louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00500500: Effect of EGb 761® on Patients With Mild to Moderate Alzheimer's Disease
Official title: Effect of EGb 761® on the Ratio of the Isoforms of the Protein Precursor of Beta Amyloid Platelets on Patients With Mild to Moderate Alzheimer's Disease. A Phase II, Randomised, Double-blind Trial, on Parallel Groups Versus Placebo.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2007-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to measure the effect of EGb 761® versus placebo on the ratio of the isoform of the protein precursor of beta amyloid platelets, in patients with mild to moderate Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* female or male of 50 to 85 years old with a care giver
* Mini Mental Status (MMS) test between 16 to 26 inclusive
* Clinical Dementia Rating (CDR) test inferior or equal to 1
* National Institute of Neurological and Communicative Disorders and Stroke / Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) test positive for an Alzheimer's disease
* Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) test positive for dementia

Exclusion Criteria:

* patient already treated by medicines which could interfere with the study
* low level of vitamin B12 and folate which are considered as clinically relevant
* clinically relevant pathologies (eg: pulmonary illness, cardiovascular illness; evolutive cancer, neurological illness, blood illness....)

Primary outcomes:
measure: Effect of EGb 761® on the ratio of the isoform of the protein precursor of beta amyloid platelets.
timeFrame: Every visit
Secondary outcomes:
measure: Efficacy of EGb 761® on the cognitive functions and safety of EGb 761® at a dosage of 240 mg per day
timeFrame: Every visit
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital La Timone
Study officials:
affiliation: Ipsen
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00040300: A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: treatment experienced
HIV
Phase I
Combination Therapy
Lead sponsor: Pharmasset
Sponsor class: INDUSTRY
First posted: 2002-06-25
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how the body reacts to Racivir will be studied.

Detailed description: The study is a 14-day study with a 21-day follow-up period. During the 14-days of active study period, participants will receive Racivir once daily in combination with efavirenz and stavudine. Following the administration of the first and last dose of study medication, patients will remain in the clinic overnight. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, EKGs, and routine clinical laboratory tests.

Eligibility criteria: Inclusion Criteria

Subjects may be eligible to participate if they:

* Are males with HIV infection with a positive HIV antibody test
* Have an HIV-RNA copy number of ≥ 5000 copies/ml (Roche assay)
* Have CD4+ cell counts ≥ 50 cells/ml
* Are 18-45 years of age, inclusive
* Have a body mass index (BMI) ≥ 18 kg/m2
* Are antiretroviral nucleoside reverse transcriptase inhibitor-naive
* Have read and understand the informed consent,and is able and willing to comply with study procedures

Exclusion Criteria

Subjects may not participate if they:

* Have clinically significant ECG abnormalities
* Have clinically significant abnormalities in any safety laboratory parameters
* Have an ALT value ≥ 3xUNL
* Have previously participated in this trial
* Have participated in another trial of an investigational drug within the last 3 months or are currently participating in another trial of an investigational drug
* Have a history of chronic alcohol or drug abuse within the last 6 months
* Have a positive urine drug screening
* Have a positive alcohol breath test
* Have any medical or psychiatric condition, which in the opinion of the investigator would jeopardize or compromise the subject's ability to participate in this trial
* Have a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02083900: Use of Banana Leaf Dressing on Donor Site Wounds
Official title: Use of Banana Leaf Dressing on Donor Site Wounds: A Prospective Randomized Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Burn
Lead sponsor: University of the Philippines
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective Randomized double-blind controlled trial comparing the healing rate, infection rate, pain score, ease of care and scar formation of Banana leaf dressing versus hydrocolloid dressing.

Detailed description: Prospective Randomized double-blind controlled trial comparing the healing rate, infection rate, pain score, ease of care and scar formation of Banana leaf dressing versus hydrocolloid dressing.

Adult patients with no uncontrolled medical condition admitted at Philippine General Hospital Burn Center requiring split thickness skin graft for their burn. this is to compare the efficacy and safety of Banana Leaf Dressing with Hydrocolloid dressing among patients undergoing split thickness skin graft for their burn.

Eligibility criteria: Inclusion Criteria:

* Patient undergoing harvesting of skin graft one or both thigh
* Surgery under general anesthesia
* Given informed consent and has accomplished a written inform consent

Exclusion Criteria:

* Patient with uncontrolled medical condition such as diabetes or hypertension
* Pregnant females
* Patients in whom legs or back was used as donor site
* Surgery under regional anesthesia
* Refused inclusion into the study
* Patients who had previous skin harvesting on the area of the study

Primary outcomes:
measure: Healing Assessment and Efficacy of the dressing
timeFrame: 8th post harvest day
Secondary outcomes:
measure: Pain Scores
timeFrame: taken from 24hours, on the 48th and 72 hour post skin harvest
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Philippine General Hospital - University of the Philippines Manila
state: Metro Manila
Study officials:
affiliation: UP Manila
name: Jeane Azarcon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06656000: Digital Analysis of Mesiodistal Tooth Width
Official title: Digital Analysis of Mesiodistal Crown Width of Permanent Teeth in a Group of Egyptian Children : a Cross Sectional Pilot Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Measurement of Crown Width of Permanent Teeth
Keywords: Tooth size, mesiodistal width, Egyptian children.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Children 12-15 years of age.

Brief summary: the goal of this cross-sectional study is to determine the digital permanent crown tooth width

Detailed description: using digital intra oral scanning to measure the permanent tooth mesiodistal dimension

Eligibility criteria: Inclusion Criteria:

* Children range age 12-15 years old.
* Complete set of permanent dentitions with intact marginal ridges.
* Fully erupted teeth to the occlusal plane.
* Normal occlusion without crowding, rotation, Spacing.
* Healthy children with no systemic diseases.

Exclusion Criteria:

* Buildups, Crowns, onlays, class II restorations that affect a tooth mesiodistal
* diameter.
* Congenital defects or deformed teeth or congenital missing Teeth.
* Obvious interproximal or occlusal wear of teeth.
* Anterior teeth fractures.

Primary outcomes:
measure: Digital mesioidistal crown width of permanent anterior and Posterior teeth
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry , Cairo University
Study officials:
References:
Clinical trial NCT01324375: Prediction of Pain in Total Hip Arthroplasty
Official title: Is Preoperative Pain Response Upon Tonic Heat Stimulation Predictive for Pain After Total Hip Arthroplasty?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2011-03-29
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: PROBABILITY_SAMPLE
Study population: Patients undergoing total hip arthroplasty (THA)

Brief summary: In this consecutive, prospective cohort study the investigators evaluate if preoperative pain response upon heat stimulation is predictive for acute and subacute postoperative pain after total hip arthroplasty.

Detailed description: The preoperative heat stimulation consists of short and long tonic heat stimulation. Pain response is evaluated with an electronic visual analog scale.

Furthermore the investigators evaluate other factors possibly predictable for acute and subacute postoperative pain after total hip arthroplasty - demographic factors, preoperative pain related factors, psychosocial factors (Hospital Anxiety and Depression Scale and Pain Catastrophizing Scale).

Eligibility criteria: Inclusion Criteria:

* Ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total hip arthroplasty

Exclusion Criteria:

* Bilateral/revision arthroplasty
* Disease affection central or peripheral nerve function
* Alcohol and medical abuse
* Daily use of opioids or glucocorticoids
* Malignancy
* BMI \> 40
* Depression
* Dementia or other cognitive dysfunction

Primary outcomes:
measure: Pain (from 0-24 hours after surgery)
timeFrame: 24 hours
Secondary outcomes:
measure: Pain (from day 1 to day 7 after surgery)
timeFrame: 7 days
measure: Pain at day 14 after surgery
timeFrame: 14 days
measure: Pain at day 30 after surgery
timeFrame: 30 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dep. of Anesthesiology, Hvidovre University Hospital
state: Hvidovre
Study officials:
affiliation: Dep. of Anesthesiology, Hvidovre University Hospital
name: Troels H Lunn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05615675: Virtual Reality (VR) for Prone Pain Procedures
Official title: Immersive Audiovisual Distraction With Virtual Reality (VR) in Prone Procedures in the Interventional Pain Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Anxiety
Pain
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of virtual reality (VR) distraction in patients undergoing interventional pain procedures in the prone position. VR has been shown to improve patient experience during interventional pain procedures, however, many of these procedures are done in the prone position making VR a challenge. This study will evaluate the effect of a VR headset and support in patients undergoing prone interventional pain procedures compared to control.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years old or older, who are referred to University of California Davis Pain Medicine Clinic and require an interventional pain procedure
* English speaking and with the ability to understand oral and written instructions

Exclusion Criteria:

* Pregnant women
* Prisoners
* Patients who have high risk of motion sickness, seizure disorder, or visual/hearing impairment

Primary outcomes:
measure: Anxiety Score
timeFrame: Immediately before procedure
measure: Anxiety Score
timeFrame: Immediately after procedure
Secondary outcomes:
measure: Anxiety Score
timeFrame: Immediately before procedure, during procedure, and immediately after procedure
measure: Pain Score
timeFrame: Immediately before procedure, during procedure, and immediately after procedure
measure: Global Impression of Change
timeFrame: Immediately after procedure
measure: Patient Experience Satisfaction
timeFrame: Immediately after procedure
measure: Sedation Requirements
timeFrame: During course of procedure
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Interventional Pain Clinic
state: California
Study officials:
affiliation: University of California, Davis
name: Michael Jung, MD MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06021275: Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars
Official title: Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scars
Insulin
Keywords: Insulin
scars
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently, few studies have attempted to test the regenerative effects of human insulin application by microneedling on atrophic scars versus other topical preparations. However, the scars were limited etiologically to acne scars. In addition, a lack of inclusion of a control group instead of comparing topical preparations with insulin was also a limitation to these studies. A control group consisting of microneedling alone would have served as a better comparison in order to determine whether the effects of microneedling are augmented by topical protein-rich preparations.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 12 to 60 years
2. Atrophic scars (traumatic or surgical)
3. Completely healed scars

Exclusion Criteria:

1. Patients with a tendency or history of hypertrophic or keloidal scars
2. Patients who received treatment for their scar in the past 3 months
3. Diabetic patients or those with a history of Dysglycemia
4. Pregnant, or lactating females
5. Patients with active infection at the site of scar
6. Patients currently receiving isotretinoin treatment or in the past month

Primary outcomes:
measure: Change in Scar
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University, Faculty of Medicine
Study officials:
References:
Clinical trial NCT06928675: Cell-free DNA in Acute Stroke
Official title: CANTO - Cell-free DNA in Acute Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: cell-free DNA
stroke etiologies
reperfusion
secondary emboli
stroke subtypes
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 200
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: male or female patients over 18 years of age presenting with acute ischemic stroke due to large vessel occlusion (LVO) who require mechanical thrombectomy.

Brief summary: Cell-free DNA (cfDNA) is an important pro-inflammatory and prothrombotic mediator. With this study the investigators aim to gain new insights into the role of cfDNA in stroke and to perform a combined analysis of cfDNA in the hyperacute phase of the disease using blood and thrombus analyses. The main objectives are to analyse cfDNA in different stroke etiologies, to investigate the relationship between cfDNA and important procedural factors such as secondary embolisation and reperfusion outcomes, to analyse the correlation between blood and thrombus content of cfDNA and to investigate the specific source of cfDNA in distinct stroke subtypes.


Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke due to large vessel occlusion (LVO) who require mechanical thrombectomy (detected in CT-Scan or MRI-Scan)
* 18 years of age

Exclusion Criteria:

* Patients currently undergoing immunological therapies.
* Patients with immunological diseases
* Patients with systemic infections at the time of admission

Primary outcomes:
measure: Stroke Etiology
timeFrame: at day 1
Secondary outcomes:
measure: Correlation cfDNA concentration and perfusion outcome
timeFrame: at day 1
measure: Correlation cfDNA concentration and secondary embolism
timeFrame: at day 1
measure: Correlation cfDNA concentration and thrombus fragmentation.
timeFrame: at day 1
measure: Measures of cfDNA as a marker of systemic inflammation
timeFrame: at day 1
measure: 90-day functional outcomes
timeFrame: up to 3 month
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Gerrit Grosse, PD Dr. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01690975: Benzonatate Dose Tolerance Study
Official title: A Phase I, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Tolerability of Benzonatate Following Single Dose Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cough
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-09-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single-center, randomized, third party blind, placebo controlled, dose escalation study of benzonatate following single dose administration. The primary oobjective is to assess the safety and tolerability of increasing oral doses of benzonatate following single dose administration in healthy male and female subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG, or clinical laboratory tests.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
Secondary outcomes:
measure: Maximum tolerated dose (MTD): Assessed at end of study
timeFrame: End of study (2 months)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04530175: Modeling of Regional Citrate Anticoagulation With a Dialysate Containing Calcium in Intermittent Hemodialysis (MARC)
Official title: Modeling of Regional Citrate Anticoagulation With a Dialysate Containing Calcium in Intermittent Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Keywords: hemodialysis
modeling
Citrate anticoagulation
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated with intermittent hemodialysis for chronic renal failure, at university hospital of Clermont-Ferrand

Brief summary: The primary purpose of this study is to validate a mathematical modeling of treatment by intermittent hemodialysis using regional citrate anticoagulation with a dialysate containing calcium

Detailed description: The only visit to the study will be carried out during a usual dialysis session in the intensive care unit of Clermont-Ferrand University Hospital. In addition to the usual care, 2 blood samples will be taken from the blood circuit 1 hour after the start of the hemodialysis session by the nurse in charge of the patient.

Eligibility criteria: Inclusion Criteria:

* Major patient;
* Man or woman ;
* Treated with intermittent hemodialysis for chronic renal failure;
* In whom intermittent hemodialysis with citrate solution for regional anticoagulation is indicated;
* Affiliated with a social security scheme;
* Having given a signed agreement after detailed explanation of the protocol on the basis of the information sheet and likely to comply with it

Exclusion Criteria:

* Severe hepato-cellular insufficiency (PT \<50%, INR\> 1.5 without anticoagulant);
* Hemoglobin level \<7 g / dL
* Presenting a psychiatric pathology or cognitive impairment rendering him unable to give informed consent;
* Persons under guardianship, curatorship, deprived of liberty or safeguard of justice
* Pregnant or breastfeeding women
* Patient's refusal to participate in the study.

Primary outcomes:
measure: Ionized calcium level
timeFrame: day 0
measure: Total calcium level
timeFrame: day 0
measure: Total citratemia
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Julien Aniort
role: PRINCIPAL_INVESTIGATOR
References: