louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05672160: Overal Survival After TAVI According to Sarcopenia
Official title: CT Evaluated Sarcopenia Independently Predicts the Overal Survival After Transcatheter Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Aortic Valve Stenosis
Keywords: sarcopenia
survival
TAVI
Lead sponsor: Nemocnice AGEL Trinec-Podlesi a.s.
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 930
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients indicated for TAVI procedure because of the critical aortic valve stenosis.

Brief summary: The goal of this observational study is to compare the overal survival after transcatheter aortic valve implantation (TAVI) according to sarcopenia status evaluated from preprocedural CT scans.

The main question it aims to answer is:

• Is CT evaluated sarcopenia an independent predictor of overal survival after TAVI?

Detailed description: The patients suffering from aortic valve stenosis, that are not eligible for cardiosurgery were indicated to miniinvasive transcatheter aortic valve implantation (TAVI). The follow up of 930 patients were done in time interval from 1 to 11 years. In every patient the preprocedural CT scans were done. From these CT scans the L3 cross sections will be used for sarcopenia evaluation. Then we will statisticaly evaluate the overal survival after TAVI procedure in the relation with sarcopenia status. We will answer the main question: Is CT evaluated sarcopenia an independent predictor of overal survival after TAVI?

Eligibility criteria: Inclusion Criteria:

* patients udergone TAVI procedure

Exclusion Criteria:

* patients with incomplete TAVI procedure, patients without clinical follow up

Primary outcomes:
measure: Overal survival
timeFrame: 11 years
Secondary outcomes:
Other outcomes:
Locations:
city: Třinec
country: Czechia
facility: AGELTrinecPodlesi
state: Česká Republika
Study officials:
References:
Clinical trial NCT06371560: Antibiotics, Antibiotic Resistance, and Prescribing Practices Among Periodontists: Cross Sectional KAP Study
Official title: Antibiotics, Antibiotic Resistance, and Prescribing Practices Among Periodontists: Cross Sectional Knowledge, Attitude and Practice (KAP) Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Antibiotic Resistance
Antibiotic Use
Periodontitis
Keywords: KAP study
antibiotics use
antibiotic resistance
Prescribing practice
periodontal therapy
Periodontists
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 400
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study population is representable sample of the periodontists who practice in Egypt and have postgraduate degree in Periodontology.

Brief summary: Antibiotic resistance is a global health threats that require attention from all healthcare providers. In Periodontology, antibiotic is prescribed in many clinical situations. The aim of this study is to assess the followings among Periodontists (1) The knowledge, attitude, and practices (KAP) towards antibiotics and antibiotic resistance; (2) The prescribing practices of antibiotics in periodontal therapy; (3) The correlation between personal perception of antibiotics uses and the professional prescription patterns; and (4) The differences in antibiotics prescription in relation to the years of experience and the academic background.

Detailed description: The study is designed as a cross-sectional online-based questionnaire, and it will be distributed among periodontitis. The study will be conducted in Egypt as a nationwide survey study. Google Form was used to develop online-based questionnaires.

Eligibility criteria: Inclusion Criteria:

* Periodontists who practice in Egypt.
* Must hold at least a master's degree in Periodontology
* Willing to provide informed consent to participate in the study and agree to use the data for publication purposes.

Exclusion Criteria:

* Periodontists who don not practice in Egypt.
* Periodontists who don not hold postgraduate degree

Primary outcomes:
measure: KAP
timeFrame: 6 Months
Secondary outcomes:
measure: The prescribing practices of antibiotics in periodontal therapy
timeFrame: 6 months
measure: The correlation between personal perception of antibiotics uses and the professional prescription patterns
timeFrame: 6 months
measure: The differences in antibiotics prescription in relation to the years of experience and the academic background.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04885660: Bioequivalence Evaluation of Two Fixed-dose Combination of Lisinopril 10mg/Levamlodipine Besylate 5mg in Healthy Chinese Subjects
Official title: Bioequivalence Study of Compound Lisinopril Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Therapeutic Equivalency
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The bioavailability of compound lisinopril tablets (specification: lisinopril 10mg / amlodipine 5mg) developed by Sichuan shangrui biomedical Co., Ltd. was compared with that of reference compound lisinopril tablets (specification: lisinopril 10mg / amlodipine 5mg) produced by Hungary Gedeon Richter Pharmaceutical Co., Ltd.The bioequivalence of single dose of test preparation and reference preparation was evaluated in heathy subjects under fasting and fed conditions.


Eligibility criteria: Inclusion Criteria:

- 1.Healthy male and female aged over 18years 2.Subjects willing to provide written informed consent and to adhere to protocol requirements 3.Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)), males with minimum of 50 kg weight, females with minimum of 45kg weight.

4.Subjects have not clinically significant abnormalities, including vital signs, physical examinations, laboratory tests, and ECG as determined by clinical examination

Exclusion Criteria:

* 1.History or presence of significant cardiovascular, Urogenital, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder 2.Allergic constitution(Allergic to two or more substances) or hypersensitivity to investigational product 3.History or presence of significant gastrointestinal inflammation /ulcer. or other medical history affecting drug absorption 4.Use of any drugs or herbal medicine within 14 days prior to the first dose 5.Can not follow approved birth control methods (a double barrier method) from the screening（Female subjects from two weeks prior to the screening） till 3 months after the last dose

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
References:
citation: Li T, Liu YP, Liu SQ, Shi P, Jiang X, Tao Y, Gao XM, Ma YP, Cao Y. Bioequivalence evaluation and food effect assessment of Lisinopril/amlodipine tablets in healthy Chinese subjects under fasting and fed conditions. BMC Pharmacol Toxicol. 2022 Jul 7;23(1):45. doi: 10.1186/s40360-022-00590-6.
Clinical trial NCT04750460: Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).
Official title: The Effect of Teriparatide on the Early Postoperative Hypocalcemia After Parathyroidectomy in Dialysis Patients: a Pilot, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Hyperparathyroidism
Chronic Kidney Disease-Mineral and Bone Disorder
Dialysis
Hypocalcemia
Hypoparathyroidism
Keywords: Parathyroidectomy
Teriparatide
Parathyroid hormone
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 20
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: This is a pilot randomized controlled trial aimed to evaluate the effect of teriparatide on the clinical course of hypocalcemia after parathyroidectomy for secondary hyperparathyroidism in dialysis-dependent patients.

Detailed description: Postoperative hypocalcemia is a common complication after parathyroidectomy (PTx) for secondary hyperparathyroidism in dialysis-dependent patients. It is known to be associated with significant drop of parathyroid hormone (iPTH) level after surgery. Thus, in the present study we test the hypothesis that reducing iPTH difference before/after PTx with teriparatide injections immediately after surgery may alleviate clinical course of post-PTx hypocalcemia.

This is a feasible study aimed to determine the sample size for further large-scale trial.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years;
2. Patients with end-stage renal disease (ESRD) receiving hemodialysis or peritoneal dialysis treatment \> 3 months prior surgery;
3. Severe secondary hyperparathyroidism defined as iPTH level \> 800 pg/ml, followed with hypercalcemia and/or hyperphosphatemia; with presence of one or more nodular or diffuse parathyroid hyperplasia confirmed with CT;
4. Performed total parathyroidectomy with autotransplantation of the parathyroid tissue.

Exclusion Criteria:

1. Emergency surgery;
2. Primary hyperparathyroidism as a cause of ESRD;
3. Scheduled (before surgery) blood transfusion;
4. Re-operative surgery;
5. Known allergy to the study drug.
6. Malignant neoplasms of bone tissue (primary or metastatic).

Primary outcomes:
measure: Total serum calcium level
timeFrame: Day 1,2,3,4,5
Secondary outcomes:
measure: Parathyroid hormone level
timeFrame: Day 1, 2, 3, 4, 5
measure: Serum phosphorus level
timeFrame: Day 1, 2, 3, 4, 5
measure: Serum total alkaline phosphatase level
timeFrame: Day 1, 2, 3, 4, 5
measure: Total serum calcium level
timeFrame: Day 2, 3, 4, 5
measure: Ionized serum calcium level
timeFrame: Day 1, 2, 3, 4, 5
measure: Serious adverse events (major cardiovascular events, fractures, arrhythmia episodes, death)
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State University Hospital
Study officials:
References:
Clinical trial NCT03307460: uPAR-PET/MRI in Patients With Prostate Cancer for Evaluation of Tumor Aggressiveness
Official title: Phase II Trial: uPAR-PET/MR in Patients With Newly Diagnosed Prostate Cancer; Non-invasive Characterization of Tumor Aggressiveness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prospective study to evaluate the value of uPAR-targeted PET/MR scan using the tracer 68Ga-NOTA-AE105 in patients with newly diagnosed prostate cancer

Detailed description: Prostate cancer is one of the most frequent types of cancer in men. The characteristics of the disease varies significantly among patients where some have an indolent type of cancer, from which they will never experience symptoms while others have highly aggressive malignant disease that requires prompt therapeutic action.

Treatment of localized prostate cancer is based on a risk stratification, where patients are either offered therapy with curative intent - surgery or radiotherapy - or in case of low-risk disease an "active surveillance" strategy can be advised. In active surveillance the disease is monitored by PSA measurement, repeated biopsies and digital rectal examination. Some patients progress during active surveillance to a higher risk classification, which may lead to selection of active therapy.

The aim of this study is to investigate positron emission tomography (PET) with the radiolabelled tracer 68Ga-NOTA-AE105, combined with magnetic resonance imaging (MRI) in patients with newly diagnosed prostate cancer. 68Ga-NOTA-AE105 targets the receptor urokinase-type plasminogen activator receptor (uPAR), which is a known marker for aggressive disease in prostate cancer.

Eligibility criteria: Inclusion Criteria:

* Histologically verified prostate cancer
* Capable of understanding written information and giving informed consent
* Planned to enter active surveillance strategy or undergo therapy with curative intent (surgery or radiotherapy)

Exclusion Criteria:

* Obesity (Body weight over 140 kg)
* Known allergy to 68-Ga-NOTA-AE105
* Metallic components in the body that contradicts MRI scan
* Severe claustrophobia making the person unable to complete an MRI scan

Primary outcomes:
measure: Correlation with Gleason Score
timeFrame: 3 months after PET/MRI
Secondary outcomes:
measure: Prognostic value
timeFrame: 3 years from PET/MRI
measure: Diagnostic accuracy in staging lymph nodes
timeFrame: 3 months from PET/MRI
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
name: Marie Ø Fosboel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00270660: A Study of the Clinicopathologic Behaviour of the Different Types of Unsafe Chronic Otitis Media
Official title: A Cross Sectional Study of Clinicopathologic Behaviour of Primary, Secondary and Mixed Types of Atticoantral Chronic Otitis Media
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Otitis Media
Cholesteatoma
Keywords: retraction pockets ear
unsafe otitis media
otitis media complications
Lead sponsor: Karnataka Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2005-12-28
Enrollment: 192
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: The purpose of the study is to study the clinicopathologic behaviour of the 3 dangerous types of chronic otitis media that are prone for complications. In which type are the complications more common? Which type gives rise to more hearing loss? How does the disease process in the 3 types evolve? should the 3 types of otitis media be managed differently?

Detailed description: Design: prospective cross sectional study setting: tertiary referral medical college hospital No of groups: 3 group 1: primary acquired atticoantral disease group 2: secondary acquired atticoantral disease group 3: mixed atticoantral disease

Interventions:

1. Diagnostic nasal endoscopy
2. Eustachian tube function tests
3. Pure tone audiometry
4. biopsy of middle ear mucosa
5. culture and sensitivity of ear discharge

Eligibility criteria: Inclusion Criteria:1. Atticoantral chronic otitis media 2. complicated unsafe otitis media 3. Otitis media with cholesteatoma, polyp, granulation tissue 4. Ear with retraction pockets leading to attic -

Exclusion Criteria:

1. tubotympanic otitis media alone
2. otitis media with effusion
3. Acute otitis media -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: "hubli"
country: India
facility: Department of ENT, KIMS
state: Karnataka
Study officials:
affiliation: Karnataka Institute of Medical Sciences, Hubli, India
name: Vikram K Bhat, MS, DNB.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vijayanagar Institute of Medical Sciences, Bellary, India
name: Khaja Naseeruddin, MS, DLO.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03330860: Effectiveness of 12 Clips in Maternal and Neoanatal Health Through Applied Neuroscience Tools (Neuromarketing Strategy)
Official title: Effectiveness of 12 Clips in Maternal and Neoanatal Health Through Applied Neuroscience Tools (Neuromarketing Strategy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover randomized clinical trial
Primary purpose: OTHER

Brief summary: Objective: To evaluate the effectiveness of 12 knowledge transfer clips of maternal and neonatal health in order to generate knowledge appropriation. Methodology: Randomized cross-over clinical trial with a non-probabilistic sample of intentional feature of 150 subjects: pregnant women, non-pregnant women and men. Participants will be evaluated during the observation of 13 clips (one of them is the control clip) in which sequence will be assigned randomly. The level of attention will be assessed by means of eye tracking, to see the ocular gaze and fixation in relation to the content of clips, and emotional reaction through the psychophysiological record (galvanic skin response). In addition, recall of information will be assessed through the application of questionnaires at the end of each video. The analysis will focus on identifying differences in the three outcomes between intervention clips and the control clip, and between the three groups, and determine the clips and segments that generate greater emotional response, attention and recall.


Eligibility criteria: Inclusion Criteria:

* Pregnant women, Men, and Non-pregnant women that accept to participate in the study

Exclusion Criteria:

* Participant that don't sign informed consent or have clinically significant visual or auditory impairment

Primary outcomes:
measure: Emotional impact (electrodermal activity)
timeFrame: 1 day
Secondary outcomes:
measure: Recall (Questionnarie)
timeFrame: 1 day
measure: Attention (Eye tracking)
timeFrame: 1 day
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Universidad Nacional de Colombia
Study officials:
References:
Clinical trial NCT00971360: Cytokine Levels in Conversion Disorder
Official title: Proinflammatory Cytokine Levels in Patients With Conversion Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conversion Disorder
Keywords: conversion
cytokine
inflammation
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2009-09-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The aim of this study is whether the proinflammatory cytokine levels in patients with conversion disorder is increased or not changed in the acute phase and subacute - chronic periode, compared with controls.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease

Exclusion Criteria:

* Autoimmune disease
* Neurological disease
* Any organic disorder that could possibly affect proinflammatory cytokines
* Pregnancy
* Any drug usage within 2 weeks
* Any active or passive immunization within 6 months
* Any other DSM-IV axis I psychiatric disorder
* Mental retardation
* Developmental disorder of childhood

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University Faculty of Medicine; Department of Psychiatry
Study officials:
References:
citation: Rief W, Pilger F, Ihle D, Bosmans E, Egyed B, Maes M. Immunological differences between patients with major depression and somatization syndrome. Psychiatry Res. 2001 Dec 31;105(3):165-74. doi: 10.1016/s0165-1781(01)00338-9.
citation: Ziemssen T, Kern S. Psychoneuroimmunology--cross-talk between the immune and nervous systems. J Neurol. 2007 May;254 Suppl 2:II8-11. doi: 10.1007/s00415-007-2003-8.
citation: Dantzer R. Somatization: a psychoneuroimmune perspective. Psychoneuroendocrinology. 2005 Nov;30(10):947-52. doi: 10.1016/j.psyneuen.2005.03.011.
Clinical trial NCT05109676: Monitoring of Progesterone Administered in Infertile Patients During a Cycle of Frozen Embryo Transfer.
Official title: Monitoring of Progesterone Administered in Infertile Patients During a Cycle of Frozen Embryo Transfer: a Population Pharmacokinetic Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IVF
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 200
Sex: FEMALE
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: During an In Vitro Fertilization (IVF) attempt, several embryos are obtained but not all of them can be transferred to the uterus in the same cycle due to the risk of multiple pregnancies. Thus, it is very common for these couples to benefit from cryopreservation. Patients scheduled for frozen embryo transfer (TEC) receive estrogen and progesterone replacement therapy to prepare the endometrium for implantation. Data from the literature recently showed that low progesterone on the day of embryo transfer was responsible for a significantly higher rate of implantation failure and miscarriage.


Eligibility criteria: Inclusion Criteria:

* Adult patient undergoing a frozen embryo transfer in an artificial cycle at the AMP center of the Toulouse University Hospital.
* Affiliation to a social security scheme or equivalent
* Patient fulfilling the conditions for access to the AMP according to French bioethics law
* Patient having given her consent (oral or written) after clear and fair information

Exclusion Criteria:

* Patient who received intramuscular administration of progesterone during the endometrial preparation phase.
* Patient with comprehension difficulties.
* Protected adult patient (safeguard of justice, guardianship or curatorship)

Primary outcomes:
measure: Average plasma progesterone concentration.
timeFrame: Day of embryo transfer.
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Nicolas Gatimel, MD
role: PRINCIPAL_INVESTIGATOR
References: