louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06426693: Craving Network Neurofeedback
Official title: Connectome-based Neurofeedback of the Craving Network to Reduce Food Cue Reactivity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight or Obesity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project tests whether individuals with overweight or obesity and high craving can learn to change their brain response to food cues using neurofeedback, to impact their craving and eating behavior.

Detailed description: Aim 1 of this study is to test whether neurofeedback from the craving network is associated with reduced craving network strength.

Aim 2 of this study is to test whether neurofeedback from the craving network is associated with reduced food craving and changes in eating behavior.

Aim 3 of this study is to test whether neurofeedback from the craving network is associated with changes in resting state functional connectivity.

Eligibility criteria: Inclusion Criteria:

* Ages 18 to 60 years
* Body mass index \>25 kg/m2
* \>2.37 Food Craving Inventory score

Exclusion Criteria:

* Use of anti-obesity medications
* Weight-reduced state defined as \>10% weight reduction in the past 6 months.
* Nicotine use
* Current diagnosis of neurological or psychiatric disorder
* Obesity-related diseases such as type-2 diabetes
* Contraindications to MRI
* Baseline scanning with motion \>0.15mm frame to frame displacement.

Primary outcomes:
measure: Change in craving network strength during transfer runs
timeFrame: Week 1 and 3
measure: Change in Food Craving Inventory Mean Score
timeFrame: Week 1, Week 7
measure: Change in Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool Healthy Eating Index (HEI).
timeFrame: Week 1, Week 7
measure: Change in craving network strength during resting state runs
timeFrame: Week 1 and 3
measure: Change in Food Rating Task healthiness, tastiness, and choice scores
timeFrame: Week 1, Week 7
measure: Change in Food Snack Task caloric intake
timeFrame: Week 1 and 3
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale MRRC Anlyan Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Kathleen A Garrison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01159093: Giving Immunizations Through Vaccine Education
Official title: Using Health Information Technology to Improve Healthcare Quality in Primary Care Practices and in Transitions Between Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV Vaccines
Keywords: Clinical Decision Support Systems
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2010-07-09
Enrollment: 23675
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will test the effectiveness of clinician-focused health IT-based decision support, family-focused health IT-based decision support, and a combination of both efforts, in increasing HPV and other adolescent vaccine rates among adolescent girls. We hypothesize that a combination of clinician-focused clinical decision support and family-focused decision support will be most effective.

Detailed description: * Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.
* Family-focused intervention includes vaccine reminders and informational telephone calls prompted by the electronic health record.

Eligibility criteria: Inclusion Criteria:

* All clinicians practicing at participating sites
* Parents with an eligible adolescent girl
* Adolescent girls
* Ages 11-17
* Has a visit at one of the primary care centers within the last 15 months.
* Has not completed the teen vaccine series

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of HPV vaccination among girls actively cared for at participating sites
timeFrame: Monthly, up to 1 year
Secondary outcomes:
measure: Rates of meningococcal and tetanus, diphtheria, and pertussis vaccines among girls in the study
timeFrame: Monthly, up to 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Alexander G Fiks, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mayne SL, duRivage NE, Feemster KA, Localio AR, Grundmeier RW, Fiks AG. Effect of decision support on missed opportunities for human papillomavirus vaccination. Am J Prev Med. 2014 Dec;47(6):734-44. doi: 10.1016/j.amepre.2014.08.010. Epub 2014 Nov 18.
Clinical trial NCT06676293: Compassionate Use of Asparaginase and Pembrolizumab Combination Theaapy for Nasopharyngeal Carcinoma
Official title: Compassionate Use of Combination Therapy with Asparaginase and Pembrolizumab in Patients with Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasopharyngeal Carcinoma (NPC)
Keywords: NPC
ICB
asparaginase
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to investigate the outcomes of patients with locoregionally advanced nasopharyngeal carcinoma (LA-NPC) or recurrent-metastatic nasopharyngeal carcinoma (RM-NPC) treated with a combination of immune checkpoint blockade (ICB) and asparaginase.

Detailed description: This study is being conducted to investigate the synergistic effect of combining asparaginase with immune checkpoint blockade (ICB) in tumor-bearing mice. Findings indicate that asparaginase enhances CD8+ T cell activation, and previous reports have shown that nasopharyngeal carcinoma (NPC) patients exhibit a lower response rate to ICB treatment. This study aims to determine whether the combination therapy of asparaginase and ICB is more effective or less effective compared to the standard ICB-only approach for patients with locoregionally advanced (LA-NPC) or recurrent-metastatic NPC (RM-NPC). Participants are being enrolled who have previously received ICB but continue to experience disease progression.

Eligibility criteria: Inclusion Criteria: Patients who have previously received immune checkpoint blockade therapy but are still experiencing disease progression -

Exclusion Criteria: Active autoimmune disease

-

Primary outcomes:
measure: Quantitative Analysis of Plasma EBV DNA Levels for Treatment Response
timeFrame: Until the end of the study
Secondary outcomes:
measure: FDG PET/CT scan
timeFrame: 3 month
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Huang-Yu Yang, M.D./Ph.D
role: STUDY_CHAIR
References:
citation: Gnanaprakasam JNR, Kushwaha B, Liu L, Chen X, Kang S, Wang T, Cassel TA, Adams CM, Higashi RM, Scott DA, Xin G, Li Z, Yang J, Lane AN, Fan TW, Zhang J, Wang R. Asparagine restriction enhances CD8+ T cell metabolic fitness and antitumoral functionality through an NRF2-dependent stress response. Nat Metab. 2023 Aug;5(8):1423-1439. doi: 10.1038/s42255-023-00856-1. Epub 2023 Aug 7.
Clinical trial NCT02728193: Standard Treatments of Very-early Stage Hepatocellular Carcinoma
Official title: The Research on Standard Treatments of Very-early Stage Hepatocellular Carcinoma: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Very-early Stage
Keywords: treatments
hepatocellular carcinoma
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study was to elucidate the difference in the rates of complication, hospitalization days, medical expenses, MRI showed that the degree of tumor necrosis, and overall survival rates of the therapies between PEI, MVA and RFA, and make the standard for minimally invasive treatment of very early stage HCC.


Eligibility criteria: Inclusion Criteria:

1. Preoperative clinical, imaging and tumor markers were diagnosed as hepatocellular carcinoma
2. Tumor diameter\<2cm
3. Child-Pugh class A liver function
4. Without major organ dysfunction
5. male or female patients \> 18 years and \<=70 years of age
6. Voluntary participation in this clinical trial

Exclusion Criteria:

1. Other anticancer treatment before therapy
2. Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer
3. Patients with other diseases that may affect the treatment of this treatment
4. History of other malignant tumors
5. Patients who are participating in other clinical trials
6. Pregnant, lactating women

Primary outcomes:
measure: Recurrence
timeFrame: 3 years
measure: Death
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00631293: Study of the Effect of Lactisole on the Intestinal Glucose Uptake
Official title: Study on the Effect of Lactisole on the Intestinal Glucose Uptake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: VIB
First posted: 2008-03-07
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Study of the effect of lactisole on glucose uptake


Eligibility criteria: Inclusion Criteria:

* Male subject, between 18 and 50 years
* General good health condition

Exclusion Criteria:

* Overweight (Body Mass Index ≥30)
* Metabolic disorders
* History of gastrointestinal disorders
* Regular (daily) intake of medication
* Smoking more than 10 cigarettes/day
* History of drug abuse
* Exhaustive (\> 3 units/day) alcohol consumption
* Exhaustive (\> 5 units/day) caffeine consumption (coffee, tea, cola, or other caffeine based drinks)
* Recent (in the last 14 days) donation of blood
* Recent (in the last 2 days) donation of blood plasma
* Participation in another trial within 4 weeks before the start of the study

Primary outcomes:
measure: Differences in glucose uptake rate in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test
timeFrame: 5 weeks
Secondary outcomes:
measure: Differences in blood insulin, glucagon, triglycerides, GIP and GLP-1 in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test, ECG
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Luc Van Bortel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06535893: Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer
Official title: Sustainable and Efficient Platform of New Therapeutic Development for Early Breast Cancer (S-FACT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Nagoya City University
Sponsor class: OTHER
Collaborators: name: Japan Clinical Oncology Group
First posted: 2024-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized phase II trial targeting early-stage breast cancer (stage II-III) applicable to preoperative chemotherapy (NAC), comparing standard treatment with multiple experimental treatments.

Detailed description: This randomized phase II trial targets early-stage breast cancer (stage II-III) with preoperative chemotherapy (NAC). It compares standard treatment with multiple experimental treatments using an adaptive design, allowing new treatments to be added during or after the trial. Patients are classified by subtype and randomized between standard and experimental treatments.

The trial is flexible, permitting single or combination new drug therapies and incorporating circulating tumor DNA (ctDNA) evaluation for precise efficacy and prognosis prediction.

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed invasive breast carcinoma
2. Stage II or III
3. ECOG performance status of 0 or 1
4. Age 18-80

Exclusion Criteria:

1. Continuous systemic administration (oral or intravenous) of steroid drugs or other immunosuppressants.
2. History or complication of interstitial lung disease or pulmonary fibrosis diagnosed by imaging or clinical findings.
3. Infection requiring systemic treatment.
4. Active double cancer (however, the following are not excluded: (1) Completely resected cancers: basal cell carcinoma, squamous cell carcinoma at clinical stage I, carcinoma in situ, mucosal carcinoma, superficial bladder carcinoma, (2) Gastrointestinal cancer that has been curatively resected by ESD or EMR, (3) Other cancers that have not recurred for more than 5 years).

Primary outcomes:
measure: pathological complete response (pCR)
timeFrame: Baseline to surgery
measure: ctDNA clearance rate
timeFrame: Before Neoadjuvant chemotherapy to surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya City University
state: Aichi
Study officials:
References:
Clinical trial NCT01780493: The Long Term Follow-Up Results Of The Direct Nipple Ureteroneocystostomy Technique
Official title: The Long Term Follow-Up Results Of The Direct Nipple Ureteroneocystostomy Technique: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vesicoureteral Reflux
Nipple Ureteroneocystostomy
Keywords: Nipple
Technique
Ureter
Vesicoureteral Reflux
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 19
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: To evaluate the long term follow-up results of the direct nipple ureteroneocystostomy technique.


Eligibility criteria: Inclusion Criteria:

* Megaureter.
* Ligated Ureter during surgery.

Exclusion Criteria:

* Neurogenic bladder
* Surgical wound infection

Primary outcomes:
measure: Inter-IVU image differences and DMSA uptakes
timeFrame: 3 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty, Department of Urology
Study officials:
References:
Clinical trial NCT01693393: Low Dose Cyclosporin A in Primary Sjögren Syndrome
Official title: A Phase II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sjögren´s Syndrome
Keywords: primary Sjogren´s Syndrome
Cyclosporine
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary Sjögren Syndrome

Detailed description: NSAR are used currently for the treatment of musculoskeletal manifestations at Sjögren Syndrome for the symptomatic release of pain. For therapy-resistant cases drugs also used in Rheumatoid Arthritis are used. For these drugs there is no registration for the treatment of Sjögren Syndrome.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of a primary Sjögren´s Syndrome
* Liver values above 1,5 ULN
* uncontrolled arterial hypertension
* intraarticular or systemic use of Glucocorticoids in the last 4 weeks before
* begin with Study medication

Exclusion Criteria:

* pre-treatment with Cyclosporine A
* Infection
* Neoplasia
* relevant cardiac, pulmonary, neurologic or psychiatric disease
* life-Vaccination within 4 weeks before begin with study medication
* pregnant or breast-feeding
* weight under 45kg or more than 110kg

Primary outcomes:
measure: Examination of the therapeutic effects (improvement in number of tender, swolen joints, DAS 28) of low dose Cyclosporine A in patients with primary Sjögren Syndrome and articular involvement after a treatment-phase of 16 weeks.
timeFrame: 16 weeks
Secondary outcomes:
measure: Evaluation of the safety (type and number of adverse events and serious adverse events) of low-dose Cyclosporine A in patients with primary Sjögren Syndrome
timeFrame: 28 weeks
Other outcomes:
measure: Study the general health changes and improvement of Sicca-symptoms
timeFrame: 16 weeks
measure: Documentation of improvement of articular manifestations by ultrasound examination
timeFrame: 16 weeks
Locations:
city: Berlin
country: Germany
facility: Charite Universitätsklinikum Berlin Campus Mitte
Study officials:
affiliation: Charite University, Berlin, Germany
name: Eugen Feist, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kedor C, Zernicke J, Hagemann A, Gamboa LM, Callhoff J, Burmester GR, Feist E. A phase II investigator-initiated pilot study with low-dose cyclosporine A for the treatment of articular involvement in primary Sjogren's syndrome. Clin Rheumatol. 2016 Sep;35(9):2203-10. doi: 10.1007/s10067-016-3360-4. Epub 2016 Jul 28.
Clinical trial NCT03057171: A Study on the Gastrointestinal Disease and Helicobacter Pylori Controlled Long Non-coding RNA
Official title: A Study on the Gastrointestinal Disease and Helicobacter Pylori Controlled Long Non-coding RNA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori Infection
Gastric Ulcer
Duodenal Ulcer
Stomach Cancer
Keywords: Helicobacter pylori
long non-coding RNA
THRIL
PACER
cagA
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gastrointestinal disease associated with H.pylori infection

Brief summary: Helicobacter pylori (H.pylori) is a major human pathogenic bacterium in gastric mucosa which is linked to the development of gastritis, peptic ulcer disease, mucosa-associated lymphoid tissue lymphoma and gastric cancer. However the regulatory mechanism of H.pylori-induced immune response is not clear. Long non-coding RNA (lncRNA) has recently emerged as key post-transcriptional regulators of gene expression, differentiation. The investigators had a preliminary results which THRIL (TNFα and hnRNPL related immunoregulatory lincRNA) and PACER(p50-associated COX-2 extragenic RNA) played a potential role in H.pylori induced inflammatory cascade. However, there wasn't a previous study about expression of THRIL, PACER in a human tissue. Therefore, the investigators aimed to evaluate the expression of THRIL, PACER in patients with gastrointestinal disease according to H.pylori infection.


Eligibility criteria: Inclusion Criteria:

1. Over 19 years old
2. Patients with gastric ulcer
3. Patients with duodenal ulcer
4. Patients with stomach cancer
5. Patients with gastrointestinal discomfort symptoms

Exclusion Criteria:

1. Patients who has done helicobacter pylori eradication
2. Patients who has undergone gastrectomy
3. Patients who has undergone endoscopic submucosal dissection
4. Patients with active upper gastrointestinal bleeding

Primary outcomes:
measure: Expression of THRIL, PACER
timeFrame: Within 2 weeks after EGD
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei university College of Medicine
Study officials:
References:
Clinical trial NCT02238171: Postmarketing Surveillance Study of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease
Official title: Postmarketing Surveillance Study (as Per §67(6)AMG [German Drug Law]) of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 346
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic obstructive airways disease recruited at general practitioners, pneumologists, internists

Brief summary: To obtain further information on the tolerability and efficacy of Atrovent® inhalets in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice


Eligibility criteria: Inclusion Criteria:

* Patients of both gender, older than 40 years, who suffer from chronic obstructive Pulmonary disease
* Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion

Exclusion Criteria:

• Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® Inhalets

Primary outcomes:
measure: Investigator assessment of improvement of the clinical picture rated on a 6-point symptom profile
timeFrame: Up to 4 weeks after first drug administration
Secondary outcomes:
measure: Assessment of efficacy by investigator on a 4-point scale
timeFrame: Up to 4 weeks after first drug administration
measure: Assessment of efficacy by patient on a 4-point scale
timeFrame: Up to 4 weeks after first drug administration
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: Up to 4 weeks after first drug administration
measure: Assessment of tolerability by patient on a 4-point scale
timeFrame: Up to 4 weeks after first drug administration
measure: Number of patients with adverse drug reactions
timeFrame: Up to 4 weeks after first drug administration
Other outcomes:
Locations:
Study officials:
References: