louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04882722: Postpartum Pelvic Floor Rehabilitation and Information Provided by the Health Care Providers
Official title: Opinion Survey on Postpartum Pelvic Floor Rehabilitation According to the Quality of Information Provided by the Health Care Providers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recovery of Function
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women undergoing pelvic floor rehabilitation at the Departmental Hospital Center of Vendee

Brief summary: The aim of this work is to evaluate the experience of Postpartum Pelvic Floor Rehabilitation (PPFR) according to the information given by the health care providers. There is to improve medical practice and to give the right information in at the right time to the patient.

Detailed description: Postpartum Pelvic Floor Rehabilitation is an important central stage of the postpartum period. It allows, if it is well done, to reduce complications related to childbirth, (pelvic floor disorders: urinary, sexual or anal disorders ) and to increase quality of life of women in postpartum period.

But, what about the woman's opinion and experience of PPFR? Previous studies have evaluated the effectiveness of PPFR but not the woman's experience.

It is interesting to evaluate the experience of PPFR according to the information given by the health care providers. There is to improve medical practice and to give the right information in at the right time to the women

Eligibility criteria: Inclusion Criteria:

* All women undergoing postpartum pelvic floor rehabilitation at the Departmental Hospital Center of Vendee

Exclusion Criteria:

* Refusal to participate in the study
* Patient did not complete all her PPFR sessions at the Departmental Hospital Center of Vendee
* Patient unable to understand the protocol, read the information note and answer the questionnaires
* Patient under tutelage, curatorship, mandate of future protection, family habilitation

Primary outcomes:
measure: Overall experience of the PPFR according to information given by the health care providers
timeFrame: through study completion, an average of 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: Departmental Hospital Center of Vendee
Study officials:
affiliation: Departmental Hospital Center of Vendee
name: Guillaume DUCARME, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04331522: Allergen Provocations- HCA Children's Hospital
Official title: Allergen Provocations at Hans Christian Andersen Children's Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allergy in Children
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 8000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children referred to the department of pediatrics for investigation of allergy to foods or antibiotics

Brief summary: A prospective study of all allergen provocations performed in children at the Hans Christian Andersen Children's Hospital.

Detailed description: The purpose of the study is to investigate the impact of co-morbidities, history, and allergen tests on the outcome of allergen provocation tests.

Subjects are children aged 0-18 years old investigated for allergy to foods or antibiotics. Data entered in the database are demographics, co-morbidities, symptoms, SPT, specific IgE and details of the allergen provocations.

Eligibility criteria: Inclusion Criteria:

clinical suspicion of allergy to foods or antibiotics informed concent -

Exclusion Criteria:

-

Primary outcomes:
measure: The association of allergy tests with the result of allergen provocation
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Hans Christian Andersen Children's Hospital
state: Odense C
Study officials:
References:
citation: Gradman J, Petersen BT, Halken S. Oral food challenge with raw egg: Sixty-minute- compared with 30-minute dosing interval. Clin Exp Allergy. 2022 Sep;52(9):1114-1117. doi: 10.1111/cea.14187. Epub 2022 Jul 4. No abstract available.
citation: Petersen BT, Gradman J. Prospective study of 5-day challenge with penicillins in children. BMJ Paediatr Open. 2020 Aug 4;4(1):e000734. doi: 10.1136/bmjpo-2020-000734. eCollection 2020.
Clinical trial NCT00779922: Pharmacokinetics of Lenalidomide (Revlimid®) in Patients With Multiple Myeloma and Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Impaired Renal Function
Keywords: Multiple Myeloma
impaired renal function
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to determine the pharmacokinetic profile of Revlimid® in patients presenting with Multiple Myeloma and impaired renal function, the safety of Revlimid® in the enrolled patients population.

and evaluate the efficacy of Revlimid®-Dexamethasone combination in patients presenting MM and impaired renal function at completion of 3 cycles of treatment.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of relapsed or refractory multiple myeloma (MM).
* Age \> 18 years at the time of signing the informed consent form
* Stable renal function

Exclusion Criteria:

* Documented amyloidosis
* Any prior use of Revlimid ®
* Any contraindication to Revlimid ® and especially:
* Lack of acceptable method of birth control for female of childbearing potential (FCPB)

  * Men who don't agree to use condom during the study and 4 weeks after the last study drug intake if their partner is a FCPB.
  * Pregnant or breast feeding women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Poitiers University Hospital
Study officials:
References:
Clinical trial NCT03365622: Efficacy of IV Acetaminophen Versus Oral Acetaminophen
Official title: Randomized, Double-Blind Clinical Study Evaluating Efficacy of Intravenous Versus Enteric Acetaminophen in Donor Nephrectomy and Robot-Assisted, Laparoscopic Nephrectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nephrectomy
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether intravenous acetaminophen compared to enteric acetaminophen offers increased efficacy in patients who are scheduled for laparoscopic donor nephrectomy and for patients scheduled for robot-assisted, laparoscopic nephrectomy for cancer at the University of Rochester Medical Center. The standard surgical and post-operative care, including post-operative pain management will not be altered.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old
* Be scheduled for donor nephrectomy or robot-assisted, laparoscopic nephrectomy for cancer at University of Rochester Medical Center
* Have cognitive ability to verbally rate their pain on the Numeric Rating Scale (NRS).

Exclusion Criteria:

* Age younger than 18 years old or older than 90 years old
* Pregnancy (Pre-operative pregnancy test is standard of care for all elective operating room cases)
* Weight less than 50 kg
* Epidural use
* History of known liver disease.
* Patient unable to take enteral medications.
* Be taking opioid medications chronically.

Primary outcomes:
measure: Compare pain control for oral and intravenous acetaminophen for post-operative pain control. This will include opiates administered intra-operatively.
timeFrame: 20 to 24 hours post-operatively
Secondary outcomes:
measure: Average surgical pain intensity
timeFrame: 20-24 hours post-operatively
measure: Mean Inspiratory capacity
timeFrame: 1-2 hours post-operatively
measure: Mean total opioid dose (MME) used in 24 hours
timeFrame: 24 hours
measure: Mean dynamic pain score during incentive spirometer use
timeFrame: 20-24 hours post-operatively
measure: Mean dynamic pain score during incentive spirometer use
timeFrame: 1-2 hours post-operatively
measure: Mean time to first narcotic use
timeFrame: 24 hours
measure: Mean incidence of nausea post-operatively
timeFrame: 24 hours
measure: Mean time to discharge from post-anesthesia care unit
timeFrame: 24 hours
measure: Mean time to hospital discharge
timeFrame: 24 hours
measure: Average surgical pain intensity on a 0-10 numeric rating scale (NRS)
timeFrame: 1-2 hours post-operatively
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT00184522: On Demand Treatment of Reflux Disease
Official title: Aflurax Versus Nexium Given on Demand to Patients With Gastro-esophageal Reflux Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux
Keywords: Gastroesophageal Reflux
Esomeprazole
Drug treatment
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Ferrosan AS
First posted: 2005-09-16
Enrollment: 82
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: A comparison of the effect of on demand treatment with a pectin-containing natural product (Aflurax) with that esomeprazole (Nexium)

Detailed description: A randomized, controlled, open trial comparing the symptomatic effect of a pectin-containing product (Aflurax) with that of esomeprazole (Nexium 20 mg) given on-demand for 6 weeks.

Eligibility criteria: Inclusion Criteria:

Mild and moderate reflux symptoms Age \> 17 years Informed consent -

Exclusion Criteria:

Other conditions that might explain the symptoms Abuse of drugs or alcohol

-

Primary outcomes:
measure: Symptomatic relief
Secondary outcomes:
measure: Overall satisfaction
Other outcomes:
Locations:
city: Gjøvik
country: Norway
facility: Gjøvik Specialist Centre
city: Gjøvik
country: Norway
facility: Sykehuset Innlandet HF, Gjøvik
city: Hamar
country: Norway
facility: Sykehuset Innlandet HF, Hamar
city: Kongsvinger
country: Norway
facility: Sykehuset Innlandet HF, Kongsvinger
city: Lillehammer
country: Norway
facility: Sykehuset Innlandet HF, Lillehammer
city: Molde
country: Norway
facility: Helse Nord-Møre og Romsdal
city: Mosjøen
country: Norway
facility: Mosjøen sykehus
city: Namsos
country: Norway
facility: Helse Nord-Trøndelag
city: Tynset
country: Norway
facility: Sykehuset Innlandet HF, Tynset
Study officials:
affiliation: Norwegian University of Science and Technology
name: Per G Farup, PhD
role: STUDY_CHAIR
References:
citation: Farup PG, Heibert M, Hoeg V. Alternative vs. conventional treatment given on-demand for gastroesophageal reflux disease: a randomised controlled trial. BMC Complement Altern Med. 2009 Feb 24;9:3. doi: 10.1186/1472-6882-9-3.
Clinical trial NCT00981539: Will Cleaning the Bowel With an Enema Before Vaginal Prolapse Surgery Prevent Complications?
Official title: Do Preoperative Enemas Prevent Complications in Vaginal Pelvic Reconstructive Surgery?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cleansing
Keywords: The focus of this study is to determine whether it is beneficial to administer enemas before surgery
Lead sponsor: Illinois Urogynecology, Ltd.
Sponsor class: OTHER
First posted: 2009-09-22
Enrollment: 310
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Traditionally, many gynecologic surgeons have asked patients to perform a cleansing enema the night before a vaginal surgery done to repair pelvic organ prolapse (dropped bladder, dropped uterus). The belief is that there is then less or no stool present at the vaginal incision and less chance of infection of the wound by bowel bacteria. However, not all surgeons follow this practice. There is no evidence in the medical literature if one way is better than the other. In this study, patients scheduled for vaginal surgery to correct prolapse will be randomly assigned to perform an enema or not to perform an enema.

Detailed description: The factors to be measured will be wound infection rates, and need to cleanse an incision of escaped stool.

Eligibility criteria: Inclusion Criteria:

* female, AND
* undergoing vaginal surgery for prolapse.

Exclusion Criteria:

* pregnant women,
* age younger than eighteen,
* male sex, OR
* concurrent abdominal surgery.

Primary outcomes:
measure: wound infection rate
timeFrame: 6 weeks post op
Secondary outcomes:
measure: rate of contamination of surgical field by stool during surgery
timeFrame: day of surgery
Other outcomes:
Locations:
city: Oak Lawn
country: United States
facility: Illinois Urogynecology, LTD.
state: Illinois
city: Park Ridge
country: United States
facility: Illinois Urogynecology, LTD.
state: Illinois
Study officials:
References:
Clinical trial NCT05285839: Dupixent and Narrowband UVB for Atopic Dermatitis
Official title: Single Center, Pilot Study to Evaluate the Effectiveness and Safety of Dupilumab in Combination With Narrowband UVB (nUVB) Phototherapy in the Treatment of Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atopic Dermatitis
Lead sponsor: Psoriasis Treatment Center of Central New Jersey
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2022-03-18
Enrollment: 40
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: 24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.

Detailed description: 24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.

Eligibility criteria: Inclusion Criteria:

* Male or female adult ≥ 18 years of age;
* Diagnosis of moderate to severe atopic dermatitis as defined at baseline by:

  * EASI score of 16 or greater,
  * IGA score of 3 or greater
  * BSA of 10% or greater,

Exclusion Criteria:

* Subjects with previous exposure to dupilumab.
* Known or suspected hypersensitivity to dupilumab or any of its excipients.
* History of photosensitivity.

Primary outcomes:
measure: Investigators Global Assessment Score of score of 0 or 1
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Windsor
country: United States
facility: Eczema Treatment Center of New Jersey
state: New Jersey
Study officials:
References:
Clinical trial NCT02869139: Package of Mentholated Measures for the Relief of Thirst in the Anesthesia Recovery Room
Official title: Package of Mentholated Measures for the Relief of Thirst in the Anesthesia Recovery Room: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thirst
Mouth Dryness
Irritation Lips
Keywords: Thirst
Ice
Menthol
Perioperative Nursing.
Recovery Room
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Package of mentholated measures for the relief of thirst in the anesthesia recovery room: Randomized clinical trial

Detailed description: Perioperative thirst is intense and has a high incidence. There is evidence that strategies using cold and menthol could be viable alternatives to reduce thirst and the discomforts arising from it. For that reason, this study evaluated the efficacy of a mentholated package of measures (lip moisturizer and ice popsicle) compared to a non-mentholated package of measures in alleviating thirst in the anesthesia recovery room.

Eligibility criteria: Inclusion Criteria:

* Possess aged between eighteen and sixty-five years
* To be fasting for more than four hours
* Verbalizing headquarters spontaneously or after questioning, with greater than or equal to three intensity in numerical verbal scale
* Receive opioids or anticholinergic during surgery duration of greater than one hour anesthesia
* Being in anesthetic recovery in anesthesia recovery room
* Have been approved in the evaluation Headquarter Insurance Management Protocol which was applied to both groups
* Accept participate and sign the consent form Clarified

Exclusion Criteria:

* Being allergic to menthol
* Have continuity of injury in the oral mucosa
* Having suspended the anesthetic-surgical procedure after acceptance of participation
* Receive High operating room directly to another healthcare sector than the anesthetic recovery room, and intensive care unit or hospital unit

Primary outcomes:
measure: Change in intensity of thirst, lip hydration, dryness of the mouth and taste the final oral cavity above the original between the experimental and control groups.
timeFrame: three times: 0 minutes, 30 minutes and 60 minutes after intervention and evaluation
Secondary outcomes:
measure: Change in the extent of satiety point over an hour assessment, presented by experimental and control groups, and the number of interventions required in every moment of assessment and intervention for each group.
timeFrame: three times: 0 minutes, 30 minutes and 60 minutes after intervention and evaluation
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Viviane Moreira Serato
state: Paraná
Study officials:
affiliation: Universidade Estadual de Londrina
name: Viviane Serato
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01800539: Improving Services and Outcomes for Children With Autism Spectrum Disorder (ASD)
Official title: Improving Part C Services and Outcomes for Under-resourced Children With ASD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Keywords: Autism
Early Intervention
Minority
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2013-02-27
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on the need to characterize and improve early intervention services for minority and under-resourced children with ASD, this study translates a manualized and proven training model to examine its impact on the use of evidence-based practices (EBP) by early intervention providers, and to examine its relationship to child and family outcomes. By highlighting the impact of EBP-focused training on participating providers, children, and families, findings of the proposed study have the potential to effect significant change in the organization and delivery of early intervention services for minority and under-resourced children with ASD.


Eligibility criteria: Inclusion Criteria for Providers:

* Providers must be employed by an Infants and Toddlers Program; and
* Serve at least one eligible child with ASD

Inclusion Criteria for Families/Children:

* Children must be between 12 months, 0 days and 35 months, 30 days of age at entry into the study;
* Children must meet criteria on the Autism Diagnostic Observation Schedule (ADOS) for ASD or autism; and
* Caregiver and child must be available for all assessments

Exclusion Criteria for Families/Children:

* Children will be excluded if they are in foster care or wards of the state
* Caregiver must be fluent in speaking and understanding the English language

Primary outcomes:
measure: Change in Provider Delivery Service Practices
timeFrame: Baseline and 6 months into treatment
Secondary outcomes:
measure: Change in Baseline Mullen Scales of Early Learning
timeFrame: Baseline and 6 months into treatment
measure: Change in Baseline Autism Diagnostic Observation Schedule
timeFrame: Baseline and 6 months into treatment
measure: Change in Caregiver Interaction with Child
timeFrame: Baseline and 6 months into treatment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Rebecca Landa, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References: