louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04258969: Pedaling at a Low-Moderate Intensity During Chemotherapy Administration
Official title: Evaluating the Feasibility of Pedaling at a Low-moderate Intensity During Chemotherapy Infusions in Colorectal Cancer Patients.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Cancer
Exercise, Aerobic
Chemotherapy
Chemotherapeutic Toxicity
Keywords: Pedaling
Sarcopenia
Quality of Life
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the feasibility of completing a low-moderate intensity pedaling session concurrent to chemotherapy treatment for colorectal cancer. Secondary objectives for this study consist of evaluating the role of pedaling on sarcopenia rates, quality of life markers, chemotherapy side effects, rate of hospital admissions, and treatment delays.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosed colon or rectal cancer with previous surgical intervention and planned intravenous chemotherapy treatment (FOLFOX or FOLFIRI).
* ECOG Performance Status of Grade 0-2.

Exclusion Criteria:

* Limited functional status, demonstrated by an ECOG Performance Status of Grade 3-5.
* Severe cardiac history or comorbidities (i.e. have a cardiac defibrillator or have a history of heart failure, clinically significant aortic stenosis, cardiac arrest, uncontrolled angina, uncontrolled arrhythmias, major heart surgery, stroke, or pulmonary embolus).
* Chest pain or severe shortness of breath at rest or with physical activity.
* Orthopedic impediments to exercise (i.e. joint immobility or lower extremity lymphedema).
* Limitations to sustained exercise (i.e. bone metastases in the femur neck).
* Severe arthritis (i.e. osteoarthritis or rheumatoid arthritis).

Primary outcomes:
measure: Feasibility of Pedaling Concurrent to Chemotherapy Infusion
timeFrame: 12-24 weeks
Secondary outcomes:
measure: Quality of Life Scores
timeFrame: 12-24 weeks
measure: Sarcopenia Rates
timeFrame: 12-24 weeks
measure: Hospital Admission Rates
timeFrame: 12-24 weeks
measure: Symptom Severity
timeFrame: 12-24 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Dana M Hayden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03741569: Multisensor Technology for Beat to Beat Fetal Heart Rate Measurement
Official title: Development of a Real-time Signal Processing Algorithm, for Beat-beat Measurement of Fetal Heart Rate and Uterine Contractions by Coupling Non-invasive ABDOminal Sensors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Labor
Keywords: Fetal heart rate
Multiple sensors
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The CIC-IT 1403 laboratory of the University Hospital of Lille has developed a technological solution for acquiring and synchronizing abdominal ECG, acoustic and Doppler signals.

The purpose of this clinical trial is to build a database of signals issued from this device to develop signal processing algorithms to allow optimization of the fetal heart rate calculation.

This study will be carried out in the maternity ward of the Jeanne de Flandre Hospital in the maternal-fetal pathology department Doppler, ECG and acoustic sensors will be placed on the mother's abdomen to capture the heart rate of the fetus and mother as well as uterine contractions.

For each of the participants, we will make two 15-minute recordings: one with conventional ECG electrodes and one with ECG textile electrodes.

This procedure will not affect the usual care of the patient


Eligibility criteria: Inclusion Criteria:

* Pregnant woman
* Age\>18 years

Exclusion Criteria:

* Multiple pregnancy
* Medical termination of pregnancy

Primary outcomes:
measure: The fetal heart rate signal
timeFrame: at 15 minutes
Secondary outcomes:
measure: The uterine contraction signal
timeFrame: at 15 minutes
measure: Measuring the root mean square deviation between the heart rate signals from the device and the Doppler
timeFrame: at 15 minutes
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
Study officials:
affiliation: University Hospital, Lille
name: Charles Garrabedian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01145469: Biomarkers in DNA Samples From Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine-Based Therapy
Official title: Genome Wide Association Study Evaluating Genetic Factors Related to the Efficacy and Tolerability of Fludarabine Treatment in Patients With CLL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
B-cell chronic lymphocytic leukemia
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-16
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients enrolled on E4402 from whom samples were submitted for research

Brief summary: RATIONALE: Studying samples of DNA in the laboratory from patients who received fludarabine-based treatment may help doctors learn more about the effects of fludarabine on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying DNA samples from patients with chronic lymphocytic leukemia previously treated with fludarabine-based therapy.

Detailed description: OBJECTIVES:

* To identify genetic characteristics associated with the efficacy and toxicity of fludarabine-based treatment in patients with chronic lymphocytic leukemia who participated on E2997.
* To validate these genetic characteristics with a cancer cell model system to confirm association and dissect the mechanism of effect.

OUTLINE: Archived DNA samples are analyzed for genetic characteristics associated with the efficacy and toxicity to fludarabine-based treatment using Affymetrix 6.0 single nucleotide polymorphism arrays. The results are then compared with data of genes identified in a cancer cell model system, and with clinical data (response, toxicity, overall survival, and progression-free survival) associated with each patient sample.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of chronic lymphocytic leukemia
* Archived DNA samples
* Received fludarabine with versus without cyclophosphamide on clinical trial E2997

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Association of single SNP genotype with overall and progression-free survival
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Tait D. Shanafelt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04278469: Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy
Official title: A Prospective, Randomized, Comparative Study to Evaluate Efficacy of Anticancer Chemotherapy in Predicting Prognosis and Determining Chemotherapy Method in Early Hormone Receptor-positive Breast Cancer Patients With Clinicopathological High Risk and GenesWell™ BCT Low Risk at Multi-center in Korea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Hormone Receptor-positive Breast Cancer
Lead sponsor: Gencurix, Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-20
Enrollment: 194
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, randomized, comparative study to evaluate efficacy of anticancer chemotherapy in predicting prognosis and determining chemotherapy method in early Hormone Receptor-positive breast cancer patients with clinicopathological high risk and GenesWell™ BCT low risk at multi-center in Korea


Eligibility criteria: Inclusion Criteria:

1. Adult women aged 19-80 at screening
2. Histologically invasive carcinoma
3. Hormone receptor positive (Estrogen, ER+ and/or Progesterone, PR+)
4. Human epidermal growth factor receptor 2 negative (HER2-)
5. Axillary lymph node assessment: pN0 or pN1
6. Tumor size≥0.5cm
7. Clinical high risk (based on modified Adjuvant! Online)
8. Patients who agree to genetic testing
9. Patients who have adequate organ function
10. Genomic low risk (based on GenesWell BCT)
11. De novo primary cancer
12. Patients how performed surgery with curative aim
13. Patients who have provided written informed consent themselves

Exclusion Criteria:

1. Hormone receptor negative (Estrogen, ER- and Progesterone, PR-)
2. Human epidermal growth factor receptor 2 positive (HER2+)
3. Axillary lymph node assessment: pN2 or pN3
4. Patients who are received chemotherapy prior to operation
5. Patients who are received radiotherapy prior to operation
6. Tumor size\<0.5cm
7. Clinical low risk
8. FFPE tumor sample is not available
9. Patients with following conditions:

   * Patient with chronic liver disease
   * Patient with cerebrovascular disease
   * Patient with chronic mental disorder
   * Pregnant women, women of childbearing potential or lactating women
10. Patients who are deemed inappropriate as study participants by investigators
11. Patients with recurrent breast cancer or treatment history of breast cancer
12. Patients who have not undergone surgery

Primary outcomes:
measure: 10-year distant metastasis free survival
timeFrame: up to 10 years
Secondary outcomes:
measure: disease free survival
timeFrame: up to 10 years
measure: overall survival
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00386269: Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants
Official title: Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cleft Palate Repair
Keywords: codeine phosphate analgesia
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2006-10-11
Enrollment: 44
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study examines the analgesic efficacy of codeine phosphate. It is compared to placebo in infants receiving morphine after surgery. Codeine may be effective enough to make morphine unnecessary.


Eligibility criteria: Inclusion Criteria:

* Infants with cleft palate

Primary outcomes:
measure: Dose of morphine used within the first 6h after surgery
Secondary outcomes:
measure: Pain scores
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital, Anaesthetics
Study officials:
affiliation: Institute Of Child Health and Great Ormond Street Hospital
name: Mike Sury, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06264869: Interdental Guided Creeping Technique
Official title: A Novel Approach of Interdental Guided Creeping Technique (IGCT) for Augmentation of Deficient Interdental Papillae: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Interdental Papilla Recession
Keywords: Interdental papilla loss
Interdental papilla deficiency
Interdental papilla recession
Black triangle
Connective tissue graft
Collagen membrane
Minimally Invasive Surgery
Tunneling Techniques
Creeping Attachment
Plastic periodontal surgery
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized clinical trial is to treat interdental papillary deficiency with minimally invasive interdental guided creeping technique (IGCT) comparing collagen membrane versus connective tissue graft.


Eligibility criteria: Inclusion Criteria:

* Healthy patients having interdental papilla deficiency.
* Good Oral Hygiene.
* Age range: 18 - 50 years.

Exclusion Criteria:

* Pregnancy or lactation.
* Smokers.
* Alcoholic patients and drug abusers.
* Handicapped and prisoners.

Primary outcomes:
measure: Black triangle height
timeFrame: Baseline, 1, 3 and 6 months.
Secondary outcomes:
measure: Percentage of interdental papillary fill
timeFrame: Baseline, 1, 3 and 6 months.
measure: Papillary gain, black triangle reduction
timeFrame: Baseline, 1, 3 and 6 months.
measure: Papillary height, attached gingiva width
timeFrame: Baseline, 1, 3 and 6 months.
measure: Pocket depth, clinical attachment level, keratinized tissue thickness
timeFrame: Baseline, 3 and 6 months.
measure: Plaque index
timeFrame: Baseline, 1, 3 and 6 months.
measure: Gingival index
timeFrame: Baseline, 1, 3 and 6 months.
measure: Duration of surgery
timeFrame: At time of surgery
measure: Patient Reported Outcome
timeFrame: At the day of surgery and the 1st 10 days postoperative.
measure: Patient Reported Outcome
timeFrame: 1, 3 and 6 months.
Other outcomes:
Locations:
Study officials:
affiliation: PhD Student of Periodontology, Faculty of Dentistry, Cairo University
name: Ghada G A.GamalElDin, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Master Student of Periodontology, Faculty of Dentistry, Ain Shams University
name: Mohamed S. Morgan, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Oral Medicine, Periodontology and Oral Diagnosis - Faculty of Dentistry - Ain Shams University, Professor of Periodontology - College of Oral and Dental Surgery - Misr University for Science and Technology
name: Ahmed Y Gamal, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05308069: Contact Lens Optics and Visual Performance
Official title: Contact Lens Optics and Visual Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study will evaluate changes in visual performance at different pupil sizes between a single vision soft contact lens and multifocal soft contact lens, and compare refractive error measured between these two lenses with an autorefractor and an aberrometer


Eligibility criteria: Inclusion Criteria:

* Able to read and understand the informed consent document
* 18 to 39 years of age (inclusive)
* Best corrected visual acuity of 20/25 or better in the right eye
* Refractive error from -1.00D to -8.00D with astigmatism less than or equal to -1.00D in the right eye (corneal plane)

Exclusion Criteria:

* Any ocular or systemic conditions affecting vision, refraction, or the ability to wear a soft contact lens
* History of ocular trauma or surgery causing abnormal or distorted vision
* Current Rigid Gas Permeable (RGP) contact lens wearers
* Pregnant and/or lactating females, by self-report

Primary outcomes:
measure: Visual performance
timeFrame: Through completion of study visit, an average of 3 hours
Secondary outcomes:
measure: Refractive error
timeFrame: Through completion of study visit, an average of 3 hours
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: University of Houston College of Optometry
name: David A Berntsen, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05981469: Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?
Official title: Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Induced Vaginal Delivery
Keywords: cervical stiffness
induction of labour
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Liverpool Women's NHS Foundation Trust
First posted: 2023-08-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with singleton, term pregnancy, requiring induction of labour.

Brief summary: The purpose of this study is to determine if a new antenatal test of cervical stiffness can be used to predict which patients will have a successful vaginal delivery following an induction of labour.

A licensed, CE-marked, vacuum-aspiration device called the Pregnolia system has been developed to give quantitative cervical stiffness index score during pregnancy. The CASPAR study will compare cervical stiffness scores to bishop's scores prior to induction of labour and correlate the results to the outcome of delivery.

Detailed description: CASPAR is a single site prospective, exploratory, cohort study of 100 women with singleton pregnancy undergoing induction of labour at the Liverpool Women's Hospital (LWH).

All eligible participants giving written informed consent will be asked to undergo a sterile speculum examination for cervical stiffness assessment, prior to routine vaginal digital examination for Bishop's score assessment. Participants will then proceed with their induction of labour as per the unit policy.

Once recruited the participants will remain in the study until after delivery and discharge from hospital for the mother and baby, or 1 month after delivery, whichever comes first. Outcomes will be collected from electronic records.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Being induced
* Singleton pregnancy
* Primiparous
* ≥37+0 weeks gestation
* Intact membranes
* Able to provide informed consent

Exclusion criteria:

* Previous cervical surgery
* Any cervical pathology at 12 o'clock position on cervix
* Vaginal bleeding evident on examination
* Visible, symptomatic cervical or vaginal infections
* Known congenital uterine anomalies
* Known or suspected structural/chromosomal fetal abnormality
* Known HIV
* Cervical carcinoma

Primary outcomes:
measure: Number of participants with Vaginal Delivery
timeFrame: 5 days (time of commencing induction of labour to outcome of delivery)
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Women's Hospital
Study officials:
affiliation: University of Liverpool
name: Andrew Sharp
role: STUDY_DIRECTOR
References:
Clinical trial NCT06020469: Comparative Effects of Ciprofol and Propofol on Pain Intensity on the First Day After Surgery: a Retrospective, Propensity Score Matched, Cohort Study
Official title: Comparative Effects of Ciprofol and Propofol on Pain Intensity of the Patients Without PCA on the First Day After Surgery: a Retrospective, Propensity Score Matched, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Acute Pain
Risk Reduction
Keywords: Data Platform
Machine Learning
Postoperative Acute Pain
Lead sponsor: Guangdong Second Provincial General Hospital
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 6500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pain assessment was used by Numeric Rating Scale (NRS) score after surgery.

Brief summary: Data intelligence platform was widely used to facilitate the process of clinical research. However, a platform that integrates natural language processing (NLP) and machine learning (ML) algorithms has not been reported in perioperative medical management.


Eligibility criteria: Inclusion Criteria:

* Patients were included if they were above 18 years old, undergoing non-local anesthesia surgery.

Exclusion Criteria:

* The basic information such gender, age, height, weight, and body mass index (BMI) were missing.
* Patients undergoing day surgery, with a history of multiple operations, or entering ICU after surgery, and losing the NRS score during movement at 24h after surgery.

Primary outcomes:
measure: Area under the curve
timeFrame: October 2022 to October 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT02932969: Study With Healthy Japanese and Non-Asian Participants With BMS-986231
Official title: A Randomized, Double-Blind, Placebo-controlled, Single Continuous Intravenous Infusion Study of BMS-986231 to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Japanese and Non- Asian Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Decompensation, Acute
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-10-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase 1 study is to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is no formal hypothesis to be statistically tested.


Eligibility criteria: Inclusion Criteria:

* Ancestry

  * First generation Japanese
  * Non-Asian with grandparents and parents of non-Asian descent
* Body weight greater than or equal to 45kg and less than or equal to 110kg
* Women of childbearing potential have specific birthcontrol methods
* Males sexually active with women of childbearing potential have specific birthcontrol methods

Exclusion Criteria:

* History of chronic illness
* Chronic headaches
* Recurrent dizziness
* Personal or family history of heart disease
* Personal history of bleeding diathesis

Primary outcomes:
measure: Safety and tolerability of single continuous IV infusion of BMS-986231 in healthy Japanese and Non-Asian participants based on Adverse events, clinical laboratory values, vital signs, ECGs, and physical examinations
timeFrame: 11 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials, Llc
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: