louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02628015: Theory of Mind in Preschool Children, School Children, Youths and Adults Born Preterm or Full-term
Official title: Theory of Mind Bei Ehemals früh- Und Reifgeborenen Vorschulkindern, Schulkindern, Jugendlichen Und Erwachsenen
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Birth
Keywords: Theory of Mind
Very Low Birthweight Infants
Lead sponsor: University of Bonn
Sponsor class: OTHER
Collaborators: name: University Hospital of Cologne
First posted: 2015-12-11
Enrollment: 480
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: preterms were born in the University Hospital of Cologne

Brief summary: This study tests preschoolers, school children, youths and young adults, who were born preterm or full-term, in their theory of mind abilities.

Detailed description: Is there any difference in the development of theory of mind between preterms and full-terms? Is there a risk group of preterms to develop a deficit in theroy of mind?

Four groups are tested: prescoolers (again two years later), youths and young adults.

All participants were tested for theory of mind, executive functions, language and cognitive abilites.

Eligibility criteria: Inclusion Criteria:

* informed consent
* preterm: birthweight \<1500g
* full-term: born after 38 weeks

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: theory of mind 1
timeFrame: up to 7 months
measure: executive function 1
timeFrame: up to 7 months
measure: executive function 2
timeFrame: up to 7 months
measure: Language 1
timeFrame: up to 7 months
measure: cognitive abilities 1
timeFrame: up to 7 months
measure: theory of mind 2
timeFrame: up to 7 months
measure: theory of mind 3
timeFrame: up to 7 months
measure: theory of mind 4
timeFrame: up to 7 months
measure: theory of mind 5
timeFrame: up to 7 months
measure: Language 2
timeFrame: up to 7 months
measure: cognitive abilities 2
timeFrame: up to 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn
Study officials:
References:
Clinical trial NCT05078515: Multicenter Validation of the PREDICT Score
Official title: Multicenter Validation of the PREDICT Score for Prediction of Local Recurrence After Total Mesorectal Excision of Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stage I-III rectal cancer who underwent surgery with curative intent

Brief summary: Even after adequate TME with grade III mesorectal grading, local recurrence remains a possible event. Several studies investigated different parameters and assessed their predictive power in regards to local recurrence after TME. These parameters included a variety of patient-related, tumor-related, and treatment-related factors. A recent meta-analysis reviewed the current literature for the predictors of local recurrence after TME for rectal cancer and developed a prognostic scoring system, the PREDICT score.

The present study aimed to validate the PREDICT scoring system by applying it to a prospective cohort of patients with rectal cancer who underwent curative TME in three


Eligibility criteria: Inclusion Criteria:

* Adult patients of either sex with non-metastatic low or middle rectal cancer who underwent elective TME with curative intent

Exclusion Criteria:

* Patients with recurrent or metastatic rectal cancer at the time of presentation
* Patients with synchronous colon cancer
* Patients with missing data on the outcome of TME.

Primary outcomes:
measure: Sensitivity of PREDICT score
timeFrame: 36 months after surgery
measure: Specificity of PREDICT score
timeFrame: 36 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile, M.D., FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03896815: Expanded Access Use of INCB054329 to Treat a Single Patient With Metastatic Renal Cell Carcinoma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2019-04-01
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded access use of INCB054329 to treat a single patient with metastatic renal cell carcinoma.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan
name: Bryan Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02236715: Postmarketing Surveillance Study of Atrovent® in Chronic Obstructive Airways Disease
Official title: Postmarketing Surveillance Study (as Per §67(6)AMG[German Drug Law]) of Atrovent® Unit Dose Vial 500 µg in Chronic Obstructive Airways Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-11
Enrollment: 1039
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic obstructive airways disease recruited at general practitioners, pneumologists, internists

Brief summary: Study to obtain further information on the tolerability and efficacy of Atrovent® unit dose vial 500 µg in the treatment of Chronic Obstructive Airways Disease under conditions of daily practice


Eligibility criteria: Inclusion Criteria:

* Primarily patients of both gender, older than 30 years, who suffer from chronic obstructive airways disease
* Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion

Exclusion Criteria:

* Contraindication listed in the instructions for use/summary of product characteristics for Atrovent® unit dose vial 500 µg

Primary outcomes:
measure: Change in total severity of the clinical picture rated on a 4-point scale
timeFrame: after 4 weeks
Secondary outcomes:
measure: Assessment of efficacy by investigator on a 4-point scale
timeFrame: after 4 weeks
measure: Assessment of efficacy by patient on a 4-point scale
timeFrame: after 4 weeks
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: after 4 weeks
measure: Assessment of tolerability by patient on a 4-point scale
timeFrame: after 4 weeks
measure: Number of patients with adverse drug reactions
timeFrame: up to 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04680715: Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer
Official title: Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer : Faisability and Toxicity Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Localized Breast Cancer
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: radiotherapy treatment
Primary purpose: TREATMENT

Brief summary: Phase II study; open recruitment, multicentrique. The aim of this clinical research is to evaluate faisability and toxicity of the per-operative radiotherapy using PAPILLON + TM device for localized breast cancers patients over 65 years.


Eligibility criteria: Inclusion Criteria:

* Patient with invasive ductal adenocarcinoma \<=2cm, evaluate on all radiological exams;
* Women aged 65 years or older (patients 65 years of age in the year may be included);
* Grade 1 or 2 unifocal adenocarcinoma, all index KI67, positive HR, negative HER2 status;
* T0 or T1, N0 radio-clinic;
* Operable patient with breast volume compatible with conservative surgery;
* Patient with prior malignancy or other concurrent malignancies are eligible, including bilateral breast cancer
* Patients who have been made aware of the information sheet and have given their written signed informed consent;
* Patients benefitting from social health insurance coverage

Exclusion Criteria:

* Age less than 65 years (except if 65 years obtained during the year)
* Patient with an exclusive in situ carcinoma
* Patient with lymphatic invasion / peri-nerve involvement / vascular emboli
* Patient with a lobular adenocarcinoma
* Patient with metastatic disease
* Multifocal tumor
* Patient with grade 3 or N+ disease
* N1 proved by ultrasound guided
* patient unable to express her consent
* Patient deprived placed under the authority of a tutor
* Female patients who are pregnant or breastfeeding
* Vulnerable patient: as defined in article L1121-5 à -8

Primary outcomes:
measure: early toxicities occuring until 6 months after performing per-operative radiotherapy
timeFrame: up to 6 months
Secondary outcomes:
measure: global tolerance of per-operative radiotherapy
timeFrame: up to 5 years
measure: local disease free survival at 5 years of per-operative radiotherapy
timeFrame: up to 5 years
measure: disease free survival at 5 years of per-operative radiotherapy
timeFrame: up to 5 years
measure: quality of life of patients
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Pôle Santé République
city: Nice
country: France
facility: Centre Antoine Lacassagne
Study officials:
References:
Clinical trial NCT03475615: A Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites
Official title: A Randomized Study of the Effect of First-line Intraperitoneal Paclitaxel in Combination With SOX Versus SOX Alone in Gastric Cancer Patients With Malignant Ascites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Cancer
Stomach Neoplasms
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 215
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: This study is designed to compare the efficacy of intraperitoneal paclitaxel in combination with SOX, with SOX alone in the first-line treatment of gastric cancer with malignant ascites


Eligibility criteria: Inclusion Criteria:

* had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic
* malignant ascites(over pelvic cavity in CT scan and confirmed by cytology)
* an Eastern Cooperative Oncology Group performance status of 0 to 2
* adequate renal, hepatic, and hematologic function

Exclusion Criteria:

* previous chemotherapy or radiotherapy (unless in the adjuvant setting)
* uncontrolled cardiac disease, or other clinically significant, uncontrolled
* coexisting illness or previous or concurrent cancer
* HER2 positive and willing to use trastuzumab

Primary outcomes:
measure: overall survival
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
Study officials:
References:
Clinical trial NCT02079415: Infants of Diabetic Mothers: A Cohort Study
Official title: Study of Outcome of Infants of Diabetic Mothers in a Tertiary Hospital Set up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy in Diabetes
Fetal Complications
Keywords: NICU
Lead sponsor: Security Forces Hospital
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 601
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Infants of diabetic mothers born at security Forces Hospital, Riyadh

Brief summary: Saudi Arabia has been named by the International Diabetes Federation as among the top ten countries with highest prevalence of diabetes. Women are said to have overall prevalence twice that for men. With high birth rate in the country we decided to look at the impact of diabetic pregnancies on their off-springs

Detailed description: Diabetics are followed regularly in diabetic outpatient clinics where dietary and medical management are offered. Diabetic pregnancies are managed by a team consisting of diabetologist, obstetrician, feto-maternal obstetrician and dietician.

Management of these pregnancies depends on whether these women have pre-gestational or gestational diabetes. Very few diabetic women have exposure to preconceptual advice. For this reason we opted to find out the outcome of infants of diabetic mothers compared to those mothers who are essentially normal with no associated medical or obstetric disorders. Equally we wanted to see if there are differences in the outcome of infants born to pre-gestational and gestational diabetic mothers.

Eligibility criteria: Inclusion Criteria:All infants born to diabetic mothers

* Infants born to mothers with normal pregnancies

Exclusion Criteria:

* Infants born to mothers with other medical disorders before or during pregnancy which may affect the newborn

Primary outcomes:
measure: Congenital malformations
timeFrame: At time of first clinical examination
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Until discharge from hospital or death
Other outcomes:
measure: Preterm birth
timeFrame: Immediately at day 1
measure: Admission to neonatal intensive care unit
timeFrame: day 1
Locations:
city: Riyadh
country: Saudi Arabia
facility: Security Forces Hospital
state: Central
Study officials:
affiliation: Security Forces Hospital
name: ABEER E LASHEEN, MBBS
role: STUDY_DIRECTOR
References:
citation: Alqurashi KA, Aljabri KS, Bokhari SA. Prevalence of diabetes mellitus in a Saudi community. Ann Saudi Med. 2011 Jan-Feb;31(1):19-23. doi: 10.4103/0256-4947.75773.
citation: Persson M, Norman M, Hanson U. Obstetric and perinatal outcomes in type 1 diabetic pregnancies: A large, population-based study. Diabetes Care. 2009 Nov;32(11):2005-9. doi: 10.2337/dc09-0656. Epub 2009 Aug 12.
citation: Yang J, Cummings EA, O'connell C, Jangaard K. Fetal and neonatal outcomes of diabetic pregnancies. Obstet Gynecol. 2006 Sep;108(3 Pt 1):644-50. doi: 10.1097/01.AOG.0000231688.08263.47.
Clinical trial NCT02004015: Assessment Study of the Effect of NMBA on Bowel Peristalsis
Official title: Effect of an Induction Dose of Non Depolarizing Neuro Muscular Blocking Agents (NMBA) on Ultrasound Bowel Peristalsis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Physiopathology
Keywords: Analytical
Diagnostic
Anesthesia
Analgesia
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2013-12-06
Enrollment: 50
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: Phase III prospective randomised study : curare vs placebo, comparing bowel peristalsis (abdominal echography) in the first minutes of after general anesthesia induction.

Primary End Point: proportion of patients with a score of motion = 0

Detailed description: Primary End Point Proportion of patients with a score of motion = 0

Secondary End Point Time at which thumb adductor twitch measurement disappears (3rd consecutive measure with a twitch at 0) Mean minimal twitch measurement for those patients in who twitch measurement does not disappear Concordance study between twitch measurement and bowel peristalsis XML File Identifier: 1vUwHz2uUXeSc7soLu1cQwRAfcM= Page 15/24 ultrasound score.

Eligibility criteria: Inclusion Criteria:

* elective surgery
* scheduled oro tracheal intubation

Exclusion Criteria:

Counter indication to NMBA:

* predicted difficult airway
* surgical counter indication: facial or laryngeal nerve function monitoring
* allergy to muscle relaxants neuro muscular disease Possible alteration of sensitivity to muscle relaxants due to ongoing medication: ex Valproate or aminoglycoside antibiotics. Predictable alteration of bowel movements or difficult abdominal ultrasound:
* scheduled abdominal surgery
* abdominal surgery in last month
* obesity: body mass index over 30 Full stomach or pregnancy requiring suxamethonium for intubation

Primary outcomes:
measure: Proportion of patients with a score of motion = 0
timeFrame: 10 minutes after NMBA or placebo injection
Secondary outcomes:
measure: Time at which thumb adductor twitch measurement disappears
timeFrame: 1 month after injection
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique Adolphe de Rothschild
name: Guillaume Taylor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01714115: Use of Eylea for the Treatment of an Optic Nerve Hemangioma
Official title: Use of Eylea for the Treatment of an Optic Nerve Hemangioma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Retinal Hemangioma
Lead sponsor: Vitreous -Retina- Macula Consultants of New York
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2012-10-25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is a single patient investigative treatment study. The patient was diagnosed with a retinal tumor in one eye. In the last 2 years, the patient has been treated with all available and conventional therapies, including intraocular injections of Avastin and Lucentis, steroids, and photodynamic therapy. Any positive results were short-term, and caused an eventual decline in central vision. Aflibercept has been shown to be effective against the growth of new vessels, secondary to macular degeneration. This study proposes that it may also be more effective in treating this particular patient and case. The study treatment plan is for 6 months initially, with the intention to continue treatment.

Detailed description: The treatment plan will be to administer aflibercept 2.0 mg intravitreally every two to four weeks for at least six consecutive injections. Prior to initiation of therapy and at each study visit, a full ophthalmic examination, best-corrected visual acuity, and a complete review of systems to monitor for any toxicity will be performed. In addition, the investigators will perform fluorescein and indocyanine green angiography at baseline and obtain color fundus photographs as well as spectral domain OCT images to properly document the extent and degree of activity of the vascular tumor at baseline and at all study visits.

Eligibility criteria: Inclusion Criteria:

* retinal hemangioma
* previously treated with conventional therapies, including Avastin, Lucentis, steroid, and photodynamic therapy, with less than ideal results

Exclusion Criteria:

* ongoing reevaluation of adverse events, including inflammation, elevated intraocular pressure, or any suspected toxicity from aflibercept

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Vitreous Retina Macula Consultants of New York
state: New York
Study officials:
References:
citation: Mennel S, Meyer CH, Callizo J. Combined intravitreal anti-vascular endothelial growth factor (Avastin) and photodynamic therapy to treat retinal juxtapapillary capillary haemangioma. Acta Ophthalmol. 2010 Aug;88(5):610-3. doi: 10.1111/j.1755-3768.2008.01449.x. Epub 2009 Feb 12.
citation: Baba T, Kitahashi M, Kubota-Taniai M, Oshitari T, Yamamoto S. Subretinal hemorrhage after photodynamic therapy for juxtapapillary retinal capillary hemangioma. Case Rep Ophthalmol. 2011 Apr 22;2(1):134-9. doi: 10.1159/000328384.
Clinical trial NCT06525415: Foot Perfusion by Dynamic Contrast Enhanced MRI in Patients With Peripheral Artery Disease
Official title: Foot Perfusion by Dynamic Contrast Enhanced MRI in Patients With Peripheral Artery Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peripheral Arterial Disease
Perfusion
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with peripheral artery disease, who had a successful endovascular treatment and completed both pre- and post-operative MRI workups

Brief summary: We investigate the peri-operative foot perfusion through dynamic contrast enhanced MRI in patients with peripheral artery disease


Eligibility criteria: Inclusion Criteria:

* 18 to 80 years old;
* PAD patients with Fontaine grade II-IV or Rutherford grade 2-6 and underwent a successful revascularization;
* Patients completed both pre- and post-operative MRI workups;
* Patients signed the informed consent form and be able to complete the clinical follow-up for 1 months.

Exclusion Criteria:

* Patients has participated in other clinical studies;
* Patients with Heart failure (NYHA III/IV)/right to left shunt heart disease/ severe aortic and mitral insufficiency/acute coronary syndrome/malignant arrhythmia/severe pulmonary hypertension (pulmonary artery pressure at least 90 mmHg)/moderate to severe renal insufficiency (creatinine clearance rate\<60 ml/min)
* Any allergic constitution;
* Pregnancy and childbirth;
* Life expectancy\<12 months.

Primary outcomes:
measure: preoperative perfusion parameters
timeFrame: Between Aug.1 2024 and OCT.31 2024
Secondary outcomes:
measure: ankle brachial index
timeFrame: Between Aug.1 2024 and OCT.31 2024
measure: clinical success
timeFrame: Between Aug.1 2024 and NOV.30 2024
measure: survival
timeFrame: Between Aug.1 2024 and NOV.30 2024
Other outcomes:
Locations:
Study officials:
References: