louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01390012: Oral Versus Intravenous Dexamethasone
Official title: Oral Versus Intravenous Dexamethasone in Community-Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess bioequivalence for dexamethasone administered orally versus intravenously in patients admitted to hospital for pneumonia.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years and older
* Presenting to the emergency room with suspected pneumonia (to be confirmed within 24 hours from admission) Pneumonia is defined as a new or progressive infiltrate on a chest X-ray plus at least two of the following criteria: cough, sputum production, temperature \>38°C or \<35°C, auscultatory findings consistent with pneumonia, leucocytosis or leucopenia (\>10 g/l, \<4 g/l or \>10% rods in leucocyte differentiation), C-reactive protein \>3 times the upper normal limit Corticosteroid naive at time of presentation

Exclusion Criteria:

* Patients needing corticosteroid treatment above study medication
* Failure to obtain written consent to participate
* Patients using medication drugs that interact with dexamethasone (i.e. phenytoin, barbiturates, rifampicin, erythromycin, clarithromycin, aprepitant, colchicine, everolimus, itraconazole, ketoconazole, pazopanib, tipranavir, and vinorelbine)
* Moribund patients (defined as expected to die within 24 hours)
* Patients with proven or suspected allergy to dexamethasone
* Patients not capable of taking tablets orally

Primary outcomes:
measure: Area Under the Concentration time curve
timeFrame: 0-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius hospital
state: Utrecht
Study officials:
References:
citation: Spoorenberg SM, Deneer VH, Grutters JC, Pulles AE, Voorn GP, Rijkers GT, Bos WJ, van de Garde EM. Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community-acquired pneumonia. Br J Clin Pharmacol. 2014 Jul;78(1):78-83. doi: 10.1111/bcp.12295.
Clinical trial NCT05899712: Digital Versus Conventional Altered Cast Techniques For Constructing Mandibular Distal Extension Removable Partial Dentures Using Digitally Fabricated Frameworks: Alveolar Bone Height Changes
Official title: Digital Versus Conventional Altered Cast Techniques For Constructing Mandibular Distal Extension Removable Partial Dentures Using Digitally Fabricated Frameworks: A Clinical Comparative Parallel Study of Alveolar Bone Height Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Denture, Partial, Removable
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study compares between digital and conventional altered cast techniques using digitally constructed frameworks in removable partial dentures' construction regarding their effect on bone height changes around abutment teeth and in residual ridge.


Eligibility criteria: Inclusion Criteria:

1. All patients having completely edentulous maxilla and class I Kennedy mandible.
2. Sufficient (not less than 15 mm) restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane). This will be detected by a tentative jaw relation.
3. All patients are of angel's class I maxillo-mandibular relationships
4. Abutment teeth must meet certain requirements :

A. Abutment teeth should be healthy with good periodontal and bone support. B. should not show advanced destructions. C. should not show a pronounced degree of mobility or advanced gingival recession.

D. Crown Root Ratio for an abutment is 1:2

Exclusion Criteria:

1. Sever undercuts or concavities on the buccal or lingual sides of the ridge.
2. Systemic diseases that may affect bone changes such as diabetes and osteoporosis.
3. History of radiotherapy in the head and neck region.
4. Crown Root Ratio for an abutment is 1:1.

Primary outcomes:
measure: Alveolar Bone Height Changes
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlyia
Study officials:
References:
Clinical trial NCT06630546: Trabecular Microbypass IStent in Patients with Glaucoma
Official title: Trabecular Microbypass IStent in Patients with Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma (POAG)
Istent Inject W
Normal Tension Glaucoma (NTG)
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 71
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the safety and efficacy of phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent) versus phacoemulsification alone in a Taiwanese population, as well as to investigate any differences in outcomes between patients with primary open angle glaucoma (POAG) and those with normal tension glaucoma (NTG). The main question it aims to answer is:

• How much do intraocular pressure (IOP) and the number of antiglaucoma medications change after iStent insertion, with subgroup analyses for POAG and NTG? Researchers will compare phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent) versus phacoemulsification alone to see if IOP and the number of antiglaucoma medications decrease.

Participants will receive their regular phacoemulsification and decided whether to receive iStent by themselves.


Eligibility criteria: Inclusion Criteria:

Patients evaluated by a clinician who require cataract surgery or cataract surgery combined with iStent implantation due to concomitant glaucoma and cataracts.

Exclusion Criteria:

* Eyes that have previously undergone vitrectomy or retinal surgery.
* Patients with ocular surface inflammation (e.g., corneal ulcers, orbital cellulitis, etc.).
* Patients with hypotony (intraocular pressure \<5 mmHg).
* Patients with a history of globe rupture.

Primary outcomes:
measure: Intraocular pressure (IOP) in mmHg or percentage changes
timeFrame: From enrollment to the end of treatment at 18 months
measure: glaucoma medication changes in number
timeFrame: From enrollment to the end of treatment at 18 months
measure: Visual acuity changes in LogMAR scale
timeFrame: From enrollment to the end of treatment at 18 months
Secondary outcomes:
measure: Complete success and qualified success
timeFrame: From enrollment to the end of treatment at 18 months
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou Branch
state: No.5, Fuxing St., Guishan Dist.,
Study officials:
References:
Clinical trial NCT00580346: Dynamic Laryngotracheal Separation for Aspiration
Official title: Dynamic Laryngotracheal Separation for Aspiration. Prevention of Silent Aspiration Pneumonia During Swallowing by an Implanted Stimulator
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Aspiration Pneumonia
Keywords: Aspiration pneumonia
Implanted laryngeal stimulator
Vocal cord closure
Modified barium swallow
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: People who aspirate after neurologic insults such as stroke often develop fatal pneumonia. This study examines the effects of dynamic vocal cord closure on swallowing. Implants placed over the chest wall are connected to electrodes placed around the nerve that closes the vocal cords. The patient triggers closure by flipping the switch of a coil taped over the skin covering the internal stimulator. Vocal cord motion is verified by videotaping through an endoscope, and the status of swallowing is documented radiologically by a modified barium swallow.

Detailed description: Data pending

Eligibility criteria: Inclusion Criteria:

* Aspiration pneumonia after neurological insults (e.g. stroke)
* Ability to understand the purpose of the research
* Appropriate hand motor control
* Inability to improve under standard treatments (speech-language pathologists)
* Acceptance of a tracheostomy

Exclusion Criteria:

* Lack of understanding the research
* Poor hand motor coordination
* Uncontrolled seizures
* Pregnancy
* Refusal to accept a tracheostomy

Primary outcomes:
measure: Videotaping vocal cords and modified barium swallows
timeFrame: several months
Secondary outcomes:
measure: Tolerance of implanted device
timeFrame: immediate to several years
measure: comfort in swallowing
timeFrame: one year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Health System
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Michael Broniatowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Broniatowski M, Grundfest-Broniatowski S, Tyler DJ, Scolieri P, Abbass F, Tucker HM, Brodsky S. Dynamic laryngotracheal closure for aspiration: a preliminary report. Laryngoscope. 2001 Nov;111(11 Pt 1):2032-40. doi: 10.1097/00005537-200111000-00031.
Clinical trial NCT05734846: Multifocal Contact Lenses Fitting Methods Comparison
Official title: Biofinity Multifocal Contact Lenses Fitting Methods Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the clinical performance of two fitting approaches for multifocal contact lenses.

Detailed description: This was a prospective, cross-over, double-masked (participants and investigator), randomized order of testing study. It compared two fitting approaches for silicone hydrogel multifocal contact lenses to assess which method achieved greater vision satisfaction and performance.

Eligibility criteria: Inclusion Criteria:

* At least 40 years old;
* Have read and understood the Participant Information Sheet;
* Have read, signed and dated the Informed Consent;
* Best corrected visual acuity of at least 20/25 in each eye;
* Have normal eyes with the exception of the need for visual correction;
* Current multifocal contact lens wearer;
* Spectacle refraction:

Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: Established Presbyopes: +1.50D \& +1.75D

* Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.

Exclusion Criteria:

* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
* Monocular participants (only one eye with functional vision) or participants fit with only one lens;
* Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit;
* History of herpetic keratitis, ocular surgery or irregular cornea;
* Known pregnancy or lactation during the study period;
* Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.

Primary outcomes:
measure: Overall Vision Satisfaction
timeFrame: One week
measure: Overall Lens Preference
timeFrame: Two weeks
Secondary outcomes:
measure: Overall Binocular Visual Acuity Index
timeFrame: One week
measure: Number of Contact Lenses
timeFrame: One week
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Ocular Technology Group - International
Study officials:
affiliation: Ocular Technology Group - International
name: Michel Guillon, PhD, FCOptom
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04982146: Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei
Official title: Intratumoral Bromelain + N-acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei. Phase I Single-arm Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pseudomyxoma Peritonei
Keywords: pseudomyxoma peritonei
n-acetylcysteine
acetylcysteine
NAC
bromelain
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm experimental analytical study
Primary purpose: TREATMENT

Brief summary: This trial pursues studying a compassionate treatment option for patients with inoperable pseudomyxoma peritonei through percutaneous administration of bromelain + N-acetylcysteine (NAC) in order to decrease tumoral volume. Secondary endpoints are the decrease of ascites, compressive symptoms and pain through the dilution of mucins, which would better intestinal blockage.


Eligibility criteria: Inclusion Criteria:

* Pseudomyxoma peritonei diagnosis through imaging tests and/or histological studies
* Pseudomyxoma peritonei relapse in abdominal area in patients who comply inoperability criteria, which are:

At least two HIPEC operations or major abdominal surgery (PSS \> 3). Patients with acute morbidities (ASA score IV)

* ECOG 0-2
* Age ≥ 18
* Signs informed consent

Exclusion Criteria:

* Candidates to other potentially healing treatments
* Allergy to bromelains (pineapple), N-Acetylcysteine or possible cross-reactive allergy (eggs, sulphate. latex, carrots, celery, wheat...)
* Non-manageable coagulation alterations
* No possibility of intraabdominal drainage catheter
* Acute respiratory pathology (asthma, COPD), acute hepatic, cardiopathic or kidney pathology
* Allergy to any substance that might cause crossed reactivity to bromelain
* Unwillingness to participate in this clinical trial

Primary outcomes:
measure: Tumoral Mass Change
timeFrame: Day 3, Day 7 (if it applies),1 month and 12 months after treatment is finished.
Secondary outcomes:
measure: Symptoms improvement
timeFrame: Basal visit, 1 month and 12 months after treatment.
measure: TTP (Time to tumor progression)
timeFrame: Period of 12 months after treatment.
measure: Overall survival
timeFrame: Period of 12 months after treatment.
measure: Tumoral DNA diminution in biological samples
timeFrame: Basal visit, all treatment visits and 12 months after treatment is finished.
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
Study officials:
affiliation: Hospital Universitario Reina Sofía
name: Lidia Rodríguez Ortiz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Reina Sofía
name: Álvaro Arjona Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06717646: Using Laser Spatiotemporal Photoplethysmogram and Computational Method for Management of Chronic Disorders.
Official title: Laser Spatiotemporal Photoplethysmogram and Computational Method for Extended Chronic Cardiometabolic Therapeutic Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Glucose Monitoring
Blood Pressure Measurement
Lead sponsor: National Heart Centre Singapore
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
First posted: 2024-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from National Heart Centre Singapore

Brief summary: This investigational study is carried out to find out if a smartwatch monitor worn on the wrist that acts like a blood pressure monitor, will be able to replace the traditional blood pressure measurements using the traditional cuff that is wrapped around your arm.

Detailed description: NHC inpatients (Group A) Patients will be required to put on the LSPPG wearable sensor to take measurement once a day, starting from the day of recruitment till day of discharge. 3 ECG electrodes with cable linking to the LSPPG sensor wearable will also be attached on the chest. This helps to capture ECG rhythm at the same time. Study team member will assist the patient to take daily measurement.

NHC Outpatients scheduled for 24-Hour ABP monitoring (Group B) Patients will wear the LSPPG wearable sensor whilst wearing the 24-hour ambulatory blood pressure monitor. 3 ECG electrodes with cable linking to the LSPPG sensor wearable will also be attached on the chest. This helps to capture ECG rhythm at the same time. Readings will be obtained on an hourly basis during the duration of wearing the ambulatory blood pressure machine (clinical grade device).

Eligibility criteria: Inclusion Criteria:

* Above 21 years of age
* Sufficient language skills in English, Chinese, Malay or Tamil
* Provided informed consent

Exclusion Criteria:

* Skin sensitivity to adhesives

Primary outcomes:
measure: Comparable results to traditional methods
timeFrame: 24 Hours
measure: Improve efficiency
timeFrame: 24 Hours
measure: Lifestyle Improvement
timeFrame: 24 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
Study officials:
References:
Clinical trial NCT00944346: Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fed, Healthy, Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Torrent Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2009-07-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: * Objective:

  * A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects.
* Study Design:

  * Randomized,single-dose,2-way crossover.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years old.
* Subject had no clinically significant abnormal lab values at the screening evaluation.
* Subject's drugs of abuse, Hepatitis B, Hepatitis C, and HIV screenings were negative or non-relative.
* Acceptable screening of ECG.
* Female subject's pregnancy test at screening is negative.
* Subject had no evidence of underlying disease at the pre-entry physical examination.
* Subject has given written consent to participate.
* Female subject has not received any injectable or implantable contraceptive for a period of six months preceding this study.
* Agreed to undergo at least a 14-day pre-dose washout.
* Beginning two weeks prior to dosing and throughout the study, female subject of childbearing potential agrees to utilize one of the following methods of contraception:

  1. Condom and topical spermicide
  2. Condom and diaphragm
  3. Intra-uterine device (I.U.D)
  4. Complete abstinence.
* Agree to abstain from consuming caffeine or alcohol for at least 48 hours. prior to study and throughout the blood collection periods.

Exclusion Criteria:

* History of treatment for alcoholism, substance abuse, or drug abuse with in the past 24 months.
* History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
* History of GRD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
* History of treatment for asthma, hypoxemia, dehydration, sepsis, metabolic acidosis and congestive heart failure.
* Subject is pregnant or lactating.
* History of drug hyper sensitivity.
* Subject was treated with any investigational drug during the four weeks prior to initial dosing for the study.
* Subject smokes more then 15 cigarettes per day or uses tobacco products or currently uses nicotine products.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St, Charles
country: United States
facility: Gateway Medical Research, Inc.
state: Missouri
Study officials:
References: