louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03319914: Observational Follow-up to ST-001 Calciphylaxis Pain Treatment With Intravenous Sodium Thiosulfate
Official title: Observational Follow-up to ST-001 Calciphylaxis Pain Treatment With Intravenous Sodium Thiosulfate
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Calciphylaxis
Keywords: calciphylaxis, calcific uremic arteriolopathy,
calcium metabolism disorders
metabolic diseases
sodium thiosulfate
Lead sponsor: Hope Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-10-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those calciphylaxis patients that previously participated in the ST-001 CALISTA study (A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial).

Brief summary: This is an 8-week observational follow-up study of patients who participated in the ST-001 CALISTA study (A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial).

Detailed description: This is an 8-week observational follow-up study of patients who participated in the ST-001 CALISTA study. In this ST-003 (OF-CALISTA) study, the occurrence of delayed adverse events, standard of care treatments for calciphylaxis (medications \[including Sodium Thiosulfate Injection and pain medication\], wound debridement, amputation, hyperbaric oxygen therapy, and surgical parathyroidectomy), and calciphylaxis-related complications (new or worsening skin lesions, ulceration, infection, sepsis and hospitalizations) will be recorded during an 8-week observation period following patient participation in the ST-001 CALISTA study (A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial).

Eligibility criteria: Inclusion Criteria:

* Previously enrolled as a patient in ST-001 CALISTA study
* Willing to provide written informed consent
* Willing and able to adhere to all study-related procedures
* Willing to authorize release of medical records
* Willing to authorize collection of medical data from health care providers
* Provide email, home address and phone number where he/she can be reached

Exclusion Criteria:

• Patient did not participate in ST-001 CALISTA study

Primary outcomes:
measure: Observation of delayed adverse events, standard of care treatments for calciphylaxis following participation in ST-001
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Albany
country: United States
facility: Veterans Administration Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Hope Pharmaceuticals
name: Craig Sherman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01653314: Megavec 400 mg (Imatinib Mesylate) in Healthy Adult Male Volunteers
Official title: A Randomized, Open-label, Single Dose, 2-Treatment, 2-Period, 2-Way Crossover Study to Assess Safety and Pharmacokinetics of Megavec 400 mg (Imatinib Mesylate) Under Fasted Conditions 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: 2012-07-31
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this Study is to Assess Safety and Pharmacokinetics of megavec 400 mg (Imatinib mesylate) under Fasted Conditions in Healthy Male Subjects.


Eligibility criteria: * Inclusion Criteria:

  * Healthy and male subjects aged 20 to 55 years
  * The subject has a Body weight ≥55 kg and ideal body weight (IBW) within ±20%
  * A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
  * A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints.
* Exclusion Criteria:

  * A subject with sign or symptoms or previously diagnosed disease of respiratory, cardiovascular, endocrinology, liver, kidney, hematology, neurology and psychology function or other significant diseases and history
  * Known allergy or hypersensitivity to the study medication
  * AST or ALT greater than 1.25 times the upper limit of reference range or Total bilirubin greater than 1.25 times the upper limit of reference range base on screening results
  * A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests

Primary outcomes:
measure: Safety
Secondary outcomes:
measure: Pharmacokinetics
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04931914: Antibiotic Regimens Tailored by Clinical Pharmacist Suppored by Intensivist Enhanced Rational Use of Antibiotics
Official title: Antibiotic Regimens Tailored by Clinical Pharmacist Suppored by Intensivist Enhanced Rational Use of Antibiotics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the information including the age, gender, comorbidity (presented as Charlson comorbidity index score ), surgical procedure done, patients' temperature, white blood cells count, type of infection (e.g., pneumonia, wound infection, Urinary tract infection,.....), prescribed antibiotics regimen either they will use empirical or based on cultures, results of culture sensitivity tests, length of stay, and mortality of patients

Brief summary: adding pharmaceutical services to patient care and changing the professional activity of pharmacists from drug-focused to patient-oriented care,in the current study, clinical pharmacists will be assigned to monitor pharmacotherapy regimens, participate in patient care, and cooperate in educating the staff and evaluating care.

Detailed description: During the intervention period, the pharmacist attended daily unit rounds with ICU intensivist with a focus on optimization of antibiotic regimens. Pharmacist consultative services were also available by phone calls 24 hours x 7 days if needed. For every patient surgical prophylactic antibiotic initiated immediately before surgery and continued for 48 hours following surgery. Antibiotic therapy had given as either directed or empiric. Directed therapy was defined as treatment of a documented infection based on culture and sensitivity. Empiric therapy was defined as any antibiotic therapy administered when no documented infection was present, and the patient had clinically suspected infection following surgery. Empiric antibiotic administration was required in majority of our SICU patients. Antibiotics had given after exclusion of allergy by history and intradermal sensitivity test.

Eligibility criteria: Inclusion Criteria:

* all admitted patients to the ICU between age 18-80 years old

Exclusion Criteria:

* Patient admitted for less than 24 hours (including deaths and transfers) will be excluded from the study.

Pediatric patients weighted less than kilograms.

Primary outcomes:
measure: Antibiotics consumption
timeFrame: 1 year
measure: Average length of stay
timeFrame: 1 year
measure: Mortality rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
Study officials:
References:
Clinical trial NCT05922514: A Clinical Registry of Spontaneous Intracranial Hypotension
Official title: Spontaneous Intracranial Hypotension Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spontaneous Intracranial Hypotension
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being seen at Mayo Clinic in Rochester, Minnesota, for spontaneous intracranial hypotension (SIH) treatment evaluation by a neurologist with expertise in SIH. Patients would then be scheduled to meet with vascular radiology interventionalist for treatment (discussion and treatment(s) planning/scheduling purposes per standard of care. Patients would then speak with the study's coordinator to see if they would be interested to participant with and enroll in this study prior to SIH treatment.

Brief summary: The purpose of this research is to determine the efficacy of paraspinal vein embolization for treatment of digital subtraction myelography (DSM) or CT myelography (CTM) confirmed cerebrospinal fluid (CSF)-venous fistulas so that researchers can inform the development and design of future clinical trials of this technique.


Eligibility criteria: Inclusion Criteria:

* Study subjects will be patients who meet the International Classification of Headache - Disorders 3rd Edition (ICHD-3) criteria for a diagnosis of SIH or the Schievink criteria with imaging confirmed CSF-venous fistulas on DSM or CTM.
* Availability of a clinically prescribed contrast enhanced MRI positive for SIH.
* Negative urine or serum pregnancy test at time of study consent and three-months.

Exclusion Criteria:

* Patients who have a contraindication or inability to undergo the procedure (i.e., severe contrast allergy).
* Inability to provide informed consent.
* Expected inability to complete the follow-up assessment.
* Current pregnancy or breast-feeding during study enrollment (from consent to study conclusion approximately 90-days).

Primary outcomes:
measure: Change in Headache Impact Test (HIT-6)
timeFrame: Baseline, 3 months
measure: Change in Bern SIH MRI Score
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in Pain Numerical Rating Scale (NRS)
timeFrame: Baseline, 3 months
measure: Change in Migraine Disability Assessment (MIDAS)
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Waleed Brinjikji, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04326114: Effectiveness and Safety of Respiratory Training in the Prevention and Severity of COVID-19
Official title: Effectiveness and Safety of Respiratory Training Devices in the Prevention and Severity of COVID-19: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disease, Infectious
Respiratory Disease
Safety Issues
Effectiveness
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Drugs
* Surgery
* Neurology diseases
* Rheumatic diseases
* Systemic diseases
* Smokers

Primary outcomes:
measure: COVID-19 disease diagnosis
timeFrame: Change from Baseline COVID-19 disease diagnosis at 8 weeks
Secondary outcomes:
measure: COVID-19 disease symptoms severity
timeFrame: Change from Baseline COVID-19 disease symptoms severity at 8 weeks
measure: Adverse effects
timeFrame: Change from Baseline adverse effects at 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02161614: Vascular Effect of Estradiol Valerate Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
Official title: Flow-mediated Evaluation of the Brachial Artery of Climacteric Women Using Estradiol Valerate and Placebo. Randomized, Double Blinded, Placebo Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flow-mediated Dilation Evaluation of the Brachial Artery
Keywords: hormone replacement therapy
Dopplervelocimetry
Flow-mediated dilation
menopause
Estradiol valerate
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
First posted: 2014-06-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the vascular effects of estradiol valerate on climacteric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.

Detailed description: The interruption of the secretion of sex steroids that occurs after menopause, determines a change in vascular pattern at various levels. As a result, several side effects might appear and interfere with women's quality of life and health. The use of hormone replacement therapy has contributed to the improvement in these effects. It has been observed vascular beneficial effects of sex steroids in premenopausal women, and of hormone replacement therapy (HRT) in climacteric women, on the central retinal arteries. The objective of this study is to evaluate the effects of estradiol valerate on flow-mediated dilation of the brachial artery.

Eligibility criteria: Inclusion Criteria:

* Women without menstrual cycles within the last 12 months and follicle stimulating hormone (FSH)\>30International Units / Liter
* Healthy women
* Women that were not using drugs with potential vascular effect within the last 1 year
* Women that never used hormone replacement therapy

Exclusion Criteria:

* Smoking
* Blood Pressure \> 160/90 mm Hg.
* Breast and or endometrial cancer
* History of acute myocardial infarction
* Diabetes
* Vaginal bleeding of any origin
* Hepatic disease
* thrombophlebitis or thromboembolic disorders

Primary outcomes:
measure: Flow-mediated dilation of the brachial artery
timeFrame: 30 days after treatment started
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital das Clinicas - Universidade Federal de Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Selmo Geber, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Faria AF, de Souza MA, Geber S. Vascular resistance of central retinal artery is reduced in postmenopausal women after use of estrogen. Menopause. 2011 Aug;18(8):869-72. doi: 10.1097/gme.0b013e31820cc60c.
Clinical trial NCT04683614: Intraoperative Norepinephrine Versus Fresh Frozen Plasma in Patients Undergoing HIPEC to Reduce Renal Insult
Official title: Intraoperative Norepinephrine Versus Fresh Frozen Plasma in Patients Undergoing HIPEC to
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: comparing the effect of low dose norepinephrine infusion versus fresh frozen plasma in patients undergoing HIPEC to reduce renal insult

Detailed description: To compare the efficacy of maintaining intraoperative hemodynamic stability through infusing low dose norepinephrine versus fresh frozen plasma in patients undergoing cytoreductive surgery and heated intraperitoneal chemotherapy in cancer patients undergoing cytoreductive surgery and heated intraperitoneal chemotherapy

Eligibility criteria: Inclusion Criteria:

* ASA I and II
* World Health Performance Status ≤2
* scheduled for CRS/HIPEC operations

Exclusion Criteria:

* patient's refusal
* allergy to any of the used drugs
* impaired renal or liver functions

Primary outcomes:
measure: Renal insult
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Walaa Y Elsabeeny
Study officials:
affiliation: Lecturer
name: Walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04384614: Covid-19 In Tunisia: An Observational Cross-Sectional Registry Study
Official title: Covid-19 In Tunisia: An Observational Cross-Sectional Registry Study Multicentric Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Covid 19
BCG Vaccination
Keywords: covid 19
BCG Vaccination
Lead sponsor: Direction des Soins de Santé de Base
Sponsor class: OTHER_GOV
Collaborators: name: Eshmoun Clinical Research Center
name: Dacima Consulting
First posted: 2020-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 400 Patients will be included between COVID19 (+) and COVID19 (-) patients who have been in contact with COVID19 (+)

Brief summary: Covid-19 In Tunisia: AN Observational Cross-Sectional Registry Study


Eligibility criteria: Inclusion Criteria:

* COVID-19 (+), inpatient or outpatient, confirmed by PCR test
* COVID-19 (-) confirmed by PCR test having been in contact with COVID-19 (+)

Exclusion Criteria:

* COVID(+) and COVID(-) diagnosed by other tests than PCR
* COVID-19 (-) Not having been in contact with COVID19(+)

Primary outcomes:
measure: Differences related to epidemiological demographic characteristics
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Eshmoun Clinical Research Centre
Study officials:
affiliation: Hopital Abderrahmane Mami
name: Agnès Hamzaoui, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04205214: A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia
Official title: A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alopecia
Keywords: Cognitive Behavioural Therapy
Mindfulness
Narrative Therapy
Alopecia Areata
Alopecia Universalis
Alopecia Totalis
Psychology
Health Psychology
Lead sponsor: City, University of London
Sponsor class: OTHER
Collaborators: name: Royal Free Hospital NHS Foundation Trust
First posted: 2019-12-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Randomised Control Trial (RCT) aims to test a novel Alopecia-tailored, protocolled, integrative individual psychological intervention offered to patients with enduring Alopecia. The pilot study aims to assess the impact of the intervention on 8 patients, by assessing changes in their psychological and physical symptoms (stress, anxiety, depression, quality of life, scalp hair, and other bio-markers) compared to 7 patients in the wait-list control group.

Detailed description: Alopecia is a stress-related auto-immune skin condition that results in hair-loss on the scalp and around the body. This pilot RCT aims to test a newly developed Alopecia-specific, psychological intervention with 8 patients diagnosed with enduring Alopecia. The intervention is an Integrative Cognitive Behavioural Therapy, implemented through a protocolled programme entailing 12 weeks of hourly individual sessions. The trial will be delivered at The Dermatology Department at the Royal Free Hospital in Hampstead, London. The pilot study aims to evaluate the impact of the intervention on patients' psychological and physical symptoms (stress, anxiety, depression, quality of life, scalp hair, and other bio-markers) compared to the wait-list control group.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Alopecia received by medical profession over 1 year prior to beginning trial
* Fluent in Written and Verbal English

Exclusion Criteria:

* Another more dominant skin condition
* Another more dominant severe and enduring mental illness
* Women who are pregnant
* Learning difficulties, brain injuries or dementia
* Drug and alcohol dependency
* Received therapy in the last year

Primary outcomes:
measure: Hospital Anxiety And Depression Scale (HADS)
timeFrame: 12 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: 12 weeks
measure: Dermatology Life Quality Index (DLQI)
timeFrame: 12 weeks
measure: Severity of Alopecia Tool (SALT) Scalp Assessment
timeFrame: 12 weeks
measure: Blood Test
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical Measures
timeFrame: 12 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: Royal Free Hospital NHS Foundation Trust
name: Sharon Hart, Doctorate
role: PRINCIPAL_INVESTIGATOR
References: