louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03583151: Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger
Official title: Injection With Amniotic Fluid Versus Corticosteroid in Patients With Stenosing Tenosynovitis: a Randomized, Blinded Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stenosing Tenosynovitis
Keywords: Corticosteroid
Lead sponsor: J&M Shuler
Sponsor class: INDUSTRY
Collaborators: name: Vivex Biomedical
First posted: 2018-07-11
Enrollment: 100
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: The proposed study aims to investigate whether amniotic fluid injections are a better alternative to corticosteroid injections as a conservative treatment for stenosing tenosynovitis. Based on results from our most recent pilot study exploring patient outcomes after receiving an amnion injection, we were able to observe symptom resolution in more than half of the study population. Adverse events were extremely rare and not related to study participation. Given the numerous occurrences of successful symptom resolution, the next step is to compare patient outcomes to those of patients who receive the standard steroid injection. This study will compare outcome measurements of patients who receive amnion injections to those who receive steroid injections.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is diagnosed with stenosing tenosynovitis

Exclusion Criteria:

* Patient is less than 18 years of age
* Pregnancy
* Enrolling clinician does not believe that the patient is mentally capable of understanding the research nature of the procedure due to mental handicap/disability or illiteracy.

Primary outcomes:
measure: Patient reported pain level
timeFrame: 12 months
Secondary outcomes:
measure: Trigger frequency
timeFrame: 12 months
measure: Disabilities of the Arm Shoulder and Hand score
timeFrame: 12 months
Other outcomes:
Locations:
city: Athens
country: United States
facility: Athens Orthopedic Clinic
state: Georgia
Study officials:
affiliation: Athens Orthopedic Clinic
name: Michael Shuler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00047554: Study of TRAVATAN in Subjects With Iris Pigmentation Changes
Official title: A Five-Year, Multicenter, Commercial Label Safety Study of TRAVATAN® 0.004% in Patients With TRAVATAN-Induced Iris Pigmentation Changes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: open-angle
glaucoma
ocular
hypertension
primary open-angle glaucoma
iris
pigmentation
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2002-10-18
Enrollment: 336
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were identified and enrolled from 23 investigational centers in the US.

Brief summary: The purpose of this study was to monitor iris pigmentation changes over a 5-year period in patients with open-angle glaucoma or ocular hypertension. To be eligible for the study, these individuals must have experienced an iris pigmentation change while previously dosing with TRAVATAN.


Eligibility criteria: Inclusion:

* Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension;
* Has experienced an iris pigmentation change while dosing with TRAVATAN;
* Currently dosing with TRAVATAN;
* Other protocol-defined inclusion criteria may apply.

Exclusion:

* Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension;
* Not currently using TRAVATAN;
* Females of childbearing potential if pregnant, breast-feeding, or not using highly effective birth control measures;
* History of any severe ocular pathology (including severe dry eye);
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change in Iris Pigmentation from Baseline for Study Eye by Visit
timeFrame: Baseline, Up to Year 5
Secondary outcomes:
measure: Incidence of Change in Eyelash Characteristic from Baseline for Study Eye by Visit
timeFrame: Baseline, Up to Year 5
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Theresa Landry, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06499454: Adequacy Assessment of Bronchoscopic Biopsy Samples Using a Novel Instrument
Official title: Adequacy Assessment of Bronchoscopic Biopsy Samples Using a Novel Instrument
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer
Lung Diseases
Keywords: lung biopsy
bronchoscopy
Lead sponsor: Ruby Robotics Inc
Sponsor class: INDUSTRY
Collaborators: name: Beth Israel Deaconess Medical Center
First posted: 2024-07-12
Enrollment: 50
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: The cohort will be selected from patients undergoing routine transbronchial lung and/or thoracic lymph node biopsy procedures

Brief summary: The goal of this study is to learn whether the Ruby Robotics system enables pathologists to determine whether a bronchoscopic biopsy sample is adequate for diagnosis. The main question it aims to answer is:

- Are pathologists' evaluations of Ruby digital images concordant with their evaluations of manually created rapid on-site evaluation slides?


Eligibility criteria: Inclusion Criteria:

* The subject will undergo a planned, non-emergent transbronchial lung and/or thoracic lymph node biopsy.

Exclusion Criteria:

-

Primary outcomes:
measure: Concordance between pathologists' rapid evaluations of Ruby images and manually-prepared slides
timeFrame: 2 months from time of sample collection
Secondary outcomes:
measure: Pathologist ratings of quality metrics for Ruby images and manually-prepared slides
timeFrame: 2 months from time of sample collection
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02295254: Microbiome Changes in Travelers to Tropical Destinations
Official title: Microbiome Changes in Travelers to Tropical Destinations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intestinal Diseases
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Weizmann Institute of Science
First posted: 2014-11-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Travelers who intended to travel to tropical areas.

Brief summary: The human gut contain a wide range of microorganisms creating the gut microbiome. The microbiome has great impact on metabolic and immunologic processes and responses. Travelers who travel to tropical destinations where the intestinal infection risk is high are prone to microbiome changes. During the current study the travelers will give feces specimen before and after the travel and their microbiome will be analyzed.

Detailed description: Individual differences in the microorganisms variety are affected by external factors such as food, age, geographic location, medication consumption, host genetics and exposure to microorganisms in early stages of life. During the current study the geographic location affect will be tested by comparing the microorganism environment before and after traveling to tropical destinations.

Eligibility criteria: Inclusion Criteria:

* Travelers who intended to travel to tropical areas
* Good general health

Exclusion Criteria:

* Medication consumption
* Background diseases

Primary outcomes:
measure: Type and number of intestinal microorganisms
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Center of Geographic Medicine
Study officials:
affiliation: Eli.schwartz@sheba.health.gov.il
name: Eli Schwartz, MD, DTMH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01393054: Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension
Official title: Effect of Nigella Sativa Seed Extract on the Blood Pressure of Elderly With Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertension
Keywords: Nigella sativa seed extract
hypertension
elderly
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 76
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Despite of the development of new anti hypertensive agents, hypertension in elderly is still a big health problem. Nigella sativa seed extract, derived from a small plant originating in Middle east which can be found abundantly in Asia, has shown small antihypertensive effect in adult. Diuretic effect of Nigella sativa is thought to be the main mechanism for the effect but as it also shows anti-inflammatory and vasodilatory activity which are important contributors in arterial stiffness, the main pathogenesis of hypertension in elderly, thus it has a superior potential benefit for this population. We will conduct a randomized, double blind, placebo-controlled trial to prove the effect of Nigella sativa seed extract in elderly patients with hypertension. Our hypothesis is 300 mg Nigella sativa seed extract twice daily will have anti-hypertensive effect in the blood pressure of elderly with hypertension.

Detailed description: The study will be conducted in Geriatric Outpatient Clinic of Cipto Mangunkusumo National Hospital, Jakarta, Indonesia.

Eligibility criteria are men and women over 60 years old and available to participate in the study for 4 weeks with blood pressure higher than 140/90.

Exclusion criteria are renal disease, hepatic failure, dementia and orthostatic hypotension and malignant hypertension.

Outcome measures are systolic and diastolic blood pressure after 4 weeks administration of 300 mg Nigella sativa seed extract twice daily.

Eligibility criteria: Inclusion Criteria:

* Men and women more than 60 years old
* Systolic Blood Pressure 140 mm Hg AND OR diastolic blood pressure 90 mmHg
* Available during study duration (4 weeks)

Exclusion Criteria:

* Renal failure
* Hepatic failure
* Dementia
* Orthostatic hypotension
* Malignant hypertension

Primary outcomes:
measure: systolic blood pressure
timeFrame: 4 weeks
Secondary outcomes:
measure: diastolic blood pressure
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo National Hospital
Study officials:
affiliation: Faculty of Medicine University of Indonesia
name: Aulia Rizka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04896554: Comparison of the Health Literacy of Our Patients Who Quit Smoking and Who Cannot Quit Smoking
Official title: Comparison of the Health Literacy of Our Patients Who Quit Smoking and Who Cannot Quit Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Health Literacy
Keywords: smoking cessation
health literacy
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-05-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of the study was determined to examine the relationship between the health literacy scales of the patients who came to the smoking cessation clinic and their smoking cessation success.

The patient follow-up files registered in the archive of the smoking cessation clinic will be scanned for the last 2 years and the demographic data and follow-up information of the patients will be reached. Patients who have completed the 1-year follow-up period will be contacted by phone, questioning whether they smoke or not, and will be invited to answer the health literacy scale. Accepting patients will be divided into two groups as those who quit smoking and those who cannot, and health literacy scales will be compared.


Eligibility criteria: Inclusion Criteria:

1. Patients who applied to the smoking cessation clinic for smoking cessation
2. over the age of 18
3. Those who agree to answer the health literacy scale form

Exclusion Criteria:

1. Patients under the age of 18
2. Those who do not agree to answer the health literacy scale form

Primary outcomes:
measure: Health literacy
timeFrame: After 1 year of follow-up in the smoking cessation clinic
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas EAH
state: Eyalet/Yerleşke
Study officials:
affiliation: Bursa Yüksek İhtisas Education And Training Hospital
name: Seyhan Dülger
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00499954: Investigation of Correlation Between Concentrations of Glucose in Blood and Interstitial Fluid in Type 1 Diabetics
Official title: An Open, Mono-Centre Trial to Investigate the Correlation Between Concentrations of Glucose in Arterialized Venous Blood and Subcutaneous Interstitial Fluid Applying Different Extracorporeal Sensor Techniques in Type 1 Diabetics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: microdialysis
subcutaneous adipose tissue
glucose sensor
glucose monitoring
type 1 diabetes
Guardian RT
Glucoday S
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2007-07-12
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: This is a mono-centre trial performed at the Center for Clinical Research at the Medical University Graz. There will be a screening information and a study visit.In the study visit arterialized venous blood glucose values will be monitored and subcutaneous sampling of interstitial fluid (ISF) with microdialysis for glucose determination will be performed. Additionally to the laboratory analysis of the subcutaneous glucose samples, the glucose will be measured with extracorporeal on-line sensors and two marketed devices (Guardian RT and Glucoday S).The study visit will last 30 hours starting with the insertion of microdialysis catheters in the abdominal subcutaneous tissue and the insertion of the catheters for the Glucoday S system and Guardian RT system. The primary hypothesis of the study is: Interstitial fluid glucose concentration profiles correlate to the arterialized venous blood glucose concentration profile in type 1 diabetic subjects.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent obtained before any trial-related activities.
* Skin fold thickness of minimally 5 mm
* Age of patients in the range from 19 to 60 years.
* Type 1 diabetes

Exclusion Criteria:

* Severe acute and/or chronic diseases
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
* Taking of any vasoactive substances or anticoagulation medication.
* Diseases of the skin which could interfere with application of the catheters
* Pregnancy or breastfeeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz - Clinical Research Center
state: Styria
Study officials:
affiliation: Medical University Graz, Graz, Austria
name: Thomas R Pieber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01155154: Antibiotic Prophylaxis for Simple Hand Lacerations
Official title: Antibiotic Prophylaxis for Prevention of Infection in Emergency Department Patients With Simple Hand Lacerations
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Simple Hand Lacerations
Keywords: wounds and lacerations
hand
infection
Antibiotics
antibacterial agents
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
Collaborators: name: Staten Island University Hospital
name: Kings County Hospital Center
First posted: 2010-07-01
Enrollment: 73
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: Research Question: In emergency department patients with simple hand cuts, do prophylactic antibiotics reduce the risk of wound infections?

Detailed description: Simple hand lacerations, defined as hand lacerations that do not involve special structures such as bones, tendons, vessels, or nerves, are common in the emergency departments. The exact rate of infection in such wounds is unclear. It is also not clear whether prescribing prophylactic antibiotics reduces the risk of infection in simple hand lacerations. The objective of this randomized double blind controlled study is to: 1. Identify the rate of infection in simple hand lacerations, 2. Identify factors or wound characteristics that increase the risk of infection, and 3. Assess whether prescribing prophylactic antibiotics decreases the risk of infections in such wounds compared to placebo.

Eligibility criteria: Inclusion Criteria:

* All adult patients (≥ 18 years of age) presenting to the ED with simple hand lacerations. Anatomically, lacerations distal to the radial carpal ligament will be considered "hand" lacerations. "Simple" or "uncomplicated" laceration refers to one that does not involve any special tissue (bone, tendon, blood vessel, or nerve).

Exclusion Criteria:

* Immunocompromised patients (cancer, chemotherapy, transplant, HIV/AIDs)
* Current or recent (within two weeks) use of any antibiotics
* Allergy to clindamycin or cephalexin
* Bites (e.g. dog, cat, or human)
* Lacerations resulted from crush injury
* Lacerations involving bone, tendon, blood vessel, or nerve
* Lacerations inflicted more than 12 hours prior to ED visit
* Pregnant or breast-feeding women

Primary outcomes:
measure: Number of Participants With Presence of Wound Infection
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Kings County Hospital Center
state: New York
city: Brooklyn
country: United States
facility: State University of New York, Downstate Medical Center
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: State University of New York - Downstate Medical Center
name: shahriar zehtabchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05829954: Body Awareness in Dentistry Students and Working Dentists
Official title: The Body Awareness and Its Relationship Musculoskeletal Problems in Dentistry Students and Dentists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Diseases
Body Image
Dentistry
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Dentistry students and dentists

Brief summary: The current study aims to comparison the body awareness and musculoskeletal problems of 1st dentistry students, intern students and working dentists and also investigate the factors affecting the body awareness over the years in dentistry profession.

Detailed description: Dentists also have the highest prevalence among the occupational groups providing health services. More than 60% of dentists have pain in at least one of their body parts.Pain due to musculoskeletal disorders can affect body awareness of person have chronic pain. Body awareness is known as the capacity to distinguish body parts and has an important role in promoting well-coordinated movements. The current study aims to comparison the body awareness and musculoskeletal problems of 1st dentistry students, intern students and working dentists and also investigate the factors affecting the body awareness over the years in dentistry profession.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria are being between the ages of 18 and 65 and had been practising dentistry for more than two years for dentists group.

Exclusion Criteria:

* The exclusion criteria are had a surgical history of vertebral column or any neurological or inflammatory disorders or trauma history.

Primary outcomes:
measure: Body Awareness Questionnaire
timeFrame: At baseline
measure: Nordic Musculoskeletal Questionnaire
timeFrame: At baseline
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: At baseline
measure: Neck Disability Index
timeFrame: At baseline
measure: Hospital Anxiety-Depression Scale
timeFrame: At baseline
measure: Tampa Scale of Kinesiophobia
timeFrame: At baseline
measure: Nottingham Health Profile:
timeFrame: At baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Sevil Bilgin
role: STUDY_DIRECTOR
References:
Clinical trial NCT02849054: CDH - Optimisation of Neonatal Ventilation
Official title: Optimisation of Neonatal Ventilation: Congenital Diaphragmatic Hernia - Determining the Appropriate Level of Volume Guarantee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Diaphragmatic Hernia
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
First posted: 2016-07-29
Enrollment: 18
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the appropriate volume (size) of ventilator breath during volume-targetted ventilation for infants born with congenital diaphragmatic hernia.


Eligibility criteria: Inclusion Criteria:

* Congenital diaphragmatic hernia - post-operative Mechanically ventilated Born at \>34/40

Exclusion Criteria:

* neuromuscular blockade contraindications to NG/OG tube insertion

Primary outcomes:
measure: Change in Pressure Time Product of the diaphragm (PTPdi) at different levels of targetted tidal volume
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: King's College London
name: Anne Greenough, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
References: