louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06098963: Preliminary Outcomes of Sacral Neuromodulation Applications; Tertiary-Center Experience in Turkey
Official title: Preliminary Outcomes of Sacral Neuromodulation Applications; Tertiary-Center Experience in Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sacral Neuromodulation
Keywords: Sacral neuromodulation
Overactive bladder
Urinary incontinence
Fecal incontinence
Lower urinary tract dysfunction
Lead sponsor: Cigli Regional Training Hospital
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with urinary or faecal incontinence and interstitial cystitis who are unresponsible for medical therapy between the age of 18-85.

Brief summary: to report our patients' outcomes of SNM in tertiary health centres in Turkey

Detailed description: We retrospectively analyzed 18 patients who underwent SNM for urinary or bowel dysfunction between 2017 and 2022 in our clinic. We excluded 2 patients due to non-effective responses after the test period. After local ethics committee approval was obtained from our institute (Number and date: 21-12.1T/14). Patient characteristics and demographic data including age, gender, indications to the SNM, age at diagnosis, and comorbidities were collected from our Hospital patients' record system. Urinary functions were evaluated by the ICIQ-SF questionnaire form. Patients' diagnosis, implantation duration, complications, and improvement of symptoms were recorded.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with urinary incontinence
* Patients diagnosed with faecal incontinence
* Patients diagnosed with interstitial cystitis

Exclusion Criteria:

* Presence of urinary infection
* Presence of previous incontinence surgery
* Presence of 2nd motor neurone disease
* Inability of detrusor muscle contraction activity
* Previous radical cystoprostatectomy history
* Presence of bladder outlet obstruction

Primary outcomes:
measure: Recovery of urinary or fecal incontinence
timeFrame: 1 year
Secondary outcomes:
measure: increase in the score of ICIQ-SF questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07021963: A Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy
Official title: A Multicenter, Open-label Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study mainly evaluates the long-term safety of HRS-1893 in subjects with hypertrophic cardiomyopathy.


Eligibility criteria: Inclusion Criteria:

1. Subjects with hypertrophic cardiomyopathy who have previously completed HRS-1893 related studies.
2. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and must be non-lactating during the study. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time they sign the informed consent form until 3 months after the last dose of trial drug, and to comply with relevant contraceptive requirements.
3. Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.

Exclusion Criteria:

1. Previous history of coronary artery disease (stenosis of one or more coronary arteries \>70%) or myocardial infarction.
2. Have received medication for negative inotropic other than disopyramide, β-blocker, verapamil, diltiazem 4 weeks before screening.
3. History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
4. Other conditions that the investigator considers the subject to be unsuitable for participating in this trial, such as physical or psychological diseases or conditions that may increase the risk of the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial.

Primary outcomes:
measure: Incidence and severity of adverse events (AEs).
timeFrame: About 1 year.
measure: Incidence of left ventricular ejection fraction (LVEF) <50%.
timeFrame: About 1 year.
Secondary outcomes:
measure: The change in cardiac troponin from baseline.
timeFrame: Week 24 and Week 52.
measure: The change in N-terminal B-type natriuretic peptide (NT-proBNP) from baseline.
timeFrame: Week 24 and Week 52.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
state: Beijing
Study officials:
References:
Clinical trial NCT02878863: Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Auto-immune Hepatitis
Official title: Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Treatment of Auto-immune Hepatitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hepatitis, Autoimmune
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild necroinflammatory activity on liver biopsy.


Eligibility criteria: Inclusion Criteria:

* Patients aged 20-70 years;
* Diagnosed with AIH or primary biliary cirrhosis-autoimmune hepatitis overlap syndrome based on liver biopsy results and without indication of immunosuppressive therapy;
* High levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)(1-3 X ULN);
* High levels of IgG(1-1.5 X ULN);
* Liver biopsy showed mild lymphocytic piecemeal necrosis (interface hepatitis);
* Agreed to participate in the trial, and assigned informed consent.

Exclusion Criteria:

* The presence of hepatitis A, B, C, D, or E virus infection;
* Patients with presence of liver cirrhosis or portal hypertension;
* Patients with presence of fulminant liver failure;
* Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease confirmed by liver biopsy;
* Pregnant and breeding women;
* Severe disorders of other vital organs, such as severe heart failure, cancer;
* Parenteral administration of blood or blood products within 6 months before screening;
* Recent treatment with drugs having known liver toxicity;
* Taken part in other clinic trials within 6 months before screening.

Primary outcomes:
measure: Percent of patients that achieve biochemical remission of AIH
timeFrame: Month 6 during treatment with paeoniflorin combination of hepatoprotective drugs or hepatoprotective drugs only
Secondary outcomes:
measure: Alanine transaminase (ALT)
timeFrame: Month 1, 3, 6
measure: Aspartate transaminase(AST)
timeFrame: Month 1, 3, 6
measure: Immunoglobulin G(IgG)
timeFrame: Month 1, 3, 6
measure: Globin(GLB)
timeFrame: Month 1, 3, 6
measure: Total bilirubin(TB)
timeFrame: Month 1, 3, 6
measure: Direct bilirubin(DB)
timeFrame: Month 1, 3, 6
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital,Chengdu, Sichuan, China
name: Li Yang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06032663: Use of PET-MR in Head and Neck Cancer Patients - Diagnostic and Therapeutic Applications
Official title: Use of PET-MR in Head and Neck Cancer Patients - Diagnostic and Therapeutic Applications
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Head
Neck
Cancer
PET MRI
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 10
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: The primary research question to be answered in this project is "Are patients with locally-advanced head and neck cancer able to tolerate a PET-MRI scan when they are immobilised in a radiotherapy treatment shell?" This will be assessed by measuring the proportion of patients that complete the full scanning protocol and by obtaining participant feedback on their experience of completing the scan.

The secondary question is "Can a PET-MRI scan fused with a planning CT scan improve the accuracy in radiotherapy planning of patients with head and neck cancer? Accuracy will be assessed by:

1. Comparing the radiotherapy target volumes and radiotherapy plans with and without the use of a PET-MRI scan.
2. Comparing inter- and intra-observer variability in treatment contours with and without the use of a PET-MRI scan within and between oncologists and implications of that.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or over
2. Able to give informed written consent.
3. New diagnosis of biopsy-proven head and neck cancer.
4. WHO performance status ≤ 2.
5. MDT-recommended treatment with radical radiotherapy, with or without concurrent systemic therapy.
6. MRI and PET-CT staging scans for diagnosis.

Exclusion Criteria:

1. Known intolerance/sensitivity to 18F-2-deoxyglucose or gadolinium-containing contrast agents.
2. Claustrophobia or other contraindications to MRI.
3. Unable to pass through a 55 cm hula hoop.
4. Female patients that are pregnant or breastfeeding.
5. Unable to understand written or spoken English.
6. Patients not undergoing radical intent radiotherapy.
7. Patients with stage 4 or 5 chronic kidney disease or other biochemical abnormalities e.g. uncontrolled blood glucose levels which can have an impact on PET-MRI imaging or contrast administration.

Primary outcomes:
measure: Completion of PET-MRI
timeFrame: 12 months
Secondary outcomes:
measure: Impact of additional PET-MRI on radiotherapy target volumes
timeFrame: 12 months
measure: Impact of additional PET-MRI on treatment plan
timeFrame: 12 months
measure: Impact of additional PET-MRI on treatment plan
timeFrame: 12 months
Other outcomes:
measure: Added benefit to diagnostic investigations
timeFrame: 12 months
Locations:
city: Sheffield
country: United Kingdom
facility: Cancer Research Centre at Weston Park Hospital
state: England
Study officials:
affiliation: STH Contracted Consultant
name: Satya Garikipati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01994863: Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy
Official title: An Open-labeled, Randomised, Controlled, Comparative, Cross-over Study Investigating the Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care 1-piece in Subjects With Ileostomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2013-11-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Be able to handle the appliance themselves or with help from caregiver (e.g. spouse)
4. Have an ileostomy with a diameter between 15 and 45 mm
5. Have had their ostomy for at least three months
6. Currently use a 1-piece flat product with open bag
7. Use minimum 1 product every second day.
8. Be suitable for participation in the investigation and for using a standard adhesive, flat base plate
9. Must use custom cut product
10. Accept to test two 1-piece products within the study

Exclusion Criteria:

1. Use irrigation during the study (flush the stoma with water)
2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
3. Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area
4. Are pregnant or breastfeeding
5. Participating in other interventional clinical investigations or have previously participated in this investigation
6. Has more than three days wear time

Primary outcomes:
measure: Leakage
timeFrame: 14+/-3 days per product
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: QPS Netherland B.V.
Study officials:
affiliation: Coloplast A/S
name: Daniel Carter, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02297763: Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Delirium
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 194
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of low dose quetiapine for the prophylaxis of delirium in critically ill patients in medical intensive care unit.


Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 19 years of age, admitting to medical ICU, anticipated to stay more than 72hours

Exclusion Criteria:

* Female patients who are pregnant or breastfeeding
* active delirium
* Received other anti-psychotic drug before attend the study
* severe bradycardia
* alcohol intoxication
* No written consent from the legal representatives
* Being ill with renal or hepatic failure

Primary outcomes:
measure: Development of delirium within 14 days after admitting to ICU (Rate)
timeFrame: 14 days after admitting to intensive care unit
Secondary outcomes:
measure: Duration of delirium occurring within 14 days after admitting to ICU (Days)
timeFrame: 14 days after admitting to ICU
measure: Length of stay in ICU and hospital (Days)
timeFrame: up to 24 weeks
measure: 60 days in hospital mortality (Rate)
timeFrame: 60 days after admitting to ICU
measure: Duration of mechanical ventilation in ICU (Days)
timeFrame: 14days after admitting to intensive care unit
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01937663: A Single-blind, Dose-tapering Study of KWA-0711 in Patients With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Constipation
Keywords: Chronic Constipation
Constipation
Functional gastrointestinal disorders
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-09-09
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of tapered KWA-0711 dose in chronic constipation patients.


Eligibility criteria: Inclusion Criteria:

* The patients who experienced fewer than three spontaneous bowel movements per week for more than 6 months prior to the enrollment.
* The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation

Exclusion Criteria:

* Patients who have secondary constipation caused by systemic disorder.
* Patients who have organic constipation.
* Patients who received intestinal resection.

Primary outcomes:
measure: Improvement of signs and symptoms associated with constipation
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
Clinical trial NCT01344863: A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe
Official title: A Randomized, Open-label, 2-arm, Parallel Group, Single Dose, Multi-center Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of Trastuzumab Administered Subcutaneously as the Trastuzumab/rHuPH20 Formulation Using a Handheld Syringe or Using the Proprietary Single-use Injection Device (SID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-04-29
Enrollment: 119
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, open-label, parallel, 2-arm, multicenter study will compare the administration of Herceptin (trastuzumab) with a single-use injection device versus a handheld syringe in healthy male volunteers. The volunteers will receive a single dose of 600 mg Herceptin. The anticipated time of the study is 21 weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy male patients, 18 to 45 years of age, inclusive
* No history of hypersensitivity or allergic reactions following drug administration
* No history of clinically significant or clinically relevant cardiac condition
* No history of previous anticancer treatment
* Body mass index (BMI) between 18-32 kg/m2, inclusive

Exclusion Criteria:

* Positive test result for drugs of abuse
* Positive test result for hepatitis B, hepatitis C, or HIV 1 or 2
* Systolic blood pressure greater than 140 mmHG or less than 90 mmHG, or diastolic blood pressure greater than 90 mmHG or less than 50 mmHG
* Clinically significant abnormal laboratory values

Primary outcomes:
measure: Area under plasma concentration curve of trastuzumab
timeFrame: 21 days
measure: Maximum observed plasma concentration of trastuzumab
timeFrame: 21 days
Secondary outcomes:
measure: Plasma concentration of trastuzumab
timeFrame: Day 21
measure: Safety: Incidence of adverse events
timeFrame: 21 weeks
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
city: Grafton
country: New Zealand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Wynne CJ, Ellis-Pegler RB, Waaka DS, Schwabe C, Lehle M, Heinzmann D, Mangat R, Li C, Dick AE, Cranshaw NA, Lum BL. Comparative pharmacokinetics of subcutaneous trastuzumab administered via handheld syringe or proprietary single-use injection device in healthy males. Cancer Chemother Pharmacol. 2013 Nov;72(5):1079-87. doi: 10.1007/s00280-013-2273-z. Epub 2013 Sep 22.
Clinical trial NCT05637086: Clinical Study Evaluating Safety of Pentoxifylline and Celecoxib in Patients With Grand-Mal Epilepsy Treated by Phenytoin Monotherapy
Official title: Clinical Study Evaluating and Comparing the Safety and the Possible Efficacy of Pentoxifylline and Celecoxib in Patients With Grand-Mal Epilepsy Treated by Phenytoin Monotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Epilepsy
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Tanta University
name: Principal Investigator Maha Ahmed Younis, PhD Pharmacy Practice Department- Horus University
First posted: 2022-12-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Epilepsy is a chronic neurological disorder affecting millions of people all over the world. Epileptic seizures are caused by abnormal synchronized electrical neuronal discharges that could be either focal or widespread. Pathogenesis of epilepsy involves multiple processes including genetics, oxidative stress, ion channels, neuroinflammation, and cellular damage through autophagy and apoptosis.

Neuroinflammation is considered one of the most important factors contributing critically to epileptogenesis.


Eligibility criteria: Inclusion Criteria:

- Patients aged ≥ 18 years old. Patients with grand mal epilepsy on phenytoin monotherapy. Women with a negative pregnancy test and women on effective contraception

Exclusion Criteria:

- Patients with significant liver and kidney function abnormalities. Alcohol and/or drug abusers. Patients with known allergies to the study medications Patients with known allergy to sulfonamides (cross hypersensitivity with celecoxib).

Pregnant women and women with a planned pregnancy. Subjects on medication are known to have possible positive effects on epilepsy. Patients who are currently using other antiepileptic drugs. Patients with CVD and a history of coronary artery bypass graft (CABG) surgery. Patients on aspirin or fluconazole therapy Patients with a recent retinal or cerebral hemorrhage

Primary outcomes:
measure: The clinical outcome will be assessed through Quality of Life questionnaire (QOLIE-31)
timeFrame: 6 months
Secondary outcomes:
measure: The secondary outcome is the change in the serum level of the measured biological parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
References:
Clinical trial NCT05469386: Single and Combined Effects of Behavioral, Academic, and Medication Treatments for ADHD in the Classroom
Official title: Single and Combined Effects of Positive Behavior Support, Medication and Academic Accommodation for Children With ADHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: ADHD
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 288
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is the first to systematically evaluate the efficacy of single and combined academic accommodation, behavioral treatment, and medication treatment in a large sample of children with ADHD. Using a scientifically rigorous, cross-over design the impact of these approaches on ecologically valid measures of outcome (on-task behavior, quiz scores, academic productivity) will be assessed to inform effective school intervention.


Eligibility criteria: Inclusion Criteria:

* ADHD Diagnosis
* IQ \>= 70

Exclusion Criteria:

* Prior adverse reaction to methylphenidate
* Autism Spectrum disorder level 2/3
* Child is home schooled

Primary outcomes:
measure: Behavioral frequency count of rule violations
timeFrame: Through study completion, a maximum of eight weeks
measure: Seatwork completion
timeFrame: Through study completion, a maximum of eight weeks
measure: Quiz Scores
timeFrame: Through study completion, a maximum of eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: FIU Center for Childern and Families
state: Florida
city: Amherst
country: United States
facility: Center for Children and Families
state: New York
Study officials:
References: