louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01867827: Real-time fMRI Neurofeedback for Treatment of Parkinson's Disease
Official title: Real-time fMRI Neurofeedback for Treatment of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Cardiff University
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to train patients with Parkinson's Disease to increase activity in a brain area that is involved in the control of motor functions with the use of a technique called real-time fMRI neurofeedback (NF) along with regular physical exercise. This will be a randomised and controlled clinical trial to evaluate the benefits of a novel treatment. The investigators expect NF training along with physical exercise practise to better improve motor functions compared to physical exercise alone.


Eligibility criteria: Inclusion Criteria:

* People with Parkinson's Disease
* Hoehn and Yahr stages 1-3 of the disease

Exclusion Criteria:

* Patients with dementia or significant comorbidity
* those who fail the safety screening to go into an MRI scanner
* those who cannot travel to the University

Primary outcomes:
measure: Change from Baseline in the 'Movement Disorder Society - Unified Parkinson's Disease Rating Scale' (MDS-UPDRS)
timeFrame: Change from Baseline in the 'Movement Disorder Society - Unified Parkinson's Disease Rating Scale' (MDS-UPDRS) in 12 weeks
Secondary outcomes:
measure: Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39)
timeFrame: Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39) at 4 weeks
measure: Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39)
timeFrame: Change from baseline in the 'Parkinson's Disease Questionnaire 39' (PDQ-39) in 12 weeks
measure: Change from baseline in the 'Actigraph'
timeFrame: Change from baseline in the 'Actigraph' at 12 weeks
measure: Change from baseline in the 'GaitRite'
timeFrame: Change from baseline in the 'GaitRite' at 12 weeks
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: School of Medicine, Cardiff University
state: Wales
Study officials:
affiliation: Cardiff University
name: David Linden, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02739360: Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820
Official title: An Open Label, Roll Over Study to Provide Idelalisib to Subjects Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Lymphoid Malignancies
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2016-04-15
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: TREATMENT

Brief summary: The primary objective of this study is to provide idelalisib to participants receiving GS-9820 in Gilead-sponsored Study GS-US-315-0102 at the time of study closure.


Eligibility criteria: Key Inclusion Criteria:

* Receiving GS-9820 in Study GS-US-315-0102 with objective evidence of clinical benefit
* Evidence of a personally signed informed consent

Key Exclusion Criteria:

* Known hypersensitivity or intolerance to any of the active substances or excipients in the formulation of idelalisib
* Toxicities that would preclude initiating therapy with idelalisib prior to enrollment
* Concurrent participation in another therapeutic clinical trial
* Ongoing infection, treatment, or prophylaxis for cytomegalovirus (CMV) within the past 28 days.

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths
timeFrame: Up to Day 602 plus 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05916560: A Study of LY3437943 in Participants With Impaired and Normal Liver Function
Official title: A Parallel-Group, Single-Dose, Phase 1, Open-Label Study to Investigate the Pharmacokinetics of LY3437943 in Participants With Hepatic Impairment Compared With Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Hepatic Insufficiency
Keywords: Pharmacokinetics
Hepatic Impairment
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-06-23
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to measure how much of LY3437943 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to healthy participants with normal liver function. The safety and tolerability of LY3437943 will also be evaluated. The study may last up to 9 weeks for each participant including the screening period.


Eligibility criteria: Inclusion Criteria:

All Participants:

* Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²), inclusive
* Healthy or various degrees of hepatic impairment depending on the study group

Exclusion Criteria:

Participants with hepatic impairment:

* Have or are anticipating an organ transplant within the next 6 months
* Requires needle evacuation of ascites fluid more than 2 times per month
* Have had variceal bleeding within 3 months of check-in, unless the participant has undergone a successful banding procedure; in that case, may check-in from 1 month after the banding procedure

Primary outcomes:
measure: Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943
timeFrame: Predose up to 30 days postdose
measure: PK: Maximum observed concentration (Cmax) of LY3437943
timeFrame: Predose up to 30 days postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Clinical Trials - Chandler
state: Arizona
city: DeLand
country: United States
facility: Accel Research Sites- Clinical Research Unit
state: Florida
city: Miami
country: United States
facility: Advanced Pharma Clinical Research
state: Florida
city: San Antonio
country: United States
facility: American Research Corporation at Texas Liver Institute
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06073860: A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemia
Official title: Reblozyl® (Luspatercept) Post-Marketing Surveillance in Korean Patients With Myelodysplastic Syndrome or Beta Thalassemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myelodysplastic Syndrome
Beta Thalassemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 104
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with transfusion-dependent anemia associated with very low, low, and intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or MDS/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) who had an unsatisfactory response to, or are ineligible for erythropoietin-based therapy, and adults with transfusion-dependent anemia associated with beta thalassemia, who will begin therapy with luspatercept.

Brief summary: The purpose of this observational study is to assess the real-world safety of luspatercept in Korean participants with myelodysplastic syndrome (MDS) or beta thalassemia. Investigators will enroll participants who will begin treatment with at least 1 dose of luspatercept.


Eligibility criteria: Inclusion Criteria:

* Adult participants 19 years of age or older
* Participants who will be treated with luspatercept according to the approved label in the Republic of Korea
* Participants who sign the informed consent form

Exclusion Criteria:

* Participants who are prescribed luspatercept for therapeutic indications not approved in the Republic of Korea
* Participants for whom luspatercept is contraindicated as clarified in the Korean prescribing information approved by the Ministry of Food and Drug Safety

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0001
city: Seoul
country: Korea, Republic of
facility: Novotech Laboratory Korea Co., Ltd.
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03741660: Konjac-Mannan Improves Glycemia and Other Risk Factors for CHD in T2DM
Official title: Konjac-Mannan (Glucomannan) Improves Glycemia and Other Associated Risk Factors for Coronary Heart Disease in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type2 Diabetes
Coronary Heart Disease
Keywords: konjac
type2 diabetes
fiber
coronary heart disease
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Dicofarm
name: University of Toronto
First posted: 2018-11-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To examine whether Konjac-mannan fiber improves metabolic control measured by glycemia, lipidemia, and blood pressure in individuals with type-2 diabetes.


Eligibility criteria: Inclusion Criteria:

* hyperlipidemia controlled by medication
* hypertension controlled by medication
* type 2 diabetes controlled by medication
* minimum 3 years since onset of all three conditions
* sedentary lifestyle

Exclusion Criteria:

* regular smoking
* regular alcohol consumption
* family history of premature coronary heart disease
* hypothyroidism
* renal, hepatic or gastrointestinal disease

Primary outcomes:
measure: change in total:HDL cholesterol
timeFrame: change from baseline at week 3, relative to control
measure: change in fructosamine
timeFrame: change from baseline at week 3, relative to control
measure: change in systolic blood pressure
timeFrame: change from baseline at week 3, relative to control
Secondary outcomes:
measure: change in total cholesterol
timeFrame: change from baseline at week 3, relative to control
measure: change in LDL cholesterol
timeFrame: change from baseline at week 3, relative to control
measure: change in HDL cholesterol
timeFrame: change from baseline at week 3, relative to control
measure: change in apolipoprotein A-1
timeFrame: change from baseline at week 3, relative to control
measure: change in apolipoprotain B
timeFrame: change from baseline at week 3, relative to control
measure: change in glucose
timeFrame: change from baseline at week 3, relative to control
measure: change in insulin
timeFrame: change from baseline at week 3, relative to control
measure: diastolic blood pressure
timeFrame: change from baseline at week 3, relative to control
measure: change in body weight
timeFrame: change from baseline at week 3, relative to control
measure: change in apoB:ApoA-1
timeFrame: change from baseline at week 3, relative to control
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03053960: Helical CT, PET/CT, MRI, and CBCT Alone or in Combination in Predicting Jaw Invasion in Patients With Oral Cancer
Official title: Predictability of Carcinomatous Invasion of the Maxilla or Mandible: An Assessment of Radiologic Modalities With Histologic Correlation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Oral Cavity Squamous Cell Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The data from all of the subjects that are enrolled and have consented to be a part of the study will be analyzed

Brief summary: This clinical trial studies how well helical computed tomography (CT), positron emission tomography (PET)/CT, magnetic resonance imaging (MRI), and cone beam computed tomography (CBCT) work alone or in combination in predicting whether tumor cells have spread to the jaw bone (jaw invasion) in patients with oral cancer. Imaging, such as helical CT, PET/CT, MRI, and CBCT, may help find out how far cancer has spread. Accurate prediction of the presence or absence of jaw invasion may help create a better surgical treatment plan for patients with oral cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To determine which imaging modality or combination of imaging methods, in conjunction with clinical and histological examination, will most accurately predict the presence or absence of invasion of the mandible or maxilla by intraoral squamous cell carcinoma (SCC).

SECONDARY OBJECTIVES:

I. To compare the histopathologic findings to the radiologic findings.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of squamous cell carcinoma of the oral cavity
* Able to read and sign and informed consent

Exclusion Criteria:

* Prior mandibular surgery
* Primary intraosseous carcinoma
* Prior history of radiation to the mandible
* Obvious finding of clinical invasion of the mandible

Primary outcomes:
measure: Accurate Predication of the Presence or Absence of Bone Invasion by Oral Squamous Cell Carcinoma by Helical CT, PET/CT, MRI and CBCT
timeFrame: Up to 2 years
Secondary outcomes:
measure: Incidence of Sparing Resection
timeFrame: Up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Lionel Gold, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01666860: Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.
Official title: Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Lumbar Interbody Fusion Procedure
Keywords: anterior lumbar interbody fusion
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have an Anterior Lumbar Interbody Fusion Procedure as treatment for degenerative disc disease.

Brief summary: During the period 1989-1999, a number of patients underwent an ALIF-procedure. Anterior Lumbar Interbody Fusion procedure (ALIF) is a type of lumbar spinal fusion. The approach of the lumbar region is by incision of the abdominal wall. The intervertebral disc is removed and replaced by a bone graft. These patients form the population of this study. The goal of this study is to evaluate their current medical condition and to determine the clinical outcome.

The clinical result will be stipulated by means of standardized questionnaires (VAS-score, Oswestry low Back Pain Questionnaire and SF-36)


Eligibility criteria: Inclusion Criteria:

* An Anterior Lumbar Interbody Fusion procedure between 1999 and 2005

Exclusion Criteria:

* None

Primary outcomes:
measure: A clinical evaluation before an Anterior Lumbar Interbody Fusion procedure.
timeFrame: Baseline
measure: A clinical evaluation after an Anterior Lumbar Interbody Fusion procedure.
timeFrame: 5 years after the operation
Secondary outcomes:
measure: Union of the vertebrae.
timeFrame: 1 day (At the standard follow up consultation)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Bart Poffyn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06141460: Safety and Efficacy of RRG001 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Official title: A Phase I/IIa, Dose-escalation and Dose-extension Study to Evaluate the Safety and Efficacy of Single Subretinal Injection of RRG001 in Subjects With Neovascular Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Shanghai Refreshgene Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-21
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: dose escalation
Primary purpose: TREATMENT

Brief summary: A Phase I/IIa, Dose-escalation and Dose-expansion Study to Evaluate the Safety and Efficacy of Single Subretinal Injection of RRG001 in Subjects With Neovascular Age-related Macular Degeneration

Detailed description: This study adopts a multicenter, single-arm, open-label phase I/IIa seamless study design and comprises two stages, i.e., phase I 3+3 dose escalation study and a phase IIa dose expansion study. Four dose groups are preset for the phase I dose escalation study; 3-6 subjects will be enrolled for each dose group, and it is planned to enroll 12-24 subjects. The phase IIa dose expansion study will be conducted successively at the doses after safety assessments of dose 2 and/or dose 3 in phase I are completed. Twelve subjects are expected to be enrolled for each dose group, with a total of 24 subjects will be enrolled overall. The sponsor will assess whether or not to adjust the dose(s) and sample size for the exploration study based on the results in the phase I exploration study.

Eligibility criteria: Inclusion Criteria:

* Subjects that are willing and able to follow study procedures.
* Patinets ≥50 years old.
* Clinically diagnosed with CNV secondary to nAMD.
* BCVA of the study eye is ≥5 letters and ≤73 letters(Snellen 20/800\~20/40), as well as that of the other eye ≥19 letters(Snellen 20/400).
* Responding to anti-VEGF

Exclusion Criteria:

* Presence of any other eye diseases other than nAMD in study eye that would affect the treatment or confusing the interpretation of the study results , as judged by the investigator.
* CNV or macular edema in the study eye secondary to any causes other than AMD.
* Uncontrolled glaucoma.
* Uncontrolled hypertension despite medication.
* Pregnant or lactating women or individuals with reproductive potential who are unwilling to take effective contraception during the study period.

Primary outcomes:
measure: Safety and tolerability
timeFrame: Week 52
Secondary outcomes:
measure: Efficacy after RRG001 injection
timeFrame: Week 52
measure: Efficacy after RRG001 injection
timeFrame: Week 52
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT00773760: MOR and COMT SNP Polymorphism and Pain
Official title: Does mu Opioid Receptor (MOR) and Catechol-O-methyltransferase (COMT) Genes Polymorphism Correlate of Clinical Postoperative Pain and Response to Analgesics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain Relief
Keywords: opioids
COMT
SNP
analgesia
postoperative pain
Lead sponsor: East Tallinn Central Hospital
Sponsor class: OTHER
First posted: 2008-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with prostate cancer

Brief summary: Patients with certain polymorphism in the MOR and COMT genes will display differences in their response to analgesics.

Detailed description: After tissue injury, there is great interindividual variability among patients in the amount of pain experienced (pain intensity and duration of pain) and in the degree of pain relief from analgesics. In experimental settings, Single Nucleotide Polymorphisms (SNP) at the MOR and COMT genes have been found to alter the response to opioids in in vitro models and in human.We will collect clinical data on one hundred patients undergoing surgery. We will obtain DNA extracted via PCR techniques from the patients' blood and we will identify SNPs at the mu opioid receptor and catechol-O-methyltransferase genes. We will analyze the data to search for correlation between clinical patterns of postoperative pain and opioid effects and SNPs.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Give informed consent to participate in this study

Exclusion Criteria:

* Neurologic or psychiatric disease sufficient, in the clinical judgment of the investigator, to compromise informed consent or data collection
* ASA classification score 3 or above
* Patients with past or present history of substance abuse.
* Patients with a history of chronic pain requiring daily analgesic use for more then one month.
* Patients with a current diagnosis of anxiety or depression requiring medical treatment
* Patients allergic to morphine

Primary outcomes:
measure: Postoperative assessments include PCA use (e.g., number of patient demands, total morphine administered) in each 24-h interval during the 48-h study period - primary endpoint.
timeFrame: 48 hours
Secondary outcomes:
measure: No secondary outcome endpoint
timeFrame: no time frame
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: Yuri Kolesnikov MD PhD
Study officials:
affiliation: ETCH
name: Yuri Kolesnikov, MD PhD
role: STUDY_DIRECTOR
References: