louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04902170: Long-shaft Vitrectomy Probe in Highly Myopic Eyes
Official title: The Surgical Outcomes of Long-shaft Vitrectomy Probe for Vitreoretinal Diseases in Highly Myopic Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Diseases
High Myopia
Keywords: High myopia
Pars plana vitrectomy
Vitreoretinal disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 86
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare the safety and efficacy of vitrectomy probe with different shaft lengths in vitreoretinal surgery of highly myopic patients. In this randomized controlled study, highly myopic patients who had axial length more than 26 mm and needed vitreoretinal surgery will be enrolled. The enrolled patients will be randomized into "30 mm shaft length group"(trial group) and "27mm shaft length group"(controlled group). We will compare the rate of wound leakage, hypotony, subconjunctival hemorrhage, probe bending, trocar removal, and endophthalmitis between the two groups. We would like to evaluate the efficacy and safety of the 30 mm shaft length vitrectomy probe.


Eligibility criteria: Inclusion Criteria:

* Highly myopic patients (axial length \> 26mm) with vitreoretinal diseases or maculopathy requiring pars plana vitrectomy

Exclusion Criteria:

* Previous history of pars plana vitrectomy
* Surgical plan combining encircling buckle
* Silicone oil or perfluorocarbon liquid use intraoperatively
* Previous history of pterygium surgery, trabeculectomy, glaucoma surgery
* Previous history of corneal, conjunctival, or scleral laceration
* History of connective tissue disease

Primary outcomes:
measure: trocar removal rate
timeFrame: intra-operative
measure: operation time
timeFrame: intra-operative
Secondary outcomes:
measure: instrument bending
timeFrame: intraoperative
Other outcomes:
measure: Complications
timeFrame: Until post-op 6 month
measure: wound status evaluation by slit lamp biomicroscopy
timeFrame: until post-op 1 month
measure: anatomical success evaluation by optical coherence tomography and indirect ophthalmolscopy
timeFrame: post-op 3 month
measure: anatomical success evaluation by optical coherence tomography and indirect ophthalmolscopy
timeFrame: post-op 6 month
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Tzyy-Chang Ho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01479270: Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect on Quality of Recovery
Official title: Randomized Trial of Transversus Abdominal Plane (TAP) Block at Total Laparoscopic Hysterectomy: Effect of Regional Analgesia on Quality of Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Anesthesia
Keywords: recovery
postoperative
pain
laparoscopy
hysterectomy
ropivacaine
TAP block
local anesthesia
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2011-11-24
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Transversus Abdominal Plane (TAP) block has been used with good success to decrease postoperative pain following laparatomy. If the TAP block provides any improvement in the quality of recovery following laparoscopic hysterectomy, it could decrease the need for postoperative narcotics and allow for more outpatient hysterectomy procedures.


Eligibility criteria: Inclusion Criteria:

* Any patient undergoing laparoscopic hysterectomy
* Age ranges 18-80
* Reading literacy
* English speaking
* Able to give informed consent

Exclusion Criteria:

* History of relevant drug allergy
* Chronic opioid users who may have tolerance to pain medications
* Inability to understand written consent forms or give consent
* Age less than 18 or over 80
* Any conversion to open surgery

Primary outcomes:
measure: Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2
timeFrame: Postop Day #1 or Day #2
Secondary outcomes:
measure: Narcotic Use
timeFrame: Postop Day #0 and Day #1
measure: Visual Analog Scale (VAS) for Pain
timeFrame: 2 and 24 hours post operative
measure: Intraoperative Time
timeFrame: the total intraoperative time in minutes
Other outcomes:
Locations:
Study officials:
affiliation: MetroHealth Medical Center
name: Sarah M Kane, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kane SM, Garcia-Tomas V, Alejandro-Rodriguez M, Astley B, Pollard RR. Randomized trial of transversus abdominis plane block at total laparoscopic hysterectomy: effect of regional analgesia on quality of recovery. Am J Obstet Gynecol. 2012 Nov;207(5):419.e1-5. doi: 10.1016/j.ajog.2012.06.052. Epub 2012 Jun 29.
Clinical trial NCT03175770: Feasibility of Radiofrequency Resection in Oropharyngeal Tumor Surgery
Official title: Feasibility of Radiofrequency Resection in Oropharyngeal Tumor Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiofrequency Resection
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 25
Sex: ALL
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: 18 years or older, benign or malign tumor of the oropharynx. the resection must be done transorally

Brief summary: In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety.

Goal of this study is to show feasibility and safety of Radiofrequency Resection in Oropharyngeal Tumor Surgery.

Detailed description: In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety.

Goal of this study is to show feasibility and safety of Radiofrequency Resection in Oropharyngeal Tumor Surgery.

Eligibility criteria: Inclusion Criteria:

- 18 years and older benign or malign tumor of the oropharynx tumor must be resectable transorally

Exclusion Criteria:

* Prior radiotherapy or chemotherapy

Primary outcomes:
measure: total blood loss,
timeFrame: intraoperative
measure: tissuesticking
timeFrame: intraoperative
measure: coagulation
timeFrame: intraoperative
measure: Duration of Operation
timeFrame: intraoperative
Secondary outcomes:
measure: Zone of coagulation
timeFrame: within one month after the operation
measure: postoperative parameters
timeFrame: within one month after the operations
measure: postoperative pain
timeFrame: within one month after the operations
measure: accuracy of section
timeFrame: within one month after the operations
measure: status of resection
timeFrame: within one month after the operations
measure: postoperative dysfunctions by descriptive name of scale
timeFrame: within one month after the operations
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Ear Nose Throat
state: Bayern
Study officials:
affiliation: department for ENT, Klinikum Rechts der Isar der Technischen Universität München, Ismaninger Straße 22, 81675 München, Germany
name: Clemens Heiser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05060770: Transcriptomic Study of IBD-associated Colorectal Cancer
Official title: Transcriptiomic Analysis of Inflammatory Bowel Disease-associated Colorectal Cancer. A French Retrospective Study of 26 Cases Identified at the Nancy University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer, Genetics of
Keywords: inflammatory bowel disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: \>/= 18 years old patient operated on at the Nancy university hospital for IBD associated CRC

Brief summary: Chronic inflammatory bowel disease (IBD) is associated with an increased risk of colorectal cancer (CRC) in historical cohorts. The pathways of oncogenesis of these CRCs, which are very different clinically from de novo CRCs, are currently unknown. The aim of our work is to identify specific molecular signatures of CRC occurring in the setting of IBD.


Eligibility criteria: Inclusion Criteria:

* Person 18 years of age or older
* Person with colorectal cancer in the context of IBD
* Person who has received complete information on the organization of the research and who has signed an informed consent
* Person affiliated to a social security plan or beneficiary of such a plan.

Exclusion Criteria:

* Person referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code:
* Pregnant woman, parturient or nursing mother
* Minor (not emancipated)
* Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
* Person of legal age who is unable to express his or her consent
* Person deprived of liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L. 3213-1.

Primary outcomes:
measure: IBD associated CRC oncogenesis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00214370: Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma
Official title: Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia
Lymphoma
Keywords: pediatric
acute leukemia/lymphoma
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The hypothesis of the study is that propofol-fentanyl sedation for lumbar punctures in children with acute leukemia/lymphoma results in fewer adverse events than propofol sedation alone. Secondary hypotheses state that propofol-fentanyl sedation results in a better sedation induction, recovery profile and is preferred by patients/families. The study is a double blind, randomized, placebo controlled crossover study. Following the induction phase of chemotherapy, children will be randomized in a crossover manner to receive either fentanyl-propofol or propofol-placebo for future lumbar punctures. Patients will be studied on two separate occasions, once with propofol-placebo (normal saline) and once with propofol-fentanyl. Children will be monitored continuously by pulse oximetry, electrocardiogram (ECG) and direct nursing and physician observation during the sedation in accordance with the University of Wisconsin (UW) Pediatric Policy and Procedure. Propofol will be titrated to a Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score of ≤ 7 for all children. Oxygen saturation, respiratory rate, heart rate and blood pressure will be recorded every 3 minutes by a study investigator during sedation.


Eligibility criteria: Inclusion Criteria:

* Children ages 2 years to 18 years with acute leukemia/lymphoma cared for by physicians in the Division of Hematology/Oncology in the Department of Pediatrics and receiving sedation for diagnostic/therapeutic lumbar punctures (LPs) in the UW Pediatric Sedation Program
* Enrollment will occur after the induction phase of chemotherapy.

Exclusion Criteria:

* American Society of Anesthesiology score ≥ 3
* Cardiorespiratory instability
* Allergy to propofol or its components
* Age less than 2 years
* Patients receiving other sedative analgesics
* Patients with an oxygen requirement

Primary outcomes:
measure: Fewer adverse cardiorespiratory events defined as oxygen desaturations and hypotension
Secondary outcomes:
measure: Patient/family preference, ease of induction, and recovery pattern
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Gregory Hollman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03789370: Maintenance of Anaesthesia With Sevoflurane Versus Propofol and the Occurrence of Postoperative Headache.
Official title: Maintenance of Anaesthesia With Sevoflurane Versus Propofol and the Occurrence of Postoperative Headache.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Headache
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 130
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: PREVENTION

Brief summary: Postoperative headache is a major issue after general anaesthesia and surgery. The aim of this study is to investigate the possible difference in the occurrence of postoperative headache when general anaesthesia is maintained with propofol, which is supposed to have protective effects on migraine patients, versus sevoflurane.

Detailed description: Postoperative headache is a major issue after general anaesthesia and surgery. The aim of this study is to investigate the possible difference in the occurrence of postoperative headache when general anaesthesia is maintained with propofol, versus sevoflurane. Propofol acts throught a GABA, and is known to have a therapeutic effect on migraine patients with accute attacts. However, its role on postoperative headache has not been studied, when used for maintainance of anaesthesia, this study aims to investigate the occurrence of headache after anaesthesia and surgery, when patients receive randomly two different anaesthetics: propofol and sevoflurane.

Eligibility criteria: Inclusion Criteria:

* ASA I-III
* scheduled operation under general anaesthesia
* operations \<4 hours
* minorgynaecological operatios (leiomyomectomy)
* hernia repair
* arthroscopic procedurs
* minor orthopaedic operations without the use of tourniquet or cement
* saphenectomy
* minor urologic operations
* minor other operations of general surgery

Exclusion Criteria:

* age \<18 and \>65 years old
* ASA\>III
* Diseases of the central nervous system (ie Parkinsons's disease, Multiple sclerosis, previous ischaemic attack, hydrocephalus, seizure disorder, etc)
* Psychosis under medication
* Cognitive impairement or/and inability to fill in the questionaires
* Allergy or contraindication to the study protocol included drugs
* Operations of more than 4 hours duration
* Head and neck procedures, procedures with neck extension (eg thyroidectomy), ENT procedures
* renal impairement
* hepatic impairement
* patient refusal

Primary outcomes:
measure: incidence of postoperative headache (yes or no)
timeFrame: up to 24 hours postoperatively
Secondary outcomes:
measure: Nausea and vomiting
timeFrame: up to 24 hours postoperatively
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Study officials:
References:
Clinical trial NCT06962670: Predicting Cancer Risk With Digital and Molecular Markers
Official title: Digital and Molecular Detection of Markers for Disease Risk Prediction, Improvement of Diagnostic Detection Accuracy and Implementation for Preventive Measures of Cancer - A Combined Case-control and Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Colorectal Cancer
Gynecologic Cancer
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 1250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to identify new markers to predict the risk of developing cancer, primarily breast cancer. For this purpose, researchers will compare data obtained from cancer patients and healthy individuals. If characteristic differences are identified, e.g. in biomarkers, life style or family history, this may indicate a person's increased risk of developing cancer.


Eligibility criteria: Inclusion Criteria:

1. Biological adult (at least 18 years old) women
2. Written informed consent for study participation and processing of personal data
3. Own smartphone that can run the BayPass mobile application and willingness to use said smartphone for study purposes

   Additional inclusion criterion for case group:
4. Pre-existing or current diagnosis of at least one of the following oncological diseases: breast cancer, lung cancer, colorectal cancer, gynecologic cancer (incl. ovarian cancer, endometrial cancer, cervical cancer, fallopian tube cancer, vaginal cancer and vulvar cancer)

Exclusion Criteria:

1. Known infection with HIV (Human Immunodeficiency Virus), HepA (Hepatitis A), HepB (Hepatitis B), HepC (Hepatitis C) or active SARS-CoV2 (Severe acute respiratory syndrome coronavirus type 2) infection
2. Acute severe or potentially life-threatening illness, except those specified in inclusion criterion #4

Primary outcomes:
measure: Assessment of breast cancer risk by polygenic risk score in combination with app-based self-reported health behavior in the study population
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Please refer to project homepage for details (see link below)
country: Germany
facility: DigiOnko Präventionsmobil
state: Bavaria
Study officials:
affiliation: Head of Department of Obstetrics and Gynecology
name: Matthias W. Beckmann, Prof. Dr. med.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00440570: A Study of Therapeutic Amplitude-modulated Electromagnetic Fields in Advanced Tumors
Official title: Treatment of Advanced Cancer With Amplitude-modulated Electromagnetic Fields of Low Intensity by Means of an Intrabuccal Probe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cancer
Brain Tumor
Keywords: cancer
electromagnetic fields
treatment
Lead sponsor: Pasche, Boris, M.D.
Sponsor class: INDIV
Collaborators: name: Barbault, Alexandre, M.S.
First posted: 2007-02-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: In vitro studies suggest that low levels of amplitude-modulated electromagnetic fields may modify cell growth. We have identified specific frequencies that may block cancer cell growth. We have developed a device delivering low levels of amplitude-modulated electromagnetic fields. The device is connected to a spoon-like coupler, which is placed in the patient's mouth during treatment. We will conduct a feasibility study consisting of three daily ambulatory treatments until disease progression.

Detailed description: Background: In vitro studies suggest that low levels of amplitude-modulated electromagnetic fields may modify cell growth. We have identified specific frequencies that may block cancer cell growth. We have developed a portable and programmable device delivering low levels of amplitude-modulated electromagnetic fields. The device is connected to a spoon-like coupler, which is placed in the patient's mouth during treatment.

Methods: We will conducted a feasibility study consisting of three daily treatments. All patients with advanced solid tumors and measurable disease will be eligible, irrespective of prior treatments. Patients will be assessed with laboratory exams (complete blood count, comprehensive profile, tumor markers), imaging studies every other month for the first six months, every third month thereafter.

Eligibility criteria: Inclusion Criteria:

* Advanced tumor that is either metastatic or inoperable

Exclusion Criteria:

* Pregnancy,
* Other simultaneous anticancer therapies,
* ECOG performance status less than 3

Primary outcomes:
measure: Safety of daily administration of amplitude-modulated electromagnetic fields in patients with advanced cancer
Secondary outcomes:
measure: Complete blood count, comprehensive chemistry profile, tumor markers
measure: Tumor assessment as per RECIST criteria
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Cabinet Médical Avenue de la gare 6
state: Vaud
Study officials:
affiliation: Cabinet Médical Avenue de la gare 6
name: Boris C Pasche, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barbault A, Costa FP, Bottger B, Munden RF, Bomholt F, Kuster N, Pasche B. Amplitude-modulated electromagnetic fields for the treatment of cancer: discovery of tumor-specific frequencies and assessment of a novel therapeutic approach. J Exp Clin Cancer Res. 2009 Apr 14;28(1):51. doi: 10.1186/1756-9966-28-51.