louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01571063: Treatment of Non-alcoholic Steatohepatitis (NASH) Patients With Vitamin D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-alcoholic Steatohepatitis (NASH)
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to biochemical and histological parameters.

* Trial with medicinal product


Eligibility criteria: Inclusion criteria:

* Patients with 25-OH vitamin D insufficiency
* Elevated alanine aminotransferase level
* Diagnosis of definite or possible steatohepatitis (NASH)

Exclusion criteria:

* Cirrhosis, present liver disease other than NASH
* Serious diseases limiting life expectancy,
* Breast-feeding or pregnant women
* Unhealthy alcohol consumption
* Drug abuse or substitution therapy
* Use of vitamin preparations within the previous 6 months and during the study
* Weight loss \>5% within 12 months before study entry
* Newly diagnosed Diabetes mellitus requiring medical treatment within 12 months before study entry
* Use of anti-obesity drugs
* Previous or current hypercalcemia
* Chronic renal disease

Primary outcomes:
measure: Change from Baseline in serum alanine aminotransferase levels at week 48
timeFrame: Measurement at week 0 and week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Gastroenterology and Hepatology
state: ZH
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
Study officials:
affiliation: University Hospital Zurich, Division of Hepatology
name: Andreas Geier, Prof. MD
role: STUDY_DIRECTOR
affiliation: University Hospital Zurich, Division of Gastroenterology and Hepatology
name: Beat Muellhaupt, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00502463: Induction Chemotherapy Prior to Radio-immunotherapy in Head and Neck Cancer Stage III/IV - a Methodical Trial
Official title: Induction by Docetaxel/Cisplatin/5-Fluorouracil (TCF) Prior to Radiotherapy With Concomintant Cetuximab in Locally Advanced Inoperable Head and Neck Tumours - a Methodical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: head and neck cancer, stage III/IV
no prior radiotherapy of head and neck region
Lead sponsor: Austrian South Oncology Group
Sponsor class: NETWORK
Collaborators: name: Change of sponsor 2008: new sponsor AGMT
First posted: 2007-07-17
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to determine the feasibility of an induction chemotherapy with radio-immunotherapy in patients with head and neck cancer stage III/IV

Detailed description: 3 Cycles of: Docetaxel 75 mg/m2 on d1, Cisplatin 75 mg/m2 on d1, 5-FU 750 mg/m2 on days 1-5 as continuous i.v. infusion, Duration of 1 cycle: 21 days;

Followed by Cetuximab 400 mg/m2, Start of radiotherapy: 1 week after the first application of Cetuximab, During radiotherapy (35 x 2 Gy): Cetuximab 250 mg/m2 weekly, Up to 8 applications of Cetuximab.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed, locally advanced head and neck cancer
* stage III/IV
* performance status: ECOG 0-1

Exclusion Criteria:

* distant metastases
* prior radiotherapy of the head and neck region
* myocardial infarct in the last six months
* florid peptic ulcer
* neuropathy grade III/IV

Primary outcomes:
measure: Locoregional tumour control
timeFrame: 12 months
Secondary outcomes:
measure: Response rate
timeFrame: 24 months
measure: Progression free survival
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: Toxicities
timeFrame: 24 months
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: LKH Feldkirch, Dept. of Radiooncology
city: Graz
country: Austria
facility: Medical University of Graz, Dept. of Radiooncology
city: Leoben
country: Austria
facility: LKH Leoben Dept. of Hemato-Oncology
city: Salzburg
country: Austria
facility: UK Salzburg, LKH: Universitätsklinik für Innere Medizin III
city: Vienna
country: Austria
facility: Medical University of Vienna, Dept. of Medicine I
Study officials:
affiliation: LKH Leoben, Dept. for Hemato-Oncology
name: Felix Keil, MD
role: STUDY_CHAIR
References:
citation: Keil F, Selzer E, Berghold A, Reinisch S, Kapp KS, De Vries A, Greil R, Bachtiary B, Tinchon C, Anderhuber W, Burian M, Kasparek AK, Elsasser W, Kainz H, Riedl R, Kopp M, Kornek G. Induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil followed by radiotherapy with cetuximab for locally advanced squamous cell carcinoma of the head and neck. Eur J Cancer. 2013 Jan;49(2):352-9. doi: 10.1016/j.ejca.2012.08.004. Epub 2012 Sep 14.
Clinical trial NCT02591563: Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.
Official title: A Study Evaluating Pathogens and Immunity to Acute Otitis Media and Nasopharyngeal Colonization in Healthy Children.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Nasopharyngeal Colonization and Acute Otitis Media
Lead sponsor: Rochester General Hospital
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 1320
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy 6-36 month old children or Acute Otitis Media diagnosed children \>/= 6mo but \</= 36 months

Brief summary: The purpose of this study is to Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.

Detailed description: A prospective evaluation of bacterial pathogens Streptococcus. pneumoniae, Haemophilus influenzae, Moraxella. catarrhalis and Staphylococcus aureus and their antibiotic susceptibility when colonizing the nasopharynx and/or causing acute otitis media in the years 2015-2025. The goal will be to recruit children into a prospective group beginning at 6 months of age and followed to 36 months of age in suburban Rochester, New York. Nasopharyngeal and nasal wash samples will be obtained at each well child visit and at acute otitis media (AOM) episodes. Middle ear fluid will be obtained from every child with an acute otitis media episode who undergoes a tympanocentesis procedure. All of the nasopharyngeal and middle ear fluid samples collected will be tested by standard microbiologic techniques to identify the presence of 4 potential otopathogens (S. pneumoniae, H. influenzae, M. catarrhalis and S. aureus). All S. pneumoniae will undergo serotyping and antibiotic susceptibility testing. All samples that are culture negative will be evaluated with a multi-locus PCR test to examine for presence of potential otopathogens.

Eligibility criteria: Inclusion Criteria:

Healthy Children:

* Male or female age greater than/equal to 6 months or less than/equal to 36 months old.
* Parent/guardian willing to bring to all study visits

Exclusion Criteria:

* Any major illness/condition that in investigator opinion would put subject at risk during study.
* Otorrhea or tympanostomy tubes present in either ear @ time of enrollment.
* Direct descendant of study site personnel.
* Subjects \< 6 months old or \>36 months old at the time of enrollment

Primary outcomes:
measure: The distribution of bacteria causing acute otitis media.
timeFrame: 10 years
Secondary outcomes:
measure: The distribution of potential otopathogens colonizing the nasopharynx.
timeFrame: 10 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
Study officials:
affiliation: Rochester General Hospital
name: Michael E Pichichero, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06331663: SPI and Remifentanil in Skull Pin Fixation
Official title: To Explore the Optimal Dose of Remifentanil for Skull Pin Fixation Under Surgical Pleth Index Monitor in Intracranial Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Pain, Procedural
Keywords: remifentanil, pain, surgical pleth index
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Forty patients were enrolled, and all patients used total intravenous anesthesia (remifentanil-propofol based total intravenous analgesia) as anesthesia induction and maintenance. According to the preliminary data of this department, patients who underwent intracranial surgery for skull pin fixation used remifentanil 5.0-6.0 ng/ml, while the hemodynamics is relatively stable. Therefore, when this plan is implemented, the patient needs to be under the same depth of anesthesia (monitored by electroencephalography, maintaining a value of 40-60), first start with remifentanil 5.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. Inadequate antinociception (Surgical Pleth Index(SPI) \> 80 and hyperdynamics (the increased heart rate (HR) and mean blood pressure (MBP) above 20% of baseline or HR\>100bpm and arterial blood pressure(ABP)\>180/100mmHg)) is defined as failure, therefore we increase remifentanil by 0.5 ng/ml; otherwise, the setting is considered successful without abovementioned situations.

Data collection: heart rate, mean blood pressure, Surgical Pleth Index, bispectral Index, pulse pressure variance, systolic pressure variance, concentrations of propofol and remifentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed.


Eligibility criteria: Inclusion Criteria:

1. Must be at least 20 years old and less than 80 years old
2. With anesthesia risk grade below grade three (including grade three) (ASA I\~III).
3. Patients who are expected to undergo intracranial surgery for skull pin fixation

Exclusion Criteria:

1. Those with anesthesia risk classification ASA class IV or higher
2. Those who are allergic to opioid analgesics or propofol drugs
3. Emergency patients

Primary outcomes:
measure: 50% effect concentration of remifentanil
timeFrame: peri-fixation period
measure: 90% effect concentration of remifentanil
timeFrame: peri-fixation period
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
References:
Clinical trial NCT01594463: Routine Ultrasound Screening in the Third Trimester
Official title: Third Trimester Routine Ultrasound in Low-risk Pregnancies : Comparison of Two Timing Periods Procedure for Screening Intrauterine Growth Restriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Growth Retardation
High-Risk Pregnancy
Keywords: Intrauterine growth restriction
Screening
Ultrasound
Perinatal morbidity
Maternal complications
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2012-05-09
Enrollment: 3760
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Late intrauterine growth restriction is infrequently diagnosed with an overall sensitivity of 40 % in low-risk pregnancies. In addition, late intrauterine growth restriction may be associated with intrauterine death and poor neonatal outcomes i.e. birth asphyxia and hospitalization in intensive care unit. The investigators hypothesis that a later third trimester routine ultrasound may be more accurate to diagnose late intrauterine growth restriction.


Eligibility criteria: Inclusion Criteria:

* Accurate gestational dating using crown-rump length at 11-14 weeks
* Singleton pregnancy
* Primiparity
* Normal First trimester (11-14 weeks) and second trimester (20-25 weeks) scans
* Maternal age \> 18 years
* No maternal opposition for the study

Exclusion Criteria:

* Maternal diseases i.e. chronic renal disease, hypertension, diabetes, collagen vascular disease, antiphospholipid syndrome
* Pregnancies with congenital anomalies or foetal growth restriction diagnosed before 30 weeks of gestation

Primary outcomes:
measure: Number of small for gestational age infant screened by a routine ultrasound in the third trimester (sensitivity).
timeFrame: At birth
Secondary outcomes:
measure: Number of neonate with a customized birth weight upper the tenth percentile adequately screened by a routine ultrasound in the third trimester (specificity).
timeFrame: At birth
measure: Number of prenatal consultations, ultrasound scans performed, maternal hospitalization, labor induction, and caesarean section induced by the third trimester routine ultrasound
timeFrame: After the delivery
measure: Maternal complications and neonatal outcomes.
timeFrame: In the postpartum period
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Eric VERSPYCK, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01951963: Sub-dissociative Ketamine for the Management of Acute Pediatric Pain
Official title: Sub-dissociative Ketamine for the Management of Acute Pediatric Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: pain management
ketamine
morphine
pediatrics
emergency medicine
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2013-09-27
Enrollment: 77
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed trial is a prospective, double blinded, randomized control trial with the primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease the total narcotic requirements of pediatric patients requiring intravenous analgesia in an urban emergency department (ED) compared to a group of patients who receive morphine alone for pain management. Patients are randomized to receive either a single bolus of ketamine (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). All subsequent pain management will be accomplished using morphine. Patient, family member, and research staff pain scores will be recorded, until 3 hours post study medication administration. Family members are contacted via telephone 24 hours post-ED discharge, and again at 7 days post-hospital discharge, for evaluation via Post Hospitalization Behavior Questionnaire. Narcotic equivalents will be calculated for up to 3 hours post study medication administration and compared between the ketamine and morphine groups.


Eligibility criteria: Inclusion Criteria:

* Age: 3-17 years old
* Condition (medical or trauma) requiring opioid pain management per standard of care
* Need to establish an IV per standard of care
* Treating physician agrees to manage the patient's pain with morphine following randomization.

Exclusion Criteria:

* Trauma Team Activation
* Known allergy to ketamine
* Family member unable/unavailable to provide informed consent
* When appropriate, patient unwilling to provide assent
* High suspicion of injury related to child abuse
* Patient and/or family member is non-English speaking
* Patient is incarcerated

Primary outcomes:
measure: Cumulative Narcotic Consumption
timeFrame: 3 hours post study drug administration
measure: Adverse Drug Reaction
timeFrame: 3 hours post study drug administration
Secondary outcomes:
Other outcomes:
measure: Pain Scale Rating Agreement Among Patient, Parent, and Research Staff
timeFrame: Up to 3 hours post pain medication administration
Locations:
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
Study officials:
affiliation: Regions Hospital
name: Aaron M Burnett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04886063: Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
Official title: Open-Label Extension of Studies ATH-1017-AD-0201 and ATH-1017-AD-0202 in Subjects With Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Alzheimer Disease
Keywords: Alzheimer's
Dementia
ATH-1017
Open Label
Lead sponsor: Athira Pharma
Sponsor class: INDUSTRY
First posted: 2021-05-13
Enrollment: 423
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label extension
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the safety and tolerability of fosgonimeton (ATH-1017) in subjects with mild to moderate Alzheimer's disease who completed the 26-week randomized treatment in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202.

Detailed description: This is a multicenter, seamless, open-label extension (OLEX) study of ATH-1017 treatment in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease who completed 26 weeks treatment in the randomized, placebo-controlled, double-blind studies, ATH-1017-AD-0201 and ATH-1017-AD-0202. This OLEX study will provide additional, longer-term safety and tolerability information on ATH-1017 administration up to 48 months in subjects with mild to moderate Alzheimer's disease.

Eligibility criteria: Inclusion Criteria:

* Subject has completed the Week 26 visit of either of the two blinded parent studies (ATH-1017-AD-0201 or ATH-1017-AD-0202).
* Reliable and capable support person/caregiver who is willing to accept responsibility for supervising the daily treatment or, if required, administering study drug.
* Subject capable of giving signed informed consent, or by a legally acceptable representative.
* Subjects must be in generally good health.
* Male subjects and their partners must agree to continue to use a double-barrier method of contraception during the study, including the follow-up period, unless the partner is not of childbearing potential.

Exclusion Criteria:

* Subject has experienced a serious adverse event during the parent study, which could present an increased safety risk during the open label extension.
* New diagnosis of severe major depressive disorder even without psychotic features.
* Any subject with formalized delusions or hallucinations.
* Significant suicide risk.
* Newly-diagnosed malignant tumor, except for the following conditions that are stable in the judgement of the investigator:

  * Adequately treated squamous and basal cell carcinoma, or squamous and basal cell carcinoma in situ
  * Prostate carcinoma in situ

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 173 weeks (study termination)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester-AD-CARE Program
state: New York
Study officials:
References:
Clinical trial NCT05632263: Evaluate the Predictive Impact of the EHMRG
Official title: Evaluate the Predictive Impact of the EHMRG Score for Patients Admitted to the Emergency Department With Final Diagnosis of Acute Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergencies
Heart Diseases
Keywords: EHMRGscore
ACUTE HEART FAILURE
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is a prospective cohort study carried out in the ED of Monastir over a period from February 2009 to September 2020 which included patients admitted to the ED with a discharge diagnosis of AHF.

Brief summary: External validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department

Detailed description: It is a prospective cohort study carried out in the ED of Monastir which included patients admitted to the ED with a discharge diagnosis of AHF.

Eligibility criteria: Inclusion Criteria:

* Patients consulted for acute dyspnea and were diagnosed with acute heart failure.
* Major patient.
* Subject who accept to participate in the research.

Exclusion Criteria:

* Patient who refuse to participate in the study.
* Impossibility of giving the patient informed information

Primary outcomes:
measure: EHMRGscore
timeFrame: 7days
Secondary outcomes:
measure: Re-admission rate 30-day re-admission rate
timeFrame: 30days
measure: Mortality rate Mortality rate at 30 days
timeFrame: 30day
Other outcomes:
Locations:
Study officials:
affiliation: University of Monastir
name: Nouira Semir, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03098563: Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis
Official title: Maximizing Analgesia to Reduce Pain Sensitivity in Chronic Knee Osteoarthritis Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Osteoarthritis
Keywords: Clinical Trial
Phase II
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-04-04
Enrollment: 58
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will include 4 sessions. Participants will be randomly assigned to the order in which they receive one drug (or combination of drugs) per session at each study visit.
Primary purpose: BASIC_SCIENCE

Brief summary: This research is being done to evaluate whether combining medications that are FDA approved, but have not yet been approved for combination treatment, can be effective in reducing pain.

Detailed description: This study will evaluate whether a combination of pharmacotherapies can effectively alleviate pain. Subjects will complete two screening sessions before completing four study sessions that will occur once weekly. Participants will receive double blind doses of study medications the morning of each experimental session day and will undergo standardized pain testing, physical functioning assessment, blood draws, ratings of drug effects and cognitive testing.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of knee osteoarthritis
* Urine sample tests negative for common illicit substances of abuse (e.g., cannabis)
* Medically cleared to take study medications
* Are not pregnant or breast feeding
* Willing to comply with the study protocol.

Exclusion Criteria:

* Pain other than Knee Osteoarthritis
* Taking opioids for pain
* Prescribed and taking gabapentinoid, Tricyclic Antidepressants (TCA), venlafaxine, duloxetine, stimulants or benzodiazepines
* Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event
* Known allergy to the blinded study medications

Primary outcomes:
measure: Largest Change From Baseline on Clinical Pain Rating
timeFrame: 8 hour study session
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Claudia M Campbell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Kelly E Dunn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: