louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05581758: A Study to Assess the Effect of Food on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
Official title: An Open-label, Randomized, 2-period, 2-treatment Crossover Study to Assess the Effect of Food 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
Sotorasib
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-10-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of the study is to evaluate the PK of AMG 510 administered in the fasted and fed state in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Healthy male participants or female participants, 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 Plasma Concentration (Cmax) of AMG 510
timeFrame: Day 1 and Day 4
measure: Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 510
timeFrame: Day 1 and Day 4
measure: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 510
timeFrame: Day 1 and Day 4
Secondary outcomes:
measure: Number of Participants with an Adverse Event (AE)
timeFrame: Day 1 to Day 6
measure: Cmax of AMG 510 Metabolite M24
timeFrame: Day 1 and Day 4
measure: AUClast of AMG 510 Metabolite M24
timeFrame: Day 1 and Day 4
measure: AUCinf of AMG 510 Metabolite M24
timeFrame: Day 1 and Day 4
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 NCT05325658: Influence of Modified Diet, Exercise and Electrical Swallowing Muscle Stimulation on Swallowing Function and Quality of Life in Elderly Patients With Oropharyngeal Dysphagia
Official title: Influence of Modified Diet, Exercise and Electrical Swallowing Muscle Stimulation on Swallowing Function and Quality of Life in Elderly Patients With Oropharyngeal Dysphagia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oropharyngeal Dysphagia
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Geriatric patients treated at Kaunas Hospital who meet the inclusion criteria.

Brief summary: Tasks of biomedical research:

1. To determine the severity of oropharyngeal dysphagia and the risk of aspiration in elderly patients.
2. To evaluate the quality of life of older patients with oropharyngeal dysphagia by performing validation of the Lithuanian version of the quality of life questionnaires in patients with oropharyngeal dysphagia.
3. To evaluate the severity of oropharyngeal dysphagia in elderly patients, the risk of aspiration, and quality of life after interventions.

Data on the sex, age and disease of the swallowing disorder will be collected. No processing of other personal data and health indicators is planned. All data will be collected in questionnaires. The data will be depersonalized by giving the patient a code.

The results and conclusions of the research will be described in the doctoral dissertation and will be used for scientific articles.


Eligibility criteria: Inclusion Criteria:

* Patients 60 years of age and older;
* Swallowing disorder suspected during hospitalization - oropharyngeal dysphagia;
* Patient's written consent.

Exclusion Criteria:

* severe oropharyngeal dysphagia (when feeding into the stomach through a nasogastric tube is required);
* Significant respiratory or heart failure: dyspnoea (respiratory rate\> 20 rpm, SpO2 \<90%), tachycardia (HR\> 100 rpm);
* very severe malnutrition (severe exhaustion, severe signs of sarcopenia);
* final stage of oncological disease;
* severe dementia (Short Mental Test (MMSE) \<10 points);
* Ingestion assessment with a fibroendoscope (FEES) did not reveal any swallowing problems (no dysphagia).

Primary outcomes:
measure: Evaluation of the influence of modified diet, exercise and electrical swallowing muscle stimulation on swallowing function and quality of life in elderly patients with oropharyngeal dysphagia.
timeFrame: 2021-2024
measure: Evaluation of the influence of modified diet, exercise and electrical swallowing muscle
timeFrame: 2021-2024
measure: Evaluation of the influence of modified diet, exercise and electrical swallowing muscle
timeFrame: 2021-2024
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Margarita Rugaitienė
Study officials:
References:
Clinical trial NCT05897658: Levetiracetam Prophylaxis in Brain Tumor Resection Pilot
Official title: Pilot Study: Levetiracetam Prophylaxis Randomized Controlled Trial in Brain Tumor Resection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Seizures
Brain Tumor
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2023-06-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate feasibility of a double-blind randomized controlled trial for levetiracetam prophylaxis for prevention of seizure in the perioperative phase of brain tumor resection.


Eligibility criteria: Inclusion Criteria:

* Adult age 18 years or older
* Undergoing craniotomy for a brain tumor
* Intra-axial tumor location
* Supratentorial tumor location

Exclusion Criteria:

* Documented seizure history or epilepsy diagnosis
* Currently taking an antiepileptic medication
* Unable to take levetiracetam (e.g. allergy, inability to swallow)
* Inability to obtain consent from participant or substitute decision maker prior to surgery
* Renal impairment with eGFR less than 50
* Pregnancy

Primary outcomes:
measure: Recruitment Rate
timeFrame: Through study completion, approximately 1 year
Secondary outcomes:
measure: Fraction of eligible patients approached
timeFrame: Through study completion, approximately 1 year
measure: Fraction of approached patients consent
timeFrame: Through study completion, approximately 1 year
measure: Role of individual who approached patients
timeFrame: Through study completion, approximately 1 year
measure: Protocol adherence
timeFrame: Through study completion, approximately 1 year
measure: Protocol adherence
timeFrame: Through study completion, approximately 1 year
measure: Protocol adherence
timeFrame: Through study completion, approximately 1 year
measure: Protocol adherence
timeFrame: Through study completion, approximately 1 year
measure: Adverse events
timeFrame: Through study completion, approximately 1 year
measure: Unblinding events
timeFrame: Through study completion, approximately 1 year
Other outcomes:
measure: New onset seizure within 7 days of surgery
timeFrame: 7 days post-surgery, reviewed at follow-up between post-operative day 8 and 14
measure: Incidence of infection during Study Drug administration
timeFrame: Follow-up between post-operative day 8 and 14
measure: Incidence of psychiatric symptoms during Study Drug Administration
timeFrame: Follow-up between post-operative day 8 and 14
measure: Length of hospital stay in days
timeFrame: Hospital discharge
measure: Incidence of administration of any antiepileptic drugs
timeFrame: Follow-up between post-operative day 8 and 14
measure: Incidence of administration of any benzodiazepines
timeFrame: Follow-up between post-operative day 8 and 14
Locations:
Study officials:
References:
Clinical trial NCT02453958: Mild Traumatic Brain Injury Discrimination
Official title: Non-Invasive Assay to Discriminate Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Concussion
Keywords: Injury
Brain
Traumatic Mild
Mild Traumatic Brain Injury
Lead sponsor: Empirical Technologies Corporation
Sponsor class: INDUSTRY
Collaborators: name: Hunter Holmes Mcguire Veteran Affairs Medical Center
name: Walter Reed Army Medical Center
First posted: 2015-05-27
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of the utility of a multi-modal assessment tool in distinguishing between individuals with and without a history of mild traumatic brain injury.

Detailed description: This was a preliminary validational study of a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests on a new hardware platform, the Computerized Brain Injury Assessment System (CBIAS). Using receiver operator curve (ROC) analyses, 1) a subset of the most discriminating neuro-physiological assessment tests involving smooth pursuit eye motion (SPEM) tracking errors, corrective saccade counts, a balance score ratio sensitive to vestibular balance performance and two neurocognitive tests of response speed and memory/incidental learning, was identified, 2) the enhancement in discriminatory capability of detecting concussion-related deficits through the combination of the identified subset of assessments was demonstrated, and 3) the effectiveness of a robust and readily implemented global scoring approach was demonstrated for both eye track and balance assessment tests. These results are significant in introducing a comprehensive solution for concussion assessment that incorporates an economical, compact and mobile hardware system and an assessment battery that is multi-modal, time efficient and whose efficacy has been demonstrated on a preliminary basis. This represents a significant step toward the goal of a system capable of making a dependable return-to-play/duty determination based on concussion likelihood.

Eligibility criteria: Inclusion Criteria:

* Military personnel
* Age 18 to 45
* Diagnosis of mTBI within past 5 years
* Rancho Los Amigos Scale score of 7 or above

Exclusion Criteria:

* Non-military individuals
* Below age 18 or older than 45
* No diagnosis of mTBI within past 5 years
* Rancho Los Amigos Scale score of 6 or below

Primary outcomes:
measure: Receiver-operator-curve area under the curve (AUC)
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Empirical Technologies Corporation
name: Martin C. Baruch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05771558: The Effect of a Lighting Intervention on Sleep in Parkinson Disease
Official title: Non-motor Features of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Sleep Disturbance
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 50 participants with Parkinson's disease will be recruited to complete actigraphy studies to assess sleep disturbances. For this, participants will wear an Actigraph for seven days. Thirty of these participants with sleep disturbance will go on to receive a tailored lighting intervention (TLI) to assess the effect on sleep, fatigue, and circadian entrainment via urinary melatonin levels.

Detailed description: Participants will undergo one week of baseline data collection using the actigraph and light meter and one night of an overnight urine collection. At the completion of the baseline week, the lighting intervention will be installed in the participants' home. Participants will be exposed to the lighting intervention for 2 hours each morning after awakening for 8 weeks. During the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days and collect one overnight urine sample. Participants will complete questionnaires before and after the intervention to further assess its effects.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Parkinson's disease and difficulties with sleep and/or cognition

Exclusion Criteria:

* There are no exclusion criteria

Primary outcomes:
measure: Sleep duration using Actigraph
timeFrame: at Baseline for 7 days
measure: Sleep duration using Actigraph
timeFrame: at Week 8 for 7 days
Secondary outcomes:
measure: Sleep efficiency using Actigraph
timeFrame: at Baseline for 7 days
measure: Sleep efficiency using Actigraph
timeFrame: at Week 8 for 7 days
measure: Urine melatonin levels
timeFrame: at Baseline
measure: Urine melatonin levels
timeFrame: at Week 8
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
Study officials:
affiliation: Mount Sinai Beth Israel
name: Rachel Saunders-Pullman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01065558: Safety and Tolerability of the D1 Dopamine Receptor Antagonist Ecopipam in Patients With Lesch-Nyhan Disease
Official title: A Safety and Pilot Activity Study of Ecopipam (PSYRX 101) in the Symptomatic Treatment of Self-Injurious Behavior in Subjects With Lesch-Nyhan Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lesch-Nyhan Disease
Keywords: Ecopipam
Lesch-Nyhan Disease
Safety
Self-Injurious Behavior
Lead sponsor: Psyadon Pharma
Sponsor class: INDUSTRY
First posted: 2010-02-09
Enrollment: 5
Sex: MALE
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of ecopipam in patients with Lesch-Nyhan Disease (LND). Ecopipam specifically blocks the actions of one chemical in the brain that helps nerves talk to one another; ecopipam does this by stopping the chemical (dopamine) from binding to one of its family of receptors (i.e, the D1 family). LND is a very rare genetic disease. The sponsor is doing this study to find out what side effects ecopipam causes in LND patients, and whether ecopipam may be able to relieve the self-injurious behaviors seen in these patients.


Eligibility criteria: Inclusion Criteria

* Diagnosis of Lesch-Nyhan disease with moderate to severe Self- Injurious Behavior and are routinely restrained
* Male - 6 years of age and above
* Body weight greater than or equal to 44 pounds

Exclusion Criteria:

* Taking Neuroleptic or Dopamine Depleting medications
* Currently treated with medications for depression or seizures
* Impaired renal function
* Medical conditions that may interfere with completing the study

Primary outcomes:
measure: Number of Participants With Clinically Significant Changes in Standard Laboratory Tests
timeFrame: Two weeks
Secondary outcomes:
measure: Decrease in Self-injurious Behavior at End of Study (Two Weeks After Screening) Compared to Screening
timeFrame: Screening visit and end of study (two weeks)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: Atlanta
country: United States
facility: Emory Univesity
state: Georgia
Study officials:
affiliation: Emory University
name: Hyder A Jinnah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: William L Nyhan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chipkin RE, Iorio LC, Coffin VL, McQuade RD, Berger JG, Barnett A. Pharmacological profile of SCH39166: a dopamine D1 selective benzonaphthazepine with potential antipsychotic activity. J Pharmacol Exp Ther. 1988 Dec;247(3):1093-102.
Clinical trial NCT01969396: Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology
Official title: Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Menorrhagia
Endometrial Neoplasms
Polycystic Ovary Syndrome
Uterine Neoplasms
Keywords: Biopsy
Endometrial biopsy
Endometrial sampling
sonohysterography
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2013-10-25
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.


Eligibility criteria: Inclusion Criteria:

* Patient with thickened endometrium
* Abnormal uterine bleeding

Exclusion Criteria:

* Pregnant
* Active pelvic infection
* Pelvic inflammatory disease
* Blood clotting disorders
* Sexually transmitted disease
* Uterine perforation
* Recent cesarean section

Primary outcomes:
measure: percentage of adequate endometrial biopsies utilizing sonohysterography
timeFrame: 7 days
measure: percentage of adequate endometrial biopsies collected without sonohysterography
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Panama City
country: Panama
facility: Hospital Punta Pacifica
Study officials:
affiliation: Hospital Punta Pacifica
name: Ricardo Mastellari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03271996: Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus
Official title: Two Surgical Techniques for the Treatment of Pilinidal Sinus: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pilonidal Sinus
Keywords: Pilonidal sinus
Bascom
Cleft lift
Fistulectomy
Karydakis
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

Brief summary: This study wants to improve patient care affected by pilonidal sinus during and after surgery. Pilonidal sinus excision is a frequent procedure, despite this, there is still not an appropriate surgical technique because of a lack of quality comparative studies.

Detailed description: This is a randomized controlled trial. The study will compare the healing of the surgical wound and the recurrence rate after excision and primary para-median closure versus narrow orifice excision (fistulectomy)

Group A: excision and paramedian closure according to modified Karydakis technique

Group B: removal / fistulectomy by scalpels or trephines of primary and drainage orifices, healing of the wound by secondary intention

Eligibility criteria: Inclusion Criteria:

* Pilonidal cyst requiring surgery
* Signed Informed Consent Form

Exclusion Criteria:

* Abnormal lesions
* Injuries requiring a closing with rotation flap

Primary outcomes:
measure: Complete healing
timeFrame: 3 weeks
Secondary outcomes:
measure: Time to recovery
timeFrame: 12 months
measure: percentage of relapse
timeFrame: 12 months
Other outcomes:
Locations:
city: Lugnao
country: Switzerland
facility: Ospedale Regionale di Lugano
Study officials:
References:
citation: Popeskou SG, Pravini B, Panteleimonitis S, Vajana AFDT, Vanoni A, Schmalzbauer M, Posabella A, Christoforidis D. Conservative Sinusectomy vs. excision and primary off-midline closure for pilonidal disease: a randomized controlled trial. Int J Colorectal Dis. 2020 Jul;35(7):1193-1199. doi: 10.1007/s00384-020-03551-9. Epub 2020 Mar 6.
Clinical trial NCT05064696: PICO- Single-use Negative Pressure Wound Therapy System
Official title: Prospective Comparison of Wound Complications After Anterior Total Ankle Arthroplasty With and Without PICO Negative Pressure Incisional Dressing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Ankle Arthroplasty
Keywords: Total ankle arthroplasty
PICO
Ankle
Ankle joint
Arthroplasty
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2021-10-01
Enrollment: 150
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: To compare the rate of wound complications with the PICO dressing versus a standard nonstick gauze dressing in patients undergoing anterior total ankle arthroplasty.

Detailed description: Participating subjects will be randomized to one of the study groups: Group 1 (Control group) or Group 2 (Treatment group). If randomized to Group 1- after surgery, the doctor will apply the standard non-stick gauze dressing to the wound. If randomized to Group 2- after surgery, the doctor will apply the PICO dressing to the wound.

The goal of the study is to measure the rate of wound complications based on wound assessment, patient-reported outcomes surveys, as well as peri- and post-operative data.

Eligibility criteria: Inclusion Criteria:

* Patient ≥18 years old
* Subjects undergoing total ankle arthroplasty or uncomplicated revision total ankle arthroplasty
* Subjects able to provide informed consent
* Subjects who are able to understand and comply with study visit schedule and procedures

Exclusion Criteria:

* History of previous deep infection or history of wound complication necessitating plastic surgery intervention
* Allergy to products used in the study
* Pregnant and breastfeeding women due to anesthesia risks
* Subjects with a known history of poor compliance with medical treatment
* Subjects who decline participation in this research study
* Prisoners

Primary outcomes:
measure: Wound complications
timeFrame: Approximately 12-weeks after surgery (or until 3-month postop visit is completed)
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Amy Loveland
state: Maryland
Study officials:
affiliation: MedStar Health
name: Walter C Hembree, MD
role: PRINCIPAL_INVESTIGATOR
References: