louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05009121: The Reliability of the Box and Block Test in People After Stroke
Official title: The Reliability of the Box and Block Test in People After Stroke
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Motor Activity
Keywords: standardized test
occupational therapy
fine motor skills
Box and Block Test
inter-rater reliability
variability
Czech language
Stroke
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Czech adult people after stroke

Brief summary: The main aim of the pilot project is to establish inter-rater reliability, internal variability and variability of results got in Box and Block Test administered according to the new Czech extended version of its manual.

Detailed description: New Czech manual for the Box and Block Test was made by back-translation method. It was updated and extended by new rules for unification of it´s performing. The manual include instructions for performing three trials.

At least 20 adult people after stroke will be tested by this test according to this new Czech manual. Video of patients' performance will be obtained.

The inter-rater reliability, internal variability and variability of results will be established.

Eligibility criteria: Inclusion Criteria:

* Czech language as a mother tongue
* Adult (age 18 and more)
* Patient after Stroke attending the Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
* Able to move 25mm X 25mm block at least by 10 cm
* Able to complete testing with full 3 attempts
* Able to sit for 20 minutes

Exclusion Criteria:

* use of drugs affecting attention
* vision impairment uncorrectable with glasses
* severe hearing loss
* inability to understand instructions
* inability to complete testing
* failure to sign Informed consent for probation with inclusion to research and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague

Primary outcomes:
measure: results from the Box and Block Test
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
Study officials:
References:
Clinical trial NCT01765621: Clinical and Economic Impact of an Electronic Medical Record Interfaced Decision Support System Reinforced With Patient Specific Pharmacogenetic Data for Minimizing Severe Drug-Drug Interactions
Official title: Clinical and Economic Impact of a Web Based, Electronic Medical Record Interfaced Electronic Decision Support System Incorporating Pharmacogenetic Evaluation for Physicians Intended, Mainly for Drug-drug Interaction. A Controlled Study in an Ambulatory Health Maintenance Organization Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthcare
Keywords: health care expenditure
drug drug interactions
electronic decision support systems
pharmacogenetics
Potential Reduction
Lead sponsor: Leumit Health Services
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 973
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Leumit Health Services, an health maintenance organization operating in Israel, will incorporate a web-based, decision support system for handling drug-drug interactions and drug information, termed DDI+ reinforced with patient specific pharmacogenetic data. The investigators hypothesize that implementing such a system will reduce health-care expenditures (e.g., hospital admissions, referrals to ERs, Imaging procedures).


Eligibility criteria: Inclusion Criteria:

* Number of chronic concomitant drugs ≥5
* treated with 1 or more drugs with a well established interaction with 1 or more of the following CYP450 enzymes: 2c9, 2c19, 2d6

Exclusion Criteria:

* Patients diagnosed with HIV/AIDS, and/or viral hepatitis B or C

Primary outcomes:
measure: Hospital Admissions
timeFrame: up to 12 month post initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Leumit Health Services
Study officials:
References:
Clinical trial NCT00433121: Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD
Official title: Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - an Open Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dementia
Keywords: Antidepressive Agents
Neuroleptica
Dementia
Discontinuation study
Behavioural- and Psychological Symptoms in Dementia
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: Demensforbundet, Norway
First posted: 2007-02-09
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).

Detailed description: Patients with dementia have cognitive deficits, but also hallucinations, delusions, agitation, aggression and apathy. These symptoms are called Behavioural- and Psychological Symptoms in Dementia (BPSD), and are difficult to treat. Antipsychotic and antidepressant medication is in use, despite its lack of clinical evidence.

We will discontinue antipsychotics in one group of 12 patients and antidepressants in one group of 12 patients. Patients should have dementia of Alzheimer- or vascular origin. They should live in Nursing Homes and have no other psychiatric disease for which they receive psychotropic drug. They will be registered with 7 different questionnaires at baseline and after 3, 6, 12 and 24 weeks. The study period is 24 weeks. The questionnaires are filled in by the patients and the nurses at the nursing homes.

This is an open labelled study with no control group. Based on the results of this study, we will design a RCT study with placebo-controlled group.

Eligibility criteria: Inclusion Criteria:

* Vascular- or Alzheimer Dementia
* Nursing Homes resident for 3 months or more
* Given antipsychotics or antidepressants for 3 months or more
* Clinical Dementia rating 1, 2 or 3

Exclusion Criteria:

* Dementia of other origin
* Psychiatric disease
* Life expectancy less than 3 months
* Acute infection last 10 days
* Unstable Diabetes Mellitus
* Terminal disease

Primary outcomes:
measure: Changes in Neuropsychiatric Inventory
timeFrame: 24 weeks
measure: Changes in weight
timeFrame: 24 weeks
measure: Changes in Cornell's Depression Scale
timeFrame: 24 weeks
measure: Changes in UPDRS subscale
timeFrame: 24 weeks
measure: Changes in "Quality of Live - Alzheimer Disease"
timeFrame: 24 weeks
Secondary outcomes:
measure: Changes in Severe Impairment Battery
timeFrame: 24 weeks
measure: Changes in Lawton's PADL
timeFrame: 24 weeks
measure: Oxazepam given p.n.
timeFrame: 24 weeks
measure: Drop outs
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Ottestad
country: Norway
facility: Sykehuset Innlandet HF - Sanderud
state: Oppland
Study officials:
affiliation: The Norwegian Centre for Dementia Research (NCDR), Norway
name: Knut Engedal, Ph D
role: STUDY_CHAIR
References:
Clinical trial NCT04827121: Comparison of Fascial Iliac Compartment Block and Quadratus Lumborum Block for Hip Surgery
Official title: Transmuscular Quadratus Lumborum Block Versus Supra-inguinal Fascial Iliac Compartment Block for Total Hip Arthroplasty: a Randomized, Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Keywords: Ultrasound
Total hip arthroplasty
Nerve block
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 100
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: Iliac fascia block has a long history of analgesia in patients with hip fractures. A large number of clinical studies have confirmed its efficacy, and there are also randomized controlled studies supporting its effectiveness in analgesia after total hip replacement surgery.Quadratus lumborum block is a new block technique developed in last decade, and there are also a few randomized controlled studies supporting its effectiveness in postoperative analgesia for total hip replacement.The purpose of the present study was to find out whether these two different approaches of fascial compartment block have similar effects on postoperative analgesia after total hip replacement.


Eligibility criteria: Inclusion Criteria:

* ASA class 1-3
* BMI between 20-36kg/m\^2
* Scheduled to undergo total hip replacement

Exclusion Criteria:

* A history of chronic opioids or steroid consumption
* Coagulapathy or anticoagulation
* Pregnancy
* Allergic to local anesthetics Neurological dysfunction

Primary outcomes:
measure: Cumulative opioids consumption at 24 hours
timeFrame: Within 24 hours
Secondary outcomes:
measure: NRS score with movement at 6,12,and 24 hours
timeFrame: at 6,12,and 24 hours
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Wei Mei, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03804021: Long-Term Follow-up Study of ADVM-043
Official title: Post-treatment Long-term Follow-up Study of ADVM-043 Gene Therapy in Alpha-1 Antitrypsin Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alpha-1 Antitrypsin Deficiency
Keywords: Alpha-1 Antitrypsin Deficiency
alpha1-antitrypsin deficiency
alpha 1-antitrypsin deficiency
alpha1AT
A1AT
ADVM-043
AAVrh.10halpha1AT
AAVrh.10hA1AT
Gene transfer vector
Gene therapy
Lung disease
Emphysema
COPD
ADVANCE study
Long Term Follow Up
Lead sponsor: Adverum Biotechnologies, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received ADVM-043 in a treatment protocol

Brief summary: ADVM-043-03 is a long-term follow-up (LTFU) study of subjects who participated in the ADVM-043-01 (NCT02168686) multi-center gene therapy clinical study (ADVANCE) that evaluated ADVM-043 for the treatment of Alpha-1 Antitrypsin (A1AT) deficiency.

Detailed description: ADVM-043-03 was a multi-center, observational study without administration of the ADVM-043 investigational product. Subjects who participated in the ADVANCE study (ADVM-043-01; NCT02168686) were enrolled into this LTFU study for continued safety monitoring for a 2-year period.

Eligibility criteria: Key Inclusion Criteria:

* The subject has A1AT deficiency and has previously received ADVM-043 gene therapy

Key Exclusion Criteria:

* The subject is unwilling or unable to participate in all required study evaluations in the long-term follow-up protocol
* The subject is participating in another investigational treatment protocol
* The subject is unable to understand the purpose and risks of the study or cannot provide a signed and dated informed consent form (ICF)

Primary outcomes:
measure: Number of Participants With Adverse Events of Special Interest and of Serious Adverse Events Related to ADVM-043
timeFrame: 2 years from start of long-term follow-up study ADVM-043-03 (NCT03804021) (2 years from completion of the parent study (ADVM-043-01, NCT02168686)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina, Charleston, SC, USA
name: Charlton Strange, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida, Gainesville, FL, USA
name: Mark Brantly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Remih K, Amzou S, Strnad P. Alpha1-antitrypsin deficiency: New therapies on the horizon. Curr Opin Pharmacol. 2021 Aug;59:149-156. doi: 10.1016/j.coph.2021.06.001. Epub 2021 Jul 10.
Clinical trial NCT03118921: Body Image Disorder in Anorexia Nervosa and Virtual Reality
Official title: Body Image Disorder in Anorexia Nervosa and Virtual Reality
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anorexia
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 17
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Evaluation of the tolerance and acceptability of the virtual representation of its body image.


Eligibility criteria: Inclusion Criteria:

* Women, aged between 16 and 40
* Post-puberty
* Pure restrictive anorexia nervosa, diagnosis by the DSM-V
* BMI \<17.5
* Patient attending an outpatient clinic at the Bohars Psychiatric Hospital in France
* Having signed the Informed Consent Form
* For minor patients, signing the form of informed consent of both parents

Exclusion Criteria:

* Associated eating disorder (bulimia, or the binge eating / purging form of anorexia nervosa),
* Psychiatric disorders (characterized depressed, anxiety disorder)
* Neurological Disorders
* Mental retardation
* Abuse or addiction to alcohol
* Abuse or dependence on psychoactive substances in the previous year.
* Patient with a protective justice measure

Primary outcomes:
measure: Self-questionnaire assessing tolerance
timeFrame: Day 15
measure: Self-questionnaire assessing acceptability
timeFrame: Day 15
Secondary outcomes:
measure: Feeling of presence
timeFrame: Day 15
measure: Subjective experience by EDI-2 questionnaire
timeFrame: Day 15
measure: Subjective experience by BSQ questionnaire
timeFrame: Day 15
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
References:
Clinical trial NCT05351021: Efficacy of Metformin as Preventive Treatment in Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
Official title: Efficacy of Metformin as Preventive Treatment in Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Neuropathy
Breast Cancer
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: At present, there are no FDA-approved treatments for chemotherapy-induced neuropathy. Discrete neuro anti-inflammatory effects of metformin support its repurposing as a neuroprotective agent in patients with neurodegenerative diseases. Therefore, this study aims to evaluate the effect of metformin on the amelioration of paclitaxel induced neuropathy in cancer patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years old)
* Early-stage breast cancer patients who will receive adjuvant paclitaxel
* Performance status according to Eastern Cooperative oncology group (ECOG) \< 2.
* Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count ≥100,000/mm3), liver function (serum total bilirubin \<1.5 mg/dl), renal function (creatinine\<1.5 mg/dl).

Exclusion Criteria:

* Clinical neuropathy at prior to enrollment.
* Patients treated with medications that increase the risk of neuropathy like amiodarone, Colchicine, metronidazole, phenytoin.
* Patients with a history of hypersensitivity to metformin.
* Pregnant or lactating females.
* Patients who are using metformin for any other cause.
* Patients with Diabetes mellitus.
* Receiving vitamin B1, B6, B12 or another vitamin supplemental therapy.
* Receiving antidepressants, opioids, adjuvant analgesic agents (eg, anticonvulsants, clonazepam, or mexiletine), topical analgesics, and amifostine.

Primary outcomes:
measure: The incidence of grade II or more peripheral neuropathy at the end of paclitaxel treatment
timeFrame: 8 weeks
Secondary outcomes:
measure: Time to develop grade 2or 3 PIPN
timeFrame: 8 weeks
measure: the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale
timeFrame: 8 weeks
measure: Pain Severity
timeFrame: 8 weeks
measure: Serum biomarkers level in (ng/mL)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
References:
Clinical trial NCT00972621: Clinical Evaluation of a New Viscoelastic for Cataract Surgery
Official title: Clinical Evaluation of a New Viscoelastic for Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2009-09-07
Enrollment: 400
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 purpose of this study is to evaluate the safety and effectiveness of a new opthalmic viscoelastic material for the use in cataract surgery. The new viscoelastic will be compared to a currently marketed viscoelastic material.


Eligibility criteria: Inclusion Criteria:

* Otherwise healthy eye with no pathology other than the presence of cataract
* Visual potential of 20/40 or better

Exclusion Criteria:

* Taking any medications that affect vision, intraocular pressure or ease of cataract surgery (e.g. flomax, glaucoma medications, etc.)
* Known intraocular pressure increases from steroid treatment
* Low endothelial cell count

Primary outcomes:
measure: Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Postoperative Mean Endothelial Cell Count
timeFrame: 3 months postoperative
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: AMO Clinical Research Call Center for Trial Locations
state: California
Study officials:
References:
Clinical trial NCT02536521: Predictive Variables of the Hemodynamic Effect During the Laparoscopic Surgery in Children
Official title: Study on the Predictive Variables Able to Predict the Hemodynamic Effect of Intra-abdominal Pressure in the Children Undergoing Laparoscopic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-09-01
Enrollment: 123
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients undergoing laparoscopic surgery

Brief summary: This prospective observational study aimed to identify the intraoperative variables to predict the hemodynamic change according to intra-abdominal pressure in the children undergoing laparoscopic surgery.

The intraoperative variables includes Pulse pressure variation (PPV), systolic pressure variation (SPV), stoke volume variation (SVV), Pulse oximeter plethysmographic waveform amplitude (△POP),and pleth variability index (PVI).


Eligibility criteria: Inclusion Criteria:

* Pediatric patients undergoing laparoscopic surgery

Exclusion Criteria:

* known arrhythmia
* known lung disease
* known cardiac dysfunction (Ejection fraction less than 30%)

Primary outcomes:
measure: Pleth variability index(PVI)
timeFrame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes.
Secondary outcomes:
measure: Systolic pressure variation(SPV)
timeFrame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes.
measure: Pulse pressure variation(PPV)
timeFrame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes
measure: Pulse oximeter plethysmographic waveform amplitude (△POP)
timeFrame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Kim EH, Lee JH, Song IK, Ryu HG, Kim HS, Kim JT. Assessment of dynamic variables of fluid responsiveness to predict desufflation-induced hypotension during paediatric laparoscopic surgery. Br J Anaesth. 2017 Nov 1;119(5):956-963. doi: 10.1093/bja/aex172.