louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04238039: Ketamine Long Therm Follow Up Study
Official title: Five Years Follow up: Add on Intravenous Ketamine for Major Depressive Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Followin Ketamine Treatment
Keywords: Major Depressive Disorder, ketamine, follow up, relapse
Lead sponsor: The Chaim Sheba Medical Center
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 16
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in the ketamine study

Brief summary: Results of the study and of 5 years follow up of depressed patients who participated in the study during 2014-2015. We will locate the participants and will interview them will use the same questionnaires to evaluate their depressive symptoms. We will also measure the time to relapse.

Detailed description: Anamnestic data will be collected from the patients, in addition, depressive symptoms will be measured using Montgomery Asberg Depression Scale (MADRAS). In addition, the Clinical Global Severity Scale (CGI-S) and Clinical Global Improvement (CGI-I) were performed 2 hours after treatment. In addition, we performed to prolong the time to relapse in this patient.

Eligibility criteria: Inclusion Criteria:

* Participants in the ketamine study

Exclusion Criteria:

-

Primary outcomes:
measure: Time to relapse
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Revital Amiaz
state: RI
Study officials:
References:
Clinical trial NCT02086539: Comparison of Outreach Approaches to Increase Enrollment in a Healthy Cholesterol Study
Official title: A Randomized Controlled Trial of Outreach Approaches to Increase Enrollment in the Habit Formation for Adherence to Statin Use and LDL Reduction Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Rutgers University
name: National Institute on Aging (NIA)
First posted: 2014-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to determine the effectiveness of 4 different recruitment techniques for enrollment into a cholesterol study. 2,000 people that meet initial eligibility criteria for the study will be randomized into one of 4 groups and will all receive the same recruitment letter inviting them to participate in the study by enrolling on an online platform. Group 1 will receive the recruitment letter in a normal sized envelope, Group 2 will receive the recruitment letter in an 8.5 x 11 inch envelope, Group 3 will receive a recruitment letter shipped via USPS priority mail and a Group 4 will receive a recruitment letter with the image of an Amazon gift card and told they will receive a $25 gift card if they enroll in the study. All other groups are told that they will receive a $25 check upon enrollment in the study.


Eligibility criteria: Inclusion Criteria:

* Diabetes and or history of CVD
* LDL \> or = 130 mg/dl - measured during screening
* A prescription filled for statin medication within the last 12 months
* Medication Possession Ratio (MPR) \<80%
* CVS Caremark Beneficiary

Exclusion Criteria:

* Less than 18 years old
* Contraindication to further statin use or have suffered side effects from statins, such as myopathy
* Will not or cannot give consent
* History of active or progressive liver disease or abnormal liver function tests on baseline screening
* Currently participating in another clinical trial with related aims
* Co-morbidities likely to lead to death within a short-period

Primary outcomes:
measure: Enrollment into the Habit Formation study
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kevin G Volpp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00418639: Study of Nitazoxanide in the Treatment of Chronic Hepatitis C
Official title: Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in the Treatment of Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
Lead sponsor: Romark Laboratories L.C.
Sponsor class: INDUSTRY
First posted: 2007-01-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of treatment with 24 weeks nitazoxanide monotherapy on end of treatment virologic response, sustained virologic response, reduction of quantitative serum HCV RNA, changes in ALT and safety parameters.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-HCV-antibodies and a positive quantitative RT-PCR amplification of HCV RNA.
* Chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis.

Exclusion Criteria:

* Patients unable to take oral medications.
* Use of interferon alpha within 90 days or ribavirin within 30 days prior to enrollment.
* Females of child bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.
* Any investigational drug therapy within 30 days prior to enrollment.
* Patients with other causes of liver disease.
* Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus based on enzyme immunoassay.
* Patients with history of alcoholism or with an alcohol consumption of \>40 grams per day.
* Patients who are clinically unstable.
* Patients with any concomitant condition that, in the opinion of the investigator would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed.
* History of hypersensitivity or intolerance to nitazoxanide or any of the excipients comprising the nitazoxanide tablets.

Primary outcomes:
measure: Virologic response
Secondary outcomes:
measure: Sustained virologic response
measure: Quantitative serum HCV RNA
measure: Changes in ALT
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Department of Tropical Medicine & Infectious Diseases, Alexandria University
city: Cairo
country: Egypt
facility: Cairo Liver & GIT Center
city: Tanta
country: Egypt
facility: Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
Study officials:
affiliation: Cairo Liver & GIT Center
name: Samir M Kabil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Tropical Medicine & Infectious Diseases, Alexandria University
name: Yehia El-Gohary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
name: Asem Elfert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02707939: Observational Prospective Study on Behavioral Outcomes of Children With Autism Spectrum Disorder (ASD) in Comparison to Those Without Neurodevelopmental Diagnoses
Official title: Observational Prospective Study on Behavioral Outcomes of Children With Autism Spectrum Disorder (ASD) in Comparison to Those Without Neurodevelopmental Diagnoses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism Spectrum Disorder
Anesthesia
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with an ASD diagnosis and control patients who do not have any history of neurodevelopmental concerns who are scheduled for a procedure under anesthesia at Boston Children's Hospital.

Brief summary: Autism Spectrum Disorder (ASD) is the fastest growing neurodevelopmental disorder in the world. Approximately 1% of the population worldwide is affected by this disorder. Children with ASD exhibit some very stereo-typical behaviors. Their daily functionality depends on very rigid and predictable schedules and routines. Any changes in their schedules can often trigger negative emotional outbursts. The need to come to the hospital for procedures can be one such trigger. The purpose of this study is to examine the post anesthesia behavior outcomes of children with ASD.


Eligibility criteria: Inclusion Criteria:

* Patients aged 2 years through 17 years of age scheduled for a procedure with anesthesia at Boston Children's Hospital
* Patients must have a diagnosis of Autism Spectrum Disorder (ASD) according to the DSM IV and DSM V (autism group) or an ASA score of I or II and no history of neurodevelopmental concerns (control group)

Exclusion Criteria:

-Families who are not able to read and speak English well enough to complete the validated surveys

Primary outcomes:
measure: Incidence of postoperative behavioral changes in the participants
timeFrame: up to two weeks following anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Bistra Vlassakova, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnold B, Elliott A, Laohamroonvorapongse D, Hanna J, Norvell D, Koh J. Autistic children and anesthesia: is their perioperative experience different? Paediatr Anaesth. 2015 Nov;25(11):1103-10. doi: 10.1111/pan.12739. Epub 2015 Sep 4.
citation: Taghizadeh N, Davidson A, Williams K, Story D. Autism spectrum disorder (ASD) and its perioperative management. Paediatr Anaesth. 2015 Nov;25(11):1076-84. doi: 10.1111/pan.12732. Epub 2015 Aug 6.
citation: van der Walt JH, Moran C. An audit of perioperative management of autistic children. Paediatr Anaesth. 2001 Jul;11(4):401-8. doi: 10.1046/j.1460-9592.2001.00688.x.
Clinical trial NCT05161039: Serranator Recoil Study
Official title: Recoil Feasibility Study for the Treatment of Atherosclerotic Lesions in the Infrapopliteal Arteries Comparing Serration Angioplasty (Serranator® Device) vs. Plain Balloon Angioplasty (POBA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Critical Limb Ischemia
Lead sponsor: Cagent Vascular LLC
Sponsor class: INDUSTRY
First posted: 2021-12-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post treatment recoil, lumen gain, and dissection will be collected.

Detailed description: Multi-center, feasibility study treating up to 20 atherosclerotic lesions in the infrapopliteal arteries. The study will capture angiographic imaging (pre, during, post, and post 15 mins) for all lesions, and a subset (up to 10) of IVUS imaging data (pre, post, and post 15 mins), to compare serration angioplasty vs standard angioplasty and its effects on vessel recoil and final diameter stenosis.

Eligibility criteria: Inclusion Criteria:

1. Male or female of \>18 years old.
2. Women of childbearing potential must have a negative urine pregnancy test within 7 days of index procedure.
3. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and comply, and has signed the consent form.
4. Subject has Rutherford Clinical Category 3, 4, 5, or 6.

Angiographic Inclusion Criteria:

1. Target lesion(s) has stenosis \>70% by visual assessment;
2. De-novo, or non-stented re-stenotic lesions;
3. Reference vessel diameter is between 2.5 mm and 3.5 mm, inclusive;
4. Target lesions involve infrapopliteal tibial arteries including pedal;
5. A target lesion may consist of one long or multiple serial lesions that are up to and including 12 cm in length;
6. If a second lesion is identified in another vessel, the second lesion can also be treated and if treated will be treated with the alternate treatment.

Exclusion Criteria:

1. Evidence of aneurysm or acute thrombus in the target vessel.
2. Subject has an allergy to contrast medium that cannot be pretreated.
3. Subject is pregnant or breastfeeding.

Angiographic Exclusion Criteria:

1. Acute Total Occlusions; evidence of acute thrombus formation by angiography.
2. In-stent restenotic lesions.
3. Inability to cross the lesion with the assigned study device.
4. Treatment of target lesion with atherectomy.

Primary outcomes:
measure: Presence of post treatment recoil
timeFrame: 15 minutes post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Arnsberg
country: Germany
facility: Klinik für Angiologie, Klinikum Hochsauerland GmbH
Study officials:
References:
Clinical trial NCT02150239: A Survey on Postoperative Pain (POP) Experience in Asian Patients.
Official title: A Survey on Postoperative Pain (POP) Experience in Asian Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pain
Keywords: pain
postoperative
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult with age ≥ 18 who undergo operation

Brief summary: Pain management is becoming an important ethical responsibility of the medical profession and a focus of the health care system. However, there are limited literature evaluate the postoperative pain experience and management in our local setting.

Detailed description: We need to identify those patients who, from a demographic, psychology and surgical viewpoint, are more at risk of experiencing postoperative pain.

Eligibility criteria: Inclusion Criteria:

* 1. Adult with age ≥ 18 who undergo operation

Exclusion Criteria:

* 1. Refused to give informed consent

Primary outcomes:
measure: postoperative pain experience
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Center
state: KL
Study officials:
affiliation: University of Malaya
name: Wang Chew Yin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01398839: Safety Study of the VEGA UV-A System to Treat Ectasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ectasia
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2011-07-21
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL) when used to treat ectasia.


Eligibility criteria: Inclusion Criteria:

* 18 Years of age or older
* Diagnosis of Ectasia
* Presence of central or inferior steepening
* Topography consistent with ectasia
* BSCVA 20/20 or worse
* If contact lens wearer; removal of contact lenses for required period of time
* Signed informed consent
* Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

* Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
* History of chemical injury or delayed epithelial healing
* A known sensitivity to study medications
* Nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests
* A condition that would interfere with or prolong epithelial healing
* Presence or history of any other condition or finding that makes the patient unsuitable for treatment

Primary outcomes:
measure: Changes in Corneal Curvature
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barnet Dulaney Perkins Eye Center
state: Arizona
city: Atlanta
country: United States
facility: Woolfson Eye Institute
state: Georgia
city: Bloomington
country: United States
facility: Minnesota Eye Consultants, P.A.
state: Minnesota
city: New York
country: United States
facility: Laser and Corneal Surgery Assoc. PC
state: New York
city: New York
country: United States
facility: Mt. Sinai Hospital
state: New York
city: New York
country: United States
facility: Pamel Vision & Laser Group
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic-Cole Eye Institute
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University College of Medicine
state: Ohio
city: Columbus
country: United States
facility: ReVision Advanced Laser Eye Center
state: Ohio
city: Austin
country: United States
facility: Dell Laser Consultants
state: Texas
city: Houston
country: United States
facility: Slade & Baker Vision
state: Texas
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
Study officials:
References:
Clinical trial NCT03229239: Corneal Stroma Implantation for the Treatment of Keratoconus
Official title: Implant the Corneal Stroma to the Diseased Cornea in Order to Cure Keratoconus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Keratoconus
Lead sponsor: Shandong Eye Hospital
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether corneal stroma implantation is effective in the treatment of keratoconus.

Detailed description: Keratoconus is a corneal disease with the progressive thinning of the central corneal stroma. The main treatment methods are corneal transplantation, corneal collagen cross-linking, etc. The effect of corneal collagen cross-linking is limited, and the lack of donor cornea is really a very big problem. In this pilot project, investigators would like to study whether corneal stroma implantation can increase the biomechanics of the cornea, which can, to some extent, delay the progress of keratoconus. This will allowed us to determine if useful data can be obtained, and if so, the donor cornea can be greatly saved.

Eligibility criteria: Inclusion Criteria:

1. Advanced and completed keratoconus patients
2. Voluntarily signed informed consent
3. No surgery and anesthesia contraindications

Exclusion Criteria:

1. Acute edema of cornea
2. Primary keratoconus patients
3. The patients combined systemic diseases
4. Reject study and follow visit
5. Cannot tolerate surgery or anesthesia

Primary outcomes:
measure: The best corrected visual acuity of the operated eye
timeFrame: 1 month after operation
measure: The best corrected visual acuity of the operated eye
timeFrame: 3 months after operation
measure: The best corrected visual acuity of the operated eye
timeFrame: 6 months after operation
measure: The best corrected visual acuity of the operated eye
timeFrame: 12 months after operation
Secondary outcomes:
measure: The biomechanics of the operated eye
timeFrame: 1 month after operation
measure: The biomechanics of the operated eye
timeFrame: 3 months after operation
measure: The biomechanics of the operated eye
timeFrame: 6 months after operation
measure: The biomechanics of the operated eye
timeFrame: 12 months after operation
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Eye Hospital
state: Shandong
Study officials:
affiliation: director of shandong eye hosiptal
name: Weiyun Shi, sponsor
role: STUDY_CHAIR
References:
Clinical trial NCT04914039: Evaluation of CTA on the Assessment of Brain Death
Official title: Evaluation of CTA on the Assessment of Brain Death
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Death
Keywords: brain death
CT angiography
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 63
Sex: ALL
Minimum age (years): 12
Maximum age (years): 72
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CTA imaging data of 63 patients with clinically suspected brain death

Brief summary: At present, different countries have different standards for the diagnosis of brain death, but according to the classic brain death confirmation test, it needs to be combined with transcranial Doppler, EEG, evoked potential and apnea test in clinical practice. Some patients cannot undergo a complete clinical examination and apnea test due to certain factors, and the determination of brain death is limited. The American Academy of Neurology (AAN) guidelines regard cerebral angiography as an acceptable auxiliary examination and is widely regarded as the gold standard for cerebral blood flow evaluation. CT cerebrovascular angiography (CTA) is a noninvasive and widely used examination method that can identify missing or severely reduced cerebral blood flow. However, due to limited experience and lack of sufficient evidence to prove its reliability, it is not included in the AAN A recognized auxiliary examination; there are also a large number of domestic and foreign literature reports that CTA can be used as a new confirmation test for clinical judgment of brain death.

This study aims to explore the value of CTA in the judgment of patients with brain death.


Eligibility criteria: Inclusion Criteria:

* Recruiting, no definite

Exclusion Criteria:

* Recruiting, no definite

Primary outcomes:
measure: CTA used as an auxiliary diagnosis to determine brain death
timeFrame: through study completion, an average of 3 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Brain Center, Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: