louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01671657: US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)
Official title: US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: In vitro fertilization
Assisted reproductive therapy
Time-lapse image recording
Image analysis software
Lead sponsor: Progyny, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-23
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing in vitro fertilization treatment who provide informed consent and plan to undergo Day 3 embryo transfer.

Brief summary: The purpose of this clinical investigation is to gather data to evaluate the impact of using Eeva with traditional morphology grading on implantation rates.

Detailed description: The purpose of this clinical investigation is to gather data to evaluate the impact of implantation rates for Day 3 embryo transfers using Eeva and morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (from a concurrent control group).

Eligibility criteria: Inclusion Criteria:

* Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
* IVF cycle attempts ≤ 2.
* Egg age ≤ 40 years.
* Planned Day 3 embryo transfer.
* At least 4 normally fertilized eggs (2PN).
* All 2PN embryos must be imaged by Eeva.
* Ejaculated sperm or sperm from the epididymis (fresh or frozen).
* Willing to comply with study protocol and procedures.
* Willing to provide written informed consent.

Exclusion Criteria:

* Planned preimplantation genetic diagnosis or preimplantation genetic screening.
* Planned "freeze all" cycle (oocytes or embryos).
* Sperm retrieved from testicular tissue.
* Abnormal uterine cavity as evaluated by standard methods.
* Gestational carrier.
* Endometriosis
* Hydrosalpinx.
* History of cancer.
* Concurrent participation in another clinical study.

Primary outcomes:
measure: Rate of implantation
timeFrame: 5-6 gestational age
Secondary outcomes:
measure: To evaluate clinical pregnancy rates from the Eeva Test group to the Control group
timeFrame: 5-6 weeks gestational age
measure: Ongoing pregnancy rate
timeFrame: Gestational age week 8-12
measure: Multiple pregnancy rate
timeFrame: Gestational age weeks 5-6 and 8-12
measure: Spontaneous miscarriage rate
timeFrame: Gestational age week 8-12
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Fertility Physicians of Northern California
state: California
Study officials:
affiliation: Progyny, Inc.
name: Shehua Shen, MD, ELD
role: STUDY_DIRECTOR
References:
citation: Adamson GD, Abusief ME, Palao L, Witmer J, Palao LM, Gvakharia M. Improved implantation rates of day 3 embryo transfers with the use of an automated time-lapse-enabled test to aid in embryo selection. Fertil Steril. 2016 Feb;105(2):369-75.e6. doi: 10.1016/j.fertnstert.2015.10.030. Epub 2015 Nov 18.
Clinical trial NCT06316557: HOPE from the Cerebellum: TMS-Induced Cognitive Recovery After Stroke
Official title: HOPE from the Cerebellum: TMS-Induced Cognitive Recovery After Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-stroke Cognitive Impairment
Ischemic Stroke
Keywords: Post-stroke Cognitive Impairment
Repetitive transcranial magnetic stimulation
High-frequency
Cerebellar
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter Randomized Double-Blind Controlled Study
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial is to investigate the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) in the cerebellum for individuals with post-stroke cognitive impairment. Participants will undergo rTMS in the cerebellar hemisphere opposite the lesion site, once daily for a total of five days.

Detailed description: The primary objective of this clinical trial is to investigate the effectiveness and safety of intermittent theta burst stimulation ( iTBS) in the cerebellum for individuals with post-stroke cognitive impairment. The trial aims to answer two main questions: (1) What is the effectiveness of iTBS in improving post-stroke cognitive impairment? (2) Is iTBS in the cerebellum safe for individuals with post-stroke cognitive impairment? Participants will undergo iTBS in the cerebellar opposite the lesion site, twice daily for five days. The control group will receive sham rTMS with the same parameters and positions.

Eligibility criteria: Key inclusion criteria:

(1)ischemic stroke, with an initial incident occurring within 2 weeks;(2)MoCA\<26;

Key exclusion criteria:

(1)Cerebral hemorrhage or subarachnoid hemorrhage;(2)A pre-existing history of epilepsy;

Primary outcomes:
measure: The efficacy of improving cognitive function of post-stroke cognitive impairment
timeFrame: 3 months follow-up after treatment
Secondary outcomes:
measure: The safety of improving cognitive function of post-stroke cognitive impairment
timeFrame: day1-day7
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Tiantan Hospital
name: Zixiao LI, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01224457: Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.
Official title: Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Seizure
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 52
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The pharmacogenomic profiles of drug metabolizing enzymes play an important role in pharmacokinetics (PK) of drugs. Phenobarbital (PB), worldwidely used for neonatal seizure, is a drug that requires careful dose adjustments based on therapeutic drug monitoring. It was reported that phenobarbital (PB) metabolism was affected by CYP2C9 and CYP2C19 polymorphisms in adults. This study aims to evaluate the effects of the CYP2C9 and CYP2C19 genetic polymorphisms on PB PK in infants with neonatal seizure for an optimal dosing strategy.


Eligibility criteria: Inclusion Criteria:

* Infant treated by phenobarbital monotherapy, diagnosed neonatal seizure
* Infant taken the drug concentration one more time
* given the informed consent

Exclusion Criteria:

* progressed CNS disorder
* severe systemic illness
* GOT/GPT level more than 2times of normal value,more than 3times elevation of BUN/creatinine level
* congenital hemolytic anemia
* genetic disorder

Primary outcomes:
measure: pb drug concentration
timeFrame: 48 hours after administering phenobarbital
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02069548: Analysis of Three-dimensional Movements of the Head in Cervical Dystonia
Official title: Analysis of 3-D Movements of the Head in Cervical Dystonia: Comparative Assessment of the Cervical Mobility With the Mean of 3D Sensors Motion Capture Between Patients With Cervical Dystonia and Control Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dystonia
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2014-02-24
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study-group: 30 patients meeting the criteria for cervical dystonia (Spasmodic Torticollis) and without botulinum toxin injections during the last 6 previous months before baseline. Patients will be selected consecutively among the outpatients with movement disorder of 3 study sites: Fondation OPH Rothschild, Salpetriere Hospital and Sainte-Anne Hospital (Paris)

Control-group: 30 healthy volunteers matched in age (+/- 5 years) and gender with the 30 CD subjects. They will be selected in Sainte-Anne Hospital (Paris)

Brief summary: This study addresses postures and range of motion in cervical dystonia (Spasmodic Torticollis). It uses 3D miniature and wireless motion captures sensors, and aims to increase the understanding of the biomechanics of the movement disorders of the cervical column in this pathology. In addition, the clinical state of cervical dystonia of the patients will be assessed, using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). The investigators will compare the results between control and study groups.


Eligibility criteria: Inclusion Criteria:

* Segmental cervical dystonia diagnosed by a neurological specialist in movement disorders

Exclusion Criteria:

* Neurological pathology other than cervical dystonia such as Parkinson's disease, head tremor, severe pain or cervical ailment, which would have required a treatment within the last six months
* Neuroleptic treatment in course
* Pregnancy
* breast feeding

Primary outcomes:
measure: Range of motion of the voluntary mobility of the cervical spine in the three spatial planes
timeFrame: baseline
Secondary outcomes:
measure: movements disorders in cervical dystonia
timeFrame: baseline
measure: head posture
timeFrame: baseline
measure: range of motion
timeFrame: baseline
Other outcomes:
measure: score on the Toronto Western Spasmodic torticolis rating scale
timeFrame: baseline
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
state: Ile de France
Study officials:
affiliation: Fondation Ophtalmologique Adolphe de Rothschild
name: Sangla Sophie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04591548: Biomarkers in Endometriosis
Official title: Biomarkers in Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: Endometriosis
Biomarkers
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana
First posted: 2020-10-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary infertility or endometriosis with clinical indication for surgery.

Brief summary: Endometriosis is a common gynecological benign disease which significantly compromise quality of life in patients and is a major cofactor of infertility. With the proteomic approach the investigators will search for proteins with significantly different levels in peritoneal fluid, serum and uterine fluid samples of women with endometriosis versus control group. Results will be validate using ELISA aproach.

Detailed description: Informed consent will be obtained from all individual participants included in the study. Blood sample will be obtained the day before laparoscopic surgery during regular clinical preoperative procedures. Peritoneal fluid and uterine fluid will be obtained during regular laparoscopic procedure indicated for infertility, the exact protocol of sample obtaining will be revealed after publication of results. The aim of the study was to identify potential diagnostic and predictive biomarkers or drug targets.

Eligibility criteria: Inclusion Criteria:

* primary infertility
* normal semen analysis of the partner
* normal BMI.

Exclusion Criteria:

* hormonal therapy in the last year,
* irregular menstrual cycle,
* previous pelvic surgery,
* history of previous pelvic inflammatory disease,
* smokers and patients with autoimmune diseases,
* malignant or suspected malignant diseases,
* previous pelvic inflammatory disease, leiomyoma uteri or polycystic ovaries

Primary outcomes:
measure: Derivation of the panel of proteins indicative of endometriosis using comparative proteomics
timeFrame: 3 years to collect all speciments
Secondary outcomes:
measure: Concentrations of proteins in body fluids to validate the identified panel of proteins indicative of endometriosis
timeFrame: 3 years to collect all speciments
Other outcomes:
Locations:
Study officials:
affiliation: UKCLjubljana
name: Vid Jansa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01502748: Endovascular Magnesium Sampling in Acute Stroke
Official title: Magnesium Therapy: a Novel Platform for Neuroprotectant Sampling in Acute Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Stroke
Keywords: stroke
Magnesium
Endovascular
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2012-01-02
Enrollment: 2
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This investigation will address the safety and feasibility of distal, intra-arterial sampling through endovascular access, in acute stroke patients. Levels of Magnesium will be measured in the region of infarct in patients who had been treated with intravenous Magnesium therapy following an acute stroke. This study attempts to address whether the traditional intravenous means of neuroprotectant administration achieves adequate concentration of the therapeutic agent in the area of diseased tissue.


Eligibility criteria: Inclusion Criteria:

1. Patient with acute cerebral ischemia due to ICA or MCA occlusion,
2. Patient already enrolled in the NIH FAST-MAG clinical trial,
3. Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care.
4. Age 40-95 inclusive (age criteria for FAST-MAG Trial).

Exclusion Criteria:

1. Technical inability to navigate microcatheter to target clot.
2. Patient or surrogate unavailable for consent

Primary outcomes:
measure: Magnesium concentration
timeFrame: intra-procedure (at time of first pass of retrieval device)
Secondary outcomes:
measure: Sampling feasibility
timeFrame: intra-procedural (at time of first pass of retrieval device)
measure: Safety
timeFrame: post-operative day 1
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University California Los Angeles: Ronald Reagan and Santa Monica Hospitals
state: California
city: Los Angeles
country: United States
facility: University of Southern California University and LA County Hospitals
state: California
Study officials:
affiliation: University of Southern California
name: William J Mack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Jeffrey Saver, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04975048: SREBF1 Polymorphism and Egg Yolk on Cardiovascular Disease Risk in Healthy Young Adults: a Randomised, Two-period, Single Blinded, Crossover Trial
Official title: SREBF1 Polymorphism and Egg Yolk on Cardiovascular Disease Risk in Healthy Young Adults: a Randomised, Two-period, Single Blinded, Crossover Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Healthy
GEN1 Gene Mutation
Keywords: Gene-by-Diet Interaction
Egg Yolk
Sterol Regulatory Element Binding Protein 1 Gene
HDL-C
LDL-C/HDL-C
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Chinese Nutrition Society
name: Fudan University
First posted: 2021-07-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Our previous analysis showed that sterol regulatory element binding protein gene (SREBF1) rs2236513/rs2297508/rs4925119 polymorphism modulated the relation between dietary cholesterol and serum low density lipoprotein cholesterol /serum total cholesterol. This study aims to confirm and extend this finding by characterizing the effects of cholesterol from egg yolks on lipid profiles in healthy young adults with different SREBF1 genetic makeup. 32 SREBF1 C/G/G minor allele carriers at rs2236513/rs2297508/rs4925119 and 32 SREBF1 AA/CC/AA major homozygotes at rs2236513/rs2297508/rs4925119 were enrolled to test their response to egg yolks.


Eligibility criteria: Inclusion Criteria:

* SREBF1 C/G/G minor allele carriers and AA/CC/AA major homozygotes at rs2236513/rs2297508/rs4925119, age 18-25 years, body mass index (BMI) 18\~23.9 kg/m2 , blood pressure within normal ranges (Systolic blood pressure \< 140mmHg, diastolic blood pressure \< 90mmHg), lipid profiles within normal ranges according to test kit instructions (fasting serum triglycerides \< 1.7mmol/L, fasting serum total cholesterol \< 5.2 mmol/L, fasting serum low density lipoprotein cholesterol (LDL-C) \< 3.12 mmol/L, fasting serum high density lipoprotein cholesterol (HDL-C) \>1.04 mmol/L ), liver and kidney functions within normal ranges according to test kit instructions (alanine aminotransferase (ALT) 9\~50 U/L for male, 7\~40 U/L for female; aspartate transaminase (AST) 15\~40 U/L for male, 13\~35 U/L for female; creatinine 62\~115 μmol/L for male, 53\~97 μmol/L for female; blood urea nitrogen (BUN), 1.43\~7.14 mmol/L), both parents are Chinese Han nationality, willing to eat two or more eggs, and willing to maintain "Three Low Diet" except when they were given egg yolks during the study.

Exclusion Criteria:

* History of diabetes, cancer, stroke, heart disease or any other known diseases, allergic to eggs, or having habits such as drinking or smoking.

Primary outcomes:
measure: Changes in serum lipids
timeFrame: Week 0, week 4, week 8, week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong University
state: Shandong
Study officials:
affiliation: Shandong University
name: Shixiu Zhang, Ph. D.
role: STUDY_CHAIR
References:
Clinical trial NCT01663948: International Plastic Bronchitis Registry
Official title: International Plastic Bronchitis Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Plastic Bronchitis
Keywords: Plastic bronchitis
PB
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2012-08-14
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is open to patients around the world suffering from Plastic bronchitis

Brief summary: The purpose of the international plastic bronchitis registry is to understand the natural course and long term health outcomes of subjects diagnosed with plastic bronchitis due to different types of casts. This provides essential data for identifying best practices and treatments. The secondary aim is to understand the structure of casts and mechanism of their formation.

Detailed description: Plastic bronchitis (PB) patients have casts removed during bronchoscopy as part of their routine care or that they are able to expectorate (cough out) casts naturally. The casts are normally discarded. Patients that agree to participate in the registry ship the airway casts and medical history to Dr. Bruce Rubin's Research Laboratory at Virginia Commonwealth University Richmond Virginia, USA.

The lab evaluates the biopolymer composition and structure of the airway casts by immunohistochemistry in order to identify microscopic differences between expectorated casts of subjects with plastic bronchitis and sputum from other populations (cystic fibrosis,chronic obstructive pulmonary disease , and normal airways). The lab also conducts in vitro evaluation of clearability, adhesivity, cohesivity, and inflammatory mediator concentrations to better understand the nature of the disease.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Plastic bronchitis

Primary outcomes:
measure: natural course and long term health outcomes
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Children's Hospital of Richmond at VCU
name: Bruce K Rubin, MEngr, MD, MBA, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02492048: Effectiveness of CelluTome Epidermal Harvesting System in Autologous Skin Grafting of Chronic Wound Patients
Official title: Effectiveness of CelluTome Epidermal Harvesting System in Autologous Skin Grafting of Chronic Wound Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wounds and Injuries
Lead sponsor: LifeBridge Health
Sponsor class: OTHER
Collaborators: name: Kinetic Concepts, Inc.
First posted: 2015-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is multi-center prospective, longitudinal case series with comparison to historical controls.

Detailed description: The primary objective to this study is to determine the effectiveness of CelluTome™ epidermal harvesting system as an outpatient skin grafting system for selected patients versus inpatient skin graft harvest. This is multi-center prospective, longitudinal case series with comparison to historical controls. In this study, all subjects will receive the same treatment protocol regardless of institution. This will include routine wound photography. Ongoing healing process will be recorded and reviewed. The secondary objectives of this study are to establish an ideal donor site size, recipient site size and ideal patient population (especially high operative risk patients) that would benefit from the use of CelluTome™ Epidermal Harvesting System.

Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Patients requiring split-thickness skin grafting with non-infected wounds
* Age of participants: 18 years and above at the time of informed consent
* Gender: Male or Female
* Subjects who will be locally available for the next 6 months.

Exclusion Criteria:

* Infected chronic wound
* Patients who are unable to adhere to scheduled study visits
* Patients who have severe arterial insufficiency requiring vascular intervention to restore adequate blood flow
* Patients who have an active drug/alcohol dependence or abuse history
* Use of Investigational Agents/Devices on study or within 30 days prior to informed consent or within 30 days prior to use of device.

Primary outcomes:
measure: Healing Time
timeFrame: 8 weeks
Secondary outcomes:
measure: Healing at Donor Site
timeFrame: 8 weeks
measure: Scarring
timeFrame: 8 weeks
measure: Complications
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health
state: Maryland
Study officials:
affiliation: Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health
name: Noman A Siddiqui, DPM, MHA
role: PRINCIPAL_INVESTIGATOR
References: