louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05839002: Primary Tumor Burden Score:A Novel Staging Parameter for ESCC After nCRT
Official title: Primary Tumor Burden Score: A Novel Staging Parameter Superior to ypT-category for Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemoradiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasm, Esophagus
Neoplasm, Squamous Cell
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
First posted: 2023-05-03
Enrollment: 187
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ESCC undergoing nCRT at the Department of Thoracic Surgery, Zhongshan Hospital of Fudan University (training cohort), and the Department of Thoracic Surgery, Zhongshan Hospital Xiamen Branch (validation cohort), between January 2010 and February 2019 were reviewed. The inclusion criteria were (I) thoracic ESCC; (II) McKeown or Ivor-Lewis transthoracic approach; (III) locally advanced resectable tumor with cT3-4aNany staging treated with nCRT; (IV) no history of concomitant or prior malignancy.

Brief summary: In this case-only study, the investigators try to define a novel staging parameter, the Primary Tumor Burden Score (PTBS).

Detailed description: In this case-only study, the investigators try to define a novel staging parameter, the Primary Tumor Burden Score (PTBS), which will combine the proportion of residual primary tumor cells and pre-treatment pathological T stage (prepT stage). The investigators will also try to improve ypTNM stage by results of PTBS.

Eligibility criteria: Inclusion Criteria:

- Neoadjuvant chemoradiotherapy and surgical resection of esophageal squamous cell carcinoma

Exclusion Criteria:

* Patients receiving neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma without surgical resection

Primary outcomes:
measure: Five-year survival of patients
timeFrame: From surgery to the end of follow-up(at least 5 years later)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02660502: An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects
Official title: A Double-blind, Comparator-controlled, Randomised, Three-period Crossover Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Adocia
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2016-01-21
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomised, three period crossover phase 1 trial using automated 8-hour euglycemic clamps in healthy Japanese subjects.

Each subject will be randomly allocated to one out of nine sequences to receive either three single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single doses of BioChaperone insulin lispro on three separate dosing visits.

The total trial maximum duration for a subject will be up to 10 weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese male or female subjects by completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
* BMI between 18.5 and 25.0 kg∙m-2, both inclusive.
* Fasting Plasma Glucose ≤ 5.6 mmol/L (100 mg/dL).
* Signed and dated informed consent obtained before any trial-related activities.

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products.
* Receipt of any investigational medicinal product within 3 months before randomisation in this trial.
* Any history or presence of a life threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (including type 1 and type 2 diabetes mellitus, haematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator.
* History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

Primary outcomes:
measure: AUCLispro(0-30min)
timeFrame: Up to 30 minutes
Secondary outcomes:
measure: AUCGIR(0-last)
timeFrame: Up to 8 hours
measure: Adverse Events
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
affiliation: Profil GmbH
name: Grit Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01101802: Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)
Official title: A Prospective, Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Mycophenolate Mofetil on 'Surrogate Markers' for Atherosclerosis in Female Patients With SLE.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Systemic Lupus Erythematosus
Atherosclerosis
Keywords: SLE
Atherosclerosis
Endothelial function
Mycophenolate mofetil
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Institute of Child Health, University College London, London, UK.
First posted: 2010-04-12
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Systemic lupus erythematosus (SLE) is an independent risk factor for atherosclerosis. Endothelial dysfunction is the earliest marker of atherosclerosis and is measured by flow mediated dilation (FMD) of the brachial artery. The purpose of the study was to measure FMD in mild, stable SLE patients and look for change in FMD with the immunosuppressant drug mycophenolate mofetil (MMF).


Eligibility criteria: Inclusion Criteria:

* Female SLE patients
* Age 18-60 years
* If premenopausal using a reliable method of contraception
* Clinically stable disease
* Taking hydroxychloroquine and up to 15mgs of prednisolone daily

Exclusion Criteria:

* Smokers
* Pregnancy or breast feeding
* Use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted)
* Use of any investigational drug within 1 month prior to screening
* Acute infections 2 weeks prior to Visit 1
* History of ischaemic heart disease or end stage renal disease
* Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease

Primary outcomes:
measure: Flow mediated dilation
timeFrame: 8 weeks
Secondary outcomes:
measure: BILAG, SLEDAI,
timeFrame: 8 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Lupus Research Unit, St Thomas' Hospital
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: David P D'Cruz, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05312502: Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor
Official title: Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Labor Pain
Satisfaction
Keywords: Birth ball
birth satisfaction
pain
midwifery care
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 111
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sample size was 106 pregnant women, 53 in each group, with a known score using the G\*Power 3.1.7 program (intervention group=29.19±5.86-control group=26.51±5.13) with 85% power, 0.48 effect size and 0.15 error. was calculated as. Considering data loss, it is planned to reach 10% more pregnant women. Intervention group=57, control group=54 pregnants, and the study was terminated. The women were divided into two groups using the random numbers table in the simple random sampling method. Single blinding was performed on the women participating in the study. However, in order to prevent bias, the researcher who collected the data gave codes to the questionnaire forms of the pregnant women.
Primary purpose: SUPPORTIVE_CARE

Brief summary: H0: There is no difference between birth satisfaction and pain levels of pregnant women who used and did not use a birth ball during labor.

H1: There is a difference between birth satisfaction and pain levels of pregnant women who used and did not use a birth ball during the birth process.


Eligibility criteria: Inclusion Criteria:

* the consent of the pregnant women to participate in the study,
* have signed the informed consent form,
* be over the age of 18,
* Vaginal opening was determined as 4 cm

Exclusion Criteria:

* Having a psychologically diagnosed disorder
* Pregnant women diagnosed with risky pregnancy

Primary outcomes:
measure: Introductory Information Form
timeFrame: pre-intervention
measure: Birth Process Follow-up Form
timeFrame: during the intervention
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: during the intervention
measure: Birth Satisfaction Scale-Short Form (DME-F)
timeFrame: in the first hour in postpartum period
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Dr. Ali Kemal Belviranlı Gynecology and Pediatrics Hospital
Study officials:
References:
Clinical trial NCT05138302: A Clinical Study of BRCA and DNA Damage Repair Genes in Blood Samples of Chinese Pancreatic Cancer Patients
Official title: A Prospective Multicenter Clinical Study of BRCA and DNA Damage Repair Genes in Blood Samples of Chinese Pancreatic Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 1000
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 diagnosed with pancreatic cancer

Brief summary: This study aims to know the status of BRCA and DDR genes in PDAC patients in China. Peripheral venous blood samples of the patients will be collected for next-generation sequencing of BRCA and DNA damage repair related genes. At the same time, it is necessary to record clinical information such as age, gender, tumor pathological type, tumor stage and grade, whether surgery is performed, the size of postoperative residual lesions, and treatment methods. Prognostic indicators include the association of factors such as PFS, ORR, and DCR are also recorded.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with pancreatic cancer
* PS score ≤ 2
* no severe heart, cerebrovascular disease, severe coagulation dysfunction or severe mental disorder

Exclusion Criteria:

* PS score \> 2
* with severe heart, cerebrovascular disease, severe coagulation dysfunction or severe mental disorder

Primary outcomes:
measure: OS
timeFrame: 2years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJiH
state: Shanghai
Study officials:
References:
Clinical trial NCT01395602: Effect of Cabergoline on Weight and Glucose Tolerance
Official title: Randomized Controlled Pilot Study of the Effect of Cabergoline on Body Weight and Glucose Tolerance in Healthy Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Body Weight
Impaired Glucose Tolerance in Obese
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2011-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study is to determine the efficacy of cabergoline, a long-acting dopamine receptor agonist, on body weight and blood glucose in healthy obese adults.

This is a randomized double-blind placebo controlled study. Twenty subjects each will be randomly assigned either placebo or cabergoline for 16 weeks.

The effect of treatment on body weight and blood glucose and insulin levels will be compared in the treatment versus the placebo arm.


Eligibility criteria: Inclusion Criteria:

* age 18 - 55 years
* BMI 30 -40

Exclusion Criteria:

* diabetes,
* clinically significant medical condition,
* use of medications that effect blood glucose or body weight

Primary outcomes:
measure: body weight
timeFrame: 16 weeks
Secondary outcomes:
measure: glucose
timeFrame: 16 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Judith Korner, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03099902: Secondhand Smoking in Asthmatic Children
Official title: Association Between Maternal Smoking and GSTP1 and TNFa Polymorphism in Children With Asthma/Wheezing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma in Children
Wheezing
Keywords: Asthma
Wheezing
GSTP1
TNFa
Secondhand smoking
Passive smoking
Intrauterine smoking
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects attending the Pediatric Outpatient Clinic

Brief summary: This study will investigate the interaction between GSTP1 / TNFa polymorphisms and passive smoking in children with asthma/wheezing. Contemporary second hand-smoke exposure will be confirmed by laboratory testing.


Eligibility criteria: Inclusion Criteria:

* Subjects 1-18 years old with doctor diagnosed asthma/wheezing

Exclusion Criteria:

* Premature birth (\< 36 gestation weeks)
* Asthma-like symptoms due to other conditions (infectious, congenital, mechanical)

Primary outcomes:
measure: GSTP1 and TNFa variants in children with asthma
timeFrame: 0 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03059602: Biopsychosocial Impact on Caregivers in Patients Undergoing Joint and Spine Surgery
Official title: Characterizing the Biopsychosocial Impact on Caregivers in Patients Undergoing Joint Replacement and Cervical/Thoracic/Lumbar Spine Surgery: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Lead sponsor: Defense and Veterans Center for Integrative Pain Management
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caregivers of male and female military health care beneficiaries age 18 years and older presenting for total knee arthroplasty, total hip arthroplasty, and Cervical/Thoracic/Lumbar spine surgery. Caregivers are defined as individuals who will be the primary source of assistance (medical, rehabilitative, daily living, etc) within the first 30 days after surgery.

Brief summary: The purpose of this study is to describe the biopsychosocial impact of caregivers in patients undergoing total knee arthroplasty, total hip arthroplasty, and cervical/thoracic/lumbar spine surgery.Defining such impacts may offer opportunities to enhance caregiver capability to provide care following surgery on a loved one.

Detailed description: This is a pilot feasibility study with the goal of enrolling 50 caregivers in each surgical subgroup, with a total of 150 subjects. Caregivers for patients undergoing the above surgeries will be administered Patient Reported Outcome Measurement Information System (PROMIS) measures preoperatively, 7 days postoperatively, 14 days postoperatively, and 1 month postoperatively. PROMIS item banks will include Global Health, Anxiety, Fatigue, Depression, Self Efficacy, Social Satisfaction, and Sleep Disturbance. If the caregiver reports the presence of persistent pain, Pain Interference and Physical Function will be administered.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* Are the primary person helping in the recovery of a patient undergoing one of the following surgeries below with in the first 30 days after surgery Total knee arthroplasty Total hip arthroplasty Cervical/Thoracic/Lumbar spine surgery
* Able to understand English and can verbalize their pain level

Exclusion Criteria:

* Younger than 18 years old
* Refuse participation
* Cannot understand English
* Has cognitive deficiencies (subject unable to provide consent for the study, subject unable to complete initial post consent measures)

Primary outcomes:
measure: Natural history of biopsychosocial impact of Caregivers
timeFrame: 1 month
Secondary outcomes:
measure: Change of biopsychosocial measures over time
timeFrame: 1 month
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
References:
Clinical trial NCT06117202: The Effect of Interactive Music Therapy Applied for Women During the Perioperative Period for IVF on Their Stress Levels
Official title: The Effect of Interactive Music Therapy Applied for Women During the Perioperative Period for In Vitro Fertilization(IVF) on Their Stress Levels
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Infertility
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of music therapy on stress levels in female patients applying for in vitro fertilization.

Detailed description: If the patients participate in the study, when they apply to the in vitro fertilization center, they will meet with their anesthesiologist, anesthesia assessment will be done face to face and asked some questions about the diseases that may affect the procedure. . If patients are included in the study, their blood pressure, blood oxygen value and heart rate will be measured and recorded, as in every patient. Subsequently, a test will be administered to assess stress and anxiety levels of the patients. The patients involved in the study will be randomly divided into two groups. One group will be provided with a set of headphones that completely cover the ears and will be played their selected music from a predetermined album for 20 minutes before the procedure. The music will continue to be played through the headphones during the procedure. The other group will be taken to the operating room without any procedure, and this process will be applied to both groups. When patients are brought to the operating room, blood pressure, blood oxygen levels, and heart rate will be measured and recorded once again. Routine anesthesia procedures, applicable to all, will be carried out. After patients are fully awake, their pain condition will be assessed using a visual test.

Eligibility criteria: Inclusion Criteria:

* 18 years and older,
* American Society of Anesthesiologists (ASA) scores I-III.

Exclusion Criteria:

* Patients who did not provide informed consent,
* Used anxiolytics, alcohol, or drugs before the procedure,
* Refused to participate in the study,
* Lost their hearing ability for any reason.

Primary outcomes:
measure: stress,anxiety levels
timeFrame: 30 minutes
Secondary outcomes:
measure: Postoperative pain level
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Uludag University
Study officials:
affiliation: Uludag University
name: Selcan AKESEN
role: STUDY_DIRECTOR
References:
Clinical trial NCT05185102: Modeling Variation of the Objective Mental Workload for Tasks Requiring Different Cognitive Functions.
Official title: Modeling Variation of the Objective Mental Workload for Tasks Requiring Different Cognitive Functions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study focuses on the identification of objective mental workload (through ElectroEncephaloGraphy) during tasks involving different cognitive functions.

Detailed description: In a medical context based on the solicitation of various cognitive functions, it is essential to be able to modulate the level of difficulty of the task, to maintain a constant level of mental workload while preserving the playful aspect of the activity. This must be sufficient to maintain the person's involvement without inducing too high a mental workload.

However, currently, there is no standardized model of variation of mental workload for cognitive tasks that could be used to modulate the difficulty. The present study is therefore part of this context and concerns the identification of the mental workload during tasks requiring cognitive functions such as memory or attention.

Further this study will allow to adapt in real time the difficulty of virtual tasks to the mental workload of people. In other words, to have a universal brain decoder of the mental workload.

Eligibility criteria: Inclusion Criteria:

* Age\> 20 years old and \<50 years old
* French-speaking men or women
* Fluent in French (native speaker or fluent)
* Hold at least a baccalaureate +2
* Right-handed
* Having normal or corrected to normal vision
* Having normal or corrected to normal hearing

Exclusion Criteria:

* Minors
* Adults under guardianship or curatorship
* Non-French speakers
* Sleep debt at the time of the experience
* Daltonism
* Vision and hearing uncorrected to normal
* Pregnant or breastfeeding women
* History of associated cranial trauma or any other neurological pathology altering the cerebral sensory-motor system or the cognitive capacities and higher functions.

Primary outcomes:
measure: Identification of the variation in mental workload for different cognitive tasks.
timeFrame: Day 1
Secondary outcomes:
measure: Analysis of the influence of the quantity of EEG signals analyzed by our brain decoder on its accuracy
timeFrame: Day 1
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Vincent ROUALDES, Doctor
role: PRINCIPAL_INVESTIGATOR
References: