louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03206268: RNFL Thickness Measurements Obtained Using SD-OCT and SLP Using GDx Variable Corneal Compensation
Official title: Correlation in Retinal Nerve Fiber Layer Thickness in Uveitis and Healthy Eyes Using Scanning Laser Polarimetry and Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis
Keywords: retinal nerve fiber layer thickness
uveitis
SD-OCT
GDx VCC
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sixty-eight consecutive patients were screened between May 2015 and October 2015, 3 (4.4%) of whom were excluded based on poor OCT quality criteria, 7 (10.3%) for poor GDx VCC quality criteria, and 4 (5.9%) for poor visual field quality or reliability criteria. Fifty-four patients were included and divided into two groups: 50 healthy eyes in 29 patients and 42 uveitic eyes in 25 patients. Of these 42-uveitic eyes, 25 eyes (59.5%) had active uveitis and 17 eyes (40.5%) had inactive uveitis

Brief summary: The aim of this study is to evaluate the correlation of retinal nerve fiber layer (RNFL) thickness measured using spectral domain optical coherence tomography (SD-OCT) and scanning laser polarimetry (SLP) in uveitic eyes compared to healthy eyes.

A descriptive, observational, prospective, consecutive, cross-sectional, controlled, mono-center case series was conducted from May to October 2015. Clinical characteristics, best-corrected visual acuity, intra-ocular pressure, RNFL thickness measurement with SD-OCT and SLP using GDx variable corneal compensation (GDx VCC) were performed for each patient. An evaluation of anterior chamber inflammation with laser flare cell meter was also carried out. Correlations between SD-OCT and GDx VCC RNFL measurement were evaluated by linear regression analysis.


Eligibility criteria: Inclusion Criteria:

* age ≥18 years,
* best-corrected visual acuity better than or equal to 20/40,
* spherical refraction between -6.00 and +3.00 diopters,
* no retinal disease or non-glaucomatous neuropathy, and no ophthalmic surgery in the past 6 months.

Exclusion Criteria:

* Healthy eye were excluded in case of consecutive and reliable abnormal standard automated perimetry with abnormal Glaucoma Hemifield Test and pattern standard deviation outside 95% of normal limits, and optic nerve damage (asymmetric cup-to-disc ratio ≥ 0.2, rim thinning, notching, excavation, or retinal nerve fiber layer defect).
* any history of ophthalmic disease.

Primary outcomes:
measure: Retinal nerve fiber thickness (RNFL)
timeFrame: at inclusion
measure: Retinal nerve fiber thickness (RNFL)
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix-Rousse University Hospital
Study officials:
affiliation: Hospices Civils de Lyon
name: Philippe Denis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00616668: Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees
Official title: Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vascular Diseases
Keywords: Transtibial amputees due to vascular diseases.
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-02-15
Enrollment: 20
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: The aim of the study is to check whether an early adjustment of the Air-Limb prosthesis to Transtibial amputees due to vascular diseases, will shorten the healing time of the stump and the process of rehabilitation.

Detailed description: The method of immediate adjustment of a temporary Prosthesis has been developed in the past, aiming to reduce the healing time of the stump and the process of rehabilitation. According to this method, a temporary Prosthesis is being adjusted immediately after amputation, or during the first week after it. Rehabilitation starts with the patient's standing while partial weight bearing on the Prosthesis.

In spite of many experiments and trials to adopt this process of rehabilitation, it is not universally adopted, because of the bad adjustment and damages to the stump caused by the Plaster of Paris. At present, with the improvement of materials and research experiments are being renewed, to check the efficiency of the process, using the Air- Limb a temporary Prosthesis.

Eligibility criteria: Inclusion Criteria:

* Transtibial amputees due to vascular diseases.

Exclusion Criteria:

* Bilateral amputation.
* Upper extremity can't bear weight.
* The sound leg can't bear weight.
* Amputee that needs Dialysis treatment.
* Cognitive impairment.

Primary outcomes:
measure: The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis.
timeFrame: 1-4 month
measure: The total duration of the rehabilitation process,from amputation until the end of the hospitalization, with the permanent prosthesis.
timeFrame: 2-6 month
Secondary outcomes:
measure: The duration of stump healing and functional status of transtibial amputees.
timeFrame: 1-6 month
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Itzhak Siev- Ner, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01975168: The Effect Evaluation of Laser Acupuncture in Obesity
Official title: The Effect Evaluation of Laser Acupuncture in Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: laser acupuncture
obesity
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized double-blind placebo-controlled crossover trial is conducted. 200 subjects aged above 20 years with body mass index (BMI) more than 25 kg/m2 are randomly divided into 2 groups (Group 1 and Group 2). Group 1 receives laser acupuncture therapy first while Group 2 receives sham laser acupuncture therapy first. After 12 weeks of treatment and 14 days of washout, Group 1 switch to sham laser acupuncture therapy while Group 2 switch to laser acupuncture for 12 weeks. The subjects are treated with a gallium aluminum arsenide Handylaser Trion, which is used to apply at each of the acupuncture points for 10 seconds every time, 3 times per week. The measurements of outcomes are performed in the beginning, weekly during treatment, and monthly after treatment for 3 months.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index over 25 kg/m2 or Waist girth over 80cm in female, waist girth over 90cm in male

Exclusion Criteria:

* Pathmakers user
* Epilepsy history
* Pregnancy
* Immuno-inhibiting agents user
* Malignancy
* Skin contacted disease
* Weight controlled agents user during trial period
* Eating disorder

Primary outcomes:
measure: body composition
timeFrame: 12 weeks
Secondary outcomes:
measure: body mass index
timeFrame: 12 weeks
Other outcomes:
measure: waist circumference
timeFrame: 12 weeks
measure: hip circumference
timeFrame: 12 weeks
measure: body fat
timeFrame: 12 weeks
measure: blood pressure
timeFrame: 12 weeks
measure: heart rate
timeFrame: 12 weeks
Locations:
city: Kaohsiung
country: Taiwan
facility: Chinese Medicine Department Clinic, Kaohsiung Medical University
Study officials:
affiliation: Doctor of Chinese Medicine Department, Kaohsiung Medical University Hospital
name: Cheng-Che Lin, MD
role: STUDY_CHAIR
affiliation: Department of Public Health, College of Health Sciences, Kaohsiung Medical University
name: Hung-Yi Chuang, ScD, MD
role: STUDY_DIRECTOR
affiliation: Family Medicine Department, Kaohsiung Medical University Hospital and Kaohsiung Municipal Ta-Tung Hospital
name: Chen-Cheng Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wozniak P, Stachowiak G, Pieta-Dolinska A, Oszukowski P. Laser acupuncture and low-calorie diet during visceral obesity therapy after menopause. Acta Obstet Gynecol Scand. 2003 Jan;82(1):69-73. doi: 10.1034/j.1600-0412.2003.820113.x.
Clinical trial NCT06573268: Da-vinci sp Versus xi Thyroid Surgery
Official title: One-year Clinical Experiences of Single-port and Multi-port Robotic Thyroid Surgery in Single Institution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Thyroid Nodule
Keywords: thyroid
robotic surgical procedures
minimally invasive surgical procedures
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received robot thyroid surgery in our institution during study period

Brief summary: One year comparative analysis between SPRA\* versus BABA\*\* thyroid surgery. \* SPRA: da-Vinci SP Robotic Areolar approach thyroid surgery

\*\* BABA: da-Vinci Xi robotic Bilateral. Axillary Breast Approach thyroid surgery

Detailed description: Study design: retrospective data analysis Study period: December 2022 to December 2023 Candidate: Patients who received robot thyroid surgery during study period Numbers of candidates: total of 270 patients Group : SPRA (n=111) versus BABA (n=159) Statistic analysis: t-test for continuous variable, fisher's exact test for categorical variable

Eligibility criteria: Inclusion Criteria:

* Patients who received robot thyroid surgery in our institution
* Retrospective review

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Total operation time (minutes)
timeFrame: on the surgery day (1 day)
Secondary outcomes:
measure: Hospital stay days after surgery
timeFrame: after the surgery day (up to 2 weeks)
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
References:
citation: Choi YS, Choi JH, Jeon MS, Yu MJ, Lee HM, Shin AY, Yi JW. First Experience of Single-Port Robotic Areolar Approach Thyroidectomy. Clin Exp Otorhinolaryngol. 2023 Aug;16(3):275-281. doi: 10.21053/ceo.2023.00682. Epub 2023 Jul 5.
citation: Choi YS, Shin WY, Yi JW. Single Surgeon Experience with 500 Cases of the Robotic Bilateral Axillary Breast Approach (BABA) for Thyroid Surgery Using the Da-Vinci Xi System. J Clin Med. 2021 Sep 7;10(18):4048. doi: 10.3390/jcm10184048.
Clinical trial NCT01223768: Acetyl-L-Carnitine In Severe Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Encephalopathy (Grade 3 of the West Haven Grading Scale)
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2010-10-19
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT

Brief summary: To assess the clinical efficacy of ALC in the treatment of severe hepatic encephalopathy (grade 3 of the West Haven grading scale), we performed a randomised, double blind placebo-controlled study administering ALC to cirrhotic patients, evaluating the effects on ammonia levels and performance in cognitive functions.


Eligibility criteria: Inclusion Criteria:

* patients with severe hepatic encephalopathy (grade 3 of the West Haven grading scale) with hepatic cirrhosis

Exclusion Criteria:

* Patients with a history of recent alcohol abuse, patients using psychotropic drugs (e.g., antipsychotics, interferon, benzodiazepines, anti-epileptics, sedatives and antidepressants)
* Other exclusion criteria were the following: major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis; acute superimposed liver injury;patients with metabolic disorders such as diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease; any additional precipitating factors such as high protein intake (additional high-protein meals), constipation; illiteracy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Cannizzaro Hospital
Study officials:
References:
Clinical trial NCT02886468: DEpth of EPinephrine Delivery With Auto-injectors Devices
Official title: Determinants of Muscle - Skin Distance at the Injection Site in Patients With an Indication for the Use of Epinephrine Auto- Injector Pens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaphylactic Shock
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Although there are several causes of fatal anaphylaxis, food allergy is one of the most common. Epinephrine is recommended as the initial treatment of choice for anaphylaxis. A delay in epinephrine administration may contribute to an increased risk of death. Therefore, the World Allergy Organization recommends that, for the treatment of anaphylaxis, epinephrine solution be administered intramuscularly in the mid-anterolateral thigh.

In France 3 auto-injector pens are available: Anapen®, Epipen® and Jext®. For weight\> 30 kg, the devices have a needle size respectively of 7.49 mm, 15.02 mm and 15.36 mm. For the weights between 15 and 30 kg needle size is 7.49 mm to 12.7 mm and Anapen® for Epipen® and Jext®.

Several studies suggest that the needle length needle is sometim


Eligibility criteria: Inclusion Criteria:

* a weight of over 30 kg at Baseline
* with food or an Hymenoptera venom allergy (diagnosed by skin tests or serum-specific IgE testing, requiring prescription epinephrine auto-injector pen according to European recommendations,

Exclusion Criteria:

* having a skin lesion on the lateral aspect of the thigh,
* with a known or suspected allergy to the contact gel

Primary outcomes:
measure: Skin-to-muscle and muscle-to-bone distance assessment, with compression, for intramuscular injection depending on needle length of the auto-injector pen.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Metz
country: France
facility: Chr Metz Thionville
Study officials:
References:
Clinical trial NCT02098668: Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON
Official title: Model Driven Computation for Infertility Related Endocrinological Diseases - PAEON
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Endometriosis
Hyperprolactinemia
Keywords: menstrual cycle dynamics
PCOS
hyperprolactinemia
endometriosis
infertility
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-03-28
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with normal and distrubed menstrual cycles Women receiving fertility treatment

Brief summary: Development of a bio-mathematical model of the human female cycle

Detailed description: From hormonal measurements throughout 1-2 menstrual cycles in women with and without endocrinological pathology a mathematical model of the human menstrual cycle will be generated. The model will serve to predict development of the cycle including ovulation as well as to better understand the pathophysiology of endocrinological disorder. In a second step current treatment protocols for fertility treatment will be integrated into the model in order to optimize treatment outcome.

Eligibility criteria: Inclusion criteria:

- Women during their reproductive phase, no hormonal therapy

Exclusion criteria:

- Amenorrhoae

Primary outcomes:
measure: Hormonal parameters
timeFrame: 3 years
Secondary outcomes:
measure: Dynamics of fertility treatment
timeFrame: 2 years
Other outcomes:
measure: Dynamics of gyneco-endocrinological diseases
timeFrame: 3 years
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Reproductive Endocrinology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Reproductive Endocrinology
name: Brigitte Leeners, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leeners B, Kruger THC, Geraedts K, Tronci E, Mancini T, Egli M, Roblitz S, Saleh L, Spanaus K, Schippert C, Zhang Y, Ille F. Associations Between Natural Physiological and Supraphysiological Estradiol Levels and Stress Perception. Front Psychol. 2019 Jun 11;10:1296. doi: 10.3389/fpsyg.2019.01296. eCollection 2019.
Clinical trial NCT02306668: Ocular Surface Dry Eye Microbiome
Official title: Microbiome Analysis of the Ocular Surface in Dry Eye Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Eyes
Keywords: Dry eye
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will recruit 40 subjects from University of Washington Medicine Eye Institute with ocular surface discomfort consistent with dry eye syndrome, and 40 control subjects

Brief summary: The investigators seek to characterize the identity of all microorganisms residing on the eye's surface (conjunctiva) in healthy eyes and those with dry eye syndrome, using a combination of analyses. Dry eye disease is thought to have an inflammatory basis and in the vast majority of cases the cause of the chronic inflammatory condition is unknown.


Eligibility criteria: Inclusion Criteria:

* dry eye syndrome with OSDI score greater than 60
* control group with OSDI score less than 30

Exclusion Criteria:

* recent history of contact lens wear
* use of topical antibiotics or prescription eye medication in past 6 months
* penetrating ocular surgery in the last 12 months
* age less than 18 years

Primary outcomes:
measure: Identification of bacteria or fungus from conjunctival swab
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: UW Medicine Eye Institute
state: Washington
Study officials:
affiliation: UW Medicine Eye Institute
name: Russell Van Gelder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00195468: Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus
Official title: A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporine Dose Reduction With Cyclosporine Elimination in De Novo Renal Allograft Recipients Receiving Rapamune.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure
Graft vs Host Disease
Keywords: Kidney Failure
Transplant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 280
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: Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II).


Eligibility criteria: Inclusion Criteria:

* Subjects with end-stage renal disease scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor. Subjects must be at least 18 years of age.

Exclusion Criteria:

* Subjects with active major infection, including active hepatitis B or C infection, decreased platelets, elevated lipids, or multiple organ transplants.

Primary outcomes:
measure: Calculated creatinine clearance at 12 months post transplantation for patients on therapy.
Secondary outcomes:
measure: Calculated creatinine clearance at 6 months Serum creatinine at 6 and 12 months post-transplantation. Graft survival at 6 and 12 months post-transplantation. Incidence of biopsy confirmed acute graft rejections at 6 and 12 months post transplantation.
Other outcomes:
Locations:
city: Curitiba
country: Brazil
state: PR
city: Rio de Janeiro
country: Brazil
state: RJ
city: Rio de Janeiro
country: Brazil
state: RJ
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Ribeirao Preto
country: Brazil
state: RS
city: Sao Jose do Rio Preto
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Torreon
country: Mexico
state: Coahuila
city: Chihuahua
country: Mexico
city: Mexico City DF
country: Mexico
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Brazil, xavierl@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Mexico, gomezlj@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: