louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02562521: A Smoking Cessation Intervention for Yale Dining Employees
Official title: A Smoking Cessation Intervention for Yale Dining Employees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 25
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 a smoking cessation program for employees at the Yale University dining hall. Two pilot dining halls and six paired dining halls (3 test and 3 control sites) will be offered a contingency management/pharmacotherapy smoking cessation intervention at the work site.

Detailed description: The primary aim of this study is to test the effect of a smoking cessation intervention provided to Yale University dining hall employees on smoking quit rates and quit attempts at the end of six weeks of treatment. It is hypothesized that participants from the test site will have higher rates of smoking cessation and quit attempts compared to participants from the control site. In addition, this study will examine the number of participants who enroll in the smoking cessation program who successfully quit smoking at 6 months.

There will be 3 test sites and 3 control sites in this study (broken down into 3 pairs of test/control). Each test site will be matched to on a control site. Self-reported smoking status will be obtained for all participants in the test and control sites at 3 time points (baseline, 6 weeks and 6 months). The study start time for each pair will be delayed by 4-8 weeks for feasibility issues.

Eligibility criteria: Inclusion Criteria:

* Current smoker
* Interested in receiving treatment for quitting smoking.
* Employed for more than 20 hours per week by one of the 7 residential college dining halls selected for inclusion in this study.
* English speaker.

Exclusion Criteria:

* None specified, other than failure to meet all inclusion criteria listed above.

Primary outcomes:
measure: Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks
timeFrame: 6 weeks
measure: Number of Participants Who Quit Smoking for at Least 24 Hours in the Prior Six Weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Participants Who Quit Smoking at 2 Months
timeFrame: Month 2
measure: Number of Participants Who Quit Smoking at 3 Months
timeFrame: Month 3
measure: Number of People Who Quit Smoking at 4 Months
timeFrame: Month 4
measure: Number of People Who Quit Smoking at 5 Months
timeFrame: Month 5
measure: Number of People Who Quit Smoking at 6 Months
timeFrame: Month 6
measure: Wisconsin Predicting Patient's Relapse Questionnaire
timeFrame: Baseline
measure: Wisconsin Predicting Patient's Relapse Questionnaire
timeFrame: Month 6
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Stephanie O'Malley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03876821: Collect of Cord Blood From Subjects at Risk for Sickle Cell Disease, for the Purpose of Laboratory Research
Official title: Collect of Cord Blood From Subjects at Risk for Sickle Cell Disease, for the Purpose of Laboratory Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Centre Hospitalier Sud Francilien
First posted: 2019-03-15
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study includes pregnant women, aged 18-45 years of age, carrying at least one HbS allele, and who are followed and giving birth at the maternity unit of the Centre Hospitalier Sud Francilien in Evry, France.

Brief summary: The study consists in collecting umbilical cord blood cells from newborns at risk of sickle cell disease, to perform laboratory experiments aiming to characterize the cells with HbS/HbS mutation, to develop methods to prepare, to gene-modify and to preserve these cells.

Detailed description: Pregnant individuals carrying at least one HbS allele will be included in the study to collect the umbilical cord blood of the child at birth. Collected cells will be used anonymously for genetic and bioexperimental laboratory research, aiming to develop autologous gene therapy for sickle cell disease.

Eligibility criteria: Inclusion Criteria:

* Pregnant women, giving birth at CHSF and consenting to the collect and study of placental blood after delivery
* Age 18 to 45 years
* Biological testing of the participant includes hemoglobin electrophoresis and shows at least one HbS allele

Exclusion Criteria:

* Lack of written consent
* Minors (not 18 years old) or under guardianship
* Diseases : HIV, Hepatitis B, Hepatitis C or HTLV (Human T Leukemia Virus).

Primary outcomes:
measure: Number of samples with HbS/HbS genotype
timeFrame: 3 years
Secondary outcomes:
measure: Number of samples with bio-experimental data
timeFrame: 4 years
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: CHSF
Study officials:
affiliation: CHSF
name: Luc Rigonnot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Anne Galy, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00772421: Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Rhythm
Official title: Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Rhythm (SANTE RR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
Recruitment rhythm
DBS
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll the number of patients necessary to achieve the required sample size of 18 responders and 18 non-responders at a minimum of six (6) centers participating in the U.S. SANTE study.

Brief summary: The primary objective is to demonstrate that a higher proportion of responders to deep brain stimulation (DBS) in the anterior nucleus (AN) of the thalamus in refractory epilepsy patients in the SANTE study exhibit a recruitment rhythm relative to non-responders.


Eligibility criteria: Inclusion Criteria:

* Enrolled in the SANTÉ study, have been implanted with a complete DBS system, and is currently receiving stimulation in the long-term follow-up phase (post Month 13) of the study
* Patient or legal representative is able to understand and provide signed consent for participating in the study
* Willing and available to attend the visit as scheduled and to comply with the study protocol

Exclusion Criteria:

* Patients unable to tolerate stimulation turned OFF during the testing period
* Are pregnant or suspected of being pregnant

Primary outcomes:
measure: To demonstrate that a higher proportion of DBS responders exhibit a RR relative to non-responders, using maximum tolerated voltage settings, at activated electrode contacts used for DBS stimulation in the SANTE study.
timeFrame: Study testing to occur during the long-term follow-up phase of the SANTE trial.
Secondary outcomes:
measure: For patients without a RR at their activated DBS electrode contacts used in the SANTE study, demonstrate that activating other electrode contacts generates a RR.
timeFrame: Study testing to occur during the long-term follow-up phase of the SANTE trial.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05286021: Comparison of the Clinical Performance and Safety of the Ambu®AuraGainTM Laryngeal Mask in Children Undergoing Surgery in the Supine and Prone Position - A Prospective, Noninferiority Clinical Trial
Official title: Comparison of the Clinical Performance and Safety of the Ambu®AuraGainTM Laryngeal Mask in Children Undergoing Surgery in the Supine and Prone Position - A Prospective, Noninferiority Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Marrow Examination
Urologic Surgical Procedures
Orthopedic Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 126
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be done in pediatric patients between the ages 2 and 12 years, weight 10 and 30 kg, that are eligible to use the Ambu Auragain LMA for surgical procedures within 2 hours. The patients will undergo surgery in either the supine or prone position.

Brief summary: The Ambu Auragain is a 2nd generation laryngeal mask airway that is widely used in adult and pedicatric patients. While its use is generally recommended in patients undergoing surgery in the supine position, depending on patient characteristics, type of surgery and experience of the anesthesiologist, it may also be used in the lateral or prone position. There have been reports of LMA use in patients undergoing short procedures in the prone position, but its safety in pediatric patients is not clear. This study was designed to compare oropharyngeal leak pressure between children undergoing surgery in the supine and prone position using the Ambu Auragain LMA.


Eligibility criteria: Inclusion Criteria:

Pediatric patients undergoing surgery within 2 hours under general anesthesia in either the supine or prone position using the Ambu Auragain LMA.

Patients aged 2-12 years, weight 10-30 kg, ASA class 1\~3

Exclusion Criteria:

Active URI, symptomatic lung disease (uncontrolled asthma, pneumonia etc), patients with history of difficult airway, anticipated difficult mask ventilation, risk of aspiration such as gastroesophageal reflux

Primary outcomes:
measure: Oropharyngeal leak pressure immediately after LMA insertion
timeFrame: During procedure (Immediately after AmbuAuragain LMA insertion)
Secondary outcomes:
measure: Oropharyngeal leak pressure 10 minutes after positioning for surgery
timeFrame: 10 minutes after positioning (either supine or prone position) for surgery.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References:
Clinical trial NCT06596421: Effect of Abdominal Massage on Constipation After Cardiac Surgery
Official title: Effect of Abdominal Massage on Constipation After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Massage
Keywords: Cardiac surgery
abdominal massage
constipation
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background and Aim: Although the incidence of gastrointestinal complications after cardiovascular surgery is reported to be rare, it has been reported that patients experience problems with constipation within the week after discharge. The presence of abdominal distension due to constipation after cardiac surgery may lead to prolonged wound healing, paralytic ileus and gastric dilatation. This study aimed to evaluate the effect of abdominal massage on constipation after cardiac surgery.

Methods: A prospective, randomised controlled quasi-experimental study was conducted in the cardiovascular surgery clinic of a public hospital between September 2022 and July 2023. A power analysis was performed to determine the sample size. A total of 130 patients were randomly assigned to the experimental or control group using a simple randomisation method. Data were collected using a 21-item form from the first day after surgery. Burping and defecation times of the patients were evaluated and recorded.

Results: The mean age of the experimental group was 55.2±13.3 years, while the mean age of the control group was 60.4±10.6 years (p=0.015). There was no statistically significant difference between the groups in terms of sociodemographic characteristics, bowel preparation and preoperative fasting times. It was observed that bowel sounds started earlier in the experimental group (70.8% on the first postoperative day) compared to the control group (46.2% on the first postoperative day) (X2=16.629; p=0.005). The first burping time measurements in the control group (x̄=46.415 hours) were higher than those in the experimental group (x̄=31.262 hours). Postoperative defecation time was longer in the control group (x̄=99.51 hours) than in the experimental group (x̄=61.611 hours).


Eligibility criteria: Inclusion Criteria:

* - Being older than 18 years
* Agreeing to participate in the study
* Undergoing a cardiac surgery
* Not having a barrier for communication
* Not having a mental or cognitive disability
* Not using constipation treatment (like laxatives or enemas)
* Having no history of constipation disorders or gastrointestinal surgery.

Exclusion Criteria:

-

Primary outcomes:
measure: patient sociodemographic characteristics and physical measurements form
timeFrame: 2 days to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahcesehir Universty
Study officials:
References:
Clinical trial NCT04824521: A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder
Official title: The Mindful Pregnancy Study: A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: University of Montana
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2021-04-01
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Thirty pregnant women with substance use disorder will be recruited to participate in eight sessions of MORE.

Detailed description: Participants will be asked to complete a battery of self-report measures and a semi-structured qualitative interview at three times points-before the intervention begins, after session four, and again after session eight. Participants will also be asked to complete self-report measures before and after each session. The primary aims of this study are as follows.

Aim 1: To adapt the in-person MORE intervention for telehealth delivery. Aim 2: To assess the overall feasibility and acceptability of this telehealth intervention. Hypothesis: MORE delivered via telehealth will be both feasible and acceptable to participants.

Eligibility criteria: Inclusion Criteria:

* Must be pregnant.
* Must be able to communicate in English.
* Must have met criteria for opioid use disorder in the past year.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Client Satisfaction
timeFrame: 8 weeks
Secondary outcomes:
measure: SUD Symptoms - Mini Neuropsychiatric Interview
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Missoula
country: United States
facility: University of Montana
state: Montana
Study officials:
affiliation: University of Montana
name: Sarah Reese
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00577421: Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO
Official title: An Extension Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2007-12-20
Enrollment: 32
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080, and RVE2001079 (NCT01249261)

Detailed description: A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080, and RVE2001079 (NCT01249261)

Eligibility criteria: Inclusion Criteria:

* have satisfactorily completed Clinical Study RVE2001079 (Year 8 extension study)

Exclusion Criteria:

* Can not use any bone modifying substances except risedronate

Primary outcomes:
measure: To assess the safety and tolerability profile of 5 mg daily oral risedronate therapy administered for 2 years in patients with post-menopausal osteoporosis, who had received risedronate for 2 or 7 years and then had a risedronate-free year.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: Australia
facility: Research Site
city: Sienna
country: Italy
facility: Research Facility
city: Warsaw
country: Poland
facility: Research Facility
city: Barcelona
country: Spain
facility: Research Facility
city: Goteborg
country: Sweden
facility: Research Facility
Study officials:
affiliation: Procter and Gamble
name: Dietrich H Wenderoth, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05854121: FES VS Constrained Induced MT Recovery and Spasticity in Upper Limb Hemiparetic Ischemic Patients
Official title: Functional Electrical Stimulation Versus Constrained Induced Movement Therapy for Motor Recovery and Spasticity in Upper Limb Hemiparetic Chronic Ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 56
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determines the effects of Functional Electrical Stimulation versus Constrained Induced Movement Therapy for motor recovery and spasticity in Upper Limb Hemiparetic Chronic Ischemic Stroke Patients


Eligibility criteria: Inclusion Criteria:

Clinically diagnosed chronic ischemic stroke patients. Patients from both genders Age 45 year and older. Patients having upper limb spasticity equal to 2 or less than 2 according to modified ash worth scale.

Patients having active cognitive scoring on Mini Mental State Examination.

Exclusion Criteria:

Having pacemaker and other stimulation devices. Prosthesis of bones, joints in targeted region of treatment. Patients presenting the history of recurrent stroke. Patients having history of bilateral hemiparesis. Co-morbid history of tumor, heart disease, hypertensive. Patients presenting with skin lesions, wounds, discoloration will be excluded from this research.

Primary outcomes:
measure: Scale Modified Ash worth
timeFrame: 6 Months
measure: Motor Function assessment test
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shadman Medical Care
state: Punjab
Study officials:
References:
Clinical trial NCT03261921: Caudal Combination of Dexamethasone and/or Dexmedetomidine to Bupivacaine in Pediatric Hypospadias Surgery
Official title: Adjuncts to Caudal Block in Pediatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Caudal Block
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 63
Sex: MALE
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Sixty-three patients with ASA I-II aged from 1-6 years scheduled for hypospadias surgery in Abu El-Resh pediatric Hospital-Cairo university, were included in this prospective randomized double-blinded clinical study. Patients with contraindication to caudal anesthesia, cardiovascular diseases, drug allergy, type I diabetes, clotting disorders, mentally retarded children or those whose families did not approve inclusion in the study were excluded from the study.

Patients were randomly divided on the morning of surgery into three groups group I( dexamethasone 21 patients), Group II ( Dexmedetomidine 21 patients) and group III(Dexmedetomidine and dexamethasone 21 patients).
Primary purpose: DIAGNOSTIC

Brief summary: One of the most commonly used regional anesthetic techniques in pediatric surgeries is the caudal epidural block. Its main disadvantage remains the short duration of action. Hence, different additives have been used. Dexmedetomidine as an additive to the local anesthetic bupivacaine in caudal epidural analgesia prolongs the duration of postoperative analgesia so is dexamethasone. The investigators aimed to study the effect of combining both additives in the duration of analgesia, decreasing side effects and decreasing anesthetic doses

Detailed description: Sixty three children scheduled for hypospadias randomized into 3 groups. Group I (n=21) (dexamethasone 0.1mg/kg+ 0.5ml/kg bupivacaine 0.25%), group II(n=21)( dexmedetomidine 0.01ug/kg+ 0.5ml/kg bupivacaine 0.25%)and groupIII(n=21)(dexamethasone0.1mg/kg+dexmedetomidine0.01ug/kg +0.5ml/kg bupivacaine 0.25%).intraoperative and postoperative hemodynamics were recorded. In PACU, MOPS scores and sedation scores were recorded at 30min,1,2,3,6and 12hrs. Also the time of first analgesic request was recorded.

Eligibility criteria: Inclusion Criteria:

1 - ASA I-II 2- Males only 3- Children aged from 1-6 years 4- Children scheduled for hypospadias surgery

Exclusion Criteria:

1. Contraindication to caudal anesthesia.
2. cardiovascular diseases.
3. drug allergy.
4. Type I diabetes.
5. Clotting disorders.
6. Mentally retarded children or those whose families did not approve inclusion in the study

Primary outcomes:
measure: Time of first request of analgesia
timeFrame: 12 hours
measure: pain scores
timeFrame: 12 hours
Secondary outcomes:
measure: sedation score
timeFrame: 12 hours
measure: heart rates(beat/minute)
timeFrame: 3 hours.
measure: mean arterial pressure (mmhg)
timeFrame: 3 hours
Other outcomes:
Locations:
Study officials:
References: