louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00765349: Clinical Observational Study Investigating the Role of Diastolic Dysfunction in Determining Abnormal Cardiorespiratory Exercise Testing Parameters in Patients Undergoing Major Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diastolic Dysfunction
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing major elective surgery

Brief summary: REASON FOR STUDY

Major non-cardiac surgery has a high degree of morbidity and mortality. Recently, suitable measurements of a patient's preoperative cardiorespiratory reserve, performed non-invasively by cardiopulmonary exercise testing, have been shown to be predictive of outcome following non-cardiac surgery. Although the exact mechanisms behind poor reserve in this population are unknown, poor cardiac function and particularly diastolic dysfunction are likely to be important.

AIMS

The aim of the present study is to investigate the role of diastolic dysfunction in determining poor cardiorespiratory reserve in elderly patients undergoing major non-cardiac surgery. This will provide suitable information to inform a further therapeutic preoperative interventional study.

OBJECTIVES AND METHODS

1. To determine the presence and severity of diastolic dysfunction, measured by preoperative transthoracic echocardiogram, in a series of elderly surgical patients undergoing major elective non-cardiac surgery
2. To investigate the relationship between diastolic dysfunction and poor cardiorespiratory function during and following exercise measured by non-invasive testing including cardiopulmonary exercise testing, non-invasive blood pressure measurements and biochemical analysis
3. To determine whether patients with poor diastolic dysfunction are likely to have worse outcomes following major surgery compared with those who show no evidence of diastolic dysfunction. Outcomes will be measured in terms of length of hospital stay and early postoperative morbidity (validated scoring system) and mortality.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing major surgery
* Low functional capacity

Exclusion Criteria:

* Unable to give consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
state: Tyne and Wear
Study officials:
References:
Clinical trial NCT03780049: HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B
Official title: Hepatic Artery Infusion Chemotherapy Plus Recombinant Human Type-5 Adenovirus vs Hepatic Artery Infusion Chemotherapy Alone for Unresectable Hepatocellular Carcinoma at Barcelona Clinic Liver Cancer A-B Stage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Hepatic artery infusion chemotherapy
Oxaliplatin, 5-fluorouracil and leucovorin
Recombinant Human Type-5 Adenovirus
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 304
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: Hepatic artery infusion chemotherapy (HAIC) is effective and safe for hepatocellular carcinoma (HCC). Recombinant Human Type-5 Adenovirus (H101) is safe for HCC. The purpose of this study is to evaluate the efficacy and safety of HAIC combined with H101 compared with HAIC alone in patients with unresectable hepatocellular carcinoma (HCC) at barcelona clinic liver cancer A-B stage.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of HCC
* Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
* With no previous treatment
* Single lesion with tumor size larger 7cm or multiple lesions
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* BCLC A-B stage
* The following laboratory parameters:

Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

Exclusion Criteria:

* Patients complicated by history of heart disease, history of gastrointestinal bleeding within 1 month, severe infection (\> grade 2 National Cancer Institute \[NCI\] -common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0) or other serious associated diseases will not be able to tolerate treatment
* With other malignant tumors
* Known or suspected allergy to the investigational agents or any agent given in association with this trial
* History of organ allograft
* Pregnant or lactating woman
* patients with poor compliance

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 24 months
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 24 months
measure: Number of adverse events
timeFrame: 30 days
measure: Conversion rate to resection
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01541449: Plaqenil Role in Prevention of Age Related Macular Degeneration
Official title: Observational Study Between People That Use Plaquenil and Those Who do Not in Prevention of AMD.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age Related Macular Degeneration
Keywords: AMD
PLAQUENIL
CNV
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2012-03-01
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ziv Medical center retina clinic population

Brief summary: The investigators think that there is a connection between the use of plaquenil and the prevention of Age related macular degeneration (AMD). The investigators believe that the use of plaquenil makes bruch's membrane thicker, thereby preventing Chroidal Neovascularization (CNV) growth.

Detailed description: the study is done by comparing to groups RA patients who take plaquenil Vs. group of patients who do not take plaquenil. after measuring the retina thickness we compare the avg. thickness of both groups.

Eligibility criteria: Inclusion Criteria:

* all people who suffer from rheumatoid arthritis (RA) and use plaquenil

Exclusion Criteria:

* patients who did not complete follow-up

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Medical Center
Study officials:
affiliation: Ziv Medical Center
name: Joseph pikkel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02422849: Acute Combined Care for Seniors in Southern Denmark
Official title: Acute Combined Care for Seniors in Southern Denmark
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Medical Conditions
Keywords: Patient admission
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 131
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: the elderly population (+ 65 years) is increasing. Acute medical conditions often leads to hospital admissions in this age group. However hospital admission is linked to adverse events. like confusion, medication errors or new infections.

the ACCESS project aims to examine alternatives to acute admissions for senior medical patients.

the aims are:

1. How many patients will be admitted to hospital due to acute medical conditions if cared for by their own General Practitioner (GP) versus a hospital intern specialist ?
2. how many patients will be admitted to hospital due to acute medical conditions if cared for by acute team in their home versus in specialised care centres ?


Eligibility criteria: Inclusion Criteria:

* acute medical condition requiring immediate intervention.

Exclusion Criteria:

* GP not available next days
* absolutely admission requiring condition
* no informed consent obtainable
* nursing home resident
* inclusion in ACCESS within the last 3 months
* home care capacity limit reached

Primary outcomes:
measure: number of participants with hospital admission
timeFrame: 3 months after inclusion
Secondary outcomes:
measure: change from baseline in De Morton Mobility Index (DEMMI)
timeFrame: 3 months after inclusion
measure: change from baseline in quality of life (EQ5D scale)
timeFrame: 3 months after inclusion
measure: change from baseline in Orientation Memory-Concentration (OMC)
timeFrame: 3 months after inclusion
measure: patient and relatives satisfaction questionnaire
timeFrame: 3 months after inclusion
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Aabenraa Sygehus Emergency Department
Study officials:
References:
Clinical trial NCT03387449: Adaptive Arm Training for Children With Hemiplegia
Official title: Adaptive Arm Training for Children With Hemiplegia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Hemiplegia
Hemiparesis
Acquired Brain Injury
Lead sponsor: Blythedale Children's Hospital
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this research is to provide limb training in children with hemiplegia using a bimanual-to-unimanual training approach. Twenty pediatric patients aged 5-17 years with acquired brain injury will receive training on the bimanual-to-unimanual device for a period of 9 weeks. During the training, children use both arms to operate robotic arms to play a video game. We will assess changes in hand impairment after the training.


Eligibility criteria: Inclusion Criteria:

* Hemiplegia due to brain injury at least 3 months before study enrollment.

Exclusion Criteria:

* Any social or medical problem that precludes compliance with the protocol.
* Treatment with botulinum toxin or intrathecal baclofen in the 3 months preceding enrollment.
* Implanted neuromodulatory or electronic device or other complicating illness.

Primary outcomes:
measure: Change in Assisting Hand Assessment
timeFrame: Before intervention compared to after intervention
measure: Change in Box and Box Test
timeFrame: Before intervention compared to after intervention
measure: Change in range of motion
timeFrame: Before intervention compared to after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hartsdale
country: United States
facility: Kathleen M Friel
state: New York
Study officials:
References:
Clinical trial NCT02909049: Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
Official title: Open Randomized Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostatic Cancer
Keywords: Prostate Biopsy
Local Anesthesia
Pain
Biopsy of prostate
Lead sponsor: Complexo Hospitalario Universitario de A Coruña
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 100
Sex: MALE
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: To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS), to obtain saturation prostate biopsies.

Detailed description: To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS), to obtain saturation prostate biopsies.

Anesthetic technique (control) - Intravenous sedation with Midazolam, Fentanile and Ketamine.

Anesthetic technique (intervention) - Regional Mepivacaine infiltration of periprostatic region.

Eligibility criteria: Inclusion Criteria:

* Male patient
* Persistence of suspected prostate cancer by altering the prostatic specific antigen and / or digital rectal examination.
* Two previous negative prostate biopsies .
* Age \< 75 years.
* Signature of informed consent to perform prostate biopsy.
* Signature of informed consent for the study.

Exclusion Criteria:

* Age \> 75 years.
* Absence of consent or refusal to the study .
* Presence of prostate cancer in previous biopsy observation .
* Medical-surgical patient's problems, absolutely contraindicating biopsy under local anesthesia.
* Presence of any allergies to medications involved in the study .
* Patient's clinical situation that does not allow an outpatient operation and aftercare required .
* Medical condition of the patient, preventing the realization of outpatient biopsy.
* No companion.

Primary outcomes:
measure: Change in visual analog scale (VAS)
timeFrame: 1 hour baseline
Secondary outcomes:
measure: Number of patients with complications after anesthesic procedure and prostate biopsy procedure, after 24 hours of the procedure and at end of study visit. All units will be measured as numbers.
timeFrame: One week
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Jose Luis Ponce Diaz-Reixa
Study officials:
affiliation: Complejo Hospitalario Universitario, A Coruña
name: Jose L Ponce, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03452449: Physical Activity, Disability and Quality of Life Before and After Lumbar Spine Surgery
Official title: Accelerometry-based Physical Activity, Disability and Quality of Life Before and After Lumbar Spine Surgery: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Spine Degeneration
Physical Activity
Quality of Life
Disability Physical
Pain
Keywords: activity monitor
questionnaire
Oswestry Disability Index
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing planned lumbar spine surgery

Brief summary: To date it is unknown how physical activity levels in adults is limited before and after lumbar spine surgery and if physical activity level is associated with disability and limitations of quality of life. The main objective is to compare physical activity preoperatively and 6 and 12 weeks postoperatively in patients undergoing lumbar spine surgery with norm data. In addition, the investigators will study the association of changes in physical activity, disability and quality of live.

Detailed description: Patients scheduled for planned lumbar spine surgery will be contacted to participate in this study. All outcomes will be assessed within 1 week preoperatively and at 6 and 12 weeks postoperatively. Changes in outcome scores will be detected using analysis of variance. Association of changes in physical activity and changes in secondary outcomes will be detected using stepwise linear regression models.

Eligibility criteria: Inclusion Criteria:

* primary lumbar spine surgery
* single or multi level surgery on segments L2 to S1 (e.g. discectomy, decompression, laminectomy, foraminotomy)
* German speaking

Exclusion Criteria:

* stabilisation or fusion surgery or surgery above L2
* previous lumbar spine surgery
* indication: scoliosis, fracture, trauma, infection, tumor
* limited walking ability due to other conditions
* psychiatric conditions or dementia

Primary outcomes:
measure: Physical activity
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Disability
timeFrame: up to 12 weeks
measure: Quality of life assessed by questionnaire
timeFrame: up to 12 weeks
measure: Pain assessed by questionnaire
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clinic for Orthopaedics and Traumatology, University Hospital basel
state: Basel Stadt
city: Basel
country: Switzerland
facility: Bethesda Spital AG
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Corina Nüesch, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01312649: Feeling of Being in Control of One's Own Action
Official title: Feeling of Being in Control of One's Own Action: Which Mechanisms in Healthy Volunteers and in Mental Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Bipolar Disorders
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2011-03-11
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators aim is to understand the cognitive mechanisms that contribute to the emergence of delusions of control (the belief that one's own actions or thoughts are controlled by an external force). These symptoms are mainly encountered in patients with schizophrenia, and the investigators will distinguish patients with schizophrenia with or without this symptom together with patients with bipolar disorder. Based on the investigators previous studies, this project will help to determine the role of two elementary mechanisms in the ability to feel in control of voluntary actions: (1) the processing of the sensory consequences of action, and (2) the ability to build mental representations for sequenced actions.


Eligibility criteria: Inclusion Criteria:

* Patients with schizophrenia or bipolar disorders (criteria DSM IV) or healthy controls matched with patients on age, sex and education level
* 18-55 years old

Exclusion Criteria:

* Past history affecting CNS
* Invalidating sensory disorders
* Intake of psychotropic drugs, except for patients
* Intake of benzodiazepines

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Pôle de Psychiatrie - Hôpital civil
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Anne GIERSCH, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05542849: The Efficacy and Tolerability of Acarbose in Healthy Individuals
Official title: The Efficacy and Tolerability of Acarbose in Healthy Individuals: A Prospective Trial for Acarbose in Healthy Individuals Assessing Safety and Efficacy in Reducing Glucose Spikes After Carbohydrate Consumption.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tolerance
Side Effect
Glucose Response
Lead sponsor: AgelessRx
Sponsor class: INDUSTRY
First posted: 2022-09-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A Prospective Trial for Acarbose in Healthy Individuals Assessing Safety and Efficacy in Reducing Glucose Spikes After Carbohydrate Consumption.


Eligibility criteria: Inclusion Criteria:

1. Age 18-85
2. Any sex
3. Any ethnicity
4. Interest in taking Acarbose off-label
5. Approved by the AgelessRx Medical team to take Acarbose
6. Willing and technically able to use and operate a CGM
7. Own a CGM-compatible phone
8. Relatively good health with only well-managed chronic diseases (hypertension, coronary artery disease, type II diabetes, etc.) clinically stable
9. Adequate cognitive function to be able to give informed consent

Exclusion Criteria:

1. Diabetes of any type
2. Taking metformin or any other glucose lowering medication
3. Any uncontrolled endocrine disorder (thyroid, pancreatic, adrenal, etc...)
4. Active malignancy of any kind
5. Clinically relevant renal or kidney disease or dysfunction
6. History of eating disorder
7. Taking any medication, or has any medical condition that might interfere with the action of acarbose of the CGM sensor

Primary outcomes:
measure: Monophasic glucose response
timeFrame: 120 minutes per phase, recorded on 4 separate occasions over 2 weeks.
Secondary outcomes:
measure: Tolerability of Side Effect
timeFrame: Recorded on 4 separate occasions over 2 weeks.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: AgelessRx
state: Michigan
Study officials:
References:
Clinical trial NCT03650049: Food Protein-induced Enterocolitis Syndrome (FPIES) in 14 Children
Official title: Food Protein-induced Enterocolitis Syndrome (FPIES) in 14 Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy
Pediatric Disorder
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 14
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with acute FPIES who consulted the allergy oupatient clinic of the Nancy Regional University Hospital between November 2013 and June 2016.

Brief summary: Food protein-induced enterocolitis syndrome (FPIEES) is a particular non-Immunoglobulin E-mediated food allergy.

A retrospective descriptive single-center study was conducted. Subjects included were children with acute FPIES who consulted the allergy department of the Nancy Regional University Hospital between November 2013 and June 2016.

Detailed description: As it is a descriptive study, the Primary Outcome is not a Measure. Therefore it is not possible to include the name of the measurement or measurement tool used to assess the measure in the primary outcome measure title.

Eligibility criteria: Inclusion Criteria:

* Child from 0 to 17 years with acute FPIES

Exclusion Criteria:

-

Primary outcomes:
measure: symptoms due to FPIES
timeFrame: from november 2013 to june 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: