louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02831101: Sufentanil Bispectral Index Elderly
Official title: Impact of Sufentanil on the Depth of Sedation Measured by Bispectral Index During Induction of Anaesthesia With Propofol in the Elderly - a Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loss of Consciousness
Keywords: BIS
Elderly
Propofol
Sufentanil
Loss of consciousness
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 71
Sex: ALL
Minimum age (years): 70
Maximum age (years): 87
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: We compared BIS values during propofol stepwise induction with or without concomitant sufentanil in patients ≥ 65 years .

Detailed description: Bispectral index (BIS) is widely used to estimate the depth of anesthesia. In clinical studies, a large variability of BIS has been observed. Several factors may be responsible for this inconsistency. We were able to show that in elderly patients (average age 78 years) receiving increasing doses of propofol alone a BIS values at loss of consciousness (LOC) were about 30% higher compared with young patients (average age 35 years). We showed also that in young patients (average age 48 years) the BIS values at LOC were significantly higher in those receiving sufentanil concomitantly with propofol compared with those who had received propofol alone. It remains unknown, however, whether these data from young surgical patients are applicable to a population of elderly patients. It may be argued that in the elderly receiving propofol, the impact of advance age was so important that any addition of an opioid would not further disturb the sedation-monitor balance. Alternatively, it may be expected that in the elderly receiving an opioid added to propofol the impact of both drugs on sedation will be additive and that previous observations from younger patients will be further exaggerated. The impact of advance age and presence or absence of sufentanil during propofol induction on BIS values at LOC was investigated in this trial.

Eligibility criteria: Inclusion Criteria:

- Age ≥65 years

Exclusion Criteria:

* History of heart disease
* History of renal disease
* History of psychiatric
* Obesity
* Allergy to propofol or sufentanil

Primary outcomes:
measure: BIS at baseline
timeFrame: BIS values at baseline before administration of any study drugs
measure: BIS and sufentanil
timeFrame: BIS values 10 min after steady state concentration of sufentanil
measure: BIS and propofol
timeFrame: BIS values after steady state concentration of propofol
measure: BIS and LOC
timeFrame: BIS values at loss of consciousness
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: de Valence T, Elia N, Czarnetzki C, Dumont L, Tramer MR, Lysakowski C. Effect of sufentanil on bispectral index in the elderly. Anaesthesia. 2018 Feb;73(2):216-222. doi: 10.1111/anae.14102. Epub 2017 Nov 3.
Clinical trial NCT00865501: Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease
Official title: Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Hypertension
Keywords: primary hypertension
aldosterone
left ventricular hypertrophy
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2009-03-19
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The Renin-Angiotensin-Aldosterone-system is important in the development of cardiovascular organ damage caused by arterial hypertension. This study aims at evaluating the importance of aldosterone with regard to hypertension induced damage to the heart. In order to do this the investigators will perform a comparative cross-sectional study in hypertensives and normotensives. In addition as interventional part the hypertensives will be treated with a mineralocorticoid-receptor blocker (spironolactone).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis hypertension (BP higher than 139/89)

Exclusion Criteria:

* Antihypertensive pretreatment
* Contraindications against spironolactone
* Being unable to understand or comply with study procedures

Primary outcomes:
measure: left ventricular mass
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Erlangen-Nürnberg, Nephrology and Hypertension
Study officials:
affiliation: Universität Erlangen-Nurnberg
name: Roland E Schmieder, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04103801: Substance P as a Biomarker to Evaluate the Reduction of Multiple Immunization Pain
Official title: Substance P as a Biomarker to Evaluate the Reduction of Multiple Immunization Pain Among Infants and Toddlers: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunisation Anxiety Related Reaction
Pain, Acute
Keywords: Sucrose,
Substance P,
Pain,
Immunization.
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 132
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Immunization is one of the most significant preventive health measures in reducing morbidity and mortality caused by infectious diseases. Studies have shown that Sucrose is recommended to reduce pain associated with vaccination in neonates. The main aim of the study was to determine the effectiveness of sucrose in reducing infant's pain outcomes during immunization among 10-24 month-old infants and toddlers.


Eligibility criteria: Inclusion Criteria:

* All healthy children who were attending immunization clinic to have their 10-24 month immunization were invited to this study

Exclusion Criteria:

* Exclusion criteria included children: whose parents choose to breastfeed during immunization, who have received an analgesia in the previous 24 hours including Paracetamol (so as not to affect the response to painful stimuli during immunization), who cannot receive their immunization due to the presence of immunization risk factors as determined by the immunization nurse, who are not able to receive a sugar solution, and whose parents refuse to participate.

Primary outcomes:
measure: MBPS
timeFrame: Change MBPS score from the start of injection and up to 3 minutes after immunization
Secondary outcomes:
measure: Substance P (SP)
timeFrame: Change SP level from the start of injection and up to 3 minutes after immunization
Other outcomes:
measure: Total crying time
timeFrame: From start of injection and up to 3 minutes after the immunization
Locations:
city: Irbid
country: Jordan
facility: Maternal and child health centers
Study officials:
affiliation: Jordan Uinversity of Sceince and Technology
name: Manal K, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04688801: Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer
Official title: Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer With or Without Preoperative Chemotherapy With High Risk for Recurrence (N+ and/ or R1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Gastroesophageal Cancer
Immunotherapy
Adjuvant
Lead sponsor: The Second Hospital of Shandong University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgery with or without neoadjuvant therapy is usually used as the treatment for resectable esophageal cancer or esophageal- gastric junction cancer. Patients who have a poor response to neoadjuvant therapy and have an incomplete (R1) resection or have metastatic lymph nodes in the resection specimen (N+) are especially at risk of recurrence, to continue with the chemotherapy± radiotherapy is often used in these cases. However, the overall survival is still poor. We designed a prospective randomized controlled tial to study whether immunotherapy could be used with chemotherapy after surgery to improve overall survival. The primary endpoint ofthe study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life.


Eligibility criteria: Inclusion Criteria:

Histologically proven esophageal or EG-junction carcinoma (Siewert I-II). The heart and lung function can tolerate surgery. The cancer is resectable and incurable therapy will be perfomed.

Exclusion Criteria:

EG-junction carcinoma (Siewert III). M1 stage according to the current (8th) version of TNMclassification system. The heart and lung function can't tolerate surgery. R2 Resection Status.

Primary outcomes:
measure: disease free survival rate
timeFrame: 5 years after surgery
measure: overall survival rate
timeFrame: 5 years after surgery
Secondary outcomes:
measure: Rate of adverse events
timeFrame: within 6 months
measure: Quality of Life （KPS or PS or QOL or EORTC QLQ C30）
timeFrame: 5 years after therapy
Other outcomes:
Locations:
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT01689701: Efficacy and Safety of Hizikia Fusiformis Extract in Subjects Showing Erosive Gastritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erosive Gastritis
Keywords: Erosive Gastritis
Hizikia Fusiformis
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 54
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed a double-blind parallel study in a group of Subjects Showing Erosive Gastritis who were given Hizikia Fusiformis Extract over a period of 4 weeks. Endoscopic observations were performed before and 4 weeks after the treatment, and the cure and improvement rates were investigated.


Eligibility criteria: Inclusion Criteria:

* Males and females 19-70 years old
* Subjects Showing Erosive Gastritis (endoscopy)
* Able to give informed consent

Exclusion Criteria:

* Diagnosed of gastrointestinal disease such as ulcer, cancer within 1 months
* Allergic or hypersensitive to any of the ingredients in the test products
* History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
* Taken antibiotics and stomach medicines such as steroid, bismuth compound and proton pump inhibitor within 1 months
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.

Primary outcomes:
measure: Changes in Erosions
timeFrame: 4 weeks
measure: Changes in Score of Erosions
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in Subjects' Symptoms Total Score
timeFrame: 4 weeks
measure: Changes in Gastrin
timeFrame: 4 weeks
measure: Changes in PepsinogenⅠ
timeFrame: 4 weeks
measure: Changes in PepsinogenⅡ
timeFrame: 4 weeks
measure: Changes in Pepsinogen Ⅰ/Ⅱ Ratio
timeFrame: 4 weeks
measure: Changes in Hs-CRP(High Sensitivity C-reactive Protein)
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Chonbuk National University Hospital
name: Sang-Wook Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02017301: Vector Analysis of Body Composition in Hospitalized Cirrhotic Patients
Official title: Influence of Acute Decompensation on Body Composition Determined by Bioelectrical Impedance Vector Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Keywords: Liver Cirrhosis,Infection, Impedance, Body Composition
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort of hospitalized cirrhotic patients

Brief summary: Patients with acute decompensation of cirrhosis, or acute on chronic liver failure often present with malnutrition, and due to the in-hospital stay, their nutritional intake can vary widely, with several periods of fasting, and sometimes insufficient nutritional support. Therefore patients are prone to develop malnutrition or, the already present malnutrition worsens its status.

Our aim is to evaluate the daily changes in nutritional status in patients with acute decompensation of cirrhosis and evaluate the changes in plasma and serum biomarkers.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years old
* Patients with confirmed cirrhosis.
* Any etiology
* Hospitalized with acute decompensation of cirrhosis
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Amputation
* Incomplete data

Primary outcomes:
measure: Changes in nutritional status
timeFrame: Daily measurement up to 30 days
Secondary outcomes:
measure: Evaluation of inflammatory cytokines
timeFrame: Samples will be collected at the baseline evaluation.
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran
state: D.F
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Aldo Torre Delgadillo, M.D. M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Astrid Ruiz-Margáin, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00926601: Prevalence and Clinical Significance of Co-infection of Mycoplasma Pneumoniae in Patients With Pulmonary Tuberculosis
Official title: Prevalence and Clinical Significance of Co-infection of Mycoplasma Pneumoniae in Patients With Pulmonary Tuberculosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mycoplasma Pneumonia
Pulmonary Tuberculosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 100
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: Pulmonary tuberculosis

Brief summary: Several case report showed that the co-infection of Mycoplasma pneumoniae in patients with pulmonary tuberculosis. The aim of this study is to elucidate the prevalence and its clinical significance of co-infection of Mycoplasma pneumonia in patients with newly diagnosed pulmonary tuberculosis.


Eligibility criteria: Inclusion Criteria:

* Bacteriologically or clinically diagnosed pulmonary TB
* Older than 17years

Exclusion Criteria:

* HIV positive
* Immune-compromized

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jae-Joon Yim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02520401: The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis
Official title: The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implantitis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: BioGaia AB
First posted: 2015-08-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.

Detailed description: This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.

Study design: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind randomized, placebo controlled clinical trial. The randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients.

Selection of the study population: Adults, who consult at the departement of Periodontology at the University Hospital Leuven, with peri-implantitis and who fit the inclusion criteria will be asked to participate in this study.

Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Patients with at least one implant\* diagnosed with initial peri-implantitis.
* Willing and able to give written informed consent
* No signs of acute periodontitis
* presence of keratinized tissue around treated implant(s)

Exclusion Criteria:

* patients who smoke
* patients with periodontitis
* pregnant or lactating woman
* patients with poorly controlled diabetes
* patients taking bisphosphonate mediation
* patient who had taken systemic antibiotics 3 months prior to treatment
* peri-implantitis treatment 12 months prior intake

Primary outcomes:
measure: Probing Pocket Depth (PPD) at peri-implantitis sites
timeFrame: Baseline - 6 months
Secondary outcomes:
measure: Bleeding on Probing (BoP) at peri-implantitis sites
timeFrame: Baseline - 6 months
measure: Plaque at peri-implantitis sites
timeFrame: Baseline - 6 months
measure: Microbial samples
timeFrame: Baseline - 6 months
measure: Full mouth plaque score (FMPS)
timeFrame: Baseline - 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
References:
Clinical trial NCT02092701: Effects of Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period
Official title: Effects of a One Year Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D
Burn Injury
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2014-03-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

Brief summary: Vitamin D has pleiotropic effects. Burn patients are at risk of hypovitaminosis D and may experience post-injury osteopenia and sarcopenia. Investigators hypothesized that vitamin D supplementation during one year can improve bone and muscle health in post-burn period.


Eligibility criteria: Inclusion Criteria:

* occurrence of injury between 2005 and 2011
* burn surface area (BSA) greater than 10%

Exclusion Criteria:

* Pregnancy, renal or liver failure, hypo or hyperparathyroidism, prior vitamin D substitution, treatment using systemic corticosteroids or antiepileptic drugs, regular exposure to ultraviolet B radiation (solarium), unstable cardiovascular disease or acute muscle or skeletal injury prohibiting physical exercise

Primary outcomes:
measure: calcidiol blood concentration
timeFrame: at the end of the protocol (after one year)
Secondary outcomes:
measure: bone health
timeFrame: at the end of the protocol (after one year)
measure: muscle strength
timeFrame: at the end of the protocol (after one year)
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Burn Centre
Study officials:
References:
Clinical trial NCT00930501: Anti-Mullerian Hormone (AMH) and Antral Follicle Count as Markers of Ovarian Reserve- Prospective Followup of Young Cancer Patients
Official title: Phase 1 Prospective Study of Markers of Ovarian Reserve in Young Female Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: chemotherapy
cancer
AMH
gonadotoxicity
ovarian reserve
patients exposed to chemotherapy
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-06-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 5
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: females 5-45 years old

Brief summary: young female cancer patients have improving chances of survival. the main risk is a chronic damage to their ovarian reserve. This may lead to future infertility.

Detailed description: our objective is to prospectively follow patients before and after their cancer treatment. this should help us learn of the gonadotoxicity of various treatments as well as be able to better consult these and future patients of the need of fertility preservation techniques.

Eligibility criteria: Inclusion Criteria:

* all females prior and after chemotherapy

Exclusion Criteria:

* do not consent

Primary outcomes:
measure: Anti mullerian hormone
timeFrame: 2 years
Secondary outcomes:
measure: antral follicle count
timeFrame: 2 years
measure: FSH
timeFrame: 2 years
measure: inhibin b
timeFrame: 2 years
measure: menstrual history
timeFrame: 2 years
measure: E2 and prog
timeFrame: 2 years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah
Study officials:
References:
Clinical trial NCT00015301: Methylphenidate Raclopride Positron Emission Tomography (PET) Test - 11
Official title: Methylphenidate Raclopride PET Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cocaine-Related Disorders
Substance-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: New York MDRU
First posted: 2001-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate PET methodology to study in vivo synaptic dopamine release.

Detailed description: The objective of this study is to evaluate PET methodology to study in vivo synaptic dopamine release.

Eligibility criteria: Inclusion Criteria:

Healthy normals

Exclusion Criteria:

History of head trauma or loss of consciousness. Significant medical history. History of seizures.

Primary outcomes:
measure: Dopamine receptor availability
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York MDRU
state: New York
Study officials:
affiliation: New York MDRU
name: John Rotrosen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: