louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01200225: An Observational Study on The Impact of Insulin Resistance on Sustained Virological Response in Patients With Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
Official title: Prospective Observational Study to Asses the Insulin Resistance (IR) and Its Impact on Sustained Virological Response in a Cohort of HCV-infected Patients Treated With Pegasys and Copegus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 1155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with inadequate response or intolerant to DMARDs and anti-TNF

Brief summary: This prospective observational study will assess the insulin resistance and its impact on sustained virological response in patients with hepatitis C treated with Pegasys and Copegus. Data will be collected from each patient during the up to 72 weeks of treatment and for 24 weeks of treatment-free follow-up.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic hepatitis C (detectable HCV RNA)
* Initiation of treatment with Pegasys and Copegus

Exclusion Criteria:

* Participation in a clinical trial during the study

Primary outcomes:
measure: Effect of insulin resistance, defined as HOMA index > 2, on sustained virological response (HCV RNA assessed by Polymerase Chain Reaction assay)
timeFrame: 42 months
Secondary outcomes:
measure: Host-, virus- and treatment-related factors influencing virological response and sustained virological response
timeFrame: 42 months
measure: Parameters of metabolic syndrome
timeFrame: 42 months
measure: Management of insulin resistance
timeFrame: 42 months
measure: Quality of life: Hepatitis Quality of Life Questionnaire (HQLQ)
timeFrame: 42 months
measure: Safety: Incidence of adverse events
timeFrame: 42 months
measure: Patient characteristics
timeFrame: 42 months
Other outcomes:
Locations:
city: Neuilly-sur-seine
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01179425: Sex Differences in Attentional Bias in Marijuana-dependent Individuals
Official title: Sex Differences in Attentional Bias and Cognitive Functioning in Response to Stress in Marijuana-dependent Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Marijuana Dependence
Keywords: marijuana
dependence
cognition
stress
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to explore sex differences in cognitive functioning and responses to marijuana-related items, and to determine whether stress impacts these measures.

Hypothesis 1: Attentional bias will be greater for marijuana cues in male marijuana-dependent subjects relative to female marijuana-dependent or non-dependent male controls.

Hypothesis 2: Marijuana-dependent females will exhibit greater stress-induced changes in attentional bias and cognitive functioning than marijuana-dependent males.

Detailed description: Ample evidence implicates both environmental cues and negative affective states in maintaining drug use or triggering relapse. However, although 'craving' is believed to drive continued drug use, it is not well understood how cognitive processes influence craving and relapse, nor how they may differ between the sexes. Therefore, the goal of this study protocol is to provide insight into sex differences in the cognitive aspects of drug craving and to assess the impact of stress on attentional bias for drug-related cues as well as on the availability of cognitive resources.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria will include subjects between the ages of 18-65 who meet full DSM-IV criteria for marijuana dependence and non-dependent controls.

Exclusion Criteria:

* Exclusion criteria will include medications that may affect cognitive or HPA-axis functioning
* Current depression
* Bipolar disorder
* Attention deficit hyperactivity disorder
* History of psychosis
* Suicidal or homicidal intent
* Significant cognitive deficits
* Dependence on any substance other than marijuana, nicotine, or caffeine.

Primary outcomes:
measure: Primary outcome measures will be obtained from the auditory odd-ball task: differences while viewing the marijuana vs neutral video in reaction time (msec), errors of omission (%), and errors of commission (%).
timeFrame: ~ 3 hours
Secondary outcomes:
measure: Secondary measures include subjective (craving and stress), physiological (heart rate and skin conductance), and stress hormone level (cortisol) assessments.
timeFrame: ~ 3 hours
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina, Dept. of Psychiatry/Clinical Neuroscience Division
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Kimber L Price, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01443325: Lidocaine Patch for Treatment of Persistent Inguinal Postherniorrhaphy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inguinal Pain
Keywords: Persistent Postherniorrhaphy inguinal Pain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-09-29
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In the present placebo-controlled cross-over study the researchers intend to investigate analgesic and sensory effects of a lidocaine patch in patients with severe persistent inguinal post-herniorrhaphy pain.


Eligibility criteria: Inclusion Criteria:

* Males \> 18 yrs
* ASA (American Society´s of Anesthesiology´s classification) scores I-III, with severe Pain for more than six months and with average daily pain intensities (numerical rating scale \[NRS\] 0-10 points) during rest or during movement \> 6.

Exclusion Criteria:

* History of an allergic reaction or intolerance to amide local anesthetics or vehicle ingredients in the patches
* Use of class I antiarrhythmic drugs (e.g., tocainide and mexiletine)
* Severe cardiac impairment, e.g., NYHA (New York Heart Association) Class ≥ III
* Inflamed or injured skin at the application site
* Known severe hepatic disorder (Child-Pugh score \> 6)
* Known severe renal impairment, (creatinine clearance \< 30 mL/min)
* Signs of cognitive impairment or known drug or ethanol abuse during the last 2 years.

Primary outcomes:
measure: pain reduction with lidocaine patch
timeFrame: assessed the last three days in each treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT02433925: Resveratrol's Effects on Inflammation and Oxidative Stress in Chronic Kidney Disease
Official title: Effects of Supplementation With Resveratrol on Inflammation and Oxidative Stress of Non-dialysis Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Renal Insufficiency
Keywords: resveratrol
oxidative stress
inflammation
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Inflammation and oxidative stress are common findings in patients with Chronic Kidney Disease (CKD) undergoing conservative treatment, in addition to being associated with atherosclerotic process, are related also to the progression of CKD. In this regard, resveratrol, a phenolic compound with recognized antioxidant and anti-inflammatory properties, can play an important role in the control of metabolic disorders associated with CKD, since it can modulate the mechanisms involved in inflammation and oxidative stress cycle. Resveratrol is capable of promoting the activation of the transcription-related factor-2 nuclear factor erythroid factor 2 (Nrf2) , a nuclear factor with anti-inflammatory properties, and SIRT-1, a protein also associated with the reduction of inflammation. These two factors, in their turn, are able to inhibit / antagonize the activity of the nuclear factor κB (NF-kB), a transcription factor that participates in the inflammatory response. Although it is a promising treatment, there are no studies evaluating the effects of resveratrol supplementation in patients with CKD. Thus, this study aims to evaluate the effects of resveratrol supplementation on inflammation and oxidative stress in patients undergoing conservative treatment of CKD.


Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease patients in stages 3 or 4, undergoing conservative treatment

Exclusion Criteria:

* Patients with diabetes mellitus, AIDS, inflammatory or infectious diseases, pregnant women, smokers and those using antioxidant supplements

Primary outcomes:
measure: Antioxidants and anti-inflammatory biomarkers
timeFrame: 4 weeks
Secondary outcomes:
measure: Inflammatory biomarkers
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04187625: Cell-based Therapy for the Treatment of Kidney Disease
Official title: Cell-based Therapy for the Treatment of Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Kidney Diseases
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label single arm study
Primary purpose: TREATMENT

Brief summary: Endothelial progenitor cells derived from and delivered to the renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. It is hypothesized that endothelial progenitor cells from the kidney can transition to a phenotype that promotes endothelial repair.

Detailed description: This is an interventional study involving patients that have a diagnosis of chronic kidney disease. Patients will have at least stage 3 chronic kidney disease stage or greater. Kidney-derived endothelial progenitor cells will have been obtained using associated protocols that are currently approved by the Partners Human Research Committee.

Eligibility criteria: Inclusion Criteria:

* Enrolled patients will have endothelial progenitor cells previously acquired.

Exclusion Criteria:

* Patients without previously acquired endothelial progenitor cells will be excluded.

Primary outcomes:
measure: Safety of progenitor cell delivery
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Andrew M Siedlecki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01791725: A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia
Official title: A 4-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2a Safety and PK Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Down Syndrome
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2013-02-15
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, double-blind, placebo-controlled, parallel-group, three-arm, multicenter study of the safety and PK of ELND005 administered orally for 4 weeks. This study will enroll Down Syndrome patients 18 to 45 years of age (inclusive) without dementia.


Eligibility criteria: Inclusion Criteria:

* 18 - 45 years of age
* Has an IQ of \> 40 (K-BIT)
* Able and willing to have a brain MRI

Exclusion Criteria:

* Symptoms of dementia or worsening cognition over the past year.
* Has a history of hepatitis B, hepatitis C, or HIV

Primary outcomes:
measure: Incidence of Adverse Events (TEAEs)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
measure: Changes From Baseline in Abnormal Neurological Examination Results
timeFrame: Baseline and 4 weeks
measure: Pharmacokinetic Assessment
timeFrame: Baseline and 4 Weeks
measure: Cognitive Outcome (RADD Total Score)
timeFrame: Baseline and 4 Weeks
measure: Improvement in NPI Total Scores in Subjects With NPI Score ≥1 at Baseline Baseline
timeFrame: Baseline and 4 weeks
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: Rafii MS, Skotko BG, McDonough ME, Pulsifer M, Evans C, Doran E, Muranevici G, Kesslak P, Abushakra S, Lott IT; ELND005-DS Study Group. A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Oral ELND005 (scyllo-Inositol) in Young Adults with Down Syndrome without Dementia. J Alzheimers Dis. 2017;58(2):401-411. doi: 10.3233/JAD-160965.
Clinical trial NCT06873425: Research on the Improvement of Intestinal and Immune Functions by Probiotics
Official title: A Study on the Safety and Effectiveness of Limosilactobacillus Fermentum LF61 in Improving Intestinal and Immune Functions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intestinal Health
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effectiveness and safety of Limosilactobacillus fermentum LF61 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.


Eligibility criteria: Inclusion Criteria:

1. Willing to undergo 3 follow-up visits during the intervention period
2. Be willing to provide blood, urine and stool samples 2 times during the intervention period
3. Willing to self-administer one of the 7 probiotics (BI45, BBi32, LS97, LB42, LF61, LH76, LR08)/placebo once a day during the intervention period
4. Good eyesight, can read and write, can wear glasses
5. Have good hearing and be able to hear and understand all instructions during the intervention -

Exclusion Criteria:

1. Digestive diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease)
2. Have a serious neurological condition (epilepsy, stroke, severe head trauma, meningitis in the last 10 years, brain surgery, brain tumor, prolonged coma - not including general anaesthesia)
3. Have received/are receiving treatment for the following mental disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
4. Take medication for depression or low mood
5. Internal organ failure (heart, liver or kidney failure, etc.)
6. Have received radiation or chemotherapy in the past
7. have undergone a general anesthesia procedure/procedure within the past three years, or plan to undergo a general anesthesia procedure/procedure within the next 3 months during this trial period
8. Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past -

Primary outcomes:
measure: Change of concentration of antimicrobial peptide LL-37
timeFrame: Week 0 and Week 8
measure: Change in calcarein concentration
timeFrame: Week 0 and Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Xu fei
state: Henan
Study officials:
References:
Clinical trial NCT06751225: Evaluation of Wear Experience with a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers with Astigmatism
Official title: Evaluation of Wear Experience with a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers with Astigmatism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Astigmatism Bilateral
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2024-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will be fit into the one week replacement soft contact lens to wear for 3 weeks.
Primary purpose: TREATMENT

Brief summary: This open-label study is of adults with astigmatism who have never worn contact lenses. Subjects will be fit into a one week planned-replacement contact lenses and will wear lenses for approximately 3 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.


Eligibility criteria: Inclusion Criteria:

1. Subjects must be new to contact lenses and have astigmatism of -0.75 or greater (within the parameters available for the P7fA lenses)
2. Subjects must have 20/20 or better best corrected visual acuity.
3. Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
4. Ability to give informed consent
5. Willing to spend time for the study. Subjects will be required to attend three study visits and wear contact lenses on days between study visits.
6. Willing and able to wear contact lenses for at least 8 hours per day for 5 days per week during the study as daily wear.
7. Currently not using eye lubricating drops and willing to not use during study.
8. Either gender and 18-40 years of age.
9. Any racial or ethnic origin

Exclusion Criteria:

1. Any active ocular inflammation or infection.
2. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
3. Are presbyopic and require or habitually uses reading glasses for near work
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
5. History of refractive surgery
6. Meets the diagnosis of dry eye disease with OSDI screening score ≥13.
7. Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein
8. Is pregnant or lactating or planning a pregnancy during enrollment in the study
9. Is participating in another clinical research study that includes invasive ocular tests
10. An inability to perform contact lens application and removal after instruction.

Primary outcomes:
measure: Subjective assessment of lens wear experience
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
Study officials:
References:
Clinical trial NCT07016425: Temporal Interference for Essential Tremor
Official title: Efficacy and Safety of Non-invasive Temporal Interference Stimulation in the Treatment of Essential Tremor: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Essential Tremor
Keywords: Temporal Interference
Essential Tremor
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single-center prospective study aims to investigate the treatment efficacy of temporal interference (TI) in essential tremor patients aged 30-70.

Detailed description: Temporal Interference (TI) technology is a novel non-invasive method for deep brain stimulation (DBS). By generating an overlapping electric field from safe currents, TI creates focused stimulation in targeted deep brain areas. This approach allows for the exploration of deep brain nuclei functions and has the potential to serve as a non-invasive alternative to traditional invasive DBS for clinical treatments.

This study aims to investigate the treatment efficacy of TI deep brain stimulation by including essential tremor patients aged 30-70. Before and after TI stimulation, clinical data will be recorded. Clinical and imaging data will be analyzed and processed to advance the treatment of essential tremor.

Eligibility criteria: Inclusion Criteria:

* Aged 30-70 years old, regardless of gender. Action tremor and postural tremor in both upper limbs, or action tremor and postural tremor in one limb;
* No history of mental diseases;
* Informed consent signed.

Exclusion Criteria:

* Presence of other neurological diseases affecting the study (such as epilepsy);
* Patients with moderate to severe cognitive impairment (Montreal Cognitive Assessment ≤ 18 points);
* Orthopedic diseases that may affect motor symptoms;
* Patients taking antipsychotic or antidepressant medications;
* Presence of metal implants in the body (such as brain pacemakers or cardiac pacemakers);
* History of electroconvulsive therapy;
* Presence of cardiovascular risk factors, etc.

Primary outcomes:
measure: Tremor Level Evaluation
timeFrame: Up to 3 months after TI stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Liankun Ren, MD
role: PRINCIPAL_INVESTIGATOR
References: