louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00762229: Evaluation of LDL Cholesterol in Patients Switched From 10 to 5 Milligrams of Zetia (Ezetimibe)
Official title: Prospective Evaluation of LDL Levels in Patients Converted From Zetia (Ezetimibe)10 mg to 5 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Cholesterol
Ezetimibe
Lead sponsor: Bronx VA Medical Center
Sponsor class: FED
First posted: 2008-09-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare the effect on LDL cholesterol levels of converting patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10 milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet.


Eligibility criteria: Inclusion Criteria:

* Subjects receiving ezetimibe 10 mg
* Subjects who have demonstrated compliance with ezetimibe as evidenced by the following Proportions of Days Covered patterns (which represent a PDC of more than 75%):

  * 90 day prescriptions: Filled a ezetimibe prescription within the previous 4 months
  * 60 day prescriptions: Filled a ezetimibe prescription within the previous 2.5 months
  * 30 day prescriptions: Filled a ezetimibe prescription within the previous 1.5 months
* Patients willing and able to provide signed informed consent

Exclusion Criteria:

* Patients not receiving ezetimibe
* Patients receiving ezetimibe 5 milligrams
* Patients with a history of being titrated from ezetimibe 5 to 10 mg. Stroke,TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within the 3 months
* Cancer undergoing active treatment
* Participation in any clinical study within the last 30 days
* Drug addiction or alcohol abuse within the past 6 months
* Patients unwilling or unable to provide informed consent
* Patients with poor compliance
* Women of childbearing potential

Primary outcomes:
measure: LDL Cholesterol
timeFrame: 4 weeks
Secondary outcomes:
measure: Total Cholesterol
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx VA Medical Center
state: New York
Study officials:
affiliation: Bronx VA Medical Center
name: Lawrence Baruch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baruch L, Agarwal S, Gupta B, Haynos A, Eng C. Effect on serum lipid levels of switching dose of ezetimibe from 10 to 5 mg. Am J Cardiol. 2009 Jun 1;103(11):1568-71. doi: 10.1016/j.amjcard.2009.01.365. Epub 2009 Apr 22.
Clinical trial NCT06302829: Comparison of IMES Versus DN on ATrPs of AC
Official title: Comparison of Intramuscular Electrical Stimulation Versus Dry Needling on Active Trigger Points of Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: trigger points
range of motion
dry needling
disability
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study to compare DN and IMES for pressure pain threshold, ROM and the shoulder function in active trigger points with adhesive capsulitis. This study will add to the growing body of knowledge that if these two techniques yield comparable outcomes and if one technique is superior to the other, which should be the alternative of therapy. Moreover, it would add to the society as there are very limited researches done in Pakistan using needling for trigger points in adhesive capsulitis.


Eligibility criteria: Inclusion Criteria:

* Age 40 to 60 year of both genders
* Diagnosed patients of stage 3 Adhesive capsulitis with type I and II diabetes
* Involvement of at least 3 shoulder girdle muscles in Active MTrPs (subscapularis, latissimus dorsi, deltoid (anterior, middle, posterior)
* Active MTrPs in shoulder girdle muscles (subscapularis, supraspinatus, deltoid (anterior, middle, posterior), teres minor, latissimus dorsi)
* Reproduction of the patient's symptoms at active trigger point, Taut band, Hypersensitive spot, Referred pain pattern, local twitch response
* Minimum 60 degrees of active/passive shoulder abduction range of movement.

Exclusion Criteria:

* Systemic inflammatory joint disease of shoulder joint (RA, OA polymyalgia rheumatic)
* Cerebral Vascular Accident
* Fibromyalgia, neurological deficits of upper limb (Nerve root entrapment, Cervical radiculopathy, Thoracic outlet syndrome)
* History of Fracture, Dislocation, Acute soft tissue injury, Acute bursitis
* Avascular necrosis of humeral head or visceral referred pain to shoulder
* Pregnancy, Hypothyroidism, skin infection
* Patients who are using Antiplatelet Therapy with in past 3 days of study
* Extreme fear of needles

Primary outcomes:
measure: Algometer (pressure pain threshold)
timeFrame: 3rd week
Secondary outcomes:
measure: ROM Shoulder (Flexion)
timeFrame: 3rd week
measure: ROM Shoulder (Abduction)
timeFrame: 3rd week
measure: ROM Shoulder (External rotation)
timeFrame: 3rd week
measure: ROM Shoulder (Internal Rotation)
timeFrame: 3rd week
measure: American shoulder and elbow surgeons scale
timeFrame: 3rd week
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway general hopsital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aneela zia, MS-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00591929: Use of Continuous Passive Motion in the Post-Operative Treatment of Intra-articular Knee Fractures
Official title: Use of Continuous Passive Motion in the Post-Operative Treatment of Intra-articular Knee Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intra-articular Knee Fractures
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
First posted: 2008-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Decreased range of motion is common after fractures around the knee and can impact a patient's ability to perform activities of daily living such as rising from a seated position or getting in and out of a bathtub. A continuous passive motion (CPM) machine is a machine that continuously moves a joint (such as the knee) without the patient having to use the muscles in his/her leg. A goal of this therapy is to maintain as much motion as possible following this injury. This study is a randomized, prospective study to evaluate the effectiveness of CPM in maintaining knee range of motion following open reduction and internal fixation (ORIF) of fractures around the knee


Eligibility criteria: Inclusion Criteria:

* If the patient has an intra-articular distal femur or proximal tibia fracture
* Independent ambulatory prior to injury
* No previous knee injury limiting motion

Exclusion Criteria:

* If the patients range of motion was decreased prior to injury (ex. Osteoarthritis, previous knee fracture or injury)
* Any contraindication to CPM (concomitant hip or ankle fracture)
* Open physis of tibia or distal femur
* Pathological Fracture
* Compartment Syndrome
* Neurovascular injury
* Fracture due to gunshot wound
* Greater than 21 days from fracture to definitive open reduction and internal fixation
* Fractures treated with definitive external fixation
* Open fractures
* Extensor mechanism injuries
* Likely problems in the judgment of the investigator with maintaining follow-up

Primary outcomes:
measure: Knee Range of Motion
timeFrame: 48 hours, 2 weeks, 6 weeks, 3 months, 6 months and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Hospital System Univeristy Medical Center
state: South Carolina
Study officials:
affiliation: Greenville Hospital System
name: Kyle J. Jeray, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05608629: Vagus Nerve Stimulation as Treatment for Long Covid
Official title: Vagus Nerve Stimulation as Treatment for Long Covid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long COVID
Chronic Fatigue Syndrome
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 17
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day for 6 weeks
Primary purpose: TREATMENT

Brief summary: Many patients do not recover following Covid infection. The resulting illness is called Long Covid. Because there is no agreed upon treatment for this ailment, the research team has decided to do an open label pilot study using non-invasive, transcutaneous stimulation of the auricular branch of the vagus nerve. Inclusion criteria required the patient to fulfill criteria for having chronic fatigue syndrome. To date, fourteen patients provided evaluable data. Eight of these fulfilled the study's requirements for treatment success.

Detailed description: Patients who have had COVID and who fulfill criteria for chronic fatigue syndrome will sign IC and be mailed a parasym device with instructions its use after completing entry baseline questionnaires. Subjects will be called two, four and six weeks after beginning participation \[application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day\] to ask about adverse events. At the end of 6 weeks, patients will complete these questionnaires again plus one assessing their assessment of treatment efficacy.

Eligibility criteria: Inclusion Criteria:

* Patients had to have had COVID
* Patients have to fulfill the 1994 case definition for chronic fatigue syndrome.

Exclusion Criteria:

* BMI \> 30

Primary outcomes:
measure: Number of Participants With Treatment Success
timeFrame: Baseline to post-treatment at 6-weeks
Secondary outcomes:
measure: Number of Participants With Change in the Profile of Mood States (POMS)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Benjamin Natelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02142829: Pain Control in Bariatric Patients: EXPAREL(R) vs. the On-Q(R) Pain Ball
Official title: Pain Control in Bariatric Patients: A Prospective Trial Comparing the Effectiveness of EXPAREL(R) Versus the On-Q(R) Pain Ball
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: bariatric surgery, postoperative pain
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2014-05-20
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to compare the effectiveness of two local pain control methods in bariatric patients by assessing the amount of postoperative pain and amount of postoperative pain medications needed. This information was used to determine which local anesthetic provided the best pain control.

Detailed description: The investigators have previously utilized the On-Q® pain ball to obtain local control by continuous delivery of bupivacaine to pain fibers at the incision site. On-Q makes use of an implanted catheter and a continuous infusion pump that the patient carries with them typically for 48-72 hours after surgery. EXPAREL is a long-acting liposomal delivery vehicle that extends the life of bupivacaine in the surgical site for up to 72 hours. It can be injected in all trocar sites and offers another potential solution to patient pain control without the need for a catheter and the hardware needed to deliver the local anesthetic. Patient NRS (numerical rating scale) scores for postoperative pain and total medication consumed were used to assess the differences between the two treatment groups.

Eligibility criteria: Inclusion Criteria:

* Age 18-80, male or female

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Numeric rating scale (NRS) pain intensity scores
timeFrame: 4-6 hours postoperatively and in the mornings of postoperative Day 1 and Day 2
Secondary outcomes:
measure: Postoperative opioid consumption
timeFrame: 1 week
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Bariatric Medical Institute of Texas
state: Texas
Study officials:
affiliation: Bariatric Medical Institute of Texas
name: Franchell Richard-Hamilton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02523729: Effects of Anke Malz on Women During Lactation
Official title: Effects of Anke Malz on Women During Lactation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Malt Product in Lactation
Keywords: lactation
human milk
maltz
antioxidant
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Lorillard Tobacco Company
First posted: 2015-08-14
Enrollment: 38
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Human milk is the most optimal food to provide all infants' needs before eating solid food. However, underproduction of milk is a common and concerned problem for breastfeeding women. In this case, proper milk-making foods reveal their importance on lactation. In many European countries, ancient wisdom clams that non-alcoholic malt beverage could facilitate the secretion of breast milk. This study estimates the effects of non-alcoholic malt product during first three months of lactation.


Eligibility criteria: Inclusion Criteria:

* Single fetal pregnancy
* Full time birth

Exclusion Criteria:

* Any complication during pregnancy
* Smokers
* Alcohol or drug abuse

Primary outcomes:
measure: The concentration of prolactin on lactational women
timeFrame: three months
Secondary outcomes:
measure: Mean breast-feeding time
timeFrame: three months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Nutrition, China Medical University, Taiwan
name: Hui-Ting Yang, Doctor
role: STUDY_CHAIR
References:
citation: Grossman ER. Beer, breast-feeding, and the wisdom of old wives. JAMA. 1988 Feb 19;259(7):1016. No abstract available.
citation: Foo LL, Quek SJ, Ng SA, Lim MT, Deurenberg-Yap M. Breastfeeding prevalence and practices among Singaporean Chinese, Malay and Indian mothers. Health Promot Int. 2005 Sep;20(3):229-37. doi: 10.1093/heapro/dai002. Epub 2005 Apr 6.
citation: Carlson HE, Wasser HL, Reidelberger RD. Beer-induced prolactin secretion: a clinical and laboratory study of the role of salsolinol. J Clin Endocrinol Metab. 1985 Apr;60(4):673-7. doi: 10.1210/jcem-60-4-673.
citation: Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013 Feb;60(1):49-74. doi: 10.1016/j.pcl.2012.10.002.
citation: Adiong JP, Kim E, Koren G, Bozzo P. Consuming non-alcoholic beer and other beverages during pregnancy and breastfeeding. Can Fam Physician. 2014 Aug;60(8):724-5.
Clinical trial NCT03845829: LSA Reconstruction With Laser Fenestration During the TEVAR
Official title: Left Subclavian Artery Reconstruction With Laser-assisted Fenestration During the Procedure of Thoracic EndoVascular Aortic Repair for Type B Aortic Dissection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type B Aortic Dissection
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 100
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: This study aims to evaluate the feasibility, effectiveness, and safety of in-situ laser-assisted fenestration on the left subclavian artery during the procedure of thoracic artery endovascular repair

Detailed description: This study is a single-arm, prospective study. All patients with type B aortic dissection (TBAD) present with the proximal tear site located approximately close to the left subclavian artery and a reconstruction of the left subclavian artery is necessary are included in the present study. During the procedure of thoracic artery endovascular repair (TEVAR), the left subclavian artery will be reconstructed with laser-assisted fenestration and the fenestrated stent will be covered stents (fluency, viabhan, lifestream).

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female over 18 years of age;
* Type B Aortic Dissection;
* The left subclavian artery should be reconstructed during the TEVAR procedure.
* Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule and medication regimen;

Exclusion Criteria:

* Life expectancy of \< 5 years;
* Patients need open surgery repair for the aortic diseases.

Primary outcomes:
measure: Freedom From All-cause Reintervention, All-cause Mortality and Major Adverse Events Within 30 Days After Procedure
timeFrame: within 30 days after procedure
Secondary outcomes:
measure: Aortic Disease Related Mortality
timeFrame: 12 months
measure: Incidence of Endoleak Within 12 Months After Procedure
timeFrame: 12 months
measure: Technical Success Rate During the Procedure
timeFrame: During the procedure
measure: Patency Rate of Branches Stents 12 Months After Procedure
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Kaichuang Ye
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Kaichuang Ye, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04118829: Correlation of Serum Level of Perampanel (PER) Level to Cerebrospinal Fluid (CSF) Levels of PER
Official title: Correlation of Serum Level of Perampanel (PER) Level to Cerebrospinal Fluid (CSF) Levels of PER
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Epilepsy
Seizures
Keywords: Perampanel
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Perampanel is a drug used to treat patients with epilepsy/seizures. This study is designed to determine how much perampanel actually crosses the blood brain barrier into the cerebral spinal fluid when the drug is taken.

Detailed description: Perampanel is a drug used to treat patients with epilepsy/seizures. This study is designed to determine how much perampanel actually crosses the blood brain barrier into the cerebral spinal fluid when the drug is taken.

During a routinely scheduled neurosurgical procedure, one to two mL of cerebral spinal fluid will be obtained from the subarachnoid space of the brain. Five mL of arterial blood will also be drawn from the patients arterial line during their procedure. The blood samples and cerebral spinal fluid samples will be compared to see how much perampanel is in the blood versus the cerebrospinal fluid.

Eligibility criteria: Inclusion Criteria:

* Adults (\>18 years-old) who are scheduled to undergo brain surgery and need antiepileptic medication for prophylaxis or treatment of seizures
* Able to provide informed consent

Exclusion Criteria:

* Patient unable to provide informed consent
* Allergy to PER or its component
* Patient with significant renal (creatinine clearance 35 ml/min) or hepatic impairment
* Pregnant or lactating females will be excluded from the study.

Primary outcomes:
measure: Blood brain barrier serum levels
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
affiliation: Physician
name: Aashit Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04010929: Efficacy of Er,Cr:YSGG Laser in Partial Pupotomy
Official title: Evaluation of the Efficacy of Er,Cr:YSGG Laser in Partial Pulpotomy Therapy of Permanent Immature Molar Teeth With Deep Dentin Caries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laser
Tooth
Pulpotomy
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the efficacy of partial pulpotomy treatment using MTA and Er,Cr:YSGG + MTA in permanent immature molar teeth with deep dentin caries. The study was performed in children aged between 6-15 who had at least one deep dentine caries in permanent immature molar tooth. The patients' therapies were completed in Kırıkkale University, Faculty of Dentistry, Department of Pediatric Dentisry. A total of 90 teeth (caries exposed) were included in the study. According to the treatment, the teeth were randomly divided into two groups: 1. MTA group (n=45), 2. Laser+MTA group (n=45). In the MTA group, after removing caries, MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl. In the same session, the tooth was restored with resin modified glass ionomer cement and composite resin. In the laser+MTA group, the treatment procedures were the same as the MTA group, and before the MTA condensation, Er, Cr: YSGG laser was applied to the exposure area after bleeding control to provide biostimulation. Patients were called for followup appointments at 1, 3, 6 and 12 months after treatment and control radiographs were taken.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of immature molar tooth with deep dentin caries.

Exclusion Criteria:

History of any systematic disease Uncompliance with dental treatment

Primary outcomes:
measure: presence of spontaneous pain, percussion, palpation, mobility, presence of fistula, swelling of the mucosa, loss of lamina dura, internal or external root resorption and periapical radiolucency
timeFrame: First, third, sixth and twelfth month
Secondary outcomes:
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale University
Study officials:
References: