louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00048126: A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer
Official title: An Open-label Study of the Effect of Continuous Xeloda Therapy in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2002-10-25
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy and safety of continuous oral Xeloda administration in combination with intravenous irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* locally advanced and/or metastatic colorectal cancer;
* \>=1 target lesion.

Exclusion Criteria:

* previous treatment with Xeloda or irinotecan;
* previous systemic therapy for metastatic disease;
* progressive disease during previous adjuvant therapy or within 6 months of completion.

Primary outcomes:
measure: Tumor measurements (RECIST criteria)
timeFrame: Event driven
Secondary outcomes:
measure: Time to progression, time to response, duration of response, time to treatment failure, survival.\n
timeFrame: Event driven
Other outcomes:
Locations:
city: Hoover
country: United States
state: Alabama
city: La Jolla
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Boston
country: United States
state: Massachusetts
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Providence
country: United States
state: Rhode Island
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06672926: NEWPROMRI-PATHWAY - A New Prostate Magnetic Resonance Imaging (MRI) Pathway
Official title: NEWPROMRI-PATHWAY - A New Prostate Magnetic Resonance Imaging (MRI) Pathway
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer
MRI
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Uro-radiologists will be asked to take part, along with radiographers and members of a prostate cancer charity group

Brief summary: Prostate cancer is the second most common cancer in men worldwide. The demand for magnetic resonance imaging (MRI) to diagnose and manage prostate cancer is continually growing. There is, however, a severe global shortage of radiologists who review and make decisions on prostate scans. This shortage causes compromises that are inefficient and negatively affect care provision, patient outcomes, and patient experiences. Two key examples of these compromises are that every patient receives a gadolinium contrast injection during a prostate MRI scan and patients often require multiple imaging appointments. If radiologists' knowledge of making prostate MRI decisions around these compromises could be harnessed and passed to radiographers (who are trained to acquire the MRIs but currently do not review them) with a computerised system to support clinical decision-making, this would have enormous potential to improve the diagnosing and managing prostate cancer.


Eligibility criteria: Inclusion Criteria:

* MRI radiographers in University Hospitals of North Midlands (UHNM) and or University Hospitals of Derby and Burton (UHDB) with over 5 years' experience in MRI of the prostate.
* Radiographers from UHNM or UHDB who have completed an online and hands on study specific training materials before the testing phase.
* Retrospective data of 800 patients each from UHNM and UHDB who have had mpMRI and went on to have a biopsy.

Exclusion Criteria:

* Non-MRI radiographers.
* Radiographers who did not completed an online and hands on study specific training materials before the testing phase.
* Non-mpMRI.

Primary outcomes:
measure: Use of Gadolinium Based Contrast Agent (GBCA) injection
timeFrame: 12 months
measure: Application of WB-MRI
timeFrame: 12 months
measure: Radiographers opinions
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
state: Staffordshire
Study officials:
References:
Clinical trial NCT02607826: Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors
Official title: Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholangiocarcinoma
Pancreatic Ductal Adenocarcinoma
Colorectal Cancer
Gastric Cancer
Adenocarcinoma of the Esophagogastreal Junction
Esophagus Cancer
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-11-18
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Recent pre-clinical data provide strong evidence that short-term starvation before the administration of cytostatic drugs for the chemotherapy of solid tumors leads to significantly higher efficacy and lower toxicity levels. However, these findings have so far not been validated in patients. The aim of this trial is to provide first clinical evidence regarding the impact of pre-chemotherapeutic short-term starvation on response to therapy (primary endpoint). Additionally, progression-free survival, adverse events, and overall survival will be monitored (secondary endpoints). In perspective, short-term starvation before chemotherapy could represent a simple and secure way to improve both efficacy and tolerance of chemotherapies at low cost.


Eligibility criteria: Inclusion Criteria:

1. Patient (male/female) ≥ 18 years of age
2. Written informed consent obtained prior to any trial specific procedure
3. Patient suffering from gastrointestinal tumors: Cholangiocarcinoma (CC), Pancreatic ductal adenocarcinoma (PDAC), Colorectal Cancer (CRC), Gastric Cancer (GC)/ Adenocarcinoma of the Esophagogastreal Junction (AEG) / Esophagus cancer (EC).
4. Planned to receive palliative chemotherapy
5. No prior palliative chemotherapy
6. ECOG performance status of 0 or 1
7. Life expectancy of 12 weeks or more
8. Adequate hematological parameters, as demonstrated by:

   * Hemoglobin \> 9.0 g/dl (5.6 mmol/l)
   * WBC ≥ 3.0 x 109/l
   * ANC ≥ 1500/mm³
   * Platelets ≥ 75 x 109/l
   * S-creatinine ≤ 1.5 mg/dl (132 µmol/l)

Exclusion Criteria:

1. Underweight (BMI \< 18.5)
2. Dysphagia
3. Insulin-dependent diabetes mellitus
4. Renal failure requiring hemo- or peritoneal dialysis
5. Pregnant or breast-feeding women
6. Drug/alcohol abuse

Primary outcomes:
measure: Response to therapy on MRI or CT scancs will be measured using the RECIST criteria version 1.1.
timeFrame: Three Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03247166: A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
Official title: A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Back Pain
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-08-11
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The system is designed to afford motion of the spine segment without fusion. The pur0pose of this prospective clinical study is to establish the safety and effectiveness of the TOPS™ System, when used following decompression, in the treatment of lower back and sciatic pain.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic monosegmental lumbar spinal stenosis or facet arthrosis
* Patients with degenerative spondylolisthesis
* Patients with at least 3 months failed conservative treatment
* Narrowing of the lumbar spinal canal
* Patients with lower back pain or sciatica

Exclusion Criteria:

* Discogenic back pain at TOPS System level
* Back or non-radicular leg pain of unknown etiology at TOPS System level
* Lytic spondylolisthesis at TOPS System level
* More than one motion segment involved in degenerative pathology to the extent that justifies its inclusion in the surgical procedure
* Known allergy to titanium and/or polyurethane

Primary outcomes:
measure: Pain Improvement
timeFrame: 24 months
measure: Function Improvement
timeFrame: 24 months
measure: Fusion Prevention
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
measure: Safety
timeFrame: 24 months
Locations:
city: H̱adera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Eyal Behrbalk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01514266: Effect of Curcumin on Lung Inflammation
Official title: Effect of Curcumin on Lung Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: proven diagnosis
COPD
sputum
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2012-01-23
Enrollment: 57
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chronic obstructive pulmonary disease (COPD) and lung cancer are leading causes of death and health care use. Diffuse airways inflammation is seen in COPD and is thought to be the reason for deterioration of lung function in COPD. Currently there is no medication available that can modify or reduce this inflammation. Furthermore, from literature review it has been shown that chronic inflammation can result in cancerous changes.

Curcumin is a food additive used for centuries. Several studies showed that curcumin suppress the different inflammatory pathways. Specially, the TNF-alpha and the NF kappa-b are down regulated by this substance. This study was designed to evaluate effect of combination of curcumin+Bioprine on sputum cytology in patients with COPD. This is double-blind randomized pilot study.


Eligibility criteria: Inclusion Criteria:

* Age equal or more than 45 with moderate COPD: FEV1/FVC ratio less than 70 percent; post bronchodilator FEV1 less than 50 percent
* 20 pack year cigarette smoking
* Stable clinical course (symptoms/ medications) for 8 weeks
* Fixed address/Not planning to leave
* Being able to perform spirometry
* Able to understand and consent

Exclusion Criteria:

* Other chronic respiratory diseases such as asthma, interstitial fibrosis, sarcoidosis
* Heart failure NYH III \& IV; symptomatic liver or renal failure
* Dementia or other neurocognitive deficit preventing completion of symptom diary
* Use of inhaled or systemic corticosteroids within 8 weeks of enrollment in the study

Primary outcomes:
measure: Change in sputum dysplasia
timeFrame: 3 months
Secondary outcomes:
measure: Number of subjects with adverse events in each arm of the study.
timeFrame: 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: VA Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT03056066: Accuracy of Spircare Device as Compared to the Conventional Plethysmograph
Official title: Accuracy of Spircare Device as Compared to the Conventional Plethysmograph
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD Asthma
Pulmonary Fibrosis
Lead sponsor: Spircare Ltd.
Sponsor class: INDUSTRY
First posted: 2017-02-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Phase I Health subjects without respiratory system disease.

Phase II Subjects which are referred to a Pulmonary Functional Testing in the Meir pulmonary unit.

Brief summary: The purpose of this study is to assess the accuracy of FRC and airway resistance calculate values of Spircare device as compared to the conventional body plethysmograph in healthy adults and patients with obstructive and restrictive pulmonary diseases/disorders.


Eligibility criteria: Inclusion Criteria:

1. Signed Informed consent.
2. Age≥18 year.
3. Subject is cooperative and capable of following instructions.
4. Phase I: Healthy asymptomatic subjects, never smokers without known history of respiratory, cardiovascular, hepatic, renal or metabolic disease.
5. Phase II: Chronic pulmonary patients with lung volume disorders:

   * COPD
   * Asthma
   * Restrictive diseases such as pulmonary fibrosis, other interstitial lung diseases, kyphoscoliosis, neuro-muscular disorders.

Exclusion Criteria:

1. Subjects unable or unwilling to give informed consent.
2. Subjects who are unable to satisfactorily perform routine, full lung function testing (due to non-compliance or claustrophobia).
3. History suggesting upper respiratory infection during the four weeks prior to testing
4. Physical activity during 1 hour prior to the Study.
5. Patients with a tracheostomy.
6. Pregnant women.

Primary outcomes:
measure: The FRC and air way resistance values of the body plethysmograph will be compared to the values of the Spircare device
timeFrame: September 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: "Meir" Medical Center
Study officials:
References:
Clinical trial NCT03241966: Perception, Cognition, and Gait in Parkinson's Disease
Official title: Perception, Cognition, and Gait in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Online Study
Quality of Life
Activities of Daily Living
Perception
Cognition
Gait
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 439
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are accepted regardless of location, community, clinic, etc.

Brief summary: The investigators are examining how aspects of daily function are perceived in persons with PD and in those who interact with them on a regular basis. If eligible, participants will receive a set of online questionnaires by email. The questionnaires will take about 1 hour to complete, and can be done at the participant's convenience. The investigators are looking for volunteers who have a diagnosis of Parkinson's disease without dementia (age 40 or older and proficient English speakers). If a spouse, family member, significant other or other close associate is available (age 18 or older, proficient English speakers), the investigators will send them questionnaires as well. There is no monetary or other compensation for this study. For more information, please contact the Vision and Cognition Laboratory at vcognition@gmail.com or 617-358-1377.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Parkinson's disease without dementia OR close associate of someone with Parkinson's disease
* 40 years or older
* Proficient English speaker
* Access to a computer
* 8+ years of education

Exclusion Criteria:

* Co-existing active neoplasm, serious cardiac disease, other serious chronic medical illness
* Prior intracranial surgery
* History of traumatic brain injury
* Psychiatric or neurological diagnoses other than Parkinson's disease
* History of alcoholism or other drug abuse
* History of treatment with electroshock therapy

Primary outcomes:
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Within 24 hours of starting the study
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Vision and Cognition Laboratory at Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Alice Cronin-Golomb, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00931866: Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain
Soft Tissue Injury
Keywords: diclofenac
acute pain
topical
patch
Acute Pain due to Mild to Moderate Soft Tissue Injury
Lead sponsor: Cerimon Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2009-07-02
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing mild to moderate soft tissue injuries when applied to the painful area.

Detailed description: This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with mild to moderate soft tissue injuries.

Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the diclofenac topical patch or a matching placebo patch to be applied once daily for 14 days. Patients will return to the clinic for assessments on Day 3, Day 7 and Day 14; a follow-up assessment will be conducted on Day 21. Patients will complete an electronic diary in which assessments including pain intensity and pain relief will be recorded twice daily. Functional disability and global impression of change will be recorded in the diary at study visits, ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects 18-75 years of age
* Sustained recent, painful unilateral mild to moderate soft tissue injury (between the mid-bicep to wrist or mid-thigh to ankle)
* Meet baseline pain criterion

Exclusion Criteria:

* Open wound or infection at site of injury
* Evidence of severe injury, including fracture or nerve injury
* Use of oral NSAIDs or opioids within 12-24 hours of injury
* Presence or history of peptic ulcers or GI bleeding
* A history of intolerance to NSAIDs, acetaminophen, adhesives
* Positive pregnancy test
* Positive drug screen

Primary outcomes:
measure: Change in average pain during daily activity at Day 7
timeFrame: Day 7
Secondary outcomes:
measure: Change in average pain during daily activity at Day 14
timeFrame: Day 14
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD
state: Texas
Study officials:
References:
Clinical trial NCT05934266: Impact of Mesh Fixation With Tissue Adhesive
Official title: Impact of Mesh Fixation With Tissue Adhesive on Open Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Groin Hernia
Hernia, Inguinal
Postoperative Pain
Neuropathic Pain
Keywords: hernioplasty
mesh fixation
n-hexyl cyanoacrylate
groin hernia
postoperative pain
Lead sponsor: Hospital Universitario de Móstoles
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 160
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: Randomized controlled trial on mesh fixation using cyanoacrylate glue compared to standard suture in open inguinal hernia repair.

Detailed description: Hernioplasty with suture-fixed mesh is the standard technique for the treatment of inguinal hernia, one of the most frequent pathologies in the Surgery Service. Despite its good results in terms of recurrences, it is currently under review due to the incidence of chronic postoperative pain. Up to half of the patients report some type of pain at one year of follow-up, and 15% report moderate-severe pain.

The objective of the study is to analyze whether the use of tissue adhesive (n-hexyl cyanoacrylate 0.5 ml) for mesh fixation in patients undergoing scheduled open inguinal hernioplasty results in a better postoperative evolution, with less chronic pain and less demand for analgesia, compared with a control group of patients who undergo the same surgical intervention with standard suture repair.

Eligibility criteria: Inclusion Criteria:

* Elective open inguinal hernioplasty in patients over 18 years old

Exclusion Criteria:

* Patient refusal
* Laparoscopic surgery
* Reintervention surgery
* Urgent surgery
* Cyanoacrylate allergy
* Administration of intraoperative local anesthetics
* Comorbidities that may affect the requirements of analgesics, such as degenerative arthropathies, fibromyalgia, etc.

Primary outcomes:
measure: Postoperative pain assessed by visual numeric scale
timeFrame: 6 months
measure: Postoperative administration of analgesics
timeFrame: 6 months
Secondary outcomes:
measure: Hernia recurrence
timeFrame: 6 months
measure: Hematoma
timeFrame: 1 month
Other outcomes:
Locations:
city: Móstoles
country: Spain
facility: Hospital Universitario de Móstoles
state: Madrid
Study officials:
References: