louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04806230: Serum Concentrations of Antidepressant Drugs in Pregnant Women - a Naturalistic Study
Official title: Serum Concentrations of Antidepressant Drugs in Pregnant Women - a Naturalistic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharmacokinetics
Antidepressive Agents
Pregnancy
Keywords: Pharmacokinetics
antidepressants
pregnancy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2021-03-19
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: At inclusion, median age (min-max) was 31 years (21-42) and median BMI was 25.6 (18.9-47.0)

Brief summary: The study was a prospective naturalistic PK study of five frequently used antidepressant drugs in pregnant women; citalopram (CIT), escitalopram (ECIT), sertraline (SERT), mirtazapine (MIRT) and venlafaxine VEN) and their major metabolites (Table 1). After signing informed consent pregnant women with ongoing antidepressant treatment, regardless of indication, were recruited at nine antenatal care centers in mid- and small cities and villages in the Southeast Sweden between April 2011 and September 2013.

Detailed description: Serum samples for the antidepressant drug and metabolite(s) concentrations, albumin and creatinine were collected at the first prenatal appointment and at gestational week 15, 20, 25, 35 and at partus. The time interval between drug intake and sampling was registered in all cases. At partus, a serum samples from the umbilical cord was collected drug concentration was assessed. At the first prenatal appointment a blood sample for analyzing the CYP2D6 and CYP2C19 genotype was also collected. All drug concentration analysis were executed post hoc, after last partus, whereas physiological parameters were part of normal routine sampling. Concomitant medication, weight changes and smoking habits were registered throughout the pregnancies.

Our main findings were that dose corrected serum concentrations of neither sertralin nor citalopram changed during the pregnancy. In addition, concentrations of escitalopram and venlafaxine and their metabolites appeared to be stable throughout pregnancy, even though a linear mixed models statistic calculation could not be done due small number of samples.

Results from previous research on sertraline PK during pregnancy are inconclusive. Two studies suggested decreased levels (Freeman, Sit 2), while one study indicated increased levels (Westin). Previous studies, except for Westin's are, however, limited by small sample sizes (six and eight) and a substantial inter-individual variance.

Eligibility criteria: Inclusion Criteria:

* Pregnancy
* Ongoing treatment with one of the five studied antidepressants.

Exclusion Criteria:

• None

Primary outcomes:
measure: Serum concentrations of drugs and metabolites
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
Study officials:
References:
Clinical trial NCT05967130: Treatment Chronic UTI Post Kidney Transplant
Official title: Treatment of Chronic Relapsing Urinary Tract Infection With Bacteriophages in Renal Transplant Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Urinary Tract Infections
Transplant-Related Disorder
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Urinary tract infections (UTIs) with extended-spectrum -lactamase (ESBL)-positive Enterobacteriums (ESBL-E) are a common infectious complication of renal transplant recipients, with 10% of patients suffering from UTIs with ESBL-E within the first year posttransplant. Moreover, recurrence rates of UTI caused by ESBL-E are almost three times higher than those by cephalosporin-susceptible Enterobacteriums demonstrating the decreased efficacy of antibiotics in the treatment of these UTIs.

Detailed description: According to each patient's urine culture, resistant urinary tract infections will be treated with specific phages and patients will be followed up with their urine cultures for response to therapy.

Eligibility criteria: Inclusion Criteria:

* Stable Kidney Transplant Recipients
* Stable Immunosupression Dose
* Stable Renal Function
* Resistant Urinary Infection with Positive UC

Exclusion Criteria:

* Rejection periods
* Frail Patients

Primary outcomes:
measure: Urine culture
timeFrame: 1 week after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Nooshin Dalili
Study officials:
affiliation: SBMU
name: Dalili
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00117130: Study to Evaluate Effectiveness of Aranesp®
Official title: Aranesp® Monthly Preference Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Disease
Keywords: Kidney disease, Renal, CKD (Chronic Kidney Disease)
CRI (Chronic Renal Insufficiency), Pre-dialysis, Amgen
Aranesp®, Darbepoetin alfa, QW dosing
Q2W dosing, Q4W dosing
Patient preference, Subject preference
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate subject preference for Aranesp® administered once monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).


Eligibility criteria: Inclusion Criteria: - Subjects must have signed written informed consent - Be on Procrit® QW or Q2W for a minimum of 12 weeks - Must currently be on a stable dose of Procrit® (defined as less than 25% change in Procrit® dose over the 4 week period immediately prior to enrollment, with no missed doses) - Have Hgb 10-12 g/dL for at least 4 weeks prior to study start - Have 15 less than GFR less than 89 mL/min/1.73 m2 - Have serum vitamin B12 and folate levels above the lower limits of normal - Transferrin saturation greater than 20% Exclusion Criteria: - Currently receiving investigational erythropoietic agents - Expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - Have less than 1 year life expectancy

Primary outcomes:
measure: Subject preference
Secondary outcomes:
measure: Subject productivity and subject selection of Aranesp® or Procrit® therapy in the parallel arm portion and at study conclusion.
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04240730: Transvaginal Natural Orifice Endoscopic Surgery for Extremely Obese Patients With Early-stage Endometrial Cancer
Official title: Transvaginal Natural Orifice Endoscopic Surgery (v-NOTES) for Extremely Obese Patients With Early-stage Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Extreme Obesity
Keywords: Early stage endometrial cancer
extreme obesity
transvaginal NOTES
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-01-27
Enrollment: 6
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Extreme obese patients with early stage type-1 endometrial cancer

Brief summary: The aim of this study is to investigate the feasibility and efficacy of the v-NOTES approach for extremely obese patients with early-stage type 1 endometrial cancer.


Eligibility criteria: Inclusion Criteria:

* Extreme obese patients
* Early stage type-1 endometrial cancer proved by endometrial sampling

Exclusion Criteria:

* any contraindication for pneumoperitoneum
* any contraindication for the dorsal lithotomy position
* any contraindication for general anesthesia,
* any contraindication for v-NOTES
* suspicion of pelvic adhesions
* presence or suspicion of obliteration of the pouch of Douglas

Primary outcomes:
measure: Operating time
timeFrame: 4 hours
measure: Any conversion to conventional laparoscopy or laparotomy
timeFrame: 4 hours
measure: Pre- and post-operative hemoglobin levels
timeFrame: 24 hours
measure: Length of hospital stay
timeFrame: 2 day
measure: Any intra- or post-operative complication
timeFrame: 6 months
measure: pain scores
timeFrame: 6 hours
measure: pain scores
timeFrame: 12 hours
measure: pain scores
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences Kartal Dr. Lütfi Kirdar Training and Research Hospital
state: Kartal
Study officials:
affiliation: Kartal Dr.Lutfi Kirdar Research and Training Hospital
name: Ahmet Kale, Prof.Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05843630: Radiomic Modeling in Differentiating Uncomplicated From Complicated Acute Appendicitis
Official title: Development and Validation of an Individualized Nomogram to Differentiate Uncomplicated From Complicated Acute Appendicitis in Adults: a Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Appendicitis
Keywords: acute appendicitis
diagnosis
nomogram
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults with pathologically diagnosed as acute appendicitis after appendectomy

Brief summary: Non-operative management (NOM) with antibiotics may be a safe alternative to surgery for uncomplicated appendicitis, but preoperative differentiation between uncomplicated and complicated appendicitis is challenging. The study aimed to develop a clinical-radiomics nomogram to distinguish uncomplicated from complicated appendicitis.


Eligibility criteria: Inclusion Criteria:

* Pathologically diagnosed as acute appendicitis after appendectomy between January 2021 and December 2022.

Exclusion Criteria:

* age less than 18 years (no upper age limit);
* without CT examination within a week before surgery;
* difficult to outline the contours of the appendix due to inflammatory exudate;
* lack of clinical information.

Primary outcomes:
measure: Accuracy of clinical-radiomic model for differentiating complicated from uncomplicated appendicitis
timeFrame: January 2021 to December 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital First Medical Center
Study officials:
affiliation: Senior Department of General Surgery, Chinese PLA General Hospital
name: Kecheng Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03273530: Integrated Supported Employment in Mainland China
Official title: Integrated Supported Employment for People With Schizophrenia in Mainland China: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized controlled trial, the researchers investigated the effectiveness of integrated supported employment (ISE) as compared with individual placement and support (IPS) and traditional vocational rehabilitation (TVR) for people with schizophrenia in mainland China.

Detailed description: One hundred and sixty-two participants with schizophrenia were randomly assigned to ISE (n = 54), IPS (n = 54), and or TVR (n = 54). Blinded assessments of employment status, job tenure, and psychological outcomes were conducted at admission, completion of the 3-mo program, and follow-up at 7, 11, and 15 mo.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older;
* Diagnosis of schizophrenia for at least 2 years
* Being unemployed
* Willing to give informed consent
* Having no obvious cognitive, learning, or neurological impairment
* Having completed primary school education
* Having a desire to work

Exclusion Criteria:

• Having score lower than 18 on the 30-item Mini-Mental State Examination

Primary outcomes:
measure: Employment rate
timeFrame: 4 months
Secondary outcomes:
measure: Job tenure, duration
timeFrame: completion of the 3-mo program, and follow-up at 7, 11, and 15 mo.
Other outcomes:
Locations:
Study officials:
affiliation: HKPolyU
name: Hector WH Tsang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang GF, Tsui CM, Lu AJB, Yu LB, Tsang HWH, Li D. Integrated Supported Employment for People With Schizophrenia in Mainland China: A Randomized Controlled Trial. Am J Occup Ther. 2017 Nov/Dec;71(6):7106165020p1-7106165020p8. doi: 10.5014/ajot.2017.024802.
Clinical trial NCT04716530: The Changing Panorama in Risk Factors of Cerebral Palsy
Official title: The Changing Panorama in Risk Factors of Cerebral Palsy: A Single National Tertiary Center Experience
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Keywords: cerebral palsy
etiology
risk factors
low birth weight
prematurity
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 296
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in our cerebral palsy database

Brief summary: The study will be carried of scanning the database of 296 individuals with cerebral palsy followed in the university pediatric rehabilitation clinic. Cerebral palsy risk factors and demographic information will be obtained from the database. The data will be classified according to date of birth, divided into 3 groups: those born before 2000, those born between 2000-2010, and those born after 2010.Changes in cerebral palsy risk factors will be investigated at 10-year intervals.

Detailed description: The study will be carried of scanning the database of 296 individuals with cerebral palsy followed in the university pediatric rehabilitation clinic. Cerebral palsy risk factors and demographic information will be obtained from the database.

Cerebral palsy subtypes classified according to The Surveillance for Cerebral Palsy in Europe (SCPE) classification into four groups: spastic (unilateral and bilateral), dyskinetic (dystonic and choreoathetoic), ataxic/hypotonic, non-classifiable. Cerebral palsy risk factors will be primarily divided into 4 as preconceptional, antenatal, intrapartum and neonatal risk factors. Then, risk factors in the data will be distributed to the appropriate risk factor group.

The data will be classified according to date of birth, divided into 3 groups: those born before 2000, those born between 2000-2010, and those born after 2010. Changes in cerebral palsy risk factors will be investigated at 10-year intervals.

Eligibility criteria: Inclusion Criteria:

* cerebral palsy patients

Exclusion Criteria:

* missing data on the cerebral palsy database

Primary outcomes:
measure: Define the risk factors of cerebral palsy
timeFrame: 1 month
measure: Define the change in the risk factors among age groups
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department
Study officials:
References:
Clinical trial NCT01969630: Paclitaxel-eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-eluting Stent for the Treatment of Femoropopliteal de Novo Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peripheral Artery Disease
Keywords: femoropopliteal lesions
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2013-10-25
Enrollment: 250
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: To determine in patients with symptomatic femoropopliteal lesions whether percutaneous revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol stent is superior with respect to the 12-month incidence of restenosis compared to treatment with systematic paclitaxel-eluting stent (PES) angioplasty


Eligibility criteria: Inclusion Criteria:

* intermittent claudication or critical limb ischemia
* de novo stenosis ≥ 50% or occlusion of at least 40 mm in length located in femoropopliteal arteries
* presence of a clear healthy segment between the lesion in superficial femoral and common femoral artery and between popliteal and tibioperoneal trunk
* presence of at least 1 patent tibial vessel with distal run-off (below-the-knee artery was considered patent if free from obstructive lesions determining angiographic stenosis \>70%)

Exclusion Criteria:

* life expectancy \<1 year
* contraindication for combined antiplatelet therapy or known allergy to nickel or paclitaxel
* need for major amputation (MA) at the time of enrolment
* Failure to recanalize intended below-the-knee arteries in CLI patients at risk of major amputation

Primary outcomes:
measure: angiographic binary restenosis
timeFrame: 12 months
Secondary outcomes:
measure: Composite of all cause mortality, major amputation and target lesion revascularization.
timeFrame: 12 months
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Cardiovascular Department, Ospedale S.Donato
state: AR
Study officials:
References:
citation: Liistro F, Angioli P, Porto I, Ducci K, Falsini G, Ventoruzzo G, Ricci L, Scatena A, Grotti S, Bolognese L. Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: The DRASTICO Study. J Am Coll Cardiol. 2019 Jul 16;74(2):205-215. doi: 10.1016/j.jacc.2019.04.057.
Clinical trial NCT04452630: Cardiovascular Consequences After COVID-19
Official title: The CardioPostCovid Study: Cardiovascular Consequences After COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Consequences After an Episode of COVID 19
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 200
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: Patients can be enrolled in this study if they survived to an episode of Covid-19, whether they were hospitalized or not. They must have been diagnosed Covid19 positive according to international recommendations between January 24, 2020 (date of the first case declared in mainland France) and June 30, 2020. They will be offered to participate to the study during the systematic consultations set up at the Nord Hospital for follow-up patients who have been infected.

Brief summary: The occurrence of cardiovascular complications in SARS-CoV-2 infections appears to be more frequent than in other viral respiratory infections, probably due to a singular pathophysiology of this coronavirus.

The lack of characterization of cardiovascular damages linked to Covid-19 could have medium and long-term consequences on the prognosis of patients. This problematic could lead to a second major public health problem linked to Covid-19 and it is therefore crucial to keep monitoring and screening patients at risk.

In this context of emerging infectious diseases, of poorly characterized cardiovascular damages during infection and of absence of data on the long-term evolution of the infection, the investigators propose to carry out a prospective and observational cohort study focused on the evaluation and the systematic cardiovascular follow up of patients who survived an episode of Covid-19, regardless of their cardiovascular profiles.


Eligibility criteria: Inclusion Criteria:

• All adults affiliated to social security attending the post-Covid follow-up consultation, having presented an episode of Covid-19 diagnosed by at least one positive nasopharyngeal RT-PCR test for SARS-Cov-2 and considered recovered.

Exclusion Criteria:

* Age \<18 years old
* Major under guardianship or curatorship
* Absence of non-opposition

Primary outcomes:
measure: Presence of at least one clinical, biological and/or imaging cardiovascular anomaly within 1 month of recovering
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
References: