louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00503282: Urinary Catheter Exchange on Admission of Septic Elderly With Permanent Catheter Before Initiation of Antibiotics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fever
Heart Rate
Blood Pressure
C-Reactive Protein
Erythrocyte Sedimentation Rate
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2007-07-18
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: In the era of emerging antibiotics resistant microbiology, we look for better outcome in the treatment of infections in the elderly.

We look for guidelines to manage an elderly who has a permanent urinary catheter, admitting to E.R. with Fever/Sepsis.

We assume that exchanging the permanent urinary catheter prior to the Urine Culture sample as well as for initiating antibiotic treatment will improve the outcome of the patients.It could help the day-to-day fight for the proper antibiotics treatment to avoid resistance.


Eligibility criteria: Inclusion Criteria:

* \>65 years
* Permanent Urinary Catheter
* FEVER or Septic State

Exclusion Criteria:

* Supra-Pubic Aspiration Catheters
* Septic Shock
* I.V. Antibiotics Initiated before admission

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: HEBREW UNIVERSITY, JERUSALEM
name: Ron Ben - Itzhak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01363882: Polysomnography-directed Noninvasive Ventilation in Amyotrophic Lateral Sclerosis (ALS)
Official title: Progression of Respiratory Dysfunction in Amyotrophic Lateral Sclerosis (ALS) Patients: A Comparison of Standard of Practice vs Polysomnography-Directed Nocturnal Non-Invasive Positive Pressure Ventilation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: Amyotrophic Lateral Sclerosis
Noninvasive Ventilation
Respiratory Dysfunction
Positive Pressure Ventilation
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: ALS Association
First posted: 2011-06-02
Enrollment: 25
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: SUPPORTIVE_CARE

Brief summary: Use of noninvasive ventilation (NIV, also known colloquially as "Bipap") has been associated in some studies with improvement in pulmonary function, quality of life and survival. NIV is typically applied during sleep, and without the benefit of sleep study to determine the optimal settings. The investigators have shown that when NIV is used in this fashion, failure of nocturnal oxygenation and ventilation is prominent. This study is randomizing patients to standard application of NIV vs application guided by use of sleep study data to determine the effect of titrated therapy on pulmonary function, quality of life and survival.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of probable or definite Amyotrophic Lateral Sclerosis (ALS) per El Escorial criteria
* Between ages of 18 and 80 yrs old

Exclusion Criteria:

* Inability to clear secretions from the airway
* Life expectancy \< 6 months from a comorbid condition
* Dementia sufficient to impair ability to use NIV, perform respiratory muscle pressure testing (PFTs), or complete Health-related Quality of Life (HRQOL) instruments
* Inability to follow up at the ALS Center on a regular basis
* Previously diagnosed obstructive Sleep Apnea

Primary outcomes:
measure: Change from baseline in spirometric, respiratory muscle strength, and gas exchange measures
timeFrame: Up to 6 months after starting NIV
Secondary outcomes:
measure: Duration that the Mental Component Summary (MCS) is maintained above 75% of baseline score for the Medical Outcomes Study Health Survey (SF-12)
timeFrame: Up to 6 months after starting NIV
measure: Survival
timeFrame: Up to 6 months after baseline
measure: Nocturnal oxygenation and ventilation
timeFrame: Up to 6 months after starting NIV
measure: Modified Borg dyspnea score (see description)
timeFrame: Up to 6 months after baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Robert C Basner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03014882: Sperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants?
Official title: Sperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Endocrine Disease
Fertility Decreased Male
DNA Damage
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 30
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Accumulation of iron in patients with beta thalassemia major causes free radical formation which leads to damage of biological membranes. Sperm DNA damage may result from these generated antioxidants.

We aimed at investigating the current DNA damage in the sperms of adult patients with beta thalassemia major and the effect generated by giving antioxidant treatment for 6 months.


Eligibility criteria: Inclusion Criteria:

* Pubertal patients with beta thalassemia major

Exclusion Criteria:

* Associated endcrinopathy

Primary outcomes:
measure: DNA fragmentation index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo Governorate
country: Egypt
facility: Ain Shams University Hospitals
state: Cairo
city: Cairo Governorate
country: Egypt
facility: Ain Shams University
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Heba H Elsedfy, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05633082: A Clinical Performance of Two Soft Toric Contact Lenses
Official title: A Clinical Performance of Two Soft Toric Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2022-12-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants received Lens 1 and then Lens 2 in fixed-sequence order.
Primary purpose: TREATMENT

Brief summary: The study objective was to gather short-term clinical performance data for two soft toric contact lenses.

Detailed description: This participant-masked, non-randomized, controlled non-dispensing study was to compare the performance of two soft toric lenses. Participants attended one study visit which lasted for approximately 1.5 hours.

Eligibility criteria: Inclusion Criteria:

* They are of legal age (18) and capacity to volunteer.
* They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They currently wear soft contact lenses, or have done so within the past two years.
* They have ocular astigmatism in both eyes of between 0.75DC and 3.00DC.
* They are expected to be able to be fitted with the study lenses within the power range available.

Exclusion Criteria:

* They have an ocular disorder which would normally contra-indicate contact lens wear.
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They are aphakic.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
* They are pregnant or lactating.
* They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
* They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Primary outcomes:
measure: Subjective Overall Score
timeFrame: 15 minutes
Secondary outcomes:
measure: Subjective Comfort
timeFrame: 15 minutes
measure: Subjective Vision
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research
Study officials:
affiliation: Eurolens Research
name: Philip Morgan, PhD, MCOptom
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00464282: Fluorine-18-α-Methyltyrosine Positron Emission Tomography for Diagnosis and Staging of Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Fluorine-18-α-methyltyrosine,
Positron emission tomography,
Fluorodeoxyglucose
Lung cancer,
Amino acid transportor 1,
Ki-67
Proven or suspected non-small cell lung cancer were enrolled in the study
Lead sponsor: Gunma University
Sponsor class: OTHER
First posted: 2007-04-23
Sex: ALL
Minimum age (years): 8
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Objective: L-\[3-18F\]-α-methyltyrosine (FMT) is an amino-acid tracer for PET. We evaluated the diagnostic usefulness of 18F-FMT PET in non-small cell lung cancer (NSCLC) patients. Tumor uptake of 18F-FMT PET was compared with 18F-FDG PET and the correlation with L-type amino acid transporter 1 (LAT1) expression also investigated.

Method: Fifty patients with NSCLC were enrolled in this study, and a pair of PET study with 18F-FMT and 18F-FDG was performed. LAT1 expression and Ki-67 labeling index of the resected tumors were analyzed by immunohistochemical study.


Eligibility criteria: Inclusion Criteria:

* proven or suspected non-small cell lung cancer

Exclusion Criteria:

* uncontrolled diabetes mellitus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gunma Unversity Graduate School of Medicine
name: kyoichi kaira, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaira K, Oriuchi N, Shimizu K, Tominaga H, Yanagitani N, Sunaga N, Ishizuka T, Kanai Y, Mori M, Endo K. 18F-FMT uptake seen within primary cancer on PET helps predict outcome of non-small cell lung cancer. J Nucl Med. 2009 Nov;50(11):1770-6. doi: 10.2967/jnumed.109.066837. Epub 2009 Oct 16.
Clinical trial NCT06665282: Efficacy of Pulsed High Intensity Laser Therapy in Psoriatic Hand Arthritis
Official title: Efficacy of Pulsed High Intensity Laser Therapy in Treatment of Psoriatic Hand Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Intensity Laser Therapy
Psoriasis
Hand
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 76
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to evaluate the therapeutic efficacy of pulsed high intensity level laser therapy in improving symptoms of psoriatic hand arthritis.

Detailed description: Psoriatic arthritis is a chronic, inflammatory joint disease affecting 20%-30% of patients with psoriasis. It affects peripheral joints and axial skeleton, causing pain, stiffness, swelling, and joint destruction. High-intensity laser therapy can control inflammation and improve pain relief, range of motion, and functional improvement. This study aims to examine High-intensity laser therapy efficacy in managing Psoriatic arthritis, aiming to provide a safe, effective, and noninvasive treatment method.

Eligibility criteria: Inclusion Criteria:

* Both sexes of patients their age range between 30-50 years.
* Bilateral PsA following psoriasis
* All participants who are diagnosed with PsA, and experience clinical symptoms such as pain, swelling, tenderness and stiffness less than 1 year from the beginning of disease.
* All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

* Positive rheumatic factor
* Circulatory disorders
* Diabetes
* Pregnant woman
* Skin diseases like urticaria.

Primary outcomes:
measure: Assessment of change of Hand Grip Strength using manual dynamometer
timeFrame: at baseline and after 2 months
Secondary outcomes:
measure: assessment of Joint counts for tenderness
timeFrame: at baseline and after 2 months
measure: assessment of Joint swelling count
timeFrame: at baseline and after 2 months
measure: assessment of pain intensity using visual analogue scale
timeFrame: at baseline and after 2 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: out-patient clinic, faculty of physical therapy, Cairo university
Study officials:
References:
Clinical trial NCT05362682: Effectiveness Evaluation of the Sinopharm Vaccine in the Dondo District in Mozambique
Official title: Effectiveness Evaluation of the Sinopharm Vaccine in the Dondo District in Mozambique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sars-CoV-2 Infection
Lead sponsor: International Vaccine Institute
Sponsor class: OTHER
Collaborators: name: The Coalition for Epidemic Preparedness Innovations (CEPI)
name: Instituto Nacional de Saúde, Mozambique
name: University of Antananarivo
name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Harvard University
name: Heidelberg University
First posted: 2022-05-05
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted in the Dondo District. For surveillance the catchment area will include participants from Dondo Sede and Mafambisse administrative posts. The participant will come for screening in the following health facilities; Dondo, Baptista, Mandruzi, Canhandula, Samora Machel) and in Mafambisse (Mafambisse and Bloco Nove) and at the community level, the study will involve walk-throughs for COVID-19 testing.

Brief summary: Three complementary activities will be implemented:1) Baseline and repeat census of the catchment population; described in a separate protocol (IVI-ECOVA-03-WS1); 2) Enhanced surveillance for COVID-19 disease, and 3) AEFI-enhanced surveillance. The mass vaccination campaign will be conducted by the Government and is not part of this protocol.


Eligibility criteria: Inclusion Criteria:

1. They resided in the study area at the time of mass immunization with the Sinopharm vaccine; and
2. They are at least 18 years of age during first round of mass vaccination.
3. Their onset of symptoms was \<10 days prior to testing.
4. For each selected PCR test-positive case, we will select up to 3 test-negative controls from generally eligible subjects, matched to each case by age on the date of testing, sex, and calendar date of testing + 3 days.

Exclusion Criteria:

1. We will exclude subjects for selection as controls if they have had a positive test result within the following 21 days
2. Any Participant not matching the inclusion criteria mentioned above.

Primary outcomes:
measure: Protection conferred by two completed doses of Sinopharm vaccine against confirmed COVID-19 disease
timeFrame: 2 years
Secondary outcomes:
measure: Evaluate the effectiveness of two completed doses of the Sinopharm vaccine against severe SARS-CoV-2 infection
timeFrame: 2 years
Other outcomes:
Locations:
city: Dondo
country: Mozambique
facility: Dondo Health Facility
Study officials:
References:
Clinical trial NCT04408482: Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?
Official title: Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endoscopic Retrograde Cholangiopancreatography
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the risk of PEP after pancreatic sphincterotomy performed for difficult cannulation in a group of patients with and in a group of patients without placement of a prophylactic pancreatic stent. The definition of difficult cannulation is defined according to the literature.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients with naïve papilla presenting to ERCP with indication of common bile duct (CBD) cannulation will be considered to the study.

Exclusion Criteria:

* Exclusion criteria are age below 18 years, acute pancreatitis and no consent to the study.

Primary outcomes:
measure: Post-ERCP pancreatitis rate
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki Univeristy Hospital
Study officials:
References:
Clinical trial NCT06666582: Real-world Data of Paclitaxel and Ramucirumab Compared to Other Treatment Regimens in Advanced Gastric Cancer
Official title: Real-world Efficacy and Toxicity Data of the Combination of Paclitaxel and Ramucirumab Compared to Other Treatment Regimens in Patients With Advanced Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer Stage IV
Second-line Treatment
Ramucirumab Paclitaxel
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus who had been treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG). All patients had received second-line treatment for advanced disease based on international/national guidelines. All regimens, combinations of drugs as well as monotherapy, were accepted. Patients were included in the analysis if they have received at least two months of second-line treatment. Patient clinicopathological characteristics and outcome data were retrospectively recorded from patient medical records. Toxicity data were retrospectively recorded from the clinicians' documentations of patient-reported symptoms and laboratory results during scheduled clinical visits or patient hospitalizations.

Brief summary: Our aim was to evaluate whether second-line treatment with paclitaxel and ramucirumab was associated with improved clinical outcomes compared to other available therapies. This study involved real-world data collection, focusing on the safety and efficacy of therapeutic combinations, administered to patients with pretreated advanced gastric cancer in the Oncology Departments affiliated with the Hellenic Cooperative Oncology Group (HeCOG).


Eligibility criteria: Inclusion Criteria:

* Patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus
* Treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG)
* Second-line treatment for advanced disease
* Treatment for at least two months of second-line treatment.

Exclusion Criteria:

* Lack of informed consent in case the patient was alive

Primary outcomes:
measure: Progression-free survival
timeFrame: From the initiation of second-line treatment to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, through study completion, up to 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: From the date of disease progression to the date of death from any cause or last contact, through study completion, up to 2 years.
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hellenic Oncology Cooperative Group
Study officials:
References:
Clinical trial NCT06930482: Evaluation of The Effectiveness of The SAFE Early Intervention Program
Official title: Effect of SAFE Early Intervention Program on Neurodevelopmental Outcomes At 1 Year of Age in Infants at Risk of CP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Sensory Disorders
Cerebral Palsy
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 46
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, it was aimed to examine the effect of SAFE, which is a sensory-based, activity-oriented early intervention approach applied in an enriched environment with family cooperation, on cognitive, language, motor and sensory development in 3-6 months old risky infants. 46 infants with neurodevelopmental risk, whose corrected age was 3 months, were included in the study. Infants were randomly divided into two groups. Infants in the treatment group were included in an early intervention program according to the SAFE approach. Infants in the control group were included in the family education program based on the principles of Neurodevelopmental Therapy (NDT). The intervention was performed for 12 weeks, and all infants were evaluated with Bayley Developmental Scale for Infants and Young Children III (Bayley III) by a blinded investigator before treatment (3rd months) after treatment (6th months) and 12th months.


Eligibility criteria: Inclusion Criteria:• Corrected age of 3 months

* Any neurodevelopmental risk (perinatal stroke, perinatal asphyxia, HIE, GMK-IVK, PVL or gestational age of 32 and below)

Exclusion Criteria: • Having a congenital anomaly

* Having a genetic syndrome diagnosis (e.g. Down Syndrome)
* Parents do not speak Turkish

Primary outcomes:
measure: Bayley Scales of Development for Infants and Toddlers III (Bayley-III)
timeFrame: 3 months,6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum Technical University
Study officials:
References: