louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03326856: ET-01 in Subjects With Lateral Canthal Lines
Official title: Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Canthal Lines
Crow's Feet
Lead sponsor: Eirion Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-31
Enrollment: 48
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: sequential, dose escalating study
Primary purpose: TREATMENT

Brief summary: This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).

Detailed description: This product is being tested for its ability to reduce lateral canthal lines, also known as Crow's Feet.

Eligibility criteria: Inclusion Criteria:

* 25 - 65 years of age
* minimal to moderate Crow's Feet wrinkles at rest
* moderate to severe Crow's Feet wrinkles on contraction
* willingness to refrain from any product affecting skin remodeling
* female subjects must be not pregnant and non-lactating-

Exclusion Criteria:

* history of adverse reactions to any prior botulinum toxin treatments
* history of vaccination or non-response to any prior botulinum toxin treatments
* botulinum toxin treatment in the prior 6 months
* present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"
* history of peri-ocular surgery, brow lift or related procedures
* procedures affecting the lateral canthal region in the prior 12 months
* application of topical prescription medication to the treatment area
* female subjects who are pregnant or are nursing a child

Primary outcomes:
measure: Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2
timeFrame: Week 4
Secondary outcomes:
measure: Total Number of Observations With a Response Defined as IGA-C Score ≤ 2
timeFrame: Week 2, 4, 8,12,18
measure: Total Number of Observations With a Response Defined as SSA-C Score ≤ 2
timeFrame: Week 2, 4, 8,12,18
Other outcomes:
Locations:
city: Cary
country: United States
facility: Cary Skin Care
state: North Carolina
Study officials:
affiliation: Eirion Therapeutics
name: Klaus Theobald, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02700256: Electronic Reporting of Symptoms After Surgery
Official title: Electronic Patient-Reported Outcomes in Patients Recovering From Ambulatory Cancer Surgery: Measuring Early Postoperative Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Scheduled to Undergo Surgery on the Gynecology Service
Keywords: surgery
15-315
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 135
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: Patients scheduled to undergo surgery on the Gynecology service through the AXR program or are discharged within 24-hours of surgery with internet access or a phone number will be recruited from the Rockefeller Outpatient Pavilion in the GYN Surgery Clinic.

Brief summary: The purpose of this pilot study is to find out if patients are willing to self-report symptoms in the first 5 days following discharge, or when they leave the hospital after "ambulatory surgery" ("ambulatory surgery" is when the patient has surgery and then goes home within 24 hours).


Eligibility criteria: Inclusion Criteria:

* The patients must be undergoing surgery for an indication tracked within the Gynecologic AXR program or have an expected postoperative discharge within 24 hours of surgery. These surgical procedures typically include: minimally invasive hysterectomy or radical hysterectomy, salpingo-oophorectomies \[mentioned above\], and minimally invasive staging procedures.
* The patient must have a phone number or an email address.
* The patient must be willing to self-report postoperative symptoms over an automated phone system or via an online platform.
* The patient must speak and read fluent English.

Exclusion Criteria:

* Non-English speaking patients
* Patients unwilling to provide contact information (email or phone number)

Primary outcomes:
measure: number of patients who respond to the survery
timeFrame: up to 5 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering Cancer Center
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Oliver Zivanovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03516656: Evaluation of Anti-Xa Levels in Surgery Patients Receiving Weight-based Heparin
Official title: Evaluation of Anti-Xa Levels in Surgery Patients Receiving Weight-based Heparin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Venous Thromboembolism
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if weight-based heparin infusions at a rate of 10 units/kg/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for VTE prophylaxis in patients undergoing microvascular surgery. Additionally, a pilot protocol has been developed to titrate these heparin infusions to ensure patients have sufficient VTE prophylaxis. All patients will be enrolled in the observational arm of the study and receive anti-Xa level monitoring. Patients with out-of-range anti-Xa levels will cross over to the interventional arm of the study and receive real time heparin infusion dose adjustments per the pilot protocol. The primary outcome measured will be the percentage of patients with anti-Xa levels in the target range of 0.1-0.35 IU/mL while on a heparin infusion at 10 units/kg/hour.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgical procedures
* Initiation of a heparin infusion at a rate of 500 units/hour intraoperatively or postoperatively

Exclusion Criteria:

* Age \<18 years old
* Pregnant
* Incarcerated
* Mentally disabled

Primary outcomes:
measure: Percentage of Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Number of Rate Adjustments
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Anne Prazak, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02536456: China PEACE Million Persons Project
Official title: China PEACE Million Persons Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Disease
Keywords: screening
counseling
follow-up
cardiovascular disease
population-based project
China
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2015-08-31
Enrollment: 4000000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents from the communities or villages in selected sites

Brief summary: China PEACE Millions Persons Project is a national screening project for cardiovascular disease in China. This Project was approved by National Health and Family Planning Commission (NHFPC), China and founded by Ministry of Finance, China in 2014.

The specific objectives of the project are to:

1. identify subjects at high-risk of CVD and provide counseling for medication and lifestyle improvements
2. evaluate the feasibility of such screening methods for subjects at high risk of CVD, and to assess the effect of health counseling on CVD incidence rates and risk factors control
3. inform future intervention and long-term follow up efforts for primary and secondary CVD prevention in China.


Eligibility criteria: Inclusion Criteria:

1. 35 - 75 years old
2. registered in the Hukou of the selected region
3. sign the consent form

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence of Cardiovascular diseases
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
affiliation: China National Center for Cardiovascular Diseases
name: Lixin Jiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lu J, Xuan S, Downing NS, Wu C, Li L, Krumholz HM, Jiang L. Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Million Persons Project pilot. BMJ Open. 2016 Jan 4;6(1):e010200. doi: 10.1136/bmjopen-2015-010200.
Clinical trial NCT06851156: Transcranial Temporal Interference Stimulation In Severely Brain Injured Patients With Disorders of Consciousness
Official title: An Exploratory Trial Evaluating Temporal Interference Stimulation of CM-pf In Patients With Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disorders of Consciousness
Severe Brain Injury
Unresponsive Wakefulness Syndrome
Minimally Conscious State
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this academic lead study is to explore the effect of noninvasive neuromodulation of the CM-pf via tTIS for patients with disorders of consciousness.


Eligibility criteria: Inclusion Criteria:

* traumatic and nontraumatic etiology of VS/UWS or MCS according to published diagnostic criteria.

Exclusion Criteria:

* patients in coma, with less than 1 week after acute brain insult, with fluctuating diagnosis on baseline assessment, and with a metallic cerebral implant or pacemaker, and with epilepsy.

Primary outcomes:
measure: CRS-R total score changes
timeFrame: From enrollment to the end of treatment at 10 days
Secondary outcomes:
measure: Numbers of patients with improved consciousness
timeFrame: From enrollment to the end of treatment at 10 days
measure: EEG changes
timeFrame: From enrollment to the end of treatment at 10 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: wen Jiang, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02935556: Characterization and Epigenetics of Post-Partum Preeclampsia
Official title: Characterization and Epigenetics of Post-Partum Preeclampsia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Post Partum Pre-eclampsia
Keywords: Post Partum Pre-eclampsia
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: New York University
name: Society for Obstetric Anesthesia and Perinatology
First posted: 2016-10-17
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who present to the hospital with postpartum pre-eclampsia are matched with women who never have PP-PEC (post-partum preeclampsia).

Brief summary: This study will recruit women with post partum pre-eclampsia and match them to controls without postpartum pre-eclampsia to identify an epigenetic signature that is specific to women with post partum pre-eclampsia to help characterize the underlying pathophysiology of post partum pre-eclampsia.

Detailed description: Preeclampsia (PEC) is a heterogeneous disease that complicates 5-8% of pregnancies. Approximately 10% of PEC patients will present with post-partum PEC without having developed the syndrome during the pregnancy (PP-PEC). Management of post-partum preeclampsia (PP-PEC) is challenging because many women do not seek care until neurologic symptoms result from severe-range elevated blood pressure. The pathogenesis and clinical characteristics of PP-PEC are understudied and poorly understood. Identifying clinical risk factors and biomarkers of PP-PEC would help to identify women at risk.

Eligibility criteria: Inclusion Criteria:

* Post partum pre-eclampsia

Matching based on:

* maternal age (years +/-3)
* BMI (+/-5 points)
* Ethnicity
* Mode of delivery
* Gestational age at delivery (+/7 days)
* Smoking status

Exclusion Criteria:

* Intrapartum pre-eclampsia

Primary outcomes:
measure: methylation signature on circulating monocytes
timeFrame: 1 week post delivery
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Columbia University
name: Marie-Louise Meng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02293356: Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma
Official title: Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Biotech Pharmaceutical Co., Ltd.
Sponsor class: OTHER
First posted: 2014-11-18
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of Nimotuzumab in the treatment of nasopharyngeal carcinoma and to provide a more reasonable basis for clinical drug programs.

Detailed description: This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of Nimotuzumab in the treatment of nasopharyngeal carcinoma and to provide a more reasonable basis for clinical drug programs.

Subjects who meet the inclusion/exclusion criteria are administered of Nimotuzumab based on medication instructions or adjusted by clinicians according to the treatment. In case of the progression of disease, unacceptable toxicity, withdrawal of the consent, or judgment by investigator that the treatment needs to be stopped, the treatment of Nimotuzumab is stopped.

Eligibility criteria: Inclusion Criteria:

1. Patients with histologically or cytologically confirmed nasopharyngeal carcinoma
2. Sex and age without limiting
3. Treatment without limiting
4. Subjects with reproductive potential (males and females) willing to use reliable means of contraception
5. Able and willing to give written informed consent and comply with the requirements of the study protocol

Exclusion Criteria:

1. Patients with severe allergies or idiosyncratic constitution
2. Women who are pregnant (determined by urine pregnancy test)or breast feeding
3. Any other severe complications or functional disorder of organ systems, which will affect the evaluation of safety of patients or will interfere with the test drug according to the researcher's point of view

Primary outcomes:
measure: To determine the safety of the treatment with Nimotuzumab(NCI Common Terminology Criteria for Adverse Events v4.03)
timeFrame: up to 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute & Hospital.Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: li gao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00721656: Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes
Official title: A Randomized, Double Blind, Placebo Controlled, Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Keywords: Dry eye syndromes
Corneal diseases
Conjunctival Diseases
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-07-24
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of KLS-0611 compared to placebo in patients with dry eye syndromes.


Eligibility criteria: Inclusion Criteria:

* Corneal and conjunctival damage
* Insufficiency of lacrimal secretion
* Ocular symptom

Exclusion Criteria:

* Severe ophthalmic disorder
* Punctual plugs or surgery for occlusion of the lacrimal puncta

Primary outcomes:
measure: Corneal-conjunctival staining
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hokkaido region
country: Japan
facility: Japan
city: Kansai region
country: Japan
facility: Japan
city: Kanto region
country: Japan
facility: Japan
city: Kyushu region
country: Japan
facility: Japan
city: Shikoku region
country: Japan
facility: Japan
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Yasuhiro Omori
role: STUDY_DIRECTOR
References:
Clinical trial NCT02852356: Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator
Official title: Prospective Observational and Validation Study Using Time-lapse Morphometry MIRI Imaging Incubator (TiMMI Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility
Lead sponsor: Ovation Fertility
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the MIRI-TL time-lapse incubator and CultureCoin dish compared to standard big-box incubators and standard culture dishes used for embryo culture.

Detailed description: Following randomization and standard ovarian stimulation protocols to obtain a sufficient number of mature (MII) oocytes, these oocytes will be fertilized by Intra-Cytoplasmic Sperm Injection (ICSI). If a patient has been randomized to the study group, all inseminated oocytes and subsequently all fertilized diploid (2PN) zygotes will be placed in the CultureCoin and then into the MIRI-TL Time-lapse incubator and cultured as per normal protocol to the blastocyst stage (Day 5/6 or 7). Top quality blastocyst(s) will be transferred and monitored for implantation, pregnancy and ongoing birth. Embryo transfers will either occur in a fresh or frozen embryo transfer cycle.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Women undergoing in vitro fertilization treatment using their own or frozen oocytes
* Fresh or Frozen Embryo Transfer
* Fertilization by ICSI
* At least 4 diploid (2PN) embryos at fertilization check
* Willing to have all inseminated oocytes imaged by Miri
* Willing to comply with study protocol and procedures Willing to provide written informed consent

Exclusion Criteria:

* Fertilization using surgically removed sperm
* History of cancer

Primary outcomes:
measure: Number of Participants With a Positive bHCG Level as Detected by a Blood Test
timeFrame: 14 days after embryo transfer
Secondary outcomes:
measure: Number of Patients With Embryo Implantation
timeFrame: 28 days
measure: Embryo Development
timeFrame: 7 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ovation Fertility
state: Texas
Study officials:
affiliation: Ovation Fertility
name: Matthew VerMilyea, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01142856: Mesenchymal Stem Cells for Treatment of Amyotrophic Lateral Sclerosis (ALS)
Official title: A Single Patient Treatment Protocol for Autologous Mesenchymal Stem Cell Intraspinal Therapy in Amyotrophic Lateral Sclerosis (ALS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-06-11
Enrollment: 1
Sex: ALL
Minimum age (years): 18
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 determine the safety of injecting mesenchymal stem cells through intraspinal delivery for the treatment of ALS.

Detailed description: A single patient safety study for harvesting, expanding ex vivo and injecting autologous mesenchymal stem cells (MSC's) into the subarachnoid space of a patient with amyotrophic lateral sclerosis (ALS). Cells will be isolated from adipose tissue by subcutaneous biopsy and expanded using an FDA-approved protocol. They will then be injected by lumbar puncture into the cerebrospinal fluid. Injection will be completed in the in- patient clinical research unit (CRU). the patient will be followed for two years.

Eligibility criteria: Inclusion Criteria:

* age greater than 18 years, if female, must be menopausal or had hysterectomy
* resident and citizen of the United States
* history of a chronic onset of a progressive motor weakness
* able to comply with protocol requirements
* can provide written consent

Exclusion Criteria:

* does not have renal disease (Creatine \> 2.0)
* does not have active systemic disease
* does not have any clinically significant abnormalities on prestudy laboratory evaluation
* does not have any clinically significant medical condition (e.g.,within 6 months of baseline, had a myocardial infarct, angina pectoris, and/or congestive heart failure), that in the opinion of the investigator, would compromise the safety of the patient
* does not have a history of cancer including melanoma with the exception of localized skin cancers (with no evidence of metastasis, significant invasion,or re-occurrence within 3 years of baseline).
* has not used an investigational drug within 30 days of baseline visit
* does not have a tracheostomy
* does not have a Beck's Depression Inventory score \>16

Primary outcomes:
measure: Safety
timeFrame: 2 year follow-up
Secondary outcomes:
measure: Neurologic disability score
timeFrame: Two year follow-up
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Anthony J. Windebank, MD
role: PRINCIPAL_INVESTIGATOR
References: