louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06903676: Utility of Trypsinogen -2 in Early Detection and Follow Up of Post-pancreatectomy Acute Pancreatitis (PPAP)
Official title: Utility of Trypsinogen -2 in Early Detection and Follow Up of Post-pancreatectomy Acute Pancreatitis (PPAP)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatitis
Pancreatectomy
Keywords: Pancreatectomy
Post-pancreatectomy acute pancreatitis
PPAP
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to learn if urine trypsinogen can be used to diagnose post-pancreatectomy acute pancreatitis in patients undergoing pancreatectomy.

Participants will have their urine measured by dipsticks during and after their surgery.

Detailed description: Patients will be identified utilizing preoperative scheduling and clinic visits. Patients undergoing any pancreatectomy (such as: pancreatoduodenectomy, distal pancreatectomy, duodenal preserving pancreatic head resection) will be identified. These patients will be educated about possible enrollment in the prospective study in the preoperative clinic or in the surgery preoperative area. If enrolled, these patients will receive the standard of care postoperative laboratory tests. These include, but are not limited to, postoperative serum amylase, drain amylase, complete blood counts, and complete or basic metabolic panels. These patients will have standard of care pathologic review of their operative specimens. These patients will also have their urine tested for TRP-2. This design will allow for the direct comparison of the TRP-2 dipstick tests against the standard of care serum amylase tests. Furthermore, the measuring of serum amylase will allow for the evaluation of post-pancreatectomy acute pancreatitis by the ISGPS definition.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years of age
* Undergoing elective pancreatectomy for any indication

Exclusion Criteria:

* Younger than 18 years of age
* Pregnant women
* Prisoner

Primary outcomes:
measure: Detection of PPAP by Urine Trypsinogen 2
timeFrame: Day of surgery and post-operative days 1, 2 and 3
Secondary outcomes:
measure: Correlation of PPAP diagnosis
timeFrame: Postoperative Day 3
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT06522776: Remote Psychological Intervention for COVID-19 Survivors With AKI and Caregivers (REPICOV-AKI)
Official title: Effectiveness of Brief Remote Psychological Intervention for COVID-19 Survivors With Acute Kidney Injury and Their Informal Primary Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Anxiety
Depressive Symptoms
Acute Kidney Injury
Lead sponsor: Instituto Nacional de Enfermedades Respiratorias
Sponsor class: OTHER_GOV
First posted: 2024-07-26
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The frequency of psychological conditions in recovered COVID-19 patients with Acute Kidney Injury (AKI) and their informal primary caregivers (IPC) is unknown; as well as the effects of psychological therapy in this population. The present study was initiated to determine the effectiveness of a brief remote psychological intervention (BRPI) to reduce anxious and depressive symptoms in survivors of AKI.

The investigator designed a single-case experimental design A-B with prospective follow-up. We used the Patient Health Questionnaire-9 (PHQ-9) and the General Anxiety Disorder Scale-7 (GAD-7) to screen for depressive and anxiety symptoms, one week later after hospital discharge. Those with moderate or severe symptoms received cognitive behavioral therapy (CBT) and were evaluated over time with the instruments and daily self-report of symptoms. The statistical analysis was conducted using statistical software.


Eligibility criteria: Inclusion Criteria:

* Survivors of severe COVID-19 who had AKI during hospitalization
* Informal primary caregivers

Exclusion Criteria:

* They did not accept to participate in the study
* They did not answer three attempted phone calls or text messages making it impossible to complete the intervention.

Primary outcomes:
measure: Anxious symptoms score for identifying changes in psychological behavior before and after to brief remote psychological intervention.
timeFrame: From the date of one week later after hospital discharge at the hospital until the date of the end intervention, in average one month
measure: Depressive symptoms score for identifying changes in psychological behavior before and after to brief remote psychological intervention.
timeFrame: From the date of one week later after hospital discharge at the hospital until the date of the end intervention, in average one month
Secondary outcomes:
measure: General perception scale for identifying the utility of each technique used for the management of psychological symptoms.
timeFrame: From the date of one week later after hospital discharge at the hospital until the date of the end intervention, in average one month
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Respiratory Diseases
state: Ciudad DE México
Study officials:
affiliation: INER
name: Jesús Rivero, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04265976: ED Hypernatremia. Prognostic Factors and Epidemiology.
Official title: Emergency Departement (ED) Hypernatremia. Prognostic Factors and Epidemiology. About a Single-center Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypernatremia
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Every \>18 years old patient from who a blood sample was taken in the ED with a natremia \> 145 mmol/l and don't show a refusal after information.

Brief summary: This study evaluate the 1-month mortality of patients who proceed a blood sample while in the ED with an hypernatremia (\>145 mmol/l). This prospective study will try to show several prognostic factors, and show the epidemiology of hypernatremia in this single center evaluation.


Eligibility criteria: Inclusion Criteria:

* Natremia \> 145 mmol/l

Exclusion Criteria:

* Age \< 18 years
* Refusal

Primary outcomes:
measure: one month survival
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
Study officials:
References:
Clinical trial NCT06969976: the Effect of Dry Cupping on Muscle Strength in Normal Individual
Official title: Effect of Immediate Use of Dry Cupping on Muscle Strength in Normal Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Adults
Student Education
Keywords: adults
dry cupping
muscle strength
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 84
Sex: MALE
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: assessment of strengthening exercise during the application of dry cupping in normal adults

Detailed description: this study will be conducted to answer the following questions: is the application of dry cupping will be effective during strengthening biceps muscle in normal adults who randomly assigned to 2 groups

Eligibility criteria: Inclusion Criteria:

* age ranges from 20 to 25 years
* the assessment is done on dominant hand

Exclusion Criteria:

* age \>25 and \<20 years
* having any problem in the tested upper limb (disease affecting shoulder, elbow, wrist and hand)
* having any cardiovascular problems
* cervical disorders affecting upper limb

Primary outcomes:
measure: strength of biceps muscle
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT00479076: A Phase I Study of Intravenous Aflibercept in Combination With S-1 in Japanese Cancer Patients
Official title: A Single Agent-combination Hybrid Phase I, Open-label, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous AVE0005 (VEGF Trap)Administered Every 2 Weeks in Combination With Oral S-1 in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: antineoplastic agents
VEGF Trap
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2007-05-25
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the recommended phase II dose of AVE0005 in combination with S-1 in Japanese cancer patients.

The secondary objectives of this study are to assess the safety profile of AVE0005, to determine the pharmacokinetics of AVE0005, to make a preliminary assessment of antitumor effects.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed cancer patients without standard of care
* ECOG performance status 0, 1, or 2
* Adequate organ and bone marrow function

Exclusion Criteria:

* Need for a major surgery or radiation therapy during the study
* History of hypersensitivity to S-1
* Known dihydropyrimidine dehydrogenase deficiency
* Uncontrolled hypertension
* History of brain metastases
* Ascites requiring drainage
* Pregnancy or breastfeeding
* Patients who have previously been treated with AVE0005

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities
timeFrame: during the first cycle of study treatment
Secondary outcomes:
measure: safety: physical examination, laboratory safety tests, adverse events
timeFrame: treatment period
measure: pharmacokinetic values
timeFrame: treatment period
measure: objective response rate
timeFrame: treatment period
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT01520376: Anxiety and Depression in Patients Hospitalizes for an Acute Exacerbation of COPD
Official title: A Prospective Randomized Trial to Asses the Efficacy of an Early Psychiatric Counseling Compared to Usual Care in a Cohort of Patients Hospitalized for an Acute Exacerbation of COPD in Prevention of Re-exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Anxiety
Depression
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2012-01-27
Enrollment: 169
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will try to elucidate wheter the impact of a psychiatric intervention in patients hospitalized because an acute exacerbation of COPD and anxiety/depression and reconsulting at 1 and 6 month after discharge.


Eligibility criteria: Inclusion Criteria:

* Men and women of any ethnic group
* Above 40 years old
* Diagnose with Chronic Obstructive Pulmonary disease (COPD) according to the ATS/ERS guidelines
* Acute exacerbation of COPD according to the following criteria:

  a) Cyanosis b) Obnubilations or mental confusion d) Respiratory Rate above 25 per minute e) Failure of ambulatory treatment f) Co-morbidities that worsens respiratory condition g) Dyspnea

Exclusion Criteria:

* Less than 6 months expectancy of life
* Needing of mechanical ventilation
* Severe cardiovascular disease
* Pregnancy
* Previous diagnosis of depression/anxiety

Primary outcomes:
measure: Efficacy of the intervention
timeFrame: 6 months
Secondary outcomes:
measure: Impact of diagnosis
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona
state: Catalonia
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Arturo Huerta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02679976: Marketed Contact Lens Real World Through Focus Curve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-visit prospective study to establish a real world Marketed Contact Lens 'Through Focus Curve' (TFC) measurement by comparing the consistency of vision between myopes and hyperopes. 33 subjects will be enrolled (at least 15 myopes and 15 hyperopes), who are 40 years of age or older, for a 1-visit, 4-hour study for measurements to be taken.


Eligibility criteria: Inclusion Criteria:

* The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* The subject must be ≥40 years of age.
* The subjects' optimal vertexed spherical equivalent distance correction must be between -6.00 Diopters (D) and +4.00 D in each eye.
* The subject's refractive cylinder must be ≤ -0.75 D in each eye.
* The subject's ADD power must be in the range of +0.75 to +2.50 D in each eye.
* The subject must have best corrected visual acuity of 20/25 or better for each eye.
* The subject can be either a new contact lens wearer or an existing soft contact lens wearer.

Exclusion Criteria:

* Currently pregnant or lactating.
* Any ocular or systemic allergies that contraindicate contact lens wear.
* Any ocular or systemic disease, autoimmune disease, or use of medication that contraindicates contact lens wear.
* Any ocular abnormality that may interfere with contact lens wear.
* Use of any ocular medication, with the exception of rewetting drops.
* Any previous intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
* Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) which may contraindicate contact lens wear.
* History of herpetic keratitis.
* Any ocular infection or inflammation.
* Any corneal distortion or irregular cornea.
* History of binocular vision abnormality or strabismus.
* Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
* History of diabetes.
* Participant in unrelated research involving test product within 30 days before planned study visit.

Primary outcomes:
measure: Distance Binocular LogMAR Visual Acuity
timeFrame: 4 Hr. Post Fitting
measure: Near Binocular LogMAR Visual Acuity
timeFrame: 4 Hr. Post Fitting
measure: Intermediate Binocular LogMAR Visual Acuity
timeFrame: 4 Hr. Post Fitting
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Optometry Technology Group, Ltd.
Study officials:
References:
Clinical trial NCT06546176: End to End Anastomosis With Omega Suture Versus End to Anterior Rectal Wall In Colorectal Anastomosis in Sigmoid and Upper Rectal Cancer
Official title: Comparative Study Between End to End Anastomosis With Omega Suture Versus End to Anterior Rectal Wall In Colorectal Anastomosis in Sigmoid and Upper Rectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End to End Anastomosis
Colorectal Anastomosis
End to Anterior Rectal Wall
Sigmoid Cancer
Upper Rectal Cancer
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 40
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 aim of this study is to compare end to end anastomosis with omega suture versus end to anterior rectal wall in colorectal anastomosis as regard post operative anastomotic leakage, bowel function, operative time and intra operative blood loss.

Detailed description: Colorectal cancer has been reported to be the 3rd most common and the second most deadly cancer world wide.

Anterior resection is the gold standard operation for both rectal and recto-sigmoid cancer with considering oncological safety maintenance to be the most important goal which can be achieved by keeping abundant resection margin and ensuring anastomotic safety, despite the technical difficulties of working in a narrow deep pelvis.

Understanding the characteristics of each anastomotic technique and establishing a stable anastomotic procedure both are pillars in anastomotic leakage prevention.

The intersection of the linear staple line and circular staple line in conventional anastomotic way is considered a risk factor for anastomotic leakage by creating stapled corners (called "dog-ears") which considered potentially ischemic and represent the area with high incidence of anastomotic leakage. Single stapled technique using ether end to end with omega suture or end to side stapled anastomosis allows avoidance of the formation of this intersection.

Eligibility criteria: Inclusion Criteria:

* Patients aged \>18 years.
* Both sexes.
* Recto sigmoidal carcinoma.
* Upper rectal cancer.

Exclusion Criteria:

* Patients younger than 18 years
* Recurrent or non-resectable cancer
* Complicated cancer (e.g., obstructed or perforated)
* Previous left-sided colorectal surgery or anorectal surgeries
* Lower rectal cancer

Primary outcomes:
measure: Anastomotic leakage
timeFrame: 5 days after surgery
Secondary outcomes:
measure: Operative time
timeFrame: Until the procedure is completed
measure: Hospital stay
timeFrame: 28 days postoperative
measure: Time of bowel function
timeFrame: 7 days postoperative
measure: Wound complications
timeFrame: 7 days postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT04675476: A Patient and Provider Intervention to Address Health Disparities in Lung Cancer Screening
Official title: A Multilevel Intervention to Address Health Disparities in Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 368
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: To test the impact of a multilevel intervention on primary (provider-patient communication, intentions, and knowledge) and secondary (screening referrals and completion) outcomes.

Detailed description: The proposed study will target two key levels of influence in the healthcare setting: provider and patient behavior in order to address disparities between African American and whites in lung screening awareness and utilization. Guided by NIH's Health Disparities Research Framework and building on the formative work conducted in the K99 phase, we will conduct a quasi-experimental study (pretest-posttest, with a nonequivalent control group) in partnership with four primary care clinics within the MedStar Health system in the R00 phase.

Eligibility criteria: Inclusion Criteria:

* 50-80 years old;
* current cigarette smoker or quit within 15 years;
* a 20+ pack-year smoking history;
* non-adherent to lung screening (\>13 months);
* English-speaking;
* scheduled for an upcoming clinic appointment (4 weeks - 8 weeks); and
* able and willing to provide meaningful consent and complete telephone interviews

Exclusion Criteria:

* Individuals with a history of lung cancer

Primary outcomes:
measure: provider-patient discussion
timeFrame: 1-week post-visit
measure: lung cancer screening intentions
timeFrame: 1-week post-visit
measure: lung cancer screening knowledge
timeFrame: 1-week post-visit
Secondary outcomes:
measure: lung cancer screening referrals
timeFrame: 6-months
measure: lung cancer screening completion rates
timeFrame: 6-months
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Health
state: District of Columbia
Study officials:
References:
Clinical trial NCT02572076: Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System
Official title: Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CRC
Lead sponsor: Motus GI Medical Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2015-10-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.

Detailed description: The main objective of the study is to evaluate the performance of the Motus cleansing system used in conjunction with screening, diagnostic or surveillance colonoscopy

Eligibility criteria: Inclusion Criteria:

1. Subjects being considered for diagnostic, screening or surveillance colonoscopy
2. Subjects in the age range of 18-75 years inclusive
3. Subjects with Body Mass Index (BMI) within the range of 18.5-35 inclusive
4. Subject has signed the informed consent

Exclusion Criteria:

1. Subjects with known Inflammatory Bowel Disease
2. Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
3. Subjects with known or detected (during colonoscopy) bowel obstruction
4. History of prior surgery to colon and/or rectum
5. ASA≥IV
6. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
7. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
8. Subjects taking anticoagulants drugs (excluding aspirin) and dual anti-platelet therapy
9. Pregnancy (as stated by patient) or breast feeding
10. Subjects with altered mental status/inability to provide informed consent
11. Patients who have participated in another interventional clinical study in the last 2 months

Primary outcomes:
measure: Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS
timeFrame: Within 24 hours- During the colonoscopy procedure
Secondary outcomes:
Other outcomes:
Locations:
city: 'Afula
country: Israel
facility: HaEemek Medical Center
state: IL
Study officials:
affiliation: HaEmek Medical Center, Afula Israel
name: Ian Gralnek, PHD
role: PRINCIPAL_INVESTIGATOR
References: