louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03858387: PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients
Official title: Pharmacokinetics/Pharmacodynamics and Clinical Outcomes of β-lactams in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Bacterial Infections
Keywords: pharmacokinetics
pharmacodynamics
meropenem
imipenem
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 102
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: Critically ill patients

Brief summary: Meropenem and imipenem are broad-spectrum carbapenem antibiotic and are frequently prescribed in critically ill patients with severe infections. These patients show several pathophysiological changes that may alter the carbapenem pharmacokinetic (PK) normally found in other populations. Although the PK of carbapenems has been widely studied, most studies have been conducted on small populations, and clinical outcome data are sparse. Therefore, the aims of this study are (i) describe the population pharmacokinetic parameters of meropenem and imipenem in critically ill subject (ii) evaluate the pharmacodynamic of meropenem and imipenem as a predictor of clinical treatment outcome.


Eligibility criteria: Inclusion Criteria:

* age \>18 years
* severely ill patient who admitted to medical or surgical intensive care unit who require a treatment with meropenem or imipenem antibiotic

Exclusion Criteria:

* severe renal impairment and require renal replacement therapy
* APACHE II score \>30
* History of hypersensitivity to carbapenems
* Pregnancy or breast-feeding female

Primary outcomes:
measure: Population pharmacokinetic parameters of meropenem and imipenem
timeFrame: 24-48 hours after treatment
measure: %fT>MIC of meropenem and imipenem
timeFrame: 24-48 hours after treatment
Secondary outcomes:
measure: The relationship between %fT>MIC and clinical cure
timeFrame: Day 3-7 after treatment and end of therapy (7-14)
measure: The relationship between %fT>MIC and microbiological cure
timeFrame: Day 3-7 after treatment and end of therapy (7-14)
measure: The relationship between %fT>MIC and mortality
timeFrame: during hospital stay and at day 28
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University, Thailand
state: Songkla
Study officials:
affiliation: Faculty of Medicine, Prince of Songkla University, Thailand
name: Sutep Jaruratanasirikul, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaruratanasirikul S, Boonpeng A, Nawakitrangsan M, Samaeng M. NONMEM population pharmacokinetics and Monte Carlo dosing simulations of imipenem in critically ill patients with life-threatening severe infections during support with or without extracorporeal membrane oxygenation in an intensive care unit. Pharmacotherapy. 2021 Jul;41(7):572-597. doi: 10.1002/phar.2597. Epub 2021 Jun 18.
Clinical trial NCT01728987: The Significance of Vitamin D Storage in Adipose Tissue
Official title: The Significance of Vitamin D Storage in Adipose Tissue
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Obesity
Lead sponsor: University of Tromso
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study will examine the role of adipose tissue in vitamin D physiology, particularly its role as a depot. the study is randomized double blind and placebo controlled.

Detailed description: vitamin d versus placebo will be given for 12 months. Biopsies will be taken at baseline and every 6 month for 2 years. Blood samples will be collected every 6th month. the study will thus give information on storage during vitamin d supplementation as well as use of vitamin d fat stores after stopping vitamin D supplementation

Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* hypercalcemia
* pregnancy
* women without safe contraception

Primary outcomes:
measure: vitamin D in adipose tissue biopsies
timeFrame: 12 months
Secondary outcomes:
measure: rate of decline of 25ohd in serum
timeFrame: 12 months
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University of Tromsø
Study officials:
affiliation: University of Tromsø, Norway
name: rolf jorde, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00912587: Effect of Ghrelin on Sympathetic Nervous System
Official title: Effect of Ghrelin on Sympathetic Nervous System and Stress Reactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Obesity
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Ghrelin is a newly discovered peptide that is secreted by the stomach. Its main role is to stimulate food intake but recent studies indicate that it also acts on the cardiovascular system to confer beneficial effects. The mechanism of action is unclear but experimental studies suggest that ghrelin decreases the sympathetic nervous system. Beside there is new evidence in animal models that ghrelin may also be involved in stress reaction as ghrelin injection seems to protect against symptoms of stress. Given that circulating levels of ghrelin are reduced in obesity, this suggests that the effect of ghrelin may differ between lean and obese subjects. Ghrelin could represent an attractive therapeutic strategy for the treatment of cardiovascular diseases. The aim of the study if to gain more knowledge of the effect of ghrelin on the sympathetic nervous system and stress reactivity in both lean and obese subjects.

Detailed description: This study will investigate the effect of intravenous administration of ghrelin on blood pressure, heart rate, muscle sympathetic nervous activity and baroreflex control in lean and obese individuals and will investigate whether ghrelin administration can influence the response to stress. Both lean and obese individuals will be recruited and will receive an intravenous administration of ghrelin at increasing doses for 1 hour. Their blood pressure, heart rate and sympathetic activity (small recording electrode in the peroneal nerve) will be recorded and subjects will be submitted to a mental arithmetic stress towards the end of the infusion. Blood samples will be taken at regular intervals for various metabolic tests. These responses will be compared to those when submitted to saline infusion.

Eligibility criteria: Inclusion Criteria:

* healthy lean subjects with a BMI \< 25 kg/m2 and subjects with central obesity (according to IDF definition)

Exclusion Criteria:

* any current medication
* a history of diabetes
* hypertension
* cardiovascular, cerebrovascular, liver, thyroid disease
* mental illness

Primary outcomes:
measure: Sympathetic nervous activity
timeFrame: 60 min
Secondary outcomes:
measure: blood pressure
timeFrame: 60 min
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred & Baker Medical Unit
state: Victoria
Study officials:
References:
Clinical trial NCT00004387: Phase II Double Blind Controlled Trial of Nigral Grafting in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Parkinson disease
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Icahn School of Medicine at Mount Sinai
First posted: 1999-10-19
Enrollment: 34
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the effectiveness of fetal nigral transplantation in patients with Parkinson's disease.

Detailed description: PROTOCOL OUTLINE: This is a placebo controlled, randomized, double blind study. Patients are randomly assigned to 1 of 3 treatment groups. All patients receive 2 separate operations in which the substantia nigra from either 4 fetuses (Group A) or 1 fetus (Group C) is implanted into the striatum of each side.

Group B patients receive 2 separate placebo operations without fetal transplantation.

The second surgical procedure begins approximately 1 week after the first operation.

After 2 years, treatments are compared. If transplant is shown to benefit Parkinson's disease, then patients who received placebo operation will be offered transplant surgery in the final year of the study.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Advanced Parkinson's disease Hoehn-Yahr stage IV or worse during "off" periods Hoehn-Yahr stage III or better during "on" periods Predictable motor fluctuations with at least 20% of waking day in the "off" stage No atypical parkinsonism or secondary parkinsonism --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Stable doses of levodopa/carbidopa or any other antiparkinson therapy for 2 months prior to study Surgery: No previous intracranial/neurosurgical procedures --Patient Characteristics-- Renal: Creatinine clearance at least 70 mL/min or creatinine no greater than 1.8 mg/dL Protein no greater than 300 mg/dL Other: Not pregnant or nursing Adequate contraception required of fertile patients Prior history of good response to levodopa No sensitivity to cyclosporine Not HIV positive (e.g., HIV I or II) No human T-cell leukemia/lymphoma virus (HTLV-1) No tremors interfering with stereotactic surgery No clinically significant medical, neoplastic or infectious disease No clinically significant laboratory abnormality No dementia that precludes signing informed consent or score of less than 24 on Mini-Mental status examination

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: C. Warren Olanow
role: STUDY_CHAIR
References:
Clinical trial NCT06142487: Assessment of the Effects of Silk Pillowcases on Acne Prone Skin
Official title: Prospective Double Blinded Randomized Assessment of the Effects of Silk Pillowcases on Acne Prone Skin
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acne Vulgaris
Keywords: acne
non-cystic acne
mild to moderate acne
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
First posted: 2023-11-21
Enrollment: 48
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of using silk pillowcases in mild to moderate non-cystic acne prone skin in comparison to cotton pillowcases.

Detailed description: The investigators will evaluate acne severity/ lesion count, trans-epidermal water loss, and sebum production in participants. There is an equal chance of being assigned a 100% silk pillowcase or 100% cotton pillowcase.

Eligibility criteria: Inclusion Criteria:

* Males and females between the ages of 15-45 years of age
* The presence of mild to moderate acne vulgaris based on investigator global assessment
* Presence of at least 5 inflammatory lesions and at least 5 non-inflammatory lesions

Exclusion Criteria:

* The presence of severe acne as noted by investigator global assessment.
* Those who are unwilling to discontinue systemic antibiotics and benzoyl peroxide for 4 weeks meet the washout criteria prior to enrolling.
* Those who are unwilling to keep their facial regimen consistent throughout the study, and for 1 month prior to enrolling.
* Individuals who are unwilling to wash pillowcase every week using provided detergent.
* Use of isotretinoin within the three months prior to enrolment
* Individuals who primarily sleep on their back
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack year
* Individuals on oral contraceptive pills or progesterone or estrogen containing therapies.
* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study
* Individuals with known allergy or sensitivity to Mulberry Silk or Cotton Fibers in fabric

Primary outcomes:
measure: Acne Lesion Counts: Inflammatory Lesions
timeFrame: 8 weeks
measure: Acne Lesion Counts: Non-Inflammatory Lesions
timeFrame: 8 weeks
measure: Facial Erythema Intensity Score
timeFrame: 8 Weeks
Secondary outcomes:
measure: Transepidermal water loss
timeFrame: 8 Weeks
measure: Sebum Excretion Rate
timeFrame: 8 weeks
measure: Skin Microbiome, relative abundance of C. acnes
timeFrame: 8 Weeks
measure: Skin Hydration
timeFrame: 8 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Study Principal Investigator
name: Raja K Sivamani, MD MS AP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04821687: A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatment of Wearing-off in Patients With PD
Official title: A Randomized, Parallel Group, Multicenter, Prospective, Open-label, Exploratory, Phase 4 Study to Evaluate the Add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Keywords: COMT inhibitor
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 169
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Study to evaluate the add-on efficacy and safety of opicapone 50 mg or an extra dose of L-DOPA 100 mg for the treatment of wearing-off in patients with PD.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (2006) or according to the Movement Disorder Society (MDS) Clinical Diagnostic Criteria (2015).
2. Disease severity Stage III (H\&Y staging) at ON.
3. Treated on a stable regimen for at least four weeks before screening with immediate-release L-DOPA/DDCI, three to four intakes per day, and up to maximum daily dose of 600mg L-DOPA.
4. Signs of wearing-off phenomenon with average total daily OFF-time while awake of at least 1 hour, including the early morning pre-first dose OFF (i.e. the time between wake-up and response to the first L-DOPA/DDCI dosage), despite optimal anti-PD therapy (based on Investigator's assessment).

Exclusion Criteria:

1. Non-idiopathic PD (atypical Parkinsonism, secondary \[acquired or symptomatic\] parkinsonism, Parkinson-plus syndrome.
2. Severe and/or unpredictable OFF periods, according to Investigator judgment.
3. Average total daily OFF-time while awake of \>5 hours, including the early morning pre-first dose OFF, despite optimal anti-PD therapy (based on Investigator's assessment).
4. Treatment with prohibited medication: entacapone, tolcapone, monoamine oxidase (MAO) inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation, rasagiline up to 1 mg/day or safinamide up to 100 mg/day), apomorphine or antiemetics with antidopaminergic action (except domperidone) within the last four weeks before screening.
5. Previous or planned (during the entire study duration) deep brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy).

Primary outcomes:
measure: Hauser's diary
timeFrame: Baseline, at 2 weeks, and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT03953287: Pharmacokinetic Study of Paracetamol.
Official title: Pharmacokinetic/Pharmacodynamic Study of Paracetamol Taken as an Oral Chewing Capsule Versus Normal Tablet in Healthy Young Men.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pharmacological Action
Lead sponsor: Kolding Sygehus
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional (Clinical Trial)
Primary purpose: TREATMENT

Brief summary: Brief Summary:

The study evaluate the absorption rate and pharmacodynamic of different formulation of paracetamol either in the form of normal tablets or a new rapid absorbable gelation capsule formulation "Paracetamol1523" by determining T-max and area under the response curve of paracetamol in blood concentration as well as from clinical effects after intake. Data is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: "The applicant's rights in a biomedical research project

Detailed description: Detailed Description:

Twelve healthy young volunteers are recruited, and the experiments begin at 07:45 after an overnight fast. Clinical data are recorded and a catheter is inserted in an antecubital vein for blood samples.

At 08.00 paracetamol (500 mg) taken as tablet or a "Paracetamol1523" c in random order. Subsequently, blood samples are taken every 3 minute for one hour minutes, then every 10 minutes the following two hours. In addition, blood pressure and puls rate are measured every 10 minute the first hour, and then every 30 minutes.Side effects and time to the participants registrate any effect of the drugs are assessed in a prefabricated scheme.

The disadvantages associated with the experiment are sought monitored by adverse event registration which ends at the end of the trial. The trial day lasts 4 hours in which blood samples are taken as described above, and blood pressure and records are stored .

Eligibility criteria: Inclusion Criteria:

* Normal healthy volunteers
* Must be able to swallow tablets

Exclusion Criteria:

* Diabetes
* Thyroid disease
* any medial treatment

Primary outcomes:
measure: Pharmacokinetic study of paracetamol
timeFrame: 4 hours
Secondary outcomes:
measure: Pharmacokinetic study of paracetamol
timeFrame: 4 hours
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Kolfding Sygehus, SLB
Study officials:
affiliation: Medical Dept.,Kolding Hospital, SLB, Denmark
name: ole Rasmussen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00063687: Oxypurinol Compared With Placebo for Class III-IV NYHA Congestive Heart Failure
Official title: A Phase II-III Prospective, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oxypurinol Added to Standard Therapy in Patients With NYHA Class III-IV Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Congestive Heart Failure
Lead sponsor: Advanz Pharma
Sponsor class: INDUSTRY
First posted: 2003-07-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The OPT-CHF (OxyPurinol Therapy for CHF) study is designed to demonstrate the efficacy and safety of oral oxypurinol vs. placebo in a randomized, double-blind, twenty-four week trial in 400 patients in up to 50 centers. Measures of clinical efficacy (NYHA class and Patient Global Assessment) as well as clinical outcomes (e.g., death, worsening heart failure, and hospitalization) will be assessed as a composite endpoint in this trial.


Eligibility criteria: Inclusion criteria

* 18-85 years old,
* Stable NYHA Class III-IV
* Hospitalization or ER visits in past 18 months for worsening Heart Failure (or addition of new heart failure medication added to regimen due to lack of stability on current regimen.
* EF =\< 40%

Exclusion criteria

* Any condition (other than CHF) that could limit exercise
* Any concurrent disease likely to limit life expectancy.
* Participation in another clinical trial
* Primary valvular disease, active myocarditis, or an obstructive or restrictive cardio-myopathy
* Heart Attack, Stroke, Unstable Angina or Cardiac surgery within previous 3 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Carr-Dzindzio Cardiology
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: New York
country: United States
facility: Saint Vincents Hospital and Medical Center
state: New York
Study officials:
affiliation: Johns Hopkins University
name: Joshua Hare, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hare JM, Mangal B, Brown J, Fisher C Jr, Freudenberger R, Colucci WS, Mann DL, Liu P, Givertz MM, Schwarz RP; OPT-CHF Investigators. Impact of oxypurinol in patients with symptomatic heart failure. Results of the OPT-CHF study. J Am Coll Cardiol. 2008 Jun 17;51(24):2301-9. doi: 10.1016/j.jacc.2008.01.068.