louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02884804: Study of Biological Determinants of Bleeding Postpartum
Official title: Study of Biological Determinants of Bleeding Postpartum : Predictive Role in the Number of Immature Platelets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Keywords: Postpartum Hemorrhage
Immature platelet
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 3599
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman giving birth in a maternity of Finistère (France)

Brief summary: At the entry of the delivery room, a standard blood analysis will be performed (Blood count, PT, aPTT, Fibrinogen, and D-Dimer) for each women (if they are agree), according to the center's practices.

The percentage of the immature platelets is a an additional parameter on the hemogram.

The clinical assessments (recorded in medical records) and biological values will be used to determine if there is a correlation between these data and the occurrence of postpartum hemorrhage.


Eligibility criteria: Inclusion Criteria:

* Woman giving birth in a maternity of Finistère

Exclusion Criteria:

* Refuse to participate in the study

Primary outcomes:
measure: Postpartum Hemorrhage
timeFrame: Volume of blood loss up to 24 hours after delivery and / or weight compresses collected at delivery, and / or diagnosis of the clinician
measure: Percentage of immature platelets
timeFrame: Percentage of immature platelets just before the entry in the birth room
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de BREST
Study officials:
affiliation: CHRU de BREST
name: PAN-PETESCH Brigitte, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01123304: Safety Study of Human IgM (MORAb-028) to Treat Metastatic Melanoma
Official title: A Phase 1 Clinical Trial of Intra-Tumoral Injection of Human IgM Monoclonal Antibody (MORAb-028) to the Ganglioside GD2 in Subjects With Injectable Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Melanoma
Keywords: melanoma
Lead sponsor: Morphotek
Sponsor class: INDUSTRY
First posted: 2010-05-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research is being done to find out the safety of MORAb-028 in subjects with metastatic melanoma.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed AJCC Stage IIIB, IIIC or IV melanoma with injectable metastases (in transit, intradermal, or subcutaneous nodules)
* Tumor accessible to intra-tumoral injections
* Cumulative tumor volume great enough to accept MORAb-028 injections for a given dose level, based on intent to inject at a concentration of 1 mg/cm3

Exclusion Criteria:

* Are candidates for curative surgical excision or lymphadenectomy
* Prior non-surgical treatment within 4 weeks
* Known central nervous system (CNS) tumor involvement or metastases
* Hypersensitivity to MORAb-028

Primary outcomes:
measure: Safety of multiple intralesional administration of MORAb-028
timeFrame: Day 33
Secondary outcomes:
measure: Maximum tolerated dose of intralesional administration of MORAb-028
timeFrame: 22 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute
state: California
Study officials:
affiliation: Morphotek
name: Bruce Wallin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04212104: The Effect of Watching Mukbang on the Desire to Eat
Official title: The Effect of Watching Mukbang on the Desire to Eat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mukbang
Keywords: mukbang
randomized and controlled trail
desire to eat
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study randomly assigned participants to watch either a mukbang, or a non-food content video. Participants report their attitudes such as satiation and disgust, and report their desire to eat several kinds of foods after watching the assigned video.
Primary purpose: OTHER

Brief summary: The current study is designed to find the effect of mukbang on dieters. Mukbang is an online eating broadcast where a host (Asian mukbangs generally feature a young and slim female host) consumes a large amount of food while chatting with audiences. Since some dieters watch mukbang to get satiation and control their appetites, the investigators proposed the hypothesis that mukbang could increase people's satiation level and decrease their desire to eat. To test this hypothesis, one randomized controlled study was conducted and female participants were randomly selected to watch either a mukbang or a non-food related video. Their desire to eat were reported and measured after the video.


Eligibility criteria: Inclusion Criteria:

* Female, English native speakers

Exclusion Criteria:

* Male, English is not mother language

Primary outcomes:
measure: satiation
timeFrame: report the feeling right after the intervention (since participants were first randomized to watch a video when participated in the study, after the intervention, i.e., after the video means 3 minutes after participants started the study)
measure: disgust
timeFrame: report the feeling right after the intervention (since participants were first randomized to watch a video when participated in the study, after the intervention, i.e., after the video means 3 minutes after participants started the study)
measure: desire to eat dim sum
timeFrame: report the feeling right after the intervention (since participants were first randomized to watch a video when participated in the study, after the intervention, i.e., after the video means 3 minutes after participants started the study)
measure: desire to eat fruits or vegetables
timeFrame: report the feeling right after the intervention (since participants were first randomized to watch a video when participated in the study, after the intervention, i.e., after the video means 3 minutes after participants started the study)
Secondary outcomes:
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Cornell University
state: New York
Study officials:
References:
Clinical trial NCT04469504: Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer
Official title: Prehabilitaion Program for Sarcopenic Patients Prior to Pancreaticoduodenectomy for Periampullary Malignant Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Pancreatic Cancer
Keywords: morbimortality
Prehabilitaion
pancreatic surgery
cephalic duodenopancreatectomy
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Groupement Interrégional de Recherche Clinique et d'Innovation
name: Santelys Association
First posted: 2020-07-14
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Major digestive surgery is associated with a significant rate of postoperative complications. To improve postoperative outcome, efforts are focused on postoperative course leading to the concept of rehabilitation. However, the rehabilitation concept does not allow to improve muscular and functional reserves at the time of surgery. Sarcopenia is a condition characterized by loss of skeletal muscle mass and function. Also, the prevalence of sarcopenia in patients with cancer is high and has a prevalence of around 25% in patients with pancreatic cancer, with a considerable impact on postoperative and survival outcomes.

The hypothesis is the preoperative management of sarcopenia by a rehabilitation program could improve patients' operative outcomes by reducing the rate of postoperative complications.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing pancreaticoduodenectomy for cancer
* Sarcopenic status

Exclusion Criteria:

* Age younger than 18 years
* Medical contraindications including cardiovascular disease or clinically significant vascular disease
* Physical inability to exercise
* Emergent surgery

Primary outcomes:
measure: Post-operative severe pancreatic fistula (Grade B and C)
timeFrame: at 90 days
Secondary outcomes:
measure: Rate of Severe postoperative complications
timeFrame: at 90 days
measure: Overall survival
timeFrame: at 1 year and at 3 years
measure: Program acceptance measure by Modified ACCEPT© questionnaire
timeFrame: at 30 days
measure: Rate of program completion
timeFrame: at 30 days
measure: Satisfaction questionnaire by EVAN-G
timeFrame: at 30 days
measure: Satisfaction questionnaire by the questionnaire for satisfaction of hospitalized (QSH-45)
timeFrame: at 30 days
measure: Quality of life by EORTC-QLQc30 scale
timeFrame: at 1 month, 3 months, 6 months and at 1 year
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Mehdi ELAMRANI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04746404: Application of a Positive Psychology Program for the Development of Emotional Skills in Prison
Official title: Application of a Positive Psychology Program for the Development of Emotional Skills in Prison : Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Borderline Personality Disorder
Keywords: Borderline
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major patients followed up at the Health Unit of the Villeneuve-lès-Maguelone Remand Prison

Brief summary: Studies show that emotional competence plays a significant role in psychological and physical health, and that programs aimed at their development are effective. Can a positive psychology program aimed at the development of emotional competence be implemented as part of care in lieu of deprivation of liberty? The investigators hypothesize the interest and possibility of implementing an emotional skills development program in the specific context of custodial care.

The main expected outcome of this study is the identification of necessary adaptations of the emotional skills development program of Kotsou, I. et al (2011) for its implementation in remand homes.

Detailed description: The expected secondary outcome is the identification of the interest of emotional skills development program (in prison) regarding :

* Therapeutic support for patients meeting the criteria for borderline personality disorder
* Participant satisfaction
* The development of emotional skills

Eligibility criteria: Inclusion criteria:

* Meet the criteria for borderline personality disorder (DSM-V),
* Interest in the issue of emotional skills development,
* Comprehension and use of the French language adapted to the study,
* Disposition to group practice,
* Attentive disposition allowing to participate in a therapeutic activity for 3 hours.
* Psychological/psychiatrical follow-up at the Health Unit of the Villeneuve-lès-Maguelone prison

Exclusion criteria:

* Minor patients
* Releasable before July 2021,
* Decompensated psychiatric disorders,
* Patient in withdrawal syndrome.

Primary outcomes:
measure: rate of vompliance with the number of sessions
timeFrame: 1 day
measure: Rate of respect of the frequency of sessions
timeFrame: 1 day
measure: rate of respect of the duration of each session
timeFrame: 1 day
measure: rate of respect of the minimum number of participants
timeFrame: 1 day
Secondary outcomes:
measure: Respect of the duration of the theoretical/practical reminders
timeFrame: 1 day
measure: respect of the frequency of theoretical/practical remote reminders
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Magali RUBIO, Psychologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03924804: Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.
Official title: Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystolithiasis and Thyroid Nodule
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Doppler Ultrasonography Assessed Bladder and Blood Volume
Primary purpose: TREATMENT

Brief summary: The objective of the trial was to explore the effect of different infusion volume on perioperative bladder and blood volume in patients undergoing daytime surgery assisted by bladder and vascular ultrasound and transthoracic echocardiography.

Detailed description: The objective of the trial was to evaluate the effects of different infusion volume of Ringer's solution acetate (2 ml/kg,8ml/kg, 16ml/kg) on bladder volume, hemodynamics,transthoracic echocardiography and vascular ultrasound including the inferior vena cava(IVC) and the right subclavian vein(SCV) diameter and the IVC and SCV collapsibility index in patients undergoing daytime surgery through a randomized controlled clinical study, so as to provide better guidance for clinical transfusion avoiding bladder catheterization . The patients in this trial were visited before induction and discharge from the postanaesthesia .We also collected the first time and times of micturition and whether the patients have the dysuria.

Eligibility criteria: Inclusion Criteria:

* 1. ethnic Chinese;
* 2. age, 18 to 65 years old;
* 3. American Society of Anaesthesiologists (ASA) physical status I or II;
* 4. Daytime patients scheduled for general anesthesia

Exclusion Criteria:

* Patients unwilling to cooperate with the experiment
* Body mass index exceeding 30 kg/m2;
* Patients with a history of heart ,liver and Renal failure ,hypertension,diabetes mellitus or arteriosclerosis; and any allergy to drugs used in the study.
* Patients with the urinary diseases, such as kidney, ureteral calculi and tumors, prostatic hypertrophy.

Primary outcomes:
measure: 1. The change of bladder volume
timeFrame: baseline and 10 minutes before leaving the post-anesthesia care unite
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT03792204: the Prevalence of "Wearing-off" in Patients With Parkinson's Disease in Shanghai
Official title: the Prevalence of "Wearing-off" in Patients With Parkinson's Disease in Shanghai, China: a Cross-sectional Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wearing Off Effect
Parkinson Disease
Keywords: wearing off
wearing-off 9 questionnaire
prevalence
sensitivity
specificity
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 1480
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: clinical diagnosed PD patients

Brief summary: The study would be designed as a multi-center cross-sectional investigation on the prevalence of Wearing-off in Parkinson's patients in Shanghai as well as related influencing factors.

Detailed description: PD patients would be randomly recruited into this investigation from around thirty hospital covering the 16 districts of Shanghai. The wearing off would be defined by two methods: the doctors' judgement or the WOQ-9 questionnaire which was a patient-determining tool. The investigation also includes the medicine, the severity of PD symptoms, the demographic factors. The study would be designed with the purpose of clarifying the prevalence of the "wearing-off" and its related influencing factors.

Eligibility criteria: Inclusion Criteria:

* have been clinical diagnosed with Parkinson's disease
* have received stable anti-Parkinson's treatment before being recruited to the study.

Exclusion Criteria:

* being suspicious of atypical Parkinson syndrome or secondary Parkinson syndromes
* have not received anti Parkinsonian treatment.
* being combined with serious cognitive dysfunction or psychiatric symptoms
* unable to complete the investigations.

Primary outcomes:
measure: the prevalence of wearing off effect in Parkinson's patients that received stable anti Parkinsonian therapy in Shanghai of China
timeFrame: 1 year
Secondary outcomes:
measure: the sensitivity and the specificity of the wearing-off 9 questionnaire in the diagnosis of wearing-off effect in Parkinson's disease.
timeFrame: 1 year
measure: the risk factors of wearing-off in Parkinson disease
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua hospital affiliated to Shanghai jiaotong university school of medicine
state: Shanghai
Study officials:
affiliation: Xinhua hosipital affiliated to Shanghai Jiaotong university school of medicine
name: Zhenguo Liu, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01974804: Assessment of Early Treatment Response by Diffusion and Perfusion MRI in Patients With Brain Metastasis
Official title: Assessment of Early Treatment Response by Diffusion and Perfusion MRI in Patients With Brain Metastasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Cancer
Keywords: MRI
Brain metastases
13-094
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The protocol investigators on the study will identify potential research participants from those patients who are scheduled for MRI examination as part of their routine clinical care.

Brief summary: Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. The purpose of this study is to determine if new imaging methods can help tumor evaluation in the brain. The extra images will be obtained using diffusion and perfusion MRI techniques to assess early treatment response in patients with brain metastasis, and will be compared to methods currently being used.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and over.
* Patients/Subjects able to give informed consent
* Patients/Subjects whose weight does not exceed 275 lbs.
* Patient with metastatic brain tumors greater than or equal to 1.0 cm that will be treated with stereotactic radiosurgery and scheduled for an MRI scan as part of their routine care

Exclusion Criteria:

* Patients who are unwilling or unable to undergo MRI including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.

Primary outcomes:
measure: feasibility of diffusion and perfusion magnetic resonance imaging (MRI)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kathryn Beal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02710604: Phase 2, Multiple Ascending Dose Proof of Concept Study
Official title: A Phase 2, Randomized, Open-label, Ascending, Sequential Dose Group, Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of CMX157 in HBV-infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infectious Disease
Keywords: chronic hepatitis B(CHB)
Lead sponsor: ContraVir
Sponsor class: UNKNOWN
First posted: 2016-03-17
Enrollment: 62
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: This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.

Detailed description: This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels in hepatitis B virus(HBV) infected subjects.

Eligibility criteria: Inclusion Criteria:

* Capable of giving written informed consent.
* Capable of completing study requirements.
* Chronic hepatitis B positive.
* HBV treatment naïve.

Exclusion Criteria:

* Positive result for HCV(hepatitis C virus), HDV(hepatitis D virus) or HIV(human immunodeficiency virus).
* History or medical condition that could impact patient safety.
* Current or past abuse of alcohol or illicit drugs.
* Abnormal laboratory value or ECG.
* Pregnant or breastfeeding.
* Clinical, histologic or laboratory evidence of significant liver fibrosis or cirrhosis.
* Systemic immunosuppression.
* Received an investigational drug or investigational vaccine within the 90 days prior to the first dose of study drug.

Primary outcomes:
measure: Evaluation of the safety and tolerability of increasing multiple oral doses of CMX157 in HBV + patients
timeFrame: 28 days
measure: To evaluate the antiviral activity of CMX157 versus tenofovir disproxil fumarate(TDF).
timeFrame: 28 days
Secondary outcomes:
measure: Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects, Cmax.
timeFrame: 28 days
measure: Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Tmax.
timeFrame: 28 days
measure: Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: AUC.
timeFrame: 28 days
measure: Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Cmin.
timeFrame: 28 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
Study officials:
affiliation: ContraVir Pharmaceuticals, Inc.
name: John Sullivan-Boylai, MD
role: STUDY_CHAIR
References: