cyrilzakka/clinical-trials huggingface dataset:
Rate of Torque Development in Adolescents With Osgood-Schlatter

Osgood-Schlatter is a growth-related condition involving multiple different types of tissue in the tendon-bone interface at the tibial tubercle. Osgood-Schlatter affects one in ten adolescents causing persistent pain and reduced ability to maintain physical activities. Changes in rate of torque development is associated with decreased neuromuscular functioning and pain chronicity, thereby affecting athletic performances and general physical activities. However, changes in rate of torque development has not been investigate in patients with Osgood-Schlatter and could help characterize the condition and guide management.

The aim of the study is to investigate early and peak rate of torque development during maximal voluntary isometric knee extension and knee flexion in adolescents with Osgood-Schlatter, compared to a matched group of asymptomatic adolescents (controls), in a cross-sectional study.

The study will include 13 adolescent participants with Osgood-Schlatter and a group of 13 pain free controls matched on sex, age, and sports participation on the group level. Testing will include rate of torque measurements of knee extension and flexion for each limb with a fixated handheld dynamometer during a single test-session lasting approximately two hours. The examiner responsible for strength-testing will be blinded to case-status. Along with anthropometric data, participants will perform the anterior knee pain provocation test to assess pain-response to sustained knee loading, a countermovement jump test to assess power and jump height, and provide patient-reported measures of condition severity, pain, disability, and quality of life. Data collection will start March 2023 and is expected to finish by May 2023.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 9-16 years of age
* Presence of pain for 12 weeks or more
* Pain at tibial tubercle during loading activities
* Palpable pain at the tibial tuberosity

Exclusion Criteria:

* Previous knee or hip surgery
* Other main diagnose of anterior knee pain (patellofemoral pain, Sinding-Larsen Johansson disease, Jumpers knee, etc.)
* Hip and/or back pain interfering with activities of daily living or physical activities
* Suspicion of other main diagnose such as meniscal tears and or ligamental tears
* Unable to communicate verbally or orally in Danish
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults

Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults.

More than 2 billion people living in tropical and subtropical regions of the world are at risk of dengue virus infection. Dengue viruses cause dengue fever, as well as the more severe dengue hemorrhagic fever/shock syndrome, and dengue virus infection is the leading cause of hospitalization and death in children in several tropical Asian countries. This study will evaluate the safety and immunogenicity of a live, attenuated dengue virus called rDEN1delta30, which is derived from the Western Pacific DEN1 serotype.

This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive rDEN1delta30 or placebo at study entry. Cohort 2 will begin only after safety review of all participants in Cohort 1. Participants in Cohort 2 will receive a higher dose of rDEN1delta30 or placebo.

After vaccination, participants will be asked to monitor their temperature every day for 16 days. Study visits will occur every other day after vaccination until Day 16, followed by 4 additional visits at selected days through Day 180. Blood collection and a targeted physical exam will occur at each study visit. Some participants will be asked to undergo a skin biopsy or additional blood collection at selected visits.

Eligibility Criteria:
Inclusion Criteria:

* Willing to be followed for the duration of the study
* Willing to use acceptable methods of contraception
* Good general health

Exclusion Criteria:

* Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
* Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
* Liver, renal, or hematologic disease
* Alcohol or drug abuse within 12 months of study entry
* History of severe allergic reaction or anaphylaxis
* Emergency room visit or hospitalization for severe asthma within 6 months of study entry
* HIV-1 infected
* HCV infected
* Hepatitis B surface antigen positive
* Known immunodeficiency syndrome
* Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical or nasal corticosteroids are not excluded.
* Live vaccine within 4 weeks of study entry
* Killed vaccine within 2 weeks of study entry
* Blood products within 6 months of study entry
* Investigational drugs or vaccines within 60 days prior to study entry or while currently enrolled in this clinical trial
* Previously received a licensed or experimental yellow fever or dengue vaccine
* Surgical removal of spleen
* History of dengue virus infection or other flavivirus infection
* Other condition that, in the opinion of the investigator, would affect the participant's participation in the study
* Pregnancy or breastfeeding
* Plan to travel to an area where dengue infection is common
Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects

The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C) lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled.


Eligibility Criteria:
Inclusion Criteria:

* Subjects whose LDL-C is not controlled by a stable dose of atorvastatin (Population A).
* Subjects who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled (Population B).

Exclusion Criteria:

* Severe acute or chronic medical or psychiatric condition or laboratory abnormality.
* Pregnant females; breastfeeding females; males and females of childbearing potential; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
* Subjects who were administered or prior exposed to PF-04950615 and/or anti-body targeting PCSK9.
Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Oocytes Recipients

The objective of this study is to evaluate the efficacy of embryo transfer procedure guided by transvaginal ultrasound versus abdominal ultrasound in recipients of oocytes as well as the advantages and disadvantages of the new technique.


Eligibility Criteria:
Inclusion Criteria:

* Oocyte recipients.
* Uterus without previously detected anomalies.
* Patients able to understand the study requirements who want to participate during all its duration and that have signed the informed consent.

Exclusion Criteria:

* Turner syndrome, Black race (significantly lower implantational rates)
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve

Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system

Study to assess the feasibility, safety, and performance of the HighLife CLARITY TSMV, and its deliver systems, in NYHA Class ≥ II-IV patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment according to the local multidisciplinary Heart Team decision, and who are at high risk for potential LVOT obstruction(LVOTO).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Moderate-severe or severe mitral regurgitation (≥ 3+)
3. Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
4. Patient is under guideline directed medical therapy for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team
5. Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty, and disability
6. Patient meets the anatomical criteria for HighLife valve
7. Patient is willing to participate in the study and provides signed informed consent
8. Patients with a high risk for LVOTO

Exclusion Criteria:

1. Any stroke/TIA within 30 days
2. Severe symptomatic carotid stenosis (\> 70% by non-invasive imaging)
3. Active infections requiring antibiotic therapy
4. Active ulcer or gastro-intestinal bleeding in the past 3 months
5. History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
6. Patients in whom TEE is not feasible
7. Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.
8. Patient is unable to comply with the follow-up schedule and assessments
9. Participation in another clinical investigation at the time of inclusion
10. Patient has known allergies to the device components or contrast medium
11. Patient cannot tolerate anticoagulation or antiplatelet therapy
12. Patients with a life expectancy of less than 12 months due to non-cardiac conditions
13. Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months

    -
Assessment of Treatment Efficacy Using Smile Arc Marginal Ridge Approach Versus MBT Chart Method for Bracket Positioning

The goal of this randomized clinical trial is to evaluate the effect of Smile Arc Marginal Ridge Approach (SAMRA) versus MBT chart method for bracket positioning on orthodontic treatment results.

The main questions it aims to answer are:

Is there a difference in orthodontic treatment results between smile arc marginal ridge approach (SAMRA) and MBT chart method for bracket positioning?

Does SAMRA provide more accurate orthodontic results and reduce the number of archwire bendings and brackets repositioning needed during finishing?

The investigators will compare Smile Arc Marginal Ridge Approach (SAMRA) with MBT Chart Method (gold standard) to see if SAMRA provides more accurate orthodontic results and reduce the need for archwire bendings and brackets repositioning during finishing.

Participants will:

* Undergo orthodontic treatment and divided into two groups, Group A (SAMRA) and Group B (MBT Chart Method).
* 0.018-inch MBT brackets will be used in both groups.
* Follow ups every 1 month will take place to change the archwires after becoming passive.
* After leveling and alignment is completed, orthodontic treatment results, number of archwire bendings and brackets repositioning needed will be determined to see which type of intervention is better or if both provide similar results.


Eligibility Criteria:
Inclusion Criteria:

* Orthodontic patients aged 11-30 years old.
* Mild or moderate crowding not requiring tooth extraction.
* Full permanent dentition including fully erupted 7s not necessarily 8s.
* Good oral hygiene.
* Skeletal and dentoalveolar class I malocclusion.

Exclusion Criteria:

* Systemic disease potentially affecting the study outcome.
* Cleft lip and palate/syndromic patients.
* Any signs or symptoms of temporomandibular disorders (TMD).
* Previous orthodontic treatment.
* Pregnant females.
* Chronic use of medications.
Intrawound Vancomycin Prophylaxis for Neural Stimulator

The implantable pulse generator (IPG) is a device that generates electrical current to stimulate the spine, heart, or brain for various chronic conditions. In neurosurgery, the IPG is implanted in a subcutaneous pocket under the collarbone. This pocket is highly avascular and thus, antibiotics administered intravenously cannot reach a potential surgical site infection (SSI). SSIs cause millions of health care dollars to be wasted due to repeat surgery and hospital re-admissions. The investigators hope to to determine the effects of "intrawound vancomycin-saline and IV antibiotics" compared to "saline and IV antibiotics" on the incidence of IPG SSI rates 6-months post-surgery.

Patients requiring neurosurgical IPG replacements will be recruited into this trial on a volunteer basis. The participants meeting the inclusion criteria will be randomized to either the treatment arm (intrawound Vancomycin-saline + IV antibiotics) or control arm (intrawound saline + IV antibiotics alone) by site in a 1:1 ratio. A sample size calculation using STplan determined that 405 patients per arm is required to reduce overall infection rate from 3.5% to 0.5% (80% power, α=0.05, two-tailed). Final sample size per arm will be 410 after generously accounting for loss to follow-up, non-compliance, and unrelated death.

The primary outcome will be a binary Yes/No on if IPG explantation due to infection was required within 6-months post-surgery.

This is a superiority trial and the investigators hypothesize intrawound Vancomycin-saline + IV antibiotics is superior to intrawound saline + IV antibiotics alone. An intention-to-treat analysis will be applied in a blinded manner once all patients have completed the trial and the database is locked.

The results of this trial will not only be applicable to neurosurgery, but also spine and cardiology.

Eligibility Criteria:
Inclusion Criteria:

* individuals who require INS replacement from Dr. C.R. Honey
* individuals who are between the ages of 18 to 80.
* individuals who consent to report any redness or swelling to their primary caregiver and follow-up as requested by their surgeon
* individuals who consent to keeping the study team informed of any medical concerns they may have regarding their INS for a minimum of 6 months postoperatively
* individuals who are capable of providing informed consent

Exclusion Criteria:

* individuals who have a history of autoimmune disease
* individuals who are undergoing any surgery or procedural intervention within six-months post-operatively of entrance into this study
* individuals who are on immunosuppression or any medication that would influence infection susceptibility
* individuals who are allergic to Vancomycin or Cefazolin
Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)

A randomized controlled trial comparing modular dual mobility inserts with ceramic multilayer coating versus standard polyethylene inserts for primary THA in a cementless acetabular cup

The aim of this study is to show in a randomized controlled trial that cobalt and chromium ion serum levels are comparable to the metal ion levels in patients with standard articulation with metal head. The metal on polyethylene articulation is accepted as standard articulation since many decades, and which is currently in the Czech Republic the most used combination. Most studies which focused on the topic of metal ion release from modular dual mobility systems do not present results of a control group with standard articulation hip implants.

Eligibility Criteria:
Inclusion Criteria:

* Primary coxarthrosis patients indicated for cementless total hip arthroplasty
* Written informed patient consent

Exclusion Criteria:

* Hip trauma or revision surgery
* Rheumatoid or neurologic disease
* BMI \>35
* Ongoing oncologic therapy
* Preoperatively elevated Co or Cr serum levels \>1.0 µg/L
* Patients with other joint implants, or anticipated need for another joint replacement surgery within the study period
* Acetabular cup size \<52 expected
* Patients not able to mentally or physically comply with the study demands and follow-up visits
* Patients \<18 years at surgery
* Pregnancy
STEPs to Blood Pressure Reduction.

The Stroke Transitions Education and Prevention (STEP) Clinic is a new type of clinic designed for stroke patients and was established to provide a comprehensive approach to stroke risk factor reduction. The goal of this study will be more effective than usual care at reducing blood pressure in patients with poorly controlled blood pressure after an ischemic or hemorrhagic stroke or transient ischemic attack.

STEP clinic patients will receive personalized goals, instructions to self-monitor, a blood pressure monitor, prescription medications, sleep apnea screening, dietary counseling, and more frequent follow-up if needed. A stroke neurologist will see patients in the usual care group and recommendations will be sent to their primary care providers.

Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18
* Clinical ischemic stroke, intracerebral hemorrhage, or transient ischemic attack
* Plan to discharge home or to short stay inpatient rehab after stroke
* Two of following required:
* History of hypertension (prior to hospitalization)
* Hospital blood pressure ≥ 140/90 on two or more occasions during hospitalization
* Discharge home on blood pressure medication
* Willingness and ability to follow-up in University of Texas Physicians stroke clinic

Exclusion Criteria:

* Modified Rankin scale (mRs) \> 3 at enrollment
* Terminal illness
* Chronic kidney disease stage 4 or greater (eGFR \< 30)
* Pregnancy
* Symptomatic flow limiting carotid stenosis without plan for intervention prior to clinic visit
* Stroke etiology presumed unrelated to atherosclerotic risk factors (amyloid angiopathy, vasculitis, malignancy associated)
Group Sessions and Web-based Treatment Targeting Children With Obesity Age 5-12 Years and Their Families

The aim of this study is to assess the efficacy of group sessions and a web-based program for children with obesity age 5-12 years and their parents.

The intervention consist of a doctor's appointment, four group-based education sessions over four weeks, psychical activity on prescription and a 12-week web-based treatment program and will be offered to children aged 5-12 years with obesity (International Obesity Task Force-BMI \>30), and their parents.

Obesity in children and adolescents worldwide has increased from 1 % in 1975 to about 6 % in 2016. Experts have estimated that the world will have more obese children and adolescents than underweight at the year 2022. Preventing and reversing excess weight gain in children is important since obesity often tracks into adulthood with adverse health consequences.

Web-based interventions have been shown to be effective, to have a beneficial treatment outcome and have been proposed to have great potential to reach many children and improve cost effectiveness.

This is a randomized controlled study with cross-over design. The intervention consist of a doctor's appointment, four group-based education sessions over four weeks, psychical activity on prescription and a 12-week web-based treatment program. The control group will have standard care treatment consisting of doctor's appointment and, in some cases, contact with dietician.

Eligibility Criteria:
Inclusion Criteria:

* Obesity according to International Obesity Task Force (IOTF)
* Be able to speak and write Swedish
* Have internet access in parents' home

Exclusion Criteria:

* Obesity together with other severe disease including neuropsychiatric disorder
Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective Study

This research study is for patients who are schedule to have carpal tunnel release surgery. The investigators have developed this study in order to determine if post-operative splinting is effective in improvement of patient outcomes after this surgical procedure. The study is being conducted under the direction of Huey Tien, MD. The purpose of this study is to determine if post-operative splinting is effective in improving patient outcomes after having short-incision carpal tunnel release. The investigators will randomize each patient into group 1, splinting after surgery or group 2 no splinting after surgery. Each group will have the same outcome measurements done to determine the best outcome of the two groups.

Your participation in this study will last for five office visits of approximately 30 minutes each. If you decide to participate in this study, we would first have you come to clinic where you would undergo some standard measurements. This includes measuring grip and key pinch strength and completing a patient questionnaire. During your visits we will scan the cross-sectional area of the median nerve at the pisiform bone level to determine the level of CTS with the Ultrasound Biomiscroscopy machine (Vevo 2100). This is a new technique with a machine similar to a regular ultrasound machine. The primary difference is that the frequency of soundwaves is higher than a standard ultrasound machine. There are no known significant risks associated with the use of this machine. At this time the machine is experimental, and is not currently approved by the FDA for clinical use. However, this device is not considered to pose significant risk. Candidates for this study must have been diagnosed with single carpal tunnel syndrome and are going to receive nerve decompression with short incision, over the age of 18, and able to give informed consent to participate in a research study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with carpal tunnel syndrome and are going to receive nerve decompression with short incision
* The Criteria of CTS
* Numbness, tingling, pain and night symptoms in median nerve distribution
* Positive Tinel signs over the median nerve at the Carpal Tunnel
* Negative Tinel signs at the Supraclavicular and Infraclavicular areas
* Positive Carpal Tunnel Tests
* Electrophysiological changes (confirmed with NCT)
* Over the age of 18
* Ability to give informed consent to participate in a research study

Exclusion Criteria:

* Patients with peripheral neuropathy of the median nerve secondary to trauma, external compressions (tumours, bone malunion) or other non-compressive causes.
* Patients with the presence of Thoracic Outlet Syndrome (Tinel must be negative at the Supraclavicular and Infraclavicular areas)
* Patients with the presence of Cervical Disc disease
* Patients with another site of compression (such as pronator teres compression)
* Patients who have had previous carpal tunnel release on the same hand
* Patients under the age of 18