louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01383291: Prolift Versus IVS for Pelvic Floor Prolapse
Official title: Postoperative Comparison Between Posterior Prolift Mesh Placement and Posterior IVS Sling Placement
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pelvic Floor Prolapse
Keywords: pelvic floor prolapse
prolift
IVS
Surgery
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2011-06-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with pelvic floor prolapse

Brief summary: * Women who underwent mesh or sling procedures to correct pelvic organ prolapse will be enrolled.
* Their data will be collected from the files.
* Comparison between two groups will be carried our: Those who underwent a posterior IVS and those who underwent posterior prolift procedure.
* The data will be obtained by questionaires by a telephone interview by a physician who did not participate in the surgery.
* Follow-up physical examination data will also be obtained.


Eligibility criteria: Inclusion Criteria:

* Women who previously underwent surgery for pelvic floor prolapse at least a year before

Exclusion Criteria:

* Women who did not have surgery for pelvic floor prolapse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Department of Obstetrics and Gynecology, Western Galilee Hospital
city: Rishon Lezion
country: Israel
facility: Clinics of Dr Neuman
Study officials:
References:
Clinical trial NCT02596191: Tools for Therapeutic Evaluation in Charcot-Marie-Tooth Disease Type 1A: Outcome Measures and Biomarkers
Official title: Tools for Therapeutic Evaluation in Charcot-Marie-Tooth Disease Type 1A: Outcome Measures and Biomarkers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Charcot-Marie-Tooth Disease Type 1A
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a 2-year follow-up study of a cohort of 60 CMT1A patients. The objective is to identify markers allowing to better understand the phenotypic variability observed on patients with CMT1A, to identify predictive markers of the disease's progression and to provide validated measurement tools that can be used as outcome measures in future clinical trials.


Eligibility criteria: Inclusion Criteria:

* Patients with CMT 1A disease
* Diagnosis of CMT 1A confirmed by genotyping (duplication of the 17p11.2 region)

Exclusion Criteria:

* Patients suffering from co-morbidity at the origin of peripheral neuropathy (diabetes, hypothyroidism, renal insufficiency, drugs...) or muscle, articular, rheumatological disease
* With HIV or cancer
* With a significant progressive disease in the previous month
* With a contra-indication for MRI
* With a dislocation, fracture, or recent surgery (less than 6 months before inclusion)
* with alcohol or psychoactive substances abuse
* Treated by an anti-inflammatory drug over the past four weeks
* Pregnant or breastfeeding women
* Homeless patients

Primary outcomes:
measure: Change of functional scores
timeFrame: 3 months, 12 months and 24 months
measure: Change of functional scores
timeFrame: 3 months, 12 months and 24 months
measure: Change of functional scores
timeFrame: 3 months, 12 months and 24 months
measure: Change of functional scores at
timeFrame: 3 months, 12 months and 24 months
Secondary outcomes:
measure: Walkin test
timeFrame: 12 months and 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
city: Montpellier
country: France
facility: CHU Gui de Chauliac, CHU MONTPELLIER
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle Desalbres
role: STUDY_DIRECTOR
References:
Clinical trial NCT01419691: Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL)
Official title: A Phase I Phase II Two-Step Study of the Oral Gold Compound Auranofin in Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)/ Prolymphocytic Lymphoma (PLL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma
Leukemia, Prolymphocytic
Keywords: auranofin
chronic lymphocytic leukemia
relapsed
refractory
CLL
SLL
PLL
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: The Leukemia and Lymphoma Society
name: Kansas Bioscience Authority
name: Therapeutics for Rare and Neglected Diseases (TRND)
First posted: 2011-08-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of auranofin to treat patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or prolymphocytic lymphoma (PLL).


Eligibility criteria: Inclusion Criteria:

* histologically confirmed B-cell chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), prolymphocytic leukemia arising from CLL/SLL or Richter's transformation according to WHO criteria who require therapy based on the 2008 revised IWCLL criteria.
* Relapsed or refractory disease after receiving at least 1 prior therapy for CLL
* At least 18 years old; ECOG status of 1 or less; life expectancy 2 months or greater
* Adequate organ and marrow function (total bilirubin less than 1.5x IULN; ALT less than 2x IULN; serum creatinine less than 1.5x ULN)

Exclusion Criteria:

* have had chemotherapy, radiotherapy or immunotherapy within 4 weeks prior to entering study
* have not recovered from AEs due to agents administered more than 4 weeks prior
* receiving any other investigational agent
* known second malignancy that limits survival to less than 2 years
* known HIV positive
* uncontrolled intercurrent illness
* pregnant or breastfeeding

Primary outcomes:
measure: Response Rate
timeFrame: 24 months
measure: type, incidence, severity, seriousness and relationship to auranofin of adverse events and any laboratory abnormalities
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Suman Kambhampati, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rousselle B, Massot A, Privat M, Dondaine L, Trommenschlager A, Bouyer F, Bayardon J, Ghiringhelli F, Bettaieb A, Goze C, Paul C, Malacea-Kabbara R, Bodio E. Conception and Evaluation of Fluorescent Phosphine-Gold Complexes: From Synthesis to in vivo Investigations. ChemMedChem. 2022 Jun 3;17(11):e202100773. doi: 10.1002/cmdc.202100773. Epub 2022 Mar 29.
Clinical trial NCT00622791: Propofol Pharmacokinetics and Pharmacodynamics During Cardiopulmonary Bypass
Official title: Effects of Cardiopulmonary Bypass on Plasma Propofol Concentrations and Bis Values During Coronary Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Cardiopulmonary Bypass
Coronary Artery Bypass Graft
Keywords: Cardiopulmonary bypass
coronary artery bypass graft
coronary artery disease
propofol
pharmacokinetics
pharmacodynamics
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2008-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty patients undergoing elective coronary artery bypass graft surgery

Brief summary: Cardiopulmonary bypass (CPB) is known to alter pharmacokinetics (PK) and brain sensitivity to several drugs, including propofol. Few studies, however, have tested if propofol pharmacokinetical alterations observed after CPB could contribute to the increased hypnotic effect of propofol after CPB. This study was designed to test the hypothesis that changes in the PK of propofol contribute to an increase in its hypnotic effects after CPB as evidenced by changes in bispectral index (BIS) values.

Twenty undergoing coronary artery bypass graft patients will be allocated in two groups: 1) CPB groups and 2) off-pump coronary artery bypass graft. Bispectral Index values and blood samples for plasma propofol concentration measurements will be collected along the surgery and up to 12 hours in the post-operative period. Plasma propofol concentrations, Bispectral index values and propofol PK will be compared between the groups.


Eligibility criteria: Inclusion Criteria:

* Isolated coronary artery bypass indication
* Left ventricular ejection fraction greater than 50 %
* Absence of preoperative pulmonary dysfunction

Exclusion Criteria:

* Intra and postoperative circulatory shock
* Postoperative pulmonary dysfunction

Primary outcomes:
measure: Propofol pharmacodynamics and pharmacokinetics
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: Faculdade de Medicina da Universidade de São Paulo
name: Maria M Carmona, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barbosa RA, Santos SR, White PF, Pereira VA, Silva Filho CR, Malbouisson LM, Carmona MJ. Effects of cardiopulmonary bypass on propofol pharmacokinetics and bispectral index during coronary surgery. Clinics (Sao Paulo). 2009;64(3):215-21. doi: 10.1590/s1807-59322009000300012.
Clinical trial NCT00629291: MRI Evaluation of Iron Overload in the Heart, Liver and Pancreas in Patients Receiving Multiple Blood Transfusions.
Official title: Evaluation of Iron Overload in the Heart, Liver and Pancreas: Patients With Sickle β Thalassemia and Sickle Cell Anemia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Overload
Keywords: iron overload
Thalassemia
Anemia, Sickle Cell
Magnetic Resonance Imaging
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sickle cell anemia and Sickle cell β thalassemia patients from dedicated outpatient hospital clinic.

Brief summary: Sickle cell anemia and Sickle cell β thalassemia patients require multiple transfusions in order to avoid chronic anemia sequel. This regimen entails intrinsic deleterious effects, the majority of which are related to iron deposition in the reticuloendothelial system. Thus, iron is deposited in hepatic, myocardial and endocrine glands tissues. Tools available for iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are non specific.

The purpose of this work is to compare iron overload in the liver, heart and pancreas in Sickle cell anemia and Sickle cell β thalassemia patients using T2\* MRI sequences.

Detailed description: Sickle cell anemia and Sickle cell β thalassemia patients recieving multiple transfusions are exposed to the effects of iron deposition in the reticuloendothelial system, including cardiac muscle, liver and pancreas. Tools available for iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are non specific.

The purpose of this work is to compare iron overload in the liver, heart and pancreas in Sickle cell anemia and Sickle cell β thalassemia patients using T2\* MRI sequences.

Patients and Methods: 27 Sickle cell anemia and 28 Sickle cell β thalassemia will undergo transthoracic echocardiography, cardiac MRI using T2\* sequences and clinical and laboratory evaluation for iron overload including ferritin levels and oral glucose tolerance test

.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of Sickle cell anemia or Sickle cell β thalassemia having received multiple blood transfusions.

Exclusion Criteria:

* contraindication to MRI

Primary outcomes:
measure: outcome measure: iron overload on T2* MRI in the heart , liver and pancreas.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center , Imaging Dept
Study officials:
affiliation: Sheba Medical Center
name: Orly Goitein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04573491: Implementation of Pharmacogenetic Testing in Hospital Wards
Official title: Implementation of Pharmacogenetic Testing as Part of Medication Reviews in Hospital Wards
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Admitted Multimorbid Patients
Keywords: pharmacogenetics
implementation
medication review
Lead sponsor: Hospital Pharmacy Enterprise, South Eastern Norway
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
name: Diakonhjemmet Hospital
name: University of Oslo School of Pharmacy
First posted: 2020-10-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether it is feasible to implement pharmacogenetic testing as part of medication review while the patient is admitted to hospital.

Detailed description: Earlier studies have shown that pharmacogenetic testing may contribute to optimizing the efficacy of medication treatment and to reduce the risk of adverse effects. Inclusion of pharmacogenetic testing as part of medication reviews reveals more serious drug related problems and leads to more changes in medication treatment than medication review alone.

The use of pharmacogenetic testing as part of medication reviews has not earlier been systematically investigated in hospital patients in Norway. There is little documentation of what is needed to implement the use of pharmacogenetic testing in a hospital ward.

The investigators are conducting a descriptive study in two internal medicine wards at Akershus University Hospital. 50 patients using minimum 5 regular drugs including at least one relevant for pharmacogenetic testing will be enrolled in the study.

Eligibility criteria: Inclusion Criteria:

* at least 2 long-term conditions
* at least 5 regular drugs of which at least one relevant for pharmacogenetic testing
* at least 2 years life expectancy
* able to communicate in Norwegian
* able to give informed consent
* summary care record

Exclusion Criteria:

* moderate to severe dementia

Primary outcomes:
measure: Number of patients with results from pharmacogenetic testing included in medication review
timeFrame: from admission to discharge, an average of 1 week
Secondary outcomes:
measure: Acceptance of recommendations
timeFrame: after medication review and before discharge, an average of 3 days
measure: Documentation of information from pharmacogenetic testing
timeFrame: after medication review and before discharge, an average of 3 days
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
state: Nordbyhagen
Study officials:
affiliation: Hospital Pharmacy Enterprise, South Eastern Norway
name: Kathrin Bjerknes, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT03623191: Clinical Aspect of Erosive Pustular Dermatosis of the Leg
Official title: Clinical Aspect of Erosive Pustular Dermatosis of the Leg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erosive Pustular Dermatosis of the Leg
Keywords: Erosive pustular dermatosis of the leg
Erosive pustular dermatosis of the scalp
Venous insufficiency
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with erosive pustular dermatosis of the leg

Brief summary: Erosive pustular dermatosis of the leg is a fairlyrecent clinical entity that was described the first time in 1987.

Diagnosis of erosive pustular dermatosis of the leg is made on clinical grounds. It presents as non-follicular pustules of variable size and numbers that rapidly give way to erosions and crusts on one or both legs, and which are found in particular on the anterior aspect of the middle third of the leg (. The lesions are of chronic progression, despite topical therapy. Erosive pustular dermatosis of the leg is seen in elderly patients, mainly female, and may be associated with chronic venous insufficiency or cutaneous atrophy. In the absence of specific criteria and because of the existence of misleading clinical forms, diagnosis is based upon exclusion.

Detailed description: The primary objective of this investigation was to describe the different clinical aspects of cases of Erosive pustular dermatosis of the leg.

Eligibility criteria: Inclusion Criteria:

- non-follicular pustules and multiple erosions on one or both legs showing no evidence of improvement after application of compression in the event of clinical signs of chronic venous insufficiency and showing no improvement following treatment with local and/or systemic antibacterial therapy, fungal samples from the pustules negative on direct examination, negative direct immunofluorescence results for biopsy samples (taken from around the lesion)

Exclusion Criteria:

- age \< 18 years old

Primary outcomes:
measure: Lesions location
timeFrame: Day 0
measure: number of lesions
timeFrame: Day 0
measure: Presence of chronic venous insufficiency
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
citation: Nicol P, Perceau G, Barbe C, Bernard P; members of GAD. Erosive pustular dermatosis of the leg: A prospective, multicentre, observational study of 36 cases. Ann Dermatol Venereol. 2017 Oct;144(10):582-588. doi: 10.1016/j.annder.2017.02.007. Epub 2017 May 19.
Clinical trial NCT05549791: A Non-intervention Fiberoptic Bronchoscopy Study of Remazolam Toluene Sulfonate for Injection Under General Anesthesia and Fiberoptic Bronchoscopy
Official title: A Domestic, Prospective, Non-interventional Study of Remimazolam Tosilate for Injection in the Real-world for General Anesthesia and Fiberoptic Bronchoscopy Sedation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: General Anesthesia and Bronchoscopy Sedation
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-22
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving remazolam toluenesulfonate for general anesthesia or bronchoscopy sedation

Brief summary: This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 1000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained


Eligibility criteria: Inclusion Criteria:

1. Patients using rebinim ® during general anesthesia and fiberoptic sedation
2. Patients need to sign informed consent

Exclusion Criteria:

1. Patients who are participating in or planning to participate in any interventional clinical trial
2. The investigator considers that there are any other reasons for the patient's ineligibility for the study

Primary outcomes:
measure: Adverse events
timeFrame: Within 3 days of receiving General anesthesia and bronchoscopy sedation
Secondary outcomes:
measure: Serious adverse events
timeFrame: Within 3 days of receiving General anesthesia and bronchoscopy sedation
measure: Adverse drug reactions
timeFrame: Within 3 days of receiving General anesthesia and bronchoscopy sedation
measure: Injection pain
timeFrame: Within 3 days of receiving General anesthesia and bronchoscopy sedation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05889091: A Study of the Use of Fat Flap Reconstruction to Reduce Neck Injury After Cancer Treatment
Official title: The Safety of a Buried, Free Fat Flap to Reduce Neck Morbidity Following Cancer Treatment: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Free fat flap
Reconstruction
Quality of life
23-102
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a descriptive, single-arm pilot study.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether the fat ALT flap procedure is a safe and practical option for reducing neck morbidity in HNSCC patients following cancer treatment of the neck. Neck morbidity after radiation therapy and surgery includes difficulty swallowing, neck or shoulder pain, stiffness, swelling, or changes to the appearance of the treated area. In addition, the researchers will find out whether the study procedure is effective at reducing neck morbidity and improving quality of life after cancer treatment. The researchers will measure quality of life by having participants answer questionnaires.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older
* Diagnosed with HNSCC (e.g., oropharyngeal, hypo/laryngeal SCC)
* Primary treatment is with radiotherapy with or without chemotherapy
* Salvage neck dissection is subsequently indicated for persistent or recurrent, nonmucosal disease in cervical lymph nodes
* At the time of salvage neck dissection additional flap coverage is indicated to improve carotid coverage or replace missing skin

Exclusion Criteria:

* Patients with primary site mucosal recurrence in addition to neck disease

Primary outcomes:
measure: Proportion of patients that experience a complications
timeFrame: within 90 days post operatively
Secondary outcomes:
measure: changes in HRQOL scores
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Evan Matros, MD
role: PRINCIPAL_INVESTIGATOR
References: