cyrilzakka/clinical-trials huggingface dataset:
Rapid HIV Tests for Women Late in Pregnancy and During Labor

This study will look at how well the OraQuick HIV 1/2 Antibody rapid test works and how women accept being tested for HIV late in pregnancy and during labor. For women with positive test results, the study will look at whether or not these women accept anti-HIV drugs and which drugs they receive.

A simple HIV test design and easily interpretable, fast results are logistical advantages in clinical settings such as the labor and delivery unit. A fast test result means that a woman can make important choices about her and her baby's medical care before she delivers her baby. If a woman finds out she has HIV, she can decide to take antiretroviral drugs before delivery to decrease the risk of passing HIV to her baby. These advantages are also important for women with little or no prenatal care who present for care late in pregnancy, but may not be inclined to return for a standard test result or adhere to subsequent prenatal visits.

Eligible women who elect to participate in this study will be enrolled in either the Late Presenter Group (women who are not in active labor, and for whom delivery is not imminent) or the Peripartum Group (women who are in active labor with anticipation of delivery within 24 hours). Step I for all women will include rapid HIV testing with OraQuick HIV 1/2 and standard testing with enzyme-linked immunosorbant assay (EIA) or Western blot. Women with a positive HIV test and their infants will be offered preventative antiretroviral therapy and enrollment into Step II. Step II will include clinical evaluations, laboratory evaluations, and an adherence assessment for the women and their infants. Women in the Late Presenter Group who participate in Step II will have one prenatal visit, a visit at labor and delivery, and three postpartum visits. Women in the Peripartum Group who participate in Step II will have three postpartum visits. All infants in Step II will have five study visits through 24 weeks of age.

All antiretroviral drugs will be obtained by prescription and will not be provided through this study.

Eligibility Criteria:
INCLUSION CRITERIA

Late Presenter Group:

* Unknown HIV serostatus
* \>= 34 weeks gestation

Peripartum Group:

* Unknown HIV serostatus
* \>= 24 weeks gestation
* In active labor or delivery expected within 24 hours

Infants:

* Maternal Step I enrollment
* Positive maternal OraQuick and/or EIA/Western blot result

EXCLUSION CRITERIA

Late Presenter Group:

* Previous or current antiretroviral therapy for treatment of HIV infection
* In active labor
* Evidence of ruptured membranes

Peripartum Group:

* Previous or current antiretroviral therapy for treatment of HIV infection
Does Point of Care Ultrasound Change Needle Insertion Location During Routine Bedside Paracentesis?

Paracentesis is a bedside procedure in which a needle is inserted into a patient's peritoneum in order to obtain ascitic fluid. This is a safe bedside procedure with very low risks of complications that is usually performed using physical exam maneuvers to determine the site of needle insertion. Point of care ultrasound (POCUS) technology has improved the safety of central venous catheter insertion and thoracentesis, yet the data on safety in paracentesis is equivocal. In a practical study, we aim to determine if POCUS will change the needle insertion site over the traditional anatomic landmarking method. Operators will landmark for paracentesis using conventional physical exam and then utilize POCUS to determine if there is a more optimal site. The primary endpoint will be whether POCUS yielded a change in the needle insertion site, as defined by a location greater than 5cm from the anatomic site, at least 20% of the time. The results will further our understanding of POCUS in improving procedural safety, thereby adding to the currently limited literature on this topic. Furthermore, this study will inform residency training programs about the utility in POCUS training for paracentesis and may advocate for the availability of POCUS devices to physicians performing this procedure.


Eligibility Criteria:
This is in effort to capture routine paracentesis cases.

Inclusion Criteria:

* Participants scheduled to have either a diagnostic of therapeutic paracentesis.
* Participants can be either inpatients under the care of general internal medicine, or outpatients under the care of gastroenterology or general internal medicine.
* Operators will be recruited on a volunteer basis and will include medical residents or subspecialty fellows with knowledge of POCUS for paracentesis purposes, either through core residency programs or more advanced training.

Exclusion Criteria:

* Loculated ascites
* Current anticoagulation
* Hemodynamic instability
* Bowel obstruction
* Pregnancy
* Abdominal wall cellulitis
* Platelet count \<20
Magnetic Resonance Imaging (MRI) of Appendicitis in Children

Study to find out if MRI can diagnose appendicitis in children as well as or better than CT scan and/or ultrasound scan performed at the same time. No additional contrast material or sedation will be used to perform the MRI.


Eligibility Criteria:
Inclusion Criteria:

* Age 8-18 years, referred from emergency department for suspected appendicitis and receiving either CT scan or ultrasound of the abdomen for diagnosis

Exclusion Criteria:

* Failure to pass MRI metal screening. Claustrophobia or need for sedation due to inability to hold still.
Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane

The study is being undertaken to establish the effectiveness and safety of Macrolane volume restoration factor 30 (VRF30) when used for treatment of HIV-infected subjects with buttocks lipoatrophy.


Eligibility Criteria:
Inclusion Criteria:

* Have buttocks lipoatrophy and is unable to remain seated for more than 30 minutes due to pain.
* Have undergone HIV treatment for more than 2 years.
* Have RNA copies less than 50/ml.
* Have CD4 more than 200 cell/mm3.

Exclusion Criteria:

* Active infections.
* Active skin disease, inflammation or related conditions.
* Perineal pathology.
* Condition that may affect pain assessment.
* Skin with underlying fibrous tissue.
* BMI less than 19.
* Insufficient tissue cover in the area to be treated.
* Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 14 days prior to treatment, or a history of bleeding disorders.
* Permanent implant placed in the treatment area.
* Other injectable implant, liposuction or other surgical therapy in the treatment area.
* Presence or history of connective tissue diseases.
* Tumors or pre-malign tissue disorder near or on the area to be treated.
* Contraindications for MRI
* Previous hypersensitivity to hyaluronic acid, or to the local anesthetic or antibiotic used in the study.
Central Aspects of Pain in Rheumatoid Arthritis

This study seeks to measure the psychometric properties of a newly developed Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA) questionnaire, and investigate the ability of this questionnaire to measure central mechanisms of pain and also to predict worse pain and fatigue outcomes in people with Rheumatoid Arthritis (RA).

Persistent pain and fatigue are prevalent and disabling symptoms in people with Rheumatoid Arthritis, even in the absence of active inflammation. The investigators believe that these symptoms may be a result of abnormal pain processing by the Central Nervous System (CNS), in a process called central sensitization.

The investigators have developed a short, self-report questionnaire to measure central pain mechanisms in people with RA. It is called Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA), and was adapted from a pre-existing questionnaire called CAP-Knee (which measures central sensitization in people with chronic knee pain).

This study aims to measure the psychometric properties of CAP-RA, and the ability of the questionnaire to predict worse pain in the RA population. Secondary objectives of the study include predicting worse fatigue in people with RA, deriving CAP-RA scoring recommendations, investigating other factors associated with persistent RA pain, the association between central sensitization and pain, and investigating the course of pain and fatigue in RA.

Participants will be recruited from a Rheumatology clinic. At baseline and 12 weeks these participants will undergo quantitative sensory testing (QST, pain tests), ultrasound for synovitis, clinical assessments, laboratory tests for systemic inflammation and, complete a questionnaire booklet, including the CAP-RA questionnaire.

Some participants will complete the CAP-RA questionnaire 1 week after the baseline visit to assess the test-retest reliability of the questionnaire.

In addition, participants will provide weekly pain and fatigue self-report via text message (SMS) for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age≥18y) of any sex and ethnicity.
* Satisfy EULAR criteria for RA.
* Active RA, as defined as DAS28 ≥3.2 at baseline visit

Exclusion Criteria:

* Unable to give informed consent.
* Insufficient understanding of spoken or written English to comply with the requirements of the study protocol
* Unable or unlikely to complete the proposed 12-week study follow up (eg. moving house, terminal diagnosis, current or planned pregnancy).
* Active comorbidity (e.g. uncontrolled diabetes mellitus, cancer, infection) requiring changes in medical treatment at baseline
* Major active psychiatric condition (e.g. major depression)
* Inability to meet the requirements of clinical assessments
Treatment of Chronic Stroke With IpsiHand

The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor-impaired stroke survivors. This ultimate goal will be approached through two different means. The first method is to develop a functioning brain-computer interface that operates based on cortical activity ipsilateral to an intended movement on the motor-impaired side of the body. And secondly, to develop new methods of rehabilitation that involve stimulating peripheral muscles based upon cortical activity ipsilateral to intended movements. Finally, the study seeks to assess changes in functional connectivity as a result of using a BCI device.

This study will be carried out in two phases designed to achieve the objectives described above. The first phase will determine the feasibility of recording ipsilateral (contralesional) motor commands and use the signals to control a computer. This phase will involve recording EEG signals during the performance of real and imagined motor movements of both the impaired and non-impaired hand in stroke survivors. After recording the signals and analyzing the data, the signals will be used to try to control a cursor on a computer screen or a robotic hand. The second phase of the study will determine if the BCI system can be used to impact rehabilitation. Motor commands would be performed as in phase 1 to determine the accompanying EEG signals. The EEG signals would then be used to control stimulation of the impaired limb. Rehabilitation would be assessed by examining changes in commonly used functional motor scores.

The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor-impaired stroke survivors. This ultimate goal will be approached through two different means. The first method is to develop a functioning brain-computer interface that operates based on cortical activity ipsilateral to an intended movement on the motor-impaired side of the body. And secondly, to develop new methods of rehabilitation that involve stimulating peripheral muscles based upon cortical activity ipsilateral to intended movements. Finally, the study seeks to assess changes in functional connectivity as a result of using a BCI device.

Eligibility Criteria:
Inclusion Criteria:

* 6 months post stroke
* Modified Ashworth Scale of 1+ or less of elbow flexion in the affected upper extremity
* Short Blessed Test Score of 8 or less
* Unstructured Mesulam with 2 or less omissions

Exclusion Criteria:

* Dementia
* Severe spasticity in affected upper extremity
* Unilateral Visual Inattention (neglect)
* Contracture(s) in the affected upper extremity
* Botox injections administered within 9 months
* Aphasia which limits effective communication
Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

This open-label study will determine if chlorthalidone is safe and effective for the use of reducing urinary calcium excretion over 4 weeks in subjects with type 1 diabetes

Type 1 diabetes (T1D) is associated with increased urinary calcium loss, which may contribute to the low bone mineral density and increased fracture risk observed in patients with this condition. Chlorthalidone is a thiazide-like diuretic that is commonly used to reduce urinary calcium excretion in other conditions such as idiopathic hypercalciuria. Its safety and efficacy has not been specifically tested in an adolescent type 1 diabetes population.

T1D subjects with hypercalciuria and who meet inclusion/exclusion criteria will be given chlorthalidone daily. Blood and urine tests, blood pressure, and glycemic control will be assessed at weekly study visits for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T1D
* Age 12-21 years
* Tanner Stage 2 or greater pubertal development
* Urine calcium excretion ≥ 4 mg/kg/day
* Able to swallow pills

Exclusion Criteria:

* BMI \> 99th percentile for age (\<18 years) or BMI \>35 kg/m2 (≥ 18 years)
* Coexistent conditions that may affect calcium metabolism including:

  * celiac disease
  * Graves' Disease
  * Addison's disease
  * hypo- or hyperparathyroidism
* History of diabetes related complications including:

  * neuropathy
  * retinopathy
  * nephropathy
  * gastroparesis
* History of oral or inhaled corticosteroid use for ≥ 5 consecutive days within the past month
* History of any diuretic use within the past month
* Laboratory abnormalities on screening bloodwork including:

  * estimated glomerular filtration rate \<90 mL/min per 1.73 m2 of body surface area
  * serum calcium \>10.5 mg/dL
  * serum potassium \<3.5 mmol/L
* Systolic or diastolic blood pressure \<5th percentile for age and sex50 for age \<18 years or systolic \<90 mmHg or diastolic blood pressure \<60 mmHG for age ≥18 years
Vibroacoustic Study of Lung Development in Newborn Infants

Investigators hypothesize that premature newborns with poor cardiopulmonary performance have higher morbidities and poorer physical and cognitive developmental outcomes.

Investigators further hypothesize that audible sounds combined with novel inaudible vibrations above and below human perception interpreted with transparent and auditable AI algorithms can detect and identify early gas and fluid movement anomalies not uncovered by conventional tools in an non-invasive, easy, fast, and low cost examination.

Worldwide preterm birth (\<37 weeks of gestation) affects approximately 10% of live births and is the leading cause of death in children less than 5 years of age. Preterm birth disrupts normal lung development leading to several respiratory complications in the neonatal period and later in life. Consequently, factors that negatively affect prenatal and early life respiratory growth can compromise the achievement of "personal-best lung function".

This novel study will generate normative, audible/inaudible frequencies, visible/invisible frequencies, and perceptible/imperceptible energies, termed vibrome biosignatures, of cardiopulmonary development and function during early postnatal development. Once baseline patterns are established, future studies will be designed to characterize vibrome biosignature differences across acute neonatal respiratory problems, such as respiratory distress syndrome, meconium aspiration, sepsis, persistent pulmonary hypertension, and congenital heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants include all infants admitted to the NICU.

Exclusion Criteria:

* There are no exclusions to enrollment in this study.
Anticipatory Guidance to Prevent Childhood Obesity

The purpose of this pilot project is to test anticipatory guidance, which is information given to families during a well child visit to prevent obesity during childhood. The objectives were to compare two styles of anticipatory guidance during the first year of life, maternal focused and infant focused, versus usual care and determine which style, if any, showed the most ideal infant feeding behaviors at age 1 year and to see if there were any differences in infant weight for height at one year of age. The investigators hypothesized that mothers who received the maternal focused anticipatory guidance (which gave information on eating family meals, not having tv on during meals, and maternal nutrition) would actually have the best infant feeding behaviors and weight for height of infants at one year.


Eligibility Criteria:
Inclusion Criteria:

Maternal/infant pairs Infant under 2 months of age Mother English speaking

Exclusion Criteria:

History of Neonatal ICU stay in infant Gestation less than 37 weeks in infant chronic disease in infant known genetic disorder in infant foster care placement in infant
A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer

To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV) administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with pTNM stage IIB or III colorectal cancer as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.

To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV) administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with pTNM stage IIB or III (UICC Sixth version) colorectal cancer/histological curability A (Japanese Classification of Colorectal Carcinoma, Sixth version) as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pTNM stage IIB or III (UICC Sixth version) primary colon cancer/rectal cancer who have undergone surgery of histological curability A (including laparoscopic surgery) (the curability is judged after surgery)
* Patients with primary tumor that directly invades other organs or structures and/or perforates into the visceral peritoneum (T4) or with histologically positive lymph node metastasis (N+) (to be judged after surgery)
* Patients who is between 20 and 80 years old at the time of obtaining informed consent
* Patients with performance status of 0 - 2
* Patients without receiving any cancer treatment such as radiation, chemotherapy, and immunotherapy before surgical operation
* Patients without severe dysfunction of renal, hepatic, or bone marrow function
* Patients without serious complications such as bone marrow suppression, diarrhea, and infections diseases
* Patients who have given consent to participate in this clinical study by himself/herself or his/her family

Exclusion Criteria:

* Patients in whom the bottom of tumor reaches the peritoneal reflection
* Patients with lower rectal cancer (Rb), anal canal (P), or circumanal skin (E)
* Patients who has active multiple cancers or whose disease-free survival is less than 5 years even though the cancers are metachronous (except carcinoma in situ and skin cancers)
* Women who are currently pregnant or wish to be pregnant during this clinical study
* Patients who are judged to be inappropriate to participate in this clinical study by the investigator or subinvestigator
What Happens in Vegas: PEP to PrEP Opportunities

Observational study looking at barriers to care for individuals seeking care, Post Exposure Prophylaxis (PEP) after an actual or perceived exposure to HIV. Following PEP treatment subjects will be asked about there intent to transition to Pre-Exposure Prophylaxis (PrEP) and surveyed about barriers to care or perceptions of care

The primary objective of this study is to assess the rate of engagement in a PEP to PrEP HIV provider network for those patients presenting following a non-occupational HIV exposure.

The development of a referral network and intensive clinical follow up of PEP patients will result in more patients appropriately initiating PEP, being referred to appropriate follow up, and post exposure transition and maintaining on PrEP (if indicated) at completion of the PEP medications.

Eligibility Criteria:
Inclusion Criteria:

* Actual or perceived non-occupational exposure to HIV, by self report, within 72 hours of enrollment and referred for care
* able and willing to provide informed consent
* available for 12 months of post expoure follow-up Southern Nevada Ryan White defined service area

Exclusion Criteria:

* HIV+ at time of screeing via 4th genderation (Antibody/Antigen) testing
* Current PEP and/or PrEP product condrainidications as listed in the medication product insert.
INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion.


Eligibility Criteria:
Inclusion Criteria:

* Participants with MF who are transfusion-dependent or present with symptomatic anemia, defined as follows:

  1. Anemia: An Hgb value \< 10 g/dL demonstrated during screening recorded on 3 separate occasions with at least 7 days between measurements (Note: RBC transfusion must be at least 2 weeks before the Hgb measurement during screening).
  2. Transfusion-dependent: Participant has received at least 4 units of RBC transfusions during the 28 days immediately preceding Cycle 1 Day 1 OR has received an average of at least 4 units of RBC transfusions in the 8 weeks immediately preceding Cycle 1 Day 1, for an Hgb level of \< 8.5 g/dL, in the absence of bleeding or treatment-induced anemia. In addition, the most recent transfusion episode must have occurred in the 28 days before Cycle 1 Day 1.
* ECOG performance status score of the following:

  1. 0 or 1 for the dose-escalation stages.
  2. 0, 1, or 2 for the dose-expansion stage.
* Life expectancy is greater than 6 months
* Agreement to avoid pregnancy or fathering children.
* Ineligible to receive or have not responded to available therapies for anemia such as ESAs.
* For TGA:
* Participants previously treated with JAK inhibitors for at least 12 weeks.
* Participants with intermediate-2 or high DIPSS MF according to IWG-MRT criteria.
* For TGB:
* Participants must have been on a therapeutic and stable regimen of ruxolitinib for at least 12 consecutive weeks immediately preceding the first dose of study treatment.
* Participants with intermediate-1, intermediate-2, or high DIPSS MF according to IWG-MRT criteria.
* For TGC:
* Participants must be JAK inhibitor treatment naive (no prior treatment with any JAK inhibitor) and have an indication for initiation of ruxolitinib treatment.
* Participants with intermediate-1, intermediate-2, or high DIPSS MF according to IWG-MRT criteria.

Exclusion Criteria:

* Undergone any prior allogenic or autologous stem cell transplantation or a candidate for such transplantation.
* Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating agent to treat the participant's disease, with the exception of ruxolitinib for TGB only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
* Laboratory Values outside of protocol defined range at screening.