louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01709656: A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis
Official title: A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators will recruit active ankylosing spondylitis patients for injection treatment of Human Mesenchymal Stem Cells (a prospective, open-label, masculine medicine controlled(NSAIDs), clinical trial), and collect their Peripheral Blood Lymphocyte (PBMCs) and sera before and after the treatment of 24 weeks to test the gene expression profiles and study related pathogenesis of AS


Eligibility criteria: Inclusion Criteria:

1. Aged from 16-65 years, sign the Informed Consent
2. Fulfill 1984 modified NewYork classification criteria for AS
3. Have an active refractory disease defined by a score ≥40 on the Bath AS Disease Activity Index (BASDAI) (0-100) despite optimal non-steroidal anti-inflammatory drug (NSAID) treatment.
4. Commitment to contraceptive for woman

Exclusion Criteria:

1. Completely stiff spine
2. Received spinal or joint surgery within 2 months
3. Received anti-TNF therapy within 3 months
4. History of the listed diseases: heart failure, Multiple sclerosis, severe chronic obstructive pulmonary disease, frequent infections, lymphoma or other cancers, tuberculosis
5. Female of pregnancy or breast feeding
6. Hb≤ 9g/dl for male or Hb ≤ 8.5 g/dl for male, ALT/AST≥2folds of upper level normal range, Creatine≥120mol/L(≤1.4mg/dl)

Primary outcomes:
measure: the proportion of patients which disease activity reaches ASAS(assessment in ankylosing Spondylitis)20 remission criteria
timeFrame: 24 weeks
Secondary outcomes:
measure: BASDAI score comparing to baseline
timeFrame: 24 weeks
measure: BASFI score comparing to baseline
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Rheumatology , Third Affiliated Hospital of Sun Yat-sen University
name: Jieruo Gu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06858956: Real-World Study of Chidamide Combined With PD-(L)1 Inhibitors and Anti-Angiogenic Therapy for Advanced MSS-Type Colorectal Cancer
Official title: Real-World Study of Chidamide Combined With PD-(L)1 Inhibitors and Anti-Angiogenic Therapy for Advanced MSS-Type Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Cancer
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced MSS-Type Colorectal Cancer

Brief summary: This is an observational , multicenter, real-world study aimed at evaluating the efficacy and safety of the combination of immune checkpoint inhibitors, chidamide and antiangiogenic agents in Microsatellite Stable advanced colorectal cancer patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years, male or female.

Histologically confirmed advanced colorectal cancer with microsatellite stable (MSS)/proficient mismatch repair (pMMR) status confirmed by immunohistochemistry (IHC) or molecular testing.

No restriction on prior immunotherapy or combined anti-angiogenic agents (e.g., bevacizumab or small-molecule TKIs).

ECOG performance status of 0-2.

At least one post-treatment efficacy evaluation.

Life expectancy ≥3 months.

Chidamide treatment duration \>3 weeks

Exclusion Criteria:

- 1. Malignancies in other organs or systems, except for cured basal cell/squamous cell skin cancer or cervical carcinoma.

2. Severe comorbidities that may interfere with efficacy or safety analysis. 3. Conditions deemed unsuitable for study inclusion by the investigator.

Primary outcomes:
measure: TTF
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01720056: Verapamil vs Steroid to Prevent Keloid Recurrence
Official title: Assessment of Verapamil as an Adjunct for Prevention of Keloid Recurrence After Surgical Removal
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Keloid Scars
Lead sponsor: The University of Western Australia
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 14
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: Keloid scarring is a severe cosmetic and painful disease of the skin. The gold standard treatment is yet to be clarified. This randomized clinical pilot study will compare the effects of two local treatments for preventing keloid recurrence after surgical removal; steroid and verapamil.

Study hypothesis: Intralesional therapy with the calcium antagonist verapamil has equal treatment efficacy as steroid injection.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing surgical removal of keloid
* Patient 18 years old or greater
* Length of excisional scar after surgical removal of keloid between 2 and 10 cm

Exclusion Criteria:

* Keloid in face or hands
* Pregnancy or lactation
* Dementia
* Any heart or pulmonary condition
* Systemic treatment with beta-blockers, ACE-inhibitors or calcium antagonists
* Systemic corticosteroidal therapy
* Intralesional steroid treatment within 2 months of surgery to remove keloid
* Flap surgery
* Lesions to face, hands and other cosmetically sensitive areas

Primary outcomes:
measure: Keloid recurrence
timeFrame: 1 year
Secondary outcomes:
measure: Vancouver Scar Scale Score
timeFrame: 1 year
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
Study officials:
affiliation: The University of Western Australia
name: Fiona M Wood, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00218556: Preventing Depression in Methadone Maintenance Patients Receiving Hepatitis C Treatment - 1
Official title: Preventing Depression in MMT Patients on Interferon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder, Major
Hepatitis C
Keywords: Hepatitis C, Depressive Symptoms
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Rhode Island Hospital
First posted: 2005-09-22
Enrollment: 42
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 purpose of this study is develop and test a cognitive-behavioral intervention to prevent depression in methadone maintenance patients receiving medical treatment for hepatitis C.

Detailed description: The purpose of this study is to develop a CBT-D intervention tailored to meet the needs of MMT patients undergoing antiviral treatment for hepatitis C. In the first phase of this project (Year 1), we will develop and pilot the intervention with 20 patients. In the second phase of the project (Years 2 and 3), we will conduct a preliminary, randomized trial with 60 MMT patients to examine the efficacy of the CBT-D intervention relative to standard care condition (SC).

We expect that, relative to the SC condition, participants randomized to the CBT-D condition will have decreased likelihood of depression-related antiviral treatment failure, will report lower levels of depressive symptoms, will complete more IFN injections, will have lower HCV RNA levels, and will have fewer illicit drug use days. If the efficacy of this intervention can be established in this trial and in subsequent clinical trials, MMT patients who elect to undergo antiviral therapy will have a valuable adjunct or alternative to the use of antidepressants to prevent depression. If found to be efficacious, this intervention will maximize the receipt of IFN treatment by MMT patients, thereby aiding in the prevention of liver failure, hepatocellular carcinoma, and liver-related death among those with HCV.

Eligibility criteria: Inclusion Criteria:

* Currently undergoing HCV treatment at RIH
* Enrolled in MMT for at least 6 months

Exclusion Criteria:

* Current major depressive episode
* Current suicidality
* Currently taking antidepressant medication
* Received HCV treatment in past

Primary outcomes:
measure: depression-related antiviral treatment failure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Susan E Ramsey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01584856: Small Dense Low-density Lipoprotein in Patients With Prediabetes and Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prediabetes / Type 2 Diabetes
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-04-25
Enrollment: 60
Sex: MALE
Minimum age (years): 20
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: Prediabetes / Type 2 Diabetes

Brief summary: It is known that small dense LDL particles are associated with an increased cardiovascular risk. LDL particles can be separated by gradient gel electrophoresis (GGE) according to their size. The risk to suffer from coronary heart disease is 3-7 fold elevated in subjects with small dense LDL particles compared to subjects with large LDL particles. This study aims at evaluating the predictive value of small dense LDL particles in patients with prediabetes and type 2 diabetes mellitus concerning future changes in intima media thickness, flow-mediated dilation and other risk factors of atherosclerosis (e.g. insulin resistance). 60 patients with prediabetes or type 2 diabetes will be recruited for the study. Assessment will include medical history (risk factors), physical examination (blood pressure, BMI, waist-to-hip ratio), collection of serum, oral glucose tolerance test, measurement of intima media thickness and endothelial dysfunction by ultrasound. All measurements will be repeated after 2 years. Data will be analysed to assess whether the amount of small dense LDL particles can predict further structural and functional changes of the cardiovascular system or changes in the severity of the disease (insulin resistance).


Eligibility criteria: Inclusion criteria: - male gender

* impaired fasting glucose OR type 2 diabetes (ADA criteria)
* BMI \> 25 kg/m2
* given informed consent

Exclusion criteria: - HbA1c \> 9.0%

* insulin therapy
* fasting glucose \> 11mmol/l
* total cholesterol \> 6.5 mmol/l OR triglycerides \> 2.5 mmol/l
* malignant or severe renal, hepatic, pulmonary, neurological or psychiatric disease
* alcohol or drug abuse
* HIV infection.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Endocrinology and Diabetology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Endocrinology and Diabetology
name: Kaspar Berneis, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01427556: The Hormonal and Behavioral Impact of Eating Breakfast
Official title: CCRC: The Hormonal and Behavioral Impact of Eating Breakfast
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eating Behavior
Keywords: Food intake
Breakfast eating
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: USDA Beltsville Human Nutrition Research Center
First posted: 2011-09-01
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred and twenty pre-menopausal women, aged 20 to 45y, who report eating breakfast regularly or skipping breakfast regularly.

Brief summary: This study is exploring the relationship between food intake behavior and the hypothalamic-pituitary axis (HPA) in women who regularly skip breakfast compared to women who regularly eat breakfast.

Detailed description: Healthy women will be studies in a cross-sectional fashion to examine the metabolic, hormonal and behavioral factors associated with breakfast skipping.

Eligibility criteria: Inclusion Criteria:

* Pre-menopausal women (as determined by self-report of menstrual history and confirmation with plasma FSH)
* 20 to 45 years old,
* BMI less than 40 kg/m2
* Stable body weight (fluctuation of less than ± 3%) for past 3 months.
* Breakfast eaters: defined as eating at least 15% of total daily energy intake at a meal between 0400-1000 h at least 6 days/week.
* Breakfast skippers: defined as eating no foods or beverages between 0400-1000h at least 4 days/week or only taking beverages (no solid food) containing less than \~100 kcal.

Exclusion Criteria:

* Erratic/intermittent breakfast eating
* Currently pregnant or lactating
* Shift workers/diagnosed sleep disorders
* Use of tobacco products
* Use of non-prescription drugs/hormone replacement/steroid-based medications
* Diagnosed endocrine, metabolic, or digestive disorder
* Hemoglobin \<11 g/dl
* Plasma Glucose \>120 mg/dl

Primary outcomes:
measure: Food Intake Behavior
timeFrame: week 6
Secondary outcomes:
measure: Markers of nutrient metabolism
timeFrame: week 6
Other outcomes:
Locations:
city: Davis
country: United States
facility: Western Human Nutrition Center, University of California Davis
state: California
Study officials:
affiliation: WHNRC, ARS, University of California Davis
name: Nancy Keim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forester SM, Widaman AM, Krishnan S, Witbracht MG, Horn WF, Laugero KD, Keim NL. A Clear Difference Emerges in Hormone Patterns Following a Standard Midday Meal in Young Women Who Regularly Eat or Skip Breakfast. J Nutr. 2018 May 1;148(5):685-692. doi: 10.1093/jn/nxy020.
Clinical trial NCT03120156: Effects of Sensomotoric Insoles on Postural Control in Elderly People
Official title: Effects of Sensomotoric Insoles on Postural Control in Elderly People - a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensorimotor Gait Disorder
Keywords: sensomotoric insoles
postural control
proprioceptive insoles
insoles
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled trial
Primary purpose: TREATMENT

Brief summary: People with weak balance ability or subjective feeling of dizziness and unsure gait are separated into 3 training-groups. One Group is getting no insoles, the second group is getting modern sensomotoric insoles, and the third group is getting normal standard insoles. All are passing a 6 week proprioceptive training.

Main outcome measurements are posturography at baseline, 3 weeks and 6 weeks. Secondary measurements are ABC-Scale, Tinetti Gait and balance test and functional reach test at baseline and after 6 weeks.

Detailed description: People with weak balance ability or subjective feeling of dizziness and unsure gait are separated into 3 training-groups. Exclusion criteria are structural neuropathic cause for dizziness, severe ocular deficience, cochlear causes for dizziness.

The 3 Groups differ in following criteria:

Group 1: Gets basic insoles after 3-D-Scan of the foot Group 2: Gets sensomotoric insoles (Jahrling) after 3-D-Scan of the foot. Group 3: Control-Group = no insoles

Alle groups are doing a 6 weeks proprioceptive training 2 times a week for 45min. Balance-Ability is measured by a posturographic plate prior to the training, after 3 weeks training and after 6 weeks of training. ABC-Score, Tinetti Gait and Balance test and functional reach test are secondary outcome measurements and are evaluated prior the training and after 6 weeks of training.

Eligibility criteria: Inclusion Criteria:

ABC-Scale \< 70% Functional reach test \< 30cm Subjective feeling of unsure gait or several falls in the last 5 years

Exclusion Criteria:

Structural pathologies in the balance system Neuropathologies like Polyneuropathy

Primary outcomes:
measure: Posturographic measurement with Kistler's measuring plate
timeFrame: 30 min.
Secondary outcomes:
measure: Tinetti Balance and Gait instrument
timeFrame: 15 min.
measure: Functional reach test
timeFrame: 5 min
measure: ABC-Scale
timeFrame: 15 min
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation
Study officials:
References:
Clinical trial NCT05799456: Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma
Official title: Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Lead sponsor: Chalmers University of Technology
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2023-04-05
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective case-control study to compare patients elected for transurethral resection of the bladder (TURB) for bladder cancer (BCa) \[cases\] versus patients with no evidence of disease (NED) during the follow-up of previously localised BCa \[controls\].

Brief summary: Early detection of bladder cancer (BCa) is considered an effective strategy to curb mortality from the disease. However, current urinary biomarkers have insufficient specificity to warrant BCa screening. Urine free glycosaminoglycan profiles (or GAGomes) are promising noninvasive biomarkers of cancer metabolism. In this study, samples are obtained from patients with BCa and controls to compare the glycosaminoglycan profiles between groups.


Eligibility criteria: Cases (Bladder cancer \[BCa\])

Inclusion Criteria:

* Primary BCa diagnosis at cystoscopy, planned for TURB

Exclusion Criteria:

* No histopathological diagnosis of BCaTa-T4 N0-2 MX-0 after TURB

Controls (No evidence of disease \[NED\])

Inclusion Criteria:

* In follow-up with cystoscopy after treatment Ta-T3 N0-2 M0 BCa or upper tract urothelial cancer no evidence of disease at cystoscopy for at least 6 months prior to inclusion
* No history of cancer except urothelial

Exclusion Criteria:

* Positive cytology at inclusion visit
* Intravesical instillation therapy during 6 months prior to inclusion visit

Primary outcomes:
measure: Area-under-the-receiving operating characteristic (ROC)-curve (AUC) for the classification of BCa versus NED
timeFrame: Before primary surgery for BCa; at a post-surgical follow-up visit for controls up to 5 years from primary surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg
Study officials:
References:
Clinical trial NCT02778256: Study of the Effectiveness of Vestibular Stimulation Treatment in the Depressive Phase of Bipolar Disorder
Official title: Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in the Depressive Phase of Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Depression, Bipolar
Keywords: depression, bipolar disorder
Lead sponsor: Vest Brain,Centro de Estudios Neurovestibulares
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vestibular stimulation has been shown to be a very effective noninvasive treatment for major depression. Bipolar disorder is a mental illness that presents cyclic sequences of depressive and euphoric states. Depressive phases of bipolar disorder are difficult to treat and usually are resistant to actual available treatments. This study investigates the effectiveness of a particular technique of vestibular stimulation in a group of 120 bipolar type I and II patients. After randomization 60 of them will receive specific vestibular stimulation (experimental group) and 60 will receive a sham vestibular stimulation.The study will conducted in Vest Brain, Centro de Estudios Neurovestibulares, in Chile.


Eligibility criteria: Inclusion Criteria:

* males
* females
* 3 previous weeks with depression symptoms.
* bipolar disorder type I actual depressive phase
* bipolar disorder type II actual depressive phase
* Montgomery Asberg depression scale(MADRS) score equal or more than 20
* stable psychiatric medication during 2 weeks previous the recruitment

Exclusion Criteria:

* pregnancy
* neurologic disorder
* drugs or alcohol abuse during the 2 weeks previous the recruitment
* presence of maniac state(Young mania scale score more than 7)

Primary outcomes:
measure: Remission rates of depression.
timeFrame: 90 days
Secondary outcomes:
measure: Percentage of vestibular change.
timeFrame: 90 days
measure: Response rates of depression
timeFrame: 90 days
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Vest Brain, Centro de Estudios Neurovestibulares
Study officials:
affiliation: Vest Brain,Centro de Estudios Neurovestibulares
name: Ana M Soza, M.D.
role: PRINCIPAL_INVESTIGATOR
References: