louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05013281: Suprachoroidal Hemorrhage Associated With Pars Plana Vitrectomy
Official title: Suprachoroidal Hemorrhage Associated With Pars Plana Vitrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suprachoroidal Hemorrhage (Diagnosis)
Pars Plana Vitrectomy
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: any participants who treated with PPV and occured Suprachoroidal hemorrhage with PPV

Brief summary: To analyze the characteristics, related risk factors, and prognosis of suprachoroidal hemorrhage (SCH) associated with pars plana vitrectomy (PPV).


Eligibility criteria: Inclusion Criteria:

* Suprachoroidal hemorrhage associated with pars plana vitrectomy

Exclusion Criteria:

* Patients with eye trauma-related Suprachoroidal hemorrhage were excluded.

Primary outcomes:
measure: pathogenesis
timeFrame: baseline
Secondary outcomes:
measure: vision acuity
timeFrame: up to 7 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03927781: Perioperative Pregabalin in Ureteroscopy: a Pilot
Official title: Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Pain After Ureteroscopy With Stent Placement: a Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nephrolithiasis
Urolithiasis
Perioperative/Postoperative Complications
Pain, Postoperative
Pain, Acute
Anesthesia
Urologic Diseases
Anesthesia Morbidity
Keywords: Pregabalin
Perioperative medicine
Opioid sparing
Urolithiasis
Ureteroscopy
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive 300mg PO pregabalin one hour before procedure start
Primary purpose: TREATMENT

Brief summary: The investigators propose a pilot clinical trial on the use of perioperative pregabalin in order to decrease ureteral stent related symptoms and decrease opioid usage after ureteroscopy with stent placement. Patients undergoing ureteroscopy with stent placement will receive a single dose of 300 mg pregabalin PO in the preoperative area. This work will assess safety and feasibility of studying this regimen at our institution, with the aim of performing a randomized, placebo-controlled, double-blinded study in the future.


Eligibility criteria: Subject Population Undergoing elective ureteroscopy with stent placement by Dr. Murray at University of Missouri Hospital and affiliated facilities

Subject Inclusion

Age \>= 18 years

Subject Exclusion

* Renal insufficiency (eGFR \< 30 mL/minute/1.73 m2)
* Chronic indwelling ureteral stent
* Chronic opioid use
* History of opioid abuse
* Chronic gabapentinoid use
* Plan for inpatient hospitalization
* Pregnancy
* Inability of the patient to consent for themselves in English
* Allergy to gabapentinoid
* Liver failure or hepatic dysfunction

Primary outcomes:
measure: Number of Participants With One or More Adverse Events Related to Study Drug
timeFrame: Day of surgery
measure: Number of Participants Who Were Administered the Study Drug Correctly
timeFrame: Day of surgery
measure: Respondent Reported Usability of Instruments
timeFrame: 30 days post-op
Secondary outcomes:
measure: Early Post-op Stent Related Symptoms
timeFrame: Post-op day 3
measure: Early Post-op Opioid Needs
timeFrame: First 30 post-operative days
measure: Opioid Use
timeFrame: Up to 1 year post-op
measure: Amount of Opioid Use
timeFrame: Up to 1 year post-op
measure: Unplanned Healthcare Contacts
timeFrame: First 30 post-operative days
measure: Patient Satisfaction
timeFrame: First 30 post-operative days
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: Assistant Professor
name: Katie Murray, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01210781: Target Planning for Placement of DBS-electrodes and Follow-up of the Clinical Efficacy of Stimulation
Official title: Target Planning for Placement of DBS-electrodes and Follow-up of the Clinical Efficacy of Stimulation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Movement Disorders
Epilepsy
Keywords: All indication for deep brain stimulation (DBS)
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-09-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive patients implanted with DBS electrodes at our institution

Brief summary: Deep brain stimulation (DBS) has been established as therapy for severe forms of Parkinson's disease and other indications. A common target for stimulation is the subthalamic nucleus (STN). Nevertheless, there is no agreement on the mechanisms how DBS leads to clinical improvement.

The project aims to describe the variability of target coordinates in the patient group and to relate it to clinical outcome as documented in standardized questionaires.

* Trial with surgical intervention

Detailed description: Deep brain stimulation (DBS) has been established as therapy for severe forms of Parkinson's disease and other indications. A common target for stimulation is the subthalamic nucleus (STN). Nevertheless, there is no agreement on the mechanisms how DBS leads to clinical improvement.

The project aims to describe the variability of target coordinates in the patient group and to relate it to clinical outcome as documented in standardized questionaires.

Eligibility criteria: Inclusion criteria:

* Patients fullfill all criteria for implantation of deep brain stimulation (DBS) electrodes
* Patients are able to give informed written consent

Exclusion criteria:

* Patients do not their give informed written consent

Primary outcomes:
measure: neurological outcome
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Neurosurgery
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Neurosurgery
name: Johannes Sarnthein, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00711581: Evaluation of Laparoscopic Internal Retractor Device
Official title: Evaluation of the Efficacy and Safety of the Endograb: A Laparoscopic Internal Retractor Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholelithiasis
Keywords: Cholecystectomy
Cholecystectomy, Laparoscopic
Laparoscopy
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-07-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of the Endograb system which is an internal laparoscopic retractor device. This retractor device is inserted into the abdominal cavity through one of the 5 mm trocars and obviates the need for a separate dedicated trocar for retraction. Therefore enables the reduction of the number of abdominal incisions in a laparoscopic operation.


Eligibility criteria: Inclusion Criteria:

* Symptomatic cholelithiasis
* Age 18-60
* ASA 1-2
* Able to sign an informed consent

Exclusion Criteria:

* ASA 3 or more
* Acute cholecystitis
* Choledocholithiasis
* Coagulation disorders
* Patients on blood thinners
* Use of Steroids

Primary outcomes:
measure: Outcome will be either "success" or "failure". Success if the organ will be retracted adequately with the Endograb retractor. Failure if it will be necessary to add another trocar for inserting a retracting instrument.
timeFrame: 1 year
Secondary outcomes:
measure: No adverse effects related directly to the use of the Endograb retractor.
timeFrame: 1 year
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Yoav Mintz
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Yoav Mintz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Ram Elazary, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02548481: Validation and Standardisation of a Pool of Simplified Evaluation Aimed to the Diagnoses of Aphasic Disorders and Adapted to the Patients Suffering an Acute Phase of Stroke
Official title: Validation and Standardisation of a Pool of Simplified Evaluation Aimed to the Diagnoses of Aphasic Disorders and Adapted to the Patients Suffering an Acute Phase of Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Administration of BESTA scale (test to assess) within 3 days after stroke and at 3 months and 1 year after stroke. This scale will be compared to standard scales.

Brief summary: Every year in France, from 100 000 to 145 000 people are affected by a stroke. 75% patients survived with aftereffects, in particular aphasic disorders.

A sketch of a new tool called BESTA aiming to a rapid handover to the acute phase post stroke had been worked out. After a meeting, 13 multidisciplinary experts have discussed, adjusted and a new complete tool (BESTA) had been created in order to evaluate the different states of aphasia.

The goal of this study is the validation and the standardization of this new BESTA tool.


Eligibility criteria: Inclusion Criteria:

Patients with stroke:

* Every patient over 18,
* admitted among neuro-vascular unit,
* native french speaker,
* the level of vigilance is satisfactory in order to allow a speech therapy test.

Healthy Volunteers:

* Every volunteers over 18,
* without any medical history of a stroke or any speech disorders,
* native french speaker.

Exclusion Criteria:

Patients with stroke and Healthy Volunteers :

* dementia disease
* psychiatric condition
* non-equipped deafness
* pregnant woman
* patient with medical histories of stroke

Primary outcomes:
measure: validity of concomitant criterion at T0 versus LAST
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges Hospital
Study officials:
affiliation: University Hospital, Limoges
name: Francisco MACIAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00795795: Preimplantation Genetic Screening in Women of Advanced Maternal Age
Official title: Randomized Controlled Trial (RCT) of Preimplantation Genetic Screening (PGS) in Women of Advanced Maternal Age (AMA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chromosomal Abnormalities
Keywords: Chromosomal abnormalities in preimplantation embryos
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 640
Sex: ALL
Minimum age (years): 38
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: An increased incidence of aneuploid pregnancies has been reported in women of advanced maternal age, with higher miscarriage rates. Cytogenetic studies in preimplantation embryos have shown elevated aneuploidy rate, particularly in women over 38 years. For these reasons, PGS has been applied to these patients to improve ongoing implantation rates, and most importantly, to decrease the risk of further miscarriages and affected offspring. In the past two years, several RCT have raised the question whether PGS is benefitial or not in AMA patients.

In our experience, PGS outcome in these patients offers higher ongoing implantation rates than the previously published in RCT studies, where no benefits for PGS were found. In these papers, poor technical skills, as well as unclear patients selection could explain the reported lack of PGS benefits.

Therefore, the objective of the present RCT is to analyze the outcome of IVF cycles with and without PGS in two age groups:

* Patients 38-39 years of age: 200 cyles per arm reaching embryo transfer should be performed
* Patients 40-44 years of age: 120 cycles per arm reaching embryo transfer Sample size has been calculated according to our retrospective experience with higher differences in ongoing implantation rates between cycles with and without PGS in patients of 40-44 years of age. In all patients embryo transfer will be performed on day 5. In the PGS group one cell will be biopsy in embryos with ≥5 cells on day-3 and chromosomes 13, 15, 17, 18, 21, 22, X and Y will be analyzed in two rounds. In the third round, nuclei with undoubtful or non-conclusive results will be analyzed using subtelomeric probes.


Eligibility criteria: Inclusion Criteria:

* Female Patients over 37 years old, attending a fertility clinic

Exclusion Criteria:

* Azoospermic partners
* Female patients with uterine malformations
* number of retreived oocytes below 5

Primary outcomes:
measure: ongoing implantation per embryo and per pacient
timeFrame: one month
Secondary outcomes:
measure: Take home baby
timeFrame: 9 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Instituto Valenciano de Infertilidad
Study officials:
References:
Clinical trial NCT01447095: Effects of Prostacyclin Infusion on Cerebral Vessels and Metabolism in Patients With Subarachnoid Haemorrhage
Official title: Effect of Prostacyclin Infusion on Cerebral Vessels, Cerebral Bloodflow and Cerebral Metabolism in Patients With Subarachnoid Haemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Subarachnoid Hemorrhage
Keywords: Subarachnoid hemorrhage
vasospasm
prostacyclin
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 90
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: The purpose of this study is to determine whether prostacyclin is effective in prevention of cerebral vasospasm in patients with subarachnoidal hemorrhage (SAH).


Eligibility criteria: Inclusion Criteria:

* SAH verified by CT
* Aneurysm identified and treated
* Fisher grade 3 + 4
* WFNS grade 1-4 (World Federation of Neurosurgical Societies )

Exclusion Criteria:

* Pregnancy/lactation
* Heard failure
* Kidney failure
* Liver failure
* Hemorrhagic diathesis

Primary outcomes:
measure: Radiographic vasospasm measured by CT perfusion
timeFrame: Day 8 (+/- 1 day) after aneurysm treatment
Secondary outcomes:
measure: Cerebral metabolism measured by microdialysis
timeFrame: every 2. hour day 3-10 after aneurysm treatment
measure: Glasgow outcome scale (GOS) at 3 months
timeFrame: 3 months efter SAH
measure: Clinical vasospasm
timeFrame: day 5-10 after SAH
measure: Brain tissue oxygen (PtiO2)
timeFrame: continuous measurement day 3-10 after SAH
measure: Mean arterial pressure (MAP)
timeFrame: Continuous day 1-10 after SAH
measure: Radiographic vasospasm measured by CT angiography
timeFrame: Measured day 8 +/- 1 day
measure: Level of brain damage biomarker
timeFrame: daily day 4-11 after SAH
Other outcomes:
measure: Neuropeptide Y
timeFrame: May 2014
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, dep. of neurosurgery
Study officials:
affiliation: Rigshospitalet, Denmark
name: Rune Rasmussen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rasmussen R, Wetterslev J, Stavngaard T, Juhler M, Skjoth-Rasmussen J, Grande PO, Olsen NV. Effects of prostacyclin on cerebral blood flow and vasospasm after subarachnoid hemorrhage: randomized, pilot trial. Stroke. 2015 Jan;46(1):37-41. doi: 10.1161/STROKEAHA.114.007470. Epub 2014 Nov 20.
citation: Rasmussen R, Juhler M, Wetterslev J. Effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: statistical analysis plan for a randomized controlled trial. Trials. 2014 Jun 14;15:228. doi: 10.1186/1745-6215-15-228.
citation: Rasmussen R, Wetterslev J, Stavngaard T, Skjoth-Rasmussen J, Grande PO, Olsen NV, Romner B. The effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: study protocol for a randomised controlled trial. Trials. 2012 Jul 2;13:102. doi: 10.1186/1745-6215-13-102.
Clinical trial NCT02110095: Picosure Alexandrite Laser for the Treatment of Unwanted Tattoos
Official title: Picosure Alexandrite Laser for the Treatment of Unwanted Tattoos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unwanted Tattoos
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Picosure Laser System for the treatment of unwanted tattoos.


Eligibility criteria: Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old.
2. Is willing to consent to participate in the study.
3. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
4. The tattoo must include red pigment.

Exclusion Criteria:

1. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
2. Is hypersensitive to light exposure OR takes photo sensitized medication.
3. Has active or localized systemic infections.
4. Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
5. Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
7. Has used Accutane within 6 months prior to enrollment.
8. Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. Has a history of keloids.
11. Has evidence of compromised wound healing.
12. Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
13. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
14. Is allergic to topical lidocaine or topical steroids.

Primary outcomes:
measure: Number of Patients With Tattoo Clearance
timeFrame: 2 months post last treatment
Secondary outcomes:
measure: Physician Satisfaction Questionnaire
timeFrame: 2 months post last treatment
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Skin Care Physicians
state: Massachusetts
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References:
Clinical trial NCT00257595: Perennial Allergic Rhinitis In Pediatric Subjects
Official title: Long-term Study of Cetirizine Dry Syrup in Children. Suffering From Perennial Allergic Rhinitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Keywords: Perennial Allergic Rhinitis pediatric
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-11-23
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Children with perennial allergic rhinitis.
* Giving informed consent.
* Children with a positive response to specific IgE antibody test.
* Children assessed as positive in the nasal eosinophil count.
* Children whose severity score of nasal symptom is 4 or higher.

Exclusion criteria:

* have a history of drug hypersensitivity.
* are pregnant, lactating or possibly pregnant female children.
* Sensitivity to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods.
* have vasomotor rhinitis and eosinophilic rhinitis.
* have asthma that requires the treatment with corticosteroid.
* have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs.
* have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation.
* have started specific desensitization treatment.
* nonspecific modulation treatment but who have not reached the maintenance level of treatment.
* have received surgical treatment for reduction and modulation of nasal mucosa.
* redintegration therapy of nasal cavity to improve the degree of nasal airway.
* surgical operation to improve rhinorrhea.

Primary outcomes:
measure: safety
Secondary outcomes:
measure: Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating
Other outcomes:
Locations:
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: