louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04434794: Treatment of Gingival Recession Using Mesenchymal Stem Cells
Official title: Treatment of Gingival Recession Using Autologous Adipose-derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gingival Recession
Keywords: Gingival Recession
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian Medical Academy of Post-Graduate Education
First posted: 2020-06-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of patients with gingival recession by injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel

Detailed description: Treatment of patients with gingival recession by injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel (1×106cells/0.2 ml). The volume of the mixture is divided into 4 equal injections in the gingival region of one tooth (one place injection volume is 0.05 ml of mixture).

Eligibility criteria: Inclusion Criteria:

-gingival recession

Exclusion Criteria:

* pregnancy
* breast-feeding
* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
* mental disorders

Primary outcomes:
measure: number of patients cured
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study officials:
affiliation: Head of the Lab of Institute of Biophysics and Cell Engineering
name: Igor D Volotovski, Prof
role: STUDY_DIRECTOR
affiliation: Head of the Department of Prosthodontics of BMAPE
name: Sergey Rubnikovich, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT01258894: Investigation of Human Alpha-fetoprotein Genes
Official title: Investigation of Human Alpha-fetoprotein Genes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elevated or Normal Alpha-fetoprotein Patients
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-12-13
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients and their family with elevated AFP (\>20 ng/mL) and normal AFP patients being control groups.

Brief summary: Studies revealed that patients with hereditary persistence of AFP also had persistent abnormal AFP. Therefore, this study will recruit the patients and their family with elevated AFP (\>20 ng/mL) and normal AFP patients being control groups. Then, their AFP genes extracted from the blood will be analyzed.

Detailed description: Abnormal AFP elevation was usually noted in liver regeneration, HCC, nonseminomatous germ cell tumors or other malignant tumors. However, some studies revealed that patients with hereditary persistence of AFP also had persistent abnormal AFP. Therefore, we study will recruit the patients and their family with elevated AFP (\>20 ng/mL) and normal AFP patients being control groups. Then, their AFP genes extracted from the blood will be analyzed. The hypothesis of this study is that the mutation of AFP gene might be one of the causes of abnormal AFP.

Eligibility criteria: Inclusion Criteria:

* The patients and their family with elevated AFP (\>20 ng/mL) and normal AFP patients being control groups. More than 20 years old

Exclusion Criteria:

* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jin Chuan Sheu, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02636894: Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek Fold (Radial Smile Lines)
Official title: Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek Fold (Radial Smile Lines)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smile Lines
Lead sponsor: Nashville Centre for Laser and Facial Surgery
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Filler study for smile lines in cheek folds


Eligibility criteria: Inclusion Criteria:

* Male or female between 21-65 years of age
* Willing to comply with study visits and procedures
* Willingness to refrain form surgical, laser, or injectable treatments in cheek region during study

Exclusion Criteria:

* History of trauma, acne scarring, burns, or other changes to skin in treatment area
* Use of botulinum toxin in the lateral cheeks/perioral region in past 6 months
* Use of injectable fillers in the lateral cheeks/perioral within last 2 years
* History of facelift in the last year
* History of facial nerve palsy

Primary outcomes:
measure: Evaluation of the Efficacy of Restylane Silk in the Treatment of Cheek folds (Radial Smile Lines)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00880360: A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer
Official title: A Phase II Trial of Intravenous Ontak to Treat Epithelial Ovarian Cancer FIGO Stage III or Stage IV, or Extraovarian Peritoneal Carcinoma, of Fallopian Tube Carcinoma Failing or Ineligible for First-Line Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epithelial Ovarian Cancer
Extraovarian Peritoneal Cancer
Fallopian Tube Carcinoma
Keywords: Epithelial Ovarian Cancer
FIGO (International Fed of Gyn and Ob)Stage III or Stage IV
Extraovarian Peritoneal Cancer
Fallopian Tube Carcinoma Failing
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2009-04-13
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study tests whether denileukin diftitox will deplete regulatory T cells, boost tumor-specific immunity and treat epithelial ovarian cancer in patients who have failed, or who are ineligible for front line therapy.

Detailed description: This is a non-randomized, single-arm, Phase II trial. Selected patients with advanced-stage epithelial ovarian cancers who have no reasonable chance of cure using standard regimens, or who will not receive such regimens (due to contraindication or intolerance) are eligible. Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.

Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent
* Not on Immune modulating drugs
* Life expectancy less than 6 months

Exclusion Criteria:

* Unable to tolerate phlebotomy
* Germ cell or stromal cell cancers of the ovaries
* Active autoimmune disease

Primary outcomes:
measure: Number of Participants Demonstrating Clinical Response
timeFrame: 2 years
Secondary outcomes:
measure: Toxicity
timeFrame: 3 years
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: CTRC at UTHSCSA
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Tyler Curiel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04758260: Influence of the Antioxidant Treatment in the Oxidant-reduction Potential in Seminal Plasma in Men Whose Partners Will Undergo Through an Egg Donation Cycle
Official title: Influence of the Antioxidant Treatment in the Oxidant-reduction Potential in Seminal Plasma in Men Whose Partners Will Undergo Through an Egg Donation Cycle
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Compare the sORP Rate in Sperm Samples, Obtained by the Mioxsys System, Before and After 2.5 Months Antioxidant Men Supplements Treatment (Fertybiotic Man)
Lead sponsor: IVI Bilbao
Sponsor class: OTHER
Collaborators: name: Aytu BioPharma, Inc.
First posted: 2021-02-17
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the influence of antioxidant men supplements treatment (Fertybiotic Hombre) in the rate of sORP (stactic Oxidation Reduction Potential) defined as the balanced measure between the total oxidant activity (ROS, superoxides, nitric oxide, peroxide) and total reducing activity (alpha tocopherol, β carotene, uric acid) in sperm samples during egg donation cycles.

We will also evaluate the influence of the sORP rate in the embryo development during the egg donation treatments; taking in account the fecundation rate, percentage of blastocyst stage arrival embryos, number of frozen embryos, implantation rate, on-going pregnancy rate and miscarriage rate.

The sperm sample will be measured by electrochemical technology using Mioxsys system for a quantitative measurement in millivolts (mV), in those male patients who participate in an egg donation assisted reproduction treatment.

After 14 days, the pregnancy stage will be available. This information will be obtained from the patient's clinical history using the human chorionic gonadotropin hormone (shCG) in blood. It will be performed either in our Clinic or externally within the usual practice derived from the treatment carried out. These values will be compared with the results obtained from sORP.


Eligibility criteria: Male Inclusion Criteria

* Sperm count greater than 2 million per milliliter
* Sperm origin: ejaculate

Exclusion Criteria:

* Taking oral antioxidants in the 3 months prior to inclusion in the study
* Total astenozoospermia or Severe teratozoospermia (including balloonzoospermia)

Primary outcomes:
measure: Compare the sORP rate in sperm samples,
timeFrame: 2.5 months
Secondary outcomes:
measure: Evaluate the influence of the sORP rate in embryo development
timeFrame: 1 year
measure: Evaluate the relationship between the sORP rate in sperm samples
timeFrame: 1 year
measure: Determinate a reproductive prognosis value based on sORP rate and the different sperm parameters
timeFrame: 1 year
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: IVI Bilbao
state: Vizcaya
Study officials:
affiliation: IVI Bilbao
name: Marcos Ferrando
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00520260: Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase
Official title: Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Disease
Ocular Comfort
Lead sponsor: Florida Eye Microsurgical Institute
Sponsor class: OTHER
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2007-08-23
Enrollment: 42
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: To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of treatment for chronic dry eye disease


Eligibility criteria: Inclusion Criteria:

* Must be in general good health
* Diagnosis of moderate to severe dry eye syndrome

Exclusion Criteria:

* Patients who are unlikely to respond to cyclosporine ophthalmic emulsion therapy
* Patients who are pregnant or nursing females
* Unwilling to discontinue use of contact lenses during the run-in and duration of the study
* Presence or history of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of the study results in the study eye
* Previous treatment failure on CSA 0.05% (Restasis)
* Known hypersensitivity to any component of the study or procedural medications
* Participation in any other clinical trial within 30 days prior to screening
* Known contraindication to any study medication or any of their components.
* Should not be taking any oral anti-histamines, beta blockers or diuretics.

Primary outcomes:
measure: Ocular comfort
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute
state: Florida
Study officials:
affiliation: Florida Eye Microsurgical Institute
name: Barry Schechter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00817960: Effects of Ritalin on Postural Stability of Old Adults
Official title: Effects of Methylphenidate on Postural Stability of Old Adults Under Single and Dual Task Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Imbalance
Keywords: Dual tasking
Postural Control
Methylphenidate (Ritalin)
old adults
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2009-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Experimental design overview The proposed project is a prospective experimental study design. independent old adults(age 65 years old and older) who do not suffer from balance problems willing to participate in the study will be tested with well-established measuring techniques of Balance control before and 2 hours after taking of Methylphenidate (Ritalin) in the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins \& De Luca, 1993). For each of the conditions (before and 1 hour after the use of Ritalin) in three task conditions single task; dual task (concentrating and identifying specific music); and just Listening to a relaxing music. Participants will be required to stand on the platform 10 times for 30 s. For each trial, they will be instructed to sway as little as possible.


Eligibility criteria: Inclusion Criteria:

* Age 65 years old and older
* independent elderly adults
* do not suffer from balance prblems
* minimental score 24 and above

Exclusion Criteria:

* old adults who suffer from neurological disease or stroke
* old adults who suffer from psychiatric state
* old adults who suffer from orthopedic condition (1/2 a year after a fracture in the lower limb)
* old adults who suffer from heart conditions
* old adults who suffer from blindness

Primary outcomes:
measure: Postural sway measures
timeFrame: Time 1: pre test' and hour later time 2: post testinng proceedure
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: SorokaUMC
Study officials:
affiliation: Ben-gurion University of the Negev, Beer-Sheva, Israel
name: Itshak Melzer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soroka University Medical Centar
name: Zmir Shorer, m
role: STUDY_CHAIR
affiliation: Soroka University Medical Center
name: Yan Press, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00888160: Timing of Orthopaedic Surgery in the Multiply-injured Patient: Development of a Protocol for Early Appropriate Care
Official title: Timing of Orthopaedic Surgery in the Multiply-injured Patient: Development of a Protocol for Early Appropriate Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unstable Pelvic Ring Fracture
Unstable Acetabulum Fracture
Femur Fracture
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2009-04-27
Enrollment: 360
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients at least 16 years of age treated at a major urban level 1 trauma center between the years 2000 and 2006, who had any of the following musculoskeletal injuries: unstable pelvic ring fracture, unstable acetabulum fracture, or femur fracture.

Brief summary: Early fixation of unstable fractures of the femur, pelvis, and acetabulum reduces some complication rates. However, in patients with multiple injuries, the optimal treatment of skeletal trauma may be affected by severe injury to the head, chest, or abdomen. The relationship between associated injury severity and the timing of definitive management of unstable fractures is not well-understood. The practice of "early total care," early definitive fracture management, has been criticized by some, who have suggested that additional hemorrhage with surgery may be associated with a deleterious systemic inflammatory response. The alternative extreme of "damage control orthopedics (DCO)" has been recently proposed as a means of providing provisional stability of major skeletal injury, generally through external fixation. It is speculated that DCO will diminish the potential for systemic compromise. However, the need for further (definitive) surgery on a delayed basis, and the potential additional complications and costs associated with this strategy are controversial. The investigators' goals are to define which injuries or parameters warrant delay of definitive orthopaedic care, and to determine what time interval for fracture fixation promotes optimal patient outcome. The investigators will assess the effects of fracture fixation on head injury, chest injury, abdominal injury, mortality, complications, patient outcomes, and costs.


Eligibility criteria: Inclusion Criteria:

* All patients at least 16 years of age treated at a major urban level 1 trauma center between the years 2000 and 2006, who had any of the following musculoskeletal injuries:

  * unstable pelvic ring fracture
  * unstable acetabulum fracture, or
  * femur fracture
* Patients will be included regardless of race or gender. Isolated fractures will be included

Exclusion Criteria:

* Low-energy pelvis and hip fractures will be excluded
* Patients younger than 16 years of age will be excluded

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT06246760: Differences in Ventilatory Function, Body Composition, and Cardiorrespiratory Fitness According to Training Status
Official title: Prestación de Servicios científicos, evaluación y Control Del Rendimiento
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Body Composition
Cardiovascular Health
Ventilatory Physiology
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 1272
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this cross-over study is to evaluate the physiological response to exercise and body composition according to training status in participants with a wide spectrum of fitness states. The main questions it aims to answer are:

* Which are the physiological differences across participants with different training status?
* Which are the body composition differences across participants with different training status?

Detailed description: To satisfy the objective of the project, participants will perform an incremental test until volitional exhaustion. During this test, respiratory gases will be measured via a gas analyser as well as the cardiac response via an electrocardiogram. The same participants will have their body composition measured by dual X-ray densitometry (DXA).

Eligibility criteria: Inclusion Criteria:

* Be in enough physical fitness to perform the incremental test to volitional exhaustion.

Exclusion Criteria:

* Present any health condition preventing to perform the incremental exercise test until volitional exhaustion.

Primary outcomes:
measure: Training status
timeFrame: breath-by-breath during the whole test
measure: Body composition
timeFrame: one determination before the test
measure: Bone mineral density
timeFrame: one determination before the test
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Faculty of physical activity and sport sciences
state: Comunity of Madrid
Study officials:
References:
Clinical trial NCT01135160: Evaluation of Weight Bearing After Total Hip and Knee Replacement
Official title: Evaluation of Weight Bearing in Patients After Total Hip and Knee Replacement
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthropathy of Hip
Arthropathy of Knee
Keywords: weight bearing
pain
total hip arthroplasty
total knee arthroplasty
weight bearing after TKA or THA
Lead sponsor: Kantonsspital Münsterlingen
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients receiving TKA or THA at our institution between August 2010 and August 2011

Brief summary: The regime in the aftercare after total hip and knee arthroplasty(THA/TKA) differs a lot between orthopedic surgeons concerning weight bearing. The type of implant and the way of implants' anchoring are considered.

In the literature there is no data so far about the way patient take care of the recommended weight bearing during the first 6 weeks after THA and TKA.

Over a one year period starting August 2010 all patients undergoing TKA or THA at the investigators institution will have a technical device in their shoes (sole) to measure the load in each step they do in these shoes during the first 6 weeks. Patients are asked to fill out a standardised pain protocol every day (VAS) and document need of pain medication. The investigators recommend 20kg of weight on the operated leg for 6 weeks and full weight bearing at the end of week six.

The investigators believe that patients will adjust weight bearing to their level of pain and not to their surgeons recommendations.


Eligibility criteria: Inclusion Criteria:

* received a THA or TKA in the mentioned period of time
* is able to walk on crutches
* is able to understand our recommendations
* signed informed consent

Exclusion Criteria:

* not able to walk on crutches
* not able to understand our recommendations
* other deformities of lower limbs

Primary outcomes:
measure: full weight bearing allowed and accomplished end of 6th week
timeFrame: 6 weeks
Secondary outcomes:
measure: pain under partial weight bearing (recommended)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Münsterlingen
country: Switzerland
facility: Kantonsspital Münsterlingen
state: Thurgau
Study officials:
affiliation: Chief of the department for orthopedic surgery Kantonsspital Münsterlingen, Schweiz
name: Michael Schueler, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: