louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00963365: AZD6765 Oral Single Ascending Dose/Multiple Ascending Dose (SAD/MAD)
Official title: Pt. A: Ph I, Sngl-Blind, Randomized, Pcbo-Controlled 3-Way Crossover Study Followed by an Open-label Food Effect Study to Assess the PK of IV and Oral AZD6765 in Healthy Male and Female Subjects Pt.B: Ph I, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability and PK of AZD6765 When Administered in Multiple Ascending Doses to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
Healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-08-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to determine the safety of AZD6765 when given in single and multiple oral doses and to compare an oral and intravenous (IV) formulation of AZD6765 to placebo.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Females must be of non-childbearing potential.

Exclusion Criteria:

* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product.
* Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months (if half-life was \< 24 hours) of the first administration of study drug
* Plasma or blood product donation within one month of screening or any blood donation/blood loss \> 500mL during the 3 months prior to screening.

Primary outcomes:
measure: The objective of the study is to investigate the safety and tolerability of AZD6765 when administered orally in single and multiple doses to healthy subjects by assessment of adverse events, vital signs, physical examinations, electrocardiograms(ECG).
timeFrame: Safety assessments are made prior to and after drug administration.
Secondary outcomes:
measure: Part A 1. To characterize the single dose pharmacokinetics of AZD67652. To assess the absolute bioavailability of AZD67653. To assess the effect of food on the pharmacokinetics of AZD6765
timeFrame: Blood samples will be obtained on Days 1-5.
measure: Part B 1. To characterize the single and multiple dose pharmacokinetics of AZD6765 2. To assess dose linearity and proportionality of AZD67653. To assess the degree of accumulation and the time dependence of the pharmacokinetics of AZD6765
timeFrame: Blood samples will be obtained on Days 1-4 and 7-11.
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: Quintiles, Inc.
name: Phillip Leese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02510131: Is Hyacinth Exercise Better Than Kegel's Exercise in Women With Urinary Incontinence?
Official title: Is Hyacinth Exercise Better Than Kegel's Exercise in Women With Urinary Incontinence?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 180
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether Hyacinth exercises are more effective than Kegel's exercise at improving pelvic floor weakness among women aged 55 and above with urinary incontinence.

Detailed description: Individuals who admit to have urinary leakage will be examined to determine the nature of their problem and individuals for whom Kegel exercises are likely to be for benefit will be recruited into this study.

One hundred and eighty women who participants who agree to be randomized to Kegel's or Hyacinth exercises will be randomized.

The treatment allocation will be sealed opaque enveloped and stored in a secure location.

Participants will be blinded from the treatment arm, and as much as possible, participants in different arms of the study would be given different appointment dates to avoid contamination.

Exercises will be prescribed by a trained personnel, and flexibility is added to the routine to enable tailoring to individual lifestyles and choices.

Eligibility criteria: Inclusion Criteria:

* Woman aged above 55 with urinary incontinence.

Exclusion Criteria:

* Individuals who are unable or unwilling to provide written informed consent.
* Stage 3 and 4 pelvic organ prolapse.
* Individuals who have physical weakness and are unable to do kegel plus exercises.
* Neuropathic injury of pelvic floor muscles.

Primary outcomes:
measure: Female pelvic floor questionnaires scoring
timeFrame: 6 months
Secondary outcomes:
measure: intravaginal biofeedback measurements
timeFrame: 6 months
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Center
state: Wilayah Persekutuan
Study officials:
References:
Clinical trial NCT02316431: Diagnostic Comparison of PET-magnetic Resonance and PET-CT in Patients With Oncologic Diseases
Official title: Diagnostic Comparison and Workflow Evaluation of Whole Body PET-magnetic Resonance and PET-CT With and Without Contrast Media in Patients With Oncologic Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasm Staging
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a proven or suspected oncological disease referred for a clinically indicated PET/CT with of without contrast media.

Brief summary: Diagnostic accuracy of PET/magnetic resonance and PET/CT will be compared concerning primary tumor, regional nodes, metastasis (TNM) staging and therapeutic influence. Workflow scenarios will be evaluated to create imaging protocols which are time efficient and diagnostically accurate.


Eligibility criteria: Inclusion Criteria:

* Male and female patients from 18-90 years
* Written informed consent
* Patients with a proven or suspected oncological disease referred for a clinically -Indicated PET/CT with of without contrast media

Exclusion Criteria:

* Pregnant or breast feeding women
* Non compliance of the patient to follow the study instructions (e.g. hearing problems, dementia)
* Inclusion in another clinical trial 30 days prior to inclusion
* Age \< 30years
* Contraindication for MRI (cardiac pacemaker, certain metal implants, claustrophobia
* Known allergies to contrast CT or MRI contrast media
* Patients with an glomerular filtration rate of \< 60ml/min/1.73m2

Primary outcomes:
measure: Number of patients with correct TNM staging defined with PET/magnetic resonance versus PET/CT
timeFrame: 12 month
Secondary outcomes:
measure: Number of minutes needed per PET/magnetic resonance protocol compared to PET/CT
timeFrame: 12 month
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Diagnostic and Interventional Radiology
Study officials:
affiliation: University of Zurich
name: Patrick Veit-Haibach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sekine T, Delso G, Zeimpekis KG, de Galiza Barbosa F, Ter Voert EEGW, Huellner M, Veit-Haibach P. Reduction of 18F-FDG Dose in Clinical PET/MR Imaging by Using Silicon Photomultiplier Detectors. Radiology. 2018 Jan;286(1):249-259. doi: 10.1148/radiol.2017162305. Epub 2017 Sep 14.
Clinical trial NCT01479231: Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis
Official title: Predictors of PPI Response in Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Gastroesophageal Reflux Disease
Eosinophilic Esophagitis
Dysphagia
Keywords: GERD
Eosinophilic esophagitis
Proton pump inhibitor
dysphagia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-11-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators will determine the prevalence of gastroesophageal reflux disease (GERD) in Eosinophilic Esophagitis (EoE) and importantly determine the predictors of response to Proton Pump Inhibitor (PPI) therapy in EoE. Moreover, the investigators will determine the effect of GERD on the location of esophageal eosinophilia.


Eligibility criteria: Inclusion Criteria:

* 18 years of age \< 80 years of age
* 14 eosinophils / hpf on biopsies from esophagus

  * Abnormal validated Mayo dysphagia questionnaire (MDQ-30) (question 2"yes", question 4 \> "moderate" and question 7 \> "once a week")
  * Clinically performed EGD with \> 14 eosinophils/hpf completed within last 3 months

Exclusion Criteria:

* Other cause of dysphagia identified at endoscopy (e.g. stricture, web, infection, ring, achalasia, esophageal neoplasm)
* Dilatation of esophagus at time of index endoscopy
* Treatment with topical steroid within 3 months of index endoscopy
* Treatment with PPI in last 30 days prior to index EGD

Patient population - adults with EoE recruited from Mayo Clinic Rochester, MN patient population

Primary outcomes:
measure: Prevalence of Gastroesophageal Reflux Disease
timeFrame: 24 hour
Secondary outcomes:
measure: Heartburn/regurgitation
timeFrame: 30 day
measure: Abnormal 24 hour acid exposure
timeFrame: 24 hour
measure: Ratio of distal/proximal mean esophageal eosinophil number
timeFrame: 6 weeks
measure: Mean distal eosinophil number
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Jeffrey A Alexander, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06434831: Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation
Official title: Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bladder Hyperactivity
Sacral Neuromodulation
Keywords: Bladder hyperactivity
autonomic nervous system
sacral neuromodulation
urodynamic assessment
heart rate variability
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 40
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: Overactive bladder syndrome (OAB) is defined by urgent and frequent urges to urinate associated with frequent night-time urination and sometimes urinary incontinence. Sacral neuromodulation (SNM) is now one of the second-line treatments for OAB.

The mode of action of SNM is still poorly understood but a number of data from recent scientific literature suggest that SNM may act, among other things, by altering the balance of the autonomic nervous system (ANS) - located at the interface between the urinary tract and the brain structures regulating the functioning of the urinary tract.

The aim of this study would therefore be to develop a predictive tool for the effectiveness of SNM.


Eligibility criteria: Inclusion Criteria:

* Male of female ≥ 18 years
* OAB syndrome
* Indication for a two-staged SNM
* Under general anaesthesia with Remifentanil and Propofol
* Patient who has given written consent to participate in the trial
* Patient willing to comply with all study procedures and duration

Exclusion Criteria:

* Tibial neuro-stimulation (last 3 months)
* Sacral neuromodulation (last 3 months)
* Botulinum toxin A intra-detrusor injection (last 9 months)
* Pregnancy in progress
* Administrative reasons
* Guardianship/curatorship

Primary outcomes:
measure: Comparison of HFVI analysed through HRV at baseline and during standardized stimulation protocol randomly delivered at the level of the 4contact points of the quadripolar lead at the time of lead implantation between the effective and noneffective groups
timeFrame: 1 year
Secondary outcomes:
measure: Comparison of other HRV parameters at baseline and during a standardized stimulation protocol randomly delivered at the level of the 4 contact points of the quadripolar lead at the time of lead implantation
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05176431: Radial and Focused ESWT in the Treatment of Coccydynia According to Age and Body Mass Index
Official title: Comparation of Radial and Focused Extracorporeal Shock Wave Therapies According to Age and Body Mass Index in the Treatment of Coccydynia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coccyx Disorder
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 69
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: To date, focused and radial types of ESWT have been effectively used in the treatment of coccydynia. However, studies directly addressing a comparison between radial and focused types of ESWT in coccydynia have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused ESWT options on coccydynia.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of coccydynia by clinical examination and X-ray imaging.
* be aged ≥18 at the time of diagnosis
* be give informed consent

Exclusion Criteria:

* Malignancy
* Those who have received ESWT treatment before
* Pediatric patients
* Patients with infection.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 1 minute
measure: Oswestry Disability Index
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University
Study officials:
References:
Clinical trial NCT04003831: Navigated OCT Imaging With the P200TxE
Official title: Navigated Peripheral OCT Imaging With the P200TxE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Disease
Lead sponsor: Optos, PLC
Sponsor class: INDUSTRY
First posted: 2019-07-01
Enrollment: 26
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The P200TxE will be used to obtain peripheral OCT (optical coherence tomography) images.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
2. Subjects who can follow the instructions by the clinical staff at the clinical site,
3. Subjects who agree to participate in the study;
4. Subjects presenting with some form of peripheral retina pathology or retina pathology with peripheral manifestations.

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;

Primary outcomes:
measure: Qualitative Assessment of OCT Clinical Utility
timeFrame: 1 year
measure: Qualitative Assessment of OCT Scan Quality
timeFrame: 1 year
Secondary outcomes:
measure: Safety Assessment from Adverse Events
timeFrame: 1 year
Other outcomes:
Locations:
city: Poway
country: United States
facility: Retina Consultants of San Diego
state: California
Study officials:
References:
Clinical trial NCT04309331: Market Research - Acceptability Trial for a New PKU Amino Acid Based Protein Substitute
Official title: Market Research - Acceptability Trial for a New PKU Amino Acid Based Protein Substitute (Dr Schär Medical Nutrition - Mevalia Amino Acids) Mevalia PKU Motion 10 - Tropical or Red Fruits Mevalia PKU Motion 20 - Tropical or Red Fruits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PKU
Phenylketonurias
Inborn Errors of Metabolism
Metabolic Disease
Lead sponsor: Dr. Schär AG / SPA
Sponsor class: INDUSTRY
First posted: 2020-03-16
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of PKU or PKU variant requiring a phenylalanine-free protein substitute
* Subjects who are already taking a phenylalanine-free protein substitute and are willing to try the study product for 7 days
* Patients aged 3 years of age to adulthood
* Written informed consent obtained from parental caregiver

Exclusion Criteria:

* Presence of serious concurrent illness
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
* Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
* Patients less than 3 years of age.

Primary outcomes:
measure: Gastrointestinal tolerance
timeFrame: 7 days
measure: Product compliance
timeFrame: 7 days
measure: Product palatability
timeFrame: 7 days
measure: Product acceptability
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
Study officials:
References:
Clinical trial NCT06454331: tDCS and Upper Extremity Function in Stroke
Official title: Effects of Transcranial Direct Cranial Stimulation on Upper Limb Function and Quality of Life in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
upper limb
tDCS
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Research on the effects of Anodal transcranial Direct Current Stimulation (tDCS) on hand dexterity and quality of life in stroke patients is limited. While the highlighted article focuses on Parkinson's disease, it underscores anodal tDCS potential to modulate brain activity and promote neural plasticity, suggesting potential relevance to stroke rehabilitation

Detailed description: tDCS seems like a hopeful way to help stroke patients improve their upper limb function, but there are still some problems and questions that need to be answered. Previous studies have investigated the impact of (tDCS) on upper limb recovery among stroke patients. However, evidence is scarce on the effect of tDCS on hand dexterity and quality of life in stroke patients. Furthermore, these studies have not adequately explored how the severity of stroke influences the efficacy of tDCS on upper limb motor recovery. Additionally, there is a lack of research examining the cumulative effects of tDCS on both upper limb motor recovery and hand dexterity, as well as QoL, particularly concerning stroke severity.

Eligibility criteria: Inclusion Criteria:

* Stroke for more than 6 months.
* Age 40-80 years
* Both gender
* National Institutes of Health Stroke Scale (NIHSS) for severity level (Mild (1-4), Moderate (5-15), Moderate to Severe (16-20), Severe (21-42)

Exclusion Criteria:

* Any patient with Upper limb amputation on the effected side, contracture, burn injury that leads to joint limitation and functional limitation.
* Known cases of Multiple Sclerosis and Parkinson and any Musculoskeletal disorder and Cardiopulmonary disorder.
* Any patient with Metallic implants
* Individuals with a history of seizures or epilepsy
* Individuals with Skin allergies on the scalp

Primary outcomes:
measure: FMA-Upper Extremity
timeFrame: 8 week
measure: Action Research Arm Test
timeFrame: 8 week
Secondary outcomes:
measure: Stroke Specific Quality of Life
timeFrame: 8 week
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mirza Obaid Baig, MSPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05653531: Clinical Significance of Hepatic Biomarkers in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
Official title: Significance of Hepatic Biomarkers in the Evaluation of Response to Treatment and Prognosis in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Immune Checkpoint Inhibitor
Lung Cancer
Liver Biomarkers
Transaminases
Keywords: immune checkpoint inhibitor
Lung Cancer
liver biomarkers
transaminases
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-12-16
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: Lung cancer is the leading cause of cancer death worldwide. The emergence of immune checkpoint inhibitors (ICIs) has revolutionized the treatment of lung cancer over the past 10 years. Nivolumab, ipilimumab, pembrolizumab, atezolizumab, and durvalumab have been successively approved in non-small cell lung cancer, small cell lung cancer, and pleural mesothelioma. Although the efficacy of ICIs is remarkable in some patients, the objective response rate is only about 20%. The development of predictive biomarkers for treatment response is essential. Non-invasive methods and easily accessible biomarkers at low cost are required.ICIs activate the immune system through the inhibition of checkpoints (PD-L1, PD-1). The immune system and the liver are interconnected and constantly interact through a complex regulatory system. Patients with lung cancer frequently suffer from liver damage, due to metastases, treatments or underlying pathologies. The objective of the study is to evaluate the clinical significance of key liver biomarkers (AST, ALT, PAL, GGT, bilirubin, PT) in patients with lung cancer treated with ICI.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria:
* Age \> 18 years
* Patient with lung cancer of any histological type
* Initiation of ICI therapy
* Signed consent for the study

Exclusion Criteria:

* Patient with previous ICI treatment

Primary outcomes:
measure: basal ALT blood concentration in lung cancer patients treated with ICI determined
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References: