cyrilzakka/clinical-trials huggingface dataset:
PERFORMANCE STUDY OF THE AL-SENSE

This is an open-label, comparative, and prospective pivotal study to demonstrate that AL-SENSE can indicate whether wetness sensed by pregnant women may be caused by amniotic fluid leakage rather than by urinary incontinence.

Subjects arriving at the hospital will receive a single AL-SENSE to use until they notice any wetness.

The blinded physician will perform a diagnosis according to the standard diagnostic methods (clinical assessment). The standard diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test or positive result in both the pH test and the Ferning test is defined as a positive clinical assessment.

This is an open-label, comparative, and prospective pivotal study to demonstrate that AL-SENSE can indicate whether wetness sensed by pregnant women may be caused by amniotic fluid leakage rather than by urinary incontinence. Subjects arriving at the hospital and reporting unidentified wetness (undetermined whether this is amniotic fluid leakage or urinary incontinence) will receive a single AL-SENSE to use up to 12 hours or until they notice any wetness. The clinician will explain the proper use and handling of the AL-SENSE.

In each case, the blinded clinician will be required to read and record any occurrence of color change of the AL-SENSE 10 minutes after the AL-SENSE removal and to mark if it changes color to blue or to green on the designated form.

The blinded physician (other than the clinician who records the AL-SENSE results) will perform a diagnosis according to the standard diagnostic methods (clinical assessment). The standard diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test or positive result in both the pH test and the Ferning test is defined as a positive clinical assessment.

In cases where the AL-SENSE shows positive results but the clinical assessment results are negative, reference laboratories, or any other standard procedure will check for the possibility of BV or Trichomonas in addition to the tests noted above.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or greater.
2. Subject minimum 16 weeks of pregnancy.
3. Who will sign the informed consent form.
4. Who arrive at the obstetric department reporting a feeling of vaginal wetness feeling (undetermined whether this is amniotic fluid leakage or urinary incontinence).

Exclusion Criteria:

1. Subject who has experienced intermittent vaginal bleeding between the 2nd and 3rd trimesters.
2. Subjects that have had sexual intercourse within the last 12 hours.
3. Subject is unable or unwilling to cooperate with study procedures.
4. Subject that has been diagnosed with Bacterial Vaginosis or Trichomonas infection within the last 3 days.
A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects

This study investigates whether YM178 has an effect on the pharmacokinetics of warfarin, to exclude any drug-drug interaction between YM178 and warfarin, and evaluates the safety and tolerability of warfarin alone and combined with YM178.


Eligibility Criteria:
Inclusion Criteria:

* Female subject must be of non-child bearing potential, i.e. postmenopausal, surgically sterilized (e.g. tubal ligation), hysterectomy in medical history, or must practice adequate (double barrier) non-hormonal contraceptive methods to prevent pregnancies.
* Body Mass Index (BMI) ≥ 18.5 and \< 30 kg/m2, inclusive

Exclusion Criteria:

* Female who is pregnant
* Any of the liver function tests (i.e. alanine aminotransferase (ALT), aspartate aminotransferase (AST) and Alkaline Phosphatase (AP)) above the upper limit of normal (ULN)
* Any clinically significant history of disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator
* Abnormal pulse and/or blood pressure measurements and the pre-study as follows: Pulse \< 40 or \> 90 bpm; mean systolic blood pressure \> 140 mmHg; mean diastolic blood pressure \> 90 mmHg (blood measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically
* A marked baseline prolongation of QT/QTc interval after repeated measurements of \>450 ms, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
* Use of any prescribed or OTC (over-the counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for paracetamol (up to 3 g/day)
* Any use of drugs of abuse within 3 months prior to admission to the clinical unit
* History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit
* History of drinking more than 21 units of alcohol per week (1 unit = 270 ml of beer or 40 ml of spirits or 1 glass of wine) (\> 14 units of alcohol for female subjects) within 3 months prior to admission to the clinical unit
* Donation of blood or blood products within 3 months prior to admission to the clinical unit
The Safety of Remote DBS Programming System

Remote programming has significant advantages over conventional programming methods on some issues. This research will test the safety of SceneRay remote and wireless DBS programming system.

Programming is a crucial aspect of deep brain stimulation (DBS), directly influences the final success of DBS. Optimal programming helps patients achieve maximized control of clinical symptoms and higher life quality. However, there are a number of inadequacies in conventional programming methods. First, the programming probe must come into close contact with the implantable pulse generator (IPG) and test stimulator to complete programming. And during initial postoperative programming, only the parameters of one patient can be ascertained. In addition, the same frequency is typically used in the left and right brain for dual channel IPG. The patient also need to repeatedly travel between their home and the hospital, leading to increased time and expense. Therefore, the investigators developed the SceneRay wireless and remote DBS system to address the outline issues. This system has significant advantages over conventional programming methods on all the issues above. This research will test the safety of this remote and wireless DBS programming system.

Eligibility Criteria:
Inclusion Criteria:

* Primary PD patients volunteered to receive DBS surgery with SceneRay wireless and remote DBS system,
* Age 18-75 years,
* Achieved optimal control of clinical symptoms after coventional programming for 3-12 months,
* Significant difference in motor function when DBS is switched on/off,
* Good compliance and easy to follow-up,

Exclusion Criteria:

* No significant improvement or clinical efficacy in symptoms after surgery,
* Severe cognitive impairment due to dementia (Mini-Mental State Examination score: illiteracy \<17, elementary school \<20, junior high school or above \<24) or inability to accurately record in a diary,
* Active psychosis or a history of psychosis,
* Serious heart, liver, or kidney diseases,
* Severe hypertension or orthostatic hypotension, severe diabetes, or diabetes accompanied by brain and cardiovascular diseases,
* Malignant cancer, brain injuries, epilepsy, or other unstable medical conditions,
* Severe alcohol dependence or drug abuse,
* Any situation that may jeopardize the patient's safety or lead to a failure to participate in the study (medical, psychological, social, or georational factors) at present or in the future,
* Participating in other clinical trials,
* Other factors that researchers think may not be suitable for research.
PD-1 Inhibitor Based Induction Chemotherapy Followed by De-escalation Protocols in OPSCC

More and more studies have shown that the efficacy and prognosis of HPV （Human papillomavirus）-positive oropharyngeal cancer (OPC) patients are better than those of others. However, in the NCCN (National Comprehensive Cancer Network) Oncology Clinical Guidelines for OPC treatment, each group of p16+ is consistent with the corresponding group of p16-, which indicates that the treatment of OPC is basically the same regardless of whether it is related to HPV. Several studies attempted to reduce the toxicities of treatment of HPV related OPC through reduced-dose radiation and showed promising results, and all of the studies have shown that induction chemotherapy is a good way to screen followed treatment. Those who are effective in induction chemotherapy are usually more sensitive to radiation therapy, and reducing the intensity of subsequent treatment will not affect the survival outcome of patients. Immune checkpoint inhibitors (ICIs) have proved to improve outcomes of head and neck cancers. However, In KEYMAT-048, a Phase III controlled trial of relapsed/metastatic head and neck squamous cell carcinoma, ICIs showed an overall survival advantage, but the survival advantage was independent of HPV status. Therefore, patients with HPV-negative OPC still have a good response to ICIs. So we added anti-PD-1 antibody Toripalimab to induction chemotherapy in order to achieve better response rates to receive de-escalation chemoradiotherapy followed regardless of whether it is related to HPV.


Eligibility Criteria:
Inclusion Criteria:

Histological diagnosis of squamous cell carcinoma of oropharynx; IHC p16 positive or PCR HPV16 positive; IHC p16 negative or PCR HPV16 negative; T3-4N0-3M0 or T1-2N2-3M0 according to UICC/AJCC 8th staging system; Age ≥18; No prior anti-tumor treatment; Informed consent obtained; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Normal complete blood count; Normal hepatic function; Normal renal function (creatinine ≤ 1.5 times the upper limit of normal). -

Exclusion Criteria:

Previous radiotherapy; A history of any other type of malignancy; Pregnancy or lactation; Obvious disfunction of liver, renal, cardiac or lung function; Un controlled infection; Systemic metastasis or distant metastasis; Patients with severe gastrointestinal diseases; Patients with mental disorders affecting patient participation in trial judgement.

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Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Dermatologists

The purpose of this study is to evaluate the safety profile and the effectiveness of etanercept under usual care settings in patients with PsA treated by dermatologists.

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Psoriatic Arthritis

Exclusion Criteria:

* Sepsis or risk for sepsis,
* Acute infection,
* Hypersensitive against Etanercept
An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Adults With Dravet or Lennox-Gastaut Syndromes

To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut syndromes.

This is a multi-center, open-label extension study for participants with Dravet syndrome or Lennox-Gastaut syndrome who have previously participated in double-blind, placebo-controlled clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], GWEP1424 \[NCT02224703\], GWEP1414 \[NCT02224560\], GWEP1424 \[NCT02224703\], and GWEP1423 \[NCT02224690\]). The first participant was enrolled into the open-label extension study after the Data Safety Monitoring Committee reviewed the safety data from Part A of study GWEP1332.

Eligibility Criteria:
Key Inclusion Criteria:

• Participant has completed the treatment phase of their Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], GWEP1424 \[NCT02224703\], GWEP1414 \[NCT02224560\], GWEP1424 \[NCT02224703\], and GWEP1423 \[NCT02224690\].

Key Exclusion Criteria:

* Participant is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to study entry other than the investigational medicinal product (IMP) received during the Core Study and are unwilling to abstain for the duration for the study.
* Any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1.
* Participant has been part of a clinical trial involving an IMP during the inter-study period.
* Female participant is of child bearing potential or male participant's partner is of child bearing potential, unless willing to ensure that they or their partner use highly effective contraception, for example, hormonal contraceptives, intrauterine devices/hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence, during the study and for 3 months thereafter (however, a male condom should not be used in conjunction with a female condom).
* Participant has significantly impaired hepatic function at the 'End of Treatment' visit of their Core Study or at Visit 1 if re-assessed: i) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 × upper limit of normal (ULN); ii) ALT or AST \>3 × ULN and (total bilirubin \[TBL\] \>2 × ULN or international normalized ratio \[INR\] \>1.5); iii) ALT or AST \>3 × ULN with the presence of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (\>5%). This criterion must be confirmed prior to entering the study.
IPI-145 ADME and Absolute Bioavailability Study

This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME) and absolute bioavailability study in 6 healthy adult male subjects.

In Period 1, subjects will receive a single oral dose of 25 mg IPI-145, followed by a 15-minute IV infusion of approximately 2.8 μg 14C-IPI-145 containing 14.8 kBq of radioactivity.

In Period 2, the same subjects will receive a single dose of 25 mg 14C-IPI-145 as an oral suspension, containing approximately 3.15 MBq of radioactivity.

There will be a washout period of at least 14 days between Period 1 and Period 2.

Eligibility Criteria:
Inclusion Criteria:

* Males, between 18 and 45 years of age, inclusive Body Mass Index (BMI) : 18.0-30.0 kg/m2
* In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs
* Provision of signed and dated, written informed consent prior to any study specific procedures

Exclusion Criteria:

* Evidence of clinically significant medical conditions
* History of gastrointestinal surgery that may affect drug absorption
* Positive or indeterminate QuantiFERON-TB Gold test at screening
* Any active infection at the time of screening or admission
* Participation in another ADME study with a radiation burden \>0.1 mSv in the period of 1 year before screening
* Irregular defecation pattern (less than once per 2 days)
A Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite Identification of BIIB122/DNL151 in Healthy Male Subjects

This is a single-center, non-randomized, open-label Phase 1 study to determine the absorption, metabolism, and excretion (AME) of BIIB122 (DNL151) following administration of a single oral dose of \[14C\] BIIB122 (\[14C\] DNL151) following a fast. The mass balance, excretion, and PK of BIIB122 (DNL151) will be used to evaluate AME.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
key Inclusion Criteria:

* For men who choose to have sex with women, either: vasectomy, use of condoms, or sex with a woman who is of non-childbearing potential
* Body mass index ≥18.0 kg/m2 and ≤32.0 kg/m2
* Body weight ≥5.0 kg and ≤100.0 kg
* Considered to be in good health
* Non-smoker

Key Exclusion Criteria:

* History or presence of any condition or prior surgery that, in the opinion of the investigator, poses a significant risk to subject safety and/or achievement of study objectives
Tissue, Blood and Biomarkers to Predict Future Atrial Fibrillation

Patients undergoing coronary artery bypass grafting (CABG), aortic (valve) or mitral valve surgery are at risk of developing postoperative and new-onset atrial fibrillation (AF), but adequate risk prediction is currently impossible. This study aims to discover tissue and circulating microRNAs and protein biomarkers that may help to unravel the pathophysiological processes underlying AF and are potential tools for risk stratification and prognosis or may become future targets of therapy.

This study will be a single-center cohort study of 150 patients undergoing cardiac surgery, which will constitute the beginning of the follow-up period. Left atrial appendages, whole blood and epicardial mappings will be collected. Patients will be followed for 2 years with regular holter investigations to detect postoperative and new-onset AF.

Study procedures:

The left atrial appendage (LAA) will be removed for research and intended prophylactic purposes, using a surgical stapler or surgical knife prior to the standard procedure. Epicardial mappings may be performed during cardiac surgery with a 48-multi-electrode. Patients will be followed with regular 24-hour Holter investigations.

This study will be an exploratory study with a required inclusion of 150 patients, based on the estimated event rate. Patients will be recruited by the investigators during pre-operative assessment.

Clinical data will be gathered at baseline and stored in a customized microsoft access entry database. Statistical analysis will be performed in collaboration with the Bioinformatics Laboratory from the Academic Medical Center.

Eligibility Criteria:
Inclusion Criteria:

* Elective sternotomy for either coronary artery bypass surgery or aortic (valve) surgery or mitral valve surgery
* CHA2DS2 VASC score ≥ 2
* Sinus rhythm
* Age between 18 and 80 years
* Legally competent and willing and able to sign informed consent

Exclusion Criteria:

* Unable or unwilling to comply with study procedures
* Documented or reported history of atrial fibrillation, atrial flutter (duration \> 5 minutes) or ventricular tachycardia
* Emergency or redo of CABG
* Emergency valvular surgery or pericarditis or endocarditis
* NYHA class IV heart failure symptoms or left ventricular ejection fraction \< 35%
* Pregnancy or of childbearing potential without adequate contraception
* History of previous radiation therapy of the thorax
* Active malignancy
* Active inflammtion or auto-immune disease
* Surgery for congenital anomalies
* Circumstances that prevent follow-up (no permanent home or address, transient, etc.)
A Pilot Study of 123I-MIP-1072 SPECT/CT Imaging With Optional Compact Gamma Camera Probe Imaging in Men With Prostate Cancer Undergoing Prostatectomy

This is a single arm, open label study of up to 20 patients with prostate cancer scheduled for prostatectomy at the NIH Clinical Center. 123I-MIP-1072 image data will be evaluated for visible uptake and compared with histopathology.

This is an exploratory, single arm, open label pilot study evaluation of 123I-MIP-1072 intraprostatic uptake determination by SPECT/CT imaging (and optional CGCP imaging), with histological confirmation of disease localization and staging. Methodical evaluation of 123I-MIP-1072 in intraprostatic tumorous and non-tumours regions will provide important preliminary data upon which further clinical studies can be based. The optional additional CGCP imaging was added, because of its inherent potential for higher resolution scintigraphic detection of 123I-MIP-1072 localization. This imaging feasibility data will provide important preliminary information for the use of CGCP imaging in prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the NIH Clinical Center.
* Have had or will undergo multiparametric endorectal coil 3T MR at the NIH clinical center
* Recent (within 12 months of study entry) trans-rectal biopsy indicating the presence of adenocarcinoma of the prostate gland
* Participant must be 18 years or older.
* ECOG Performance grade of 0 to 2. (see Appendix 1)
* Ability to understand and provide informed consent. All subjects must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
* Participants of childbearing potential must agree to use an acceptable form of birth control, defined as abstinence, barrier or other acceptable, effective contraceptive method until 7 days after the infusion of study drug.

Exclusion Criteria:

* Participants for whom participating would significantly delay the scheduled standard of care therapy.
* Subjects must not have prostate biopsies performed within 12 weeks before imaging; or within 8 weeks before imaging providing that the absence of hemorrhage is confirmed by MR imaging.
* SGOT and SGPT ≥ 2 x of the upper limits of normal; total bilirubin, of ≥ 1.5 x the upper limits of normal or ≥ 3.0 mg/dl in patients with Gilbert's syndrome.
* Administered a radioisotope within 5 physical half lives prior to study enrollment.
* Patients with severe claustrophobia unresponsive to oral anxiolytics
* Subjects weighing ≥350 lbs or are unable to fit within the imaging gantry
* Subjects who have received androgen deprivation therapy.
* Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.