louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01548235: Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting or Switching to Biphasic Insulin Aspart 30 Treatment
Official title: A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus, Starting or Switching to NovoMix® 30 Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-08
Enrollment: 423
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who started insulin therapy with biphasic insulin aspart 30 and subjects who switched from other insulin regimens to biphasic insulin aspart 30 by prescription of their physician as part of routine clinical practice in order to improve glycemic control.

The selection of patients was at the discretion of the treating physician.

Brief summary: This study is conducted in Europe. The aim of this study is to investigate safety and efficacy in subjects with type 2 diabetes mellitus starting or switching to biphasic insulin aspart 30 (NovoMix® 30) treatment.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes

Primary outcomes:
measure: Incidence of SADR (serious adverse drug reactions) including major hypoglycaemia
Secondary outcomes:
measure: Change from baseline in HbA1c (glycosylated haemoglobin)
measure: Mean FPG (fasting plasma glucose)
measure: Overall, daytime and nocturnal frequency of hypoglycaemic events
Other outcomes:
Locations:
city: Copenhagen S
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Breum L, Almdal T, Eiken P, Lund P, Christiansen E; Danish BIAsp Study Group. Initiating or switching to biphasic insulin aspart 30/70 therapy in subjects with type 2 diabetes mellitus. An observational study. Rev Diabet Stud. 2008 Fall;5(3):154-62. doi: 10.1900/RDS.2008.5.154. Epub 2008 Nov 10.
Clinical trial NCT04176835: Oxytocin and Social Decision Making in Schizophrenia
Official title: Neurobiological Effects of Oxytocin on Social Decision Making in Schizophrenia: A Pharmacological MRI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: National Institute of Mental Health and Neuro Sciences, India
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 55
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: schizophrenia patients and healthy volunteers will be included. Subjects who meet the inclusion and exclusion criteria for the study will be recruited. After completion of clinical assessments and neuropsychological assessments, all subjects will undergo two fMRI scans. In one scan subjects will receive a single dose of intranasal oxytocin and in another scan, they will receive intranasal saline. The order of administration of oxytocin or saline will be counterbalanced so that they are not administered in the same order to all subjects. Subjects will be blind to the drug administered.


Eligibility criteria: Schizophrenia group -

Inclusion Criteria:

1. Males between 18 and 45 years with at least 7 years of education
2. The DSM-IV diagnosis of Schizophrenia or schizoaffective or schizophreniform disorder
3. capacity to provide informed consent

Exclusion Criteria:

1. Current comorbid DSM-IV axis I diagnosis
2. General impaired intellectual functioning
3. history of alcohol or substance abuse or dependence in the last 12 months
4. contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
5. past history of head injury resulting in loss of consciousness or neurosurgery
6. concomitant severe medical conditions
7. metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.

Healthy volunteers:

Inclusion Criteria:

1. Males between 18 and 45 years with at-least 7 years education
2. Capacity to provide informed consent
3. absence of past or present psychiatric illnesses including substance abuse/dependence

Exclusion criteria:

1. General impaired intellectual functioning
2. contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
3. past history of head injury resulting in loss of consciousness or neurosurgery
4. concomitant severe medical conditions
5. metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.
6. Family history of schizophrenia or schizoaffective or schizophreniform disorder in a first-degree relative

Primary outcomes:
measure: fMRI changes with oxytocin while performing ultimatum game and at rest
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05697835: Perioperative Mental Health in Orthopedic Surgery
Official title: Behavioral Activation and Medication Optimization for Perioperative Mental Health in Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Surgery
Older Adults
Depression
Anxiety
Keywords: Behavioral: Behavioral activation
Medication optimization
Care as usual
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-01-26
Enrollment: 104
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid Type 1 effectiveness-implementation randomized controlled trial design
Primary purpose: TREATMENT

Brief summary: This Hybrid 1 Study will test the effectiveness of a bundled intervention comprised of behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing Orthopedic surgery (compared with usual care), while examining implementation outcomes.


Eligibility criteria: Inclusion criteria:

* Adults ≥ 60 years
* Scheduled primary hip or primary knee arthroplasty procedure
* PHQ-ADS ≥ 10, indicating clinically significant depression or anxiety symptoms

Exclusion criteria:

* Barrier to communication (Unable to read, speak, and understand English)
* Severe cognitive impairment screened by the SBT (Short Blessed Test) \>10
* Acutely suicidal
* Previous participation in this study or another CPMH study of the intervention bundle or its feasibility.

Primary outcomes:
measure: PHQ-ADS
timeFrame: 3 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ryan Calfee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03240835: The Function of PA, RBP and TRSF in Malnutrition Detecting and Nutritional Status Monitoring for NPC Patients
Official title: The Function of Pre-Albumin, Retinol Conjugated Protein and Transferrin in Early Malnutrition Detecting and Nutritional Status Dynamic Monitoring for Local Advanced Nasopharyngeal Carcinoma Patients With Chemoradiotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Malnutrition
Keywords: pre-Albumin
Retinol Conjugated Protein
Transferrin
Locoregionally Advanced Nasopharyngeal Carcinoma
nutrition
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Wu Jieping Medical Foundation
First posted: 2017-08-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: III-IVb(Union for International Cancer Control,UICC 8th) NPC patients with histologic diagnosis of World Health Organization(WHO) II/III

Brief summary: The purpose of this study is to study the function of pre-albumin, retinol conjugated protein and transferrin in early malnutrition detecting and nutritional status dynamic monitoring for local advanced nasopharyngeal carcinoma patients with chemoradiotherapy.


Eligibility criteria: Inclusion Criteria:

* Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
* All genders，range from 18～60 years old
* Karnofsky performance status(KPS) ≥ 80
* Clinical stage III\~IVb(UICC 8th)
* Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease
* Without significant cardiac，respiratory，kidney or liver disease
* Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy)
* white blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 10g/L, platelet(PLT) count ≥ 100×109/L
* alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 1.5×upper limit of normal(ULN), bilirubin \< 1.5×ULN, alanine aminotransferase (CCR) ≥ 30ml/min
* Inform consent form

Exclusion Criteria:

* Distance metastases
* Second malignancy within 5 years
* Drug or alcohol addition
* Do not have full capacity for civil acts
* Active systemic infections
* Chronic consumptions
* Mental disorder
* Pregnancy or lactation
* Concurrent immunotherapy or hormone therapy for other diseases
* Severe complication, eg, uncontrolled hypertension

Primary outcomes:
measure: changes of PA/RBP/TRSF
timeFrame: baseline and during treatment
Secondary outcomes:
measure: Change of Body weight
timeFrame: baseline and during treatment
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: baseline and during treatment
measure: Acute Toxicity
timeFrame: baseline and during treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT00756535: Exercise Training in a Geriatric Hospital Ward
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frail Elderly
Keywords: Exercise Therapy
Length of Stay
Disability Evaluation
Lead sponsor: Health Center of the City of Joensuu
Sponsor class: OTHER
First posted: 2008-09-22
Enrollment: 160
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to describe the effects of physical exercise consisting of strength, balance and flexibility training on functional abilities and the length of stay in older (+75) patients hospitalized in a primary-care health- center hospital.

Detailed description: Hospitalization of older people is connected with several adverse events. Hospitalization increases the risk of disability and long-term institutionalization. Immobilization during hospitalization can lead to deterioration of muscle strength and falls. Earlier studies have shown that strength training is beneficial even in the oldest old. Rehabilitation based on strength training exercises can prevent decline in functional capacity and shorten the length of hospitalization.

Eligibility criteria: Inclusion Criteria:

* age 75 years or older
* ability to walk independently or assisted or move unassisted in a wheelchair

Exclusion Criteria:

* patients in long-term care
* those who are bedridden
* severe circulatory disease
* acute bone fracture
* terminal disease
* acute infection.

Primary outcomes:
measure: Changes in functional abilities during hospitalization
timeFrame: at the discharge from the hospital
Secondary outcomes:
measure: The length of stay in the hospital
timeFrame: at the discharge from the hospital
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: Health Center of the City of Joensuu
state: North Karelia
city: Joensuu
country: Finland
facility: Siilainen Hospital ward 1A
state: North Karelia
Study officials:
References:
citation: Rydwik E, Frandin K, Akner G. Effects of physical training on physical performance in institutionalised elderly patients (70+) with multiple diagnoses. Age Ageing. 2004 Jan;33(1):13-23. doi: 10.1093/ageing/afh001.
Clinical trial NCT04998435: Paravertebral Block Versus Erector Spinae Plain Block In Percutaneous Nephrolithotomy
Official title: Ultrasound-Guided Paravertebral Block Versus Erector Spinae Plain Block For Perioperative Analgesia In Adults Undergoing Percutaneous Nephrolithotomy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stone
Nephrolithiasis
Analgesia
Anesthesia
Keywords: Erector spinae plain block
Paravertebral block
Ultrasound-guided
Percutaneous nephrolithotomy
Analgesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 50
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: SUPPORTIVE_CARE

Brief summary: Nowadays, Percutaneous Nephrolithotomy (PCNL) has been the surgical procedure of choice for renal stones larger than 2cm or staghorn stones. Yet, the associated postoperative pain is a major drawback. The regional anesthetic management of pain in PCNL operation has been of great concern. The introduction of ultrasound guided erector spinae plane block and paravertebral plane block has been under great focus regarding the efficacy of postoperative pain management. Paravertebral plane block (PVB) is a regional nerve block technique that depends on local anesthetic injection adjacent to the vertebra to block spinal nerve roots in a dermatomal distribution. Erector spinae plane block (ESPB) is a newer regional anesthesia technique that depends on injecting local anesthetic (LA) in a plane between the transverse process and erector spinae muscle. The LA diffuses into the paravertebral space and spreads on both rami (dorsal and ventral) of spinal nerves through spaces between adjoining vertebrae.

The aim of this study is to compare the effect of ultrasound guided Paravertebral blockade versus Erector spinae blockade on postoperative opioid use as well as postoperative pain control in patients undergoing unilateral PCNL.


Eligibility criteria: Inclusion Criteria:

* ASA I - II.
* Patients undergoing unilateral percutaneous nephrolithotomy (PCNL) surgery under general anesthesia.

Exclusion Criteria:

* Patient refusal.
* Uncooperative patients.
* Allergy to local anesthetics.
* Infection or anatomical abnormality at injection site.
* Coagulopathy.
* Bilateral PCNL.
* Spinal anesthesia or any other regional anesthesia.
* Block failure: the block will be considered a failed block if the patient requires more than two doses of rescue analgesia in the first hour postoperatively.

Primary outcomes:
measure: Morphine consumption.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University.
name: Atef K Salama, MD
role: STUDY_DIRECTOR
affiliation: Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University.
name: Nazmy S Michael, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00140335: Evaluation of a Handwashing Promotion Program in Chinese Elementary Schools
Official title: Evaluation of a Handwashing Promotion Program in Chinese Elementary Schools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Communicable Diseases
Keywords: handwashing
communicable diseases
health education
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Procter and Gamble
name: Centers for Disease Control and Prevention, China
name: Fujian Province CDC
First posted: 2005-09-01
Enrollment: 5000
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effects of a commercial hand washing promotion program on hygiene knowledge, attitudes, and practices, and on health outcomes such as reported infectious illnesses and school absences.

Detailed description: Diarrheal and respiratory diseases cause 3.8 million deaths annually among children in the developing world. Reduced rates of these diseases have been measured during intensive, home-based handwashing interventions. We evaluated a school-based handwashing program for 1st grade students to determine whether a more scalable intervention could also reduce illness rates, and impact hygiene knowledge and attitudes.

Thirty schools from each of 3 counties in Fujian Province, China, were randomized to one of the following groups: a) control; b) standard intervention, which included a handwashing program (1 hour of hygiene instruction and 1 soap sample kit per pupil); or c) expanded intervention, which included the handwashing program, soap for school sinks and 1 peer hygiene monitor per class. Teachers collected illness symptom information from students weekly and recorded student absences daily between January and April, 2005. Mean illness and absence rates were calculated for each school. Students were given a knowledge, attitudes, and practices questionnaire before the intervention and again 5 months later.

Eligibility criteria: Inclusion Criteria:

* school has running water

Exclusion Criteria:

* school has not previously received commercial handwashing promotion program

Primary outcomes:
measure: student illness rates
measure: student absence rates
Secondary outcomes:
measure: teacher illness rate
measure: changes in student hygiene knowledge
measure: changes in student hygiene attitudes
measure: changes in school water use
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Province CDC
state: Fujian
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Anna B Bowen, MD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT00196235: Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Diabetes Mellitus
Official title: Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: Assessment, Risk
Diabetes mellitus
Autonomic nervous system
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study was to evaluate the performance of established and new risk predictors in predicting mortality in post-infarction patients suffering from diabetes mellitus


Eligibility criteria: Inclusion Criteria:

acute myocardial infarction, presence of sinusrhythm

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Munich
country: Germany
facility: 1. Medizinische Klinik, Klinikum rechts der Isar
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Georg Schmidt, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Petra Barthel, MD
role: STUDY_DIRECTOR
affiliation: Deutsches Herzzentrum Muenchen
name: Axel Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt G, Malik M, Barthel P, Schneider R, Ulm K, Rolnitzky L, Camm AJ, Bigger JT Jr, Schomig A. Heart-rate turbulence after ventricular premature beats as a predictor of mortality after acute myocardial infarction. Lancet. 1999 Apr 24;353(9162):1390-6. doi: 10.1016/S0140-6736(98)08428-1.
citation: Barthel P, Schneider R, Bauer A, Ulm K, Schmitt C, Schomig A, Schmidt G. Risk stratification after acute myocardial infarction by heart rate turbulence. Circulation. 2003 Sep 9;108(10):1221-6. doi: 10.1161/01.CIR.0000088783.34082.89. Epub 2003 Aug 25.
citation: Makikallio TH, Barthel P, Schneider R, Bauer A, Tapanainen JM, Tulppo MP, Schmidt G, Huikuri HV. Prediction of sudden cardiac death after acute myocardial infarction: role of Holter monitoring in the modern treatment era. Eur Heart J. 2005 Apr;26(8):762-9. doi: 10.1093/eurheartj/ehi188. Epub 2005 Mar 18.
citation: Bauer A, Guzik P, Barthel P, Schneider R, Ulm K, Watanabe MA, Schmidt G. Reduced prognostic power of ventricular late potentials in post-infarction patients of the reperfusion era. Eur Heart J. 2005 Apr;26(8):755-61. doi: 10.1093/eurheartj/ehi101. Epub 2005 Jan 26.
Clinical trial NCT01825135: Electrical Stimulation to Strengthen Muscles in the Lower Legs in Patients Requiring Prolonged Mechanical Ventilation
Official title: Electrical Stimulation to Strengthen the Quadriceps Muscles in Patients Requiring Prolonged Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Keywords: muscle strength
muscle function
functional status
Lead sponsor: RML Specialty Hospital
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this proposal is to test the effectiveness of NMES in improving functional status and muscle function in patients requirng prolonged mechanical ventilation


Eligibility criteria: Inclusion Criteria:

* duration of mechanical ventilation for 14 days or more
* sufficiently awake
* able to speak and comprehend English

Exclusion Criteria:

* known primary neuromuscular disease
* lower extremities paresis or amputee
* patients with left-ventricular assist device (LVAD)
* cardiopulmonary instability

Primary outcomes:
measure: modified Functional Independence Measurement (FIM) score
timeFrame: Hospital discharge, an expected average stay of 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hinsdale
country: United States
facility: RML Specialty Hospital
state: Illinois
Study officials:
affiliation: RML Specialty Hospital
name: Amal Jubran, MD
role: PRINCIPAL_INVESTIGATOR
References: