louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00206713: Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim
Official title: Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Retreatment Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease and Prior Treatment Response to Sargramostim
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn Disease
Keywords: Crohn Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether treatment with Leukine in patients with Crohn's disease who have previously responded to Leukine can be helped again, once they have relapsed.

Detailed description: On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Eligibility criteria: Inclusion Criteria:

* You must be 18 years or older.
* You must have active Crohn's disease at the time of screening.
* You must be 18 years or older.
* You must have active Crohn's disease at the time of screening.
* You must be able to give yourself an injection of study drug or have another person who can help you give the injection.
* You must not be pregnant and agree to use birth control if you are a sexually active male or female of childbearing potential.

Exclusion Criteria:

* You may not be pregnant or breastfeeding.
* You may not have a colostomy or ileostomy.
* You may not be taking prohibited medications.
* You may not have had GI surgery or a bowel obstruction in the last 6 months.
* You may not have ever taken this drug or drugs of similar type in the past.

Primary outcomes:
measure: Proportion of patients achieving clinical response or remission
timeFrame: At Day 57 of the randomized retreatment phase
Secondary outcomes:
measure: Proportion of patients achieving clinical response or remission
timeFrame: At the end of Week 8 of the open-label phase.
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Morristown
country: United States
state: New Jersey
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00841113: Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer
Official title: Phase III Study of the Comparison of Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer. A One Year Randomised, Open Label, Multi-Centre Phase III Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate cancer
Advanced
Metastatic
Lead sponsor: Speciality European Pharma Limited
Sponsor class: INDUSTRY
First posted: 2009-02-11
Enrollment: 177
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer.

Detailed description: Inclusion Criteria

* Males over 18 with documented advanced or metastatic prostate cancer

Outcome measures

* Comparative castration rates one week after starting therapy
* Degree of testosterone surge in the first month of treatment.
* Maintenance of medical castration during one year of therapy.
* Comparison of the treatments on QTc prolongation

Eligibility criteria: Inclusion Criteria:

* Histologically proven prostate cancer and not previously treated with hormones
* Evidance of advanced disease or metastases
* Life expentancy of at least 3 months
* Normal serum testosterone levels
* Written informed consent

Exclusion Criteria:

* Previous endocrine or cytoxic theapy for prostate cancer
* Known tumour complication of prostate cancer which owuld require immediate treatment
* Another malignancy other than basal cell cancer
* History of significant drug hypersensitivity to either LHRH agonists or GnRH antagonists.
* Congenital or acquired coagulation disorders contraindicating intramuscular injections
* Pagets disease of the bone
* QTcB \> 450 msec at Day - 14

Primary outcomes:
measure: Early castration rates
timeFrame: One week
Secondary outcomes:
measure: Maintenance of medical castration
timeFrame: 48 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Nijmegen
name: Frans M J Debruyne, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03663413: Oculocardiac Reflex Brain Wave Monitor
Official title: The Oculocardiac Reflex Influenced at Different Levels of Brain Wave Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Strabismus
Lead sponsor: Alaska Blind Child Discovery
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 188
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: strabismus surgery

Brief summary: Oculocardiac reflex during routine strabismus surgery was prospectively observed in association with routine brain wave monitoring.

Providence Hospital institutional review board (IRB) approved this observational study without need for consent.

Detailed description: Introduction: The oculocardiac reflex (OCR), bradycardia that occurs during strabismus surgery, is blocked by anticholinergics and enhanced by opioids and dexmedetomidine. Two recent studies suggest that deeper inhalational anesthesia monitored by bispectral index (BIS) protects against OCR; the investigators wondered if our data correlated similarly.

Methods: In an ongoing, prospective study of OCR elicited by 10-second, 200 gram square-wave traction on extraocular muscles (EOM) from 2009 to 2013, anesthetic depth was estimated in cohorts using either BIS or Narcotrend monitors. The depth of anesthesia was deliberately varied between first and second EOM tested.

Eligibility criteria: Inclusion Criteria:

* all

Exclusion Criteria:

* those receiving anticholinergic medications

Primary outcomes:
measure: heart rate change
timeFrame: intraoperative 10 seconds
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alaska Childrens EYE & Strabismus
name: Robert W Arnold, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnold RW, Biggs RE, Beerle BJ. Intravenous dexmedetomidine augments the oculocardiac reflex. J AAPOS. 2018 Jun;22(3):211-213.e1. doi: 10.1016/j.jaapos.2018.01.016. Epub 2018 May 5.
citation: Arnold RW, Bond AN, McCall M, Lunoe L. The oculocardiac reflex and depth of anesthesia measured by brain wave. BMC Anesthesiol. 2019 Mar 14;19(1):36. doi: 10.1186/s12871-019-0712-z.
Clinical trial NCT01654913: Influence of Oxygen on Non-invasive Measurement of Hemoglobin
Official title: Influence of the Inspired Oxygen Fraction on the Noninvasive Measurement of Hemoglobin Using Two Different Devices (Namely Pronto 7 and NBM-200)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: hemoglobin determination
oxygen
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2012-08-01
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study examines the effect of oxygen supplementation on the non-invasive measurement of hemoglobin.


Eligibility criteria: Inclusion Criteria:

* adult patients scheduled for a potentially hemorrhagic surgical procedure

Exclusion Criteria:

* anomaly (malformation, infection, swelling, irritation, ulceration, degenerative changes or significant edema) of the fingers,
* tremors.

Primary outcomes:
measure: influence of the inspired oxygen fraction on the noninvasive measurement of hemoglobin (Pronto 7 and NBM-200 devices)
timeFrame: one year (end of the recrutement period)
Secondary outcomes:
measure: agreement between the noninvasive methods of measurement of hemoglobin and the laboratory analysis
timeFrame: one year (end of the recrutement period)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Lariboisière
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
References:
citation: Gayat E, Aulagnier J, Matthieu E, Boisson M, Fischler M. Non-invasive measurement of hemoglobin: assessment of two different point-of-care technologies. PLoS One. 2012;7(1):e30065. doi: 10.1371/journal.pone.0030065. Epub 2012 Jan 6.
citation: Gayat E, Bodin A, Fischler M. Instability in non-invasive haemoglobin measurement: a possible influence of oxygen administration. Acta Anaesthesiol Scand. 2011 Aug;55(7):902. doi: 10.1111/j.1399-6576.2011.02469.x. Epub 2011 Jun 9. No abstract available.
citation: Gayat E, Imbert N, Roujansky A, Lemasle L, Fischler M. Influence of Fraction of Inspired Oxygen on Noninvasive Hemoglobin Measurement: Parallel Assessment of 2 Monitors. Anesth Analg. 2017 Jun;124(6):1820-1823. doi: 10.1213/ANE.0000000000001783.
Clinical trial NCT06104813: Evaluation of Deaf Men's Knowledge About Sexual Health
Official title: Evaluation of Deaf Men's Knowledge About Sexual Health, in Nancy's CHRU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deafness
Sexual Satisfaction
Sexually Transmitted Diseases
Sexual Violence
Educational Problems
Keywords: Deafness
Sexual Health
Sexually Transmitted Diseases
Sexual Violence
Sexual Health Awareness
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteer deaf men over 18 whitout curatorship or tutelage, using french signe language as their main language.

Brief summary: Evaluation of Deaf men's knowledge about sexual health in Nancy, France. The study consists of interviews with voluntary deaf men from Nancy, France, in order to assess their knowledge about sexual health, and determine if there is a lack of sexual health awareness.

If there is indeed a lack of information about sexual health, the study aims at finding ways of improving the situation, and see how the deaf men would like to have this information delivered to them.

Detailed description: Evaluation of Deaf men's knowledge about sexual health in Nancy, France. The study consists of interviews with voluntary deaf men from Nancy, France. The goal is to assess their knowledge about sexual health, and determine if there is a lack of sexual health awareness.

If there is indeed a lack of information about sexual health, the study aims at finding ways of improving the situation, and see how the deaf men would like to have sexual health information delivered to them.

Patients from Nancy's Regional Deaf Healthcare Service (URASSM) will be contacted and volunteers adult deaf men, using sign language as their main langage, will be recruited into the study.

The interviews will consist of a series of open questions aiming to evaluate the volunteers knowledge about sexual health, and evaluate their expectations about how sexual health care for deaf men should be dealt with.

A professional french sign language translator will be present during the interviews, and all the questions and answers will be delivered using french sign language.

Eligibility criteria: Inclusion Criteria:

* Deaf
* Over 18
* Using french sign language
* Whithout curatorship or tutelage

Exclusion Criteria:

* Female
* Under 18
* Non deaf

Primary outcomes:
measure: Deaf volunteer's sexual health knowledge questionnaire
timeFrame: 1 day Interview
Secondary outcomes:
measure: Deaf volunteer's expectation about sexual health care questionnaire
timeFrame: 1 day Interview
Other outcomes:
Locations:
city: Nancy
country: France
facility: Central Hospital
state: Grand Est
Study officials:
References:
Clinical trial NCT02345213: A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)
Official title: A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dementia, Lewy Body
Lewy Body Disease
Keywords: DLB
Dementia with Lewy bodies
Lewy Body Disease
Dementia
E2020
Donepezil
Aricept
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-26
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm the efficacy of Aricept in patients with dementia with Lewy bodies (DLB).


Eligibility criteria: Inclusion Criteria

1. Patients diagnosed with probable DLB according to the diagnostic criteria for DLB
2. Patients having caregivers throughout the study who submit written consent to cooperate with this study, can routinely stay with patients at least 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance, and escort the patients on required visits to study institution
3. Clinical Dementia Rating (CDR) score is greater than or equal to 0.5
4. Mini-Mental State Examination (MMSE) score is greater than or equal to 10 and less than or equal to 26

Exclusion Criteria

1. Patients diagnosed with Parkinson's disease with dementia (PDD)
2. Patients who have received anti-dementia drug therapy within 12 weeks before the start of the observation period
3. Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency
4. Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than or equal to IV)
5. Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/minute at screening test

Primary outcomes:
measure: Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus)
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saitama
country: Japan
Study officials:
affiliation: Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
name: Megumi Ohdake
role: STUDY_DIRECTOR
References:
Clinical trial NCT04115241: Activity Levels in Bone Marrow Transplant Patients
Official title: Activity Levels in Bone Marrow Transplant Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Marrow Transplant
Keywords: leukemia
multiple myeloma
myelodysplastic syndrome
stem cell transplant
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will be receiving a bone marrow transplant

Brief summary: Participants in this study will be receiving a bone marrow transplant. This study is designed to evaluate correlations between activity levels and length of stay, quality of life, and hand grip strength.

Detailed description: Participants in this study will be receiving a bone marrow transplant. Participants will be given actigraphs to wear around their waists starting 3 weeks prior to bone marrow transplants until they are discharged from the hospital. Participants will be asked to complete quality of life questionnaires and hand grip tests at three separate time points during their hospitalizations. All data gathered from these activities will be compared with patients' activity levels gathered from the actigraphs both before and during the hospitalization. This study is designed to determine the relationship between activity levels and length of stay, quality of life, and hand grip strength.

Eligibility criteria: Patients who will be receiving a bone marrow transplant are eligible for this study

Primary outcomes:
measure: To determine the correlation between activity levels and length of stay in hospital
timeFrame: From study intitiation for up to 5 years
measure: To determine the correlation between activity levels and quality of life
timeFrame: From study intitiation for up to 5 years
measure: To determine the correlation between activity levels and hand grip strength
timeFrame: From study intitiation for up to 5 years
Secondary outcomes:
measure: To determine barriers to activity for patients recovering from bone marrow transplantation and design an intervention to increase activity levels in patients post-transplantation
timeFrame: From study intitiation for up to 5 years
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Michael Tomasson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05572541: Temporomandibular Joint Dysfunction in Patients With Traumatic Brain Injury
Official title: Assessment of Temporomandibular Joint Dysfunction in Patients With Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Temporomandibular Dysfunction
Keywords: Temporomandibular Dysfunction,
traumatic brain injury
headache
Lead sponsor: Konya Beyhekim Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-10-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 30 Patient with traumatic brain injury 30 healthy volunteer

Brief summary: Trauma, neurological disorders and psychological problems, which are the etiological factors of temporomandibular joint dysfunction, can be seen in patients with traumatic brain injury.

The aim of this study is to investigate temporomandibular joint dysfunction in patients with traumatic brain injury.

Participants (traumatic brain injury patients and healthy volunteers) will be evaluated once for temporomandibular joint dysfunction.

Detailed description: Temporomandibular joint range of motion, Fonseca questionnaire, facial asymmetry, and massater and temporal pain threshold will be evaluated by measuring both TBI patients and healthy individuals. In addition, post-injury dietary intake and dominant chewing side will be questioned in TBI patients. Temporomandibular movements will be measured with a disposable cardboard ruler.

Exclusion criteria; communication and cooperation problems, congenital or systemic disease affecting the head and neck region, being treated for TMED and having a history of orthognathic surgery.

Eligibility criteria: Inclusion Criteria:

clinical diagnosis of traumatic brain injury not receiving treatment for temporomandibular joint dysfunction

Exclusion Criteria:

communication and cooperation problems, congenital or systemic disease affecting the head and neck region, being treated for TMED and having a history of orthognathic surgery.

Primary outcomes:
measure: Frequency of temporomandibular joint dysfunction in patients with traumatic brain injury
timeFrame: 01.11.2022
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Beyhekim Research and Training Hospital
state: Selçuklu
Study officials:
References:
Clinical trial NCT06695741: Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy to Treat Severe Aplastic Anemia
Official title: Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy as Front-line Therapy in Patients With Severe Aplastic Anemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Severe Aplastic Anemia
Cyclophosphamide Reduced-dose
Immunosuppressive Therapy
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 75
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-center, single-arm, phase 2 study. This study aims to evaluate the efficacy and safety of anti-lymphocyte globulin plus herombopag in combination with the reduced dose of cyclophosphamide (hypo-CASH) for severe aplastic anemia.


Eligibility criteria: Inclusion Criteria:

* Subject has a diagnosis of naïve severe or very severe aplastic anemia
* Male or female age ≥ 12 years
* Unwilling or unable to receive allogeneic hematopoietic stem cell transplantation.
* ECOG performance status ≤2
* Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

* Previously received immunosuppressive therapy \> 4 weeks
* Previously treated with TPO-RA \> 4 weeks
* Have an allergy or intolerance to anti-lymphocyte globulin, cyclosporine, herombopag or cyclophosphamide.
* Uncontrolled fungal, bacterial, or viral infection. Hepatitis-associated aplastic anemia is allowed; hepatitis B or C infection is permitted unless it causes severe liver failure.
* Tested positive for HIV or syphilis
* Presence of severe liver, kidney, or heart failure, or other life-threatening comorbidities.
* History of radiotherapy and chemotherapy for malignant solid tumors in recent 5 years
* Combined with other serious disorders
* Pregnant or breast-feeding patients
* Patients considered to be ineligible for the study by the investigator for reasons other than the above.

Primary outcomes:
measure: Overall response rate
timeFrame: Within 3 months
Secondary outcomes:
measure: Superior response rate
timeFrame: With in 6 months
measure: Overall response rate
timeFrame: With in 6 months
measure: Incidence of the adverse event
timeFrame: Within 6 months
measure: Time to achieve robust superior response
timeFrame: Within 6 months
measure: First time to response
timeFrame: Within 6 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Red Blood Cell Disorders Center and Regenerative Medicine Center
state: Tianjin
Study officials:
References: