louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04582110: The Role of OCTA in Patients Affected by Beta Thalassemia
Official title: Retinal and Choriocapillaris Vascular Features in Patients With Beta Thalassemia by Means of Optical Coherence Tomography Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thalassemia
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 82
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 35 years with diagnosis of Beta Thalassemia. They did not present other ophthalmological diseases.

Brief summary: To investigate, using optical coherence tomography angiography (OCTA), the retinal and choriocapillaris vascular features in patients affected by Beta Thalassemia. Moreover we analyzed the structural retinal parameters (ganglion cell complex and retinal nerve fiber layer), using optical coherence tomography (OCT) in these patients

Detailed description: Beta Thalassemia is one of the most common genetic hemoglobinopathy characterized by a defective β globulin chain synthesis leading to hemolysis and ineffective erythropoiesis.

The study investigated the changes in retinal and choriocapillaris vascular features using optical coherence tomography angiography, a novel and noninvasive diagnostic technique that allows a detailed analysis of retinal and choriocapillaris blood flow.

Eligibility criteria: Inclusion Criteria:

* age older than 35 years
* diagnosis of Beta Thalassemia
* absence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* absence of significant lens opacities, low-quality OCT and OCT-A images.

Exclusion Criteria:

* age older than 50 years
* absence of diagnosis of Beta Thalassemia
* presence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* presence of significant lens opacities, low-quality OCT and OCT-A images.

Primary outcomes:
measure: The measurements of retinal and choriocapillaris features in patients with Beta Thalassemia, using optical coherence tomography angiography.
timeFrame: Four months
Secondary outcomes:
measure: The measurements of retinal structural parameters in patients with Beta Thalassemia, using optical coherence tomography.
timeFrame: Four months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
References:
Clinical trial NCT06109610: Cognitive Behavioral Therapy on Adherence and Depression (CBT-AD) Among HIV/AIDS Patients
Official title: A Randomized Control Trial of Cognitive Behavioral Therapy on Adherence and Depression (CBT-AD) Among HIV/AIDS Patients on Follow up at Mattu Karl and Bedele Hospital, 2019
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Medication Adherence
Lead sponsor: Mattu University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Depression is highly comorbid with HIV/ AIDS and is associated with worse poor adherence to antiretroviral therapy (ART), and potentially to long-term immune functioning. Cognitive behavioral therapy may solve these problem.

Detailed description: Depression is highly comorbid with HIV/ AIDS and is associated with worse poor adherence to antiretroviral therapy (ART), and potentially to long-term immune functioning. Poor adherence decreases the benefits of ART as well as chances of prolonged survival. An intervention that integrates CBT for depression with a cognitive behavioral approach to adherence counseling (cognitive behavioral therapy intervention for adherence and depression (CBT-AD)) has been found to be effective in improving adherence and reducing depression in PLWH.

Eligibility criteria: Inclusion Criteria:

* PLWHA who were 18 years old and above were included in the study

Exclusion Criteria:

* PLWHA who were previously took CBT and participants with acute physical or mental disturbances were excluded.

Primary outcomes:
measure: The mean score of Depression will change after intervention
timeFrame: Through study completion, an average of 1 yea
Secondary outcomes:
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Mattu University
Study officials:
affiliation: Mattu Universitry
name: Zakir Abdu, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Mattu University
name: Mohammedamin Hajure, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT06642610: CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis
Official title: CGM Dynamic Index (CDI) for Predicting Prediabetes in People With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prediabetes
Cystic Fibrosis (CF)
Cystic Fibrosis-related Diabetes
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective of this pilot study is to develop a CGM-based model to predict the progression from prediabetes to diabetes in individuals with cystic fibrosis.


Eligibility criteria: Inclusion Criteria:

* CF individuals aged 12-55 years.
* CF without diabetes or with prediabetes (as defined by OGTT and HbA1c).
* Willing to use a continuous glucose monitoring system with compatible smart phone for glucose data collection.

A person with CFRD and already using CGM, we will just collect their personal CGM data, and they are not required to have OGTT or HbA1c visit.

Exclusion Criteria:

* Pregnancy.
* History of transplant.
* Use of immunosuppressant drugs.
* Use of oral steroids or any medication known to interfere with glucose.
* Allergy to adhesives.
* Individuals with severe concurrent medical conditions that could confound glucose monitoring data (e.g., terminal illness, major organ failure).
* Conditions that may make unsafe for participants to do study or impair or confound the study at the discretion of the investigator

Primary outcomes:
measure: CGM Dynamic Index (CDI) for predicting prediabetes in people with cystic fibrosis
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health, University Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT00461110: A Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)
Official title: A Phase 1 Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-04-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the maximum tolerated dose and assess the safety and tolerability of escalating doses of BMS-663513 when given in combination with either radiotherapy alone or radiotherapy plus paclitaxel and carboplatin.


Eligibility criteria: Inclusion Criteria:

* NSCLC who are eligible to receive a 6 week course of RT
* Part 1 - not candidates for definitive RT
* Part 2 - candidates for definitive RT

Exclusion Criteria:

* Severe COPD, pulmonary infection or interstitial pneumonitis
* Recent cellulitis
* Autoimmune disease

Primary outcomes:
measure: To determine the MTD and assess safety and tolerability of single ascending doses of BMS-663513 when given in combination with radiotherapy alone or radiotherapy plus paclitaxel and carboplatin to subjects with Non Small Cell Lung Carcinoma
timeFrame: throughout the study
Secondary outcomes:
measure: Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers
timeFrame: end of study
measure: Describe anti-tumor activity
timeFrame: throughout the study
measure: Obtain blood and plasma for exploratory research
timeFrame: several timepoints throughout the study
measure: Obtain archival tissue for predictive marker research
timeFrame: at screening
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: The Cancer Institute Of New Jersey
state: New Jersey
city: New York
country: United States
facility: Nyu Clinical Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson Univ Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: University Of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00005510: Strong Heart Study Analyses Obesity and Lipoproteins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Obesity
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To examine the relationship of obesity and body fat distribution to lipoprotein concentrations in members of the Strong Heart Study.

Detailed description: BACKGROUND:

The Strong Heart Study is a longitudinal cohort study of several American Indian groups in three participating centers. The overall aim of the main study is to determine the role of various risk factors in the development of cardiovascular disease in this native American population.

DESIGN NARRATIVE:

Data from the first and second clinical exams of the Strong Heart Study were analyzed to determine if body fat distribution as measured by waist-to-hip circumference was a better correlate of lipoproteins than was body mass index. In addition, change in body mass index (BMI) and waist-to-hip ratio (WHR) were correlated with change in lipoproteins.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03893110: Carbon PEEK Versus Titanium Pedicle Screws in the Treatment of Spinal Tumors
Official title: Carbon PEEK Versus Titanium Pedicle Screws in the Treatment of Spinal Tumors - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Tumor
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Radiation therapy is a cornerstone in the treatment of spinal neoplasms as radical resections are often limited anatomically. Frequently, a surgical stabilization with implants is required. However, metallic implants not only make the CT-based planning of a subsequent radiation therapy more difficult, but might also have an uncontrolled dose modulating effect in adjuvant radiotherapy. At the spine, radiation is limited by the effective dose posed to the relatively radiosensitive spinal cord. While metallic implants might result in an inhomogeneous and uncontrollable dose distribution due to the interface effect, the use of new radiolucent implants consisting of carbon/polyether ether ketone (PEEK) might allow a more homogeneous and predictable dose distribution. This study aims to evaluate the potential benefits of the use of carbon/PEEK pedicle screws during adjuvant radiation therapy and follow-up imaging of spinal tumors.

60 patients will randomized 1:1 into either treatment arm (Pedicle System Carbon/PEEK vs. Pedicle System Titanium). The feasibility of planning the radiation therapy will be evaluated. The postoperatively administered total radiation dose is documented. The radiological visualization of the area of interest will be evaluated The surgical outcome is evaluated by fusion rate, implant integrity and anchorage. Patients will be followed up for 12 months according to local standards.


Eligibility criteria: Inclusion Criteria:

* Patients 18 to 99 years of Age
* Primary and secondary spinal tumors of the thoracolumbar spine requiring posterior instrumentation and radiation therapy

Exclusion Criteria:

* Need of cement augmentation or anterior cage support (corpectomy)
* Patients with contraindication against surgical resection
* Patients with incomplete medical records or insufficient imaging

Primary outcomes:
measure: radiation dose
timeFrame: within 6 weeks of radiation therapy
measure: feasibility of planning the radiation therapy
timeFrame: before radiation therapy
Secondary outcomes:
measure: radiological visualization of the area of interest
timeFrame: during radiation therapy
measure: time to recurrence
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Balgrist
state: Zurich
Study officials:
affiliation: Balgrist University Hospital
name: Mazda Farshad, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04019210: Modified Trabeculectomy for Glaucoma Surgery
Official title: Modified Trabeculectomy a New Procedure for Glaucoma Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IOP Decreased
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 17
Sex: ALL
Minimum age (years): 30
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A combination of hypotony, flat anterior chamber and choroidal detachment is the most common complications after filtering surgery. The purpose of this study is to present a new modification in standard trabeculectomy technique to reduce such complications.

Detailed description: Recta-angular scleral flap (one half the scleral thickness) is dissected,reaching 2 mm into the cornea. The dissection through the cornea is carried out with great care, leaving only thin corneal stroma over Descement's membrane.

Application of direct heat cautery using a prob Imm in size (the prob was heated for 45 seconds) the cautery was applied at 4 points two of them just in front of blue corneal line and the other two at 2 mm anterior to the blue line, the diameter of each point is 1 - 1.5 mm. The horizontal distance between each point is 3.5 mm Figure(1). The application of the cautery continue till the color of the tissue becomes brown.

Then with aid of a 23-gauge needle we penetrate these cauterized points to create 4 holes, each of them is nearly 0.3-0.5 mm in length (the opening of each hole takes the shape of a slit). Through one of these holes iridectomy is done.

These holes drain the aqueous under the scleral flap with anatomical preservation of tissue in between.

Close the scleral flap by two 10-0 nylon suture.

Eligibility criteria: Inclusion Criteria:

* 1ery glacouma

Exclusion Criteria:

* Previous surgery

Primary outcomes:
measure: IOP
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut U
Study officials:
References:
Clinical trial NCT06980610: A Randomized Open Controlled Clinical Trial Comparing the Mean Healing Time With Collatamp Versus Directed Healing in Digestive Stoma Closures
Official title: A RANDOMIZEZ OPEN CONTROLLED CLINICAL TRIAL COMPARING THE MEN HEALING TIME WITH COLLATAMP VERSUS DIRECTED HEALING IN DIGESTIVE STOMA CLOSSURES
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgery, Colorectal
Keywords: SURGERY,
digestive stoma closures
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional research with minimal risks and constraints, not involving a product mentioned in Article L. 5311-1 of the CSP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The process of directed healing is a slow one, not without any constraints for patients. In contact with the intestinal flora during the stoma time, the tissues harboring digestive bacteria do not allow direct skin closure without the risk of complications during the restoration of digestive continuity after having to perform an ileal or colonic stoma. Collatamp interposition would allow direct wound closure without additional complications. Various studies have compared directed healing and direct skin closure during stoma closure/restoration of continuity. Overall, directed healing reduces the risk of infection, abscesses, and surgical time, but results in greater constraints for the patient, i.e., longer healing time, more pain, and a poorer cosmetic result compared to direct skin closure.


Eligibility criteria: Inclusion Criteria:

* Person having received full information on the organization of the research and having signed their informed consent
* Patients aged 18 and over
* Patients requiring ileostomy or colostomy closure, or restoration of digestive continuity
* Person affiliated with a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

* Patient suffering from an immune deficiency (which would alter the healing process)
* Patient unable to complete the questionnaire
* Patient with a known intolerance, hypersensitivity, or allergy to aminoglycosides or bovine collagen
* Patient suffering from myasthenia gravis
* Woman of childbearing age without effective contraception
* Person referred to in Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code
* Pregnant woman, woman in labor, or breastfeeding mother
* Minor (non-emancipated)
* Adult subject to a legal protection measure (guardianship, curatorship, or legal protection)
* Adult unable to express consent . Person deprived of liberty by a judicial or administrative decision, person receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1

Primary outcomes:
measure: Time until complete healing expressed in days
timeFrame: 6 months maximum
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05974410: Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Glioblastoma
Squamous Cell Carcinoma
Hodgkin Lymphoma
Non-hodgkin Lymphoma
Breast Cancer
Prostate Cancer
Gastric Cancer
Ovarian Cancer
Acute Leukemia
Pancreatic Cancer
Spindle Cell Sarcoma
Cancer
Tumor, Solid
Tumor, Brain
Esophageal Andeocarcinoma
Mixed Phenotype AML
Desmoplastic Round Cell Sarcoma
Lead sponsor: AVM Biotechnology Inc
Sponsor class: INDUSTRY
First posted: 2023-08-03
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: AVM Biotechnology, Inc., provides immunomodulatory AVM0703 to solid tumor and blood cancer patients upon request by a US licensed MD or DO. As of July 2024, 37 patients have been treated through this FDA-EAP including patients diagnosed with relapsed or recurring glioblastoma, inoperable/chemotherapy ineligible CNS Squamous Cell Carcinoma, metastatic Breast Cancer, ovarian cancer, gastric cancer, Hodgkin's Lymphoma, Mixed Phenotype Acute Myelogenous Leukemia, colon cancer, B-ALL, Malignant Myxoid Spindle Cell Neoplasm, non-small cell lung cancer, DLBCL with CNS involvement, metastatic prostate cancer, Anaplastic T-cell Non-Hodgkin's Lymphoma and metastatic pancreatic cancer. Drug-related side-effects are predominantly grade 1 and include itching during the infusion and about 1 week of low grade insomnia.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AVM Biotechnology Inc
name: Edward Loniewski, D.O.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00712010: Metabolic Effect of High-protein Meals in Men
Official title: Acute Metabolic Effect of the Protein Quality of a High-protein Meal Replacement in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Glucose
Insulin
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2008-07-09
Enrollment: 25
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the clinical study is to investigate the effect of the protein quality of high-protein meal replacements on the management of post-prandial blood glucose in healthy men.

Detailed description: It was a double-blind, single center, randomized, crossover adaptive study design with 7 arms.

The subjects were submitted to 7 tests of ingestion of a high-protein meal replacement (test meal) in randomized order preferably a week apart. The 7 test meals were isocaloric, isonitrogenous and differed in their protein quality.

Eligibility criteria: Inclusion Criteria:

* 20 - 50 years, male
* Healthy as determined by a medical questionnaire
* Normal weight: BMI 20 - 24.9 kg.m-2
* Normal fasting glycemia and insulinemia
* Normal fasting lipidemia (cholesterol and triglycerides)
* Normal liver function (transaminases, γ-GT) and kidney function (urea, creatinine)
* Capable of fast ingestion of the meal replacement (5-10 min)
* Having signed informed consent

Exclusion Criteria:

* Intestinal or metabolic diseases/disorders such as diabetic, renal, dyslipidemia, hepatic, hypertension, pancreatic or ulcer, including lacto-intolerance.
* Hypertension \>150/95 mmHg
* Have had a gastrointestinal surgery
* Have a regular consumption of medication
* Vegetarian, vegan, under dietary supplements
* Have an alcohol intake: \> 2 units a day or smoker
* Currently participating or having participated in a clinical trial during the last month
* Having given blood in the last month
* More than 5 x 45 min of intense exercise per week
* Volunteer who cannot be expected to comply with treatment

Primary outcomes:
measure: Post-prandial Plasma Responses of Glucose Concentrations
timeFrame: 180 minutes
measure: Calculation of the Area Under Curve Over Baseline for Plasma Insulin
timeFrame: 180 minutes from baseline
Secondary outcomes:
measure: Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Nestec Clinical Development Unit / Metabolic Unit
Study officials:
affiliation: Société des Produits Nestlé (SPN)
name: Etienne Pouteau, Ph.D.
role: STUDY_DIRECTOR
References: