louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01787747: Pharmacokinetics (PK) and Tolerability of AVP-786 in Healthy Volunteers
Official title: A Phase 1, Single-center, Randomized, Double-blind, Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Doses of AVP-786 (Deuterated Dextromethorphan) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Healthy Volunteers
dextromethorphan with quinidine
deuterated dextromethorphan
Lead sponsor: Avanir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-02-11
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To assess the single- and multiple-dose pharmacokinetic (PK), safety and tolerability of AVP-786 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males
* 18 - 45 years of age
* BMI 18 - 30 kg/m2

Exclusion Criteria:

* History or presence of significant disease
* History of substance and/or alcohol abuse within the past 3 years
* Use of tobacco-containing or nicotine-contining products within 6 months
* Use of any prescription of over-the-counter (OTC) medication within 14 days

Primary outcomes:
measure: Plasma concentrations of parent and metabolites
timeFrame: 8 Days
Secondary outcomes:
measure: Safety and tolerability
timeFrame: 8 days
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX
state: South Australia
Study officials:
affiliation: CMAX
name: Sepehr Shakib, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04142047: Skeletal Muscle Energetics and Fatiguability in Older Individuals
Official title: Skeletal Muscle Energetics and Fatiguability in Older Individuals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
HIV Infections
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-10-29
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with and without HIV, ages 60 and above will be enrolled

Brief summary: The investigators are studying whether metabolic abnormalities in calf (leg) muscle in older people with and others without HIV are associated with decreased abilities to exercise.

Detailed description: This research is being done to better understand why some older people living with HIV experience more fatigue and difficulty exercising than older people without HIV. This is important because fatigue and problems exercising are predictors of disability and hospitalization in older individuals. We will use non-invasive magnetic resonance imaging (MRI) and spectroscopy (MRS) of the leg muscle to measure muscle metabolites and fat content, as well as blood samples measures levels of inflammation.

Eligibility criteria: Inclusion Criteria:

* Participants who are \>= 60 years of age
* HIV serostatus positive participants on stable antiretroviral therapy (ART) (no regimen change in last month) with undetectable HIV viral load (\<100 copies).
* HIV serostatus negative participants

Exclusion Criteria:

* Unable to understand the risks, benefits, and alternatives of participation and give meaningful consent
* Contraindications to MRI
* Significant cardiovascular, pulmonary or musculoskeletal or orthopedic disease that significantly limits exercise capacity
* Significant lower extremity peripheral vascular disease.
* Weight greater than 350 lbs
* Cognitive or speech impairments that would limit completion of questionnaires or fatigue reporting.

Primary outcomes:
measure: Maximal mitochondrial oxidative capacity (VmaxPCr)
timeFrame: Baseline
measure: Rate of PCr decline during plantar flexion exercise
timeFrame: Baseline
measure: Six minute walk distance
timeFrame: Baseline
Secondary outcomes:
measure: Skeletal muscle fat content
timeFrame: Baseline
measure: Gait speed
timeFrame: Baseline
measure: Frailty status (as measured by the Fried Frailty Index)
timeFrame: Baseline
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Robert G Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05054647: Mental Stress Symptoms in Family Caregivers of Palliative Patients
Official title: Mental Stress Symptoms in Family Caregivers of Palliative Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Family Caregivers
Palliative Patients
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Family caregivers of palliative patients

Brief summary: Receiving a life-limiting diagnosis is often a shock for those affected as well as for their relatives, which changes the entire life situation of the family. New perspectives often arise, as well as feelings of worry, sadness and powerlessness. Caregiving is often an extreme physical challenge, but above all a psychological one.

Aims of the study

1. To investigate whether family caregivers of palliative patients with severe trait anxiety in the care situation also suffer from severe state anxiety.
2. To investigate whether family caregivers of palliative patients with increased stress levels and burnout-promoting work-related behaviour suffer more from burnout symptoms, health-related anxiety and psychosomatic complaints.
3. To investigate the impact of nursing support by a mobile palliative team on family caregivers of palliative patients.


Eligibility criteria: Inclusion criteria:

* Women and men between 18 and 90 years of age
* Current palliative care situation of a relative with a life-limiting diagnosis.

Exclusion criteria:

* Persons incapable of giving consent (e.g. dementia, delirium, etc.)
* Failure to meet the inclusion criteria

Primary outcomes:
measure: burn-out syndrome, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up)
timeFrame: 2 months
Secondary outcomes:
measure: health-related anxiety, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up)
timeFrame: 2 months
measure: State/Trait anxiety, Outcome is the difference between measurement 1 (Baseline) and measurement 2 (Follow-up)
timeFrame: 2 months
measure: Work-related behaviour and experience pattern, Outcome is the difference between measurement 1 (Baseline) and measurement 2.
timeFrame: 2 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Andreas Baranyi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02032147: Treatment of Cerebral Radiation Necrosis (CRN) With Nerve Growth Factor (NGF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Necrosis
Nashopharyngeal Cancer
Nerve Growth Factor
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients must have undergone definitive RT for histologically confirmed NPC years before. They were required to have at least two consecutive magnetic resonance imaging (MRI) study supporting the diagnosis of CRN with an interval of 3-4 months, with the second MRI showing progressive disease compared with the first MRI. The necrotic mass shown on MRI must be measured in two dimensions in order to define the response to treatment. Other radiologic studies were also required to support the non-existence of local or regional recurrence, distant metastasis. Patients must have undergone mental status examinations and had progressive neurologic symptoms or signs. In addition, they were required to have a Karnofsky performance status of at least 70 and were supposed to live more than 6 months.

Brief summary: Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy for cancers, and may have a devastating effect on the patient's quality of life (QOL). However,CRN was once regarded as a progressive and irreversible disease, no standard therapy has been suggested for CRN. In our clinical practice, we have used nerve growth factor(NGF) to treat CRN, and found that GM1 can successfully reverse CRN. A case report has been published in Journal of Clinical Oncology (JCO) in 2011. So we carried out this prospective study to test the efficacy of NGF for CRN.


Eligibility criteria: Inclusion Criteria:

* The necrotic mass shown on MRI must be measured in two dimensions. No local or regional recurrence, no distant metastasis. Karnofsky performance status of at least 70 and were supposed to live more than 6 months.

Exclusion Criteria:

* CRN combined with local or regional relapse, or with distant metastasis.
* CRN combined with other cerebrovascular disease.
* CRN combined with the second primary malignancy.
* CRN without neurologic symptoms or signs.
* CRN combined with diabetes.
* CRN patients that were supposed to live less than 6 months.

Primary outcomes:
measure: efficacy of using NGF for treating CRN
timeFrame: 6-8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Cancer Center, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT06792747: Evaluation of Diagnostic Accuracy of Artificial Intelligence in Treatment Planning for Non-growing Class II Cases
Official title: Evaluation of Diagnostic Accuracy of Artificial Intelligence in Treatment Planning for Non-growing Class II Cases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Class II Malocclusion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian non-growing individuals with class II malocclusion

Brief summary: The goal of this observational study is to evaluate the diagnostic accuracy of artificial intelligence in non-growing class II cases. The main question it aims to answer is:

Is Artificial Intelligence (AI) accurate in choosing a treatment modality for non-growing class II cases -whether to camouflage or surgical treatment?

participants already undergone orthodontic treatment, their pre-treatment and post-treatment records will be collected from the archive of orthodontic department at Cairo university


Eligibility criteria: Inclusion Criteria:

cases of non-growing patients with class II malocclusion

Exclusion Criteria:

Growing patient with class II malocclusion

Primary outcomes:
measure: Accuracy of Artificial intelligence in choosing\predicting the best treatment modality
timeFrame: from enrollment to the end of treatment at 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03167047: Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery
Official title: Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Inguinal
Lead sponsor: Medway NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Two methods of pain control in children undergoing surgery on the groin and scrotum are caudal injection (a form of epidural) with local anaesthetic, and a regional nerve block (an injection of local anaesthetic around the nerves supplying the area). A pilot study at our hospital showed a significant decrease in post-operative pain and nausea and vomiting in these two methods when compared to intravenous morphine and local anaesthetic to the wound.

One potential side effect from caudal injections is temporarily decreased motor power in the legs due to the local anaesthetic - it is thought that this might be overcome using a more dilute solution of local anaesthetic along with clonidine. This study is to demonstrate that this method is as effective as the use of a regional nerve block.


Eligibility criteria: Inclusion Criteria:

* Children undergoing day case elective inguinal-scrotal surgery

Exclusion Criteria:

* Contraindication to technique
* Significant comorbidities
* Patient/parent refusal

Primary outcomes:
measure: Pain relief
timeFrame: Discharge postoperatively (approximately 2-4 hours postoperatively)
measure: Pain relief
timeFrame: Discharge postoperatively (approximately 2-4 hours postoperatively)
Secondary outcomes:
measure: Motor paresis assessed with the Bromage score
timeFrame: Discharge postoperatively (approximately 2-4 hours postoperatively)
Other outcomes:
Locations:
city: Gillingham
country: United Kingdom
facility: Medway NHS Foundation Trust
state: Kent
Study officials:
affiliation: Medway NHS Foundation Trust
name: Kumarvel Veerappan, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01233947: Study of AFP464 +/- Faslodex in ER + Breast Cancer
Official title: A Randomized Phase II Study of AFP464 +/- Faslodex in ER Positive Breast Cancer Patients Who Had Progressed on Aromatase Inhibitor (AI) Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Neoplasm
Lead sponsor: Tigris Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-11-03
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: AFP464 is an investigational agent which may be effective in the treatment of cancer. The purpose of this study is to test the efficacy of AFP464 +/- Faslodex in ER+ breast cancer patients.

Detailed description: This is a randomized, open-label study. Patients will be randomized in a 1:1 ratio to single arm AFP464, or AFP464+Faslodex. Patients will be treated until disease progression is noted.

Eligibility criteria: Inclusion Criteria:

* proven breast cancer, ER+ status; progression on an aromatase inhibitor; measurable disease or evaluable disease with serum CA27.29\>=50 U/mL; adequate bone marrow, liver and renal function; DLco grade 0 or 1.

Exclusion Criteria:

* HER2 positive, thoracic radiotherapy or symptomatic pulmonary disease, brain metastases,

Primary outcomes:
measure: Clinical Benefit Response
timeFrame: 6 months
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 6 months
measure: Number of participants with adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
Study officials:
affiliation: Texas Oncology-Baylor Charles A. Sammons Cancer Center
name: Joanne L. Blume, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01103947: EcoAnaesthesia Facemask Versus Standard Facemask During Anesthesia Induction
Official title: A Comparison of the Efficiency of the New EcoAnaesthesia Facemask With a Standard Facemask During Induction of Anesthesia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anesthesia Induction
Keywords: Anesthesia induction
Facemask
surgery
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will evaluate the efficiency of the EcoAnesthesia mask and its advantages over the standard facemask used in our practice. The satisfaction by the anesthesia provider and its ease of use may change the standard practice in airway management. In addition to these additional effects on patient safety, the facemask is affordable and may reduce the environmental burden of anesthesia waste.


Eligibility criteria: Inclusion Criteria:

* ASA physical status class 1-2
* Undergoing elective surgery
* Aged between 18 and 75 years

Exclusion Criteria:

* Severe acute or chronic lung disease requiring oxygen-therapy;
* Hiatus hernia with gastro-esophageal reflux or other esophageal or gastric abnormalities that require a rapid sequence induction;
* Food intake within the last 6 hours or clear fluid intake within 2 hours prior to surgery;
* Ischemic or congenital heart disease;
* Pregnancy (confirmed by a pregnancy test);
* Patient is scheduled for regional anesthesia and denies conductance of general anesthesia during the surgical procedure;
* Known difficult intubation in the past.
* Difficult Mask Ventilation. Patients having any two of the criteria listed below will be Categorized as "Difficult Mask Ventilation (DMV)" (5,13,14) and will be excluded from enrollment. All others will be classified as "Normal." Age \> 55 BMI \> 26 kg/m2 Lack of teeth Presence of beard History of snoring Limited mandibular protrusion

Primary outcomes:
measure: End-tidal oxygen concentration
timeFrame: three minutes
Secondary outcomes:
measure: Maximum airway pressure
timeFrame: End of 3 minutes with each mask
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Detlef Obal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87.
Clinical trial NCT02292147: Functional Outcome After Cardiac Arrest
Official title: Functional Outcome After Cardiac Arrest; Prediction and Prognosis Factors for Patients Awake Within the First 15 Days
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Out of Hospital Cardiac Arrest
Keywords: Cerebral anoxia
Functional outcome
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting an Out of hospital cardiac arrest

Brief summary: Descriptive and prognosis study of the functional outcome after cardiac arrest for the patients awake within the first 15 days.

Detailed description: Functional outcome after cerebral anoxia due to cardiac arrest is poorly documented.. Survival after out of hospital cardiac arrest has improved and long term follow up of the patients is not routinely effective. Patients showing sign of awakening very early are considered in a good outcome group. Nevertheless they can experience some restriction and difficulties when they try to return to their premorbid level of functioning.

We aim to study their long term functional outcome and their level of anxiety, depression, quality of life and caregiver burden as well as their general cognitive functioning. Prognosis factors will be studied in the acute phase.

Eligibility criteria: Inclusion criteria :

* age 18 to 85
* Out of hospital cardiac arrest ; cardiac arrest in the ER is eligible
* Glasgow Coma Score ≥ 12 within 15 days after onset
* Living in the parisian area

Exclusion criteria :

* no social security
* Neurological condition (multiple sclerosis, parkinson disease, AMS, stroke) priori to the cardiac arrest
* Psychiatric condition (schizophrenia, severe bipolar syndrome, long term neuroleptic medication, autistic spectrum disorders
* Deafness and blindness
* Neoplasia
* Premorbid limitation of autonomy.
* Difficulties in speaking and writing the French language

Primary outcomes:
measure: Glasgow outcome Scale Extended score
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié salpetriere Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Anne Peskine, MD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Charles-Edouard Luyt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peskine A, Cariou A, Hajage D, Deye N, Guerot E, Dres M, Sonneville R, Lafourcade A, Navarro V, Robert H, Azouvi P, Sharshar T, Bayen E, Luyt CE; Hanox Study Group. Long-Term Disabilities of Survivors of Out-of-Hospital Cardiac Arrest: The Hanox Study. Chest. 2021 Feb;159(2):699-711. doi: 10.1016/j.chest.2020.07.022. Epub 2020 Jul 20.
Clinical trial NCT06957847: Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 (WIHYP-GP)
Official title: Clinical Validation Of The Brachial Blood Pressure Measuring Device Withings BPM Pro 2 According To "The Universal Protocol For The Validation Of Blood Pressure Measuring Devices By The Association For The Advancement Of Medical Instrumentation / European Society Of Hypertension / International Organization For Standardization (AAMI/ESH/ISO) (And Its Amendment 1 (2020) And 2 (2024))" In The General Population.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Withings
Sponsor class: INDUSTRY
First posted: 2025-05-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The aim of the study is to assess the accuracy of the automatic oscillometric BP measuring device at the brachial level, the WITHINGS BPM Pro 2, in the general population


Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years;
* Patient who signed the informed consent form;
* Patient followed-up at site (in-patient or out-patient);
* Patient with arm circumference between 22 cm and 42 cm.

Exclusion Criteria:

* Patient unable to give a consent or understand properly protocol information;
* Patient suffering from arrhythmia;
* Patient with poor quality of Korotkov sounds;
* Patient for whom K5 sounds are absent;
* Patient wearing an implantable electric medical device (pacemaker,...);
* Patient with both upper arms suffering from open wound and/or damaged skin.

Primary outcomes:
measure: Blood pressure measurement performance evaluation per measure
timeFrame: The time frame is three months.
measure: Blood pressure measurement performance evaluation by subject
timeFrame: The time frame is three months.
Secondary outcomes:
measure: Safety use of the device
timeFrame: The time frame is three months.
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: N2
Study officials:
References: