louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06998667: Cooling Solutions for Outdoor Workers
Official title: Cooling Solutions for Outdoor Workers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hyperthermia
Heat Acclimation and Thermotolerance
Keywords: outdoor work
heat stress
kidney injury
cooling interventions
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators aim to test the effectiveness of two cooling interventions in reducing the core temperature of outdoor workers.

Detailed description: Workers in a variety of US industries-construction workers, welders, farmers, firefighters, and warehouse workers among them-are at risk for hyperthermia during work, yet very few interventions are being developed to mitigate heat related organ injury, particularly when workers do not have obvious symptoms of heat related illness. The investigators plan to test whether two active cooling technologies can help mitigate hyperthermia and risk for kidney injury. This work will enhance worker safety using evidence-based technology.

To accomplish the aims of testing two active cooling interventions, the investigators plan to implement a case-cross over randomized control trial design at the work site conducted in partnership with an employer and with 30 workers at risk for hyperthermia. Over three sequential weeks, the investigators will measure rate of core temperature change (primary outcome). Secondary outcomes will include changes in kidney injury markers; changes in worker productivity; and worker acceptability of interventions.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18
2. Anticipated to be working in the same job category for the duration of the study
3. Able to communicate in English or Spanish

Exclusion Criteria:

1. Cannot provide informed consent
2. Weight less than 40 kg
3. Inability to swallow pills
4. Known history of having a pacemaker or ICD
5. Pregnancy as determined by self report and confirmed on Day 1
6. Gastrointestinal disorders (e.g., gastroparesis, prior surgery on GI tract with the exception of appendectomy or cholecystectomy, diverticulosis or inflammatory bowel disease)
7. Plan for an elective MRI in the 7 days post last planned pill ingestion

Primary outcomes:
measure: Core Temperature
timeFrame: up to 10 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Shuchi Anand, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Julie Parsonnet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Maria Montez Rath, mrath@stanford.edu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01543867: Safety and Efficacy of Long-term Somatropin Treatment in Children
Official title: Non-interventional Study of the Safety and Efficacy of Long-term Somatropin Treatment in Children (GrowthWIN II / GrowthWIN II SGA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Disorder
Growth Hormone Deficiency in Children
Foetal Growth Problem
Small for Gestational Age
Genetic Disorder
Turner Syndrome
Growth Disorder
Idiopathic Short Stature
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-05
Enrollment: 5442
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children treated with somatropin

Brief summary: This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height. A subgroup of children small for their gestational age is included.


Eligibility criteria: Inclusion Criteria:

* In need of somatropin or current user

Primary outcomes:
measure: Number of adverse events
timeFrame: Up to 10 years
Secondary outcomes:
measure: Number of patients continuing somatropin treatment
timeFrame: Up to 10 years
measure: Change in height
timeFrame: Up to 10 years
measure: Onset of puberty in children small for gestational age
timeFrame: Up to 10 years
measure: Co-morbidities in children small for gestational age
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Mainz
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04110067: Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia
Official title: Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myopia
High Myopia
Keywords: Myopia
Refractive Surgery
Small Incision Lenticule Extraction
SMILE
Lead sponsor: St. Franziskus Hospital
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with myopia more than -7.75 D seeking refractive surgery

Brief summary: Small Incision Lenticule Extraction (SMILE) was introduced in 2011 using the VISUMAX femtosecond laser (Carl Zeiss Meditec, Jena, Germany). It is designed for correction of myopia and myopic astigmatism.

It involves the creation of a corneal tissue disk called lenticule and its extraction through a minimally invasive incision, utilizing only a femtosecond laser. This enables rapid visual recovery with very little discomfort to the patient.

This observational case series monitors visual and refractive outcomes of myopic correction for more than -7.75 D.

It is to

* gather long-term results and refractive stability
* detect rare complications or side-effects
* evaluate the efficacy in a large number of patients


Eligibility criteria: Inclusion Criteria:

* adults
* myopia more than -7.75 D
* refractive stability more than 1 year

Exclusion Criteria:

* corneal irregular astigmatism
* ectatic conditions

Primary outcomes:
measure: Subjective Distance Refraction
timeFrame: 1 year
measure: Distance Visual Acuity
timeFrame: 1 year
Secondary outcomes:
measure: Tectonic stability as assessed by Pentacam
timeFrame: 1 year
measure: Epithelial thickness map in Optical coherence tomography
timeFrame: 1 year
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Center for Refractive Surgery
state: NRW
Study officials:
affiliation: Center for Refractive Surgery Muenster
name: Suphi Taneri, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01762267: Effects of DASH Diet on Corticosteroids Medication Use
Official title: Phase 3 Study of Beneficiary Effects of Dietary Approaches to Stop Hypertension (DASH) on the Metabolic Aeffects of Corticosteroids Medications Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nutritional and Metabolic Disease
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 62
Sex: FEMALE
Minimum age (years): 27
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the metabolic side effects of corticosteroids medications use.

Detailed description: Objective: To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the metabolic side effects of corticosteroids medications use.

Design: A randomized clinical trial was undertaken in 60 patients on corticosteroid therapy for 10 weeks. Patients were randomly assigned to a DASH or control diet. Fasting blood sample were measured to determine blood glucose and lipid profile. Blood pressure and anthropometric measurements were measured based on the standard guidelines.

Eligibility criteria: Inclusion Criteria:

* patients who were on corticosteroid therapy

Exclusion Criteria:

* refuse to follow the visits

Primary outcomes:
measure: the amount of weight reduction and change of blood pressure
timeFrame: up to 10 weeks
Secondary outcomes:
measure: lipid profile, fasting blood glucose
timeFrame: 10 weeks
Other outcomes:
measure: lipid profile (mg/dl), fasting blood glucose (mg/dl), blood pressure (mmHg), weight reduction (kg)
timeFrame: july
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: 1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science
Study officials:
affiliation: 1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science, Isfahan, Iran
name: Leila azadbakht, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02027467: Study to Assess the Effect of StemAlive® Supplement on the Levels of Stem Cells in Human Volunteers
Official title: Assessment of the Effect of StemAlive® Herbal Supplement on the Levels of Circulating Hematopoietic Stem Cells in Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Hematopoietic stem cells
Herbal
Dietary
CD cells
Basic research
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Stem Vida International
First posted: 2014-01-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Combination of various herbs is known to promote mobilization of hematopoietic stem cells. Hence the current study has been intended to study the effect of Stem Alive® on mobilization of stem cells. Stem Alive® include ingredients like green tea, ashwagandha, etc which are known to be used as traditional medicine. They are also tested qualitatively in academic and nutritional science research centers throughout the world and which substantially according to those studies stimulate the augmented availability of circulating hematopoietic cells. This study is projected to investigate the mobilization of stem cells on healthy human volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy Male and Female Volunteers
* Willing to sign Informed Consent Form

Exclusion Criteria:

* Anemia
* SGOT and Serum Creatinine values twice the upper limit of normal
* Volunteers who smoke / consume alcohol / take recreational drugs
* Fever or Flu in the last one week of screening
* History of Gastric or Duodenal Ulcer
* Volunteers on vitamins, nutritional or herbal products since last one month
* Pregnant, Breast feeding and Lactating women
* Volunteers taking antibiotic, NSAIDS, anti-inflammatory within last 7 days
* Allergic to ingredients of test product
* Any co morbid or systemic condition or immunocompromised state making volunteer unfit for participation.
* Volunteers deemed unfit for the study by the Investigator

Primary outcomes:
measure: CD34+
timeFrame: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
measure: CD45+
timeFrame: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
measure: CD133+
timeFrame: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Dhanwantari Clinic
state: Maharashtra
Study officials:
name: Sandip Patil, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03755167: A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV
Official title: An Open-Label, Multi-Center, Follow up Study to Protocol 101/2 - Continued Treatment by Intravenously Administered IPL344 to Amyotrophic Lateral Sclerosis (ALS) Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Lead sponsor: Immunity Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, open-label, follow up study to protocol 101/2 - continued treatment by IPL344 IV administered once a day in up to 15 participants with ALS.

The study is designed to determine the safety, tolerability and initial efficacy of IPL344, administered once a day, by IV infusion for up to 36 months


Eligibility criteria: Inclusion Criteria:

1. Male or female participants ages ≥ 18 to 75 years.
2. Participants that have completed study protocol #101/2
3. A written informed consent signed prior to any study procedure being performed
4. Medically capable to undergo study procedures at the time of study entry

Exclusion Criteria:

1. Participants that did not participate or did not complete 28 treatment days of study protocol #101/2.
2. Concurrent therapy, that in the PI's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
3. Presence of any other condition or circumstance that, in the judgment of the Investigator, might contraindicate or increase the risk to the participant.
4. Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative serum pregnancy test from protocol 101/2)
5. Women of child-bearing potential or males whose partners are women of child-bearing potential, unwilling or unable to use an effective method of contraception throughout the trial

Primary outcomes:
measure: Adverse Events (AEs) and Serious Adverse Events (SAEs) Reporting
timeFrame: upto 36 month
Secondary outcomes:
measure: Changes from baseline in ALS disease progression
timeFrame: upto 36 months
Other outcomes:
measure: Changes from baseline in Pulmonary Function
timeFrame: upto 36 months
measure: Changes from baseline in Muscle strength
timeFrame: upto 36 months
measure: Changes from baseline in Muscle strength
timeFrame: upto 36 months
measure: Changes from baseline in Anti-Depression effect
timeFrame: upto 36 months
measure: Changes from baseline in Anti-Depression effect
timeFrame: upto 36 months
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center/Neuromuscular / EMG service and ALS / Motor Neuron Disease Clinic
city: Jerusalem
country: Israel
facility: Hadassah Medical Center -Motor Neuron Disease Clinic
Study officials:
References:
Clinical trial NCT02646267: The Efficacy and Safety Study of Dabigatran and Warfarin to Non-valvular Atrial Fibrillation Patients
Official title: The Efficacy and Safety of Dabigatran Etexilate and Different Intensity Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Dabigatran
Warfarin
Anticoagulation
Elderly
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 210
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to demonstrate the efficacy and safety of dabigatran etexilate and different intensity warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of atrial fibrillation
2. Echocardiography confirmed a non-valvular heart disease
3. Age≥60 years

Exclusion Criteria:

1. Unable to cooperate with doctors
2. CHA2DS2-VASc\<2
3. Life expectancy of less than 1 year
4. Rheumatic heart disease or dilated cardiomyopathy
5. History of artificial valve replacement surgery
6. Infectious endocarditis
7. Stroke or transient ischemic attack(TIA) within the last 6 months
8. Previous history of intracranial hemorrhage, gastrointestinal, respiratory or urogenital bleeding
9. Previous intolerance/allergy to warfarin or dabigatran etexilate
10. Blood pressure greater than 180/110 mmHg
11. Chronic liver dysfunction, alanine aminotransferase above the normal reference value of the upper limit 3 times
12. Chronic renal failure, serum creatinine clearance rate (Ccr) less than 30 ml / min
13. Patient was receiving antiplatelet or anticoagulant therapy due to other reasons

Primary outcomes:
measure: ischaemic stroke
timeFrame: 2 years
measure: major haemorrhage
timeFrame: 2 years
Secondary outcomes:
measure: minor bleeding
timeFrame: 2 years
measure: myocardial infarction
timeFrame: 2 years
measure: pulmonary embolism
timeFrame: 2 years
measure: cardiovascular death
timeFrame: 2 years
measure: all-cause mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Wu Jun, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu J, Wang J, Jiang S, Xu J, Di Q, Zhou C, Min X, Pang S, Wang H, Xu D, Guo Y. The efficacy and safety of low intensity warfarin therapy in Chinese elderly atrial fibrillation patients with high CHADS2 risk score. Int J Cardiol. 2013 Sep 10;167(6):3067-8. doi: 10.1016/j.ijcard.2012.11.078. Epub 2012 Nov 28. No abstract available.
Clinical trial NCT06699667: CT Findings in Surgically Treated Focal Pancreatic Disease- A Retrospective Study
Official title: CT Findings in Surgically Treated Focal Pancreatic Disease- A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Pancreatitis
Keywords: autoimmune pancreatitis
pancreatic ductal adenocarcinoma
radiology
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population in Copenhagen

Brief summary: To retrospectively investigate CT imaging features of autoimmune and chronic pancreatitis (AIP and CP) mimicking pancreatic ductal adenocarcinoma in surgically resected patients.


Eligibility criteria: Inclusion Criteria:

* Definite diagnosis of autoimmune pancreatits or adenocarcinoma

Exclusion Criteria:

* No surgery

Primary outcomes:
measure: Imaging features of autoimmune pancreatitis
timeFrame: Time frame for each study object is the time between tumor board conference and surgery - typically 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Surgery and Transplantation, Rigshospitalet
name: Carsten P Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06340867: Intraoral Scanner With and Without Orthodontic Brackets
Official title: Effect of Two Different Intraoral Scanners on the Scanning Quality and Time in Patients With/Without Orthodontic Brackets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intra-oral Scanner
Adolescent Behavior
Keywords: Dentsply with/ without bracket
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: full permenant dentition with mild to moderate crowding

Brief summary: this study aim to evaluate the effect of two different intraoral scanners on the scanning Quality and Time in Patients With/Without Orthodontic Brackets

Detailed description: aim of study : evaluate two types of Intra-oral scanner in patients with/without orthodontics brackets

methodology:

* patient preparation diagnosis, photos, x-rays
* starting scanning in 3 techniques bucco-palatal , palato-buccal ,s shape
* brackets bonding by indirect technique
* scanning after brackets placement also by same 3 techniques
* data measurements by linear and angular measurements.

outcome:2 scanners will be evaluated

Eligibility criteria: Inclusion Criteria:

1. Patients of both sexes.
2. Full permanent dentition cases.
3. Class I/II/III molar relationship.
4. Mild to moderate crowding cases

Exclusion Criteria:

1. Dental anomalies.
2. Congenital missing teeth.
3. Impaction.
4. Orthognathic surgery

Primary outcomes:
measure: compare the readings resulted from the models produced from the 3 scanners (2 intraoral scanners + the desktop scanner) before bonding and to compare the 2 intraoral scanners after bonding.
timeFrame: 3 to 4 weeks
Secondary outcomes:
measure: compare the readings resulted from the models produced from the 2 scanners with and without orthodontic brackets.
timeFrame: 3 to 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo university
Study officials:
References:
Clinical trial NCT04197167: Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis
Official title: Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometritis
IVF
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-12-12
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: DIAGNOSTIC

Brief summary: The Investigator propose to develop an in-vitro technique for the measurement and analysis of freshly excised biopsies during hysteroscopy procedure in patients with suspected Chronic Endometritis (CE) condition. Furthermore, the investigator propose to develop a discrimination model between the CE and inflammatory CE types using the measured spectroscopic data from freshly excised biopsies.

Detailed description: It is common practice that, following hysteroscopy, the clinician needs to wait for about two weeks before the results of the histology are returned and the clinical treatment is initiated. In this research, the investigator intent to show that the mid infrared ATR (Assisted Reproductive Treatment) spectroscopy method will provide the physician with sufficient information about the CE inflammation status in a considerably shorter period of time to allow immediate initiation of the appropriate treatment.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings.
* Patients scheduled for any histological evaluation including endometrial biopsy, dilatation and curettage (D\&C), biopsy/excision of uterine polyp or fibroid or any other cervical or uterine lesion.
* Age 18 and over.

Exclusion Criteria:

* Pregnant women, minors and lack of judgment women will not included
* At the request of the examined woman

Primary outcomes:
measure: Comparison of infrared spectroscopy (ATR-FTIR technique) with routine histopathology
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Einat Shalom-Paz, Prof
role: PRINCIPAL_INVESTIGATOR
References: