louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05571072: Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator
Official title: Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Opioid Use
Prolapse Genital
Keywords: post operative pain
opioid use
urogynecologic surgery
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
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 to determine if the investigators can precisely predict how much pain medication the subjects will need after surgery using a special calculator that was developed for this purpose.


Eligibility criteria: Inclusion Criteria:

* Age 18-89
* Able to provide informed consent
* Patients undergoing any of below urogynecologic procedures

Included urogynecologic procedures:

1. Sacrocolpopexy - robotic or laparoscopic

   1. With or without hysterectomy
   2. With or without salpingo-oophorectomy
   3. With or without anterior colporrhaphy
   4. With or without posterior colporrhaphy/perineorrhaphy
   5. With or without midurethral sling
2. Sacrospinous ligament fixation

   1. With or without hysterectomy
   2. With or without salpingo-oophorectomy
   3. With or without anterior colporrhaphy
   4. With or without posterior colporrhaphy/perineorrhaphy
   5. With or without midurethral sling
3. Uterosacral ligament suspension - robotic, laparoscopic, or vaginal

   1. With or without hysterectomy
   2. With or without salpingo-oophorectomy
   3. With or without anterior colporrhaphy
   4. With or without posterior colporrhaphy/perineorrhaphy
   5. With or without midurethral sling
4. Colpocleisis

   1. Lefort colpocleisis
   2. Complete colpectomy with colpocleisis
5. Isolated anterior and/or posterior colporrhaphy

Exclusion Criteria:

* Non-English speakers
* pre-operative diagnosis of cancer
* scheduled for any concurrent non-urogynecologic procedure (ex: abdominoplasty)
* \<18 years or \>89 years of age
* unable to provide informed consent

Primary outcomes:
measure: Change in pain scores measured by team-created pain questionnaires
timeFrame: baseline, 1 week post-op, 2 weeks post-op
Secondary outcomes:
measure: Change in satisfaction scores measured by team-created questionnaire
timeFrame: 1 week post-op, 2 weeks post-op
measure: Change in number of opioid tablets remaining measured by team-created questionnaire
timeFrame: 1 week post-op, 2 weeks post-op
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: David Sheyn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02890004: Observational Study of Patients With Subarachnoid Hemorrhage
Official title: A Prospective, Observational Registry of Patient With Subarachnoid Hemorrhage in Neurocritical Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subarachnoid Hemorrhage
Keywords: Subarachnoid Hemorrhage
Neurointensive care
Observational registry
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 1000
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 admitted to the unit of investigator with subarachnoid hemorrhage, whatever the etiology, is included in their prospective registry

Brief summary: This prospective, observational study aim to identify :

* Prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care unit
* The impact of standard therapeutic used (surgery, embolization ; medical treatment of vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, ...)


Eligibility criteria: Inclusion Criteria:

* Subarachnoid hemorrhage

Exclusion Criteria:

* None

Primary outcomes:
measure: Survival
timeFrame: at day 0
measure: Survival
timeFrame: at 6 months
measure: Survival
timeFrame: at 12 months
Secondary outcomes:
measure: Neurological outcome with the Glasgow Coma Scale (GCS) score
timeFrame: at day 0
measure: Neurological outcome with the Glasgow Coma Scale (GCS) score
timeFrame: at 6 months
measure: Neurological outcome with the Glasgow Coma Scale (GCS) score
timeFrame: at 12 months
measure: Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score
timeFrame: at day 0
measure: Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score
timeFrame: at 6 months
measure: Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score
timeFrame: at 12 months
measure: Brain lesions with MRI
timeFrame: at day 0
measure: Brain lesions with MRI
timeFrame: at 6 months
measure: Brain lesions with MRI
timeFrame: at 12 months
measure: delay of apparition of hyponatremia
timeFrame: on alternte days after Day 0
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de réanimation polyvalente neurologique Hôpital Neurologique HCL
Study officials:
affiliation: Service de réanimation neurologique Hospices Civils de Lyon
name: Frédéric DAILLER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02016404: The Effect of a Low Sodium-High Potassium Salt on Blood Pressure in Vietnamese Adults
Official title: The Effect of a Low Sodium-High Potassium Salt on Blood Pressure in Vietnamese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: blood pressure
sodium
salt
low sodium high potassium salt
potassium
Vietnam
randomized controlled trial
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: National Institute of Nutrition, Vietnam
First posted: 2013-12-20
Enrollment: 180
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to investigate the effects of low-sodium, high-potassium condiments and salt on blood pressure in untreated (pre)hypertensive Vietnamese adults.


Eligibility criteria: Inclusion Criteria:

Untreated prehypertension or mild hypertension (systolic BP between 130 and 160 mmHg and/or diastolic BP between 85 and 100 mmHg) based on the mean of two measurements with a 1-week interval

Exclusion Criteria:

Diagnosed or self-reported cardiovascular disease Diagnosed or self-reported kidney disease

Primary outcomes:
measure: Change in office systolic blood pressure (SBP)
timeFrame: Change during 8 weeks of intervention
Secondary outcomes:
measure: Change in office diastolic blood pressure (DBP)
timeFrame: Change during 8 weeks of intervention
Other outcomes:
measure: Change in 24-hour urinary sodium excretion
timeFrame: Change during 8 weeks of intervention
measure: Change in 24-hour urinary potassium excretion
timeFrame: Change during 8 weeks of intervention
measure: Change in body weight
timeFrame: Change during 8 weeks of intervention
measure: Change in 24-hour urinary calcium excretion
timeFrame: Change during 8 weeks of intervention
measure: Change in 24-hour urinary iodine excretion
timeFrame: Change during 8 weeks of intervention
measure: Change in 24-hour urinary creatinine excretion
timeFrame: Change during 8 weeks of intervention
measure: Change in 24-hour urinary protein
timeFrame: Change during 8 weeks of intervention
measure: Change in heart rate
timeFrame: Change during 8 weeks of intervention
Locations:
city: Hanoi
country: Vietnam
facility: National Institute of Nutrition (NIN), Department of Community Nutrition
state: Hai Ba Trung dist.
Study officials:
affiliation: Community Nutrition, National Institute of Nutrition, Vietnam
name: Ha TP Do
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03749304: Monitoring Analgesia by ANI (Analgesia The Nociception Index)
Official title: Monitoring Analgesia by ANI (Analgesia The Nociception Index) During Surgery Inflammatory Bowel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nociceptive Pain
Surgical Procedure, Unspecified
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this research is to study the variations of the ANI(Analgesia The Nociception Index) according to 2 periods: the "NoStim" period before surgical incision under general anesthesia and the period of hemodynamic reactivity "ReactHemo" peroperative. This period is defined by a 20% increase in FC and / or PAS (the only gold standard today).


Eligibility criteria: Inclusion Criteria:

* patient with IBD
* Scheduled surgery: laparotomy or laparoscopic resection with high risk of laparo-conversion

Exclusion Criteria:

* patient included in another current study or the previous month
* urgent surgery
* toxicomania or receiving opioids preoperatively
* pregnant woman
* psychosis
* betablocker treatment
* diabetic dysautonomia
* non-sinus heart rate
* pacemaker heart transplant

Primary outcomes:
measure: Change of ANI greater than 20 points
timeFrame: During the surgery, an average Three hours and a half
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
Study officials:
affiliation: University Hospital, Lille
name: Gilles Lebuffe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02008604: Influence of Stroke on the Composition of Intestinal Microbiota
Official title: Influence of Stroke on the Composition of Intestinal Microbiota (GUTSTROKE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Transient Ischemic Attack (TIA)
Keywords: ischemia
stroke
transient ischemic attack (TIA)
microbiome
microbiota
gut
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Prof. Dr. Ulrich Dirnagl, Experimental Neurology, Charité Berlin, Germany
name: Dr. Christian Meisel, Medical Immunology, Charité Berlin, Germany
name: PD Dr. Andreas Nitsche, Robert-Koch-Institut, Berlin, Germany
name: NeuroCure Clinical Research Center, Charite, Berlin
First posted: 2013-12-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients at the rescue center, the Stroke Unit and the neurological intensive care unit of the Charité University hospital

Brief summary: The aim of the study is to verify the hypothesis that the microbial colonisation of the gut is changed in patients after stroke and that the gut microbiome of severely affected stroke patients differs from that of patients with only a short disruption of blood circulation in the brain (transient ischemic attack, TIA). For this, the composition of gut microbiota in stool samples will be analyzed by 454 pyrosequencing. Further, the correlation of stroke-associated changes in the microbiome with immunological parameters will be analyzed.


Eligibility criteria: Inclusion Criteria:

* age: 18 and older
* ischemic cerebral infarction within the last 40 hours, anterior circulation infarct (ACA, MCA) and/or posterior circulation infarct (PCA, BA) of any severity
* patient consent or consent by a legal representative
* NIHSS \> or =9 (stroke patients)
* NIHSS \< 1 (for TIA patients)

Exclusion Criteria:

* intracranial hemorrhage
* preexisting dysphagia
* signs of infection upon admission (clinical/paraclinical)
* existing antibiotic therapy upon admission or within the last 2 weeks before admission
* mechanical ventilation upon admission
* participation in an interventional therapy study

Primary outcomes:
measure: composition of intestinal microbiome
timeFrame: change between day 1, day 4, day 7, day 14 after stroke
Secondary outcomes:
measure: test of correlation between most changed group of bacteria with changes in immunological parameters (HLA-DR)
timeFrame: days 1, 4, 7 after stroke
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Andreas Meisel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06034704: Plantar Fascia Release With Magnetic Fascia Ball
Official title: Investigation of the Effect of Plantar Fascia Release With Magnetic Fascia Ball on Hamstring and Lumbar Spine Flexibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flexibility
Muscle Tightness
Keywords: Massage
Hamstring Muscles
Magnets
Lumbar Fascia
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the effect of plantar fascia release with a magnetic fascial cork ball on hamstring and lumbar extensor muscle elasticity will be investigated.

Detailed description: The use of tools such as foam rollers or massage balls to resolve myofascial tension is highly preferred by both therapists and patients. It is theorized that the sweeping pressure generated during rolling causes the fascia to stretch and increase the range of motion. In addition, the warming caused by the friction during rolling can dissolve the adhesions between the fascial layers and restore the elasticity of the myofascial tissues. In addition to similar mechanical effects, the use of cork balls with magnetic properties is becoming increasingly common. Studies have shown that static magnetic magnets reduce pain, increase microcirculation and oxygenation and cause changes in presynaptic membrane function. As far as we know, there is no study examining the myofascial relaxation effect of magnetic balls in the literature. Evaluating the clinical impact and efficacy of this device which allow the person to perform self-massage might contribute the current literature. This study was planned to evaluate the myofascial relaxation caused by two different fascial cork balls with and without magnetic properties.

Eligibility criteria: Inclusion Criteria:

* Having scored 3 or less according to the Beighton scoring system
* 18-35 years old,
* Having asymptomatic
* Voluntary participation in the research

Exclusion Criteria:

* Having Beighton score of 4 and above
* Having history of previous surgery
* Having diagnosed pathology of the lower extremities and lumbar region

Primary outcomes:
measure: Goniometric Measurement of Hamstring Flexibility
timeFrame: Two times in one day (before intervention, immediately after intervention)
Secondary outcomes:
measure: Sit and reach test
timeFrame: Two times in one day (before intervention, immediately after intervention)
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Faculty of Health Sciences Bolu Abant İzzet Baysal University
Study officials:
affiliation: Bolu Abant İzzet Baysal Üniversitesi
name: Ömer Osman PALA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00585104: Myocardial Hemodynamic Effects of Levosimendan
Official title: Myocardial Hemodynamic Effects of Levosimendan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2008-01-03
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: This study will test the hypothesis that mechanical efficiency as measured by pressure-volume loop assessment should improve during short-term treatment with intravenous levosimendan.

Levosimendan (SimdaxTM, Abbott Laboratories, Abbott Park, IL) is a calcium sensitizer which has been shown to have beneficial hemodynamic effects in patients with decompensated congestive heart failure (CHF). Levosimendan is a new calcium sensitizer that binds to troponin C. This agent is approved in Europe for treatment of heart failure patients. In the United States, this agent is currently under phase III investigation for intravenous treatment of patients with acutely decompensated HF who have dyspnea at rest or with minimal activity. Levosimendan has been studied in these patients with acute HF and is considered experimental in the United States for this population.


Eligibility criteria: Inclusion Criteria:

* All patients will have either a sinus or paced atrial rhythm with atrioventricular synchrony on electrocardiography
* All patients will have a history of heart failure diagnosed clinically with history of prior symptoms or signs of heart failure with at least one of the following symptoms within the past month: dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea, pedal edema
* In asymptomatic patients, patients may be enrolled if they have at least one of the following clinical signs of heart failure: left ventricular third and/or fourth heart sound, jugular venous pressure \>7 mmHg, sustained left ventricular impulse, or pulmonary congestion on auscultation
* all patients will have echocardiographic evidence of left ventricular dysfunction

Exclusion Criteria:

* Under age 18

Primary outcomes:
measure: Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter.
timeFrame: From baseline to 30-minutes after levosimendan started.
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Andrew Michaels, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01096004: Study to Evaluate Methods That Assess the Effect of AZD4017 in Adipose Tissue
Official title: A Randomised, Single-blind, Placebo-controlled, Single-centre, Phase I Study in Abdominally Obese Healthy Volunteers to Evaluate Methods to Assess 11-βHSD1 Activity in Adipose Tissue and Related Downstream Biomarkers After Single and Repeated Oral Doses of AZD4017 for 10 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Pharmacodynamic method evaluation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-03-30
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary purpose of this study is to investigate different methods to evaluate the effect of AZD4017 in adipose tissue after single and multiple doses of AZD4017 in abdominally obese but otherwise healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Provision of signed written and dated informed consent
* Have a body mass index (BMI) between 27 and 35 kg/m2
* Waist circumference of \>102 cm

Exclusion Criteria:

* History of any clinical significant disease
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator

Primary outcomes:
measure: To investigate the effect of single and repeated doses of AZD4017 and placebo on mechanisms in adipose tissue involved in metabolic regulation
timeFrame: A adipose tissue biospy is taken at baseline, on first day of dosing day, on 4th dosing day and on 9th dosing day.
Secondary outcomes:
measure: Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables
timeFrame: The variables will be measure predose and the repeatedly during the following 10 days after dosing
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Research Site
Study officials:
affiliation: Avdelningen för molekylär och klinisk medicin Lundberglaboratoriet
name: Per-Anders Jansson, Ass Prof, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Mikaela Sjöstrand
role: STUDY_CHAIR
References:
Clinical trial NCT01891604: Study the Safety and Efficacy of Probiotics Use in Premature Infants
Official title: Study the Safety and Efficacy of Probiotics Use in Premature Infants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infant, Premature, Diseases
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Lallemand Health Solutions
First posted: 2013-07-03
Enrollment: 0
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Intervention model: PARALLEL

Brief summary: Prophylactic enteral probiotics may enhance clinical markers and biomarkers of preterm infants' health, and may also play a role in reducing NEC and associated morbidity.


Eligibility criteria: Inclusion Criteria:

* born with weight\<1500 g
* hospitalized within 48 hours after birth

Exclusion Criteria:

* present with evidence or suspicion of congenital intestinal obstruction
* perforation
* gastroschisis
* large omphalocele
* congenital diaphragmatic hernia
* major congenital heart defects

Primary outcomes:
measure: Calprotectin will be used to determine the effect for probiotics
timeFrame: day1 and day30 of the observation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: