louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06538025: Correlation Between Family Functioning and PSF
Official title: Post-stroke Fatigue and Its Correlation With Family Functioning in Patients With First-episode Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: post-stroke fatigue
family functioning
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 212
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with first-episode stroke admitted to the Department of Neurology of our hospital between October 2021 and July 2022 were rigorously screened using convenience sampling.

Brief summary: In the present study, the investigators investigate the effect of family functioning on PSF in neurologic stroke patients in the early stages of the disease by surveying the current status of post-stroke fatigue to provide theoretical support for clinical care.


Eligibility criteria: Inclusion Criteria:

* patients whose clinical manifestations met the diagnostic criteria for stroke and whose stroke was confirmed by imaging (cranial computed tomography or cranial magnetic resonance imaging)
* those with first-episode stroke and in a stable condition
* those who were conscious and able to cooperate with the investigation
* those who gave informed consent and volunteered to participate in the study

Exclusion Criteria:

* patients with severe aphasia
* those with severe cognitive impairment who were unable to cooperate with examinations or questionnaires
* those with malignant tumours
* those with degenerative diseases of the central nervous system, such as Parkinson's disease
* those who were unable to cooperate with the doctor in the examination for other reasons
* those with a previous history of mental illness
* those with other recent major stressful life events, such as divorce or death of a loved one
* those with pre-stroke fatigue (PrSF)

Primary outcomes:
measure: activities of daily living
timeFrame: Before hospitalization
measure: family adaptation, partnership, growth, affection and resolve (APGAR) score
timeFrame: First day after hospitalization
measure: Post-stroke fatigue
timeFrame: Day 5 of hospitalization
measure: Sleep Disturbances
timeFrame: Day 5 of hospitalization
measure: Anxiety and Depression
timeFrame: Day 5 of hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Meichun Shu
state: Zhejiang
city: Wenzhou
country: China
facility: Xianchai Hong
state: Zhejiang
Study officials:
References:
Clinical trial NCT05278325: Improved Treatment Course for Patients With Migraine and Tension-type Headache
Official title: Improved Treatment Course for Patients With Migraine and Tension-type Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Tension-Type Headache
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to improve treatment for newly referred patients with migraine and tension-type headache to the Danish Headache Center.

All patients will recieve an electronic questionnaire just before the first visit concerning their current and previous history of headache and headache treatment.

Half of them will enter a special telephone-intervention (TeII) program with two planned phone-calls after 8 and 16 weeks from first visit. The other half of patients will follow the normal follow-up program.

All patients will be seen by a headache specialist after 6 months and will be asked to fill in a follow-up electronic questionnaire.


Eligibility criteria: Inclusion Criteria:

* Migraine and/or tension-type headache

Exclusion Criteria:

* Other headache diagnoses, including cluster headache, medication overuse-headache, other secondary headaches, trigeminal neuralgia.
* Included in clinical trials at the DHC.

Primary outcomes:
measure: Change in preventive headache medication
timeFrame: From baseline to six months
measure: Change in acute headache medication
timeFrame: From baseline to six months
Secondary outcomes:
measure: Change in headache frequency
timeFrame: From baseline to six months
measure: Change in migraine frequency
timeFrame: From baseline to six months
measure: Change in Headache Under response to Treatment (HURT-8) score
timeFrame: From baseline to six months
measure: Change in Insomnia Severity Index (ISI) score
timeFrame: From baseline to six months
measure: Change in Hospitality Anxiety Depression Scale (HADS) score
timeFrame: From baseline to six months
measure: Change in patient satisfaction score
timeFrame: At six months
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
state: Copenhagen
Study officials:
affiliation: Rigshospitalet-Glostrup, Afdeling for Hjerne- og Nervesygdomme
name: Henrik W Schytz, Ass Prof
role: STUDY_CHAIR
References:
Clinical trial NCT04623125: Spaced Retrieval as Treatment for Aphasia
Official title: Spaced Retrieval as Treatment for Aphasia: Does Adaptive Spacing Enhance Picture Naming Performance?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia, Acquired
Aphasia Primary Progressive
Keywords: Adaptive Spaced-Retrieval
Aphasia
Anomia
Anki
Lead sponsor: Rotman Research Institute at Baycrest
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2020-11-10
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Spaced Repetition training has been found to be more effective than massed repetition for individuals with aphasia. This study seeks to examine the relative efficiency of three kinds of spacing for picture-naming training: traditional random presentation, non-adaptive spaced repetition, and adaptive spaced repetition.

Detailed description: Participants undergo a screening evaluation including the Quick Aphasia Battery (administered via teleconferencing software), and a preliminary picture naming test of approximately 300 pictures, used to select individual items for treatment. Participants then undertake online picture naming training for 30 minutes a day, over two weeks. Pictures are repeated according to three different schedules to be compared: random presentation, non-adaptive spaced repetition, and adaptive spaced repetition. We compare the number of pictures successfully learned and the verbal reaction time for the pictures assigned to the three conditions.

Eligibility criteria: Inclusion Criteria:

* presence of a post-stroke word finding deficit (i.e. aphasia), or primary progressive aphasia.
* ability to evaluate the correctness of one's own responses when subsequently provided the with the correct answer

Exclusion Criteria:

* diagnosis of a neurological disorder other than post-stroke or primary progressive aphasia
* inability to evaluate the correctness of ones responses when subsequently provided with the correct answer

Primary outcomes:
measure: Change in Picture Naming performance across conditions
timeFrame: Change from baseline to post-intervention immediately after two weeks of daily sessions, and one month followup.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
Study officials:
References:
Clinical trial NCT01083225: Effect of Patient Participation in Mental Health Care
Official title: Randomised Controlled Trial on the Effect of Individual User Involvement in a Mental Health Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Norwegian Foundation for Health and Rehabilitation
name: The Research Council of Norway
First posted: 2010-03-09
Enrollment: 75
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 effect of individual user involvement in an outpatient mental health center. The intervention consists of patients completing a self-report symptom and problem questionnaire and reviewing it with a clinician.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age.

Exclusion Criteria:

* Not able to complete the questionnaires.

Primary outcomes:
measure: Mental health symptom score (Basis-32)
timeFrame: Baseline, 6 weeks, 6 months & 12 months
measure: Patient activation (Patient Activation Measure)
timeFrame: Baseline, 6 weeks, 6 months & 12 months
measure: Alliance (Inpatient treatment alliance scale)
timeFrame: Baseline, 6 weeks, 6 months & 12 months
Secondary outcomes:
measure: Patient satisfaction (Client Satisfaction Questionnaire)
timeFrame: Baseline, 6 weeks, 6 months & 12 months
measure: Quality of life (Short form 12)
timeFrame: Baseline, 6 weeks, 6 months & 12 months
measure: Evaluation of problems (Outcome rating scale)
timeFrame: Baseline, 6 weeks, 6 months & 12 months
measure: Evaluation of consultations (Session Rating Scale)
timeFrame: Baseline, 6 weeks, 6 months & 12 months
measure: Evaluation of involvement
timeFrame: Baseline, 6 weeks, 6 months & 12 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital, Nidaros Mental Health Center
Study officials:
affiliation: Norwegian University of Science and Technology
name: Aslak Steinsbekk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rise MB, Eriksen L, Grimstad H, Steinsbekk A. The long-term effect on mental health symptoms and patient activation of using patient feedback scales in mental health out-patient treatment. A randomised controlled trial. Patient Educ Couns. 2016 Jan;99(1):164-8. doi: 10.1016/j.pec.2015.07.016. Epub 2015 Jul 19.
Clinical trial NCT05592522: Efficacy of External Oblique Intercostal Block in Laparoscopic Bariatric Surgery
Official title: Is External Oblique Intercostal Block Under Enhanced Recovery After Bariatric Surgery (ERABS) Superior to Oblique Subcostal Transversus Abdominus Block? A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Pain, Postoperative
Narcotic Use
Analgesia
Lead sponsor: Al Mashfa Medical Center
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Laparoscopic bariatric procedures nowadays are employed under ERAS protocol as an ambulatory surgery. Pain after laparoscopic procedures arises significantly from port site incisions in the anterior abdominal wall, and shoulder pain (referred from visceral pain). Narcotic medications are utilized to manage postoperative pain, but its disadvantages include, increased post-operative nausea and vomiting (PONV), ileus, sedation and delayed hospital discharge.

Oblique subcostal transversus abdominis plane block (OSTAP) had been studied before and found to be effective in reducing post-operative morphine usage and produce good analgesia for about 24hours postoperatively.

The ultrasound-guided external oblique intercostal (EOI) block is a new technique which proved to produce unilateral analgesia at thoracic dermatomes supplying the anterior and lateral aspects of the upper abdomen.

The aim of this study was to test the hypothesis that US-guided EOI blocks can produce more reduction in opioid usage during the first 24 h after of laparoscopic bariatric surgeries when compared to oblique subcostal TAP (OSTAP) block.


Eligibility criteria: Inclusion Criteria:

* age of 18 and 65;
* American Society of Anesthesia (ASA) class II or III
* elective laparoscopic bariatric procedure through trocars positioned at or above the um-bilicus (T10 dermatome).

Exclusion Criteria:

* preoperative chronic use or contraindication to opioid or NSAID
* allergy to bupivacaine
* local skin infection at the injection site of EOI or OSTAP blocks
* liver or renal insufficiency
* psychiatric, or neurological disease
* prior open abdominal surgery above T10 dermatome
* patients converted to open surgery; and patients expected to be subjected to more tissue trauma.

Primary outcomes:
measure: 24h equivalent oral morphine consumption
timeFrame: 24 hour
measure: Numerical rating scale (NRS)
timeFrame: 24 hours
Secondary outcomes:
measure: Quality of recovery 40 score(QoR-40)
timeFrame: 24 hours
measure: AMBULATION TIME
timeFrame: 24 hours
measure: Readiness for discharge
timeFrame: 24 hours
Other outcomes:
Locations:
city: Khobar
country: Saudi Arabia
facility: Al Mashfa medical center
state: Eastern Provence
Study officials:
affiliation: Al Mashfa Medical Center
name: Mohamed I ElSayed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05641922: Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures (PANORAMA2)
Official title: Pilot Study to Assess the Safety and Effectiveness of the Use of BioTraceIO 360 for PSM and Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Metastatic Liver Cancer
Lead sponsor: Techsomed Medical Technologies LTD
Sponsor class: INDUSTRY
First posted: 2022-12-08
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Pilot study planned to demonstrate the safety and effectiveness of the use of BioTraceIO 360 for Planning, Monitoring and Assessment of liver tissue ablation procedures

Single-center prospective single-arm clinical investigation.

Sample size - 10 subjects.


Eligibility criteria: Inclusion Criteria:

* Scheduled and indicated for standard-of-care liver tumor ablation for either hepatocellular carcinoma (HCC) or metastatic liver tumor(s) microwave (MW) energy.
* Patient must have at least one prior CT or CECT scan (up to 6 months before enrollment).
* Tumor must be visualized on at least one diagnostic imaging modality (MRI or contrast-enhanced CT).
* Single tumor, or multiple tumors only if the distance between the ablated tumor and all other tumors allows for distinct separation between the necrotic zones.
* Distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones.
* At least 21 years of age.
* Able and willing to give informed consent.

Additional inclusion criteria for subgroup:

- Single ablation, using a single ablation needle, per tumor.

Exclusion Criteria:

* Planned ablation includes adjunctive means other than MW energy (e.g., ethanol, hepatic artery embolization, etc.).
* Planned ablation includes the use of more than two ablation needles, per tumor
* Ablation area cannot be visualized and monitored continuously using ultrasound throughout the entire ablation procedure.
* Pregnant or breastfeeding.
* Patient judged unsuitable for study participation by the physician for any other reason.
* Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period.
* Unable or unwilling to give informed consent.

Additional exclusion criteria for subgroup:

* Liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion.
* Planned ablation includes repositioning and/or overlapping ablations using a single ablation needle.

Primary outcomes:
measure: Effectiveness
timeFrame: 1 year
measure: Safety
timeFrame: 1 year
Secondary outcomes:
measure: Planning Module
timeFrame: 1 year
measure: Monitoring Module
timeFrame: 1 year
measure: Assessment Module (1)
timeFrame: 1 year
Other outcomes:
measure: Assessment Module (2)
timeFrame: 1 year
Locations:
Study officials:
References:
Clinical trial NCT02891122: Effect of the Duration of Preoperative Fasting on Hypotension Induced by General Anesthesia in the Elderly Person
Official title: The Influence of Duration of Fluid Abstinence on Hypotension During General Anaesthesia Induction for Traumatic Hip Surgery in the Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preoperative Fasting and Hypotension
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 56
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for fracture of the proximal femur requiring surgical treatment

Brief summary: This study aims to determine if prolonged fasting represents an independent risk factor for hypotension during induction of general anesthesia in the elderly.

Detailed description: Preoperative fasting aims to reduce the risk of adverse events (eg, inhalation), but may be responsible for dehydration whose consequence is a major hypotension. This problem of hypotension is important because it (MAP \<55 mmHg) is directly correlated to the occurrence of pejorative events on the cardiac and renal level and even more so that the duration of the hypotension is long.

Eligibility criteria: Inclusion Criteria:

* Risk Score anesthetic ASA I-III
* Patients ≥ 70 years
* Suffering from a femoral neck fracture to be treated surgically:

  * either through prosthesis,
  * either by intramedullary nailing (gamma nail)

Exclusion Criteria:

* Risk Score anesthetic ASA IV
* Patient on Angiotensin Converting Enzyme (ACE) inhibitors or ARBs (ARA2) within 10 hours before surgery
* Obesity (BMI\> 35) or weight \<40kg
* Need to make a rapid sequence induction
* Inability to achieve the femoral block (standardization of induction) or patient refusal with respect to the technique.

Primary outcomes:
measure: Follow-up of the variation of the Mean arterial pressure
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Pierre Lafère, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06051422: Correlation of Pelvic Asymmetry and Joint Movement During Gait in Children With Cerebral Palsy
Official title: Correlation of Pelvic Asymmetry and Joint Movement During Gait in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Correlation of Pelvic Asymmetry and Joint Movement During Gait in Children With Cerebral Palsy
Keywords: Cerebral palsy
pelvic obliquity
joint movement
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 20 kids with spastic cerebral palsy

Brief summary: the study's particular goals were to determine whether excessive hip, knee, and ankle displacement at first contact during locomotion correlates with pelvic rotation.


Eligibility criteria: Inclusion Criteria:

* the lower extremities' degree of spasticity ranged from grade 1 to grade +1 on the Gross Motor Function Classification System (GMFCS) \[7\] classified motor function levels as being between levels I and II. Children have the cognitive ability to understand and follow instructions.

Exclusion Criteria:

* having an extensive intellectual disability, orthopedic issues, upper or lower limb surgery, visual or hearing issues, usage of behavior-altering medicines, or a major neurological illness (epilepsy)

Primary outcomes:
measure: pelvic asymmetry and joints movement measures
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
state: Eldoky
Study officials:
References:
Clinical trial NCT01120522: Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3 ("RETRIEVE 3")
Official title: Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Embolism
Keywords: Vena Cava
Vena Cava Filter
Pulmonary Embolism
Venous Thromboembolism
Risk of Pulmonary Embolism
Lead sponsor: Crux Biomedical
Sponsor class: INDUSTRY
First posted: 2010-05-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.


Eligibility criteria: Inclusion Criteria:

* Patient has a permanent or temporary risk of Pulmonary Embolism.
* Patient must provide informed consent At least one of the following conditions -
* Proven PE
* Recurrent PE despite adequate
* Contraindication to anticoagulation
* Inability to achieve/maintain therapeutic anticoagulation
* Iliocaval DVT
* Large, free-floating proximal DVT
* Massive PE treated with thrombolysis/thrombectomy
* Chronic PE treated with thrombectomy
* Protection during thrombolysis for iliocaval DVT
* PE with limited cardiopulmonary reserve
* Poor compliance with anticoagulation medication
* High risk of injury worsening on anticoagulation
* Multi-trauma patient with high risk of PE
* Surgical patients at high risk of PE
* Medical condition with high risk of PE Patients with a documented vena cava diameter of 17-28mm Patient has IVC anatomy suitable for infra-renal placement Patient is willing to be available for the appropriate follow up

Exclusion Criteria:

* Age \<18 years old
* Patient has any one of the following conditions:

  * Renal vein thrombosis
  * IVC thrombosis extending to the renal veins
  * Duplicate IVC
  * Gonadal vein thrombosis
  * Requires supra-renal placement
* Vena cava diameter of 17-28mm
* Uncontrolled infectious disease
* Risk of aseptic PE
* Uncontrolled coagulopathy
* Existing inferior vena cava filter implant
* Life expectancy less than 6 months
* Pregnant or planning a pregnancy in the next 6 months
* Condition that inhibits radiographic visualization of the IVC
* Known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol
* Known hypersensitivity to contract which cannot be pretreated
* Access vessels preclude same insertion of delivery system
* Participation in another drug or device trial
* Unable or unwilling to cooperate with study procedures or required follow-up visits

Primary outcomes:
measure: Clinical Success
timeFrame: 6 Months
Secondary outcomes:
measure: Retrieval Success
timeFrame: 6 months
measure: Filter Migration
timeFrame: 6 Months
measure: VCF Thrombus
timeFrame: 6 Months
measure: Device Integrity
timeFrame: 6 Months
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Dendermonde
country: Belgium
facility: A. Z. St. Blasius Hospital
Study officials:
References: