louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06707740: Comparison of the Effect of Capsular Bend on the Rotational Stability Between Two Toric Intraocular Lenses
Official title: Comparison of the Effect of Capsular Bend on the Rotational Stability Between Two Toric Intraocular Lenses
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cataract
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation"

Brief summary: (1) To compare the difference of rotational stability and CBI between AcrySof IQ(SN6AT) and TECNIS(ZCU) after cataract surgery. (2) To evaluate the influence of capsular bending on the rotational stability of these two kinds of intraocular lenses.

Detailed description: To compare the difference of rotational stability and CBI between AcrySof IQ(SN6AT) and TECNIS (ZCU) torus intraocular lenses implanted after cataract surgery, and analyze the influence of capsular bag bending on the rotational stability of two kinds of astigmatism correction intraocular lenses after cataract surgery.

Eligibility criteria: Inclusion Criteria:1.The patient's age is over 18 years old. 2.Diagnosed as age-related cataract Corneal astigmatism measured before operation is \> 0.75 D or predicted after operation after taking into account surgical astigmatism (SIA).

3.Pupil diameter \> 7 mm after mydriasis. 4.The astigmatism meridian between IOLMaster and Pentacam is the same (the meridian difference between the two instruments is within 15).

5.After operation, the anterior capsule completely covered the edge of intraocular lens optical surface.

6.Able to understand, cooperate and complete all follow-up.

-

Exclusion Criteria:

1. Moderate and severe dry eye
2. There is irregular corneal astigmatism.
3. Combined with other ophthalmic diseases Previous history of ophthalmic surgery.
4. The capsulorhexis is too large or eccentric, which can not cover the optical zone of intraocular lens all around, and there are intraoperative or postoperative complications.

   -

Primary outcomes:
measure: Capsular bend index
timeFrame: 1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.
measure: IOL rotation degree
timeFrame: 1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.
measure: Toric IOL total axial deviation
timeFrame: 1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Ophthalmology and Optometry Hospital
state: Wenzhou
Study officials:
References:
Clinical trial NCT02234440: Effect of Metformin on Disease Progression in Patients With Cryptogenic Cirrhosis (NASH-related Cirrhosis) With Diabetes or Impaired Glucose Tolerance or Insulin Resistance
Official title: Effect of Metformin on Disease Progression in Patients With Cryptogenic Cirrhosis (NASH-related Cirrhosis) With Diabetes or Impaired Glucose Tolerance or Insulin Resistance: a Prospective Randomized, Open Labeled, Clinical Trial"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NASH Related Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 86
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: In this study, consecutive patients with cryptogenic cirrhosis (NASH-related cirrhosis), coming to ILBS (Institute of Liver \& Biliary Sciences) OPD (Out patient Department) or getting admitted in the ward will be enrolled on fulfillment of inclusion/exclusion criteria and consent of the patient. These patients will be randomised to either metformin arm or conventional treatment arm. After enrollment these subjects will be monitored every three monthly for total of 12 months or till the primary endpoint is achieved. At the end of the study, outcome will be measured appropriately.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years and above
2. Patients with cryptogenic cirrhosis {NASH (Nash Alcoholic Steatohepatitis)-related cirrhosis}
3. Presence of diabetes mellitus or insulin resistance

Exclusion Criteria:

1. Patients with heart failure
2. Patients with acute kidney injury at the time of enrollment
3. Patients with CKD (Chronic Kidney Disease) or with S. Creatinine \> 1 mg/dL
4. Patient with active upper GI bleeding- not settled
5. Patient with SIRS/sepsis/shock
6. Patient in ICU (Intensive Care Unit)
7. Pregnancy
8. Patients with hepatocellular carcinoma
9. Patients who are not willing to participate in the study
10. Patients with any form of decompensation at the time of enrollment in the study
11. Patient with large esophageal varices/ patients who are on beta blocker other than those patients with HVPG (Hepatic Venous Pressure Gradient) non responder to betablocker
12. Patient who has already been receiving Metformin prior to enrollment in the study

Primary outcomes:
measure: Reduction of portal pressure
timeFrame: 1 Year
Secondary outcomes:
measure: Improvement in fibrosis(assessed by noninvasive methods like Fibroscan and Fib 4 index)
timeFrame: 1 Year
measure: Safety profile of the drugs like Random Blood Sugar (RBS) and serum lactate monitoring regularly.
timeFrame: 1.5 year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Tanmay S Vyas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03702140: Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy
Official title: Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Osteoporosis
Lead sponsor: Shinshu University
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the efficacy and adverse events in the following 3 groups in osteoporosis patients:

1. The administration period of teriparatide is less than 6 months and thereafter, denosumab for 24 months.
2. The administration period of teriparatide is from 6 to 12 months and thereafter, denosumab for 24 months.
3. The administration period of teriparatide is more than 12 months and thereafter, denosumab for 24 months.


Eligibility criteria: Inclusion Criteria:

* Osteoporotic patients who want to take teriparatide and denosumab

Exclusion Criteria:

* Patients who are allergic to teriparatide or denosumab Patients who are pregnant or breast-feedin

Primary outcomes:
measure: Bone mineral density
timeFrame: Change from Baseline Values at 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Yukio Nakamura
state: Nagano
Study officials:
References:
Clinical trial NCT04266340: Different Premedication in Pediatric Patients
Official title: Effects of Different Premedication on Preoperative Sedation and Postoperative Agitation in Children Undergoing Ophthalmic and Otorhinolaryngologic Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Agitation
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 320
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators studied the effects of intranasal dexmedetomidine compared with oral midazolam with different doses for premedication in children. One hundred and twenty children aged between 2 and 12 years were randomly allocated to one of four groups:2.5µg/kg intranasal dexmedetomidine group ; 0.5mg/kg oral midazolam group;0.05 mg/kg intravenous injection midazolam group; no premedication group.

Sedation levels 10, 20, and 30min after premedication were evaluated using a 5-point sedation scale. A 4-point emotional state score was used to evaluate participators when they were separated from their parents and their response to intravenous cannulation or facemask application. Agitation scores (Pediatric Anesthe-sia Emergence Delirium \[PAED\] scale) and POV were assessed in the postanesthetic care unit (PACU).Times to endotracheal tube or laryngeal mask airway removal, discharge from the PACU and patients' satisfaction degree were also assessed.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* a recent history of upper respiratory tract infection, a known allergy to dexmedetomidine or midazolam, inability to understand the consent process or parental refusal.

Primary outcomes:
measure: Sedation
timeFrame: 10 minutes after premedication
measure: Sedation
timeFrame: 20 minutes after premedication
measure: Sedation
timeFrame: 30 minutes after premedication
measure: Emotional state
timeFrame: 0 minutes after they were separated from their parents
measure: Emotional state
timeFrame: 0 minutes after intravenous cannulation
measure: Emotional state
timeFrame: 0 minutes after facemask application
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Anesthesiology, The Eye, Ear, Nose and Throat Hospital of Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT05637840: Study of Metabolic Content of Urine
Official title: Longitudinal Study of Metabolic Content of Human Urine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Content of Urine
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Morgridge Institute for Research
First posted: 2022-12-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to test the different components in urine and see if they can be matched to food, exercise and sleep that participants report. The researchers are trying to find out if urine would allow them to predict medical problems as they are happening. Participants are healthy volunteers who are willing to give urine samples on a daily basis, and can expect to be in the study for 28 days.

Detailed description: The purpose of this research study is to analyze urine samples using Mass Spectrometry to identify metabolites that have the potential to be used for medical diagnosis. This data, along with data from wearable devices, will be combined and analyzed to correlate what an individual does on a daily basis with how their body metabolizes their choices. This type of data may provide insights into the origins and progression of diseases in a short time span.

Eligibility criteria: Inclusion Criteria:

* Must be 18 years or older
* Be able to provide informed consent
* Stated willingness to comply with all study procedures and have availability for the duration of the study

Exclusion Criteria:

* Presence of a condition(s) or diagnosis, either physical or psychological, that limits the ability to urinate in the collection apparatus
* Individuals who do not consistently get at least 6 hours of sleep per night
* Individuals who have a sleep disorder diagnosis.
* Individuals who live in the state of New York

Primary outcomes:
measure: Change in inflammation
timeFrame: Baseline to day 14
measure: Correlate biohealth data with concentrations of urine metabolites
timeFrame: Daily for 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Joshua Coon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02585440: A Multiple Dose Study of the Safety, Tolerability and PK of CMX157 in Healthy Subjects
Official title: A Phase 1, Randomized, Partial-Blind, Placebo-controlled, Sequential Dose Group, Ascending, Multiple Dose Study of the Safety, Tolerability and Pharmacokinetics, With Food Effect, of CMX157 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infectious Disease
Lead sponsor: ContraVir
Sponsor class: UNKNOWN
First posted: 2015-10-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.

Detailed description: This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels, in a fasted state and a fed state.

Eligibility criteria: Inclusion Criteria:

* Age: 18-55.
* Capable of giving written informed consent.
* Capable of completing study requirements.

Exclusion Criteria:

* Positive result for HIV, HBV, or HCV.
* History or medical condition which could impact patient safety.
* Current or past abuse of alcohol or illicit drugs.
* Participation in another clinical trial within the past 30 days.

Primary outcomes:
measure: Evaluation of the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
timeFrame: 28 days
Secondary outcomes:
measure: Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
timeFrame: 28 days
measure: Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
timeFrame: 28 days
measure: Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
timeFrame: 28 days
measure: Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
timeFrame: 28 days
measure: Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
timeFrame: 28 days
measure: Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
timeFrame: 28 days
measure: Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.
timeFrame: 28 days
measure: Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.
timeFrame: 28 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
Study officials:
affiliation: ContraVir
name: John Sullivan-Bolyai, MD, MPH
role: STUDY_CHAIR
References:
Clinical trial NCT03993340: Rescue Stenting for Failed Endovascular Thrombectomy in Acute Ischemic Stroke (ReSET)
Official title: Rescue Stenting for Failed Endovascular Thrombectomy in Acute Ischemic Stroke (ReSET)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Intracranial Artery Occlusion
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 78
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with emergent large vessel occlusion and who have not achieved successful recanalization (defined by mTICI, 2b or 3) by mechanical thrombectomy using stent retriever or aspiration thrombectomy.

Brief summary: This study is a prospective, open-label, multi-center, registry study, designed to show that rescue stenting is safe and effective for emergency large vessel occlusion (ELVO) patients who have mechanical thrombectomy failure. Participants with ELVO will initially underwent mechanical thrombectomy usig stent retriever, contact aspiration or both. After failure of mechanical thrombectomy, rescue stenting will be performed.


Eligibility criteria: Inclusion Criteria:

* 1. Subjects experiencing acute ischemic stroke due to large vessel occlusion (intracranial internal carotid artery and middle cerebral artery M1 segment)
* 2. Age 19 or greater
* 3. mRS before qualifying stroke, 0 or 1
* 4. Baseline NIHSS score 4 or more
* 5. CT ASPECTS \> 6 or MR ASPECTS \> 5
* 6. Good collateral statues on CT angiogram (collateral grade by Calgary group, 4 or 5) or corresponding to DEFUSE 3 or DAWN trial on perfusion imaging.
* 7. Onset (last-seen-well) time to femoral puncture time \< 24 hours
* 8. Failure of mechanical thrombectomy with stent retriever, contact aspiration or both
* 9. Subjects who received rescue stenting after failure of mechanical thrombectomy
* 10. Anticipated life expectancy of at least 12 months
* 11. Signed informed consent for study enrollment

Exclusion Criteria:

* 1. Any contraindication to antiplatelet medication
* 2. Multiple simultaneous large vessel occlusions
* 3. Pregnancy
* 4. Severe contrast allergy or absolute contraindication to iodinated contrast agent
* 5. Patient has a severe or fatal combined illness that will prevent improvement of follow-up or will render the procedure unlikely to benefit the patient.

Primary outcomes:
measure: modified Rankin scale
timeFrame: 3 months
Secondary outcomes:
measure: Patency of the target artery
timeFrame: 1 day to 28 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Stroke Center, Yonsei University College of Medicine
state: Yeonsei-ro Seodaemun-gu
Study officials:
References:
Clinical trial NCT03318640: Mindfulness and Cognition in Schizophrenia
Official title: Effect of Mindfulness (MBSR) on the Parasympathetic System and Cognition in Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
mindfulness
parasympathetic system
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir
First posted: 2017-10-24
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison between treated group or not
Primary purpose: BASIC_SCIENCE

Brief summary: Mindfulness (innovative and integrative practice in care) allows the individual to adapt his/her behavior (physical and emotional), in a stressful environment, by regulating cardiac activity, especially the parasympathetic system. In schizophrenia, despite the positive effect of treatments on symptoms (delusions and hallucinations), patients have altered markers of the parasympathetic (high frequency, HF) system. The investigator propose a session of Mindfulness Based Stress Reduction (MBSR) for patients suffering from schizophrenia in order to measure the impact on the parasympathetic system (HF), self-awareness (being well in one's body and being aware of their own actions; EASE) and cognition (attention) in relation to the management of conflicts or emotions. The study compare with patients who receive a session of techniques based on the management of emotions and social cognition (cinemotion, Michael's Game and Tom Remed).


Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia (men only)
* aged 18-55
* with no change in antipsychotic medication and clinical status within four weeks prior to the study
* affiliates or entitled to a social security scheme
* who have given their informed consent before participating in the study.

Exclusion Criteria:

* History of head trauma, neurological disease or not stabilized serious physical illness
* Disorders related to the use of a psychoactive substance, as defined by the DSM-IV (abuse, dependence or withdrawal) within 6 months
* Beta blocking and anti-arrhythmic medications.

Primary outcomes:
measure: High Frequency spectral power
timeFrame: 2 months
Secondary outcomes:
measure: Score
timeFrame: 2 months
measure: Score
timeFrame: 2 months
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Anne GROSSELIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02468440: Evaluation of ESPAIR, an Educational Therapy's Program of Patients With Renal Insufficiency Before Kidney Transplant
Official title: Evaluation of ESPAIR, an Educational Therapy's Program of Patients With Renal Insufficiency Before Kidney Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency
Keywords: renal insufficiency
kidney transplant
educational therapy
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Treatment care of end-stage renal insufficiency is an important public health issue. The balance between patients waiting for a kidney transplant and available graft raises questions. Because of the non-adherence, risk of graft loss is increased to 7 times so in this trial patients will experiment an educational therapy's program as soon as they register on the transplant list.


Eligibility criteria: Inclusion Criteria:

* Patient with renal insufficiency on dialysis or not
* Registered on transplant list

Exclusion Criteria:

* Patient with psychological disorder
* transplantation from living donor
* Patients with renal transplant antecedent

Primary outcomes:
measure: Quality of life Questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life Questionnaire
timeFrame: One year
measure: Quality of life Questionnaire
timeFrame: 1 day
measure: Composite measure of impact of educational therapy's program
timeFrame: 6 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Chu Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Laure Esposito, MD
role: PRINCIPAL_INVESTIGATOR
References: