cyrilzakka/clinical-trials huggingface dataset:
Nutritional Supplements for Exercise Recovery

This study will examine the effects of nutritional supplement on post-exercise muscle soreness as well as recovery of muscle strength and function.


Eligibility Criteria:
Inclusion Criteria:

* Ability to consume supplement
* Willing to adhere to the study intervention regimen
* Willing to abstain from analgesics for duration of the study
* Agreement to adhere to Lifestyle Considerations

Exclusion Criteria:

* Current use of NSAIDs
* Use of other nutritional or herbal supplements (e.g., protein powders, tart cherry juice, BCAAs, Vitamin D, probiotics, etc.) that have been shown to effect primary or secondary outcomes
* Presence of chronic diseases, including, but not limited to, cancer, HIV, hepatitis, cardiovascular, metabolic, and orthopedic conditions
* Weight \> 350 pounds
* Pregnancy or lactation
* Known food allergies or sensitivities or dietary restrictions
* Habitual consumption of \> 2 alcoholic drinks per day
* Febrile illness or antibiotic use within 1 month prior to baseline testing
* Treatment with another investigational drug or other intervention within 1 month
* Current smoker or tobacco use within 1 month
* Any condition(s) or diagnosis, both physical or psychological, that, in the opinion of the principal investigator or study physician, precludes participation and/or ability to consent
* Any other factor that, in the opinion of the principal investigator or study physician, would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence with or completion of the study
The Johns Hopkins Heartburn Center Registry

A multi-center, multi-year registry of patients with gastroesophageal reflux disease (GERD) undergoing diagnostic evaluation and/or treatment of GERD and associated diseases and complications.

This registry is a prospective, multicenter registry of patients undergoing diagnostic evaluation and/or treatment of gastroesophageal reflux disease and associated diseases and complications.

Patients who are eligible will have disease and therapy-specific data collected throughout treatment and long-term (5-year) follow-up.

Electronic data capture via REDCap will be utilized for all sites.

Eligibility Criteria:
Inclusion Criteria:

* Referred GERD patients willing to participate in long term follow-up (5 years)

Exclusion Criteria:

* Potential participants will be excluded if unwilling or unable to complete surveillance questionnaires through this registry
Use of Pharmacogenetics in the Treatment of Children With Autistic Spectrum Disorders

Children with autism are often treated with psychiatric drugs. These medications have been shown to improve their language and social function, and are important in improving their quality of life. In many cases it is difficult to determine the best drug dose, and a favorable response occurs in only 30%-70% of individuals, with many children suffering significant adverse drug reactions.

Pharmacogenetics is the study of the role of different genes on drug behavior. The cytochrome P450 is the most important enzyme, involved in the metabolism of a vast number of drugs, including psychiatric medications. The multiple variations in this gene can result in the different response observed in different patients, even when treated with similar doses of the drug.

Hypothesis(es):

Mapping the different types of cytochrome P450 gene, in children with autistic disorders will improve the rate of success of medical treatment, and prevent adverse drug reactions.

Potential Impact:

If successful, our study can help thousands of children and their families by developing a system of "tailored medicine" that is based on the specific activity of the various enzymes present in that particular patient. Better medical treatment will facilitate better daily interactions with the children and enhance their quality of life. Furthermore, recognizing children that are resistant to medication will prevent unnecessary use of drugs.

It should be noted this is the first study focusing on children receiving psychiatric medications using pharmacogenetics. Found to be effective, this method can also be applied to other groups of medications and to other patients.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 3 years
* Diagnosed with autism
* Treated with neuroleptics

Exclusion Criteria:

* Patients with known allergy to second generation neuroleptics.
* Patients with moderate to severe renal insufficiency
* Patients with liver disease
* Patients with active cardiac disease
* Patients with hypertension not responsive to anti-hypertensive therapy
* Patients with substance abuse
* Suicidal patients
Evaluating Palpation Guided Injections in Trapeziometacarpal Arthritis

The objective of this study is to evaluate the accuracy of trapeziometacarpal injections using palpation alone. The importance of this study is one of education, cost containment, and decreased risk to the patient. If it can be shown that the accuracy of trapeziometacarpal injections using palpation alone is similar to the reported accuracy of ultrasound and fluoroscopy, then these guided techniques may not be needed.

The objective of this study is to evaluate the accuracy of trapeziometacarpal injections using palpation alone. If it can be shown that the accuracy of trapeziometacarpal injections using palpation alone is similar to the reported accuracy of ultrasound and fluoroscopy, then fluoroscopy and ultrasound guided techniques may not be needed. Due to the expenses associated with medications and testing, it is important to not accrue unnecessary costs if there is no perceived benefit. The investigators plan to enroll 50 patients presenting with trapeziometacarpal joint arthritis who agree to participate. These participants will undergo an injection technique consisting of palpating the base of the thumb and placing the needle into the trapeziometacarpal joint without the guidance of ultrasound or fluoroscopy. Contrast dye will be included in the standard injection of lidocaine and corticosteroid. After injection, the participant will have 2 fluoroscopy views of the thumb. The images will not be evaluated for injection accuracy prior to the patient leaving the clinic, so as to not introduce any bias by the treating physician. These images will be blindly reviewed by three investigators at a later date, and determined by consensus if there is contrast material in the joint. The accuracy rate can then be compared to data regarding accuracy of fluoroscopic and ultrasound guided injections of the trapeziometacarpal joint. If there is a similar accuracy rate between modalities, it can be concluded that ultrasound may not be worth the added cost to the patient and fluoroscopy may not be worth the added cost or radiation to the participant. Additionally, participants will be contacted at 6 weeks post injection to evaluate post-injection arthritis symptoms.

Eligibility Criteria:
Inclusion Criteria:

* The patient has clinical signs of trapeziometacarpal arthritis and are willing to obtain a post injection x-ray
* The patient is over the age of 18 years of age.

Exclusion Criteria:

* The patient has a known allergy to contrast dye
* The patient has a planned surgery on the trapeziometacarpal joint within 6 weeks following injection
* Patients who are pregnant or believe they may be pregnant
* Prisoners
* Patients who are unable to provide informed consent
Observing the Morphology of Schlemm's Canal and Crystalline Lens in Different Age

The aim of this study is to quantify and observe the morphology of trabecular meshwork (TM), Schlemm's canal (SC), ciliary body and crystalline lens before and after cycloplegia in patients with different ages using swept-source optical coherence tomography.


Eligibility Criteria:
Inclusion Criteria:

* healthy patients who can cooperated with the swept-source OCT measurements

Exclusion Criteria:

* history of ocular disease
* presence of central nervous system or systemic disease
Task or Virtual Reality Intervention for Improving UE Function

People with one arm that does not function well due to a stroke, head injury, or cerebral palsy, and a fully functional other arm, will be randomly assigned to receive one of the two interventions first, followed by the other intervention. The two interventions include a task-based intervention and a virtual reality intervention that provides a reflected image of the involved arm. The task-based intervention will consist of setting up activities of interest to be done using the involved arm and structuring practice and meaningful feedback to assist learning. The virtual reality intervention will consist of the person wearing the virtual reality device and practicing virtual tasks using the intact arm while seeing the involved arm. Intervention sessions will last approximately 30 minutes and will be held 3 times/week for 3 weeks each for a total of 9 sessions for each intervention. Testing of the involved arm's function will be done before the interventions, after receiving 9 sessions of each intervention, and one month after completing the second intervention received.

Potential participants will be screened for age, history of stroke, brain injury, or cerebral palsy, and having one functional arm and one poorly functioning arm by phone. Those who meet the basic criteria will be scheduled for an Intake Evaluation consisting of obtaining voluntary informed consent, complete a demographic survey, visual field testing, cognitive screening, perceptual testing, and an arm/hand function test. Participants who meet the inclusion criteria will be scheduled for a Preliminary Evaluation.

The Preliminary Evaluation will measure the current motor control ability, perception of level of disability, and amount of active and passive motion in the involved arm.

Participants will participate in the first form of intervention (randomly assigned) for three 30 minute sessions per week for 3 weeks (total of 9 sessions) and be re-evaluated using the same tests conducted during the Preliminary Evaluation with the addition of the arm/hand function test conducted during the initial screening.

Participants will participate in the second form of intervention for three 30 minute sessions per week for 3 weeks (total of 9 sessions) and be re-evaluated using the same tests conducted following the first intervention.

One month after completing the second form of intervention, participants will be re-evaluated using the same tests used following the second intervention and will also receive a semi-structured interview regarding their thoughts and experiences during the study and their perceptions of the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 89 years old
* One arm not fully functional due to a stroke, brain injury, or cerebral palsy
* More than 1 year since neurologic even that impaired arm function

Exclusion Criteria:

* Cognitive impairment
* visual field loss (homonymous hemianopsia)
* perceptual deficits (MVPT4 lower than 2 standard deviations from the norm)
* Seizure disorder
* Currently receiving rehabilitation services (PT or OT) for the involved arm.
Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?

The goal of this clinical trial is to compare two different types of reverse shoulder replacements. Researchers will compare a conventional reverse shoulder replacement with a lateralized reverse shoulder replacement to see if there is a difference in how well the patients function after two years.

Many studies have showed pain relief and improvement in shoulder function following reverse shoulder arthroplasty (RSA), but medialization of the centre of rotation (COR) in RSA may cause complications like limited range of motion (ROM), luxation of the prosthesis, and scapular notching, where the lower part of the scapular neck becomes eroded due to impingement against the humeral component. Joint centre lateralization with a bone transplant placed underneath the glenoid component (BIO-RSA) was introduced to maximize ROM in the prosthetic joint, increase stability and to prevent scapular notching. In recent years it has been claimed that lateralization of the COR with BIO-RSA decreases the risk of the aforementioned complication, but no consensus on when or how to lateralize the COR exists as of today. This knowledge will also be of critical importance when it comes to decision making on how these patients are best treated. Results from this research project is expected to have a significant impact on how these patients are treated in the future, both nationally and internationally.

The purpose of this study is to compare functional results between patients with bony increased offset-reversed shoulder arthroplasty (BIO-RSA) and conventional reverse shoulder arthroplasty (RSA) to investigate if lateralization of the glenosphere yields superior outcomes and fewer complications after 2 years.

This multicenter study will include 130 patients in 4 hospitals scheduled for RSA. Patients will be asked to participate in a blinded RCT, where they are randomly assigned to either BIO-RSA or conventional RSA. Functional results will be measured primarily by the patient-reported outcome measure Western Ontario Osteoarthritis Shoulder (WOOS), but they will also be examined by a physiotherapist and CT imagery will be assessed by a radiologist.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for primary RSA due to OA, massive RC tear, failed RC repair or post-instability osteoarthritis
* Able to read or write Norwegian

Exclusion Criteria:

* Severe osteoporosis
* Osteonecrosis of the humeral head
* Dementia
* Poor deltoid function
* Revision surgery
* ASA IV
* Suspected chronic infection
* Acute fracture
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)

Participants are free to decide if they want to take part in this study or not. The study will be conducted to collect information about the influence of adherence to growth hormone therapy with Norditropin® in children and teenagers in daily practice in Germany. This study will look mainly at the difference in near final height between children and teenagers who adhere to their therapy plan with Norditropin® to non-adherent patients. Participants will get Norditropin® as prescribed to them by their doctor. The study will last as long as the therapy with growth hormone is seen necessary by the participants' doctors and the participants, up to a maximum of 10 years. During the visits at the participants' doctors participants will be asked to fill in a questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent of parent or legally acceptable representative of subject and child assent, as age-appropriate must be obtained before any study-related activities.

  1. The parent or legally acceptable representative of the child must sign and date the Informed Consent Form (according to local requirements) and
  2. The child must sign and date the Child Assent Form or provide oral assent (if required according to local requirements).
* The decision to initiate treatment with commercially available Norditropin® FlexPro® has been made by the treating physician and the patient's parents/legal guardian before and independently of the decision to include the patient in this study.
* Male or female, all age groups equal to or below 15 years with more than 2 years expected remaining treatment time until reaching NFH. Patients who self-inject should be above 8 years of age in order to be able to fill in the questionnaire.
* Children being GH naïve at baseline with one of the following confirmed diagnoses

  1. Isolated growth hormone deficiency (iGHD)
  2. Small for gestational age (SGA)

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Patients who have an expected future duration of therapy of less than 2 years are not eligible for the study.
Phase 1 Safety and Tolerability Study of ALN-F1202 in Healthy Adults

This clinical research trial will evaluate the safety and tolerability of an experimental drug, ALN-F1202, in healthy participants.

The purpose of this trial is to learn about how safe and tolerable the experimental drug is. The trial is looking at several other research questions, including:

* What side effects may happen from taking the experimental drug?
* How much experimental drug is in the blood at different times?
* Whether the body makes antibodies against the experimental drug (which could make the drug less effective or could lead to side effects).
* What is the best dose of the experimental drug?


Eligibility Criteria:
Key Inclusion Criteria:

1. Has a body mass index between 18 and 32 kg/m2, inclusive
2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed at screening and/or prior to administration of initial dose of study drug
3. Is in good health based on laboratory safety testing obtained at the screening visit, as described in the protocol
4. Normal aPTT, normal PT, and normal platelet counts at screening period and at day -1 as defined by the local laboratory
5. Hemoglobin values at screening period and at day -1 as described in the protocol

Key Exclusion Criteria:

1. History of any major surgical procedure or clinically significant physical trauma, in the opinion of the investigator, that may pose a risk to the participant by study participation
2. Whole blood donation within the previous 56 days or plasma donation within the previous 7 days prior to screening
3. History of clinically significant bleeding, requiring hospitalization or blood products, that in the opinion of the investigator may pose a risk to the participant by study participation
4. History of bleeding diathesis as described in the protocol
5. Members of the clinical site study team and/or his/her immediate family, unless prior approval granted by the sponsor
6. Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study

NOTE: Other protocol-defined inclusion/exclusion criteria apply
KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor

This is a phase Ib, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN026 combined with KN046 in subjects with advanced HER2 positive solid tumors.

The study is composed of 2 stages. Stage 1 consists of dose escalation cohorts for determining the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Part 2 consists of 4 tumor type expansion cohorts for expanding the information on clinical safety, clinical pharmacokinetics and antitumor activity in HER2 positive patients.

Eligibility Criteria:
Inclusion Criteria:

* Signed inform consent form (ICF)
* Age ≥ 18 years and ≤ 75 years, male or female
* Histologically or cytologically documented advanced HER2 positive solid tumor
* Received at least one prior standard therapy
* At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function
* LVEF≥ 50% (ECHO)
* Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
* Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures

Exclusion Criteria:

* Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
* Accepted radiotherapy within 4 weeks before enrollment
* An anthracyclines antibiotic treatment was received exceeding 320 mg/m² or other equivalent dose antharcyclines
* Subjects are eligible with clinically controlled and stable neurologic function \>= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
* Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to \< 10 mg prednisone daily, inhaled steroids and topical use of steroids)
* Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines)
* Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study
* Severe chronic and active infection, need to system antibiosis/antiviral treatment
* Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management
* Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage
Study of 111In-DAC as a Medical Imaging Agent for the Detection of Breast Cancer

The purpose of this study is to investigate the safety and imaging ability of 111In-DAC when used with planar and SPECT imaging for the detection of breast cancer.


Eligibility Criteria:
Inclusion Criteria

Patients will be eligible for the study if they:

* Are non-pregnant, non-lactating females 18 years of age or older(must agree to use an appropriate and effective method of birth control during the study and for 2 weeks after study)
* Are being evaluated for a known or suspected breast tumor (must present with either a mammographic abnormality 10mm or larger or a mammographically occult but palpable abnormality of the breast)
* Have been previously scheduled for biopsy or surgical excision of the known or suspected tumor of the breast
* Have signed an informed consent form

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have a history or suspicion of significant allergic reaction or anaphylaxis to any of the 111In-DAC components
* Have a clinically unstable medical condition or opportunistic infection, a life-threatening disease state, impaired renal or hepatic function or are immunosuppressed
* Are taking or have taken part in any investigational study within 30 days of start of study
* Have received an indium agent within 30 days of start of study
* Are not able to remain immobile during scanning time
* Have taken drugs that may damage the kidneys within 2 weeks of start of study
* Have abnormal laboratory test results: hemoglobin \< 9.5 gms/dl, serum creatinine \> 1.5 mg/100ml, alkaline phosphatase 2X the upper limit of normal
* Have undergone an excisional and/or needle localization biopsy within 4 days prior to start of study