cyrilzakka/clinical-trials huggingface dataset:
WavSTAT® Optical Biopsy System to Target Esophageal Biopsies

The purpose of this study is to demonstrate the clinical utility of the WavSTAT Optical Biopsy System as an adjunctive tool to improve the endoscopist's clinical sensitivity to identify dysplasia or cancer in the esophagus.

In the clinical portion of this prospective study, the algorithm developed in the preclinical evaluation will be blindly tested using the pathologists' assessment of the biopsies as a gold standard to determine the clinical sensitivity and specificity of the WavSTAT Optical Biopsy System to identify dysplastic or cancerous tissue in the esophagus. In addition, the endoscopist's unaided clinical sensitivity and specificity to identify dysplasia or cancerous tissue will also be determined by recording the endoscopist's visual assessment of whether the physical biopsy has dysplasia or cancer or does not have dysplasia or cancer prior to performing the biopsy The endoscopist's assessment will be correlated and compared with the pathologist's interpretation. The clinical utility of the WavSTAT System to improve the endoscopist's clinical sensitivity to identify dysplasia or cancer in the esophagus will be evaluated by testing the hypothesis that the sensitivity of a WavSTAT-assisted endoscopic examination improves that of standard endoscopy alone.

Eligibility Criteria:
Inclusion Criteria:

* The patient is between 18 and 80 years of age.
* The patient is willing to sign an informed consent form.
* The patient is a candidate for endoscopic examination
* Female patients of child-bearing age, uncertain of pregnancy status, must have a negative pregnancy test.

Exclusion Criteria:

* The patient has congenital deformities, which preclude a physical biopsy procedure during endoscopy.
* The patient is pregnant or nursing by admission.
* The patient has other contraindications for physical biopsy.
Artificial Intelligence in Functional Imaging for Individualized Treatment of Head and Neck Squamous Cell Carcinoma Patients

The two curative treatment modalities for patients with HNSCC - primary chemoradiation (CRT) or primary surgery (often combined with postoperative (C)RT) - are both associated with serious side effects for which reason further stratification, optimization and personalization of treatment is urgently needed. As novel quantitative image analyses are a promising tool for further risk stratification, the investigators training a three-dimensional Convolutional Neural Network on 18F-Fluorodesoxyglucose (FDG) positron emission tomography (PET) imaging and clinical / histopathological data of a multicentric, retrospective cohort of 1200 patients treated with primary CRT and 800 patients treated with primary surgery at Charité and cooperation institutes in order to predict individual treatment-specific outcomes and identify patients with excellent outcome after primary CRT or primary surgery or unfavorable outcome for both. The trained algorithm of the artificial intelligence will be validated in a prospective trial to see if predicted loco-regional control and recommended treatment strategies are reliable. In total 250 curative HNSCC patients, treated with CRT or primary surgery, will be enrolled on this prospective validation trial with observational character, while biomarker, clinical and FDG-PET data are collected from these patients and follow-up visits will be concluded.


Eligibility Criteria:
Inclusion Criteria:

* All patients older than 18 years with diagnosed HNSCC, attending the Department of Radiooncology and Radiotherapy or the Department of Oral and Maxillofacial Surgery at Charité for a treatment with curative intension ( R(C)T or primary surgery / combined).
* All patients received as pretherapeutic diagnostic method a 18F-Fluorodesoxyglucose (FDG) positron emission tomography (PET) imaging

Exclusion Criteria:

* Patients with HNSCC who cannot be treated in a curative approach
* Patients with HNSCC treated in a curative approach but unable to receive FDG PET imaging before start of treatment
* Data from patients who have withdrawn their study consent
Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST)

This implementation study aims to evaluate the efficacy, acceptability, and safety of first-trimester screening and prevention for preterm-preeclampsia. It is a multicenter stepped wedge cluster randomized trial including maternity / diagnostic units from ten regions in Asia. The study involves a period where no intervention will take place at all recruiting units, and then at regular intervals, one cluster will be randomized to transit from non-intervention group to intervention group in which first-trimester screening for preterm-preeclampsia by the Bayes based method followed by the commencement of low-dose aspirin in high-risk women.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy;
* Live fetus;

Exclusion Criteria:

* Multiple pregnancy;
* Major fetal defects identified at 11-13 weeks of assessment;
* Non-viable fetus (missed spontaneous abortion or stillbirth).
Precision Feedback to Improve Health Care Quality

This cluster-randomized trial will assess the effectiveness of a precision feedback service on anesthesia provider performance. The precision feedback service enhances a standard audit and feedback (A\&F) email with a brief message and visual display about high-value performance information. The control arm will receive a standard "one size fits most" A\&F email that is currently sent to anesthesia providers each month. Hypothesis: Providers receiving precision feedback will increase a) care quality for improvable measures and b) email engagement (click-through and dashboard login rates) when compared with providers receiving standard A\&F emails. The study investigators will assess unintended consequences in a mixed-methods process evaluation.


Eligibility Criteria:
Inclusion Criteria (assessed before interventional period):

* Participation in the Multicenter Perioperative Outcomes Group (MPOG) provider feedback email program.

Exclusion Criteria (assessed after interventional period):

* Ended participation in the MPOG provider feedback email program for any reason during the study period
* Changed professional roles (e.g. transitioned from resident to attending) before the end of the intervention period
* Changed institutions during the study period
* Had no institution-selected quality measures in common between the pre-intervention and intervention period
* Were not candidates to receive a precision feedback email for the majority of the trial.
Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease

The purpose of this study is to determine the effectiveness of cardiac shock wave therapy (CSWT) for the treatment of severe coronary artery disease (CAD) in a Chinese cohort.

This study was approved by the Institutional Review Board and Ethics Committee of 1st Hospital of Kunming Medical University, and all study subjects signed informed consent for participation in the study and all treatments performed. Subjects were patients who were hospitalized at Department of Cardiology of our hospital from December 2008 to December 2009.

Patients were eligible to be included in the study if they met any of the following criteria: 1) Coronary angiography (CA) or multi-slice CT coronary angiography (CTCA) suggestive of moderate to severe coronary artery stenosis. 2) Chest tightness, onset of shortness of breath, and poor exercise tolerance after receiving formal drug treatment (with or without stent or bypass graft). 3) Hospitalized more than 2 times within 1 year due to the aforementioned problems. 4) CCS angina grading higher than grade II, and NYHA functional classification of I-III. 5) More than 1 month after acute myocardial infarction (AMI) and more than 2 weeks after PCI surgery. The diagnosis and treatment in all the patients was in accordance with the related domestic and European guidelines developed in 2007

Eligibility Criteria:
Inclusion Criteria:

* coronary angiography or multi-slice spiral ct coronary angiography suggestive of moderate to severe coronary artery stenosis.
* Chest tightness, onset of shortness of breath, and poor exercise tolerance after receiving formal drug treatment with or without stent or bypass graft).
* Hospitalized more than 2 times within 1 year due to the aforementioned problems.
* Canadian Cardiovascular Society angina grading higher than grade II, and New York Heart Association functional classification of I-III.
* More than 1 month after acute myocardial infarction (AMI) and more than 2 weeks after PCI surgery. The diagnosis and treatment in all the patients was in accordance with the related domestic and European guidelines developed in 2007.

Exclusion Criteria:

* Acute myocardial infarction or coronary artery bypass graft within the 4 weeks prior to the study.
* History of heart transplantation.
* History of metal valve replacement surgery.
* Intracardiac thrombus.
* Left ventricular ejection fraction \< 30% and unstable hemodynamics.
* Arrhythmia with a rate \< 40 bpm or \> 120 bpm.
* Skin ulceration or infection in the treatment area.
* Severe obstructive lung disease.
Robotic Rehabilitation Vs Occupational Therapy Chronic Stroke Upper Limb Rehabilitation

The functional recovery of the upper limb represents a critical element in post-stroke rehabilitation; hemiplegic/hemiparetic patients who achieve optimal recovery are a minority, and incomplete recovery has relevant consequences both on functioning and on quality of life of those who survive a stroke. The project aims to assess the effects on the functional recovery, with manual dexterity as the primary outcome, of a treatment protocol using an innovative tool (Gloreha Sinfonia) that enables assisted execution of three-dimensional tasks combined with Serious Games for cognitive stimulation, targeting the functional recovery of the upper limb in patients with stroke outcomes at least 6 months after the acute event (chronic phase). Patients with residual dysfunction of the upper limb, at least 6 months after the stroke, will be randomly assigned to the Robotic Rehabilitation group (ROBOT), the Occupational Therapy group (OT), focused on the use of the upper limb in functional tasks (task-oriented training), or the control group (CT - prescription of a home exercise program). Patients in the ROBOT and OT groups will undergo a total treatment period of 5 weeks, with 3 sessions per week lasting 1 hour, for a total of 15 sessions/hours of treatment. Patients assigned to the CT group will undergo an initial functional assessment required for defining the exercise program. All patients will be evaluated at baseline (T0), at a 5-week interval (T1), and 6 months after the end of treatment (T2). Outcome indicators include measures of manual dexterity/upper limb performance, anxiety/depression, cognitive abilities, and patient-perceived outcomes. The analysis of Surface Plasmon Resonance imaging (SPRi) of serum exosome content, detected at T0, T1, and T2, will be correlated with variations in functional measures to verify the hypothesis that induction of neuroplasticity underlies any observed changes. Short- and medium-term effects on functional, psychological outcomes, as well as indicators of neuroinflammation and neural regeneration from serum analysis using innovative SPRi, will be compared among the 3 groups.


Eligibility Criteria:
Inclusion Criteria:

1. First ischemic or hemorrhagic stroke occurring at least 6 months prior.
2. Persistent motor deficit in the affected upper limb (Motricity Index between 18 and 77).
3. Willingness to participate in the study, with the provision of informed consent.

Exclusion Criteria:

1. Severe spastic hypertonia at the wrist and fingers (Modified Ashworth Scale equal to or greater than 3).
2. Orthopedic, rheumatological, and/or peripheral nervous system disorders affecting the paretic upper limb.
3. Neurodegenerative and neuromuscular disorders.
4. Acute pathologies affecting other body systems.
5. Severe cognitive, language, and behavioral disorders that significantly limit understanding and participation in the planned activities.
A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters

The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.


Eligibility Criteria:
Inclusion Criteria:

1. Has a competent, adult caregiver(s) who is able to recognize and observe the subject's seizure cluster episodes
2. Has an established diagnosis of partial or generalized epilepsy that includes all the following:

   * A documented history of seizure clusters lasting a minimum of 10 minutes, seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any)
   * A second seizure in the seizure cluster typically occurs within 6 hours from the time of recognition
   * A seizure cluster pattern composed of multiple (≥ 2) partial or generalized seizures
   * A seizure cluster pattern established \>3 months before Visit 1
   * A frequency of ≥ 3 stereotyped seizure clusters during the year before Visit 1
   * At least 1 stereotyped seizure cluster occuring ≤ 4 months before Visit 1
3. Currently on a stable regimen of AED(s) that includes a benzodiazepine
4. Weight is 40 kg to 125 kg, inclusive

Exclusion Criteria:

1. Has a neurological disorder that is likely to progress in the next year
2. Has a severe chronic cardio-respiratory disease
3. Has a psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
4. Has a history of their stereotypical seizure cluster progressing to status epilepticus within 2 years before Visit 1
5. Has a history of acute narrow-angle glaucoma
6. Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.


Eligibility Criteria:
Key Inclusion Criteria:

* Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry \[IHC\]), HER2-negative \[IHC = 0 or 1, or (IHC = 2 and in situ hybridization \[ISH\]-negative)\] on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
* Participants considered at high risk of recurrence at initial staging
* Participants who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i)
* Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments.

Key Exclusion Criteria:

* Participants with inflammatory breast cancer
* History of any prior (ipsilateral and/or contralateral) invasive breast cancer
* Participant with history of malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
* Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who discontinued adjuvant endocrine therapy more than 6 months prior to randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
An Observational Study of Valcyte (Valganciclovir) in D+/R- Liver Transplant Recipients

This retrospective review will evaluate the efficacy of Valcyte (valganciclovir) in preventing Cytomegalovirus (CMV) disease in D+/R- liver transplant recipients. Data from eligible patients will be collected for the 6 months following transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Liver transplant recipients, \>/= 16 years of age
* Transplantation between January 2004 and June 2009
* CMV seronegative recipient (R-) who received a liver transplant from a seropositive donor (D+)
* Valganciclovir therapy for at least 70 days beginning within 10 days post transplantation
* Assessment of CMV disease status within the first 6 months post transplantation

Exclusion Criteria:

* None
Conservative Management for PAS Pilot

Conservative in situ management is a promising alternative treatment to hysterectomy for patients with placenta accreta spectrum and may be safer and preferable for some patients. This study will assess feasibility of a future randomized clinical trial comparing these treatments and provide novel data to inform shared decision-making and cost-effective care for patients with this deadly pregnancy disorder.

Placenta accreta spectrum (PAS) is an extremely morbid and increasingly common pregnancy condition that often results in massive obstetric hemorrhage. The standard treatment in the United States is hysterectomy, but this treatment is complex, morbid, and costly. A promising alternative for PAS treatment is conservative in situ management (CM), a strategy in which the placenta is left in the uterus. Unfortunately, there are insufficient data available to compare outcomes of these two treatments because past studies are limited by non-randomized study designs, minimal inclusion of patient values in making treatment decisions, and nominal consideration of economic barriers to care. A large clinical trial comparing PAS treatments is needed. But there are key logistic barriers to an adequately powered trial, including questions of whether patients will enroll and adhere to randomization allocation. This pilot trial will evaluate the feasibility of randomizing patients to CM versus hysterectomy for PAS.

While pilot studies cannot make final assessments of safety and efficacy between interventions, safety and efficacy will be monitored, including those related to hemorrhage, transfusion, infection and re-operation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* History of cesarean delivery AND placenta previa OR anterior low-lying placenta AND suspected of having PAS on prenatal imaging (ultrasound/MRI)
* Patients who would typically be recommended for hysterectomy
* Planned delivery between 34w0d and 36w0d gestation.

Exclusion Criteria:

* Plan to delivery before neonatal viability (\<24 weeks gestation)
* Hospitalized for antenatal hemorrhage
* Have a low antenatal suspicion for PAS based on imaging
* Are pregnant with multiples (twins, triplets)
* Have a uterine fetal demise
Diagnostic of Iron Deficiency by Means of Non Invasive Measurement of Zink Protoporphyrin IX

ZnPP is being build in the case of a functional iron deficiency. Zinc instead of iron is implemented into protoporphyrin IX. This ZincProtoporphyrin (ZnPP) can be detected non invasively. Non invasive and invasive optical measurement of ZnPP will be compared. Additionally ZnPP measurements will be compared to other iron deficiency parameters for validation by the investigators.

Zinc-protoporphyrin (ZnPP) will be measured by a fluorescence technique. Restricted wave light (407/425 nm) is used to detect ZnPP in the bloodstream non-invasively through the oral mucosa. The spectroscopic measurements are translated into a ZnPP value (mumol/mol heme).

The non-invasive measurement of ZnPP is validated and compared to optical measurement of ZnPP in whole blood and high performance liquid chromatography (HPLC) measurement of ZnPP in whole blood.

The ZnPP value is compared to other iron-deficiency parameters: Ferritin, Transferrin saturation and soluble Transferrin receptor.

Eligibility Criteria:
Inclusion Criteria:

* Patients seen preoperatively in the Anesthestic clinic
* Patients \> 18 years of age
* Understood and signed patient consent

Exclusion Criteria:

* transfusion of blood products 8 weeks prior to screening
* Pregnancy
* Porphyria
The Relation Between Oral Hygiene and Microbial Load in the Oral Cavity After Restoring Primary Molars with Two Types of Ready-made Crowns

Following the restoration of primary molars with stainless steel and bioflex crowns, an evaluation of the current state of oral hygiene in relation to the amount of microorganisms and gingival health in the oral cavity will be carried out.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged between 4 and 8 years.
* Pulp therapy treated primary molars on the contralateral side, requiring a full coverage restoration (split-mouth technique).
* No history of any antibiotic consumption 2 weeks before the procedure.
* No history of fluoride application 2 weeks before the procedure.

Exclusion Criteria:

* Special children with physical disabilities or emotional disturbances.
* Children are diagnosed with systemic diseases.
* Grossly destructed teeth with non-restorable crown structure.
* Primary teeth with shedding or pathological tooth mobility.
An Escalating Dose Indomethacin for the Treatment of Persistent Patent Ductus Arteriosus (PDA) In Preterm Infants

A large patent ductus arteriosus (PDA) is associated with congestive heart failure, pulmonary hemorrhage, chronic lung disease (CLD), necrotizing enterocolitis (NEC) and intraventricular bleeding. Indomethacin is the first line of treatment for PDA. Failure of ductal closure with the first course of indomethacin is reported in 30-40% of infants, with a higher failure rate in infants weighing \< 1000 gm. PDA ligation is associated with early postoperative hypotension, oxygenation failure and adverse neurodevelopmental outcome in preterm infants. The use of escalating doses of Indomethacin in the treatment of persistent PDA was found to be safe and decreased the need for PDA ligation without adverse effects in one observational study.We hypothesize that the use of an escalated dose of intravenous indomethacin will result in an increase in the probability of survival without need for surgical ligation of PDA as compared to a standard dose indomethacin in newborn infants \< 29 weeks of gestational age with persistent PDA.

This study is a randomized control trial.Those eligible infants will be randomized to either a Standard Dose group or to Escalating Dose indomethacin group after obtaining parental consent. The infants randomized to the standard dose group will receive indomethacin (0.1 mg/kg) at 24 hr intervals for 5 days. Escalating Dose group infants will receive indomethacin (0.2 mg/kg/dose) at 12 hr intervals for 2 doses, followed by indomethacin (0.3 mg/kg/dose) at 12 hr interval for 2 doses, then Indomethacin (0.4 mg/kg/dose) at 12 hr interval for 2 doses, increased to indomethacin (0.5 mg/kg/dose) at 12 hour interval for 2 doses and finally indomethacin 0.6 mg/kg/dose at 12 hourly interval for 2 doses. To keep the study blinded, the standard group will receive 5 extra doses of normal saline infusion of similar volume at 12 hrly intervals between the indomethacin schedules to match the Escalating dose Indomethacin Schedule. Daily Echo will be performed and if the Echo showed closure of PDA after 3 days of assigned treatment, no further indomethacin will be given in both the groups.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with gestational age \< 29 weeks and/or birth weight \< 1251gm
* Presence of PDA after completion of first course of indomethacin

Exclusion Criteria:

* Infants with PDA dependent congenital heart disease
* Chromosomal or major congenital anomalies
* Infants in whom use of indomethacin is contraindicated.(i.e.infants with acute renal failure,necrotizing enterocolitis,severe thrombocytopenia (platelet count \< 60,000/ mm3) and evidence of clinical bleeding (pulmonary bleeding, severe intraventricular bleeding grade 3\&4)