louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06241066: The Prognostic Value of Tertiary Lymphatic Structure in Esophageal Squamous Cell Carcinoma
Official title: The Prognostic Value of Tertiary Lymphatic Structure in Esophageal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 359
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients pathologically confirmed esophageal squamous cell carcinoma(ESCC) who underwent complete surgical resection at Tianjin Medical University Cancer Hospital between 2014 and 2021

Brief summary: Retrospective analysis of the presence and maturity of tertiary lymphoid structures in pathological sections of patients with esophageal squamous cell carcinoma after surgical treatment. Pay attention to the overall survival and disease free survival of these esophageal squamous cell carcinoma patients.


Eligibility criteria: Inclusion Criteria:

* 1. Pathologically diagnosed as esophageal squamous cell carcinoma; 2. Surgery for esophageal cancer; 3. Complete medical records;

Exclusion Criteria:

* Patients with a previous history of malignant tumor

Primary outcomes:
measure: OS
timeFrame: The time from treatment to death or last follow-up, assessed up to 100 months.
measure: DFS
timeFrame: The time from treatment to the first recurrence or last follow-up, assessed up to 100 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Wencheng Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02772666: Novel Portable Diagnostic Device for Automatic Detection of Relative Afferent Pupillary Defect
Official title: New Automatic Portable Ophthalmology Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Glaucoma
Keywords: Relative afferent pupillary defect (RAPD)
Multiple sclerosis
Glaucoma
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is to evaluate the ability of a newly designed device, Optic Nerve Glass (O-Glass) to detect relative afferent pupillary defect (RAPD). In this prospective study, 44 patients (diagnosed RAPD- positive) enrolled the study. They were examined for an RAPD by O-Glass and also manual swinging flashlight method (SFM) . This newly designed instrument captures and records eye pictures. The images will be processed and analyzed using computerized software to calculate pupillary measurements.

Detailed description: Pupil response to light stimulation is a basic clinical approach to the assessment of a patient with visual loss. Asymmetric response may indicate a relative afferent pupillary defect (RAPD). The rapid detection device for relative afferent pupillary defect (present device) is a newly designed portable facility with computerized software on a mobile device. This allows for field ophthalmic examination and identification of RAPDs quickly and accurately and also record pupillary movements for further processing and analysis or send the information and images via Wi-Fi. We aimed at comparing and evaluating this device with available methods to develop a test which is practically easy and quick with objective results and no need for specialist interpretation, so that any technician can perform the test automatically. Distinctive software allows simple use of the device by field personnel with minimal training. Each patient was investigated by swinging flashlight method and the newly constructed automated O-glass. The swinging flashlight test procedure, also called as Marcus Gunn Test, is well known in ophthalmology science.The hardware for this device includes 4 different parts: Camera and optics, light control system, power control system, and the microcontroller.The two main components of the software are the ability to communicate with the hardware wirelessly, and the pattern recognition system.

Eligibility criteria: Inclusion Criteria:

* positive relative afferent pupillary defect

Exclusion Criteria:

-

Primary outcomes:
measure: Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD)
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mashhad University of Medical Sciences
name: Amirhossein Vejdani, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05342766: Precision Nutrition
Official title: Nutritia de Precizie
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrient Deficiency
Keywords: Genotypes
Nutrient intakes
Nutrient plasma levels
Lead sponsor: Shape Divine Center SRL
Sponsor class: OTHER
Collaborators: name: SmartepigenetX SRL
name: Advanced Nutrigenomics LLC
First posted: 2022-04-25
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy adults

Brief summary: Determine the relationship between relevant genotypes and nutrient plasma levels, with the aim to normalize such levels using a nutritional intervention.

(Original text in Romanian language: Caracterizarea precisa a relatiei dintre variatiile genetice si nivelul de nutrienti din sange/plasma/ser, in scopul de a defini modul in care aportul alimentar poate normaliza aceste nivele.)

Detailed description: 1. Define plasma levels prediction formulas for each involved nutrient, based on relevant genotypes;
2. Characterize the roles that food intakes may have in the alteriations of such plasma levels, depending on genotype structure;
3. Based on clinical data, create predictive equations using dependent variables (genotypes) in order to define optima nutrient intakes;
4. (Secondary aim): compare the efficacy of a nutrigenetic-based intervention with a non-nutrigenetic intervention (classical approach).

(Original text in Romanian language:

1. Definirea unor formule de predictie a nivelelor din sange, in functie de variatiile genetice;
2. Caracterizarea rolului pe care aportul alimentar de nutrienti il are in modularea acestor valori, in contextul variatiilor genetice.
3. Gasirea unor formule de predictie in care variabilele independente (variatii genetice si combinatii ale acestora) sa defineasca necesarul de nutrienti pentru a normaliza valorile sangvine ale acestor nutrienti.
4. (Obiectiv secundar): compararea eficacitatii unei interventii nutrigenetice fata de o interventie clasica nutritionala (non-nutrigenetica).)

Eligibility criteria: Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* any pathology

Primary outcomes:
measure: blood/serum nutrient levels
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Shape Divine SRL
Study officials:
References:
Clinical trial NCT03379766: Quality Control of CE-Certified Phonak Hearing Aids - 2017_37
Official title: Quality Control of CE-Certified Phonak Hearing Aids - 2017_37
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2017-12-20
Enrollment: 20
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: Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features and functions. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).


Eligibility criteria: Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years) with at least 3 months experience with hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Central hearing disorders

Primary outcomes:
measure: Spontaneous acceptance of the initial pre-calculation (first fit)
timeFrame: One week
Secondary outcomes:
measure: Listening effort in noisy listening environment
timeFrame: One week
measure: Speech intelligibility in noisy listening environment
timeFrame: One week
Other outcomes:
measure: TV streaming
timeFrame: Three weeks
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
state: Zürich
Study officials:
References:
Clinical trial NCT05962866: The Effect of Pregnant Women's Maneuvers on Pregnancy Distress and Perception of Maternity Role"
Official title: Pregnancy of I. and II. Leopold Manoeuvres Performed by Pregnant Women Under Midwife Supervision Effects on Distress and Perception of Motherhood Role
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Mother-Child Relations
Keywords: Leopold maneuver
pregnancy
midwifery
fetus
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The role of motherhood; Motherhood can be defined as a learning process that includes knowledge, skills, attitudes and behaviors of a woman who has been handed down from generation to generation. Mother-infant attachment; At the behavioral and emotional level, it is the mother's attachment to her baby, which becomes stronger as the pregnant woman's body changes, her uterus expands and the mother begins to feel fetal movements. The fact that women adopt the role of motherhood throughout pregnancy is very important for attachment behaviors and infant attachment patterns in the early and late postpartum period.

Detailed description: It is very important for midwives to implement and teach the interventions that will enable pregnant women to take an active role in this period, in terms of perception of the role of motherhood and pregnancy distress. . The literature provides a data source for leopard maneuvers. However, I and II. There is no study on the effect of Leopold maneuvers on pregnancy distress and the perception of maternal role. This study, which is planned to support and develop awareness in this area, is important in terms of literature.

Eligibility criteria: Inclusion Criteria:

* Spontaneous single pregnancy,
* 28th gestational week,
* Over the age of 18, under the age of 40,
* Not having communication difficulties and mental disabilities, Literate,
* Not having any chronic health problems (hypertension, heart disease,
* obesity etc.)
* Does not have a psychiatric disease and does not use psychiatric drugs, Exclusion Criteria
* Not open to communication and cooperation during the working period,
* Reluctant to participate in the research,
* Not completing the questionnaires,
* Pregnant women who gave birth prematurely were not included in the study.

Primary outcomes:
measure: Measuring pregnancy distress of pregnant women
timeFrame: two months
Secondary outcomes:
measure: Measuring pregnant women's perception of maternal role
timeFrame: two months
Other outcomes:
Locations:
city: Muş
country: Turkey
facility: Muş Hasköy Family Health Center
Study officials:
affiliation: Muş Hasköy Family Health Center
name: Songül Kekil
role: PRINCIPAL_INVESTIGATOR
affiliation: Ataturk University Faculty of Health Sciences Department of Midwifery
name: Sibel Öztürk, Asst. Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01554566: Metabolic Effects of Honey in Type 1 Diabetes Mellitus
Official title: Metabolic Effects of Honey in Type 1 Diabetes Mellitus: a Cross Over Randomised Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes Mellitus
Keywords: honey
diabetes
lipids
c-peptide
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed at evaluation of the metabolic effects of honey, as a supplemental food, in patients suffering from type 1 diabetes mellitus. A crossover design (two 12-weeks intervention periods) was used to measure honey effects. The subjects were randomized into two groups (intervention to control \[I/C\] and control to intervention \[C/I\] groups. Each group consisted of 10 patients. . The subjects in the I/C group consumed 0.5 ml honey/kg/day in the first 12-week period (period 1) while the subjects in the C/I group did not receive honey as a control in period 1. After period 1 the subjects of each group exchanged their protocol for the following 12-week period (period 2).


Eligibility criteria: Inclusion Criteria:

* All patients with type 1 diabetes mellitus with their last HbA1C less than 10% were candidates for this study.

Exclusion Criteria:

* Coexisting renal or hepatic impairment
* Coexisting diseases e.g., malignancy, other endocrine disorders
* Patients on steroid therapy or other drugs that may affect the body weight or serum lipids.

Primary outcomes:
measure: serum lipids
timeFrame: 12 wk
Secondary outcomes:
measure: C-peptide
timeFrame: 12 week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Institute of Diabetes and Endocrinology
state: Kasr El Ainy
Study officials:
affiliation: pediatric department, faculty of medicine, ain shams university
name: Mamdouh AM Abdulrhman, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: national institute of diabetes and endocrinology, cairo, egypt
name: Mohamed H El Hefnawy, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: pediatric department, faculty of medicine, ain shams university
name: Rasha H Aly, assist. prof
role: PRINCIPAL_INVESTIGATOR
affiliation: pediatric department, faculty of medicine, ain shams university
name: Rania H Shatla, lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: pediatric department, faculty of medicine, ain shams university
name: Doaa M Mohamed, M.B.B.Ch
role: PRINCIPAL_INVESTIGATOR
affiliation: pediatric department, faculty of medicine, ain shams university
name: Waheed S Mohamed, M.B.B.Ch
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdulrhman MM, El-Hefnawy MH, Aly RH, Shatla RH, Mamdouh RM, Mahmoud DM, Mohamed WS. Metabolic effects of honey in type 1 diabetes mellitus: a randomized crossover pilot study. J Med Food. 2013 Jan;16(1):66-72. doi: 10.1089/jmf.2012.0108. Epub 2012 Dec 20.
Clinical trial NCT05906966: Cognitive, Emotional, Communicative, and Motor Development in Children Born From IOC
Official title: Cognitive, Emotional, Communicative, and Motor Development in Children Born From in Vitro Fertilization of Cryopreserved Oocytes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ART
Child Development
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 377
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Live births from pregnancies resulted from fresh and frozen embryo transfer after fertilization of cryopreserved oocytes are included.

Brief summary: The study focuses on children born after in vitro fertilization (IVF) of cryopreserved oocytes.

Detailed description: * Evaluate whether the cognitive development of children born by IVF of cryopreserved oocytes is comparable to expected peer development.
* Evaluate whether the emotional development of children born by IVF of cryopreserved oocytes is comparable to expected peer development.
* Evaluate whether the communicative development of children born by IVF of cryopreserved oocytes is comparable to expected peer development.
* Evaluate whether the motor development of children born by IVF of cryopreserved oocytes is comparable to expected peer development

Eligibility criteria: Inclusion Criteria:

* Live births from pregnancies resulted from fresh and frozen embryo transfer after fertilization of cryopreserved oocytes are included.

Exclusion Criteria:

* Children born from pregnancies obtained from cryopreserved donated oocytes have been excluded.

Primary outcomes:
measure: Cognitive development
timeFrame: 18 YEARS
measure: Communicative development
timeFrame: 18 YEARS
measure: Motor development
timeFrame: 18 YEARS
measure: Emotional development
timeFrame: 18 YEARS
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
affiliation: Istituto Clinico Humanitas
name: Paolo Emanuele Levi Setti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00456066: Coronary Thromboaspiration and Infarct Size
Official title: Assessment of Efficacity of Coronary Thromboaspiration (Export System) Performed Before Angioplasty on Infarct Size in Patients Treated by Coronary Percutaneous Interventions During Acute Phase.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ischemic Heart Disease
Acute Myocardial Infarction
Keywords: Acute myocardial infarction
Thromboaspiration
Infarct size
Left ventricular remodelling
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2007-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Distal embolization can occur during coronary angioplasty performed in the acute phase of myocardial infarction and is associated with poor long-term outcome. We hypothesize that the use of a system allowing thrombus aspiration before angioplasty and stent implantation will limit infarct size and its severity.

Detailed description: Patients scheduled for emergency angioplasty in the acute phase of a first ST-elevation myocardial infarction will be treated either by thromboaspiration followed by angioplasty or by angioplasty alone. The infarct size and severity will be assessed by ce-MRI and rest Tc99m-mibi gated SPECT performed during initial hospital stay (5th-8th day). A control MRI will be performed at 6-month follow-up to analyse the evolution of left ventricular volumes.

Eligibility criteria: Inclusion Criteria:

* acute phase of myocardial infarction (\>48 hours from the onset of chest pain)
* stable hemodynamic conditions
* completely occluded infarct related artery

Exclusion Criteria:

* heart failure signs in the acute phase
* contra indication for MRI or SPECT IMAGING

Primary outcomes:
measure: Infarct size and severity assessed by ce-MRI and rest Tc99m-mibi gated SPECT
timeFrame: by ce-MRI and rest Tc99m-mibi gated SPECT
Secondary outcomes:
measure: Probability of evolution toward left ventricular remodelling (defined as an increase of end-diastolic volume of>20% between the acute phase and 6-montcontrol)
timeFrame: of end-diastolic volumeof>20% between the acute phase and 6-montcontrol)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Departement of Cardiology and Radiology, University Hospital, and Departement of Nuclear Medicine, Jean Perrin Cancer Centre
state: Auvergne
Study officials:
name: Janusz Lipiecki, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05396066: Respiratory and Quadriceps Muscle Fatigability After an ICU Acquired Weakness
Official title: Comparison Between Respiratory and Quadriceps Muscle Fatigability During a Maximal Loading for ICU Weakness Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ICU Acquired Weakness
Keywords: ICU acquired weakness
Muscle strength
fatigability
respiratory muscle
Quadriceps muscle
Lead sponsor: Groupe Hospitalier du Havre
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients weaned from mechanical ventilation and developping ICU muscle weakness diagnosed by a maximal inspiratory pressure and a MRC score

Brief summary: Muscle dysfunction can be lead to poor outcomes moreover ICU muscle weakness recovery are not correctly described.

The investigators aimed to assess the ability for quadriceps or respiratory muscles to repeat an effort at a maximal loading.


Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated at least at 24 Hours
* Maximal inspiratory pressure \< 30 centimeter of water
* MRC score \< 48/60

Exclusion Criteria:

* Age \< 18 years
* Patients with neurological pathology or pre existing neuromuscular dysfunction
* Patient unable to walk 50 meters before ICU admission
* Patient with a thoracic or abdominal surgery
* Inability to carry out maximal voluntary contraction

Primary outcomes:
measure: Change in Respiratory muscle strength
timeFrame: One day
measure: Change in quadriceps muscle strength
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Montivilliers
country: France
facility: Groupe Hospitalier du Havre
state: Groupe Hospitalier Du Havre
Study officials:
References: