louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05568082: A Study to Evaluate the Drug-drug Interaction Effect of Itraconazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
Official title: An Open-label Study to Evaluate the Drug-drug Interaction Effect of Itraconazole, a CYP3A4 Inhibitor, on the Pharmacokinetics of AMG 510 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy participants
AMG 510
Itraconazole
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-10-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of AMG 510 administered alone and in combination with itraconazole in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of Screening.
* Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.
* Females of nonchildbearing potential

Exclusion Criteria:

* Inability to swallow oral medication or history of malabsorption syndrome.
* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Poor peripheral venous access.
* History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of AMG 510
timeFrame: Day 1 and Day 6
measure: Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 510
timeFrame: Day 1 and Day 6
measure: AUC from Time Zero to Infinity (AUCinf) of AMG 510
timeFrame: Day 1 and Day 6
Secondary outcomes:
measure: Number of Participants with an Adverse Event (AE)
timeFrame: Day 1 to Day 8
measure: Cmax of AMG 510 Metabolite M24
timeFrame: Day 1 and Day 6
measure: AUClast of AMG 510 Metabolite M24
timeFrame: Day 1 and Day 6
measure: AUCinf of AMG 510 Metabolite M24
timeFrame: Day 1 and Day 6
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Unit, Inc
state: Florida
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04100382: Laser Treated vs SLA Treated Short Implants in Terms of Stability.
Official title: Implant Stability in Laser Treated Surface vs SLA Treated Short Implants (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Will Laser Treated Dental Implants Improve Stability Early Healing
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Laser treated short dental implants will be placed in a posterior atrophic ridge with only 8-10 mm available bone height. Their stability will be measured through a period of 12 weeks. They will be compared to the stability of SLA treated Short dental implants placed in the same situations.

Detailed description: Laser treated short dental implants will be placed in a posterior atrophic ridge with only 8-10 mm available bone height. Their stability will be measured through a period of 12 weeks. They will be compared to the stability of SLA treated Short dental implants placed in the same situations.

Eligibility criteria: Inclusion Criteria:

* • Adult patients with Edentulous posterior maxillae with insufficient ridge for placement of standard length dental implant, but allowing placement of short 8mm dental implant.

  * Males and females.

Exclusion Criteria:

* • Heavy smokers more than 20 cigarettes per day.

  * Patients with systemic disease that may affect normal healing.
  * Psychiatric problems
  * Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
  * Patients suffering from immunodeficiency, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
  * Intraoral soft and hard tissue pathology.

Primary outcomes:
measure: Rate of change in implant stability at base line, 2,4,8, 12 weeks
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02019082: Electrical Stimulation and Expression of VEGF and NO in Diabetic Foot Ulcer
Official title: The Effect of Low-intensity Direct Current on the Expression of Vascular Endothelial Growth Factor and Nitric Oxide in Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: Tarbiat Modarres University
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the effect of low intensity cathodal direct current on the release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in diabetic foot ulceration.

Detailed description: Twenty type 2 diabetic patients with foot ulceration and 13 age-matched healthy subjects were enrolled. Patients were randomly assigned to electrical stimulation (ES, n=10) or sham ES (placebo, n=10) groups. ES group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions). Blood sample was collected for VEGF and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area (WSA) and skin temperature were measured at 1st, 6th, and 12th session.

Eligibility criteria: Inclusion Criteria:

* Wagner classification DFU 2;
* age 40-60 years;
* mild to moderate diabetic neuropathy;
* ABI\>0.7
* wound surface area\>1.5cm2

Exclusion Criteria:

* fracture in a lower limb,
* a severe infection,
* a malignancy,
* kidney failure,
* skin diseases,
* osteomyelitis,
* pregnancy,

Primary outcomes:
measure: The plasma level of VEGF(pg/ml) and NO (microM)
timeFrame: prior to the 1st electrical stimulation session(day 1) and 1 hour later, and prior to the 12th electrical stimulation session(day 26) and 1 hour later
Secondary outcomes:
measure: skin temperature (degree of centigrade)
timeFrame: prior the 1st electrical stimulation session (day 1) and 1 hour later
measure: skin temperature (degree of centigrade)
timeFrame: prior the 6th electrical stimulation session (day 12) and 1 hour later
measure: skin temperature (degree of centigrade)
timeFrame: prior the 12th electrical stimulation session (day 26) and 1 hour later
measure: Wound surface area(cm2)
timeFrame: on day 1, 12, and 26
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Physical Therapy Department, Faculty of Medical Sciences
Study officials:
affiliation: professor of physical therapy, physical therapy department, faculty of medical sciences, tarbiat modares univercity
name: giti torkaman, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05044182: Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula
Official title: Clinical Study of Decompression and Drainage Seton for the Treatment of High Horseshoe Anal Fistula
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anal Fistula
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with high horseshoe anal fistula will be randomized to one of two equal group: treatment group will have decompression and drainage seton and control group will undergo cutting seton.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from high horseshoe anal fistula

Exclusion Criteria:

* Specific cause of fistula e.g. Crohn's disease.
* Previous anorectal surgery.
* Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.
* Patients with serious primary diseases such as tumor, malnutrition, endocrine and hematopoietic system.

Primary outcomes:
measure: Recurrence rate
timeFrame: 12 months after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan friendship
state: Beijing
Study officials:
References:
Clinical trial NCT01211782: AC-1204 Long-term Efficacy Response Trial (ALERT Protocol)
Official title: A Phase 2-3, 6-12 Month, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Daily Administration of AC-1204 in Subjects With Mild to Moderate Alzheimer's Disease Who Are APOE4(-)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
AD
AC-1204
ketogenic
ketosis
Lead sponsor: Cerecin
Sponsor class: INDUSTRY
First posted: 2010-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the safety \& efficacy of AC-1204, a ketogenic compound, administered orally on a daily basis for 6 months. Following the 6 month double-blind phase of the study, subjects may enroll in an optional 6 month open-label extension phase. Efficacy will be evaluated by standard tests of memory and cognition, along with other measurements of activities of daily living and quality of life. Safety will be assessed by frequency of adverse events and changes in laboratory test results. Subjects will be stratified and outcomes will be separately analyzed based on apolipoprotein E4 genotype (APOE4).

Detailed description: Two primary outcome measures will be assessed in APOE4(-) patients:

1. differences from baseline between AC-1204 and placebo groups' ADAS-cog scores at 6 months
2. differences from baseline between AC-1204 and placebo groups' CIBIC+ scores at 6 months Secondary endpoints will include differences between AC-1204 \& placebo groups' scores for these same instruments at 3 months.

Eligibility criteria: Inclusion Criteria:

* Males/females between age of 55 -85 years
* MMSE scores between 16-26
* Probable mild to moderate AD

Exclusion Criteria:

* Presence of other CNS disorders as alternative causes of dementia
* Type 1 or Type 2 diabetes
* Significant renal/hepatic disease

Primary outcomes:
measure: Alzheimer's disease assessment scale - cognitive subscale (ADAS-cog)
timeFrame: 6 months
Secondary outcomes:
measure: Clinicians Interview Based Impression of Change with Caregiver Input (CIBIC+)
timeFrame: 6 months
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: Meridien Research
state: Florida
Study officials:
affiliation: Meridien Research
name: Mildred Farmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04599582: Prospective Randomised Study of a New an Uncemented Stem.
Official title: Prospective Randomised Study of a New Anteverted Uncemented Stem. Randomised Study Between the SP-CL and the Corail Stem With the Use of a Delta Cup.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: hip arthroplasty
Joint replacement
Uncemented stem
Anatomical stem
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Link America, Inc.
First posted: 2020-10-22
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients will be randomised to either operation with a Corail stem or a SP-CL stem. The groups are examined with RSA, conventional x-rays, PROM-data and DXA. First evaluation will be done at two years.


Eligibility criteria: Inclusion Criteria:

* Primary osteoartritis Secondary osteoartritis

Exclusion Criteria:

* Ongoing treatment with corticoid steroids, Active cancer disease, previously known osteoporosis or osteomalacia, inflammatory arthritis, unsuitable anatomy, difficulties to speak or understand the Swedish language.

Primary outcomes:
measure: Oxford hip score
timeFrame: two years
Secondary outcomes:
measure: RSA-examination
timeFrame: two years
measure: Conventional X-rays
timeFrame: two years
measure: Harris hip score
timeFrame: two years
measure: DXA
timeFrame: Two years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04992182: Reactogenicity, Safety, and Immunogenicity of Covid-19 Vaccine Booster
Official title: Reactogenicidad, Seguridad e Inmunogenicidad de Dosis de Refuerzo de Vacunas Contra SARS-CoV-2 en Chile (Estudio REFUERZO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Covid19
Keywords: covid-19
inactivated vaccine
booster
Chile
Lead sponsor: Universidad del Desarrollo
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Chile
name: University of Chile
name: Pontificia Universidad Catolica de Chile
First posted: 2021-08-05
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preliminary data suggest that inactivated vaccine-induced neutralizing antibodies against SARS-CoV-2 decrease at six months after vaccination. Observational, unpublished data also indicate that vaccine effectiveness against Covid-19 wanes over time. Thus, the investigators aimed to determine the reactogenicity, safety, and immunogenicity of a homologous or heterologous booster of SARS-CoV-2 vaccines among people already immunized with an inactivated SARS-CoV-2 vaccine. The study focuses on the elderly population and healthcare workers.


Eligibility criteria: Inclusion Criteria:

* Full immunization with CoronaVac (2 doses; 0,28) prior to April 15, 2021
* Being a resident of any of the eligible Nursing Homes (located in the Metropolitan Region of Chile)
* Healthcare workers of one of the eligible Nursing Homes.
* Healthcare workers of Hospital de Urgencia Asistencia Publica (HUAP, Santiago, Chile)

Exclusion Criteria:

* Prior history of Covid-19
* Not able to consent

Primary outcomes:
measure: Early humoral response
timeFrame: Baseline (90-120 days after second dose of CoronaVac) and 15 days post booster dose
measure: Immunogenicity
timeFrame: Baseline, 15, 30, 60, and 90 days post booster dose
Secondary outcomes:
measure: Reactogenicity
timeFrame: days 7, 28, and 3 months post booster dose
measure: Safety of booster dose
timeFrame: In addition to the scheduled visits mentioned in Outcome 3, Telephone numbers, including the PI´s cell phone will be available 24/7 throughout the study (1 year) for reporting any unsolicited reaction.
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: ELEAMs (Nursing Homes)
city: Santiago
country: Chile
facility: Hospital de Urgencia Asistencia Publica
Study officials:
References:
Clinical trial NCT01495182: Effects of Dietary Fiber on Gastrointestinal Function
Official title: A Double-blind, Randomized, Crossover Trial to Assess the Gastrointestinal Tolerability of a Dietary Fiber Ingredient in Healthy Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Health
Keywords: Dietary fiber
Gastrointestinal toleration
Fecal weight
Lead sponsor: Ingredion Incorporated
Sponsor class: INDUSTRY
First posted: 2011-12-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in healthy, adult volunteers.

Detailed description: The study is a blinded, cross-over design with subjects completing three, two-week treatment periods, separated by two, two-week washouts. Volunteers will consume a dietary fiber for two of the treatment periods at two dose levels. The fiber will be added to foods and dispensed to subjects to be consumed twice a day during each treatment period. During the control period, subjects will receive the same study foods, but with no added fiber. Major outcomes will include fecal weight, and responses to questionnaires that assess fecal characteristics, bowel habits and gastrointestinal tolerability.

Eligibility criteria: Inclusion Criteria:

* healthy men and women
* age 18 - 54 years
* BMI \< 30 kg/m2

Exclusion Criteria:

* presence of GI or other serious diseases known to affect GI function
* recent use of antibiotics
* very high fiber intake
* use of medications known to affect GI function
* presence of allergies to study foods

Primary outcomes:
measure: Gastrointestinal tolerability
timeFrame: subjects will report weekly for 6 weeks
Secondary outcomes:
measure: Fecal output
timeFrame: subjects will collect fecal output for 12 days within a six-week period
Other outcomes:
Locations:
city: Glen Ellyn
country: United States
facility: Provident Clinical Research and Consulting Inc
state: Illinois
Study officials:
affiliation: Provident Clinical Research Center
name: Kevin Maki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05722782: Oral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics
Official title: The Investigation of the Efficacity and Safety of Oral Non Steroidal Anti Inflammatory (NSAI) Drugs Such as Piroxicam as a Second Line Treatment of Patients Consulting the Emergency Department for Renal Colics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Renal Colic
Keywords: Renal Colic
NSAI
Acetaminophen
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 500
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: Treatment with NSAI in renal colics has not been well investigated and there is no clear recommendations regarding this subject.

The aim of this study is to determine if an oral NSAI treatment is beneficial in patients discharged for the emergency department after the first line treatment of a renal colic investigating the reccurence of pain, the reconsultation rates and the admissions.

Detailed description: Renal colic (RC) are a frequent cause of consultation in the emergency departement (ED). It counts for approximatively 20 % of patients presenting to the ED with severe acute onset abdominal pain.

The first line treatment of renal colics is based on NSAI drugs associated with antalgics and is further investigated in the NSAI vs Morphine study (NCT02156596) But there is no clear recommendations regarding the outpatient treatment of renal colics. Oral NSAI are still widely used as a second line medicine for this condition and variety of molecules were tried with non solid scientific arguments.

Piroxicam, a non-selective COX inhibitor drug appared to the oxicam class of NSAI, is widely used to treat rhumatoid and inflammatory disesases, and often prescribed in Tunisia as a second line treatment of RC.

In this study, the investigators aimed to investigate the efficiency and safety of the use of oral NSAI drugs (piroxicam) compared to Acetaminophen or placebo as a second line treatment of renal colics

Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Consenting to participate in the study
* Patients treated in the ED for RC
* No contraindications of NSAI or paracetamol treatment

Exclusion Criteria:

* Contraindication of NSAI treatment
* Patients non reachable by telephone call
* Patients that did not receive or use the treatment

Primary outcomes:
measure: Efficacity of oral NSAI
timeFrame: 07 days
Secondary outcomes:
measure: Safety of NSAI
timeFrame: 07 days
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba University Hospital
Study officials:
References:
Clinical trial NCT02409082: Alzheimers Disease and Neuromarkers in Patients With Acute Hip Fractures
Official title: The Presence of Pre-Alzheimers/Alzheimers Disease (AD) and Neuromarkers Related to Morbidity/Mortality in Patients With Acute Hip Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimers Disease
Inflammation
Hip Fracture
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2015-04-06
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with an acute hip fracture receiving a spinal anesthesia

Brief summary: The investigators explore the presence of AD factors beta-amyloid and tau in CSF and plasma to verify AD diagnosis in patients with acute hip fracture. Clinical dementia test is performed prior to operation. Blood samples and CSF samples are collected at surgery and blood samples are collected postoperatively at intervals. Mortality is assessed at 30 days, 3 months and 1 year. Morbidity is assessed at , 3 months and \>1 year. Neuromarkers specifically addressing the inflammatory component are to be analyzed and correlated to outcome together with AD markers, as above.

Detailed description: The hypotheses explored in this investigation is that patients being pre-AD or having AD have worse prognosis following an acute hip fracture. This has been demonstrated in retrospective studies. In this study we admit all patients with a hip fracture planned tro receive a spinal anesthesia. Our golden standard of anesthesia in this patient cohort. Preoperatively Clinical Dementia Score is assessed after study inclosure. At the performance of the spinal dosage is standardized. Prior to giving this 5 ml of CSF is collected and blood is collected. Blood is then collected at intervals up until day 3 postoperatively. We plan to analyze beta-amyloid and tau in CSF and plasma to verify AD diagnosis in patients with acute hip fracture. Mortality is assessed at 30 days, 3 months and 1 year. Morbidity is assessed at, 3 months and \>1 year. Neuromarkers specifically addressing the inflammatory component are to be analyzed and correlated to outcome together with AD markers, as above.

Eligibility criteria: Inclusion Criteria:

* Hip fracture with a planed spinal anesthesia

Exclusion Criteria:

* Not receiving a spinal anesthesia i.e. no CSF is available

Primary outcomes:
measure: Mortality and morbidity
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Molndal
country: Sweden
facility: Sahlgrenska University Hospital
state: Vastra Gotaland
Study officials:
affiliation: Sahlgrenska University Hospital
name: Bengt M Nellgard, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: