louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00459459: Prognostic Significance of Fine-Needle Aspiration Cytology Features in Papillary Thyroid Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Neoplasms
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2007-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this study is to investigate the relationship between prognosis and fine needle aspiration cytology character of papillary thyroid cancer.

Detailed description: Papillary thyroid carcinoma is the most common thyroid malignancy worldwide. The influence of clinicopathologic features on prognosis has been examined, but the relationship between cytologic features obtained by fine-needle aspiration (FNA) and prognosis has been minimally studied. We retrospectively studied the cytologic features with computerized morphometry in 83 patients with usual-type papillary thyroid cancer and followed them for more than 10 years except for one with metastasis at diagnosis. The cytologic features of FNA and recurrence of cancer were examined statistically.

Eligibility criteria: Inclusion Criteria:

* Papillary thyroid cancer diagnosed in NTUH from 1977 to 2000

Exclusion Criteria:

* Patient without complete medical record

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dou-Liou city
country: Taiwan
facility: Shyang-Rong, Shih
state: Yun-Lin County
Study officials:
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: Shyang-Rong Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00380159: Open-Label, 48-Week Extension Study of Elvucitabine in Combination With Background Antiretroviral Therapy (ART) for Participants Who Have Completed Study ACH443-014A
Official title: An Open-Label, 48-Week Extension Study of Elvucitabine Administered In Combination With Background Antiretroviral Agents in Participants Who Have Completed 14 Days of Treatment in Protocol ACH443-014A.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Human Immunodeficiency Virus (HIV)-1 Infection
Keywords: Extension study to Study ACH443-014A
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Achillion, a wholly owned subsidiary of Alexion
First posted: 2006-09-25
Enrollment: 4
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: To assess the safety of 48 weeks of treatment with 10 milligrams (mg) of elvucitabine in combination with background antiretroviral therapy (ART) in participants who completed Study ACH443-014A and meet the inclusion and exclusion criteria.

Detailed description: This study is an open-label extension study for participants who have completed 14 days of treatment in Study ACH443-014A and meet all inclusion and exclusion criteria. Elvucitabine treatment (10 mg) will begin on Day 1 (Day 15 following completion of Study ACH443-014A) for all consenting participants in combination with background ART as determined by the Principal Investigator. Participants will have clinical and laboratory assessments every 2 weeks for the first 8 weeks and then every 4 weeks to Week 48.

Eligibility criteria: Inclusion Criteria:

* Participants who have completed 14 days of treatment in Study ACH443-014A and who, in the Investigator's judgment, remain candidates to receive elvucitabine together with background ART.

Exclusion Criteria:

* Failure to meet inclusion criteria

Primary outcomes:
measure: To Assess The Safety Of 48 Weeks Of 10 mg/daily (QD) Of Elvucitabine In Combination With ART
timeFrame: September 2008
Secondary outcomes:
measure: To Describe The Anti-viral Activity Of Elvucitabine In Combination With ART As Measured By Plasma HIV-1 Ribonucleic Acid (RNA) Over 24 Weeks
timeFrame: September 2008
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Clinical Trial Site
state: Georgia
city: Cincinnati
country: United States
facility: Clinical Trial Site
state: Ohio
city: Santo Domingo
country: Dominican Republic
facility: Clinical Trial Site
city: Berlin
country: Germany
facility: Clinical Trial Site
city: Bonn
country: Germany
facility: Clinical Trial Site
city: Köln
country: Germany
facility: Clinical Trial Site
city: Madrid
country: Spain
facility: Clinical Trial Site
Study officials:
References:
Clinical trial NCT05786300: Effect of NMES+ on Hamstring Lesion (3a/3b)
Official title: Is Early Superimposed Neuromuscular Electrical Stimulation (NMES+) Useful to Improve Muscle Tissue Recovery From Type 3a/3b Hamstring Strain Injuries (HSI)?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hamstring Injury
Muscle Rupture
Hamstring Sprain
Keywords: Electrical Muscle Stimulation (EMS)
NMES+
Hamstring strain injury
Neuromuscular Electrical Stimulation (NMES)
Lead sponsor: Università degli studi di Roma Foro Italico
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to analyze the effect of the electrical stimulation superimposed onto movement in healthy semi-professional athletes who sustained a type 3a/3b hamstring strain injury.

The main questions it aims to answer are:

* Is NMES+ useful for the treatment of type 3a/3b hamstring strain injury?
* Does NMES+ improve the quality of the injured muscle tissue? Participants will follow a 3 week protocol, following the latest evidence available.\[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\]. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\].


Eligibility criteria: Inclusion Criteria:

* recreational or semi-professional athletes
* Body Mass Index between 18,5 e 24,9
* Hamstring strain lesion type 3a/3b

Exclusion Criteria:

* previous hamstring strain lesions
* Anterior Cruciate Ligament Reconstruction using Hamstring graft
* Current hamstring strains

Primary outcomes:
measure: Tear monitoring and muscle quality
timeFrame: Baseline
measure: Tear Monitoring
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00937300: T-cell Based Immunotherapy for Head and Neck Cancer
Official title: T-cell Based Immunotherapy for Treatment of Patients Squamous Cell Carcinoma in the Oral Cavity. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Squamous Cell Carcinoma
Head and Neck Cancer
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2009-07-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the toxicity and immune response of therapy with tumor infiltrating lymphocytes as adjuvant treatment for head and neck cancer after primary operation and radiotherapy.

Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity and immune response.


Eligibility criteria: Inclusion Criteria:

* Patients with histological proven squamous cell carcinoma T3 or more in the oral cavity planned for primary surgery. Performance Status 0 to 1. Acceptable CBC and blood chemistry results. Acceptable organ functions.

Exclusion Criteria:

* Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.

Primary outcomes:
measure: toxicity
timeFrame: week 0 to 20
Secondary outcomes:
measure: immune response
timeFrame: week 0 to 20
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Oncology, Copenhagen University Hospital, Herlev
Study officials:
affiliation: Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
name: Inge Marie Svane, Professor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03064100: Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel
Official title: Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Infection
Lead sponsor: BioFire Diagnostics, LLC
Sponsor class: INDUSTRY
First posted: 2017-02-24
Enrollment: 1500
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients under the age of 18 suspected of systemic infection

Brief summary: The purpose of this study is to collect data to support decisions made by BioFire regarding assay development, panel composition, and intended use for the final FilmArray CSI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 18 years of age that present with acute fever.


Eligibility criteria: Inclusion Criteria:

* Subject has presented to the ED and is suspected of a systemic infection as indicated by a clinician order for blood culture
* Parent/guardian gives written permission (and assent is obtained from children of sufficient maturity)
* Blood specimen can be collected at the same time as the blood culture during the ED visit (or within 12 hours of being admitted from the ED)
* Specimen is at least 500 µL (1.5 mL collection desired)

Exclusion Criteria:

* Parent/guardian is unavailable or unable to give permission, or assent is not obtained (from children of sufficient maturity)
* Physician determines that participation in the study is an unacceptable health risk
* Minimum volume requirement is not met

Primary outcomes:
measure: Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising FilmArray CSI Panel with respect to reference methods (bacterial culture and independent molecular assays)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
References:
Clinical trial NCT02641600: Elastic Compression in Chronic Venous Disease
Official title: Randomised Trial Comparing the Effectiveness of Elastic Compression in Treating Chronic Venous Disease (CEAP C2-C5)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicosity
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with chronic venous disease causing pain or ache will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings

Detailed description: Patients with chronic venous disease causing pain or ache satisfying the inclusion and exclusion criteria will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings. The primary outcome of the study (pain/ache scored using a visual analogue scale) and a number of secondary symptoms, signs and rVCSS (revised Venous Clinical Severity Score) will be obtained at baseline and after one week of wearing the active or placebo stocking.

Eligibility criteria: Inclusion Criteria:

* Primary varicose veins causing pain/ache located only at the calf level

Exclusion Criteria:

* Venous ulceration
* Dermatitis
* Itching
* Superficial vein thrombosis
* Peripheral arterial disease
* Symptoms of non-venous origin
* Previous use of elastic stockings

Primary outcomes:
measure: Pain/ache assessed using a visual analogue scale (0-10)
timeFrame: One week
Secondary outcomes:
measure: revised Venous Clinical Severity Score (rVCSS)
timeFrame: One week
measure: Heaviness assessed using a visual analogue scale (0-10)
timeFrame: One week
measure: Night cramps assessed using a visual analogue scale (0-10)
timeFrame: One week
measure: Swelling sensation assessed using a visual analogue scale (0-10)
timeFrame: One week
measure: Burning sensation assessed using a visual analogue scale (0-10)
timeFrame: One week
measure: Paresthesia assessed using a visual analogue scale (0-10)
timeFrame: One week
measure: Restless legs assessed using a visual analogue scale (0-10)
timeFrame: One week
measure: throbbing assessed using a visual analogue scale (0-10)
timeFrame: One week
measure: insomnia assessed using a visual analogue scale (0-10)
timeFrame: One week
measure: Ankle circumference
timeFrame: One week
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University Hospital of Patras
state: Achaia
Study officials:
affiliation: University of Patras
name: Stavros K Kakkos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05866900: The Impact of Daily Carbohydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop System
Official title: The Impact of Daily CarboHydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop System (Medtronic MiniMed 780G): a Multi-center Real-world Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 1
Keywords: MiniMed 780G
automated insulin delivery
nutrition
diet
time in range
insulin pump
Lead sponsor: University of Ljubljana, Faculty of Medicine
Sponsor class: OTHER
Collaborators: name: University of Messina
First posted: 2023-05-19
Enrollment: 250
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from electronical records of two Pediatric Diabetes departments located in Slovenia and Italy

Brief summary: Lifestyle factors, including diet, play an important role in the achievement of glycemic targets in patients with diabetes, even with the use of automated insulin delivery (AID) systems. Advanced hybrid closed-loop systems (AHCL), by implementing innovative and powerful control algorithms, have been shown to improve the post-meal glycemic control in their users through the delivery of automatic correction boluses. However, data about the influence of the daily amount of carbohydrate intake on glycemic outcomes in youth with type 1 diabetes using AHCL are missing. Therefore, this study will evaluate the association between daily carbohydrate intakes and meal patterns on glycemic control of young people living with type 1 diabetes using an AHCL system (Medtronic MiniMed 780G; Medtronic, Northridge, California) under real-life conditions.


Eligibility criteria: Inclusion Criteria:

* Patients with type 1 diabetes
* Patients aged 7-18 years
* Patients using Medtronic MiniMed 780G with SmartGuard activated
* Patients whose informed consent has been obtained
* \>70% CGM data during observational period

Exclusion Criteria:

* Patients with partial clinical remission according to the Hvidovre Study Group definition
* Concomitant treatment with steroids or other drugs known to interfere with blood glucose levels
* Previous diagnosis of psychological or eating disorders

Primary outcomes:
measure: Time in range (%)
timeFrame: 6 months
measure: Time above range level 1 (%)
timeFrame: 6 months
measure: Time above range level 2 (%)
timeFrame: 6 months
measure: Time below range level 1 (%)
timeFrame: 6 months
measure: Time below range level 2 (%)
timeFrame: 6 months
measure: Mean sensor glucose (mg/dl or mmol/L)
timeFrame: 6 months
measure: Coefficient of variation (%)
timeFrame: 6 months
Secondary outcomes:
measure: BMI Z-score
timeFrame: Baseline, 3 months, 6 months
measure: Weight Z-score
timeFrame: Baseline, 3 months, 6 months
measure: Height Z-score
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00508300: Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery
Official title: Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery: A Monocentric Controlled Non-blinded Randomized Superiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Colectomy
Keywords: laparoscopic
colectomy
Fast Track
epidural
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2007-07-27
Enrollment: 128
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 purpose of this study is to determine whether a epidural analgesia versus patient controlled analgesia reduces the medical recovery in patients undergoing elective laparoscopic colon surgery.

Detailed description: Allocation by individual random number generated by a computer program to either EDA or PCA for 48h after laparoscopic colonic surgery.

Short, both groups are treated according to a recent Fast track protocol. Group A will preoperatively receive a mid thoracic EDA (th 8-9; naropine 0,1%) while group B will receive a PCA (morphine) postoperatively. Both EDA and PCA are removed the afternoon at day 2. Patients with a non-functioning EDA within the first 24h will be crossed over to the PCA group.

Eligibility criteria: Inclusion Criteria:

* All patients admitted for elective laparoscopic colonic surgery

Exclusion Criteria:

* Age \< 18y
* No informed consent
* Emergency situation
* Contraindication for EDA (according to local Anesthesia guidelines)

Primary outcomes:
measure: Medical Recovery (Defined as Pain Sufficient Controlled by Oral Analgesia, Fully Mobile Patients or at Least as Mobile as at Admission and Tolerance of the Patient of Oral Food Intake (More Than 2/3 of Daily Meal))
timeFrame: 30 days
Secondary outcomes:
measure: Complication Rate, Peridural Analgesia Failure Rate, Patient Comfort
timeFrame: 30 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Visceral Surgery, University Hospital CHUV, Lausanne
Study officials:
affiliation: Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
name: Nicolas Demartines, MD
role: STUDY_CHAIR
References:
citation: Hubner M, Blanc C, Roulin D, Winiker M, Gander S, Demartines N. Randomized clinical trial on epidural versus patient-controlled analgesia for laparoscopic colorectal surgery within an enhanced recovery pathway. Ann Surg. 2015 Apr;261(4):648-53. doi: 10.1097/SLA.0000000000000838.
Clinical trial NCT05773300: Registry for Mayo Clinic Adult Congenital Heart Disease Control Population
Official title: Control Population for the Mayo Clinic Adult Congenital Heart Disease Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-03-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be healthy individuals with no history of cardiovascular disease selected from Mayo Clinic in Rochester, Minnesota.

Brief summary: This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry.


Eligibility criteria: Inclusion Criteria:

* BMI ≤ 30.
* No current cardiac medications.
* Systolic BP ≤ 140 mmHg.
* Diastolic BP ≤ 90 mmHg.
* Capacity to consent.

Exclusion Criteria:

* To be assessed via EMR screening.
* Patient confirmation during screening visit.
* Screening tests as applicable.
* History of cardiovascular disease. eGFR \< 30.
* Current orthopedic limitations.

Primary outcomes:
measure: Peak Oxygen Uptake
timeFrame: 6 Months
measure: Peak Right Ventricular - Pulmonary Coupling
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Alexander Egbe, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
References: