cyrilzakka/clinical-trials huggingface dataset:
Video-based Intervention to Address Disparities in Blood Pressure Control After Stroke

The purpose of this study is to examine the impact of a multidisciplinary telehealth-based model of outpatient stroke care on blood pressure control following stroke, and further, to evaluate its impact on racial disparities in post-stroke blood pressure control.

Blood pressure is poorly controlled for many stroke survivors and racial disparities in blood pressure control and stroke recurrence exist.

The purpose of this study is to examine the impact of a multidisciplinary, telehealth based, outpatient model of care on outcomes after stroke with a focus on blood pressure control. The Video-based Intervention to Reduce Treatment and Outcome Disparities in Adults Livings with Stroke and Transient Ischemic Attack (VIRTUAL) has several components including early follow-up via telehealth with a multidisciplinary team, remote blood pressure monitoring, and medication adjustment by a pharmacist.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke, hemorrhagic stroke (intracerebral hemorrhage),or transient ischemic attack (TIA
* Presence of hypertension (by clinical history or hospital BP ≥140/90 mmHg on two occasions)
* Plan to discharge home after stroke
* Ability to provide consent (patient or caregiver) in English or Spanish. Patients with cognitive impairment or aphasia limiting participation will be included if they have a caregiver to assist with monitoring and telehealth visits.
* Two neurologists must agree on TIA diagnosis

Exclusion Criteria:

* Modified Rankin scale (mRs) \> 4 (severe disability) at time of discharge
* Life expectancy \< 1 year or terminal illness
* Stroke unrelated to vascular risk factors (RFs) (drug use, trauma, vasculitis)
* Pregnancy
* Symptomatic flow limiting carotid stenosis without plan for intervention
* Long-term BP goal ≥ 130/80 mmHg according to clinical team
Cognition in the Study of Tamoxifen and Raloxifene

The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive aging in selected cognitively-healthy women.

Recent reports indicate that hormone therapy (HT) may have a protective effect on the aging brain. Although previous studies have examined the effects of HT on age-related cognitive changes, there is little information on the effect of a new class of estrogenic agents, selective estrogen receptor modulators (SERMs), on cognitive aging. The two most commonly prescribed SERMs are tamoxifen, for treatment and prevention of breast cancer, and raloxifene, for maintaining bone density. In the face of potential widespread use of SERMs in healthy women, information on the effects of these agents on memory and other cognitive functions is essential.

The principal goals of Co-STAR are to compare the effects of tamoxifen and raloxifene

* on age-associated declines in measures of verbal and nonverbal memory in women over age 65
* other cognitive abilities and mood
* with those resulting from more common forms of HT, specifically ET (conjugated equine estrogen) and ET plus progesterone

Co-STAR results will be compared to results from the Women's Health Initiative Study of Cognitive Aging (WHISCA), a study involving 6-year longitudinal assessment of cognitive outcomes in 2969 women randomly assigned to receive active treatment (Premarin or Premarin plus medroxyprogesterone acetate) or placebo. A comparison of the Co-STAR treatment groups with the group of WHISCA participants receiving placebo will provide insights into the effects of SERMs relative to no treatment. A comparison of the Co-STAR treatment groups with WHISCA treatment groups receiving ET or ET plus progesterone will provide insights into the effects of SERMs relative to common HT treatments.

Co-STAR participants will be recruited from The National Cancer Institute's (NCI) Study of Tamoxifen and Raloxifene (STAR) NCT00003906, a multi-center, 5-year, randomized clinical trial among 22,000 women at increased risk for breast cancer, to compare the effects of tamoxifen and raloxifene on risk for breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Women enrolled in STAR trial at a site participating in Co-STAR
* 65 years of age or older
* Have been randomized into STAR but have not started taking the study drug OR enrolled in STAR for a minimum of one year
* Have not been diagnosed with dementia
* Have signed a separate consent document for the Co-STAR Study
* Previous diagnoses of chronic neurologic disease (Parkinson's disease, stroke, epilepsy, multiple sclerosis), history of head injury, depression, alcohol addiction, drug addiction, and other neurologic or psychiatric conditions will be recorded but will not serve as exclusion factors for this study

Exclusion Criteria:

* Not enrolled in the STAR Trial
* Younger than 65 years of age
* Diagnosed with dementia
The Quality of Life and Direct Financial Costs Associated With Home Ventilation of Children: A Prospective Study

The investigators wish to learn about the quality of life (QOL) of children needing long term home ventilation and also that of their regular caregivers. In addition, the investigators will monitor the extra health-related expenses these families must meet. Data will be collected using two age-specific questionnaires of QOL plus a third one validated for assessing chronic health care costs. Questionnaires will be administered at an initial face to face meeting, supplemented by two telephone follow-up calls, to monitor medical expenses, one and two months later.


Eligibility Criteria:
Inclusion Criteria:

All families, or appointed guardians, caring for children that need home ventilatory support will be eligible for enrollment

Exclusion Criteria:

Refusal to join the study
Adipose-Induced Regeneration of Breast Skin to Treat Post-Mastectomy Radiation Injury in Breast Cancer Patients

Researchers are trying to identify the therapeutic effect of injection into the subcutaneous tissue to treat radiation-induced skin injury of post mastectomy in patients with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Females above 18 years old
* Diagnosis with breast cancer, who will be treated by mastectomy and undergo radiotherapy, and will receive breast reconstruction
* Able and willing to sign consent to participate

Exclusion Criteria:

* Breast cancer patients that do not accept to participate
* Patients with previous breast reconstruction surgery
Conservative Management in Patients Diagnosed With Grade 2 or Grade 3 CIN

Consecutive inclusion and collection of information for all women attending the Cervical Disease Unit with an histological diagnosis of grade 2 or grade 3 CIN during the last 5 years, from January 2012 to December 2016, which meet the inclusion criteria, have voluntarily manifested pregnancy intendedness and had a minimum follow-up time of 2 years and a maximum of 7.

The aim is to evaluate whether the HSIL resolution rates (CIN 2 or CIN 3) are sufficient to support conservative management.

Follow-up is performed every 4 months with colposcopy, cytology and biopsies. Colposcopy and cytology are performed for all control subjects. The need for biopsy is established according to the colposcopy exam findings to confirm H-SIL or cervical cancer. Follow-up is spaced every 6 months if the cytology and biopsy results indicate L-SIL / ASCUS in agreement with the colposcopic image. HPV tests are performed every 8-12 months. This strategy is maintained until the resolution of the H-SIL.

The conservative management stops if the H-SIL lesion persists after 24 months of follow-up, if the inclusion criteria are no longer met or if the exclusion ones are met.

Inclusion and exclusion criteria are reviewed at each visit and the conservative management ceases in case the patient decides to undergo conization.

Eligibility Criteria:
Inclusion Criteria:

* Reproductive age and willing to get pregnant in the future
* Acceptance of conservative management
* Commitment to study visits.
* Colposcopy with zone of transformation (ZT) type 1 or 2 (Unio esco-columnar totally visible) with image compatible with H-SIL and visible in its entirety.

Exclusion Criteria:

* Pregnant women
* Immunosuppression for human immunodeficiency virus (HIV) or iatrogenic type
* suspicion or diagnosis of Glandular Cell Atipia (ACG), Adenocarcinoma in situ (AIS) or cervical cancer (CC)
* Provided that inclusion criteria are not met
Muscle Energy Technique Versus Mulligan Technique for Treating Neck Pain in Breast Feeding Women

The purpose of this study will determine the effect of muscle energy technique versus mulligan technique on neck pain in breastfeeding women.

Conservative treatments used to manage neck pain are numerous and include usual medical care ( face to face interview, education, reassurance, medication, ergonomic and stay active advice), various forms of exercise, massage, and acupuncture among others, but a lack of evidence regarding their relative efficacy was found.

More research is needed to determine specific exercise programs that can decrease neck pain in breastfeeding women. So, this study will be conducted to determine clinical evidence of the effectiveness of muscle energy technique versus mulligan technique on neck pain, which constituted a great problem facing the mother during the breastfeeding period.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be examined by a physician before the study and will be chosen according to the following criteria:
* All patients will be in the breastfeeding period at least 6 weeks after delivery.
* All patients will be clinically diagnosed with neck pain (with no neurological or rheumatological problem).
* Their ages will range from 25-35years.
* Their BMI will be less than 30 kg/m².
* Their parity will not be more than 3 times.

Exclusion Criteria:

* The patients will be excluded if they have any of the followings:

  1. Any contraindication to spinal mobilization (e.g., inflammation, infection, advanced degeneration, congenital malformation, trauma, cerebrovascular abnormalities).
  2. Positive neurological examination (presence of positive motor reflex, or sensory abnormalities indicating spinal root compression).
  3. Cervical spine surgery or stenosis, metabolic or systemic disorder, or cancer.
  4. Associated pathology of the upper cervical region or upper limb that may cause overlapping with the clinical finding as referred pain from the costotransverse joint, rotator cuff tendonitis, and cervical rib syndrome.
Assessment of the Minimal Residual Disease in Ovarian Cancer From Circulating Tumor DNA and Immune Repertoire

To analyze the proportion of hereditary tumors in ovarian cancer patients in China, as well as the spectrum of variations; the ctDNA characteristics in patients with ovarian cancer; the correlation between the clonal status of mutations and therapy response; whether ctDNA detection can be used to predict the risk of ovarian cancer recurrence; and the characteristics of immune repertoire before and after treatment in patients with ovarian cancer.

100 OC cases with available matched tumor DNA and plasma will be collected. All patients will be treated according to clinical guidelines, and receive circulating tumor DNA (ctDNA) liquid biopsy at the time of diagnosis, at mid treatment, at the end of treatment and during follow-up. The study will be ended when the patients have progressive disease (PD) or reach the longest follow-up time (2 years).

Eligibility Criteria:
Inclusion Criteria:

* Patients who have not received treatment including radiotherapy, chemotherapy, and surgery.
* Expected to achieve satisfactory tumor cytoreductive surgery.
* Estimated lifetime is more than 3 months.
* Understand the research plan and voluntarily participate in the study, sign the informed consent form.
* Ability to collect specimens from each time point and provide corresponding clinical information.

Exclusion Criteria:

* Patients who will receive new adjuvant therapy.
* Patients who have other primary cancer.
* Pregnant or breast-feeding woman.
* Patients with severe mental illness.
* Patients achieve unsatisfactory tumor cytoreductive surgery.
* Patients who voluntarily withdraw for any reason.
* Patients who cannot complete the research plan.
Partnership for Glaucoma

The purpose of this study is to develop new ways of assisting patients with glaucoma and their eye doctors in using the recommendations from practice guidelines.

Glaucoma is a leading cause of blindness and visual impairment in the United States, particularly among disadvantaged populations. Despite the presence of therapies proven in NEI, randomized controlled trials that can be delivered by more than 18,000 ophthalmologists and 34,000 optometrists, almost nothing is known about the content and quality of glaucoma care delivered by non-MD providers such as optometrists. With the numbers of people with glaucoma expected to more than double in the next twenty years in the face of no more than a 15% increase in the supply of eye care providers, methods to better support appropriate and high-quality care for chronic eye diseases such as glaucoma delivered by optometrists will become as critical, if not more so, as techniques to enhance quality care among ophthalmologists.

Our study is a community-based, randomized, controlled trial that evaluates the suitability and effectiveness of a technology-based (tablet computer) intervention within the context of a novel partnership between optometrists and patients with glaucoma to improve the process quality of care and ultimately outcomes of care. By using successfully implemented technology in novel applications,and by building on the success of ongoing community-based quality improvement projects in our region, the study provides a means for rapid translation into community care if the intervention is successful.

Eligibility Criteria:
Inclusion Criteria:

-Diagnosis of open angle glaucoma with documented visual field loss.
Microbiota Upper Respiratory Tract

The aim of this study is to investigate whether the microbiota in the upper respiratory tract (URT) (nose, nasopharynx and sinuses) of chronic rhinosinusitis (CRS) patients is disturbed compared to healthy individuals. Therefore, bacterial DNA from swabs, aspirates and tissue will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the bacterial species present in these samples. Special attention will go to microbial species that are overrepresented in the healthy populations as potential health promoting microbes (i.e. probiotics). A better understanding of the URT microbiome might help us to better understand the pathology of CRS and might help to develop new microbiota-based strategies for CRS.


Eligibility Criteria:
Exclusion Criteria healthy population:

* no use of antibiotics in the past year
* no acute or chronic airway infections
* no cancer
* no autoimmune diseases
* pregnant women

Exclusion Criteria CRS population:

--\> no exclusion criteria
Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD), of ivacaftor in children with cystic fibrosis (CF) who are 2 through 5 years of age and have a CF Transmembrane Conductance Regulator (CFTR) gating mutation in at least 1 allele.

Part A is designed to evaluate the safety and PK of multiple-dose administration of ivacaftor in participants 2 through 5 years of age and to confirm the doses for Part B. Part B is designed to evaluate the safety, PK, PD, and efficacy of ivacaftor in participants 2 through 5 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Male or female with confirmed diagnosis of CF
* Must have a CFTR gating mutation in at least 1 allele
* Aged 2 through 5 years at screening and Day 1
* Weight \>= 8 kg at screening and Day 1
* Hematology, serum chemistry, coagulation, and vital signs results at screening with no clinically significant abnormalities that would interfere with the study assessments, as judged by the investigator

Exclusion Criteria:

* History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant
* An acute upper or lower respiratory infection, or pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks before Day 1
* Abnormal liver function, at screening
* History of solid organ or hematological transplantation
* Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A within 2 weeks before Day 1
* Participation in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 terminal half-lives before screening
NHFOV as Primary Support in Very Preterm Infants With RDS

This will be a prospective, multi-center, two-arms,parallel, randomized, controlled trial with a superiority design,conducted in China. The investigators conduct this multi-centre, randomized, controlled trial to test the hypothesis that NHFOV is more effective than nCPAP in the treatment of respiratory distress syndrome (RDS) in infants with a gestational age of less than 28 weeks when used as a primary noninvasive ventilation (NIV) mode.

Preterm infants are eligible to the study if they they match the following inclusion criteria: (1) Gestational age between 240/7 and 286/7 weeks; (2) diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and a fraction of inspired oxygen (FiO2) greater than 0.25 for target saturation of peripheral oxygen (SpO2) 89% to 94%;; (3) Age less than 2 hours; (4)Informed parental consent has been obtained.

Neonates will be randomized and assigned either to nCPAP or NHFOV arms with a 1:1ratio, when patients fulfill all inclusion criteria. Randomization cannot be done earlier. Simple randomization will be done according to a computer-generated random number table and will be posted in a specific secured website 24/7 available. Twins will be allocated in the same treatment group. Infants randomized to one arm cannot crossover to the other or vice- versa during the study. For all the groups, if the fraction of inspired oxygen (FiO2) requirement is persistently higher than 0.30 per target SpO2 89-94% after starting the respiratory support, newborns receive Surfactant by "LISA" technique, administration of surfactant (Curosurf,Chiesi Pharmaceutics, Parma, Italy) 200 mg/kg.

After the administration of surfactant, if FiO2 requirement is persistently \>0.4 to keep SpO2 89-94% or severe apnea episodes are present (defined as recurrent apnea with \>3 episodes/h associated with heart rate \<100/min or a single episode of apnea requiring bag and mask ventilation within a 24-hour period ) or at the blood gas (arterial or free-flowing capillary blood) PaCO2\>60 mmHg and potential of hydrogen (pH)\<7.20 obtained at least 1 hour after commencement of the assigned treatment, newborns are intubated and mechanically ventilated.

For all the newborns enrolled in the study, arterial or free-flowing capillary blood gas is checked every 6-12 hours, a cerebral and cardiac ultrasound screening is performed within 24 hrs. Further controls follow the routine of the ward.

Eligibility Criteria:
Inclusion Criteria:

(1) Gestational age between 240/7 and 286/7 weeks; (2) diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and a fraction of inspired oxygen (FiO2) greater than 0.25 for target saturation of peripheral oxygen (SpO2) 89% to 94%；（3） Age less than 2 hours

Exclusion Criteria:

* Intubated forany reasons at birth

  * Major congenital malformations or known complex congenital heart disease
  * No parental consent
Assessment of Starch Digestibility and Amylase Sufficiency in Children

Research has demonstrated that there is a relationship between malnourishment and insufficient production of pancreatic enzymes, such as α-amylase which digests starch into glucose. Starchy foods that can be easily digested into glucose are critical to the development child for energy and proper growth. This study investigated the use of a noninvasive breath test for the assessment of amylase sufficiency, digestibility of normal and modified sorghum porridges and gastric emptying rate of a sorghum porridge in Malian and U.S. children.

The purpose of this research is to test the hypotheses that: 1.) Moderately malnourished stunted children have low pancreatic α-amylase activity; and 2.) Modified starchy food preparations will have better (higher) digestibility than the commonly given foods for both moderately malnourished stunted and healthy non-stunted children. A noninvasive breath test was used to assess amylase insufficiency in moderately malnourished and stunted children in Mali, as well as in healthy children in Mali and the United States. Moderately malnourished and healthy children in Mali were fed sorghum porridges, which are commonly consumed in Mali. Porridges contained a 13C-labeled substrate (algal starch or octanoic acid) for assessment of amylase insufficiency and gastric emptying rate. In a follow-up study, healthy children in the United States were also assessed for amylase sufficiency.

Eligibility Criteria:
Inclusion Criteria:

* Stunted weaned children in the age range 18 - 30 months with height-for-age Z-score (HAZ) below -2 (HAZ\<-2)
* Healthy, weaned children 18-30 months of age for study 1
* Healthy, weaned children up to 5 years old

Exclusion Criteria:

* Acutely ill and wasted child with weight for height lower than -2 z-score
* No medical problems other than their malnutrition status
* No medications
Evaluation of the Relationship Between OND and ONSD Measured by TOS With Clinical, Radiological, and Electrophysiological Parameters in MS Patients

The primary aim of this study is to evaluate the reliability of optic nerve diameter (OND) and optic nerve sheath diameter (ONSD) measurements made with transorbital sonography (TOS) and magnetic resonance imaging (MRI) in patient groups that may progress with subclinical optic atrophy over time, such as those with multiple sclerosis (MS). The secondary aims of this study are to compare the relationship of TOS with visual evoked potentials (VEP) and optical coherence tomography (OCT) parameters used in the assessment of the afferent visual pathway in MS and its clinical subtypes and to evaluate the potential of TOS as a diagnostic and monitoring tool for detecting optic nerve atrophy, subclinical axonal loss, and clinical disability in MS.

The study included 102 patients with MS-81 with relapsing-remitting MS (RRMS), 19 with secondary progressive MS (SPMS), and 2 with primary progressive MS (PPMS)-as well as 34 healthy controls, all selected according to the inclusion and exclusion criteria. Demographic data for all participants, and clinical characteristics of the MS patient group, were recorded. Expanded Disability Status Scale (EDSS) measurements were performed for the patients. Then, TOS, orbital MRI, VEP and OCT examinations were applied to the individuals in the patient group on the same day for each eye. Measurements recorded included OND and ONSD by TOS and MRI, P100 latency and amplitude by VEP, and peripapillary retinal nerve fiber layer (pRNFL) thickness by OCT. In the healthy control group, OND and ONSD were measured using only transorbital TOS to establish normal measurement ranges.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Having been diagnosed with Multiple Sclerosis
* Undergoing disease-modifying therapy (DMT) for more than 6 months
* EDSS score ≤ 7

Exclusion Criteria:

* Patients whose Multiple Sclerosis diagnosis is uncertain
* Having ocular pathology that may affect optic nerve measurements (e.g., glaucoma, high myopia, history of ocular surgery)
* Having major systemic diseases that may affect optic nerve measurements (e.g., diabetes mellitus, hypertension)
* EDSS score \> 7
* Having experienced a clinical relapse or optic neuritis within the last 6 months.