louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00925067: Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects
Official title: Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: Inguinal hernia
Laparoscopic repair
Prostheses
Male fertility
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
name: Agentschap voor Innovatie door Wetenschap en Technologie
First posted: 2009-06-19
Enrollment: 59
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, prospective clinical trial analyzing whether the use of lightweight prostheses during laparoscopic inguinal hernia repair of male patients could have a beneficial effect on postoperative discomfort, chronic pain development, recurrence and male fertility aspects.


Eligibility criteria: Inclusion Criteria:

* Primary, unilateral or bilateral, inguinal hernia patients
* Informed consent

Exclusion Criteria:

* Sterilized patients

Primary outcomes:
measure: Male fertility aspects
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life, pain development, recurrence
timeFrame: 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Marc Miserez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peeters E, Spiessens C, Oyen R, De Wever L, Vanderschueren D, Penninckx F, Miserez M. Laparoscopic inguinal hernia repair in men with lightweight meshes may significantly impair sperm motility: a randomized controlled trial. Ann Surg. 2010 Aug;252(2):240-6. doi: 10.1097/SLA.0b013e3181e8fac5.
Clinical trial NCT04737967: The Potential Protective Role of Venlafaxine Versus Memantine in Paclitaxel Induced Peripheral Neuropathy
Official title: The Potential Protective Role of Venlafaxine Versus Memantine in Paclitaxel Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Oncology Pain
Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Mendel AI
Sponsor class: INDUSTRY
Collaborators: name: Cairo University
First posted: 2021-02-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a double blinded two-arm randomized case-only interventional trial. A total of 60 patients who are to receive Paclitaxel to be included and allocated in two groups. The protocol is to be reviewed by the Research Ethics Committee of Faculty of Medicine Cairo University.

All procedure will be done in Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine.

The first arm (Venlafaxine group) will receive Venlafaxine extended release (37.5 mg) tablets (Zimmerman et al., 2016).

The second arm (Memantine group) will receive memantine 10 mg once daily (Morel et al., 2016)


Eligibility criteria: Inclusion Criteria:

1. All patients, 18 years of age or older, with a cancer treated with Paclitaxel
2. Patients must have a life expectancy of at least 24 weeks.
3. Patients must sign an informed consent.
4. Patients may have a grade 0 (chemotherapy naive) or 1 neuropathy (history of prior chemotherapy) prior to entry.
5. Patient matching high risk on the CIPN risk stratification scoring system

Exclusion Criteria:

1. Patients with symptomatic brain metastases.
2. Pregnant women or nursing mothers. Patients of child bearing potential must use adequate contraception.
3. Patients may receive no other concurrent complementary medicines during this study.
4. Patients with neuropathy induced diabetes.
5. Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections.

Primary outcomes:
measure: Change in average daily pain intensity
timeFrame: 6 weeks
measure: Electrophysiological studies
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Cairo University - Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine
Study officials:
References:
Clinical trial NCT04566367: Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer
Official title: Detection Rate by Blue Laser Imaging (BLI) of Secondary or Early Squamous Head and Neck Cancer in Patients Undergoing Elective Percutaneous Endoscopic Gastrostomy (PEG)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head Neck Cancer
Esophageal Cancer
Gastrostomy
Keywords: esophageal cancer
Blue laser imaging
percutaneous endoscopic gastrostomy
head neck cancer
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a prospective randomised mono centric study with a one to one allocation in two different treatment arms.
Primary purpose: DIAGNOSTIC

Brief summary: This study wants to focus on Carcinoma detection rates with blue laser imaging (BLI) for participants with head-neck cancer who need a percutaneous endoscopic gastrostomy (PEG). BLI is a new imaging technique that can easily be used within a standard gastroscopy.

Detailed description: Head-Neck cancers are a significant burden all around the world. Patients suffering from one tumor are at high risk for a second cancer or another precancerous lesion. Before or during cancer treatment a PEG is needed to maintain a sufficient calories intake. PEG is established by performing a standard gastroscopy.

This randomised study wants to compare the detection rates of standard white light endoscopy compared to the additional use of blue laser imaging for second cancers or precancerous lesions in participants presenting for PEG establishment.

Eligibility criteria: Inclusion Criteria:

* All participants with the need of PEG due to head neck cancers or esophageal carcinoma

Exclusion Criteria:

* Minors, pregnant women, contraindication for endoscopy, contraindications for establishment of a PEG

Primary outcomes:
measure: Detection rate of a second cancer or precancerous lesions
timeFrame: The time frame is during the PEG insertion (approximately 15min)
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Klinikum der J. W. Goethe-Universität
state: Hessen
Study officials:
affiliation: Goethe University
name: Mireen Friedrich-Rust, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05222867: The Effect of Lower Back Massage on Perceived Labor Pain
Official title: Angle Labor Pain Questionnaire Turkish Version: Validity and Reliability Study and Evaluation of Efficacy With a Non-pharmacological Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study was to assesment the change in pain scores with lower back massage, a non-pharmacological method, on perceived labor pain in the early active phase of the first stage of labor.


Eligibility criteria: Inclusion Criteria:

* The study group consisted of pregnant women who were at 37-40 weeks of pregnancy,
* had cervical dilatation of 4-6 cm,
* had a single, live, and vertex fetus,
* had an uncomplicated pregnancy,
* had no contraction anomalies,
* could communicate in Turkish
* planned for a vaginal delivery.

Exclusion Criteria:

* with cognitive dysfunction
* using narcotic analgesics or sedative drugs
* had any contraindications for applying a back massage

Primary outcomes:
measure: assessment of change in pain scores with lower back massage
timeFrame: Change in perceived labor pain scores in an average of 30 minutes (During the lower back massage application)
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Burcu Tuncer Yilmaz
Study officials:
affiliation: ESKISEHIR OSMANGAZI UNIVERSITY FACULTY OF HEALTH SCIENCES DEPARTMENT OF MIDWIFERY
name: NEBAHAT OZERDOGAN, PROF.DR.
role: STUDY_DIRECTOR
References:
citation: Angle PJ, Kurtz Landy C, Djordjevic J, Barrett J, Kibbe A, Sriparamananthan S, Lee Y, Hamata L, Zaki P, Kiss A. Performance of the Angle Labor Pain Questionnaire During Initiation of Epidural Analgesia in Early Active Labor. Anesth Analg. 2016 Dec;123(6):1546-1553. doi: 10.1213/ANE.0000000000001679.
citation: Angle P, Landy CK, Charles C, Yee J, Watson J, Kung R, Kronberg J, Halpern S, Lam D, Lie LM, Streiner D. Phase 1 development of an index to measure the quality of neuraxial labour analgesia: exploring the perspectives of childbearing women. Can J Anaesth. 2010 May;57(5):468-78. doi: 10.1007/s12630-010-9289-1. Epub 2010 Mar 13.
citation: Capogna G, Camorcia M, Stirparo S, Valentini G, Garassino A, Farcomeni A. Multidimensional evaluation of pain during early and late labor: a comparison of nulliparous and multiparous women. Int J Obstet Anesth. 2010 Apr;19(2):167-70. doi: 10.1016/j.ijoa.2009.05.013. Epub 2010 Mar 9.
citation: Angle P, Kurtz-Landy C, Djordjevic J, Barrett J, Kibbe A, Sriparamananthan S, Lee Y, Hamata L, Kiss A. The Angle Labor Pain Questionnaire: Reliability, Validity, Sensitivity to Change, and Responsiveness During Early Active Labor Without Pain Relief. Clin J Pain. 2017 Feb;33(2):132-141. doi: 10.1097/AJP.0000000000000386.
Clinical trial NCT04981067: Dose-finding Study: Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery
Official title: Median Effective Concentration of Ropivacaine for Ultrasound-guided Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetic Foot
Diabetic Neuropathies
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The biased coin design up-and-down method
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the minimum effective dose of a local anesthetic for proper anesthesia for popliteal sciatic nerve block under ultrasound guidance in patients undergoing surgery for diabetic foot disease.

Detailed description: Unlike general patients, patients with diabetic foot disease often have diabetic neuropathy and thus have increased sensitivity to local anesthetics. Therefore, when performing sciatic nerve block, it is essential to properly adjust the dose to prevent neurotoxicity and delay in recovery due to local anesthetics.

If the appropriate effective dose of local anesthetic for sciatic nerve block is found in patients with diabetic foot through this study, it is expected that it will be a useful basis for establishing a safe anesthetic method in the case of diabetic foot surgery.

Eligibility criteria: Inclusion Criteria:

* Adult patients who can be operated under popliteal sciatic nerve block among patients undergoing surgery for diabetic foot disease

Exclusion Criteria:

1. Infection of the popliteal region
2. Severe coagulation abnormality
3. Allergic reaction or hypersensitivity to local anesthetics
4. Neurological abnormalities other than diabetic neuropathy in the lower extremity of the operation site
5. When it is impossible to evaluate sensory blockage and motor blockage
6. When the patient refuses

Primary outcomes:
measure: Median effective anesthetic concentration 90 (MEAC 90)
timeFrame: within 30 minutes from the popliteal sciatic block
Secondary outcomes:
measure: Median effective anesthetic concentration 50 (MEAC 50)
timeFrame: within 30 minutes from the popliteal sciatic block
measure: Sensory block onset time
timeFrame: within 30 minutes from the popliteal sciatic block
measure: Motor block onset time
timeFrame: within 30 minutes from the popliteal sciatic block
measure: Block duration
timeFrame: within 24 hours post-operatively
measure: Time to first rescue analgesia
timeFrame: within 24 hours post-operatively
measure: Any adverse events
timeFrame: within 24 hours post-operatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seokha Yoo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05690867: Pressure Controlled Ventilation Versus Volume Controlled Ventilation in Upper Abdominal Surgery
Official title: Comparison of Pressure and Volume Controlled Ventilation in Terms of Mechanical Power in Upper Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Lung
Keywords: mechanical power
volume controlled ventilation
pressure controlled ventilation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Comparison of mechanical powers produced at volume controlled and pressure controlled mechanical ventilation

Detailed description: The mechanical power created by mechanical ventilation, as a new concept, can enable to evaluate the effect of different components in the lung.Our aim in this study is to calculate mechanical power in different ventilation modes ( pressure controlled and volume controlled ventilation) and to compare them. To calculate the mechanical powers we will use Van der Meijden's mechanical power formula for pressure controlled ventilation and for volume controlled ventilation we will use Gattinoni's mechanical power formula. In the literature we haven't seen any publication comparing the mechanical power of two commonly used ventilation modes (volume controlled and pressure controlled ventilation)

Eligibility criteria: Inclusion Criteria:

* ASA1-2 , \>18 years old patients having upper abdominal surgery

Exclusion Criteria:

* chronic obstructive lung disease, interstitial lung disease
* chronic renal failure
* Child-Pugh \> 6 liver disease
* Patients who don't give consent
* NYHA \> 2 heart failure

Primary outcomes:
measure: calculation of mechanical power changes in two different ventilation modes
timeFrame: change from at the beginning of surgery till the end of surgery
Secondary outcomes:
measure: postoperative pulmonary complications
timeFrame: post-operative 7 days
measure: hospitalisation time
timeFrame: up to 20 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Department of Anesthesiology
Study officials:
affiliation: Istanbul University
name: Istanbul University
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gattinoni L, Marini JJ, Collino F, Maiolo G, Rapetti F, Tonetti T, Vasques F, Quintel M. The future of mechanical ventilation: lessons from the present and the past. Crit Care. 2017 Jul 12;21(1):183. doi: 10.1186/s13054-017-1750-x.
citation: van der Meijden S, Molenaar M, Somhorst P, Schoe A. Calculating mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Oct;45(10):1495-1497. doi: 10.1007/s00134-019-05698-8. Epub 2019 Jul 29. No abstract available.
Clinical trial NCT05616767: Prevention and Screening for Early Detection of HPV-related Cancers in Gay and Bisexual Men in Tanzania
Official title: Prevention and Screening for Early Detection of HPV-related Cancers in Gay and Bisexual Men in Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 83
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The long-term objective of the parent study is "to reduce the effects of OPCa through secondary prevention (i.e., early detection, diagnosis and treatment referral)." Consistent with this, this supplement will test HPV-related interventions tailored for Sexual Minority Men (SMM). Acceptability, feasibility and preliminary effectiveness of a smart-phone delivered Oropharyngeal Cancer (OPCA) self-assessment tool will be assessed. Given that homosexuality is stigmatized and criminalized in Tanzania, and that cell phone use is the key way SMM communicate in Tanzania, a self-assessment screening cell phone intervention holds particular promise for SMM in Tanzania but warrants separate evaluation.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* gay or bisexual men
* speak Kiswahili or English
* resident in Dar es Salam

Primary outcomes:
measure: assess screening practices of hrHPV-related OPCa
timeFrame: Baseline
measure: To assess the acceptability and feasibility of teaching SMM in Tanzania to conduct self-exams
timeFrame: baseline to 6 months
measure: To assess the acceptability and feasibility of hrHPV vaccination
timeFrame: baseline
measure: To assess the acceptability and feasibility of hrHPV vaccination
timeFrame: 1 month
measure: To assess the acceptability and feasibility of hrHPV vaccination
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Dar es Salaam
Study officials:
References:
Clinical trial NCT06872567: Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain
Official title: Resorbable Embolization MicroSpheres for OsteoaRthritis Benefit
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis (Knee OA)
Lead sponsor: North American Science Associates Ltd.
Sponsor class: NETWORK
Collaborators: name: Next Biomedical Co., Ltd.
First posted: 2025-03-12
Enrollment: 126
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Multi-center, prospective, randomized trial of GAE using Nexsphere-F against steroid injection


Eligibility criteria: Inclusion Criteria:

* Patient has localized knee pain
* Must be an appropriate candidate for arterial vascular access procedure

Exclusion Criteria:

* Known sensitivity or allergy to implant materials
* Unable or unwilling to comply with study requirements

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 and 12-month post treatment
measure: Serious Adverse Events (SAE)
timeFrame: Treatment, 1,3,6,9 and 12-month post treatment
Secondary outcomes:
measure: WOMAC total score
timeFrame: 9 month post treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04329767: A Prospective Post-Market Study to Evaluate the Clinical Utility of IRIS, a Three-dimensional (3-D) Anatomical Modeling Software for Pre-operative Surgical Planning and Intra-operative Navigation for Nephrectomy
Official title: A Prospective Post-Market Study to Evaluate the Clinical Utility of IRIS, a Three-dimensional (3-D) Anatomical Modeling Software for Pre-operative Surgical Planning and Intra-operative Navigation for Nephrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2020-04-01
Enrollment: 122
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: Subjects with kidney cancer who will undergo robotic-assisted partial or robotic-assisted radical nephrectomy.

Brief summary: This is a prospective, multi-center, post-market study to evaluate the clinical utility of IRIS, a 3D anatomical modeling software, with standard CT scans during pre-operative planning and intra-operative navigation for nephrectomy. The study will be conducted over the course of 21-24 months and enroll approximately 60-120 subjects.


Eligibility criteria: Inclusion Criteria:

1. Subject is 18 years or older
2. Subject is undergoing robotic-assisted partial or robotic-assisted radical nephrectomy being performed by participating surgeon
3. Subjects who has had or plan to have a CT scan (with IV contrast medium)

Exclusion Criteria:

1. Subject has a solitary or horseshoe kidney
2. Subject has more than two masses in the applicable kidney requiring multiple partial nephrectomies on the same kidney
3. Subject with prior surgery (ex: partial nephrectomy etc.) on the affected kidney excluding endoscopic kidney stone surgery
4. Subject with renal vein tumor thrombus
5. Subjects planned to have a bilateral operation (ex: bilateral partial nephrectomies planned at the same time)
6. Metastatic disease with life expectancy of less than 1 year
7. Pregnant or suspect pregnancy
8. Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
9. Subject belonging to other vulnerable population, e.g, prisoner or ward of the state

Primary outcomes:
measure: Clinical utility of IRIS 3D model with CT scans during Intra-Operative navigation
timeFrame: Intra-operative
Secondary outcomes:
measure: Clinical utility of IRIS 3D model with CT scans during preoperative surgical planning
timeFrame: Preoperative
Other outcomes:
Locations:
city: Edison
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: