louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06884657: Effect of Mannitol on Propofol Level
Official title: Propofol Level At TCI During Mannitol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Mannitol Adverse Reaction
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 40
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: SUPPORTIVE_CARE

Brief summary: Group 1 will include 20 patients aged 18 years and over, American Society of Anesthesiologist (ASA) II-III class, who will undergo supratentorial tumor surgery, and Group 2 will include 20 patients who will undergo pituitary surgery without mannitol. Total intravenous anesthesia (TIVA) will be adjusted to propofol 4 µg/dl and remifentanil 2-4 µg/dl with target-controlled infusion pumps. In the mannitol group, 2.5 ml/kg (0.5 g/kg) will be given to all patients 15 minutes after induction and the mannitol infusion will be adjusted to be 10 minutes.In Group 2, mannitol will not be used and 2.5 ml/kg isotonic will be administered in 10 minutes. Both blood and urine samples will take for measurement to propofol levels.

Detailed description: The participants will divide into the two groups. Group 1 will include 20 patients aged 18 years and over, American Society of Anesthesiologist (ASA) II-III class, who will undergo supratentorial tumor surgery, (Mannitol group) and Group 2 will include 20 patients who will undergo pituitary surgery without mannitol (Control Group). Total intravenous anesthesia (TIVA) will be adjusted to propofol 4 µg/dl and remifentanil 2-4 µg/dl with target-controlled infusion pumps. In the mannitol group, 2.5 ml/kg (0.5 g/kg) will be given to all patients 15 minutes after induction and the mannitol infusion will be adjusted to be 10 minutes.In Group 2, mannitol will not be used and 2.5 ml/kg isotonic will be administered in 10 minutes. Both blood and urine samples will take for measurement to propofol levels. Beside to standard monitoring invasive hemodynamic monitorization (cardiac output, cardiac index, stroke volume variability) and bispectral index will apply to the all participants.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist (ASA) II participants
* supratentorial tumor surgery
* eligible for mannitol use
* eligible for Total intravenous anesthesia (TIVA)

Exclusion Criteria:

* American Society of Anesthesiologist (ASA) III and upper
* Chronic kidney failure
* sepsis
* multiorgan failure

Primary outcomes:
measure: Serum propofol levels
timeFrame: Blood samples will take at intraoperatif period during total intravenous anesthesia (TIVA). (Till the 100th minutes of anesthesia)
Secondary outcomes:
measure: Urine propofol levels
timeFrame: The sample collection will continue till the 100th minutes of anesthesia (TIVA)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01737957: Safety and Efficacy of Low-Fluence PRP for PDR
Official title: Safety and Efficacy of Single-session, Low-fluence Panretinal Photocoagulation (PRP) for Proliferative Diabetic Retinopathy (PDR)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Proliferative Diabetic Retinopathy
Keywords: Proliferative Diabetic retinopathy
Pan-retinal photocoagulation
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of a single session of low-fluence panretinal photocoagulation when compared to full-fluence PRP. Hypothesis: a single-session of low-fluence PRP will be safe regarding the progression of macular edema and the presence of adverse events, and will efficiently induce regression of neovascularization.


Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetics
* Proliferative diabetic retinopathy

Exclusion Criteria:

* Previous treatment with PRP
* Media opacities
* Previous treatment for macular edema (LASER or intravitreal injections)
* Recent (less than 6 months) ophthalmic surgery
* Only eyes
* Intra-retinal or sub-retinal fluid with foveal involvement
* Chronic renal failure
* History of liver or pancreatic transplant

Primary outcomes:
measure: Macular thickness change
timeFrame: Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 16 weeks
Other outcomes:
measure: Regression of neovessels, change over time
timeFrame: Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks
Locations:
city: Mexico City
country: Mexico
facility: Asociación Para Evitar la Ceguera en México
state: DF
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Guillermo Salcedo-Villanueva, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03266757: Borderline Resectable or Resectable or Advanced Pancreatic Adenocarcinoma
Official title: Observational Study of the Clinical Practice in Patients With Borderline Resectable or Resectable or Advanced Pancreatic Adenocarcinoma in Greece
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Adenocarcinoma
Lead sponsor: Hellenic Society of Medical Oncology
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Public and Private Hospital Institutions

Brief summary: Observational study of the Clinical Practice in patients with Borderline resectable or resectable or advanced pancreatic adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

* Patients Age 18 or older with histologically confirmed ductal pancreatic adenocarcinoma as a primary tumor
* Patients with ductal pancreatic adenocarcinoma (Borderline resectable or resectable or advanced)
* Patients that are alive and under treatment or follow up
* Signed informed consent (ICF)

Exclusion Criteria:

* Presence of other primary tumors
* Pancreatic adenocarcinoma due to metastasis from other primary tumor(s)
* Neuroendocrine or other pancreatic carcinoma other than ductal adenocarcinoma
* Patients who refuse to provide informed consent

Primary outcomes:
measure: clinical practice-treatments
timeFrame: 2 years
Secondary outcomes:
measure: progression Free Survival
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02634957: Impact of Duration Of Absolute Voice Rest on Voice Outcome After Phonomicrosurgery
Official title: Impact of Duration Of Absolute Voice Rest on Voice Outcome After Phonomicrosurgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Benign Neoplasm of True Vocal Cords
Keywords: phonomicrosurgery
benign vocal fold lesions
voice rest
vhi-10
CPP
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 17
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: Absolute voice rest is commonly prescribed after vocal fold surgery, also known as phonomicrosurgery, for benign vocal fold lesions. This is thought to decrease scarring of vocal folds, which could result in increasing tissue stiffness and limitations in optimal vocal outcome. Unfortunately there is no standardized protocol as to how long patients should rest their voice after phonomicrosurgery. To date, there are no studies in the literature directly comparing the impact of short-term and long-term voice rest on vocal fold healing and voice outcome after phonomicrosurgery.

Detailed description: The purpose of this study is to determine whether 3 days versus 7 days of absolute voice rest will result in different voice outcomes in patients who have undergone phonomicrosurgery for benign vocal fold lesions.

Eligibility criteria: Inclusion Criteria:

1. Patients with benign mid membranous vocal fold lesions such as the following:

   1. Polyps
   2. Cysts
   3. Sub-epithelial fibrous mass
2. Undergoing elective phonomicrosurgery for vocal fold lesions, which involves microflap excision +/- truncation +/- steroid injection into the vocal folds.
3. Age 18 and older

Exclusion Criteria:

Patients with any of the following will be excluded from the study:

1. Reinke's edema
2. Active smokers
3. Ligamentous mid membranous vocal fold lesions
4. RRP (Recurrent Respiratory Papillomatosis)
5. Dysplasia
6. CIS (Carcinoma-in-situ)
7. SCC (squamous cell carcinoma)
8. Extent of surgery exceeds what is mentioned in the inclusion criteria (e.g., CO2 laser, balloon dilatation, vocal fold augmentation in addition to phonomicrosurgery)
9. Previous vocal fold surgery
10. Systemic steroids
11. History of systemic illness that could affect wound healing

Primary outcomes:
measure: Voice Handicap Index - 10
timeFrame: 3 months post op
measure: Voice Handicap Index - 10
timeFrame: 1 month post op
Secondary outcomes:
measure: Cepstral Peak Prominence (CPP)
timeFrame: 1 month and 3 months post op
measure: Average phonatory airflow in all voiced sentence
timeFrame: 1 month and 3 months post op
measure: video stroboscopy findings
timeFrame: 1 month and 3 months post op
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Libby Smith, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02198157: Urinary Catheterization and Second Stage of Labor
Official title: Effect of Intermittent Versus Continuous Bladder Catheterization During Labor on Second Stage Duration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor, Second Stage
Keywords: duration of second stage
urinary catheterization
epidural anaesthesia
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 184
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Labor is divided into three stages: the first stage is from labor onset until full dilation, second stage is from full dilation until delivery of the baby, and the third stage from the delivery of the baby until the delivery of the placenta
* The mean duration of second stage in nulliparas as defined by the American college of obstetricians and gynecologists (ACOG) is 54 minutes
* Epidural anesthesia is a known cause for prolongation of the second stage of labor. Prolonged second stage in nullipara women with epidural is defined as more than 3 hours, and more than 2 hours in those without epidural.
* Although perinatal outcome is not compromised with a prolonged second stage , there is evidence that maternal morbidities such as perineal trauma, chorioamnionitis ,instrumental delivery and postpartum hemorrhage increase with prolonged second stage
* Another effect of epidural anesthesia during labor is urinary retention and a need for catheterization.
* Full bladder may behave as a tumor previa and interfere to fetal head descent in the birth canal, increasing by that the duration of the second stage.
* This study aims to investigate the effect of intermittent versus continuous catheterization on the duration of the second stage of labor


Eligibility criteria: Inclusion Criteria:

* Nulliparous women
* Gestational age 24-42 weeks
* epidural anaesthesia
* Vertex presentation
* Singleton

Exclusion Criteria:

Primary outcomes:
measure: duration of second stage of labor
timeFrame: within the first 48 hours after delivery
Secondary outcomes:
measure: chorioamnionitis
timeFrame: within the first 48 hours after delivery
Other outcomes:
measure: post-partum hemorrhage
timeFrame: within the first 48 hours after delivery
Locations:
city: Afula
country: Israel
facility: Dep. OB/GYN, HaEmek Medical Center
Study officials:
affiliation: Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
name: raed salim, MD
role: STUDY_DIRECTOR
affiliation: Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
name: abeer suleiman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02514057: Gastrointestinal Symptom Questionnaire Validation
Official title: Gastrointestinal Symptom Questionnaire Validation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Those With and Without Gastrointestinal Disorders
Lead sponsor: University of East Anglia
Sponsor class: OTHER
First posted: 2015-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As above

Brief summary: Assessment of a new gastrointestinal symptom questionnaire in comparison to 2 well established and validated questionnaires that do not fully fit the requirements of an investigator concerned about gastrointestinal side effects in a patient without primary gastrointestinal disease.

Detailed description: 210 subjects Healthy (n=70), ill with non-GI disease (n=70), with GI disease (n=70) Age above 18 COnsent after full explanation Each subject completes 3 questionnaires Glasgow Dyspepsia Score Gastrointestinal Symptom Rating Scale New score This is a total of 48 questions Analysis will seek to validate the new score. There is no other intervention and no risks are anticipated.

Eligibility criteria: Inclusion Criteria:

* As above Either healthy or GI disease or non-GI disease

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
measure: Construct validity measured by Validation of new score
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UEA
name: Alastair Forbes, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01133457: Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition
Official title: Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg and Merck & Co., Propecia in Healthy Adult Males Under Fed Condition.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence,Finasteride,Crossover
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2010-05-28
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Merck \& Co. (Propecia®)

1 mg finasteride tablets under fed conditions following administration of a 3 mg dose.

Detailed description: Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers and 2 alternates. A total of 24 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 36-hour blood draw. Single oral 3 mg doses were separated by a washout period of 7 days.

Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

History or presence of significant:

• cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

In addition, history or presence of:

* alcoholism or drug abuse within the past year;
* hypersensitivity or idiosyncratic reaction to finasteride or any other 5-a reductase inhibitor.

Subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study.

Subjects who, through completion of the study, would have donated in excess of:

* 500 mL of blood in 14 days, or
* 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
* 1000 mL of blood in 90 days,
* 1250 mL of blood in 120 days,
* 1500 mL of blood in 180 days,
* 2000 mL of blood in 270 days,
* 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.

Primary outcomes:
measure: Bioequivalence based on Cmax and AUC parameters
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cohen street, saint-laurent, montreal (quebec)
country: Canada
facility: MDS Pharma Services
Study officials:
affiliation: MDS Pharma Services
name: Gaetano Morelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01490957: Functional Assessment of Cancer Therapy - Bone Marrow Transplant
Official title: Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hodgkin Disease
Lymphoma, Non-Hodgkin
Keywords: HD
NHL
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2011-12-13
Enrollment: 113
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lymphoma database

Brief summary: Functional Assessment of Cancer Therapy - Bone Marrow Transplant

Detailed description: Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)

Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed Hodgkin's Disease and Non-Hodgkin's Lymphoma

Exclusion Criteria:

* Patients with diagnosis other than HD and NHL.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Kfsh & Rc
Study officials:
affiliation: KFSH & RC
name: A Al-Zahrani, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05303948: Evaluation of Two Positions for Free Floating Tracheal Intubation in Weightlessness
Official title: Evaluation and Comparison of Two Positions for Free Floating Tracheal Intubation in Weightlessness: An Ice-Pick Position With a Direct Laryngoscopy and the Classic Approach With VideolaryngoscopyY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Intubation Complication
Lead sponsor: Groupe Hospitalier de Bretagne Sud
Sponsor class: OTHER
Collaborators: name: Centre National d'Etudes Spatiales
First posted: 2022-03-31
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A simulation study, in which participants alternatively perform oro-tracheal intubation on a manikin, either using a videolaryngoscope (McGrath model, Medtronic TM) or a direct laryngoscope
Primary purpose: OTHER

Brief summary: In a non-randomized, controlled, cross-over simulation study, the investigators evaluated and compared intubation performance of trained operators, using either a conventional laryngoscope in an ice-pick position or a video laryngoscope in a free-floating classic position, in weightlessness and in normogravity.

Data were analyzed with the generalized linear mixed-effects models.

Primary endpoint was the success rate of tracheal intubation. Time to intubation and the confidence score into the success of tube placement were also recorded as secondary endpoints.


Eligibility criteria: Inclusion Criteria:

Healthy volunteers

* aged between 18 and 65 years old.
* Absence of pregnancy
* Belonging to a Health Insurance Coverage by the French Social Security Program or equivalent, proved by a European Health Insurance Card (EHIC).
* Medically fit to fly after a JAR FCL3 - Class 2 examination

Exclusion Criteria before the flight

* positive pregnancy test on flight day
* anxiety
* non-participation in flight safety briefing

Exclusion Criteria during the flight

* failure to follow safety guidelines
* occurence of motion sickness during the procedure

Primary outcomes:
measure: First pass success
timeFrame: 1 day (1 flight)
Secondary outcomes:
measure: Time
timeFrame: 1 day (1 flight)
measure: Confidence Score
timeFrame: 1 day (1 flight)
Other outcomes:
Locations:
city: Lorient
country: France
facility: Groupe Hospitalier de Bretagne Sud
Study officials:
affiliation: Groupe Hospitalier de Bretagne Sud
name: Séamus Thierry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03197948: Electronic Patient Reported Outcomes in Measuring Health-Related Quality of Life in Patients With Stage I-IV Prostate Cancer Undergoing Treatment
Official title: A Pilot Feasibility Trial Examining the Use of Electronic Patient-Reported Outcomes in Prostate Cancer Patients With Apple ResearchKit Smartphone Application
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 20
Sex: MALE
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: The participants will consist of adult male volunteers, all of whom will be participating in a prostate cancer treatment clinical trial at Thomas Jefferson University Sidney Kimmel Cancer Center.

Brief summary: This pilot clinical trial studies how well electronic patient reported outcomes work in measuring health-related quality of life in patients with stage I-IV prostate cancer undergoing treatment. Using a smartphone application to measure and monitor symptoms before, during, and after treatment may help patients better detect, understand, and manage their health.

Detailed description: PRIMARY OBJECTIVES:

I. To explore the feasibility of collecting electronic patient-reported outcome data using validated health-related quality of life (HRQOL) assessment tools at baseline, during, and after treatment through a smartphone application in adult men throughout their course of treatment for prostate cancer.

Eligibility criteria: Inclusion Criteria:

* Self-reported ability to speak and read English
* Be able to communicate on a touch screen iPhone
* Willing to provide signed informed consent
* Willing and able to comply with all study activities
* Access to WiFi connection or cellular data
* An established clinical history of prostate cancer in a spectrum of severity (all stages)

Exclusion Criteria:

* A subject will not be eligible for inclusion in this study if in the investigator's opinion the patient has any concurrent medical or psychiatric condition that may preclude participation in this study or completion of self-administered questionnaires (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia, or other condition that would render them unable to complete a questionnaire)
* Cognitive or other impairment (e.g., visual) that would interfere with completing a self- administered questionnaire and with participating in a group discussion

Primary outcomes:
measure: Feasibility defined as satisfactory completion (60%) of weekly questionnaires
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Adam Dicker, MD
role: PRINCIPAL_INVESTIGATOR
References: