louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03111797: Robot-assisted Lobectomy Versus Video-assisted Lobectomy
Official title: Robot-assisted Lobectomy Versus Video-assisted Lobectomy : a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Robotic Surgical Procedures
Pneumonectomy; Status
Anesthesia and Analgesia
Cardiac Output
Lead sponsor: Hospital Nord
Sponsor class: OTHER
Collaborators: name: Gary DUCLOS (Medical Doctor, investigator)
First posted: 2017-04-13
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: NON_PROBABILITY_SAMPLE
Study population: All patients needing a lung lobectomy surgery for an early stage cancer in our center during the period of inclusion.

Brief summary: This prospective and observational cohort studies the morphine consumption difference during the first 48 hours after a lung lobectomy between patients operated with a robot assisted or a video-assisted technique for a lung cancer lobectomy.

Second outcome was to search eventual cardiac output difference during the surgery in 100 patients (50 in each group) using a non invasive monitoring device of cardiac output

All patients operated between january 2016 and March 2017 for a lung cancer lobectomy were included.


Eligibility criteria: Inclusion Criteria:

* Volunteers
* Mono lobectomy of lung for early stage cancer (T2Nx and earlier)
* Video or robot assisted procedure

Exclusion Criteria:

* Advanced stage of cancer (T3Nx and greater)
* Need of thoracotomy conversion during procedure
* Morphine intolerance or addiction.

Primary outcomes:
measure: Morphine consumption
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: cardiac output
timeFrame: during 30 minutes after incision and optic introduction
Other outcomes:
Locations:
city: Marseille
country: France
facility: Departement anesthesie reanimation hopital nord
Study officials:
References:
Clinical trial NCT01472497: Effects of Pioglitazone in Hypertensive Patients
Official title: Effects of Pioglitazone and Glimepiride in Hypertensive Patients - Relationship With AGE, Inflammatory Cytokines and Cardiac Markers -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Insulin Resistance
Keywords: hypertension
insulin resistance
oral glucose tolerance test
AGE
inflammatory cytokine
Lead sponsor: Tottori University Hospital
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Insulin resistance is often complicated with hypertension. AGE and inflammation play important roles in insulin resistance. Some studies reported that pioglitazone, insulin sensitizer, is effective for patients with insulin resistance, however, the mechanisms are still unclear. The aim of this study to evaluate the effect of pioglitazone compared with glimepiride on AGE, inflammatory cytokines and cardiac markers (BNP and echo) in hypertensive patients during oral glucose tolerance test.


Eligibility criteria: Inclusion Criteria:

* Hypertension with insulin resistance

Exclusion Criteria:

* Chronic systolic heart failure, ACS

Primary outcomes:
measure: advanced glycation end-product (AGE)
timeFrame: 24 weeks
measure: inflammatory cytokines (TNF-alfa, IL-6 and MCP-1)
timeFrame: 24 weeks
measure: cardiac function (echo and BNP)
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yonago
country: Japan
facility: Tottori University Hospital
Study officials:
affiliation: Tottori University Hospital
name: Kazuhide Ogino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06112197: Study of Visceral Fat in type2diabetic Patients and Its Relation to Microvascular Complications
Official title: Study of Visceral Fat in Type 2diabetic Patients and Its Relation to Microvascular Complications
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Visceral Fat
Insulin Resistance
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of T2DM, either newly diagnosed or previously diagnosed and on treatment with antidiabetic oral hypoglycemic agents or insulin and attending diabetes OPD or admitted to the Medicine Department, were taken as cases. Age- and gender-matched nondiabetic people admitted to the Medicine Department were taken as control subjects. Both these groups will be interviewed, examined, investigated, and included in the study.

Brief summary: Study the correlation between METS IR and visceral fat in type 2 diabetes and its relation to microvascular complication

Detailed description: The Metabolic Score for Insulin Resistance (METS-IR) is a metabolic index developed with the aim to quantify peripheral insulin sensitivity in humans; it was first described under the name METS-IR by Bello-Chavolla et al in 2018. It was developed by the Metabolic Research Disease Unit at the Institute National de Ciencias Médicas Salvador Zubirán and validated against the euglycemic hyperinsulinemic clamp and the frequently-sampled intravenous glucose tolerance test in Mexican population.It is a non-insulin-based alternative to insulin-based methods to quantify peripheral insulin sensitivity and an alternative to the Homeostatic Model Assessment (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI).

Very limited research correlate between visceral obesity and microvascular complications in type 2 diabetic patients and how can the metabolic score for insulin resistance predict visceral obesity and microvascular complications in type2 diabetic patients. In this study the investigators will search for these correlations.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years Both male and female subjects Subjects capable of giving consent and voluntarily willing to participate in the study

Exclusion Criteria:

* Chronic kidney disease patients Any nondiabetic nephropathy patients Patients affected by hypertension Patients affected by ocular disorders Neuropathies of other etiologies like chronic liver disease patients, alcoholics, or drug addicts Critically ill patients of type 2 diabetes mellitus Patients who have not given consent

Primary outcomes:
measure: correlation between METS IR and visceral fat in type 2 diabetes
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Mahmoud Soliman
Study officials:
affiliation: Sohag University
name: mahmoud soliman
role: STUDY_DIRECTOR
References:
Clinical trial NCT04392297: Clinical and Immunological Features of the CMV Infection Atypical Course in Immunocompetent Individuals
Official title: To Identify the Clinical and Immunological Features of the CMV Infection Atypical Course in Immunocompetent Individuals and to Develop Methods for the Diagnosis and Treatment of Patients in This Category
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CMV
Keywords: Cytomegalovirus
Lead sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology
Sponsor class: OTHER
Collaborators: name: Belarusian State Medical University
First posted: 2020-05-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CMV infection

Brief summary: Current study evaluates possible correlations between the content of various cell populations, the genetic material of the virus and antibodies to it in the blood of patients and the risk of thrombosis development in patients with acute CMV infection.

А new method for the early detection of immunological and clinical signs of thromboembolic complications of CMV infection in immunocompetent individuals and the treatment of patients in this category will be developed.

Detailed description: * evaluate the immune status main indicators that characterize the activation of immune system, immunosuppression and anergy (myeloid suppressor cells, T-regulatory cells, T-cells according to the stages of differentiation (naive - effector - memory), activated T-cells);
* identify and characterize immunological disorders in patients with CMV infection complicated by thromboembolism of various localization;
* determine the presence and quantitative content in plasma / serum and neutrophils of the CMV genetic material by real-time PCR;
* study humoral immunity to CMV (IgM / IgG antibodies to CMV in serum);
* determine the content of CMV specific T-cells in peripheral blood;
* develop a method for the early detection of immunological and clinical signs of thromboembolic complications of CMV infection in immunocompetent persons and treatment of patients in this category.

Eligibility criteria: Inclusion Criteria:

* age 18 - 80 years;
* fever of not clear etiology
* confirmed CMV infection

Exclusion Criteria:

* HIV infection
* taking hormones, cytostatics;
* drug addiction
* malignant neoplasms over the past 5 years.
* active viral hepatitis or liver cirrhosis;
* immunosuppressive conditions of any etiology

Primary outcomes:
measure: Number of patients with thrombosis
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: The Republican Research and Practical Center for Epidemiology and Microbiology
Study officials:
affiliation: Head of the laboratory, RSPCEM
name: Elena Fomina, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00682097: A Multiple Ascending Dose Study of RO4998452 in Patients With Type 2 Diabetes Mellitus.
Official title: A Randomized, Double-Blind, Multiple-Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO4998452 Following Oral Administrations in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-05-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Successive cohorts of patients will be randomized to receive either active drug, at escalating doses, or placebo. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-65 years of age;
* type 2 diabetes;
* either treated by diet and exercise alone or with metformin.

Exclusion Criteria:

* type 1 diabetes mellitus;
* uncontrolled hypertension;
* clinically severe diabetic complications.

Primary outcomes:
measure: AEs, laboratory parameters, vital signs.
timeFrame: Throughout study
measure: AUC0-24h, Cmax
timeFrame: Days 1 and 14
Secondary outcomes:
measure: Parameters of glucose metabolism
timeFrame: Throughout study
Other outcomes:
Locations:
city: Chula Vista
country: United States
state: California
city: San Antonio
country: United States
state: Texas
city: Neuss
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01338597: Impact of Dissection Area on the Clinical Outcome of Endoscopic Thyroidectomy
Official title: Clinical Benefits of Reduced Subcutaneous Dissection in Endoscopic Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Tumor
Keywords: thyroidectomy
invasiveness
Lead sponsor: Second Military Medical University
Sponsor class: OTHER
First posted: 2011-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether reduced subcutaneous dissection area could offer patients more clinical benefits.

Detailed description: To create a working place in the chest wall is an inevitable step of endoscopic thyroidectomy. Large subcutaneous area was considered a drawback of endoscopic thyroidectomy. The purpose of this study is to investigate whether subcutaneous dissection area has influence on clinical outcome of endoscopic thyroidectomy, such as post-operative pain, complication rate and post-operative discomfort.

Eligibility criteria: Inclusion Criteria:

* thyroid nodule diagnosed by ultrasound
* willing to undergo endoscopic thyroidectomy

Exclusion Criteria:

* conversion to open surgery
* unwilling to join the research

Primary outcomes:
measure: post-operative pain
timeFrame: 24h post-operation
Secondary outcomes:
measure: number of patients with adverse effect
timeFrame: within 3 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of General Surgery, Changzheng Hospital
state: Shanghai
Study officials:
affiliation: Changzheng Hospital
name: ming qiu, MD
role: STUDY_CHAIR
References:
citation: Wang M, Zhang T, Mao Z, Dong F, Li J, Lu A, Hu W, Zang L, Jiang Y, Zheng M. Effect of endoscopic thyroidectomy via anterior chest wall approach on treatment of benign thyroid tumors. J Laparoendosc Adv Surg Tech A. 2009 Apr;19(2):149-52. doi: 10.1089/lap.2008.0296.
Clinical trial NCT00818597: Extracorporeal Immune Support System (EISS) for the Treatment of Septic Patients
Official title: PhaseI/II Study of the Safety and Efficacy of the Use of Granulocyte-Concentrates Applied in Extracorporeal Circulation Devices-the EISS-1 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Severe Sepsis and Septic Shock
Keywords: septic shock
immunoparalysis
extracorporeal
granulocyte bioreactor
plasmapheresis
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2009-01-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
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 investigate the effect of an extracorporeal application of a bed-side bioreactor containing human donor granulocytes on the course and outcome of septic shock in humans.


Eligibility criteria: Inclusion Criteria:

* sepsis with at least one organ failure (severe sepsis) or septic shock

Exclusion Criteria:

* Participation in another study within the last 30 days
* Earlier participation in this study
* Pregnancy
* Bleeding, clinically not controlled (needing more than 2 red blood cell-transfusions per day)
* Hemodynamic shock for more than 12 hours (systolic BP \<90mmHg) despite adequate therapy
* HIV infection
* HCV infection, active

Primary outcomes:
measure: single organ functions (circulation, kidney, lung, liver)
timeFrame: 28day post inclusion
Secondary outcomes:
measure: survival
timeFrame: 28day post inclusion
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University of Rostock, Department of Medicine, Division of Nephrology
Study officials:
References:
citation: Mitzner SR, Freytag J, Sauer M, Kleinfeldt T, Altrichter J, Klohr S, Koball S, Stange J, Ringel B, Nebe B, Schmidt H, Podbielski A, Noeldge-Schomburg G, Schmidt R. Use of human preconditioned phagocytes for extracorporeal immune support: introduction of a concept. Ther Apher. 2001 Oct;5(5):423-32. doi: 10.1046/j.1526-0968.2001.00378.x.
citation: Sauer M, Altrichter J, Kreutzer HJ, Logters T, Scholz M, Noldge-Schomburg G, Schmidt R, Mitzner SR. Extracorporeal cell therapy with granulocytes in a pig model of Gram-positive sepsis. Crit Care Med. 2009 Feb;37(2):606-13. doi: 10.1097/CCM.0b013e318194aa77.
citation: Altrichter J, Sauer M, Kaftan K, Birken T, Gloger D, Gloger M, Henschel J, Hickstein H, Klar E, Koball S, Pertschy A, Noldge-Schomburg G, Vagts DA, Mitzner SR. Extracorporeal cell therapy of septic shock patients with donor granulocytes: a pilot study. Crit Care. 2011;15(2):R82. doi: 10.1186/cc10076. Epub 2011 Mar 3.
Clinical trial NCT05307497: An Exploration of Antenatal Hand Expression.
Official title: An Exploration of Mother's Experiences of Antenatal Hand Expression of Colostrum, and the Effects Upon Breastfeeding Continuation and Maternal Emotional Health.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Feeding; Difficult, Newborn
Lead sponsor: University of Liverpool
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with experience of antenatal hand expression

Brief summary: The study is an exploration of mother's experiences of antenatal hand expression of colostrum, and the effects upon breastfeeding continuation and maternal emotional health

Detailed description: Second-line feeding strategies including hand expression and syringe feeding are used as an aid to breastfeeding, however little is known about their efficacy. This research explores the experiences of women who have used antenatal hand expression to identify how it affects maternal emotional health and breastfeeding continuation. UK women with recent experience of the practice were interviewed and the data analysed using thematic analysis. The results identified five themes in relation to these experiences including; The emotional distress of struggling with breastfeeding, Support as panacea but inconsistent, A crisis of confidence, Discord between knowledge, expectations and reality, and Syringe feeding as challenging but constructive. The study concludes that hand expression and syringe feeding supports women to establish breastfeeding, however, those struggling with breastfeeding need extra practical and emotional support to protect breastfeeding self-efficacy, emotional health and breastfeeding continuation. The findings highlight the importance of realistic, antenatal breastfeeding education to achieve this. Further research into second-line strategies and antenatal education programmes could contribute to the improvement of women's infant feeding experiences and improve UK breastfeeding rates.

Eligibility criteria: Inclusion Criteria:

* Women over the age of 18,
* Women with experience of antenatal hand expression within the last three months,
* Women with a good grasp of the English language.

Exclusion Criteria:

* Mothers of babies born before 37 weeks or with a medical issue (eg. tongue tie),
* Women with a mental health diagnosis

Primary outcomes:
measure: Semi-structured interview
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: University of Liverpool
state: Merseyside
Study officials:
References:
Clinical trial NCT05689697: Induced Physiological Ketosis in Asthenia and\or Decreased Tolerance to Physical and\or Mental Exertion
Official title: Efficacy of Physiological Ketosis Induced by Liquid Technology Formula PanTrek in Asthenia and\or Decreased Tolerance to Physical and\or Mental Exertion (Double-blind, Placebo-controlled Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Activation
Keywords: Physiological Ketosis
PanTrek
Asthenia
Physical functioning
Mental functioning
beta-oxibutiric acid
Lead sponsor: Ketonic Pharm LLC
Sponsor class: INDUSTRY
First posted: 2023-01-19
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is evaluating of efficacy of innovative dietary strategy -stimulation of physiological ketosis with Liquid Technology Formula PanTrek, in patients with asthenia and or decreased tolerance to physical and\\or mental exertion. PanTrek is a liquid formula of potassium and magnesium salts of beta-oxibutiric acid, ginsenosides and rosmarinic acid.

Detailed description: It will be double-blind, placebo-controlled study in 88 patients of both sex, aged from 18 to 65. Patients will be randomly assigned to one of two groups: placebo or IP group in 1:1 proportion. Study instruments: D-Fis, MoCA, TMT, VAS, assessment of blood keton concentration before and after first and last administration per os of 25 ml of placebo or PanTrek. PanTrek will be served in ampuls, 25 ml per ampule.

The duration of the study will be 15 days of treatment and 15 days of follow-up observation.

Patients will be assessed at screening/baseline, after 15 days and after 30 days.

The dose regimen: the shot of PanTrek, 25 ml, will be administered per os, twice per day, in the morning and in the evening, per se or deluted in 100 ml of water one hour before or after meal.

Eligibility criteria: Inclusion Criteria:

* informed consent
* diagnosis of astenia and/or decreased tolerance to physical and\\or mental exertion
* ability of patients to understand assessment procedures

Exclusion Criteria:

* intollerance of components of PanTrek
* participation in other trials

Primary outcomes:
measure: Primary outcome
timeFrame: 15 days
Secondary outcomes:
measure: indused ketosis
timeFrame: 15 days
Other outcomes:
measure: Improvement in cognitive function
timeFrame: 15 days
measure: Improvement in visual attention and task switching.
timeFrame: 15 days
measure: Improvement in physical function
timeFrame: 15 days
measure: Safety profile in active and follow-up period
timeFrame: 30 days
Locations:
city: Moscow
country: Russian Federation
facility: Laboratory of psychopharmacology Research center of mental health
Study officials:
affiliation: Mental health research center
name: Denis Burminskiy, MD, PhD
role: STUDY_DIRECTOR
References: