louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02446977: Administration of CBG000592 (Riboflavin/Vitamin B2) in Patients With Acute Ischemic Stroke
Official title: Randomized Clinical Trial to Investigate Whether Administration of CBG000592 (Riboflavin/Vitamin B2) in Patients With Acute Ischemic Stroke Causes a Reduction of Glutamate-mediated Excitotoxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Stroke
Keywords: ischemic
stroke
vitamin B2
Lead sponsor: Castillo, José, M.D.
Sponsor class: INDIV
First posted: 2015-05-18
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: Administration of CBG000592 (riboflavin/vitamin B2) in patients with acute ischemic stroke to know if it causes a reduction of glutamate-mediated excitotoxicity.

Detailed description: The investigators hypothesis focuses on the effect of riboflavin given for the first three hours of ischemic stroke, as a reducing agent of cerebral glutamate concentration. This administration would produce a reduction of excitotoxic damage and consequently generate clinical improvement, while a lower income and a better functional outcome of patients at three months.

Eligibility criteria: Inclusion Criteria:

1. Patients older than 18 years, both men and women.
2. Patient or legal representative able to understand and sign the informed consent.
3. Patients with suspected stroke within 3 hours of onset.

Exclusion Criteria:

1. Women of childbearing age, with potential for pregnancy or breastfeeding.
2. Patients with a score ≥ 2 point 1a in the NIHSS scale.
3. Scale pre-stroke modified Rankin ≥ 2.
4. Inability to prior testing image needed for the study.
5. Previous disorders that may interfere with the interpretation of neurological scales.
6. Treatment with probenecid, tricyclic antidepressants, phenothiazines, streptomycin, erythromycin, tyrothricin, tetracyclines and carbomycin, at the time of inclusion.

Primary outcomes:
measure: Reduction of serum glutamate concentration
timeFrame: 7 hours
Secondary outcomes:
measure: Days of hospitalisation
timeFrame: 3 months
measure: Percentage of clinical improvement (basal-high)
timeFrame: 3 months
measure: Functional outcome using Rankin Scale at 90 days
timeFrame: 3 months
measure: Serum glutamate concentrations
timeFrame: 7 hours
measure: Prognosis of patients using Rankin Scale at 90 days
timeFrame: 3 months
measure: Number of participants with Adverse Event
timeFrame: 3 months
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: A Coruña
Study officials:
affiliation: Complejo Hospitalario Universitario de Santiago
name: José Castillo, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03753477: Clinical Trial to Investigate the Efficacy and Safety of DWJ1351
Official title: An Open-label, Randomized, 2X2 Crossover Study to Compare the Pharmacokinetics and Safety Between DWJ1351 and Co-administration of Amlodipine/Olmesartan and Rosuvastatin in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2018-11-27
Enrollment: 64
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers

Detailed description: The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers.

Eligibility criteria: Inclusion Criteria:

* Subject who provided written informed consent to participate in this study
* Healthy adult male subjects aged 19 to 50 years
* Subjects whose body weight ≥ 55 kg and Body Mass Index(BMI) ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2
* Subject who was judged to be healthy and suitable for the participation by the investigator based on screening test results

Exclusion Criteria:

* Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs
* Subjects who had a serious clinical illness that can impact fate of drugs absorption
* Subject who shows vital signs with the number of systolic blood pressure of \>140 mmHg or \<100 mmHg, and the number of diastolic blood pressure of \>90mmHg or \<65mmHg
* Subject who have experienced drug abuse
* Subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month)
* Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication

Primary outcomes:
measure: AUC
timeFrame: [ Time Frame: 0 - 72 hours ]
measure: Cmax
timeFrame: [ Time Frame: 0 - 72 hours ]
Secondary outcomes:
measure: AUCinf
timeFrame: [ Time Frame: 0 - 72 hours ]
measure: Tmax
timeFrame: [ Time Frame: 0 - 72 hours ]
measure: t1/2β
timeFrame: [ Time Frame: 0 - 72 hours ]
measure: CL/F
timeFrame: [ Time Frame: 0 - 72 hours ]
measure: Vdss/F
timeFrame: [ Time Frame: 0 - 72 hours ]
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Busan Paik Hospital
Study officials:
affiliation: Busan Paik Hospital
name: JG Shin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06467877: Causes, Characteristics and Treatment of Hypercalcemia in the Emergency Room of a German Hospital
Official title: Retrospective Analysis of Causes, Clinical Presentation and Treatment in Patients With Hypercalcaemia in the Emergency Department of a Tertiary German Hospital
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypercalcemia
Keywords: hypercalcemia
calcium
emergency room
mortality
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients reporting to the Emergency Room of the University Hospital Cologne and recieved a determination of the total calcium level

Brief summary: Patients with hypercalcemia were identified in the patient population of a German emergency department during a 11 year time period and studied regarding reproducibility of elevated calcium values, causes of hypercalcemia, symptoms. acute renal injury, mortality and treatment response.

Detailed description: Patients, who presented to the emergency department of a tertiary German hospital with a total calcium of ≥2.65 mmol/l between January 2010 and March 2021, was retrospectively studied. From the electronic patient records we analyzed if the elevated calcium values were reproducible in follow-up measurements, identified the cause of hypercalcemia, listed the symptoms, investigated a correlation between calcium and creatinine values to study acute renal injury directly due to hypercalcemia, calculated the mortality rate stratified by the calcium value on presentation and studied the treatment response regarding lowering calcium values by different treatments.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Total calcium ≥ 2.65 mmol/l
* Female and male

Exclusion Criteria:

* Age \< 18 years
* Total calcium \< 2.65 mmol/

Primary outcomes:
measure: Development of total calcium values
timeFrame: 5 days after enrollment
Secondary outcomes:
measure: Reproducibility of elevated calcium values
timeFrame: 5 days after enrollment
measure: Correlation creatinine calcium
timeFrame: 5 days after enrollment
measure: Mortality
timeFrame: 5 days after enrollment
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department II of Internal Medicine,University of Cologne
Study officials:
affiliation: University Hospital of Cologne
name: Volker Burst, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05514977: Ultrasound Guided Thoracic ESPB for Post Mastectomy Pain Control, Comparing 2 Dosing Regimens of Lidocaine With Different Drug Volumes
Official title: Ultrasound Guided Thoracic Erector Spine Plane Block for Post Mastectomy Pain Control, Effect of Volume With Constant Drug Mass, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 82
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: SUPPORTIVE_CARE

Brief summary: The investigators compare 2 different drug regimens using 2 different volumes of lidocaine with the same drug content (i.e. different concentrations) as regards efficacy of post operative analgesia following mastectomy surgery


Eligibility criteria: Inclusion Criteria:

* ASA 2 \& 3 for elective breast cancer surgery

Exclusion Criteria:

* ASA \> 3
* BMI \> 35 kg/m2
* Contraindications to LA (coagulopathy and local infection)
* Allergy to the drug
* Cardiac, hepatic and renal patients

Primary outcomes:
measure: Effective analgesia
timeFrame: First 24 hours
Secondary outcomes:
measure: Analgesic efficiency
timeFrame: Every 2 hours in the first 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Kasr alainy hospital, Cairo University
name: Ahmed Kareem
role: STUDY_DIRECTOR
References:
Clinical trial NCT02506777: Neoadjuvant FDC With Melatonin or Metformin for Locally Advanced Breast Cancer.
Official title: Phase II Multicenter Randomized Study to Compare Neoadjuvant FDC With Melatonin or Metformin Versus FDC Alone in The Therapy of Locally Advanced Breast Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Melatonin, metformin, chemotherapy
Lead sponsor: N.N. Petrov National Medical Research Center of Oncology
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 96
Sex: FEMALE
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 evaluates the addition melatonin and metformin to conventional chemotherapy FDC (Fluoruracil, Doxorubicin, cyclophosphamide) in the treatment of locally advanced breast cancer. Third of patients will receive FDCх6 cycles, other third will receive combination of melatonin and FDCх6 cycles and other patients will receive combination of metformin and FDCх6 cycles.

Detailed description: The treatment of locally advanced breast cancer is a complicated issue. For neoadjuvant treatment is often needed to downstage locally advanced BC tumors prior to surgery, however many patients do not achieved objective response during treatment. The ability of melatonin and metformin to decrease side effects of chemotherapy had been investigated, moreover several studies confirm, that this drugs in combination with conventional treatment may increase objective response. But, this data is still controversial. We hypothesized that combinations of melatonin and conventional chemotherapy regimen such as FDC could be more effective than FDC alone in terms of response rate.

Eligibility criteria: Inclusion Criteria:

* Age \>18. Obtained Inform Consent Morphologically confirmed breast cancer stage IIB, IIIA,IIIB,IIIC. ( triple negative, luminal B) Eastern Collaborative Oncology Group Performance Status Scale 0 - 2. Expected survival \>6 month Adequate liver and bone marrow function

Exclusion Criteria:

* Systemic treatment for breast cancer IV stage disease Evidence of liver and bone marrow clinically meaningful disfunction Severe uncontrolled concomitant conditions and diseases Pregnancy or lactation Second malignancy Diabetes mellitus requiring drug therapy Any condition preventing study participation by investigator opinion

Primary outcomes:
measure: Response rate
timeFrame: 6 months after FPFV
measure: Pathomorphological response
timeFrame: 6 months after FPFV
Secondary outcomes:
measure: Adverse events incidence
timeFrame: Until 30 days after last patient treatment visit
Other outcomes:
Locations:
city: Saint - Petersburg
country: Russian Federation
facility: N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department
Study officials:
affiliation: N.N. Petrov Research Institute of Oncology
name: Vladimir F Semiglazov, MD, PhD, DSc, Professor
role: STUDY_DIRECTOR
affiliation: N.N. Petrov Research Institute of Oncology
name: Tatiana Y Semiglazova
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03520777: A Pilot Study of Creative Arts Interventions for Neurology Inpatients
Official title: A Pilot Study of Creative Arts Interventions for Neurology Inpatients in the Epilepsy Monitoring Unit and the Headache Service
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Migraine
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to assess the feasibility of a Creative Artists Program intervention with epilepsy and headache patients admitted to Dartmouth-Hitchcock Medical Center for care by the Department of Neurology.

Detailed description: Qualifying patients admitted to Epilepsy monitoring or Headache treatment will be approached for participation in the study. Patients who consent to the study will be given a chance to work with one of three creative artists (visual artist, creative writer, therapeutic musician). The artist will be selected according to a pre-determined schedule, and the arts intervention may last up to 90 minutes. Subjects will be asked to complete study questionnaires before and after the arts intervention.

Eligibility criteria: Inclusion Criteria:

1. Age \> or = 18 years
2. Diagnosis of refractory chronic epilepsy, status migrainosus, or chronic daily headache
3. Elective admission to the Dartmouth-Hitchcock Medical Center Epilepsy monitoring unit or Headache service
4. Capable of giving informed consent

Exclusion Criteria:

1. Active psychiatric illness that prohibits safe visitation by artists
2. Impairment of vision or hearing that would prohibit able to participate with participation in instructions necessary for the interventions.
3. Active general medical condition that would impair consciousness.

Primary outcomes:
measure: Feasibility of conducting a creative arts intervention study
timeFrame: Through study completion, approximately 1 year
Secondary outcomes:
measure: Change in patient anxiety before and after the intervention
timeFrame: Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).
measure: Change in patient distress before and after the intervention
timeFrame: Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).
measure: Change in patient depression before and after the intervention
timeFrame: Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).
measure: Change in frequency of as-needed pain medication use
timeFrame: Each patient as-needed medication use will be assessed after the arts intervention and until discharge from the hospital (approximately Day 3 - 21).
measure: Length of hospital stay
timeFrame: Each patient's admission duration (approximately 3 - 21 Days).
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
Clinical trial NCT02816177: Telemedicine and Nursing Home
Official title: Impact of Telemedicine on Avoiding Emergency Hospital Admissions and Hospitalization for Nursing Home Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Multimorbidity
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 428
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Telemedicine-based care provides remote health and social care to maintain people's autonomy and increase their quality of life. The rapidly aging population has come with a significant increase in the prevalence of chronic diseases and their effects, and thus the need for increased care and welfare.

This solutions give a new opportunity for diagnosis, treatment, education, and rehabilitation, and make it possible to monitor patients with a number of chronic diseases. It also reduces socioeconomic disparity with regard to access to care and gives equal chances to patients from urban and rural areas.

This a randomized trial of telemedicine versus usual care alone to reduce hospitalization and emergency hospital admissions for Nursing Home Residents .

After an initial assessment , each participant is monitored by teleconsultation on six occasions over 12 months. Patients with usual care have an initial and a 12 months assessments.


Eligibility criteria: Inclusion Criteria:

* Elderly over 60 years

  * Resident in nursing homes
  * Resident with multiples chronic diseases with at least two comorbidities
  * Having given free and informed consent in writing and signed by himself and / or his legal representative

Exclusion Criteria:

* Resident unaffiliated or not beneficiary of Social Security
* Resident with a life-threatening disease

Primary outcomes:
measure: Efficacy
timeFrame: 12 month
Secondary outcomes:
measure: MAST
timeFrame: 12 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: Service de Gériatrie
Study officials:
affiliation: CHU Limoges
name: Thierry DANTOINE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01145677: Efficacy of Topiramate for Hospitalized Patients With Alcoholism
Official title: Efficacy of Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Randomized, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alcohol Dependence
Keywords: Alcohol dependence
Alcoholism
Topiramate
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2010-06-17
Enrollment: 90
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: This is a 12-Week, randomized controlled study of topiramate in hospitalized patients with alcoholism


Eligibility criteria: Inclusion Criteria:

* patients hospitalized due to alcohol-related problem
* DSM-IV-TR alcohol dependence
* for male: history of alcohol drink \>=35/week, female: history of alcohol drink \>=28/week for at least 1 week during four weeks prior to the admission
* AUDIT score at least 8
* mild or no alcohol withdrawal symptom
* BMI \> 18 kg/m2
* not pregnant and no plan for pregnancy
* intention to decrease or stop drinking

Exclusion Criteria:

* severe psychiatric and cognitive disorders
* other substance dependence, except nicotine and caffeine dependence, during 6 months prior to enrollment
* taking antipsychotics, mood stabilizers, anticonvulsants, opioid analgesics, systemic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram
* unstable medical condition
* medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures
* moderate to high risk of suicide
* under legal process
* plan to receive a formal treatment for alcoholism from other treatment settings
* pregnancy and nursing woman
* abnormal laboratory tests, including blood urea nitrogen, creatinine, electrolytes, and fasting blood sugar

Primary outcomes:
measure: Alcohol drink/day
timeFrame: 12 weeks
Secondary outcomes:
measure: Common adverse effect
timeFrame: 12 week
Other outcomes:
Locations:
city: Maerim
country: Thailand
facility: Chiang Mai Drug Dependence Treatment Center
state: Chiang Mai
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
state: Chiang Mai
city: Muang
country: Thailand
facility: Suanprung Psychiatric Hospital
state: ChiangMai
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
state: ChiangMai
Study officials:
affiliation: Department of Psychiatry, Faculty of Medicine, Chiang Mai University
name: Surinporn Likhitsathian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04478877: Establishment and Characterization of Meningioma Patient-derived Organoids
Official title: Establishment and Characterization of Meningioma Patient-derived Organoids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningioma
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 20
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: Patients with meningioma admitted to Prince Wales Hospitals neurosurgical services

Brief summary: In this study, meningioma organoids will be established from patients' tissues and the characterization of the organoid will be performed.

Detailed description: Aims and Hypothesis to be tested:

The investigators hypothesized that the derived organoid should have a similar morphological and genetic mutation signatures to the patient primary tissue.

Study period: 1 year for patient recruitment and organoid generation from patient tumor

Study population: 30

Study samples:

Patient's meningioma tumor sample are collected from patients with surgical needs. Sample collected are used for organoid culture. Morphological and genetic characteristics will be compared between the patient tumor sample and the corresponding derived organoids

Primary outcome measures:

Whole exome sequencing data of patient tumor tissue and patients-derived organoids

Eligibility criteria: Inclusion Criteria:

1. Adult patients (aged \>18 years) with meningioma
2. Admission into Prince Wales hospitals neurosurgical services
3. Patients with surgical needs of meningioma removal

Exclusion Criteria:

1. Patients (or next-of-kin as appropriate) refuse to participate into the study

Primary outcomes:
measure: Whole exome sequencing data
timeFrame: 7 days
Secondary outcomes:
measure: Immunostaining
timeFrame: 7 days
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Surgery, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: George KC Wong
role: PRINCIPAL_INVESTIGATOR
References: