louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02807935: The in Vivo Effect of Medical and Surgical Glaucoma Treatments on the Schlemm's Canal Micro-structure
Official title: The in Vivo Effect of Medical and Surgical Glaucoma Treatments on the Schlemm's Canal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Cataract
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-06-21
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of our current series of studies is to evaluate different glaucoma treatments in vivo effect on the conventional outflow pathway, and specifically on the Schlemm's canal (SC) anatomy using Enhanced Depth Imaging (EDI)-optical coherence tomography (OCT) . The images will be taken as part of the patients routine medical follow up (before starting the treatment, and 1,4 and 12 weeks afterwards) diameter, cross-sectional area and volume will be measured using commercially available 3-dimensional reconstruction.

The series of studies will be divided into 3 branches, each branch contains different treatments.For each treatment different patients will be recruited.

The branches are as following-

1. The surgical branch-

   1. Before and after trabeculotomy
   2. Before and after cataract surgery
   3. Before and after vitrectomy surgery
   4. Before and after XEN™ Gel Stent implant
2. The pharmacological branch-

   1. Before and during the treatment with prostaglandins analogs
   2. Before and during the treatment with alpha blockers
   3. Before and during the treatment with beta blockers
   4. Before and during the treatment with carbonic anhydrase inhibitor
3. The laser branch-

   1. Before and after trabeculoplasty
   2. Before and after laser iridotomy
   3. Before and after yag capsulotomy laser


Eligibility criteria: Inclusion Criteria:

1. Male or female of any race, at least 18 years of age.
2. Has provided verbal and written informed consent.
3. Able and willing to follow instructions, including participation in all study assessments and visits.
4. Has been referred to one of the treatments mentioned

Exclusion Criteria:

1. Has history of ocular conditions that may affect the SC structure (e.g., ocular neovascularization, anterior segment congenital anomalies)
2. Subject uncooperativeness that restricts adequate examination of IOP, ocular fundus or
3. any ocular or systemic conditions that may reduce OCT image quality (e.g., severe dry eye syndrome, visually significant cataract, limbal opacities, nystagmus, Parkinsonism, etc),
4. Pregnant women or male or female younger than 18 years of age

Primary outcomes:
measure: Mean SC (schlemm's canal) cross-sectional area and volume
timeFrame: 1 year
Secondary outcomes:
measure: Correlation of changes with intraocular pressure (IOP) reduction
timeFrame: 1 year
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: SHEBA medical center
Study officials:
References:
Clinical trial NCT00643435: Self-Efficacy Enhancing Interviewing Techniques Study
Official title: Self-Efficacy Enhancing Interviewing Techniques Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Depression
Anxiety
Asthma
Post-Traumatic Stress Disorder
Keywords: self-efficacy
chronic illness
health behavior
education, medical, residency
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-03-26
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patient self-efficacy, or confidence in one's ability to take the necessary steps to achieve a goal, has been shown to influence a number of important health behaviors and outcomes. However, current ways of increasing patient self-efficacy are time and labor intensive and occur away from doctor visits, where most health care is delivered. We developed, and are testing in a study the effectiveness of a new way of teaching doctors how to talk to patients during office visits in a way that will boost their patients' self-efficacy for changing important health behaviors.


Eligibility criteria: Inclusion Criteria:

* Family medicine or internal medicine residents in training at the University of California Davis Medical Center

Exclusion Criteria:

* None

Primary outcomes:
measure: Resident physician use of self-efficacy enhancing patient interviewing techniques, assessment via coding of audio recordings from standardized patient encounters
timeFrame: Within 6 months of completion of intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Family and Community Medicine, University of California Davis School of Medicine
name: Anthony F Jerant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01900535: Evaluation and Comparison of the Efficacy of Triphala Mouthwash and 0.2% Chlorhexidine
Official title: A Randomized Clinical Trial to Evaluate and Compare the Efficacy of Triphala Mouthwash With 0.2% Chlorhexidine in Hospitalized Patients With Periodontal Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Disease
Keywords: chlorhexidine
gingivitis
periodontitis
Lead sponsor: Tatyasaheb Kore Dental College
Sponsor class: OTHER
First posted: 2013-07-16
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants were selected from patients admitted to three different medical hospitals namely Mahatma Gandhi Hospital, New Pargaon, Sub district Government Hospital, Kodoli and Yeshwant Chavan Hospital, Kodoli

Brief summary: The purpose of this study is to evaluate the usefulness of triphala mouthwash in comparison with the gold standard chlorhexidine in hospitalized and periodontally diseased patients.


Eligibility criteria: Inclusion Criteria:

* age group of 20-65 years having periodontal diseases according to American Academy of Periodontology (AAP) classification 1999

Exclusion Criteria:

* patients seeking any periodontal treatment during the course of study

Primary outcomes:
measure: plaque index
timeFrame: 15 days
Secondary outcomes:
measure: gingival index
timeFrame: 15 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06207435: Community Support Program for Lung Cancer Screening
Official title: Community Support Program for Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Behavior
Keywords: screening adherence
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The research study aims to create a program for lung cancer screening attendance

Detailed description: The overall objective of this project is to demonstrate the impact of a community support program (CSP) on improving adherence to LCS follow-up guidelines in an urban environment. The project aims to collaborate with community partners to develop an infrastructure and iterative process to provide social support to community members that facilitates obtaining their follow-up LDCT for LCS. It utilizes novel population level data that includes geospatial analysis of neighborhood-level data of patients residing in Philadelphia who have received a LDCT for LCS. This allows for targeted community level interventions and the ability to evaluate impact on a population level.

A Community Support Program Representative will reach out to eligible patients via telephone. The CSP Representative and Patient Navigator will communicate with consented patient directly, assist with travel and the appointment. The PN will log the date of the appointment, zip code of the patient and the adherence (or lack of) of the appointment completion. We will utilize Lyft transportation vouchers to provide rides to participants from their home location in West Philadelphia to and from the Penn Medicine downtown hospital locations on the day of their LDCT.

Eligibility criteria: Inclusion Criteria:

* Upcoming or missed follow-up LDCT (low dose CT)
* West Philadelphia resident
* Between 18-89 years' old

Exclusion Criteria:

* No upcoming LDCT
* Lives outside West Philadelphia
* Outside age range

Primary outcomes:
measure: Develop a community support program for lung cancer screening adherence
timeFrame: 12 months
Secondary outcomes:
measure: Measure the impact of the community support program in improving adherence to lung cancer screening follow-up
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Farouk Dako, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01511835: Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gestational Diabetes
Keywords: diabetes
pregnancy
myo-inositol
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
First posted: 2012-01-19
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT

Brief summary: The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.


Eligibility criteria: Inclusion Criteria:

60 women in their first trimester of pregnancy affected by one or more of the following risk factors:

* Glycemia levels \> 92 mg/dl
* BMI \> 30
* At least a parent or a brother (or sister)affected by diabetes
* Pre-existing pregnancy with gestational diabetes

Exclusion Criteria:

* Pregnant women affected by pregestational diabetes
* Twin pregnancy
* Patients affected by pre-existing diseases in pregnancy (diabetes excluded)
* Patients affected by chronic disorders

Primary outcomes:
measure: OGTT
Secondary outcomes:
measure: Number of pregnant women with gestational diabetes
measure: Number of pregnant women requiring insulin treatment
measure: Weight gain at the end of pregnancy
measure: Number of newborn infants whose weight is more than 4000 g
measure: Number of newborn infants requiring Neonatal Intensive Care (NIC)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: AGUNCO
Study officials:
References:
citation: Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2.
citation: Corrado F, D'Anna R, Di Vieste G, Giordano D, Pintaudi B, Santamaria A, Di Benedetto A. The effect of myoinositol supplementation on insulin resistance in patients with gestational diabetes. Diabet Med. 2011 Aug;28(8):972-5. doi: 10.1111/j.1464-5491.2011.03284.x.
Clinical trial NCT01535235: ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study
Official title: ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Keywords: HIV
Lymphoid fibrosis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: amfAR, The Foundation for AIDS Research
First posted: 2012-02-17
Enrollment: 31
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 investigators propose a proof-of-concept, pathogenesis-oriented, randomized, placebo-controlled pilot study to assess whether the addition of an angiotensin converting enzyme (ACE) inhibitor to standard Highly Active Antiretroviral Therapy (HAART) reverses lymphoid fibrosis, and whether this leads to more effective HIV-specific host immune responses and an accelerated clearance of the latent reservoir.


Eligibility criteria: Inclusion Criteria include:

* Stable HAART with maintenance of plasma HIV RNA levels below level of detection (\< 40-75 copies/mL) for ≥ 12 months
* \> 90% adherence to HAART within preceding 30 days

Exclusion Criteria include:

* Screening systolic blood pressure \< 110mm Hg or diastolic blood pressure \< 60mm Hg
* Current use of any ACE inhibitor, angiotensin receptor blocker, or aldosterone antagonist
* Known diabetes mellitus or cardiovascular/kidney/collagen vascular disease
* Pregnant/breastfeeding women.

Primary outcomes:
measure: Change in HIV RNA (Copies/Million Rectal Cells)
timeFrame: 22 weeks
Secondary outcomes:
measure: Change in HIV DNA (Copies/Million Rectal Cells)
timeFrame: 22 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Hiroyu Hatano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01817335: Psycho-Educational Program in Increasing Knowledge and Satisfaction and Decreasing Distress in Younger Patients With Cancer Receiving Treatment
Official title: Pilot Study of Psycho-Educational Group for Young Adults (YA) on Treatment: Impact on Knowledge, Distress, and Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm
Psychosocial Effects of Cancer and Its Treatment
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-03-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot clinical trial studies psycho-educational program in increasing knowledge and satisfaction and decreasing distress in younger patients with cancer receiving treatment. Psycho-educational program may increase knowledge and satisfaction and decrease distress in younger patients with cancer receiving treatment

Detailed description: PRIMARY OBJECTIVES:

I. Providing a psycho-educational group to young adults while examining the feasibility of such a group with patients on treatment.

II. Examining effectiveness of the program through evaluating pre-post changes in participant distress, evaluating increases in participant' knowledge regarding disease issues and coping, and evaluating participant satisfaction.

OUTLINE:

Patients undergo psycho-educational program comprising medical/symptom management and communication with a medical team, coping skills, self image, and relationships and communication for 1.5 hours once weekly for 6 weeks.

After completion of study treatment, patients are followed up for 30 days.

Eligibility criteria: Inclusion Criteria:

* Currently in active treatment (diagnosed and receiving treatment within 2 weeks of initial study enrollment; active treatment includes currently receiving any of the following: chemotherapy, radiation therapy, maintenance drugs, surgery, clinical trial enrollment, or current relapse/secondary malignancy)
* Inpatient or outpatient
* Cancer diagnosis
* Physician approval
* Informed consent

Exclusion Criteria:

* Significant psychiatric or developmental issues, as determined by screening interview conducted by psychologist or clinical social worker
* Currently off treatment (longer than 2 weeks at the time of enrollment)
* In isolation or with isolation precautions
* Non-English speaking

Primary outcomes:
measure: Proportion of subjects who are unable to attend all the sessions
timeFrame: Up to 30 days
Secondary outcomes:
measure: Mean of the YA (Young Adult) Patient Satisfaction evaluations
timeFrame: Up to 30 days
measure: Mean of the Pre/Post Test Knowledge Questionnaire
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Jeanelle Folbrecht
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00861835: Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate (TBNA)
Official title: A Randomized Prospective Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate Specimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchoscopy
Lead sponsor: MaineHealth
Sponsor class: OTHER
First posted: 2009-03-13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: Purpose: Previous studies suggested an increased diagnostic yield for bronchoscopic (FB) transbronchial needle aspirate (TBNA) specimens from mediastinal lymph nodes when using rapid on-site evaluation by cytopathology (ROSE) but were limited by lack of randomization. The investigators performed the first randomized-prospective trial comparing ROSE(R) to no on-site cytopathology assessment (NR).

Methods: All patients referred were eligible. 78 patients were randomized to R or NR groups. For R procedures, further specimens were deferred until results were available from the on-site cytopathologist. Diagnoses made by all procedures were recorded. The primary end-points were specimen adequacy and diagnostic yield.


Eligibility criteria: Inclusion Criteria:

* Eligible patients included all adults referred for bronchoscopy with anticipated TBNA.

Exclusion Criteria:

* Patients were to be excluded only if the attending physician felt ROSE must be used for diagnosis or if the patient refused consent.

Primary outcomes:
measure: diagnostic yield
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06018935: A Cohort Establishment Study of Total Management of Ovarian Cancer
Official title: A Cohort Establishment Study of Total Management of Ovarian Cancer (Including Fallopian Tube Cancer and Primary Peritoneal Cancer)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tumor of Female Reproductive System
Ovarian Cancer
Keywords: Ovarian cancer
Cohort study
Whole-process management
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with ovarian cancer (including fallopian tube cancer, primary peritoneal cancer) and intended to be treated in our hospital

Brief summary: A cohort establishment study of total management of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer).

Detailed description: 1. To investigate the effects of surgery, chemotherapy, maintenance therapy and related factors on the prognosis and quality of life of patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer);
2. To study the postoperative recovery of patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer), perioperative complications, adverse reactions after chemotherapy, adverse reactions during targeted drug maintenance therapy, and explore possible effective preventive measures;
3. The prognostic factors of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) were analyzed;
4. To study the efficacy and safety of PARPi in clinical application in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer).

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with ovarian cancer (including fallopian tube cancer, primary peritoneal cancer) and intended to be treated in our hospital;
2. Can cooperate with later follow-up.

Exclusion Criteria:

1. Patients with other malignant tumors or previous history of other malignant tumors;
2. Have cognitive impairment.

Primary outcomes:
measure: Progress Freesurvival (PFS)
timeFrame: Average six months after study completion.
measure: Overall Survival (OS)
timeFrame: Average six months after study completion.
Secondary outcomes:
measure: Occurrence of adverse reactions
timeFrame: Average six months after study completion.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
Study officials:
References:
Clinical trial NCT05734235: UVB-Induced MVP Release in Human Skin
Official title: Ultraviolet B Radiation-Induced Microvesicle Particle Release in Human Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ultraviolet B Radiation
Microvesicle Particles
Lead sponsor: Wright State University
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 8
Sex: MALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to assess if ultraviolet B radiation (UVB) found in sunlight causes the release of microvesicle particles in human skin, and if antioxidant vitamins can block their production.


Eligibility criteria: Inclusion Criteria:

* Male subjects
* Ages 21 to 45
* Skin type: Fitzpatrick Type I or II

Exclusion Criteria:

* Have underlying diseases that could affect wound healing
* On medications that are known photosensitizers (e.g., doxycycline) or anti-inflammatories (e.g., NSAIDS \[except for low-dose aspirin\] or steroids)
* History of abnormal scarring (e.g., keloids)
* Should not be on Vitamin C or E supplements for past month
* Unable to understand/complete informed consent
* Large volar arm tattoos that would inhibit the ability to conduct/evaluate the skin testing
* Renal compromise/kidney stones or allergy to Vitamin C/Vitamin E or lidocaine anaesthetic
* Use of tanning bends or recent UVB exposure to the areas in the past 3 months
* Recent (within 1 week) use to sunscreen to volar forearms

Primary outcomes:
measure: Change in microvesicle particles (MVP) levels from baseline
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
Study officials:
affiliation: Wright State University
name: Jeffrey B Travers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: