louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01709929: Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus
Official title: A Multicentre, Open Label, Nonrandomised, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-10-18
Enrollment: 2287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in North America. The aim of this trial is to evaluate the safety of insulin detemir for the treatment of diabetes.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 1 or type 2 diabetes
* Using a basal/bolus insulin regimen

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
* Subjects who previously enrolled in this study
* Subjects with a hypersensitivity to insulin detemir or to any of the excipients

Primary outcomes:
measure: Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events
Secondary outcomes:
measure: Number of adverse events (all and serious)
measure: Number of all hypoglycaemic events
measure: Change in weight
measure: HbA1c (glycosylated haemoglobin)
measure: Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22)
Other outcomes:
Locations:
city: Mississauga
country: Canada
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00298129: Autonomic Imbalance and 24-h Blood Pressure Change in Patients With Chronic Renal Disease
Official title: Autonomic Imbalance and 24-h Blood Pressure Change in Patients With Chronic Renal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Essential Hypertension
Renal Failure
Chronic Nephropathy
Lead sponsor: Yokohama City University Medical Center
Sponsor class: OTHER
First posted: 2006-03-01
Enrollment: 278
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY
Time perspective: PROSPECTIVE

Brief summary: Many patients with chronic renal disease show a loss of the nocturnal decline of blood pressure (non-dipper). However, the mechanism is not yet fully understood. We evaluate 24-hour blood pressure in patients with chronic renal disease using an ambulatory blood pressure monitoring device (A \& D TM2425). We also analyze the power spectrum of heart rate variability as an index of autonomic cardiovascular modulation using the same device.

Detailed description: The ratio of lower frequency (LF) and higher frequency (HF) heart rate rhythmic oscillations is expressed as an index of sympathovagal balance. Patients with chronic renal disease participate in the study. Blood pressure and power spectrum of heart rate variability for 24 hours are measured when they receive no medication for at least 1 week. The mean waking and sleeping time systolic and diastolic blood pressure are calculated. LF/HF ratios in the chronic renal disease are evaluated to calculate the waking/sleeping ratio for LF/HF.

Eligibility criteria: Inclusion Criteria:

* Hypertensive patients with diabetes mellitus
* Hypertensive patients
* Hypertensive patients with renal disease
* Patients with chronic renal disease

Exclusion Criteria:

* Cardiac, hematologic or hepatic disease
* Cerebral infarction or hemorrhage
* Other major diseases.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Yokohama City University Center Hospital
Study officials:
affiliation: Yokohama City University Center Hospital
name: Gen Yasuda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yasuda G, Nagasawa T, Umemura S, Shionoiri H, Ishii M. The impaired control of plasma renin activity in hypertensive patients with end-stage renal disease due to chronic glomerulonephritis. Clin Nephrol. 1994 Nov;42(5):300-8.
Clinical trial NCT05414929: Acceptability of HPV Self-sampling Among Canadian Women Aged 21 to 65
Official title: Prévention du Cancer du Col de l'UTÉrus Par dépistage d'Une Infection Partageable Sexuellement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HPV Infection
Cervical Cancer Screening
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 400
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: We propose a cross-sectional study to explore the acceptability and feasibility of HPV self-sampling among Quebec women. The study will invite eligible women to self-sample for HPV at home. The HPV risk factors of patients included in the study will be taken into consideration (vaccination, smoking, number of partners, date of last screening, etc.).


Eligibility criteria: Inclusion Criteria:

* Speak and understand French without help

  * Have internet access (for completing forms)
  * Have a mailing address

Exclusion Criteria:

* Known positive HPV status • Have already had a hysterectomy

Primary outcomes:
measure: Evaluate the acceptability of HPV self-sampling by patients
timeFrame: 2 months following recruitment
Secondary outcomes:
measure: Evaluate the percentage of samples collected correctly by patients
timeFrame: 2 months following recruitment
measure: Evaluate the return rate of mailed kits
timeFrame: 2 months following recruitment
measure: Calculate the HPV positivity rate in a population sample
timeFrame: 2 months following recruitment
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
References:
Clinical trial NCT01863329: Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasound Before and After Drainage of Cerebrospinal Fluid in Patient With Hydrocephalus
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hydrocephalus
Keywords: Optic nerve sheath diameter
Hydrocephalus
Intracranial hypertension
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-05-27
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with hydrocephalus

Brief summary: Studies in patients with intracranial hypertension have shown a good relationship between optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.


Eligibility criteria: Inclusion Criteria:

1. ASA Ⅰ-Ⅱ
2. aged between 20 and 70 year
3. hydrocephalus
4. general anesthesia for undergoing drainage of cerebrospinal fluid

Exclusion Criteria:

1. an anatomical or functional abnormality in optic nerve

Primary outcomes:
measure: both optic nerve sheath diameter (the posterior 3mm of the papilla)
timeFrame: from induction of general anesthesia to average 15 min after recovery of general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT02705729: Clinical Performance of Posterior Glass Ionomer Restorations in Adolescents (KETAC)
Official title: Clinical Performance of a Newly Developed Glass Ionomer Restorative Material for Posterior Restorations in an Adolescent Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: dental caries
proximal surfaces
posterior teeth
carious lesions
tooth diseases
dental restorations
glass-ionomer
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
Collaborators: name: 3M Oral Care
First posted: 2016-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether two tooth-colored glass ionomer materials are effective for load-bearing dental fillings.

Detailed description: In this post-market longitudinal prospective randomized control clinical trial, posterior class II restorations will be evaluated for their clinical performance. The study will investigate the efficacy of two high-strength glass ionomer restorative materials for a period of up to 3 years.

Eligibility criteria: Criteria:

* Inclusion Criteria:
* needs 2 Class II posterior restorations
* in good health
* sufficient oral hygiene
* vital tooth
* caries in the outer and/or middle third of dentin
* teeth must have at least one proximal contact to be restored
* isthmus is less than half the intercuspal distance
* has one or more enamel-supported antagonistic contact.
* both study restorations are not in contact with each other

Exclusion Criteria:

* pregnant or breast feeding
* erosion/eating disorders
* bruxism/traumatic malocclusion
* pulpitis
* cusp replacement
* radiographic bone loss/increased tooth mobility

Primary outcomes:
measure: Restoration survival
timeFrame: 3 years
Secondary outcomes:
measure: Clinical Performance of restoration and restored tooth
timeFrame: 3 years
measure: Additional Collection of Adverse Events Data
timeFrame: 3 years
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Lousiana State University Health Science Center, School of Dentistry
state: Louisiana
Study officials:
affiliation: LSUHSC School of Dentistry
name: Mathilde C Peters, DMD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01707329: Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Progressed After Icotinib Treatment
Official title: A Phase II Randomised, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Who Have Progressed After Icotinib Treatment in NSCLC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-10-16
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase II randomised, double blind, placebo controlled, multicentre trial is designed to assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy alone in patients who have progressed after benefiting from previous second or third-line icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
* No previous targeted treatment such as gefitinib, erlotinib.
* With a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)and \>=20mm with conventional CT) according to RECIST Criteria
* WHO performance status(PS)\<= 2
* N\>=1.5×109/L, Plt\>=1.0×109/L,Hb\>=10g/dL;AST\&ALT should \<3ULN(without liver metastasis) or \<5ULN(with liver metastasis).TBIL\<=1.5ULN.
* Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

* Allergic to icotinib
* Patients with metastatic brain tumors with symptoms.
* Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
* Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Province Tumor Hospital
state: Hunan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Medical School of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Zhang Yi Ping, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01641029: Community-Associated Uropathogen Antimicrobial Resistance Among Emergency Department Patients With Acute Pyelonephritis
Official title: Surveillance and Risk Factor Analysis of Community-Associated Uropathogen Antimicrobial Resistance Among Emergency Department Patients With Acute Pyelonephritis in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pyelonephritis
Lead sponsor: Olive View-UCLA Education & Research Institute
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Merck Sharp & Dohme LLC
First posted: 2012-07-16
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from ten U.S. university-affiliated medical center emergency departments participating in a CDC-collaborative emerging infections sentinel network, EMERGEncy ID NET. Patients presenting with symptoms of acute uncomplicated pyelonephritis will be enrolled by treating physicians or study coordinators.

Brief summary: Pyelonephritis is a serious infection that manifests with fever, back pain, nausea, and vomiting. In the U.S., it is estimated that there are 20 cases of pyelonephritis per 10,000 annually, with the highest incidence in young women. Escherichia coli (E. coli) causes over 80% of these infections. Over the last two decades, E. coli resistance has emerged to commonly prescribed antimicrobials, such as ampicillin and trimethoprim-sulfamethoxazole (TMP/SMX). Most recently, resistance to fluoroquinolones and strains producing extended-spectrum beta-lactamases (ESBL) have been observed. In order to better understand the evolution and current state of antibiotic resistance among E. coli urinary tract isolates so as to better inform treatment decisions, the investigators propose to conduct an investigation to: a) determine the prevalence of antimicrobial resistance among E. coli causing acute pyelonephritis in various patient groups, and specifically healthy community-dwellers with uncomplicated infections, b) determine the specific prevalence of fluoroquinolone-resistance and ESBL-producing E. coli, and c) determine potential risk factors for fluoroquinolone and ESBL-producing E. coli infections.


Eligibility criteria: Inclusion Criteria:

* patients \> 18 years of age with flank pain and/or costovertebral angle tenderness
* documented temperature in the emergency department of ≥38°C/100.4°F by any method of measurement,
* documented temperature in the emergency department of ≥38°C/100.4°F by any method of measurement,

Exclusion Criteria:

* complicated pyelonephritis

Primary outcomes:
measure: Prevalence of antimicrobial resistant E. coli in the U.S.
timeFrame: July 2013-July 2014
Secondary outcomes:
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
Study officials:
References:
Clinical trial NCT02413229: A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study
Official title: A Randomized Double Blind Vehicle Controlled Dose Ranging Multiple Site Phase 2 Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Moderate to Severe Scalp Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2015-04-09
Enrollment: 151
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and a Placebo in patients with moderate to severe scalp psoriasis.

Detailed description: This randomized, double-blind, vehicle-controlled, dose-ranging, parallel-group multi-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS, for the treatment of moderate to severe scalp psoriasis at different application times up to 30 minutes.

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant, non-lactating females age 12 and older.
* Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's Global Assessment score of at least 3 at screening.

Exclusion Criteria:

* Under 12 years of age.
* Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other concomitant topical therapies during the study.
* Has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp.

Primary outcomes:
measure: Clinical Response of Success
timeFrame: 28 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: http://www.novumprs.com/contact
name: Novum Pharmaceutical Research Services
role: STUDY_CHAIR
References:
Clinical trial NCT02375529: A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy
Official title: Estudio Prospectivo Aleatorizado de la colecistectomía laparoscópica Por Puerto único vs colecistectomía laparoscópica Por Cuatro Puertos en Pacientes Con Colelitiasis sintomática y régimen de cirugía Sin Ingreso.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholelithiasis
Lead sponsor: Consorci Sanitari Integral
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Single-incision laparoscopic cholecystectomy (SILC) is increasingly being used as a minimally invasive surgery with potential benefits over 4-port laparoscopic cholecystectomy (LC) in terms of postoperative pain and faster recovery.

Methods: Seventy-three patients with symptomatic cholelithiasis were randomized to SILC (n=37) or LC (n=36). Data measures included operative details, adverse events, postoperative pain and analgesic requirements, success of the ambulatory process, return to normal activity and return to work, cosmetic results and quality of life score.


Eligibility criteria: Inclusion Criteria:

* age higher than 18 and lower than 80
* American Society of Anesthesiologists class (ASA) I-II,
* absence of any previous anesthetic complication,
* accompaniment by a responsible adult during 24 hours,
* symptomatic gallstones candidate to cholecystectomy
* and a signed informed consent.

Exclusion Criteria:

* a Body Mass Index (BMI) higher than 35,
* any laparoscopic contraindication,
* acute cholecystitis background, suspect of Mirizzi's Syndrome, common duct stones or malignancy,
* anti-inflammatory allergy
* psychiatric history that could hinder ambulatory procedure

Primary outcomes:
measure: evolution of postoperative pain
timeFrame: 2, 4, 6 and 8 postoperative hours, 1, 3, 7 and 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01192529: Evaluation of a Diet in Patients With Senile Dementia
Official title: Clinical Evaluation of an Specific Diet for People With Dementia Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Disease
Parkinson's Disease
Senile Dementia
Keywords: Senile
Dementia
Neurodegenerative
Supressi
Specific diet
Cognitive Status
Memory
Malnutrition
Parkinson
Alzheimer
Lead sponsor: Vegenat, S.A.
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 184
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The most common symptoms associated to senile dementia disease are confusion about schedules, hyperactivity... In this sense, these patients have frequently poor nutrition, resulting in malnutrition problems or malnutrition high risk.

Detailed description: The purpose of this study is to assess if the daily intake of a specific nutritional supplement versus a non specific supplement one is related to malnutrition or malnutrition risk reduction and contributes to an improvement in cognitive and functional parameters in patients with senile dementia.

Eligibility criteria: Inclusion Criteria:

* Patients over 70 years with neurologist or geriatrician dementia diagnosis (Alzheimer's disease, Parkinson's or mixed), with mild or moderate cognitive impairment degree (Between 24 and 14 MMSE).
* Patients with or at malnutrition risk (Mini Nutritional Assessment screening positive)

Exclusion Criteria:

* Patients with decompensated kidney failure, creatine and/or bilirubin greater than 2, uric acid higher than 8 mg/dl, and glomerular filtration under 60 ml/minute.
* Patients with Diabetes mellitus poorly controlled (Glycemia \> 200 mg/dl)
* Patients with decompensated hypertension.
* Patients with pharmacological treatment or consuming supplements containing specific supplementation of experimental product (omega 3 and/or vitamins supplements).
* Post-stroke vascular dementias.
* Do not achieve any inclusion criteria.

Primary outcomes:
measure: Nutritional and cognitive status in elderly people
timeFrame: 1 year
Secondary outcomes:
measure: Biochemical parameters measure
timeFrame: 8 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves
city: Granada
country: Spain
facility: Department of Biochemistry and Molecular Biology II. University of Granada
city: León
country: Spain
facility: Neurological Unit, Complejo Asistencial de León
Study officials:
affiliation: Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves
name: Antonio J Pérez de la Cruz, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Biochemistry and Molecular Biology II. University of Granada
name: Ángel Gil Hernández, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurological Unit, Complejo Asistencial de León
name: Adrián Arés Luque, MD
role: PRINCIPAL_INVESTIGATOR
References: