cyrilzakka/clinical-trials huggingface dataset:
Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer

This study seeks to study the population of HPV-related oropharynx cancer patients that appear to be at highest risk for treatment failure with loco-regional failure and distant metastases including cT4 or cN3. The study team aims to determine if it is feasible to use multi-modality imaging (both DCE MRI and FDG-PET) to optimize the radiation boost in high risk p16+ OPSCC with similar or decreased toxicity compared to historic standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have pathologically confirmed, locally/regionally advanced p16+ squamous cell carcinoma of the oropharynx referred for definitive chemo-RT
* AJCC 8 Stage III (cT4 or N3)
* ECOG 0-1 performance status within two weeks of enrollment
* Pre-treatment laboratory criteria within four weeks of enrolment: WBC \> 3500/ul, granulocyte \> 1500/ul. Platelet count \> 100,000/ul. Total Bilirubin \< 1.5 X ULN. AST and ALT \< 2.5 X ULN. Estimated Creatinine clearance \>30cc/min
* Patients must be able to receive protocol chemotherapy in the judgment of the treating Medical Oncologist
* Age \>18
* All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
* Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study.

Exclusion Criteria:

* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
* Patients should have no contraindications to having a contrast enhanced MRI scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Institutional Standard Practice.
* Patients should have no contraindications to having a contrast enhanced PET scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Institutional Standard Practice.
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
* Any prior therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if \> 3 years prior to study;
Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed.

Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Multiple doses of etentamig in combination with iberdomide will be explored. Each treatment arm receives a different dose of etentamig and iberdomide to determine a tolerable dose. Approximately 135 adult participants with R/R MM will be enrolled in the study in approximately 50 sites worldwide.

In phase 1 participants will receive escalating intravenous (IV) etentamig in combination with oral iberdomide. In phase 2 participants will receive IV etentamig at one of two doses in combination with oral iberdomide, as part of the approximately 129 month study duration.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and and monitoring of side effects.

B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) or BCMA antibody-drug conjugate (ADC) are allowed.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance of 0 to 1.
* Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol.
* All participants must have measurable diseases per central laboratory as outlined in protocol

Exclusion Criteria:

* Has received prior etentamig treatment.
* Prior exposure to BCMA-targeted therapy as noted in the protocol.
* Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide).
Novel Stent Placement Technique for Intestinal Stenosis Assisted by an Ultrafine Endoscope

Colorectal cancer is the third most common cancer worldwide and results in 8-25% acute malignant bowel obstruction. Since Dohmoto et al. first applied and reported the self-expanding metal stents (SEMS) in the treatment of colorectal stenosis, they have been widely used not only as an alternative treatment as a bridge to surgery (BTS), but also as a mean of palliative option for stenosing lumen in clinical practice. Numerous publications have reported that the stent placement technique showed 75% to 100% technical success rates and 84% to 100% clinical success rates. However, it is sometimes difficult to place due to the distorted anatomy or acute angulations in patients and other conditions with poor endoscopic visualization with the normal colonoscope. The aims of this study were to present our results with two novel SEMS implantation techniques.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patients with colorectal cancer stenosis
* Patients with intestinal stent implantation in digital subtraction angiography room

Exclusion Criteria:

* Patients undergoing conventional intestinal stent implantation
Transcatheter Aortic Valve Replacement (TAVR) Double Balloon Valvuloplasty

In this study, the investigators evaluate whether routine double inflation of the valve could have a lasting impact. The investigators hypothesize that a routine second reinflation of the balloon, or "double tap", will improve flow across the valve when compared to a single inflation. The investigators hypothesize that "double tap" (1) will decrease mean gradient between first and second inflation during the procedure, (2) will decrease mean gradient on immediate post procedure and 30 day postprocedure echocardiograms when compared to mean gradient gradient after single inflation. Less obstruction indicated by lower mean gradient early after deployment may translate to improved 5 and 10 year outcomes. Furthermore, the investigators hypothesize that this small change in technique will have no effect on procedure time or complications and the change will not result in any increase in perioperative vascular complications, or new permanent pacemaker insertion.

The primary objective of this study is to determine if double valve inflation during a TAVR procedure improves valve area and mean gradients as measured by echocardiogram immediately following the procedure and at 30 days follow up.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age
2. Diagnosis of severe native valve aortic stenosis
3. Meets the standard of care indications to undergo TAVR procedure (aortic valve area \<1.0 cm2 or mean pressure gradient \>40 mmHg or peak velocity \>4.0 m/s or aortic valve area index \<0.6).
4. Provided informed consent.

Exclusion Criteria:

1. History of prior aortic valve replacement
2. Pre-existing moderate to severe aortic regurgitation
3. Lacking pre-procedure echocardiogram
4. Patients planning to undergo multiple valve replacements simultaneously
5. Intraoperative arrhythmia
6. Intraoperative hemodynamic instability
7. Intraoperative complication during initial inflation (such as: aortic dissection, coronary artery occlusion, coronary artery dissection)
8. At the discretion of the principal investigator, any reason that the potential subject may be unfit for participation, such as frailty.
Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients

This study is a multi-center, double-blind, active-controlled, randomized, parallel clinical study to evaluate the efficacy and safety of DA-2803 in chronic hepatitis B subjects


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female subjects of ages in the range over 19
* The subjects HBsAg positive for at least 6 months or has history of Chronic Hepatitis B
* The subjects whose HBV DNA above 20,000 IU/mL when HBeAg positive or above 2,000 IU/mL when HBeAg negative or positive when has history of Chronic Hepatitis B
* The subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent

Exclusion Criteria:

* The subjects who have been infected with HCV, HDV, HIV
* The subjects who have Hemochromatosis, Wilson's disease, autoimmune liver disease, and α-1 antitrypsin deficiency
* The subjects whose α-fetoprotein over 50 ng/mL and who are persumed to be Hepatocelluar carcinoma
Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation

The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.

To compare efficacy and safety between the zonisamide group and the carbamazepine group. The zonisamide group will be divided into 2 subgroups: Slow-titration group and Fast-titration group to find out optimum titration of zonisamide. This study will proceed through 25\~27 weeks.

Eligibility Criteria:
Inclusion criteria:

1. Epilepsy patients over 15 years old.
2. Occurrence of seizure should be more than one time within recent 3 months and more than two times within recent 6 months.
3. Patients who have not taken antiepileptic drugs (AEDs) in recent 3 months.
4. Female who can be in the month of pregnancy should agree to prevent conception.
5. Patients who agree with Informed Consent Form.

Exclusion criteria:

1. Patients who have Myoclonic seizures and/or Absence seizures.
2. Patients who have progressive central nervous system (CNS) disorder.
3. Patients who have serious systemic disorder.
4. Upward of doubled normal serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) level and/or tripled blood urea nitrogen (BUN)/Creatinine levels.
5. Patients who have renal stones.
6. Medical history of medicinal poisoning and/or alcoholism.
7. Patients who have long-term medication history (more than 6 months) of zonisamide and/or carbamazepine.
Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

The study's purpose is to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)


Eligibility Criteria:
Inclusion Criteria:

1. Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at Screening; The duration of the subject's illness must be ≥ 1 year
2. An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response as defined per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the subject
3. Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trial as designed

Exclusion Criteria:

1. Subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the MGH-TRQ-OCD.
2. Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourette's disorder, body dysmorphic disorder, hoarding disorder; or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results
3. Previous treatment in a study with troriluzole
Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients

Objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3 months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.

Hydrocodone combinations are the most commonly prescribed pain medications in the United States. All the current available Hydrocodone formulations are short acting and have Acetaminophen/Ibuprofen in them. Chronic pain patients who take pain medications for extended time are overloaded with Acetaminophen and there is a very serious concern about liver failure from excessive concurrent alcohol use. Also all the current hydrocodone combinations available in the U.S. are short acting and provide pain relief for 3-6 hrs.

Hydromorphone is a metabolite of Hydrocodone and plays a significant role in providing pain relief in these patients. Although there are no long acting or extended release hydrocodone formulations that are FDA approve at this time, there is once a day extended release Hydromorphone (ER) approved by FDA and is currently marketed under the name Exalgo ®. PK study of chronic hydrocodone/acetaminophen usage is important to determine equivalent potency with hydromorphone ER, so that clinicians can use a simple conversion formula to switch to hydromorphone ER.

Although medical professionals use the Opiate conversion formula on a regular basis for Opioid rotation, there are no published studies showing the pharmacokinetic data in patients taking hydrocodone for chronic pain.

Our goal is to use this PK data to guide clinicians with this data in using extended release hydromorphone for chronic pain management to provide predictable pain relief and minimize the acetaminophen usage.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged 18-75
* Documented clinical diagnosis of chronic pain.
* Have been taking hydrocodone/APAP for their chronic non-cancer pain.
* Subjects currently on hydrocodone/APAP must be taking minimal daily dose of 15mg of Hydrocodone for at least 30 days.
* Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

* Subjects who are taking concomitant medications or Nutraceuticals that interfere with Hydrocodone metabolism as listed in Appendix 11 and/or as deemed clinically significant by a pharmacovigilance team that is contracted to monitor and advise.
* Health concerns that the study physician feels may confound study results.
* Individuals who are cognitively impaired or who are not able to give informed consent.
* Previous participation in a clinical research trial within 30 days prior to randomization.
* The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.
Proteiomic Fingerprints of Gastric Juice

No accurate, inexpensive and non-invasive test for gastric cancer screening is currently available. The investigators' recent study identified a1-antitrypsin and other proteins as potential biomarkers of gastric cancer in gastric juice. The aim of this study was to develop a novel non-invasive modality for detecting gastric cancer by measurement of biomarkers in gastric juice.

Patients and methods: The study consisted of two parts: (1) investigating the differences in gastric juice biomarker concentrations between gastric cancer patients and controls, and (2) screening gastric cancer using string test to obtain gastric juice followed by immunoassay for biomarker concentration.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects and gastric cancer patients documented by endoscopy.

Exclusion Criteria:

* the use of proton pump inhibitors or histamine-2 receptor antagonists within 4 weeks prior to the study
* coexistence of two kinds of gastroduodenal lesions
* coexistence of severe systemic diseases
Bandage Contact Lens in Post Operative Ptosis Patients

This study is being conducted to determine whether the use of bandage contact lens after ptosis surgery provides any benefits for the patient or is unnecessary.

This study is being conducted to determine whether the use of bandage contact lens after ptosis surgery provides any benefits for the patient or is unnecessary. The investigators hope to show through questionnaires based on the patient's experience after their surgery to see if the bandage contact lens has provided any benefit for the patient. This is a randomized control trial in which patients undergoing bilateral ptosis surgery (Fasanella servat procedure) will have one of their eyes randomized to receive a bandage contact lens after surgery while the other eye will not receive anything.In this randomized control trial, patients requiring surgery with bilateral ptosis will have one eye randomized to receive a bandage contact lens whereas the other eye will not after their surgery. Follow up will occur in one week where the outcomes will be obtained through questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* patients who have bilateral ptosis (drooping eyelids) and will require surgery to correct this

Exclusion Criteria:

* patient having any other eye related pathologies
Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.

Compare the results of reconstruction and mitral valve replacement in the surgical treatment of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.

Many years myoectomy for Morrow was the gold standard in the treatment of obstructive hypertrophic cardiomyopathy. Currently more retrospective data in the literature about the good results the extended septal myectomy. But the question remains what is best for patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency: use extended myoectomy with mitral valve repair a or replacement.

Eligibility Criteria:
Inclusion Criteria:

* Able to sign Informed Consent and Release of Medical Information forms
* Age ≥ 18 years
* obstructive hypertrophic cardiomyopathy
* surgically significant mitral insufficiency
* II-IV (NYHA),
* average systolic pressure gradient greater than 50 mm Hg. Art. at rest;
* basal or medium ventricular obstruction

Exclusion Criteria:

* Related defect of the aortic valve;
* Organic mitral valve disease (dysplasia, rheumatic fever, infective endocarditis);
* Surgically significant coronary artery lesions;
* Patients requiring implantation of a cardioverter-defibrillator
Immediate Effect of Postural Muscle's Vibrations on Gait in Chronic Vascular Hemiplegia

Balance disorders are very common after strokes and often last for long periods of time. Their origin is multifactorial and their impact on the daily lives of patients are particularly important, especially on gait.

The vibration technology for rehabilitation was already studied in static posture with force plats but their impact on gait have yet to be evaluated.

This present study aims at investigating the effects of vibrations applied by an approved medical device to the posterior neck muscles and the gluteus medius - major actors of proprioception and posture mechanisms - on gait disorders in patients with hemiplegia during the chronic phase after stroke.

An inclusion medical exam will occur in order to explain the protocol to the patients, to receive their written informed consent and to check the inclusion and absence of non-inclusion criteria.

The study visit will happen in a 2 weeks' time span at most after the inclusion exam.

During the study visit, the patients will undergo:

* A quantitative gait analysis with Gait Rite and Optitrack before any intervention;
* Then, in a randomized order:

  * A vibration stimulation on a non-postural muscle (biceps brachii muscle) in order to get a control stimulation (or "sham") with a new gait analysis with Gait Rite and Optitrack during the stimulation, then 2 and 10 minutes after it stopped,
  * A vibration stimulation of the posterior neck muscles on the hemiplegic side, with a new gait analysis with Gait Rite and Optitrack during the stimulation, then 2 and 10 minutes after it stopped. The precise stimulation location will be located by the pressures centre deviation on a medio-lateral axis on a strength platform (this area can vary for a few centimetres from patient to patient),
  * In order to assess the secondary outcome aiming at defining the best stimulation location, a vibration stimulation of the gluteus medius on the hemiplegic side, with a new gait analysis with Gait Rite and Optitrack during the stimulation, then 2 and 10 minutes after it stopped. In the same way than for the neck muscles, the scouting of the precise location will be assessed facing the greater trochanter by the pressures centre deviation on a medio-lateral axis on a strength platform.

The realisation of the entire protocol will last approximately 90 minutes.

At the end of the test, an optoelectronic recording by Optitrack will be realised on a treadmill in order to highlight potential differences between the gait on the ground and trained gait at comfortable speed for 2 minutes maximum.

Eligibility Criteria:
Inclusion Criteria:

Hemiplegic subjects after stroke:

* Men or women aged over 18
* Stroke due to ischemic or haemorrhagic cause
* More than 6 months after stroke
* First episode of stroke
* Gait asymmetry before stimulation
* Able to walk more than 100 meters with or without cane
* Written informed consent

Exclusion Criteria:

* Orthopaedic or rheumatologic disorders impeding the good realisation of the measurement
* Adults under legal protective regimen or deprived of liberty
Effects of Olive Polyphenols in Fibromyalgia Patients

To study the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with FM.

This work has studied the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with FM, analyzing the complete blood count, the biochemical, lipid and coagulation profiles as well as the inflammatory and oxidative statuses in blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Patients to be included in the study must be female over 18 years of age. The patients had to be previously diagnosed with FM according to the criteria of the American College of Rheumatology.

Exclusion Criteria:

* Other chronic diseases: diabetes mellitus, hypertension, cardiovascular disorders, cancer...
* Patients with grade II obesity (body mass index ≥ 35 kg/m2).
* Active smokers.
* Pregnancy.
* Regular treatment with acetylsalicylic acid, estrogen, corticosteroids, antioxidants or lipid-lowering drugs.
* Participation in another research study.