louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01194050: An Observational Study of Tarceva (Erlotinib) in Routine Practice For First Line Maintenance Therapy in Patients With Non Small Cell Lung Cancer
Official title: Erlotinib (Tarceva) in Routine Clinical Practice for First Line Maintenance Therapy (1LM) in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-09-02
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non small cell lung cancer patients

Brief summary: This observational study will investigate the tolerability and efficacy of Tarceva (erlotinib) in daily clinical practice under routine conditions in patients with locally advanced or metastatic non small cell lung cancer. Data will be collected for approximately 12 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients with locally advanced or metastatic non-small cell lung cancer (stage IIIb or IV) with stable disease after 4 cycles of standard platinum-based first-line chemotherapy

Exclusion Criteria:

* Not willing or not able to sign written informed consent form

Primary outcomes:
measure: Overall survival at 1 year
timeFrame: 12 months
Secondary outcomes:
measure: Tolerability of Tarceva in daily clinical practice under routine conditions
timeFrame: 12 months
measure: Efficacy of Tarceva in daily clinical practice under routine conditions
timeFrame: 12 months
measure: Reproducibility of the results of the controlled SATURN study
timeFrame: 12 months
Other outcomes:
Locations:
city: Villingen-Schwenningen
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04319250: The Effectiveness Of Ischemic Compression And IASTM In Trigger Point Treatment In Patients With Rotator Cuff Tear
Official title: The Effectiveness Of Ischemic Compression And Instrument Assisted Soft Tissue Mobilization In Trigger Point Treatment In Patients With Rotator Cuff Tear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Shoulder Pain
Myofascial Trigger Point Pain
Keywords: ischemic compression
instrument assisted soft tissue mobilization
trigger point
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effects of ischemic compression and IASTM techniques on pain, EHA, functionality, anxiety and depression in patients with the diagnosis of RM tear and presence of ATN. In addition, ischemic compression and EDYDM methods were aimed to compare and to reveal which application would be more useful.

Detailed description: In this study participants were randomly divided into two groups. While ischemic compression was applied to one group for the determined active trigger points, instrument assisted soft tissue mobilization (IASTM) was applied to the other group for active trigger points. In addition to the treatment, both groups were subjected to a joint rehabilitation program.

Eligibility criteria: Inclusion Criteria:

* Being between 40-65 years old
* Having been diagnosed with partial RM rupture
* RM rupture in MRI image
* At least 3 ATNs in the shoulder complex
* Hawkins-Kennedy and Empty Can tests positive Symptoms for at least 3 months

Exclusion Criteria:

* Sensory problems in the back and shoulders,
* Shoulder instability
* Osteoarthritis in the shoulder joint area
* Glenoid or bone fracture
* Frozen shoulder pathology
* Massive RM rupture
* Rheumatological joint problems
* Shoulder surgery history

Primary outcomes:
measure: Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
timeFrame: Change from Baseline at 6 weeks
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Change from Baseline at 6 weeks
measure: Shoulder Range of Motion (ROM)
timeFrame: Change from Baseline at 6 weeks
measure: Active trigger points
timeFrame: Change from Baseline at 6 weeks
measure: Pain Pressure Threshold (PPT)
timeFrame: Change from Baseline at 6 weeks
measure: The American Shoulder and Elbow Surgeons Standardized Shoulder Assesment Form (ASES)
timeFrame: Change from Baseline at 6 weeks
measure: Emotional state
timeFrame: Change from Baseline at 6 weeks
measure: Global Rating of Change (GRC) scale
timeFrame: After 6 weeks treatment
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Aydin University
Study officials:
References:
Clinical trial NCT02809950: Effects of Preoperative Oral Carbohydrates Loading in Patients at High Risk of Postoperative Nausea and Vomiting Undergoing Spinal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spinal Disease
Keywords: postoperative nausea and vomiting, oral carbohydrate beverage
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 288
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Many patients receiving opioid based analgesia after spinal surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with antiemetic agents. Dehydration caused by fasting prior to surgery is associated with the development of PONV. The aim of this study is to investigate the effect of oral carbohydrates loading prior to surgery in patients at high risk of PONV undergoing spinal surgery.


Eligibility criteria: Inclusion Criteria:

* female patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅱ
* patient scheduled for elective spine surgery
* no smoking history

Exclusion Criteria:

* hepatorenal disease
* BMI \> 35 kg/m2
* gastrointestinal disease
* vomiting within 24h
* administration of antiemetics or opioids within 24 h prior to surgery
* pregnant
* problem with communication

Primary outcomes:
measure: incidence of nausea and vomiting
timeFrame: 48 hours
Secondary outcomes:
measure: severity of nausea
timeFrame: 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT03705650: SHAPE:SeeingtheHeartwithAIPoweredEcho
Official title: SHAPE: Seeing the Heart With AI Powered Echo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Keywords: Disease detection
Medicare aged patients
routine physical examination
primary care
limited echocardiogram
Lead sponsor: Caption Health, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-15
Enrollment: 55
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Establish transthoracic echocardiogram (TTE) exams performed with Bay Labs EchoGPS guidance technology can be used in a primary care setting to accurately identify cardiac disease. In Phase I TTE exams with EchoGPS will be compared to findings from a commercially available, FDA 510(k)-cleared reference device (Terason uSmart 3200t, point-of-care ultrasound) without EchoGPS assistance technology. Study is non-significant risk (NSR).


Eligibility criteria: Inclusion Criteria:

1. Patients indicated for a standard physical examination
2. Patients ≥65 years old

For patients in Phase I, one of the following additional inclusion criteria must be present:

1. Patient presenting with a new murmur, or history of a murmur but no prior echo within 3 years of the exam
2. Patient presenting with shortness of breath
3. Unexplained pedal edema

Exclusion Criteria:

1. Unable to lie flat for study
2. Significant anatomical abnormality, recent trauma, or recent thoracic/abdominal surgery that would limit the ability to obtain adequate images
3. Subjects unwilling or unable to give written informed consent
4. Patients experiencing a known or suspected acute cardiac event Eligibility criteria for Phases II and III of this study will be finalized once results from Phase I are available. The current plan is to have similar criteria for Phases II and III.

Primary outcomes:
measure: % of diagnostic quality clips acquired by a non-specialist using experimental guidance software, with quality assessed using the American College of Emergency Physician (ACEP) Suggested Quality Assurance Grading Scale
timeFrame: 1 year
Secondary outcomes:
measure: Number of minutes for non-specialists to perform studies using EchoGPS experimental guidance software
timeFrame: 1 year
Other outcomes:
Locations:
city: Winfield
country: United States
facility: Northwestern Memorial, Central DuPage
state: Illinois
Study officials:
References:
Clinical trial NCT02288650: Incidence of Post-operative Vomitings (POV) After Early Refeeding in Pediatric Day Case Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-operative Vomiting Incidence
Pediatric Day Case Surgery
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 808
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: At the child, the post-operative vomitings (POV) remain the main post-operative complication in term of frequency. They also represent the first cause of unforeseen hospitalization in day case surgery. The causes of POV are multiple, including in particular the post-operative prescription of opioids. The role of the premature refeeding remains discussed.

Up to the age of 4 years, acute pain is difficult to distinguish from other causes of distress (anxiety, anger but also hunger) being able to make prescribe wrongly opioids in post-operative.

The main objective of this study is to estimate the POV in pediatric day case surgery after early refeeding with clear liquids in the recovery room or only in the day case wards (usual practice).

The secondary objectives are to estimate the time on returning to the day case ward, at home, the post-operative opioid consumption, early refeeding adverse effects (desaturation, swallowing trouble)


Eligibility criteria: Inclusion Criteria:

* Patient of less than 4 years old
* A pediatric day case surgery scheduled

Exclusion Criteria:

* Child lower age or 3 month old equal
* Premature child of conceptional age lower than 60 weeks
* Anesthetic or surgical constraint dissuading day case surgery or early refeeding
* Digestive pathology predisposing to the VPO (Hernia hiatal, gastro-oesophageal reflux)
* treatment interfering with emesis (imidazoles, neuroleptic)
* Period of exclusion defined by another study

Primary outcomes:
measure: Time between withdrawal of orotracheal tube and POV
timeFrame: The participant are followed for 3 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References:
citation: Chauvin C, Schalber-Geyer AS, Lefebvre F, Bopp C, Carrenard G, Marcoux L, Mayer JF, Schwaab C, Joshi GP, Diemunsch P. Early postoperative oral fluid intake in paediatric day case surgery influences the need for opioids and postoperative vomiting: a controlled randomized trialdagger. Br J Anaesth. 2017 Mar 1;118(3):407-414. doi: 10.1093/bja/aew463.
Clinical trial NCT04563650: COVID-19 Serology and Immunosenescence
Official title: Kinetics of COVID-19-neutralising Antibodies in Patients Residing in EHPAD / USLD: Influence of Immunosenescence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Covid19
Geriatric Medicine
Seroconversion
Immunosenescence
Keywords: Covid19
geriatric medicine
seroconversion
immunosenescence
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study aims to determine how long COVID-19 neutralizing antibodies can be detected in an elderly institutionalized population presenting fragility factors.

This study also aims to stratify seroconversion by immunological profiles of the elderly patients residing in the EHPAD. This stratification requires the measurement of immunological marker levels already described in immunosenescence and also involved in the development of certain chronic infectious diseases more common in the elderly population. This analysis will enable the investigators to describe an immunological, clinical and biological profile representing a patient who has developed an immunity against COVID 19. It will also help the investigators to understand the different mechanisms leading to a reduced immune response after a potential administration of a vaccine. Finally, it will help describe the immune profiles of elderly residents who presented with non-severe forms of COVID-19.


Eligibility criteria: Inclusion Criteria:

* Residents of the EHPAD/USLD St Victor of the Amiens CHU who took part in the screening campaign (RT-PCR and serology) organized by the Amiens CHU
* residents who signed a consent form to participate in the study

Exclusion Criteria:

* The patient or his legal representative refused to participate in the study
* Heavily sedated patients

Primary outcomes:
measure: titers of COVID-19 neutralising antibodies
timeFrame: day 0
measure: titers of COVID-19 neutralising antibodies
timeFrame: at 3 months
measure: titers of COVID-19 neutralising antibodies
timeFrame: at 6 months
measure: titers of COVID-19 neutralising antibodies
timeFrame: at 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT03788850: Factors Associated With Residual Disease In The Central Cone
Official title: Factors Associated With Residual Disease In The Central Cone: A Disease Prediction Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Intraepithelial Neoplasia
Keywords: residual disease
central cone
predictive model
Lead sponsor: National Institute of Cancerología
Sponsor class: OTHER_GOV
First posted: 2018-12-28
Enrollment: 397
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent a cervical cone procedure at the Dysplasia Clinic of the Instituto Nacional de Cancerologia in Mexico City

Brief summary: Cervical conization using the loop electrosurgical excision procedure (LEEP) is the standard treatment for patients with high-grade cervical intraepithelial neoplasia. Several studies have shown that excising a central cone reduces the rate of positive endocervical margins. The purpose of this study is to identify clinicopathological factors associated with residual disease in the central cone and to develop a predictive model to better determine which patients may require this additional procedure.

Detailed description: This study pretends to create a retrospective database including all patient who underwent a loop electrosurgical excision procedure by treatment for high-grade cervical intraepithelial neoplasia and create a a predictive model for top-hat resection in patients with high grade CIN

Eligibility criteria: Inclusion Criteria:

* patients who underwent a loop electrosurgical excision procedure (LEEP)

Exclusion Criteria:

* a diagnosis of micro-invasion or nonsquamous histology
* less than six months of follow-up
* incomplete information in their clinical charts.

Primary outcomes:
measure: Identify the clinical and pathologic factors associated with residual disease
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05467150: Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers
Official title: Maternal Probiotic Supplementation for Improved Neurodevelopmental Outcomes in Infants of Diabetic Mothers (IDMs)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant of Diabetic Mother
Keywords: infant of diabetic mother
probiotic
gut microbiome
neurodevelopment
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the hypothesis that maternal probiotic supplementation is associated with infant gut microbiome variation and improved neurodevelopmental outcomes as measured by ERP performance in infants of diabetic mothers (IDMs), a cohort that is at-risk for recognition memory abnormalities.


Eligibility criteria: Inclusion Criteria:

* Pregnant people in their second or third trimester with a diagnosis of gestational diabetes.
* BMI 18.5-45 kg/m2 at first prenatal visit
* Age 21-45 at time of delivery
* Report social support for and intention to exclusively breastfeed for at least 3 months
* Singleton pregnancy

Exclusion Criteria:

* Alcohol consumption \>1 drink per week during pregnancy/lactation
* Tobacco consumption during pregnancy/lactation
* Inability to speak/understand English
* Known congenital metabolic, endocrine disease (other than GDM), or congenital illness affecting infant feeding
* History of type I Diabetes
* Birthing parent currently taking over the counter probiotic preparation

Primary outcomes:
measure: Infant auditory recognition ERP performance at 1 month: P200 amplitude
timeFrame: 1 month of age
measure: Infant auditory recognition ERP performance at 1 month: Negative slow wave difference score
timeFrame: 1 month of age
measure: Infant visual recognition ERP performance at 6 months: Slow wave difference score
timeFrame: 6 months of age
measure: Infant VEP performance at 6 months: latency to peak of P100
timeFrame: 6 months of age
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT05928650: Comparison of Menstrual Function Among Sprinters, Long Marathon Runners, and Non-Athletic Females
Official title: Comparison of Menstrual Function Among Sprinters, Long Marathon Runners, and Non-athletic Females: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstruation Disturbances
Keywords: Menstrual function
Serum estradiol levels
Sprinters
Long Marathon Runners
Non-Athletic Females
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 42
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian sprinters, long marathon runners, and non-athletic females

Brief summary: The purpose of this study is to compare between sprinters and long marathon in menstrual characteristics and serum estradiol level.

Detailed description: Menstrual function and dysfunction conversations have long been stigmatized both in the general population and in sport settings (O'Flynn, 2006). However, Discussions of menstruation in the sport context often focuses on the impact of physical menstrual symptoms and dysfunction on activities such as training and sport performance (Bruinvels et al., 2016; Knowles et al., 2019). In addition, no study had been compare between sprinters and long-marathon runners in menstrual characteristics and estradiol level. Therefore, the purpose of this study to compare between sprinters and long marathon in menstrual characteristics and serum estradiol level.

Eligibility criteria: Inclusion Criteria:

* Virginal females.
* Their age ranged from 16 to 19years.
* All females had the same socio-economic status.

For athletic groups only:

* They have been starting the practice of sport at least one year before the onset of menarche.

Exclusion Criteria:

* Females who had been used oral contraceptives or any hormonal treatment in the previous six months.
* Smoking.
* History of chronic disease.
* Having any psychiatric problems.

For athletic groups only:

* injured females who were absent from training for at least three months.

Primary outcomes:
measure: serum estradiol level
timeFrame: 3 months
measure: Menstrual history characteristics
timeFrame: 3 months
measure: Age of participation to sport
timeFrame: 3 months
measure: Weekly training workload
timeFrame: 3 months
measure: Training experience
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical therapy, Cairo University
Study officials:
affiliation: Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
name: Doaa Osman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04654650: Prospective Registry and Biobank for Long-term Observational Studies in Adult Patients with Pulmonary Hypertension
Official title: Prospective Registry and Biobank for Long-term Observational Studies in Adult Patients with Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 5000
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: Patients diagnosed with pulmonary hypertension and patients referred to a pulmonary hypertension center for suspected pulmonary hypertension.

Brief summary: Prospective registry and biobank for long-term observational studies in adult patients with pulmonary hypertension

Detailed description: In a prospective registry prevalent and incident patients diagnosed with group 1 to 5 pulmonary hypertension will be enrolled. In an integrated biobank body fluid samples will be collected at enrollment and sequentially during treatment with targeted drugs for pulmonary hypertension.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of pulmonary hypertension group 1 to 5
* Ability to give informed consent

Exclusion Criteria:

- Withdrawal of informed consent

Primary outcomes:
measure: Transplant-free survival
timeFrame: Up to 20 years of follow-up after enrollment
Secondary outcomes:
measure: Risk score (averaging low, intermediate and high risk categories) as proposed by the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines for pulmonary hypertension
timeFrame: Up to 20 years of follow-up after enrollment
measure: Registry to Evaluate Early And Long-term PAH Disease Management (REVEAL) 2.0 risk score
timeFrame: Up to 20 years of follow-up after enrollment
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
References: