louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02174341: The Pilot Study of Chikungunya Virus Infections in Southern Taiwan
Official title: Investigate the Prevalence of Serum Chikungunya Virus Infection, and Against Those Suspected Dengue Fever, Chikungunya Disease-related Tests Conducted
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chikungunya Fever
Keywords: Chikungunya fever
Chikungunya Virus
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The samples are obtained from the Kaohsiung Medical University Chung-Ho Memorial Hospital in Kaohsiung, Taiwan.

Brief summary: This test is to be collected during the dengue outbreak samples, including samples back in the past and forward to close the case, investigating the prevalence of serum Chikungunya virus infection, and against those suspected dengue fever, Chikungunya disease-related tests conducted to clarify dengue and Chikungunya disease of clinical judgment, rapid method to detect Chikungunya virus and then develop.

Detailed description: During the execution of this project was ended March 1, 2012 to December 31, 2015, is expected to gather 300 suspected dengue infection, of whom 150 dengue-negative test results, test results of 150 dengue positive. And closed the case into prospective and retrospective analysis of the last sample into two parts.

Case closed after part of a prospective analysis of the study, subjects were required to complete consent forms and collect 20 ml blood samples, blood samples will be checked to identify dengue and Chikungunya disease associated serum antigen-antibody reaction , PCR (polymerase chain reaction) test and sequence analysis and pathogen identification and separation, in order to identify the source of infection difference. In addition, retrospective analysis of the last part of the specimen, sucked "after the health of the host track dengue infection, host immune regulation changes, and possible interactions with viral hepatitis" (KMUH-IRB-960195) collected by the inspection plan body, the number of samples included in the plan to close the case, and contact with the subjects, changes to inform the content of the plan to re-sign the consent form.

Eligibility criteria: Inclusion Criteria:

* Suspected of being infected with dengue fever

Exclusion Criteria:

* none

Primary outcomes:
measure: For persons with suspected dengue fever, Chikungunya disease-related testing conducted to clarify the clinical dengue and Chikungunya disease of judgment
timeFrame: 75 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaoshing Medical University Chung-Ho Memorial Hospital
Study officials:
References:
Clinical trial NCT03298841: Clinical Comparison of Length of Cataract Procedures With Zeiss Lumera Versus Older Zeiss Microscope
Official title: Zeiss Lumera Microscope With Callisto Software
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Toyos Clinic
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 patients with visually significant cataracts

Brief summary: Study design will be a mix of retrospective (older Zeiss microscope previously in use at our surgery center) and prospective data collection with the Lumera and Callisto software.

The Lumera and Callisto software system will be used for all cataract surgeries including toric analyses and lens placement.

Detailed description: Needs Assessment

Research on this topic is needed as over 3 million cataract surgeries are performed in the United States each year. The number of surgeries performed is growing as baby boomers age. Reimbursements continue to decline, necessitating ever improving operating and surgical efficiencies in the operating room setting for physicians and small business owners to remain financially viable. New governmental regulations dictate that physician payments will be related to patient satisfaction and outcomes which may be better provided by newer and better surgical technologies.

The Lumera operating microscope and Callisto software system provide several features that may enhance operating room flow including HD video screen and co-observant microscopes that can be independently adjusted to help operating room staff anticipate the needs of the surgeon. Enhanced retroillumination would be expected to translate into fewer complications and more confidence during surgery which could lead to less operating time, phaco energy used and improved visual outcomes. The toric alignment assistance device may lead to more accurate toric placement and improved visual outcomes after surgery.

Target audience would include all cataract surgeons both high and lower volume.

There is currently a dearth of published literature on this technology and its benefits in routine cataract surgery. There are no registered similar trials on Clinicaltrials.gov

Eligibility criteria: Inclusion Criteria:

* Visually significant cataract

Exclusion Criteria:

* Not visually significant cataract

Primary outcomes:
measure: Improvement in Operating Room Efficiencies During Cataract Surgery With the Use of the New Lumera Operating Microscope Versus an Older Zeiss Model Operating Scope
timeFrame: during surgery assessed up to one hour
Secondary outcomes:
measure: Number of Serious Adverse Events During Intra-operative and Post-operative Period
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Toyos Clinic
state: Tennessee
Study officials:
affiliation: Toyos Clinic
name: Melissa Toyos, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03444441: Estimation of the Minimal Important Difference and Validation of Foot and Ankle Instruments
Official title: Estimation of the Minimal Important Difference and Validation of Finnish Versions of Foot and Ankle Patient-reported Outcome Instruments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foot Diseases
Ankle Disease
Keywords: Foot
Ankle
Finnish
Validation
FAOS
EFAS
LEFS
FAAM
VAS-FA
MOxFA
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Central Finland Hospital District
name: Seinajoki Central Hospital
name: Oulu University Hospital
First posted: 2018-02-23
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study recruits adult patients who are undergoing foot or ankle surgery for various reasons.

Brief summary: The present study investigates the minimal important change and validity of foot and ankle measures.

Detailed description: Patients who are waiting for foot and ankle surgery are recruited from four large referral centers (Peijas Hospital, Seinäjoki Central Hospital, Central Finland Central Hospital, Oulu University Hospital). Participants fill in foot and ankle-specific, generic and sosiodemographic questionnaires on the day of surgery, 6 months after surgery, and 6 months 2 weeks after surgery. Both pen-and-paper and electronic options for completing the questionnaire set are provided.

The data obtained from the Foot and ankle outcome score (FAOS), European foot and ankle society (EFAS) score, modified Lower extremity functional scale (LEFS), Visual analog scale foot and ankle (VAS-FA), Manchester Oxford foot and ankle (MOxFA) questionnaire, and the Foot and ankle ability measure (FAAM) are analyzed using the Rasch Measurement Theory and several other psychometric approaches to investigate minimal important change, reliability, responsiveness and validity of foot and ankle PRO instruments.

Eligibility criteria: Inclusion Criteria:

* Full understanding of Finnish language
* Undergoing foot or ankle surgery
* At least 18 years old

Exclusion Criteria:

* Unbalanced mental disorder such as schizophrenia or depression
* Age under 18
* Does not understand Finnish
* Undergoing operation other than foot or ankle

Primary outcomes:
measure: Minimal important difference
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Reliability
timeFrame: 6 months, 6.5 months
measure: General health question
timeFrame: Baseline, 6 months
measure: General health question
timeFrame: 6 months, 6.5 months
measure: Global assessment scale
timeFrame: 6 months
measure: Validity
timeFrame: Baseline
measure: Validity
timeFrame: 6 months
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Seinäjoki
country: Finland
facility: Seinäjoki Central Hospital
city: Vantaa
country: Finland
facility: Peijas Hospital
Study officials:
References:
Clinical trial NCT03201341: Multisensory Body and Space Representations (BASES-EXTINCTION)
Official title: Cerebral Bases of Multisensory Perception of the Body and Its Action Space
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Blindness
Keywords: Stroke
Multisensory
Plasticity
Body
Space
MRI
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 1540
Sex: ALL
Minimum age (years): 5
Maximum age (years): 71
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To accurately control body movements to interact with objects, our brain needs representations of the body and the nearby space. The broader aim of this research project is to study the behavioural and physiological mechanisms involved in the constitution of these representations, to identify their neural bases, in order to better understand the dysfunctions in the context of neurological or developmental disorders.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 5 to 71
* Subject affiliated to the general social security scheme or a similar scheme
* Subject agreeing to participate in the study with informed consent -Capable of understanding information and simple instructions related to the study

Exclusion Criteria:

* Subject under tutelage or guardianship- Subject under tutelage or guardianship
* Subject not able to give informed consent, unable to receive information about the study
* Subject not affiliated to a French or non-French social security system holder of a European health insurance card

Primary outcomes:
measure: Behavioural measure: reaction times
timeFrame: Day 30
measure: Behavioural measure : accuracy
timeFrame: Day 30
measure: Number of particpants with changed kinematics , via 3D optoelectronic motion tracking systems
timeFrame: Day 30
Secondary outcomes:
measure: Physiological Indices
timeFrame: Day 30
measure: Neuronal response indices
timeFrame: Day 120
Other outcomes:
Locations:
city: Saint Genis Laval
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT03421041: Study of Value of Dexamethasone Used in Ovulation Induction
Official title: A RCT Study of Value of Dexamethasone Used in Ovulation Induction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study intends to solve the following problems: whether use dexamethasone can obviously decrease transplant cancelling probability in fresh embryo transplant cycle or not, reduce time and frequency going to hospital repeatedly for patients need frozen embryo transplant or not, and reduce the economic burden for patients or not; By comparing pregnancy rate of single transplant, hope to make clear in IVF-ET treatment for patients progesterone increases to a certain level whether it is a good choice to transfer fresh embryo after dexamethasone treatment, or frozen embryo transplant is better.


Eligibility criteria: Inclusion Criteria:

- female, 18 years old≤age≤35 years old, 18≤BMI≤25, standard patient, menstrual regularity

Exclusion Criteria:

Hyperprolactinemia, Thyroid dysfunction, uterine malformation ( inadequacy mediastinal uterus ≥1.0cm, Unicornate uterus, double uterus, T Angle of uterus, etc.), uterus adhesion, untreated hydrosalpinx , hysteromyoma（ hysteromyoma≥1.0 cm, and/or endometrial hysteromyoma≤1 cm), endometriosis, diabetes, hypertension, adrenal cortex hyperplasia, Cushing's syndrome, a pituitary amenorrhea

Primary outcomes:
measure: cumulative pregnancy rate per oocyte retrieval cycle
timeFrame: Until 28 day after embryo transferred
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Reproductive & Genetic Hospital of CITIC-XIANGYA
state: Hunan
Study officials:
References:
Clinical trial NCT00143741: Use of Atorvastatin (Lipitor) to Decrease Panel Reactive Antibody Titers
Official title: Use of Atorvastatin (Lipitor) to Decrease Panel Reactive Antibody Titers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: End-Stage Kidney Disease
Keywords: Kidney Disease, Lipitor, Atorvastatin, Allosensitization
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify subjects who are highly sensitized with antibodies. It is difficult for these patients to find suitable kidneys. We propose to treat such patients to decrease the antibodies in such a way, that it may become possible to safely transplant kidneys into them.

Detailed description: Kidney transplantation is the desired treatment of choice in subjects with end-stage kidney disease (ESRD). The average waiting time for subjects to receive a "deceased donor" kidney transplant is 3-5 years. Currently, there are about 60,000 subjects on the national waiting list, and about 13,000-14,000 kidney transplants are performed each year. Approximately, 25% of subjects on the waiting list are "highly sensitized", meaning that they have natural proteins (antibodies) that aggressively protect their bodies from the invasion of foreign proteins. These individuals often have a difficult time accepting transplanted kidneys. The purpose of this study is to identify subjects who are highly sensitized with these antibodies, and treat them in such a way, that it may become possible to transplant kidneys into them. Drugs like atorvastatin (Lipitor) may decrease the levels of these anti-bodies and increase the possibility of these subjects to receive a kidney transplant. This research study is being done because currently, there are very limited and cumbersome treatment options to address this issue, subjects who are highly sensitized with antibodies, may unfortunately wait for a very long time or may never get transplanted.

Eligibility criteria: Inclusion Criteria:

1. Eighteen years or older,
2. On the waiting list for a kidney transplant list
3. On hemodialysis or peritoneal dialysis

Exclusion Criteria:

1. Pregnant woman
2. Patients who need ongoing blood products
3. Patients with failed organs having active rejection
4. Other therapies to decrease PRA
5. Patients listed for multi-organ transplants (other than kidney-pancreas)

Primary outcomes:
measure: This study is to identify subjects who are highly sensitized with these antibodies, and treat them in such a way, that it may become possible to transplant kidneys into them.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: The University of Chicago, 5841 South Maryland Ave., MC 5100 Chicago, IL 60637
name: Pradeep Kadambi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06529341: Efficacy of High-precision Transcranial Direct Current Stimulation on Anxiety Disorders
Official title: Efficacy of High-precision Transcranial Direct Current Stimulation on Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
High-definition Transcranial Direct Current Stimulation
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Current research has found that tDCS has a positive effect on improving the negative attention bias of AD patients, and this study uses HD-tDCS intervention to improve the cognitive function and neural mechanisms of AD patients in the OFC to provide a theoretical basis for AD neural mechanism research. Verify Hypothesis 1: HD-tDCS cathodal stimulation of the left OFC reduces the excitability of this region, modulates its connectivity with the attentional function network, and thus changes the emotional experience of social threat.
2. Currently, there is no consensus on the stimulation parameters for tDCS in the treatment of AD, and more evidence is needed to prove and explore. It is hoped that the HD-tDCS intervention protocol will become an effective treatment method for improving cognitive function and clinical symptoms in AD patients. Hypothesis 2: The HD-tDCS with intensified stimulation parameters (2mA, twice a day, with a 20-minute interval, for 5 consecutive days) has an impact on the main and secondary clinical variables of AD patients.


Eligibility criteria: Inclusion Criteria:

1. Meet the DSM-5 AD diagnostic criteria;
2. The Chinese version of the Brief International Neuropsychiatric Interview (MINI) screening meets the diagnosis;
3. Age: 18-55 years old;
4. The patient participated voluntarily, obtained the consent of the family members, and signed the informed consent form;
5. Scale score criteria: 14 points on the Hamilton Anxiety Scale (HAMA) and 17 points on the Hamilton Depression Scale (HAMD).

Exclusion Criteria:

1. Neurological diseases or other psychiatric disorders;
2. severe somatic diseases;
3. received medical treatment including medication, psychotherapy, electroconvulsive therapy, and physical therapy within the first half months of enrollment;
4. tDCS examination contraindications, such as intracranial metal or electronic implants, skull plate, or other skull implants.
5. Pregnancy and lactation.

Primary outcomes:
measure: Hamilton Anxiety Scale
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT02056041: Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma
Official title: Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma: Validation on 336 Consecutive Hepatectomies.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatectomy
Hepatecellular Carcinoma
Cirrhosis
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The records of 336 consecutive patients who were submitted to hepatectomy between 2004-2012 were reviewed.

Brief summary: Selection criteria for safe hepatectomy for HCC are not well established. The aim of this study was the validation of the selection criteria for safe hepatectomy for hepatocellular carcinoma.

Detailed description: All consecutive patients submitted to hepatectomy for HCC based on the same preoperative selection criteria from our prospectively-maintained liver unit database. Such criteria included the value of bilirubin (BIL), the value of cholinesterases (CHE), the presence of ascites, the presence of esophageal varices, and the rate of residual liver volume.

Eligibility criteria: Inclusion Criteria:

* any patient with HCC submitted to hepatic resection at our Unit in the established frame time

Exclusion Criteria:

* any patient with missing data or lost at follow-up

Primary outcomes:
measure: Safety of surgery for HCC
timeFrame: 90 days
Secondary outcomes:
measure: Score systems HCC
timeFrame: 90 days
Other outcomes:
Locations:
city: Rozzano, Milan
country: Italy
facility: Humanitas Research Hospital
Study officials:
References:
citation: Donadon M, Costa G, Cimino M, Procopio F, Fabbro DD, Palmisano A, Torzilli G. Safe hepatectomy selection criteria for hepatocellular carcinoma patients: a validation of 336 consecutive hepatectomies. The BILCHE score. World J Surg. 2015 Jan;39(1):237-43. doi: 10.1007/s00268-014-2786-6.