louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00305435: Safety Study of AMG 531 in Japanese Subjects With ITP
Official title: An Open Label Phase 2 Study Evaluating the Safety of Starting Dose of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Keywords: AMG 531, ITP, Phase 2, Japanese
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2006-03-22
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.

Detailed description: The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.

Eligibility criteria: Inclusion Criteria: - Japanese patients with diagnosis of ITP according to the diagnostic criteria proposed by Research Committee for Idiopathic Hematopoietic Disorders of the Ministry of health, labor and welfare Exclusion Criteria: - Documented diagnosis of arterial thrombosis in the previous year; history of venous thrombosis and receiving anticoagulation therapy

Primary outcomes:
measure: Incidence of all adverse events including evaluation of antibody status
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of subjects who achieve a platelet response
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Shirasugi Y, Ando K, Hashino S, Nagasawa T, Kurata Y, Kishimoto Y, Iwato K, Ohtsu T, Berger DP. A phase II, open-label, sequential-cohort, dose-escalation study of romiplostim in Japanese patients with chronic immune thrombocytopenic purpura. Int J Hematol. 2009 Sep;90(2):157-165. doi: 10.1007/s12185-009-0361-y. Epub 2009 Jun 20.
Clinical trial NCT05515835: Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.
Official title: Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rocuronium
Body Composition
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with ASA class I-II undergoing total intravenous general anesthesia

Brief summary: The induction dose of rocuronium is typically decided based on the patient's body weight, but the effect duration of rocuronium is variable. Some studies suggest that body composition analysis data, such as skeletal muscle mass or total body water, may correlate better with the duration time of rocuronium. Therefore, we plan to analyse body composition in patients undergoing total intravenous general anesthesia, give the patients a fixed dose (50mg) of rocuronium, and check the correlation between duration time of rocuronium and body composition analysis data.


Eligibility criteria: Inclusion Criteria:

* Adult patients with ASA class I-II undergoing total intravenous general anesthesia

Exclusion Criteria:

* too overweight (over 111.11kg, which corresponds to less than 0.45mg/kg of induction dose of rocuronium)
* too underweight (under 41.67kg, which corresponds to more than 1.2mg/kg of induction dose of rocuronium)
* pregnancy
* prediagnosed muscle or nerve related disease
* unsuitable for body composition analysis using bioelectrical impedance method
* unsuitable for neuromuscular block monitoring

Primary outcomes:
measure: time to TOF1
timeFrame: up to 1 hour after rocuronium administration during induction of anesthesia
measure: time to TOF4
timeFrame: up to 1.5 hour after rocuronium administration during induction of anesthesia
Secondary outcomes:
measure: time to loss of TOF
timeFrame: up to 5 minutes after rocuronium administration during induction of anesthesia
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University, School of Medicine
Study officials:
References:
Clinical trial NCT05527535: Expansion of Integrated AI Solution for Diabetic Retinopathy Screening in Thailand
Official title: Expansion of Integrated AI Solution for Diabetic Retinopathy Screening in Thailand: An Implementation Research
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Retinopathy
Keywords: Diabetic Retinopathy, Screening, Deep Learning Algorithm, Human Grader
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
Collaborators: name: Health Systems Research Institute,Thailand
First posted: 2022-09-02
Enrollment: 34500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All diabetes mellitus patients who visit for diabetic retinopathy screening at selected primary care units and hospitals in 13 health districts in Thailand

Brief summary: Efficiency and effectiveness of real-world diabetic retinopathy screening by artificial intelligent (AI) are limited. Investigators will implement AI for diabetic retinopathy screening in 13 health districts in Thailand and investigate the efficiency, effectiveness as well as patients and health care personnel's satisfaction by an implementation research.


Eligibility criteria: Inclusion Criteria:

1. Type 1 or 2 diabetes mellitus patients whose name are in primary hospital record
2. No full-time ophthalmologists in those primary hospital
3. Age more than or equal to 18 years
4. Eligible for fundus photo imaging at least 1 eye

Exclusion Criteria:

1. Type 1 or 2 diabetes mellitus patients whose name are in primary hospital record that have full-time ophthalmologists
2. Patients who previously diagnosed with other causes of macular edema, for example, Age-related Macular Degeneration, Radiation Retinopathy, Retinal Vein Occlusion etc.
3. History of retinal laser or surgery
4. Other ocular diseases that require referral to ophthalmologists
5. Not eligible for fundus photo imaging for both eyes (any causes)

Primary outcomes:
measure: Effectiveness of AI in diabetic retinopathy screening
timeFrame: Throughout the whole period of screening, approximately 6 months
measure: Efficiency of AI in diabetic retinopathy screening
timeFrame: Throughout the whole period of screening, approximately 6 months
measure: Efficiency of AI in diabetic retinopathy screening
timeFrame: Throughout the whole period of screening, approximately 6 months
Secondary outcomes:
measure: Satisfaction of patients and health care personnel in AI-based screening
timeFrame: At the end of the screening, approximately at Month 6
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04131335: Use of Prophylactic Lubricating Drops After Cataract Surgery
Official title: Patient Satisfaction and Dry Symptoms in NHS Patients Undergoing Routine Uncomplicated Cataract Surgery Treated With Prophylactic Phosphate-free, Preservative-free Lubricant Eye Drops. A Randomised Controlled Prospective Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Cataract Surgery
Patient Related Outcome Measures
Patient Satisfaction
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: City, University of London
name: King's College London
First posted: 2019-10-18
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomised controlled trial to assess the use of prophylactic lubricant eye-drops for 6 weeks following uncomplicated, routine cataract surgery to improve patient satisfaction and symptoms of dry eye, compared to controls.

Detailed description: On entry into the study patients will be randomized to receive either lubricant eye-drops (phosphate-free, preservative-free lubricant eye drops containing 0.15% Sodium Hyaluronate with vitamins A and E (AEONTM Repair) to be administered four times a day for 6 weeks following surgery (in addition to the usual post-operative topical medications of Chloramphenicol 0.5 % eye drops for 1 week and topical dexamethasone 0.1% eyedrops (Maxidex) four times a day for 4 weeks) or no additional lubricant drops in addition to the usual medications described above

Eligibility criteria: Inclusion Criteria:

* Bilateral or unilateral cataracts requiring surgical intervention
* Age over 18 years
* Able to understand informed consent and the objectives of the trial
* Not pregnant, not breast feeding
* No previous eye surgery

Exclusion Criteria:

* age-related macula degeneration
* glaucoma
* previous retinal vascular disorders
* previous retinal detachment or tear
* any neuro-ophthalmological condition
* any inherited retinal disorder or pathology
* previous strabismus surgery or record of amblyopia
* previous TIA, CVA or other vaso-occlusive disease
* already enrolled in another study

Primary outcomes:
measure: Patient Satisfaction (CatPROM 5)
timeFrame: 6 weeks
measure: Self-reported Health Outcome
timeFrame: 6 weeks
measure: Patient Reported Symptoms (Speed II questinnaire)
timeFrame: 6 weeks
Secondary outcomes:
measure: Visual Acuity
timeFrame: 6 weeks
measure: Cornea and Conjunctival Staining Scores
timeFrame: 6 weeks
measure: Schirmer 1 test
timeFrame: 6 weeks
measure: Tear Break up Time
timeFrame: 6 weeks
measure: Cataract incision site and size
timeFrame: 6 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Thomas' Hospital NHS Trust London
Study officials:
References:
Clinical trial NCT03734835: The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome
Official title: The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome and Its Components: A Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of Hesperidin, flaxseed and both together in patients with metabolic syndrome, 100 patients will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and 30 gram flaxseed) for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, metabolic factors will be assessed and compared between groups.


Eligibility criteria: Inclusion Criteria:

* Age of 18 to 70 years
* having 3 of 5 of high blood sugar, hypertension, high TG, high waist circumference, low HD

Exclusion Criteria:

* pregnancy or lactation
* history of Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
* Following a program to lose weight in recent 3 mo

Primary outcomes:
measure: Metabolic syndrome: Number of participants with treated metabolic syndrome
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
state: Iran (the Islamic Republic Of)
Study officials:
References:
Clinical trial NCT04002635: Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS)
Official title: Endometrial Preparation Using Letrozole Compared to Artificial Cycle for Frozen Embryo Transfer in PCOS Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Infertility, Female
Polycystic Ovary Syndrome
IVF
Ovulation Disorder
Keywords: frozen embryo transfer
Lead sponsor: CRG UZ Brussel
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2019-06-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To offer patients with oligomenorrhoea or amenorrhoea an alternative to frozen embryo transfer in an artificial cycle, endometrial preparation using letrozole may be a valuable option. Letrozole, a potent, reversible nonsteroidal aromatase inhibitor with relatively short half-life, can successfully induce ovulation without any adverse anti-estrogenic effects and thus without affecting the endometrium. The use of letrozole typically results in monofollicular growth and this reduces the effect of supraphysiological levels of estrogen on the endometrium and embryo. The purpose of this study is to compare a frozen-thawed embryo transfer in an artificial cycle with a letrozole-induced ovulatory cycle, specifically in PCOS patients. The primary outcome is early pregnancy loss.


Eligibility criteria: Inclusion Criteria:

* Age more than or equal to 18 and less than or equal to 40
* BMI more than or equal to 18 and less than or equal to 35
* Diagnosis of PCOS according to Rotterdam criteria
* Normal gynaecological ultrasound \< 6 months before inclusion
* Signed informed consent form
* Day 5 or 6 frozen-thawed embryo transfer, blastocyst stage

Exclusion Criteria:

* Recurrent implantation failure
* Recurrent miscarriage
* Presence of adenomyosis
* Untreated intrauterine pathology
* rAFS (revised American Fertility Society) Grade III or IV endometriosis
* Hydrosalpinx
* In vitro maturation (IVM)
* Untreated autoimmune disorders
* (History of) malignancy
* Allergy or reaction to the use of progynova, utrogestan and/or letrozole in the past
* Pre-implantation genetic testing (PGT)

Primary outcomes:
measure: early pregnancy loss
timeFrame: 12 weeks after frozen embryo transfer
Secondary outcomes:
measure: cancellation rate
timeFrame: 2 months
measure: number of visits to the clinic
timeFrame: 2 months
measure: endometrial thickness on the day of planning of FET
timeFrame: 1 day
measure: implantation rate
timeFrame: 1 day
measure: biochemical and clinical pregnancy rate
timeFrame: 12 weeks
measure: live birth rate
timeFrame: 1 year
measure: neonatal birth weight
timeFrame: 1 year
measure: term of delivery
timeFrame: 1 year
measure: hypertensive disorders of pregnancy
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00566735: The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning
Official title: The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depression
Bipolar Depression
Schizoaffective Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil Janssen Scientific Affairs, LLC
First posted: 2007-12-04
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to see if galantamine HBr (Razadyne) is safe and can help treat problems with thinking and memory caused by electroconvulsive therapy (ECT).


Eligibility criteria: Inclusion Criteria:

* Criteria to enter the study include males and females between the ages of 18-90 (females must be post menopausal) and a DSM-IV diagnosis of Major Depressive Disorder, Major Depressive Disorder with psychotic features, Bipolar Disorder, depressed type, or Schizoaffective Disorder, depressed type (19).

Exclusion Criteria:

* DSM-IV diagnoses of dementia and its subtypes
* Substance use disorder (active use within the last 6 months)
* Organic mental disorders; seizure disorder
* Unstable physical disorder or physical disorder judged to significantly affect the central nervous system function
* A heart rate of \<60
* A systolic blood pressure \< 90
* Heart block
* Pre-existing sick-sinus
* Chronic treatment with beta blockers
* Any cardiac arrythmia
* Hypotension
* Coronary artery disease
* Liver and renal function impairment
* Urge incontinence, colitis Crohn's disease, GI motility disorders, asthma and COPD
* Treatment with anti-cholinergic and cholinomimetic medications; and
* Female patients who are pregnant.
* Additionally, women subjects must be postmenopausal, surgically sterile, or using prescription oral contraceptives (e.g. estrogen-progestin combinations) , contraceptive implants (e.g. NorplantTM, DepoProveraTM ), or transdermally delivered contraceptives (Ortho EvraTM) before entry and throughout the study; and have a negative serum b-HCG pregnancy test at screening.

Note: Abstinence and the use of double barrier contraceptive methods are not acceptable in this study.

Primary outcomes:
measure: Number of Side Effects
timeFrame: Participants were followed for the duration of hospital stay, an average of 3 weeks
Secondary outcomes:
measure: Cognitive Functioning
timeFrame: Participants were questioned at baseline and after their last electroconvulsive therapy treatment
measure: Baseline Depressive Symptoms
timeFrame: Participants were questioned at baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: John D Matthews, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05099835: Ultrasound-Guided Stellate Ganglion Block With Botulinum
Official title: Ultrasound-Guided Stellate Ganglion Block With Botulinum Toxin Versus Steroid in Refractory Bell's Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Change From Baseline House-Brackmann
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the local stellate ganglion block with bupivacaine and corticosteroid treatment for acute peripheral facial nerve palsy in patients can induce hyperglycemia, and an alternative local therapy may be necessary and some time may ve ineffective. Our purpose in this study is to evaluate therapeutic effects of stellate ganglion block (SGB) Botulinum Toxin on referactory facial nerve palsy

Detailed description: :Idiopathic facial nerve palsy (Bell's palsy) is caused by damage to the facial nerve at any site of the peripheral branches after the facial nucleus.Stellate ganglion block is inteneded to increase blood flow and promotes nerve regeneration. the local stellate ganglion block with bupivacaine and corticosteroid treatment for acute peripheral facial nerve palsy in patients can induce hyperglycemia, and an alternative local therapy may be necessary and some time may ve ineffective. Our purpose in this study is to evaluate therapeutic effects of stellate ganglion block (SGB) Botulinum Toxin on referactory facial nerve palsy

Eligibility criteria: Inclusion Criteria:

* Diagnosed by clinical and neurological assessment as one-sided idiopathic facial palsy
* Age 18 to 60 •-ASA i-II

Exclusion Criteria:

* Exclusion Criteria:

  * diabetic
  * coagulation dysfunction
  * mental or cognitive dysfunclion
  * allergy to injected medication

Primary outcomes:
measure: Change from Baseline House-Brackmann
timeFrame: : Baseline ,change from baseline House-Brackmann at 7th day,one month,two month, three month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
Clinical trial NCT06033235: Computed Tomography Scanning in ICU
Official title: Impact of Computed Tomography Scanning on ICU Patient Management: Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CT Scans in the Intensive Care Unit
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent CT examinations during hospitalization in the intensive care unit for any etiology, from January 2020 to January 2023.

-

Brief summary: Patients admitted to the intensive care unit often require CT imaging. Performing this diagnostic test on a critically ill patient involves risks, such as those associated with transferring a ventilated and unstable patient and those associated with the injection of intravenous contrast material. Also, multiple CT examinations may create a burden on the X-ray institute and the medical staff, result in the postponement of CT examinations for other patients, as well as increase hospitalization costs.

In this work, we would like to check the rate of complications involved in performing a CT scan in patients hospitalized in the general intensive care unit of our institution, while analyzing the differences between the times the test is performed (morning, night shift), as well as examine in what percentage of the CT scans the test performed contributed to a significant progress in the diagnosis or a significant change in the treatment plan of the patient, while referring to subgroups (sepsis, trauma, respiratory failure, with an emphasis on covid patients, patients with scoliosis, patients with intracranial pathology).


Eligibility criteria: Inclusion Criteria:All patients who underwent CT examinations during hospitalization in the intensive care unit for any etiology, from January 2020 to January 2023.

-

Exclusion Criteria:Patients who did not meet the above criteria or for whom data were missing.

-

Primary outcomes:
measure: Change in diagnosis and/or patient management
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT04617535: Compassionate Use of REGN-COV2 for the Treatment of COVID-19
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: COVID-19
Keywords: Post-exposure
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-11-05
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Compassionate Use requests will be considered for individuals who test positive for SARS-CoV-2 and where there is reasonable basis to believe that the patient is infected with a susceptible variant.

Detailed description: Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.


Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.