louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00178295: Radiation-Induced Cytokine Cascades and Their Correlation With Central Nervous System Injury
Official title: Radiation-Induced Cytokine Cascades and Their Correlation With Central Nervous System Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Neoplasm
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 44
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: Patient who are going to receive radiation therapy as part of the treatment for their brain cancer

Brief summary: Treatment for brain cancer may include radiation therapy. Radiation therapy is the treatment of tumors with X-rays. This study is related to understanding the side effects of radiation treatment for brain tumors.

This study is being conducted by the University of Rochester Cancer Center to compare the extent of side effects of brain cancer treatment with changes in levels of blood proteins called cytokines.


Eligibility criteria: Inclusion Criteria:

* Any patient who will be treated to the brain or spinal axis for a CNS tum Patients so treated will be stratified according to whether or not the hypo is included in the treatment fields.
* Patients receiving external beam radiation to the brain may also be rece chemotherapy or interferon-beta. (Add. #1, 11-9-95)
* Patients receiving high dose rate (stereotactic radiosurgery) are eligible.
* Patients must sign a study specific informed consent meeting all federal a guidelines.
* Patients of any age, including children, are eligible (Add. #3, 11/25/97).

Exclusion Criteria:

* Patients who have a malignancy involving the hypothalamic-pituitary ax
* Patients who are not treated with irradiation to the brain or spinal axis.

Primary outcomes:
measure: Change from baseline in Cytokine blood levels
timeFrame: 12 weeks from start of radiation
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester, Dept. Radiation Oncology
state: New York
Study officials:
affiliation: Universtiy of Rochester, Dept of Radiation Oncology
name: Louis S Constine, MD
role: STUDY_CHAIR
affiliation: University of Rochester, Department of Radiation Oncology
name: Ralph Brasacchio, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04806295: The Leukemia and Lymphoma Society (LLS) National Research Registry
Official title: The Leukemia and Lymphoma Society (LLS) National Research Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Cancer
Lead sponsor: Lymphoma and Leukemia Society
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with blood cancer, before, during, and after blood cancer treatments.

Brief summary: The Leukemia and Lymphoma Society (LLS) has built a National Research Registry to evaluate real world experiences and medical outcomes for people with blood cancer, before, during, and after blood cancer treatments.

Detailed description: The LLS National Research Registry is a real-world experiences and outcomes research registry; a collection of patient information and medical data, over time, about people who have a particular disease or condition, or who receive a particular treatment.

The LLS National Research Registry Protocol will:

1. Answer research questions using data collected from people with blood cancers. Such research involves analyses of subject profile information completed by subjects and medical records data.
2. Obtain permission from LLS National Research Registry research subjects to have Ciitizen, a third-party engaged by LLS, act as their proxy to retrieve full medical record data including images at no cost to research subjects. Note: Patient can choose to upload their medical records into their account, directly.
3. Obtain permission from LLS National Research Registry research subjects to share summary data with research partners (like academic researchers, advocacy groups, and pharmaceutical companies) that are advancing treatments for blood cancer. "Summary data" represents the important elements of medical record data, coded for research use, with personal identifiers like name, address, and phone number removed.
4. Obtain permission from LLS National Research Registry research subjects to be contacted from time to time, for them to provide updated medical information.

Eligibility criteria: Inclusion Criteria:

People with blood cancer, before, during, and after blood cancer treatments.

Exclusion Criteria:

People unable or unwilling to sign informed consent.

Primary outcomes:
measure: LLS will monitor outcomes of people being treated for blood cancer.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rye Brook
country: United States
facility: Lymphoma and Leukemia Society
state: New York
Study officials:
References:
Clinical trial NCT00005414: Validation of a Historical Physical Activity Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
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 compare long-term recall of physical activity up to 15 years in the past with physical activity reports and physical fitness levels assessed at the baseline examination.

Detailed description: BACKGROUND:

Sedentary habits in middle-aged individuals are associated with increased risk for cardiovascular disease. Studies examining this association typically have assessed physical activity participation in a narrow window, (for example, 1 week or 1 month) relative to probable disease etiology and progression. When the study was initiated, the possible relation of long-term physical activity patterns over decades or a lifetime to disease risk was not known because there existed no validated method of determining such exposure, but such studies were needed. It was hypothesized that validation of long-term recall of activity could lead to the application of lifetime physical activity patterns questionnaires. Data on lifetime activity patterns might be useful in case-comparison and prospective studies of cardiovascular disease.

DESIGN NARRATIVE:

Data analyzed for this project were from a cohort that had been under observation in the Aerobics Center Longitudinal Study. Baseline preventive medical examinations were given to 6,902 men and women during the interval from 1971-1982. Current physical activity and physical fitness levels (maximal exercise treadmill test) were assessed at baseline. Participants also completed a lifetime physical activity pattern questionnaire as part of a mail survey done in 1986. Self-reported physical activity from the 1986 questionnaire was used to categorize participants' physical activity levels for the years 1971-1985. These recalled levels of activity were compared to physical activity and physical fitness levels assessed during those same years at the baseline examinations (measure of truth). For example, participants who reported in the 1986 survey that they engaged in relatively high levels of physical activity in 1976 were expected to have recorded higher levels of physical fitness at the 1976 examination than participants who reported in 1986 that they were relatively sedentary in 1976. The study design permitted evaluation of how accurately participants recalled their physical activity up to 15 years in the past and allowed quantification of the errors investigators might expect from such assessments.

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 NCT02224014: Lendormin D® Tablet (Drug Use Result Survey)
Official title: Lendormin D® Tablet (Drug Use Result Survey)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Initiation and Maintenance Disorders
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-22
Enrollment: 485
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 insomnia, receiving Lendormin D tablet under condition of normal clinical practice

Brief summary: Study to investigate the safety and the efficacy in patients with insomnia, receiving Lendormin D tablet under condition of normal clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients with insomnia

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 2 months
measure: Number of patients with adverse drug reactions
timeFrame: up to 2 months
measure: Number of patients with serious adverse events
timeFrame: up to 2 months
Secondary outcomes:
measure: Physician's overall efficacy assessment on a 3-point scale
timeFrame: up to 2 months
measure: Patient's impression questionnaire
timeFrame: up to 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02900014: Validation of a Production Method of Stem Cell Isolated From the Nasal Cavity for an Innovative Cell Therapy of Cleft Palate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Palate
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 2
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Cell therapy appears to be an alternative to treat bone defects. Scientific advances have shown in animal models and in humans that mesenchymal stem cells were good candidates to support cellular bone regeneration after transplantation. However, their collection requires invasive sampling usually bone marrow. A new candidate stem cells able to stimulate bone regeneration has recently been identified in the nasal cavity, these cells are called "ecto-mesenchymal" cells. These stem cells have very similar biological characteristics of mesenchymal stem cells of bone marrow. They exhibit a high mitogenic activity and hold great potential for differentiation into osteoblast lineage. Given their properties and their ease of access within the nasal cavity, ecto-mesenchymal stem cells offer new prospects for cell therapy targeting bone involvement. In this context, the ecto-mesenchymal stem cells represent a nasal bone reconstruction interesting alternative in particular in indication of the cleft. They are directly and easily accessible in these children when conventional surgical reconstruction. The investigators propose in this study to validate a production method of stem cell called "ecto-mesenchymal" isolated from a biopsy of the nasal cavity of children with cleft lip and palate to be able to soon propose cell therapy innovative in this indication.


Eligibility criteria: Inclusion Criteria:

* Paediatric patients with unilateral cleft lip and alveolar (or maxilla) or labio-maxillo-palatal, requiring surgical management of reconstruction
* Children weighing more than 2 kg

Exclusion Criteria:

* Children with concomitant pathology that might alter bone turnover: osteogenesis imperfecta, kidney failure, chronic inflammatory diseases, infections, other diseases

Primary outcomes:
measure: number of nasal mesenchymental stem cells
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle Desalbres
role: STUDY_DIRECTOR
References:
Clinical trial NCT00335114: Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers
Official title: Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Wearers With Dry Eye Syndrome
Keywords: cyclosporine, dry eye syndrome, contact lens
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2006-06-08
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cyclosporine Ophthalmic Emulsion is currently used in the treatment of dry eye syndrome. Contact lens wearers frequently suffer from dry eye syndrome. The purpose of this study is to evaluate cyclosporine ophthalmic emulsion verses re-wetting drops in the relief of dry eye symptoms in contact lens wearers


Eligibility criteria: Inclusion Criteria:

* contact lens wearer
* clinical diagnosis of dry eye syndrome

Exclusion Criteria:

-

Primary outcomes:
measure: Ocular exams and questionnaires at baseline and at 3 months will determine
measure: the effect of cyclosporine on dry eye syndrome.
Secondary outcomes:
measure: Increased contact lens wearing time due to a decrease in severity
measure: of dry eye symptoms
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Ophthalmology Services Foundation
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Carol E Rosenstiel, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02104414: Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy
Official title: Comparison of Rectal Infiltration of Exparel vs. 0.25% Bupivacaine With Epinephrine vs. Placebo for Analgesic Benefit Following Hemorrhoidectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hemorrhoid
Keywords: Liposomal Bupivacaine
Exparel
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the quality and duration of pain relief after a hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more effective postoperative pain relief than both bupivacaine hcl and the control.


Eligibility criteria: Inclusion Criteria:

* patients undergoing hemorrhoidectomy for grade 3 or 4 hemorrhoids who are English-speaking patients, 21-65 yr of age, ASA physical status I-III, BMI\<30

Exclusion Criteria:

* contraindications to administration of local anesthesia (e.g., local anesthetic allergy), difficult airway (Mallampati\>2), psychiatric or cognitive disorders, pregnancy , and history of substance abuse or chronic opioid use

Primary outcomes:
measure: Post Operative Pain Control
timeFrame: up to 4 days
Secondary outcomes:
measure: Number of Oxycodone Tablets Taken
timeFrame: up to 4 days
measure: Postoperative Opioid Consumption - Hydromorphone I.V
timeFrame: 1 hour and 2 hours post op
measure: Number of Participants With Postoperative Nausea and Vomiting
timeFrame: up to 4 days
measure: Number of Participants With Pain During Bowel Movements
timeFrame: Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days
measure: Number of Participants With Urinary Retention
timeFrame: up to 4 days
Other outcomes:
Locations:
city: New York
country: United States
facility: St.Luke's-Roosevelt Hospital Center
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Ali Shariat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06634914: 30-Day MoonBrew Sleep & Stress Study
Official title: 30-Day MoonBrew Sleep & Stress Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep
Stress
Dietary Supplement
Lead sponsor: Efforia, Inc
Sponsor class: INDUSTRY
First posted: 2024-10-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single arm interventional.
Primary purpose: TREATMENT

Brief summary: This study aims to assess how consuming MoonBrew each evening for 30 days impacts sleep quality and stress levels. Poor sleep and high stress often go hand-in-hand, worsening overall health. By using validated self-reported outcome measures, this study bridges the gap between anecdotal evidence and scientific proof (without requiring a connected health device), contributing valuable insights into natural solutions for better sleep.

Detailed description: Poor sleep and high stress levels are pervasive issues affecting millions globally, leading to significant health problems. Research has consistently shown that poor sleep quality can exacerbate stress, while high stress levels can further disrupt sleep patterns. We have some great anecdotal evidence that suggests Moonbrew really works. This study aims to bridge the gap between anecdotal evidence and scientific evidence.

The aim of this study is to scientifically assess the impact of MoonBrew on sleep quality and stress levels using the PROMIS Sleep Disturbance Scale and NIH Toolbox® Item Bank v3.0 - Perceived Stress survey. Our objective is to determine whether regular consumption of MoonBrew can significantly improve sleep patterns and reduce stress over a 30-day period.

This study is significant as it seeks to provide scientific evidence on the efficacy of MoonBrew, a popular natural remedy, in enhancing sleep quality and reducing stress. Expected outcomes include improved sleep patterns and lower stress levels among participants. However, limitations include self-reported data and individual variations in response to MoonBrew. Nonetheless, the findings could pave the way for evidence-based recommendations and broader acceptance of natural sleep aids.

Eligibility criteria: Inclusion Criteria:

* US-based participants

Exclusion Criteria:

* allergies to mushrooms or adaptogens

Primary outcomes:
measure: PROMIS Sleep Disturbance Scale
timeFrame: 30 days
measure: NIH Toolbox® Item Bank v3.0 - Perceived Stress (Ages 18+) - Fixed Form Survey: NIH Toolbox® Item Bank v3.0 - Perceived Stress (Ages 18+) - Fixed Form Survey Score
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05255614: Pelvic vs Virtual Reality Simulator
Official title: Comparative Study to Determine Proper Sequence of Simulation Training Pelvic Versus Virtual Reality Simulator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Training
Keywords: Simulation training
Pelvic trainer
Virtual reality Simulator
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 26
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to evaluate the proper sequence of Pelvic trainer and VR simulator training in order to improve gynecological laparoscopic skills and assess training levels.

Detailed description: In this study, the investigators will determine the proper sequence of simulation training. Pelvic Trainer Versus Virtual reality Simulator in order to improve laparoscopic skills of residents with no or little previous laparoscopic experience.

* This study will compare the proper sequence of simulation training. Pelvic Trainer Versus Virtual reality Simulator of two groups: Group A versus Group B.
* Group A will start training on the pelvic trainer (training on educational intervention 1) and assessment will be via assessment via a checklist (test 1). Then at a later time, they will be trained on VR simulator (Sim Surgery) (educational intervention 2) and assessment will be via Electronic auto assessment via the Simulator (test 2).
* Group B will start training on the VR simulator (Sim Surgery) (educational intervention 2) and assessment will be via Electronic auto assessment via the Simulator (test 2). Then at a later time, they will be trained on the pelvic trainer (training on educational intervention 1) and assessment will be via assessment via a checklist (test 1).

Eligibility criteria: Inclusion Criteria:

* All the residents in Obstetrics and Gynecology department who have no or little previous laparoscopic experience

Exclusion Criteria:

* Residents who have previous good laparoscopic experiences.
* Age below 26 or Above 29 years

Primary outcomes:
measure: assessment of time needed to accomplish the tests before and after pelvic trainer
timeFrame: 6 months
measure: assessment of time needed to accomplish the tests before and after victual reality simulator
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Kasralainy teaching hospital
name: Marwa M Abdalla, MD
role: PRINCIPAL_INVESTIGATOR
References: