louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01530061: The Satiating Effect of Eggs in Children
Official title: The Satiating Effect of Eggs in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Egg Nutrition Center
First posted: 2012-02-09
Enrollment: 28
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study will determine which breakfast (egg breakfast or bagel breakfast) has the most beneficial effect on appetite.

Detailed description: Test Day 1 (about 4 hours)

* This is a fasting visit (nothing besides water 12 hours prior to visit)
* Your child will be offered one of two breakfasts (egg breakfast or bagel breakfast)

  . He/she will be asked to eat all the food that is provided.
* He/she will be asked to rate the taste of the meal.
* He/she will be offered a pasta lunch.

Test Day 2 (about 4 hours)

* This will be scheduled 1 week after Test Day 1
* This is a fasting visit (nothing besides water 12 hours prior to visit)
* The procedures for this visit are the same as for Test Day 1. Your child will be offered the breakfast that he/she did not receive at the last visit.

The sequence of the 2 breakfasts will be randomly assigned to each child.

Eligibility criteria: Inclusion Criteria:

* • Is a healthy boy or girl between 14 and 17 years of age

  * Is a healthy boy or girl between 4 and 6 years of age

Exclusion Criteria:

* • Is suffering from any diseases such as major heart conditions, type 1 diabetes, cancer, eating disorders, or any serious illness that requires intensive and long-term medical treatment

  * Has allergies/sensitivities/dislikes to eggs, soy, or wheat
  * Uses drugs recreationally
  * Is actively attempting to lose weight

Primary outcomes:
measure: Lunch time food intake
timeFrame: 1 day
Secondary outcomes:
measure: Visual Analog Scale Ratings
timeFrame: 1 day
measure: Blood appetite hormone
timeFrame: 1 day
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Nikhil Dhurandhar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06746961: Efficacy and Safety of QL1706 Plus Lenvatinib As 2nd Line Theapy in Patients with Metastatic Esophageal Carcinoma After Disease Progression on ICIs Therapy
Official title: A Single-arm, Open-label, Multicenter Phase Ⅰb/Ⅱ Clinical Study of QL1706 (bispecific Antibody Targeting PD-1 and CLTA-4) in Combination with Lenvatinib in Second-line Therapy for Advanced Esophageal Squamous Cell Carcinoma After Disease Progression on Immune Checkpoint Blockades Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Esophageal Squamous Cell Carcinoma (ESCC)
Keywords: QL1706
lenvatinib
immune checkpoint blockades
esophageal squamous cell carcinoma
ESCC
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of QL1706 plus lenvatinib in second-line therapy for patients with metastatic esophageal squamous cell carcinoma after progression on immune checkpoint inhibitor therapy


Eligibility criteria: Inclusion Criteria:

1. Subjects participate voluntarily and sign informed consent.
2. 18-75 years, male or female.
3. Histologically or cytologically verified diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma
4. Patients who have disease progression verified by imaging on standard first-line immunotherapy with anti-PD-1/PD-L1 antibodies
5. At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).
6. ECOG PS 0-1

Exclusion Criteria:

1. Presence of any active autoimmune disease or history of autoimmune disease (such as: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism)
2. Those who are taking immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (dose\> 10 mg/day prednisone or other equivalent cortiremonial hormones) and are taking within 2 weeks before recruitment
3. Severe allergic reaction to other monoclonal antibodies
4. Those who terminated treatment due to related toxicity during anti-PD-1/PD-L1 antibody treatment
5. Prior treatment with bispecific anti-PD-1/CTLA-4 checkpoint blockades or VEGFR inhibitors

Primary outcomes:
measure: Phase Ib：Dose Limiting Toxicities (DLTs) and recommended phase 2 dose (PR2D)
timeFrame: up to ~21 days
measure: Phase II: Overall Survival (OS) in all participants
timeFrame: up to ~48 months
Secondary outcomes:
measure: PFS
timeFrame: up to ~42 months
measure: ORR
timeFrame: up to ~42 months
measure: DOR
timeFrame: up to ~42 months
measure: Number of Participants With AEs
timeFrame: Up to ~53 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01441661: Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma
Official title: Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma: a Multicenter, Non-interventional, Retrospective Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: Sunitinib
kidney diseases
urogenital neoplasms
kidney cancer
Lead sponsor: Cancer Foundation, China
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-09-28
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with RCC and treated with Sunitinib from 2008 to present will be eligible. This will include current active patients as well as patients who have expired and have medical records available.

Brief summary: This non-interventional study includes patients with advanced renal cell carcinoma who are treated with Sunitinib alone or combined with other systemic therapies. The aim of the trial is to increase knowledge about usage, dosage, efficacy and safety under conditions of routine use of Sunitinib.

Detailed description: Because State Food and Drug Administration (SFDA) exempted manufacturers from conducting clinical trials of Sunitinib in China, overall efficacy and safety data of Sunitinib in Chinese patients with renal cell carcinoma were deficiency. The investigators carried out this research project will be sufficient evidence, and help clinicians in China to make decision in real daily practice.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed, unresectable advanced renal cell carcinoma;
* Sunitinib as first-line treatment alone or combined with other therapies.

Exclusion Criteria:

* History of Grade 3/4 severe allergic reaction to Sunitinib or its metabolites

Primary outcomes:
measure: Disease control rate (DCR)
timeFrame: 2008-2011 (up to 3 years)
Secondary outcomes:
measure: Progression Free survival (PFS)
timeFrame: 2008 - 2011 (up to 3 years)
measure: Overall Survival (OS)
timeFrame: 2008 - 2011 (up to 3 years)
measure: Number of patients with adverse events
timeFrame: 2008 - 2011 (up to 3 years)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of Hust
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Zhangqun Ye, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04772261: GEBT Lot-to-Lot and Biological Variability
Official title: 13C-Spirulina Breath Test (13C-GEBT) Lot-to-Lot and Biological Variability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroparesis
Keywords: Gastroenterology
Gastric emptying breath test
Lead sponsor: Cairn Diagnostics
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to collect information regarding lot-to-lot variability in 13C-Spirulina test meal lets and within-subject biological variability.

Detailed description: In this study participants will participate in one or two arms of the study. In one arm the participants will be administered GEBT tests that contain different 13C-Spirulina/Egg mix drug lots. In the second arm, the participants will be administered GEBT tests from the same 13C-Spirulina/Egg mix drug lot. All GEBT kit lots will be administered according to the FDA-approved labeling.

Eligibility criteria: Inclusion Criteria:

* Males and females, 18-85 years old at time of signing the informed consent form
* Ability to eat test meal and provide breath samples

Exclusion Criteria:

* History or physical exam suggestive of systemic disease such as diabetes mellitus or pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease, or malabsorption.
* History of abdominal surgery except appendectomy
* Use of any medications that may alter gastric motility within two days of the study
* Use of narcotics or anticholinergics within two days of the study
* Females on hormone replacement therapy other than birth control medications
* Pregnancy
* Intolerance or allergy to any component of GEBT test meal
* History of neurologic or psychiatric disorders

Primary outcomes:
measure: Lot to Lot Variability
timeFrame: up to 3 months
measure: Lot to Lot Variability
timeFrame: up to 3 months
measure: Lot to Lot Variability
timeFrame: up to 3 months
measure: Biological Variability
timeFrame: Up to 3 months
measure: Biological Variability
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brentwood
country: United States
facility: Cairn Diagnostics
state: Tennessee
Study officials:
affiliation: Cairn Diagnostics
name: Alex Ryder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04470661: Point-of-care Ultrasound for Acute Kidney Injury
Official title: Diagnostic Accuracy of Point-of-Care Ultrasound in the Etiology of Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 130
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: Patients with acute kidney injury diagnosed in the ED.

Brief summary: It is aimed to determine prerenal, renal and postrenal diagnoses of patients with acute kidney injury with POCUS performed in the emergency department. Patients who presented to the emergency department and who have acute kidney injury (AKI) according to the KDIGO criteria will be evaluated and patients diagnosed with AKI will be included in the study. The diagnostic accuracy of POCUS with the AKI etiologies of the patients will be evaluated.


Eligibility criteria: Inclusion Criteria:

• AKI diagnosis according to KDIGO criteria

Exclusion Criteria:

* Patients with end stage renal failure,
* Failure to perform POCUS in the first two hours of presentation of patient,
* Those with renal malignancy,
* Pregnant women,
* Renal transplantation patients,
* Patients with a single kidney,
* Those with polycystic kidney disease,
* Patients with nephrostomy,
* Patients who are referred from another center,
* Unable to perform adequate imaging,
* Patients who do not give consent for the study will be excluded.

Primary outcomes:
measure: The diagnostic accuracy of POCUS in the patients with AKI
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Facaulty of Medicine
Study officials:
affiliation: Gazi University
name: Mehmet Aslaner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06704061: Online Yoga vs Acceptance and Commitment Therapy for Treating Chronic Musculoskeletal Pain
Official title: Online Yoga vs Acceptance and Commitment Therapy for Treating Chronic Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Musculoskeletal Pain
Keywords: chronic pain
veteran
musculoskeletal pain
yoga
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 274
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: This study will compare online yoga with Acceptance and Commitment Therapy (ACT), an established treatment for chronic pain. We will compare the efficacy of the two treatments for reducing chronic musculoskeletal pain in veterans.

Detailed description: This study will test if online yoga is not inferior than ACT for treating chronic pain in veterans. Participants will be randomly assigned to receive either online yoga instruction or ACT, once a week for 12 weeks in an online group class. They will complete self-report questionnaires about their experience of chronic pain. There will be a 6-month follow up period, during which the research team will check in with the participant to record any adverse events and maintain study contact.

Eligibility criteria: Inclusion Criteria:

* Veteran of the United States Armed Forces ≥ 18 years old
* Chronic pain \> 6 months related to at least one musculoskeletal pain-related diagnosis indicated by an ICD-9 or -10 code
* Minimum pain intensity at screening ≥4 on a 0-10 using the Defense and Veterans Pain Rating Scale (DVPRS)
* Not begun new pain treatments or medications in the past month
* Stable medication regimen for at least 4 weeks prior to entry to the study
* English literacy
* Wireless internet connection at home

Exclusion Criteria:

* Participation in another clinical trial, unless given prior authorization from both our research team and that of the other study
* Back surgery within the last 12 months
* Back pain potentially attributed to a specific known condition
* Baseline pain \<4 or ≥9 on a 0-10 Numeric Rating Scale
* Unstable, serious coexisting medical illness, mental illness or psychiatric conditions
* Attended or practiced yoga ≥ 1 x in the past 12 months
* Current suicidal intent or plan

Primary outcomes:
measure: Pain Interference (Brief Pain Inventory-Short Form)
timeFrame: Baseline, End-of-treatment at 12 weeks, and 6 months after treatment
Secondary outcomes:
measure: Depression (BDI-II)
timeFrame: Baseline, End-of-treatment at 12 weeks, and 6 months after treatment
measure: Sleep (Pittsburgh Sleep Quality Index)
timeFrame: Baseline, End-of-treatment at 12 weeks, and 6 months after treatment
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto VA Medical Center
state: California
Study officials:
affiliation: Palo Alto Veterans Institute for Research
name: Peter Bayley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01387061: Resection for Multiple Hepatocellular Carcinomas (HCC)
Official title: Hepatic Resection for Multiple Hepatocellular Carcinoma on Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Multiple Tumors
Cirrhosis
Keywords: liver resection
hepatic resection
intraoperative ultrasound
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2011-07-04
Enrollment: 87
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Surgical resection in patients with multiple hepatocellular carcinomas (HCC) remains controversial. The aim of this study was to investigate the outcome of a consecutive cohort of patients resected for multiple HCC, without macrovascular invasion, in order to identify clinically reliable parameters to select patients for surgery.


Eligibility criteria: Inclusion Criteria:

* patients with multiple HCC without macrovascular invasion on liver cirrhosis

Exclusion Criteria:

* macrovascular invasion;
* normal liver;
* distant or lymphnodes metastasis

Primary outcomes:
measure: Overall survival plus multivariate analysis
timeFrame: 10 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 10 years
Other outcomes:
Locations:
city: Rozzano, Milan
country: Italy
facility: University of Milan IRCCS Istituto Clinico Humanitas
state: MI
Study officials:
affiliation: University of Milan
name: Guido Torzilli, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06221761: A Study on the Prophylactic Use of Antibiotics Within 72 Hours After Acute Burn Injury in Patients
Official title: A Prospective Randomized Controlled Study on the Prophylactic Use of Antibiotics Within 72 Hours After Acute Burn Injury in Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Burn Infection
Keywords: burn
infection
antibiotic
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly divided into two groups, one using antibiotics and the other not using antibiotics
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare in acute burn patients.

The main question it aims to answer are:

• what is the impact of early prophylactic use of antibiotics on prognosis Participants will be randomly divided into an antibiotic group and a non antibiotic group.

Researchers will compare the two groups to see the 72 hour wound bacterial culture negative rate.


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent form
* Promise to comply with research procedures and cooperate with the implementation of full process research
* Age 18 and above
* Emergency hospitalization of patients in the burn department, within 24 hours after injury
* No immunodeficiency disease, no history of using immunosuppressive drugs, no antibiotics being used or infectious diseases at the time of admission
* If a woman is in the reproductive period, she should not be pregnant

Exclusion Criteria:

* Unable to obtain informed consent from subjects, family members, or authorized agents
* At the time of admission, antibiotics were being administered
* During pregnancy
* Presence of infectious diseases before admission
* Existence of immunodeficiency diseases or use of immunosuppressive drugs
* The subjects are currently undergoing other clinical studies

Primary outcomes:
measure: Negative rate of bacterial culture
timeFrame: hour 72
Secondary outcomes:
measure: 28 day mortality rate
timeFrame: 28 day after burn
Other outcomes:
Locations:
Study officials:
References:
citation: ISBI Practice Guidelines Committee; Steering Subcommittee; Advisory Subcommittee. ISBI Practice Guidelines for Burn Care. Burns. 2016 Aug;42(5):953-1021. doi: 10.1016/j.burns.2016.05.013.
citation: Avni T, Levcovich A, Ad-El DD, Leibovici L, Paul M. Prophylactic antibiotics for burns patients: systematic review and meta-analysis. BMJ. 2010 Feb 15;340:c241. doi: 10.1136/bmj.c241.
Clinical trial NCT00592761: Treatment of Dysphagia Using the Mendelsohn Maneuver
Official title: Treatment of Dysphagia Using the Mendelsohn Maneuver
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Dysphagia
Keywords: Deglutition Disorders
Mendelsohn Maneuver
SEMG
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2008-01-14
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary goal of the investigation is to determine the effects of the Mendelsohn maneuver on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs of pharyngeal dysphagia.

Detailed description: The primary goal of the investigation is to determine the effects of the Mendelsohn maneuver (voluntary prolongation of laryngeal excursion at the midpoint of the swallow) on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs of pharyngeal dysphagia (specifically, reduced duration of hyoid maximum elevation, reduced extent of hyoid maximum elevation, reduced duration of hyoid maximum anterior excursion, reduced extent of hyoid maximum anterior excursion, and reduced duration of upper esophageal sphincter (UES) opening with subsequent residue in the pyriform sinuses and, potentially, aspiration). Participants are assessed with videofluoroscopy at the initiation of the study and after each week of the study. After the 4 weeks of participation are complete, all participants will be discharged from treatment and will be brought back to the clinic for a final Videofluoroscopic Swallow Study (VFSS) evaluation after 2 weeks. This means that individuals in Group 1 will be re-analyzed after 1 month of additional no-treatment, and Group 2 will be re-analyzed after 2 additional weeks of no-treatment.

Eligibility criteria: Inclusion Criteria:

* Stroke (1-18 months post)
* Pharyngeal Dysphagia

Exclusion Criteria:

* Other neurologic or structural abnormality to oropharynx
* History of dysphagia prior to latest stroke

Primary outcomes:
measure: Change in Duration of Superior Hyolaryngeal Movement
timeFrame: baseline and six weeks
measure: Change in Duration of Hyoid Maximum Anterior Excursion
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change in Oral Intake Ability
timeFrame: Baseline and 6 weeks
measure: Change in Duration of Opening of Upper Esophageal Sphincter
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: UArkansas/UAMS Medical Center
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Gary H McCullough, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: