louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01860885: Critical Respiratory Events in Children Requiring Naloxone: Naloxone Use as Opioid Safety Measure
Official title: Study of Hospital-wide Critical Respiratory Events Requiring Naloxone in a Pediatric Institution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Induced Respiratory Depression
Keywords: naloxone
children
opioid
respiratory depression
safety
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 95
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who required rescue with naloxone between June 2006 and June 2012; identified based upon an automated trigger report generated from the hospital's risk management database for any dispensation of naloxone from the hospital pharmacy

Brief summary: Opioids are the mainstay of analgesia in hospitalized children but opioid therapy is associated with life-threatening respiratory depression requiring antagonism with naloxone. Hence, it is hypothesized that naloxone requirement can be used as a quality measure of opioid safety. A retrospective medical chart review of 95 patients, who received naloxone for life threatening events, from June 2006-2012, is planned, to identify significant factors associated with risk for opioid induced respiratory depression and formulation of preventive strategies.


Eligibility criteria: Inclusion Criteria:

* any gender, age or race
* administered naloxone for opioid induced respiratory depression

Exclusion Criteria:

* Any one who did not require naloxone for opioid induced respiratory depression

Primary outcomes:
measure: Descriptive: Medical history and Risk Factors for critical respiratory events requiring Naloxone in children
timeFrame: about 6 hours around the event
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT01310985: A Trial of Pre-Operative Chemoradiotherapy Using Capecitabine, Radiation & Cetuximab, in Rectal Cancer
Official title: A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized (Non-Metastatic) Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Rectal Cancer Duke Stage Stageval
Keywords: Rectal Cancer
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 15
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Localized (Non-Metastatic) Rectal Cancer

Brief summary: A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized (Non-Metastatic) Rectal Cancer

Detailed description: Its a pilot study of pre-op chemotherapy and RT utilizing CAPECITABINE, XRT and CETUXIMAB in pts with locally advanced rectal carcinoma.

Eligibility criteria: Inclusion Criteria:

* Patients with Localized Non-Metastatic Rectal Cancer

Exclusion Criteria:

* Patients with diagnosis other than Localized Non-Metastatic Rectal Cancer

Primary outcomes:
measure: Evaluate the safety of pre-operative concurrent chemotherapy with capacitabine (Xeloda), weekly cetuximab (Erbitux), and external beam radiation.
timeFrame: For the duration of the experiment
Secondary outcomes:
measure: Evaluate efficacy of sphincter preserving surgery rate, local recurrence rate and the disease free and overall survival in patients.
timeFrame: For the duration of the experiment
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Kfsh & Rc
Study officials:
affiliation: KFSH & RC
name: Shouki Bazarbashi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05857085: Novel Therapeutics and Endothelial Dysfunction in T1DM Patients
Official title: Impact of Additional Treatment With Empagliflozin or Semaglutide on Endothelial Function and Other Clinical Parameters and Biomarkers in T1DM Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endothelial Dysfunction
Diabetes Mellitus, Type 1
Biomarkers
Endothelial Progenitor Cells
SGLT 2 Inhibitors
Incretins
Glucose Excursions
FMD
FPF
Arterial Stiffness
Lead sponsor: General and Teaching Hospital Celje
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 therapeutic arms - adding empagliflozin or semaglutide to basic insulin treatment and control arm in type 1 diabetic patients
Primary purpose: TREATMENT

Brief summary: The aim of study is impact of additional treatment with new antidiabetic drugs (semaglutide or empagliflozine) compared to control group in T1DM patients - impact on endothelial function measured by FMD and FPF, arterial stiffness - measured by PWV, inflammatory biomarkers, markers of oxidative stress and endothelial progenitor cells (CD 34+/VDRL2, CD 133+/VDRL2) and correlation with glucovariability or time in range, measured with CGM system.


Eligibility criteria: Inclusion Criteria:

* T1DM
* HbA1C\<=9%
* prone to CGM system
* 20 - 70 years

Exclusion Criteria:

* HbA1C \>9%,
* BMI\<22,
* pregnancy or lactation,
* known hypersensitivity to study drug,
* malignant disease ( excluded \>5 years disease free, bazocellular or planocellular ca of skin),
* liver cirrhosis child C,
* eGFR\<60 ml/min,
* chronic inflammatory disease,
* proliferative diabetic rethinopathy,
* MEN or medullary thyroid cancer in familly,
* concomitant drugs with influence on glycemia and antiinflammatory influence (corticosteroids, immunosupresive therapy),
* Major cardiovascular event last 2 months ( stroke, MI)

Primary outcomes:
measure: evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery
timeFrame: 12 weeks
measure: evaluation of endothelial function by strain gauge plethysmography as change in forearm blood flow
timeFrame: 12 weeks
measure: evaluation of arterial stiffness with peak wave velocity ( PWV)
timeFrame: 12 weeks
Secondary outcomes:
measure: evaluation of change in inflammatory biomarkers
timeFrame: 12 weeks
measure: evaluation of change in biomarkers of endothelial dysfunction
timeFrame: 12 weeks
measure: evaluation of endothelial progenitor cells EPC count
timeFrame: 12 weeks
Other outcomes:
measure: body impedance measurements
timeFrame: 12 weeks
measure: changes of glycemia endpoints glucovariability/time in range
timeFrame: 2 weeks
Locations:
city: Celje
country: Slovenia
facility: General Hospital Celje
Study officials:
affiliation: General and teaching hospital Celje and UKC Ljubljana/Maribor
name: Andrej Janez, prof PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00876785: Effect of Rye Bread Breakfasts on Eight Hour Satiety Ratings
Official title: Effect of Rye Bread Breakfasts on Subjective Hunger and Satiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Rye bread satiety breakfast
Lead sponsor: Swedish University of Agricultural Sciences
Sponsor class: OTHER
Collaborators: name: Lantmännen R&D
name: Good Food Practice, Sweden
First posted: 2009-04-07
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of the present study was to investigate subjective appetite during 8 hours after intake of iso-caloric rye bread breakfasts varying in dietary fiber composition and content.

Detailed description: Energy-dense foods that require little effort to consume and that are rapidly digested may cause passive over-consumption by failure to provide a feeling of fullness corresponding to the energy content. A diet that is predominantly based on such foods may lead to overweight. It is therefore important to identify properties of foods that facilitate energy balance by creating a high satiety per calorie. A number of studies have confirmed that foods naturally rich in dietary fiber promote the feeling of fullness and reduce hunger in the short term.

Eligibility criteria: Inclusion Criteria:

* age between 20 and 60 years
* body mass index (BMI) 18-27 kg/m2
* a habit of consuming breakfast, lunch and dinner everyday
* fasting plasma glucose 4.0-6.1 mmol/L
* haemoglobin (Hb) in men 130-170 g/L, in women 120-150 g/L
* thyroid-stimulating hormone (TSH) 0.3-4.0 mlE/L
* willingness to comply with the study procedures

Exclusion Criteria:

* intake of medicine likely to affect appetite or food intake
* any medical condition involving the gastrointestinal tract
* eating disorder
* smoking
* consumption of more than three cups of coffee per day
* change in body weight of more than 10% three months prior to screening
* consumption of any restricted diet such as vegan, gluten-free, slimming etc.
* pregnancy, lactation or wish to become pregnant during the study period

Primary outcomes:
measure: Subjective satiety, hunger and desire to eat
timeFrame: During 8 hours after intake of test meal
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Swedish University of Agricultural Sciences
Study officials:
affiliation: university
name: Per Aman, Professor
role: STUDY_DIRECTOR
References:
citation: Isaksson H, Fredriksson H, Andersson R, Olsson J, Aman P. Effect of rye bread breakfasts on subjective hunger and satiety: a randomized controlled trial. Nutr J. 2009 Aug 26;8:39. doi: 10.1186/1475-2891-8-39.
Clinical trial NCT03650985: Diagnosis and Intervention of Complicated Twin Diseases
Official title: Diagnosis and Intervention of Complicated Twin Diseases in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Twin Diseases
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pregnancy women with complicated twin diseases, who are able to withstand risks of intrauterine treatments and informed consent.
Primary purpose: TREATMENT

Brief summary: Fetal medicine in China is still a new, young discipline, and the development is very rapid. After nearly 10 years of development, the clinical diagnosis and treatment guidelines of some complicated twin diseases has been established , but they are still needed to be improved. Through this study, the investigators expect to achieve better prediction indicators and early intrauterine precise diagnosis of complicated twin diseases. Also, better procedures of implementing effective intrauterine intervention and assessing the safety and effectiveness of intrauterine intervention are anticipated to be established.

Detailed description: A better guideline for complicated twin diseases are anticipated to be established in China. Molecular genetics and imaging technology are applied to evaluate the outcome and prognosis of intrauterine intervention for complex twin diseases. 3D printing technology is used to assist the preoperative evaluation of fetal intrauterine intervention. Better fetal intrauterine intervention technique and prognosis evaluation are expected to be established.

Eligibility criteria: Inclusion Criteria:

* Pregnancy women with complicated twin diseases who are able to withstand intrauterine treatment and consent informed.

Exclusion Criteria:

* Pregnancy women who refuse intrauterine treatment.

Primary outcomes:
measure: Gene expression of fetuses
timeFrame: At 20 week of gestational age
measure: Change of volume of amniotic fluid in Milliliter
timeFrame: At every two week from the sixteenth week of gestational age to delivery of babies
measure: Change of umbilical artery blood flow
timeFrame: At every two week from the sixteenth week of gestational age to delivery of babies
Secondary outcomes:
measure: Neurodevelopment at early childhood
timeFrame: At age of 1 year old
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Caixia Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00739856: Use of Electroconvulsive Therapy (ECT) in Chronic, Severe, Treatment Resistant Posttraumatic Stress Disorder
Official title: Efficacy of ECT in Chronic, Severe, Antidepressant- And CBT-Refractory Posttraumatic Stress Disorder: An Open, Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: posttraumatic stress disorder
electroconvulsive therapy
medication refractoriness
Lead sponsor: Government Medical College Srinagar
Sponsor class: OTHER_GOV
Collaborators: name: Government Psychiatric Diseases Hospital, Srinagar
First posted: 2008-08-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Post Traumatic Stress Disorder is a chronic debilitating illness and few treatment options have demonstrated effectiveness. The study will look at the use of electroconvulsive therapy for the treatment of Post Traumatic Stress disorder in patients who have not responded to multiple antidepressants or cognitive behavioral therapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of PTSD
* Treatment resistance to 4 different antidepressants from 3 different classes
* Treatment resistance to CBT
* Severe PTSD

Exclusion Criteria:

* Significant substance abuse
* Pregnancy
* History of Traumatic Brain Injury
* Unstable comorbid medical illness
* Organic brain syndrome

Primary outcomes:
measure: Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS) SCORE
Secondary outcomes:
measure: Montgomery-Asberg Depression Rating Scale score
timeFrame: baseline, 48 hrs post 3rd, 6th ECT
Other outcomes:
Locations:
city: Srinagar
country: India
facility: Government Hospital for Psychiatric Disease
state: Jammu & Kashmir
Study officials:
affiliation: Government Medical College Srinagar
name: Mushtaq Margoob, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Margoob MA, Ali Z, Andrade C. Efficacy of ECT in chronic, severe, antidepressant- and CBT-refractory PTSD: an open, prospective study. Brain Stimul. 2010 Jan;3(1):28-35. doi: 10.1016/j.brs.2009.04.005. Epub 2009 May 27.
Clinical trial NCT01768156: Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer
Official title: Determination of the Prognostic and Predictive Value of the New Marker HE4 in Metastatic Ovarian Cancer Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Ovarian Cancer
Keywords: ovarian cancer
biomarker
metastatic
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: HE4 is a new marker that could improve the detection of ovarian cancer. The HE4 assay may have an advantage over the CA-125 assay in that it is less frequently positive in patients with non malignant disease. Since the evaluation of HE4 for detection and diagnosis of ovarian cancer is well known, the behaviour of the marker during chemotherapy and follow-up period after treatment in metastatic ovarian cancer should be studied. It could be used in patient with non CA-125 secretary tumors. Prognosis and predictive value of HE4 should be compared with information provided by CA-125. The kinetics of HE4 values after treatment should be also analysed to determine the role that HE4 could play in the detection of recurrences during the follow-up of metastatic patients.


Eligibility criteria: Inclusion Criteria:

* Histologically proved epithelial ovarian cancer (serous, mucinous, clear cell, endometrioid, undifferentiated type)
* Recurrence of anytime necessitating a new line of chemotherapy
* Patient having received adjuvant chemotherapy
* Informed consent signed prior any study specific procedures

Exclusion Criteria:

* More than 3 lines of chemotherapy
* Pregnancy or breastfeeding
* History of other cancers within the past 5 years (except curatively treated non-melanoma skin cancer and in situ cervical cancer)
* Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment modalities and study follow-up).

Primary outcomes:
measure: To evaluate the predictive and prognostic value of HE4 marker
timeFrame: 18 months
Secondary outcomes:
measure: Determine the rate of patients without elevation of CA-125 presenting an elevation of HE4 that could be used for monitoring the disease.
timeFrame: 18 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
city: Montpellier
country: France
facility: CRLC Val d'Aurelle-Paul Lamarque
Study officials:
References:
Clinical trial NCT05743556: The Comparison of Effectivity Therapy by HILT and TRT in Muscle Hypertonus
Official title: Comparison of the Effect of HILT and TRT on Muscle Tone in Cervicobrachial Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Tone Abnormalities
Muscle Spasm
Keywords: muscle tone
HILT
TRT
scalene muscle
levator scapulae
trapezius muscle
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Comparing the effect of high-intensity laser therapy (HILT) and targeted radiofrequency therapy (TRT) on muscle tone in the cervical and thoracic regions. The research aims to determine the effectiveness of the effect of novel physical therapy on the change of muscle tone in the cervical and thoracic region. This is an intervention experiment applied to a group of 60 probands.

Detailed description: Approximately 60 probands, aged 18-60 years, with no gender preference, will be recruited from patients of an unnamed healthcare facility based on their voluntary participation while receiving a current indication for physiotherapy with a diagnosis of CB syndrome.

Subjects will be randomized into three groups. The first probands (n'20) will have HILT applied bilaterally to the mm. scalene, m.levator scapulae and m.trapezius pars descendens. The second group (n'20) will have TRT applied bilaterally to mm. scalene, m.levator scapulae and m.trapezius pars descendens. No physical therapy or physiotherapy will be used for the third group (n'20) for the duration of the study. Subjects will be examined and treated three times a week for a total of 6 times. The effect of each type of therapy will be demonstrated palpationally and subjectively using an analogue pain scale and an algometer. The obtained results will be further statistically processed.

Eligibility criteria: Inclusion Criteria:

* the presence of hypertonus in the mm.scalene, m.levator scapulae and m.trapezius pars descendens bilaterally
* tension demonstrated by palpation and subjective assessment of the patient on an analogue pain scale

Exclusion Criteria:

* Individuals with acute or infectious disease
* probands psychiatric diagnoses
* patients with cancers
* problems with skin integrity disorders
* other contraindications to the use of HILT and TRT

Primary outcomes:
measure: determine whether HILT causes a change in neck muscle tone after 6 applications
timeFrame: 15 minutes
measure: determine whether TRT causes a change in neck muscle tone after 6 applications
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Charles University, Faculty of physical education and sport
Study officials:
affiliation: Charles University Prague
name: Jitka Malá, PhDr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05443256: TMS Alteration of the Reward Positivity
Official title: Causal Dissociation of Value Contributions to the Reward Positivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anhedonia
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two separate arms of study
Primary purpose: OTHER

Brief summary: The aim of this proposal is to demonstrate that stimulation of different brain regions differently affects the electroencephalographic feature known as the Reward Positivity (RewP).

Detailed description: The aim of this proposal is to demonstrate that stimulation of different brain regions differently affects the electroencephalographic feature known as the Reward Positivity (RewP). The RewP is a sensitive and specific biomarker of reward receipt. This proposal will advance a causal test of the hypothesis that there are two major sources of variance that contribute to this brain response: a dorsal midline contribution to information encoding and a ventral midline contribution that is modulated by affect. Together, these findings will reveal how the RewP acts to blend multiple aspects of value together in the service of motivated learning. The objective of this proposal is to gather pilot data to demonstrate the feasibility of using transcranial magnetic stimulation (TMS) to perturb idiosyncratically-defined (fMRI-based) dorsal or ventral targets in order to causally test the hypothesis that these different sources contribute different types of variance to the RewP. TMS double cone deep coil stimulation should diminish +RPE encoding in the RewP when compared to sham. TMS Figure-8 coil stimulation should diminish affective modulation of RewP amplitude when compared to sham.

Eligibility criteria: Inclusion Criteria:

• Men or women aged 18-30

Exclusion Criteria:

* Participants unwilling or unable to give informed consent
* Presence of other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study
* MEG/MRI contraindications
* History of psychosis
* Not fluent in English

Primary outcomes:
measure: Reward Positivity
timeFrame: During intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico - Logan hall
state: New Mexico
Study officials:
References: