louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05940753: Flash Mob Study With Regard to Travel Willingness Among Patients With Cancer
Official title: Flashmobstudie Landelijke Meting Reisbereidheid Medisch Oncologische Zorg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: oncology
hospital choice
willingness to travel
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical Oncology patients who have an (call) appointment with our medical oncology outpatient clinic and/or day treatment unit on 13 or 14 march 2023.

Brief summary: This is a cross-sectional study in the form of a flash mob study, in which an inventory will be made on 13 and 14 March 2023 of the willingness to travel of oncology patients in the participating hospitals. Patients who have an appointment with an internist-oncologist or oncology specialist nurse at the outpatient clinic or by telephone and patients who come to day treatment unit for medical oncology are asked to participate. Willingness to travel is examined by means of a survey, in which a minimal set of categorized patient data (e.g. age, gender, level of education) is collected as part of the survey.


Eligibility criteria: Inclusion criteria:

* Medical oncology patients with an appointment in the out-patient clinic or day treatment unit on 13 or 14 march 2023
* Medical oncology patients with an (video) call appointment in the out-patient clinic on 13 or 14 march 2023

Exclusion criteria:

* Patients in the inpatients oncology unit
* Medical oncology patients with no appointment on 13 or 14 march 2023

Primary outcomes:
measure: Travel willingness
timeFrame: 1 day
Secondary outcomes:
measure: Facilitating and inhibiting factors for willingness to travel
timeFrame: 1 day
measure: Which patient characteristics are associated with willingness to travel?
timeFrame: 1 day
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: An KL Reyners, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01481753: Pancreaticoduodenectomy With or Without Braun Enteroenterostomy: Comparison of Postoperative Pancreatic Fistula and Delayed Gastric Emptying
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Pancreatic Fistula
Delayed Gastric Emptying
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 341
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: The investigators plan to perform a prospective randomized, head-to-head trial to test the hypothesis that the addition of Braun enteroenterostomy to standard pancreaticoduodenectomy (PD) reconstruction can decrease the rates of Postoperative Pancreatic Fistula (POPF) and/or Delayed Gastric Emptying (DGE).


Eligibility criteria: Inclusion Criteria:

* Patients undergoing pancreaticoduodenectomy surgery at Johns Hopkins Hospital

Exclusion Criteria:

* Pregnant women
* Patients under the age of 18
* adults lacking ability to consent,
* patients scheduled for laparoscopic whipple surgery
* non-english-speakers, and
* prisoners

Primary outcomes:
measure: Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy
timeFrame: patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery
Secondary outcomes:
measure: Reduced incidence of delayed gastric emptying in patients with Braun enteroenterostomy
timeFrame: patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Christopher L Wolfgang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02270853: SAS in Patients With Bronchial Carcinoma
Official title: Incidence of Sleep Apnea Syndrome (SAS) in Patients With Bronchial Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea Syndrome
Bronchial Carcinoma
Keywords: ApneaLink
bronchial carcinoma
sleep apnea screening
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: In this study it will be analyzed how often the sleep apnea syndrome can be observed in patients with newly diagnosed lung cancer with the help of ApneaLink device by ResMed.

Detailed description: Determination of the SAS- frequence in patients with bronchial carcinoma. The patients will be screened at home for 1 night with the ApneaLink device by ResMed. The apneaLink device is a standard screening tool for sleep apnea in clinical practice.

Eligibility criteria: Inclusion Criteria:

* Patients with reasonable suspicion of bronchial carcinoma or histologically proven bronchial carcinoma, which has not been medicated until the study entry and
* Patients with sleep apnea who had recently been diagnosed with bronchial carcinoma.

Exclusion Criteria:

* Pregnancy
* other already known malignancies or tumors
* Patients with non-invasive artificial respiration due to a chronic respiratory insufficiencies

Primary outcomes:
measure: percent of sleep apnea in patients with bronchial carcinoma
timeFrame: two days
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Medizinische Klinik I Uniklinik RWTH Aachen
state: NRW
city: Köln
country: Germany
facility: Krankenhaus Merheim
state: NRW
city: Düsseldorf
country: Germany
facility: Florence-Nightingale Hospital
Study officials:
affiliation: RWTH Aachen University Hospital
name: Michael Dreher, Univ.-Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dreher M, Kruger S, Schulze-Olden S, Keszei A, Storre JH, Woehrle H, Arzt M, Muller T. Sleep-disordered breathing in patients with newly diagnosed lung cancer. BMC Pulm Med. 2018 May 16;18(1):72. doi: 10.1186/s12890-018-0645-1.
Clinical trial NCT06014853: A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SOL-804 in Healthy Male Subjects
Official title: A Randomized, Open-label, Four-sequence, Four-period, Crossover, Single Dosing, Phase 1 Clinical Trial to Compare the Safety, Tolerability, and Pharmacokinetics of SOL-804 and Zytiga in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Abiraterone
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Dyna Therapeutics
First posted: 2023-08-28
Enrollment: 48
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study Design : A randomized, open-label, four-sequence, four-period, crossover, single dosing, phase 1 study

Detailed description: To evaluate the safety, tolerability and pharmacokinetic characteristics of SOL-804-F and Zytiga tablets following a single oral dose and Zytiga 1,000 mg in healthy male volunteers.

Eligibility criteria: Inclusion Criteria:

1. healthy adult male volunteers between 19 to 50 years of age at screening visit.
2. Body mass index (BMI) between 19.0 to 30.0 kg/m2
3. The subjects voluntarily decide to participate in the study after receiving a full explanation and understanding and provide written consent
4. The subjects are suitable for this study as determined by the investigator (physical examination, clinical laboratory tests, etc.)

Exclusion Criteria:

1. Clinically significant abnormal physical examination, vital signs or ECG
2. The subjects who have a medical history of hepatobiliary, renal, neurological, immune, respiratory, endocrine, hematologic, oncologic, cardiovascular, urinary, psychiatric or sexual dysfunction.
3. The subjects who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
4. The subjects who have a history of drug abuse or positive with urine drug screening test

Primary outcomes:
measure: AUClast of abiraterone
timeFrame: 72 hours
measure: Cmax of abiraterone
timeFrame: 72 hours
Secondary outcomes:
measure: AUCinf of abiraterone
timeFrame: 72 hours
measure: Tmax of abiraterone
timeFrame: 72 hours
measure: t1/2 of abiraterone
timeFrame: 72 hours
measure: CL/F of abiraterone
timeFrame: 72 hours
measure: Vd/F of abiraterone
timeFrame: 72 hours
Other outcomes:
measure: Rmax of serum testosterone
timeFrame: 72 hours
measure: Imax of serum testosterone
timeFrame: 72 hours
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: SeungHwan Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01121653: Impact of Oral Magnesium on Neuropathic Pain
Official title: Impact of Oral Magnesium on Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patient With Neuropathic Pain
Keywords: Neuropathic pain, magnesium
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2010-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Use lay language.

The aim of this study is to evaluate on pain scores (neuropathic pain questionnaire and pain numeric scale) and on quality of life, the effect of oral magnesium intake on patients with neuropathic pain comparing with patients receiving placebo,. The study drug will be taken during 4 weeks.

Detailed description: Protocol description

Visit D0

* patient inclusion after informed signed consent
* clinical exam
* blood sampling (magnesium dosage)
* questionnaires (neuropathic pain and quality of life)
* daily self-evaluation on neuropathic pain scale (Week0 to Week5)

D8 : first intake of study drug (magnesium or placebo)

Visit Week5:

* questionnaires (neuropathic pain and quality of life)
* blood sampling (magnesium dosage)
* clinical exam

Eligibility criteria: Inclusion Criteria:

- neuropathic pain

- informed signed consent

Exclusion Criteria:

* magnesium intake contra-indication
* severe renal insufficiency
* quinidine intake
* concomitant treatment change 2weeks before inclusion
* evolutive pathology

Primary outcomes:
measure: Pain scores (neuropathic pain evaluation questionnaire)
timeFrame: Visit D0
Secondary outcomes:
measure: - Numeric scale - quality o f life questionnaires
timeFrame: Visit Week 5
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle PICKERING, MCU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05119153: Effects of Coffee Roasting on Blood Sugar Levels in Healthy Humans
Official title: Effects of Coffee Roasting on Blood Sugar Levels in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Keywords: coffee
glucose challenge
blood glucose levels
Lead sponsor: North Carolina State University
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, single-blinded, partial block, crossover design
Primary purpose: BASIC_SCIENCE

Brief summary: The present study determined the effects light, medium, and dark roasted, brewed coffees on blood glucose responses in normal (n = 19) subjects.

Detailed description: This is a single-blinded, randomized partial block design conducted over 6 weeks in two parts.

In part 1 (3 weeks), participants were randomly assigned to consume four beverages: a placebo containing water and caramel color, light, medium, or dark roast coffee before, during, or after consumption of a beverage containing 50 g of glucose.

In part 2 (3 weeks), participants were randomly assigned to consume four beverages: a placebo containing water and caramel color, light, medium, or dark roast coffee before, during, or after consumption of a standardized breakfast (corn flakes cereal + skim milk) containing 50 g of glucose.

In each part, fasting and postprandial glucose profiles were determined.

Eligibility criteria: Inclusion Criteria:

• Age 18-64 years old with BMI less than 29 and fasting blood glucose less than 125 mg/dl.

Exclusion Criteria:

* Age 18-64 years old with BMI less than 29 and fasting blood glucose less than 125 mg/dl.
* Weight less than 110 pounds (55 kg)
* Pre-existing health conditions, such as:

  * High cholesterol
  * Hypertension
  * Cardiovascular disease
  * Gastrointestinal motility disorders
  * Hypo- or hyperthyroidism
  * Anemia
  * Renal disease
  * Liver disease, including hepatitis B or C, cholestasis, cirrhotic liver disease, or non-alcoholic fatty liver disease
  * Chronic or acute pancreatitis
  * Diabetes type 1 or 2
  * Insulin resistance
  * Polycystic ovary syndrome
* Food allergies or intolerances to coffee/caffeine/dairy/corn-based cereals.
* Currently taking prescription medication
* Current smoker
* Consumes more than 3 alcoholic beverages per day
* Pregnant or breastfeeding
* Not willing to take their own blood samples with finger sticks

Primary outcomes:
measure: Changes in Blood Glucose
timeFrame: 6 weeks
Secondary outcomes:
measure: Changes in Glucose Area Under the Curve
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Schaub Hall, Campus Box 7624
state: North Carolina
Study officials:
affiliation: North Carolina State University
name: Gabriel K Harris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05579353: The Roles of Exosomal Circ-LRBA and 451/CRTC2 Signaling Axis in Colorectal Cancer
Official title: The Roles and Molecular Mechanism of Exosomal Circ-LRBA That Regulates miR-451/CRTC2 Signaling Axis in Colorectal Cancer Progression
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1

Brief summary: Colorectal cancer (CRC) is one of the most common malignant tumors in the world. Most of the patients with colorectal cancer were diagnosed in poor stage. Although 40% to 50% patients of colorectal cancer can be cured by surgery, but most patients have undergent metastasis or recurrence, and eventually death. In recent years, molecular targeted therapy has shown significant efficacy in specific patients. It was necessary to detect the corresponding molecular targets of tumors before selecting appropriate targeted drugs in clinic. The changing state of related gene molecules in colorectal cancer played a key role in drug selection, there were few effective targets so far. At present, metastasis and recurrence still be the most difficult problems in treatment. Therefore, investigators should deeply study the occurrence and development of colorectal cancer at the gene level and look for new biomarkers to predict the prognosis. Furthermore, the study can clarify the exact molecular mechanism of colorectal cancer. These will be important clinical significance for targeted therapy of colorectal cancer.


Eligibility criteria: Inclusion Criteria:

1.18-80 years old.

2.18.5 \< BMI \< 27.9.

3. The surgical methods are radical resection of rectal cancer, resection of right colon cancer, resection of left colon cancer and radical resection of sigmoid colon cancer.

Exclusion Criteria:

1. Those who refuse to collect samples.
2. Patients with severe dysfunction of coagulation, hepatorenal dysfunction or severe cardiopulmonary diseases.
3. Patients who has a history of neoadjuvant radiotherapy or chemotherapy.
4. Combining with distant multiple metastases of tumor

Primary outcomes:
measure: expressional quantity
timeFrame: Through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Lixia
Study officials:
References:
Clinical trial NCT04539353: HRV and Pain Intensity
Official title: The Association Between Pain Intensity and Heart Rate Variability in Chronic Pain Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic pain patients (regardless of the cause of the pain).

Brief summary: The aim of this study is to explore the association between pain intensity and heart rate variability in patients with chronic pain.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic pain for at least 3 months
* Age \> 18 years
* Patient has been informed of the study procedures and has given written informed consent
* Patient willing to comply with study protocol

Exclusion Criteria:

* Healthy patients or patients with acute pain.
* Evidence of an active disruptive psychiatric disorder that may impact perception of pain, and/or ability to evaluate treatment outcome as determined by investigator
* Patients were excluded if they had one or more coexisting conditions known to affect HRV analysis.

Primary outcomes:
measure: Heart Rate Variability
timeFrame: During study visit, cross-sectional, once, during 5 minutes.
measure: Pain Intensity with Numeric Rating Scale
timeFrame: During study visit, cross-sectional, once.
measure: Pain Intensity with Visual Analogue Scale
timeFrame: During study visit, cross-sectional, once.
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Roeselare
country: Belgium
facility: AZ Delta
Study officials:
References:
Clinical trial NCT02915653: Adult Primary and Preventive Practice (APPP) Study
Official title: Adult Primary and Preventive Practice (APPP) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preventive Care
Lead sponsor: Qure Healthcare, LLC
Sponsor class: INDUSTRY
Collaborators: name: Applied Proteomics Inc
First posted: 2016-09-27
Enrollment: 213
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: DIAGNOSTIC

Brief summary: The study is a pre-post two round, randomized controlled study design of PCPs randomly assigned to a control or 1 of 2 intervention arms.


Eligibility criteria: Inclusion Criteria:

* 1. Provide consent to participate in the study 2. Board-certified physician currently practicing in the following areas: 3. Internal medicine 4. Family medicine 5. Have practiced as a board-certified physician in internal or family medicine for greater than 2 but less than 30 years. 6. English-speaking 7. Community / non-academic based practice setting 8. ≥ 40 patients under care weekly 9. Access to the internet

Exclusion Criteria:

* 1. Not board certified in their respective area of care 2. Academic-based practice 3. Have practiced as a board-certified physician for less than 2 or greater than 30 years 4. Follow \<40 patients weekly 5. Non-English speaking 6. Unable to access the internet

Primary outcomes:
measure: Quality of Care
timeFrame: 8 weeks
Secondary outcomes:
measure: Intervention Impact on Care
timeFrame: 8 weeks
measure: Healthcare Utilization
timeFrame: 8 weeks
measure: Diagnostic Method Comparison
timeFrame: 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: QURE Healthcare
state: California
Study officials:
affiliation: QURE Healthcare
name: John Peabody, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01380353: Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine
Official title: Pilot Study to Test Uniformity of Transdermal Drug Delivery to the Breast Using Diclofenac Epolamine as a Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: Women undergoing total mastectomy
Breast cancer prevention
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to look for ways to improve breast cancer treatment by giving breast cancer drugs through the skin of the breast.

The drug used in this study is a diclofenac epolamine patch and is a nonsteroid anti-inflammatory pain reliever. The drug amount that gathers in the breast, after application of a patch to the skin of the breast, will be measured and compared to the amount that is found in the breast when the patch is applied to the skin of the belly.

Detailed description: This is a randomized study where participants in group 1 will apply the diclofenac epolamine patch to the breast and participants in group 2 will apply the same drug to her abdomen. Participants are instructed to apply a new patch every 12 hours for 3 days. Total participation in this study will be for three days, ending on the day of surgery. On the day of surgery, participants will have blood drawn to measure the level of diclofenac epolamine in the body, and the final patch will be removed.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 18 and 80 years, undergoing total mastectomy for, with or without axillary surgery for diagnosis or prevention of breast cancer.
* ECOG performance status less than 2.
* Ability to understand and the willingness to sign a written informed consent.
* Participants must have normal organ and marrow function

Exclusion Criteria:

* Prior history of ipsilateral breast radiotherapy.
* Pregnant women and those who will be actively breast-feeding in the preoperative period will be excluded.
* Inability to discontinue aspirin or warfarin use during the period of participation.
* Known allergy to diclofenac epolamine, or aspirin, diclofenac (Cataflam, Voltaren), or another non-steroidal anti-inflammatory drug (NSAID).
* Renal failure

Primary outcomes:
measure: Compare concentrations of diclofenac epolamine patch when applied to breast vs. abdomen
timeFrame: after 3 days of treatment prior to surgery
Secondary outcomes:
measure: Determine how the concentrations of the study patch is distributed in the breast.
timeFrame: after three days of treatment prior to surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Seema Khan, MD
role: PRINCIPAL_INVESTIGATOR
References: