louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01364285: A Study of Patient Reported Outcomes After Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia
Official title: A Study of Patient Reported Outcomes After Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trigeminal Neuralgia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-06-02
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All of the patients since 2000 who have undergone stereotactic radiosurgical rhizotomy at Stanford for treatment of trigeminal neuralgia.

Brief summary: The investigators know little about how patients feel following radiosurgery treatment of trigeminal neuralgia. Patient satisfaction may ultimately be one of the most important outcome measures for an individual patient; however, this has not been adequately assessed or followed. Multiple questions remain unanswered, including whether there is a correlation between patient satisfaction, the level of their current pain score, and the presence and degree of facial numbness, a possible side effect after radiosurgery. Therefore, the goal of this study is to gather this information from the patients who received radiosurgery for trigeminal neuralgia at Stanford and evaluate post-treatment patient satisfaction, the degree of facial numbness, and current pain score. This data will help the investigators understand outcomes that are important for patient satisfaction following treatment of a chronic pain syndrome.


Eligibility criteria: Inclusion Criteria:

* All of the patients since 2000 who have undergone stereotactic radiosurgical rhizotomy at Stanford for treatment of trigeminal neuralgia.

Exclusion Criteria:

* None

Primary outcomes:
measure: Patient satisfaction following CyberKnife radiosurgery
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Clara Choi
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Scott Soltys
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00620685: A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking Methotrexate
Official title: A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Safety And Pharmacokinetic Profile Of 1 And 5 Mg Ph-797804 Administered Once Daily In Subjects With Rheumatoid Arthritis Who Are Taking Oral Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis, rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 27
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 hypothesis of this study is that the p38 inhibitor (PH-797804) will be safe and well tolerated in subjects with rheumatoid arthritis who are taking methotrexate and will not effect the blood levels of methotrexate.


Eligibility criteria: Inclusion Criteria:

* Adult with RA for at least 6 months
* Stable weekly dosage of oral methotrexate 12.5- 25 mg/week

Exclusion Criteria:

* Severe, progressive and/or uncontrolled other disease
* Chronic or recent serious infection; current infection
* Concomitant use of RA therapy other than methotrexate with some exceptions

Primary outcomes:
measure: Adverse events, laboratory data, vital signs, 12-lead ECGs and physical examination findings
timeFrame: 6 weeks
Secondary outcomes:
measure: Estimate the effects of multiple doses of PH-797804 on the pharmacokinetic profile of methotrexate in subjects with RA taking a stable dose of MTX
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Frederick
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Bingham Farms
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06617585: The Role of CircDENND4C in Epithelial Ovarian Cancer
Official title: The Role of CircDENND4C in Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: apparently healthy group and group of known diagnosed as ovary cancer in assiut uni hospital

Brief summary: circular RNAs (circRNAs), a newly discovered type of endogenous noncoding RNAs \[8\], are involved in the regulation of various biological functions. They act by sponging off certain microRNAs (miRNAs) and play a role in the pathogenesis of many diseases, including cancers \[9-11\]. In addition, circRNAs are not com- monly degraded by RNA enzymes present in body flu- ids \[8\], and most of them possess expression specificity at the tissue, cell, and developmental stage level \[12,13\]. Thus, they can be ideal clinica

Detailed description: epithelial OC (EOC), the most common form of OC, accounts for 90% of all OC cases \[2\]. EOC has the highest mortality among all gynecologic tumors and poses a serious threat to women's life \[3\].herefore, early clinical diagnosis is crucial. Commonly used laboratory indicators for OC diagnosis

Eligibility criteria: Inclusion Criteria:

- patients at South Egypt Cancer institute and Recently diagnosed ovarian cancer patients 2. Patients not went to surgery.

Exclusion Criteria:

* . Patients receive any anti-cancer therapy. 2. Patients diagnosed with other concomitante cancer or chronic disease

Primary outcomes:
measure: role of circDENND4c in the diagnosis of ovarian cancer
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04095585: Molecular Characterization of Patients Affected by Williams Syndrome and Autism.
Official title: Molecular Investigation, Using Chromosomal Microarray and Whole Exome Sequencing, of Patients Affected by Williams Beuren Syndrome and Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Williams Beuren Syndrome
Autism Spectrum Disorder
Keywords: Williams Beuren Syndrome
Autism Spectrum Disorder
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: patients with WBS and ASD.

Brief summary: Williams Beuren syndrome (WBS) is a multiple malformations/intellectual disability (ID) syndrome caused by 7q11.23 microdeletion and clinically characterized by a typical neurocognitive profile including excessive talkativeness and social disinhibition, often defined as "overfriendliness" and "hypersociability". WBS is generally considered as the polar opposite phenotype to Autism Spectrum Disorder (ASD). Surprisingly, the prevalence of ASD has been reported to be significantly higher in WBS (12%) than in general population (1%). This study aims to investigate the molecular basis of the peculiar association of ASD and WBS. The investigator performed chromosomal microarray analysis and whole exome sequencing in six patients presenting with WBS and ASD, in order to evaluate the possible presence of chromosomal or gene variants considered as pathogenic.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of WBS was confirmed by fluorescent in situ hybridization.
* All patients met formal ASD criteria
* written informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Possible presence of pathogenic chromosomal
timeFrame: Day 0
measure: Possible presence of gene variants
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon
name: Massimiliano Rossi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Masson J, Demily C, Chatron N, Labalme A, Rollat-Farnier PA, Schluth-Bolard C, Gilbert-Dussardier B, Giuliano F, Touraine R, Tordjman S, Verloes A, Testa G, Sanlaville D, Edery P, Lesca G, Rossi M. Molecular investigation, using chromosomal microarray and whole exome sequencing, of six patients affected by Williams Beuren syndrome and Autism Spectrum Disorder. Orphanet J Rare Dis. 2019 May 31;14(1):121. doi: 10.1186/s13023-019-1094-5.
Clinical trial NCT03023085: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
Official title: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colonoscopy
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2017-01-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.


Eligibility criteria: Key Inclusion Criteria:

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
2. Have previously had a colonoscopy performed
3. At least 18 years of age
4. Subjects must be scheduled for a morning colonoscopy (prior to 12:00PM)
5. If female, and of child-bearing potential, is using an acceptable form of birth control.
6. Negative urine pregnancy test at screening, if applicable
7. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Key Exclusion Criteria:

1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
2. Subjects who had previous significant gastrointestinal surgeries.
3. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
4. Subjects with a prior history of renal, liver or cardiac insufficiency
5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
6. Subjects undergoing colonoscopy for foreign body removal and/or decompression.
7. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
8. Subjects of childbearing potential who refuse a pregnancy test.
9. Subjects allergic to any preparation components.
10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
11. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

Primary outcomes:
measure: Number and Percentage of Subjects With Successful Bowel Cleansing
timeFrame: Day of colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Braintree Research Site 1
state: California
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT05845385: Postoperative Pain Relief After Major Abdominal Gynecological Surgery
Official title: Comparison of Lumbar Epidural Analgesia, Transversus Abdominis Plane Block and Wound Infiltration for Postoperative Pain Relief in Major Abdominal Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: epidural analgesia
pain score
morphine
transversus abdominis plane block
wound infiltration
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study was to compare the effects of Lomber Epidural Analgesia (LEA), Transversus Abdominis Plane (TAP) block and Local Anesthetic Infiltration (LAI) on postoperative morphine consumption, time to first recue analgesic request, pain and patient satisfaction scores and side effects were compared in the patients undergoing major gynecologic/oncology lower abdominal surgery.

Detailed description: Following faculty ethical committee approval and written informed consent, 81 patients were included in our prospective, randomized and double-blind study. Patients were divided into 3 groups: lumbar epidural block (Group E), TAP block (Group T), and wound infiltration (Group I). Demographic data, surgical characteristics, hemodynamic values, pain scores at rest and on movement, morphine consumption, additional analgesic requirement, side effects at 1, 2, 6, 12, 24, 36 and 48th hours after surgery, and patient satisfaction scores at 24 and 48th hours were recorded.

Eligibility criteria: Inclusion Criteria:

* ASA I-II,
* between the age of 18-69,
* undergoing major gynecological abdominal surgery under general anesthesia

Exclusion Criteria:

* lack of patient consent
* ASA \> III
* sensitivity or contraindication to study drugs
* conditions in which epidural anesthesia is contraindicated
* emergency and urgent surgery
* inability to comprehend pain scale
* any contraindication to the use of patient controlled analgesia (PCA) device.

Primary outcomes:
measure: morphine consumption
timeFrame: change from baseline morphine comsumption at 48 hours
Secondary outcomes:
measure: pain scores
timeFrame: change from baseline pain scores at 48 hours
measure: patient satisfaction score
timeFrame: postoperative 24 and 48 hours
measure: time to first rescue analgesic
timeFrame: postoperative 48 hours
measure: side effects
timeFrame: postoperative 48 hours
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
affiliation: Cukurova University
name: Hakkı - Unlugenc, Proffessor
role: STUDY_CHAIR
References:
Clinical trial NCT00481585: The Biology of Claudin 3 in Primary Human Mammary Epithelial Cell Culture
Official title: The Biology of Claudin 3 in Primary Human Mammary Epithelial Cell Culture
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: claudin
electrophysiology
breast
screening
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2007-06-01
Enrollment: 13
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 13 subjects - Subjects of this pilot study are limited to those female patients who are undergoing therapeutic or prophylactic mastectomy procedures conducted by the department of Surgery at HUMC.

Brief summary: The objective of the present study is to determine whether or not primary human mammary epithelial cells are competent for use in molecular studies of transepithelial electrophysiology focusing on the function of the tight junction protein claudin 3.

Human breast Tissue will be removed from mastectomy specimens and used as a source to generate epithelial cells for study.


Eligibility criteria: Inclusion Criteria:

* Subjects of this pilot study are limited to those female patients who are undergoing therapeutic or prophylactic mastectomy procedures conducted by the department of Surgery at HUMC.

Exclusion Criteria:

* From within this population, no exclusion criteria shall be applied based on age, race, ethnicity, gender, HIV status, or menopause.

Primary outcomes:
measure: Cell line data study
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack Univeristy Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Erik F Young, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01632085: Comparison of Two Laryngoscopes: Single-use Device Laryngobloc ® (SU) Versus Reusable Handle With Disposable Metal Blade (R)
Official title: Comparison of Two Laryngoscopes: Single-use Device Laryngobloc ® (SU) Versus Reusable Handle With Disposable Metal Blade (R) : Quality of Laryngoscopy and Bacterial Contamination of the Handle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contamination of the Handles
Quality of the Laryngoscopy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Reduce the risk of nosocomial transmission of germs related to the reusability of the laryngoscope handle. The alternative is to replace it with a disposable device, provided that it is as effective as the reference strategy at a reasonable cost.


Eligibility criteria: Inclusion Criteria:

* Men or women over 18 years·
* Hospitalized for elective surgery and targeted for orotracheal intubation under direct laryngoscopy under general anesthesia with neuromuscular blockade resolved·
* Subject has signed informed consent·
* Suject affiliated to a social protection·
* Subject informed of the results of medical examination

Exclusion Criteria:

* Contraindication to general anesthesia or one of its components·
* General anesthesia without a competitive muscle relaxant·
* Patient with criteria for difficult intubation·
* Patient targeted for special care of the airway (fiberoptic or vidéolaryngoscopy), whatever the indication as Mallampati class 4·
* Subject in class 4 Mallampati·
* Acts performed in the emergency setting·
* Pregnancy and obstetric procedures·
* Breastfeeding·
* Difficulty in communication with the patient (including obtaining informed consent, evaluation of pain in the recovery Room ·
* Subject in exclusion period (determined by a previous study or a study in progress)

Primary outcomes:
measure: The quality of laryngoscopy
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation microbiological and evaluation of intubation
timeFrame: 1 year
Other outcomes:
Locations:
city: Strasbourg cedex
country: France
facility: Hôpitaux Universitaires de Strasbourg
state: Alsace
Study officials:
References:
Clinical trial NCT00823485: Clinical Efficacy of In-situ Thrombolysis in Case of Intraventricular Haemorraghia by Aneurysm Rupture
Official title: Clinical Efficacy of In-situ Thrombolysis in Case of Intraventricular Haemorraghia by Aneurysm Rupture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Aneurysm, Ruptured
Subarachnoid Hemorrhage
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2009-01-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the impact of in situ fibrinolysis on the mortality at 30 days in case of subarachnoid hemorrhage.


Eligibility criteria: Inclusion Criteria:

* subarachnoid hemorrhage by aneurysm rupture
* severe intraventricular hemorraghia

Exclusion Criteria:

* pregnant women
* hemostasis disturbance

Primary outcomes:
measure: assessment of mortality
timeFrame: at 30 days
Secondary outcomes:
measure: assessment of morbidity
timeFrame: at 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Neurosurgery department , Nice University Hospital
Study officials:
References:
citation: Litrico S, Almairac F, Gaberel T, Ramakrishna R, Fontaine D, Sedat J, Lonjon M, Paquis P. Intraventricular fibrinolysis for severe aneurysmal intraventricular hemorrhage: a randomized controlled trial and meta-analysis. Neurosurg Rev. 2013 Oct;36(4):523-30; discussion 530-1. doi: 10.1007/s10143-013-0469-7. Epub 2013 May 2.
Clinical trial NCT00718185: Pharmacokinetics and Pharmacdynamics of Sildenafil
Official title: The Pharmacokinetics and Pharmacodynamics of Sildenafil in Pediatric and Adult Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Hypertension
Keywords: Sildenafil
Pediatrics
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2008-07-18
Enrollment: 9
Sex: ALL
Minimum age (years): 28
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants, Children, and Adults receiving sildenafil as standard of care for the treatment of pulmonary hypertension.

Brief summary: The study is being done to investigate what happens to sildenafil in the body and how long it takes to get rid of this drug. Understanding how long the drug stays in the body and how it is changed by the body will help doctors determine the best dose. We also want to learn how well the medicine works based on the size of the dose or amount in the bloodstream.

Detailed description: There is no data regarding sildenafil drug disposition in infants and children with pulmonary hypertension. Sildenafil is used at The Children's Hospital of Philadelphia for the treatment of pulmonary hypertension. Patients receiving sildenafil as standard of care will be approached for consent.

Eligibility criteria: Inclusion Criteria:

* Receive enteral sildenafil as standard of care
* \> 28 days to \>18 years of age
* Informed consent/assent

Exclusion Criteria:

* Parents/guardians and/or subjects who, in the opinion of the investigator, may be noncompliant with study schedules or procedures.

Primary outcomes:
measure: To define the PK of sildenafil administered as standard of care in infants with pulmonary hypertension
timeFrame: predose, .5mins after dose, 2-4 hrs after dose, and 5-7 hrs after dose
Secondary outcomes:
measure: To describe the PD effects of sildenafil administered as standard of care in infants and children with pulmonary hypertension.
timeFrame: Multiple time points throughout the study
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Athena Zuppa, MD
role: PRINCIPAL_INVESTIGATOR
References: