louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01985490: Change in Foveal Avascular Zone After Removal of Epiretinal Membrane and Internal Limiting Membrane
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epiretinal Membrane
Keywords: epiretinal membrane
foveal avascular zone
internal limiting membrane
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Fovea is characterized by its vessel-free zone, called foveal avascular zone and it can be visualized by fluorescein angiography. Removal of epiretinal membrane and internal limiting membrane is frequently performed procedure and we suspected that these procedures may affect integrity of foveal avascular zone.

The purpose of the present study is to evaluate the change of foveal avascular zone after removal of epiretinal membrane and internal limiting membrane


Eligibility criteria: Inclusion Criteria:

* epiretinal membrane

Exclusion Criteria:

* history of vitrectomy, intraocular surgery
* any macular disease other than epiretinal membrane
* media opacity obscuring the image of fluorescein angiography

Primary outcomes:
measure: area of foveal avascular zone
timeFrame: postoperative 6 months
Secondary outcomes:
measure: change in visual acuity
timeFrame: postoperative 6 months
measure: change in macular thickness
timeFrame: at 6 months
measure: change in metamorphopsia
timeFrame: postoperative 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Se Woong Kang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05737290: Effects of Clear Aligners Versus Fixed Appliances on Occlusion After Treatment of Mild Anterior Crowding
Official title: Effects of Clear Aligners Versus Fixed Appliances on Occlusion After Treatment of Mild Anterior Crowding: A T-scan Study.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Occlusion
Keywords: Clear aligners
Fixed appliances
Anterior crowding
Occlusion
T scan
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 16
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate effects of clear aligners versus fixed appliances on occlusion after treatment of mild anterior crowding a T-scan study.

Detailed description: Intervention:

Group 1. Patients treated with clear aligner. Patients with mild anterior crowding will be treated with non-extraction treatment using clear aligners.

Group 2. Patients treated with fixed appliance. Patients with mild anterior crowding will be treated with non-extraction treatment using fixed appliances.

Observations:

Multi-bite closure of left and right excursive T-Scan® recordings were obtained before and after treatment from each subject to measure the occlusal parameters to be analyzed during this study.

Eligibility criteria: Inclusion Criteria:

* Patients between the age (14-19 y).
* Fully erupted permanent dentition, 3rd molars excluded.
* Healthy, compliant, and motivated patients who can visit the department regularly.
* Non-extraction treatment.
* Class I with mild anterior crowding lower and/ or upper.
* Good oral and general health.

Exclusion Criteria:

* Previous orthodontic treatment.
* Craniofacial abnormalities, congenital syndromes of the craniofacial area.
* Anterior or posterior crossbite.
* Anterior or lateral open bite.
* Poor oral hygiene or periodontally compromised patient.

Primary outcomes:
measure: Distribution of occlusal forces
timeFrame: At 6 months
measure: Distribution of occlusal forces
timeFrame: At 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar University
state: Nasr City
Study officials:
affiliation: Al-Azhar University
name: Moaz Hafez Abdelrhman, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weir T. Invisalign treatment of lower incisor extraction cases. Aust Orthod J. 2016 May;32(1):82-7.
Clinical trial NCT06181890: The Effect of Motivational Interviews
Official title: The Effect of Motivational Interviews Applied to Infertile Women on Infertility Affect, Self-Efficacy and Coping With Stress
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Infertility, Female
Keywords: Infertility
Motivational Interview
Stress
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 84
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The population of the research will be infertile women who come to Kahramanmaraş Necip Fazıl City Hospital Gynecology and Pediatrics Annex Building for infertility treatment.

Brief summary: The aim of the study was to determine the effect of motivational interviews applied to infertile women on their ability to cope with infertility, self-efficacy and stress.

Detailed description: There is no study in the literature on the effectiveness of motivational interviewing on being affected by infertility, self-efficacy and coping with stress. It is important for healthcare personnel to be easy to apply and short-term, to be aware of the effectiveness of the motivational interviewing technique, and to use this technique in communicating with the patient and changing behavior. Based on these, it was deemed necessary to examine the effect of motivational interviews for infertile women.

Eligibility criteria: Inclusion Criteria:

* Ages 18 and over and have no problems communicating Those who have not previously or currently been diagnosed with a psychiatric disease Infertile women who volunteer will be included in the sample of the research

Exclusion Criteria:

* Pregnancy during the study, Having previously or currently participated in a motivational interviewing program, Those who want to leave the research, Not completing motivational interviewing sessions, Infertile women with any deficiencies or errors in any of the forms from which the data are obtained will be excluded from the sample.

Primary outcomes:
measure: motivational interview
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Eda Sever
state: Onikişubat
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Esra Karataş Okyay
role: PRINCIPAL_INVESTIGATOR
affiliation: Kahramanmaras Sutcu Imam University
name: Eda Sever
role: STUDY_DIRECTOR
References:
Clinical trial NCT01188590: Transcutaneous Carbon Dioxide Monitoring Post Cardiac Surgery: Incidence and Severity Resp Insufficiency
Official title: Pilot Study: Transcutaneous Carbon Dioxide Monitoring Post Cardiac Surgery: Incidence and Severity of Respiratory Insufficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Insufficiency
Keywords: Post operative Respiratory insufficiency
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2010-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cardiovascular surgical patients at Baylor University Medical Center

Brief summary: The purpose for the investigators study is to investigate the severity and incidence of respiratory insufficiency using transcutaneous carbon dioxide (TcPCO2) monitoring as an adjunct to the current standard of care for early detection of inadequate ventilation in post-operative surgical in-patients undergoing cardiac surgery after discharge from intensive care unit (ICU) or post anesthesia recovery unit (PACU).

Detailed description: This observational study is to determine the baseline carbon dioxide and severity of respiratory distress and acute respiratory failure (ARF)/respiratory arrest in the post cardiac surgery patients in the first 24 hours on a monitored telemetry floor.

Eligibility criteria: Inclusion Criteria:

* ASA Class 1, 2, 3, or 4 men and women who are having cardiac surgery by one of the participating surgeons

Exclusion Criteria:

1. Subject has participated in a trial with any experimental drug or device trial within 30 days prior to enrollment in the study, or has ever been enrolled in this study;
2. Subject has a condition that would require an extensive amount of time off of 13 Roberts during the first 24 hours of admission to the telemetry unit. (e.g., hemodialysis);
3. Subject has a condition or allergy which would prohibit placing the probe on the earlobes;
4. Subject is unable to undergo any procedure required by the protocol;
5. Subject has any other condition or factor which, in the Investigator's opinion, might increase the risk to the subject; or
6. If female, subject is non-lactating, and is either:

   * Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or
   * Of childbearing potential but is not pregnant as confirmed by negative serum pregnancy test at time of screening.

Primary outcomes:
measure: Determine the baseline TcPCO2 levels for first 24 hours post ICU of cardiac surgery patients.
timeFrame: 24 hours
Secondary outcomes:
measure: Classify levels of hypercarbia found
timeFrame: 24 hours
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Michael A Ramsay, MD, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02302690: Immunity Against AAV in Crigler Najjar Patient
Official title: Study of the Prevalence of Pre-existing Immunity Against the Adeno-associated Virus (AAV) in Patients With Crigler-Najjar Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crigler Najjar Syndrome
Lead sponsor: Genethon
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Crigler Najjar syndrome

Brief summary: The proposed research protocol aims at addressing these points by pre-screening CN patients for their AAV serology in link with their medical history and current medical status. A first objective is to assess the presence of neutralizing AAV antibodies in the serum of CN patients.


Eligibility criteria: Inclusion Criteria:

* The patient has a Crigler-Najjar syndrome
* The molecular diagnosis has been confirmed by UGT1A1 gene DNA sequencing

Exclusion criteria:

* The patient is liver transplanted
* The patient is suffering from severe associated pathologies precluding further enrolment in a future interventional clinical study

Primary outcomes:
measure: To assess the presence of neutralizing AAV antibodies in the serum of CN patients
timeFrame: 1 day visit
Secondary outcomes:
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hopital Antoine Béclère
Study officials:
References:
Clinical trial NCT00825890: The High Cup/Disc Ratio in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: high cup disc ratio
glaucoma suspect
Lead sponsor: Kim's Eye Hospital
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: high cup disc ratio in children

Brief summary: To investigate of high cup/disc ratio in children.

Detailed description: ophthalmologic examination

1. cycloplegic refraction
2. axial length and anterior chamber depth
3. intraocular pressure

B. optic nerve head and retinal nerve fiber layer

1. disc photography
2. Heidelberg Retina Tomograph

Eligibility criteria: Inclusion Criteria:

* high cup/disc ratio more than 0.5
* age : five to twelve

Exclusion Criteria:

* previous surgery (except strabismus surgery) previous glaucomatous medication history poor cooperated children.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kim's Eye Hospital
Study officials:
affiliation: Kim's Eye Hospital, University of Konyang
name: Ungsoo S Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05906290: Formative Development of a Multigenerational eHealth Intervention for Grandparents and Grandchildren
Official title: Formative Development of a Multigenerational eHealth Intervention for Grandparents and Grandchildren
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Physical Inactivity
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Center on Aging and Adult Development Disabilities (CADD)
First posted: 2023-06-15
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study develops a multigenerational electronic Health (eHealth) (web and mobile phone-based) program to improve physical activity levels and to better understand the relationship between grandparents and their grandchildren. The importance of social and familial support for older adults and the need to address increasing declines in physical activity for both children and older adults. Health promotion interventions that capitalize on the existing relationship between grandparents and grandchildren may simultaneously improve health-related outcomes for older adults and children.


Eligibility criteria: Inclusion Criteria:

* Female or male grandparent with a grandchild
* Grandparent is at least 45 years old
* Grandparent has a grandchild between the ages of 6-12 years old
* Grandparent is English or Spanish speaking

Exclusion Criteria:

* Grandparent has a chronic medical condition that interferes with physical activity (e.g., wheelchair bound, severe heart disease, uncontrolled hypertension, brittle diabetes mellitus, chronic arthritis)
* Grandparent has a diagnosis of dementia or significant cognitive impairment based on the telephone interview for cognitive status (TICS)

Primary outcomes:
measure: Program acceptability as measured by Qualitative Interview Guide Field Trial
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: Sara M St. George, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kobayashi MA, St George SM, Leite RO, Noriega Esquives B, Wetstone R, Pulgaron ER, Prado G, Czaja SJ. Formative Development of a Technology-Based Physical Activity Intervention for Grandparents and Grandchildren. J Aging Phys Act. 2022 Jun 1;30(3):482-494. doi: 10.1123/japa.2020-0481. Epub 2021 Oct 5.
Clinical trial NCT04194190: A Single Patient Will be Treated With Individual Patient TCR-Transduced PBL
Official title: Single Patient Protocol: A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2019-12-11
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: A single patient will be treated with Individual Patient TCR-Transduced PBL

Detailed description: Background:

-Please refer to National Cancer Institute Surgery Branch (NCI-SB) protocol 18-C-0049, Amendment F.

Objective:

-Under Individual Patient Expanded Access, to treat a patient with metastatic breast cancer with autologous peripheral blood lymphocytes (PBL) that have been transduced with genes encoding T-cell receptors that recognize mutated neoantigens in the autologous cancer.

Eligibility:

* Must have measurable, metastatic disease as assessed per RECIST v1.1 criteria.
* Must sign the informed consent document.
* Willing to sign Durable Power of Attorney Form.
* Must have all regulatory approvals prior to start of treatment.

Design:

* Please refer to NCI-SB protocol 18-C-0049, Amendment F.
* The patient will be treated with a non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine, followed by the infusion of autologous transduced PBL and then high-dose aldesleukin. The patient will also receive pembrolizumab on Day -2 prior to cell administration and additional doses every 3 weeks following cell infusion until the time of disease progression.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05825690: BRIEF TITLE * (in English and Sufficiently Descriptive) Role of MRI in Anti-LGI1 Encephalitis
Official title: Investigating the Prognostic Role of Brain MRI in Anti-LGI1 Encephalitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Encephalitis
Keywords: Autoimmune encephalitis
LGI1 antibodies
MRI
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be included from the from the database of the French Reference Centre for Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis (Lyon, France)

Brief summary: The term "autoimmune encephalitis" denotes an heterogenous group of diseases commonly associated with autoantibodies targeting neural or glial antigens. Patients harboring antibodies against the leucine-rich glioma-inactivated protein 1 (LGI1) usually respond well to immunotherapy, but a significant percentage develop cognitive sequelae and disability nonetheless. These patients would likely benefit for more aggressive and prolonged immunotherapy, aiming to prevent permanent neurological deficits. Identifying features predicting poor outcome would be crucial to guide treatment decisions. Brain magnetic resonance imaging is a key diagnostic tool in the acute phase, but radiological changes may also appear in follow-up studies, including global brain atrophy, hippocampal atrophy and mesial temporal sclerosis. We hypothesize that specific changes identifiable in the acute and chronic phase underlie a higher risk of poor outcome and persistent neurological deficits.


Eligibility criteria: Inclusion Criteria:

* - Patients with a definite diagnosis of LGI1-antibody-associated encephalitis
* available MRI records
* Ascertained positivity for LGI1-antibodies in serum and/or CSF

Exclusion Criteria:

* - Positivity for another antibody against neural or glial antigens
* MRI images not available
* Not enough clinical data to ascertain outcome

Primary outcomes:
measure: Cognitive dysfunction and disability
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes
Study officials:
References:
Clinical trial NCT00682890: Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)
Official title: Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
PCOS
Insulin Sensitivity
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2008-05-23
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to determine if adding Metformin, a drug that reduces insulin resistance, to birth control pills will reduce the risk of developing type 2 diabetes, high blood pressure. high lipid levels and heart disease in women with PCOS

Detailed description: Inclusion criteria: PCOS women between the ages of 18-45,\< 8 periods annually, elevated serum free testosterone, normal thyroid function tests and serum prolactin, exclusion of late onset adrenal hyperplasia, acceptable health based on interview and medical history, physical exam and lab tests, ability to comply with the requirements of the study and to provide signed, witnessed informed consent.

Eligibility criteria: Inclusion Criteria:

* Ages 18-45, , 8 menstrual cycles annually, elevated serum free testosterone, normal thyroid function test and serum prolactin, exclusion of late onset adrenal hyperplasia

Exclusion Criteria:

* Diabetes mellitus, pulmonary, cardiac, renal, hepatic, cholestatic, neurologic, psychiatric, infectious, malignant diseases,history of breast cancer, history of Deep Vein Thrombosis, pregnancy and lactation.

Primary outcomes:
measure: Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI)
timeFrame: baseline and 3 months
measure: Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI)
timeFrame: baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: General Clinical Research Center
state: Virginia
Study officials:
affiliation: DSMB
name: Leo Dunn, MD
role: STUDY_DIRECTOR
References:
citation: Essah PA, Arrowood JA, Cheang KI, Adawadkar SS, Stovall DW, Nestler JE. Effect of combined metformin and oral contraceptive therapy on metabolic factors and endothelial function in overweight and obese women with polycystic ovary syndrome. Fertil Steril. 2011 Aug;96(2):501-504.e2. doi: 10.1016/j.fertnstert.2011.05.091. Epub 2011 Jul 5.