cyrilzakka/clinical-trials huggingface dataset:
Multicenter, Open-label, Safety and Tolerability Study

This will be a multicenter, 52 week, open label study to assess the safety and tolerability of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study will be conducted on an outpatient basis. Enrollment into the study will be drawn from eligible subjects who have completed participation in Study 331-07- 203 and who, in the investigator's judgment, would benefit from continued treatment with oral OPC-34712.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who participated in 331-07-203 and who, in the opinion of the investigator, have the potential to benefit from continued administration of OPC-34712 for the treatment of schizophrenia.
2. Outpatient status at last visit of Study 331-07-203.

Exclusion Criteria:

1. Sexually active males who are not practicing two different methods of birth control during the study and for 90 days after the last dose of study medication or who will not remain abstinent during the study and for 90 days after the last dose, or sexually active females of childbearing potential who are not practicing two different methods of birth control during the study and for 30 days after the last dose of study medication or who will not remain abstinent during the study and for 30 days after the last dose. If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injection, birth control implant, condom, or sponge with spermicide.
2. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving open-label OPC-34712.
3. Subjects who during the course of their participation in 331-07-203 were treated in violation of the protocol or who developed ANY exclusion criteria during the course of their participation.
4. Subjects who do not continue to meet all applicable inclusion/exclusion criteria for Protocol 331-07-203 at the last visit (ie, Week 6) of Protocol 331-07-203.
5. Subjects who represent a risk of committing suicide based on an answer of "Yes" to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS, or an answer of "Yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior) on the "Suicidal Behavior" portion of the C-SSRS. A subject who has had any suicidal ideation within the last 6 months, any suicidal behaviors within the last two years, or who in the clinical judgment of the investigator presents a serious risk of suicide should be excluded from the study.
6. Subjects who would be likely to require prohibited concomitant therapy during the study.
7. Any subject who, in the opinion of the investigator, should not participate in the study.
COVID-19 Epidemiological Surveillance on Healthcare Workers and Patients in a Rehabilitation Medicine Facility

The recent SARS-CoV2 pandemic has highlighted that the transmission of the virus within health care facilities plays a fundamental role in its propagation and, therefore, in the increase in COVID-19 cases registered among patients and healthcare workers.

This study, original for the current lack of data on nosocomial transmission mechanisms compared to what happens in the community, proposes to conduct a study in patients, health workers and people in real-life setting.

The study will be monocentric and performed at the San Raffaele Pisana Institute in Rome, that is able to guarantee the necessary number and the right case-mix that will allow to evaluate any possible correlations between infection and pre-existing disease.

Furthermore, hospitals, especially those dedicated to chronic patients, as well as other communities that are not completely closed (such as school and work communities), are also at greater risk of small outbreaks that also affect healthcare professionals.

It is therefore necessary to carry out periodic checks on all healthcare professionals who work in healthcare facilities both to ensure their health and avoid the risk of possible contamination and to prevent the possible transmission of infection from the community to the hospital.

Another essential aspect to prevent infection in such facilities is the control of colonization in admitted patients.

Negativity from SARS-CoV2 should be carefully monitored in these patients prior to their placement in different departments.

On this basis, the study aims to determine the presence of SARS-CoV2 by monitoring with serial nasopharyngeal swabs carried out on healthcare professionals working within the facility and on new patients admitted.

In order to exclude the possibility of false negatives due to low viral load found in the early stages of infection (incubation time) or any exposure that may occur in the days following the execution of the swab, the study will i provide for the repetition of the swab examination, 3 times, at weekly intervals.

In order to verify the correspondence between the presence of IgM and IgG antibodies against the virus and the positivity to the swabs, the healthcare professionals and patients who undergoing nasopharyngeal swab will be previously subjected to the rapid antibody detection test (prick test for IgG and IgM).

Eligibility Criteria:
Inclusion Criteria:

* Patients/Participants \> 18 years
* Subjects who agree with the study signing the informed consent

Exclusion Criteria:

* Age \<18 years;
* Pregnancy in progress;
* Simultaneous participation in another clinical study
* Ongoing immunosuppressive therapy or during the last month
Absorption of Heme and Non-Heme Iron in Pregnant and Non-pregnant Women and Mechanisms of Fetal Iron Transfer

The three specific aims of this study are 1) to assess the impact of iron status on relative differences in absorption of heme and non-heme iron among pregnant women and non-pregnant women, 2) to assess the magnitude and the determinants of heme and non-heme iron transfer to the fetus over the last trimester of pregnancy, and 3) to characterize relationships between placental iron binding proteins with the enrichment of stable iron isotopes in the neonate at birth. The investigators hypothesize that there will be up regulation of heme and non-heme iron absorption and up regulation of placental iron transport proteins in response to low maternal iron stores.

To measure the absorption of heme and non-heme iron in women, pregnant and non-pregnant women will consume a standardized meal of pork (intrinsically labeled with 58Fe) and a second meal of non-heme 57Fe (as ferrous sulfate). Two weeks after ingesting these test meals, a blood sample will be collected from each women and the amount of heme (58Fe) and non-heme (57Fe) iron incorporated into red blood cells will be measured with magnetic sector thermal ionization mass spectrometry. Cord blood samples and placental tissue will be obtained at delivery to measure how these two forms of dietary iron were transferred across the placenta to the fetus. Maternal and neonatal iron status and placental proteins involved in iron transport will also be measured. Data from this study will provide information that aims to improve human health by better understanding the iron requirements of a population at high risk of iron deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant subjects (15-35 yrs): non-smoking,healthy with uncomplicated pregnancies at time of enrollment
* Non-pregnant subjects (18-35 yrs): healthy, non-smoking, not taking vitamin or mineral supplements and not planning on becoming pregnant during course of study.

Exclusion Criteria:

* Pregnant subjects: gestational diabetes, hypertension, preeclampsia, underlying malabsorption diseases or other diagnosed medical problems known to impact iron homeostasis
* Non-pregnant subjects: underlying malabsorption diseases or other diagnosed medical problems known to impact iron homeostasis.
The Combination of Terbutaline and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Single-arm, open-label, single center study to assess the efficacy and safety of terbutaline plus danazol in patients with corticosteroid resistant/relapsed ITP.

Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of corticosteroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. β2-AR agonist terbutaline modulates T cell differentiation and effector cell function.

A single center prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were assigned to terbutaline plus danazol group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study, in order to assess the efficacy and safety of terbutaline plus danazol in patients with corticosteroid-resistant/relapsed ITP.

Eligibility Criteria:
Inclusion Criteria:

* ITP confirmed by excluding other supervened causes of thrombocytopenia;
* Platelet count of less than 30×10\^9/L at enrollment;
* Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
* Subject has signed and dated written informed consent.
* Fertile patients must use effective contraception during treatment and observational period
* Negative pregnancy test.

Exclusion Criteria:

* Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
* congestive heart failure
* severe arrhythmia
* nursing or pregnant women
* aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
* creatinine or serum bilirubin levels each 1•5 times or more than the normal range
* active or previous malignancy
* Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.
* diagnosis with any of the following diseases: chronic hypertension, hyperthyroidism, diabetes, or seizure disorder.
Bariatric Surgery and Pharmacokinetics of Hydrochlorothiazide

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on hydrochlorothiazide are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Local Anesthesia With Lidocaine or Articaine for Molars Affected by MIH

Aims: Comparison of injection pain with lidocaine and articaine in children with MIH .

Comparison of the efficacy of lidocaine and articaine during treatment of MIH molars.

Design: A randomized, controlled, crossover, double-blind clinical study including twenty cooperative children, aged 6-12years old

Background and Aims: Effectively achieving anesthesia is one of the difficulties a dentist faces when treating MIH molar There are no studies comparing the effectiveness of lidocaine and articaine in MIH molar Design: A randomized, controlled, crossover, double-blind clinical study including twenty cooperative children , aged 6-12 years old Each child will receive either lidocaine or articaine at their ﬁrst or second visit.

Eligibility Criteria:
Inclusion Criteria:

* Absolute positive or positive behavior according to the Frankel Scale.
* Healthy, both physically and mentally.
* Do not take medications that interfere with the assessment of pain within 24 hours prior to treatment.
* A child with a MIH-affected mandibular permanent first molar on the right and left sides .

Exclusion Criteria:

* Teeth with non-response pulpitis Inflammation at the injection site.
* Allergy to the substances used in anesthesia.
* Presence of general or developmental medical conditions.
Rampart Duo Clinical (RaDical) Post-Market Study

This exempt, minimal risk, prospective, post-market, registry, multi-center, Institution Review Board (IRB) approved observational clinical evaluation was conducted at 10 centers. A total of 197 patients were enrolled. The evaluation collected data in a real-world patient population and was a data collection initiative only. No patient treatments or care were performed as a component of the protocol. All patient care received was on-label and standard of care for lateral lumbar interbody fusions. The data collected in this evaluation is intended to contribute to the body of literature for lateral lumbar interbody fusions.

The purpose of this study was to collect data that reports on the clinical outcomes of patients that were treated with the Spineology Rampart DUO device in a standard of care instrumented lateral lumbar interbody fusion procedure at one or two contiguous levels from L2-L5. Data was collected prospectively at specified time points per protocol and included both objective and subjective measures. The study concluded when the final patient achieved their 12-month evaluation.

Eligibility Criteria:
Inclusion Criteria:

* A clinical decision has been made to treat the patient with the Rampart Duo Interbody Spacer prior to enrollment into this research evaluation. This decision is independent (made outside) of the decision to take part in the research.

Exclusion Criteria:

* Previous interbody fusion or total disc replacement at the index level(s).
* Enrolled in a concurrent clinical investigation that may confound the findings of the present investigation.
Investigating Safety, Tolerability and Pharmakinetics When Giving Single and Fractionated Doses of AZD3241 to Healthy Volunteers

The study is carried out in order to investigate safety, tolerability and pharmacokinetics after administrating single and fractionated doses of AZD3241 to healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Body Mass Index (BMI) 19 to 30 kg/m2 inclusive
* Clinically normal physical findings, including BP, pulse rate, ECG and laboratory findings, as judged by the investigator

Exclusion Criteria:

* Clinically significant illness within the 2 weeks prior to the administration of the investigational product
* Heart rate (resting, recumbent) \<50 bmp or \>85 bmp
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity as judged by the investigator
Natural History Study of MNGIE

Non-interventional, prospective, multicenter, natural history study of patients with mitochondrial neurogastrointestinal encephalomyopathy (MNGIE)


Eligibility Criteria:
Inclusion Criteria:

* Has MNGIE

Exclusion Criteria:

* Substance abuser
Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke

Intravenous (IV) tissue plasminogen activator (tPA) is the only FDA-approved therapy for treatment of acute ischemic stroke. In the United States, IV tPA is typically administered in the Emergency Department (ED) for patients presenting with acute ischemic stroke within 4.5 hours of symptom onset. It is current practice that post-tPA patients are monitored in an intensive care unit or intensive care unit (ICU)-like setting for at least 24 hours, in part due to frequent vital sign and neurological monitoring that is currently the standard of care. However, rigorous evidence to support this practice is largely lacking. In a retrospective analysis of 153 patients receiving IV tPA at Johns Hopkins Hospital (JHH) and Johns Hopkins Bayview Medical Center (JHBMC), investigators have shown that most patients who have ICU needs in the first 24 hours after tPA administration develop such needs by the end of the tPA infusion. Patients without ICU needs by the end of the tPA infusion, do not require further ICU resources if patients' presenting NIH Stroke Scale (NIHSS) is below 10. This study is a prospective clinical trial that aims at establishing the first proof-of-concept and feasibility of whether patients with a low NIHSS (NIHSS 9 or less) and that do not need ICU care by the end of the tPA infusion, can be monitored safely in a non-ICU setting with a novel monitoring protocol. Identifying post-tPA patients who can be safely monitored in a non-ICU environment may improve cost-effective utilization of ICU resources and reduce the length of hospitalization for stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent (or a Legally Authorized Representative (LAR) available to provide informed consent) and comply with study assessments for the full duration of the study.
* Age 18-80 years
* Patients to be included will be diagnosed as having an acute ischemic stroke by history and physical exam and receive IV tPA within 4.5 hours of symptom onset according to current guidelines for acute stroke care.
* NIHSS at presentation \<10
* Patients do not have ICU needs in the judgment of the treating ED physician or neurologist by the end of the tPA infusion
* NIHSS at the end of tPA infusion \<10

Exclusion Criteria:

* For patients receiving IV tPA according to the current standard of care, the following exclusion criteria apply:

  * Age \<17 or \>80
  * ICU need or indication by the end of the tPA infusion
  * NIHSS \>9 at presentation or at the end of the tPA infusion
  * Indication/need for endovascular recanalization therapy
Caffeine as a Therapy for Parkinson's Disease

Parkinson's disease is a common neurodegenerative disorder in which patients experience progressive motor disability and many disabling non-motor symptoms. Recent studies have consistently found that people who do not use caffeine are at higher risk of developing Parkinson's disease. This suggests that caffeine may have potential as a treatment for PD.

In a pilot study of caffeine for daytime sleepiness in PD, there was evident benefit on the motor manifestations of disease. There have been other lines of evidence that have suggested caffeine could be useful in PD. This study is to evaluate the efficacy of caffeine 200 mg BID vs matching placebo for motor and non-motor aspects of disease. This will be in three stages. In the first six-month stage, medications will be held constant, to see whether caffeine does have motor benefits. Then we will perform a four-year extension stage to define if the effects of caffeine persist (or even magnify), and to see if caffeine helps reduce dose of other PD meds and/or prevents their side effects. Finally, we will finish with a six-month stage in which we will place all patients on caffeine - this will allow us to assess caffeine's use in later disease, but more importantly, will assess whether early use of caffeine produces long term changes beyond its immediate effects.


Eligibility Criteria:
Inclusion Criteria:

All patients must have idiopathic PD diagnosed as parkinsonism according to the UK brain bank criteria, and PD considered the likeliest underlying cause according to the treating physician. Other inclusion criteria include:

1. PD diagnosis: between 6 months and 8 years
2. Hoehn and Yahr stage I-III
3. Age at least 45 and less than 75 (to optimize survival over the 5-year trial).
4. Receiving symptomatic therapy for PD for at least 6 months. Dose must have been stable over the previous 3 months.

Exclusion Criteria:

1. Caffeine intake \>150 mg per day (i.e. more than one cup of filtered coffee per day) or prescribed adenosine antagonists - caffeine intake will be measured by a standardized intake questionnaire. Intake will be converted into estimated caffeine mg dose by standard caffeine-content charts.
2. Active peptic ulcer disease, or symptomatic gastroesophageal reflux disease.
3. Supraventricular cardiac arrhythmia (such as atrial fibrillation or atrial flutter) - Electrocardiogram will be measured at baseline to rule out supraventricular tachycardia.
4. Uncontrolled hypertension - systolic bp \>170 or diastolic bp \>110 on two readings.
5. Pre-menopausal women who are not using effective methods of birth control
6. Cognitive impairment, defined as MoCA \<23/30.
7. Moderate-Severe Depression, as defined by a Beck Depression Inventory score of \>19.
8. Changes to antiparkinsonian medication in the last 3 months, or changes to antiparkinsonian medication are anticipated during the next six months.
9. Current use of lithium or clozapine (pharmacokinetic interactions).
Analyses of Human Samples Collected in Clinical Trials

Cancer patients in clinical trials donate various human samples (e.g., serum, plasma, blood, urine, feces, bile, saliva) for research purposes.

The purpose of this study is to conduct further analyses on these existing samples from clinical trials that are being performed outside of, but in collaboration with, the National Cancer Institute.

Various human samples (e.g., serum, plasma, whole blood, erythrocytes, urine, feces, bile, and/or saliva) will be collected from cancer patients enrolled on approved clinical trials, in accordance with the local protocol. These trials are being conducted at outside institutions, in collaboration with the National Cancer Institute (NCI) and the samples will be sent to the NCI for pharmacological analysis, involving determination of parent drug and/or metabolite concentrations and subsequent pharmacokinetics and statistical data analysis. This study aims to further characterize the clinical pharmacokinetic behavior of select cancer therapeutics. Future collaborators will be added via the protocol amendment procedure.

Eligibility Criteria:
* INCLUSION CRITERIA:

Any patients entered on approved trials of cancer therapeutics or agents that are commonly administered to patients with cancer at institutions outside of the intramural NCI are eligible for inclusion, provided that they have consented to pharmacological analysis in the original consent form.

EXCLUSION CRITERIA:

None anticipated at this time.
Thrombolysis Endovascular Treatment of Pulmonary Embolism

To assess the efficacy and safety of endovascular thrombolysis of pulmonary embolism with right ventricular dysfunction with single-dose rtPA

The patients with right ventricular dysfunction who are diagnosed by CT pulmonary angiography will receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the in this study. The Change of RV to LV Diameter Ratio,Rate of death,rate of major bleeding,pulmonary embolism recurrence at 1month will be reviewed to assess the efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* CT evidence of proximal PE
* Age ≥ 18 years
* Pulmonary embolism symptom duration ≤14 days
* Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) OR Submassive PE (RV diameter-to-LV diameter ≥ 0.9 on contrast-enhanced chest CT)

Exclusion Criteria:

* Age \<18 years
* PE symptom duration \>14 days
* Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
* Recent (within one month) or active bleeding from a major organ
* Pregnancy
* Chronic pulmonary hypertension or severe chronic obstructive pulmonary disease
* Administration of thrombolytic agents within the previous 3 days
* Life expectancy \< 30 days
* Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
* Inability to follow protocol requirements