louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01806415: Pharmacokinetics and Side Effects of the mGlu5 Antagonist Fenobam in Adult Healthy Volunteers
Official title: A Double Blind, Randomized, Single Dose, Placebo Controlled Study of the Pharmacokinetics and Side Effects of the mGlu5 Antagonist Fenobam in Adult Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Fenobam,
Pharmacokinetics
side effects
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-03-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a randomized, blinded, parallel group, placebo-controlled trial on 32 evaluable healthy male and non-pregnant female, 18-50 year old volunteers. The investigators goal is to observe the pharmacokinetics of fenobam after oral administration of 50, 100 or 150 mg in groups of healthy individuals and to compare the side effects and tolerability of a single dose of fenobam with placebo.

Detailed description: Treatment regimen 1: Fenobam \[1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate\], oral administration of one 50 mg gelatin capsule.

Treatment regimen 2: Fenobam, oral administration of one 100 mg gelatin capsule.

Treatment regimen 3: Fenobam, oral administration of one 150 mg gelatin capsule.

Treatment regimen 4: Placebo (lactose), oral administration of one 150 mg gelatin capsule.

Eligibility criteria: Inclusion Criteria

1. 18-50 yr old
2. Good general health with no remarkable medical conditions (e.g liver, kidney, heart, or lung failure), BMI\<33 and no known drug allergies.
3. Willing to comply with study guidelines as outlined in protocol
4. Willing to provide informed consent.

Exclusion Criteria

1. Medication use (prescription or non prescription medications, vitamins, herbals, dietary and mineral supplements and grapefruit products during or within 14 days prior to study participation; excludes contraceptives)
2. History of addiction to drugs or alcohol (prior or present addiction or treatment for addiction)
3. Pregnant or nursing female
4. Lactose intolerance
5. Smokers

Primary outcomes:
measure: Pharmacokinetic data after oral administration of 50, 100 or 150 mg of fenobam in groups of healthy individuals.
timeFrame: 24 hours
Secondary outcomes:
measure: Number of participants with adverse events as a measure of tolerability
timeFrame: 1 week
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Laura Cavallone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02044315: Prevention of Inappropriate ICD Shocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Inappropriate ICD Therapy
Appropriate ICD Therapy
Lead sponsor: Yuksek Ihtisas Hospital
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 201
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: The aim of the present study is to investigate whether increasing detection zones can effectively reduce inappropriate ICD therapies in primary prevention patients.


Eligibility criteria: Inclusion Criteria:

* \> 18 years
* Cardiomyopathy (ischemic or not)
* Current accepted indication for ICD implantation

Exclusion Criteria:

* Previous device implantation
* Secondary prevention patients
* Pregnancy,
* Primary electrical disorders,
* Patient refusal,
* \<1 year of expected mortality

Primary outcomes:
measure: First total inappropriate therapy
timeFrame: 12 months
measure: Occurence of first total appropriate therapy at 12-month follow-up
timeFrame: 12 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: 12 months
measure: Hospitalization for heart failure
timeFrame: 12 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Yuksek Ihtisas Hospital
state: Cankaya
Study officials:
References:
Clinical trial NCT05728515: A Small-molecule Carbonic Anhydrase IX Targeting PET Tracer in Clear Cell Renal Cell Carcinoma
Official title: Pilot Clinical Evaluation of a Small-molecule Carbonic Anhydrase IX Targeting PET Tracer in Clear Cell Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Clear Cell Renal Cell Carcinoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this pilot clinical trial is to see the potential application of a CAIX targeted PET. tracer in patients with clear cell renal cell carcinoma. The main question\[s\] it aims to answer are:

* The biodistribution of the PET tracer
* Whether RCC lesions can be identified by the PET tracer Participants will undergo 68Ga-NY104 PET/CT scan and images will be reviewed by nuclear medicine specialists.

Detailed description: PET/CT imaging of three patients using 68Ga-NY104 for medical reasons will be performed. Patients received an intravenous injection of 68Ga-NY104. Images will be obtained at 0.5 h, 1 h, and 2 h after injection. A comparative 18F-FDG PET/CT scan will also be performed if necessary. The study will be carried out on a time-of-flight PET/CT scanner. SUVmax and SUVmean of normal organs and lesions, as well as tumor-to-background ratios, will be quantitatively assessed using a region-of-interest technique.

Eligibility criteria: Inclusion Criteria:

1. Confirmed or suspected metastatic ccRCC
2. Age ≥ 18 y
3. Written informed consent provided for participation in the trial
4. In the opinion of investigator, willing and able to comply with required study procedures.

Exclusion Criteria:

1. Patients on VEGF TKI treatment \< 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required.
2. Pregnancy or breastfeeding.
3. Severe claustrophobia.

Primary outcomes:
measure: Biodistribution of 68Ga-NY104 in normal organs
timeFrame: From study completion to 2 hour after completion
measure: Tumor uptake of 68Ga-NY104
timeFrame: From study completion to 2 hour after completion
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Uion Medical College Hospital
name: Li Huo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01701115: Effect of Local Anesthetic Dose on Interscalene Block
Official title: Effect of Local Anesthetic Dose on Interscalene Block for Shoulder Arthroscopy, Patient Satisfaction and Return of Handgrip Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Arthroscopy
Interscalene Block
Keywords: Interscalene Block
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a decrease in the standard volume of local anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate anesthesia for the procedure and decrease the amount of time until you are ready for discharge from the hospital.

Detailed description: Traditionally, an interscalene block is done either with nerve stimulator or ultrasound guided using 40-60mL of local anesthetic. The study plans to investigate the difference in hand grip strength post-operatively in patients who will receive interscalene blocks with 40mL versus a lower dose (20mL) of local anesthetic. We suspect the lower dose will achieve adequate surgical anesthesia while creating less motor block and thus, increase patient satisfaction, present fewer complications or adverse affects and decrease time in the recovery room.

Eligibility criteria: Inclusion Criteria:

* Age: 18 - 80 years old
* Surgical time \< 2.5 hours
* ASA I, II or III
* Shoulder arthroscopy

Exclusion Criteria:

* Age \< 18 or \> 80 years old
* Chronic pain patients (on narcotics/opioids \> 3 months)
* Open shoulder surgical procedure
* BMI \> 40
* Pre-existing neurological condition
* Patient refusal of interscalene block
* Severe respiratory disease or hemidiaphragmatic dysfunction
* Allergy to any local anesthetics
* Planned general anesthesia

Primary outcomes:
measure: Handgrip Strength
timeFrame: Difference between between baseline and postoperative.
Secondary outcomes:
measure: Patient Readiness to Discharge
timeFrame: Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)
measure: Duration of Analgesia
timeFrame: Postoperative Day 2
measure: Side Effects
timeFrame: Postoperative Day 2
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References:
Clinical trial NCT04100915: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in ME/CFS
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent by patient
2. Male or female patients age 18 and older.
3. Diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) based on the proposed diagnostic criteria of the National Academy of Medicine

Exclusion Criteria:

1. Refusal by patient to sign informed consent form
2. Treatment with antibiotics within 2 weeks prior to screening
3. Treatment with probiotics within 6 weeks prior to screening
4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
5. Postoperative stoma, ostomy, or ileoanal pouch
6. Participation in any experimental drug protocol within the past 12 weeks
7. Treatment with total parenteral nutrition
8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
9. Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire stud

Primary outcomes:
measure: Correlation of Microbiome to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) via Relative Abundance Found in Microbiome Sequencing
timeFrame: 1 year
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: 1 year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02414815: Reverse Prediction of Ion Channel Remodeling in Patients With Atrial Fibrillation Utilizing Monophasic Action Potential and Mathematical Modeling
Official title: Reverse Prediction of Ion Channel Remodeling in Patients With Atrial Fibrillation Utilizing Monophasic Action Potential and Mathematical Modeling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-04-13
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Atrial fibrillation(AF) is the most common sustained arrhythmia in humans. The loss of rate-dependent action potential duration(APD) adaptation is one of the characteristics of atrial fibrillation, but detailed understanding of mechanism is limited. Thus, we propose to utilize the monophasic action potential recording data from human patients in three groups, control, paroxysmal and persistent atrial fibrillation, and apply reverse engineering method to quantify the extent of electrical remodeling of ionic channel parameters using a mathematical model of atrial cell. Our approach will be useful in developing drug targets for ion channels in atrial fibrillation patients.


Eligibility criteria: Inclusion Criteria:

* Patients agreement of consent
* AF patient age 19-75
* Patients who undergoing catheter ablation of atrial fibrillation or supraventricular tachycardia
* Patient agreement of consent who admission for catheter ablation

Exclusion Criteria:

* Patients who do not agree with study inclusion
* Permanent AF refractory to electrical cardioversion
* AF with rheumatic valvular disease
* Patients with left atrial diameter greater than 60mm
* Patients with age less than 19 or more 75

Primary outcomes:
measure: Recurrence of AF
timeFrame: One year after the last enrollment
measure: Antiarrhythmic drug sensitivity
timeFrame: One year after the last enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University Health System
Study officials:
References:
Clinical trial NCT06421415: Long Term Effect of AIT in Children
Official title: Long Term Effect of AIT in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allergy in Children
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with moderate to severe allergy to grass pollen, birch, house dust mites or venom who are prescribed allergen immunotherapy

Brief summary: The present study will investigate the long term effect of allergen immunotherapy in a real-life study in children with allergy undergoing subcutaneous or sublingual immunotherapy with grass pollen, birch, house dust mites or venom.

Detailed description: The study will include children aged 5- 18 years who are treated with immunotherapy at Hans Christian Andersen Children' Hospital, Odense University Hospital.

Informed consent to be registered in a database and to receive a questionnaire 5 and 10 years after end of treatment are obtained before start of immunotherapy.

Base line data include information from the patient record: symptoms, medication, blood test and skin prick test results. During treatment effect, medication use, lung function and adverse events are monitored systematically once a year.

The questionnaires 5 and 10 years after end of treatment will focus on allergy symptoms, use of medication and asthma symptoms.

Eligibility criteria: Inclusion Criteria: treated with allergen immunotherapy at HCA Children'sHospital, Odense University Hospital -

Exclusion Criteria: received less than 12 months of treatment with allergen immunotherapy

-

Primary outcomes:
measure: Effect of immunotherapy 5 years after end of treatment
timeFrame: 5 years
Secondary outcomes:
measure: Effect of immunotherapy 10 years after end of treatment
timeFrame: 10 years
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Hans Christian Andersen Children's Hospital
state: Odense C
city: Odense
country: Denmark
facility: Hans Christian Andersen Children's Hospital
Study officials:
affiliation: Odense University Hospital
name: Josefine Gradman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04542915: COVID-19-Related Health and Practices Among Dental Hygienists
Official title: COVID-19-Related Health and Practices Among Dental Hygienists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV Infection
Anxiety
Depression
Occupational Problems
Severe Acute Respiratory Syndrome
Coronavirus Infection
Lead sponsor: American Dental Association
Sponsor class: OTHER
Collaborators: name: American Dental Hygienists Association
First posted: 2020-09-09
Enrollment: 6976
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dental hygienists licensed in the United States

Brief summary: As dental practices reopen their practices during a global pandemic, the risk of 2019 novel coronavirus (COVID-19) infection that dental hygienists face in providing dental care remains unknown. Estimating the occupational risk of COVID-19, and producing evidence on the types of infection control practices and dental practices that may affect COVID-19 risk, is therefore imperative. These findings could be used to describe the prevalence and incidence of COVID-19 among dental hygienists, determine what infection control steps dental hygienists take over time, describe dental hygienists' employment during the COVID-19 pandemic, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence.


Eligibility criteria: Inclusion Criteria:

* Dental hygienist
* Licensed in the United States
* 18 years of age or older

Exclusion Criteria:

* Not employed as a dental hygienist as of March 1, 2020

Primary outcomes:
measure: COVID-19 probable or confirmed case
timeFrame: 18 months
Secondary outcomes:
measure: Anxiety
timeFrame: 12 months
measure: Depression
timeFrame: 12 months
measure: Dental practice infection control efforts
timeFrame: 12 months
measure: Personal protective equipment
timeFrame: 12 months
measure: Employment status
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: American Dental Association
state: Illinois
Study officials:
References:
citation: Eldridge LA, Estrich CG, Gurenlian JR, Battrell A, Lynch A, Vujicic M, Morrissey R, Dershewitz S, Geisinger ML, Araujo MWB. US dental health care workers' mental health during the COVID-19 pandemic. J Am Dent Assoc. 2022 Aug;153(8):740-749. doi: 10.1016/j.adaj.2022.02.011.
citation: Estrich CG, Gurenlian JR, Battrell A, Bessner SK, Lynch A, Mikkelsen M, Morrissey R, Araujo MWB, Vujicic M. COVID-19 Prevalence and Related Practices among Dental Hygienists in the United States. J Dent Hyg. 2021 Feb;95(1):6-16.
Clinical trial NCT05566015: Relationship Between Self-compassion and Treatment Adherence in Schizophrenic Spectrum Disorders
Official title: Relationship Between Self-compassion and Treatment Adherence in Schizophrenic Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Treatment Adherence
Selfcompassion
Schizophrenic Spectrum Disorder
Keywords: Treatment Adherence
Selfcompassion
schizophrenic spectrum disorder
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Crysalid center Clermont de l'Oise
name: CMP de Montataire
name: CMP de Chambly
name: CMP de Clermont de l'Oise
name: CMP de st Just en Chaussée
name: CMP de Senlis
name: CMP de Crepy en Valois
name: CMP de Pont St Maxence
name: CMP de Chantilly
name: CMP de Creil
First posted: 2022-10-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Treatment adherence is defined by the World Health Organisation (WHO) as the extent to which the patient's history of therapeutic drug-taking coincides with the prescribed treatment. In patients suffering from psychiatrical diseases, especially in those who are suffering from schizophrenic spectrum disorders, the quality of treatment adherence has to be improved. Indeed, non adherance to anti-psychotic treatment increases the risk of hospitalization, of substance use, violent behaviour and of functionnal and cognitif impairment. Selfcompassion, which involves being touched by and open to one's own suffering and to heal oneself with kindness and without judgement and self-criticism has never beed studied as a possible factor infuencing treatment adherence.

This study aims to evaluate if a link between selfcompassion and treatment adherence exists in patients suffering from schizophrenic spectrum disorders.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with schizophrenia spectrum disorder ( ICD 10 and DSM 5 criteria)
* stabilized (PANNS score under 80)
* aged 18 or above
* In case of tutor or curator, agreement of this person is requiered
* psychiatrist who's following the patient agrees with the study

Exclusion Criteria:

* underage
* non stabilized patient (PANSS score under 80 )
* patient suffering from toxic psychosis
* difficulties to understand french or cognitive impairment which are making it to difficult to answer the different self-administered questionnaires.

Primary outcomes:
measure: Average level of self compassion
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References: