louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05685511: Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery
Official title: Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Anxiety
Depression
Major Surgical Resection of a Thoracic Malignancy
Major Surgical Resection of an Abdominal Malignancy
Keywords: behavioral activation
medication optimization
thoracic surgery
oncologic surgery
perioperative mental health
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-01-17
Enrollment: 105
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using a Hybrid Type 1 Effectiveness-Implementation randomized control trial (RCT) design, the investigators will test the effectiveness of a bundled behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing oncologic surgery (compared with usual care), while examining implementation outcomes.


Eligibility criteria: Inclusion Criteria:

Pre-screening:

To be considered for participation, patients will be screened using PHQ-4 questionnaire. Scores \>3 will indicate positive pre-screen (i.e. can be considered for participation and formal screening). Scores \< 3 will indicate negative screen (i.e. patient not considered for formal screening due to low risk for anxiety or depression).

Screening:

* Adults age ≥60 years
* Scheduled major thoracic, breast, or abdominal surgery for suspected or confirmed malignancy
* PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥10 indicating clinically significant depression or anxiety symptoms.

Exclusion Criteria:

* Barrier to communication (Unable to read, speak, and understand English)
* Severe cognitive impairment screened by the SBT (Short Blessed Test) \>10
* Acutely suicidal
* Considered ineligible per the discretion of the oncologic surgeon or study PI
* Previous participation in this study or another CPMH study of the intervention bundle or its feasibility.

Primary outcomes:
measure: Change in depression as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
timeFrame: Baseline, 1-month follow-up, and 3-month follow-up
measure: Change in anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
timeFrame: Baseline, 1-month follow-up, and 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Benjamin D Kozower, M.D., MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00719511: Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration
Official title: Single Center Phase I/IIa, Placebo Controlled, Randomized, Double-blind, Dose-response Study to Assess the Optimal Dose as Well as Clinical Efficacy and Safety of a Novel Method of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergies
Keywords: Rhinoconjunctivitis
Allergic
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2008-07-21
Enrollment: 132
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: Evaluation of patch as specific immunotherapy in allergic patients


Eligibility criteria: Inclusion criteria:

* Written informed consent
* History of grass pollen allergic rhinitis
* Male and female between 18 years to 65 years
* Positive skin-prick test to grass pollen
* Positive conjunctival provocation test

Exclusion criteria:

* Eczematous skin lesions on the upper arms
* Perennial allergic rhinitis
* Symptoms of infectious disease with rhinitis in between the last 2 weeks
* Surgical intervention in between the last 30 days
* Pregnancy or nursing
* History of HIV or AIDS
* History of mastocytosis (cutaneous or systemic)
* History of significant cardiovascular disease
* Hypertension (blood pressure \> 160 / 95)
* History of significant pulmonary, renal and/or hepatic disease
* History of significant hematological disorder
* Moderate or severe asthma
* History of malignancy
* History of neurological or psychiatric disease
* History of autoimmune disease
* Antihistamines with longed half-lives in the last week
* Systemic or topical steroids for 5 days
* Active infectious disease
* Contraindicated medications:

  * immunosuppressive agents
  * Betablockers
  * ACE-inhibitors, AT 2 Antagonists
  * tricyclic antidepressants
  * daily use of Beta-agonists or steroid inhalers
* Participation in another clinical trial /study at the moment or within the last 60 days

Primary outcomes:
measure: Comparison of the efficacy of the placebo with that of three different test doses of the epicutaneous pollen allergen administration evaluated by visual analog scales after the treatment
timeFrame: 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT02826811: Role of Anti-BK Virus Neutralizing Antibodies (BKV) as a Prognostic Marker for the Development of Nephropathy BK
Official title: Role of Anti-BK Virus Neutralizing Antibodies (BKV) as a Prognostic Marker for the Development of Nephropathy BK
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Graft Dysfunction
Keywords: Graft dysfunction
Graft loss
kidney
Transplantation
BKV
Anti-BKV
Nephropathy
Immunosuppression
Prognostic markers
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Kidney transplant patients between 1 July 2012 and 31 July 2014 at the University Hospital of Strasbourg

Brief summary: BKV nephropathy (BKV) is one of the most frequent complications of kidney transplantation.

In the absence of specific anti-BKV treatment, pre-emptive reduction of immunosuppression is the main strategy that has proven effective in reducing the risk of BKVN. However, it exposes a transplant rejection risk estimated between 4 and 14% according to studies.

Despite the pre-emptive reduction of immunosuppression, a significant number of patients continue to progress towards BKVN suggesting that pre-emptive strategy is late. It's therefore urgent to develop new prognostic markers to identify earlier and more effectively patients with a higher risk of developing BKVN.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years
* Grafted kidney patient between 1 July 2012 and 31 July 2014 at Strasbourg University Hospital with regular monitoring

Exclusion Criteria:

* Patient under 18 years

Primary outcomes:
measure: Quantification of anti-BKV
timeFrame: up to 12 months post-transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Virologie - Hôpital Civil
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Samira FAFI-KREMER, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04356911: The Strontium Chloride Associated With Photobiomodulation in the Control of Post-bleaching Sensitivity
Official title: The Association of Strontium Chloride With Photobiomodulation in the Control of Tooth Post-bleaching Sensitivity: Clinical Trial, Randomized, Double-blind and Split-mouth.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2020-04-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 31
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study investigated the effects of the association of strontium chloride with photobiomodulation on the dental bleaching process, testing the hypothesis that they may control dental sensitivity post-bleaching teeth.

Detailed description: The objective of this double-blind, randomized, controlled clinical study was to evaluate the effect of 10% strontium chloride associated with photobiomodulation (FBM) on teeth exposed to 35% hydrogen peroxide during 3 weeks of whitening treatment. Methods: 50 volunteers were evaluated by the split mouth model, where the hemiarchy patients were randomized and subsequently allocated to one of the experimental groups: PLACEBO (negative control) - group with no desensitizing treatment, only bleached; FBM (positive control) - group treated with placebo gel and application of the LLLT (Low Level Laser Therapy); ESTRÔNCIO (positive control) - group treated with 10% strontium chloride and simulation of LLLT application (without light emission); and FBM + ESTRÔNCIO - group treated with LLLT + 10% strontium chloride.

Eligibility criteria: Inclusion Criteria:

* good oral hygiene
* absence of active caries lesions
* never having undergone previous whitening therapy
* not present dental hypersensitivity
* don't be a smoker
* not be pregnant
* present at least 28 teeth in the oral cavity.

Exclusion Criteria:

* volunteers who were under orthodontic treatment,
* presence of periodontal disease
* dental cracks or fractures
* restorations and prostheses on anterior teeth
* extensive molar restorations
* gastroesophageal disorders
* severe internal dental darkening
* presence of dentinal exposure in anterior and / or posterior teeth.

Primary outcomes:
measure: Efficacy of desensitizer treatment in the control of tooth post-bleaching sensitivity (P21)
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Para's Federal University
state: Pará
Study officials:
affiliation: clinical professor
name: Cecy M Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03300011: Ultrasonic Cardiogram Evaluate the Prognosis of Percutaneous Revascularization of Chronic Total Occlusions
Official title: Ultrasonic Cardiogram to Evaluate the Long-term Outcome and Prognosis of Coronary Artery Chronic Total Occlusions for Percutaneous Revascularization Versus Optimal Medical Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Chronic Total Occlusion
Keywords: ultrasonic
chronic total occlusion
heart function
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: Chronic total occlusions (CTO) are encountered in almost one-fourth of patients undergoing coronary angiography. The presence of an untreated CTO has been related to adverse clinical prognosis, both in stable angina and acute myocardial infarction, and is often associated with persistent symptomatic angina. Depending on their symptomatic and functional status as well as anatomical complexity, CTO can be treated by optimal medical therapy only or therapy combined with coronary revascularization. This study designed to evaluate the safety and efficacy of coronary chronic total occlusion PCI by ultrasonic cardiogram.

Detailed description: UCEPPCIOCT maintains a prospective clinical registry of all individual who undergo cardiac angiography,PCI or optimistic medicine treatment.

1. research objective to observe the changes of cardiac function postoperative PCI in patients with CTO and the incidence of major adverse cardiovascular events, and provide the reality basis for PCI strategy in clinical patients with CTO . 2. research content: follow up the patients with CTO by using echocardiography in preoperative and postoperative PCI in 1m, 3ms, 6ms, 12ms to assess the changes of cardiac structure and cardiac function. 2, comparison the 'incidence of major adverse cardiovascular events undergo PCI treatment in success and failure group in patients with CTO (such as severe angina attack, severe acute coronary syndrome, severe heart failure should be rehospitalized , fatal arrhythmia and sudden cardiac death, etc.)

Eligibility criteria: Inclusion Criteria:

coronary artery of chronic total occlusion

Exclusion Criteria:

ACS in 3months; once PCI or CABG; AF

Primary outcomes:
measure: cardiac death,
timeFrame: postoperation 1year
measure: MACE
timeFrame: postoperation 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT02150811: Observational Study of Hunner's Ulcer in Patient With Interstitial Cystitis/Bladder Pain Syndrome
Official title: Longitudinal Change of Distribution Pattern of Hunner's Ulcer in Patient With Interstitial Cystitis/Bladder Pain Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Cystitis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary care clinic

Brief summary: The purpose of this study is to observe change of distribution pattern of Hunner's ulcer in patient with interstitial cystitis/bladder pain syndrome

Detailed description: This is observational, 12 months study

Eligibility criteria: Inclusion Criteria:

1. must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study
2. Pain VAS ≥4
3. O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2)
4. PUF score ≥ 13
5. cystoscopic record within 2 years
6. Hunner ulcer lesion in cystoscopic finding

Exclusion Criteria:

1. Scheduled for or use of intravesical therapy (eg, bladder distention,transurethral resection of bladder ulcer, instillation) during or within 6months prior to the study and use of pentosan polysulfate sodium within 1 months prior to the study
2. Patients who are pregnancy or, childbearing age without no contraception
3. Patients with voided volume \<40 or, \> 400ml
4. Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination
5. Patients with urine culture showing evidence of urinary tract infection 1month prior to the study
6. Accompanied medical problem below

   * Tuberculosis in urinary system
   * Bladder cancer, urethral cancer, prostate cancer
   * Recurrent cystitis
   * Anatomical disorder
7. Patients had prior surgery (eq, bladder augmentation, cystectomy
8. Patients with neurologic disorder
9. Patients with indwelling catheter or intermittent self-catheterization
10. Patients with psychologic problem

Primary outcomes:
measure: Change of distribution pattern of Hunner's ulcer
timeFrame: 1 month, 6month, 12month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Myung-Soo Choo, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00468611: Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis
Official title: A Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Multiple Sclerosis, Secondary Progressive
Keywords: Secondary Progressive Multiple Sclerosis
Multiple Sclerosis
Lead sponsor: BioMS Technology Corp.
Sponsor class: INDUSTRY
First posted: 2007-05-03
Enrollment: 510
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: This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects with Secondary Progressive Multiple Sclerosis (SPMS)


Eligibility criteria: Inclusion Criteria:

* Male of female subjects, 18-65 years of age with a diagnosis of SPMS
* HLA DR2 and/or DR4 positive
* Absence of a relapse in the 3 months prior to baseline
* EDSS of 3.0 - 6.5

Exclusion Criteria:

* Therapy with Beta-interferon, glatiramer acetate within 3 months or mitoxantrone, cyclophosphamide, methotrexate, azathioprine or any immune modulating or immunosuppressive drugs within 6 months of baseline
* Treatment with Tysabri within 2 years of baseline
* Females who are breast feeding, pregnant (pregnancy test at baseline) or not using a medically approved method of contraception regularly

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment
timeFrame: 24 Months
Secondary outcomes:
measure: To assess the safety of MBP8298, degree of change in the EDSS scores, effect of MBP8298 on MRI parameters, difference in relapse rates, effect on MSFC, subject's quality of life (MSQoL54) and fatigue (MFIS) after 24 months of treatment
timeFrame: 24 Months
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Clyde E Markowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02384811: Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma
Official title: Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Esophageal squamous cell carcinoma
postoperative radiotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 70
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: The primary object of this trial is to evaluate the 2-year local control rate adding extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma.


Eligibility criteria: Inclusion Criteria:

* Joined the study voluntarily and signed informed consent form;
* Age 18-75；ECOG 0-2
* Esophageal squamous cell carcinoma , radical surgery ≤3 months,R0 resection. The operative incision healed well.
* T3-4N0M0, T1-4N1-3M0 (according to AJCC2009)
* No radiotherapy, chemotherapy or other treatments pre(post)surgery
* PS ECOG 0-2
* Life expectancy of more than 3 months
* Hemoglobin(Hb)≥9 g/dL • WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L • platelet count (Pt) ≥100x 109/L • Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\<1.5 x ULN • Renal function: creatinine \< 1.5 x ULN
* No immuno-deficiency
* Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

* Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis
* Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
* Participation in other interventional clinical trials within 30 days
* Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
* Drug addiction, Alcoholism or AIDS
* Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
* Unsuitable to be enrolled in the trial in the opinion of the investigators

Primary outcomes:
measure: Local control rate
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 year
measure: Safety: Frequencies of treatment-related adverse event categories by NCI-CTC
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Cancer hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jia-qing Xiang, M.M
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang X, Ai D, Wang J, Chen Y, Liu Q, Deng J, Yang H, Nie Y, Chen W, Zhao W, Zhao K. The Prognosis and Feasibility of Extensive Clinical Target Volume in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma: A Phase II Clinical Trial. Front Oncol. 2021 Jul 2;11:669575. doi: 10.3389/fonc.2021.669575. eCollection 2021.