louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00212498: Tuberculosis Research Blood Bank
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Tuberculosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TB patients

Brief summary: To create a Tuberculosis Research Blood Bank for future molecular genetics and serological studies


Eligibility criteria: Inclusion Criteria:

* TB suspect with positive sputum smear

Primary outcomes:
measure: Develop TB Blood Bank
timeFrame: Long-Term
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine Division of Pulmonary and Critical Care Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Rany Condos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00597298: Diaphragm Training Post-Cardiac Surgery
Official title: Randomized Controlled Trial on the Diaphragm Training With Threshold for Patient With Post-Cardiac Surgery Diaphragmatic Paralysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaphragmatic Paralysis
Keywords: diaphragmatic paralysis
cardiac surgery
respiratory muscle training
Lead sponsor: Ospedali Riuniti Trieste
Sponsor class: OTHER
First posted: 2008-01-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Diaphragm paralysis is a possible complication of cardiac surgery. The spontaneous recovery of the diaphragm mobility is slow and partial or absent in most cases. We hypothesize that a program of diaphragm muscle training by means of the Threshold variable resistance device could improve the rate of complete diaphragm mobility recovery in a shorter time period. Patient with post-cardiosurgical diaphragm paralysis will be random assigned to the specific training protocol or to a generic non-training physical activity.

Detailed description: Inclusion criteria: All consecutive patients aged from 18 to 80 years old with RX-defined diaphragm paralysis post a major cardiosurgery intervention such as coronary bypass, valve substitution or both.

Exclusion criteria: Acute cardiac failure, COPD, chronic respiratory failure with indication to home oxygen therapy, neuromuscular diseases.

Outcome measures: MIP, MEP, diaphragm function recovery assessed by chest X-ray, lung function tests.

Eligibility criteria: Inclusion Criteria:

* post-cardiosurgical diaphragmatic paralysis recent cardiosurgical intervention for by-pass and/or valve replacement

Exclusion Criteria:

* heart failure
* COPD
* neuromuscular disease

Primary outcomes:
measure: chest x-ray mobility of the diaphragm
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Maximal inspiratory pressure (MIP), cm H2O
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Fisiopatologia Respiratoria
state: TS
Study officials:
affiliation: AOUTS
name: Maja Demsar, MD
role: STUDY_DIRECTOR
affiliation: AOUTS
name: Marco Confaloniei, MD
role: STUDY_CHAIR
References:
citation: Versteegh MI, Braun J, Voigt PG, Bosman DB, Stolk J, Rabe KF, Dion RA. Diaphragm plication in adult patients with diaphragm paralysis leads to long-term improvement of pulmonary function and level of dyspnea. Eur J Cardiothorac Surg. 2007 Sep;32(3):449-56. doi: 10.1016/j.ejcts.2007.05.031. Epub 2007 Jul 19.
citation: Kodric M, Trevisan R, Torregiani C, Cifaldi R, Longo C, Cantarutti F, Confalonieri M. Inspiratory muscle training for diaphragm dysfunction after cardiac surgery. J Thorac Cardiovasc Surg. 2013 Mar;145(3):819-23. doi: 10.1016/j.jtcvs.2012.07.087. Epub 2012 Aug 29.
Clinical trial NCT01801098: Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After TAVI
Official title: Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation With a Self-expanding Bioprosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Aortic Valve Stenosis
Keywords: TAVI
complete AV-block
HV-interval
permanent pacemaker
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic aortic valve stenosis screened for TAVI will be enrolled in this study.

Brief summary: The development of a high grade AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be enrolled in this study. The HV-interval will be determined before and immediately after implantation.

The hypothesis is that a prolonged HV-interval is associated with a high rate of complete AV-block following TAVI.


Eligibility criteria: Inclusion Criteria:

* symptomatic aortic valve stenosis
* patients screened for TAVI
* written informed consent

Exclusion Criteria:

* unconsciousness, not able to consent
* \< 18 years
* permanent pacemaker

Primary outcomes:
measure: Determination of HV interval
timeFrame: Changes in Baseline to 24 hours
Secondary outcomes:
measure: AV-block development after 1 month, 6 months and 12 months
timeFrame: 1 month, 6 months and 12 months
Other outcomes:
measure: cardiovascular mortality
timeFrame: 1 month, 6 months and 12 months
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
state: NRW
Study officials:
affiliation: Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
name: Malte Kelm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonary Diseases, Vascular Medicine University Hospital Duesseldorf
name: Marc W. Merx, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
name: Dong-In Shin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05799898: Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors
Official title: Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors: Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Immune Checkpoint Inhibitor
Cardiovascular Complication
Immune-related Adverse Event
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
First posted: 2023-04-05
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: Adults on immune checkpoint inhibitors for cancer treatment

Brief summary: Prospective study cohort on patients addressed for suspected cardiovascular event on immune checkpoint inchibitors.

Longitudinal prospective single center cohort. Inclusion criteria: all patient willing to particiupate seen in the cardio-oncology unit at our institution for the suspicion of heart failure, atherosclerosis related event, Tako Tsubo, arrhymias, pericarditis, myocarditis on antiPD1, antiPDL1, or antiCTLA4 immune checkpoint inhibitors.

Description of patients characteristics, investigations, diagnosis after multidisciplinary meeting, outcomes.


Eligibility criteria: Inclusion Criteria:

* all patient referred to the cardio oncology unit for suspected immune related cardiovascular complication on immune checkpoint inhibitors

Exclusion Criteria:

* none

Primary outcomes:
measure: Major cardiovascular event
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Intitut Mutualiste Montsouris
Study officials:
affiliation: Institut Mutualiste Montsouris
name: Mariana Mirabel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05061498: Impact of Pacing Output and Cycle Length on QRS Morphology
Official title: Impact of Pacing Output and Cycle Length on QRS Morphology in Ablation of Premature Ventricular Contractions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PVC - Premature Ventricular Complex
Catheter Ablation
Keywords: Catheter ablation of PVC
Pacemapping
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Current recommendations for pacemapping are based on expert opinion and animals models. Present study sought to evaluate the influence of different parameters of pacemapping on QRS morphology. Pacemapping is performed with different cycle length (fixed burst vs. coupling interval) and stimulation output (maximum output vs. threshold) and resulting QRS complexes are compared to clinical PVC and the standard of care to determine the optimal parameter setting in pacemapping.

Detailed description: Pacemapping is a common technique to determine to origin of ventricular ectopy during catheter ablation of premature ventricular contractions (PVC). During the pacemapping process an electrical pacing stimulus is applied via the ablation catheter and the resulting QRS complex is compared the clinical target PVC. The higher the consistency between the stimulated QRS complex and the clinical PVC, the nearer the catheter is located to the origin of ectopy.

Current recommendations for the execution of pacemapping are based on expert opinion and animals models. The investigators sought to assess for the first time in a clinical real life setting the different parameters for pacemapping (i.e. Cycle length and stimulation output). Therefore during the pacemapping process in routine PVC ablation pacing is performed with different cycle length (fixed burst vs. coupling interval of PVC) and different electrical output (maximum output vs. stimulation threshold). The resulting QRS morphologies are on the one hand compared to the ablation target (clinical PVC) and on the other hand to the suggest standard of care (Coupling interval at pacing threshold) to determine the optimal setting of parameters in pacemapping.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing PVC ablation

Exclusion Criteria:

* patients \<18 years
* patients not able to consent
* pregnancy
* contraindication for PVC ablation
* unavailability of vascular access
* patients with complex congenital heart disease
* expected hemodynamical instability during pacemapping

Primary outcomes:
measure: Template Matching with clinical PVC
timeFrame: Immediately during PVC ablation. No follow up intended.
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
state: NRW
Study officials:
affiliation: Heart Center University of Cologne
name: Jakob Lüker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00144898: GF-GS 01: Comparing Conventional Axillary Dissection Versus Sentinel Node Resection in Clinically Node-negative Operable Breast Cancer
Official title: A Randomized, Phase III Clinical Trial GF-GS 01 to Compare Conventional Axillary Dissection Versus Sentinel Node Resection (GS) in Clinically Node-negative Operable Breast Cancer Unifocal N0 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast cancer
sentinel node resection
survival
Breast cancer unifocal N0
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-09-05
Enrollment: 1627
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sentinel node resection appears as a promising advancement in the surgical treatment of breast cancer.

The GF-GS 01 study, sponsored by a National Hospital Research Program, compares this new surgical method with a classical method in patients having a negative sentinel node.

The duration of the follow-up is 5 years.


Eligibility criteria: Inclusion Criteria:

* Women older than 18 years with clinically node-negative operable unifocal N0 breast cancer (clinical tumour size \< 30 mm).
* Written consent is obtained from all patients before randomization.

Primary outcomes:
measure: Survival without recurrence
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Alain LEIZOROVICZ
Study officials:
affiliation: Institut Paoli Calmette
name: Gilles HOUVENAEGHEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roy P, Leizorovicz A, Villet R, Mercier C, Bobin JY. Systematic versus sentinel-lymph-node-driven axillary-lymph-node dissection in clinically node-negative patients with operable breast cancer. Results of the GF-GS01 randomized trial. Breast Cancer Res Treat. 2018 Jul;170(2):303-312. doi: 10.1007/s10549-018-4733-y. Epub 2018 Mar 10.
Clinical trial NCT04960098: Patient-reported Outcome Measures in Patient Underwent Total Hip and Knee Arthroplasty
Official title: Patient-Reported Outcome Measures in Patient Underwent Total Hip and Knee Arthroplasty in Galeazzi Orthopaedic Institute Milano
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Osteoarthritis
Knee Osteoarthritis
Prosthesis Survival
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 5816
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients underwent hip and knee arthroplasty included in inclusion criteria

Brief summary: Registry of Galeazzi Orthopedic Institute: provides for the regular and systematic collection of all data (clinical and some PROMs) obtained from patients undergoing hip and knee arthroplasty to which questionnaires are proposed investigating the specific functional sphere of the joints undergoing surgery (Knee injuryOsteoarthritisOutcomeScore (KOOS-PS) and Hip injuryOsteoarthritisOutcomeScore (HOOS-PS) but also the sphere of general health (ShortForm health survey-12 (SF-12) and VisualAnalogueScale (VAS)) , in addition, of course, to the satisfaction rate.


Eligibility criteria: Inclusion Criteria:

* male and female
* age more than 18
* patient underwent hip or knee arthroplasty

Exclusion Criteria:

* age less than 18
* comorbidity that can results in the difficulty to come back for the follow up

Primary outcomes:
measure: outcome measurements
timeFrame: pre operative to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Ortopedico Galeazzi
Study officials:
References:
Clinical trial NCT01253798: Group Exercise After Hip Replacement Surgery
Official title: What Type of Group Exercise Should be Chosen for Osteoarthritis Patients in the Rehabilitation Phase Following Hip Replacement Surgery?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis, Hip
Keywords: exercise
hydrotherapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2010-12-03
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which group exercise one should choose when hip osteoarthritis patients have undergone hip replacement surgery. To determine this, we want to answer the following research question:

Are there differences in function and muscle strength in osteoarthritis patients who conduct group training either on land or in water in the rehabilitation phase following hip replacement surgery?


Eligibility criteria: Inclusion Criteria:

* Hip osteoarthritis patients who undergo surgery with total prosthesis at St. Olav's Hospital, Department Orkdal.
* Participants must live in commuting distance from the hospital, as the training is organized as outpatient training
* Participants must be able to take instruction and master the Norwegian language

Exclusion Criteria:

* Patients who experience serious complications after surgery
* if a person has a disease that causes that one can not complete the planned training

Primary outcomes:
measure: Function1
timeFrame: Pre-operative
measure: Function2
timeFrame: Post-operative
measure: Funtion3
timeFrame: After 12 weeks training
Secondary outcomes:
measure: Muscle strength1
timeFrame: Pre-operative
measure: Muscle strength2
timeFrame: Post-operative
measure: Muscle strength3
timeFrame: After 12 weeks training
Other outcomes:
Locations:
city: Orkanger
country: Norway
facility: St. Olavs Hospital, department Orkdal
state: Sør-Trøndelag
Study officials:
affiliation: NTNU, Medisink fakultet, Institutt for samfunnsmedisin
name: Ottar Vasseljen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01486498: Quality of Life and Health Economic Measurements in Allergic Patients Treated With Immunotherapy
Official title: Health Economic Analyses of Treatment Strategies for Allergic Respiratory Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypersensitivity
Asthma
Rhino-Conjunctivitis
Quality of Life
Effects of Immunotherapy
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 571
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The intervention group consisted of 254 patients receiving subcutaneous allergen specific immunotherapy (SCIT) with grass pollen and/or house dust mite extracts. The control group consisted of 317 patients with grass pollen and/or house dust mite allergy, who were not receiving SCIT.

Brief summary: Grass pollen and house dust mites (HDM) are the most common allergens causing allergic rhino-conjunctivitis (RC) and/or asthma (A). Subcutaneous allergen specific immunotherapy (SCIT) reduces symptoms and use of medication. The purpose of SABAL is to assess the effect of SCIT on disease severity classifications in terms of number of days affected- and sick days on patients with grass pollen and/or HDM induced disease. These outcome measures will be gathered in one single measure: Quality Adjusted Life Years (QALY)


Eligibility criteria: Inclusion Criteria:

* Adults (\> 16 years) and allergic to grass pollen and/or house dust mites.

Exclusion Criteria:

* Allergic patients who had been immunotherapy treated before.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor
name: Karin D Petersen, PhD
role: STUDY_CHAIR
References:
citation: Petersen KD, Kronborg C, Larsen JN, Dahl R, Gyrd-Hansen D. Patient related outcomes in a real life prospective follow up study: Allergen immunotherapy increase quality of life and reduce sick days. World Allergy Organ J. 2013 Sep 9;6(1):15. doi: 10.1186/1939-4551-6-15.
Clinical trial NCT05626998: Dexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty
Official title: The Effect of Intramuscular Dexmedetomidine Versus Oral Gabapentin Premedication on the Emergence Agitation After Rhinoplasty. A Prospective, Randomized, Double-blind Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty.

Detailed description: Emergence agitation (EA) is a clinical condition characterized by agitation, confusion, disorientation, and aggressive behavior in the early phase of recovery from general anesthesia (incidence about 21.3%). This may lead to various injuries, self-extubation, bleeding, increased pain, removal of catheters, increased blood pressure, heart rate, and myocardial oxygen consumption. Premedication with dexmedetomidine and gabapentin are promising options for EA.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists grade I or II.
* Sex: Both sexes.
* Age between 18 and 40 years.
* Patients scheduled for rhinoplasty under general anesthesia

Exclusion Criteria:

* Declining to give written informed consent.
* History of allergy to the medications used in the study.
* history of cardiovascular diseases including bradycardia, heart block, and hypertension.
* History of chest problems including bronchial asthma.
* Had a history of drug or alcohol abuse.
* Taking opioids or sedative medications.
* Inability to communicate with patients to evaluate postoperative pain.
* Hepatic or renal failure.
* Psychiatric disorders with antipsychotics or antidepressants.
* Bleeding disorders, antiplatelets (aspirin, clopidogrel), or anticoagulant (warfarin).

Primary outcomes:
measure: emergence agitation (EA)
timeFrame: During first hour of recovery.
Secondary outcomes:
measure: Postoperative pain in the form of visual analog scale
timeFrame: every 4 hours for 12 hours
measure: Incidence of the common adverse effects
timeFrame: at 12 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine, Ain Shams University
Study officials:
affiliation: Faculty of medicine, Ain Shams University, Cairo, Egypt
name: tamer S abdelaziz, MD
role: PRINCIPAL_INVESTIGATOR
References: