louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04758377: Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI
Official title: Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Spinal Cord Haemorrhage
Keywords: vasopressors
magnetic resonance imaging
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2021-02-17
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study is designed to determine whether hemorrhage within the injured spinal cord is influenced by mean arterial pressure (MAP) augmentation with vasopressors and by venous thromboembolism (VTE) prophylaxis with anticoagulants in the first two weeks following a traumatic spinal cord injury (tSCI).

Detailed description: This will be a single-center prospective observational study of patients with an acute cervical traumatic spinal cord injury

Eligibility criteria: Inclusion Criteria:

* Acute tSCI injury involving bony spinal levels between C0 and T1
* Baseline Asia Impairment Scale (AIS) grade of A, B, or C
* Admission to study site within 24 hours of injury
* Male or female age 19 or older
* Able and willing to provide informed consent

Exclusion Criteria:

* Pathological fracture due to metabolic condition or neoplasia
* Spinal cord injury due to infection
* Presence of pacemaker, aneurysm clip or other device which is a contraindication to MRI
* BMI \> 40 and unable to fit within the MRI scanner
* Multiple life threatening injuries (ISS \>16) that make transport to MRI not in the patient's best interest
* Any condition that, at the time of admission, prevents a complete ISNCSCI assessment from being performed

Primary outcomes:
measure: Hemorrhage Quantification 1
timeFrame: Serial MRI assessments: Injury to 2 weeks post injury
measure: Hemorrhage Quantification 2
timeFrame: Serial MRI assessments: Injury to 2 weeks post injury
measure: Hemorrhage Quantification 3
timeFrame: Serial MRI assessments: Injury to 2 weeks post injury
measure: Hemorrhage Quantification 4
timeFrame: Serial MRI assessments: Injury to 2 weeks post injury
Secondary outcomes:
measure: Hemodynamic Management Assessment 1
timeFrame: Injury to 2 weeks post injury
measure: Hemodynamic Management Assessment 2
timeFrame: Injury to 2 weeks post injury
Other outcomes:
measure: Neurologic Assessments
timeFrame: Injury to 6 months post injury
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Brian Kwon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00905177: Predictors of Anticoagulation Control on Warfarin Therapy
Official title: Predictors of Anticoagulation Control on Warfarin Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Deep Vein Thrombosis
Heart Valve Replacement
Keywords: Atrial Fibrillation
deep vein thrombosis
anticoagulation
warfarin
coumadin
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-05-20
Enrollment: 687
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will include all self-identified Caucasians and African Americans initiating warfarin therapy.

Brief summary: The goal of this research study is to develop better dosing of anticoagulation medication in both Caucasian and African Americans through analysis of various genetic factors.

Detailed description: This is a prospective cohort study among adult patients requiring warfarin therapy. Patients presenting for anticoagulation will be identified at the start of therapy and followed throughout their course until they reach maintenance dose. We will then develop a dosing equation for warfarin using patient, environmental and genetic factors.

Eligibility criteria: Inclusion Criteria:

* All Caucasians and African Americans who are new to warfarin therapy

Exclusion Criteria:

* Under 21 years of age
* Non caucasian
* Non african american
* Have an abnormal INR before warfarin or heparin therapy
* Unable to provide consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania, Anticoagulation Management Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Veteran Affairs Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Stephen E. Kimmel, M.D. MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03013777: A Trial of Cognitive Behavioral Therapy in Familial Dysautonomia
Official title: An Open-Label Pilot Trial of Cognitive Behavioral Therapy in Familial Dysautonomia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysthymia
Anxiety Disorders
Familial Dysautonomia
Paroxysmal Hypertension
Autosomal Recessive Disease
Keywords: Familial dysautonomia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 15
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: To determine the effect of cognitive behavioral therapy (CBT) in the severity of anxiety and depression in adult patients with familial dysautonomia. Patients will be enrolled in an 8-week CBT program. All CBT sessions will be done either in person at the NYU Dysautonomia Center or over the phone to help accommodate disability and potential physical limitations of our patient population.

Detailed description: Cognitive behavioral therapy (CBT), defined as a program of interventions that utilize education to teach relaxation, healthy coping skills, stress management, assertiveness training in order to help the individual identify and correct maladaptive beliefs in combination with education to help practice symptom reduction and improve quality of life and function. Patients will participate in eight forty-five minute sessions of CBT with a mental health therapist in order to help treat generalized anxiety disorder, anxiety disorder due to another medical condition (familial dysautonomia), major depressive disorder, persistent depressive disorder (dysthymia), substance/medication- induced depressive disorder, depressive disorder due to another medical condition.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of FD (genetically confirmed)
* DSM-V criteria of major depressive disorder OR anxiety disorder
* STAI score ≥ 25 OR a PHQ-9 depression scale score ≥ 5 or greater
* Willing and able to complete 8 CBT sessions
* Maintain constant psychoactive medication through out study and no concurrent talk therapy from another therapist.

Exclusion Criteria:

* Currently suicidal or having current suicidal ideations
* Currently under psychiatric treatment for depression or anxiety
* Have started any psychoactive medication within 3 months prior to screening

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9) depression scale
timeFrame: 8 Weeks
measure: Rosenberg Self-Esteem Scale
timeFrame: 8 Weeks
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Horacio Kaufmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01455077: Portable Monitoring Device for the Diagnosis of Sleep Apnea in Obese Patients
Official title: Validation of a Portable Monitoring System for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Level II and III Obesity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea Syndrome
Obesity
Keywords: obesity
sleep apnea
portable monitoring
Lead sponsor: Associacao Fundo de Incentivo a Psicofarmcologia
Sponsor class: OTHER
Collaborators: name: Federal University of São Paulo
First posted: 2011-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults BMI \> 35 Male and female

Brief summary: Introduction The portable monitoring system (PMS) recording of cardiopulmonary parameters (level III of ASDA) has been validated in subjects with high probability of Obstructive Sleep Apnea (OSA) without comorbidities.

However, there is not any study evaluating this system when OSA is associated with morbid obesity, so the validation of PMS will be very useful in order to properly work-up this highly risk population.

Objective:

To evaluate the accuracy of level III type of PMS - Stardust™" (STD), on patients with level II and III of obesity and high clinical suspicion of OSA.

Methods:Participants with BMI \> 35 kg/m2 and with suspicion of OSA will consecutively be selected from an Outpatients Sleep Clinic of UNIFESP. They will be randomized for the following order of recordings:

1) STD at home for 1 night 2) STD in the sleep lab simultaneous to PSG. AHI will be taken for subsequent analysis:a) AHI PSG b) AHI STD -lab and c) AHI STD- home.


Eligibility criteria: Inclusion Criteria:

* BMI \> 35
* Complaints of snoring, sleep apnea, daytime sleepiness

Exclusion Criteria:

* use of home oxygen
* other sleep diseases
* inability to perform PSG

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Associacao Fundo de Incentivo a Psicofarmacologia
state: SP
Study officials:
References:
Clinical trial NCT04134377: High-Protein Food Snack for Dialysis Patients
Official title: High-Protein Food Snack and Albumin Outcomes in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Albumin; Double
Diet Habit
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care North America
name: National Kidney Foundation, United States
First posted: 2019-10-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study team aims to provide a food snack that is high in protein (30 g) for two weeks each month (6 treatments per patient per month) for 6 consecutive months, post-dialysis treatment, to in-center hemodialysis patients of all vintages and with all levels and types of comorbidities. The study team will compare changes in serum albumin during the intervention (6 months) using the patients' own serum albumin results that are collected for three months prior to and three months after the intervention. Additionally, the study team will determine participants' dietary habits and appetite pre-, during and post-intervention.


Eligibility criteria: Inclusion Criteria:

* Chronic Hemodialysis (CHD) therapy
* Active and permanent patients to the area Fresenius Kidney Care (FKC) Dialysis clinic
* No food allergies or dietary restrictions
* No contraindications to consuming anything by mouth as per the medical director and/or personal reporting.

Exclusion Criteria:

* Patients unable to commit to the full time commitments of the study
* Those who have food allergies, especially to Chicken, Pork Sausage, Eggs, Fresh Cilantro, Red and yellow bell peppers, Cucumbers, Mrs. Dash Grill Seasoning, Newman's Own Ranch Salad Dressing, Minced garlic, Sweet pickle relish, Vidalia onions, tomatoes
* Dietary restrictions as medically indicated,
* Trouble chewing/swallowing as confirmed by medical director, and/or personal reporting.

Primary outcomes:
measure: Serum albumin
timeFrame: Up to 12 months
Secondary outcomes:
measure: Serum phosphorus
timeFrame: Up to 12 months
measure: Diet Intake
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Fresenius Medical Care
state: Florida
Study officials:
affiliation: University of Florida
name: Jeanette M Andrade, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00688077: FGF-23 Suppressibility by Calcitonin
Official title: Evaluation of FGF-23 Suppressibility by Calcitonin in Healthy Men - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypophosphatemia
Keywords: Fibroblast growth factor - 23
Calcitonin
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2008-06-02
Enrollment: 49
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Introduction:

Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important regulator of FGF-23 production and secretion in healthy humans.

Aim:

In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men.

Study Design:

placebo-controlled, cross-over study

Method:

* All twelve subjects are examined on two occasions, once after exposure to placebo 1 ml NaCl 0.9% subcutaneously, and once following calcitonin 200 IU/ml subcutaneously
* On both occasions frequent bloodsampling will take place, out an indwelling catheter in de forearm vein.
* Sampling times: -15, 0, 60, 120, 240, 360, and 480 minutes
* Mealtimes: Calcium and Phosphate intake standardized on both occasions
* All samples are analyzed for FGF-23, using a C-terminal FGF-23 ELISA kit (Immunotopics, San Clemente, USA) that measures intact and C-terminal fragments of FGF-23, and one that measures only intact FGF-23
* Samples obtained at T-15, T0, T240 and T480 are stored for later analysis of Ca, albumin, PO4, PTH, 25-OHD and 1,25-OHD

Endpoint:

A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.


Eligibility criteria: Inclusion Criteria:

* Healthy man, who are between 20-55 years old, and have a BMI 20-27 kg/m2.

Exclusion Criteria:

* Serum creatinin \>100 mmol/L, or glomerular filtration rate \<80 ml/min.
* Abnormal serum Ca, PO4, albumin, 25-OH vitamin D, or PTH levels.
* Any medication.

Primary outcomes:
measure: A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.
timeFrame: eight hours
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
Study officials:
References:
Clinical trial NCT05069077: the Effect of Music on Pain and Women Satisfaction During Diagnostic Outpatient Hysteroscopy in Postmenopausal Women
Official title: the Effect of Music on Pain and Women Satisfaction During Diagnostic Outpatient Hysteroscopy in Postmenopausal Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hysteroscopy
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Hospital El Gezeera
First posted: 2021-10-06
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to demonstrate the value of music in diagnostic outpatient hysteroscopy on patients' level of pain and satisfaction in postmenopausal women


Eligibility criteria: Inclusion Criteria:

* Menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings)

Exclusion Criteria:

* patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding

Primary outcomes:
measure: Intensity of pain
timeFrame: 5 minutes
Secondary outcomes:
measure: Intensity of pain
timeFrame: 20 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06135077: Titanium Prepared Platelet-rich Fibrin in Bone Regeneration in Lateral Window Maxillary Sinus Augmentation
Official title: Evaluation of Titanium-prepared Platelet-rich Fibrin in Bone Regeneration in Lateral Window Maxillary Sinus Augmentation (Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Lifting
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial aims to evaluate the effect of the sole use of T-PRF in bone formation process as applied in maxillary sinus floor elevation in comparison to traditional T-PRF/bone graft combination.

This study is clinical trial that will include 18 patients seeking implant placement in upper posterior maxilla compromised with maxillary sinus pneumatization. Patients will be assigned into control and test groups. All the patients will undergo sinus lifting procedure through which a combination of xenograft and T-PRF was used in the control group whereas; sole T-PRF will be applied in the test group.


Eligibility criteria: Inclusion Criteria:

* Systemically in a healthy condition.
* Residual bone height is ≤5mm in the posterior maxilla as measured with CBCT.
* Non-smokers.
* Good oral hygiene as indicated by plaque and bleeding scores

Exclusion Criteria:

* Medically compromised conditions will be excluded to avoid infections or any adverse reaction related to immunity suppression.
* Acute maxillary sinusitis.
* Patients administering any antibiotics or regular anti-inflammatory drugs.

Primary outcomes:
measure: Change in pain level
timeFrame: up to 2 weeks
measure: Change in bone volume
timeFrame: up to 3 months
measure: Change in bone denisty
timeFrame: up to 3 months
measure: Change in bone height
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT04517877: Caring Light Project for Family Caregivers
Official title: Caring Light Project for Caregivers of Individuals With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: Photozig, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-18
Enrollment: 164
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: Caring Light is designed to help caregivers of someone with Alzheimer's Disease and related dementia to cope with the difficulties related to caregiving, reduce stress, and improve quality of life.

Detailed description: The goals of this study are to evaluate materials related to dementia caregiving and how to cope with difficult situations faced by caregivers. Based on this research, the investigators are developing the new Caring Light mobile app with a self-paced program to enhance the quality of life, a curriculum that incorporates relaxation techniques, and coping skills training.

Eligibility criteria: Inclusion Criteria:

* Care for an individual with Alzheimer's Disease or other dementia.
* Own a smartphone or tablet and have Internet access.
* Minimum age of 18 years old.
* Spend at least 8 hours/week caring for a person with dementia.

Exclusion Criteria:

* Severe psychological or physical illness.
* Inability to read and follow English instructions.
* High level of depressive symptoms.
* Unwillingness to participate in all aspects of the study.

Primary outcomes:
measure: Center for Epidemiological Studies Depression Scale
timeFrame: 3 months
measure: Revised Memory and Behavior Problems Checklist
timeFrame: 3 months
measure: Perceived Stress Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Photozig, Inc.
state: California
Study officials:
affiliation: Photozig, Inc.
name: Bruno Kajiyama, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00262977: Improving Aspirin Use in Diabetes: A Cluster Randomized Trial
Official title: Improving Appropriate Aspirin Use Among Adults With Diabetes in a Primary Care Setting: Using an Electronic Medical Record to Target a Physician-supervised Nurse Practitioner Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus
cardiovascular diseases
aspirin
quality of healthcare
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2005-12-07
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Our aim is to determine if a patient-directed intervention is more effective than computerized clinician reminders alone for improving aspirin use in adults with diabetes.

Detailed description: Many patients with diabetes do not use aspirin to prevent cardiovascular events. Quality improvement initiatives involving both patients and physicians may be more effective than physician-directed approaches alone.

In a large urban primary care internal medicine practice, this study seeks to test if a patient-directed intervention is more effective than computerized clinician reminders alone for improving the appropriate use of aspirin in adults with diabetes.

The study design is a cluster-randomized trial by physician. The frequency of self-reported regular aspirin use will be compared between patients cared for by physicians in the computerized reminder alone group and the computerized reminder plus physician-supervised, nurse practitioner intervention group.

Eligibility criteria: Inclusion Criteria:

Diabetes mellitus

* Age at least 40 years old
* At least 2 clinic visits in the 18 months prior to the intervention

Exclusion Criteria:

* Primary care physician declined enrollment

Primary outcomes:
measure: Patient reported aspirin use daily or every other day.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University, Division of General Internal Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Stephen D Persell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: