louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04990011: Amnion Chorion Membrane and Oroantral Communication
Official title: Evaluation of Amnion Chorion Membrane in the Repair of Oro Antral Communication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oroantral Communication
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An oroantral communication is a relatively common yet, serious complication following the extraction of posterior maxillary teeth because of their close relationship to the maxillary sinus.

Several surgical techniques exist for the repair of oroantral communication, including local and free flaps, tissue expansion, allogenic tissue, and biomaterials.

The present study aims to evaluate the use of the BioXclude amnion chorion membrane in the repair of oroantral communication.

Detailed description: This study will be performed on ten patients who have oroantral communication after extracting posterior maxillary teeth. The oroantral communication will be repaired by using the BioXclude amnion chorion membrane.

Eligibility criteria: Inclusion Criteria:

* Patients should be free of any relevant systemic diseases.
* Patients with recent oroantral communication (O.A.C) (24:72) hours .
* Good oral hygiene

Exclusion Criteria:

* An immune compromised state.
* Previous sinus disease.
* History of sinus surgery.
* Presence of intra-antral foreign bodies and need for cold well-luc procedure.
* Presence of intra-sinus pathology

Primary outcomes:
measure: success of surgery
timeFrame: 1 month
Secondary outcomes:
measure: Pain level
timeFrame: 12 hours
measure: Change in bone formation
timeFrame: at 3rd, 6th months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT00341211: Specimens From Normal Controls
Official title: Specimens From Normal Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Viral Infections
Keywords: AIDS
Cancer
Epidemiology
Immunology
Virology
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The Viral Epidemiology Branch (VEB) of the National Cancer Institute (NCI) conducts research on viral infections and their associations with various diseases including AIDS and cancer. For some research questions, specimens are available from "case" subjects as part of ongoing protocols but are not available from normal "control" subjects (i.e., those without the infection or disease under study) to whom the case subjects can be compared. This protocol is to obtain routine specimens (usually peripheral venous blood, occasionally other body fluid such as saliva, urine, or tears) from healthy volunteers.

Detailed description: The Viral Epidemiology Branch (VEB) of the National Cancer Institute (NCI) conducts research on viral infections and their associations with various diseases including AIDS and cancer. For some research questions, specimens are available from "case" subjects as part of ongoing protocols but are not available from normal "control" subjects (i.e., those without the infection or disease under study) to whom the case subjects can be compared. This protocol is to obtain routine specimens (usually peripheral venous blood, occasionally other body fluid such as saliva, urine, or tears) from healthy volunteers.

Eligibility criteria: * INCLUSION CRITERIA:

Subjects can be friends of VEB investigator or collaborator, hospital or office workers, repeat volunteer blood donors, etc.

EXCLUSION CRITERIA:

Must not be minors, prisoners, pregnant women or incapable of providing informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI), 9000 Rockville Pike
state: Maryland
Study officials:
References:
Clinical trial NCT01861028: Study Comparing Fit of the iTotal Versus Standard Total Knee Implants
Official title: Study Comparing Fit of the iTotal Versus Standard Total Knee Implants
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis
Keywords: total knee replacement
total knee arthroplasty
patient-specific
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2013-05-23
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving either a standard total knee implant or an iTotal patient-specific total knee implant

Brief summary: This study compares intraoperative fit of the patient-specific iTotal knee replacement to other standard knee replacement implants

Detailed description: The study is designed as a single center, two arm analysis. The study will be completed in two phases, based on measurement type.

All additional data will be obtained from pre and post-operative subject surveys, operative and discharge records and radiographs.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled for a standard total knee replacement
* Patient who are scheduled for patient-specific total knee replacement (iTotal)
* Patient age \> 18 years

Exclusion Criteria:

* Patients who do not receive a total knee replacement
* Unwilling or unable to comply with study requirements

Primary outcomes:
measure: Phase I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater
timeFrame: Intraoperatively, up to 120 minutes
measure: Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater
timeFrame: Intraoperatively, up to 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
Study officials:
affiliation: JFK Medical Center
name: Gregory Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03990428: Supportive Care Needs of Caregivers of People With Erdheim-Chester Disease and Other Histiocytic Diseases
Official title: A Study to Identify the Supportive Care Needs of Caregivers of Patients With Erdheim-Chester Disease and Other Histiocytic Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Supportive Care Needs of Caregivers
Keywords: Supportive care
Erdheim-Chester Disease
Other Histiocytic Diseases
19-213
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A target sample of 120 ICs of patients with Erdheim-Chester Disease will be enrolled in this study. Additionally, a target sample of 50 ICs of patients with other histiocytic disorders will be enrolled.

Brief summary: This study is being done to answer the following question: What are the supportive care needs of informal caregivers of people with Erdheim-Chester disease and other histiocytic diseases?


Eligibility criteria: Inclusion Criteria:

* Self-identified informal caregiver (family member or friend who provides unpaid support) for a patient with Erdheim-Chester Disease (or LCH, RDD, or JXG for the exploratory aim).
* Proficiency to complete study assessments in English, evaluated at the time of consent.
* Age 18 or over.

Exclusion Criteria:

* Participant unwilling to sign consent.
* Participant unable to complete web-based assessments.

Primary outcomes:
measure: Supportive Care Needs of informal caregivers
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Eli Diamond, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03599128: Effect of Phenolic Acids on the Human Vasculature
Official title: Effect of Phenolic Acids on the Human Vasculature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study evaluates effects of different doses of phenolic acids on healthy volunteers.

Detailed description: It has been suggested that consumption of food rich in phenolic acids can help to improve vascular health, measured by flow mediated dilation (FMD).

Eligibility criteria: Inclusion Criteria:

* Male or postmenopausal female healthy volunteers aged 45-65 years old
* Willing and able to sign written informed consent prior to trial entry
* Healthy as determined by the medical history and physical examination

Exclusion Criteria:

* Premenopausal women
* Current smokers
* Abnormal blood pressure as defined as follow: systolic \<90 or \>140 mmHg and diastolic \<60 or \>90 mmHg
* Regular consumption of cholesterol-lowering medication
* Regular consumption of antihypertensive medication
* Regular consumption of any vasoactive medication that cannot be discontinued for at least 4 half-lives before the FMD assessment
* Any food allergies
* Any intakes of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study
* Inability to refrain from coffee/tea and alcohol consumption for 12 h prior to study visits
* Acute or chronic major psychiatric illness or other major illness that in the opinion of the investigator would make the subjects' participation in the study unsafe or prevent them from fully complying with the study procedures
* Body mass index (BMI) outside 18-32 kg/m2 range

Primary outcomes:
measure: Efficacy by oral administration of phenolic acid in improving endothelial function
timeFrame: 6 hours
Secondary outcomes:
measure: AUC(Area Under Curve) of the concentration/time curve
timeFrame: 6 hours
measure: Tmax
timeFrame: 6 hours
measure: Elimination half-life
timeFrame: 6 hours
Other outcomes:
measure: Blood concentrations in plasma.
timeFrame: 6 hours
measure: To investigate safety of investigational products: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: through study completion, an average of 1 year.
Locations:
city: Crawley
country: Australia
facility: University of Western Australia
state: Perth
Study officials:
affiliation: Société des Produits Nestlé (SPN)
name: Leslie Tan
role: STUDY_CHAIR
References:
Clinical trial NCT01806428: Activated Protein C and Microcirculation
Official title: THE Activated Protein C (aPC) TREATMENT IMPROVES MICROCIRCULATION IN SEVERE SEPSIS/ SEPTIC SHOCK SYNDROME
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Sepsis
Septic Shock
Lead sponsor: Università Politecnica delle Marche
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero, Universitaria Ospedali Riuniti
First posted: 2013-03-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis

Brief summary: Objective: to test the hypothesis that recombinant activated protein C (aPC) therapy improves the microcirculation of severe septic patients.

Design: Prospective, open study. Setting: University 12-beds intensive care unit. Patients: Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis were included in a one year period.

Interventions: Patients who had no contraindication to aPC administration received aPC at a dose of 24 mcg/kg/h for 96 hours. Patients with contraindications to aPC infusion were considered as controls.


Eligibility criteria: Inclusion Criteria:

* Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis

Exclusion Criteria:

* hematologic or advanced malignancies
* liver cirrhosis
* severely impaired consciousness (Glasgow Coma Scale score \<7 of 15)
* therapeutic limitations (do-not-resuscitate orders)

Primary outcomes:
measure: Microcirculatory Flow Index (MFI) before during and after aPC infusion
timeFrame: 102 hours
Secondary outcomes:
measure: Perfused Vessel Density before during and after aPC infusion
timeFrame: 102 hours
measure: Tissue oxygen saturation (StO2) upslope before during and after aPC infusion
timeFrame: 102 hours
Other outcomes:
Locations:
city: Torrette di Ancona
country: Italy
facility: University ICU, AOU Ospedali Riuniti Ancona
state: Ancona
Study officials:
References:
citation: Donati A, Damiani E, Botticelli L, Adrario E, Lombrano MR, Domizi R, Marini B, Van Teeffelen JW, Carletti P, Girardis M, Pelaia P, Ince C. The aPC treatment improves microcirculation in severe sepsis/septic shock syndrome. BMC Anesthesiol. 2013 Sep 26;13(1):25. doi: 10.1186/1471-2253-13-25.
Clinical trial NCT04927728: The Application of a Mental Practice Protocol in the Acute Inpatient Rehabilitation Setting
Official title: The Application of a Mental Practice Protocol to Increase the Functional Recovery of the Hemiparetic Upper Extremity in the Acute Inpatient Rehabilitation Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Upper Extremity Paresis
Keywords: mental practice
stroke
upper extremity
hemiparesis
rehabilitation interventions
Lead sponsor: Adventist HealthCare
Sponsor class: OTHER
Collaborators: name: Texas Woman's University
First posted: 2021-06-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized controlled trial is to compare the effect of audio-guided mental practice (MP) and video-guided MP on the impairment and functional abilities of upper extremity (UE) hemiparesis following a stroke. Participants are recruited from Adventist Healthcare Rehabilitation Hospital. All participants must be less than one-month post-stroke with moderate UE hemiparesis. Eligible participants are randomly assigned to an experimental group, (MP or repetitive-task practice (RTP)), or the control group.

The MP groups will perform either audio-guided MP or video-guided MP, five days a week, with 20 repetitions of the following tasks: wiping a table, picking up a cup, brushing hair, and turning the pages of a book. The RTP group physically performed the same tasks. The control group received traditional stroke rehabilitation.

The investigators hypothesize that video MP will have greater improvements in UE impairments and functional abilities than audio MP, RTP, and/or traditional therapy.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of stroke
* Less than one-month post-stroke
* Hemiparesis of one upper extremity
* Moderate upper extremity impairment

Exclusion Criteria:

* History of prior stroke
* Comorbidities (severe neurological, orthopedic, rheumatoid, or cardiac impairments)
* Severe spasticity
* Severe cognitive impairments
* Inability to perform mental imagery
* Severe aphasia based on speech therapist evaluation
* Low English proficiency
* Severe pain

Primary outcomes:
measure: Fugl Meyer Assessment-Upper Extremity Portion (FMA-UE) (Measuring pre/post intervention change)
timeFrame: Within 3 days of admission and within 3 days prior to discharge
measure: Wolf Motor Function Test (WMFT) (Measuring pre/post intervention change)
timeFrame: Within 3 days of admission and within 3 days prior to discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Adventist Healthcare Rehabilitation
state: Maryland
Study officials:
References:
Clinical trial NCT02642328: High Intensity Interval Training With Strength/Power Exercises on VO2Max
Official title: Effects of Eight Sessions of High Intensity Interval Training (HIIT) With Strength/Power Exercises on VO2Max Gains and Aerobic Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: VO2Max
Aerobic Exercise
Physical Conditioning
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Traditionally, strength training and power is the main objective of providing only muscle conditioning, without possible gains on the VO2Max, however, not for aerobic performance.

Detailed description: A total of 10 visits will be performed. The subjects will be divided into two exercise groups: 1) control group (CG) who performed only aerobic activity of running or walking at moderate intensity (65% VO2max); and 2) strength and power exercise group (GFP), which held the protocol circuit. On the first visit the subjects answer an initial questionnaire of risk stratification for coronary artery disease, and performed a maximal aerobic exercise test.

The subjects performed the interval protocol with strength and power exercises at high intensity in circuit. 20 seconds stimuli will be provided with 10 seconds passive recovery, totaling 4 minutes. In the last session the subjects will be performed the same initial procedures adopted in the first visit to determine the values of VO2max after training. The control group will be performed just one training session total run time conducted in eight sessions by GFP group (approx. 30 min).

Eligibility criteria: Inclusion Criteria:

* Strength training practitioner for at least 6 months
* 18 / 45 years
* No injuries

Exclusion Criteria:

* Use of ergogenic resource
* Hypertension and cardiovascular disease
* Drugs

Primary outcomes:
measure: Oxygen Intake (VO2Max)
timeFrame: Change from Baseline VO2Max after 2 Weeks of Circuit of HIIT
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Iguaçu University
name: Alberto S. Sá Filho, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00919828: Monitor Patients With Acute Heart Failure
Official title: Adherent Monitoring of Congestive Heart Failure During Therapy for Excess Fluid Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Corventis, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients

Brief summary: This is a prospective, multi-center, non-randomized study to evaluate performance of an external monitor for heart failure patients

Detailed description: External monitoring of heart failure patients with the AVIVO System.

Eligibility criteria: Inclusion Criteria:

* Is female or male, 18 years of age or older
* Has an ejection fraction of 40% reported within 12 months of enrollment
* Having acute decompensated heart failure and receiving treatment for fluid overload

Exclusion Criteria:

* Is participating in another clinical study that may confound the results of this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06351228: Fertility-sparing in Early-stage Cervcial Cancer: The ETERNITY Project
Official title: Outcomes of Early-stage Cervcial Cancer Patients Sheduled to Have Fertility-sparing Approach: The ETERNITY Project
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervical Cancer
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with early stage cervical cancer undegoing uterine preserving surgery

Brief summary: The ETERNITY project is a retrospective analysis of outcomes of patients undergoing fertility-sparing treatment for cervcial cancer.

The primary aim is to report outcomes of those patients.

Other aims included:

1. Evaluation about the effectiveness of different treatment modalities;
2. Evaluation of outcomes according to different stages of disease;
3. Evaluation of the impactof neoadjuvant chemotherapy in patients undergoing conservative surgery


Eligibility criteria: Inclusion Criteria:

* Histological confirmed cervical cancer
* FIGO Stage IA1-IB3
* Fertility-sparing (conization plus nodal dissection)

Exclusion Criteria:

* age less than 18 yrs
* age more than 50 yrs

Primary outcomes:
measure: oncological outcomes
timeFrame: 3-yrs
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
state: Lombardia
Study officials:
References:
Clinical trial NCT00212628: Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Official title: Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Involutional Osteoporosis
Keywords: ONO-5920
osteoporosis
bisphosphonate
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
First posted: 2005-09-21
Enrollment: 444
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.


Eligibility criteria: Inclusion Criteria:

1. Patients who was included in study ONO-5920-02 and completed the medication for two years
2. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. Patients judged to be unsuitable by safety evaluation as clinical trial subjects by the investigator
2. Patients having secondary osteoporosis or another condition that presents low bone mass
3. Other exclusion criteria as specified in the study protocol

Primary outcomes:
measure: New fragility vertebral fracture
Secondary outcomes:
measure: New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spine (L2-4 BMD), lower back pain.
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Chubu Region Facility
city: Chugoku
country: Japan
facility: Chugoku Region Facility
city: Hokkaido
country: Japan
facility: Hokkaido Region Facility
city: Hokuriku
country: Japan
facility: Hokuriku Region Facility
city: Kanto
country: Japan
facility: Kanto Region Facility
city: Kinki
country: Japan
facility: Kinki Region Facility
city: Kyushu
country: Japan
facility: Kyushu Region Facility
city: Shikoku Region Facility
country: Japan
facility: Shikoku Region Facility
city: Tohoku
country: Japan
facility: Tohoku Region Facility
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader, Development Planning
role: STUDY_DIRECTOR
References: