louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03147144: Ultrasonographic Measurements of Uterine Junctional Zone and Association With In Vitro Fertilization Treatment Outcome
Official title: Ultrasonographic Measurements of Uterine Junctional Zone and Association With In Vitro Fertilization Treatment Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-05-10
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women attending the IVF clinic at Hillel Yaffe Medical Center

Brief summary: The aim of this study is to prospectively examine the relationship of the uterine junctional zone thickness, evaluated by ultrasonography and In Vitro Fertilization (IVF) treatment outcome. The study hypothesis is that the uterine junctional zones of women who did not achieve pregnancy will be thicker than those of the women who do achieve pregnancy

Detailed description: Ultrasounds of women who achieve pregnancy after IVF treatment will be compared to ultrasounds of women who do not achieve pregnancy. Their uterine junctional zone thickness will be compared.

The study hypothesis is that the uterine junctional zones of women who did not achieve pregnancy will be thicker than those of the women who do achieve pregnancy.

Eligibility criteria: Inclusion Criteria:

* Undergoing IVF treatment due to male factor, polycystic ovary syndrome and unexplained infertility

Exclusion Criteria:

* Low ovarian reserve
* Having undergone more than one D\&C

Primary outcomes:
measure: Thickened uterine junctional zone
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: H̱adera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Livna Shafat Heller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05103644: Study of the Therapeutic Effect of Atorvastatin on the Clinical Outcomes in HER2 Negative Breast Cancer Patients"
Official title: Study of the Therapeutic Effect of Atorvastatin on the Clinical Outcomes in HER2 Negative Breast Cancer Patients"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study group control group
Primary purpose: PREVENTION

Brief summary: Statins, a major class of drugs for treatment of hypercholesterolemia, are widely used due to a notable prevention of cardiovascular disease, and accumulating evidence proposes a promising role of statins in breast cancer

Detailed description: Statin has lipid independent effects include inhibition of inflammatory responses, immunomodulatory actions, apoptotic and antiproliferative effects, which might contribute to the suggested anti-tumoral effects of these agents. The epidemiological evidence projecting statins as anticancer agents is variable, depending on the particular type of cancer in question as well as the class of statin used

Eligibility criteria: Inclusion Criteria:

1. Confirmed breast cancer any stage confirmed by radiological and pathological or by clinical evaluation undergo surgery or receiving neo/adjuvant chemotherapy treatment
2. Age above 18 years
3. HER2 negative core biopsy
4. Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
5. Patients must be accessible for treatment and follow-up
6. Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2

Exclusion Criteria:

1. Known hypersensitivity reaction to the investigational compounds or incorporated substances
2. patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, cardiac arrhythmia)

Primary outcomes:
measure: Ki-67 molecular
timeFrame: 3 month
measure: TAZ (WWTR1) TAZ expression
timeFrame: 3 months
measure: cardiac markers
timeFrame: 3 months
Secondary outcomes:
measure: Overall survival OS
timeFrame: time frame 6 month
measure: Overall response rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef university hospital
city: Fayoum
country: Egypt
facility: Fayoum Oncology Center
Study officials:
affiliation: Beni-Suef University
name: Ahmed Hassan shaaban, MD
role: STUDY_DIRECTOR
affiliation: Beni-Suef University
name: Raghda RS Hussein, PHD
role: STUDY_DIRECTOR
affiliation: Fayoum University
name: Reham shehab El-Nemr, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01446692: Badalona Major Depressive Disorder Database Study
Official title: Therapeutic Strategies for the Management of Patients With Major Depressive Disorder (MDD) and Suboptimal Response to Antidepressant Drugs in Primary Care: the Badalona Database Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder
primary care
real-world evidence
database
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-10-05
Enrollment: 2260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: A retrospective study using a data base of anonymized medical records. The purpose of the study is to examine the different therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care

Detailed description: Therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care: the Badalona database study

Eligibility criteria: Inclusion Criteria:

* An International Classification of Primary Care (ICPC-2) or DSM-IV-TR diagnosis for major depressive disorder (MDD)
* At least 8 weeks of antidepressant treatment during the identification period of 01 January 2008 - 31 December 2009
* 18 months of enrollment with medical and pharmacy records after index episode date

Primary outcomes:
measure: Description of the antidepressant strategies switches
timeFrame: 18 months
Secondary outcomes:
measure: Health care resource utilization
timeFrame: 18 months
measure: Health care costs
timeFrame: 18 months
measure: Hamilton Depression Rating Scale
timeFrame: 18 months
measure: Medication possession rate to evaluate adherence
timeFrame: 18 months
measure: Referral to psychiatrist office
timeFrame: 18 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Research Site
Study officials:
References:
Clinical trial NCT03391544: Rotational Stability of V4C Toric Implantable Contact Lenses After On Axis Implantation Measured With OPD Scan 3
Official title: Rotational Stability of V4C Toric Implantable Contact Lenses After On Axis Implantation Measured With OPD Scan 3
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopic Astigmatism
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 75
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The recently introduced toric V4c toric ICL (STAAR Surgical Company, Monrovia, CA, USA) has been designed with a 360-µm central hole to allow aqueous humor to flow without the need for an iridotomy. As far as the investigators certain, there have been not well-established prospective studies on the role of the V4c toric ICL for myopic astigmatism correction. Therefore, the present study aimed to investigate the clinical outcomes and rotational stability and to analyze factors that influence the rotational stability in V4c toric ICL implanted eyes prospectively.


Eligibility criteria: Inclusion Criteria:

* Age 19-45 years
* Presence of myopia with a manifest refraction spherical equivalent between -5.00 and -20.00 diopters (D)
* Astigmatism between -0.75 and -5.00 D

Exclusion Criteria:

* Previous ocular or intraocular surgery (other than ICL implant)
* Anterior chamber depth from the endothelium \< 2.8 mm
* Corneal endothelial cell density \< 2000 cells/mm2
* Evidence of acute or chronic corneal infection, corneal inflammation
* Glaucoma, amblyopia, retinal detachment, diabetic retinopathy, macular degeneration, or neuro-ophthalmic disease

Primary outcomes:
measure: Visual outcome
timeFrame: 6 months after the surgery
measure: Refractive outcome
timeFrame: 6 months after the surgery
Secondary outcomes:
measure: Rotational stability
timeFrame: immediately after the surgery
measure: Rotational stability
timeFrame: 3 months after the surgery
measure: Rotational stability
timeFrame: 6 months after the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT03938844: BURCH Colposuspension or Transobturatuar Tape (TOT)
Official title: Which Anti-İncontinence Surgery Option is Better in Patients With Total Laparoscopic Hysterectomy? BURCH Colposuspension or Transobturatuar Tape (TOT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incontinence
Keywords: hysterectomy
anti-incontinence surgery
Burch
Tot
stress incontinence
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 69
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between the ages of 40-65 who ; tlh operation with benign reasons and planned, and concurrent stress describing urinary incontinence.

Brief summary: Stress urinary incontinence surgery combined with hysterectomy can often be applied to patients in the same session. The aim of this study was to determine which urinary incontinence surgery would be a better option for patients who would have hysterectomy.

The aim of this study was to retrospectively review the data of 69 patients between the ages of 2014 and 2017 who underwent total laparoscopic hysterectomy and anti-incontinence surgery (TOT and Burch) for benign indications (uterine pathology) and stress urinary incontinence (SUI). In addition to demographic data and preoperative examination findings, operative times, postoperative hemogram values, postvoiding residual amounts and complications were examined.

In addition, FSI test results of women with sexual activity were compared with ICIQ-UI and UDI-6 interrogations related to urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* tlh operation with benign reasons and planned,
* concurrent stress describing urinary incontinence,
* Women between the ages of 40-65

Exclusion Criteria:

* planned operation with malignant causes,
* urinary tract infection,
* medication area for incontinence

Primary outcomes:
measure: operation time
timeFrame: 2 years
measure: postoperative hemogram values
timeFrame: 2 years
measure: postvoiding residues
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT01299792: Sonographic Measurement of Bladder Wall Thickness in Patients With Neurogenic Bladder Dysfunction
Official title: Sonographic Measurement of Bladder Wall Thickness in Patients With Neurogenic Bladder Dysfunction Due to Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
urodynamics
ultrasound
neurogenic bladder dysfunction
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2011-02-18
Enrollment: 60
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: individuals with neurogenic bladder dysfunction due to spinal cord injury

Brief summary: Video-urodynamic investigations are regarded as the current standard diagnostics for neurogenic bladder dysfunction in patients with spinal cord injury. This examination is exact, but time consuming, costly and associated with the risk of urinary tract infection.

In patients with lower urinary tract symptoms due to benign prostate hyperplasia, sonographic measurement of bladder wall thickness has been demonstrated to be able to replace urodynamic testing for the diagnosis of infravesical obstruction.

Hypothesis: measurement of bladder wall thickness in patients with neurogenic bladder dysfunction due to spinal cord injury is closely related to the known risk factors for upper urinary tract deterioration (bladder compliance, detrusor leak point pressure) in this group of patients and can therefore replace urodynamic examination in selected cases.


Eligibility criteria: Inclusion Criteria:

* neurogenic bladder dysfunction due to spinal cord injury
* ability to understand German language
* willingness and capability to undergo urodynamic testing
* age \> or = 18 years

Exclusion Criteria:

* acute urinary infection at the time of examination
* known bladder tumor or bladder stone
* age \< 18 years
* not capable to understand aim and purpose of the examination

Primary outcomes:
measure: correlation bladder wall thickness and detrusor compliance
timeFrame: calculated from maximum bladder filling
Secondary outcomes:
measure: correlation bladder wall thickness and maximum detrusor pressure
timeFrame: measurement at maximum bladder capacity
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss paraplecic centre
Study officials:
affiliation: Swiss Paraplegic Centre
name: Juergen Pannek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00723892: Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)
Official title: Observatory on Treatment Adhesion in Patients Suffering From Hepatitis C Chronic Treated With ViraferonPeg® Injected / Rebetol® in Conjunction With a Psychotherapeutic Assistance Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Hepacivirus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants at sites in France who are receiving a psychotherapy support program during therapy for hepatitis C and a control group without a psychotherapy support program.

Brief summary: Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.

Detailed description: Enrollment of participants will occur in a sequential order of treatment initiation.

Eligibility criteria: Inclusion Criteria:

* Adult patients with hepatitis C

Exclusion Criteria:

* According to the products' labeling

Primary outcomes:
measure: Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.
timeFrame: 12 months after onset of treatment
Secondary outcomes:
measure: the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol
timeFrame: 12 months after onset of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05839392: Novel Approaches to Target MECOM/EVI1 in AML
Official title: Novel Approaches to Target MECOM/EVI1 in Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: AML, Adult
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is an academic, no-profit, multicenter, biological, non-pharmacologic study aimed at characterizing genome, transcriptome and proteome of patients affected by AML with MECOM or atypical 3q26 rearrangements.

Detailed description: This is an academic, no-profit, multicenter, biological, non-pharmacologic study aimed at characterizing genome, transcriptome and proteome of patients affected by AML with MECOM or atypical 3q26 rearrangements. To this end, BM samples and formalin fixed/paraffin-embedded BM biopsies will be collected at enrolment, before and after treatment, at relapse.

Eligibility criteria: Inclusion Criteria:

* AML with MECOM or atypical 3q26 rearrangements.
* Age ≥18.
* Signed written informed consent according to ICH/EU/GCP and national local laws.

Exclusion Criteria:

* None

Primary outcomes:
measure: Identification of MECOM/EVI1 regulators or downstream effectors potentially druggable
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Piacenza
country: Italy
facility: Ematologia
Study officials:
affiliation: Department of Medicine and Surgery, University of Parma, Parma
name: Giovanni Roti
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01692392: Health-related Quality of Life in Patients Undergoing Surgery for Pectus Carinatum
Official title: Short and Long-term Effects of Surgical Repair of Pectus Carinatum - A Questionnaire Study of Health-related Quality of Life, Persisten Post-surgical Pain and Sensory Disturbances.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pectus Carinatum
Quality of Life
Pain, Postoperative
Somatosensory Disorders
Keywords: Pectus carinatum
Quality of life
Pain, postoperative
Somatosensory disorders
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients referred to the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby for the purpose of surgery for pectus carinatum from May 1, 2012 to May 1, 2013 are invited to participated in the study

Brief summary: The purpose of the study is to assess changes in health-related quality of life in patients undergoing surgical correction of pectus carinatum. In addition, the study assessed long-term effects of surgical intervention in relation to the development of persistent postoperative pain and / or sensory disturbances in the surgical field.


Eligibility criteria: Inclusion Criteria:

* all patients undergoing surgery for pectus carinatum

Exclusion Criteria:

* patients without pectus carinatum

Primary outcomes:
measure: Change from Baseline in health-related quality of life at 6 months
timeFrame: From baseline (the day before surgery) to six month follow-up (six months after surgery)
Secondary outcomes:
measure: Persistent post-surgical pain
timeFrame: Six month following surgery
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vacular Surgery
Study officials:
References:
Clinical trial NCT06560892: Comparison of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine
Official title: Comparison Between Mean Duration of Post-operative Analgesia of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine Following Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: LAPAROSCOPIC CHOLECYSTECTOMY
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
Collaborators: name: Bahawal Victoria Hospital
First posted: 2024-08-19
Enrollment: 68
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: OTHER

Brief summary: For patients with symptomatic cholelithiasis, laparoscopic cholecystectomy (LC) is a customary procedure for treatment these days. After LC, patients may experience considerable pain. This study was performed with the objective of comparing the mean duration of analgesia of intraperitoneal bupivacaine with dexmedetomidine to intraperitoneal bupivacaine alone in patients undergoing laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* Patients of either gender
* Aged between 20 and 70 years
* ASA (American Society of Anesthesiologists Classification) physical status I and II
* Undergoing Laparoscopic Cholecystectomy under general anesthesia

Exclusion Criteria:

* Patients sensitive to local anesthetics
* Patients with acute cholecystitis, choledocholithiasis, or ascending cholangitis (temperature≥38.6°C, serum bilirubin≥1.2mg/dl, and ultrasound showing common bile duct diameter of ≥1cm).
* Patients with uncontrolled diabetes (FBS≥110 mg/dl)
* Uncontrolled blood pressure (SBP≥140 mmHg)
* Ischemic heart disease (EF≤40%)
* Pulmonary dysfunction (FEV≤70 percent of normal)

Primary outcomes:
measure: Duration of analgesia
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bahawalpur
country: Pakistan
facility: Quaid-e-Azam Medical College
state: Punjab
Study officials:
affiliation: Bahawal Victoria Hospital
name: Qazi Anees, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahida Islam Teaching Hospital
name: Syed Shakeel Ahmed, FCPS
role: PRINCIPAL_INVESTIGATOR
References: