louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03230617: Dynamic Hyperinflation In Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
Official title: Evaluation Of Dynamic Hyperinflation In Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient who diagnosed as chronic obstructive pulmonary disease admitted to the respiratory intensive care unit, chest department, Assiut university hospital, who are mechanically ventilated.

Brief summary: Chronic obstructive pulmonary disease is a common respiratory condition that is characterized by inflammation of the large and small peripheral airways , the alveoli and adjacent capillary networks. Severe airflow obstruction that imposes a significant load on the respiratory system is a major manifestation of Chronic obstructive pulmonary disease. The reduced expiratory airflow also causes air trapping at the end of expiration , producing alveolar pressure that are higher than atmospheric pressure before the next breath. This condition is intrinsic positive end-expiratory pressure .


Eligibility criteria: Inclusion Criteria:

* patient with acute exacerbation of Chronic obstructive pulmonary disease and respiratory failure who are intubated and mechanically ventilated.

Exclusion Criteria:

* patient with neuromuscular diseases.
* patient with pulmonary vascular diseases e.g pulmonary embolism.

Primary outcomes:
measure: The duration of mechanical ventilation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
citation: Reddy VG. Auto-PEEP: how to detect and how to prevent--a review. Middle East J Anaesthesiol. 2005 Jun;18(2):293-312.
Clinical trial NCT01582217: Patients Undergoing Percutaneous Coronary Intervention (PCI) Through Optimal Platelet Inhibition
Official title: TRIAGE: Patients Undergoing Percutaneous Coronary Interventions to Improve Clinical Outcomes Through Optimal Platelet Inhibition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Percutaneous Coronary Intervention
Dual Antiplatelet Therapy
Aspirin
Clopidogrel
Keywords: Bleeding
Risk Score
Outcomes
Prasugrel
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo
name: Accumetrics, Inc.
First posted: 2012-04-20
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects in any of the participating sites who are on chronic clopidogrel treatment and return for PCI will be considered for this study.

Brief summary: The purpose of this study is to assess the the 1-year rates of ischemic and bleeding complications in patients whose dual antiplatelet therapy regimen post-PCI has been determined with the use of a clinical algorithm that includes both clinical risks and platelet reactivity while on chronic clopidogrel therapy.

Detailed description: Prospective multicenter registry. Patients already on chronic dual antiplatelet therapy with aspirin and clopidogrel will be assessed for (1) clinical risks factors for future bleeding and ischemic complications, and (2) on-treatment platelet reactivity as measured by the VerifyNow P2Y12 assay (Accumetrics, Inc., San Diego, CA, USA). These will be considered by utilization of a clinical algorithm to determine the dual antiplatelet regimen post-PCI (aspirin in combination with 1. clopidogrel, 2. prasugrel 5mg daily, or 3. prasugrel 10mg daily).

Eligibility criteria: Inclusion Criteria:

* The subject has provided informed written.
* The subject must be ≥ 18 years of age (or minimum age as required by local regulations) at the time of enrollment.
* Patient is established on chronic clopidogrel therapy when he/she returns for PCI, and the components of DAPT are determined by the clinical decision algorithm as local standard of care.
* The subject is willing and able to cooperate with the study procedures and required follow-ups.

Exclusion Criteria:

* Patients with cardiogenic shock will be excluded.
* The subject is participating in an investigational device or drug study. Subject must have completed the follow up phase of any previous study at least 30 days prior to enrolment in this study.
* Pregnant women.

Primary outcomes:
measure: MACE
timeFrame: 12 months
Secondary outcomes:
measure: Rates of major bleeding
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: George Dangas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04707417: Home Care in Allogeneic Haematopoietic Stem Cell Transplantation
Official title: Impact of Home Care for Recipients of Allogeneic Haematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stem Cell Transplant Complications
Quality of Life
GVH - Graft Versus Host Reaction
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 16
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: Adult patients planned for treatment with allogeneic stem cell transplantation

Brief summary: Mixed methods study with focus groups interviews and a prospective observational cohort study aimed to investigate the impact of advanced home care on transplant specific outcomes and quality of life in recipients of allogeneic hematopoietic stem cell transplantation

Detailed description: Study of advanced home care after allogeneic haematopoietic stem cell transplantation (allo-HSCT). The main objective is to investigate the impact of home care on transplant specific variables and quality of life (QoL). The main hypothesis is that home care patients will home care patients will have significantly better measured QoL than patients receiving in-hospital care during the first 6 weeks after allo-HSCT. The study will be conducted as part of routine care at the departement of haematology, Oslo University Hospital.

There are qualitative and quantitative aspects to the study. The qualitative part involves focus groups interviews with patients that have been treated with allo-HSCT and have recieved home care and their caregivers.

In the prospective observational cohort study data will be collected to compare patients receiving home care and patients treated in-hospital (control group). Patients in both groups wil answer the questionnaire EORTC QLQ-C30 once weekly for 6 weeks. In addition transplant- and treatment-specific variables will be collected and compares between the groups.

Eligibility criteria: Inclusion Criteria:

* Consent competency and written informed consent to participation
* Age ≥18
* Understanding and willing to comply with written and oral instructions in Norwegian
* Planned treatment with allo-HSCT
* ECOG performance status 0-2
* Caregiver (age ≥18) present 24 hours a day during the aplastic phase
* Travelling distance from residence to the hospital must be less than one hour.

Exclusion Criteria:

* Not meeting inclusion criteria
* Uncontrolled infection or other medical condtion unsuitable for out patient care

Primary outcomes:
measure: GRFS
timeFrame: 1 year
measure: QoL
timeFrame: 6 weeks
Secondary outcomes:
measure: GvHD
timeFrame: 1 year
measure: TRM
timeFrame: 1 year
measure: Infection
timeFrame: 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Haematology, Division of Cancer Medicine, Oslo University Hospital
Study officials:
References:
Clinical trial NCT00396617: Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy
Official title: Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pharyngeal Neoplasms
Laryngeal Neoplasms
Carcinoma
Keywords: Laryngeal or pharyngo-laryngeal's carcinoma,
voice prosthesis tracheooesophageal shunt,
titanium beads,
cellular colonization
Laryngeal or pharyngo-laryngeal's carcinoma
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: OseoAnvar
name: Réseau National des Technologies de Santé
First posted: 2006-11-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The benefits of this new material, as demonstrated in animal studies and preliminary studies in man, could provide the answer to problems encountered by surgeons in the field of phonatory implants. This novel application is a step towards resolving the very real problems which still exist in the field today. The functional concept, which will allow better control over integrating implants in tissue, should also, it is hoped, favour cellular colonization, thereby fulfilling a currently unmet medical need. The aim is to avoid well-identified potential complications linked to the use of silicone-only implants (with or without a surface coating), like leakage around the prosthesis (by cellular colonization), and so reduce the risk of protrusion/extrusion of the prosthesis as far as possible, and to avoid trauma to the peri-prosthetic tissues by repeated interventions


Eligibility criteria: Inclusion criteria:

* age more than 18
* total laryngectomy or pharyngo-larynctomy

Exclusion criteria:

* pregnant women-age less than 18
* major pulmonary bronchitis
* major neurological disorders

Primary outcomes:
measure: Clinical measures concerning peri and intra prosthetic leakage
timeFrame: days 8,15,21,30 - months : 2 ,4,6,8, 10, 12, 15,18,21,24,30, 36
Secondary outcomes:
measure: Phonology's measures
timeFrame: months 1, 3,12
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Christian DEBRY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005417: Fifteen Year Follow-up of 5,500 Black and 5,500 Other Hypertensives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Kidney Failure, Chronic
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To seek predictors of mortality, hospitalization, and dialysis using data from a hypertensive population which began treatment in 1974.

Detailed description: DESIGN NARRATIVE:

Patients dying before 1989 were identified using the VA's Beneficiary Identification Records Location Subsystem and the National Death Index (NDI). Using NDI information to locate them, death certificates were obtained on all dead patients. Arrangements were made to collect data on the VA hospitalizations occurring after antihypertensive treatment had begun, and application was made to match patients against the USRDS Dialysis and Transplant Registry. The basic clinical data were collected in 32 VA Hypertension Screening and Treatment Program (HSTP) clinics during the 40 month period beginning in 1974. Approximately 30,000 completed Screening and Evaluation Forms and 75,000 Treatment Visit Forms were completed during the 40 months of data collection. The collected information was entered into the HSTP Master File at the VA Computer Center in Austin, Texas. Predictors were sought for (1) all-cause mortality, (2) cause-specific mortality (obtained from death certificates and hospitalization and clinic records), (3) endstage renal disease (obtained from the USRDS Dialysis and Transplant Registry), (4) VA hospital usage combined with other data related to cost care.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Perry HM Jr, Miller JP, Fornoff JR, Baty JD, Sambhi MP, Rutan G, Moskowitz DW, Carmody SE. Early predictors of 15-year end-stage renal disease in hypertensive patients. Hypertension. 1995 Apr;25(4 Pt 1):587-94. doi: 10.1161/01.hyp.25.4.587.
Clinical trial NCT02714517: Efficacy of Hydrotherapy in Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy of hydrotherapy on pain and balance in patients affected by neuropathy.


Eligibility criteria: Inclusion Criteria:

* patients affected by peripherical neuropathy able to walk

Exclusion Criteria:

* pain of water
* medical contraindications at treatment in heated swimming pool

Primary outcomes:
measure: balance change assessed using Berg Balance Scale
timeFrame: 0 and 4 weeks
measure: disability change assessed using Functional Independence Measure scale
timeFrame: 0 and 4 weeks
measure: gait change assessed using Dynamic Gait Index scale
timeFrame: 0 and 4 weeks
measure: gait change assessed using Functional Ambulation Classification scale
timeFrame: 0 and 4 weeks
measure: pain change assessed using Overall Neuropathy Limitation Scale
timeFrame: 0 and 4 weeks
measure: disability change assessed using Neuropathy Pain Scale
timeFrame: 0 and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gravedona ed Uniti
country: Italy
facility: Ospedale generale di zona Moriggia Pelascini
state: CO
Study officials:
References:
Clinical trial NCT00429117: Interest in Spirituality and Oncology: Is It An International Phenomenon?
Official title: Interest in Spirituality and Oncology: Is It An International Phenomenon?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stress
Keywords: Spirituality
Work Related Stress
Religious Beliefs
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-01-31
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physician members of the International Gynecologic Oncologists Society or the Society of Gynecologic Oncologists.

Brief summary: Primary Objective:

-To assess correlations between spiritual and religious beliefs and physician burnout using the Work Related Stress Inventory.

Secondary Objectives:

* To assess relationships between a physician's spiritual/religious beliefs and age, race, sex, marital status, and nationality.
* To explore differences in survey responses among oncologists from different countries: Duke University Religion Index (DUREL), Hoge (Intrinsic religiosity scale), Templer's Death Anxiety Scale, Locus of Control Scale, Work Related Strain Inventory, and non-validated case scenarios.
* To correlate survey responses to management of specific patient case situations.

Detailed description: Few studies have explored the spiritual/religious beliefs of physicians and almost none have been done outside of the United States until the last two years. Therefore, this is the first study of its kind to evaluate this subject internationally.

In the next few weeks individuals will be receiving an on line survey from Survey Monkey.

The purpose of the survey is to explore the spiritual/religious beliefs of oncologists from a world side perspective, to identify areas in which spiritual/religious beliefs may affect medical decision making, and to explore any correlation that may exist between spiritual/religious beliefs of oncologists and physician burn out.

The surveys will take about 30 to 40 minutes to complete. Survey results will be encrypted even in transmission and sent to a secure server for anonymity. Even if one chooses not to fill out the surveys investigators ask that each person complete the demographic questionnaire.

Without input, investigators will lose the opportunity to further an understanding of how spirituality and religious beliefs impact patient care and physician well being.

Investigators welcome any feed back.

Eligibility criteria: Inclusion Criteria:

* Physician members of the International Gynecologic Oncologists Society or the Society of Gynecologic Oncologists

Exclusion Criteria:

* None

Primary outcomes:
measure: Survey response to assess correlations between spiritual and religious beliefs and physician burnout.
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lois M. Ramondetta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00836641: Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics
Official title: Prospective Randomized Controlled Phase 4 Study on the Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: preschool asthma
sequential pneumococcal immunization
immunogenicity
safety
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2009-02-04
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Asthma is a major health problem in preschool children. Infections by pneumococci a the most frequent cause of airway infections, which tend to cause worsening of asthma. Vaccination against pneumococci is recommended by scientific boards and the medical community, in order to reduce the burden of disease. Data on the immunogenicity and safety of pneumococcal immunization in preschool asthmatics are scarce.

Detailed description: Respiratory infections are major triggers of exacerbations in preschool asthma. Many countries' guidelines recommend immunization against pneumococci for patients suffering from chronic airway disease. Also the interval between priming and booster is a matter of debate.

We immunize a large group of preschool asthmatics (2-5 years old) sequentially: one dose of seven-valent pneumococcal conjugate vaccine (PCV-7) followed by a single dose of 23-valent pneumococcal polysaccharide vaccine (PPV-23). We randomly assign half of the vaccinees to receive PPV-23 eight weeks after PCV-7 (group A), and the rest to a 10-month interval (group B). Pneumococcal antibody concentrations to serotype 4, 5, 6B, 7, 9V, 14, 18c, 19F, and 23F are determined initially, after two, and 12 months after PCV-7. Local and systemic reactions to each vaccine are recorded.

Eligibility criteria: Inclusion Criteria:

* asthma classified according to the Global Initiative on Asthma (GINA) °1-2

Exclusion Criteria:

* antecedent pneumococcal immunization

Primary outcomes:
measure: Immunogenicity of Pneumococcal Vaccination
timeFrame: 12 months
Secondary outcomes:
measure: Number of Vaccinees With Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Goethe University Childrens Hospital
name: Stefan Zielen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rose MA, Schubert R, Kujumdshiev S, Kitz R, Zielen S. Immunoglobulins and immunogenicity of pneumococcal vaccination in preschool asthma. Int J Clin Pract. 2006 Nov;60(11):1425-31. doi: 10.1111/j.1742-1241.2006.01093.x.
Clinical trial NCT03140241: Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults
Official title: Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nociceptive Pain
Monitoring, Intraoperative
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively.

Detailed description: An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in response to incremental nociceptive stimuli. The PDR is a robust reflex, even in patients under general anesthesia, and may provide a potential evaluation of the autonomous nociceptive circuit. American Society of Anesthesiologists (ASA) classification I or II patients undergoing elective surgery under general anesthesia are recruited. Enrolled patients perioperative undergo PDR measurement at 2 different standardized times (before and after opioid administration) generated by an inbuilt pupillary pain index (PPI) protocol. PPI, as a surrogate for nociception includes noxious stimulations from 10 up to 60 milli ampere (mA) until pupil dilation is larger than 13% from baseline diameter. Therefore, no inappropriate high stimulation is executed.

Eligibility criteria: Inclusion Criteria:

* Scheduled abdominal or gynecological surgery
* ASA I-II

Exclusion Criteria:

* History of eye deformity, invasive ophthalmologic surgery
* Known cranial nerve(s) deficit
* Infection of the eye
* Predicted difficult airway management (DAF Guidelines)
* Chronic opioid use (\>3 months)
* Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine
* Preoperatively administrated benzodiazepins or antiemetics

Primary outcomes:
measure: Stimulation Intensity
timeFrame: During perioperative period
Secondary outcomes:
measure: Pupillary Pain Index score
timeFrame: During perioperative period
measure: Systolic blood pressure
timeFrame: During PDR measurements
measure: Heart rate
timeFrame: During PDR measurements
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Michiel Baeten, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Antwerp
name: Natasja Peeters, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Antwerp
name: Vera Saldien, MD
role: STUDY_CHAIR
References: