louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01382875: The Comparison of Comprehensive Multi-disciplinary Program and Conventional Care Program on Fragility Fracture Elderly
Official title: Medico-social Impact of a Comprehensive Multi-disciplinary Program for the Care of Fragility Fracture of the Elderly -Implications for Healthcare Policy in Hong Kong
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hip Fracture
Keywords: Multi-disciplinary management program
Conventional care program
Balance Ability
Quality of Life
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Elizabeth Hospital, Hong Kong
First posted: 2011-06-27
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Fragility fractures are one of the commonest injuries among elderly people in Hong Kong and account for 12% of the disease burden in elderly aged 65 or above.

A good management healthcare program and training helps elderly to restore full functional level and prevent re-fracture in the following 2 years after primary fracture, but Hong Kong lacks of such program. Some reports from other countries pointed out a well-organized multi-disciplinary management programs are cost-effective to identify and treat osteoporosis, reduce the fracture rate, improve quality of life and raise awareness of fragility fracture.

This study aims to compare the cost-effectiveness of multi-disciplinary management program with conventional care controls. The clinical effectiveness outcomes (re-fracture rate, fall rate, mortality, mobility, quality of life and specialist follow-up time) of the fragility hip fracture patients in New Territories East receiving the proposed management program will be compared with those from Kowloon Central with usual care as controls. The findings will provide useful data for the policy maker to evaluate the current clinical service for fragility fracture patients and consider the implementation of new multi-disciplinary management program into our healthcare system.


Eligibility criteria: Inclusion Criteria:

* Fragility hip fracture patients within age 65-90

Exclusion Criteria:

* Taking medication affecting bone metabolism or intensive exercise training;
* Those living in old age homes or anyone who is not able to comply with our program

Primary outcomes:
measure: Cost effectiveness of the multi-disciplinary management program and conventional care program
timeFrame: 1 year
Secondary outcomes:
measure: Mobility
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
name: Kwok-Sui Leung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06231875: Difference Between Pressing and Vacuum Techniques in Fabrication of Orthodontic Aligners in Cases With Spacing: A Cross-sectional Study
Official title: Difference Between Pressing and Vacuum Techniques in Fabrication of Orthodontic Aligners in Cases With Spacing: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Orthodontic Aligners
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patient with maxillary moderate spacing.

Brief summary: This cross sectional study is aiming to compare 2 techniques of clear aligners fabrication identifying which is better.


Eligibility criteria: Inclusion Criteria:

* Maxillary arch with moderate spacing.
* Full permenant dentition.

Exclusion Criteria:

* Missing teeth.
* Any restorations.

Primary outcomes:
measure: Maxillary arch dimensions
timeFrame: 6 months
Secondary outcomes:
measure: Model superimposition
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT02073175: Development of Dietary Supplements for Mood Symptoms in Postpartum
Official title: Development of Dietary Supplements for Mood Symptoms in Postpartum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postpartum Blues
Healthy
Keywords: Postpartum
Dietary Supplements
Mood Symptoms
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether a dietary supplement (DS) is effective in protecting against sad mood in postpartum.

Detailed description: The specific aim of this open-label study is to assess whether the proposed dietary supplement can reduce the intensity of sadness in women vulnerable to sadness (day-5 postpartum women and women within the first 18 months postpartum with crying spells).

Eligibility criteria: Inclusion Criteria:

* Age 18 to 45
* The subject, as reported by them, should be in a good health.
* The subject is not taking any medication.
* The subject is not taking any investigational medicinal product within 8 weeks.
* BMI 19 to 40 (kg/m2)
* Resting pulse between 45 and 100 bpm
* Systolic blood pressure between 91 and 139 mmHg (inclusive)
* Diastolic blood pressure between 51 and 90 mmHg (inclusive)

Exclusion Criteria:

* The subject has been diagnosed with any axis 1 and 2 disorders based on Structured Clinical Interview (SCID) for DSM-IV interview.
* Substance abuse disorder
* Subjects who have been smoking in the past 5 years.

Primary outcomes:
measure: Change in Visual Analog Scale (VAS)
timeFrame: Assessment will be done on day-5 postpartum or within the first 18 months postpartum (depending on which group subject belongs to). On the assessment day, the VAS will be administered before and after sad mood indcution and compared
Secondary outcomes:
measure: Change in Profile of Mood States (POMS) Scores
timeFrame: Assessment will be done on day-5 postpartum or within the first 18 months postpartum (depending on which group subject belongs to). On the assessment day, the POMS will be administered before and after sad mood indcution and compared
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiciton and Mental Health
state: Ontario
Study officials:
affiliation: Research Imaging Centre, Centre for Addiction and Mental Health
name: Jeffrey H Meyer, MD,PhD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dowlati Y, Ravindran AV, Segal ZV, Stewart DE, Steiner M, Meyer JH. Selective dietary supplementation in early postpartum is associated with high resilience against depressed mood. Proc Natl Acad Sci U S A. 2017 Mar 28;114(13):3509-3514. doi: 10.1073/pnas.1611965114. Epub 2017 Mar 13.
Clinical trial NCT06520475: Efficacy of Bupivacaine-magnesium Combination Versus Bupivacaine Alone in Genicular Nerve Block
Official title: Efficacy of Bupivacaine-magnesium Combination Versus Bupivacaine Alone in Genicular Nerve Block in Total Knee Replacement Surgeries: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Post Operative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is proved that the addition of magnesium sulfate to local anesthetics for neuraxial anesthesia improves the quality of analgesia and prolongs the duration of anesthesia . In-vitro and in-vivo studies have demonstrated that magnesium enhances the local anesthetics effect on peripheral nerves .

No previous studies were conducted on magnesium sulfate as an adjuvant to the local anesthetic in genicular nerve block. Hence, this study will be conducted to assess analgesic efficacy of magnesium sulfate when added to bupivacaine in ultrasound guided genicular nerve block


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist (ASA) I or II physical status.
* Between 18 and 70 years of age.
* Both genders.
* Patients undergoing total knee replacement surgery.

Exclusion Criteria:

* Patient refusal.
* ASA Ⅲ and Ⅳ patients.
* Known allergy to the study drugs.
* Hypermagnesemia.
* Central or peripheral neurological disease.
* Pregnancy.
* Drug or alcohol abuse.
* Localized infection at the site of the block.
* Bleeding disorder (platelets count less than 100,000 or international normalized ratio more than 1.4)

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: 24 hours post-operatively
Secondary outcomes:
measure: First request for analgesia
timeFrame: 24 hours post-operatively
measure: Total opioid consumption
timeFrame: 24 hours post-operatively
measure: Patient satisfaction
timeFrame: 24 hours post-operatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00448175: Overactive Bladder Innovative Therapy Trial (OrBIT)
Official title: Overactive Bladder Innovative Therapy Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: OAB symptoms of urgency, frequency, and urge incontinence
Lead sponsor: Uroplasty, Inc
Sponsor class: INDUSTRY
First posted: 2007-03-16
Enrollment: 100
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 compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).


Eligibility criteria: Inclusion Criteria:

* Is at least 18 years of age
* Experiences OAB with a voiding frequency of at least 8 times per day
* Is ambulatory and able to use a toilet independently and without difficulty

Exclusion Criteria:

* On OAB pharmacotherapy within the previous month
* Primary complaint is stress urinary incontinence
* Has pacemaker or implantable defibrillator
* Has history of heart problems
* Has nerve damage or neuropathy
* Has gastric or urinary retention
* Has uncontrolled narrow-angle glaucoma
* Has known sensitivity to drug ingredients
* Is pregnant or planning to become pregnant during the trial

Primary outcomes:
measure: Frequency of Voids at 12 Weeks
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Urge Incontinence Episodes at 12 Weeks
timeFrame: 12 weeks
measure: Volume Voided at 12 Weeks
timeFrame: 12 weeks
measure: OAB Quality of Life at 12 Weeks
timeFrame: 12 weeks
measure: Known Side Effects Through 12 Weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Minnetonka
country: United States
facility: Uroplasty, Inc
state: Minnesota
Study officials:
affiliation: Uroplasty, Inc
name: Megan O'Toole
role: STUDY_DIRECTOR
References:
Clinical trial NCT01241175: The Effect of Intravenous Magnesium Sulfate on Intraocular Pressure Following Tracheal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Increased Intra Ocular Pressure (IOP)
Keywords: IOP
ophthalmic anesthesia
magnesium sulfate
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-11-16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the effect of preoperatively administered intra venous magnesium sulfate in attenuating pressure response to laryngoscopy and endotracheal intubation in adult patients scheduled for elective non ocular surgery


Eligibility criteria: Inclusion Criteria:

* 18 to 38 years old
* ASA I
* scheduled for elective ENT ambulatory surgeries under general anesthesia

Exclusion Criteria:

* specific major hepatic, renal and cardio-vascular disease
* known to have allergic reaction to magnesium sulphate or other drugs , -hypermagnesemia
* hypocalcemia
* anuria
* heart block
* pregnancy
* any degree of renal insufficiency
* digitalised patients
* positive history of glaucoma or intra ocular hypertension
* refused to participate

Primary outcomes:
measure: Intra ocular pressure
Secondary outcomes:
measure: blood pressure,heart rate
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Hilda Mahmoudi, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT05748275: Randomized Trial Comparing Prediction Accuracy of Two Swept Source Optical Coherence Tomography Biometers
Official title: Randomized Trial Comparing Prediction Accuracy of Two Swept Source Optical Coherence Tomography Biometers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Multack Eye Care
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults presenting with clinically significant cataracts.

Brief summary: To assess if the Alcon Argos Biometer utilizing the Barrett Universal II formula for IOL calculations can give a non-inferior outcome when compared to the Zeiss IOL master 700 utilizing the (PCA) with the Barrett Universal II (TK) formula, when comparing the (mean absolute prediction error of the predicted target spherical equivalencies).


Eligibility criteria: Inclusion Criteria:

* Age: 50-85 years old
* Clinically Significant Cataracts that interfere with daily activities
* Patient is able to understand and able to consent to informed consent
* Patient is able to come to all postoperative visits and agrees to follow up at 30 days -2/+14 days
* Patient undergoing cataract surgery, with implantation of the Alcon SN60WF lens in the capsular bag.

Exclusion Criteria:

* Axial Length \< 22.00 and \> 26.00
* Corneal Astigmatism \> +1.00 Diopters
* CCTS: \< 490 and \> 600
* Prior Refractive Surgery: RK, PRK, LASIK, INTACTS
* History of contact lens use: Soft lenses within 2 months of surgery, RGP within 60 months of surgery
* Corneal Disease: Keratoconus, Corneal Dystrophies, Any prior corneal Surgery, Prior infections
* Retinal Disease: Macular Pathology, CSCR, CME, Macular Degeneration, Drusen, Retinal Detachment, TPPV, SB, prior IVT, Prior PRP or Focal Laser, Diabetic Retinopathy
* History of Uveitis
* POAG: Undergoing any concomitant MIGS procedure- iStent, Omni, iTrack, Hydrus, etc
* Enrollment in any prior clinical trial within 2 years
* Systemic Disease that in the investigator's opinion may affect outcome
* Currently Pregnant or Breastfeeding
* Severe Dry Eye
* Tear Osmolarity \> 320mOsms/L (Moderate)
* Any Surgical Complication(s)
* IOL implanted outside of the capsular bag /capsular damage /weakness /CTR placement

Primary outcomes:
measure: Mean Absolute Prediction Error (D)
timeFrame: 1 month postoperatively
Secondary outcomes:
measure: Percentage of Eyes With Absolute Prediction Error 0.5 D or Less
timeFrame: 1 month postoperatively
measure: Median Absolute Prediction Error (D)
timeFrame: 1 month postoperatively
Other outcomes:
Locations:
city: Frankfort
country: United States
facility: Multack Eye Care
state: Illinois
Study officials:
affiliation: Multack Eye Care
name: Sam Multack, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01450475: Study of Remote Ischemic Postconditioning
Official title: A Randomized Control Trial of Effect of Remote Ischemic Postconditioning on Children Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ischemia
Bypass Complications
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2011-10-12
Enrollment: 65
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cardiac surgery is associated with cardiac and cerebral injury because of ischemia/reperfusion in approximately one third of cases. Ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI). As another ischemic conditioning, remote ischemic postconditioning, limits MI size in animal models. The purpose of this study is to evaluate the cardiac and cerebral protective effect of remote ischemic postconditioning in children undergoing cardiac surgery, as a single-center, randomized controlled trial.

Detailed description: Cardiac surgery is associated with Troponin release because of ischemia/reperfusion injury in approximately one third of cases. And I/R injury may also induce cerebral insult, even Postoperative Cognitive Dysfunction (POCD).Transient sublethal episodes of ischemia before a prolonged ischemia/reperfusion injury, known as ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI).And remote ischemic postconditioning(RIPoC), as another ischemic condition, limits MI size in animal models.

However, there are limited outcome to demonstrate protection from RIPoC during cardiac surgery. The purpose of this study is to investigate the cardiac and cerebral protective effect of remote ischemic postconditioning , as a single-center, randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* All Children aged from 0 to 12 who are undergoing open congenital cardiac surgery.

Exclusion Criteria:

* Simple atrial septal defect
* Bidirectional cavopulmonary shunt undergoing Fontan completion
* Chromosomal defects
* Airway or parenchymal lung disease
* Immunodeficiency
* Blood disorder

Primary outcomes:
measure: cTnI,CK-MB concentration
timeFrame: 24h after Remote Ischemic Postconditioning
Secondary outcomes:
measure: NSE，S100β concentration
timeFrame: 24 hours after Remote Ischemic Postconditioning
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Wang Qiang, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01273675: An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy
Official title: An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Nephropathy
Keywords: Hypertension
Primary disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-01-10
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type II Diabetic diasese with hypertension ( systolic 140-160 mm/Hg, dystolic 80-100 mm/Hg) for 8 weeks.

Brief summary: It is well understood that hypertension, dyslipidemia, and diabetes mellitus are the major risks of chronic kidney disease. Current guidelines recommend screening kidney estimated glomerular filtration function with serum creatinine. But it is not the utmost effective method and the GFR would be underestimated. Since good correlation was noticed between serum creatinine and chronic kidney disease, urinary microalbumin levels is better for patients with risks of chronic kidney diseases. With adequate and early education, or antihypertensive agents with angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB), all could alleviate renal function deterioration and the severity of proteinuria. As a result, high sensitive methods is urgent and needed for early screening and diseases following up under medication with ACEi and ARB in chronic kidney disease patients. In this project, the investigators are going to include the patients with typy II diabetes mellitus combining with hypertension who are treated with antihypertensive agents. Such volunteers will be treated with Candesartan 8-16mg/ day and maintain systolic blood pressure \<130 mm/Hg, diastolic blood pressure \< 80 mm/ Hg as the goal. Therefore, this project would make effort on correlation with urinary microalbumin and other biomarkers changes under Candesartan treatment- one of ARB medication for 12 weeks, and further exploration of new biomarkers that may be related to renal parenchymal injuries.


Eligibility criteria: Inclusion Criteria:

1. Type II Diabetic disease with hypertension (BP: systolic 140-160 mm/Hg, diastolic 80-100 mm/Hg) for 8 weeks.
2. HbA1c\< 8.0%
3. Cre. \<1.5 g/dL and eGFR: 89 - 30 mL/min/1.73 m2

Exclusion Criteria:

1. Pregnancy
2. During the observation, BP: systolic \>160 mm/Hg, diastolic \>100 mm/Hg).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Yu Chu-Su, PhD candidate
role: PRINCIPAL_INVESTIGATOR
References: