louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04467970: Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy.
Official title: Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Knee Arthroplasty
Keywords: Unicompartmental knee Replacement
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 88
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Valgus high tibial osteotomy (HTO) and unicompartmental knee arthroplasty (UKA) are established treatment options for patients with medial compartmental osteoarthritis (OA) of the knee.However, the clinical outcomes of these treatment modalities for unicompartmental OA have become subjects of debate.

Detailed description: Although HTO for the correction of malalignment in the medial osteoarthritic knee has been shown to provide successful outcomes in some studies, it is technically difficult to achieve the ideal valgus position postoperatively, and the likelihood of postoperative complications after HTO is greater than that after UKA . As compared with HTO, UKA has been reported to provide better long-term results, to have a shorter time to full weight bearing, to allow easier rehabilitation, and to have fewer perioperative complications. Furthermore, indications for UKA are broadening, including younger and more active patients, since encouraging midterm and long-term results were published.

Eligibility criteria: Inclusion Criteria:

1. - Medial compartment osteoarthritis with exposed bone on both femur and tibia.
2. -Functionally intact Anterior Cruciate Ligament (superficial damage or splitting is acceptable)
3. -Full thickness and good quality lateral cartilage present
4. -Correctable intra-articular varus deformity (suggestive of functionally intact medical cruciate ligament) 5-Medically fit showing an American Society of Anesthesiologists (ASA) of 1 or 2

Exclusion Criteria:

1. Require revision knee replacement surgery.
2. Have rheumatoid arthritis or other inflammatory disorders.
3. Are unlikely to be able to perform required clinical assessment tasks.
4. Have symptomatic foot, hip or spinal pathology.
5. Previous knee surgery other than diagnostic arthroscopy and medial menisectomy.
6. Previously had septic arthritis.
7. Have significant damage to the patella-Femoral Joint especially on the lateral facet.

Primary outcomes:
measure: Pain and Function using Oxford Knee Score
timeFrame: at least two year follow up.
Secondary outcomes:
measure: Range of Motion and Function using the American Knee Society Score.
timeFrame: at least two year follow up
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT03977870: Identification of New Genetic Markers for the Risk of Recurrence of Venous Thromboembolism by Whole Genome Analysis
Official title: Identification of New Genetic Markers for the Risk of Recurrence of Venous Thromboembolism by Whole Genome Analysis: Case-control Study Nested in the MARTHA Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism (VTE)
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 843
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: The Martha cohort is composed of 1542 subjects from the Region of Marseille with at least one episode of VTE documented. Patients in the MARTHA cohort have already all been genotyped for approximately 500,000 polymorphisms

Brief summary: Venous thromboembolism (VTE) is a common and potentially fatal pathology in France. The risk of recurrence is around 5 to 7% per year. The identification of patients at risk of VTE and its prevention is a real health issue in particular. 50% of MTEV recurrences occur in the absence of a risk situation, suggesting the involvement of specific risk factors for MTEV recurrence that have not been identified to date.

In the last ten years, so-called "genome-whole" or "genome wide" association (GWAS) approaches have identified new genetic risk factors for the first episode of VTE. On the other hand, no study has focused on the predictive factors of recurrence.

The previous project, conducted from 2012 (NCT02904967), had as its main objective to identify new genes for susceptibility to MTEV recurrence by comparing cases of MTEV recurrence versus controls having had a single episode of MTEV. The MARTHA cohort (1,542 patients) is extremely valuable study material and is one of the few cohorts in the world with genome-wide data in the field of VTE. Follow-up could only be performed in 359 patients, 76 (21%) of whom presented with a new episode of VTE.

The objective of this project is to increase the number of patients for whom the investigators will have information on recurrence / non-recurrence of VTE, by querying national registries on the vital status of patients, and possible causes of death. .

These new data on the occurrence or not of a new thrombotic episode, will be confronted with the genetic data already available in all the patients in order to identify specific genetic risk factors and potentially predictive of the recurrence of MTEV.


Eligibility criteria: Inclusion Criteria:

* patients of the MARTHA cohort

Exclusion Criteria:

* none

Primary outcomes:
measure: MTEV recurrence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Emilie Garrido Pradalié
role: STUDY_DIRECTOR
References:
Clinical trial NCT02109042: A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants
Official title: A Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Blosozumab Proposed Phase 3 Formulation in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-04-09
Enrollment: 15
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose(s) of this study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given in multiple doses, subcutaneously (SC) (by inserting a needle just under the surface of the skin in the lower abdominal area), to postmenopausal (PMP) female participants. Information about any side effects that may occur will also be collected.

This study will also be looking for special markers called "biomarkers" that can be used to study osteoporosis and/or the effects of the study drug.

There will be 2 parts to this study. The first part will last approximately 6 weeks and the second part will last approximately 7 weeks.


Eligibility criteria: Inclusion Criteria:

* Part A: Overtly healthy PMP females
* Part B: PMP women who are currently taking oral bisphosphonates
* Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m\^2)

Exclusion Criteria:

* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Show evidence of hepatitis C and/or positive hepatitis C antibody
* Show evidence of hepatitis B and/or positive hepatitis B surface antigen
* Have known allergies to blosozumab, its constituents, or related compounds
* Have an abnormality in the 12-lead electrocardiogram (ECG)

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab
timeFrame: Predose and daily up through 7 days postdose
measure: PK: Area Under the Concentration Curve of Blosozumab
timeFrame: Predose and daily up through 7 days postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Dallas
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04199442: Anxiety Assessment Before Regional Anesthesia.
Official title: Assessment of Anxiety Incidence Before Regional Anesthesia Achieving.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anxiety Regional Anesthesia Pre-operative
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-12-16
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 who come to the operating room for surgery under regional anesthesia.

Brief summary: We want to assess the level of anxiety of patients who arrive in the operating room before performing regional anesthesia.

Detailed description: When patients arrive in the operating room, we want to submit them a validated questionnaire (APAIS score and STAI-6 score) to assess their anxiety. After that, the care (anesthesia and surgeries) will take place in a very usual way and similar to our standards of care.

Eligibility criteria: Inclusion Criteria:

* patient\> 18 years
* surgery performed under general anesthesia or not but preceded by a regional anesthesia.

Exclusion Criteria:

* refusal of the patient
* psychiatric disorders (pathological anxiety, psychosis, depression)
* language barrier
* major drug impregnation.

Primary outcomes:
measure: APAIS score
timeFrame: Achievement of the score on arrival at the operating area (between 15-30 minutes before to realise the regional anesthesia block). Only one determination of the score is made
measure: STAI-6 score
timeFrame: Achievement of the score on arrival at the operating area (between 15-30 minutes before to realise the regional anesthesia block). Only one determination of the score is made
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: MontLegia Hospital
Study officials:
affiliation: MontLegia Hospital, Groupe Santé CHC
name: Pierre Goffin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Celik F, Edipoglu IS. Evaluation of preoperative anxiety and fear of anesthesia using APAIS score. Eur J Med Res. 2018 Sep 11;23(1):41. doi: 10.1186/s40001-018-0339-4.
citation: Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
Clinical trial NCT04809870: Esophagectomy in Patients With Liver Cirrhosis
Official title: Esophagectomy in Patients With Liver Cirrhosis - an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Liver Cirrhosis
Keywords: esophagectomy
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: retrospective analysis of a prospective maintained database of EC patients operated at the institution between 2012 to 2016

Brief summary: Retrospective and confounder adjusted comparison of perioperative and longterm outcomes of patients requiring an esophagectomy for esophageal cancer with and without concomitant liver cirrhosis.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* primary esophageal cancer with indication for curative treatment
* follow up period ≥ 5 years
* LC cohort: pre- or intraoperative histological proof of liver cirrhosis

Exclusion Criteria:

* recurrent esophageal cancer
* missing indication for curative treatment of esophageal cancer
* esophagectomy for benign esophageal lesions

Primary outcomes:
measure: Long-term survival
timeFrame: 5 years
Secondary outcomes:
measure: Major complication
timeFrame: 90 days postoperatively
measure: Anastomotic leakage rate
timeFrame: 90 days postoperatively
measure: Sepsis rate
timeFrame: 90 days postoperatively
measure: Renal failure rate
timeFrame: 90 days postoperatively
measure: Hepatic failure rate
timeFrame: 90 days postoperatively
measure: Cardiac complication
timeFrame: 90 days postoperatively
measure: Chylus fistula rate
timeFrame: 90 days postoperatively
measure: Pulmonary complications
timeFrame: 90 days postoperatively
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University of Hamburg Medical Institutions
Study officials:
affiliation: 1Department of General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf
name: Reeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01287442: Evaluation of Filtering Blebs Using the "Wuerzburg Bleb Classification Score" Compared to Other Clinical Findings, e.g. the Intraocular Pressure (IOP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of glaucoma, status post trabeculectomy

Brief summary: It is well established to assess the functionality of a filtering bleb by intraocular pressure (IOP), either as an absolute value or as a percent reduction, and by the need of additional antiglaucoma drugs. It is also possible to evaluate the appearance of a bleb by a clinical score, e.g. the "Wuerzburg bleb classification score" (WBCS). The purpose of this study was to find out whether there is a correlation between clinical findings, in particular IOP and the WBCS.

100 eyes within two years after trabeculectomy were included into the study. Using colour photographs the filtering bleb was evaluated according to the WBCS from two different examiners, both on different levels of clinical experience. WBCS = 1 indicates poor bleb appearance, WBCS = 15 indicates optimal bleb appearance. At the same time, clinical findings like intraocular pressure, best corrected visual acuity, slit lamp biomicroscopy and medical history were taken by another examiner.

* Trial with surgical intervention


Eligibility criteria: Inclusion criteria: Diagnosis of glaucoma, status post trabeculectomy

Exclusion criteria: age \<18 Jahre, other optic neuropathy than glaucoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Ophthalmic Clinic
state: ZH
Study officials:
affiliation: University Hospital Zurich, Ophtalmic Clinic
name: Jens Funk, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Furrer S, Menke MN, Funk J, Toteberg-Harms M. Evaluation of filtering blebs using the 'Wuerzburg bleb classification score' compared to clinical findings. BMC Ophthalmol. 2012 Jul 17;12:24. doi: 10.1186/1471-2415-12-24.
Clinical trial NCT00422370: Lipid Based Food Additives for Treating Patients With Dry Mouth
Official title: Lipid Based Food Additives for Treating Patients With Dry Mouth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Xerostomia
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-01-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Over 10% of adult population suffers from dry mouth (xerostomia). The aim of this double blind prospective clinical trial is to examine a new lipid based food additive formulation to ease mouth dryness in these patients.


Eligibility criteria: Inclusion Criteria:

* Dry mouth patients

Exclusion Criteria:

* Disabled patients
* Pregnant
* Full upper denture
* Under 18 years old

Primary outcomes:
measure: Improvement in dry mouth symptom
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Reference: Kelly HM et al. Bioadhesive,rheological, lubricant and other aspectes of an oral gel formulation intended for the treatment of xerostomia. Int J Phramac. 2004; 278: 391-406
name: Doron J Aframian, DMD PhD
role: STUDY_CHAIR
affiliation: Salivary Gland Clinic, Department of Oral Medicine The Hebrew University-Hadassah School of Dental Medicine Jerusalem, Israel P.O.B 12272, Zip code 91120
name: Doron J Aframian, DMD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00307970: Impact of Anti-static Chamber/Mask
Official title: The Impact of an Anti-static Valved-holding Chamber on Bioavailability of Inhaled Fluticasone Propionate in Young Children With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: fluticasone
asthma therapy
spacer inhaler
HFA-134a
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2006-03-28
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare lung delivery of fluticasone propionate delivered by HFA-pMDI, using a conventional polycarbonate of anti-static chamber/mask in a randomized crossover design in 1-6 year old children.

Hypothesis: Anti-static chamber/mask would increase the amount of inhaled corticosteroid delivered to young children who passively inhale and cannot breath hold.

Detailed description: Objective -- to determine whether an anti-static chamber increases the one-hour steady-state fluticasone plasma concentration, which is an indirect measure of airway delivery and direct measure of systemic exposure. Twelve children 1-6 yrs with well-controlled persistent asthma were treated with HFA-FP pMDI, 2 actuations of 110 µg twice daily. The drug was administered by conventional polycarbonate or anti-static valved-holding chambers with masks in an unblinded, randomized, crossover manner each for at least three days. A blood sample was collected one hour after the last dose when adherence documented by electronic monitor was 100%. FP plasma concentrations were measured by liquid chromatography mass spectrometry assay. Results evaluated using regression analysis.

Eligibility criteria: Inclusion Criteria:

* children 1-6 years old; adequately controlled persistent asthma; currently receiving FP delivered by CFC MDI attached to valved-holding chamber/mask; ability to use chamber with mask effectively

Exclusion Criteria:

* inadequately controlled asthma: nocturnal awakening \> 2 nights/month, prn albuterol use \> 2x/week, more than 2 short courses of oral corticosteroids in previous 3 months, missing a dose on more than one occasion, increase in asthma symptoms during study, inability to discontinue intranasal or dermal fluticasone for 3 days

Primary outcomes:
measure: one-hour steady-state plasma concentration of fluticasone after each device
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Asthma Research Lab
state: Florida
Study officials:
affiliation: University of Florida
name: Leslie Hendeles, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00531570: Microvascular Ultrasonographic Imaging for the Detection of Early Stage Epithelial Ovarian Carcinoma
Official title: Microvascular Ultrasonographic Imaging for the Detection of Early Stage Epithelial Ovarian Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Neoplasms
Keywords: Women with ultrasound defined complex pelvic masses
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2007-09-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women must have a complex adnexal mass (as defined per ultrasound) which requires surgical intervention

Brief summary: In the United States, ovarian cancer is the fifth most common cancer to develop in women and causes more deaths than all other gynecologic malignancies combined. Because of the difficulties in detecting early stage ovarian cancer, 75% of women continue to be diagnosed with advanced stage disease (stage III or IV).

The National Ovarian Cancer Early Detection Program (NOCEDP) as part of the National Cancer Institute's Early Detection Research Network (EDRN) is committed to the development of effective means for the accurate detection of early stage ovarian cancer.

The last decade has seen rapid technological advances in diagnostic ultrasonography with the recent development of three-dimensional imaging.

Initial studies suggest that these new technologies improve upon the diagnostic accuracy of two-dimensional transvaginal imaging in the differentiation between benign and malignant pathology.

This improved diagnostic accuracy may promote improved patient care by separating complex benign masses from ovarian cancer therefore facilitating appropriate treatment.


Eligibility criteria: Inclusion Criteria:

1. Women must be greater than 21 years of age
2. Women must have a complex adnexal mass (as defined per ultrasound) which requires surgical intervention

Exclusion Criteria:

1. Known or suspected hypersensitivity to blood, blood products, or albumin.
2. Known history of congenital heart defect that creates a bi-directional or right-to-left shunt.
3. Known history of severe emphysema or a history of pulmonary emboli.
4. known history of severe pulmonary hypertension (systolic pulmonary artery pressures \> 90 mmHg).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Cancer Institute
state: New York
Study officials:
affiliation: NYU Langone Health
name: David Fishman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: