louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05003037: Surufatinib Combined With Toripalimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer
Official title: A Open-label, Single Center, Phase II Study of Surufatinib Combined With Toripalimab and Chemotherapy in Patients With Advanced Non-squamous Non-small-cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase II study to assess the efficacy and safety of Surufatinib Combined With Toripalimab and Chemotherapy as a first-line treatment in patients with advanced non-squamous non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

1. Voluntary provision of informed consent.
2. Males or females aged 18-75.
3. Histological or cytologically confirmed NSCLC, metastatic or non-resectable (stage IIIB-Ⅳ).
4. At least one lesion can be measured by imaging.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
6. Life expectancy ≥ 12 weeks.
7. None previous chemotherapy or targeted therapy(Arm:wild-type genotype).
8. Patients should be confirmed acquired EGFR T790M mutation and received adequate EGFR-TKI treatment(Arm:EGFR mutation).
9. Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment.

Exclusion Criteria:

1. Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.
2. Diagnosed with other malignant diseases other than NSCLC within 5 years.
3. Have participated in other interventional clinical research treatments now or within 4 weeks.
4. Have previously received multi-targeted kinase inhibitors therapy.
5. Have active autoimmune diseases requiring systemic treatment within 2 years.
6. Received systemic glucocorticoid therapy or immunosuppressive therapy within 2 weeks.
7. Clinically uncontrollable pleural effusion/abdominal effusion.
8. Vaccinated vaccines or attenuated vaccines within 4 weeks before the group;
9. Pregnant or breastfeeding females.
10. Other serious hazards to the safety of patients.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: up to 24 months
Secondary outcomes:
measure: Objective response rate(ORR)
timeFrame: up to 24 months
measure: Disease control rate(DCR)
timeFrame: up to 24 months
measure: Overall Survival(OS)
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guang Dong
Study officials:
References:
Clinical trial NCT01786837: Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation
Official title: A Prospective Trial to Study Whether Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Constipation
Keywords: constipation
gastric emptying
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of Functional Magnetic stimulation (FMS) on gastrointestinal motility in patients suffering from chronic constipation due to non-neurological issues.

Detailed description: The goal of this pilot study is to evaluate the usefulness of FMS as a noninvasive method to stimulate the GI motility in individuals with non-neurological constipation by adopting a 5-week conditioning protocol performed in a hospital outpatient setting. FMS has demonstrated the ability to generate significant rectal pressure and enhance GI transit in normal and spinal cord injury subjects. With proper abdominal muscle conditioning, FMS may improve colonic motility partly due to improved abdominal muscle tone.

Eligibility criteria: Inclusion Criteria:

* Age 18-80
* constipation defined by the Rome II criteria

Exclusion Criteria:

* Past history of abdominal surgery
* past history of diabetes mellitus
* past history of hypothyroidism
* past history of inflammatory bowel disease
* past history of significant psychiatric disturbances
* past history of drug abuse
* past history of cardiac pacemakers
* past history of metal implants
* patients who cannot travel to keep the follow up
* patients who are prisoners
* patients who are mentally handicapped
* patients who are pregnant

Primary outcomes:
measure: Effectiveness of FMS in accelerating the gastric emptying in patients with non-neurological constipation after 5-week conditioning protocol
timeFrame: 5 weeks after conditioning
Secondary outcomes:
measure: Effectiveness of FMS in reducing the colonic transit time in patients with non-neurological constipation after a 5 week conditioning period
timeFrame: 5 weeks after conditioning
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Digestive Disease Institute
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Massarat Zutshi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01536652: Prandial Orientated Biphasic Insulin Aspart 30 Therapy - the Physiological Premix Insulin Therapy for Type 2 Diabetes
Official title: Prandial Oriented NovoMix 30® - the Physiological Insulin Therapy of Diabetes Type 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 4994
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with diabetes mellitus type 2, using insulin glargine in combination with one or more OADs, being in inadequate glycaemic control and are indicated to receive biphasic insulin aspart 30

Brief summary: This study is conducted in Europe. The aim of this observational study is to document the glycaemic parameters, adverse events, including drug reactions, as well as hypoglycaemic episodes, in patients that switched from insulin glargine combined with oral antidiabetic drugs (OADs) to biphasic insulin aspart 30 (NovoMix® 30) combined with OADs, when applicable.


Eligibility criteria: Inclusion Criteria:

* Subjects with diabetes mellitus type 2

Primary outcomes:
measure: HbA1c (glycosylated haemoglobin)
Secondary outcomes:
measure: Body weight
measure: Preprandial and postprandial blood glucose values (self measured)
measure: Insulin dosage
measure: Incidence of (serious) adverse drug reactions
measure: Incidence of hypoglycaemic episodes
Other outcomes:
Locations:
city: Mainz
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06506552: Effects of Inferior Mesenteric Artery Preservation in Laparoscopic Colorectal Resection for Diverticular Disease.
Official title: Inferior Mesenteric Artery Preservation in Laparoscopic Colorectal Resection for Diverticular Disease; Short and Long Term Effects in Defecatory Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Diverticuar Disease
Defecatory Functions
Fecal Incontinence
Constipation
Keywords: defecatory function
anterior resection syndrome
constipation
diverticular disease
fecal incontinence
fragmented evacuation
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized study aimed to verifying the short and long-term results of inferior mesenteric artery preservation following colorectal resection for diverticular disease

Detailed description: This study wants to demonstrate that the preservation of the inferior mesenteric artery allow to improve postoperative defecatory function and improve patient\&#39;s quality of life.

Eligibility criteria: Inclusion Criteria:

* BMI \&lt; 35
* ASA I-III
* Hinchey I-III

Exclusion Criteria:

* BMI \&gt; 35
* ASA IV
* Hinchey IV
* Previous procedures that could have been modified the nervous mesenteric pattern (surgery, radiotherapy or chemotherapy)

Primary outcomes:
measure: Defecatory disorders
timeFrame: 6 months from surgery
measure: Defecatory disorders
timeFrame: 12 months from surgery
measure: Defecatory disorders
timeFrame: 6 years from surgery
Secondary outcomes:
measure: Constipation
timeFrame: 6 months from surgery
measure: Constipation
timeFrame: 12 months from surgery
measure: Constipation
timeFrame: 6 years from surgery
measure: Incontinence
timeFrame: 6 months from surgery
measure: Incontinence
timeFrame: 12 months from surgery
measure: Incontinence
timeFrame: 6 years from surgery
measure: Anorectal Muscles function
timeFrame: 6 months from surgery
measure: Anorectal Muscles function
timeFrame: 6 years from surgery
measure: Postoperative quality of life
timeFrame: 6 months from surgery
measure: Postoperative quality of life
timeFrame: 12 months from surgery
measure: Postoperative quality of life
timeFrame: 6 years from surgery
measure: Postoperative quality of life
timeFrame: 12 months from surgery
measure: Postoperative quality of life
timeFrame: 6 years from surgery
measure: Postoperative quality of life
timeFrame: 6 months from surgery
measure: Postoperative quality of life
timeFrame: 6 months from surgery
measure: Postoperative quality of life
timeFrame: 12 months from surgery
measure: Postoperative quality of life
timeFrame: 6 years from surgery
measure: Postoperative surgical complication
timeFrame: 1 month from surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02017652: Validation of Fore-Sight Cerebral & Tissue Oximeter Saturation Measurements on Neonates ≤ 5 kg
Official title: Validation of FORE-SIGHT Cerebral & Tissue Oximeter to Measure Cerebral & Somatic Tissue Oxygen Saturation Measurements at Different Body Locations on Neonates ≤ 5 kg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Motility
Keywords: bowel motility
cerebral perfusion
intestinal perfusion
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 19
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonatal subjects (32 to 36 and 6/7 weeks), with umbilical venous catheterization will be enrolled from the NICU. Demographic information of the subject will be recorded, including race, gender, weight, gestational age (GA), study age, and diagnosis.

Brief summary: CASMED, INC. wishes to validate the next generation FORE-SIGHT-II (FS-II) NIRS tissue oximeter monitor for neonatal brain and somatic tissue oxygen saturation (StO2) measurements. This monitor was recently FDA cleared for use on adult subjects.

Detailed description: 1. Validate FS-II abdominal StO2 measurements from the intestines, liver, and flank to umbilical venous and arterial blood oxygen saturation.
2. Validate FS-II cerebral StO2 measurements against the predicate FDA cleared FORE-SIGHT-I (FS-I) monitor.
3. Collect data from FS-II sensors on the forehead and abdomen (intestine) for 24 hours to compare dynamic changes vs the pulse oximeter. For larger neonates, add a predicate FS-I sensor to the opposite side forehead for dynamic comparison to FS-II measurements.
4. Obtain abdominal Near Infrared Spectroscopy (NIRS) data simultaneous with accepted measures of bowel motility (a. frequency and composition of stools, and b. Ultrasound assessment for the frequency and magnitude of bowel peristalsis, if available).

Eligibility criteria: Inclusion Criteria:

Neonatal subjects (32 to 36 and 6/7 weeks), with umbilical venous catheterization will be enrolled from the Neonatal Intensive Care Unit.

Exclusion Criteria:

Enrollment in other studies during study period. Inability to tolerate ultrasounds or NIRS sensors

Primary outcomes:
measure: StO2 measurement from intestines, liver and flank at time of venous and arterial blood oxygen saturation.
timeFrame: 1 hour
measure: Cerebral StO2 measurements from Fore-Sight FS-II monitor and Fore-Sight-I (FS-I) monitor.
timeFrame: 1 hour
measure: Pulse and Tissue oxygen saturation and infant activity
timeFrame: 24 hours
measure: Stool Interference Index over 24 hrs.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
Study officials:
affiliation: Sharp Mary Birch Hospital for Women & Newborns
name: Anuup Katheria, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00491452: Repair of Ischemic Mitral Regurgitation: Comparison Between Flexible and Rigid Annuloplasty Rings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Keywords: Ischemic MR
Annuloplasty
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2007-06-26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing CABG with Mitral valve repair for ischemic MR

Brief summary: Mitral valve repair for ischemic mitral regurgitation is performed primarily by annuloplasty. There is some degree of late failure, which may be due in part to the type of ring employed. We want to compare late results with mitral valve annuloplasty using flexible vs rigid annuloplasty rings.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing CABG with Mitral valve repair for ischemic MR

Exclusion Criteria:

* Other valve procedures

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Shuli Silberman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05769452: Closed Intravenous Catheter System on Catheter Success, Length of Stay and Complications
Official title: Effect of Closed Intravenous Catheter System on Catheter Success, Length of Stay and Complications in Pediatric Hematology and Oncology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Complications
Catheter Leakage
Keywords: closed IV catheter system
pediatric hematology oncology
first IV attempt
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 214
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, the intervention group was given a closed IV catheter system called BD Nexiva™; the control group received an open IV catheter called BD Insyte™ Autoguard™. Within the scope of the study, "Peripheral IV Catheter Care Bundle Approach" was applied to all patients.
Primary purpose: PREVENTION

Brief summary: Peripheral intravenous catheters (PIVCs) can be used frequently in pediatric hematology oncology patients. There are different types of PIVCs as open and closed. There are studies on adults using the closed IV catheter system, which is a type of PICK. However, no study was found in the literature in which the closed IV catheter system was used in the pediatric population.

Detailed description: The primary purpose of this research is; to evaluate the effect of two different catheter systems (closed IV catheter system: BD Nexiva™/ peripheral open IV catheter: BD Insyte™ Autoguard™) on catheter stay in pediatric hematology and oncology patients aged 1-12 years.

The secondary aim of the research is; to evaluate the effect of two different catheter systems on the success of catheter placement and the development of complications in the first attempt in pediatric hematology and oncology patients.

Eligibility criteria: Inclusion Criteria:

* Age range of pediatric patients is between 1-12
* Obtaining an informed consent form from the child patient and parent
* Child patient receiving intravenous therapy

Exclusion Criteria:

* port or central venous catheter in the pediatric patient

Primary outcomes:
measure: catheter indwelling time
timeFrame: during the catheterization
measure: success of catheter placement
timeFrame: at catheter insertion
Secondary outcomes:
measure: development of catheter complications
timeFrame: during the catheterization
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gülçin Özalp Gerçeker
Study officials:
affiliation: Dokuz Eylul University
name: Nur Olgun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Hale Ören, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03932552: Effects of a Novel Physical Exercise Program in Patients With Cirrhosis (the LFN-exercise Protocol)
Official title: Effects of a Physical Exercise Program on Cerebral and Hepatic Hemodynamics in Patients With Cirrhosis. (Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Portal Hypertension
Exercise
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: Universidad Nacional Autonoma de Mexico
First posted: 2019-04-30
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of a structured exercise (The LFN-exercise protocol) program plus diet, on cerebral hemodynamics (cerebral blood flow) and hepatic hemodynamics (portal pressure), as well as on nutritional status (body composition and nutritional markers) in order to facilitate the prescription of exercise in patients with cirrhosis.


Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis of any aetiology (liver biopsy or a combination of clinical and biochemical variables plus evidence of portal hypertension); without decompensation during the past month; serum creatinine \<1.5 mg/dL; able to attend the appointed visits and willing to participate in the study.

Exclusion Criteria:

* Presence of high-risk varices in upper endoscopy (red marks, large varices or gastric varices); concomitant cardiopulmonary diseases; decompensated Type 2 Diabetes Mellitus, insulin use or proliferative diabetic retinopathy; orthopaedic or osteomuscular limitations; any type of cancer, primary sclerosing cholangitis and Inflammatory bowel disease.

Primary outcomes:
measure: Improvement in Cerebral hemodynamics
timeFrame: 12 weeks
measure: Improvement in neurocognitive status-1
timeFrame: 12 weeks
measure: Improvement in neurocognitive status-2
timeFrame: 12 weeks
measure: Changes in hepatic hemodynamics
timeFrame: 12 weeks
measure: Improvement in body composition
timeFrame: 12 weeks
measure: Improvement in nutritional status
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical fitness
timeFrame: 12 weeks
measure: Physical activity
timeFrame: 12 weeks
measure: Physical activity tolerance
timeFrame: 12 weeks
measure: Oxidative stress
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Ricardo U Macías-Rodríguez, M.D., PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05615532: A Relative Bioavailability Study of LY3209590 in Healthy Participants
Official title: Effect of Injection Site on the Relative Bioavailability of Single Dose of LY3209590 and Evaluation of Absolute Bioavailability of LY3209590 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioavailability
Injection sites
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 168
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part A is Parallel design and Part B is a crossover design
Primary purpose: BASIC_SCIENCE

Brief summary: The study will be conducted in two parts (part A and part B). The main purpose of this study is to compare the amount of LY3209590 that gets into the blood stream and how long it takes the body to get rid of it, when self-administered at different body sites, abdominal wall, upper arm and thigh (part A), when administered by two different routes of injection, subcutaneously or intravenously (part B) in healthy participants.

The study may last up to 65 (part A) and 184 (part B) days, respectively.


Eligibility criteria: Inclusion Criteria:

* Male or female participants who are overtly healthy as determined by medical evaluation
* Participants with body mass index (BMI) within the range 18.5 to 35.0 kilograms per meter squared (kg/m²)
* Male or female participants must agree to use contraception

Exclusion Criteria:

* Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction
* Have known allergies to LY3209590, related compounds, or any components of the formulation
* Have an abnormality in the 12-lead electrocardiogram
* Intend to use prescription medication, including herbal medications and traditional medications
* Show evidence of human immunodeficiency virus infection or positive human immunodeficiency virus antibodies, hepatitis C or positive hepatitis C antibody, or hepatitis B or positive hepatitis B surface antigen
* Are lactating or pregnant

Primary outcomes:
measure: Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590
timeFrame: Predose on Day 1 through Day 65
Secondary outcomes:
measure: Part B: PK: AUC0-∞ of LY3209590
timeFrame: Predose on Day 1 through Day 65
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical Pharmacology
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: