cyrilzakka/clinical-trials huggingface dataset:
Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia

To investigate the relationship between bronchopulmonary dysplasia and thrombocytopenia.

A prosepective case-control study ,the case were matched with 1:1according to gestational age,birth weight and admission diagnosis and divided into two groups according to the consensus definition of National Institute of Child Health and Human Development (NICHD). Platelet count, circulating megakaryocyte count, platelet activating markers (CD62P and CD63), thrombopoietin were recorded and compared in two groups, then, serial thrombopoietin levels and concomitant platelet counts were measured in infants with BPD.

Eligibility Criteria:
Inclusion Criteria:

1. presence of clinical and radiologic signs of BPD, according to conventional criteria (Greenough, 1992);
2. presence of peripheral arterial catheter;
3. gestation \<32 weeks;
4. birth weight \<1.5 kg;
5. requiring mechanical ventilation for the treatment of respiratory distress syndrome for at least 3 days during the first weeks of life;
6. ventilator and/or oxygen dependent at time of enrolment;

Exclusion Criteria:

1. congenital abnormalities;
2. infection (bacteria infection confirmed by positive blood culture or viral infection confirmed by serological test or viral culture)
3. evidence of complications of perinatal asphyxia including an apgar score \<3 at one or five minute after birth, evidence of hypoxic-ischemic encephalopathy, acute tubular necrosis, or transient myocardial ischemia;
4. identifiable hematologic disease;
SARS-CoV-2 IgG and IgM Serologic Assays

The primary objective is to assess and validate the ability of the Beckman Coulter Access COVID-19 IgG and IgM assays to detect immunity in COVID-19 patients in the Henry Ford Hospital Health System.

Overview: The design validation strategy for this study is to validate the detection of COVID-19 antibodies in subjects at Henry Ford Health System (HFHS) who test negative or positive with RT-PCR for SARS-CoV-2 using a fully automated system. This is a study of the immune response of subjects who have recovered from COVID-19 infection.

Methods: There are now commercial testing products from major invitro diagnostic diagnostics companies that appear to have been developed with significantly greater test performance in mind. HFHS (HFHS) intends to make this testing available in the near future after a rigorous verification of analytical performance. This verification will be done in collaboration a with select and proven IVD partner.

All HFHS patients \> 18 years of age who were evaluated and who have COVID-19 PCR test results will have their medical records studies and a left-over specimen tested for validation purposes. This validation study will begin May 15, 2020 through November 15, 2020.

Impact: IVD manufacturers must rely on test specimens from suppliers (typically hospitals and reference laboratories) and attempt to replicate the test performance that will be achieved in the actual medical testing environment. In fact, samples collected and provided to vendors are usually at the convenience of the supplying institution. Data on the real-world performance of COVID-19 antibody tests derived from this study will have significant implications for patients and health systems, including patient disposition, risk prediction, return to work decisions, health system operations and more. Furthermore, assessment of immunity in patients with minimal or symptom free infections will provide rich knowledge to assess if certain patients need further risk mitigations (masks, distancing) and which may be safely return to more normal activities.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age; COVID-19 by RT-PCR SARS-CoV-2 assay. (Phase I)

Exclusion Criteria:

* Subjects who tested for COVID-19, but have no available serum specimen.
Wingspan One Year Vascular Imaging Events and Neurologic Outcomes

The purpose of the study is to determine the one-year post stenting outcomes in patients who were treated with the Wingspan stent on-label in the WEAVE trial. This includes both the assessment of any stroke, hemorrhage, or death, as well as assessment of delayed imaging results to determine the re-stenosis rate of the stents in these patients.

The current study is a retrospective chart and imaging review of the 152 patients enrolled in the WEAVE trial to determine the one-year outcomes for these patients.

This includes both the assessment of any stroke, hemorrhage, or death, as well as assessment of delayed imaging results to determine the re-stenosis rate of the stents in these patients and the medication regimen in those patients who had symptomatic re-stenosis.

The subjects for this study are pre-defined as the 152 patients who had placement of a Wingspan stent for treatment of their intracranial artery stenosis that had symptoms of stroke and 70% or greater arterial stenosis. The study will be conducted at 24 sites in the United States. It is expected that up to 152 patients' records will be assessed for follow up data analysis. Patient's information will be included in the study if they were enrolled in the WEAVE Trial and had placement of a Wingspan stent in its on-label usage indication between 12/1/2013 and 10/31/2017. Follow up information from the patients' charts will be extracted out to the one-year interval following stenting up to December 2018.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for this study are the 152 patients stented in the WEAVE trial on-label.

The patients had the following inclusion criteria:

* Age 18-80
* Intracranial artery stenosis greater or equal to 70% stenosis
* Target artery 2 mm or larger
* Presented with stroke while on medical therapy for stroke prevention
* Prior stroke in the target territory
* Modified Rankin Score of 3 or better (neurologic function)
* Treated greater than 7 days after their last stroke
* Treated with the Wingspan stent by an approved trial NeuroInterventionalist

Exclusion Criteria:

* Patients treated outside of the trial or who did not meet the entry criteria.
* Patients that had stent treatment for arterial dissection
* Patients that had extra-cranial stenosis
* Patients outside the age range of the study
* Patients treated less than 8 days from their stroke.
Promoting the Universal Medication Schedule Via Mobile and EHR Technologies

The purpose of this study test the effectiveness of the Universal Medication Schedule (UMS), which was designed as a strategy to standardize and simplify medication instructions to support safe and effective prescription drug use among diabetic.

Research has shown the UMS (1) improves patients' understanding of how much to take of a medicine and when, and (2) reduces the number of times per day patients would take a multi-drug regimen. In this study, UMS tools will be exported into a second electronic health record platform to demonstrate ease of dissemination. Also, as patients may require assistance outside of clinic visits to adapt their prescription regimen to the UMS, this study will test the potential benefit of daily short message service (SMS) text reminders via cell phone.

We will conduct a three-arm, provider-randomized controlled trial among English and Spanish-speaking adults taking three or more prescription drugs to evaluate the effectiveness of the UMS strategy, with and without SMS text reminders, to improve patient understanding, consolidation, and adherence compared to usual care.We will conduct a three-arm, provider-randomized trial at two community health centers in Chicago, IL to evaluate the UMS and UMS+SMS text reminder strategies compared to usual care. English and Spanish-speaking patients who are prescribed three or more medications will be recruited and assessed by phone at baseline, three months, and six months.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type II diabetes
* age 30 or older
* taking 3 or more prescription medications for chronic conditions
* English or Spanish speaking

Exclusion Criteria:

* self-reported severe, uncorrectable vision
* hearing impairment
* cognitive impairment
* not responsible for administering his/her own medications
* not able to receive text messages on their cell phone
Occlusal Stabilization Splints and Sleep Disordered Breathing

The purpose of this study is to investigate the effects of mandibular occlusal stabilization splint (OSS) and modified farrar splint on sleep bruxism and respiratory indices and the effects of occlusal splints on the airway volume through imaging.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with sleep bruxism
* prescribed an occlusal splint

Exclusion Criteria:

* Less than 18 years old
* Secondary obstructive sleep apnea diagnosis
* Genetic disease that contributes to possible secondary obstructive sleep apnea
* Patient refuses to sign informed consent document
* Patient does not speak or read English
* More than two missing posterior teeth (excluding third molars)
* Presence of gross malocclusion
Treatment of Relapsed or Refractory Natural Killer/T Cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of PD-1 blockade pembrolizumab for patients with relapsed or refractory Natural Killer(NK)/T Cell Lymphoma.

Patients with relapsed or refractory NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy. The investigators have been proceeding this trial to evaluate the efficacy and safety of the immune checkpoint inhibitor PD-1 blockade, pembrolizumab in the patients with relapsed or refractory NK/T cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time \> 3 months
* Histological confirmed evidence of relapsed or refractory NK/T cell lymphoma
* Before enrollment, representative formalin-fixed paraffin-embedded tumor samples (or 15 tissue sections at least) and related pathological reports are needed
* Previous treatment with at least one chemotherapy regimen
* At least one measurable lesion
* None of other serious diseases, cardiopulmonary function is normal
* Pregnancy test of women at reproductive age must be negative
* Patients could be followed up
* None of other relative treatments including the traditional Chinese medicine, immunotherapy, biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
* volunteers who signed informed consent.
* No anti-PD1 antibody contraindication (All of the following tests are required to be finished within 14 days prior to the first research): 2.5×109/L\<WBC\<15×109/L, hemoglobin ≥ 90 g/L, neutrophil≥ 1.5×109/L, lymphocyte≥0.5×109/L, platelet ≥ 100×109/L, serum albumin≥2.5g/dL, ALT and AST ≤ 2×ULN, serum bilirubin≤ 1.5×ULN, serum creatine ≤ 1.5×ULN, Serum Albumin ≥ 30g/L, serum plasminogen is normal, creatinine clearance rate≥30 mL/min, INR≤1.5×ULN, APTT≤1.5×ULN

Exclusion Criteria:

* Disagreement on blood sample collection
* Patients allergic of chimeric or humanized antibody
* Pregnant or lactating women
* Serious medical illness likely to interfere with participation
* Serious infection
* Primitive or secondary tumors of central nervous system
* The evidence of CNS metastasis
* History of peripheral nervous disorder or dysphrenia
* History of active autoimmune disease and a concomitant second cancer
* patients participating in other clinical trials
* patients taking other antitumor drugs
* patients estimated to be unsuitable by investigator
B Vitamin Status in Premature and Small for Gestational Age(SGA) Infants

Premature birth and low birth weight implies insufficient intrauterine growth and fetal malnutrition. During the first months of life where the infant is breastfed, the low stores aquired during fetal life, may cause specific B vitamin deficiencies. In this study infants with a birth weight below 3000 g will be studied at 6 weeks, 4 and 6 months. At 6 months infants with biochemical signs of impaired cobalamin status (i.e.: tHcy \> 97.5 percentile for cobalamin treated infants, i.e.: tHcy\>6.5 µM/L) will be randomised to cobalamin treatment or placebo. At 7 months the investigators will evaluate the effect of cobalamin or placebo treatment according to infant biochemical status and neurodevelopment.

Study hypothesis: Cobalamin treatment given to infants with biochemical cobalamin deficiency will normalize biochemical status and cause improved motor neurodevelopment.


Eligibility Criteria:
Inclusion Criteria:

* Birthweight \< 3000 grams
* Age 6 months (+/- 0.5 months)
* Plasma total homocysteine \> 6.5 umol/L

Exclusion Criteria:

* Plasma total homocysteine \< 6.5 umol/L
Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure

Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.

Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.

Patients were prospectively enrolled in an observational study on a medical ward dedicated to patients with COVID-19. Closed-loop controlled oxygen was delivered by O2matic® which can deliver 0-15 liters/min and adjusts flow every second based on 15 seconds averaging of SpO2 measured by pulse oximetry. Lung function parameters were measured at admission.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Positive COVID-19 PCR analysis in pharyngeal swab or in tracheal secretion
* Need oxygen supply to maintain SpO2 ≥ 92 %
* Able to comply with continuous measurement of SpO2 by pulse oximetry.

Exclusion Criteria:

* Need of oxygen supply \> 10 liters/min at admission
Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar)

FAST is an investigator-initiated multicenter study embedded in a German multistate acute stroke network. The main objectives of the FAST study are to improve outcomes and quality of care for stroke patients, to quantify the number of patients in need of thrombectomy within an integrated stroke network, to study the best way of delivering and performing thrombectomy and to investigate the best model of pre-hospital selection and referral for stroke patients.

Since 2015, mechanical thrombectomy in patients with large vessel occlusion has become an evidence based highly efficient treatment. In contrast to thrombolysis, thrombectomy can only be delivered by qualified interventionalists at comprehensive stroke centers. Thus, the implementation of thrombectomy into clinical practice remains a challenge. The investigators aim to establish a population based approach within a patient registry in a federal state overarching regional stroke network covering over 4 million inhabitants and integrating approximately 30 hospitals with different levels of expertise. The registry will include data from all acute ischemic stroke patients - approx. 12.000 patients p.a - within the network. The investigators plan to establish a central multi-interface platform integrating clinical data from the prehospital, intrahospital and rehabilitation phase including mandatory quality assurance, neurological and neuroradiological treatment and outcome data. The registry will allow addressing important questions, such as how many patients are candidates for thrombectomy, how many resources are needed to meet that demand and how treatment procedures and times can be improved. The overarching aim is to deliver high quality stroke care to every patient in the region.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Patients with ischemic stroke who are admitted to one of the hospitals of the Stroke Consortium Rhein-Neckar (FAST)
* informed consent

Exclusion Criteria:

* no informed consent
Qigong for Breast Cancer Survivors

Objectives: (1) To investigate the effects of Qigong training on upper limb oedema, circulatory status, shoulder flexibility and muscular strength, body balance, and quality of life (QOL) in community-dwelling breast cancer survivors; and (2) to explore the relationship between the impairment outcomes and QOL outcomes.

Hypothesis: (1) The experimental participants will have less impairment and a better QOL after Qigong training compared with the no-training control group; and (2) the impairment parameters will be related to the QOL indexes in the Qigong participants.

Design and subjects: This will be a prospective, randomised, single-blinded controlled trial. Approximately 60 breast cancer survivors will be randomly assigned to either the Qigong training group (n\~30) or control group (n\~30).

Intervention: Participants in the Qigong group will receive 18 Forms of Tai Chi Internal Qigong training for 3 months with two supervised 1-hour sessions per week.

Main outcome measures: The primary outcome measures are upper limb circumference, arterial blood flow velocities and resistance index, shoulder joint passive range of motion, muscular strength (peak force) and body balance. The secondary outcome measure is quality of life as measured by the Functional Assessment of Cancer Therapy - Breast scale.

Data analysis: Data will be analysed via repeated-measures analysis of variance followed by post-hoc tests (α = 0.05).

Expected results: The investigators pilot studies produced encouraging results on the efficacy of Qigong exercise in reducing chronic breast cancer-related symptoms in survivors. Therefore, the investigators expect that participants in the Qigong group will have fewer upper limb impairments and a better quality of life after Qigong training. If the results are positive, this Qigong training regime is readily transferrable to clinical practice, and could have positive socioeconomic effects such as reduced healthcare costs.


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria are

1. history of a breast malignancy of any stage
2. history of mastectomy or lumpectomy with or without adjuvant chemotherapy or radiotherapy
3. having completed conventional cancer treatment and medically stable
4. no known neurological deficits resulting from breast cancer treatment or other neurological disorders
5. persistent lymphoedema defined as a circumference difference greater than 2 cm at any point between the surgical upper limb and contralateral upper limb13
6. female aged 18 or above.

Exclusion Criteria:

The exclusion criteria are

1. presence of major psychiatric, neurological, musculoskeletal, cardiovascular, peripheral vascular or kidney disorder
2. receiving conventional cancer treatments such as chemotherapy or radiotherapy, medications such as diuretics or traditional Chinese medicine
3. recurrent cancer or cancer that has spread to another organ
4. participation in regular physical activity
5. prior experience of Qigong or Tai Chi
6. a smoking habit
7. pregnancy during the study period.
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks

The study objective was to evaluate the safety and efficacy of repeat use of C1INH-nf for the treatment of acute HAE attacks.

A total of 113 subjects were enrolled in the study. One-hundred-one (101) subjects received C1INH-nf for the treatment of 1 or more HAE attacks and were analyzed for efficacy. The study design also allowed for short-term prophylaxis with C1INH-nf prior to emergency or non-cosmetic surgical or dental procedures, and an additional 12 subjects received C1INH-nf only for this purpose. All 113 subjects were exposed to C1INH-nf and analyzed for safety.

Eligibility Criteria:
Inclusion Criteria:

This study was open to all subjects who:

* Completed participation in LEVP2005-1/A (NCT00289211) and were not participating in LEVP2005-1/B (NCT01005888), any time after the 3-day telephone follow-up
* Completed participation in LEVP2005-1/B any time after the final prophylactic therapy in Part B
* Were enrolled but not randomized in LEVP2005-1/A after Part A was closed
* Were excluded from LEVP2005-1 for any of the following reasons:

  * Pregnancy or lactation
  * Age less than 6 years
  * Narcotic addiction
  * Presence of anti-C1INH autoantibodies
* Were not enrolled in LEVP2005-1 after enrollment in LEVP2005-1 was closed, under the following circumstances:

  * Had a diagnosis of HAE: evidence of a low C4 level plus either a low C1INH antigenic level or a low C1INH functional level, or
  * Had a known HAE-causing C1INH mutation, or
  * Had a diagnosis of HAE based on a strong family history of HAE as determined by the principal investigator

Exclusion Criteria:

* History of allergic reaction to C1INH or other blood products
* Participated in any other investigational drug study within the past 30 days
* Received blood or a blood product in the past 60 days other than C1INH-nf
Comparison of the Effectiveness of Brexpiprazole With That of Risperidone

To demonstrate that the effectiveness of brexpiprazole (2-4 mg/day) on quality of life is non-inferior to that of risperidone (4-6 mg/day) in adult patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* The patient has schizophrenia diagnosed according to DSM-5™
* The patient has his or her first formal diagnosis of schizophrenia less than 10 years ago
* The patient has been prescribed outpatient oral antipsychotic treatment at recommended dose range as stated in the Summary of product characteristics or equivalent document/label for the full 3 months prior to the Screening Visit.
* The patient has CGI-S score of 3 (mildly ill) or 4 (moderately ill) at the Screening and Baseline Visits.
* The patient has a Global Assessment Scale (GAS) score of 41 to 70 (limits included) at the Screening and Baseline Visits.
* The patient is in need of a change in the current antipsychotic treatment due to insufficient functional improvement and, in the judgement of the investigator, would benefit from a switch to another treatment. Reasons for switching include but are not limited to the following reasons:

  1. lack of adequate response to his or her current antipsychotic medication,
  2. poor tolerability to his or her current antipsychotic medication,
  3. unwillingness of the patient to adhere to his or her current antipsychotic medication.

Exclusion Criteria:

* The patient has a psychiatric disorder (DSM-5™ criteria) other than schizophrenia established as the primary diagnosis.
* The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit, between the Screening and Baseline Visits or at the Baseline Visit.
* The patient is hospitalised for his or her psychotic symptoms at the Screening Visit, between the Screening and Baseline Visits or at the Baseline Visit.
* The patient is treated with brexpiprazole, risperidone or clozapine at the time of Screening Visit.
* The patient has shown, in the investigator's judgment, significant lack of efficacy to brexpiprazole, risperidone or paliperidone when treated at recommended dose range as stated in their respective Summary of product characteristics or equivalent document/ label, in a manner that would preclude benefiting from the study medication if randomised to brexpiprazole or risperidone during the study.
* The patient is considered resistant to antipsychotic treatment according to the investigator's judgement.
* The patient is at significant risk of harming himself/herself, or others according to the investigator's judgement or based on the Columbia Suicide Severity Rating Scale (C-SSRS).