louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03096106: Visual Assessment for Pressure-time Curve
Official title: The Reliability and Validity of Visual Assessment for Pressure-time Curve
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: intubated and mechanical ventilated by volume-control ventilation with constant flow

Brief summary: Airway pressure-time (P-t) curve and stress index (SI) assessment have been proposed to guide the mechanical ventilation settings and minimize ventilator-induced lung injury.

Detailed description: The stress index (SI), which has been proposed to guide the mechanical ventilation settings and minimize ventilator-induced lung injury. It reflects the change of respiratory compliance during inspiration. Value of SI equals to 1 that indicates a constant compliance, whereas values lower and higher than 1 indicate increase and decrease of compliance over inspiratory time, suggesting tidal recruitment and tidal hyperinflation, respectively. Based on the different values of SI showing different shapes, SI of straight curve equals to 1, SI of concave curve lower than 1 and convex curve higher than 1, the investigators speculated that the SI value could be reliably and accurately estimated by visual inspection of the P-t curve.

Eligibility criteria: Inclusion Criteria:

* aged 18 years or older; intubated and mechanical ventilated by volume-control ventilation with constant flow;

Exclusion Criteria:

* evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or existing chest tube; evidence of the stiff chest wall, such as existing the pleural effusion, intra abdominal hypertension, chest injuries and abdominal injuries.

Primary outcomes:
measure: the types of pressure time curve by visual inspection.
timeFrame: up to 10min, from the ventilator screen being frozen to the two observers completing judgement.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: ICU, Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Jian-xin zhou
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun XM, Chen GQ, Chen K, Wang YM, He X, Huang HW, Luo XY, Wang CM, Shi ZH, Xu M, Chen L, Fan E, Zhou JX. Stress Index Can Be Accurately and Reliably Assessed by Visually Inspecting Ventilator Waveforms. Respir Care. 2018 Sep;63(9):1094-1101. doi: 10.4187/respcare.06151. Epub 2018 Jun 26.
Clinical trial NCT00644306: Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma
Official title: Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Newly Diagnosed, Multiple Myeloma
Keywords: Multiple Myeloma, very elderly patients, thalidomide
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2008-03-26
Enrollment: 232
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been usedsince the 1960s and is regarded as the standard of care in very elderly patients. We assess whether the addition of thalidomide at 100 mg/day to this combination would improve survival.


Eligibility criteria: Inclusion Criteria:

* Stage II or III multiple myeloma according to Durie and Salmon criteria, patients older than 75 years, previously untreated patients.

Exclusion Criteria:

* Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma)
* Primary or associated amyloïdosis
* World Health organisation performance index of at least 3
* Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more
* Cardiac or hepatic dysfunction
* Cerebral circulatory insufficiency
* Absolute contraindication to corticosteroids
* Peripheral neuropathy clinically significant
* History of venous thrombosis during the last 6 months
* HIV or hepatitis B or C positivity
* Patients who had geography, social, or psychological conditions which might prevent adequate follow-up.

Primary outcomes:
measure: overall Survival
timeFrame: May 2007
Secondary outcomes:
measure: Progression Free Survival
timeFrame: May 2007
measure: Response rates
timeFrame: May 2007
measure: Safety
timeFrame: May 2007
Other outcomes:
Locations:
city: Vandoeuvre
country: France
facility: CHU Nancy - Brabois, rue du morvan
Study officials:
affiliation: Hematology CHU Nancy and Intergroupe Francophone du Myelome (IFM)
name: Cyrille Hulin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H; Intergroupe Francophone du Myelome. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007 Oct 6;370(9594):1209-18. doi: 10.1016/S0140-6736(07)61537-2.
Clinical trial NCT04357106: COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma
Official title: COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Centro de Hematología y Medicina Interna
Sponsor class: OTHER
Collaborators: name: Laboratorios Clínicos de Puebla (Laboratorios Ruiz)
First posted: 2020-04-22
Enrollment: 10
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: COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.


Eligibility criteria: Inclusion Criteria:

* Patients with SARS-CoV2 infection who have had a serious evolution and are in an ICU
* With or without ventilatory assistance
* Treated or not with hydroxychloroquine 200 mg. every 12 hours
* Indistinct sex
* Older than 18 years
* Signed informed consent

Exclusion Criteria:

* Patients treated with the following medications: azithromycin, ritonavir / lopinavir, remdesivir, interferons, ruxolinitib, tocilizumab.
* Patients with severe kidney failure who require replacement therapy.

Primary outcomes:
measure: Lung injury
timeFrame: 7 days
measure: Overall survival
timeFrame: 15-30 days
Secondary outcomes:
measure: Adverse reactions to plasma
timeFrame: 7 days
Other outcomes:
Locations:
city: Puebla
country: Mexico
facility: Centro de Hematología y Medicina Interna
Study officials:
References:
citation: Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
citation: Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.
Clinical trial NCT00884806: 7-Day, Multi-Site Study of an Investigational Multi-Purpose Disinfecting Solution for Contact Lens Wearers
Official title: Corneal Staining Evaluation of SiH MPDS FID 114675A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Care
Keywords: Contact lenses
Disinfecting solutions
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-04-21
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to clinically evaluate solution-related corneal staining with an investigational multi-purpose disinfecting solution (MPDS) in hydrogel and silicone hydrogel contact lens wearers.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Wear contact lenses a minimum of 8 hours per day for at least 7-10 days prior to Visit 1 (screening visit).
* Vision correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses at Visit 1.
* Must discontinue contact lens wear for at least two consecutive days before Visit 2 (baseline visit).
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude safe administration of test article or safe participation in the study.
* Known sensitivity or intolerance to any protocol-specified contact lens solutions, eye drops, or products containing similar ingredients (e.g., generic products).
* Monocular vision (only one eye with functional vision) or fit with only one contact lens.
* Use of topical ocular over-the-counter or prescribed topical ocular medication, with the exception of rewetting drops, within 7 days prior to screening visit.
* Current or history of ocular infection, inflammation, disease, structural abnormality or conditions within the last 6 months that could affect study participation or may preclude safe administration of the investigational lens care solution, in the opinion of the investigator.
* Any corneal surgery, cataract surgery, intraocular lens implants or glaucoma filtering surgery within the last 12 months.
* Any slit-lamp finding score of 1 (or rated 3 or 4 for limbal and bulbar conjunctival injection) at screening or baseline visits.
* Corneal staining area assessment ≥ 20% in any corneal region in either eye at baseline visit.
* Corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye at baseline visit.
* Participation in any investigational clinical study within 30 days of baseline visit.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Solution-Related Corneal Staining
timeFrame: Day 7
Secondary outcomes:
measure: Mean Lens Comfort
timeFrame: Day 7
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00822406: Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis
Official title: Quantitative-Qualitative Clinical Trial to Evaluate the Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinitis
Keywords: allergy
rhinitis
homeopathy
double-blind
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-01-14
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 41 adults with perennial allergic rhinitis were enrolled in a first double-blind placebo-controlled phase for six months, and treated on a weekly basis with sublingual doses of single individualized homeopathic medicines or placebo. After this closed initial phase, all patients were invited to participate in an long-term open-label controlled phase, in that they would receive homeopathic treatment for the maximum period of 36 months, and the results were compared with the improvement of initial phase. Signs and symptoms scores, rescue medication requirements and quality of life were assessed by questionnaires and personal clinical evaluation by a same independent researcher, before and after each phase. Primary and secondary clinical outcome were, respectively, specific and general allergic signs and symptoms scores. Total IgE titles were performed before and after each phase.


Eligibility criteria: Inclusion Criteria:

* moderate rhinitis
* to assign written informed consent

Exclusion Criteria:

* other chronic diseases
* corticosteroid use
* pregnancy

Primary outcomes:
measure: specific allergic signs and symptoms score
timeFrame: 6 months
Secondary outcomes:
measure: general allergic symptoms score
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Teixeira MZ, Guedes CH, Barreto PV, Martins MA. The placebo effect and homeopathy. Homeopathy. 2010 Apr;99(2):119-29. doi: 10.1016/j.homp.2010.02.001.
Clinical trial NCT03410706: Xarelto for Real Life Anticoagulation in Pulmonary Embolism (PE) in China
Official title: Xarelto® for Real Life Anticoagulation in Pulmonary Embolism (PE) in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Keywords: Venous thromboembolism
Anticoagulation
Rivaroxaban
Observation study
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2018-01-25
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated in Tertiary hospitals

Brief summary: EINSTEIN PE study demonstrated that rivaroxaban is at least as effective as the current standard therapy with 51% relative risk reduction of major bleeding (1.1% vs. 2.2%, HR 0.49, 95% CI, 0.31-0.79), in the treatment and secondary prevention of PE. However these patients were required to meet strict eligibility criteria. Little is known about PE treatment in China in routine clinical practice and in a real world study patients at higher or lower risk for adverse events can possibly recruited. Bayer conducts this study to yield post-authorization safety information in rivaroxaban under real-life conditions in China.


Eligibility criteria: Inclusion Criteria:

* Female or male patients, who are at \>=18 years
* Diagnosis of acute symptomatic or asymptomatic PE, objectively confirmed
* Indication for anticoagulation therapy for at least 3 months (as assessed by the attending investigator)
* Willing to participate in this study, having given informed consent and willing to participate in the routine follow-up during the period of rivaroxaban treatment.

Exclusion Criteria:

* Pre-treatment with any anticoagulant for the index PE more than the 2 weeks.
* Patients with another indication for anticoagulation other than VTE.
* Patients who participated in another study within 30 days

Primary outcomes:
measure: Major bleedings
timeFrame: Up to 12 months
Secondary outcomes:
measure: Symptomatic recurrent venous thromboembolic events
timeFrame: Up to 12 months
measure: Major adverse cardiac events
timeFrame: Up to 12 months
measure: Other symptomatic thromboembolic events
timeFrame: Up to 12 months
measure: Drug utilization
timeFrame: Up to 12 months
measure: Number of participants with adverse events and serious adverse events
timeFrame: Up to 12 months
measure: Patient treatment satisfaction by using questionnaire of ACTS (Anti-Clot Treatment Scale)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: China
facility: Many locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05329506: Attitudes and Believes About Vaccinations in a Supportive Care Patient Population
Official title: Attitudes and Believes About Vaccinations in a Supportive Care Patient Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccinations
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: M D Anderson Cancer Center

Brief summary: To learn about the attitudes and beliefs towards vaccination both before and after the COVID-19 pandemic in patients who have received supportive care.

Detailed description: Primary Objective:

Our primary objective is to assess patient perception of efficacy and safety of vaccinations.

Secondary Objectives:

To assess demographic predictors of those who would be considered as vaccine hesitant.

To assess patient preferred source of recommendations for or against vaccination.

To assess the role past side effects or allergic reactions play on patient perception of future vaccines.

To assess patient perception of vaccination prior to COVID-19.

To assess patient willingness to get the COVID-19 vaccine.

To assess patient willingness to get the influenza vaccine.

Eligibility criteria: Inclusion Criteria:

1. Patients who are seen as part of a clinic visit with the Supportive Care Clinic at M.D.

   Anderson Cancer Center, also patients who are being seen by the inpatient Supportive Medicine Consultation Service.
2. Patients who are 18 years of age or older
3. Patients who are able to speak English.

Exclusion Criteria:

1. Patients who are unable to sign written consent
2. Patients who are considered delirious at the time of the clinic encounter as defined by a Memorial Delirium Assessment Scale score of 7 or greater. The nursing staff, as a part of the patient intake process and routine care, performs the delirium assessment for clinic patients.

Primary outcomes:
measure: Exploratory survey evaluating the solely patient's opinions and perceptions regarding the safety and efficacy of vaccinations for Parent Attitudes about Childhood Vaccines (PACV-4 scale) with a score of 2 or greater.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Michael Tang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04758806: Fecal Microbial Transplantation in Severe Alcoholic Hepatitis
Official title: Fecal Microbial Transplantation for Corticosteroids Non-responders and Non-eligible Patients With Severe Alcoholic Hepatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Alcoholic Hepatitis
Keywords: Alcoholic hepatitis
Nonresponders
fecal microbial transplantation
Lead sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Eligible for the study are consecutive consenting adult patients
Primary purpose: TREATMENT

Brief summary: 1. A subtype of Alcoholic hepatitis (AH), named severe alcoholic hepatitis (SAH) is associated with high short-term mortality (J Hepatol, 2019)
2. The only SAH treatment option - corticosteroids (CS) - are often contraindicated or ineffective (STOPAH Trial)
3. New treatment modalities for remaining patients are much needed
4. Fecal microbial transplantation (FMT) is one of the promising therapies
5. Investigators aimed to see if FMT improves survival in patients admitted with SAH, not responding to-, or non-eligible for CS.

Detailed description: * FMT via upper GI tract is provided to CS non-responders (NR) or non-eligible (NE) adult patients hospitalized with SAH (determined by the Lille-model).
* Modified version of the Sarin FMT protocol is used with microbiota material procured from unrelated healthy donors.

Eligibility criteria: Inclusion Criteria:

* consenting, adult
* severe form of acute alcoholic hepatitis (SAH)
* non-responder to corticosteroids according to the Lille model
* patients with SAH not eligible for corticosteroids based on their contraindications

Exclusion Criteria:

* active infection
* presence of untreated large / high-risk / bleeding esophageal varices
* too sick for any therapy / futility (chronic extrahepatic organ failures, no potential for recovery, etc)
* malignancy except for hepatocellular carcinoma in Milan criteria

Primary outcomes:
measure: Mortality
timeFrame: 28-day
measure: Mortality
timeFrame: 90-day
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
measure: Acute on chronic liver failure
timeFrame: In-Hospital
Other outcomes:
Locations:
city: Banska Bystrica
country: Slovakia
facility: F.D.Roosevelt Teaching Hospital
Study officials:
affiliation: Head Dept Internal Medicine F.D.Roosevelt Teaching Hospital Banska Bystrica Slovakia
name: Lubomir Skladany, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: