louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00166842: Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets
Official title: Effects of Conversion From Sirolimus Oral Solution to Tablets in Renal Transplant Recipients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Transplantation
Kidney Transplantation
Immunosuppression
Keywords: Pharmacokinetics
Sirolimus
Cyclosporine
Tacrolimus
Immunosuppressive Agents
Immunosuppression
Transplantation
Kidney Transplantation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to understand the pharmacokinetics of sirolimus tablets in different regimens in newly renal transplant patients, and the effect of dosage form conversion on the concentration of sirolimus in stable renal transplant patients. So that we can design a better tacrolimus or cyclosporine/sirolimus/steroid dose regimen for Taiwanese.

Detailed description: Sirolimus tablets will be available more than one year after the launch of sirolimus solution. Most patients on sirolimus solution will use sirolimus tablet instead.

The purpose of this study is to understand the pharmacokinetics of sirolimus tablets in different regimens in newly renal transplant patients, and the effect of dosage form conversion on the concentration of sirolimus in stable renal transplant patients. So that we can design a better tacrolimus or cyclosporine/sirolimus/steroid dose regimen for Taiwanese.

Eligibility criteria: Inclusion Criteria:

* ages of 18 and 65, renal transplant patients

Exclusion Criteria:

* pregnancy, tuberculosis, hepatitis B or C carrier status, human immunodeficiency virus-positive status, retransplantation or multiorgan transplantation, or history of rheumatoid arthritis before transplantation

Primary outcomes:
measure: Pharmacokinetics of sirolimus tablets in different regimens in de novo renal transplant patients
measure: Effect of dosage form conversion on sirolimus concentration in stable renal transplant patients.
Secondary outcomes:
measure: Effectiveness of different sirolimus dose regimens in rejection prevention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Po-Huang Lee, MD PhD
role: STUDY_CHAIR
References:
citation: Wu FL, Tsai MK, Sun SW, Chen RR, Huang JD, Lee PH. Effects of conversion from sirolimus oral solution to tablets in stable Taiwanese renal transplant recipients. J Formos Med Assoc. 2005 Jan;104(1):22-8.
Clinical trial NCT00481442: Phenylephrine Versus Norepinephrine in Septic Shock
Official title: Effects of Phenylephrine on Systemic and Regional Hemodynamics in Patients With Septic Shock: a Crossover Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Septic Shock
Keywords: Septic shock
Sepsis
Norepinephrine
Phenylephrine
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2007-06-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Clinical studies evaluating the clinical use of phenylephrine in septic shock are lacking. The present study was designed to compare the effects of norepinephrine and phenylephrine on systemic and regional hemodynamics in patients with catecholamine-dependent septic shock.


Eligibility criteria: Inclusion Criteria:

* Clical diagnosis of Septic Shock
* norepinephrine to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 12-18 mmHg and central venous pressure = 8-12 mmHg).

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Present or suspected acute coronary artery disease
* Present or suspected acute mesenteric ischemia.

Primary outcomes:
measure: Systemic and regional hemodynamics
timeFrame: 24 hours
Secondary outcomes:
measure: Organ functions, adverse effects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza"
Study officials:
affiliation: Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"
name: Andrea Morelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01652742: Study to Explore Pharmacokinetics and Pharmacodynamics of a Single Rising Dose of BI 135585 XX
Official title: Pharmacokinetics and Pharmacodynamics of BI 135585 XX Administered as Oral Dose in Healthy Male Volunteers (Open-label, Single-dose Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-07-30
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the pharmacokinetics and pharmacodynamics of BI 135585 XX following single dose administration.


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects
2. overweight or obese

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: up to 4 days postdose
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
timeFrame: up to 4 days postdose
Secondary outcomes:
measure: AUC0-8 of BI 135585 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: up to 4 days postdose
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: 1283.34.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT03880942: The Effect of Reading Book on Preoperative Anxiety
Official title: The Effect of Reading an Informative Story Book on Preoperative Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Anxiety
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-03-19
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Observe the effects of reading an informative story book on preoperative anxiety and maternal anxiety

Detailed description: Observe the effects of reading an informative story book at preoperative period on preoperative anxiety by m-YPAS in the holding area and on maternal anxiety by STAI in the holding area.

Eligibility criteria: Inclusion Criteria:

* ASA 1-2
* Elective surgery

Exclusion Criteria:

* Chronic diseases
* Development disability
* Prematurity
* Neurological diseases
* Psychoactive medication use
* Hearing/visual impairment
* History of surgery

Primary outcomes:
measure: preoperative anxiety
timeFrame: Preoperative anxiety will be evaluated at two times. At the preoperative holding area before given premedication and while entering to the operating room.
Secondary outcomes:
measure: maternal anxiety
timeFrame: It will be evaluated once. At the preoperative holding area while waiting for operation with their child.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: DiskapiYBERH
Study officials:
References:
Clinical trial NCT03281642: Efficacy of a Nurse-based Intervention on Tobacco Consumption in Hospitalized Patients
Official title: Efficacy of a Nurse-based Intervention on Tobacco Consumption in Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Smoking Patients
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All smoking patients hospitalized in one of the participating unit of the Saint-Louis-Lariboisière-Fernand Widal hospital (Diabetology, Cardiology, adults and adolescents Onco-hématology, Orthopedy, Oncology, Internal Medecine, Pneumology, Dermatology, Rhumatology, Psychiatry, Gastro-Entérology, Neurology) during the study period that include the 6 months preceding and the 6 months following the training.

Brief summary: Tobacco consumption is a major public health problem, ranking second in the leading cause of morbidity and mortality worldwide, in 2010. The prevalence of tobacco smoking in hospitalized patients is evaluated around 20% and the management of tobacco reduction/cessation is an major issue for the course and outcome of many disorders.

Recent recommendations published by the French National Health Authority ("Haute Autorité de Santé", HAS) call for the involvement of all health professionals in helping patients to stop smoking and hospitalized patients are identified as a specific target. In addition, the meta-analysis of Rigotti et al. (2012) showed that the most effective programs (tobacco cessation) were those that include all patients, starting during the hospitalization with a specific follow-up of at least one month, and with the addition of nicotine replacement therapy. This combination increased the odds of successful tobacco cessation by 54%.

The project aims to evaluate the short-term efficacy (1 month) of a nurse-based program on tobacco smoking consumption in a population of hospitalized patients.


Eligibility criteria: Inclusion Criteria:

* Adult patient (\>= 18 years), tobacco smokers, hospitalized in one of the participating unit during the inclusion period.
* For the sake of coherence with the literature, only subjects who smoked at least one cigarette a day in the previous 30 days before the hospitalization will be considered as "smokers".
* Affiliated to the national health system
* Signed informed consent

Exclusion Criteria:

* Patients enrolled in an addiction treatment during their hospitalization stay
* Cognitive deficit that makes the informed consent and the telephone interview impossible
* Aphasia
* Patient who does not speak French
* Life expectancy below 6 months

Primary outcomes:
measure: 1 month tobacco smoking prevalence
timeFrame: 1 month
Secondary outcomes:
measure: 6 month tobacco smoking prevalence
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Fernand Widal hospital
Study officials:
References:
Clinical trial NCT01756742: Effects of Respiratory Physiotherapy on Pleural Effusion
Official title: Effectiveness of a Program of Respiratory Physiotherapy on Pleural Effusion: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Effusion
Keywords: Pleural Effusion
Respiratory physiotherapy
Length of stay
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2012-12-27
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pleural effusion and the complexity of diagnosis and treatment make planning and delivering care challenging. Respiratory physiotherapy is recommended, and should be applied during the first weeks of treatment.The aim of the present study is to demonstrate the effectiveness of a respiratory physiotherapy protocol in patients with Pleural Effusion who attended a University Hospital.

Detailed description: Approximately 1.5 million patients are diagnosed with pleural effusion each year in the United States . Pleural effusion (PE) is an accumulation of fluid in the pleural space that is classified as transudate or exudate according to its composition and underlying pathophysiology. The goal in the management of pleural effusion is to provide symptomatic relief by removing fluid from the pleural space and to allow the treatment of the underlying disease. While some authors (REF) propose respiratory physiotherapy, in the majority of the cases only the medical treatment combined with the pleural fluid removal by thoracentesis are the most common practice. The objective of this study is verify the effectiveness of respiratory physiotherapy in pleural effusion

Eligibility criteria: Inclusion Criteria:

* Diagnosis of pleural effusion based on the presence of a consistent radiological finding on simple posteroanterior and lateral chest X-rays, and decubitus lateral in cases of small PE.

Exclusion Criteria:

* Non diagnosis of pleural effusion

Primary outcomes:
measure: Assessment of the severity of respiratory disease
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Length of the hospital stay
timeFrame: baseline, 12 months
measure: Severity in the pleural effusion repercussion
timeFrame: baseline, 12 months.
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Universitary Hospital San Cecilio
state: Andalucia
Study officials:
affiliation: Universidad de Granada
name: M. Carmen Valenza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06640842: Brain Health in Midlife
Official title: Brain Health in Midlife (ADORE BRAIN)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Brain Health
Gestational Hypertension
Alzheimer Disease
Dementia
Cardiovascular Diseases
Pregnancy Related
Pre-Eclampsia
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: The University of Kansas Medical Center ADRC
name: National Institute on Aging (NIA)
First posted: 2024-10-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who previously participated in the ADORE, received a hypertensive disorder diagnosis or had a healthy pregnancy during their participation.

Brief summary: The purpose of this study is to learn if hypertensive disorders during pregnancy affects brain health in midlife.


Eligibility criteria: Inclusion Criteria:

* Participated in the ADORE trial ( R01 HD083292)

Exclusion Criteria:

* History of seizures or Epilepsy
* Pregnant at screening
* Ineligible to complete MRI due to metal in the body

Primary outcomes:
measure: Cardiometabolic markers of middle age women
timeFrame: Baseline
measure: Neurovascular hemodynamics of middle age women
timeFrame: Baseline
measure: Brain structure & function of middle age women
timeFrame: Baseline
measure: Alzheimer's disease-related plasma biomarkers of middle age women
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: The University of Kansas Medical Center
name: Holly R Hull, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00143442: Study of [S,S]-Reboxetine in Patients With Postherpetic Neuralgia, Who Are Gabapentin Treatment Failures
Official title: A 5-Week, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN), Who Are Gabapentin Treatment Failures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 184
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: The purpose of this study is to determine the effectiveness of \[S,S\]-Reboxetine in the treatment of chronic pain following a shingles infection in patients who are Gabapentin treatment failures.


Eligibility criteria: Inclusion Criteria:

* Patients must have pain present for more than 3 months after the healing of shingles skin rash.
* Patients at screening must have a score \> or = 40 mm on the pain visual analogue scale.

Exclusion Criteria:

* Patients with poor renal function.
* Patients with other severe pain, that may impair the self-assessment of the pain due to shingles.
* Patients with abnormal electrocardiogram.

Primary outcomes:
measure: The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 5 will be calculated.
Secondary outcomes:
measure: - The mean endpoint (week 5) sleep interference score change from baseline - Analysis of the Patient Global Impression of Change - Analysis of the Clinical Global Impression of Change - Analysis of the SF-McGill questionnaire
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00705042: Study Evaluating Enbrel Drug Levels in Healthy Male Chinese Subjects
Official title: A Randomized, Open-Label, Single-Dose Administration, Parallel-Group, Multisite Study of the Pharmacokinetics of Etanercept, 25 or 50 mg, Administered Subcutaneously to Healthy Chinese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the Pharmacokinetics (PK) and safety and tolerability of etanercept, 25 and 50 mg, administered as a single dose to healthy male Chinese subjects.


Eligibility criteria: Inclusion Criteria:

Healthy male Chinese subjects, ages 18 to 45. BMI in the range of 18 to 30 kg/m2 and weight greater than or equal to 50 kg.

Exclusion Criteria:

Active tuberculosis (TB) or history of TB. Serious infection (associated with hospitalization and/or antibiotics) within 1 month before study drug administration.

History of protein drug hypersensitivity.

Primary outcomes:
measure: etanercept levels in the blood
timeFrame: 21 days
Secondary outcomes:
measure: Safety and tolerability of single doses of etanercept administered to healthy Chinese subjects
timeFrame: 21 days
Other outcomes:
Locations:
city: Guangzhou
country: China
state: Guangdong
city: Beijing
country: China
city: Beijing
country: China
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05598242: Amniotic Membrane Treatment for Hyposecretory Dry Eye
Official title: Amniotic Membrane Treatment for Hyposecretory Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Sjogren Syndrome With Keratoconjunctivitis
Keywords: dry eye
autologous serum
amniotic membrane extract eye drops
Lead sponsor: Hospital Nacional Profesor Alejandro Posadas
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 37
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: active-controlled, parallel-group trial
Primary purpose: TREATMENT

Brief summary: The goal of this randomized, active-controlled, parallel-group trial is to evaluate the clinical efficacy of amniotic membrane extract eye drops (AMEED) in reducing signs and symptoms of hyposecretory dry eye

Participants will receibed amniotic membrane extract eye drops 6 times daily and was evaluated at baseline day and day 30th.

Researchers will compare against autologous serum eye drops effects

Detailed description: This was a randomized, active-controlled, parallel-group trial. The perfect masked conditions could not be accomplished because the autologous serum eye drops needs venous punction for it preparation.

During de initial 2 weeks screening period, the patients received artificial tears 4 times daily to minimize the effects of any eye drops used before patients were allocated randomly to receive autologous serum eye drops (ASED) or AMEED, administered as 1 drop in each eye 6 times daily, respectively, for 30 days.

Eligibility criteria: Inclusion Criteria:

* 21 years of age or older
* dry eye related symptoms
* Fluorescein Corneal Staining score of 4 or more
* Lisamina Green Conjunctival score of 4 or more
* a no-anesthesia Schirmer test value at 5' of 10 mm or less

Exclusion Criteria:

* glaucoma treatment
* surgical procedures within 3 months of the baseline evaluation
* precense of punctal plug
* patients that were human immunodeficiency virus positive

Primary outcomes:
measure: Lisamina green conjunctival staining
timeFrame: 1 month
Secondary outcomes:
measure: Fluorescein Corneal staining
timeFrame: 1 month
measure: Schirmer's test
timeFrame: 1 month
measure: TBUT
timeFrame: 1 month
measure: OSDI
timeFrame: 1 month
Other outcomes:
Locations:
city: El Palomar
country: Argentina
facility: Hospital Nacional Posadas
state: Buenos Aires
city: El Palomar
country: Argentina
facility: Hospital Nacional Prof. A. Posadas
state: Buenos Aires
city: El Palomar
country: Argentina
facility: Hospital Nacional Profesor A. Posadas
state: Buenos Aires
Study officials:
affiliation: assistant
name: Emiliano F Ross, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00443742: Diagnosis of Depression Among Adolescents
Official title: Diagnosis of Depression Among Adolescents - a Clinical Validation Study of Key Questions and Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: Depression
Validation
Adolescent
Validation of three key questions and questionnaire
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2007-03-06
Enrollment: 323
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes

Brief summary: The objective of the study is to improve general practitioners' diagnoses of adolescent depression. Major depression is ranked fourth in the worldwide disability impact. The proportion of adolescents suffering from depressive disorders also seems to be increasing worldwide. Early interventions are known to reduce this illness. Therefore, the earlier depression can be identified in adolescents, the greater the advantage.


Eligibility criteria: Inclusion Criteria:

* age (14-16)

Exclusion Criteria:

* not fluency in the Norwegian and Danish language

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University of Oslo
name: Ole Rikard Haavet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: