louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02812810: Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) Low-frequency on Craving in Smoking Dependence
Official title: Evaluation of the Efficacy of Low-frequency rTMS on Craving in Smoking Dependence: Single-centre Randomized, Controlled Blinded Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Addiction
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The fight against smoking is a public health priority. Without help, fewer than 5% of des smokers are abstinent at 12 months after smoking cessation.

Despite well-managed attempts at smoking cessation with nicotine substitutes, the rate of success at 12 months in patients dependent on nicotine is only 18%. Moreover, other therapeutic strategies (acupuncture, hypnosis...) have not proved to be effective.

The investigators propose a new therapeutic strategy for smoking cessation, which is based on associating nicotine substitutes (to reduce physical symptoms of weaning from nicotine) with rTMS at 1 Hz to the right DorsoLateral PreFrontal Cortex (DLPFC) for 2 weeks (to diminish craving for tobacco). The principal objective is to improve the success rate for smoking cessation attempts in patients who are highly dependent on nicotine, and who have failed using usual smoking cessation strategies.


Eligibility criteria: Inclusion Criteria:

* Adult 18-65 years old
* Wishing to stop smoking
* Highly dependent on nicotine (score ≥ 7 on the Fagerström self-questionnaire)
* History of at least 2 failed attempts to stop smoking despite recommended treatments (nicotine, vareniciline, bupropion)

Exclusion Criteria:

* Abstinence in the 3 previous months
* Absence of effective contraception for women
* Progressive chronic disease
* Ongoing psychiatric disorders
* Current addiction to other substances or cessation of less than one year
* Current treatment with psychotropic agents
* Epilepsy and other contra-indications for rTMS (pacemaker, metallic clips or other electronic implants, head trauma, intracranial hypertension).
* Contra-indications for transdermal nicotine substitutes (recent myocardial infarction, unstable or worsening angina, Prinzmetal angina, severe heart rhythm disorders, recent stroke, skin disorders that could interfere with the use of transdermal treatments, hypersensitivity to one of the constituents).
* Personnel working in the psychiatric and addictology unit of the CHU (conflict of interest)

Primary outcomes:
measure: Change from Baseline score of Tabacco Craving Questionnaire (TCQ)
timeFrame: at Week 0, Week 1, Week 2, Week 6 and Week 12 after stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References:
Clinical trial NCT03934710: Mood Effects of Serotonin Agonists Extended
Official title: Mood Effects of Serotonin Agonists Extended
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-05-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: BASIC_SCIENCE

Brief summary: In this study we are examining the effects of repeated very low doses of serotonin agonists on mood individuals with negative mood.

Detailed description: Here, we are examining the effects of four repeated low doses of lysergic acid diethylamide (LSD), compared to placebo, administered to healthy adults at 3-4 day intervals, on mood, cognitive performance and responses to emotional tasks

Eligibility criteria: Inclusion Criteria:

* English fluency
* High school level education
* BMI between 19 and 30

Exclusion Criteria:

* Diagnosed medical condition
* women who are nursing, pregnant, or plan to become pregnant within 3 months
* History of psychotic disorder or family history of psychotic disorder

Primary outcomes:
measure: DASS-21
timeFrame: End of session 5, approximately 2 weeks from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Matthew Bona
state: Illinois
Study officials:
affiliation: University of Chicago
name: Harriet de Wit
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05657210: Prognostic Value of Each Codon-specific KRAS Mutation in Colorectal Cancer
Official title: Does KRAS Codon 13 Mutation Have Prognostic Value in Colorectal Cancer?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 2203
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Three tertiary referral hospitals between January 2009 to December 2019

Brief summary: This retrospective study reviewed 3,144 patients who underwent surgery for colorectal cancer. This study was designed to comprehend the clinicopathological characteristics associated with individual codon-specific KRAS mutations in colorectal cancer.

Detailed description: This study was designed to comprehend the clinicopathological characteristics associated with individual codon-specific KRAS mutations in colorectal cancer including codon 12, 13, and 61. Furthermore, the main objective of this study was to determine whether KRAS codon 13 mutation could serve as a prognostic biomarker of colorectal cancer in a relatively large cohort of subjects. Overall survival (OS) and recurrence-free survival (RFS) were calculated from the date of surgery and compared using the Kaplan-Meier method and log-rank test. For analysis of risk factors for tumor recurrence, Cox proportional hazards regression model was used with the covariance input criterion set as \< 0.1. Patients were subdivided based on primary tumor location (colon versus rectum), and MSI status (MSS/MSI-low versus MSI-high).

Eligibility criteria: Inclusion Criteria:

* Patients underwent surgery for colorectal cancer from January 2009 to December 2019.

Exclusion Criteria:

* incomplete data on KRAS mutation
* incomplete data on microsatellite instability (MSI) status
* dual or triple KRAS mutation
* stage IV

Primary outcomes:
measure: 5-year Recurrence-free survival (RFS) of KRAS wildtype and each codon-specific KRAS mutation
timeFrame: from the date of surgery to the event(recurrence and death) up to 5 years
measure: 5-year Overall survival (OS) of KRAS wildtype and each codon-specific KRAS mutation
timeFrame: from the date of surgery to the event(death) up to 5 years
Secondary outcomes:
measure: Recurrence-related factor
timeFrame: Recurrence in 5 years after the date of surgery
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT06317610: Artificial Intelligence Model for Growth Prediction of Ovarian Cancer Organoids
Official title: Development and Validation of Growth Prediction Model for Ovarian Cancer Organoids Based on Bright Field Image and Deep Learning
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: Chongqing University Cancer Hospital
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with epithelial ovarian cancer received biopsy or puncture to obtain tumor tissues or malignant effusion

Brief summary: The present study aims to collect early bright field image of patient-derived organoids with ovarian cancer. By leveraging artificial intelligence, this study will seek to construct and refine algorithms that able to predict growth of ovarian cancer organoids.


Eligibility criteria: Inclusion Criteria:

* Patients must have histologically confirmed diagnosis of epithelial ovarian cancer
* Patients received biopsy or puncture to obtain tumor tissues or malignant effusion
* Patients voluntarily participated in the study and signed informed consent.

Exclusion Criteria:

* Non-epithelial ovarian cancer
* No sufficient amount of tumor tissues or malignant effusion for organoids establishment.

Primary outcomes:
measure: AUC of growth prediction performance using deep learning model
timeFrame: up to 3 years
measure: Accuracy of growth prediction using deep learning model
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
Study officials:
affiliation: Chongqing University Cancer Hospital
name: Dongling Zou, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04348110: Evaluation of Eye Health Benefits of Blueberry Chewable Tablets
Official title: Evaluation of Eye Health Benefits of Blueberry Chewable Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-15
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of blueberry chewable tablets on Eye Health


Eligibility criteria: Inclusion Criteria:

* Adult men and women over 20 years old
* Use 3C products over 6 hours per day
* Symptoms of dry eyes or tired eyes
* Tear Break-Up Time is 10 seconds less
* No history of ocular surgery (strabismus surgery, refractive surgery etc.)

Exclusion Criteria:

* Have systemic diseases affecting the front surface of the eyes.
* Long-term use of drugs or eye drops that affect the condition of the front surface of the eyes
* Long-term contact lens wear

Primary outcomes:
measure: Changes of Schirmer's test
timeFrame: 8 weeks
measure: Changes of tear meniscus height
timeFrame: 8 weeks
measure: Changes of non-invasive tear break-up time (NITBUT)
timeFrame: 8 weeks
measure: Tear break-up time (TBUT)
timeFrame: 8 weeks
measure: Changes of accommodation
timeFrame: 8 weeks
measure: Ocular Surface Disease Index (OSDI)
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes of eye pressure
timeFrame: 8 weeks
measure: Changes of Intraocular pressure (IOP)
timeFrame: 8 weeks
measure: Changes of Near point of convergence (NPC)
timeFrame: 8 weeks
measure: Changes of Stereo vision
timeFrame: 8 weeks
measure: Changes of binocular motor fusion
timeFrame: 8 weeks
measure: Changes of Amplitude of accommodation (AA)
timeFrame: 8 weeks
measure: Changes of Amplitude of Flipper facility
timeFrame: 8 weeks
measure: Changes of Fundus photography
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
affiliation: Chung Shan Medical University
name: Bo-Yie Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06125210: Application of Early Bundle Management of Mechanical Ventilation to Prevent Ventilator Dependence in Children
Official title: Application of Early Bundle Management of Mechanical Ventilation to Prevent Ventilator Dependence in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prolonged Mechanical Ventilation
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 150
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group: The bundle treatment plan was:1) After receiving mechanical ventilation for \<7 days, three of the following four items of intensive bedside rehabilitation were initiated: ① electrical diaphragm stimulation, ② electrical muscle stimulation, ③ passive limb movement, ④ respiratory rehabilitation.

2) Receive mechanical ventilation \<14 days, start the target-oriented nutrition program, including: (1) nutrition department consultation, (2) MDT to develop individualized nutritional pathways, nutrient formulations and use methods, and achieve the target nutritional level within 2 weeks.

3) Receiving mechanical ventilation \<21 days, tracheotomy transition to home mechanical ventilation (HMV), special diseases (central nervous system diseases) receiving mechanical ventilation 14-21 days recommended tracheotomy.
Primary purpose: PREVENTION

Brief summary: This study is based on the risk factors of previous studies to formulate a bundle treatment plan to prevent ventilator dependence in children, in order to reduce the proportion of ventilator dependence in children and provide a theoretical basis for reasonable intervention of children with mechanical ventilation.

Participants will receive intensive rehabilitation, nutrition, and tracheotomy at different time periods.

Researchers will compare the control group to see whether it can reduce the incidence of ventilator dependence


Eligibility criteria: Inclusion Criteria:

（1）All stable children receiving mechanical ventilation

（1）Stable condition: respiratory rate does not exceed 20% of the basic respiratory rate, PEEP\< 8. 60%, VIS score\< 20, there is no hypotension (70mmHg+ age ×2, 70mmHg under one year old), no higher than the P95 of the same sex and age

Exclusion Criteria:

1. Status epilepticus
2. Active intracranial hemorrhage
3. Intracranial hypertension
4. Unstable fracture of the spine
5. Spinal cord injury
6. There are injuries that affect the implementation of rehabilitation
7. Acute surgery was performed on the same day.
8. Body temperature over 40℃
9. Brain function failure

Primary outcomes:
measure: limb skeletal muscle function indexes
timeFrame: 21 days after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT06201910: Evaluation of Peripartum Blood Loss and Postpartum Anaemia in Macrosomia & Gemini
Official title: Retrospective Evaluation of Peripartum Blood Loss and Postpartum Anaemia With Respect to Fetal Macrosomia and Gemini
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bloodloss in Pregnancy
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 575
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with or without twin pregnancies or macrosomere singletons

Brief summary: Anaemia in pregnant women occurs at a haemoglobin (Hb) concentration \<11 g/dL and treatment is essential to prevent increased maternal morbidity, fetal morbidity and mortality. Studies show a distinct risk of haemorrhage in pregnant women due to increased uterine dilatation, due to twins or macrosomic singletons. Currently, prepartum anaemia management, the influence of anaemia and the administration of foreign blood concentrates are insufficiently studied. The investigators intend to conduct a monocentric retrospective analysis of this subcohort.

Detailed description: Patient blood management is essentially based on three pillars, and a meta-analysis has already shown that consistent use can reduce transfusions and mortality. The WHO defines anaemia in pregnant patients as a haemoglobin (Hb) concentration \<11 g/dl.

Treatment of iron deficiency anaemia is essential because data show that iron deficiency anaemia is associated with increased maternal morbidity, fetal morbidity and mortality. Studies show a separate risk of bleeding in pregnant women due to increased uterine prolapse, for example in twin pregnancies or macrosomic singletons. At present, the prepartum anaemia management of patients, the influence of anaemia and the administration of foreign blood concentrates are insufficiently studied, which the investigators intend to investigate.

Eligibility criteria: Inclusion Criteria:

* Pregnancy

Exclusion Criteria:

* pre-existing coagulation disorder

Primary outcomes:
measure: Bloodloss
timeFrame: Within the first 24 hours after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
state: Hessen
city: Frankfurt
country: Germany
facility: Goethe University
state: Hessen
Study officials:
References:
Clinical trial NCT00245310: Indocyangreen Elimination in Cirrhosis and Acute Liver Failure
Official title: Evaluation of the Indocyangreen Elimination as a Prognostic Marker in Decompensated Cirrhosis and Acute Liver Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Liver Failure
Liver Cirrhosis
Keywords: ICG clearance
liver cirrhosis
acute liver failure
prognosis
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-10-27
Enrollment: 40
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

Brief summary: Indocyangreen (ICG)is totally biliary eliminated and corresponds to hepatocyte function and liver perfusion.

The ICG-clearance will be evaluated as a prognostic marker in liver disease.

Detailed description: patients with acute liver failure or advanced liver disease will be studied. ICG-clearance will be correlated with established clinical scores and outcome.

Eligibility criteria: Inclusion Criteria:

* acute liver failure OR end-stage liver disease
* normal hepatic perfusion by doppler ultrasound

Exclusion Criteria:

* portal vein thrombosis
* allergy to ICG or iodine
* thyroid disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
Study officials:
affiliation: Heidelberg University
name: Jens Encke, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Merle U, Sieg O, Stremmel W, Encke J, Eisenbach C. Sensitivity and specificity of plasma disappearance rate of indocyanine green as a prognostic indicator in acute liver failure. BMC Gastroenterol. 2009 Dec 3;9:91. doi: 10.1186/1471-230X-9-91.
Clinical trial NCT04046510: Comparaison of 3 Protocols of Ocytocin Administration in C Section
Official title: Comparaison of 3 Protocols of Ocytocin Administration in Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Oxytocin Adverse Reaction
Keywords: Cesarean section, ocytocin, uterine tone, side effects
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aimed to compare 3 doses of ocytocin in bolus injection and contnious perfusion during C section. these doses determined by: high, intermediate and low doses, were administred to parturients during elective or urgent C section under spinal anesthesia

Detailed description: This study aimed to compare 3 doses of ocytocin in bolus injection and contnious perfusion during C section. these doses determined by: high, intermediate and low doses, were administred to parturients during elective or urgent C section under spinal anesthesia.

The aim was to determine the lowest efficient dose to prevent post partum hemorrage and with the lowest incidence of maternal side effects.

Eligibility criteria: Inclusion Criteria:

* All adult patients scheduled for C section under spinal anesthesia, monofoetal pregnancy, full term

Exclusion Criteria:

* necessity of general anesthesia
* non conscent

Primary outcomes:
measure: uterine tone
timeFrame: 10 minutes
Secondary outcomes:
measure: hemoglobin rate
timeFrame: 30 minutes after C section
measure: Additive boluses of Ocytocin
timeFrame: 30 minutes after C section
measure: side effects of Ocytocin
timeFrame: up to 30 minutes after C section
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Mongi Slim Hospital
Study officials:
References:
Clinical trial NCT01352910: rTMS and Functional Paralysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychogenic Paralysis
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: University Hospital, Caen
First posted: 2011-05-12
Enrollment: 66
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Psychogenic paralysis presents a real treatment challenge. Despite psychotherapy, physiotherapy, antidepressants, acupuncture or hypnosis, the outcome is not always satisfactory with persistent symptoms after long-term follow-up. In a preliminary retrospective study on 70 patients with psychogenic paralysis (44F/26M, mean age : 24.7 ± 16.6 ys), repetitive transcranial magnetic stimulation (rTMS) delivered over the motor cortex at low frequency was effective in 89% of cases (recovery: n=53, improvement: n=9), with an immediate or quasi-immediate recovery in 73% of patients (n=51).

We suggest that the dramatic improvement of psychogenic paralysis after rTMS could be due to the restoration of an appropriate cerebral connectivity by activating a suppressed motor cortex. Nevertheless, the possibility of a placebo effect cannot be ruled out.

A prospective multicentric (Rouen, Caen) randomized controlled trial versus placebo will be done for 94 patients with psychogenic paralysis, 1- to evaluate rTMS efficacy for paralysis at short and long term follow-up, and 2- to confirm rTMS safety. Two rTMS sessions will be performed at D0 and D1 (120 pulses over 2 days, delivered over the motor cortex at 2 Hz) with an active or a sham coil. Post-rTMS assessment will evaluate 1- the degree of the paralysis at D2 (quantified by a videotape) and D60 (quantified by an interview and a standardized examination), 2- the number and gravity of side effects.

If psychogenic paralysis improvement by motor cortex rTMS is confirmed, rTMS could be considered a useful early therapeutic option.


Eligibility criteria: Inclusion Criteria:

* Age \> 14 years old
* Psychogenic paralysis according to the DSM-IV-R

Exclusion Criteria:

* Contra-indication of rTMS
* Pregnancy or breast-feeding
* Previous history of epilepsia
* Previous session of rTMS (for any indication)

Primary outcomes:
measure: Degree of paralysis at D2, quantified by a videotape made at D2 and interpreted by to independent examinators
timeFrame: D2
Secondary outcomes:
measure: Number of side effects occurred during the 2 days of rTMS, between D0 and D1
timeFrame: D0, D1, D2
measure: Degree of side effects gravity occurred during the 2 days of rTMS, between D0 and D1
timeFrame: D0, D1 and D2
measure: Degree of paralysis at D60, quantified by an interview and a standardized examination
timeFrame: D60
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Nathalie Chastan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: