cyrilzakka/clinical-trials huggingface dataset:
Effect of Sorting of Apoptotic Spermatozoa on the Outcome of Assisted Reproduction

In assisted reproductive technology (ART) semen needs to be processed. Commonly used methods rely on physical properties of the spermatozoa, such as the swim-up methods and density gradient centrifugation. It is now known that current processing of spermatozoa does not prevent the admixture of spermatozoa with damaged genetic material. The latter have a negative impact on the outcome of ART. The investigators developed a new method for the processing of spermatozoa with intact genetic material based on flow cytometry and sorting (FACS) and on staining using a deye, YoPro. The investigators aim at examining the effect of this novel method of sperm sorting on the outcome of ART.


Eligibility Criteria:
Inclusion Criteria:

* infertile couples needing treatment with ICSI
* male infertility as defined by the WHO 2010 criteria
* age of the treated women should be between 22 and 39 years of age.
* normal ovarian reserve, as defined by basal FSH-concentration below 10 IU/l and AMH-concentration above 10 pmol/l.
* signed consent form.

Exclusion Criteria:

* normal male infertility, as defined by the WHO 2010 criteria
* age of the treated women below 22 years and above 39 years
* reduced ovarian reserve, as defined by an elevated basal FSH-concentration or reduced AMH-concentration.
* Not more than two preceding unsuccessfull treatments with ICSI
* Severe disease of the male or female partner, such as HIV, hepatitis, or psychiatric illness.
* Participation in another study.
* lack of a signed consent form.
Remote Surveillance of Postpartum Hypertension

Women with hypertensive disorders of pregnancy need postpartum blood pressure (BP) surveillance to detect persistent hypertension. Various barriers result in only 30% attendance at postpartum BP visits. A more effective strategy is needed. Women with hypertension of pregnancy will be randomized to either text-based monitoring or office visits. Those randomized to the intervention will receive a BP cuff and text in their BP to an automated, clinician derived, HIPAA compliant text-based algorithm.

Hypertension is a leading cause of maternal morbidity, mortality and obstetrical readmissions. Peak blood pressure usually occurs 3-6 days postpartum, and is typically unaccompanied by warning symptoms. Although there is a clear need for effective and reliable blood pressure surveillance after delivery, there are significant obstacles to in-person visits in the immediate postpartum period, including sleep deprivation, newborn care, and transportation needs. These barriers have proven real as we observed only 30-50% attendance to office blood pressure visits following delivery. This proposal will investigate whether text-based communication between patients and providers is an effective alternative method for monitoring postpartum hypertension in at risk women.

Women with hypertensive disorders of pregnancy with access to a cell phone with unlimited text message capabilities will be randomized to either office visit blood pressure checks after discharge or receive a blood pressure cuff and text in blood pressures for two weeks postpartum using a standardized, HIPAA compliant, physician derived automated platform.

Eligibility Criteria:
Inclusion Criteria:

* Women with chronic hypertension, gestational hypertension, or preeclampsia who deliver at the Hospital of the University of Pennsylvania will be eligible to participate. All patients must be \> 18 years old, able to speak and read English, have a hypertension diagnosis, and have access to a cell phone with unlimited text message capabilities.

Exclusion Criteria:

* Women without access to a cell phone with unlimited text message capabilities will be excluded from the study in order to eliminate barriers to participate in remote surveillance. However, we will track the number of women not eligible for this reason in order to understand generalizability in an urban population.
Phase I Study of CD19-CAR-T2 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Acute Leukemia

The purpose of this study is to evaluate the safety and efficacy of chimeric antigen receptor 19 (CD19-CAR-T2 Cells) infusions in patients with chemotherapy resistant or refractory CD19+ acute Leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Patient with relapsed and/or refractory CD19 positive B-cell acute leukemia
* Eastern Cooperative Oncology Group (ECOG) performance status 《 3
* ALT/ AST 《 3x normal
* Bilirubin \< 2.0 mg/dl
* Creatinine \< 2.5 mg/dl and less than 2.5x normal for age
* LVEF》 45%
* Accept white blood cell collection
* Provide informed consent

Exclusion Criteria:

* Previous treatment with investigational gene or cell therapy medicine products
* Solitary extramedullary relapse
* Active hepatitis B , hepatitis C or HIV infection
* Uncontrolled active infection
* Presence of grade 2-4 acute or extensive chronic GVHD
* Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma,
* Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc.
* Any uncontrolled active medical disorder that would preclude participation as outlined.
* Received non-diagnostic purposes major surgery within the past 4 weeks
* Participated in any other clinical study within the past 4 weeks
* Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
* Pregnancy or breast-feeding women
* Use of prohibited drugs:
* Steroids: Therapeutic doses of steroids must be stopped \> 72 hours prior to CD19-CAR-T2 Cells infusion
* Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed \> 4 weeks prior to CD19-CAR-T2 Cells infusion
* GVHD therapies: Any drug used for GVHD must be stopped \> 4 weeks prior to CD19-CAR-T2 Cells infusion
* Chemotherapy: i. The following drugs must be stopped \> 1 week prior to CTL019 infusion and should not be administered concomitantly or following lymphodepleting chemotherapy: hydroxyurea, vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate \<25 mg/m2, cytosine arabinoside \< 10 mg/m2/day, asparaginase; ii. The following drugs must be stopped \> 4 weeks prior to CTL019 infusion: salvage chemotherapy (e.g. clofarabine, cytosine arabinoside \> 100 mg/m2, anthracyclines, cyclophosphamide), excluding the required lymphodepleting chemotherapy drugs
* Any situation that may increase the risk of the test or interfere with the test results
The Use of Peripheral Blood Specimens From Patients Suspected of Having SARS-CoV-2 Infections in Research Studies Intended to Support the Development of COVID-19 Detection Methods, Treatments, and/or Vaccines

Invivoscribe, Inc. and its wholly owned subsidiary LabPMM, LLC are collecting peripheral blood specimens from patients with suspected SARS-CoV-2 viral infections. These donors will be from a population of patients who are already providing nasal pharyngeal (NP) swab samples in universal transport media (UTM) for COVID-19 testing at LabPMM LLC. Specimens meeting this research protocol's inclusion criteria may be evaluated with various molecular techniques in order to identify nucleic acid sequences, antibodies, and/or antigens with the potential of being used to develop novel SARS-CoV-2 detection methods and COVID- 19 treatments and/or prevention methods (e.g. drug or vaccine development).

This research protocol describes the collection and analysis of peripheral blood samples to:

* Identify nucleic acid sequences that may be used aide in the development of SARSCoV- 2 detection methods.
* Identify antibodies that may be used aide in the development of SARS-CoV-2 detection methods.
* Identify antigens that may be used aide in the development of SARS-CoV-2 detection methods. -Identify nucleic acid sequences that may be used aide in the development of COVID- 19 treatments and/or vaccines.
* Identify antibodies that may be used aide in the development of COVID-19 treatments and/or vaccines.
* Identify antigens that may be used aide in the development of COVID-19 treatments and/or vaccines.

Eligibility Criteria:
Inclusion Criteria:

* From patients suspected of SARS-CoV-2 viral infections.
* From patients who have had COVID-19 testing prescribed by their treating physicians.
* From patients whose COVID-19 test specimen was sent to LabPMM, LLC for testing

Exclusion Criteria:

* There are no exclusion criteria related to age, gender, race, ethnicity, geography, and/or other medical conditions.
Does Wearing Hearing Aids Impact the Affective State of Older Adults With Hearing Loss in Their Daily Lives?

The proposed field trial will clarify the real-world effectiveness of HAs in remediating deficits in emotion processing for older adults with mild-to-moderate hearing loss. This study will employ a repeated reversal design to establish baseline affective state without HAs, when wearing amplification, and after HAs are removed. This study will triangulate self-report, behavioral, and physiological measures to capture nuances of emotional processing in the laboratory and in daily listening. Naturalistic stimuli will be used as it occurs in daily life to elicit emotional experiences, and ecological momentary assessment and commercially-available wearable sensors will be used to track changes in emotional state in daily listening. Anchoring real-world emotional experiences with controlled laboratory experiences will validate wearable sensors. Additionally, laboratory emotional stimuli will be related to real-world emotional experiences to establish the utility of laboratory stimuli in future studies. It is likely that benefits in emotional processing will have differential effects based on individual characteristics (such as degree of hearing loss, age, gender, cognitive ability, and personality), so participants will be analyzed according to larger groupings based on individual differences.

Thirty-five participants will complete preliminary measures, including assessments of routine audiometrics, demographics, personality, and working memory. For each arm of the trial (baseline-unaided; aided; follow-up unaided) participants will be issued sensors to use while pursuing normal daily life activities. These sensors can provide information such as heart rate (HR) and respiration activity, which have been associated with the arousal dimension of emotion. Participants also will download a mobile app that will automatically prompt them throughout their day to indicate their perceived arousal and valence and listening-related workload. For each arm of the trial interindividual and intraindividual emotion perception, speech understanding, and perceived workload will be also be assessed using laboratory-based self-report, behavioral, and physiological measures. Subjective measures of hearing aid benefit, emotional consequences of hearing loss, and the effect of hearing loss on emotional communication will be assessed through validated questionnaires at the conclusion of each arm of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral, uncomplicated, adult-onset mild-to-moderate hearing loss.
* No previous experience with hearing aids
* Fluent English speakers
* Have adequate literacy and cognitive competence to complete informed consent and required questionnaires with minimal assistance.
* Able to transport themselves to the data collection site and participate in the study without assistance from researchers.

Exclusion Criteria:

* History of otologic surgery or chronic middle or outer ear pathology
* Evidence of retrocochlear involvement
* Known psychiatric or neurologic disorder.
Relationship of Preoperative Parathyroid Hormone (PTH) and Ex-Vivo Gamma Counts in Minimally Invasive Parathyroidectomy

The intent for this study is to do a retrospective chart review of all patients who have undergone minimally invasive parathyroidectomy for primary hyperthyroidism. All data collected will be recorded under assigned identification numbers that will have no association with medical record or hospital numbers. Identifying characteristics will include age and sex. Anonymity will be upheld. The patient/family will not be contacted directly. All information will be obtained from the medical chart. Demographics, location, preoperative PTH levels and intraoperative Ex-Vivo gamma counts, co-morbid conditions, and the outcome based on the hospital notes will be obtained from patients' charts and will be transferred to a secure database. It is our hypothesis that there is a linear relationship between immediate preoperative parathyroid hormone (PTH) levels and Ex-Vivo gamma counts and the aim of this study is to better describe this relationship.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be between the ages of 18 and 90 years old who have documented primary hyperparathyroidism and have undergone minimally invasive parathyroidectomy.

Exclusion Criteria:

* Patients who have not had both intraoperative parathyroid hormone (PTH) levels and Gamma counts during their parathyroidectomy
* Patients who have parathyroidectomies for reasons other than primary hyperparathyroidism.
Comparing MTA Pulpotomy to Root Canal Treatment in Management of Permanent Molars With Irreversible Pulpitis in Children

Dental caries, highly prevalent amongst children, can cause pulpitis. Coronal pulpotomy provides an easier, cost-effective, conservative and biologically-driven treatment option compared to endodontic treatment in mature permanent teeth with irreversible pulpitis.

The aim of the current study is to evaluate postoperative pain, clinical and radiographic outcomes of MTA pulpotomy compared to root canal treatment in children's first permanent molars suffering from irreversible pulpitis.

In this randomized controlled trial, patients aged 10-14 years suffering from irreversible pulpitis in the first permanent molar with closed apex will be randomly divided into two groups. The first group will receive complete coronal MTA pulpotomy, while the second group will receive endodontic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female children, aged 10 to 14 years
* Signs and symptoms of irreversible pulpitis in carious first permanent molar.

Exclusion Criteria:

* Molars with immature roots
* Non-restorable molars, with abnormal mobility or increased probing pocket depth (normal range = 1-3 mm)
* Any indication of pulpal necrosis, such as sinus tract or swelling or no bleeding from orifices after access opening.
* Any signs of periapical or furcal rarefaction.
Caffeine and Resistance Training in Older Adults

Introduction: Several studies have evaluated and confirmed the ergogenic effect of acute caffeine intake on sports performance, specifically on strength and power performance. However, little is known about the prolonged effects of this supplement on neuromuscular adaptations to strength training.

Objectives: The present study aims to analyze the effects of acute and chronic caffeine intake on neuromuscular adaptations to strength training, according to sex (men vs. women) and type of exercise (bench press vs. squat), as well as fatigue perception, mood state, and potential side effects in older adults.


Eligibility Criteria:
Inclusion Criteria:

* Age between ≥ 55
* Body mass index (BMI) ≥ 30 kg/m².
* Physically active subjects (\&gt;150 min/week of moderate exercise).
* Healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from performing physical exercise.
* Participants capable of performing the tests.

Exclusion Criteria:

* History of neuromuscular, cardiac, or diseases that could affect liver or muscle metabolism.
* Use of drugs or other stimulants that interfere with caffeine intake and intestinal absorption during the tests and study.
* Having undergone prolonged periods of forced physical inactivity during the 6 months prior to the study.
* Performing strenuous exercise within 48 hours prior to the tests.
* Failing to replicate the same food intake on the two experimental days.
* Consuming caffeine after 6 PM on the day prior to training or testing.
Breastfeeding and Obesity on Offspring Body Composition

The purpose of this study is to explore the effect maternal obesity and breastfeeding play on infant body composition. The investigators hypothesize in the first 6 months of life breast fed offspring from overweight / obese mothers will be fatter with greater trunk fat mass and accumulate fat at a greater rate than breast fed infants from normal weight mothers. Furthermore, the investigators postulate that circulating maternal milk adipocytokines will positively correlate to total fat mass at six months of age.

The objective of this study is to determine if offspring from overweight/obese non-diabetic mothers whom breastfeed have greater total fat and trunk fat mass and accumulate fat mass at a greater rate from \~ 1 month to 6 months of life compared to breastfed infants from normal weight mothers.

Specific Aim 1: Understand how maternal obesity and breast-feeding impact body composition of the offspring. Based upon the investigators preliminary data and counter to accepted dogma the hypothesis is at six months of age total fat mass, particularly in the trunk will be elevated at 6 months of age in infants whose mother was either overweight or obese vs. infants from normal weight mothers.

Specific Aim 2: Identify adipocytokines in breast milk. The postulate is breast milk from overweight and obese mothers will have greater levels of insulin, glucose, Ghrelin, IGF-1, IL-6, TNFα, high-sensitivity C-reactive protein, and lower Leptin levels than breast milk from normal weight mothers and will be correlated with offspring fat mass.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 37 and 41 weeks
* Singleton birth
* Infant in good health
* 40±5 days old at enrollment
* Infant is being exclusively breastfed (defined as fed directly from the breast or with mother's expressed milk and receiving no formula in the last 20 days prior to enrollment)
* Mother of an infant being exclusively breastfed plans to continue this exclusive feeding from the time of enrollment until six months of age
* Parent/caregiver demonstrates an understanding of the given information and ability to record the requested data
* Having obtained informed consent of legal representative

Exclusion Criteria:

* Congenital illness or malformation that affects infant feeding and/or growth
* Significant pre-natal and/or post-natal disease
* Infant has received any complementary feeding, i.e. any nutrition besides breast milk
* In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)
* Currently participating in another clinical trial
Genomic Screening for Hereditary Erythrocytosis and Related Diseases

Unexplained polycythemias are rare diseases, and therefore, the collection of data inherent to these diseases will not only improve their characterisation, but also allow stratification according to the risks and the course of the disease. The objective of this project is to constitute a database on the disease which will allow us to better understand it and in due course improve its management.

The GENRED project thus bears uniquely on the collection of information, which will be gathered throughout the usual management of patients for this type of disease.


Eligibility Criteria:
Inclusion Criteria:

The characteristics of the patients included in the database will be described in terms of numbers and percentages for qualitative variables and in terms of means and standard deviations or medians and interquartile intervals for quantitative variables.

Exclusion Criteria:

The first step will be to exclude acquired secondary (pulmonary, renal and cardiac) or acquired primary (polycythemia vera due to JAK2 mutations) causes. The family history and the determination of serum EPO levels are very useful in the decision regarding which molecular tests should be performed first.

* patients without absolute erythrocytosis (i.e. without an increased red cell mass \>125% of mean predicted value, or if the haematocrit is \<60% in males or \<56% in females.
* erythrocytosis related to polycythemia vera according to the 2008 WHO (World Health Organization) criteria
* Secondary erythrocytosis related to an obvious cause (renal lesions, chronic lung or heart diseases, endocrine lesions, miscellaneous tumours producing EPO, drugs such as androgens, hepatic lesions...)
* Low venous blood p50: the determination of p50 (percentage at which Hb is half saturated with oxygen) is very helpful is establishing the presence of a haemoglobin variant with high oxygen affinity or a rare 2,3-diphosphoglycerate (2,3-DPG) deficiency. In such a situation, a specific HBB, HBA1 and HBA2 mutation will be screened for using Sanger sequencing (these genes are not included in NGS analysis because of redundancy of pseudogenes).

In order to rule out non-informative erythrocytosis cases, a form including mandatory further tests must be filled in for a selection step. The required tests are: complete blood counts

* Blood electrolytes
* Arterial and venous gazes
* Serum erythropoietin dosage
* Liver function tests
* JAK2 mutations (both V617F and exon 12)
* Bone marrow aspirate and/or biopsy and/or endogenous BFU-E culture
* Abdominal ultrasound
* Lung function tests
Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir

The purpose of this clinical trial is to characterize drug interactions between one medicinal herb widely used by HIV infected patients: Echinacea sp. and the protease inhibitor darunavir/ritonavir.

15 patients on antiretroviral therapy with darunavir/ritonavir 600/100 mg twice a day during four weeks will be recruited. The patients will receive treatment with Echinacea purpurea for 14 days, 500 mg every 6 hours. A 12 hour pharmacokinetic curve will be obtained at baseline and on day 14.

Eligibility Criteria:
Inclusion Criteria:

1. Patients infected with HIV-1 (at least one documented positive Western-Blot).
2. Age =/+ 18 years.
3. Patients receiving antiretroviral therapy containing darunavir / ritonavir at the approved dose of 600/100 mg twice daily for at least 4 weeks
4. HIV viral load in plasma \<50 copies / mL
5. Absence of acute infections and / or tumors in the three months prior to inclusion.
6. Subject able to follow the treatment period, without suspicion of poor adherence in previous antiretroviral treatments.
7. Voluntary written informed consent.

Exclusion Criteria:

1. Any clinical or historical observation that could interfere with the pharmacokinetics of medications, such as gastrointestinal illness or surgery (except for herniotomy and appendectomy), changes in the composition of plasma proteins, some indication of hepatic or renal dysfunction.
2. Active alcohol consumption (\> 50 g / day) or illicit drugs (except cannabis).
3. Pregnancy or lactation
The Effects of Aggressive Patient Management on Cancer Therapy Management

A study to see if coordinated aggressive patient management will improve patient treatment outcomes and is cost effective.

This is an observational study of the effects of aggressive patient management. The records of 50 patients treated under the aggressive management plan will be matched with the records of 50 previous patients and attempts made to assess the improvement, if any, found. Statistical analysis will compare the outcomes of the study group and the matched control group for initial completion of planned therapy as per prescription, weight loss during therapy, intercurrent illness, and intercurrent hospitalizations. Long term analysis will compare the study group's outcomes (compared to expected outcomes) compared to the matched control group.

Eligibility Criteria:
Inclusion Criteria:

* live 45 minutes from treatment facility
* family income less than 200% federal poverty guideline

Exclusion Criteria:

* none