louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01441427: Enteral Granulocyte Colony Stimulating Factor and Erythropoietin Early in Life Increases Feeding Tolerance in Preterm Infants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Feeding Intolerance
Necrotizing Enterocolitis
Keywords: feeding intolerance
recombinant growth factors
G-CSF
EPO
necrotizing enterocolitis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2011-09-27
Enrollment: 93
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: With preterm birth, the ingestion of amniotic fluid containing enterocyte trophic factors ceases abruptly. This likely predisposes them to villous atrophy feeding intolerance and necrotizing enterocolitis(NEC) once feedings are instituted.Granulocyte Colony-Stimulating Factor (G-CSF) and Erythropoietin (EPO) have important non-hematopoietic roles in human developmental biology. Among these roles, they have trophic actions on villous height and bowel length of the developing intestine.The aim of this study is to evaluate the efficacy of enteral recombinant human G-CSF and recombinant human EPO in prevention of feeding intolerance and /or NEC in preterm infants.


Eligibility criteria: Inclusion Criteria:

* premature neonates \< 33 weeks gestational age

Exclusion Criteria:

* major congenital anomalies
* prior use of cytokines

Primary outcomes:
measure: The times taken to establish quarter, half, three quarters, and full enteral feeding after the drug treatment (at least 150ml/kg/day).
timeFrame: one month
measure: Time to stop parentral nutrition
timeFrame: one month
measure: Day of onset of weight gain
timeFrame: one month
measure: Duration of hospitalization
timeFrame: 2 months
Secondary outcomes:
measure: Necrotizing enterocolitis (NEC)stage (if any)
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
citation: El-Ganzoury MM, Awad HA, El-Farrash RA, El-Gammasy TM, Ismail EA, Mohamed HE, Suliman SM. Enteral granulocyte-colony stimulating factor and erythropoietin early in life improves feeding tolerance in preterm infants: a randomized controlled trial. J Pediatr. 2014 Dec;165(6):1140-1145.e1. doi: 10.1016/j.jpeds.2014.07.034. Epub 2014 Aug 23.
Clinical trial NCT01139827: Association Between Framingham Risk Score, hsCRP and Vascular Inflammation: Analysis With 18F-Fluorodeoxyglucose Positron Emission Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Risk
Keywords: atherosclerosis
inflammation
hsCRP
Framingham risk score
positron emission tomography
inflammation in FDG-PET
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2010-06-09
Enrollment: 178
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects underwent routine health checkups at Korea University Guro Hospital. Patients with DM or gestational diabetes were not included.

Brief summary: Framingham risk score is well known screening tool that detect cardiovascular (CV) risk. But it is not suitable for CV risk in mild risk group. So 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) is a new imaging technique for detecting vascular inflammation within atherosclerotic plaques and hsCRP is also arising detection tool of CV risk.

The investigators are examining this association in normal and impaired glucose tolerance patients groups.

Detailed description: We examined vascular inflammation using FDG-PET scan in 178 subjects (Normal and impaired glucose tolerance groups). Vascular 18F-FDG uptake was measured as both the mean and maximum blood-normalized standardized uptake value (SUV), known as the target-to-background ratio (TBR). And We analyzed that the association with Framingham risk score, hs CRP and vascular inflammation by FDG-PET scan.

Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* a history of cardiovascular disease (myocardial infarction, unstable angina, stroke or cardiovascular revascularization)
* active inflammatory disease, recent active infection
* stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg)
* diabetes mellitus
* systemic disorders such as severe hepatic, renal, and hematologic diseases
* taking drugs known to interfere with vascular inflammation measured by FDG-PET.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea university guro hospital
Study officials:
References:
Clinical trial NCT04150627: Effect of Breathing Maneuvers on Peripheral Glucose Metabolism
Official title: Effect of Breathing Maneuvers on Peripheral Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vagus Nerve Stimulation
Insulin Sensitivity
Deep Breathing Maneuver
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Two important mechanisms play a major role in the pathogenesis of type 2 diabetes: insulin resistance of the target tissues and the impaired insulin secretion from pancreatic β-cells. Postprandial factors (such as insulin) are perceived by the human brain and induce signals that regulate glucose metabolism via the parasympathetic nervous system.

Deep breathing exercise can increase parasympathetic nerve activity. Heart rate variability (HRV) in healthy people can be significantly increased by deep breathing maneuvers, indicating a shift from sympathetic activity to parasympathetic activity.

The hypothesis is that this postprandial shift results in a change in peripheral glucose metabolism. In turn, the increased parasympathetic activity could potentially result in a change in postprandial insulin sensitivity or secretion.

To test this hypothesis, this study investigates the effect of deep breathing exercise versus normal breathing on insulin sensitivity, on insulin secretion, glucose tolerance, resting energy expenditure, and on parasympathetic tone (analysis of heart rate variability).


Eligibility criteria: Inclusion Criteria:

* HbA1c \<6.5%
* Must be able to understand the explanations of the study and the instructions

Exclusion Criteria:

* Any relevant (according to investigator's judgment) cardiovascular disease
* Neurological and psychiatric disorders
* Diabetes mellitus
* Asthma

Primary outcomes:
measure: Whole body insulin sensitivity
timeFrame: 0-120 min
Secondary outcomes:
measure: Insulin secretion
timeFrame: 0-120 min
measure: Glucose tolerance
timeFrame: 0-120 min
measure: Resting energy expenditure
timeFrame: 140-160 min after start of breathing maneuver
measure: Heart rate variability
timeFrame: -35 - 120 min
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tuebingen, Department of Internal Medicine IV
Study officials:
affiliation: University Hospital Tübingen
name: Martin Heni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02164227: Effective Use of Respiratory Patterns in the First Period of Labor in Control of Maternal Anxiety
Official title: EFFECTIVE USE OF RESPIRATORY PATTERNS IN THE FIRST PERIOD OF LABOR IN CONTROL OF MATERNAL ANXIETY: A CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Keywords: anxiety
breathing exercise
labour
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The effectiveness of breathing exercise on anxiety in women during the first period of labor.

Detailed description: The groups will be randomized into intervention groups, which will be held ventilatory patterns while the control group will receive routine care service. The measurements will be made during the admission, and every 2 hours until the final phase of dilation.

Eligibility criteria: Inclusion Criteria:

* Primiparous
* First stage of labor

Exclusion Criteria:

* Multiple gestation;
* Eclampsia;
* Pregnancy with a dead fetus;
* Use of analgesia;
* Pregnant women with clinical instability;
* Psychiatric disorders;

Primary outcomes:
measure: Anxiety
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Maternidade Professor Bandeira Filho
state: Pernambuco
Study officials:
References:
Clinical trial NCT04115527: Should a Standard Lymphadenectomy Include the No. 16 Lymph Nodes for Patients With Pancreatic Head Adenocarcinoma.
Official title: A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: RCT
Standard lymphadenectomy
Extended lymphadenectomy
Pancreaticoduodenectomy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 100
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: The aim of this study is to determine whether para-aortic lymph nodes(No.16) should be included in the lymphadenectomy during the pancreatoduodenectomy in order to improve the long-term survival of patients with pancreatic head ductal adenocarcinoma.

Detailed description: Pancreatic cancer is now raised to the 7th leading cause of death. Surgical resection seems to be the unique curative therapy for pancreatic cancer. The pancreaticoduodenectomy is widely performed for the patients with pancreatic head cancer in recent decades. The lymphadenectomy is an indispensible procedure. In 2014, the International Study Group for Pancreatic Surgery (ISGPS) recommended a standard lymphadenectomy should include lymph node stations 5, 6, 8a, 12b1, 12b2, 12c, 13a, 13b, 14a, 14b, 17a, and 17b. However, no consensus was reached on Lymph node 16 in particular 16b1. There was no stronge evidence available concerning the impact on survival.

Eligibility criteria: Inclusion Criteria:

* Pathologic diagnosis of pancreatic ductal adenocarcinoma
* Signed the informed consents

Exclusion Criteria:

* Pathologic diagnosis of other pancreatic cancers
* Pre-operative anti-cancer treatment
* Recurrence patients
* Patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
* Pre operative exam: Total bilirubin more than 250µmol/L
* AJCC stage IV
* Operation non radical

Primary outcomes:
measure: 1 year overall survival rate
timeFrame: 1 year post-operation
measure: 3 years overall survival rate
timeFrame: 3 years post-operation
measure: 5 years overall survival rate
timeFrame: 5 years post-operation
Secondary outcomes:
measure: Postoperative Complications
timeFrame: Within 90 days or before discharge
measure: 1, 3 & 5 years disease free survival rate
timeFrame: 1, 3 & 5 years post-operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Ruijin Pancreatic Disease Center
name: Jiancheng WANG, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT03431727: Acromegaly - Before and After Treatment
Official title: Sleep Apnea, Circulation and Metabolism in Acromegaly - Before and After Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acromegaly
Growth Hormone Treatment
Sleep Apnea
Cardiovascular Diseases
Bone Diseases
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 20
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: Newly diagnosed acromegalic patients

Brief summary: The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment.

Detailed description: Acromegaly is a rare disease caused by a growth hormone (GH) producing pituitary adenoma. Surgery is primary treatment, whereas medical treatment with a somatostatin analogue (SA), which suppresses GH secretion and reduces tumour size, is used when surgery is insufficient or unfeasible. Acromegaly is associated with metabolic abnormalities which contributes to an increased morbidity and mortality if left untreated. To which extend these abnormalities reverses after treatment, and if treatment modality influences the outcome, remain elusive. The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment

Eligibility criteria: Inclusion Criteria:

* Recently diagnosed with acromegaly
* Age above 18
* Written consent

Exclusion Criteria:

- Pregnancy

Primary outcomes:
measure: Sleep apnea
timeFrame: At baseline (time of diagnosis) and at an average of 1 years treatment
measure: Circulation
timeFrame: At baseline (time of diagnosis) and at an average of 1 years treatment
measure: Bone metabolism
timeFrame: At baseline (time of diagnosis) and at an average of 1 years treatment
Secondary outcomes:
measure: Heartfunction
timeFrame: At baseline (time of diagnosis) and at an average of 1 years treatment
measure: Substrate metabolism; signaling proteins
timeFrame: At baseline (time of diagnosis) and at an average of 1 years treatment
measure: Substrate metabolism; gene targets
timeFrame: At baseline (time of diagnosis) and at an average of 1 years treatment
measure: Energy expenditure
timeFrame: At baseline (time of diagnosis) and at an average of 1 years treatment
measure: Body composition
timeFrame: At baseline (time of diagnosis) and at an average of 1 years treatment
measure: Physical activity
timeFrame: At baseline (time of diagnosis) and at an average of 1 years treatment
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of internal medicine and endocrinologi
Study officials:
affiliation: Aarhus University Hospital, Department of internal medicine and endocrinology
name: Jens Otto L Jørgensen, Porfessor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03582527: PD-L1 Expression in Advanced Osteosarcoma
Official title: The Expression of Programmed Death Ligand-1 (PD-L1) on Advanced Osteosarcoma Tissue and Its Influence on Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Progression
Survival
Keywords: osteosarcoma
refractory to chemotherapy
unresectable
PD-L1
VENTANA PD-L1 (SP263)
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All those advanced osteosarcoma patients who intend to receive anti-PD-1/anti-PD-L1 therapy.

Brief summary: The expression level of PD-L1 on tumor cells is a pivotal point which might have some influence on prognosis, especially for those who might use PD-1 or PD-L1 antibody for treatment. The aim of this study is to detect the expression of PD-1 on advaced osteosarcoma patient who might use these antibodies for treatment. All those specimen should be taken by pathologist and confirmed with high tumor cellularity.


Eligibility criteria: Inclusion Criteria:

* diagnosis confirmed histologically and reviewed centrally;
* received surgery in Musculoskeletal Tumor Center of Peking University People's Hospital with appropriate sample for immunohistochemical staining;
* progressing upon prior treatment (completed \>4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high-dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);
* having measurable lesion according to RECIST 1.1;
* Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy \>3 months;
* intend to receive anti-PD-1/anti-PD-L1 antibody for therapy.

Exclusion Criteria:

* fail to be followed up regularly.
* sample disqualification.

Primary outcomes:
measure: PD-L1 expression level
timeFrame: 2 months
Secondary outcomes:
measure: progression free survival
timeFrame: 2 years
measure: overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Musculoskeletal Tumor Center of Peking University People's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01674127: Effect of Methyldopa on Uterine Artery Diameter in Pregnant Women With Mild Preeclampsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pregnant Women With Mild Preeclampsia
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-08-28
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study examined the effects of Methyldopa on uterine artery diameter, uterine artery blood flow, umbilical artery and fetal middle-cerebral artery in patients with Preeclampsia, using Doppler ultrasound.


Eligibility criteria: They met the inclusion criteria, If they had over 25 weeks of gestational age, no history of chronic hypertension, no diabetes mellitus, no chronic systemic diseases, no collagen vascular diseases and antiphospholipid syndromes, no use of antihypertensive drugs and BMI higher than 19 and lower than 30 (kg/m2).

Primary outcomes:
measure: Doppler indices
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04427527: Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia
Official title: Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia (ACCSIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Ohio State University
First posted: 2020-06-11
Enrollment: 5413
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Primary care clinics randomized to intervention or usual care
Primary purpose: SCREENING

Brief summary: This project aims to implement a multi-level group randomized trial, delayed intervention that includes components targeting clinics, providers, patients, and the community to increase colorectal cancer (CRC) screening, follow-up, and referral-to-care among patients age 50-74 in 12 counties in Appalachian Kentucky and Ohio. The 12 counties will be assigned to one of two study groups (early vs. delayed) and outcome measures (rate of CRC screening) will be obtained from clinic-level electronic health record data and a county-level behavioral assessment telephone survey. The hypothesis for the project is that the multi-level intervention will increase the clinic and county level CRC screening rates.


Eligibility criteria: Inclusion Criteria:

* age 50-74
* all races, sexes and genders
* resident of the study area

Exclusion Criteria:

.no exclusions based on gender, race or ethnicity

Primary outcomes:
measure: CRC screening - clinic level
timeFrame: 12 months
Secondary outcomes:
measure: CRC screening - community level
timeFrame: 12 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Markey Cancer Center
state: Kentucky
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: University of Kentucky
name: Mark B Dignan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kruse-Diehr AJ, Oliveri JM, Vanderpool RC, Katz ML, Reiter PL, Gray DM 2nd, Pennell ML, Young GS, Huang B, Fickle D, Cromo M, Rogers M, Gross D, Gibson A, Jellison J, Sarap MD, Bivens TA, McGuire TD, McAlearney AS, Huerta TR, Rahurkar S, Paskett ED, Dignan M. Development of a multilevel intervention to increase colorectal cancer screening in Appalachia. Implement Sci Commun. 2021 May 19;2(1):51. doi: 10.1186/s43058-021-00151-8.
Clinical trial NCT02638727: Assessment of Short-term Effect of L-Citrulline on Endothelial Function and Vasodilation in Known CAD Patients
Official title: Assessment of Short-term Effect of L-Citrulline on Endothelial Function and Vasodilation in Known CAD Patients:A Randomized Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vascular Disease
Keywords: vascular disease
endothelial function
L-Citrulline
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of oral L-Citrulline on endothelial function and vasodilation in patients with coronary artery disease(CAD) by evaluating the brachial artery diameter in the antecubital area by ultrasonography.

Detailed description: Before prescribing the drug or placebo, the patients were evaluated via the ultrasound machine equipped. The brachial artery diameter in the antecubital area was measured by the ultrasound and was recorded. Then blood pressure cuff was attached on the arm and dilated 50mmhg above the systolic pressure and for 5 minutes remained the same level to induce ischemia at distal tissues until the occurrence of compensatory vasodilatation. Then the brachial artery diameter (as an estimation of FMD) was measured and recorded. After 4 minutes of administration of 2 puffs of nitroglycerin spray, the brachial artery diameter (as an estimation of NMD) was measured.

After 15 days treatment with the L-Citrulline or the placebo, the patients underwent the ultrasonography again and the above assessments were done.

Improvement of FMD to NMD ratio (before L-Citrulline prescription) to FMD to NMD ratio (after L-Citrulline prescription) is determined as "improvement of flow mediated dilation to nitroglycerin dependent vasodilation" evaluate.

Eligibility criteria: Inclusion Criteria:

* history of documented CAD; flow mediated dilation to nitroglycerin dependent vasodilation (FMD/NMD)ratio less than 1

Exclusion Criteria:

* no documented CAD; flow mediated dilation to nitroglycerin dependent vasodilation (FMD/NMD)ratio equal /more than 1

Primary outcomes:
measure: improvement of flow mediated dilation to nitroglycerin dependent vasodilation
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Modaress Hospital , Tehran, Iran
Study officials:
affiliation: Cardiovascular Research Center
name: Morteza Safi, MD
role: STUDY_DIRECTOR
References: