louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02480231: Mid-Urethral Sling Tensioning Trial
Official title: Mid-Urethral Sling Tensioning Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Stress Incontinence
Keywords: Tension-Free Vaginal Tape
Suburethral Slings
Midurethral Slings
Mid-urethral sling
urinary retention
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2015-06-24
Enrollment: 318
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective randomized clinical trial comparing two methods of intra-operative tensioning of retropubic midurethral slings for stress urinary incontinence. Primary outcome is rate of abnormal bladder function. Secondary outcomes include validated quality of life scores, physical exam findings, and rates of immediate post operative voiding dysfunction.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Women who have elected for surgical management of symptomatic urinary incontinence
* Ability to read \& write in English
* Other prolapse surgery at time of sling placement is allowed
* Must consent to participation in trial

Exclusion Criteria:

* Women with a prior incontinence procedure
* Clinically obvious, but non-symptomatic stress urinary incontinence (latent stress incontinence)
* Declines participation in trial
* Women with existing urinary retention or significant overactive bladder (requiring medication)

Primary outcomes:
measure: Abnormal Bladder Function
timeFrame: 1 year post operative
Secondary outcomes:
measure: Rate of discharge from hospital with on-going need for catheterization
timeFrame: 12 months
measure: Duration of catheterization after surgery
timeFrame: 12 months
measure: Questionnaire scores
timeFrame: 12 months
measure: Pad test
timeFrame: 12 month
measure: Uroflow parameters
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Hospital, University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Erin A Brennand, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brennand EA, Wu G, Houlihan S, Globerman D, Gagnon LH, Birch C, Hyakutake M, Carlson KV, Al-Shankiti H, Robert M, Lazare D, Kim-Fine S; Calgary Women's Pelvic Health Research Group. Two Intraoperative Techniques for Midurethral Sling Tensioning: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):471-481. doi: 10.1097/AOG.0000000000004027.
Clinical trial NCT00001531: Potential Role of CMV in Restenosis Following Angioplasty, in Atherosclerosis, and in Endothelial Dysfunction
Official title: Potential Role of CMV in Restenosis Following Angioplasty, in Atherosclerosis, and in Endothelial Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Occlusive Diseases
Atherosclerosis
Coronary Disease
Cytomegalovirus Infections
Keywords: Atherogenesis
Cell Mediated Immunity
Coronary Artery Disease
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 355
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The purpose of this study is to investigate whether the susceptibility of subjects to atherosclerosis is influenced by prior CMV exposure, whether the susceptability to endothelial dysfunction in patients with and in patients without atherosclerosis is influenced by prior CMV exposure.

Detailed description: The purpose of this study is to investigate whether the susceptibility of subjects to atherosclerosis is influenced by prior CMV exposure, whether the susceptability to endothelial dysfunction in patients with and in patients without atherosclerosis is influenced by prior CMV exposure.

Eligibility criteria: Patients who are being evaluated to determine if they have CAD or those who have already been studied and the presence or absence of CAD has been ascertained.

No patients who have not been evaluated for CAD.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Heart, Lung and Blood Institute (NHLBI)
state: Maryland
Study officials:
References:
citation: Speir E, Modali R, Huang ES, Leon MB, Shawl F, Finkel T, Epstein SE. Potential role of human cytomegalovirus and p53 interaction in coronary restenosis. Science. 1994 Jul 15;265(5170):391-4. doi: 10.1126/science.8023160.
citation: Schrier RD, Freeman WR, Wiley CA, McCutchan JA. Immune predispositions for cytomegalovirus retinitis in AIDS. The HNRC Group. J Clin Invest. 1995 Apr;95(4):1741-6. doi: 10.1172/JCI117851.
Clinical trial NCT05649631: The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism
Official title: The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was a single-center randomized controlled trial which lasted 14 days and consisted of two stages (run-in period (stage I) and intervention period (stage II) each contain 7 days without potassium supplement. If participants meet the enrollment criteria at the end of stage I, they were assigned to the low sodium group (50mmol/d) or normal sodium group (100mmol/d), and then continued to finish stage II. The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet and the secondary outcome was the assessment of BP change following a normal sodium / low sodium diet. Patients were given nifedipine controlled-release tablets 30 mg/d to lower blood pressure and were not provided any potassium supplements during the two stages. If the subject has an increase in BP (\>180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.


Eligibility criteria: Inclusion Criteria:

1. 18-70 years;
2. diagnosed as PA by SIT;
3. no lateralization of aldosterone secretion during AVS;
4. serum potassium ≥ 2.8 mmol/L after the stage I.

Exclusion Criteria:

1. Impaired renal function (Ccr\<60 ml/min);
2. Impaired liver function (ALT, AST \> 2.5 times upper limit of normal);
3. Patients with heart failure (NYHA≥ class 3 or EF \< 50%);
4. Patients with stroke or acute infarction in the last 6 months;
5. Patients who are pregnant or breastfeeding;
6. Patients who cannot tolerate dietary arrangements;
7. Patients with history of malignant tumors in the last 6 months.

Primary outcomes:
measure: The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet
timeFrame: 2 weeks
Secondary outcomes:
measure: The secondary outcome was the assessment of BP change following a normal sodium / low sodium diet.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Yiran Jiang
state: Shanghai
Study officials:
References:
Clinical trial NCT05545631: Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome and Transcriptome
Official title: Microbiome and Transcriptome Predicts Pregnancy Outcomes Undergoing Frozen Embryo Transfer: A Multicenter Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Microbiome
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Institutes of Life Science, Chinese Academy of Sciences
First posted: 2022-09-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients attending Center of Reproductive Medicine

Brief summary: This study intends to explore the correlation between cervical microbiome, gut microbiome, transcriptome and pregnancy outcomes of frozen embryo transfer patients through a multicenter prospective observational study, and to explore the predictive value of microbiome on pregnancy outcome.


Eligibility criteria: Inclusion Criteria:

1. Infertile women receiving assisted reproductive technology treatment, preparing for frozen embryo transfer cycle;
2. Female age: 20-45 years old;
3. Single frozen-thawed blastocyst Transferred
4. Endometrial thickness ≥7mm on the day of luteal transformation
5. Written informed consent.

Exclusion Criteria:

1. Women who have pathologies or malformations that affect the pregnancy outcome:genital malformations, intrauterine adhesions, uterine fibroids (\>4 cm in diameter or compressing endometrial line), adenomyosis, endometrial polyps; untreated tubal pleura Presence of autoimmune disease;
2. Untreated hyperprolactinemia, thyroid disease, adrenal disease
3. Antibiotic use within the past 7 days;
4. Current or recent (within 3 months) drug abuse, including alcohol and tobacco;
5. Refused or unable to comply with protocol requirements;
6. Participation in any experimental drug study within 60 days prior to screening.

Primary outcomes:
measure: Concentration of serum human chorionic gonadotropin ≥10 mIU/mL
timeFrame: 09.01.2022 to 09.01.2024
Secondary outcomes:
measure: Clinical pregnancy
timeFrame: 09.01.2022 to 09.01.2024
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Xiuxia Wang
state: Liaoning
Study officials:
affiliation: Center of Reproductive Medicine, Shengjing Hospital of China Medical University
name: Xiuxia Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Reproductive and Genetic Hospital of CITIC-Xiangya
name: Sufen Cai, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00189631: UFT/LV Maintenance Vs Observation in Metastatic Breast Cancer Responsive to Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Association Européenne de Recherche en Oncologie
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare maintenance therapy to observation in metastatic breast cancer patients responding (or stabilized) after 1st-line chemotherapy. Main endpoint is disease-free survival. Secondary endpoints are overall survival and tolerance. A total of 200 patients will be included.


Eligibility criteria: Inclusion Criteria:

* metastatic breast cancer
* objective response or stabilisation after 6 to 8 cycle of a first line chemotherapy
* time period between the end of chemotherapy and randomization \< 4 weeks
* age over 18 years
* Performance status (OMS) \< 2.
* Life expectancy \> 3 months
* Biological criteria before randomization: Neutrophiles \> 1.5 x 109 G/L; Pl. \> 100 x 109 G/L; Hb \> 10 g/dl; Creatininemia \< 1,5 UNL; Bili. \< 2 UNL; Transaminases \< 2,5 UNL; Alcalines Phosphatases \< 2,5 UNL
* Signed written informed consent

Exclusion Criteria:

* Metastatic breast cancer having received more than one chemotherapy line.
* Tumor progression under chemotherapy
* Free interval between primary tumor and metastases \> 5 years, with estrogen receptors and without visceral metastases
* Free interval between primary tumor and metastases \< 18 months after adjuvant chemotherapy if first lime chemotherapy only led to a tumor stabilization
* Concomitant hormonotherapy
* Other cancer
* Symptomatic brain metastases
* Any uncontrolled severe disease except breast cancer (especially cardiac failure with LVEF \< 50% or coronary insufficiency
* Psychiatric disorder
* Other concomitant trial
* Male patient
* Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential)
* History of high dose chemotherapy with bone marrow transplantation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Creteil
country: France
facility: AERO
Study officials:
affiliation: AERO
name: Jean-Francois Berdah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AERO
name: Laurent Zelek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AERO
name: Bruno Audhuy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04331431: Outcomes of the Intradural Extramedullary Tumors Resection
Official title: Professor of Neurosurgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Tumor
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 24
Sex: ALL
Minimum age (years): 28
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The intradural extramedullary tumors remain curable diseases. Our aim in this study is to evaluate the postoperative status after the tumor resection and compare it to the preoperative status

Detailed description: Meticulous microscopic excision without nerve root or dural injuries

Eligibility criteria: Inclusion Criteria:

* neurological deficit
* back pain

Exclusion Criteria:

* old age above 80 years
* immunocompromised patients

Primary outcomes:
measure: complete excision
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01953731: A Study To Investigate The Drug-Drug Interaction Potential Of Rifampin OnThe Investigational Agent Palbociclib (PD-0332991)
Official title: A Phase 1, Open-Label Fixed-Sequence 2-Period Study To Investigate The Effect Of Multiple Doses Of Rifampin On Palbociclib (PD-0332991) Pharmacokinetics In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: palbociclib
PD-0332991
rifampin
drug-drug interaction study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-10-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will compare the plasma pharmacokinetics of a single 125mg oral dose of palbociclib in the presence and absence of rifampin-mediated enzyme induction in a fixed-sequence two-period study.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females of non-childbearing potential
* body mass index between 17.5-30.5 kg/m2 with a total body weight greater than 50kg

Exclusion Criteria:

* Evidence or history of any clinically significant physiologic, psychological, or medical conditions
* a positive drug screen or alcohol breath test
* a baseline ECG demonstrating a QTc\>450msecs or a QRS interval \>120msecs

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 0-120 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0-120 hours post-dose
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0-120 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0-120 hours post-dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0-120 hours post-dose
measure: Apparent Oral Clearance (CL/F)
timeFrame: 0-120 hours post-dose
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 0-120 hours post-dose
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06246331: Evaluation of the Clinical Efficacy and Safety of BriTurn Injection or BrisTurn Prefilled Injection
Official title: An Observational Study on the Clinical Efficacy and Safety of BriTurn Injection or BrisTurn Prefilled Injection Administered for Reversal of Neuromuscular Blockade in Patients Receiving General Anesthesia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Reversal of Neuromuscular Blockade
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 1500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults aged 19 years or older

Brief summary: This study evaluate clinical efficacy and safety in adult patients administered BriTurn injection or BrisTurn Prefilled injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium.

Detailed description: This study evaluate clinical efficacy and safety in adult patients administered BriTurn injection or BrisTurn Prefilled injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium.

* Efficacy: Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%)
* Safety: whether bradycardia and resulting cardiac arrest occur or whether bronchospasm occurs

Eligibility criteria: Inclusion Criteria:

* Adults over 19 years of age
* Subject administered BriTurn Injection or BrisTurn Prefilled Injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium

Exclusion Criteria:

* Pregnant women or nursing women
* Subject to prohibition according to the permission of BriTurn Injection or BrisTurn Prefilled Injection

Primary outcomes:
measure: Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%)
timeFrame: after administration of BriTurn Injection or BrisTurn Prefilled Injection up to 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
Study officials:
affiliation: Inje University
name: Sangseok Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06567431: Blood And Tears in Alzheimer's Disease
Official title: Examination of Alzheimer's Disease Biomarkers in Tears and Dry Blood Spots
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurodegenerative Diseases
Lead sponsor: Danish Dementia Research Centre
Sponsor class: NETWORK
First posted: 2024-08-22
Enrollment: 600
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We aim to include 177 participants in each group. The diagnoses are based on internationally recognised diagnostic criteria for the individual diseases, and the diagnosis is made at a consensus conference by experienced specialists in the field of dementia.

Brief summary: This study aims to investigate whether biomarkers of Alzheimer's disease can be found in tearfluid, as well as dried bloodspots in patients with Alzheimer's disease, other dementia diagnoses compared to controls.

Detailed description: Participants under investigation of a neurodegenerative disease who have a planned lumbar puncture in the Memory clinic will be invited to this study. On the same day of the lumbar puncture, tear fluid and dry blod spots will be collected.

Tear fluid is collected using Shirmer's test. Dried blood spots are obtained by a small prick in the finger with a lancet. The blood droplet is transferred onto a special piece of filter paper, where it dries.

As a sub-study, participants who have provided written consent specifically for this purpose will repeat the test with dried blood spots at home one week after participating in the study. The samples are submitted to the Memory Clinic at the participant's next scheduled appointment.

Tear fluid, dried blood spots, as well as blood and cerebrospinal fluid will be examined for AD-related pathology.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria for patients:

* Lumbar puncture with CSF avaiable for analysis
* Diagnosis of Alzheimer's disease, Dementia with Lewy Bodies (DLB), Frontotemporal dementia (FTD), vascular dementia (VaD) or Normal pressure hydrocephalus (NPH)
* Of legal age.

Inclusion criteria for controls:

* Lumbar puncture with CSF avaiable for analysis
* No neurological disease.
* Of legal age.

Exclusion Criteria:

* No lumbar puncture
* Clinically assessed as unfit to participate in the project.

Primary outcomes:
measure: AD related biomarkers in tear fluid
timeFrame: Two years
measure: AD related biomarkers in dry blod spots
timeFrame: Two years
Secondary outcomes:
measure: Testing dry blod spots at home
timeFrame: Two years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Dementia Research Centre
Study officials:
References:
Clinical trial NCT06819631: Characterization of Subjective Discomfort in Patients With Tear Dysfunction
Official title: Retrospective and Observational Study in Relation to the Subjective Pain of Patients Attending the Corneal and Ocularcsurface Analysis Laboratory (LACSO) Affected by Ocular Surface Dysfunctions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dry Eye Disease
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in the study are patients suffering from ocular disconfort who are referred by their doctors for second/third level diagnostic tests at the University Ophthalmology Department. Patients are adults of both sexes, with eventual concomitant systemic and other ocular pathologies, without any limitation that defines exclusion criteria.

Brief summary: Characterization of subjective discomfort/pain in patients with ocular surface dysfunction in association with clinical and laboratory parameters, for a better understanding of the underlying pathogenic mechanisms.

Detailed description: Dry Eye Disease (DED) is a multifactorial chronic disease impairing the ocular surface.

DED can be associated with conditions of inflammation and neurosensory dysfunction.

The aim of this study is to characterize the discomfort/pain in subjects affected by DED with the administration of scales, questionnaires, and analysis of corneal sensitivity by keratoesthesiometry, in association with clinical laboratory parameters.

Eligibility criteria: Inclusion Criteria:

* adult patients with suspected or diagnosed DED

Exclusion Criteria:

* nothing

Primary outcomes:
measure: Discomfort in subjects affected by Dry Eye Disease (DED)
timeFrame: Baseline (enrollment visit)
measure: Pain in subjects affected by Dry Eye Disease (DED)
timeFrame: Baseline (enrollment visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Luigi Fontana, MD
role: PRINCIPAL_INVESTIGATOR
References: