louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03072888: Effects of Transcutaneous Electrical Nerve Stimulation (TENS) Following Hysterectomy
Official title: The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Quality of Recovery After Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Keywords: acute pain
Transcutaneous Electric Nerve Stimulation
Anesthesia Recovery Period
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 50
Sex: FEMALE
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: The purpose of this study is to evaluate the effect of Transcutaneous Electrical Nerve Stimulation (TENS) in patients after abdominal hysterectomy surgery.

Detailed description: The aim of this study is to evaluate the efficacy of the Transcutaneous Electrical Nerve Stimulation (TENS) on postoperative pain and quality of recovery in patients following abdominal hysterectomy surgery under general anesthesia.

Eligibility criteria: Inclusion Criteria:

* Patients aged between18-65 undergoing elective abdominal hysterectomy
* ASA (American Society of Anesthesiologist) I,II physical status

Exclusion Criteria:

* Not agreement with the study,Dermatological lesion affecting the electrode place,
* Chronic or preprocedural use of opioids, steroids or psychoactive drugs,
* Allergy to drugs used during trials,
* Previous experience in TENS,
* Kidney, liver, neurological or cardiovascular system disease
* Body mass index\>40

Primary outcomes:
measure: Quality of Recovery
timeFrame: At twenty-four hours after surgery
Secondary outcomes:
measure: Pain
timeFrame: During 24 hours after surgery
measure: Analgesic Consumption
timeFrame: During 24 hours after surgery
measure: Postoperative Nausea and Vomiting
timeFrame: During 24 hours after surgery
Other outcomes:
measure: Adverse events
timeFrame: During 24 hours after surgery
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University Medical School
Study officials:
References:
Clinical trial NCT00472407: Screening for Convergence Insufficiency in School-age Children
Official title: Screening Eye Coordination Study Screening for Convergence Insufficiency in School-age Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Convergence Insufficiency
Keywords: Normal
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2007-05-11
Enrollment: 282
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Of the 282 subjects included in the analysis, approximately 60% were female, 81.5% identified themselves as white, 11% as African American, 2.5% as other, and 5% did not report race. Two percent classified themselves as Hispanic or Latino, 76% reported not being Hispanic or Latino, and 22% did not report their ethnicity.

Brief summary: The purpose of this study was to assess the ability of common tests of eye alignment, convergence, and accommodation to identify children with convergence insufficiency in a school screening setting.

Detailed description: The purpose of the Screening for Convergence Insufficiency in School-age Children study was to assess the ability of common tests of eye alignment, convergence, and accommodation to identify children with convergence insufficiency in a school screening setting (where it may not be feasible to do more than one test).

Eligibility criteria: Inclusion Criteria:

* Age 9 to 17 years
* Enrolled in participating school
* Parental permission, assent
* Ability to complete testing

Exclusion criteria: referral on vision screening for reduced distance visual acuity or significant uncorrected refractive error

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
Study officials:
affiliation: Ohio State University
name: Marjean Kulp, OD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Menjivar AM, Kulp MT, Mitchell GL, Toole AJ, Reuter K. Screening for convergence insufficiency in school-age children. Clin Exp Optom. 2018 Jul;101(4):578-584. doi: 10.1111/cxo.12661. Epub 2018 Mar 13.
Clinical trial NCT02854488: Yervoy Pregnancy Surveillance Study
Official title: A Global Enhanced Pharmacovigilance Pregnancy Surveillance Study of Pregnant Women Exposed to Yervoy With 5 -Year Pediatric Follow-up
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-08-03
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: The study is a global safety surveillance study of pregnancy outcomes in women who were exposed to ipilimumab during pregnancy and pediatric outcomes up to 5 years of age


Eligibility criteria: Inclusion Criteria:

* Documented exposure to Yervoy while pregnant or within 90 days of discontinuing treatment

Exclusion Criteria:

* Women whose ipilimumab exposure is outside the window of pregnancy exposure
* Pregnancies for which there is only paternal exposure to Yervoy

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Incidence of structural birth defects in infants born to mothers exposed to Yervoy while pregnant
timeFrame: Birth up to 12 months
measure: Incidence of chromosomal birth defects in infants born to mothers exposed to Yervoy while pregnant
timeFrame: Birth up to 12 months
measure: Delays in developmental milestones
timeFrame: Birth up to 5 Years
measure: Clinical Signs of Immune or Endocrine Dysfunction
timeFrame: Birth up to 5 Years
measure: Clinical Signs of Autoimmune Disorders
timeFrame: Birth up to 5 Years
measure: Clinical Signs of Serious Infections and Malignancy
timeFrame: Birth up to 5 Years
measure: Adverse Pregnancy Outcomes
timeFrame: Time of Conception up to Birth
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: UBC
state: Maryland
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06508788: Combination of the Vaginal Laser With a Moisturizing and Repairing Niosomal Gel in the Treatment of Genitourinary Syndrome in Oncology Patients
Official title: Combinación Del láser Vaginal Con un Gel Niosomal Hidratante y Reparador en el Tratamiento Del síndrome Genitourinario en Pacientes oncológicas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Genitourinary Syndrome of Menopause
Keywords: Genitourinary Syndrome of Menopause
CO2 laser
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 30
Sex: FEMALE
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 with an established SGM diagnosis who have a history of neoplasia in whom the use of estrogens as the first alternative for the treatment of GMS is not recommended.

Brief summary: Vaginal laser together with the use of moisturizing and repairing gels could be an effective therapy for the treatment of genitourinary syndrome in women with a history of neoplasia in whom the use of estrogens is not recommended.

The purpose of this study is to evaluate the effectiveness of vaginal laser together with adjuvant treatment with a hydrating and repairing niosomal gel as a beneficial treatment in this group of patients.


Eligibility criteria: Inclusion Criteria:

* Patients with an established SGM diagnosis.
* Patients with a history of neoplasia in whom the use of estrogens as the first alternative for the treatment of GMS is not recommended.

Exclusion Criteria:

* Patients with concomitant vulvovaginal pathology.
* Patients with a diagnosis of pelvic organ prolapse grade II or greater.

Primary outcomes:
measure: Effectiveness
timeFrame: 12 months
Secondary outcomes:
measure: Security
timeFrame: 12 months
measure: Duration
timeFrame: 12 months
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Carlos
state: Cataluña
Study officials:
References:
Clinical trial NCT01011088: Paternal Psychosis After Baby Born
Official title: Paternal Psychosis Evaluation After First Baby Born
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychosis
Keywords: Paternity
Psychology
Risk factor
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2009-11-11
Enrollment: 387
Sex: MALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fathers with their first baby born

Brief summary: A large number of studies have investigated the psychological disorders occurred in postpartum women, and found that postpartum psychosis is common in new mothers.

However, the situation of paternal psychological status after they had their first baby is not assessed. The investigators hypothesized that they had a high occurrence of paternal psychosis after first baby born. In addition, different factors might influence its onset and development in new fathers.


Eligibility criteria: Inclusion Criteria:

* Men will be the would-be fathers
* Chinese

Exclusion Criteria:

* Age \< 18 years or \> 50years
* Not willing to participating or completing the whole study at any time

Primary outcomes:
measure: Incidence of psychoses
timeFrame: Within the first 90 days and 90 days to 12 months postpartum
Secondary outcomes:
measure: Economic level before baby born
timeFrame: One year before baby born
measure: Social status before baby born
timeFrame: One year before baby born
measure: Psychological level before baby born
timeFrame: From birth of the fathers to the time of their baby born,this is varing from different fathers and received by history records
measure: Maternal intrapartum complications
timeFrame: From the onset of painful labor (0 min of delivery) to the completion of birth (varying in different women and/or different labor procedures)
measure: Baby characteristics
timeFrame: One minute, 5min, 15min after baby was born
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03257488: Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study
Official title: Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea, Obstructive
Resistant Hypertension
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the utility and reliability of Somnocheck micro Weinmann for obstructive sleep apnea syndrome (OSAS) screening in patients affected by resistant systemic arterial hypertension. Results are compared with a modified portable sleep apnea testing (type III portable monitoring: Somnocheck 2 Weinmann).

Detailed description: OSAS is a syndrome characterized by the partial or total collapse of the high airways which determines snore, airflow limitation, hypopnea and apnea.These events cause desaturations, daytime sleepiness and an increased risk of cardio and cerebral vascular diseases.

OSAS's prevalence is estimated between 64-83% among patients affected by resistant arterial hypertension; therefore OSAS's screening is mandatory during the clinical work-up of these patients.

This study is a randomized, interventional, spontaneous, exploratory, cross-over and monocentric trial, which assesses the utility and reliability of the reduced cardio-respiratory monitoring (type IV portable monitoring: Somnocheck micro Weinmann) to estimate the prevalence of OSAS among patients affected by resistant systemic arterial hypertension. The results are compared with a complete cardio-respiratory monitoring (type III portable monitoring: Somnocheck 2 Weinmann).

Eligibility criteria: Inclusion Criteria:

* Resistant Arterial Hypertension
* Patients must sign the informed consent

Exclusion Criteria: ,

* atrial fibrillation with haemodynamic instability
* congestive hearth failure,
* BMI\>45 kg/m2,
* respiratory failure
* renal or liver failure,
* stroke,
* implantable cardioverter-defibrillator (ICD),
* pacemaker (PM),
* previous diagnosis of OSAS,
* pregnancy,
* breastfeeding,
* patients must not be already enrolled in other clinical trial.

Primary outcomes:
measure: Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.
timeFrame: These two procedures must be done in the same patient within 5 days
Secondary outcomes:
measure: Number of Participants with cardiovascular abnormalities 1
timeFrame: Cardiovascular assessment must be done within 6 months before the sleep studies.
measure: Number of Participants with cardiovascular abnormalities 2
timeFrame: Cardiovascular assessment must be done within 6 months before the sleep studies.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda ospedaliera policlinico Sant'Orsola-Malpighi
Study officials:
References:
Clinical trial NCT00970788: A Pilot Study of Using Video Images in Advance Care Planning in Malignant Glioma Patients
Official title: A Pilot Study of Using Video Images in Advance Care Planning in Malignant Glioma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Brain Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Foundation for Informed Medical Decision Making
First posted: 2009-09-02
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer.

Detailed description: A randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer. Subjects will have three options for their goals of care: life prolonging care, basic medical care, or comfort care.

Eligibility criteria: Inclusion Criteria:

* Advanced brain cancer
* English Speaking
* Able to provide informed consent

Exclusion Criteria:

* Folstein mini mental status score of 23 or less

Primary outcomes:
measure: end of life preference at time of interview
timeFrame: 5 minutes after survey
Secondary outcomes:
measure: uncertainty regarding end of life preference at time of interview
timeFrame: 5 minutes after survey
measure: knowledge of end of life preference at time of interview
timeFrame: 5 minutes after survey
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Angelo Volandes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04700488: Magnetic Resonance Imaging (MRI) to Predict Outcomes of Pancreatic Ductal Adenocarcinoma (PDAC)
Official title: MRI Imaging to Predict Outcomes of Treatment in PDAC Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PDAC - Pancreatic Ductal Adenocarcinoma
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 36
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: The purpose of this study is to assess if Six-Dimensional Magnetic Resonance Imaging (6D-MRI) is effective in predicting outcomes in patients with pancreatic ductal adenocarcinoma (PDAC).

Detailed description: The overarching goal of this pilot study is to evaluate the usefulness of a novel Magnetic Resonance Imaging (MRI) approach, which measure properties of tumor microenvironment (i.e. vascularity, fibrosis), to predict PDAC response to neoadjuvant therapy (NAT).

Eligibility criteria: Inclusion Criteria:

* Pancreatic cancer patients (with resectable or borderline resectable or locally advanced tumors) who will undergo neoadjuvant chemotherapy
* Patients able to undergo at least two sets of MRI sessions
* Access to a device that has the capability to sync to the Fitbit (or access to a family member's, caregiver's, or friend's device)

Exclusion Criteria:

* Patients who have previously been treated for PDAC
* Patients unable to undergo MRI exam w/contrast
* Patients with metastatic pancreatic cancer visualized on index diagnostic imaging
* Patients with certain metallic implants
* Patients experiencing claustrophobia

Primary outcomes:
measure: Rate of progression-free survival from baseline
timeFrame: 2 years
measure: Number of participants with R0 resection
timeFrame: 2 years
measure: Change in overall health from baseline, as measured by the Charlson Comorbidity Index (CCI)
timeFrame: Baseline, 2 years
measure: Change in functional status from baseline, as measured by the Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status
timeFrame: Baseline, 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Stephen Pandol, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02515188: The Effect of Additional Propacetamol Infusion on Post Procedural Outcome and Opioid Consumption During Catheter Ablation of Atrial Fibrillation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-08-04
Enrollment: 98
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sedation for catheter ablation of atrial fibrillation should be performed to achieve analgesia, immobilization, and maintenance of airway. Various anesthetic agents such as propofol, dexmedetomidine, and midazolam were investigated to achieve this goal. However, propofol and midazolam causes respiratory depression and dexmedetomidine occasionally accompanies hypotension or hypertension and bradycardia. Therefore, anesthetic agent that does not induce respiratory depression with stable hemodynamics is needed.

Propacetamol (Denogan®, Yungjin, Seoul, Korea) is injectable prodrug of acetaminophen and 1st line drug for fever and pain. In a previous study, paracetamol reduced morphine consumption after surgery. And paracetamol does not cause respiratory depression. Thus, the investigators hypothesized that addition of propacetamol to previously used sedatives midazolam-remifentanil will reduce opioid consumption during the catheter ablation.

Therefore, the investigators designed this study to investigate the role of addition of propacetamol to previous used midazolam-remifentanil sedation. This study will compare the opioid consumption and respiratory effect of propacetamol with placebo-control for catheter ablation of atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* patients who are scheduled to undergo catheter ablation for arrhythmia

Exclusion Criteria:

* Subjects are ineligible if they have liver disease, kidney disease,
* American society of anesthesiology class 3 or 4,
* age under 20 years,
* cognitive dysfunction,
* disabling mental change disorder,
* patients are unable to communicate or speak Korean

Primary outcomes:
measure: total amount of opioid consumption
timeFrame: 1 day
Secondary outcomes:
measure: Respiratory rate
timeFrame: 1 day
measure: Depth of sedation
timeFrame: 1 day
measure: Post procedural pain
timeFrame: 1 day
measure: nausea point
timeFrame: 1 day
measure: number of vomiting
timeFrame: 1 day
measure: intra-procedural hemodynamics
timeFrame: 1 day
measure: satisfaction of patients
timeFrame: 1 day
measure: recovery time
timeFrame: 1 day
measure: satisfaction of surgeons
timeFrame: 1 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT03171688: Risk Factors for Nausea and Vomiting After Cesarean
Official title: Risk Factors for Nausea and Vomiting After Cesarean: Observational Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Nausea and Vomiting
Keywords: Postoperative Nausea and Vomiting
cesarean
risk factors
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 361
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with indication for cesarean section in the University Hospital of University of Brasilia.

Brief summary: Investigators will observe the incidence of post-cesarean nausea or vomiting and try to associate it with some risk factors.

Detailed description: A single prospective cohort of women submitted to cesarean section who received spinal anesthesia will be assessed for the proposed risk factors and the incidence of nausea or vomiting will be observed during the first 48 hours.

Eligibility criteria: Inclusion Criteria:

* Cesarean section indicated
* Spinal anesthesia indicated

Exclusion Criteria:

* Cesarean section did not occur
* Spinal anesthesia was not provided
* Another spinal technique was added to spinal

Primary outcomes:
measure: Postoperative Nausea or vomiting
timeFrame: 48 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: University Hospital of Brasilia University
state: Distrito Federal
Study officials:
affiliation: University of Brasilia
name: Gabriel MN Guimaraes, MD
role: STUDY_CHAIR
References: