louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05136300: Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer
Official title: Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Surgery
Lead sponsor: Isala
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: Morbidity in the post-operative phase of pulmonary surgery is characterised by impairment due to pain, dyspnoea and loss of exercise tolerance. We demonstrated previously that rehabilitation after thoracotomy is limited due to pain. Since minimal invasive surgery is the new standard in lung cancer, resulting in a reduction of postoperative pain, we believe there are new possibilities for post-operative integrated multidisciplinary rehabilitation in lung cancer.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing elective, minimal invasive surgery with intention to cure.
2. Age between 18 and 80 years.
3. ECOG 0 - 2 post-surgery.

Exclusion Criteria:

1. Patients with chronic pain
2. Previous pulmonary surgery
3. Comorbidity limiting rehabilitation

   1. Rheumatoid arthritis
   2. Severe ischaemic heart disease or myocardial failure; EF ≤ 35 %.
   3. Muscle disease
   4. Fibromyalgia
   5. Neurologic disorders (Parkinson disease, CVA and lesions of the spinal cord)
   6. Psychiatric disorders

Primary outcomes:
measure: Quality of life (SF-36)
timeFrame: 12 months
Secondary outcomes:
measure: SGRQ
timeFrame: 12 months
measure: VAS
timeFrame: 12 months
measure: WHO-PS
timeFrame: 12 months
measure: 6 minute walking distance
timeFrame: 12 months
measure: international physical activity questionnaire, iPAQ
timeFrame: 12 months
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala
Study officials:
affiliation: Isala
name: J Stigt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00600600: Tigecycline for Treatment of Rapidly Growing Mycobacteria
Official title: Use of Tigecycline for Treatment of Serious Infection Due to Rapidly Growing Mycobacteria (Especially M.Abscessus)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mycobacterium Abscessus Lung Disease
Rapidly Growing Mycobacterial Lung Disease
Lead sponsor: The University of Texas Health Science Center at Tyler
Sponsor class: OTHER
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2008-01-25
Enrollment: 8
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety, tolerance, and efficacy of Tigecycline when given daily to patients with rapidly growing mycobacterial disease (especially M.abscessus).

Detailed description: To assess the safety and efficacy of tigecycline in the treatment of drug resistant rapidly growing mycobacterial disease especially M. abscessus

Eligibility criteria: Inclusion Criteria:

* Positive cultures for rapidly growing mycobacteria
* Patients who have drug resistant isolates or are intolerant of macrolides or have serious infections unresponsive to currently available drugs
* Adults and children 10 years of age and older
* Pretreatment isolate of M. avium complex available for MIC determination
* Available for followup appointments

Exclusion Criteria:

* History of tetracycline allergy
* If a menstruating female, not pregnant and on adequate birth control

Primary outcomes:
measure: Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
timeFrame: 6 mos
Secondary outcomes:
measure: clinical and Microbiological outcomes
timeFrame: 6 mos
Other outcomes:
Locations:
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at Tyler
name: Richard J Wallace Jr., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wallace RJ Jr, Dukart G, Brown-Elliott BA, Griffith DE, Scerpella EG, Marshall B. Clinical experience in 52 patients with tigecycline-containing regimens for salvage treatment of Mycobacterium abscessus and Mycobacterium chelonae infections. J Antimicrob Chemother. 2014 Jul;69(7):1945-53. doi: 10.1093/jac/dku062. Epub 2014 Mar 14.
Clinical trial NCT00002200: A Study of 1592U89 in HIV-Infected Adults
Official title: A 1592U89 Open-Label Protocol for Adult Patients With HIV-1 Infection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV-1
Administration, Oral
CD4 Lymphocyte Count
RNA, Viral
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
abacavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give 1592U89 to HIV-positive adults. This study also examines the influence previous anti-HIV treatment has on the effectiveness of 1592U89.

Detailed description: Patients receive open-label 1592U89 administered orally in combination with at least one other antiretroviral agent that the patient has not previously received.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

Erythropoietin, G-CSF and GM-CSF.

Patients must have:

* CD4+ cell count \< 100 cells/mm3.
* HIV-1 RNA \> 30,000 copies/ml.
* Signed, informed consent from parent or legal guardian for patient under 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Renal failure requiring dialysis.
* Hepatic failure evident by grade 3/4 hyperbilirubinemia and AST 5 times the upper limit of normal.
* Documented hypersensitivity to 1592U89.
* Serious medical conditions, such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, that would compromise the safety of the patient.
* Participation in or ability to participate in an enrolling study of 1592U89.

Required:

At least 2 nucleoside reverse transcriptase inhibitors (NRTI) and one protease inhibitor (or intolerance to one protease inhibitor and one NRTI due to trying at least 2 different regimens with at least one protease inhibitor).

Alcohol or illicit drug use that may interfere with the patient's compliance.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Research Triangle Park
country: United States
facility: Glaxo Wellcome Inc
state: North Carolina
Study officials:
References:
Clinical trial NCT05726500: Evaluation of Regional Ventilation Distribution in Patients Affected by Abdominal Sepsis After Emergent Laparotomy
Official title: Evaluation of Regional Ventilation Distribution in Patients Affected by Abdominal Sepsis After Emergent Laparotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Sepsis
Acute Respiratory Failure
Ventilation Therapy; Complications
Emergencies
Keywords: Electrical impedance tomography
Emergent laparotomy
Compliance partinioning
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
Collaborators: name: University of Milan
First posted: 2023-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to evaluate regional ventilation distribution in patients admitted to the intensive care unit after emergent laparotomy due to abdominal sepsis. The main question it aims to answer is:

• evaluate if patients admitted after an open abdomen strategy have a different regional ventilation distribution compared to patients in which abdomen is closed at the end of the procedure

Participants will undergo non-invasive monitoring (esophageal pressure and electrical impedance tomography) and an blood gas analysis samples.

Researchers will compare open abdomen group and closed abdomen group to see if the ventilation distribution pattern is different.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 and \< 90 years
* Admitted to the ICU after emergent laparotomy for abdominal sepsis
* Acute respiratory failure

Exclusion Criteria:

* Controindications to electrical impedance tomography monitoring
* body mass index \> 40 kg/m2
* Haemodinamic instability
* Pneumothorax - Pneumomediastinum
* refusal to participate

Primary outcomes:
measure: Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator
timeFrame: Day 0
measure: Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator
timeFrame: Day 1
measure: Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator
timeFrame: Day 2
Secondary outcomes:
measure: Regional ventilation distribution measured using Electrical impedance tomography
timeFrame: Day 0
measure: Regional ventilation distribution measured using Electrical impedance tomography
timeFrame: Day 1
measure: Regional ventilation distribution measured using Electrical impedance tomography
timeFrame: Day 2
measure: Mortality in the intensive care unit
timeFrame: Up to 28 days
measure: Infection rate during ICU stay
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria Sant'Anna
Study officials:
References:
Clinical trial NCT05625100: Place of Intrathecal CXCL-13 in the Diagnosis of Lyme Neuroborreliosis
Official title: Place of Intrathecal CXCL-13 in the Diagnosis of Lyme Neuroborreliosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lyme Borreliosis
Keywords: Lyme borreliosis
Lyme neuroborreliosis
Bannwarth syndrome
Intrathecal CXCL-13
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥18 years old) subject having consulted at the HUS between 01/01/2013 and 31/12/2018

Brief summary: Neuroborreliosis (NBL) is diagnosed in 10-15% of patients with Lyme borreliosis. In Europe in adults, the main clinical manifestation is called "Bannwarth syndrome". This includes painful meningoradiculitis, sometimes accompanied by cranial nerve neuritis. Current European guidelines issued by the European Federation of Neurological Societies (EFNS) recommend the following triad for the diagnosis of "definite NBL": (i) Neurological symptoms suggestive of NBL without any other obvious cause; (ii) CSF pleocytosis; (iii) Intrathecal production of specific anti-Borreliella antibodies. CXCL13, C-X-C chemokine motif ligand 13, is a chemokine implicated in B cell chemotaxis. Extensive literature exists on the analysis of CXCL13i as a diagnostic marker for acute NBL. A recent meta-analysis from 2018, published by Rupprecht et al finds an overall sensitivity and specificity of 89% and 96% respectively, indicating satisfactory diagnostic value. In this study, the investigators wish to assess the place of this new marker in the diagnosis of neuroborreliosis before proposing it as a test carried out by the Borrelia CNR.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Subject having consulted at the HUS between 01/01/2013 and 31/12/2018
* Subject not having, after being informed, expressed their opposition to the reuse of their data for the purposes of this research

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Subject under guardianship or curatorship
* Subject under safeguard of justice

Primary outcomes:
measure: Positivity of the marker (CXCL13-intrathecal) for known cases of NBL and negativity of this one for known non-NBL cases
timeFrame: Files analysed retrospectively from January 01, 2013 to December 31, 2018 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Laboratoire de Bactériologie - Plateau Technique de Microbiologie - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT06242652: A Study to Evaluate 608 in Patients with Ankylosing Spondylitis (AS)
Official title: A Multicenter, Randomized, Double-blind, Double Dummy，placebo and Positive Controlled，phase II Clinical Study to Evaluate the Efficacy and Safety of 608 in Patients with Ankylosing Spondylitis (AS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Ankylosing Spondylitis
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-05
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect and safety of 608 in patients with AS.

Detailed description: The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of 608 compared to placebo and positive drug in patients with AS.

Eligibility criteria: Inclusion Criteria:

1. Female and male patients at least 18 years of age at the time of screening.
2. Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York criteria for AS.
3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4 and a Patient's Assessment of Total Back Pain score \>= 4 based on a 0 - 10 numeric rating scale (NRS) at the Screening and Baseline visits.
4. If entering the study on concomitant NSAIDs for AS, participant must be on stable dose(s) for at least 2 weeks prior to the Baseline visit.

Exclusion Criteria:

1. Patients with other uncontrolled active inflammatory diseases.
2. Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
3. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
4. History of cancer.
5. Known or suspected history of immunosuppression.

Primary outcomes:
measure: The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response.
timeFrame: Week 16.
Secondary outcomes:
measure: The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response.
timeFrame: Week 16.
Other outcomes:
measure: 608 Concentration in Serum.
timeFrame: Up to 24 Weeks.
Locations:
city: Beijing
country: China
facility: Site 01
state: Beijing
Study officials:
References:
Clinical trial NCT05770752: Lymphatic Function During Mechanical Ventilation
Official title: Effect of Mechanical Ventilation on Peripheral Lymphatic Function - do Elevated Intrathoracic Pressure Impact Lymphatic Flow?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphatic Insufficiency
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study wil examine the effect of altered intrathoracic pressure on lymphatic function, by investigating the lymphatic vessels in the lower limb during mechanical ventilation.

The lymphatic function will be examined using Near-Infrared Fluorescence Imaging.

Detailed description: This study wil examine the effect of altered intrathoracic pressure on lymphatic function. This will be done by investigating peripheral lymphatic vessels on patients undergoing surgery for malformations of the jaw who are being mechanically ventilated.

Subjects will be examined on two occasions. One to establish baseline function, and one during surgery following a ventilation protocol with altered PIP and PEEP.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery for jaw malformations
* Age \> 18 years
* Informed consent
* Cardiopulmonary healthy

Exclusion Criteria:

* History of Cardiac disease
* History of pulmonary disease
* History of lymphatic disease
* Peripheral edema
* Chronic infectious disease
* Age \> 30 years
* BMI \> 30

Primary outcomes:
measure: Peripheral lymphatic velocity (centimeters/second)
timeFrame: 3 hours
measure: Peripheral lymphatic frequency (contractions/minute)
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
Study officials:
affiliation: Copenhagen University Hospital at Herlev
name: Lene Thorup, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03360552: Evaluating the Effectiveness of a New Way of Organizing Primary Health Care to Improve the Management of Alzheimer's Disease
Official title: Evaluating the Effectiveness of a New Way of Organizing Primary Health Care to Improve the Management of Alzheimer's Disease EvaMMADom
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 320
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of the present study is to evaluate the effectiveness of a general practitioner (MG) management strategy guided by a multidimensional evaluation on the multidimensional score of fragility of patients with mild to moderately severe dementia, compared to those currently implemented (without the provision of such an assessment). The measurement of the respective effectiveness of the two types of care in primary care will itself be based on a multidimensional evaluation performed independently in the memory center having established the diagnosis of Alzheimer's disease. The secondary objectives are the evaluation of the impact of the strategy on the functional abilities of patients, the incidence of geriatric syndromes, cognitive functions, quality of life of the patient and the burden of the primary caregiver. The efficiency of the strategy will be assessed through a cost-effectiveness analysis. A survey of opinions will also be conducted among primary health care providers, carers and CMs on the implemented system.


Eligibility criteria: Inclusion Criteria:

* Patients with probable Alzheimer's disease, according to the criteria usually used in memory centers
* Aged over 64 years with mild to moderately severe dementia syndrome
* Volunteers for medical follow-up for a period of 20 months; Which the general practitioner attending agrees to participate in the research

Exclusion Criteria:

* Patients under 65 years old
* presenting with early cognitive decline or severe dementia
* Not meeting the clinical diagnostic criteria for Alzheimer's disease
* Refusing or unable to sign informed consent to participate
* Not voluntary for medical follow-up for a period of 20 months
* Whose general practitioner refuses to participate in the research

Primary outcomes:
measure: Assessment of multidimensional fragility scores
timeFrame: 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
References:
Clinical trial NCT00634452: Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
Official title: A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1401 Administered Weekly for 4 Weeks in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hodgkin's Lymphomas
Keywords: Hodgkin's
Cancer
bi-measurable disease
Lymphoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-03-13
Enrollment: 22
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry
* Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant
* Bi-measurable disease
* ECOG Performance Status of 0 - 2
* Meet all screening laboratory values

Exclusion Criteria:

* Previous treatment with any other anti-CD30 antibody
* History of allogeneic transplant
* Any tumor lesion greater than or equal to 10 cm in diameter
* Any active or chronic significant infection
* Underlying medical condition which will make the administration of MDX- 1401 hazardous
* Concomitant corticosteroids, chemotherapy, investigational agents, other anti-HL biologics, or radiation therapy

Primary outcomes:
measure: Safety and Tolerability Profile
timeFrame: Two years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Day 50
measure: Tumor response assessment
timeFrame: Two year
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Charlotte
country: United States
facility: ClinWorks Cancer Research Center
state: North Carolina
city: Temple
country: United States
facility: Scott and White Memorial Hospital and Clinic
state: Texas
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: