louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05114967: Preoperative Anxiety During COVID-19
Official title: Preoperative Anxiety Levels in Patients Undergoing Surgery During the 4th Wave of the SARS-CoV-2 Pandemic. A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Pandemic, COVID-19
Keywords: Anxiety
SARS CoV-2
Pandemic
Perioperative
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult consecutive patients, \>18 years old who will undergo surgery for one month in the University Hospital of Larissa

Brief summary: The modified Preoperative Anxiety Scale (mPAS) questionnaire as given in the article by Viola et al, will be used after permission from the authors, to investigate the preoperative anxiety of patients undergoing surgery during the 4th wave of the pandemic

Detailed description: Studies have been conducted on the stress and anxiety induced by the COVID-19 pandemic in both the general population as well as specific groups, such as health care workers, pregnant women and adolescents. Given that anxiety has a strong bearing on the physical, mental and emotional well-being of the patients and their subsequent recovery from surgery and other procedures, we were interested in assessing anxiety among the patients presenting for elective procedures in the post-lockdown phase of the pandemic. The primary objective of the present study was to assess the anxiety levels among the preoperative patients scheduled for surgeries in the 4th wave of the COVID-19 pandemic, and the secondary objective was to assess the factors accentuating the same. The modified Preoperative Anxiety Scale (mPAS) questionnaire as given in the article by Viola et al will be used after permission from the authors.

Eligibility criteria: Inclusion Criteria:

* Adult consecutive patients, \>18 years old
* Undergoing surgery in the UHL

Exclusion Criteria:

* Patients aged\<18 years
* Patients that will refuse to participate
* Patients unable/not fit to consent

Primary outcomes:
measure: Anxiety level
timeFrame: Before surgery
Secondary outcomes:
measure: Factors accentuating the anxiety levels
timeFrame: Before surgery
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Univeristy of Thessaly
state: Thessaly
Study officials:
affiliation: University of Thessaly
name: Eleni Arnaoutoglou, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00289367: Study of T3 on the Incidence of Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Official title: Randomized Prospective Study of T3 on the Incidence of Post-Operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atrial Fibrillation
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Thomas and Jeanne Elmezzi Foundation
First posted: 2006-02-09
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this project is to see whether treatment with a thyroid hormone, called triiodothyronine or T3, following open heart surgery reduces the risk of developing atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

1. Patients requiring CABG or valve repair/replacement surgery.
2. Patient must be able to provide informed consent.

Exclusion Criteria:

1. Patients less than 18 or over 85 years of age.
2. Patients less than 50kg or greater than 120kg.
3. Patients currently with endocrine disorders, excluding diabetes.
4. Patients currently with thyroid dysfunction (e.g., hyper- hyperthyroidism, goiter, Grave's disease), myxedema, or myxedema coma, even if treated.
5. Patients currently receiving thyroid replacement therapy.
6. Patients currently receiving Ketamine, levarterenol or dietary (non-food) iodine supplementation.
7. Patients who have received any investigational drugs within the previous one month or five half-lives of the drug.
8. Patients who are pregnant. Pregnancy testing will be done for women of child-bearing potential.
9. Patients currently in atrial fibrillation.

Primary outcomes:
measure: incidence of atrial fibrillation
timeFrame: during hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
affiliation: North Shore University Hospital
name: Irwin Klein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01229540: Clinical Research on Retinal Neovascularization of Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: The Mechanism of Retinal Neovascularization of Diabetic
Retinopathy.
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
First posted: 2010-10-27
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Retinal neovascularization of diabetic retinopathy might be associated with genetic risk factors and environmental risk factors.


Eligibility criteria: Inclusion Criteria:

* T2DM was diagnosed according to the World Health Organization Expert Consultation Report 1999 and consisted of one of the following: fasting blood glucose (FBG) ≥7.0 mmol/L (≥126 mg/dL), blood glucose ≥11.1 mmol/L (≥200 mg/dL) 2 hours after an oral glucose tolerance test (OGTT); or a random blood glucose ≥11.1 mmol/L (≥200 mg/dL).
* DR was clinically graded in accordance with the International Clinical Diabetic Retinopathy guidelines based on fundus fluorescence angiography.
* All participants with PDR underwent a comprehensive dilated fundus examination to detect DR by indirect ophthalmoscopy and were diagnosed by fundus fluorescence angiography.

Exclusion Criteria:

* Patients were excluded if they had acute complications of diabetes mellitus, type 1 diabetes mellitus, other types of diabetes, serious cardiovascular, hepatic, nephritic or other complications, other serious primary diseases or mental illness.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital, Clinical college of Ophthalmology ,Tianjin Medical Univercity
state: Tianjin
Study officials:
References:
Clinical trial NCT06696040: Immediate Effects on Gait and Spasticity After the Use of Passive Kinesiotherapy Equipment in the Lower Limbs of Neurological Patients
Official title: Immediate Effects of Mobilization Performed by Passive Kinesiotherapy Equipment on Lower Limbs on Spasticity and Gait in Neurological Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hemiparesis
Paraparesis
Tetraparesis
Cerebral Palsy
Spastic Gait
Spasticity
Keywords: Gait
Spasticity
Passive Kinesiotherapy
Spastic Gait
Passive mobilization device
Lead sponsor: Universidade de Caxias do Sul
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 80
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Undergo assessment of muscle tone (Ashworth Scale), gait (BAIOBIT) and risk of falling (Timed Up and Go) before using the device; Use the device on the spastic lower limb(s) for 30 minutes; Go through the same assessment carried out previously.


Eligibility criteria: Inclusion Criteria:

* agree and sign the Free and Informed Consent Form or signature of the person responsible
* individuals with spasiticity (hemiparetic, paraparetic, tetraparetic and hemiparetic children with cerebral palsy)

Exclusion Criteria:

* over 18 years old whose ability to sign the Free and Informed Consent Form is compromised, or who understand it, but are not responsible for signing the Free and Informed Consent Form
* present cardiovascular, neurological, musculoskeletal instability or other condition(s) that interfere with the use or positioning of the device or gait assessment
* present cognitive deficits that interfere with understanding the ICF and/or understanding how to carry out the protocol
* For the children's group, participants who: 1) are under 8 years of age and/or over 13 years of age will be excluded; 2) no person responsible for signing the TCLE; 3) present cognitive deficits that interfere with understanding the ICF and/or understanding how to carry out the protocol

Primary outcomes:
measure: Gait kinematics
timeFrame: Immediate post-evaluation (after using the device for 30 minutes)
Secondary outcomes:
measure: Muscle tone - spasticity
timeFrame: Immediately after using the device for 30 minutes
measure: Timed Up and Go
timeFrame: Immediately after using the device for 30 minutes
Other outcomes:
Locations:
city: Caxias do Suk
country: Brazil
facility: Universidade de Caxias do Sul
state: Rio Grande do Sul
Study officials:
References:
Clinical trial NCT05682040: Effect of Emergency Department Bedside Compression Ultrasonography on Door-to-Disposition Time in Patients Suspicious for Lower Extremity Deep Venous Thrombosis
Official title: Effect of Emergency Department Bedside Compression Ultrasonography on Door-to-Disposition Time in Patients Suspicious for Lower Extremity Deep Venous Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Extremity Deep Vein Thrombosis
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Comparing the disposition time of point of care ultrasound (POCUS) versus formal lower extremity doppler in emergency department patients.


Eligibility criteria: Inclusion Criteria: Emergency Department patients presenting for lower extremity swelling concerning Deep vein thrombosis.

-

Exclusion Criteria: n/a

-

Primary outcomes:
measure: Time to disposition
timeFrame: 3 months
Secondary outcomes:
measure: Accuracy of POCUS vs formal LE doppler
timeFrame: 3 months
Other outcomes:
Locations:
city: Wyandotte
country: United States
facility: Henry Ford Wyandotte Hospital
state: Michigan
Study officials:
References:
Clinical trial NCT03178240: Sunface Mirroring RCT in Brazil
Official title: Randomized Trial of a Photoaging Mirroring Intervention for Skin Cancer Prevention in Secondary Schools in Brazil - Study Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Cancer
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized trial looking at the effects of a behavioral photoaging software intervention on sunscreen use in the city of Itauna, Brazil.


Eligibility criteria: Inclusion Criteria:

Visiting a secondary school in Brazil.

Exclusion Criteria:

Not visiting a secondary school in Brazil.

Primary outcomes:
measure: Change in prevalence of daily sunscreen use at six months
timeFrame: 6 months
measure: Change in prevalence of daily sunscreen use at one months
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Brinker TJ, Faria BL, de Faria OM, Klode J, Schadendorf D, Utikal JS, Mons U, Krieghoff-Henning E, Lisboa OC, Oliveira ACC, Lino HA, Bernardes-Souza B. Effect of a Face-Aging Mobile App-Based Intervention on Skin Cancer Protection Behavior in Secondary Schools in Brazil: A Cluster-Randomized Clinical Trial. JAMA Dermatol. 2020 Jul 1;156(7):737-745. doi: 10.1001/jamadermatol.2020.0511.
citation: Brinker TJ, Faria BL, Gatzka M, de Faria OM, Heppt MV, Kirchberger MC, Schadendorf D, Nakamura Y, Buslaff F, Lisboa OC, Oliveira ACC, Lino HA, Bernardes-Souza B. A skin cancer prevention photoageing intervention for secondary schools in Brazil delivered by medical students: protocol for a randomised controlled trial. BMJ Open. 2018 Mar 6;8(3):e018299. doi: 10.1136/bmjopen-2017-018299.
Clinical trial NCT04556240: RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM
Official title: RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Arrhythmias, Cardiac
Keywords: Arrhythmias
Real-time Monitoring
Mobile Cardiac Telemetry
VitalPatch
Independent Diagnostic Testing Facility
Lead sponsor: VitalConnect Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of up to five-hundred (500) non-randomized subjects who have been recommended mobile cardiac telemetry by their care provider.

Brief summary: The primary purpose of this study is to evaluate performance and safety of the VitalConnect Platform when used for mobile cardiac telemetry (MCT) or as an independent diagnostic testing facility (IDTF) system during activities of daily living by subjects 18 years or older who have been recommended MCT by their care provider.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older;
2. If recommended mobile cardiac telemetry (MCT) by the care provider
3. If instructed, be willing to record information such as daily activities and symptoms
4. Able to speak, read, and write English.

Exclusion Criteria:

1. Have extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed wear sites;
2. Have a known allergy to medical adhesives;
3. Have any potentially life-threatening condition that (for example ventricular tachycardia or ventricular fibrillation), in the opinion of the Investigator, would interfere with their participation in the study.

Primary outcomes:
measure: Successfully detect heart rhythm of the study subjects using VitalConnect platform as a mobile cardiac telemetry unit
timeFrame: Each patient will be monitored for up-to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chevy Chase
country: United States
facility: Site 1
state: Maryland
Study officials:
affiliation: VitalConnect Inc.
name: Dennis Sheehan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00268840: The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer
Official title: National Trial Phase II to Study the Combination of Gemcitabine and Docetaxel in Patients With Locally Advanced or Metastatic Pancreatic or Biliary Adenocarcinoma That Cannot be Removed by Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Neoplasms
Biliary Tract Neoplasms
Keywords: Pancreas or biliary cancer
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
First posted: 2005-12-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of combination therapy with gemcitabine and docetaxelin in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma.

Detailed description: Try a new drug association on this advanced cancer

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older
* Patients must sign informed consent prior to study entry
* Patients has Karnofsky performance status of more than 50%
* No prior chemotherapy
* Histologically or cytologically confirmed adenocarcinoma of the pancreas, locally advanced or metastatic disease or biliary cancer
* No previous radiotherapy for locally advanced or metastases.
* Hematopoietic: WBC \> 3000/mm2, Absolute neutrophile count \> 1500/mm2, Hemoglobin \> 9g/dl, Platelet count \> 100 000/mm2

Exclusion Criteria:

* No intracerebral or meningeal metastases
* Pregnant
* Fertile patient must use effective contraception
* No other serious medical condition or illness that would preclude study participation
* Hepatic: Bilirubin greater than upper limit of normal(ULN) SGOT and SGPT \> 3.5 times upper limit of normal(ULN) alkaline phosphatase \> 6 times upper limit of normal(ULN)
* More than 30 days since prior investigational therapy

Primary outcomes:
measure: Overall response rate
Secondary outcomes:
measure: Clinical benefit
measure: Progression-free survival
measure: Overall survival
measure: To evaluate the frequency and severity of the adverse events related to the combination of gemcitabine and docetaxel
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Hôtel Dieu
Study officials:
affiliation: ARCAGY/ GINECO GROUP
name: Chauvenet Laure, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05110040: Multi-model Image of Immunosuppressive Agents in TAO
Official title: A Multi-model Image of Immunosuppressive Agents in Thyroid Associated Ophthalmopathy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Associated Ophthalmopathy
Keywords: Thyroid Associated Ophthalmopathy
Immunosuppressive agents
multi-modal image
function assessment
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: participants diagnosed of TAO administrated with immunosuppressive agents
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of immunosuppressive agents treating Thyroid Associated Ophthalmopathy by multi-model image.

Detailed description: Thyroid Associated Ophthalmopathy is one of autoimmune orbital diseases characterized by enlargement of the extraocular muscles and increase in fatty or/and orbit connective tissue volume affecting the appearance and visual function of the eyes. TAO can be classified into active phase and inactive phase according to the activity score and wait-and-see or surgery are widely chosen for patients in inactive phase. A great number of patients in inactive phase becoming refractory and reoccurring.

Until now, the improvement of TAO is still be measured subjectively with low reliability and less accuracy. Multi-modal image is a new method to assess both the appearance and visual function of TAO and some of the indexes can be regarded as more apparent and stable in assessing the efficacy and prognosis of TAO.

This perspective cohort study aims to evaluate the efficacy of immunosuppressive agents in TAO by multi-model image and function assessments.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age 18-70 years old
* Diagnosed with TAO.

Exclusion Criteria:

* Contraindications to immunosuppressive agents.
* Patients with HIV, Hepatitis B or C, Tuberculosis or other active significant infection.
* Patients with severe chronic diseases in heart, lung, kidney and liver, which make it not tolerant to immunosuppressive agents.
* Patients have contraindications of MRI(metal pacemaker, fake teeth, foreign body and other materials which will disturb the examination).

Primary outcomes:
measure: change of macular sensibility
timeFrame: At 6 months
Secondary outcomes:
measure: change of extraocular muscle volume and orbital fat volume by MRI
timeFrame: at month 6
measure: change of proptosis
timeFrame: at month 6
measure: change of QoL
timeFrame: at month 6
measure: change of eyelid aperture and lid lag
timeFrame: at month 6
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Dan Liang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01312740: Effects of Two Hypocaloric Diets on Weight Loss
Official title: Effects of Two Hypocaloric Diets on Weight Loss and Inflammatory Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
dietary treatment
high protein diet
Low glycaemic index
adipocytes
fat mass
systemic inflammatory markers
improvement of complications
effect on weight loss
Lead sponsor: Ceprodi S.A. Kot
Sponsor class: INDUSTRY
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Pierre and Marie Curie University
name: Assistance Publique - Hôpitaux de Paris
First posted: 2011-03-11
Enrollment: 13
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators evaluated whether an energy-restricted protein diet with low glycaemic index carbohydrates and soluble fibers (LC-P-LGI) would be more effective than a conventional diet (LC-CONV) on weight-loss and related metabolic variables.

Detailed description: The subjects (9 men and 5 post-menopausal women) were randomly allocated, in a cross-over design, to two periods of 4 weeks of an energy restricted diet of 1200 kcal as either a conventional diet (LC- CONV) or a special energy restricted diet compensated by proteins (LC-P-LGI). The two nutritional periods were separated by a wash-out interval of 8 weeks. Before the start of the study, all subjects were instructed to maintain their usual lifestyle during the experimental period.Anthropometric parameters, glucose and lipid homeostasis and inflammatory markers were evaluated before and after each dietary period.Body fat and fat-free mass distributions were measured by a dual-energy X-ray absorptiometry (DXA, GE Lunar Prodigy Corporation, Madison, WI, USA) before and after each dietary period at the fasting state.

Eligibility criteria: Inclusion Criteria:

* BMI 26 to 35 Kg/m2
* 25 to 60 years old
* non diabetic subjects

Exclusion Criteria:

* SGOT and SGPT \>2.5x the normal
* plasma glucose more than 1.26 g/l
* hepatic or renal or cardiac failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistant pubique-hopitaux Paris
Study officials:
References:
citation: Rizkalla SW, Prifti E, Cotillard A, Pelloux V, Rouault C, Allouche R, Laromiguiere M, Kong L, Darakhshan F, Massiera F, Clement K. Differential effects of macronutrient content in 2 energy-restricted diets on cardiovascular risk factors and adipose tissue cell size in moderately obese individuals: a randomized controlled trial. Am J Clin Nutr. 2012 Jan;95(1):49-63. doi: 10.3945/ajcn.111.017277. Epub 2011 Dec 14.