louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06839274: Follicular Volume at the Time of Final Oocyte Maturation in Poor Responders, and Its Correlation With Oocyte Maturity
Official title: Follicular Volume at the Time of Final Oocyte Maturation in Poor Responders, and Its Correlation With Oocyte Maturity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: OVARIAN STIMULATION
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in ART Fertility Clinics who will undergo ovarian stimulation

* Reproductive age group: 18 -48
* undergoing ovarian stimulation for oocyte vetrification
* undergoing IVF/ ICSI with PGT-A / PGT-M / PGT- Sr
* less than or equal to 3 AFC on initiation of stimulation
* follicular phase stimulation

Brief summary: Women with a severely diminished ovarian reserve and monofollicular growth are at a higher risk of premature ovulation as well as poor quality oocytes. Our group showed previously that women with severely diminished ovarian reserve benefit from receiving the final oocyte maturation at smaller follicle sizes in terms of reducing the risk of premature ovulation and finding mature oocytes even out of small size follicles.

Adding the measurement of the follicular volume at the time of final oocyte maturation might provide more information on the proper timing of trigger administration compared to the follicular size alone, hormonal profile as well as previous stimulation attempts. Setting a cutoff value of follicular volume for trigger might help to avoid premature ovulation and possibly increase the chances of ending up with a euploid embryo.


Eligibility criteria: Inclusion Criteria:

* Reproductive age group: 18 -48
* undergoing ovarian stimulation for oocyte vetrification
* undergoing IVF/ ICSI with PGT-A / PGT-M / PGT- Sr
* less than or equal to 3 AFC on initiation of stimulation
* follicular phase stimulation

Exclusion Criteria:

* surgically retrieved sperm

Primary outcomes:
measure: the investigators will see the corellation between the follicular volume at the time of trigger with the oocyte maturity in patients with less than four follicles of a follicle size of at least 11 mm .
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: ART Fertility Clinics
Study officials:
affiliation: ART Fertility Clinics LLC
name: Barbara Lawrenz, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04137874: Paramedic - Norwegian Acute Stroke Prehospital Project
Official title: Diagnostics and Triage of Acute Stroke by the National Institute of Stroke Scale (NIHSS) by Paramedics, the ParaNASPP (Paramedic - Norwegian Acute Stroke Prehospital Project) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Triage
Paramedic
Mobile Application
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Air Ambulance Foundation
First posted: 2019-10-24
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: ParaNASPP is a stepped wedge cluster randomized controlled intervention trial (SW-RCT).
Primary purpose: DIAGNOSTIC

Brief summary: The main aim of the study is to show that patients with suspected acute stroke met by the emergency medical service and assessed using the eSTROKE model including prehospital NIHSS and a mobile application will identify a higher number of patients with stroke, than those who receive conventional prehospital care.

Detailed description: Primary aims:

In patients with suspected stroke

1. The proportion of patients hospitalized with a suspected acute stroke and discharged with a stroke diagnose is significantly increased using the ParaNASPP model compared with conventional prehospital care
2. Time from onset to hospitalization is significantly reduced with the ParaNASPP model
3. The ParaNASPP model identifies patients eligible for direct transportation for comprehensive stroke center

Eligibility criteria: Inclusion Criteria:

* All patients with suspected acute stroke met by emergency medical services (ambulance and rapid response car)

Primary outcomes:
measure: Positive predictive value (PPV) of the ParaNASPP model to identify patients suffering acute stroke.
timeFrame: On discharge from hospital - typically within 7 days.
Secondary outcomes:
measure: Number of patients in hospitalized within the first 4 hours after symptom onset
timeFrame: first 4 hours On admission
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Prehospital services - Oslo University Hospital
Study officials:
References:
citation: Bugge HF, Guterud M, Bache KCG, Braarud AC, Eriksen E, Fremstad KO, Ihle-Hansen H, Ingebretsen SH, Kramer-Johansen J, Larsen K, Roislien J, Thorsen K, Toft M, Sandset EC, Hov MR. Paramedic Norwegian Acute Stroke Prehospital Project (ParaNASPP) study protocol: a stepped wedge randomised trial of stroke screening using the National Institutes of Health Stroke Scale in the ambulance. Trials. 2022 Feb 4;23(1):113. doi: 10.1186/s13063-022-06006-4.
Clinical trial NCT01522274: Quit Smoking With Nicotine Patch and Exercise/Health Education (Females Only)
Official title: Efficacy of Brisk Walking as a Smoking Cessation Treatment Adjunct Among Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-01-31
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research study is for FEMALE cigarette smokers who want to quit smoking.

Participants will be provided with brief quit-smoking education at the beginning of the study and will receive the nicotine patch for 10 weeks, free of charge.

Participants will be assigned to either an exercise program or a general health education program. The exercise and health education programs will take place over 14 weeks, with follow-up appointments 3, 6, and 12 months after the end of the 14-week program.

There is no fee for any part of this study and participants will be compensated for their time.

Detailed description: Participants must complete telephone screening process first.

All eligible participants must attend an orientation session when the investigators will explain the study in detail. After this session, interested participants will complete a consent form and the investigators will collect blood pressure, resting heart rate, body mass index (height/weight), and a carbon monoxide sample to confirm eligibility. The investigators will then explain the physician consent process (all eligible and interested participants must obtain consent from a physician or clinic that they have seen in the past year to confirm that it is safe for them to participate).

Eligibility criteria: Inclusion Criteria:

* Current smoker

Exclusion Criteria:

* Ineligible after telephone screen.
* Each participant's personal physician/clinic determines it is unsafe to participate.

Primary outcomes:
measure: Smoking Cessation
timeFrame: 7-Day Point Prevalence at 3, 6, 9 and 1-year follow-ups
Secondary outcomes:
measure: Cognitive and Affective Mechanisms of Treatment
timeFrame: Daily assessments completed throughout the day at random and scheduled times from baseline to 3 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Public Health Building @ 121 South Main St
state: Rhode Island
Study officials:
affiliation: Brown University
name: David Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04427774: A Study of Surufatinib Plus Sintilimab in Patients With Advanced Solid Tumor
Official title: A Phase Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Surufatinib Plus Sintilimab in Patients With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced or Metastatic Solid Tumors
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of Surufatinib plus Sintilimab in Patients with Advanced Solid Tumor


Eligibility criteria: Inclusion Criteria:

1. Advanced or metastatic and recurrent cancer where an appropriate treatment option is not available
2. Have measurable disease based on RECIST 1.1
3. Life expectancy \> 12 weeks
4. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1

Exclusion Criteria:

1. Any therapy with anti-PD-1, or anti-PD-L1/l2 antibodies or anti-cytotoxic T lymphocyte associated antigen-4 (CTLA-4) antibody (or any other antibody acting on T cell costimulatory or checkpoint pathway) or fruquintinib treatment in previous;
2. Prior receipt of Surufatinib
3. History of any active autoimmune disease or autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc. (except patients with hypothyroidism that can be controlled only by hormone replacement therapy and patients with type I diabetes who only need insulin replacement therapy)
4. History of gastrointestinal perforation and/or fistula, ileus, inflammatory bowel disease, or extensive enterotomy (partial colectomy or extensive enterotomy with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea within 6 months prior to first dosing
5. Any life-threatening bleeding event or grade 3 or 4 bleeding requiring blood transfusion, endoscopy, or surgery with 3 months prior to dosing.

Primary outcomes:
measure: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)
timeFrame: Baseline through 30 days after end of treatment, up to approximately 24months
Secondary outcomes:
measure: Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Baseline and every 6 weeks through week 48, and then every 12 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province
Study officials:
References:
Clinical trial NCT03963674: Effects of Diacutaneous Fibrolysis Over Neuromuscular Response
Official title: Effects of Diacutaneous Fibrolysis Over the Gastrocnemious Neuromuscular Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myofascial Pain Syndrome
Contraction
Keywords: Neuromuscular response
diacutaneous fibrolysis
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study consists in evaluating the neuromuscular response of the gastrocnemious muscles before and after a diacutaneous fibrolysis over the gastrocnemious muscles.


Eligibility criteria: Exclusion Criteria:

* Muscle injury in the last two months
* To not understand the study orders
* Suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol

Primary outcomes:
measure: Delay time change
timeFrame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
measure: Contraction time change
timeFrame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
measure: Sustain time change
timeFrame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
measure: Relaxation time change
timeFrame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
measure: Maximal displacement change
timeFrame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
measure: Stiffness change
timeFrame: 2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
measure: Elasticity change
timeFrame: 2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
measure: Relaxation change
timeFrame: 2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
Secondary outcomes:
measure: Gastrocnemious strength change
timeFrame: 8 minutes before the intervention, 1 minute after the intervention and 30 minutes later
Other outcomes:
Locations:
city: Sant Cugat del Vallès
country: Spain
facility: Albert Pérez-Bellmunt
state: Barcelona
Study officials:
References:
Clinical trial NCT00704574: Observational Study to Observe the Safety of Levemir® Treatment in Children and Adolescents With Type 1 Diabetes
Official title: Safety of Levemir® (Insulin Detemir) Treatment in Children and Adolescents With Type 1 Diabetes (PREDICTIVE™ - Youth)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 159
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children Age 6 - 18 with type 1 diabetes

Brief summary: This observational study is conducted in Europe. The trial aims to observe the incidence of serious adverse drug reactions in children and adolescents with type 1 diabetes during Levemir® treatment.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained prior to any trial-related activities
* Any patient with diabetes type 1 is eligible for the study, including newly
* The selection of the patients will be at the discretion of the individual physician

Exclusion Criteria:

* Type 2 diabetes
* Currently treated with Levemir®

Primary outcomes:
measure: Incidence of serious adverse drug reactions, including major hypoglycaemic events
timeFrame: after 6 month treatment
Secondary outcomes:
measure: Number of all hypoglycaemic events
timeFrame: after 6 month treatment
measure: Number of adverse drug reactions
timeFrame: after 6 month treatment
measure: BMI changes
timeFrame: after 6 month treatment
measure: HbA1c
timeFrame: after 6 month treatment
measure: Variability in FPG (Fasting Plasma Glucose)
timeFrame: after 6 month treatment
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Carlsson A, Forsander G, Ludvigsson J, Larsen S, Ortqvist E; Swedish PREDICTIVE-Youth Study Group. A multicenter observational safety study in Swedish children and adolescents using insulin detemir for the treatment of type 1 diabetes. Pediatr Diabetes. 2013 Aug;14(5):358-65. doi: 10.1111/pedi.12019. Epub 2013 Mar 1.
Clinical trial NCT00100074: To Assess the Safety and Tolerability of 7.5, 15 and 30 mg of Sublingual Lobeline. - 1
Official title: Safety and Tolerability Study of Sublingual Lobeline
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Amphetamine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2004-12-23
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: DIAGNOSTIC

Brief summary: To assess the safety and tolerability of 7.5, 15 and 30 mg of sublingual lobeline.

Detailed description: The primary objective of this study is to characterize the pharmacokinetics of three ascending doses of lobeline in normal volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals with a body mass index between 18 and 30.
* Willing and able to give written consent.
* Must have a negative drug test
* Females must have a negative pregnancy test prior to study drug administration
* Must have no medical contraindications as determined by routine testing

Exclusion Criteria:

* Please contact the site for more information

Primary outcomes:
measure: Safety
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: U of CA, San Francisco
state: California
Study officials:
affiliation: Langley Porter Psychiatric Institute
name: Reese Jones, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00284674: Prospective Clinical Evaluation of Three Prosthesis Re-cap, M2a-Magnum and C2a-taper.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients Undergoing a THR
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2006-02-01
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This evaluation is being conducted to evaluate the performance of thee prosthesis.


Eligibility criteria: Inclusion Criteria:

* Good general health of age (ASA I-II)
* DEXA-scanning: lower limit for a 55 years old man
* MRI normal vitality in caput
* Willing to return for follow-up evaluations
* Exclusion Criteria:
* Subjects displaying any of the following contra-indications shall be excluded from this evaluation:
* Inability to co-operate with and complete the study
* Collum \< 2 cm
* Large cysts in caput
* Mismatch between caput acetabulum
* Caput necrosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Frederiksberg University Hospital
state: Frederiksberg
Study officials:
affiliation: Frederiksberg University Hospital
name: Arne Borgwardt, M.D.
role: STUDY_DIRECTOR
References:
citation: Borgwardt A, Borgwardt L, Zerahn B, Daugaard H, Borgwardt L, Ribel-Madsen S. A Randomized Seven-Year Study on Performance of the Stemmed Metal M2a-Magnum and Ceramic C2a-Taper, and the Resurfacing ReCap Hip Implants. J Arthroplasty. 2018 May;33(5):1412-1420. doi: 10.1016/j.arth.2017.11.061. Epub 2017 Dec 5.
Clinical trial NCT01968174: Astigmatic Changes Secondary to Eyelid Surgeries
Official title: Astigmatic Corneal Changes Secondary to Eyelid Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blepharoptosis
Keywords: astigmatism
lid surgery
older than 40 years
can sign an acceptance form
uper lid surgery
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-10-23
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing eyelid surgery.

Brief summary: Eyelid surgeries change the lid position over the cornea. Previous surgeries evaluated astigmatic corneal changes in children undergoing ptosis repair. Only several studies evaluated astigmatic changes following eyelid surgeries in elderly patients. The investigators aim is to estimate this change, implications on corneal astigmatism may have great effect to future cataract surgeries for this group of patients.

Detailed description: Patients registered for a lid surgery due to blepharoptosis or ptosis will undergo a topographic examination prior to and 3 months post operative in addition to their regular pre and post operative examination astigmatic shift will be mathematically measured.

Eligibility criteria: Inclusion Criteria:

upper lid blepharochalasis

Exclusion Criteria:

prior eyelid trauma mental retardation or other causes preventing from signing an agreement form

Primary outcomes:
measure: astigmatic corneal decrease following eyelid surgery
timeFrame: 3 months
Secondary outcomes:
measure: type of astigmatism
timeFrame: 3 months
Other outcomes:
measure: complications
timeFrame: 3 months
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Arye - Nemet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03772574: Preoxygenation Using THRIVE Versus Facemask in Parturients
Official title: Preoxygenation Using THRIVE and Facemask Oxygenation in Parturients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoxygenation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 91
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine the duration for pre-oxygenation using THRIVE and facemask for parturients.

Detailed description: We aim to determine the duration required for THRIVE and facemask preoxygenation in parturients for them to achieve ETO2 \>90%.

Eligibility criteria: Inclusion Criteria:

* Pregnant patients ≥36 weeks gestation.
* Non-laboring patients admitted for elective Cesarean delivery under neuraxial anesthesia or induction of labor.
* American Society of Anesthesiologists (ASA) class 2.

Exclusion Criteria:

* Any medical conditions that are likely to affect gas exchange.
* Obstructed nasal passage.
* Unable to tolerate a tight fitting facemask.
* Body Mass Index ≥40 kg/m2.
* Patients who are in active labor (i.e. cervical dilation ≥4cm).
* Patients who are unable to give informed consent.

Primary outcomes:
measure: Preoxygenation Duration
timeFrame: Maximum 8 minutes
Secondary outcomes:
measure: Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes
timeFrame: 3 minutes of pre-oxygenation
measure: Proportion to Reach EtO2 of 90 Percent at 4 Minutes
timeFrame: 4 minutes of preoxygenation
measure: Proportion to Reach EtO2 of 90 Percent at 5 Minutes
timeFrame: 5 minutes of preoxygenation
measure: Proportion to Reach EtO2 of 90 Percent at 6 Minutes
timeFrame: 6 minutes of preoxygenation
measure: Proportion to Reach EtO2 of 90 Percent at 7 Minutes
timeFrame: 7 minutes of preoxygenation
measure: Proportion to Reach EtO2 of 90 Percent at 8 Minutes
timeFrame: 8 minutes of preoxygenation
measure: Comfort Score
timeFrame: 1 minute after data collection
measure: Acceptability Score
timeFrame: 1 minute after data collection
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Anton Chau, MD MMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Au K, Shippam W, Taylor J, Albert A, Chau A. Determining the effective pre-oxygenation interval in obstetric patients using high-flow nasal oxygen and standard flow rate facemask: a biased-coin up-down sequential allocation trial. Anaesthesia. 2020 May;75(5):609-616. doi: 10.1111/anae.14995. Epub 2020 Feb 11.