louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06246032: Impact of Modified Feeding Protocol on Neonatal Outcomes
Official title: Impact of Modified Feeding Protocol on Neonatal Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Preterm
Birth Weight
Feeding Disorder Neonatal
Keywords: Feeding protocol
Neonates
Preterm
Very low birthweight
NICU
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 30
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to compare modified feeding protocol and current feeding protocol on neonatal outcomes in preterm infants who born with weight less than 2kg.

The main questions it aims to answer are:

* Is Modified feeding protocol will decrease the duration of parenteral nutrition and length of hospital stay?
* Is Modified feeding protocol feasible, efficient, and safe in preterm infants?

Participants will undergo the modified feeding protocol since birth until discharge.

Detailed description: two group in this study Prospective group: intervention group will undergo the modified feeding protocol Retrospective group: intervention group will undergo the current feeding protocol

Both group will have care as routine care to this kind of patients But the differ will be in feeding protocol as initiation rate, advancement rate, human milk fortification rate

The outcomes of both group will be compeered to meet the study objectives

Eligibility criteria: Inclusion Criteria:

* Birth weight (\<2000g)
* Gestational Age (\<37 week)

Exclusion Criteria:

* Metabolic Disorders
* Congenital Heart Diseases
* Chronic Lung Disease
* Congenital Anomalies (can related to feeding)
* Moderate to severe GERD
* Necrotizing enterocolitis stage 3 (surgical)
* Gastrointestinal surgery

Primary outcomes:
measure: Length of Stay (LOS)
timeFrame: Up to 8 weeks
measure: Duration of Total Parenteral Nutrition (TPN)
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Incidence of Necrotizing Enterocolitis
timeFrame: Up to 8 weeks
measure: Incidence of Feeding intolerance
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Maternity and Children Hospital
state: Eastern
Study officials:
affiliation: Imam Abdulrahman Bin Faisal University
name: Hanan AlQahtani, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02730832: Validation of a Scale to Evaluate the Perception of Oral Health in Patients With Schizophrenia
Official title: Validation of Scale to Evaluate the Perception of Oral Health in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Apart from objective criteria for the evaluation of oral health (CAO, CPI...), there are no scales to evaluate the oral health of patients with schizophrenia. The only scales that do exist are for the population at large, children or the elderly. Given the severely deteriorated oral health in these schizophrenic populations, it is important to have a tool to evaluate their perception of the quality of their oral health so as to better orientate prevention programmes.

The aim of this study is to validate a tool to measure the perception of oral health in patients with schizophrenia.

To do this, patients will be invited to complete a series of self-questionnaires relative to the concept of oral health.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of schizophrenia according to DSM V
* Hospitalized patients or outpatients who have been taking an antipsychotic treatment for more than 2 years
* Patients older than 18 years
* Patients who have provided oral informed consent to take part in the study

Exclusion Criteria:

* Patients who are psychiatrically unstable or delusional
* Subjects on chemotherapy
* Adults under guardianship
* Patients without national health insurance cover

Primary outcomes:
measure: Perception of oral health by OHIP-14 scales
timeFrame: At inclusion
measure: Evaluation of quality of life by GOHAI scales
timeFrame: At inclusion
measure: Mc Nair Memory Questionnaire
timeFrame: At inclusion
measure: Evaluation of negative symptoms by scale
timeFrame: At inclusion
measure: Beck Depression Scale
timeFrame: At inclusion
measure: Evaluation of quality of life by S-Qol
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CH La Chartreuse
Study officials:
References:
citation: Frederic D, Corinne R, Matthieu R, Francesca SP, Stephanie TJ, Nathalie R. The Schizophrenia Oral Health Profile: Development and Feasibility. Transl Neurosci. 2018 Sep 22;9:123-131. doi: 10.1515/tnsci-2018-0019. eCollection 2018.
citation: Siu-Paredes F, Rude N, Rat C, Reynaud M, Hamad M, Moussa-Badran S, Denis F. The Schizophrenia Coping Oral Health Profile. Development and Feasibility. Transl Neurosci. 2018 Jun 20;9:78-87. doi: 10.1515/tnsci-2018-0014. eCollection 2018.
Clinical trial NCT05289232: Prevalence and Complications of Suture in the ED
Official title: Prevalence of Complications Post Sutured Wounds in the ED
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suture, Complication
Keywords: suture
complications
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 250
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Included patients presented to the outpatient emergency circuit of the EPS Fattouma Bourguiba Monastir having as main reason for consultation an acute suturable wound. The patients excluded are those who consulted for wounds requiring surgical treatment, septic wounds and patients who did not consent to the protocol.

Brief summary: included patients who had sutured wounds in the ED were asked about complications after suture .

Detailed description: All patients using the emergency room of EPS Fattouma Bourguiba Monastir are welcomed by a resident in the suture room. After an inclusion, patients are cared for in the outpatient circuit and the suture will be done in the dedicated box. Before discharging the patient, instructions and standardized prescriptions are given to the patient such as standard prescriptions for local wound care, removal of stitches and verification of vaccination status.

The data relevant to this study are obtained prospectively from a detailed questionnaire in the annex and a telephone call and they are completed retrospectively with the data collected in the computerized medical record.

At the healing period, between 15 days and 45 days after the suture, the investigators called the patients back in order to know the evolution of the wound, the adherence to the instructions and the prescriptions, the quality of healing and the search for complications (infection , loose stitches, hematoma, etc.)

Eligibility criteria: Inclusion Criteria:

* Patients with acute suturable wound

Exclusion Criteria:

Wounds requiring surgical treatment Septic wounds Chronic lesions Vascular wounds Patients who did not consent to the protocol.

Primary outcomes:
measure: Sutures complications after discharge of the Emergency Department PART 1
timeFrame: 15 days after the suture
Secondary outcomes:
measure: Sutures complications after discharge of the Emergency Department PART 2
timeFrame: 45 days after the suture
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia Monastir, Tunisia, 5000
state: Monastir ,Tunisia
Study officials:
affiliation: University of Monastir
name: Semir Nouira, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05884632: Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients
Official title: Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 184
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a monoinstitutional prospective pilot study, aiming to evaluate treatment-related toxicity of an hypofractionated postoperative salvage radiotherapy with daily-adaptive modality in patients affected by prostate cancer biochemical recurrence.

Patients will be treated with postoperative hypofractionated salvage radiotherapy with a dose of 59 Gy in 20 fractions with daily-adaptive modality. Considering the consolidate role and clinical outcome of postoperative hypofractionated radiotherapy with elevate level of evidence (8-10), the study will not be controlled, but compared with literature data.


Eligibility criteria: Inclusion Criteria:

* Age ≤ 80 years;
* Prostate cancer diagnosis, pT2-3 pN0, any resection margin (R0 or R1);
* Indication to local salvage treatment defined as: early salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA \<0.2 ng/ml or salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA ≥0.2 ng/ml;
* No distant metastases (M0) diagnosed with PSMA-PET-CT;
* Informed consent to trial's participation and personal data treatment.

Exclusion Criteria:

* Age \<18 years old;
* Adjuvant radiotherapy;
* Previous radiation in the same anatomical site.

Primary outcomes:
measure: Acute gastrointestinal toxicity
timeFrame: 90 days from the RT treatment
Secondary outcomes:
measure: Acute genitourinary toxicity
timeFrame: 90 days from the RT treatment.
measure: Late toxicity
timeFrame: From 90 days after the RT treatment until 24 months
measure: QLQ-C30
timeFrame: At screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months
measure: Biochemical failure
timeFrame: 24 months
measure: Time to biochemical failure
timeFrame: 24 months
measure: Local in-field relapse
timeFrame: 24 months
measure: Metastases-free survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria di Negrar
state: Verona
Study officials:
affiliation: IRCCS Sacro Cuore Don Calabria - Dipartimento di Radioterapia Oncologica Avanzata
name: Luca Nicosia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03773432: Influence of Meal Schedule: Gender Differences
Official title: Factors That Determine the Responses to Meal Ingestion: Meal Schedule and Gender Differences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: meal ingestion
meal schedule
postprandial responses
hedonic sensations
homeostatic sensations
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Gender differences in the effect of meal schedule will be studied in a parallel design (10 women and 10 men). In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be administered in the afternoon, i.e. conventional schedule, and in the morning, i.e. unconventional schedule. The effect of meal schedule will be measured as the differences between the responses on both study days. Participants will be instructed to eat standard dinner the day before and to consume standard breakfast at home the day of the afternoon test. Studies will be conducted in a quiet, isolated room with participants siting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.


Eligibility criteria: Inclusion Criteria:

* non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders

Primary outcomes:
measure: Change in digestive well-being induced by meal schedule
timeFrame: 1 day
Secondary outcomes:
measure: Change in fullness sensation induced by meal schedule
timeFrame: 1 day
measure: Change in mood induced by meal schedule
timeFrame: 1 day
measure: Change in hunger/satiety induced by meal schedule
timeFrame: 1 day
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
Study officials:
References:
citation: Pribic T, Azpiroz F. Biogastronomy: Factors that determine the biological response to meal ingestion. Neurogastroenterol Motil. 2018 Jul;30(7):e13309. doi: 10.1111/nmo.13309. Epub 2018 Feb 2.
Clinical trial NCT02691832: Measuring Core Body Temperature Using a Novel Non-invasive Sensor
Official title: Measuring Core Body Temperature Using a Novel Non-invasive Sensor - a Follow up Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Body Temperature Regulation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-02-25
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Double Sensor examined in this trial was developed by Dräger Company and is a novel non- invasive device for assessing core body temperature. In a preliminary research investigators have conducted the Double Sensor was found promising for potential use of physiological heat stress early detection. This follow-up experiment was designed to validate the data during high and changing body core temperatures and to examine the Double Sensor performance while integrated into a helmet as in intended application.

Detailed description: 12 healthy civilian volunteers will arrive to our lab and will undergo 4 experiment days: Recruitment day + VO2max test, 3 random days performing experiment protocol, dressed in uniforms: sitting in thermoneutral condition for one hour, afterwards they will walk on a treadmill in 5.5 km/h and 4% incline in hot chamber (40% celsius and 40% relative humidity) for 1.5 hours. Once connected to rectal thermistor and to the Double Sensor attached to the skin surface by sticker, once same as the day before with addition of cooling system of Icetron Technologies Ltd. worn on the wrist, and once connected to rectal thermistor and to the Double Sensor integrated into a helmet.

Eligibility criteria: Inclusion Criteria:

* Aged 18-40 years.
* Healthy civilian volunteers.
* Without known medical illness or medication use.

Exclusion Criteria:

* History of heat injury.
* The existence or suspicion of existing cardiac or respiratory disease.
* Diabetes.
* Obesity.
* Infectious disease 3 days prior to the experiment.

Primary outcomes:
measure: Double sensor temperature
timeFrame: 3 days for each participant
measure: rectal temperature
timeFrame: 3 days for each participant
Secondary outcomes:
measure: heart rate
timeFrame: 4 days for each participant
measure: skin temperature
timeFrame: 3 days for each participant
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba medical center
state: Ramat- Gan
Study officials:
affiliation: Sheba Medical Center
name: Haggai Schermann, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02174432: Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis
Official title: An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Prurigo Nodularis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prurigo Nodularis
Nodularis Prurigo
Prurigo
Keywords: Itch
Chronic Itch
Nalbupine
Lead sponsor: Trevi Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-06-25
Enrollment: 36
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: The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 50 weeks.


Eligibility criteria: Inclusion Criteria:

* Subject completed participation in the TR03 study

Exclusion Criteria:

* Medical condition or other factors that in the opinion of the Investigator may interfere with the conduct of the study.
* Subject is a pregnant or lactating female

Primary outcomes:
measure: Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs)
timeFrame: 50 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Münster
country: Germany
facility: University of Münster
Study officials:
affiliation: Trevi Therapeutics
name: Chief Development Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT03349632: Clinical Comparison of 4 Daily Disposable Soft Contact Lenses
Official title: Clinical Comparison of 4 Daily Disposable Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: Contact lenses
Myopia
Near-sighted
Daily disposable
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-11-21
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.

Detailed description: The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.

Eligibility criteria: Inclusion Criteria:

* Able to understand and must sign an approved Informed Consent Form
* Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months
* Best Corrected Visual Acuity of 20/25 Snellen or better in each eye
* Willing to stop wearing habitual contact lenses for the duration of study participation
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.
* Routinely sleeps in habitual contact lenses
* Currently wears Oasys 1-Day, MyDay, or Moist contact lenses
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Overall Quality of Vision
timeFrame: Day 8, each product
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Alcon Investigative Site
state: Florida
city: Pensacola
country: United States
facility: Alcon Investigative Site
state: Florida
city: Johns Creek
country: United States
facility: Alcon Investigative Site
state: Georgia
Study officials:
References:
Clinical trial NCT04228432: E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer.
Official title: E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Hormonotherapy
E-monitoring
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a monocentric, prospective cohort study evaluating the feasibility of an E-monitoring protocol in patients with breast cancer treated by adjuvant hormonotherapy .

45 patients will be included.

Patients will be followed during 6 months.


Eligibility criteria: Inclusion Criteria:

1. Patient treated for hormone-dependent localized breast cancer with adjuvant HT (tamoxifen or anti-aromatase +/- LHRH agonist)
2. Patient equipped with a computer or tablet computer and an internet connection at home
3. Age \> 18 years old
4. Patient affiliated to the french social security system
5. Patient who has signed informed consent before inclusion in the study and before any specific procedures for the study
6. Women of childbearing age should have effective contraception under hormonotherapy

Exclusion Criteria:

1. Patient with breast cancer who does not require adjuvant hormonotherapy
2. Patient with metastatic breast cancer
3. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
4. Patient previously treated for breast cancer (infiltrating or in-situ) with adjuvant HT or not
5. Patient protected by law.

Primary outcomes:
measure: Rate of patients who do not fail the E-Monitoring protocol
timeFrame: 6 months per patient
Secondary outcomes:
measure: Number of medical consultations required over 6 months
timeFrame: 6 months per patient
measure: Rate of hormonotherapy adherence evaluated by the GIRERD questionnaire
timeFrame: 6 months per patient
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse Oncopole
Study officials:
References: