louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00335907: Protocol-driven Hemodynamic Support for Patients With Septic Shock
Official title: Protocol-driven Hemodynamic Support for Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shock, Septic
Severe Sepsis
Sepsis
Keywords: Clinical trial
Controlled clinical trial
Shock, Septic
Lead sponsor: National Institute of General Medical Sciences (NIGMS)
Sponsor class: NIH
First posted: 2006-06-12
Enrollment: 70
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 research is being done to see if a protocol (a set of orders that determine how much and how quickly a drug/fluid is given) for fluid and drugs used to increase blood pressure (vasopressors) will work better then general clinical practices to improve outcomes in patients with septic shock.

Detailed description: Septic shock is low blood pressure caused by an infection. Sepsis is the most common cause of death in non-cardiac intensive care units, and septic shock is the most severe form of sepsis. Treatment for septic shock includes giving antibiotics, intravenous fluids, and medications to raise the blood pressure (vasopressors).

We would like to see if a protocol-driven management strategy for septic shock can shorten time on vasopressors and limit the number of side effects. We have constructed a protocol that will allow the nurse at the bedside, in conjunction with the physician's orders, to adjust the amount of fluids and medications that raise the blood pressure (vasopressors).

Eligibility criteria: Inclusion Criteria:

* ACCP/SCCM sepsis criteria
* Need for institution of vasopressors after adequate volume resuscitation

Exclusion Criteria:

* Age\< 18
* On vasopressors for \> 24 hours prior to ICU admission
* Other cause for shock ( cardiac tamponade, massive pulmonary embolus, cardiogenic shock)
* Physicians and family not committed to aggressive medical therapy ( a patient will not be excluded if he/she would receive all care except for attempts at resuscitation from cardiac arrest)

Primary outcomes:
measure: Length of vasopressor treatment
timeFrame: within 90 days
Secondary outcomes:
measure: Total number of vials vasopressors administered
timeFrame: Within 90 days
measure: Time on more than single vasopressor
timeFrame: Within 90 days
measure: Volume of intravenous fluids administered in first 7 days
timeFrame: 7 days
measure: Number of organ failures
timeFrame: Within 90 days
measure: ICU mortality rates
timeFrame: Within 90 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jonathan E Sevransky, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03442907: Personalized Blood Pressure Management
Official title: Intraoperative Blood Pressure Management Based on the Individual Blood Pressure Profile: Impact on Postoperative Organ Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Intraoperative Hypotension
Postoperative Complications
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 368
Sex: ALL
Minimum age (years): 50
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this research project is to find out whether a personalized definition of the lower blood pressure threshold based on the individual blood pressure profile by means of preoperative 24-hour blood pressure measurement can reduce organ damage (brain, kidney, heart) through reduced blood flow during surgery.


Eligibility criteria: Inclusion Criteria

* age ≥ 50 years
* ASA II-IV (Classification of the American Society of Anesthesiologists for the assessment of the perioperative risk depending on the underlying diseases)
* duration of intervention in general anesthesia at least 90 minutes

Exclusion Criteria:

* Pregnancy
* Emergency procedures
* Surgery requiring controlled hypotension (e.g., aneurysm)
* Cerebrovascular events in the past medical history
* Patients of cardiac surgery, vascular surgery, neurosurgery, and transplantation surgery
* Pre-existing dementia (anamnesis)
* kidney transplant
* dialysis-dependent renal insufficiency (KDIGO criteria)
* no patient consent
* failure to meet the inclusion criteria
* Impossibility of 24-h blood pressure measurement

Primary outcomes:
measure: Composite endpoint: Incidence of POCD or delirium
timeFrame: 3rd-7th postoperative day
Secondary outcomes:
measure: Kidney function
timeFrame: 24, 48 and 72 hrs after surgery
measure: cardiac ischemia
timeFrame: 6 hours after surgery
measure: length of hospital stay
timeFrame: 30 days
measure: 30-day mortality
timeFrame: 30 days
measure: 30-day morbidity
timeFrame: 30 days
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf
Study officials:
References:
Clinical trial NCT00243607: Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors
Official title: Prospective Randomized Feasibility Study on the Self Application of Hydrotherapy to Treat Menopausal Symptoms Caused by Breast Cancer Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amenorrhea
Hot Flashes
Keywords: climacteric symptoms
breast cancer
hydrotherapy
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
First posted: 2005-10-24
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast cancer survivors often suffer from climacteric symptoms caused by treatment or diagnosis of their disease.

Hormone replacement therapy is contraindicated and other pharmacological options may also include the risk of stimulating hormone receptors. Hydrotherapy following the guidelines of naturopathy by S. Kneipp is a non-pharmacological treatment option which may influence climacteric symptoms by affecting the regulation of body temperature. In this study, the regular self application of hydrotherapy after initial training by a professional will be evaluated for its efficacy, practicability, and compatibility.

Detailed description: Patients should use 2-5 different treatment options per day and fulfill a diary for symptoms and adherence to self-treatment for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Breast cancer diagnosis
* Menopausal complaints score \> 14 (MRS II)
* End of last chemotherapy or radiotherapy \> 2 months
* Expected stable disease for the next 6 months

Exclusion Criteria:

* Regular intake of glucocorticoids
* Regular practice of hydrotherapy before inclusion
* Start or change of other treatments/changes of lifestyle in order to influence menopausal symptoms
* Psychiatric disorders with possible influence on compliance and adherence to the protocol
* Other severe or progressive diseases with influence on compliance and adherence to the protocol
* Contraindications to hydrotherapy (severe heart failure, relevant dermatological diseases, Raynaud's Phenomenon \[M. Raynaud\], peripheral arterial occlusive disease Fontaine stage IIb \[VK IIb\] or more, acute thrombosis, or thrombophlebitis)

Primary outcomes:
measure: Menopausal complaints (MRS II)
timeFrame: 12 and 24 weeks
Secondary outcomes:
measure: Cortisol profile (saliva)
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Ambulanz für Naturheilkunde und Integrative Medizin
state: Baden-Württemberg
Study officials:
affiliation: Abt. für Naturheilkunde, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Immanual-Krankenhaus
name: Bernhard Uehleke, Dr.med. Dr.rer.nat. (PhD)
role: STUDY_CHAIR
References:
Clinical trial NCT06075407: Evaluation of Fluid Resuscitation in Shocked Patients by Electrical Cardiometry in Comparison to Transthoracic Echocardiography.
Official title: Evaluation of Fluid Resuscitation in Shocked Patients by Electrical Cardiometry in Comparison to Transthoracic Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Resuscitation
Electrical Cardiometry
Transthoracic Echocardiography
Shock
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged from 25 to 55 years old were intubated, with clinical criteria of shock (mean arterial pressure (MAP) ≤ 65 mmHg).

Brief summary: The aim of this study is to evaluate the diagnostic accuracy of electrical cardiometry (EC) for the noninvasive determination of fluid responsiveness in critically ill shocked patients and agreement of EC compared to transthoracic echocardiography (TTE)

Detailed description: Electrical cardiometry (EC), based on thoracic electrical bioimpedance, can measure SV continuously and non-invasively. The EC"s working principle of estimation of SV is to utilize changes in thoracic electrical impedance, which is mainly influenced by erythrocyte orientation and peak flow velocity in the ascending aorta throughout the cardiac cycle.

Electrical cardiometry (EC) has been validated to monitor SV and other hemodynamic parameters non-invasively compared to different techniques such as thermodilution technique, transesophageal Doppler echocardiography and cardiac catheterization including critically ill patients, intra-operative settings, in pregnant women, in children with congenital heart diseases, even in obese children

Eligibility criteria: Inclusion Criteria:

* Age from 25 to 65 years old.
* Both sexes.
* Patients with clinical criteria of shock \[mean arterial pressure (MAP) ≤ 65 mmHg and tissue hypoperfusion (ScvO2 \<70%, P(cv-a) CO2 ≥6 mmHg, CRT ≥4 s and lactate \>2mmol/l).

Exclusion Criteria:

* Refusal to sign the consent by a first degree relative.
* Previous cardiac disease, rhythm other than sinus rhythm or heart rate \> 140 beat/min.
* Renal failure (acute or chronic).

Primary outcomes:
measure: Diagnostic accuracy of Electrical cardiometry (EC) to predict fluid responsiveness
timeFrame: Intraoperative and every 30 minutes till MAP>65mmHg
Secondary outcomes:
measure: Agreement of Electrical cardiometry(EC) with Transthoracic echocardiography (TTE) in the change of stroke volume before and after fluid challenge
timeFrame: Intraoperatively.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University
Study officials:
References:
Clinical trial NCT05236907: The Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia
Official title: The Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium, Anesthesia Emergence
Delirium
Keywords: Delirium
melatonin
patients
surgery
postoperative
benzodiazepines
orthopedic
preoperatively
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were divided into three groups at random, with 12 patients in each group, using a double-blinded method.
Primary purpose: PREVENTION

Brief summary: Postoperative delirium is a complication that should not be underestimated. As it elaborates many complications that could be avoided when an accurate assessment of the risk factors and interventional measures are taken appropriately when needed.

Detailed description: Delirium is a variation in concentration capabilities that occurs acutely in association with a disturbed level of consciousness. Delirium is more common in orthopaedic surgery patients than in general surgery patients. As delirium ratios range from 44% to 55% in hip surgery patients, otherwise only 10%-14% of general surgery patients. Several studies were carried out and found that melatonin levels correlate with the development of delirium postoperatively. This study was conducted to determine the efficacy of administering melatonin preoperatively in patients undergoing orthopedic surgery to prevent postoperative delirium.

Eligibility criteria: Inclusion Criteria:

1- Patients in good general health. 2. Baseline MDAS \<13. 3. No seizure disorder.

Exclusion Criteria:

1. Patients with a neurological disorder (e.g., dementia, stroke, epilepsy).
2. Patients with a history of acute or chronic confusion.
3. Patients taking centrally acting drugs (e.g., antidepressants, antiparkinsonian drugs, sedatives, monoamine oxidase inhibitors), or alcohol abusers.
4. Patients who have medical disorders predisposing to delirium (e.g. cachexia, thyroid dysfunction, renal failure).

Primary outcomes:
measure: The efficacy of oral Melatonin in preventing Postoperative Delirium after general anesthesia
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Al-Kadhemya Private Hospital
city: Baghdad
country: Iraq
facility: Ghazi Al-Hariri Teaching Hospital
Study officials:
References:
Clinical trial NCT03454607: Foot Controlled Robotic Endoscope Enabled Robot FESS
Official title: Safety and Feasibility Study of the Foot Controlled Robotic Endoscope Enabled Robot (FREE) in Functional Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sinusitis
Polyp of Nasal Sinus
Keywords: FREE
Robotic
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate the safety and feasibility of a Foot Controlled Robotic Endoscope Enabled Robot (FREE) in performing functional endoscopic sinus surgery to answer the two key questions:

1. Is the FREE robot feasible to use in patients for endoscopic sinus surgery?
2. Is the FREE robot safe to use in patients for endoscopic sinus surgery?

Detailed description: Through previous cadaver experiments we have demonstrated and experimentally validated a new foot-controlled robotic endoscope holder prototype that allows the surgeon to directly manipulate surgical instruments with both hands at all times. The conducted ex-vivo cadaver test, corroborated the feasibility of the robotic prototype. However the next step requires further clinical trials to evaluate its use in endoscopic sinus surgery in patients that is the purpose of this study

Eligibility criteria: Inclusion Criteria:

* Undergoing FESS surgery for benign pathology

Exclusion Criteria:

* Pregnant/ lactating female patients
* Younger than 18 years of age
* Cognitive impairment or unable to provide informed consent
* Malignant sinus pathologies
* Previous endoscopic sinus surgery
* Contraindication to general anaesthesia
* Untreated active infection
* Non-correctable coagulopathy
* Emergency Surgery

Primary outcomes:
measure: Conversion
timeFrame: Intraoperative
measure: Perioperative complications
timeFrame: Within 30 days postoperative
Secondary outcomes:
measure: Surgical outcomes
timeFrame: Intraoperative and postoperative 2 weeks and 30 days
measure: Surgical outcomes
timeFrame: Intraoperative and postoperative 2 weeks and 30 days
measure: Surgical Outcomes
timeFrame: Intraoperative and postoperative 2 weeks and 30 days
measure: Quality of life
timeFrame: Within 30 days postoperative
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT00770107: Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure
Official title: Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure on Long-term Treatment With Diuretic Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2008-10-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Working Hypothesis: a treatment with thiamine improves functional status and heart function of patients with congestive heart failure when on a diuretic treatment.

Detailed description: In the treatment of congestive heart failure, diuretic drugs have become a firm cornerstone of therapy. Up to 50% of patients with congestive heart failure in industrialized nations will undergo long-term diuretic treatment. Diuretic therapy is associated with a loss of water soluble vitamins, including vitamin B1 (thiamine). Electrolyte dysbalance, a major side effect of diuretic therapy, has been extensively studied. In sharp contrast, only few data are available about the effects of vitamin loss and in particular of thiamine in this setting. Available data suggest that a diuretic treatment is associated with an increased risk for thiamine deficiency. Thiamine plays a crucial role for normal cardiac function, since severe thiamine deficiency leads to congestive heart failure (wet beriberi). Consequently, patients undergoing diuretic treatment might have compromised heart function. Supplementation of thiamine has been reported to improve cardiac function in patients with congestive heart failure on long-term treatment with diuretic drugs. However, no efforts have been made to confirm those preliminary observations by a placebo-controlled, double-blind study.

Eligibility criteria: Inclusion Criteria:

* Patients with stable congestive heart failure on a prescription for diuretic drugs

Exclusion Criteria:

* Acute heart failure
* Foreseeable need for further changes in medication
* Current medication containing vitamins
* Patients with a creatinine above 250 μmol/l

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: One day, one week, two weeks, four weeks
Secondary outcomes:
measure: Quality of life
timeFrame: One day, one week, two week, four weeks
measure: 6-minutes walking test
timeFrame: One day, one week, two weeks, four weeks
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
Study officials:
References:
citation: Schoenenberger AW, Schoenenberger-Berzins R, der Maur CA, Suter PM, Vergopoulos A, Erne P. Thiamine supplementation in symptomatic chronic heart failure: a randomized, double-blind, placebo-controlled, cross-over pilot study. Clin Res Cardiol. 2012 Mar;101(3):159-64. doi: 10.1007/s00392-011-0376-2. Epub 2011 Nov 5.
Clinical trial NCT05248607: Lived Experience of Overweight/Obese Patients Who Have Benefited From a Mindful Eating Program.
Official title: Evaluation of the Lived Experience of Overweight/Obese Patients Who Have Benefited From a Mindful Eating Program at Montpellier University Hospital by Semi-structured Face-to-face Interviews.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overweight or Obesity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited among people who have consulted a doctor in the Nutrition-Diabetes service for overweight/obesity (BMI 25-39.9 kg/m²) and who have followed a mindful eating program led by Béatrix Toto within the service. Each program has 12 participants (2 sessions per year).

Brief summary: The main objective is to understand the lived experience of overweight/obese patients who have followed the mindful eating program at Montpellier University Hospital. Semi-structured face-to-face interviews will be conducted in the Nutrition-Diabetes service by using a questionnaire.


Eligibility criteria: Inclusion criteria:

- People who have attended at least 6 out of 8 sessions of the mindful program

Exclusion criteria:

* People who have attended less than 6 sessions of the program.
* Declining participation

Primary outcomes:
measure: Number of participants with the lived experience
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Marion Van Beekum, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02674607: the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children
Official title: the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beta Thalassemia Major
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the possible immunologic effects of spirulina in children with beta thalassemia.


Eligibility criteria: Inclusion Criteria:

* children with thalassemia major

Exclusion Criteria:

* children with other chronic hemolytic anemias

Primary outcomes:
measure: cluster of differentiation (CD4/CD25) ratio
timeFrame: 3 months
measure: cluster of differentiation (CD33/CD11b/Lin) ratio
timeFrame: 3 months
measure: serum immunoglobulins levels
timeFrame: 3 months
measure: serum levels of interferon gamma
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine- Tanta University
state: Gharbia
Study officials:
affiliation: professor of pediatrics- head of hematooncology unit of pediatric department- Tanta University
name: Mohamed R El-Shanshory, MD
role: PRINCIPAL_INVESTIGATOR
References: