cyrilzakka/clinical-trials huggingface dataset:
Sun Protection Factor Assay (SPF Assay 207/2016)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
QSM and Regional DCE MRI Permeability Using GOCART Technique

This randomized pilot clinical trial studies quantitative susceptibility mapping (QSM) and regional dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) permeability using golden-angle cartesian randomized time-resolved (GOCART) technique in evaluating regional gadolinium retention in the brain in patients with intracranial neoplasm receiving gadobenate dimeglumine or gadoterate meglumine. MRI diagnostic techniques such as, QSM and DCE MRI, may help to gather information regarding brain changes associated with gadolinium deposits during 8 to 18 months after administration of gadobenate dimeglumine or gadoterate meglumine.

PRIMARY OBJECTIVES:

I. To obtain preliminary data (e.g. mean, variance, distribution) in the regional brain parenchymal changes associated with gadolinium (Gd) deposition during 8 to 18 months period after administration of gadolinium based contrast agents (GBCA) to Gd naive intracranial neoplasm patients who will be randomized to gadobenate dimeglumine (MultiHance) or gadoterate meglumine (Dotarem).

II. To explore if areas of increased regional Gd deposition at individual level are correlated with baseline regional DCE permeability metrics such as volume transfer coefficient reflecting vascular permeability (kTrans), extracellular volume ratio reflecting vascular permeability (ve) and plasma volume (vp) in intracranial neoplasm patients.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo standard of care QSM and T1 weighted imaging (T1WI). Patients then receive gadobenate dimeglumine intravenously (IV) and undergo GOCART DCE MRI over 60 minutes.

ARM II: Patients undergo standard of care QSM and T1WI. Patients then receive gadoterate meglumine IV and undergo GOCART DCE MRI over 60 minutes.

After completion of study, patients are followed up at 8-18 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient with suspected intracranial neoplasm scheduled for routine MRI with GBCA (gadolinium naive patients)
* Willingness to comply with the study protocol

Exclusion Criteria:

* Contraindications for MRI or GBCA (standard of care)
* Abnormal renal function with estimated glomerular filtration rate (eGFR) less than 30 mL/min/m\^2 based on creatinine obtained within last 30 days
* History of previous administration of GBCA
HD10 for Early Stages

This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Hodgkin´s lymphoma (histologically proven)
* CS (PS) IA, IB, IIA,IIB without any of the following risk factors:

  1. bulky mediastinal mass (\> 1/3 maximum transverse thorax diameter)
  2. extranodal involvement
  3. ESR \> 50 (A), \> 30 (B-symptoms)
  4. 3 or more lymph node areas involved
* written informaed consent

Exclusion Criteria:

* Leukocytes \<3000/microl
* Platelets \<100000/microl
* Hodgkin´s Disease as "composite lymphoma"
* Activity index (WHO) \< grade 2
Pain After Preoperative UltraSound Guided Hip Injections for Total Hip Arthroplasty (PUSH)

The purpose of the study is to assess the accuracy of Butterfly IQ ultrasound for intra-articular hip injections, and to see if an injection given intra-articular before incision provides any benefit in preemptive pain relief or blood loss reduction.

This study is designed to be prospective randomized (1:1) controlled independent trial. Subjects are male and female, aged 18 and above, who are suitable candidates for either a unilateral (i.e. single) total hip replacement. Subjects that are scheduled with a single, extensively trained Physician Assistant assisting in their surgery will be exclusively included. This is single site study with projected enrollment of 150 subjects

Eligibility Criteria:
Inclusion Criteria

Subjects meeting all of the following specific criteria will be considered for participation in the study:

1. Subject is between 18-80 years of age.
2. Subject is a suitable candidate for total hip replacement.
3. Subject scheduled for surgery with the Butterfly IQ trained PA providing surgical assistance
4. Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to AAHS RI
5. Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures.
6. Subject must be comfortable with speaking, reading, and understanding questions in English and providing an appropriate response.

Exclusion Criteria

Subjects will be excluded from participation in the study if they meet any of the following criteria:

1. Subject is a woman who is pregnant or lactating
2. Subject from the vulnerable groups: prisoners, adults unable to consent, children, non-English speaking, illiterate, and/or visually impaired)
3. Subject who is not comfortable with speaking, reading, and understanding questions in English and providing an appropriate response.
4. Subject who cannot or refuses to give voluntary, written informed consent to participate in this clinical trial
5. Subject has contraindications for any of the following: Ropivicaine, Epinephrine or Methylene Blue
6. Previous hip surgery
7. History of infection in hip
8. Morbid obesity defined as BMI\>40
Reducing Pain in Four- to Six-month Old Infants Undergoing Immunization Using a Multi-modal Approach

The aim of this study is to answer the following question: In healthy infants aged four to six months undergoing routine immunization for diphtheria, tetanus, acellular pertussis, inactivated poliovirus and Haemophilus influenzae type B (DTaP-IPV-Hib) and pneumococcal conjugate vaccine (PCV) while receiving a combination of proven analgesic interventions (least painful injection technique, holding by parent, and oral sucrose solution) and non-procedural talk by the parent, does the addition of rubbing near the site of injection reduce pain as measured by the Modified Behavioral Pain Scale (MBPS) to a greater extent than no rubbing?

Immunization is a significant source of pain and distress for infants. At present pain-relieving interventions are rarely employed to manage this pain.

There are many non-pharmacological methods that can be used to reduce immunization pain. These include: sugar water, fast injection without aspiration, holding infants during the procedure, and non-procedural related parental behaviours such as distraction. At present, there are no studies of tactile stimulation during noxious procedures in infants and its effectiveness, therefore, is unclear. Light rubbing of the skin near the injection site that is administered by a parent immediately before, during and immediately after immunization is an easily learned, cost neutral intervention that could offer improved pain management.

Eligibility Criteria:
Inclusion Criteria:

* healthy infants
* 4 to 6 months old
* routine immunization with DTaP-IPV-Hib and PCV

Exclusion Criteria:

* impaired neurological development
* history of seizure
* use of topical local anaesthetics at the injection site
* use of sedatives or narcotics in the preceding 24 hours
* fever or illness that would prevent administration of the vaccine
* parent is unable to use the assessment tools in the study
* parent does not speak English
* prior participation in this trial
A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary

This study is designed to evaluate the effect of 6-months of treatment with NPSP558 in reducing requirements for supplemental oral calcium and active vitamin D, while maintaining stable total serum calcium levels in adult subjects with hypoparathyroidism.

Subjects either must have previously completed NPSP558 Study CL1-11-040 (REPLACE) including 24 weeks of active therapy and 4 weeks of follow-up to Week 28 prior to enrolling in this study or have enrolled in REPLACE and dropped out during optimization, but currently meet inclusion/exclusion criteria for REPLACE.

Eligibility Criteria:
Inclusion Criteria:

Patients who meet all the following inclusion criteria can be enrolled into this study:

1. Signed and dated informed consent form (ICF) before any study-related procedures are performed
2. Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study, OR Enrolled in REPLACE and dropped out during optimization, but currently meet inclusion/exclusion criteria for REPLACE
3. Able to perform daily SC self-injections of study medication (or have a designee perform injection) via a multidose injection pen into the thigh
4. Willingness and ability to understand and comply with the protocol
5. Women who are: (1) postmenopausal defined as 12 months amenorrhea with appropriate serum follicle stimulating hormone (FSH) levels (\> 40 IU/L); (2) surgically sterilized; OR (3) of childbearing potential with a negative pregnancy test at screening and who consent to use two acceptable methods of contraception for the duration of the study, with pregnancy testing at every scheduled visit during the treatment period . Female partners (who are of childbearing potential) of male study patients must also use acceptable forms of contraception during their partner's participation

Exclusion Criteria:

Patients who meet any of the following exclusion criteria at baseline (Visit 1) are not eligible for enrollment in this study:

1. Any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of NPSP558
2. Any disease or condition in the opinion of the investigator that has a high probability of precluding the patient from completing the study or where the patient cannot or will not appropriately comply with study requirements
3. Pregnant or lactating woman
Using the Electronic Health Record to Guide Management of Newborn Weight Loss

Weight loss is normal for healthy newborns in the first few days, especially for those exclusively breastfed, who may have low enteral intake for several days. Although most newborns tolerate this early period of weight loss well, those with pronounced weight loss become at increased risk of feeding problems and hyperbilirubinemia, which are the two most common causes of neonatal readmission. To facilitate the assessment of risk for an individual newborn, the Newborn Weight Tool (NEWT) has been developed to categorize each infant's weight loss according to population norms, so that formula can be administered when weight loss is pronounced and avoided when weight loss is normal. The Healthy Start study will be a randomized, controlled trial testing whether displaying NEWT to clinicians providing newborn care can improve neonatal health outcomes including formula use, weight loss and readmission. Newborns will be randomly assigned either to display weight with NEWT weight categorization to their providers in the electronic health record (EHR) or to usual care (weight displayed without NEWT categorization).


Eligibility Criteria:
Inclusion Criteria:

* Assignment to a bed assignment on the well newborn service at the time of the first weight measured subsequent to birth weight and at \>6 hours and \<=96 hours of age

Exclusion Criteria:

* None
the Instant Effect of Rigid and Kinesio Taping Techniques in Stroke Individuals With Foot Drop

Stroke individuals with foot drop experience poor physical performance and walking problems. Physiological energy consumption also increases due to balance and walking problems. The aim of this study is to investigate the immediate effects of rigid and kinesio taping techniques on physical performance, gait and physiological expenditure index in stroke individuals with foot drop, and also to examine whether these approaches are superior to each other.

As a result of this study, it was seen that Rigid Taping and Kinesio Taping were effective in stroke individuals with foot drop. When we compared the groups, it was determined that both taping methods produced similar effects.

Stroke individuals with foot drop experience poor physical performance and walking problems. Physiological energy consumption also increases due to balance and walking problems. The aim of this study is to investigate the immediate effects of rigid and kinesio taping techniques on physical performance, gait and physiological expenditure index in stroke individuals with foot drop, and also to examine whether these approaches are superior to each other.

40 individuals diagnosed with hemorrhagic or ischemic stroke were included in the study. Individuals were divided into two groups: Rigid Taping Group (n=20) and Kinesio Taping Group (n=20). The physical performances of the individuals participating in the study were evaluated with the One-Leg Standing Test, Timed Up and Go Test (TUG) and the Sit-Up-from-Chair Test (SUCT), their walking speed was evaluated with the 10 Meter Walk Test, and the spatiotemporal characteristics of the gait were evaluated with gait analysis on powdered ground. Physiological Expenditure Index (FHI) was calculated with 6 Minute Walk Test (6MWT) results. Evaluations were recorded by the same physiotherapist before and after taping.

As a result of this study, it was seen that Rigid Taping and Kinesio Taping were effective in stroke individuals with foot drop. When we compared the groups, it was determined that both taping methods produced similar effects. We believe that adding rigid or kinesio taping applications for foot drop to the rehabilitation program of stroke individuals with drop foot will increase the success of the treatment.

Eligibility Criteria:
Being diagnosed with ischemic or hemorrhagic stroke, Not having cooperation and communication problems, Stroke individuals with foot drop and those with a MAS score of 2 or less, Those who score 0-3 on the Modified Rankin Scale.
The Efficacy of Prolonged Antibiotic Therapy for the Prevention of Relapsing Peritonitis in Peritoneal Dialysis Patients With High Dialysis Effluent Bacterial DNA Fragment Levels

Peritoneal dialysis (PD) is the first-line treatment of end stage renal disease (ESRD) in Hong Kong. Despite the advances in antibiotic therapy and connecting system, recurrent peritonitis remains the major cause of peritoneal failure. A recent study showed that an elevated bacterial DNA fragment levels in PD effluent 5 days prior to the completion of antibiotics predicts the development of relapsing or recurrent peritonitis episodes. We hypothesize that prolonged antibiotic therapy in PD patients with peritonitis and high PD effluent bacterial DNA fragment levels could prevent the development of relapsing and recurrent peritonitis. We plan to conduct a randomized control study of 360 patients with PD peritonitis. After inform consent, they will be randomized to receive one additional week of the effective antibiotic treatment (the Preemptive Treatment Group) or no additional treatment (the Control Group). Specimens of PD effluent will be collected 5 days prior to the completion of antibiotics for the measurement of bacterial DNA fragments. All patients will be followed for 6 months after completion of antibiotic therapy for the development of relapsing, recurrent, or repeat peritonitis episodes. Our study will determine the efficacy of a test-before-treat algorithm that could reduce the incidence of relapsing and recurrent peritonitis and, at the same time, minimize the unnecessary use of prolonged antibiotic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with peritoneal dialysis-related peritonitis

Exclusion Criteria:

* Patients with fungal peritonitis
* Patients with obvious surgical problems and require laparotomy
Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing

The goal of this observational study is to study the genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand. The main questions it aims to answer are:

* genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand who were performed FISH and/or NGS testing
* genetic correlation and genetic dependency between FISH and NGS, stratified by high- and standard-risk groups based on FISH testing in Thai MM patients.
* disease characteristics and response rates in MM patients with cytogenetic abnormalities detected by FISH and/or genetic mutations detected by NGS.
* correlation between cytogenetic abnormalities identified by FISH and genetic mutations detected by NGS with progression-free survival in MM patients.

The FISH and/or NGS testing results, disease characteristics, treatment, and treatment outcomes of patients with plasma cell disorders who underwent FISH and/or NGS testing before IRB approval will be collected through retrospective chart review. Subsequently, data will be gathered prospectively. Participants will provide approximately 12 mL of bone marrow fluid for FISH and NGS testing.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis
* Aged 18 years and older
* Performed FISH and/or NGS testing
* Has treatment follow up at least one year

Exclusion Criteria:

* Patients with missing crucial data that renders them unanalyzable
* Patients who refuse to participate in the study
uSing Wearable TEchnology to Predict Perioperative High-riSk Patient Outcomes

This is an observational, non-interventional study to assess the equivalence of wearable monitors with formal CPET testing for the prediction of physiological reserve before major surgery.

This project will exploit the rapid development of wearable technology to allow perioperative risk prediction to become logistically easier, cost effective and used more broadly. It will use low cost wearable technology to complement or act as a surrogate to complex CPET testing performed for perioperative risk stratification. The data gained from a Garmin Vivosmart HR+ wearable device, will be used in the community by patients awaiting surgery, and will be correlated with key CPET indices including anaerobic threshold and peak VO2. Ultimately, this study aims to assess whether wearable technology can provide the data needed for the formation of prediction models to risk assess perioperative outcomes in patients undergoing high-risk elective surgery. In addition, an International Physical Activity Questionnaire (IPAQ) will be completed to compare the activity captured with self-reported activity. This will be combined with frailty scores and handgrip strength as is routinely collected during CPET. Finally, a saliva based genetic analysis will be conducted on genetic variations known to be of significance in critical illness and response to physical stress. This will be delivered by a laboratory (Fitness Genes) that has developed a bespoke panel of genetic markers ideally suited to this patient cohort.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older with capacity to consent
* Clinical indications for planned CPET testing before planned major elective surgery

Exclusion Criteria:

* Atrial fibrillation
* Nickel allergy
* Unable to wear a watch
* Unable to conduct CPET
* Pregnancy
Expanded Access Single Named Patient Program With Elotuzumab (BMS-901608) for the Treatment of Patient R-A With Relapsed/Refractory Multiple Myeloma

To provide elotuzumab treatment for single-patient use.


Eligibility Criteria:
Inclusion Criteria:

* Signed Written Informed Consent

  a) Before any program procedures are performed, the patient will have the details of the program described to him or her, and she or he will be given a written informed consent document to read. Then, if the patient consents to participate in the program, she or he will indicate that consent by signing and dating the informed consent document in the presence of program personnel.
* Other Criteria

  a) Patients must be willing to refrain from blood donations during program drug therapy and for 8 weeks after therapy.
* Age and Reproductive Status

  1. Men and women, aged 18 years
  2. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
  3. Women must not be breastfeeding
  4. WOCBP must use method(s) of contraception as indicated in the Informed Consent Form. Because of the teratogenic potential of elotuzumab, a highly effective method(s) of contraception (failure rate of less than 1% per year) is required. The individual methods of contraception and duration should be determined in consultation with the investigator. In this study men and WOCBP must be using methods of contraception for at least 1 month (4 weeks) before and women for up to 8 weeks, men for up to 90 days, after the last dose of elotuzumab.
  5. Males who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. The investigator shall review contraception methods and the time period that contraception must be followed. Men that are sexually active with WOCB must agree to follow instructions for method(s) of contraception for the duration of treatment with elotuzumab plus 5 half-lives of the program drug plus 90 days (duration of sperm turnover) for a total of 90 days post-treatment completion.
  6. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile and azoospermic men do not require contraception.

Exclusion Criteria:

* Sex and Reproductive Status

  1. WOCBP not using 2 forms of effective birth control.
  2. Women with a positive pregnancy test at enrollment or prior to administration of program medication.
* Other Exclusion Criteria

  1. Prisoners or patients who are involuntarily incarcerated.
  2. Patients who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Elotuzumab CA204022 BMS-901608 Expanded Access Guidance Document 23 Eligibility criteria for this program have been carefully considered to ensure the safety of the program patients and to ensure that the results of the program can be used. It is imperative that patients fully meet all eligibility criteria.