louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02461576: Clinical Evaluation of the Xpert® HIV-1 VL
Official title: Clinical Evaluation of the Xpert® HIV-1 VL: A Method Comparison Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: HIV-1
Lead sponsor: Cepheid
Sponsor class: INDUSTRY
First posted: 2015-06-03
Enrollment: 966
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females \>18 yours who are known HIV-1 infected and may be on treatment or untreated with ARV therapy

Brief summary: Compare the clinical performance of the Xpert® HIV-1 VL to another FDA approved HIV-1 RNA quantitative assay using frozen and fresh specimens from known HIV-1 positive individuals.


Eligibility criteria: Inclusion Criteria:

* HIV-1 seropositive adults using an FDA approved method
* At least 18 years of age or older
* Informed consent, if applicable

Exclusion Criteria:

* Subject is less than 18 years of age
* Previously enrolled in this study
* Samples not collected according to the procedure

Primary outcomes:
measure: Quantification of HIV-1 RNA in copies/mL in known HIV-1 positive subjects
timeFrame: 1 day (A single time point)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01017276: A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis
Official title: A Phase 3 Study in Patients With Chronic Kidney Disease (CKD) With Hyperphosphatemia on Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Renal Dialysis
Renal Insufficiency
Keywords: Hyperphosphatemia
Peritoneal dialysis
CKD
ASP1585
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-11-20
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 in chronic kidney disease and hyperphosphatemia patients on peritoneal dialysis.


Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease patients on peritoneal dialysis
* Hyperphosphatemia
* Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not changed within 28 days.
* Written informed consent

Exclusion Criteria:

* Patients with gastrointestinal surgery or enterectomy
* Patients with severe cardiac diseases
* Patients with severe constipation or diarrhea
* Patients with a history or complication of malignant tumors
* Patients with uncontrolled hypertension
* Patients treated with parathyroid intervention

Primary outcomes:
measure: Serum phosphorus level at treatment discontinuation
timeFrame: During the 12-week treatment period
Secondary outcomes:
measure: Percent of the patients meeting the target range of serum phosphorus levels
timeFrame: During treatment
measure: Time-course changes in serum calcium levels
timeFrame: During Treatment
measure: Changes in serum Ca x P
timeFrame: During Treatment
measure: Changes in intact PTH levels
timeFrame: During Treatment
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Kantou
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT05617976: Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children
Official title: Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caudal Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 64
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Caudal anesthesia is the single most important pediatric regional anesthetic technique and is increasingly performed in pediatric regional anesthesia practices. It is preferred in order to relieve intra-operative and postoperative pain in children of all age groups undergoing pelvi-abdominal or lower limbs surgeries using levobupivacaine 0.25%.Various adjuvants have been added to levobupivacaine to prolong postoperative caudal analgesia. Nalbuphine as many opioids can be added in caudal analgesia. This prospective randomized double blind study was done to compare the effects of plain levobupivacaine versus Levobupivacaine plus nalbuphine single-shot for postoperative pain relief in children undergoing hypospadius repair surgery.


Eligibility criteria: Inclusion Criteria:

* ASA I, II.
* Age 1-3 years.
* Patients scheduled for hypospadias repair surgeries.

Exclusion Criteria:

* ASA III, IV.
* Signs of infection at site of injection.
* Known coagulopathy disorder.
* Mental and / or developmental retardation.

Primary outcomes:
measure: Quality of Postoperative analgesia
timeFrame: 24 hours
measure: duration of analgesia
timeFrame: 24hours
Secondary outcomes:
measure: analgesic consumption
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
References:
Clinical trial NCT05003076: Brain Function and EEG
Official title: Drug Effects on EEG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Mood
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this project, we will examine effects of MA on reward function using electroencephalograms (EEG), which will complement our ongoing study with MA and fMRI. We will determine how MA alters reward-related neural activity and how this is related to its subjective rewarding effects. The effects of MA on reward function will be examined using both reward-task-related activation and resting state activity. We will examine the effects of MA on ratings of drug liking and euphoria, as well as on EEG measures sensitivity to reward. Healthy young adults will undergo three EEG sessions with placebo and MA (10 and 20 mg), while performing the Monetary Incentive Delay task and the Stop Task, as a measure of inhibition. We will examine correlations between the neural responses and subjective responses to MA.

Our central hypotheses are 1) that MA will increase feelings of alertness and well-being, and 2) that MA will increase neural responses to anticipation and receipt of reward, and 3) that the effects of MA on mood will be correlated with its effects on neural responses to reward.


Eligibility criteria: Inclusion Criteria:

BMI between 19 and 26 Less than 4 alcohol or caffeinated beverages a day.

Exclusion Criteria:

High blood pressure

Any medical condition requiring regular medication Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis Individuals with a history of dependence on stimulant drugs Women who are pregnant or trying to become pregnant.

Primary outcomes:
measure: Change in SUbjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ).
timeFrame: Time Frame: Day 1(baseline), 3
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Harriet de Wit
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00207376: Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale
Official title: Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of an Intracardiac Septal Closure Device in Patients With Atrial Septum Defect (ASD) and Patent Foramen Ovale (PFO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Septal Defect
Patent Foramen Ovale
Lead sponsor: Carag AG
Sponsor class: INDUSTRY
First posted: 2005-09-21
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective multicenter clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD) and patent foramen ovale (PFO).


Eligibility criteria: Inclusion Criteria:

* ASD
* PFO with a medical history of cryptogenic stroke due to presumed paradoxical embolism caused by a PFO

Exclusion Criteria:

* Criteria that exclude catheterization (e.g. size too small, disseminated intravascular coagulopathy (DIC), high risk of bleeding such as coagulation or clotting disorders)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: German Heart Institute
Study officials:
affiliation: German Heart Institute
name: Peter Ewert, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06525376: Validity and Reliability of Smartphone Inclinometer Application for Measurement of Cervical Range of Motion
Official title: Validity and Reliability of Smartphone Inclinometer Application for Measurement of Cervical Range of Motion: a Cross-sectional Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Joint Function Disorder
Lead sponsor: Deraya University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nowadays, smartphone technology provides opportunities for assessing and treating patients in clinical facilities and during the follow-up of the patient's progress. To date, many studies have assessed the validity and reliability of the smartphone application against universal goniometer for various joint motions, for instance, the spinal column, knee, and ankle. This study aims to determine the validity and reliability of smartphone inclinometer application for measurement of cervical region range of motion.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 33 years.
* Both genders.
* Subjects that are cooperative to follow my instructions

Exclusion Criteria:

* Subjects with severe spinal pathology.
* Pregnancy and lactation.
* Any musculoskeletal diseases that affect the cervical spine.
* Any neurological diseases that affect the cervical spine.
* History of trauma in the cervical spine.
* Signs of cervical radiculopathy.
* Signs of cervical myelopathy.
* Signs of serious pathology.
* subjects have a pacemaker or any other medical equipment that the magnet might have compromised.

Primary outcomes:
measure: Cervical range of motion device (CROM)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Deraya university
Study officials:
References:
Clinical trial NCT01483976: Comparison of Medical Nutritional Supplements
Official title: Comparison of Medical Nutritional Supplements With or Without AN777 in Elderly Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Elderly
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2011-12-02
Enrollment: 27
Sex: MALE
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to verify changes in protein metabolism after ingesting a oral medical nutritional supplement.


Eligibility criteria: Inclusion Criteria:

* Male and is ≥ 60 and ≤ 90 years of age.
* Body Mass Index (BMI) \> 20.0, but \< 35.0.
* Ability to climb a flight of 10 stairs or walk an equivalent of city block without help within the 3 months prior to enrollment.
* Refrain from taking any dose of NSAIDs or acetaminophen on the day of and 24 hours prior to Visit 2 and Visit 3.
* Refrain from using any pulmonary maintenance medications on the days of Visit 2 and Visit
* Refrain from intense physical activity between visits.

Exclusion Criteria:

* Systemic corticosteroids within the 3 months prior to enrollment.
* Blood thinner or anticoagulant medication within 1 week prior to enrollment.
* Glomerular filtration rate (eGFR) of \< 40 mL/min/1.73m2.
* Antibiotics within 1 week prior to enrollment.
* Major surgery less than 3 months prior to enrollment in the study.
* Active malignant disease or treated within the last 6 months for cancer.
* Immunodeficiency disorder.
* Diabetes
* Myocardial infarction 3 months prior to enrollment.
* Chronic obstructive pulmonary disease
* History of allergy to any of the ingredients in the study products.
* Conditions precluding ingestion or absorption of the study product, inflammatory bowel disease, short bowel syndrome, or other major gastrointestinal disease.
* Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition.
* Pursuing weight loss or weight gain.
* Medications/dietary supplements/substances that could modulate metabolism or weight.

Primary outcomes:
measure: Change in protein metabolism
timeFrame: Between baseline and 8 hours later
Secondary outcomes:
measure: Intracellular signaling pathway metabolism
timeFrame: Between Baseline and 8 hours later
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: Abbott Nutrition
name: Vikkie Mustad, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04863976: Effects of Different Stretching Techniques on Extensibility, Strength and Range of Motion in Football Athletes
Official title: Effects of Different Stretching Techniques on Extensibility, Strength and Range of Motion in Football Athletes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asymptomatic Condition
Keywords: stretching
extensibility
strength
range of motion
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects dynamic stretching, passive stretching and self-stretching of the quadriceps muscle on muscle extensibility, hip strength and hip range of motion


Eligibility criteria: Inclusion Criteria:

* Footbal athletes
* Limited range of motion in ely's test

Exclusion Criteria:

* Previous surgery in the lower limb
* Previous physiotherapy threatment in the thigh
* Stretching contraindications

Primary outcomes:
measure: Range of motion
timeFrame: Baseline
measure: Range of motion
timeFrame: immediately after the intervention
measure: Strength
timeFrame: Baseline
measure: Strength
timeFrame: immediately after the intervention
measure: Extensibility
timeFrame: Baseline
measure: Extensibility
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Soria
country: Spain
facility: Luis Ceballos Laita
state: Castilla Y León
Study officials:
affiliation: University of Valladolid
name: Luis Ceballos Laita, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02111876: Systematic Follow-up of Patients Surviving an Episode of Acute Hypercapnic Respiratory Failure in the ICU
Official title: Systematic Follow-up of Patients Surviving an Episode of Acute Hypercapnic Respiratory Failure in the ICU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Hypercapnic Respiratory Failure
Keywords: ICU, COPD, OHS, OSA, heart failure
Lead sponsor: Ligue Pulmonaire Genevoise
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2014-04-11
Enrollment: 60
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: Patients surviving an episode of acute hypercapnic respiratory failure in the ICU

Brief summary: There is currently no good description of patients surviving an episode of acute hypercapnic respiratory failure in the ICU. For instance, the prevalence of OSA and sleep hypoventilation in a stable clinical condition is not known in this population.

This prospective cohort describes the clinical profile, predictors of readmission (followed over a year), and the prevalence of sleep-related breathing disorders (polysomnography in a stable clinical condition 3 months after ICU discharge) in patients treated for an episode of acute hypercapnic respiratory failure in the ICU.


Eligibility criteria: Inclusion Criteria:

* \> 18 years Informed consent surviving an episode of acute hypercapnic respiratory failure

Exclusion Criteria:

* iatrogenic hypercpania pregnant woman

Primary outcomes:
measure: Sleep apnea syndrome
timeFrame: at 2 month after ICU discharge
measure: Sleep Hypoventilation
timeFrame: at 2 month after ICU discharge
Secondary outcomes:
measure: Lung physiology ( obstructive or restrictive lung disease)
timeFrame: at week 2 after ICU discharge
measure: Inspiratory Muscle Strength
timeFrame: at week 2 after ICU discharge
measure: Cardiac function
timeFrame: at week 2 after ICU discharge
measure: Hospital and ICU readmission rate
timeFrame: 1 year follow-up after ICu discharge
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genpve
Study officials:
affiliation: HUG
name: Adler E Adler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karege G, Zekry D, Allali G, Adler D, Marti C. Gait speed is associated with death or readmission among patients surviving acute hypercapnic respiratory failure. BMJ Open Respir Res. 2020 Jun;7(1):e000542. doi: 10.1136/bmjresp-2019-000542.
citation: Adler D, Pepin JL, Dupuis-Lozeron E, Espa-Cervena K, Merlet-Violet R, Muller H, Janssens JP, Brochard L. Comorbidities and Subgroups of Patients Surviving Severe Acute Hypercapnic Respiratory Failure in the Intensive Care Unit. Am J Respir Crit Care Med. 2017 Jul 15;196(2):200-207. doi: 10.1164/rccm.201608-1666OC.
Clinical trial NCT02351076: Correlation of Right-left Shunt Detection in Cardioembolism Etiology in Stroke Patient.
Official title: Correlation of Right-left Shunt Detection in Cardioembolism Etiology in Stroke Patient. Pilot Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foramen Ovale Patent
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient after ischemic stroke including TIA, age 18-55 year

Brief summary: The aim of the study is to compare correlation for right to left shunts (mainly patent foramen ovale) detection for three methods-transesophageal echo as a gold standard, transcranial doppler with contrast agent (microbubbles) and new method- Flow detection system ( Cardiox TM) in young stoke patients ( age under 55 years).

Detailed description: The aim of the study is to compare correlation for right to left shunts (mainly patent foramen ovale) detection for three methods-transesophageal echo as a gold standard, transcranial doppler with contrast agent (microbubbles) and new method- Flow detection system ( Cardiox TM) in young stoke patients ( age under 55 years). Flow detection systém is a new method for right to left shunt detection comfortable for patients, not dependent on experienced examinator and only one method with exact valsalve maneuver measurement. Right to left shunt could be important etiology of cardioembolization in young stroke patient population, therefore screening for this condition is recommended in all young patient after ischemic stroke especially with unclear etiology. Flow detection systes seams to be ideal screening method for this patients.

Eligibility criteria: Inclusion Criteria:ischemic stroke / TIA, signed informed consent -

Exclusion Criteria:imposibillity to undergo transesophageal echo, transcranial doppler with contrast or Cardiox flow detection system

-

Primary outcomes:
measure: detection of right-to-left shunt
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: University Hospital Ostrava
Study officials:
affiliation: University Hospital Ostrava
name: Martin Kuliha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03209427: Serum Serotonin and Pruritus After Intrathecal Morphine in Cesarean Section
Official title: Pruritus After Intrathecal Morphine in Cesarean Section: Incidence, Severity and Its Relation to Serum Serotonin Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pruritus
Keywords: morphine, pruritus, serotonin
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Pruritus is the commonest side effect of intrathecal morphine especially in parturient, but the exact mechanism of pruritus is not clear. Many mechanisms have been suggested. Among these mechanisms is the activation of the 5-HT3 receptors by the intrathecally injected morphine.

Detailed description: Forty parturients underwent elective cesarean section under spinal anesthesia were divided into two groups of 20 each in this prospective randomized study. Group I received 100 µg of intrathecal morphine (ITM) mixed with 12 mg of 0.5% heavy bupivacaine (M100) while group II received 200 µg of ITM mixed with 12 mg of 0.5% heavy bupivacaine (M200). Two blood samples were taken from each patient for serotonin estimation, preoperatively and 4 hrs later. Postoperatively all patients were assessed for pruritus (incidence \& severity), visual analog scale (VAS), first request of analgesia, and total analgesic dose required within 24 hrs.

Eligibility criteria: Inclusion Criteria:

* ASA I - II term pregnant patients scheduled for elective cesarean section

Exclusion Criteria:

* patients with a known allergy to the study drugs
* significant cardiac, respiratory, renal, neurological, or hepatic disease; -coagulation disorders
* BMI \> 30 kg/m2
* any itchy skin diseases.

Primary outcomes:
measure: Pruritus
timeFrame: 24 hours postoperative
measure: Pruritus
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: serotonin
timeFrame: preoperative
measure: serotonin
timeFrame: 4 hours postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Assiut university faculty of medicine
name: Mohamed G Aly, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonnet MP, Marret E, Josserand J, Mercier FJ. Effect of prophylactic 5-HT3 receptor antagonists on pruritus induced by neuraxial opioids: a quantitative systematic review. Br J Anaesth. 2008 Sep;101(3):311-9. doi: 10.1093/bja/aen202. Epub 2008 Jul 7.