louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02448303: Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer
Official title: A Phase 2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Advanced Non-small Cell Lung Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Acerta Pharma BV
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-05-19
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Men and women ≥ 18 years of age
* ECOG performance status of 0 or 1
* Histologically confirmed recurrent or metastatic NSCLC (adenocarcinoma, large cell, squamous cell, or not otherwise specified) that has either progressed during or after platinum-based chemotherapy
* Received at least 1 platinum-based chemotherapy regimen. Note: Subjects with EGFR mutations or ALK translocations are required to have received prior therapy with appropriate TKI; prior platinum-based chemotherapy is not required for this specific patient population

Exclusion Criteria:

* Prior malignancy (other than lung cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years
* Known central nervous system metastases and/or carcinomatous meningitis
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass
* Breastfeeding or pregnant

Primary outcomes:
measure: Number of Participants With Overall Response
timeFrame: Every 12 weeks for up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Western Regional Medical Center/Cancer Treatment Center of America
state: Arizona
Study officials:
affiliation: 1-888-292-9613; acertamc@dlss.com
name: Acerta Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06128603: Analysis of Intraoperative Bleeding Characteristics in Laparoscopic Pancreaticoduodenectomy
Official title: Analysis of Intraoperative Bleeding Characteristics in Laparoscopic Pancreaticoduodenectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Laparoscopic Pancreaticoduodenectomy
Keywords: laparoscopic pancreaticoduodenectomy
intraoperative bleeding
OSATS scores
short-time outcomes
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients underwent laparoscopic pancreaticoduodenectomy for periampullary benign and malignant diseases.

Brief summary: In this study, we analyze the common bleeding characteristics in laparoscopic pancreaticoduodenectomy by reviewing and annotating bleeding information from previous surgical videos as well as surgical operation OSATS technique scores. From there, we reflect on the correlation between surgical operating technique and intraoperative bleeding, as well as on the correlation between intraoperative bleeding and short-term postoperative outcomes.


Eligibility criteria: Inclusion Criteria:

* the surgical video is complete including the resection and reconstruction phases

Exclusion Criteria:

* the surgical video is not complete
* the cases combined with resection and reconstruction of mesentericoportal vein

Primary outcomes:
measure: intraoperative bleeding characteristics
timeFrame: intraoperatively
Secondary outcomes:
measure: OSATS scores
timeFrame: intraoperatively
measure: textbook outcome
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT03132103: Vitamin D Supplementation and Immunity/Physical Performance
Official title: The Effect of Vitamin D Supplementation on Vitamin D Status, Immunity and Physical Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitamin D Status
Keywords: Vitamin D deficiency
Simulated sunlight radiation
Oral vitamin D3
Lead sponsor: Bangor University
Sponsor class: OTHER
Collaborators: name: University of East Anglia
name: University of Manchester
First posted: 2017-04-27
Enrollment: 260
Sex: MALE
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine the effect of vitamin D supplementation on vitamin D status, immunity and physical performance.

Detailed description: Vitamin D plays a key role in bone mineralisation and has been linked to immune defence maintenance and muscle function. Vitamin D is primarily obtained from endogenous synthesis in response to skin sunlight exposure and follows a seasonal pattern; whereby, vitamin D levels peak at the end of the summer and fall to a trough during winter. If winter vitamin D levels can be increased to match those found in summer using supplementation, it is proposed sufficient vitamin D levels will improve physical performance and reduce susceptibility to illness in military recruits.

Eligibility criteria: Inclusion Criteria:

* Passed medical assessment by medical doctor

Exclusion Criteria:

* Medically deferred by medical doctor
* Regular sun bed use
* Holiday in a hot sunny climate in \<3 months
* Regular vitamin D supplementation

Primary outcomes:
measure: Vitamin D status
timeFrame: Up to 20 months
Secondary outcomes:
measure: Physical performance 1
timeFrame: Up to 20 months
measure: Physical performance 2
timeFrame: Up to 20 months
measure: Physical performance 3
timeFrame: Up to 20 months
measure: Hepatitis B antibody
timeFrame: Up to 20 months
measure: Mucosal immunity
timeFrame: Up to 20 months
Other outcomes:
Locations:
city: Catterick
country: United Kingdom
facility: Infantry Training Centre
state: North Yorkshire
Study officials:
References:
citation: Kashi DS, Oliver SJ, Wentz LM, Roberts R, Carswell AT, Tang JCY, Jackson S, Izard RM, Allan D, Rhodes LE, Fraser WD, Greeves JP, Walsh NP. Vitamin D and the hepatitis B vaccine response: a prospective cohort study and a randomized, placebo-controlled oral vitamin D3 and simulated sunlight supplementation trial in healthy adults. Eur J Nutr. 2021 Feb;60(1):475-491. doi: 10.1007/s00394-020-02261-w. Epub 2020 May 10.
Clinical trial NCT01908803: Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes
Official title: Proof of Concept of Single Application of AL-60371/AL-817 Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes Compared to CIPRODEX® (BID for 7 Days)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Otitis Media
Keywords: AOMT
tympanostomy tubes
Otorrhea
anti-infective
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-07-26
Enrollment: 84
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.

Detailed description: The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.

Eligibility criteria: Inclusion Criteria:

* Parent or guardian: Read and sign the informed consent. When required by the Institutional Review Board, child must agree to sign an approved assent form;
* Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration;
* Presence of patent tympanostomy tubes;
* Refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities;
* Parent or guardian: Agree to comply with the requirements of the study, administer the study medication as directed, complete required study visits, and comply with the protocol;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* NOT otorrhea-free for at least seven days following tympanostomy tube surgery;
* Menarcheal females;
* Previous otologic surgery, except tympanic membrane, within one year of study entry;
* History of/or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);
* Current acute otitis externa, malignant otitis externa, or other conditions which could interfere with evaluation of the study drug;
* Diabetic (controlled or uncontrolled);
* Use of prohibited medications;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit
timeFrame: Day 3 post-treatment up to Day 8 or Early Exit
Secondary outcomes:
measure: Proportion of Subjects With Microbiological Success at the Day 8 Visit
timeFrame: Day 8
measure: Median Time (in Days) to Cessation of Otorrhea
timeFrame: Time to event, up to Day 8
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Manager, GCRA, Pharma
role: STUDY_DIRECTOR
References:
Clinical trial NCT05157503: Treatment of Patients With Stage III Non-small Cell Lung Cancer in Russia"
Official title: "Epidemiology, Approaches to the Diagnosis and Treatment of Patients With Stage III Non-small Cell Lung Cancer in Russia"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stage III Non-small Cell Lung Cancer
Keywords: non-small cell lung cancer
Lead sponsor: Autonomous Non-Profit Organization National Society of Onco-Pulmonologists
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with morphologically proven stage III non-small cell lung cancer

Brief summary: In connection with the transition to the 8th version of the classification of lung cancer according to the TNM system, there are currently no precise epidemiological data on stage III NSCLC, clinical characteristics of patients in this group, approaches to therapy and treatment results in the Russian Federation. The published statistics only provide information on the overall incidence of stage III lung, trachea and bronchial cancer, which is about 40%. This observational study will make it possible to characterize the Russian population of stage III non-small cell lung cancer patients, approaches to choosing a treatment option for stage III NSCLC and the outcomes of this treatment in real clinical practice.


Eligibility criteria: Inclusion Criteria:

- stage III non-small cell lung cancer

Exclusion Criteria:

- the rest of the disease stage

Primary outcomes:
measure: Examine clinical and morphological groups
timeFrame: 10/01/2023
Secondary outcomes:
measure: Explore clinical approaches
timeFrame: 10/01/2023
measure: Diagnostic algorithm:
timeFrame: 10/01/2023
measure: Percentage of treatment options
timeFrame: 10/01/2023
Other outcomes:
measure: -Evaluate the frequency of decision-making as a standard practice vs with an individual decision
timeFrame: 10/01/2023
Locations:
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Oncology. N. N. Blokhin
Study officials:
References:
Clinical trial NCT01813903: Family Welfare Pilot Intervention Study
Official title: Family Welfare Pilot Intervention Study at Finnish Welfare Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Tampere University
name: University of Helsinki
name: University of Jyvaskyla
name: VTT Technical Research Centre of Finland
name: The Finnish Heart Association
name: The National Consumer Research Centre
First posted: 2013-03-19
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to test internet and mobile-based applications to support motivating lifestyle counseling to promote healthy eating habits of the mothers and their spouses expecting first child. The feasibility of the intervention will be evaluated in the pilot.

Detailed description: Lifestyle habits during pregnancy have long-term effects of baby's as well as mother's health. Pregnancy period is a favorable time for lifestyle changes, as the parents usually have motivation and assets to change lifestyle. Maternity welfare clinic is the place to promote healthy lifestyles because most Finnish families expecting child visit there at regular intervals.

Eligibility criteria: Inclusion Criteria:

* All families expecting their child at their standard 8-10 pregnancy weeks welfare clinic visit

Exclusion Criteria:

* Parents are under 18-year-old
* Parents do not speak Finnish
* Parents do not have internet access

Primary outcomes:
measure: Food consumption of the parents
timeFrame: 7 months
measure: Maternal post-natal depression
timeFrame: 9 months
Secondary outcomes:
measure: Food and health related attitudes and aims of the parent's
timeFrame: 9 months
measure: Psychological flexibility of the parent's
timeFrame: 9 months
measure: Mental health of the parent's
timeFrame: 9 months
Other outcomes:
Locations:
city: Vantaa
country: Finland
facility: Maternal welfare clinics
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Suvi I Virtanen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04555603: Axitinib Therapy Management Study
Official title: Retrospective Analysis of Axitinib Treatment Optimization and Management of Selected Immune Related Adverse Events of Checkpoints Inhibitors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Renal Cell Carcinoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: academic and community centers

Brief summary: The objectives of the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI

Detailed description: not mandatory

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of aRCC (Stage III, Stage IV (M0) or Stage IV (M1)) at any point
* Age 18 years or older at the time of aRCC diagnosis
* Received a qualifying IO-containing combination (nivolumab and ipilimumab, axitinib and pembrolizumab, or axitinib and avelumab) in the first regimen after aRCC diagnosis or axitinib monotherapy in any line

Exclusion Criteria:

* none

Primary outcomes:
measure: To describe type of immune related adverse events and adverse events related to axitinib
timeFrame: during treatment period
measure: To describe the percentage of patients with documentation of dose modifications
timeFrame: during treatment period
measure: To describe the percentage of patients with usage of concomitant high-dose corticosteroid
timeFrame: during treatment period
measure: To describe the percentage of patients alive at pre-specified time points (6 months, 12 months, 18 months, 24 months) from start of the index therapy
timeFrame: during study period
measure: To estimate the best overall response (partial response, complete response, progressive disease, or stable disease
timeFrame: during treatment period
measure: To estimate time to treatment discontinuation
timeFrame: during treatment period
measure: To estimate PFS
timeFrame: during treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer Inc.
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06473103: Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy
Official title: Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Basal Cell Carcinoma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Rochester Dermatologic Surgery
First posted: 2024-06-25
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during standard local excision.

Detailed description: This study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (TPFM) to evaluate surgical margins followed by standard of care permanent sections for final margin confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation on permanent sections, thus all patients will receive standard of care confirmation following experimental imaging. Individual excisions from consenting patients will be selected, fluorescently labeled and the distance to inked margins measured with TPFM. Following imaging, specimens will be submitted for paraffin processing as per normal procedure and the resulting slides scanned. The distance to the inked margin will be measured on the permanent sections and compared to TPFM to determine accuracy.

Eligibility criteria: Inclusion Criteria:

* Undergoing treatment for basal cell carcinoma without Mohs surgery at the performance site
* Able to read and understand consent form

Exclusion Criteria:

* None

Primary outcomes:
measure: Quantitative agreement between clear margin distance on TPFM and conventional paraffin embedded histology
timeFrame: Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery
Secondary outcomes:
measure: Overall agreement on margin status
timeFrame: Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery
Other outcomes:
Locations:
city: Victor
country: United States
facility: Rochester Dermatologic Surgery
state: New York
Study officials:
affiliation: University of Rochester
name: Michael Giacomelli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ching-Roa VD, Huang CZ, Ibrahim SF, Smoller BR, Giacomelli MG. Real-time Analysis of Skin Biopsy Specimens With 2-Photon Fluorescence Microscopy. JAMA Dermatol. 2022 Oct 1;158(10):1175-1182. doi: 10.1001/jamadermatol.2022.3628.
Clinical trial NCT04285203: Living Donation and Kidney Transplantation Information
Official title: Living Donation and Kidney Transplantation Information Made Easy (KIDNEYTIME) With Animated Video Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to increase awareness and knowledge regarding the risks and benefits of kidney transplantation and living donation amongst patients seeking kidney transplantation and their family and friends in Buffalo, New York.

Detailed description: This prospective randomized parallel controlled trial of kidney transplant candidates receiving and educational intervention and standard of care education versus standard of care education only to improve informed decision making about kidney offers.

Eligibility criteria: Inclusion Criteria:

* be 18 years or older,
* understand and read English (or have a support person that helps them)
* have acceptable vision to watch videos
* be able to give consent

Exclusion Criteria:

* incarcerated
* involved in the former modeling phase of animation development.

Primary outcomes:
measure: Change in knowledge
timeFrame: Baseline and immediately post exposure
measure: Change in attitude about kidney offers
timeFrame: Baseline and immediately post exposure
Secondary outcomes:
measure: Change in subjective decisional self-efficacy
timeFrame: Baseline and immediately post exposure
measure: Participation and decision making
timeFrame: 1 day (During standard of care education at time of clinic visit)
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
Study officials:
affiliation: University at Buffalo
name: Liise Kayler, MD
role: PRINCIPAL_INVESTIGATOR
References: