louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04214977: Spinal Anesthesia Versus General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position
Official title: Spinal Anesthesia Versus General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position: A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Anorectal Surgery
Keywords: Anorectal surgeries
prone
spinal anaesthesia
general anaesthesia
laryngeal mask
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 66
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Anorectal surgeries are of the commonest elective surgeries that are performed worldwide under different types of anaesthesia. The aim of this prospective interventional study was to compare the use of general anaesthesia (GA) using a laryngeal mask airway (LMA) with spinal anesthesia (SA) in anorectal surgeries.

Detailed description: Anorectal surgeries are of the most frequently performed procedures worldwide. These procedures are commonly performed in prone position as it offers sufficient exposure and provides enough surgical space. Choosing the suitable anesthetic technique will help in reducing perioperative complications in patients undergoing surgical procedures in prone position, by taking into consideration changes in cardiovascular and pulmonary physiology, airway management, and proper positioning for the prevention of direct and indirect pressure injuries. The aim of this prospective interventional controlled study was to compare the use of general anesthesia (GA) using a laryngeal mask airway (LMA) with spinal anesthesia (SA) in anorectal surgeries.

Eligibility criteria: Inclusion Criteria:

* patients undergoing elective anorectal surgery (perianal fistula surgery, haemorrhoidectomy, perianal abscess, pilonidal sinus, anal fissure or evaluation under anaesthesia).
* patients older than 16-years old.
* patients who have ASA score I-III.
* Patients whose BMI is less than 35 kg/m2.

Exclusion Criteria:

* any patient who refused to participate in the study.
* patients with surgeries for anal or rectal tumors.
* any patient with expected surgery's duration more than 90 minutes
* patients with uncontrolled respiratory conditions
* any patient whose preoperative assessment was suggestive of possibility of difficult airway.

Primary outcomes:
measure: comparison was between the induction and emergence anesthesia times needed in each technique
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
References:
Clinical trial NCT05238077: Comparing the Efficacy of Visible Light-Ultraviolet A1 Light Versus Narrowband-Ultraviolet B on Generalized Vitiligo
Official title: Comparing the Efficacy of VL-UVA1 Versus NB-UVB on Inducing Repigmentation in Subjects With Generalized Vitiligo
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Generalized Vitiligo
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The subject serves as their own control.
Primary purpose: TREATMENT

Brief summary: As part of this study, you may have a procedure called phototherapy which involves either VL-UVA or NB-UVB irradiation. NB-UVB phototherapy is not experimental in vitiligo, but use of VL-UVA1 phototherapy in vitiligo is.

The purpose of this pilot study is to determine whether VL-UVA1 or NB-UVB phototherapy more efficiently induces repigmentation in patients with generalized vitiligo.


Eligibility criteria: Inclusion Criteria:

* Subjects ≥ 18 years of age with a diagnosis of generalized vitiligo
* Subjects on a stable topical/oral regimen for the past 3 months and continuing on a stable regimen
* Subjects able to understand the requirements of the study
* Subjects able and willing to sign informed consent

Exclusion Criteria:

* Subjects on photosensitizing medications
* Subjects receiving any concurrent phototherapy
* Subjects who plan to use tanning parlors or expose themselves to excess sunlight
* Subjects with known photosensitivity disorder
* Subjects with apparent phototoxicity
* Subjects with unstable vitiligo
* Subjects currently using bleaching agents
* Subjects who are pregnant, lactating, or planning on becoming pregnant
* Subjects who in the opinion of the investigator/sub-investigator, are not appropriate candidates for this study

Primary outcomes:
measure: Change in depigmentation of vitiligo lesion
timeFrame: 13 measurements over 26 visits
measure: Change in melanin content of vitiligo lesion
timeFrame: 13 measurements over 26 visits
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,
state: Michigan
Study officials:
affiliation: Henry Ford HS
name: Iltefat Hamzavi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00571077: Electrical Impedance Scanning of Thyroid Nodules Prior to Thyroid Surgery: a Prospective Study
Official title: Electrical Impedance Scanning of Thyroid Nodules Prior to Thyroid Surgery: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Neoplasms
Thyroid Nodules
Keywords: Thyroid neoplasms
thyroid nodules
electrical impedance scanning
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Walter Reed Army Medical Center
First posted: 2007-12-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 18 with thyroid nodules scheduled for surgery.

Brief summary: Patients over the age of 18 with thyroid nodules scheduled for surgery will undergo EIS scan. Each node will be scanned and graded form 1-5 (1=benign, 5=malignant). Results will be compared with final histopathology.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 with thyroid nodules scheduled for surgery.

Exclusion Criteria:

* Pregnant patients
* PAtients with electrical powered devices (cardiac pacemakers)

Primary outcomes:
measure: Sensitivity and specificity of EIS
timeFrame: 5 years
Secondary outcomes:
measure: NPV and PPV of EIS of the thyroid
timeFrame: 5 years
Other outcomes:
Locations:
city: Washington DC
country: United States
facility: Walter Reed Army MEdicla Center
state: District of Columbia
city: Jersualem
country: Israel
facility: Hadassah-Hebrew University Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Aviram Nissan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Walter Reed Army Medical Center
name: Alexander Stojadinovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nissan A, Peoples GE, Abu-Wasel B, Adair CF, Prus D, Howard RS, Lenington SG, Fields SI, Freund HR, Peretz T, Burch HB, Shriver CD, Stojadinovic A. Prospective trial evaluating electrical impedance scanning of thyroid nodules before thyroidectomy: final results. Ann Surg. 2008 May;247(5):843-53. doi: 10.1097/SLA.0b013e318165c757.
Clinical trial NCT03304977: Patient's Knowledge on Their Anticoagulating and Anti Platelet Treatment St Joseph's Hospital)
Official title: Current Situation of the Patient's Knowledge on Their Anticoagulating and Anti Platelet Treatment in GHPSJ (St Joseph's Hospital)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coagulation Disorder
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Oral antigoagulant are used more than 60 years in thrombotic diseases. Even they are indispensable, the haemorragic risk is high.That's why it's the main reason of hospitalization for iatrogeny.The complication's reasons are mainly linked to errors of drug intake, drugs interaction and the lack of understanding the treatment.Moreover, the antiplatelet agglutening treatment is frequently added to anticoagulant treatment.This increases the haemorragic risk.Different means were used to minimize the risk , like INR follow up.

The purpose of the study is to evaluate smartphone use to follow the patients'treatment.

Detailed description: Two questionnaire via smartphone with 15 days gap.

Eligibility criteria: Inclusion Criteria:

* patient under ant-thrombotic treatment
* hospitalized in vascular medecine service

Exclusion Criteria:

* refusing the participation

Primary outcomes:
measure: smartphone use level
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: GHPSJ
name: Pascal PRIOLLET, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02050477: Clinical Study of Laparoscopic Non Banded Vertical Gastroplasty in Bariatric Surgery
Official title: Laparoscopic Non Banded Vertical (Magenstrasse and Mill) Gastroplasty In Bariatric Surgery. Morbidity and Results on Weight Loss and Associated Co-morbidities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obesity
Keywords: Obesity
Bariatric
Surgery
Sleeve
Gastroplasty
Laparoscopy
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the laparoscopic approach of the Magenstrasse and Mill procedure in a prospective study of 100 patients

Detailed description: The laparoscopy is performed under general anesthesia with a 5 ports access under 14mm Hg pressure. After opening of the gastrocolic ligament and division of any adhesions between stomach and pancreas a circular opening is performed at the junction of corpus and antrum of the stomach with a circular stapler. A tubular gastric pouch is then created along a calibration tube at the lesser curvature by a vertical stapling starting from the circular opening to the angle of Hiss.

Eligibility criteria: Inclusion Criteria:

* Assessment by a multidisciplinary team specialized in bariatric and metabolic surgery including surgeon, endocrinologist, psychologist and/or psychiatrist, dietician
* BMI\>40
* BMI\>35 with diabetes or sleep apnea syndrome or hypertension treated with 3 drugs for at least one year
* Male or female patients between 18 and 75 years of age; fertile female patients must use a reliable contraception method;
* No previous bariatric procedure
* Informed consent given by patient

Exclusion Criteria:

* Medical contra-indication for a general anesthesia, or abdominal surgery (allergies to anesthetic drugs, cardio-vascular, pulmonary, or renal conditions leading to an unacceptable risk for the procedure
* Psychological-Psychiatric (boulimia, severe depression, psychotic condition)
* Non stabilized endocrine disorder, with potential interference on weight and/or diabetic condition
* Unability to understand goal of the study, plan of treatment and follow-up
* Large hiatal hernia and/or severe esophageal reflux disease
* Grazer, Sweet eater behavior

Primary outcomes:
measure: Morbidity/Mortality
timeFrame: 1 month
measure: Effect of the procedure on weight loss
timeFrame: 1 year
Secondary outcomes:
measure: Reflux disease
timeFrame: 1 year
measure: Effect of procedure on obesity associated co-morbidities
timeFrame: 1 year
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Dept of Abdominal Surgery and Transplantation, CHU Liège
Study officials:
affiliation: Dept of Abdominal Surgery and Transplantation CHU Liège Belgium
name: Arnaud De Roover, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03939377: Osteopathic Procedure on Pain in Palliative Care
Official title: Evaluation of an Osteopathic Procedure in the Management of Pain in Palliative Care Patients in a Mobile Palliative Care Support Team (EMASP): Controlled, Randomized, Single-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Palliative
Osteopathy
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The culture of the palliative is anchored more and more in France. In 2009, nearly 9 out of 10 French people (89%) believe that palliative care can reduce the suffering of people at the end of their lives. Despite the rise of palliative care in France, their access is not homogeneous between regions. In 2010, it is estimated that 2 French out of 3 likely to receive palliative care could not access it. Palliative care remains essential at the end of the patient's life, as well as for the family and caregivers.

The French government has put in place three national palliative care development programs: 2002-2005, 2008-2012, 2015-2018. The last program has unlocked a budget of 190 million euros for their development. It has been estimated from Social Security reimbursements, that the costs per patient over their last years of life are 26,000 euros, for a total of 13.5 million euros.

One of the most important aspects of palliative care is the comfort of the patients as well as their feelings in the care.

In order to best meet the expectations of cancer patients, some offer early palliative care that is effective in improving both the quality of life of the patient and its life expectancy.

Osteopathy is a manual alternative medicine whose goal is to restore the lack of mobility of tissues. It can be used as a complementary treatment when a specific support is put in place. The purpose of this study is to examine the effectiveness of osteopathy in the reduction of pain in adult patients in palliative care.


Eligibility criteria: Inclusion Criteria:

* Major patient (age\> 18) male or female
* Patient hospitalized or admitted to a day hospital that can be followed
* EVA between 40/100 and 60/100
* Signed informed consent

Exclusion Criteria:

* Patients requiring a modification of analgesic molecule during the study.
* Clinical stability of the patient estimated during the duration of the study.

Primary outcomes:
measure: VAS (Visual Analog Scale) evaluation (0 to 100)
timeFrame: day 6
Secondary outcomes:
measure: Dose of analgesic (g)
timeFrame: day 6
measure: QLQ (Quality of life questionnaire) C15 Pal score
timeFrame: days 6
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHI Creteil
Study officials:
References:
Clinical trial NCT04541147: Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients
Official title: A Randomized Control Trial of Post-operative Course of Oral Dexamethasone and Effect on Opioid Usage in Pediatric Tonsillectomies in a Tertiary Care Center
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 24
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if a post-operative course of oral dexamethasone affects opioid usage in pediatric patients undergoing tonsillectomy.

Patients who are scheduled to undergo tonsillectomy or adenotonsillectomy are randomized to receive either 1) a post-operative steroid course of oral dexamethasone in addition opioids, acetaminophen,NSAIDs or 2) opioids/acetaminophen/NSAIDS alone. All drugs are prescribed per approved FDA labeling. Children between the ages of 4-17 will be considered for enrollment.

Participants (or with the aid of parents/legal guardian for subjects unable to complete on their own) will complete a diary twice a day to record pain medication administration and visual pain scale. Remaining steroid and opioid medication will be measured at the routine post-operative appointment that occurs 4 - 6 weeks following surgery.


Eligibility criteria: Inclusion Criteria:

* Age 4-17 years at time of surgery
* Scheduled for tonsillectomy or adenotonsillectomy surgery

Exclusion Criteria:

* Prior history of intracapsular tonsillectomy
* Previous diagnoses of Down Syndrome or developmental delay
* Presence of gastrostomy (g) tube
* A contraindication to steroids or steroid usage within 30 days prior to surgery including diabetes, allergy to steroid, already on chronic steroid, immune deficiency
* Active infection or concurrent operative procedures at the time of surgery
* Unable to read or speak English
* Pregnant or breastfeeding females

Primary outcomes:
measure: Opioid Use (Number of Doses)
timeFrame: 4 weeks post-op
measure: Average Pain Score
timeFrame: 14 days post-op
Secondary outcomes:
measure: Number of Participants With Post-operative Complications
timeFrame: 30 days post-op
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center and affiliated practices
state: North Carolina
Study officials:
affiliation: Duke Health
name: Eileen Raynor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05464147: DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions
Official title: DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions (DYNAMITE Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Chronic Total Occlusion of Coronary Artery
Bifurcation of Coronary Artery
Multi Vessel Coronary Artery Disease
Long Lesions Coronary Artery Disease
Lead sponsor: Elixir Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Istituto Clinico Humanitas
First posted: 2022-07-19
Enrollment: 55
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: The aim of the DYNAMITE study is to investigate the (a) acute procedural and (b) 9-month follow-up performance of DynamX Drug-Eluting Coronary Bioadaptor System implantation in complex coronary lesions.


Eligibility criteria: Inclusion Criteria:

Presence of complex coronary lesions defined as follows:

* long lesions (\>28 mm);
* CTO, a total occlusion of duration more than 3-months;
* Lesions involving a bifurcation, defined as a division with a side branch large enough to be stented (i.e. \>2.25 mm);
* Patients requiring 4 or more stents
* Reference vessel diameter: \>2.25 mm to \<4.0 mm

Exclusion Criteria:

* Age under 18 years old;
* Significant co-morbidity precluding clinical follow-up;
* A positive pregnancy test in women with child-bearing potential;
* Contra-indication to dual anti-platelet therapy;
* Thrombocytopenia \<100,000/uL;
* Major surgery planned which will lead to discontinuation of antiplatelet therapy;
* In-stent restenosis;
* Treatment of saphenous vein graft;
* CTO with long sub-intimal tracking (\> 20 mm).

Primary outcomes:
measure: Change in mean in-device lumen area and mean device area
timeFrame: Through 9 months
Secondary outcomes:
measure: Major Adverse Cardiac Event (MACE)
timeFrame: 9 months, 12 months and 24 months
measure: Cardiac Death (CD)
timeFrame: 9 months, 12 months and 24 months
measure: Myocardial Infarction (MI)
timeFrame: 9 months, 12 months and 24 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 9 months, 12 months and 24 months
measure: Stent Thrombosis (ST)
timeFrame: 9 months, 12 months and 24 months
measure: Stent Cross-Sectional Area
timeFrame: 9 months
measure: Minimum stent diameter
timeFrame: 9 months
measure: Maximum stent diameter
timeFrame: 9 months
measure: Intimal hyperplasia (IH) area
timeFrame: 9 months
measure: Percentage of intimal hyperplasia
timeFrame: 9 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
Study officials:
References:
Clinical trial NCT01249547: Nasopharyngeal Carcinoma (NPC) Axitinib
Official title: Phase 2 Study of Axitinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent or Metastatic NPC
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 37
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: This is an open-label, single arm, phase 2 clinical trial evaluating the activity and safety of single-agent axitinib in recurrent or metastatic NPC patients who failed at least one line of platinum based chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of nasopharyngeal carcinoma (NPC) (either at initial diagnosis or at recurrence).
* Patients with recurrent or metastatic NPC that has progressed following one line of prior platinum-based chemotherapy.
* Disease must be not amenable to potentially curative radiotherapy or surgery.
* Measurable disease according to RECIST.
* Age 18 or above; ECOG performance 0 or 1.
* Adequate bone marrow, renal and hepatic reserve.

Exclusion Criteria:

* Presence of local recurrence
* Presence of neck lymph node recurrence invading vascular structure;
* Presence of central lung lesions involving major blood vessels;
* History of hemoptysis or epistaxis within 4 weeks;
* Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite adequate medical therapy;
* Gastrointestinal abnormalities, including inability to take oral medication or malabsorption syndrome;
* Concurrent use or anticipated need for treatment with known potent CYP3A4 inhibitors or CYP3A4 /CYP1A2 inducers.

Primary outcomes:
measure: To evaluate the efficacy (clinical benefit rate) of single-agent axitinib in patients with recurrent or metastatic NPC, and its impact on disease progression.
timeFrame: 3 years
Secondary outcomes:
measure: To assess objective response rate
timeFrame: 3 years
measure: To assess duration of response
timeFrame: 3 years
measure: To assess progression-free survival
timeFrame: 3 Years
measure: To assess overall survival
timeFrame: 3 Years
measure: To evaluate the safety and tolerability of axitinib
timeFrame: 3 years
measure: To evaluate axitinib plasma pharmacokinetics and to correlate these plasma concentrations with efficacy and safety parameters
timeFrame: 3 years
measure: To study blood and tissue biomarkers and correlate with cancer- and treatment-related outcomes
timeFrame: 3 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Prince of Wales Hospital
Study officials:
affiliation: Department of Clinical Oncology, The Chinese University of Hong Kong
name: Anthony TC Chan, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: