louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04056481: Expanded Access Protocol of Givosiran for Patients With Acute Hepatic Porphyria
Official title: Expanded Access Protocol of Givosiran for Patients With Acute Hepatic Porphyria (AHP)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Acute Hepatic Porphyria
Keywords: Acute Hepatic Porphyria (AHP)
Acute Intermittent Porphyria (AIP)
Porphyria
Acute Intermittent
Acute Porphyria
Hereditary Coproporphyria (HCP)
Variegate Porphyria (VP)
ALA Dehydratase Deficient Porphyria (ADP)
Givosiran
Expanded Access
EAP
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-08-14
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to provide expanded access of givosiran to patients with Acute Hepatic Porphyria (AHP).

Detailed description: Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join a research study. To learn more about this study, please have your doctor contact the study research staff using the Contacts provided. For general information, see the link provided in More Information.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Acute Hepatic Porphyria (Acute Intermittent Porphyria, Hereditary Coproporhyria, Variegate Porphyria, ALA dehydratase deficient porphyria)
* Have adequate venous access for program sample collections as judged by the Investigator for study sample collections

Exclusion Criteria:

* Previously or currently participating in a givosiran clinical trial
* Has any of the following laboratory parameter assessments at Screening:

  1. Alanine aminotransferase (ALT) \>2×ULN
  2. Total bilirubin \>1.5×ULN. Patients with elevated total bilirubin that is secondary to documented Gilbert's syndrome are eligible if the total bilirubin is \<2×ULN
  3. Estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73 m2
* On an active liver transplantation waiting list

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03535181: Pulsatility Aneurysmal Evaluation Process by Cerebral Dynamic CTA (Computed Tomography Angiography)
Official title: Pulsatility Aneurysmal Evaluation Process by Cerebral Dynamic CTA (Computed Tomography Angiography)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysm, 4D CT Scan
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from at least one intracranial aneurysm and who benefited from a 4D CTA in our institution.

Brief summary: Intracranial aneurysm are frequent with a prevalence estimated over 2-5% in the general population. These are focal dilatations occuring in the cerebral vessels. They usually remain silent until complications occur. Complications associated with intracranial aneurysms include mass effect on adjacent structures and rupture. Rupture is the most severe complication with a mortality rate of 35-50% and a high rate of morbidity including long-term disability. It incidence is estimated about 1% per year for aneurysm smaller than 1 cm.

However, preventative treatments have their own risk of complication and morbi-mortality rate including stroke and hemorrhage. Actual guidelines for treatment planning are mainly designed with the size, the location and the age of the patient. This is why working on the identification of imaging markers of aneurysmal instability is relevant.

Dynamic CTA (Computed Tomography Angiography) acquisition allow to study the variation of metrics such as dome height, dome length, ostium width, ostium area, and volume during the cardiac cycle. The goal of this study is to assess different aneurysmal metrics to determine those which may vary the most during the cardiac cycle and to assess it as an imaging marker of aneurysmal instability.


Eligibility criteria: Inclusion Criteria:

* Patient with an intracranial aneurysm assessed with a 4D CTA

Exclusion Criteria:

* Minor
* Refusal to participate

Primary outcomes:
measure: Assess the variation of different aneurysmal metrics (dome height, dome length, ostium width, ostium area, and volume) during the cardiac cycle.
timeFrame: 6months
Secondary outcomes:
measure: Evaluate among different aneurysmal metrics (dome height, dome length, ostium width, ostium area, and volume) the most relevant ones.
timeFrame: 6months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT04919681: Efficacy of Stretching on Pain Sensitivity
Official title: Efficacy of a Stretching Protocol on Regional and Distant Pain Sensitivity:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Threshold
Keywords: Stretching
Pain sensitivity
Range of motion
Exercise adherence
Lead sponsor: University College of Northern Denmark
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
name: University of Copenhagen
name: Research Unit for General Practice in Aalborg
First posted: 2021-06-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-blind longitudinal repeated measures study
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of this study is to determine the immediate efficiency of a six weeks regular stretching protocol on regional and distant pain sensitivity. It is hypothesised that regional and distant pain sensitivity will significantly decrease following six weeks of regular stretching.

The secondary objective of the study is to determine the effect after four-week cessation of the stretching protocol on regional and distant pain sensitivity. If regional and distant pain sensitivity decrease following regular stretching, it is hypothesised that the analgesic effect will abate following four-week cessation.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women aged 18-65 years are recruited. As part of the screening, volunteers will also be asked to indicate known medical issues or diseases. Participants are included if they have no known medical conditions such as
* cognitive impairments,
* neurological,
* orthopaedic,
* or neuromuscular problems that might affect the somatosensory system or preclude stretching exercises or range of motion testing at the knee.

Exclusion Criteria:

* Individuals who regularly engage in flexibility training (e.g., stretching, tai chi, pilates or yoga)
* or use any medication that might affect the somatosensory system, such as pain medication, are excluded.

Primary outcomes:
measure: Pain sensitivity
timeFrame: Baseline
measure: Pain sensitivity
timeFrame: 6 weeks
measure: Pain sensitivity
timeFrame: 10 weeks
Secondary outcomes:
measure: Range of motion
timeFrame: Baseline
measure: Range of motion
timeFrame: 6 weeks
measure: Range of motion
timeFrame: 10 weeks
measure: Passive resistive torque
timeFrame: Baseline
measure: Passive resistive torque
timeFrame: 6 weeks
measure: Passive resistive torque
timeFrame: 10 weeks
Other outcomes:
measure: Adherence to the stretching protocol
timeFrame: 6 weeks
Locations:
city: Aalborg
country: Denmark
facility: University College of Northern Denmark
Study officials:
affiliation: Department of Physiotherapy, University College of Northern Denmark
name: Dorte Drachmann, Msc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05174481: Forecasting ED Overcrowding With Statistical Methods: A Prospective Validation Study
Official title: Forecasting ED Overcrowding With Statistical Methods: A Prospective Validation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergencies
Keywords: emergency department
overcrowding
forecasting
artificial intelligence
deep learning
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 160000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tampere University Hospital is an academic hospital located in Tampere, Finland. It serves a population of 535,000 in the Pirkanmaa Hospital District and, as a tertiary hospital, an additional population of 365,700 and provides level 1 trauma centre capabilities.

Brief summary: The aim of this study is to prospectively validate statistical forecasting tools that have been widely used retrospectively in forecasting ED overcrowding

Detailed description: Emergency department (ED) overcrowding is a chronic international issue that has been repeatedly associated with detrimental treatment outcomes such increased 10-day-mortality. Forecasting future overcrowding would enable pre-emptive staffing decisions that could alleviate or prevent overcrowding along with its detrimental effects.

Over the years, several predictive algorithms have been proposed ranging from generalized linear models to state space models and, more recently, deep learning algorithms. However, the performance of these algorithms has only been reported retrospectively and the clinically significant accuracy of these algorithms remains unclear.

In this study the investigators aim to investigate the accuracy of the previously reported ED forecasting algorithms in a prospective setting analogous to the way these tools would be used if used implemented as a decision-support system in a real-life clinical setting.

Eligibility criteria: Inclusion Criteria:

* All patients presenting in the Emergency Department

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Next day overcrowding
timeFrame: 24 hours
Secondary outcomes:
measure: Number of hourly arrivals in the ED 24 hours ahead
timeFrame: 24 hour
measure: Hourly occupancy in the ED 24 hours ahead
timeFrame: 24 hour
measure: Number of daily arrivals in the ED 7 days ahead
timeFrame: 24 hour
measure: Daily peak occupancy in the ED 7 days ahead
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Gul M, Celik E. An exhaustive review and analysis on applications of statistical forecasting in hospital emergency departments. Health Syst (Basingstoke). 2018 Nov 19;9(4):263-284. doi: 10.1080/20476965.2018.1547348.
citation: Richardson DB. Increase in patient mortality at 10 days associated with emergency department overcrowding. Med J Aust. 2006 Mar 6;184(5):213-6. doi: 10.5694/j.1326-5377.2006.tb00204.x.
Clinical trial NCT00273481: Cosopt Versus Xalacom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Pharmaceutical Research Network
Sponsor class: OTHER
First posted: 2006-01-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the intraocular pressure efficacy and safety of the DTFC given twice daily versus the LTFC given once every morning following a run-in period with timolol maleate given twice daily.


Eligibility criteria: Inclusion Criteria:

* adults with primary open-angle or pigment-dispersion glaucoma, or ocular hypertension
* at baseline the intraocular pressure should be 20 to 32 mm Hg inclusive at 08:00 measurement (Visit 2) after dosing with timolol the evening before
* the intraocular pressure should be 32 mm Hg or less at all the time points in both eyes at Visit 2
* visual acuity should be 6/60 or better in the study eye(s)

Exclusion Criteria:

* any anticipated change in systemic hypotensive therapy during the trial
* use of any corticosteroids by any route for more than two weeks during the study
* contraindications to study medicines

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Lawson Health Research Insitute
state: Ontario
city: Ljubljana
country: Slovenia
facility: University Eye Clinic
Study officials:
affiliation: Pharmaceutical Research Network, LLC
name: William C. Stewart, MD
role: STUDY_DIRECTOR
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Cindy M. Hutnik, BSc, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Eye Clinic Ljubljana
name: Barbara Cvenkel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01026181: Gastric Procedures for Obesity
Official title: Phase II Study of Comparing Outcomes of Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Gastric Banding to Treat Morbid Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2009-12-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Morbidly obese patients aged from 18 to 65.

Brief summary: This is a prospective case series study; all morbidly obese patients that need surgical management in Royal Alexandra Hospital will be provided 3 surgical options: Laparoscopic Sleeve Gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LR-en-Y), and laparoscopic gastric banding (LGB), safety and effectiveness will be compared among the 3 groups. The outcome measures will be percentage of excess weight loss, BMI, operative time, hospital stays, complications and improvement of comorbidities.


Eligibility criteria: Inclusion Criteria:

* morbid obese patients aged from 18-65,
* BMI \> 40 kg/m2 or BMI\> 35 kg/m2 with severe comorbidities: diabetes, sleep apnea, hypertension etc.

Exclusion Criteria:

* psychiatric illness,
* substance abuse,
* previous gastrointestinal surgery, and
* any patient who transfers from laparoscopic to convention procedure.

Primary outcomes:
measure: Change in Body Weight
timeFrame: baseline to 2-year postoperation
measure: Change in BMI
timeFrame: from baseline to 2-year postoperation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06382181: A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness
Official title: A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness: Music Therapy, Health Education, and Physical Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Mental Health Disorder
Keywords: Music Therapy
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were assigned to three groups in parallel for the duration of the study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The absence of social relationships negatively affects physical, psychological, and social health. In other words, it alters people's quality of life and makes active aging difficult. The investigators have designed a study to reduce unwanted loneliness in people over 65 living in the community through multiple interventions (music therapy, health education, and physical exercise).

Detailed description: The proposed study will involve 4 group sessions each week for a total of 13 weeks. The program will include the following activities:

Physical exercise adapted to the physical conditions of each participant. Total of 26 sessions (2 per week).

Health education workshops. A total of 12 workshops. These will include group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, among others.

Music therapy workshops. Through listening to songs, singing, dancing, guided relaxation with music, and group instrumental performance, the enjoyment and expression of feelings will be encouraged. There will be 1 session per week. Total 12 sessions.

Eligibility criteria: Inclusion Criteria:

* Over 60 years of age with unwanted loneliness
* Must live in the city of Valencia
* Must speak Spanish or Valencian (or have sufficient knowledge to be able to answer the questions in the study).

Exclusion Criteria:

+ Severe mental disorder or dementia.

Primary outcomes:
measure: Score on the Jong Gierveld Loneliness Scale
timeFrame: 3 months
Secondary outcomes:
measure: Score on Goldberg Anxiety and Depression Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
city: Valencia
country: Spain
facility: Vanessa Ibáñez del Valle
Study officials:
affiliation: University of Valencia
name: Vanessa Ibáñez del Valle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02383381: Lateral Rectus Muscle and Anterior Segment Optical Coherence Tomography (AS-OCT)
Official title: Pre and Post-operative Rectus Muscle Insertion Site Changing Using Anterior Segment Optical Coherence Tomography in Strabismus Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intermittent Exotropia
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 30
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 patients : 21 males and 9 females age: 9 to 60 years

Brief summary: •Background and study aims : The investigators conducted this study to evaluate the movement of extraocular muscle after strabismus surgery with non-invasive tool called AS-OCT.

* Who can participate? patients who underwent typical lateral rectus recession surgery for correcting intermittent exotropia
* What does the study involve? Volunteers will attend a clinic for four visits over six months. They will undergo AS-OCT at every visits during follow up period. AS-OCT is non-invasive test to evaluate operation site. The test only requires their cooperation when they undergo AS-OCT.
* What are the possible benefits and risks of participating? This is non-invasive test for your postoperative follow up. Therefore, there will be no risks about this test.
* Where is the study run from? Samsung Medical Center
* When is the study starting and how long is it expected to run for? From Feb 2014 to Dec 2014

Detailed description: The aim of this study is 1) to evaluate the reliability and accuracy of AS-OCT in the measurement of the lateral rectus (LR) insertion distance, 2)to investigate the longitudinal change of LR muscle insertion after strabismus surgery, and 3)to determine the effect of insertion movement on the angle of deviation after strabismus surgery. An AS-OCT scan of the LR muscle was performed every visits. Preoperative limbus-LR insertion distance was compared with intraoperative surgical caliper measurement of LR insertion using intraclass correlation coefficient analysis (ICC). Data on gender, age, degree of deviation (prism diopter), and spur-LR insertion distance using AS-OCT were collected at postoperative months 1,3 6.

Eligibility criteria: Inclusion Criteria:

* patients who underwent lateral rectus recession surgery for correcting intermittent exotropia

Exclusion Criteria:

* previous ocular surgery
* other ocular diseases except intermittent exotropia
* amblyopia

Primary outcomes:
measure: The change of limbus-muscle insertion distance measured with AS-OCT
timeFrame: baseline and 1.3.6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Liu X, Wang F, Xiao Y, Ye X, Hou L. Measurement of the limbus-insertion distance in adult strabismus patients with anterior segment optical coherence tomography. Invest Ophthalmol Vis Sci. 2011 Oct 28;52(11):8370-3. doi: 10.1167/iovs.11-7752.
Clinical trial NCT06889181: Role of Plasma Rich Growth Factor in Repair Primary Cleft Palate
Official title: Evaluation of the Role of the Plasma-rich Growth Factor (PRGF) with Primary Cleft Palate Repair Versus Primary Cleft Palate Repair in Post-operative Wound Healing and Oronasal Fistula Occurrence, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cleft Palate
Plasma Rich in Growth Factors
Keywords: cleft palate
plasma rich growth factor
healing
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either control or study group in the ratio of 1:1 using random number table.
Primary purpose: TREATMENT

Brief summary: Does the plasma-rich growth factor (PRGF) with primary cleft palate repair accelerate wound healing and prevent post-operative oronasal fistula occurrence?

Detailed description: The primary objective is to assess and evaluate the improvement of wound healing (edema at 5th day post operatively) as a primary outcome, and secondary objective is to assess and evaluate the wound closure and the decreasing of the occurrence of the oronasal fistula as a secondary outcome among children with cleft palate, using plasma rich growth factor between nasal mucosa and palatal mucosa

Eligibility criteria: Inclusion Criteria:

* systemically healthy patients (American Society of Anesthesiologists -ASA I and II); not older than 6-18 months
* Patients with primary non-syndromic isolated cleft palate
* Apprehensive to be in the study.

Exclusion Criteria:

* Patients with recurrent palatal fistula
* Existence of syndromic cleft palate
* Blood diseases and platelet disorders (hematological disease)
* Systematic disease radiotherapy or chemotherapy for malignancy

Primary outcomes:
measure: wound healing assesment (edema at 5th day post operatively)
timeFrame: first day after surgery, 3rd day, and 5th day
Secondary outcomes:
measure: wound healing assesment
timeFrame: 2 years
measure: the occurrence of oronasal fistula
timeFrame: first day after surgery to end of treatment at 3 months
Other outcomes:
Locations:
city: Manial
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: Cairo
Study officials:
References: