louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02449642: LH Hormone Pulsation in the Luteal Phase in GnRH Antagonist IVF Cycles Triggered by GnRH Agonist for Final Oocyte Maturation
Official title: LH Hormone Pulsation in the Luteal Phase in GnRH Antagonist IVF Cycles Triggered by GnRH Agonist for Final Oocyte Maturation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: luteinizing hormone pulsatility
estradiol level
progesterone level
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women aged 18-42 years old BMI \< 32 kg/M2

Brief summary: Monitoring the LH pulsatility during the Luteal phase in GnRH antagonist IVF cycles triggered by GnRH agonist for final oocyte maturation.

Detailed description: About two decades ago the GnRH antagonist has been used in IVF cycles to prevent premature LH surge. In recent review GNRH antagonist has been found comparable to GnRH agonist in term of live birth rate but with reduced risk of OHSS. another advantage of using GnRH antagonist is the ability to use GnRH agonist for final oocyte maturation which has been shown to nearly eliminate the risk of OHSS. The exact mechanism of this risk reduction is still unknown.

Our aim is to do a frequent blood tests every 20 minutes for 6 hours duration in the day of ovum pick up or the day of embryo transfer to measure the level of LH, estradiol and progesterone in women triggered with GnRH agonist for final oocyte maturation.

Eligibility criteria: Inclusion Criteria:

* age: 18-42 years old BMI \< 32 kg/m2

Exclusion Criteria:

* Hypogonadotropic hypogonadism

Primary outcomes:
measure: luteinizing hormone pulsatility frequency
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam medical center, IVF unit
Study officials:
References:
Clinical trial NCT02107742: The Influence of Injection Speed on Pain During Administration of Local Anaesthetic.
Official title: The Influence of Injection Speed on Pain During Administration of Local Anaesthetic.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Needlestick Injuries
Keywords: Injections
Time factors
Pain
Healthy volunteers
Lidocaine
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2014-04-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the influence of injection speed on pain during injection of lidocaine. It is anticipated that a longer injection time will lead to less pain for the patient during the injection. This hypothesis will be tested on healthy volunteers, who will each receive three injections with the same amount of lidocaine subcutaneously on the abdomen. The injections will be given over 15, 30 and 45 seconds. After each injection, the subject will be asked to evaluate the pain on a Visual analog scale (0-100 mm). The aim of the study is to find a simple method for pain reduction that can be used in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years

Exclusion Criteria:

* Kidney, heart or liver disease
* Eczema or psoriasis on injection site
* Neuropathy
* Regular use of painkillers
* Hypersensitivity of Lidocaine
* Pregnancy
* Diabetes

Primary outcomes:
measure: Pain
timeFrame: 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Neuroscience, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Vilhjalmur Finsen, prof md
role: STUDY_DIRECTOR
References:
citation: Tangen LF, Lundbom JS, Skarsvag TI, Wago KJ, Ballo S, Hjelseng T, Finsen V. The influence of injection speed on pain during injection of local anaesthetic. J Plast Surg Hand Surg. 2016;50(1):7-9. doi: 10.3109/2000656X.2015.1058269. Epub 2015 Sep 28.
Clinical trial NCT04069442: cDC1 Prognostic and Predictive Role in Non-Small-Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors
Official title: cDC1 Prognostic and Predictive Role in Non-Small-Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non Small Cell Lung Cancer
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective cohort of pembrolizumab or cisplatin-based chemiotherapy treated patients performing these regimens in first-line according to their PD-L1 score

Brief summary: The response rate of immune checkpoint inhibitors remains relatively low and the identification of the new predictive biomarkers is necessary. The rare population of cDC1 is very interesting, as its mouse counterparts is essential for the cross presentation of tumor-associated antigens, tumor immunity and response to immunotherapies. Their role in humans has not been studied. This proposal aims to study the prognostic role of cDC1 in a cohort of patients with advanced NSCLC, possibly demonstrating their positive predictive value of immune checkpoint inhibitors response.

Detailed description: Multicenter study aiming to collect patient's clinical data retrospectively and their histological samples prospectively.

The cohort will include:

* 30 patients PD-L1 \> 50% treated with pembrolizumab in first line and having a progression free survival ≥ 3 months
* 30 patients PD-L1 \> 50% treated with pembrolizumab in first line and having a progression free survival \< 3 months
* 30 patients PD-L1 \< 50% treated with cisplatin-based chemotherapy in first line

Eligibility criteria: Inclusion Criteria:

* NSCLC diagnosis
* Advanced disease (Stage III-IV) according to the TNM 7th/8th classification
* Patients have to have performed pembrolizumab in first line if PD-L1 ≥ 50% or cisplastin-based chemotherapy if PD-L1 \< 50%
* FFPE material available from diagnostic sample

Exclusion Criteria:

-

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 1 year
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: 1 year
measure: Time to treatment failure (TTF)
timeFrame: 1 year
Other outcomes:
measure: Overall survival (OS)
timeFrame: 1 year
Locations:
city: Grenoble
country: France
facility: CHU Grenoble-Alpes
state: Isère
Study officials:
affiliation: CHU Grenoble Alpes
name: Elisa GOBBINI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02436642: AVERT Plus Post-Market Registry
Official title: AVERT Plus Post-Market Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Lead sponsor: Osprey Medical, Inc
Sponsor class: INDUSTRY
First posted: 2015-05-07
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be included if they are scheduled for a coronary diagnostic or PCI procedure using manual manifold injection with the AVERT System and Contrast Monitoring System according to the labeled indications for these devices.

Brief summary: The devices used in this observational registry are the Osprey Medical Contrast Monitoring System (CMS) and the Osprey Medical AVERT Reflux Reduction System. Both products have CE Mark designations. The purpose of this registry is to evaluate the usability characteristics of the combined Osprey Medical AVERT System and the Contrast Monitoring System during normal clinical use.

Detailed description: This is a prospective, single-center, non-randomized, single arm, observational registry of the AVERT System used in combination with the Contrast Monitoring System. Patients undergoing manual manifold injection coronary artery imaging for diagnostic or PCI procedures that utilize the AVERT System and the CMS will be included in this registry. Device use characteristics including, measurement of contrast media volume used, contrast media volume saved by the use of the AVERT System, evaluation of angiographic image quality, and physician feedback on device features and function will be obtained. All data will be collected on the day of the procedure and there will be no long-term follow-up.

Eligibility criteria: Inclusion Criteria:

* Scheduled for a coronary diagnostic or PCI procedure using manual manifold injection with the AVERT System and CMS according to the labeled indications for these devices.
* Patient consent to participate

Exclusion Criteria:

* None

Primary outcomes:
measure: Contrast media volume usage
timeFrame: Day of procedure
Secondary outcomes:
measure: Contrast media volume savings
timeFrame: Day of procedure
measure: Angiographic image quality
timeFrame: Day of procedure
measure: Physician feedback on device features
timeFrame: Day of procedure
Other outcomes:
Locations:
city: Lubeck
country: Germany
facility: Universitatsklinikum Schleswig-Holstein (Campus Lubeck)
Study officials:
affiliation: Universitatsklinikum Schleswig-Holstein (Campus Lubeck)
name: Steffen Desch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaye DM, Stub D, Mak V, Doan T, Duffy SJ. Reducing iodinated contrast volume by manipulating injection pressure during coronary angiography. Catheter Cardiovasc Interv. 2014 Apr 1;83(5):741-5. doi: 10.1002/ccd.25348. Epub 2014 Jan 7.
Clinical trial NCT04944342: Breathing After COVID-19
Official title: Thoracal Motion After COVID-19 Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gait
Covid19
Thorax Anomalies
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy individuals who have a COVID-19 illness history or have no COVID-19 history will be the participants of the study.

Brief summary: This research; It will be done to perform thoracic movement analysis of young adult individuals who have survived COVID-19 and to compare them with those without a history of COVID-19.

Detailed description: This research; It will be done to perform thoracic movement analysis of young adult individuals who have survived COVID-19 and to compare them with those without a history of COVID-19.

Individuals' sternal movements using motion analysis sensors; will be recorded in sitting position, standing, and walking. Sternal movement of the person; It will be recorded during relaxed breathing and deep breathing. They will also be asked to walk on the treadmill in such a way as to collect at least 500 steps.

Eligibility criteria: Inclusion Criteria:

* to be voluntary.
* have COVID-19 illness history.
* No COVID-19 illness history.
* treated by a standard medical treatment (vitamins, blood thinners, anti-viral drugs)

Exclusion Criteria:

* have another chronic disease such as systemic, orthopedic or neurologic.

Primary outcomes:
measure: Thoracal motion while normal breathing at sitting.
timeFrame: At first day.
measure: Thoracal motion while normal breathing at standing.
timeFrame: At first day.
measure: Thoracal motion while deep breathing at sitting.
timeFrame: At first day.
measure: Thoracal motion while deep breathing at standing.
timeFrame: At first day.
measure: Thoracal motion at walk.
timeFrame: At first day.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05614999: The Validation and Efficacy of Varix Trainer as a Training Device Esophagogastroduodenoscopy (a Multicenter Study)
Official title: The Validation and Efficacy of Varix Trainer as a Training Device Esophagogastroduodenoscopy (a Multicenter Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Varix
Keywords: Endoscopy training, Gastroscopy, Tip control, Motor skill
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this exploratory validation study is to compare levels of expertise (or non-expertise) between GI fellows and experts with the varix trainer. The main question it aim to answer is:

Can the varix trainer distinguish levels of expertise (or non-expertise) between novices and experts for specific skills (torque, small wheel and retroflexion techniques)? Does the training with the varix trainer improves these specific skills of GI fellows? Participants will do the pre-training test, practicing eight-sessions (each session is approximately 15minutes) and then do the post-training test.


Eligibility criteria: Inclusion Criteria:

* We enrolled participants from Ramathibodi hospital King Chulalongkorn Memorial hospital Siriraj hospital Rajavithi hospital Vajira hospital Nanthana-Kriangkrai Chotiwattanaphan Institute of Gastroenterology and Hepatology Srinagarind Hospital

  1. Expert (\> 1,500 EGD)
  2. Trainees (First and second year fellow)

Exclusion Criteria:

* Deny to participate in our study

Primary outcomes:
measure: Motor skill for endoscopic tip control improvement VS control
timeFrame: 4-6 weeks
Secondary outcomes:
measure: Motor skill for endoscopic tip control 1st year fellow trainee VS 2nd year fellow trainee VS expert
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Ramathibodi Hospital
state: Bangkok
Study officials:
References:
Clinical trial NCT01867099: Ten-year Outcomes After AF Ablation
Official title: Long-term Outcome After Initially Successful Catheter Ablation of Atrial Fibrillation by Pulmonary Vein Isolation: a Ten-Year Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Valley Health System
Sponsor class: OTHER
First posted: 2013-06-03
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent PVI ablation for drug refractory AF over a 10 year period and were free of AF for one year after last ablation procedure

Brief summary: Ablation of atrial fibrillation (AF) using pulmonary vein isolation is employed when patients do not respond favorably to medical therapy. Successful procedures are accomplished in the majority of patients, but the outcome after many years of follow-up after ablation is unknown.

Detailed description: A prospectively identified cohort of 445 patients who demonstrated freedom from AF for at least one year following ablation (single procedure in 391, 87.9%) was followed for 66.0 ± 34.0 months. Patients were seen at least annually as outpatients, and underwent regular ECG monitoring, especially if there were symptoms suggestive of recurrent arrhythmia. Continued absence of arrhythmia was defined as freedom from AF or flutter \> 30 secs.

Eligibility criteria: Inclusion Criteria:

* Prior AF ablation procedure
* No AF for one year post ablation

Exclusion Criteria:

* Geographic inaccessibility
* Longstanding persistent AF
* Recurrent AF within one year of ablation
* Prior AF ablation

Primary outcomes:
measure: Atrial fibrillation or flutter > 30 secs
timeFrame: More than one year after successful primary ablation or redo procedure within 6 mos
Secondary outcomes:
Other outcomes:
Locations:
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
Study officials:
References:
Clinical trial NCT02870699: Efficacy of Evonail® Solution in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer.
Official title: Study of the Effectiveness of the Film-forming Solution Evonail® Versus Placebo in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Keywords: chemotherapy neoadjuvant
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
Collaborators: name: Clinact
First posted: 2016-08-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Docetaxel is widely used in oncology for the treatment of many solid tumors. The side effects of docetaxel are many and sometimes serious. The primary toxicity of docetaxel is neutropenia. Skin and nail manifestations, frequency, the second category of adverse events after haematological adverse events.

Use of the product Evonail® was demonstrated in a patient treated by doxetaxel and having nail damage.

The purpose of this study is to confirm the effectiveness of the film-forming solution Evonail® versus a placebo on the prevention of nail damage in women with breast cancer and treated by adjuvant docetaxel.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Patient with breast carcinoma
* Patients treated with adjuvant chemotherapy (FEC + 3 docetaxel +/- Herceptin®)
* Patients who have never been treated with taxanes
* Patients with no nail damage before starting the study
* ECOG performance \< 2
* Ability to provide written informed consent

Exclusion Criteria:

* Patient allergic to any of the treatment components
* Use of film-forming solution, solvents or any other products applied to the fingernails (artificial nails ...) in three weeks before the first of docetaxel treatment
* Risk of exposure to aggressive factors nail during the study
* Using refrigerants gloves during chemotherapy treatments
* Onychophagia
* Presence of nail disease or a history of nail pathology (infectious and other)
* Pregnant or breast feeding females
* Patients whose condition is not compatible with the follow-up study

Primary outcomes:
measure: Efficacy of the film-forming solution Evonail® versus placebo on nail damage
timeFrame: up to 9 weeks
Secondary outcomes:
measure: Different types of nail damage observed in each group after chemotherapy docetaxel
timeFrame: up to 9 weeks
measure: Patient compliance for the film-forming solution Evonail®
timeFrame: up to 9 weeks
measure: Patient satisfaction regarding the use of the film-forming solution Evonail®
timeFrame: up to 9 weeks
Other outcomes:
Locations:
city: Vandoeuvre lès Nancy
country: France
facility: Institut de Cancerologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: UWER Lionel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06690099: Prospective Collection of Whole Blood Specimens From RhD Negative Pregnant Women
Official title: Prospective Collection of Whole Blood Specimens From RhD Negative Pregnant Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rhesus D Genotype
Pregnancy
Keywords: RhD negative
fetal DNA
cell free fetal DNA
Fetal RhD genotype
Lead sponsor: Devyser Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-15
Enrollment: 500
Sex: FEMALE
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: Pregnant women who are RhD negative and between 12 and 28 weeks gestation.

Brief summary: The purpose of this research is to collect blood samples and data from pregnant women who are Rh negative. The blood will be used for the future research and the development of non-invasive prenatal tests to identify Rh blood type status of the baby during pregnancy.

Detailed description: This is a prospective multi-center blood collection study. Women 18 years of age or older with a viable singleton pregnancy between12 weeks and 28 weeks gestation will be enrolled.

Whole blood samples will be collected from each enrolled patient. Maternal specimens will be processed to plasma and stored for future testing with non-invasive prenatal tests to identify fetal Rh status.

Baby RhD blood type status will be recorded after delivery. All obstetric clinical management will take place per standard clinic practices and procedures and will not be altered by participation in the study.

Eligibility criteria: Inclusion Criteria:

1. Willing and able to provide written informed consent
2. 18 years of age or older at enrollment
3. Women with a viable pregnancy (with documented fetal heartbeat) between 12 weeks, 0 days and 28 weeks, 0 days gestational age
4. Women with RhD negative antigen status by serology
5. Willing to provide neonatal ABO and RhD genotyping status

Exclusion Criteria:

1. Women with multiple gestation pregnancy

Primary outcomes:
measure: Fetal RhD determination from maternal whole blood
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Health
state: Louisiana
Study officials:
References: