louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03104101: Transcutaneous Posterior Tibial Nerve Electrostimulation With Low Dose Trospium Chloride in OAB in Females
Official title: Evaluation of Transcutaneous Posterior Tibial Nerve Electro Stimulation With or Without Low Dose Trospium Chloride in the Management of Overactive Bladder in Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: PTNS
Neuromodulation
TPTNS
Trospium chloride
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study was done to verify whether the combination of transcutaneous posterior tibial nerve stimulation (TPTNS) with low dose trospium chloride in the treatment of females with overactive bladder (OAB) would be more effective than TPTNS alone after failure of behavioral therapy.

Detailed description: The investigators randomized 30 women with OAB, in two groups: G I (15 patients) received 30 minutes TPTNS, three times a week; GII (15 patients) received TPTNS plus Low dose trospium chloride (20 mg once daily); all for 8 weeks. Patients were evaluated using Overactive Bladder Symptom Score questionnaire (OABSS), Incontinence Impact Questionnaire-short form 7 (IIQ-7), 3 day voiding diary and urodynamics at weeks 0 and 8.

Eligibility criteria: Inclusion Criteria:

* Thirty adult female patients having OAB symptoms (wet type) and proved to have detrusor overactivity by urodynamics

Exclusion Criteria:

1. Patients having urinary tract infection or bladder outlet obstruction.
2. Patients having neurological diseases.
3. Patients having gynecological problems as genital infection, pelvic organ prolapse or genital tumors.
4. Patients with electronic implants such as heart pacemakers.
5. During pregnancy
6. Patients subject to seizures

Primary outcomes:
measure: Patient satisfaction
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06629701: A Prospective Randomized Trial of External Vein Graft Support in Surgical Myocardial Revascularization
Official title: A Prospective Randomized Trial of External Vein Graft Support in Surgical Myocardial Revascularization
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Heart Attack, Revascularization
Keywords: Heart attack, revascularization
Lead sponsor: University Hospital Pilsen
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The aim of the thesis is to compare a group of patients using vein grafts with and without external support, specifically their patency. This is a prospective study with a follow-up plan of 150 patients, in whom the functionality of the grafts will be monitored at time intervals.

Detailed description: One of the most frequently used strategies to restore blood flow in affected coronary arteries in atherosclerotic disease is coronary bypass, or bridging of a narrowed or closed artery and revascularization of the ischemic area of the heart. For coronary artery bypass grafting (CABG), the great saphenous vein (VSM) remains the most commonly used graft, although the longevity of the vein graft is an important limiting factor in monitoring long-term results of CABG. Long-term follow-up found that 25% of vein grafts close within 1 year of surgery, and up to 75% of vein grafts close 10 years after surgery.

External support minimizes pathophysiological processes in the graft. For example, intimal hyperplasia, kinking, graft dilatation or graft suppression and generally improving the hemodynamic flow through the graft should also reduce the formation of thrombus. In this study we follow up the patency and function of vein grafts over a period of 4 years, and compare the resulting data with already available data from other researches.

Eligibility criteria: Inclusion Criteria:

* elective cardiosurgical revascularization using VSM vein graft, i.e. patients with MVD findings.

Exclusion Criteria:

* thromboembolic event in the past, long-term warfarinization, mechanical valves, infection during the procedure, urgent procedure, allergy to contrast material, pregnancy, elevated creatinine. A relative contraindication for exclusion from the study is: VSM varicosity, VSM damage during sampling.The age, gender or weight of the patient has no influence on the indication.

Primary outcomes:
measure: Closing of bypass in time
timeFrame: 3 years after the operation
Secondary outcomes:
measure: Chest pain
timeFrame: 3 years after the operation
measure: Shortness of breath at rest
timeFrame: 3 years after the operation
Other outcomes:
Locations:
city: Pilsen
country: Czechia
facility: University Hospital Pilsen
state: Czech Republic
Study officials:
affiliation: Head of Cardiac Surgery
name: Viktor Zlocha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01232101: Covered or Uncovered Bile Duct Stents
Official title: Covered and Uncovered Self Expandable Metallic Stents Are Equally Efficacious in Bile Duct Strictures. Results of a Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bile Duct Neoplasms
Keywords: covered, uncovered, palliative treatment, stent
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2010-11-02
Enrollment: 71
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is investigator initiated. Tumors that gives the narrowing of the bile ducts prevents bile from flowing from the liver to the intestine resulting in jaundice and the risk of bacterial growth in bile with severe infections as a result. Unresectable bile duct strictures have routinely been treated them with plastic stents. The plastic stents have been replaced by self expandable metallic stents.

These stents remain open longer for reasons that they have a larger diameter so that the bile flows through more easily. One problem with these stents, however, is that the tumor growing through the wire mesh which forms the wall of the stent. This has led to the development of so-called covered stents. Whether covered stents have longer patency is unclear as well as whether they are as safe. There is reason to believe that covered stents remain open longer, but there may be an increased risk of migration and other complications.

The purpose is to prospectively and randomized compare the two stent types. The study endpoint is the clogging of the stent or the patient's death. We also monitor complications, regress time of the jaundice and success rate of stent placement

Detailed description: 0

Eligibility criteria: Inclusion Criteria:

* Patients with unresectable, distal bile duct stricture needing relieved endoscopically
* Expected survival greater than 3 months
* The patient must give written consent to participate in the study

Exclusion Criteria:

* Stricture close to hilus
* Need for interpreter

Primary outcomes:
measure: The primary aim of the present study was to compare and stent patency between covered and uncovered bileduct SEMS
timeFrame: Stent occlusion or patient death
Secondary outcomes:
measure: Secondary objectives were to study difference in technical success, efficacy of drainage and complication rate between covered and uncovered metal stents
timeFrame: Evaluated within three days
Other outcomes:
Locations:
city: Skovde
country: Sweden
facility: Kjell-Arne Ung, Dpt of Internal Medicine, Karnsjukhuset,
Study officials:
affiliation: Dpt Int Med, Skovde
name: Kjell-Arne Ung, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04930601: HIS Bundle Pacing Synchrony Comparing HIS Pacing to Intrinsic Conduction While Using the Medtronic ECG Belt System
Official title: HBP Synchrony Using ECG Belt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HBP
Lead sponsor: Orlando Cardiac and Vascular Specialists
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population will include subjects with normal EF who have a Medtronic device and a HIS placed RV lead. In addition, we will include subjects who have intact AV conduction.

Brief summary: The HBP Synchrony Using ECG Belt study is a prospective, non-randomized single site physician-initiated research study. The study will collect ECG Belt data from up to 30 subjects at one single center. The target population will include subjects with a currently implanted Medtronic cardiac implantable device who have a HIS placed lead. The purpose of the study is to characterize the electrical dispersion using the ECG Belt provided by Medtronic in patients who have a HIS placed lead and understanding the amount of synchrony with intrinsic conduction compared to HIS pacing.


Eligibility criteria: Inclusion Criteria:

* Patient has previously been implanted with a Medtronic IPG/ICD and a HIS placed RV lead
* Patient has intrinsic AV conduction
* Normal EF, defined as EF \>50%, as shown on recent echo within last 12 months
* Patient is willing and able to comply with the protocol
* Patient is 18 years of age or older

Exclusion Criteria:

●Patient is ventricular pacer dependent

Primary outcomes:
measure: Characterize the electrical dispersion using SDAT
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Altamonte Springs
country: United States
facility: Orlando Cardiac & Vascular Specialists
state: Florida
Study officials:
References:
Clinical trial NCT01561001: IOP Fluctuations in Primary Open Angle Glaucoma Patients Before and After Deep Sclerectomy With Collagen Implant
Official title: 24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Primary Open Angle Glaucoma Before and After Deep Sclerectomy With Collagen Implant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
Collaborators: name: Clinique Monchoisi
First posted: 2012-03-22
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous humor via the trabecular meshwork towards the systemic circulation. This may lead to an increase in IOP and may damage the optic nerve. The purpose of glaucoma management is to lower IOP in order to prevent progression of the optic neuropathy and subsequent visual loss. Firstline treatment usually includes IOP-lowering drug therapy. However, if IOP remains uncontrolled and/or the optic nerve damage progresses despite controlled IOP, surgery may be indicated. Deep sclerectomy with a collagen implant (DSCI) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow. This forms the rationale to conduct this prospective, open label study to assess the 24-hour IOP fluctuation profile recorded with Triggerfish® in patients with POAG before and after DSCI.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of POAG
* Documented glaucomatous VF damage with mean defect (MD) \> 3 dB
* Progressing glaucomatous damage justifying a DSCI
* Aged ≥18 years, of either sex
* Not more than 4 diopters spherical equivalent on the study eye
* Not more than 2 diopters cylinder equivalent on the study eye
* Have given written informed consent, prior to any investigational procedures

Exclusion Criteria:

* Corneal or conjunctival abnormality precluding contact lens adaptation
* Severe dry eye syndrome
* Patients with allergy to corneal anesthetic
* Patients with contraindications for silicone contact lens wear
* Patients not able to understand the character and individual consequences of the investigation
* Participation in other clinical research within the last 4 weeks

Primary outcomes:
measure: Effect of DSCI on IOP fluctuation profile as recorded by Triggerfish® in patients with POAG.
timeFrame: 3 months
Secondary outcomes:
measure: Effect of DSCI on the diurnal and nocturnal IOP fluctuation pattern
timeFrame: 3 months
measure: Changes in visual field 3 months after DSCI
timeFrame: 3 months
measure: Safety and tolerability
timeFrame: 3 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Clinique Monchoisi, Unité du Glaucome
Study officials:
affiliation: Clinique Monchoisi, Unité du Glaucome
name: André Mermoud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05986201: Assessment of Long-term Effects of Tachosil
Official title: Assessment of Long-term Effects of Intraoperative Use of a Carrier-bound Fibrin Sealant (TachoSil®). We Had to Continue to Use it?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibrin Sealant
Haemostasis
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 32
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There were 33 (82.5%) males and 7 (17.5%) females aged 32-87 years, with a mean age of 67.8 years.

The indications for surgery were hepatocellular carcinoma 23 (57.5%), hydatid cyst 3 (7.5%), hepatic adenoma 1 (2.5%), hepatic trauma 2 (5.0%), cholecystitis 2 (5.0%), 3 (7.5%), splenic rupture or bleeding for trauma 1 (2.5%), neuroendocrine tumour and trauma of the pancreas 1 (2.5%), peptic gastric ulcer 3 (7.5%), and colon cancer 1 (2.5%).

There were 29 hepatic surgical procedures: 4 left lobectomies, 2 right hepatectomies, 9 segmentectomies, 2 bi-segmentectomies, 8 limited resections, and 1 enucleation following the Couinaud classification (23); 2 partial cystopericistectomies, 1 simple suture of the traumatic lobe of the liver after biliary check; 2 cholecystectomies, 3 total splenectomies, 1 enucleation of tumour of the tail of the pancreas, 1 haemostasis of the traumatic tail of the pancreas, 3 sutures of ulcer of the stomach, and 1 colon cancer resection.

Brief summary: This study aimed to analyse the long-term effects of a carrier-bound fibrin sealant (CBFS) after abdominal surgery by following up patients years after application.


Eligibility criteria: Inclusion Criteria:

* type of surgery, indication for surgery, type of disease

Exclusion Criteria:

* dead patients, not available on call.

Primary outcomes:
measure: fibrotic reaction
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02250001: Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C
Official title: Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: HCV
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-09-26
Enrollment: 2974
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: University hospitals, General hospitals, and clinics that have relevant departments, such as Liver Internal medicine, Gastroenterological medicine, Internal medicine, etc, where the surveillance drug is mainly prescribed

Brief summary: The primary objective of this study is: To evaluate the real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in Japanese patients chronically infected with HCV GT-1.

Detailed description: Time Perspective: Other - For patients who are treated before the contract between Bristol-Myers Kabushiki Kaisha (BMKK) and the treating physician is initiated, patient data will be collected retrospectively after the contract is signed. Data will be collected prospectively for patients who initiate DCV/ASV treatment after the contract is initiated

Patient Registry study - Yes; 48 weeks (Treatment: 24 weeks, Follow up: 24 weeks)

Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Patients who are initiating DCV and ASV treatment for the first time under the approved indications, dosage, and administration will be included in this study

Primary outcomes:
measure: The real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of Daclatasvir/Asunaprevir (DCV/ASV) dual therapy in Japanese patients chronically infected with Hepatitis C virus Genotype 1 (HCV GT-1)
timeFrame: 28 weeks
Secondary outcomes:
measure: Antiviral activity as determined by the proportion of patients with sustained virologic response at 24 weeks post-treatment Sustained virologic response at 24 weeks post-treatment (SVR24)
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03461601: Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility
Official title: The Impact of Uterine Flushing With Human Chorionic Gonadotrophin Before Intrauterine Insemination on Pregnancy and Live Birth Rates in Women With Unexplained Infertility: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unexplained Infertility
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intrauterine injection of human chorionic gonadotropin before intrauterine insemination (IUI) compared to IUI alone
Primary purpose: TREATMENT

Brief summary: A prospective randomized study included 210 women with Unexplained infertility subjected to combined ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before IUI and control group subjected to IUI alone.

Detailed description: A prospective randomized study included 210 patients with Unexplained infertility subjected to coupled ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before IUI and control group subjected to IUI alone.

Eligibility criteria: Inclusion Criteria:

* Unexplained infertility (UI)

Exclusion Criteria:

* body mass index (BMI) ≥35 kg/m2,
* Follicle Stimulating Hormone \>10 International Unit /Litter in early follicular phase,
* diagnosed cause of infertility, menstrual cycle irregularity,
* ovarian cysts,
* sever cervical stenosis,
* former IUI,
* ongoing pregnancy and
* renal or hepatic diseases were all the exclusion criteria.

Primary outcomes:
measure: Live birth
timeFrame: 10 months of randomization
Secondary outcomes:
measure: Chemical pregnancy
timeFrame: One month after randomization
measure: Clinical pregnancy
timeFrame: Two months after randomization
measure: Adverse effects
timeFrame: one hour of the procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04683601: Generation of a Surgical Field in the Left Lateral Decubitus Position
Official title: Generation of a Surgical Field at the Mid-lower Mediastinum for Thoracoscopic Esophagectomy in the Left Lateral Decubitus Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Thoracic Diseases
Keywords: Left decubitus position
Mid-lower mediastinum
Thoracoscopic esophagectomy
Lead sponsor: Shizuoka Cancer Center
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 154
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 154 patients underwent thoracoscopic esophagectomy in left decubitus position during that period.

Brief summary: The generation of a good surgical field at the mid-lower mediastinum during thoracoscopic esophagectomy in the left lateral decubitus position is often complicated. The investigators developed a simple and useful technique for surgical field generation.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent thoracoscopic esophageal resection from April 2015 to December 2019 in our hospital.

Exclusion Criteria:

* patients who underwent open thoracotomy

Primary outcomes:
measure: Completion rate of thoracoscopic esophagectomy
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00608101: Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus
Official title: Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 1
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: hypoglycemia
exercise
corticosteroids
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: The purpose of this study is to determine what corticosteroid receptor (and the dose of) is responsible for cortisol inducing hypoglycemia associated autonomic dysfunction in Type 1 DM. Specifically, we aim to determine whether stimulating the type 1 corticosteroid receptor (via fludrocortisone), the type 2 corticosteroid receptor (via dexamethasone), or both causes hypoglycemia associated autonomic dysfunction in Type 1 DM.


Eligibility criteria: Inclusion Criteria:

* 16 (8 males, 8 females) Type 1 diabetic patients aged 18-45 yr.
* HbA1c \> 7.0%
* Had diabetes for 2-15 years
* No clinical evidence of diabetic tissue complications
* 16 (8 males, 8 females) Healthy volunteers aged 18-45 yrs.
* Body mass index \< 27kg · m-2

Exclusion Criteria:

* Prior or current history of poor health
* Abnormal results following blood and physical examination
* Pregnancy

Primary outcomes:
measure: catecholamines
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University
name: Stephen N. Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: