louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05312996: Autonomic Nervous System Function - Hypertension
Official title: Perceived Stress and Patterns of Autonomic Function: a Protocol Development Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Hypertension
Lead sponsor: Life University
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The Life University Center for Chiropractic Research is conducting a research study to better understand the physiological differences, in terms of Autonomic nervous system function, between individuals with Hypertension and control individuals with out hypertension. Data will be gathered using Heart Rate Variability (HRV), and Galvanic Skin Response (GSR). A series of tests will be conducted to elicit Autonomic Nervous system responses. These tests include Cold Face Test (mammalian dive reflex), Cold Pressor test, Sit to stand, and the Valsalva maneuver.

Detailed description: The objective of the study is to ascertain the level of autonomic health in persons with hypertension versus a healthy population. Further, via the implemented protocol, the study will attempt to develop a sequence of autonomic nervous system tests to be used in future studies and clinical settings

Eligibility criteria: Participants will be included in the hypertension group if they present with the following:

* Hypertension, defined as:
* Self-reported or previously diagnosed with elevated resting state blood pressure (120-129 systolic and less than 80 mmHg diastolic) or stage 1 hypertension with a blood pressure of Systolic between 130- and 139-mm Hg with a diastolic of 80-89 mmHg.
* Or medically diagnosed and managed stage 2 hypertension with blood pressure of Systolic between 140- and 159-mm Hg or diastolic 90 and 99 mm
* between the ages of 18-65
* Able to wear a monitor on their right wrist.
* Able to wear a pulse oximeter on their left hand.

Participants will be included in the healthy group if they present with the following:

* between the ages of 18-65
* Able to wear a monitor on their right wrist.
* Able to wear a pulse oximeter on their left hand.

Primary outcomes:
measure: Heart Rate Varability
timeFrame: Through study completion, an average of 1 year
measure: Galvanic Skin Response
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Dr. Sid E. Williams Center for Chiropractic Research
state: Georgia
Study officials:
affiliation: Life Univeristy
name: Stephanie Sullivan, DC, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06109896: Clinical Stories and Psychological Experiences of Cancer Patients
Official title: ONCO_STORIES. Stress, Trauma, Origins, Psychological Responses, Interpersonal Relationships and Experiences in the Clinical History of Cancer Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Tumor
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who have been diagnosed with cancer. Patients who access the services of: Gynecology Oncology Unit, Internal Medicine and Gastroenterology Unit, Digestive Surgery Unit, Radiotherapy Oncology Unit, Senology Surgery Unit, Medical Oncology Unit, Hematology Unit, Medicine Unit will be considered.

Neurosurgery and at the same time as psychological consultation with the operators belonging to the Clinical Psychology Unit of Fondazione Policlinico Universitario A. Gemelli IRCSS.

Brief summary: The purpose of the study is to collect and analyze information from the multidimensional assessment of cancer patients (medical, psychological, psychometric, biological, etc.) treated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The collection of information will allow to investigate the possible presence of correlations between psychological aspects and clinical medical conditions of the person during the course/treatment of cancer.

In the course of the study, the possible presence of previous stressful and/or traumatic events, and the presence of psychological, post-traumatic and/or dissociative symptoms during treatment will be explored. Any correlations between medical conditions and psychological, emotional and behavioral characteristics will also be explored. Finally, it will be possible to investigate the effectiveness of psychological interventions that are carried out according to clinical practice.


Eligibility criteria: Inclusion Criteria:

* Individuals between 18 and 99 years old;
* Individuals with a diagnosis of current oncologic disease and in active oncologic treatment at the hospital where the study is conducted;
* Individuals with a history of oncologic disease who have completed oncologic treatment or in follow-up at the hospital where the study is conducted;

Exclusion Criteria:

* Non-signing of informed consent;
* Non-signing of consent/assent by patient/legal guardian;
* Patients with cognitive impairment or legal disqualification;
* Clinical/medical or psychological condition that does not allow completion of self-report questionnaires;

Primary outcomes:
measure: Collect and analyze information from the multidimensional assessment of cancer patients
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00539396: A 3 Month, Randomized, Open Label, Multi-center Study of Technosphere/Insulin Compared to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Receiving Insulin Glargine
Official title: A Phase 2 Randomized, Open Label, Multi-Center Study of the Use of Prandial Inhaled Technosphere Insulin in Combination With Basal Subcutaneous Lantus as Basal Insulin Versus Prandial Subcutaneous NovoRapid in Combination With Basal Subcutaneous Lantus Insulin in Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2007-10-04
Enrollment: 110
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: A 3 month, randomized, open label, multi-center study of Technosphere/Insulin compared to insulin aspart in subjects with type 1 diabetes mellitus receiving insulin glargine


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes currently receiving SC insulin at mealtimes for at least 3 months
* BMI \<40 kg/m squared
* HbA1c greater than or equal to 7% and less than or equal to 11.5%
* Serum creatinine less than 2 for males and less than 1.8 for females
* Acceptable pulmonary function

Exclusion Criteria:

* Significant hepatic disease
* Previously diagnosed pulmonary disease, ketoacidosis of evidence of severe secondary complications of diabetes

Primary outcomes:
measure: Change in blood glucose following a standard meal
timeFrame: 0-300 minutes
Secondary outcomes:
measure: Mean change from baseline HbA1c
timeFrame: week 12
Other outcomes:
Locations:
Study officials:
affiliation: Mannkind Corporation
name: Robert Baughman, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05909696: Median Effective Dose of Rocuronium for the Prevention of Myofibrillation Caused by the Injection of Succinylcholine
Official title: Median Effective Dose of Rocuronium for the Prevention of Myofibrillation Caused by the Injection of Succinylcholine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Succinylcholine
Myofibrillation
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Succinylcholine is an important component of rapid sequential induction of general anesthesia because of its rapid onset and short duration of action. However, myofibrillation is a common complication after succinylcholine injection and may lead to persistent postoperative myalgia, increased intraocular, intragastric and intracranial pressure in patients. Increased risk of peri-induction and postoperative patient discomfort. The effectiveness of rocuronium bromide pretreatment in reducing succinylcholine-induced myalgias has been demonstrated in several recent studies. However, the half effective amount of rocuronium pretreatment for small doses is not well known. Therefore, this study applied the Dixon sequential method to investigate the ED50 of preemptive intravenous rocuronium bromide for the prevention of succinylcholine-induced myofibrillation and to investigate the effect of age factor on the ED50 of rocuronium bromide for the prevention of succinylcholine-induced myofibrillation to provide a reference for the rational clinical selection of rocuronium bromide dose.


Eligibility criteria: Inclusion Criteria:

1. Ages ranged from 18 to 80.
2. ASA grade I-II

Exclusion Criteria:

1. Possible airway difficulties,
2. allergies or contraindications to rocuronium and succincholine ，
3. cardiac insufficiency,
4. hepatic or renal dysfunction,
5. neuromuscular disease,
6. surgery lasting more than 2 hours,
7. taking any known drug that has interaction with neuromuscular blockers.

Primary outcomes:
measure: The appearance of myofibrillation
timeFrame: Average 45 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University, Yangzhou University
state: Jiangsu
Study officials:
References:
Clinical trial NCT05983796: 18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.
Official title: Prospective Study of 18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: 18F-HER2 PET
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a open-label, one-arm, multicenter study aimed to explore the efficacy and safety of 18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.


Eligibility criteria: Inclusion Criteria:

1. Informed consent document must be signed.
2. Aged 30-80 years old, both genders.
3. Patients with locally advanced or advanced urothelial carcinoma
4. Patients plan to undergo anti HER2 treatment.

Exclusion Criteria:

1. Subjects with active malignancies other than urothelial carcinoma within 5 years should be excluded.
2. Patients with severe liver, kidney, and hematopoietic diseases
3. Patients with other mental disorders or primary emotional disorders
4. Those who are unable to understand, comply with the research protocol, or sign an informed consent form
5. PET imaging Contraindication (including pregnant women, lactating women, women of childbearing age who have a recent fertility plan, etc.)
6. Individuals who are allergic to imaging agents
7. Hypoglycemic reactions, severe pain, etc. cannot be accompanied by PET scans

Primary outcomes:
measure: Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Jianzhen Shan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04899596: High Risk Factor, Clinical Feature, and Follow up of Neonatal Arrhythmia
Official title: High Risk Factor, Clinical Feature, and Follow up of Neonatal Arrhythmia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Arrhythmia
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Chongqing Medical University
First posted: 2021-05-24
Enrollment: 1
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: neonates

Brief summary: This study included 189 newborns (77 male,112 female) diagnosed with arrhythmia in the NICU of Children's Hospital of Chongqing Medical University, China, from January 2015 through December 2019. To investigate the high-risk factors, clinical manifestations, and clinical outcomes of neonatal arrhythmia.

Detailed description: The incidence of neonatal arrhythmia is 3.94‰(189/47911), and the mortality of neonatal arrhythmia is 0.21‰(10/47911) within 1 year after birth.

Eligibility criteria: Inclusion Criteria:①Newborns admitted in the Department of Neonatology of Children's Hospital Affiliated to Chongqing Medical University from January 2015 to December 2019;② 12-lead ECG and/or 24-hour dynamic ECG suggest arrhythmias, including children with sinus tachycardia and sinus arrhythmia.

Exclusion Criteria:not have

Primary outcomes:
measure: Electrocardiogram
timeFrame: up to 12 weeks
measure: anti-arrhythmia
timeFrame: before 1 year old
measure: death
timeFrame: up to 12 weeks
measure: death
timeFrame: before 1 year old
measure: recurrence
timeFrame: before 1 year old
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT00943696: Effects of White Wine vs. Tea Intake During and an Alcoholic Digestive Following a High Fat, High Calorie Cheese Fondue Meal on Gastric Emptying and Abdominal Symptoms in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Participants
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: COOP
First posted: 2009-07-22
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Tradition holds that the intake of different drinks with a meal has an important influence on the digestion of food and postprandial symptoms such as fullness, bloating and satiety; however this assumption have never been subjected to controlled study

A classic example is the Swiss cheese fondue. The intake of white wine, tea and cherry schnapps (Kirsch) are often attributed either positive or negative effects on the gastrointestinal tract.

In this study the effect of white wine vs. tea intake during and an alcoholic digestive following a high fat, high calorie Swiss fondue meal on gastric emptying and visceral perception will be investigated using a randomized, controlled study design.

The fondue will be labeled with non-radioactive 13C octanoate for assessment of gastric emptying by breath-test.


Eligibility criteria: Inclusion criteria: • able to communicate well with the investigators and provide written consent

• Body Mass Index: 19-30 kg/m2

Exclusion criteria: • physical co-morbidity requiring active treatment

* psychiatric (DSM IV) disorders limiting the ability to comply with study
* use of medications influencing upper GI motility
* evidence of current drug or alcohol abuse
* history of gastrointestinal disease or surgery except appendicectomy or hernia repair

Primary outcomes:
measure: Effect of white wine vs. tea on gastric emptying
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
citation: Heinrich H, Goetze O, Menne D, Iten PX, Fruehauf H, Vavricka SR, Schwizer W, Fried M, Fox M. Effect on gastric function and symptoms of drinking wine, black tea, or schnapps with a Swiss cheese fondue: randomised controlled crossover trial. BMJ. 2010 Dec 14;341:c6731. doi: 10.1136/bmj.c6731.
Clinical trial NCT03914196: Fontan Associated Liver Disease
Official title: Can Ultrasound Liver Stiffness Pre-Fontan, Post-Fontan, or Change Over Time Predict Onset and Severity of Fontan-Related Complications, Including Fontan-Associated Liver Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fontans
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that are undergoing a Fontan Palliation during cardiothoracic surgery.

Brief summary: Fontan-associated liver disease (FALD), including the development of cardiac cirrhosis and liver neoplasms (benign and malignant), occurs in a majority of patients with congenital heart disease palliated with the Fontan operation. However, the specific phenotype (fibrosis only, fibrosis + lesions, etc.) of disease and severity/timing of onset are variable. Chronic passive congestion of the liver due to the absence of a functional sub-pulmonary ventricle and resultant chronic central venous hypertension is suspected to be one of the chief drivers of FALD and recent work has demonstrated that ultrasound shear wave elastography can be used to noninvasively detect and measure the degree of liver congestion. Chronic passive congestion of the liver may also be a predictor of other Fontan-related complications, such as protein losing enteropathy, plastic bronchitis, and intractable ascites.


Eligibility criteria: Inclusion Criteria:

1. Single ventricle physiology congenital heart disease undergoing Fontan operation;
2. ≤5 years of age at the time of stage 3 Fontan operation;
3. Ability to return for follow-up imaging.

Exclusion Criteria:

1. Inability to undergo ultrasound imaging.
2. Non-English speaking patients, as breath-hold is required for US shear wave elastography in older children due to excursion of the liver with breathing.

Primary outcomes:
measure: Pre/Post Fontan Liver Stiffness Changes
timeFrame: 5 years
Secondary outcomes:
measure: Correlate liver stiffness measurements with clinical outcomes at 3-, 5-, and 10-years post stage 3 Fontan operation
timeFrame: 10 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
citation: DiPaola FW, Schumacher KR, Goldberg CS, Friedland-Little J, Parameswaran A, Dillman JR. Effect of Fontan operation on liver stiffness in children with single ventricle physiology. Eur Radiol. 2017 Jun;27(6):2434-2442. doi: 10.1007/s00330-016-4614-x. Epub 2016 Oct 17.
Clinical trial NCT04267458: Prevalence of Kidney Injury in Patients With HCV Treated With Sofuspovir Containing DAA Therapy
Official title: the Prevalence of Acute Kidney Injury in Patients With Chronic Hepatitis c Virus Receiving Sofuspovir Containing Direct Acting Antiviral Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Investigate the Renal Effect of DAAs on Egyption Patients After Completion of Treatment
Keywords: DAA
HCV
egyption patients
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: this study aims is to investigate the occurrence of AKI during antiviral therapy, defined as an increase of 0.3 mg/dL or 50% at least in serum creatinine level when compared with baseline values or more than a 25% reduction in (eGFR) when compared with baseline eGFR in Egyptian patients.In addition to evaluate the change in insulin resistance value after treating patients from HCV.

Detailed description: There are limited published data, currently, suggesting the risk of AKI during oral direct acting antiviral treatment. Most case reports and retrospective studies reported the presence of an intrinsic cause of renal injury, with most of the available biopsies showing acute tubular necrosis (ATN) and acute interstitial nephritis (AIN). Most of these patients had returned to baseline renal function on cessation of sofosbuvir combination therapy.

Recently it was found that a notable percentage of patients experienced a transient increase in creatinine during therapy, which could occasionally lead to a more than 50% decrease in patients' eGFR. Previous studies had also shown that the co-use of nonsteroidal anti-inflammatory drugs (NSAIDs) and recurrent ascites were at increased risk for AKI during sofosbuvir-based antiviral therapy.

The primary endpoint of this study is to investigate the occurrence of AKI in Egyptian patients during antiviral therapy and to highlight its reasons and time of incidence in addition to the mechanism of this injury.

Eligibility criteria: Inclusion Criteria:

* patients suffering from HCV
* male or female
* easy to treat naive patients

Exclusion Criteria:

* pregnant women
* seffering from HBV
* diffecult to treat
* other comorbodities as heart diseases or COPD

Primary outcomes:
measure: investigate the renal injury which can be caused during using sofuspovir containing DAA regimen in HCV treatment
timeFrame: from the start to 6 months later
Secondary outcomes:
measure: highlight the effect of DAAs on insulin resistance in diabetic patients suffering from HCV
timeFrame: from the starting of treatment till the 3-months follow up after the end of the treatment regimen
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Thabet Thabet Hospital For Internal Diseases
Study officials:
affiliation: Lecturer of pharmacology and toxicology
name: Dalia Zaafar, PhD
role: PRINCIPAL_INVESTIGATOR
References: