louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05598294: Can Wearable Technology Products Change Our Patient Management in Laparoscopic Colorectal Cancer Surgery
Official title: Can Wearable Technology Products Change Our Patient Management in Laparoscopic Colorectal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ambulation Difficulty
Physical Examination
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The clinical progress of the patients whose mobilization the investigators follow up with wearable technology products will be observed in the early postoperative period until discharge. In this way, the investigators primarily aim to examine whether the bowel movements of our more mobilized patients return earlier.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent laparoscopic abdominal surgery
* Colorectal cancer patients
* Curative surgeries
* Stage 0,1,2,3 patients

Exclusion Criteria:

* Patients who cannot walk
* Patients converted to open procedure
* Patients with ostomy
* Patients for whom laparoscopy is contraindicated
* Palliative surgeries
* Patients with distant organ metastases

Primary outcomes:
measure: Time to start flatus
timeFrame: 1 year
Secondary outcomes:
measure: Rate of Complications
timeFrame: 1 year
measure: Length of stay
timeFrame: 1 year
measure: Rate of Mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine, Surgical Oncology Department
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
References:
citation: Daskivich TJ, Houman J, Lopez M, Luu M, Fleshner P, Zaghiyan K, Cunneen S, Burch M, Walsh C, Paiement G, Kremen T, Soukiasian H, Spitzer A, Jackson T, Kim HL, Li A, Spiegel B. Association of Wearable Activity Monitors With Assessment of Daily Ambulation and Length of Stay Among Patients Undergoing Major Surgery. JAMA Netw Open. 2019 Feb 1;2(2):e187673. doi: 10.1001/jamanetworkopen.2018.7673.
citation: Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
citation: Heron N, Tully MA, McKinley MC, Cupples ME. Physical activity assessment in practice: a mixed methods study of GPPAQ use in primary care. BMC Fam Pract. 2014 Jan 15;15:11. doi: 10.1186/1471-2296-15-11.
citation: Ganer Herman H, Kleiner I, Tairy D, Gonen N, Ben Zvi M, Kovo M, Bar J, Weiner E. Effect of Digital Step Counter Feedback on Mobility After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jun;135(6):1345-1352. doi: 10.1097/AOG.0000000000003879.
Clinical trial NCT02379494: First Trimester Prediction of Preeclampsia and Fetal Growth Restriction
Official title: First Trimester Prediction of Preeclampsia and Fetal Growth Restriction Using Uterine Artery Doppler, Maternal Blood Pressure, Maternal Characteristics, Placental Volume and Maternal Serum Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Fetal Growth Restriction
Lead sponsor: Fetal Medicine Foundation
Sponsor class: OTHER
Collaborators: name: Wright State University
First posted: 2015-03-05
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All pregnant patients during their first trimester

Brief summary: To evaluate the feasibility of screening for preeclampsia and fetal growth restriction between 11-13+6 weeks' gestation utilizing the combination of uterine artery doppler, maternal blood pressure, maternal characteristics, placental volume, and maternal serum factors, including PAPPA-A, PLGF, AFP and free Beta HCG. This is a non interventional study.

Detailed description: Preeclampsia (PE) is a condition which affects approximately 2% of all pregnancies and can be a major cause of maternal and perinatal morbidity/mortality (2). The suspected underlying mechanism of PE is thought to be impaired trophoblastic invasion of the maternal spiral arteries leading to impaired placental perfusion, placental ischemia and subsequent development of endothelial dysfunction (3). There is evidence that PE, which is commonly associated with fetal growth restriction, can be predicted effectively at 11-13 weeks gestational age by combined screening algorithms combining uterine artery pulsatility index (PI), maternal mean arterial pressure (MAP) and maternal serum concentrations of placental products including but not limited to plasma protein A (PAPP-A), and placental growth factor (PLGF) (4-6).

Aim of Study/Hypothesis:

The aim of this study is to develop an algorithm based on the combination of maternal factors, uterine artery pulsatility index, mean arterial pressure, placental volume and serum biomarkers to estimate patient specific risks for the development of Preeclampsia in a US population.

Eligibility criteria: Inclusion Criteria:

All patients during their first trimester visit

Exclusion Criteria:

Fetal anomalies Pregnancies ending in termination, miscarriage or fetal death prior to 22 weeks and cases with no pregnancy follow up.

Primary outcomes:
measure: Development of Preeclampsia
timeFrame: During the first trimester (11-13+6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
Study officials:
affiliation: Fetal Medicine Foundation/USA
name: Jiri D Sonek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04367194: Objective Examination and Rehabilitation Treatment of Patients With BPPV
Official title: Objective Examination and Rehabilitation Treatment of Patients With BPPV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Vertigo
Vertigo, Paroxysmal
Vertigo, Positional
Coordination Disorder, Developmental
Coordination and Balance Disturbances
Keywords: vertigo
balance
instability
rehabilitation
Lead sponsor: Somogy Megyei Kaposi Mór Teaching Hospital
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dizziness (BPPV) causes severe deterioration in quality of life, incoordination, and instability.

In the study, we selected a minimum of 100 patients with BPPV who were examined after specialist care. After the acute phase, a physical survey is performed where movement and coordination are examined.

After the results, the patients undergo a rehabilitation training. The workout is submaximal and high intensity that is done for 3 weeks.

Hypothesis: As a result of training, it is possible that the remaining feeling of dizziness and insecurity, impaired coordination will decrease or disappear.


Eligibility criteria: Inclusion Criteria:

* For a patient with BPPV
* With a lack of coordination
* Dizziness
* Ear nose laryngeal examination
* Neurological examination

Exclusion Criteria:

* other neurological diseases
* cardiological diseases
* underwent surgery
* severe joint pain
* alcoholism
* dementia
* drug

Primary outcomes:
measure: EQ5D-5L
timeFrame: 5 weeks
measure: Beam Walking test
timeFrame: 5 weeks
measure: Posturography
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
state: Somogy
Study officials:
References:
Clinical trial NCT05617794: Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness
Official title: Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness and Choroidal Vascularity Index in Emmetropes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
Myopia Progression
Juvenile Myopia
Lead sponsor: SightGlass Vision, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Waterloo
First posted: 2022-11-15
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to measure the effect of Diffusion Optics Technology (DOT) spectacle lenses on the choroidal thickness and choroidal vascularity index compared to control lenses.


Eligibility criteria: Inclusion Criteria:

* Are 8-14 years of age;
* Are able to read (or be read to), understand and sign the assent document;
* Are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document;
* Are emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D inclusively;
* Are willing and able to follow instructions.

Exclusion Criteria:

* Are participating in any concurrent interventional clinical or research study;
* Have a history of myopia control treatment in the past year;
* Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency;
* Have any known active ocular disease and/or infection;
* Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism;
* Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops;
* Have undergone strabismus surgery, refractive error surgery or intraocular surgery;
* Are a child of a member of the study team.

Primary outcomes:
measure: Choroidal Thickness
timeFrame: 30 minutes and 60 minutes
measure: Retinal and Choroidal Thickness
timeFrame: 30 minutes and 60 minutes
Secondary outcomes:
measure: Software Method Comparison
timeFrame: 30 minutes and 60 minutes
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Ocular Research and Education
state: Ontario
Study officials:
References:
Clinical trial NCT02363894: DEFINITIVE AR Two Year Follow-up Extension Study
Official title: Directional AthErectomy Followed by a PaclItaxel-Coated BalloN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment - Two Year Follow-up Extension Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2015-02-16
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who participated in DEFINITIVE AR I and completed the 12 month follow-up assessment in DEFINITIVE AR.

Brief summary: The purpose of this DEFINITIVE AR Two Year Follow-up Extension Study is to gather data to assess and estimate the long term effect of treating a vessel with plaque excision (PE) in combination with paclitaxel-coated balloon angioplasty (PTX PTA) compared to treatment with PTX PTA alone.


Eligibility criteria: Inclusion Criteria:

* Was a subject in DEFINITIVE AR I
* Is able and willing to provide written informated consent prior to study specific data collection.

Exclusion Criteria:

* Withdrew consent in DEFINITIVE AR I.
* Was reported dead during DEFINITIVE AR I.

Primary outcomes:
measure: Major Adverse Event Rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universitats Herzzentrum Freiburg - Bad Krozingen, Germany
name: Prof. Thomas Zeller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Rosenheim Institut fur Diagnostische und Interventionelle Radiologie - Rosenheim, Germany
name: Prof. Gunnar Tepe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00753194: False Positive Results in Newborn Hearing Screening
Official title: False-Positive Results in Newborn Hearing Screening: Possible Causes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deafness
Keywords: hearing
newborn
otoacoustic emissions
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-09-16
Enrollment: 1110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns

Brief summary: The purpose of this study is to investigate the rate of false-positive results in Newborn Universal Hearing Screening Programs and it´s possible causes.

Detailed description: False-positive results in Newborn Hearing Screening(NHS) leads to unnecessary parents anxiety and increase the cost of the procedure before hospital discharge. Getting to know the possible causes will lead to solutions to decrease the number of normal hearing babies that fail NHS with Otoacoustic Emissions.

Eligibility criteria: Inclusion Criteria:

* Healthy newborns

Exclusion Criteria:

* Risk factors for hearing loss

Primary outcomes:
measure: Otoacoustic Emissions
timeFrame: At birth
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Panamericano
Study officials:
affiliation: Federal University of São Paulo
name: Marisa Frasson, Doctor
role: STUDY_CHAIR
References:
citation: Grill E, Uus K, Hessel F, Davies L, Taylor RS, Wasem J, Bamford J. Neonatal hearing screening: modelling cost and effectiveness of hospital- and community-based screening. BMC Health Serv Res. 2006 Feb 23;6:14. doi: 10.1186/1472-6963-6-14.
Clinical trial NCT05498194: Computational Prediction and Experimental Validation of Gastric Cancer Associated Neoantigens
Official title: Computational Prediction and Experimental Validation of Gastric Cancer Associated Neoantigens
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Neoantigens
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients who were diagnosed with adavanced gastric cancer and underwent surgical resection

Brief summary: This study is to develop methods for identification of neoantigens from patients with gastric cancer.

Detailed description: Gastric cancer (GC) is the fourth most common cancer type and one of the leading causes of cancer-related death in Vietnam. Immunotherapy using checkpoint inhibitors (CPI) in combination with certain types of chemotherapy has been clinically shown to offer survival benefits for patients diagnosed with advanced stomach cancer. However, clinical outcomes of CPI are associated with the quantity as well as the quality of neoantigens which arise due to mutations in coding regions of cancer associated genes. Such neoantigens can be presentable by cancer cells to the host adaptive immune system and activate antitumor responses. Hence, the identification of neoantigens would be of significance for immunotherapeutic approaches. Recent data published by the Tumor Neoantigen Selection Alliance (TESLA) indicate that a large proportion (98%) of predicted neoantigens are not immunogenic and ineffective in activating anti-tumor responses. In the present study, we aim to develop a comprehensive pipeline incorporating both computational prediction tools and experimental validation assays to enhance the accuracy of neoantigen identification.

Eligibility criteria: Inclusion Criteria:

1. Male or Female patients aged 15 years and older
2. Diagnosed with advanced gastric cancer (T2-4b/N0-3/M0-1 stage, according to the eighth edition of the American Joint Committee on Cancer TNM (AJCC TNM) system)
3. Treatment-Naive
4. Not known for other concomitant cancers
5. Provide written informed consent

Exclusion Criteria:

1. Insufficient tumor tissues (less than 1 cm3)
2. Unable to sign informed consent
3. Underwent treatment

Primary outcomes:
measure: The neoantigen landscape of patients with gastric cancer
timeFrame: 3 months from the beginning of the study
Secondary outcomes:
measure: The ratio of predicted neoantigens being presented by HLA-I
timeFrame: 6 months from the beginning of the study
measure: The ratio of predicted neoantigens being immunogenic.
timeFrame: 12 months from the beginning of the study
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center Ho Chi Minh City
Study officials:
References:
Clinical trial NCT02675894: Radiofrequency Ablation Using Cooled-Wet Electrode
Official title: Switching Bipolar Radiofrequency Ablation Using Cooled-Wet Electrode for Treatment of Hepatocellular Carcinoma: A Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HCC
Metastasis
Keywords: RFA
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: RF medical
name: Medical Research Collaborating Center
First posted: 2016-02-05
Enrollment: 77
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine safety, ablative zone, technical success rate and early safety data of recently introduced cool-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors.

Detailed description: To determine safety, ablative zone, technical success rate and early safety data (12 months local tumor progression rate) of recently introduced cooled-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors in comparison with currently used separable clustered electrode in our institution. Owing to tissue cooling effect of internally cooled-wet electrode can be used in switching bipolar mode. Patients would be randomized into two groups (cool-wet electrode group and separable clustered electrode in switching monopolar mode). The results from this preliminary study would be used for main study to compare the efficacy and safety data between two electrodes in the future.

Eligibility criteria: Inclusion Criteria: all conditions have to be fulfilled.

* Diagnosed with HCC (1\~5cm) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
* liver metastasis histologically confirmed or characteristic findings on cross-sectional imaging
* signed informed consent
* treatment naive index tumor (no history of local treatment for an index tumor)

Exclusion Criteria:

* more than three tumors in a patients
* tumor size larger than 5cm
* tumor attaches to central portal vein or hepatic vein
* Child-Pugh classification C
* uncorrected coagulopathy
* presence of extrahepatic metastases

Primary outcomes:
measure: LTP
timeFrame: 24 months
Secondary outcomes:
measure: Technical success rate
timeFrame: 1 months
measure: IDR rate
timeFrame: 24 months
measure: EM rate
timeFrame: 24 months
measure: Maximal diameter of ablative zone
timeFrame: 7 day
measure: ablation time
timeFrame: 1 day
measure: Complication
timeFrame: 12 months
measure: Volume of ablative zone
timeFrame: 7 days
Other outcomes:
measure: US/CT or MR fusion success rate
timeFrame: 1 day
measure: Immediate assess of technique success rate
timeFrame: 2 days
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04519294: Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)
Official title: A Prospective, Randomized Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation(SURE)Using the CVAC™ Aspiration System Compared to Basketing for the Removal of Renal Calculi Following Laser Lithotripsy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Stone
Renal Stone
Urolithiasis
Lead sponsor: Calyxo, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-19
Enrollment: 162
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 the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.


Eligibility criteria: Inclusion Criteria:

* Candidate for ureteroscopy with laser lithotripsy;
* Presence of renal stone(s);
* Be willing and able to return for all study-related follow up procedures; and,
* Have been informed of the nature of the study, agreeing to its requirements, and have signed the IRB approved informed consent.

Exclusion Criteria:

* BMI \> 45;
* Significant comorbidities;
* Bladder, ureteral or kidney abnormalities;
* Pregnant individuals; or
* Unable to meet the treatment and follow up protocol requirements.

Primary outcomes:
measure: SFR
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Tucson
country: United States
facility: Arizona Institute of Urology
state: Arizona
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Voorhees
country: United States
facility: New Jersey Urology
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Austin
country: United States
facility: Urology Austin
state: Texas
city: Austin
country: United States
facility: Dell Medical School, The University of Texas at Austin
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
Study officials:
References: