louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03468439: Ultrasound and Peripheral Nerve Stimulator Guided Femoral Nerve Block
Official title: Short Term Effect of Ultrasound and Peripheral Nerve Stimulator Guided Femoral Nerve Block With Phenol on Outcomes in People With Traumatic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: nerve block
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A pre-post descriptive study was performed to examine the immediate effects of ultrasound (US) guided femoral nerve block with phenol (UGFNBwP) in managing lower limb spasticity of individuals with traumatic spinal cord injury (SCI).

Detailed description: Study Design: A pre-post descriptive study was performed. Objectives: To examine the immediate effects of ultrasound (US) guided femoral nerve block with phenol (UGFNBwP) in managing lower limb spasticity of individuals with traumatic spinal cord injury (SCI).

Setting: Ankara, Turkey Methods: Nineteen patients with traumatic SCI presenting with lower extremity spasticity were treated with UGFNBwP. Modified Ashworth Scale (MAS) of hip flexion and knee extension, functional independence measure (FIM) motor subscale, difficulty of catheterization (DoC), hygiene score (HS), spasm frequency (SF), sleep quality (SQ) and patient satisfaction (PS) were measured in all patients prior to treatment, at first week and second month.

Eligibility criteria: Inclusion Criteria:

* Traumatic etiology
* Duration of spinal cord injury more than twelve months
* Spasticity of hip flexor and/or knee extensor muscle
* Use of any oral medications to reduce spasticity at stable doses for at least one month before first assessment
* The patients have to accept to continue same dose until end of the last assessment
* Medical clearance to participate

Exclusion Criteria:

* Having established contracture of the knee/hip joint
* Aged over 65 years
* History of surgery for knee/hip disorders
* Non-traumatic etiology

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Functional independence measure
timeFrame: up to 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00661986: Effect of Different Dosages of Dark Chocolate on Arterial Blood Pressure in Cardiovascular High-risk Patients
Official title: Effect of Different Dosages of Dark Chocolate on Arterial Blood Pressure in Cardiovascular High-risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2008-04-21
Enrollment: 102
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: Low habitual intake of low-dose dark chocolate (6 g/day) has been shown to have a beneficial effect on arterial blood pressure in one previous study. The trial will assess if ingestion of a higher but still moderate dose (25 g/day) over 3 months will have a more pronounced effect. The population will consist of cardiovascular high-risk patients only (who will potentially benefit most from blood-pressure lowering).


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* mean ambulatory blood pressure 125-146 mmHg and/or 80-89 mmHg
* high cardiovascular risk profile (one or more of the following: CAD, PAD, carotid stenosis, diabetes)
* informed consent

Exclusion Criteria:

* habituary intake of dark chocolate or cocoa products
* mean ambulatory blood pressure 147 mmHg or greater and/or 90 mmHg or greater
* pregnancy
* uncontrolled diabetes
* severe comorbidity
* change in blood pressure medication within last 6 weeks
* participation in another trial

Primary outcomes:
measure: change in mean ambulatory arterial blood pressure
timeFrame: 3 months
Secondary outcomes:
measure: change in weight and BMI
timeFrame: 3 months
measure: change in various lab parameters
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02853786: Language Environment in Children With Cochlear Implants
Official title: Influence of Language Environment in Children With Cochlear Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Language Development
Keywords: cochlear implant
language environment
speech therapy assessment
LENA technology
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Hôpital Necker-Enfants Malades
First posted: 2016-08-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The Language Environment Analysis (LENA) system is a specific tool for the language environment analysis. Children aged from 18 months to 6 years old, with cochlear implants (CIs), wear an electronic device during a day and their language interactions are registered. Then the investigators can analyze with a specific software four different parameters (adult words, conversational turns, child vocalizations and media exposure) and compare them to the language ability of the children assessed by a speech therapist. With the results, the speech therapist can advise the parents how to improve the language environment to help their children with CIs for their language development. Parents are encouraged to follow these advices at home during few months (5 months +/-1 month). Then there is a new registration of the LENA device and another language assessment are performed, to see if there is any improvement. The investigators also measure the family participation.

Hypothesis : There is an influence of the language environment measured by the LENA system on language development in children with cochlear implants.

Detailed description: Over 24 months the investigators will recruit 90 patients with cochlear implants (CIs) in 2 centers.

Each patient will follow during 5 months and will have three or five visits according to the arm.

Eligibility criteria: Eligibility Criteria:\*

Inclusion criteria:

* Congenital profound deaf children
* aged from 18 months to 5 years old 11 months
* with a cochlear implant at least since 6 months
* regular following in speech therapy

Exclusion criteria:

* non-francophone parents
* syndrome (like CHARGE syndrome) or aplasia
* partial insertion of the electrode array
* associated troubles (Autism Spectrum Disorders, mental retardation...)
* visual troubles
* irregular use of the cochlear implant (externe part)
* absence of parental consent

Primary outcomes:
measure: Change in language environment measured by LENA system
timeFrame: At the inclusion, and 5 months after the inclusion
Secondary outcomes:
measure: Change in language ability measured by the Grammatical Analysis Of Elicited Language Presentence level (GAEL-P)
timeFrame: At the inclusion, and 5 months after the inclusion
measure: Change in language ability measured by a vocabulary scale with peabody images (EVIP) (EVIP)
timeFrame: At the inclusion, and 5 months after the inclusion
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00931086: Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99
Official title: An Expanded Access Trial of Belimumab Antibody (Monoclonal Anti-BLyS Antibody) in Patients With Rheumatoid Arthritis (RA) Who Were Previously Treated Under HGS Protocol LBRA99
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
RA
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-07-02
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: An expanded access trial of belimumab for named patients who participated in LBRA99.

Detailed description: An expanded access trial of belimumab for named patients with Rheumatoid Arthritis (RA) who have experienced continued benefit under HGS Protocol LBRA99.

Eligibility criteria: Inclusion Criteria:

1. Have in the clinical judgment of the investigator, experienced significant clinical benefit while on belimumab treatment in the HGS Protocol LBRA99.
2. Over the course of the study and for 60 days after the last dose of study agent, any woman with an intact uterus who is not post-menopausal must agree to practice a medically accepted method of contraception.
3. Over the course of the study and for 60 days after the last dose of study agent, all men must agree to practice a medically accepted method of contraception.
4. Have the ability to understand the requirements of this study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the required study visits.

Exclusion Criteria:

1. Had not been previously treated with belimumab in LBRA99 or were discontinued from treatment prior to HGS' decision to terminate LBRA99.
2. Had clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to RA (ie, cardiovascular, pulmonary, anemia, gastrointestinal, hepatic, renal, neurological, cancer or infectious diseases) that could, in the opinion of the principal investigator, put the patient at undue risk.
3. Are a pregnant female or nursing mother.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida
state: Florida
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01455922: A Study to Evaluate ITCA 650 Compared to Glimepiride as Add on Therapy for the Treatment of Type 2 Diabetes
Official title: A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Intarcia Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 0
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: Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* HbA1c between 7.5% - 10.5%
* on metformin monotherapy
* BMI between 25 \& 45 kg/m2

Exclusion Criteria:

* On thiazolidinedione, sulfonylurea, DPP-4, alpha glucosidase inhibitor, meglitinides or insulin within last 3 months
* history of pancreatitis

Primary outcomes:
measure: Change in HbA1c
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hayward
country: United States
facility: Intarcia Therapeutics, Inc
state: California
Study officials:
References:
Clinical trial NCT04041622: Coeliac Disease in the Nord-Trøndelag Health Study (HUNT)
Official title: Coeliac Disease in the Nord-Trøndelag Health Study (HUNT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Keywords: Prevalence
General population
Diagnosis
Prognosis
Etiology
Genes
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Oslo University Hospital
name: Helse Nord-Trøndelag HF
name: University of Groningen
name: Karolinska Institutet
First posted: 2019-08-01
Enrollment: 56000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All inhabitants of Nord-Trøndelag County, Norway, above 18 years of age are invited to participate
Primary purpose: SCREENING

Brief summary: In this study, all citizen of Nord-Trøndelag County, Norway, above 20 years of age are invited to participate in a population-based health study, the HUNT study. Blood samples are drawn from the participants and assessed for celiac disease by a serological assay. Celiac disease is a chronic inflammatory disease of the small intestine due to dietary gluten in wheat, barley and rye. The diagnosis will be verified through endoscopic assessment and biopsies from the small intestinal mucosa. The aims of the study are 1) to establish the population-based prevalence of celiac disease; 2) to assess the consequences of the disease from patient reported outcomes, symptoms, deficiencies, and co-morbidity; 3) to study possible risk factors and environmental triggering events; 4) to identify genetic predictors and gene-environmental interactions.


Eligibility criteria: Inclusion Criteria:

* Participants of the forth round of the HUNT study

Exclusion Criteria:

* None

Primary outcomes:
measure: Prevalence of celiac disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Levanger Hospital, Nord-Trøndelag Hospital Trust
Study officials:
affiliation: NTNU, Norwegian University of Science and Technology
name: Eivind Ness-Jensen, md phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01587222: Midodrine, Octreotide and Albumin: Impact on Renal Function of Patients With Liver Cirrhosis and Renal Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Fibrosis
Renal Failure
Hepatorenal Syndrome
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the treatment with midodrine, octreotide and albumin during 12 weeks in patients with hepatorenal syndrome. Fifteen patients will be enrolled and followed during 16 weeks. The effects on renal function will be evaluated 12 and 16 weeks after the beginning of the treatment by isotopic evidence and biochemist determinations. Also it will be evaluated arterial pressure and determination of vasoactive hormones (plasma renin, aldosterone and norepinephrine).


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years
* Cirrhosis of the liver defined by clinical, biochemical or histological
* Functional renal failure with serum creatinine greater than 1.2 mg / dl and less than 2.5 mg / dl.
* That, properly informed, give their consent to participate in the study and undergo tests and examinations that entails
* Women of childbearing potential: pregnancy test negative serum or urine, and acceptance of use of adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last dose

Exclusion Criteria:

* Pregnant women, nursing mothers, or those who intend to become pregnant during the study period
* Systolic blood pressure ≥ 150 mmHg and / or diastolic blood pressure ≥ 90 mmHg
* Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical portosystemic shunts
* Use of antibiotics in the seven days prior to inclusion in the study except for prophylactic (ie. prophylaxis of spontaneous bacterial peritonitis)
* Cardiac or respiratory failure
* Positive for human immunodeficiency virus
* Urinary retention
* Ischemic heart disease or peripheral vascular disease.
* Narrow Angle Glaucoma
* Cerebrovascular occlusions
* Aortic Aneurysm
* Thyrotoxicosis
* Pheochromocytoma

Primary outcomes:
measure: Glomerular filtration
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in plasma renin activity, plasma aldosterone and norepinephrine
timeFrame: 4, 12 and 16 weeks
measure: Changes in blood pressure measured by Holter
timeFrame: 4, 12 and 16 weeks
measure: Changes in renal function
timeFrame: at 4 weeks after cessation of treatment
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
Study officials:
References:
Clinical trial NCT00584922: Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation
Official title: Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Esophageal injury
Catheter Ablation
Atrial Fibrillation
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18-80 scheduled to undergo catheter ablation of atrial fibrillation

Brief summary: The purpose of this study is to prospectively follow the next 200 patients who undergo catheter ablation of atrial fibrillation for symptoms and signs of esophageal injury.

Detailed description: The purpose of this study is to prospectively follow the next 200 patients who undergo catheter ablation of atrial fibrillation and endoscopy. If any signs of esophageal injury are seen on endoscopy the patients will be treated with omeprazole and sucralfate and they will have repeat endoscopy in two weeks. Patients who do not have any esophageal injury will be contacted by telephone in two weeks to be assessed for GI symptoms.

Specific Aims: The specific aims of the study are to:

1. Assess the incidence of visible transmural esophageal injury following extensive ablation in the posterior left atrium as measured by endoscopy1
2. Assess whether early detection of esophageal injury by endoscopy and treatment will prevent development of more serious injury such as left atrial-esophageal fistula
3. Identify predictors of esophageal injury. In particular, to assess if esophageal temperature rises during ablation correlate with development of esophageal injury and if the absence of esophageal temperature rise during ablation correlate with the absence of esophageal injury.

Eligibility criteria: Inclusion Criteria:

* 18-80 years
* Scheduled to have catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.

Exclusion Criteria:

* Contraindication to endoscopy
* Pregnancy
* Prisoners
* Inability or unwillingness to give informed consent

Primary outcomes:
measure: Incidence of Esophageal Injury as Assessed by Endoscopy
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OU Medical Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Karen Beckman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06280222: The Effectiveness of Virtual Reality on Anxiety Reduction in Women Undergoing Elective Egg Cryopreservation.
Official title: Virtual Reality (VR)-Based Intervention to Improve Pre-operative Anxiety in Patients Undergoing Elective Oocyte Cryopreservation: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized trial assessing the effectiveness of virtual reality exposure prior to an oocyte retrieval procedure in terms of anxiety level .

Detailed description: Eligible women, undergoing elective egg freezing, will be offered to participate in the study, and sign a consent form.

The patients will be randomized into 2 groups:

1. No intervention (routine management).
2. Exposure to scenery video, as a VR (virtual reality) session.

All women will be addressed prior to the procedure, while they are waiting, and upon consent will be asked to state their VAS (visual analogue scale) anxiety score and to fill the STAI (The State-Trait Anxiety Inventory questionnaire.) Vital signs (Heart rate, Blood pressure) will be recorded upon arrival.

Patients who were allocated to the VR arm will watch a 20-minute scenery video and following the session before entering the procedure will be asked to rate their VAS score and answer the STAI questionnaire once again. vital signs will be recorded again.

After recovery all women will fill the STAI questionnaire, VAS score and vital signs before they will be discharged.

Eligibility criteria: Inclusion Criteria:

* Patients before egg retrieval for social reasons (elective egg freezing)

Exclusion Criteria:

* Use of any medications for pain relief/ anti -anxiety /anti -depressants medication generally or prior to the intervention
* If suffers from any condition that Use of VR is not recommended:

  1. Risk for seizures
  2. Sensitivity to ﬂashing light/motion
  3. Predisposing to nausea/dizziness (vertigo, etc.) Any injury to the eyes/face/neck that would limit the use of the hardware, including blindness.

Primary outcomes:
measure: Vital signs
timeFrame: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
measure: Vital signs
timeFrame: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
measure: VAS (visual-analogue scale)
timeFrame: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
measure: State and Trait Anxiety (STAI) Score
timeFrame: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah mound scopus IVF unit
Study officials:
References:
Clinical trial NCT00314522: Optimization of Spectroscopic Imaging Parameters and Procedures for Prostate at 3 Tesla Using an External Probe
Official title: Optimization of Spectroscopic Imaging Parameters and Procedures for Prostate at 3 Tesla Using an External Probe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2006-04-14
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clniic

Brief summary: This study performed a retrospective analysis of patient images to develop software in determining dose delivered for each fraction treatment.


Eligibility criteria: Inclusion Criteria:

* Subject 18 years of age and over

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Gino Fallone, PhD
role: PRINCIPAL_INVESTIGATOR
References: