louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00474552: Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315
Official title: An Ascending Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 Administered Orally to Healthy Young Adult and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary: To assess the safety and tolerability of ascending multiple oral doses of SAM-315, an investigational drug, in healthy young adult and elderly subjects.

Secondary: To assess the Pharmacokinetic and Pharmacodynamic profiles of multiple oral doses of SAM-315 in healthy young adult and elderly subjects.


Eligibility criteria: Inclusion Criteria:

Young healthy subjects:

* Men and women of nonchildbearing potential (WONCBP) aged 18 to 45 years inclusive on study day 1.
* Body mass index (BMI) in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg and body weight greater than or equal to 50 kg.

Elderly Healthy subjects:

* Men or women aged 65 years and above as of study day 1.
* BMI in the range of 18 to 30 kg/m2 and body weight greater than or equal to 45 kg and body weight greater than or equal to 45 kg.

Exclusion Criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* History of any clinically important drug allergy.

Primary outcomes:
measure: safety, tolerability and PK
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For France: infomedfrance@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01862952: Continuous Video- EEG Monitoring in the Acute Phase in Patients With a Cerebrovascular Attack- Randomisation of a Subpopulation Regarding Treatment Strategy
Official title: Continuous Video- EEG Monitoring in the Acute Phase in Patients With a Cerebrovascular Attack- Randomisation of a Subpopulation Regarding Treatment Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2013-05-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Stroke is a major cause of epilepsy. The pathophysiological mechanisms of poststroke epilepsy are not known. Subclinical epileptiform discharges could contribute to the neuronal damage and influence functional outcome. Electro-encefalography (EEG) is the golden standard to detect interictal, ictal and subclinical epileptic brain activity.

Patients admitted to the stroke unit with an ischemic or hemorrhagic cerebrovascular attack will undergo a 24 hours video-EEG monitoring to detect epileptiform discharges. Clinical and paraclinical (imaging, serum markers of neuronal damage) parameters will be analysed together with the EEG results. The EEG results will be correlated with the occurence of epileptic seizures and functional outcome and mortality in the acute phase and in the long-term. When subclinical epileptic discharges are found on the EEG, patients will be asked to participate in a second part of the study where they will be randomised into a treatment (with an anti-epileptic drug) versus no-treatment group for a period of 6 months. Outcome parameters will be the occurrence of epileptic seizures, mortality and functional outcome.

Our main hypothesis is that the occurrence of subclinical epileptiform discharges during the acute phase following stroke influences functional outcome.


Eligibility criteria: Inclusion Criteria:

* Patients with ischemic arteria cerebri media infarct and spontaneous intraparenchymal bleeding

Exclusion Criteria:

* Patients with subarachnoidal haemorrhage, traumatic haemorrhage (epidural/subdural bleeding), cerebral venous sinus thrombosis, epilepsy, anti-epileptic treatment, transient ischemic attack, indication for urgent neurosurgical intervention

Primary outcomes:
measure: Functional outcome
timeFrame: day 7
measure: Functional outcome
timeFrame: at month 6
Secondary outcomes:
measure: Mortality
timeFrame: at month 6
measure: occurrence of epileptic seizures
timeFrame: at month 6
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: Ghent University Hospital, Department of Neurology
name: Veerle De Herdt, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02119052: Effects of Somatostatin on Liver in ADPKD
Official title: Effect of Long-acting Somatostatin on Liver in Autosomal Dominant Polycystic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Autosomal Dominant Polycystic Kidney Disease
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 35
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: Autosomal dominant polycystic kidney disease (ADPKD) is associated with the development of a variety of extrarenal manifestations of which polycystic liver disease is most common. The investigators aimed to assess the changes over time of liver volume in ADPKD patients and whether it is affected by the treatment with the somatostatin analogue, octreotide.

35 ADPKD patients (14 males) aged 34±8 years were randomly assigned to 36 month treatment with placebo (n=18) or octreotide (n=17). Clinical and liver parameters at magnetic resonance (RM) were evaluated at baseline, study end and after 24 months of drug withdrawal.


Eligibility criteria: Inclusion Criteria:

* diagnosis of autosomal dominant polycystic kidney and liver disease
* glomerular filtration rate greater than 40 ml/min

Exclusion Criteria:

* diabetes mellitus
* proteinuria greater than 1 g/24 hours
* significant glomerular disease
* urinary tract lithiasis and infections
* symptomatic gallstones
* biliary sludge
* cancer
* pregnant women
* lactanting women

Primary outcomes:
measure: Effect of somatostatin on liver volume
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Pisani A, Sabbatini M, Imbriaco M, Riccio E, Rubis N, Prinster A, Perna A, Liuzzi R, Spinelli L, Santangelo M, Remuzzi G, Ruggenenti P; ALADIN Study Group. Long-term Effects of Octreotide on Liver Volume in Patients With Polycystic Kidney and Liver Disease. Clin Gastroenterol Hepatol. 2016 Jul;14(7):1022-1030.e4. doi: 10.1016/j.cgh.2015.12.049. Epub 2016 Feb 1.
Clinical trial NCT01813552: To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006)
Official title: A Phase I, Randomized, Open-label Study to Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of IDX719 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C Infection
Keywords: HCV
Hepatitis C
antiviral drugs
liver
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-03-19
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the potential for an effect of Ritonavir (Norvir®) or omeprazole (Prilosec®) on the pharmacokinetics of samatasvir and to assess the safety and tolerability of the study drugs when administered alone and in combination in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained.
* All participants of childbearing potential must agree to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug.

Exclusion Criteria:

* Pregnant or breastfeeding.

Primary outcomes:
measure: Pharmacokinetic parameter: Area under the concentration-time curve (AUC) from time zero to last measurable concentration
timeFrame: 0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours
measure: Pharmacokinetic parameter: AUC from time zero to infinity
timeFrame: 0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours
measure: Pharmacokinetic parameter: Maximum observed drug concentration (Cmax)
timeFrame: 0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours
Secondary outcomes:
measure: Percentage of participants who experienced at least one serious adverse event
timeFrame: Up to 17 days
measure: Percentage of participants who experienced at least one adverse event
timeFrame: Up to 17 days
measure: Percentage of participants who experienced at least one Grade 1 - 4 laboratory abnormality
timeFrame: Up to 17 days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06880952: Effect of Post-operative Chlorhexidine on Postoperative Pain and Complications After Surgical Removal of Mandibular Third Molars
Official title: Effect of Post-operative Chlorhexidine on Postoperative Pain and Complications After Surgical Removal of Mandibular Third Molars: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Third Molars Extraction
Keywords: third molar
chlorhexidine
Lead sponsor: Isala
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aimed to assess the impact of postoperative chlorhexidine use on pain management following mandibular third molar removal

In this prospective, randomized controlled trial,130 patients who underwent mandibular third molar surgical removal were divided into two groups: one group used chlorhexidine for postoperative rinsing and the other did not rinse. Pain levels, measured using the Numeric Rating Scale (NRS), were recorded daily for the first seven days post-surgery. Paired-samples t-tests were utilized for data analysis.


Eligibility criteria: Inclusion Criteria:

• healthy adults (18+) referred by their dentist for third molar removal

Exclusion Criteria:

* active pericoronitis or other infections
* planned coronectomy
* trismus
* chronic pain
* pregnancy
* known allergies to local anesthesia

Primary outcomes:
measure: Postoperative pain after removal of third molar
timeFrame: 7 days after the inclusion pain was measured on a numerical rating scale
Secondary outcomes:
measure: Post-operative complications
timeFrame: 7 days after the treatment the patient was seen at the outpatient clinic for clinical assessment. At this moment the number of patients with alveolitis, foodimpaction and bleeding was scored.
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Hospital
state: Overijssel
Study officials:
References:
citation: Ghaeminia H, Hoppenreijs TJ, Xi T, Fennis JP, Maal TJ, Berge SJ, Meijer GJ. Postoperative socket irrigation with drinking tap water reduces the risk of inflammatory complications following surgical removal of third molars: a multicenter randomized trial. Clin Oral Investig. 2017 Jan;21(1):71-83. doi: 10.1007/s00784-016-1751-1. Epub 2016 Feb 27.
Clinical trial NCT03858452: Relations Between Pelvic Floor, Diaphragm and Trunk Muscles
Official title: Evaluation of Functional Relations and Their Changes Between Pelvic Floor, Diaphragm and Trunk Muscles in Men After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Urinary Incontinence
Keywords: Prostatectomy
Rehabilitation
Incontinence
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 148
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study evaluates the functional relations of pelvic floor, diaphragm, and torso muscles, their variation and correlations with urinary incontinence while separately training physical characteristics of the mentioned muscles in men after radical prostatectomy.

Detailed description: During the last two decades, the connection between pelvic floor muscles (PFM) and abdominal muscles or diaphragm has been detected: PFM contract and relax during the inhalation and exhalation in pace with the diaphragm; the activity of the PFM increases with the increase of intra-abdominal pressure during forced exhalations or cough. The role of pelvic floor is essential for the synergy of diaphragm and abdominal muscles in maintenance of intra-abdominal pressure. According to the aforementioned physiological functional relationships, the investigators have postulated a hypothesis that diaphragm muscles training and abdominal muscles training could have similar effect as direct PFM training on pelvic floor muscles strength and pelvic floor muscles endurance measured using perineometer in men after radical prostatectomy.

Eligibility criteria: Inclusion Criteria:

* stable somatic state
* written informed consent.

Exclusion Criteria:

* chronic obstructive pulmonary disease,
* surgical interventions in abdominal area,
* complains in lower back,
* acute musculoskeletal injuries in last 6 months
* cognitive dysfunction

Primary outcomes:
measure: Effect of activation of different muscles groups on pelvic floor muscles strength
timeFrame: 6 months after radical prostatectomy.
measure: Effect of activation of different muscles groups on pelvic floor muscles endurance.
timeFrame: 6 months after radical prostatectomy.
Secondary outcomes:
measure: Urinary loss dynamics
timeFrame: 6 month after radical prostatectomy
measure: correlation between urinary incontinence and pelvic floor muscles strength and endurance dynamics
timeFrame: 6 months after radical prostatectomy
Other outcomes:
Locations:
Study officials:
affiliation: LUHS
name: Daimantas Milonas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zachovajeviene B, Siupsinskas L, Zachovajevas P, Milonas D. Dynamics of pelvic floor muscle functional parameters and their correlations with urinary incontinence in men after radical prostatectomy. Neurourol Urodyn. 2017 Jan;36(1):126-131. doi: 10.1002/nau.22887. Epub 2015 Sep 30.
Clinical trial NCT00999752: Study to Determine the Effects of Nebivolol and Hydrochlorothiazide in African Americans With Hypertension
Official title: A 25 Week, Open Label Study to Determine the Effects of Nebivolol When Added to Hydrochlorothiazide on Diastolic Function and Arterial Stiffness in African Americans With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
African Americans
Arterial Stiffness
Vascular Resistance
Lead sponsor: InVasc Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this study is to evaluate the effects of Nebivolol and Hydrochlorothiazide on blood pressure in African Americans with high blood pressure.

Detailed description: Many blood pressure medications are not effective in African American men and women. The two lower chambers of the heart contract to pump blood to the body. The lower chambers have to relax so they can refill with blood to pump out again. Many patients with high blood pressure have stiffness in the lower chambers which prevents the heart from relaxing so it can properly fill with blood. Some patients with the stiffness in the lower chambers of the heart will develop heart failure.

The study is to test whether or not Nebivolol (Bystolic)and a diuretic Hydrochlorothiazide (HCTZ) will help the heart relax so the heart can properly fill and prevent stiffness of the lower heart chambers.

Eligibility criteria: Inclusion Criteria:

* Known Hypertension by history
* Self-described African American

Exclusion Criteria:

* Uncontrolled Diabetes Mellitus (HbA1C\>10)
* Known CAD, Cerebrovascular Disease, PVD or Renovascular Disease
* Liver disease
* Chronic Renal Disease
* Uncontrolled Hypertension (\>199 systolic and/or \>115)

Primary outcomes:
measure: Changes in systolic and diastolic blood pressure after treatment with nebivolol and reaching normal blood pressure <140/90
timeFrame: Every visit for 25 weeks (9 study visits)
Secondary outcomes:
measure: Differences after nebivolol treatment on diastolic function as measured by tissue doppler imaging (ECHO), arterial compliance and stiffness and vascular nitric oxide availability determined by neutrophil function
timeFrame: At the begining and end of study
Other outcomes:
Locations:
city: Tucker
country: United States
facility: Atlanta Vascular Research Foundation
state: Georgia
Study officials:
affiliation: InVasc Therapeutics, Inc.
name: Bobby V Khan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06579352: Expanded Access Study of UC-MSC in DMD Patients
Official title: Intermediate Size Expanded Access Study of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) In Patients With Duchenne Muscular Dystrophy
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Duchenne Muscular Dystrophy
Lead sponsor: MED Institute Inc.
Sponsor class: INDUSTRY
Collaborators: name: Signature Biologics
First posted: 2024-08-30
Sex: MALE
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD

Brief summary: The primary objective of this study is to provide UC-MSC treatment to patients with DMD.

Secondary objectives will be to further evaluate treatment-related adverse events as well as changes in DMD-related functional testing/assessments, blood laboratories, and inflammation related biomarker levels over time.

Detailed description: The study will enroll ambulatory male participants between the ages of 5 and 10, who will receive four, 3-day intravenous dose cycles of UC-MSC treatment, each administered every three months. Participants will be closely monitored throughout the study period for treatment-related adverse events and changes in DMD-related functional assessments at specific follow-up intervals through 24 months.

Eligibility criteria: Inclusion Criteria:

1. Male sex by birth with a genetically confirmed diagnosis of Duchenne Muscular Dystrophy (DMD).
2. Age is greater than or equal to 5 and less than or equal to 10 years.
3. Has a North Star Ambulatory Assessment (NSAA) score greater than 13 and less than 30.
4. Demonstrates the ability to perform the "time to rise" test in under 10 seconds.
5. Is up-to-date on immunizations.
6. Is on a stable dose of glucocorticoids for at least 12 weeks prior to study participation, except for weight-based or toxicity-related adjustments.
7. Is on a stable dose of supplements for at least 12 weeks prior to study participation.
8. Has the ability to comply with the requirements of the study and the ability to understand and provide written informed assent and a guardian's consent.
9. Patient must be either a non-responder to or a poor candidate for treatment with another established therapy.

Exclusion Criteria:

1. Active cancer or prior diagnosis of cancer within the past year (patients with basal and squamous cell cancer of the skin will not be excluded).
2. BMI \> 45 kg/m².
3. Any other condition (including concomitant treatment) that, in the judgment of the Investigator or Sponsor, would be a contraindication to enrollment, study product administration (e.g., known hypersensitivity to dimethyl sulfoxide (DMSO), Human Serum Albumin (HSA), or PlasmaLyte), or follow-up.
4. Treatment with an exon skipping therapy within 3 months of study start.
5. Cognitive delay or impairment that can confound motor development in the opinion of the investigator.
6. Major surgery within 3 months prior to Day 0 or planned surgery or procedures that could affect the conduct of the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denton
country: United States
facility: Neurology Rare Disease Center
state: Texas
Study officials:
References: