louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06789341: Retrospective Data Collection for a Correlation Study Between Gastric Cancer and Clinical and Laboratory Variables
Official title: Retrospective Data Collection for a Correlation Study Between Gastric Cancer and Clinical and Laboratory Variables
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer Patient
Keywords: gastric cancer, helicobacter pylori
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Saranno considerati eleggibili ad entrare nella raccolta dati tutti i pazienti con diagnosi di carcinoma gastrico (casi) o che abbiano effettuato un esame istologico gastrico (controlli) rilevati nell'archivio elettronico dell'istituto di anatomia patologica dal 2016 al 2020.

Brief summary: This is an observational, retrospective, case-control, single-center, national study that involves the collection of anamnestic, clinical and therapeutic data of patients diagnosed with gastric cancer by histological examination at the Pathological Anatomy Unit (Prof. D'Errico) in the period 2016-2020.

Detailed description: The corresponding medical records will be analyzed to derive information on the socio-demographic characteristics and risk factors of the included subjects. Each case will be paired with two controls chosen from patients who have performed a gastric biopsy with relative histological examination during an endoscopic examination carried out at the IRCCS Azienda Ospedaliero-Universitaria of Bologna.

Eligibility criteria: Inclusion Criteria cases:

* Età \> 18 anni.
* Diagnosi istologica di carcinoma gastrico
* Ottenimento del consenso informato.

Inclusion criteria controls:

* Età \> 18 anni.
* Esecuzione di indagine endoscopica gastrica con relativo esame istologico (mucosa sana, gastrite acuta, gastrite cronica con o senza infezione da Helicobacter pylori, metaplasia intestinale)
* Ottenimento del consenso informato.

Exclusion Criteria:

* none

Primary outcomes:
measure: Collection of data
timeFrame: 2016-2020
Secondary outcomes:
measure: Data interaction in the developement of gastric cancer
timeFrame: 2016-2020
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
state: BO
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Giulia Fiorini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04041141: Oral Stent Device for Radiation Treatments of Oral Cancers
Official title: A Pilot Study Assessing an Oral Stent Device for Radiation Treatments of Oral Cancers
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Tongue Tumor
Tongue Cancer
Keywords: tongue tumor
tongue cancer
oral cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 0
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: Potential patients will be identified in the Oncology outpatient clinics or by referrals from outside physicians at the Indiana University Simon Cancer Center.

Brief summary: The purpose of this study is to examine that ability of the experimental oral stent device to reduce the volume of mandible receiving \>55 Gy by 50%during radiation treatment as assessed duri radiation treatment planning. Patients will have CT scans at three time-points during their standard of care radiation treatment. During these visits patients will receive scans via CT or cone beam CT scan, with both the standard and experimental oral stent devices.

During radiation treatment patients will receive the standard oral stent device.


Eligibility criteria: Inclusion Criteria:

* ≥18 year old at the time of informed consent
* Ability to provide written informed consent and HIPAA authorization
* Accepted for curative radiation treatment of a tongue tumor, either intact or postoperatively
* Signed consent to study participation
* No history of bleeding disorder
* Platelets within normal limits (150-450 k/cumm)

Exclusion Criteria:

* History of bleeding disorder
* History of allergy to dental grade material

Primary outcomes:
measure: The volume of mandible irradiated to >55 Gy
timeFrame: volume irradiated at Day 0
Secondary outcomes:
measure: The position of the fiducial marker
timeFrame: Change in position at Day 0, Week 3, Week 5
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin & Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Mark Langer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04428541: Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children with Operable Bilateral Ocular Pathologies
Official title: Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children with Operable Bilateral Ocular Pathologies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eye Diseases
Vision Disorders
Keywords: Eye Diseases
Vision Disorders
Questionnaire Design
Children
Infant
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2020-06-11
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In some symmetrical pediatric ocular pathologies, the treatment is surgical with usually satisfactory postoperative results in visual terms.

However, it is often difficult to choose the right moment to operate. The main difficulty is that the child's vision is unknown since the child is still in a preverbal age.

The investigators have developed a questionnaire with the aim of quantifying the child's vision so that the decision is most justified. The items of this questionnaire were established based on the literature and were submitted to a panel of experts in ophthalmo-pediatrics. The objective of this study is to determine the internal validity and as far as possible (since there is no equivalent tool) the external validity of the questionnaire developed.


Eligibility criteria: Inclusion Criteria:

Common to the three groups:

* Patient aged 0 to 36 months
* Diagnosis of known ocular pathology

For patients targeted by the questionnaire:

- Patient with operable bilateral ocular pathology

For negative controls:

- Patient without ocular pathology inducing a decrease in vision

For positive controls:

* Patient with inoperable bilateral ocular pathology
* Patient without light perception

Exclusion Criteria:

* Patient with unilateral ocular pathology
* Verbal patients (able to express themselves through speech)

Primary outcomes:
measure: Measure the internal validity of the questionnaire developed to assess the visual acuity of preverbal children
timeFrame: Inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation A de Rothschild
Study officials:
affiliation: Fondation A. de Rothschild
name: Pascal DUREAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03505541: Adipokines Effect in Myometrial Contractility
Official title: Effect of Adiponectin and TNFa on Uterine Contractility in GDM and Obese Pregnant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myometrium; Contractility
GDM
Obesity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant subjects undergoing a scheduled C-section delivery.

Brief summary: Investigate the effect of two adipokines which are adiponectin and TNFa on the force of myometrial contractility in diabetic, non-obese pregnant women and obese, non-diabetic term pregnant women at the time of scheduled cesarean delivery


Eligibility criteria: Inclusion Criteria:

* Pregnant patients scheduled for a CS at 37-41 weeks of gestation at M Health Birth Place
* Participants age ≥18.
* Full informed consent able to be provided by the participant.

Exclusion Criteria:

* Patients undergoing general anesthesia for their CS.
* Pre-gestational DM, and DM diagnosed \<24 weeks gestation.
* Patients unable to consent for themselves
* Multiple gestation

Primary outcomes:
measure: Effect on force of contractility
timeFrame: 24 hours
Secondary outcomes:
measure: Force of contractility between study groups
timeFrame: 24 hours
measure: Progesterone effect in control group
timeFrame: 24 hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Fairview Hospital
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Katherine Jacobs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06099041: ND-YAG Laser Iris Depigmentation for Cosmoses
Official title: ND-YAG Laser Iris Depigmentation for Cosmoses
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Iris Depigmentation
Keywords: Nd-YAG Laser
Iris
Cosmoses
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Nd-YAG Laser for changing iris coloration by the principle of depigmentation for cosmoses Is that procedure safe or not a prospective study

Detailed description: Nd-YAG Laser for changing iris coloration by the principle of depigmentation for cosmoses Is that procedure safe or not a prospective study safety will be assessed by measuring IOP using Goldman applanation tonometry pre and post-session.

visual acuity assessment in Log-Mar pre and post-session. Refraction assessment pre and post-session. Lens and fundus assessments on slit-lamp and using auxiliary lens 78D

Eligibility criteria: Inclusion Criteria:

* clear cornea
* clear lens
* normal IOP \< 20 mmHg
* adults aged more than 18 years old
* normal fundus
* dark pigmented iris (black or brown)

Exclusion Criteria:

* Glaucomatous patients and those receiving anti-glaucoma treatment.
* corneal or lens opacity.
* any fundus abnormality

Primary outcomes:
measure: Monitoring intra-ocular pressure (IOP) by the standard Goldman applanation tonometer before and after ND-YAG Laser for iris depigmentation
timeFrame: one year
measure: Safety of ND-YAG Laser, by visual acuity assessment in log-mar subjectively by using Snellen chart before and after ND-YAG Laser
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Elshimaa A.Mateen
Study officials:
References:
Clinical trial NCT04496141: Evaluation of Commercial SARS-CoV-2 Antibody Immunoassays for COVID-19
Official title: Evaluation of Commercial SARS-CoV-2 Antibody Immunoassays for COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Hong Kong Sanatorium & Hospital
Sponsor class: INDUSTRY
First posted: 2020-08-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who attended clinic and had a positive SARS-CoV-2 PCR and subjects who had COVID-19 negative serum during the epidemic in Hong Kong.

Brief summary: Achieved serum samples of persons with or without evidence of COVID-19 infection are tested using the different commercial SARS-CoV-2 antibody immunoassays. The performance of the immunoassays is then assessed by comparing the 2 groups of samples.

Detailed description: Achieved serum samples of the different testing groups are retrieved and tested with the immunoassays according to manufacturer's instruction.

The test results are then compared and analyzed with statistical tests to assess the immunoassays'performance

Eligibility criteria: Inclusion criteria for COVID-19 infected sera: any patient with PCR confirmed COVID-19 infection

Inclusion criteria for COVID-19 negative sera: sera collected after a negative SARS-CoV-2 PCR

Exclusion Criteria:

-

Primary outcomes:
measure: The accuracy of the different commercial SARS-CoV-2 antibody immunoassays
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Sanatorium & Hospital
Study officials:
affiliation: Hong Kong Sanatorium & Hospital
name: Jonpaul Sze Tsing Zee, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03070041: The Impact of Baby-friendly Hospital Initiative to Breastfeeding, Breastfeeding Counselling and Breastfeeding Attitudes
Official title: Vauvamyönteisyysohjelman Vaikutus Imetykseen, Imetysohjaukseen ja Imetysasenteisiin / The Impact of Baby-friendly Hospital Initiative to Breastfeeding, Breastfeeding Counselling and Breastfeeding Attitudes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 425
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The impact of Baby-friendly Hospital Initiative (BFHI) to breastfeeding, breastfeeding counselling and breastfeeding attitudes will be examined in Satakunta Central Hospital, Finland. The baseline measurement will be conducted before the implementation of BFHI in 2017 and second measurement will be conducted in 2019 after the certification process. Both staff members and breastfeeding mothers will be recruited in the study. The main outcomes are the duration of breastfeeding and breastfeeding attitudes.


Eligibility criteria: Inclusion Criteria:

* Staff: All staff members taking care of mothers and/or infants in the hospital.
* Mothers: Mothers who have given birth in the study hospital during the data collection period.

Exclusion Criteria:

* Mothers:

  * who have given birth outside the hospital,
  * whose infant's condition is critical,
  * whose infants are transferred to another unit.

Primary outcomes:
measure: Duration of breastfeeding
timeFrame: Six months
Secondary outcomes:
measure: Breastfeeding attitude of the staff (questionnaire)
timeFrame: Two years
measure: Breastfeeding attitude of the mothers (questionnaire)
timeFrame: Four months
Other outcomes:
Locations:
city: Pori
country: Finland
facility: Satasairaala Central Hospital
Study officials:
References:
Clinical trial NCT05928741: Short-term Effects of Juice Consumption With Biofunctional Compounds and Probiotics on Subjective Appetite
Official title: Short-term Effects of Fruit Juice Enriched With Vitamin D3, n-3 Fatty Acids, and Probiotics on Subjective Appetite, Energy Intake, and Glycemic Responses, in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Appetite
Keywords: subjective appetite
feeding behavior
glycemic responses
enriched juice
probiotics
vitamin D3
n-3 fatty acids
Lead sponsor: Agricultural University of Athens
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study investigated the short-term effects of fruit juice enriched with vitamin D3, n-3 fatty acids, and probiotics on subjective appetite, energy intake, and glycemic responses, in both normal-weight and overweight, healthy adults.

Detailed description: This study aimed to 1. Assess the subjective appetite of participants after the consumption of fruit juice (100% orange) enriched with vitamin D3, n-3 fatty acids, and probiotics compared to regular fruit juice (without any fortification), and 2. Examine the short-term effects of enriched fruit juice compared to regular fruit juice on glycemic responses and blood pressure, in both normal-weight and overweight healthy adults

Eligibility criteria: Inclusion Criteria:

* Healthy Non-diabetic men and women Body mass index between 18.5 and 29.9 kg/m2

Exclusion Criteria:

* Severe chronic disease (i.e., cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions)
* Gastrointestinal disorders
* Pregnancy
* Lactation
* Competitive sports
* Alcohol abuse
* Drug dependency

Primary outcomes:
measure: Subjective appetite rating
timeFrame: 7 hours
Secondary outcomes:
measure: Energy intake after preload and the next 24 hours
timeFrame: 24 hours
Other outcomes:
measure: Capillary blood glucose responses
timeFrame: 7 hours
measure: Blood pressure
timeFrame: 7 hours
Locations:
city: Athens
country: Greece
facility: Agricultural University of Athens
state: Attica
Study officials:
affiliation: Agricultural University of Athens
name: Aimilia Papakonstantinou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05386641: Risk Factors for Shoulder Joint Motion Restriction
Official title: Risk Factors for Shoulder Joint Motion Restriction in Breast Cancer Survivors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Survivors
Keywords: breast cancer
range of motion
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 72
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer survivors with or without shoulder joint restriction will be evaluated

Brief summary: In breast cancer patients, limitation of shoulder joint movement may occur following cancer treatment. Shoulder limitation causes a significant decrease in the patient's participation in activities of daily living. The aim of the study is to define these limitations, to evaluate in detail all the structures that cause the problem, and to determine the causes of the limitations in patients with shoulder joint movement limitation developed after breast cancer survivors.


Eligibility criteria: Inclusion Criteria:

* Women between the ages of 30-60
* Having breast cancer treatment within 5 years

Exclusion Criteria:

* Not having agreed to participate in the study
* Presence of additional orthopedic (scoliosis, etc.), neurological (multiple sclerosis, stroke, etc.) and rheumatological diseases (ankylosing spondylitis, rheumatoid arthritis, etc.) that will affect upper extremity functions

Primary outcomes:
measure: measurement of tissue stiffness (N/m)
timeFrame: Baseline
measure: measurement of passive muscle tone (Hz)
timeFrame: Baseline
measure: measurement of creep of tissue
timeFrame: Baseline
measure: measurement of the range of shoulder joint motion
timeFrame: Baseline
Secondary outcomes:
measure: measurement of skin temperature
timeFrame: Baseline
measure: measurement of pain
timeFrame: Baseline
measure: measurement of pain pressure threshold
timeFrame: Baseline
measure: measurement of grip strength
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Medeniyet University
Study officials:
References:
Clinical trial NCT06431841: Atropine and Spectacle Combination Treatment (ASPECT): 12-month Results of a Randomized Clinical Trial for Myopia Control
Official title: Postmarketing Parallel Randomized Clinical Trial to Determine the Efficacy and Safety of Atropine and DIMS Lenses in the Control of Myopia in a Pediatric Population.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Myopia
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 111
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase IV clinical trial to evaluate whether there is a significant difference in the control of myopia progression in myopic children treated with 0.025% atropine and DIMS spectacle lenses compared to 0.025% atropine and single vision (SV) lenses. Open-label, randomized, parallel clinical trial with 2 arms, involving 111 patients in total. The primary efficacy endpoint will be the change in cycloplegic spherical equivalent refraction (SER) and axial length (AL) compared to baseline values.


Eligibility criteria: Inclusion criteria

* Age between 4-16 years.
* Signing of informed consent.
* Refractive error: myopia greater than -1.00 diopters (D).
* Myopia progression of at least -0.50 D in the last 12 months.
* Astigmatism of 2 D or less and anisometropia of 1.50 D or less.
* Best-corrected monocular visual acuity (VA) of 0.2 logMAR(6/9) or better.

Exclusion criteria

* Children under 4 years old and over 16 years old
* Strabismus and binocular vision anomalies.
* Alterations in eye fundus that the researcher consider necessary the patient exclution.
* Ocular pathology of the anterior segment (media opacity such as cataracts, glaucoma, aphakia, pseudophakia, uveitis, keratoconus or surface alterations), and any pathology of the posterior segment that prevents correct vision
* Amblyopia
* Previous eye surgery
* Systemic pathology (cardiopulmonary pathology, connective tissue alterations, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination to be carried out (such as mental or psychomotor retardation)
* Previous myopia control treatments including orthokeratology, rigid contact lenses, bifocal or myopia control soft contact lenses, bifocal and multifocal ophthalmic lenses within 3 months prior to the study.

Primary outcomes:
measure: Cycloplegic spherical equivalent refraction (SER) change
timeFrame: 2 years (24 months)
measure: Axial length (AL) change
timeFrame: 2 years (24 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Noemi Guemes
Study officials:
References: