louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05646225: Early Mobilization With and Without Chest Physiotherapy in Chronic Bronchitis Patients.
Official title: Effects of Early Mobilization With and Without Chest Physiotherapy on Dyspnea, Pulmonary Function Test and Quality of Life in Elderly Patients With Chronic Bronchitis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Bronchitis
Keywords: early mobilization, chest physiotherap, chronic bronchitis
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 26
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It will be a randomized control trial study in which data are collected from hospital. A sample of 26 patients will divided into two group. One group of 13 patients will receive early mobilization and other group of 13 patients will receive early mobilization and chest physiotherapy only. All subject will receive 30 minute two session per day till two weeks. Outcome will be measured with MRC dyspnea scale and Pulmonary function test with spirometry to measure FEV1 and FEV1/FVC and quality of life will be checked by using ST. GEORGE'S respiratory questionnaire. Data will be analyzed by using SPSS version 21.

Detailed description: It will be a randomized control trial study in which data are collected from Jinnah hospital Lahore. A sample of 26 patients will be included and divided into two group. One group of 13 patients will receive early mobilization with chest physiotherapy and other group of 13 patients will receive early mobilization only. All subject will receive 30 minute two session per day till two weeks. Outcome will be measured with MRC dyspnea scale and Pulmonary function test with spirometry to measure FEV1 and FEV1/FVC and quality of life will be checked by using ST. GEORGE'S respiratory questionnaire. Data will be analyzed by using SPSS version 21.

Eligibility criteria: Inclusion Criteria:

* Both gender of age 45-70 years
* Patient diagnosed with chronic bronchitis (admitted patients)
* Taking bronchodilators

Exclusion Criteria:

* • Patient having any other condition cardiovascular, diabetes mellitus and neurological conditions

  * Patient history of radiotherapy
  * Unconscious ICU patients
  * Patient received any pre-admitted Physiotherapy protocol

Primary outcomes:
measure: St. George Respiratory Questionnaire
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
measure: pulmonary function test FEV1
timeFrame: Two weeks
measure: pulmonary function test
timeFrame: Two weeks
measure: MRC dyspnea scale
timeFrame: Two weeks
Locations:
city: Lahore
country: Pakistan
facility: Jinnah hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Madiha younas, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00646425: The Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis
Official title: Randomized, Double-Masked, Placebo-controlled Evaluation of the Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis Who Undergo Tapering of Concomitant Immunosuppressive Medications
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-infectious Uveitis
Keywords: Non-infectious uveitis
Lead sponsor: Cerimon Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2008-03-28
Enrollment: 5
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to assess if treatment with basiliximab allows subjects to taper off other immunosuppressive drug regimens without causing an increase in their uveitis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of noninfectious intermediate, posterior or panuveitis of at least 3 months duration
* Treatment with greater than or equal to 20 mg/day of Prednisone at baseline or immunosuppressive drug score of greater than or equal to 5 at baseline
* BCVA by ETDRS protocol better than or equal to 20/200
* Intraocular pressure of 24 mmHg or less
* Anterior chamber cells and vitreous haze of less than or equal to 1
* Male or females, aged 12 or greater, body weight of 40 kg or greater

Exclusion Criteria:

* Prior treatment with Retisert
* Primary diagnosis of anterior uveitis, uveitis of infectious etiology or Behcet's disease
* Pregnancy or breast-feeding
* Increase in systemic immunosuppressive treatment regimen within 6 weeks before baseline

Primary outcomes:
measure: To prevent an increase in disease activity as measured by anterior cell count, vitreal haze and visual acuity while subjects with stable noninfectious uveitis undergo tapering of concomitant immunosuppressive medications
timeFrame: The primary outcome will be assessed at Week 16
Secondary outcomes:
measure: Secondary objectives are to assess changes in visual acuity, retinal thickness, corticosteroid dose, and immunosuppressive drug score. Basiliximab pharmacokinetics and immunogenicity will also be assessed
timeFrame: These measures will be assessed at Week 16
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Ocular Immunology & Uveitis Foundation
state: Massachusetts
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: Belmont
country: United States
facility: Southeast Clinical Research Associates
state: North Carolina
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Vitreoretinal Consultants
state: Texas
Study officials:
affiliation: Cerimon Pharmaceuticals
name: Shaily Reichert
role: STUDY_DIRECTOR
References:
Clinical trial NCT06424925: Use of Artificial Intelligence (AI) to Predict Clinical Outcomes in Patients Hospitalized for COVID19 Pneumonia During the 4 Pandemic Waves
Official title: Use of Artificial Intelligence (AI) for the Prediction of Clinical Outcomes Such as Death and Complications in Patients Hospitalized for COVID Pneumonia During the 4 Pandemic Waves at the ASST of Lecco.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COVID-19 Pandemic
Lead sponsor: Azienda Ospedaliera di Lecco
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For each patient, information will be collected regarding:

* Personal data (i.e. age, sex, nationality);
* Date of hospitalization and discharge (or death)
* Comorbidities;
* Treatments undertaken for Covid19;
* Possible vaccination for Covid19, date and number of doses;
* Possible onset of secondary infections and/or complications;
* Blood chemistry tests upon admission

Brief summary: Predictive models can be applied in different areas, during the emergency of the COVID-19 pandemic, in fact, they have proven important in supporting health systems in planning strategic decisions and in formulating health policies for the containment of the disease.

The Covid-19 pandemic, in particular, has represented a real challenge for our healthcare system. In Italy, it was divided into four main waves, each characterized by different types of patients and different therapeutic approaches progressively improved based on new scientific evidence.

The objective is to carry out a study on the data of patients hospitalized for COVID-19 at the ASST of Lecco during all four pandemic waves, with different degrees of severity of illness, collecting the data of interest and applying it to they use artificial intelligence to identify recurring patterns of clinical outcome in terms of survival and secondary infectious complications, so as to build new reliable predictive statistical models that can be used to predict the outcome of the patients themselves.

The strong ambition of this project is that the application of artificial intelligence to data of such significant quantity can allow us to build valid statistical models which can then be hypothetically applied to any patient to predict, based on anamnestic characteristics, blood chemical parameters. at baseline and at the set treatment, the probability of survival and complications


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years;
* Hospitalization for COVID-19 pneumonia at ASST Lecco.

Exclusion Criteria:

* Hospitalization or finding of asymptomatic SARS CoV-2 infection.

Primary outcomes:
measure: Construction of predictive models
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lecco
country: Italy
facility: Stefania Piconi
Study officials:
References:
Clinical trial NCT00585325: Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes
Official title: Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-01-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients will be randomized prospectively to one of two groups. One group will receive 5 mg/kg of 1% lidocaine, and the other will receive .9 normal saline, instilled into their VAC sponge ½ hour prior to VAC dressing change. All patients will complete a pain assessment tool prior to receiving the instilled lidocaine/placebo, immediately after the procedure and 1 hour after the procedure. Pain scores will then be compared between the lidocaine and placebo groups.

Risks: Lidocaine toxicity is a potential risk, but 5 mg/kg of 1 % Lidocaine is below toxicity thresholds in an adult.

Detailed description: • All Burn service patients (inpatients and outpatients in burn clinic) who are receiving VAC therapy will be screened for study inclusion criteria. Those with allergies to lidocaine will be excluded. Participants will be enrolled until a sample size of 80 wound VAC changes is achieved. Up to 4 VAC dressing changes can be included in this study per participant. Subjects will be randomized prospectively for each dressing change. Utilizing a randomized bracketed approach, patients will be assigned to one of two groups: Lidocaine group or Placebo group. The Pharmacy Research Center (PRC) will assign patient a study Identification (ID) number and record it along with their medical record number on the Master Study ID List. They will then randomize the participants by drawing randomly shuffled green vs white index cards. (40 white card = 0.9 normal saline and 40 green card = 5 mg/kg of 1% Lidocaine). They will draw up the appropriate amount of medication to be used, label it with the patients Medical Record (MR) #, date, and administration instructions and deliver it to the nurse who is doing the VAC dressing change. They will keep the Master Randomization Data Collection Tool in a locked drawer in her office.

Eligibility criteria: Inclusion Criteria:

* all burn service patients with a wound vac

Exclusion Criteria:

* allergy to lidocaine

Primary outcomes:
measure: Pain During Dressing Change
timeFrame: During dressing change
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael J Schurr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00422825: Effect of Food on Bioavailability of a Modified Release Formulation of Imatinib
Official title: A Phase I, Open-label, Randomized, Crossover Study to Investigate the Effect of Food on the Bioavailability of a Single 800 mg Imatinib Dose in a Modified Release Formulation (MR2) and Compare the Bioavailability Between MR2 and Imatinib 400 mg Twice Daily Immediate Release Tablet (IR) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Food effect
bioavailability
pharmacokinetic
imatinib
STI571
modified release formulation of STI571
CML
Chronic Myeloid Leukemia
Philadelphia Chromosome
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-17
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single center, four-treatment, four period, crossover study to evaluate the effect of food on the relative bioavailability of a single dose of imatinib (STI571) given as a 800 mg modified release tablet, MR2 compared to twice-daily doses of 400 mg film-coated imatinib tablets. There will be a 10 day wash out phase between treatments and a 1 week safety period at the end of the study. Each participant will receive all four treatments


Eligibility criteria: Inclusion criteria

* Healthy male or female subjects (postmenopausal women)
* Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion criteria

* Smokers
* Subjects using any prescription drug or over-the-counter (OTC) medication (including herbal and alternative medication) within 2 weeks prior to dosing.
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
* A past medical history or presence of clinically significant ECG abnormalities including:
* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
* History of medications pre-disposing the subjects for GI bleedings/cerebral hemorrhage.
* Women taking any biphosphonates (Fosomax like drugs)
* History of being immunocompromised, including a positive HIV test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* Females nursing infants. Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Assess the effect of food on bioavailability and pharmacokinetics of modified and immediate release formulations of imatinib
Secondary outcomes:
measure: To compare safety and tolerability of 800 mg modified release formulation with or without food.
measure: To compare the relative bioavailability of a single dose 800 mg modified release formulation (with a low fat breakfast) with the marketed 400 mg immediate release tablet administered (with a low fat breakfast) twice daily
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00463125: Platelet Gel in Systemic Sclerosis
Official title: Platelet Gel for Digital Ulcers in Patients With SSc: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Scleroderma, Systemic
Keywords: Scleroderma, systemic
therapeutic
platelet gel
Lead sponsor: Università Politecnica delle Marche
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 40
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: * Systemic sclerosis (scleroderma; SSc) is a connective tissue disease characterized by a progressive fibrosis of the skin and visceral organs.
* A diffuse cutaneous microvascular damage occurs in 30-50% of patients, often leading to digital ulcers development, responsible for pain, functional disability, disfiguring scars, digital bony reabsorption, infection and osteomyelitis.
* Although the availability of drugs as i.v. prostacyclin analogs, oral vasodilating agents, oral phosphodiesterase-5 inhibitors, oral endothelin receptor blockers has improved the prognosis, digital ulcers are frequently refractory to the medical treatment.
* Preliminary data seems to demonstrate a pivotal role played by some growth factors (PDGF, TGF beta 1-2, IGF) in the process of ulcers healing: tissue regeneration and re-epithelization. Alpha-granules in the platelets store these factors in significant amount.
* Recently, the application of a gel rich in platelets, prepared from donors' plasma taken by apheresis, seems to be beneficial to enhance pressure and vascular ulcers healing.
* On the basis of these considerations we expect that application of a platelet gel, combined with advanced dressing and conventional medical therapy, makes a more rapid healing of digital ulcers in patients with systemic sclerosis. We decided to conduct a double blind RCT to test this hypothesis


Eligibility criteria: Inclusion Criteria:

* Digital ulcers (NPUAP stage≥2) in patients with SSc (ACR criteria)
* Current medical treatment with intravenous prostanoids
* Availability to come to our centre for weekly ulcer assessment and medication
* Capacity to give informed consent

Exclusion Criteria:

* Clinical evidence of skin infection
* Current treatment with Bosentan or Sildenafil
* Presence of necrotic material occluding the wound bed.

Primary outcomes:
measure: Time from diagnosis to complete ulcer healing
measure: Rate of ulcers healed during the follow up period (10 weeks)
Secondary outcomes:
measure: Rate of ulcers healed during the follow up period (10 weeks)
measure: Pain evaluation (VAS scale)
measure: Rate of complications
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Università politecnica delle marche
Study officials:
affiliation: Università Politecnica delle Marche
name: Armando Gabrielli, MD, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03675425: The Effects of Phototherapy in Preterm Infants Pda
Official title: Chest Shielding for Prevention of a Patent Ductus Arteriosus in Preterm Infants Receiving Phototherapy Effect of Phototherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patent Ductus Arteriosus After Premature Birth
Hyper Bilirubinemia
Keywords: Chest shielding
Patent Ductus Arteriosus
Chest Childing
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 54
Sex: ALL
Minimum age (years): 3
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The study was designed to assess whether chest shielding during phototherapy reduces the incidence of PDA, as assessed by serial echocardiographic examinations, in a population of extremely preterm infants born at lower 30 week gestation.

Detailed description: Phototherapy is a therapeutic intervention frequently used for management of neonatal hyperbilirubinaemia in extremely premature infants, especially in the first week when patency of the ductus is a clinical problem. Phototherapy has also been implicated in increased ductal patency. One randomized, controlled trial showed that chest shielding during phototherapy reduced the incidence and severity of PDA by 50% in preterm infants. These findings were mainly based on clinical evaluation of the ductus with echocardiographic studies performed only on a subgroup of infants noted to have a murmur on clinical examination.

Eligibility criteria: Inclusion Criteria:

* Gestational week ≤ 30 weeks receiving phototherapy due to jaundice and infants who can perform echocardiography before and after treatment will be included in the study.

Exclusion Criteria:

* Babies with congenital heart disease.
* Infants with major structural anomalies and infants who can not undergo echocardiography before or after treatment.

Primary outcomes:
measure: echocardiographic examination
timeFrame: first week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Matarnity Teaching
Study officials:
affiliation: zekai tahir burak matarnity teaching hospital
name: Evrim Alyamaç Dizdar, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06480825: Application of Ultra-high Frequency Ultrasonography (UHFUS) to the Study of Gingival Tissues
Official title: Ulta-High Frequency Ultrasound Assessment of Normal Versus Gingivitis Affected Gingival Tissues
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gingivitis
Periodontitis
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients referred to the Sub-Unit of Periodontology, Halitosis, and Periodontal Medicine of the Unit of Dentistry and Oral Surgery at the University Hospital of Pisa will be enrolled.

Brief summary: Gingival inflammation triggered by the accumulation of bacterial is the primary risk factor for the development of periodontitis. Clinically, localized signs of inflammation limited to the gingiva, presence of significant bacterial plaque load, and stable attachment levels on the periodontium can be observed in course of gingivitis. The aim of the present study is to compare clinical aspects of gingival tissue in healthy patients versus patients with gingivitis to assess the ultrastructural variations present in course of inflammation.

Patients with gingivitis and healthy controls will be enrolled. All patients will undergo ultra-high frequency ultrasonographic scans (70 MHz) of gingival tissue on three areas per dental arch (anterior, middle right, middle left). Gingival thickness, echogenicity, and vascularization assessed through resisitive index will be evaluated.


Eligibility criteria: Inclusion Criteria:

* males or females of age \> 18 years
* presence of at least 20 teeth
* full-mouth plaque score (FMPS) \>50%
* FMBS \>30%
* ability and willingness to give informed consent

Exclusion Criteria:

* pregnancy or breastfeeding
* pharmacological treatment with antinflammatory drugs, statins, or either local or systemic antibiotics (within the previous 30 days)
* smoking habit
* dental or periodontal condition requiring immediate treatment
* refusal to be enrolled in the study

Primary outcomes:
measure: Echogenicity
timeFrame: measured once at enrollemnt
Secondary outcomes:
measure: Vascular parameters
timeFrame: measured once at enrollemnt
measure: DMFT
timeFrame: measured once at enrollement
measure: PPD
timeFrame: measured once at enrollement
measure: FMBS
timeFrame: measured once at enrollement
measure: FMPS
timeFrame: measured once at enrollement
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University of Pisa
city: Pisa
country: Italy
facility: Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University Hospital of Pisa
Study officials:
References: