louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00027443: Study of Muromonab-CD3 and Cyclosporine in Patients With Giant Cell Myocarditis
Official title: Giant Cell Myocarditis Treatment Trial Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocarditis
Keywords: Giant Cell Myocarditis
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2001-12-07
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This is a study to determine the efficacy of muromonab-CD3 and cyclosporine as treatment in patients with giant cell myocarditis (GCM). T lymphocytes appear to be involved in GCM. Muromonab-CD3 has been shown to reduce the number of lymphocytes and cyclosporine inhibits lymphocyte activation. This treatment may prolong patient survival until transplantation or ventricular assist device placement is possible.

Detailed description: Each patient will be randomized to receive either standard care and immunosuppression therapy (treatment group) or standard care alone (control group). To prevent bias, randomization will be stratified by recency of symptom onset to ensure that both the treatment and control groups are balanced with respect to it. Within each of these 2 strata, permuted-block randomization will be done to keep the number of treatment and control patients balanced. Due to the necessary monitoring of the patients randomized to receive immunosuppression therapy, treatment cannot be blinded. Approximately 1 year after the last patient has been randomized, the observed times from randomization to the composite endpoint (death, transplantation, or LVD placement) will be compared in the treatment and control groups.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: Inclusion criteria:

* Idiopathic heart failure and/or arrhythmia of less than 3 months duration
* Endomyocardial biopsy diagnostic of idiopathic giant cell myocarditis
* Negative pregnancy test

Exclusion criteria:

* Clinical evidence of sepsis or active infection (e.g., meningitis or osteomyelitis)
* Pregnant
* Any contraindication to immunosuppression
* Allergy to cyclosporine or muromonab-CD3
* Creatinine greater than 2.5 mg/dL
* AST or ALT greater than 3 times upper limit of normal
* Other severe concurrent disease that would preclude study
* Unreliable or uncooperative subject

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Leslie T Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cooper LT Jr, Hare JM, Tazelaar HD, Edwards WD, Starling RC, Deng MC, Menon S, Mullen GM, Jaski B, Bailey KR, Cunningham MW, Dec GW; Giant Cell Myocarditis Treatment Trial Investigators. Usefulness of immunosuppression for giant cell myocarditis. Am J Cardiol. 2008 Dec 1;102(11):1535-9. doi: 10.1016/j.amjcard.2008.07.041. Epub 2008 Sep 18.
Clinical trial NCT01181843: Incidence of Respiratory Depression in Cesarean Section
Official title: A Prospective, Observational, Double-blind (Black-Box) Study Evaluating Incidence, Severity and Predictive Factors of Respiratory Depression During Postoperative Neuraxial Opioid Analgesia in Obstetric Patients After Cesarean Delivery Using Current Standard Intermittent Postoperative Monitoring Compared to Continuous Pulse Oximetry / Capnography
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Respiratory Depression
Postoperative Pain
Keywords: postoperative pain management
respiratory depression
capnography
duramorph
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Forsyth Medical Center
First posted: 2010-08-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects having an elective cesearean section and having as their anesthetic either a spinal or epidural and receiving duramorph

Brief summary: This study is designed to determine the incidence and severity of respiratory depression in elective cesarean section patients who have received a spinal or epidural narcotic called duramorph for management of postoperative pain. A monitoring device called a capnograph as well as a device called a pulse oximeter is placed on the patient once in the recovery room after delivery. The capnograph monitors the carbon dioxide level that the patient breathes out as well as their respiratory rate. The pulse oximeter is a device that is taped on the patient's finger and measures their oxygen saturation level. The monitoring is maintained for 18-24 hours after surgery.


Eligibility criteria: Inclusion Criteria:

* Are female \>= 18 years of age and \<=55 years of age with ASA class I-III
* Schedule for cesarean surgery
* Are willing and able to sign informed consent form for this study
* Are willing and able to follow the instruction in this study protocol

Exclusion Criteria:

* Have known contraindication/allergy to neuraxial anesthesia or morphine.
* Have an ASA class \> III
* Age \> 55 years

Primary outcomes:
measure: RESPIRATORY DEPRESSION
timeFrame: 24 HOURS
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Forsyth Medical Center-Dept of OB Anesthesia
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Peter Pan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01704443: Integrated Mindfulness for Provoked Vestibulodynia
Official title: Integrated Mindfulness for Provoked Vestibulodynia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Provoked Vestibulodynia
Keywords: provoked vestibulodynia
dyspareunia
vulvodynia
mindfulness
cognitive behavioural therapy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 97
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to test the efficacy of a 4-session intervention (Group psychoeducational treatment) using a randomized study design. Participants will be randomized in to 'immediate treatment' or 'waitlist control'. Women in the wait-list condition will receive the 4-session IMPROVED treatment, just as women randomized to the experimental group, after the end of their wait-list period.


Eligibility criteria: Inclusion Criteria:

* must be a patient at the British Columbia Centre for Sexual Medicine
* diagnosis of provoked vestibulodynia (PVD)
* 19 years of age or older
* premenopausal
* fluent in English

Exclusion Criteria:

* not at patient at the BC Centre for Sexual Medicine
* unprovoked vulvar pain, other pathology causing pain with penetration, or chronic pelvic pain
* being uncomfortable and unwilling to participate in a group setting.

Primary outcomes:
measure: Pain intensity
timeFrame: one week pre-treatment to one week post treatment
measure: Long-term pain intensity
timeFrame: One week pre-treatment to 6 months post preatment
Secondary outcomes:
measure: Sexual Distress
timeFrame: One week pre-treatment, one week post treatment and 6-months follow up
Other outcomes:
measure: Pain Catastrophising
timeFrame: one week pre-treatment, one week post treatment and 6-months follow-up
measure: Pain hypervigilance
timeFrame: one week pre-treatment, one week post treatment and 6-months follow-up
Locations:
city: Vancouver
country: Canada
facility: British Columbia Centre for Sexual Medicine
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Lori A Brotto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01478243: Study of Psycho-Social Impact of Keloid
Official title: Study of Psycho-Social Impact of Keloid
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Keloid
Keywords: Keloid
Lead sponsor: Tirgan, Michael H., M.D.
Sponsor class: INDIV
First posted: 2011-11-23
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with clinical diagnosis of Keloid are invited to particiapate in this study.

Brief summary: Despite their benign nature, keloids may constitute a severe aesthetic, and in some cases, functional problem which translates to various repercussions on person's quality of life, including much stress and insecurities.

Keloids are mostly observed between the ages of 10 and 30. Although keloid is a common condition and the investigators can make assumptions about those living with keloids, the investigators do not know the actual impact of the illness on the overall performance of patients' and how this disease, day to day, is impacting their lives. The investigators are conducting this study, aimed to investigate the psychosocial impact of keloid on daily life. Information is collected anonymously. You must be 18 years of age or older to take this survey. Parents can respond on behalf of their children who are not 18 years of age yet. The online survey will take 20-30 minutes to complete.


Eligibility criteria: Inclusion Criteria:

1. Clinical Diagnosis of Keloid
2. Informed consent
3. Age above 18 to answer the survey questions
4. Parents shall respond on behalf of their minor children

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Michael H. Tirgan MD
state: New York
Study officials:
affiliation: Keloid Research Foundation
name: Michael H Tirgan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01956643: Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation
Official title: Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Ileus
Keywords: sham feeding
postoperative ileus
liver transplantation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative ileus is a common after abdominal surgery. Multifactorial etiology such as surgical trauma, bowel manipulation and perioperative opioids contributes to delayed return of normal gut function Chewing gum has recently been used as a form of sham feeding to stimulate acceleration of gut function after abdominal surgery.

The investigators hypothesize that sham feeding with chewing gum will accelerate return of gut function after liver transplantation.


Eligibility criteria: Inclusion Criteria:

* elective liver transplantation surgery
* an ability to chew gum

Exclusion Criteria:

* emergency surgery
* age less than 18 years,
* inability to provide written informed consent
* an inability to chew gum
* hepaticojejunostomy
* sedated patients
* reintubated patients
* Glasgow Coma Scale \<13
* reoperation before gas out
* previous bowel surgery

Primary outcomes:
measure: time to flatus
timeFrame: an expected average of 75 hours
Secondary outcomes:
measure: percentage of target calories
timeFrame: an average 4 days
measure: ICU length of stay
timeFrame: an average 96 hous
measure: hospital length of stay
timeFrame: an average 20 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hogeol Ryu, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06019143: GoalNav® Clinic Module - Pilot Trial
Official title: GoalNav® Clinic Module - Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Geriatric Assessment
Lead sponsor: Ardea Outcomes
Sponsor class: OTHER
Collaborators: name: National Research Council, Canada
First posted: 2023-08-31
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pilot study to test the feasibility of GoalNav® Clinic, an Electronic Data Capture platform which is specifically designed to collect data on patient goals, live in a clinical setting.

Detailed description: Goal Attainment Scaling (GAS) is an individualized outcome measure that quantifies the effects of an intervention based on personalized goals.

Ardea Outcomes has developed an electronic data capture system called GoalNav® Clinic that is designed to capture GAS data (individual goals) in addition to other outcome measures that is useful to the doctor such as assessment information, patient demographics, cognitive status, etc..

With the help of a study doctor and/or a member of the research team trained in the process of conducting GAS interviews, patients and/or care partners set goals that are meaningful and relevant to them or their loved one's condition. Goals are then followed up in three months, and ratings are provided by the GAS interviewer and patient and/or care partner.

Eligibility criteria: Inclusion Criteria:

* a new or returning patient who has been referred and has a pre-scheduled appointment to the study doctor's clinic for a geriatric assessment
* of any age, with or without a disease diagnosis/memory complaint
* the patient is accompanied by a family member or friend who is willing to participate
* the patient and/or their care partner must be able to respond to questions in English
* the patient and their care partner give informed consent

Exclusion Criteria:

* the patient does not have a family member or friend who is willing to participate
* neither the patient nor their care partner can respond to questions in English
* either or both the patient and care partner decline to provide informed consent
* the study doctor deems that the patient and/or care partner is not suitable for the study
* either the patient or their care partner indicates on the informed consent form that they do not wish to be contacted by email or by telephone

Primary outcomes:
measure: Goal Setting Survey
timeFrame: 4 months
Secondary outcomes:
measure: GAS Interviewer Individual Qualitative Interview
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Nova Scotial Health
name: Arlene Kelly-Wiggins, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiresuk TJ, Sherman RE. Goal attainment scaling: A general method for evaluating comprehensive community mental health programs. Community Ment Health J. 1968 Dec;4(6):443-53. doi: 10.1007/BF01530764.
Clinical trial NCT00365443: Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study (V502-003)
Official title: Proprietary Information - Exploratory (Non-Confirmatory) Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cervical Cancer
Condylomata Acuminata
Keywords: anogenital warts
premalignancy
HPV
Human papillomavirus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-08-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, and persistent infection caused by the HPV types in the study vaccine, (2) To demonstrate that the vaccine is well-tolerated in women, (3) To evaluate vaccine immune responses in women.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* Female, between the ages of 16 and 26

Exclusion Criteria:

* History of an abnormal PAP test or abnormal cervical biopsy result
* History of external genital/vaginal warts
* History of positive HPV test
* Currently a user of any illegal drugs or an alcohol abuser
* Are pregnant
* Currently enrolled in another clinical trial
* Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent).

Primary outcomes:
measure: Proprietary Information - Exploratory (Non-Confirmatory) Trial
Secondary outcomes:
measure: Proprietary Information - Exploratory (Non-Confirmatory) Trial
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03711643: Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging
Official title: Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostatic Diseases
Keywords: prostatic biopsies echo-guided
Pain measurement
Anxiety assessment
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 172
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The prostatic biopsies echo-guided are a painful and stressful. The purpose is to test a new medical device created recently, " Hypnos-Pro ", wich uses connected technologies. This connected device is a mask with diodes coupled with an audio headset and a touch pad. This connected mask is an another option to induce an hypnotic state for our patients. the objective is to value hypnotic mask effectiveness, to reduce the level pain and anxiety for the patients who benefit a prostatic biopsies echo-guided with local anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patient eligible for prostate biopsies
* Having accepted and signed the consent, for performing a prostate biopsy ultrasound examination
* No contraindication to the gesture
* Supporting the left lateral decubitus

Exclusion Criteria:

* Patient isolation contact / droplets
* Patient with hearing and / or epilepticus and / or dementia and / or having a history of stroke and / or allergic to lidocaine
* Person unable to consent, or benefiting from a system of legal protection (tutelage / curatorship).
* Patients with epileptic seizures.
* Patients with known allergies to plastics and other resins that may develop allergic contact dermatitis.
* Patients who are hypersensitive to radio frequency.
* Patients with Rocephin administration before the gesture

Primary outcomes:
measure: Visual analogic Scale
timeFrame: at 20 minutes after the removal of the probe
Secondary outcomes:
measure: State-Trait Anxiety Inventory ou STAI forme Y-A
timeFrame: Baseline, at 20 minutes after the removal of the probe
measure: Percentage of positive response of satisfaction of the patient
timeFrame: at 20 minutes after the removal of the probe
measure: Percentage of positive response of satisfaction of the operator
timeFrame: at 20 minutes after the removal of the probe
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
Study officials:
affiliation: University Hospital, Lille
name: Philippe Puech, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01781143: Self-operated Endo-vaginal Telemonitoring (SOET), an Economic and Patient-empowered Method for Ovarian Stimulation for In-vitro Fertilization (IVF)
Official title: Self-operated Endo-vaginal Telemonitoring (SOET), an Economic and Patient-empowered Method for Ovarian Stimulation for In-vitro Fertilization (IVF).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IVF Treatment
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Flanders Care
First posted: 2013-01-31
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The SOET project introduces a new strategy for routine follow-up of follicle growth during the hormonal treatment phase of an in-vitro fertilization (IVF) treatment cycle. After a learning instruction and demo, patients should be able to perform most of their vaginal echoes at home. The images can be sent to the medical center over the internet. These images are analyzed by the expert.


Eligibility criteria: Inclusion Criteria:

* Woman, suffering from subfertility.

Primary outcomes:
measure: Higher efficacy by taking an echo at home.
timeFrame: Every 2 days, up to a year.
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University Hospital VUB
city: Genk
country: Belgium
facility: Hospital Oost-Limburg
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Rocourt
country: Belgium
facility: Clinique Saint-Vincent
Study officials:
affiliation: University Hospital, Ghent
name: Jan Gerris, Ph.D, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerris J, Delvigne A, Dhont N, Vandekerckhove F, Madoc B, Buyle M, Neyskens J, Deschepper E, De Bacquer D, Pil L, Annemans L, Verpoest W, De Sutter P. Self-operated endovaginal telemonitoring versus traditional monitoring of ovarian stimulation in assisted reproduction: an RCT. Hum Reprod. 2014 Sep;29(9):1941-8. doi: 10.1093/humrep/deu168. Epub 2014 Jul 3.