louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06451796: Investigation of Novel Non-CE Marked Catheter
Official title: A Urethral Valve Catheter for the Treatment of Women With Stress Urinary Incontinence (SUI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Female Stress Incontinence
Keywords: Female Stress Incontinence
Lead sponsor: MagCath
Sponsor class: UNKNOWN
Collaborators: name: Herlev Hospital
First posted: 2024-06-11
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women suffering from stress urinary incontinence

Brief summary: Hypothesis: Treatment with the hydrophilic coated valved intraurethral catheter up to 16 hours per day is effective, well tolerated and seemingly safe for treatment of women with stress incontinence.

Test persons: Ten to twenty stress incontinent women. Treatment time: Up to two weeks

Detailed description: Demonstrate ease and comfort of device insertion, indwelling and removal. Patient acceptability during use.

Other:

* Symptom and QOL questionnaire.
* Drop out analysis.
* Is the patient motivated to continue using the valve catheter?
* Is the patient motivated to recommend the valve catheter to other stress incontinent women?

Eligibility criteria: Inclusion Criteria:

* Willing to participate
* Adult, competent woman who understands Danish.
* SUI as dominant symptom; daily or almost daily.
* Residual urine \< 150 ml.
* POP-Q prolapse ≤ grade 2.
* Negative urine stix/Urine D+R.
* Min. 2 months local vaginal estrogen treatment if the woman is postmenopausal.
* Mobile and self-reliant woman.
* Motivated.

Exclusion Criteria:

* Allergy to the silicone material
* Pregnancy or breastfeeding
* Unexplained hematuria.
* Current inflammatory disorders
* Malignant disorders of the urethra.
* Urethral stricture
* Visual diverticulum.
* AK treatment.
* Prosthetic heart valve surgery.

Primary outcomes:
measure: Safety primary: Migration of device to bladder
timeFrame: 2 weeks
Secondary outcomes:
measure: Safety secondary: Culture confirmed urinary tract infections.
timeFrame: 2 weeks
measure: Safety secondary:Need for antibiotics.
timeFrame: 2 weeks
measure: Safety secondary: Discomfort at self-catheterization.
timeFrame: 2 weeks
measure: Safety secondary: Difficulties emptying the bladder.
timeFrame: 2 weeks
measure: Safety secondary: Discomfort at catheter removal.
timeFrame: 2 weeks
measure: Safety secondary: Hematuria (stick test/macroscopic).
timeFrame: 2 weeks
measure: Safety secondary: Allergy.
timeFrame: 2 weeks
measure: Safety secondary: Loss of device.
timeFrame: 2 weeks
Other outcomes:
measure: Functionality: Is long term continuous use acceptable?
timeFrame: 2 weeks
Locations:
city: Herlev
country: Denmark
facility: GynCare
state: DK
Study officials:
affiliation: Herlev Hospital
name: Pia Sander, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01164696: A Prospective Observational Study to Evaluate the Quality of Life and the Costs in a Real Life Setting in Patients Who Are Treated With 90Y-Zevalin
Official title: A Prospective Observational Study to Evaluate Quality of Life and Costs in a Real Life Setting in Patients Treated With 90Y-Zevalin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Follicular
Non-Hodgkin Lymphoma
Keywords: Quality of Life, Health Care Costs
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-07-19
Enrollment: 30
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: All patients with relapsed or refractory FL who have been treated with 90Y-Zevalin in Belgium within the first 24 months after ethics approval

Brief summary: The objective of this study is to compare hematological toxicity, costs, health-related quality of Life (HR-QOL) and outcomes observed in real life in the Belgian Non-Hodgkin Lymphoma (NHL) population receiving 90Y-Zevalin, with model-predicted data at reimbursement on the basis of a clinical trial in heavily pre-treated NHL.


Eligibility criteria: Inclusion Criteria:

* Advanced cancer of the lymph nodes of follicular type at study inclusion
* The patient has relapsed or has refractory disease, after previous treatment with rituximab
* Treating physician has decided to treat the patient with a 90Y-Zevalin regimen
* The patient is \>= 18 years of age
* Patient has given informed consent

Exclusion Criteria:

* Patient is unwilling or unable to give informed consent
* Patient is participating in another clinical trial

Primary outcomes:
measure: The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment
timeFrame: one year after inclusion
Secondary outcomes:
measure: the health related quality of life prior to and following treatment (using EQ-5D and FACT-LYM)
timeFrame: baseline: before 1st administration, 8 days after baseline, 1, 2 & 3 months after baseline
measure: the clinical outcomes (survival status, response status), TTNT (time to next treatment)
timeFrame: 1 year
Other outcomes:
Locations:
city: Many Locations
country: Belgium
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06661096: Comparative Study Between Level I and Level II Temporomandibular Joint Arthroscopy in Wilkes Stage III Patients
Official title: Temporomandibular Joint Dysfunction (TMJD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Dysfunction Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Temporomandibular joint dysfunction (TMJD) represents a common health problem. Its prevalence is nearly 31% in adults and 11% in adolescence, more common in females. Aetiologies of TMJD are multifactorial and can be attributed to both physical and psycho-social factors. Internal derangement of the temporomandibular joint (TMJ) is the most frequent disorder; with anterior disc displacement is the most common form. Wilkes has classified internal derangement into five stages; patients with stage III usually present with limited mouth opening, joint pain and deviation of jaw upon opening to the affected side. MRI is considered the gold standard for diagnosis. Treatment of TMJD include non-surgical and surgical methods. Non-surgical treatment includes instructions, pharmacotherapy, physiotherapy and occlusal splints; while surgical interventions include minimally invasive procedures (arthroscopy and arthrocentesis) and open joint surgery

Detailed description: Arthroscopy of TMJ was first introduced by Ohnishi in 1975. There are three different levels of TMJ arthroscopy. Level I, single puncture arthroscopy, it allows lysis of adhesions in the upper joint compartment and lavage of the joint space and the inflammatory products. Level II is done by double puncture and it enables to perform maneuvers such as lateral pterygoid myotomy and ablation of the retrodiscal tissue. Operative devices including arthroscopic instruments, Nd-YAG and Holmium laser, and the high-frequency wave system (Coblation) is very useful for tissue coagulation and cutting. Both levels enabled getting joint mobilization and significant pain reduction. Level III (arthroscopic discopexy), it needs customized special instruments.

Eligibility criteria: Inclusion Criteria:

* Wilkes stage III patients

Exclusion Criteria:

* previous TMJ surgery

Primary outcomes:
measure: maximum inter-incisal opening
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: MGThabet
name: Mohamed Gamal Thabet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04484896: Message Framing on Recruiting Rh-D Negative Blood Donors
Official title: Effects of Message Framing on Recruiting Rh-D Negative Blood Donors in an Emergency Situation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Donation
Lead sponsor: Guangzhou Blood Center
Sponsor class: OTHER_GOV
First posted: 2020-07-24
Enrollment: 1082
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Rh negative blood group is a rare blood group in China, as it only accounts for 0.3-0.4 percent of the Han population. Therefore, low inventory is often found in blood collection and supply agencies in many regions in China. On July 22, 2020 blood stockpile of O-negative and A-negative in Guangzhou Blood Center reached the warning line, and we took measures for emergency recruitment. O-negative and A-negative blood donors whose last donation dates were between January 1, 2018 and December 31, 2019 were identified and randomly assigned to four groups. Three different recruitment text messages were send three groups. We observed the re-donation rates among four groups within one week.


Eligibility criteria: Inclusion Criteria:

- O and A Rh- negative blood donors Last donations were between January 1, 2018 and December 31, 2019

Exclusion Criteria:

- With an obviously invalid phone number Serological results of the last donation were positive

Primary outcomes:
measure: Re-donation rate
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Blood Center
state: Guangdong
Study officials:
References:
Clinical trial NCT04269096: Laparoscopic Cholecystectomy Care Protocol
Official title: Compliance With Laparoscopic Cholecystectomy Care Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic Cholecystectomy
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the ages of 18 years and 75 years who had surgery for choledocolithiasis at Prisma Health-Upstate.

Brief summary: The purpose of this study is to determine compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol.

Detailed description: Evidence based medicine calls for the application of scientific advances to clinical care. In an effort to address the most common complications of a surgical procedure, perioperative protocols have recently been created in an effort to apply best practices consistently and enhance the recovery from surgery. In addition to evaluating the validity of the protocol components themselves, it is valuable to measure compliance with said protocol. Failure to complete the steps of a care pathway may be caused by several reasons, and a study of application of these steps may help future efforts at standardization of care.

The purpose of this study is to determine compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol.

Hospital inpatient data from patient charts, office charts, and hospital medical data systems of Prisma Health-Upstate System will be used to review the records of all patients age 18-75 years, inpatient and outpatient, who had surgery for choledocolithiasis between January 1, 2016 to April 1, 2017.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 years and 75 years who had surgery for choledocholithiasis at Prisma Health-Upstate.

Exclusion Criteria:

* Patients under 18 years of age and older than 75 years of age.

Primary outcomes:
measure: Protocol Compliance
timeFrame: 15 months
Secondary outcomes:
measure: Length of Stay
timeFrame: 15 months
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: William Hand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00145496: Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771)
Official title: A Multicenter, Double-Blind, Flexible -Dose, 6-Month Trial Comparing the Efficacy and Safety of Asenapine With Olanzapine in Stable Subjects With Predominant, Persistent Negative Symptoms of Schizophrenia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, has shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.


Eligibility criteria: Inclusion Criteria:

* Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms.
* No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.
* Caregiver required.

Exclusion Criteria:

* Have an uncontrolled, unstable clinically significant medical condition.
* Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.

Primary outcomes:
measure: Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score
timeFrame: Day 182
Secondary outcomes:
measure: Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score
timeFrame: Day 182
measure: Change From Baseline in Body Weight
timeFrame: Day 182
Other outcomes:
Locations:
Study officials:
References:
citation: Buchanan RW, Panagides J, Zhao J, Phiri P, den Hollander W, Ha X, Kouassi A, Alphs L, Schooler N, Szegedi A, Cazorla P. Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol. 2012 Feb;32(1):36-45. doi: 10.1097/JCP.0b013e31823f880a.
Clinical trial NCT02157896: Vascular Endothelial Growth Factor and Endostatin in Angiogenesis After Acute Ischemic Stroke
Official title: Dynamic Changes of Vascular Endothelial Growth Factor and Endostatin in Association With Circulating Endothelial Progenitor Cells After Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Keywords: Acute ischemic stroke
Vascular endothelial growth factor
Endostatin
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient group comprised twenty male and ten female. Their age ranged from 45 to 74 years. Locations of infarct, as evidenced by radiologic and neurologic symptoms or signs, included the territories of the middle cerebral artery (9 cases), the posterior cerebral artery (8 cases) the anterior cerebral artery (6 cases), vertebrobasilar area (5 cases), and watershed area (2 cases with cortical and subcortical low densities crossing typical vascular territories).

Brief summary: Vascular endothelial growth factor (VEGF) and Endostatin (ES) participate angiogenesis after cerebral ischemia. Circulating endothelial progenitor cells (EPCs) also play a crucial role in neovascularization and tissue repair after acute ischemic stroke (AIS). The investigators sought to compare the expression of VEGF and ES in serum and the circulating EPCs in patients after AIS with that of healthy control subjects. The investigators obtained peripheral blood and serum samples from study subjects. EPCs in blood samples from AIS patients and healthy controls were quantified by flow cytometry 1 day, 3 days, 5 days and 7 days after AIS. VEGF and ES were measured by enzyme linked immunosorbent assay at the same time points. The relation between them and the relation of them to prognosis of such patients with acute ischemic stroke were assessed.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute ischemic stroke
* Admission within 12 hours
* National Institutes of Health Stroke Scale score 6-25

Exclusion Criteria:

* Lacunar infarction
* Cerebral hemorrhagic infarction
* Epilepsy or epileptic persons
* History of neurological diseases, myocardial infarction, renal and hepatic abnormalities and metabolic diseases
* Contraindications to antiplatelet treatments
* Died within the first week of hospitalization
* Serial blood samples could not be obtained

Primary outcomes:
measure: Modified Rankin Scale scores
timeFrame: 3 months
Secondary outcomes:
measure: Glasgow Outcome Scale scores
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Lixia Xue, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00515996: Genetic Abnormalities and Biological Changes of Panic Disorder Patients After Pharmacotherapy
Official title: Genetic Abnormalities and Changes of Autonomic Nervous System, Serotonin System, and Neuroendocrine System According to Pharmacotherapy in Panic Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Panic Disorder
Keywords: panic disorder
paroxetine
genetic polymorphism
serotonin
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2007-08-14
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: We plan to examine genetic polymorphism of catechol-O-methyltransferase in panic disorder and neurobiological changes of panic disorder patients after 12 weeks of pharmacotherapy with paroxetine. We plan to include 40 panic disorder patients and 40 normal control subjects in this study for 3 years.


Eligibility criteria: Inclusion Criteria:

* Panic disorder

Exclusion Criteria:

* Other major medical or psychiatric illnesses

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Bum-Hee Yu, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03595696: Core Strengthening for DRA in Postpartum Women
Official title: Effect of a Core Strengthening Program on Diastasis Rectus Abdominus in Postpartum Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diastasis Recti
Postpartum
Low Back Pain
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will prospectively measure the effectiveness of a core strengthening program on reducing the inter-rectus distance (IRD) and abdominal wall muscle contraction in postpartum women with diastasis rectus abdominus (DRA). Additionally, this study will aim to investigate and clarify the association between IRD and low back pain.

Detailed description: DRA is a separation of the abdominal wall muscles that commonly occurs during pregnancy and is caused by the stretching of the linea alba to accommodate a growing fetus. Separation of core muscles is thought to be factor in postpartum low back pain, stress urinary incontinence, and core strength, as well as being cosmetically undesirable. This study will evaluate the effect of a core strengthening program on shortening the IRD and improving the connectivity and strength of abdominal wall muscles in postpartum women with a DRA. It will also investigate the relationship between IRD and low back pain.

Eligibility criteria: Inclusion Criteria:

* Healthy women who have given birth within the last 36 months but are at least 12 weeks postpartum
* Not currently pregnant
* Current DRA diagnosed using ultrasound with an IRD of at least 2.0 cm

Exclusion Criteria:

* History of ventral/umbilical hernia prior to pregnancy
* \>36 months postpartum
* Currently pregnant
* Beighton's score \>5/9
* Unable to participate in a regular core strengthening program
* Unable to attend the three data collection sessions

Primary outcomes:
measure: Change in inter-recti distance (IRD)
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Abdominal wall muscle function
timeFrame: Up to 24 weeks
measure: Low back pain
timeFrame: Up to 24 weeks
measure: Pelvic function
timeFrame: Up to 24 weeks
measure: Stress urinary incontinence
timeFrame: Up to 24 weeks
measure: Body image
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Ellen Casey, MD
role: PRINCIPAL_INVESTIGATOR
References: