cyrilzakka/clinical-trials huggingface dataset:
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)

The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).

Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)

Eligibility Criteria:
Inclusion Criteria:

* Participant was randomized in Study ROPP-2008-01 Section D (NCT01096784).
* Participants parent or legally authorized representative(s) must provide written informed consent prior to performing any study-related activities. Study-related activities are any procedures that would not have been performed during normal management of the participant.

Exclusion Criteria:

* Any other condition or therapy that, in the Investigator's opinion, may pose a risk to the Participant or interfere with the participants ability to be compliant with this protocol or interfere with the interpretation of results.
* The participant or participants parent or legally authorized representative(s) is unable to comply with the protocol as determined by the Investigator.
Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer

This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or Metastatic Breast Cancer.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed Breast cancer
* Metastatic Breast Cancer currently of stage IV disease or unresectable locoregionally recurrent breast cancer
* refractory to the most recent chemotherapy, documented by progression on or within six (6) months of therapy
* At least 14 days from the completion of any previous cancer therapy
* Adequate organ function
* Life expectancy of 3 months or more
* Willing and able to comply with the protocol and able to understand and willing to sign an informed consent

Key Exclusion Criteria:

* Previously treated with eribulin
* Peripheral neuropathy Grade ≥3
* Receipt of prior CXCR4 therapy
* Receipt of colony stimulating factors (CSFs) filgrastim, pegfilgrastim, or sargramostim, or radiation therapy within 14 days prior to study Day 1
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to balixafortide or eribulin or other agents used in the study
* Breast feeding or pregnant
* Patients with congestive heart failure, electrolyte abnormalities, bradyarrhythmias, known congenital long QT syndrome, QT interval corrected with Fridericia's formula (QTcF) ≥470 msec at baseline in the absence of bundle branch block, or currently taking drugs at known risk of prolonging the QT interval or causing torsades de pointes
A Study of Ramucirumab (LY3009806) Plus MEDI4736 in Participants With Advanced Gastrointestinal or Thoracic Malignancies

The main purpose of this study is to evaluate the safety of ramucirumab plus MEDI4736 in participants with locally advanced and unresectable or metastatic gastrointestinal or thoracic malignancies including gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or hepatocellular carcinoma (HCC).


Eligibility Criteria:
Inclusion Criteria:

* Measurable metastatic disease or locally advanced and unresectable disease

  * Has histopathologically confirmed gastric or GEJ adenocarcinoma with documented disease progression after 1-2 prior lines of systemic therapy
  * Has histopathologically confirmed nonsquamous or squamous NSCLC with documented disease progression after 1-3 prior lines of systemic therapy
  * Has histopathologically or cytologically confirmed HCC, Child-Pugh Class A, with documented disease progression during or after discontinuation of sorafenib therapy, or intolerance of sorafenib therapy, and an α-fetoprotein (AFP) ≥ 1.5x upper limit of normal
* Availability of tumor tissue for biomarker analysis
* Has an Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Has adequate organ function

Exclusion Criteria:

* Has known brain metastases
* Has a history of prior cancers not included in this study that were either not treated with curative intent or have been active within the past 5 years
* History of allogeneic organ transplant
* Has active or prior documented autoimmune disease within the past 24 months
* Has human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness, or a history of immunodeficiency
* Has active hepatitis B or hepatitis C infection, or co-infection with both hepatitis B and C virus
* For gastric/GEJ and NSCLC participants, has chronic hepatitis B or hepatitis C infection. (For HCC participants, those with chronic hepatitis B virus \[HBV\] infection with a negative HBV deoxyribonucleic acid \[DNA\] test and who are on antiviral therapy, and those with chronic hepatitis C virus \[HCV\] infection are eligible)
* Has a history of interstitial lung disease, idiopathic pulmonary fibrosis, pneumoconiosis, non-infections pneumonitis, radiation-induced or drug-induced pneumonitis
* Has received any previous systemic therapy targeting programmed death (PD) 1 or PD-ligand 1/2 signaling pathways, and other immune checkpoint inhibitors
* Have received previous systemic therapy with ramucirumab
High-dose Intravenous Vitamin C (HDIVC) as Adjuvant Therapy in Critical Patients With Positive COVID-19. A Pilot Randomized Controlled Dose-comparison Trial.

The objective of this study is to evaluate the impact of this HDIVC therapy in the first treatment of symptomatic Covid-19 patients in a time period of one week.

We consider that treatment with high doses of injectable vitamin C HDIVC could have a positive impact as an adjunct on the immunity of patients with Covid while reducing the possibility of worsening their clinical picture. Similarly, we wish to evaluate the efficacy of this treatment, for one week, in patients hospitalized in the ICU, in order to reduce the inflammatory burden and reduce hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with consent, adult men or women, age ≥ 18 years.
* Laboratory confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assays; and/or clinical findings suggesting infection.
* Hospitalized with a SARS-CoV-2 infection of any duration.
* Ability to provide an informed consent signed by the study patient or a legally acceptable representative.
* Willingness and ability to comply with the procedures/evaluations related to the study.
* Have an oxygen saturation (SaO2) of 94% or less while breathing room air; or a ratio between the partial pressure of oxygen (PaO2) and the fraction of inspired oxygen (FiO2) (Pao2: Fio2) equal to or less than 300 mg. Hg. (WHO defines PAFI less than or equal to 250; being mild: 200-300; moderate: 100-200; severe: 100 or less.
* Normal kidney function: (creatinine 0.7 mg / dl for men or 20 to 200ng / ml and 0.6 to 1.1 mg / dl for women or 15-150 ng / ml); urinary output greater than or equal to 1 cc / kg / hour; glomerular filtration rate greater than 30 cc / min).
* Without chronic kidney disease (CKD) defined by stage II or higher according to the Kidney Disease Improving Global Outcomes (KDIGO) classification.

Exclusion Criteria:

* Age \<18 or pregnant or lactating woman.
* Allergy to vitamin C.
* Severe liver failure.
* eGFR ≤ 30 ml / min / 1.73 m2 (defined by the CKD-EPI SCr formula).
* History of any organ transplants requiring treatment active immunosuppressant that may interfere with kidney function.
* If you required cardiopulmonary resuscitation (CPR) within 14 days, and/or DNR orders (do not resuscitate) DNI (do not intubate).
* If death is considered imminent or unavoidable during this admission, and the treating physician, patient, or surrogate decision-maker is not engaged in active treatment.
* Be on dialysis (either acute or chronic) or need dialysis imminent at the time of enrollment.
* Patients with known HIV infection.
* Patients with a known or suspected history of nephropathy due to oxalate or hyperoxaluria, scurvy, chronic iron overload, deficiency by G-6PD.
* Patients with known hemochromatosis.
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions

The objective of this study was to prove the bioequivalence of Valacyclovir Hydrochlorothiazide Caplet under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to valacyclovir hydrochloride or any comparable or similar product.
Examining the Effectiveness of a Group Cognitive-behavioural Treatment Program for Persistent Genital Arousal Disorder

This study seeks to provide information regarding the effectiveness of a virtual, synchronous cognitive behavioural therapy (CBT) group program for women with Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia (PGAD/GPD). The program consists of 8 weekly sessions of two hours each, which focus on education and understanding, and learning skills and strategies to manage PGAD/GPD symptoms, and related mental health and lifestyle impacts, as well as structured opportunities for discussion and shared reflection. The group therapy program involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT). Participants in the present study will provide responses to online surveys (before, during, and immediately after treatment, also 3 and 6 months after treatment) regarding their PGAD/GPD symptoms, mental health symptoms, and sexual wellness (sexual pleasure and distress).


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* fluent in English
* have a physician-based diagnosis of PGAD/GPD
* reside in Ontario, Canada
* be comfortable answering questions about their health (mental and physical) and sexuality in online surveys
* be comfortable discussing their mental and physical health and PGAD/GPD symptoms in group online therapy sessions with video on

Exclusion Criteria:

* under the age of 18 years
* nonfluent in English
* lack of physician based diagnosis of PGAD/GPD
* not comfortable with answering questions about mental, physical, sexual health
* not comfortable with discussing mental and physical health and PGAD/GPD symptoms in group online therapy sessions with video on
* mental or physical health conditions that preclude involvement in group therapy
Anticholinergic Deprescription in Schizophrenia

In this study, the investigators will examine whether a deprescription of unnecessary anticholinergic drugs (benztropine or trihexyphenidyl) can augment quality of life, functioning, and neurocognition in individuals who with schizophrenia. Individuals identified by clinical services who have unneeded prescriptions benztropine or trihexyphenidyl will be eligible for deprescription and study entry. Following a baseline evaluation and magnetic resonance imaging (MRI), participants will will be randomized to either staying on their anticholinergic drugs or undergoing deprescription per routine clinical care, and will undergo follow-up evaluations across 6 months. The investigators predict that reducing and deprescribing these drug, if clinically determined to be unnecessary will will enhance functioning, neurocognition


Eligibility Criteria:
Inclusion Criteria:

1. Primary DSM-defined diagnosis of schizophrenia or schizoaffective disorder verified by the Structured Clinical Interview for DSM-5 (SCID).
2. Prescription of benztropine or trihexyphenidyl for at least 6 months
3. Age 40-70 years.
4. ACBS score \>= 3.
5. Mild or absent extrapyramidal symptoms (Determined by clinical pharmacists and prescribers).
6. Competency and willingness to sign informed consent.

Inclusion criteria for the healthy control group:

1. Age 40-70 years.
2. Competency and willingness to sign informed consent.

Exclusion Criteria:

1. Serious anticholinergic side-effects (e.g., fever, blurred vision) indicative of a need for immediate removal of anticholinergics,
2. Serious neurologic or medical condition/treatment that impacts the brain and Neurodegenerative conditions such as Parkinson's, dementia, etc.; autoimmune conditions such as Multiple Sclerosis (MS) and lupus; as well as traumatic brain injury (TBI).
3. Significant risk of suicidal or homicidal behavior.
4. Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent.
5. Contraindications for MR imaging (e.g., a pacemaker).
6. Current SCID-verified substance use disorder will be excluded to avoid the confounding impact of significant substance use comorbidity. Participants with a history of substance use disorder that is in early or full remission will be eligible, to enhance generalizability.
7. Patients concurrently treated with electroconvulsive therapy will be excluded because of its effects on cognition.

Exclusion criteria for Healthy Control (HC) subjects:

1. No history of psychotic illness and no active Axis I disorder as determined by clinical interview using the SCID-NP.
2. Score greater than 1 on the ACB scale.
3. MR imaging contraindications.
4. Neurologic conditions, any serious non-psychiatric disorder that could affect brain functioning, or intellectual disability.
5. HC with family history of psychosis will be excluded, as such individuals show subtle, but significant cognitive and neurobiological abnormalities.
6. Individuals currently taking anticholinergic medications for reasons other than SSD.
Registry For Patients Treated With BeneFix In Usual Care Setting In Germany

The purpose of this observational study is to describe the incidence of adverse events among patients treated with BeneFix® in usual health care settings in Germany.

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

Eligibility Criteria:
Inclusion Criteria:

* Patients with hemophilia B already receiving or starting treatment with reformulated BeneFIX®.

Exclusion Criteria:

* Patients with hemophilia B treated with a product other than BeneFIX®.
* Inclusion in the ongoing prospective registry of European hemophilia B patients using BeneFIX®.
Study of Cytrix Use in Pelvic Floor Prolapse Treatment

To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the treatment of pelvic organ prolapse.


Eligibility Criteria:
Inclusion Criteria:

* Female \>30 years of age
* Willing and able to comply w/ the study procedures and provide written informed consent to participate in the study.
* Diagnosed with pelvic organ prolapse with or without pelvis floor dysfunction
* Patient is willing to complete PFDI-SF20 and PISQ-12 questionnaires at 6 and 12 months post-operatively
* Patient is willing to answer phone questionnaires at 2 weeks, 6 weeks, and 3 months
* Patients with a history of pelvic surgery (cystocele/anterior repair, hysterectomy, vault suspension, etc) prior to this procedure are allowed to participate in the study except if the patient had a dermal graft implanted.

Exclusion Criteria:

* Patients who, in the clinical judgment of the investigator, are not suitable for this study
* Patients who are, in the Investigators opinion, mentally or legally incapacitated preventing informed consent or unable to read or understand written material.
* Patients who have participated in an investigational study within 30 days of study entry that may impact analysis of this device or have previously participated in the current trial
* Patient whose pelvic organ prolapse is Stage I
* Patient with Diabetes Mellitus type I or II
* Patient with morbid obesity (weight parameters determined by physician)
* Patient with undiagnosed pelvic mass outside of the uterus (not expected to be functional in nature)
* Patient with unexplained abnormal menstrual bleeding
* Patient with any acute or chronic infection (kidney, bladder, lung, etc)
* Patient with coagulopathy
* Patient participating in other investigational device or drug study
* Patients must not be pregnant
* Patients with life expectancy less than 2 years
* Patients with known or suspected hypersensitivity to collagen or bovine products
* Patients with preexisting local or systemic infection
* Patients with a history of soft tissue pathology where the implant is to be placed
* Patients with any pathology that would limit the blood supply and compromise healing
* Patient diagnosed with autoimmune connective tissue disease
Small Cell Lung Cancer Community Engagement to Eliminate Research Discepancies

This study will evaluate if a direct-to-patient, de-centralized, remote approach will improve clinical research outreach and engagement for patients with SCLC, in the context of a bio-specimen collection study. The study will also assess self-reported preferences and needs of patients with SCLC, regarding choosing and accessing novel therapies in research or standard clinical care settings and supportive gaps in this area, through an initial and 3 month follow up survey.

This is a non-interventional, non-treatment, non-randomized, single coordinating center, study to determine the feasibility of decentralized bio-specimen collection in USA-based adult subjects with SCLC, to be conducted in conformance with Good Clinical Practices. Potential study subjects will be referred to contact staff through a dedicated study webpage form or dedicated study phone hotline at the coordinating center (ALCMI) who will handle informed consent, coordinate remote blood sample collection with study subjects, and collect medical records to confirm diagnosis and treatment history. Subjects will also be asked to complete a baseline and follow up questionnaire/survey documenting their self-report diagnosis, treatment history, factors impacting care and quality of life, and needs/preferences regarding supportive resources.

Patients who have been diagnosed with either extensive stage primary SCLC or patients diagnosed with primary NSCLC who experienced histological "transformation" with a SCLC component after initial diagnosis and subsequent treatment (transformed SCLC; tSCLC) will be invited to volunteer for this study.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women greater than or equal to 18 years of age at the time of consent
2. Ability to read, write and communicate in English
3. Provide voluntary consent to participate in this study, documented via a signed informed Consent Form (ICF)
4. Willing to provide clinical and medical information related to his/her cancer diagnoses to the study team as required
5. Willing to comply with the requirements of the study
6. Diagnosis of extensive stage primary SCLC or tSCLC

Exclusion Criteria:

1. Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements
2. Subjects who previously enrolled to this study

Note: Concurrent enrollment in other clinical trials is NOT exclusionary
X-ray Dose Reduction in Electrophysiology

Allura Clarity is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly. This is realized by anatomy-specific optimization of the full acquisition chain (grid switch, beam filtering, pulse width, spot size, detector and image processing engine) for every clinical task individually. Furthermore, smaller focal spot sizes and shorter pulses are used, which are known to positively influence image quality .

The primary aim of this study is to verify if a significant reduction in total procedural X-ray dose during electrophysiological interventions can be achieved by using advanced image processing (Allura Clarity).

X-ray dose and image quality are related by laws of physics. Low dose and high image quality cannot be achieved at the same time. However, image processing algorithms can help an x-ray system to acquire images with lower dose without influencing image quality or achieving higher image quality with equal dose.

In order to introduce a dose reduction technology the most important aspect is to validate the diagnostic image information. Philips has developed a new algorithm that is capable to process images with similar image quality but acquired at lower dose.

Eligibility Criteria:
Inclusion Criteria:

* Patients with heart rhythm disturbances undergoing an interventional treatment for their heart rhythm disturbance
* Patients who are allowed, able, willing to and have provided informed consent
* Patients to be treated with ablation for atrial fibrillation (paroxysmal, persistent or permanent), atypical atrial flutter or patients to be treated with ablation for ischemic or non-ischemic ventricular tachycardia
* Patients who are treated in heart catheterization room 5 (HCK5) of the Catherina Hospital

Exclusion Criteria:

* Patients under 18 years of age.
* Patient who are pregnant or breast feeding.
Postural Training Device (UPRIGHT) for Back Pain

Participants with low back pain who are referred for physical therapy will be randomized to routine physical therapy or routine physical therapy plus receiving a postural training device

Participants with low back pain who are referred for physical therapy will be randomized to routine physical therapy or routine physical therapy plus receiving a postural training device.

Physical therapy will be completed 1-2 times per week over 4-6 weeks. If randomized to the group that also receives a postural training device, one of the physical therapy sessions will instruct the patient on use of the device, which can be used thereafter as tolerated by the patient.

At 6 weeks and 3 months, questionnaires that assess patients pain and function will be completed to assess outcomes

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, and capable of attending all planned therapy sessions
* Primary complaint of lumbar or thoracic pain thought to be at least in part due to mechanical/postural etiologies based on clinical presentation
* 7 day average numeric pain rating score (NPRS) of at least 4 on a 0-10 scale at baseline evaluation
* Pain duration of at least 2 months
* Patient owns and is familiar with the use of a personal smart phone
* Patient consents to treatment with postural based physical therapy. In order to maintain blinding, patients will not be provided with details of the treatment plan until after the randomization process has been performed. They will only be informed of the treatment protocol for the group to which they have been assigned.

Exclusion Criteria:

* \*History of prior thoracic or lumbar fusion surgery

  * Acute Spine fracture
  * Current pregnancy
  * BMI over 40
  * Inability to sense UPRIGHT vibration
  * Active Systemic inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing spondylitis, lupus)
  * Medical conditions causing significant functional disability (e.g. stroke, spinal cord injury, amputation)
  * Severe Chronic widespread pain or somatoform disorder (e.g. fibromyalgia)
  * Severe clinical depression, or psychotic features
  * Implanted electrical medical device (i.e. cardiac pacemaker/defibrillator, spinal cord stimulator, bladder stimulator)
  * Allergic skin reaction to tapes or adhesives
  * Worker's compensation claim or legal action related to the thoracic or lumbar pain
  * Patients unable to read English and complete the assessment instruments
  * Patients unable to attend assigned physical therapy sessions
  * Incarcerated patients