* pregnancy
* TPN or PPN

Primary outcomes:
measure: paracetamol induced liver toxicity
timeFrame: every six months
Secondary outcomes:
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilai medical center
Study officials:
affiliation: Barziali medical center, Ashkelon
name: Albert Grinshpun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05617274: Digital Assessment of Mandibular Flexure in Full Arch Fixed Restorations
Official title: Retrospective Digital Study of Mandibular Flexure in Patients With Long-span Fixed Restorations Supported by Natural Teeth.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mandibular Flexure
Full Arch Fixed Prosthesis
Keywords: Mandibular flexure
Prosthesis Failure
Full arch restorations
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All had the entire mandibular natural dentition (6-8 abutments) splinted with a single-unit metal-ceramic (long-span fixed prosthesis). All of them suffered from different negative consequences of their one-piece fixed restorations. The retrospective collection of the patient's data was tabulated and analyzed. Nine patients were included in this study. Five males and four females, with an age range of 50-76 years were enrolled in this study.

Brief summary: Nine patients (five males and four females) were included in this study who had long-term (10-15 years) of long-span rigid mandibular fixed prostheses that may have led to radiographic changes around the supporting teeth. The treatment plans included the removal of the long-span fixed rigid prostheses followed by restoring the patients with segmented implant-supported prostheses. In order to digitally measure the mandibular flexure, reference markers were adhered to the prostheses, and intraoral scans were obtained before and after splitting the preexisting prostheses at the minimum and maximum mouth opening. The distances between the markers were measured, and mandibular flexure was calculated by subtracting the distance between the markers during the maximum mouth opening from the minimum mouth opening. An independent sample T-test was used to compare mandibular flexure before and after splitting the long-span fixed prostheses.


Eligibility criteria: Inclusion Criteria:

* full-arch mandibular single fixed prostheses that served for many years (average 12 years) opposed by natural dentition.
* Patients were free from any systemic or debilitating diseases such as bone diseases, diabetes melilites, or blood dyscrasias.

Exclusion Criteria:

* patients with healthy fixed full-arch prosthesis
* patients with segmented prosthesis
* patients with systematic debilitating diseases.
* Patients with temporomandibular joint dysfunction, maxillofacial surgeries, or mandibular trauma.

Primary outcomes:
measure: change in mandibular flexure
timeFrame: immediately after the splitting of the full arch fixed prosthesis.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Future University in Egypt
Study officials:
References: