cyrilzakka/clinical-trials huggingface dataset:
Prospective Trial of Serial CT Imaging for Evaluation of Dosimetric/Volumetric Changes During IMRT for Head/Neck Cancer

Anatomical changes that take place during Intensity modulated radiation therapy (IMRT) treatments for cancers of the head and neck cause significant dosimetric changes.

The investigator's hypothesis is that those patients with bulky head and neck cancers who undergo definitive radiation therapy with or without chemotherapy have changes in their dose distribution that lead to significant changes in dose to tumor and/or normal tissue. It is possible for these dosimetric changes could occur in either those patients who undergo resection or not. In this study those patients who have undergone a resection will be stratified separately for analysis, however, this study is not powered to detect a difference between the two groups. The rational for stratification into an operated group of patients is that these patients will also lose weight in treatment and will provide us a detection of the magnitude of change in dose caused by weight loss independent of tumor shrinkage.

Eligibility Criteria:
Inclusion Criteria:

* AJCC pathological stage I-IV cancers of the head and neck meeting the following criteria:

  * If gross total resection is performed it must be completed within 7 weeks of registration
* Site of tumor origin in the nasopharynx, oral cavity, oropharynx, parotid, larynx, or hypopharynx (excluding lip, or sinuses)
* Pretreatment evaluations required for eligibility include:

  * History and physical examination within four weeks prior to study entry
  * Dental evaluation with management according to the guidelines in Appendix IV prior to start of radiation
  * Serum pregnancy test, if applicable, within one week prior to study entry; urine dipstick test on the first day of treatment
  * Radiographic Studies: Pre-operative CT or MRI of the primary tumor and neck for clinical staging is required
* Patients must be ≥ 18 years of age.
* Women of childbearing potential (WOCBP) must be willing to consent to using effective contraception while on treatment.
* Pregnant women are ineligible as radiation therapy involves unforeseeable risks to the embryo or fetus. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[hCG\], or in accordance with local regulations, whichever is more sensitive).
* Patients must sign a study-specific informed consent form prior to registration.

Exclusion Criteria:

* Histology positive for melanoma.
* Gross (visible or palpable) disease left after surgery.
* Less than gross total resection or patients requiring staged surgery.
* Prior head and neck radiotherapy.
* Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy Participants

The purpose of this study is to demonstrate the bioequivalence between lorcaserin XR tablets manufactured in Kawashima and lorcaserin XR tablets manufactured in Zofingen.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking, healthy participants at the time of informed consent.
* Body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m\^2) (inclusive) at Screening.

Exclusion Criteria:

* Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing.
* Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing; eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism.
* History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug, cotinine, or alcohol test at Screening or Baseline.
* Participants who contravene the restrictions on concomitant medications, food and beverages.
* Currently enrolled in another clinical study or used any investigational drug or device within 4 weeks preceding informed consent.
* Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing.
Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

The purpose of this study is to examine the efficacy and safety of ursodeoxycholic acid (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP).

In the randomised (double-blind, placebo-controlled) study 20 pregnant women with ICP received (random allocation of) either 450 mg/day UDCA or placebo for 14 days during the third trimester of pregnancy. The severity of pruritus was registered. Itching scores and serum levels of alanine aminotransferase, total bile acids, estradiol, progesterone, prolactin, cholesterol, HDL-cholesterol, triglycerides, activated partial thromboplastin time (APTT), fibrinogen D-dimers (FIDD) and platelet count were assessed before the treatment and weekly thereafter. Data on pregnancy and delivery outcome was recorded and analysed.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with intrahepatic cholestasis of pregnancy
Effect of Epidural Analgesia During Labor on Force of Maternal Push

There are multiple factors that determine progress of normal vaginal delivery. Frequency, duration and strength of uterine contractions are important for progress throughout labor, and abdominal wall muscle contractions contribute to progress during the final stage. Epidural analgesia helps to alleviate the pain associated with uterine contractions, this however this comes at the expense of prolonging labor by reducing the strength of abdominal wall muscle contractions.

The purpose of this prospective study is to quantify how much epidurals decrease the strength of abdominal wall contractions. Intraabdominal pressure will be used as surrogate to strength of abdominal wall contractions, and it will be measured via a foley catheter inserted into the urinary bladder as part of standard procedure for patients receiving labor epidurals. We will compare the change in intraabdominal pressure when patients perform forceful abdominal contractions (valsalva maneuvers) prior to and during epidural analgesia. This will lay the foundation for a future study in which we plan to compare the effects of different epidural analgesia types and concentrations on abdominal wall muscle contractions.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years and older)
* Pregnant women in their third trimester
* Able to read and speak English
* Capacity to consent to participate
* Receiving a labor epidural catheter during their labor and delivery at HFH-Main

Exclusion Criteria:

* Severe cardiac disease
* People who are unable/medically recommended not to perform valsalva maneuvers
* People who are not undergoing labor epidural analgesia
Outreach for Patients That Are Newly Eligible for Colorectal Cancer Screening

The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventative screenings for those patients who, based on national quality standards, have become newly eligible for screening measures. We hypothesize that educational outreach may increase completion rates.


Eligibility Criteria:
Inclusion Criteria:

* Patient of Northwestern Medical Faculty Foundation General Internal Medicine
* Patient has a scheduled appointment with a GIM physician in the next several weeks
* Patient will be 50 years old at the time of this appointment
* Patient is male or female

Exclusion Criteria:

* This is the first time the patient is seen in the NMFF GIM clinic
* There is a prior completion of CRC screening noted in EHR.
* There is a prior order placed for CRC screening in EHR.
* Patient has a history of CRC
* Patient has a diagnosis of ulcerative colitis, inflammatory bowel disease, Crohn's Disease, or documented colectomy.
Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer

The purpose of this study is to test the safety and tolerability of PMD-026 in patients with metastatic breast cancer. PMD-026 is a targeted oral agent designed to kill tumor cells in metastatic breast cancer.

Combination with fulvestrant (Part 3):

This study will prospectively enroll RSK2+, HR+, and human epidermal growth factor receptor 2 negative (HER2-) patients to evaluate PMD-026 in combination with a standard dose and schedule of fulvestrant. Fulvestrant will be dosed per the package insert in combination with PMD-026 at the RP2D determined in the monotherapy phase of the study. Up to 20 patients will be enrolled with locally advanced or metastatic HR+/HER2- breast cancer previously treated with a CDK4/6 inhibitor in combination with endocrine therapy.

Eligibility Criteria:
Inclusion Criteria, Combination with fulvestrant (Part 3):

* RSK2 positive from available archival or fresh tumor tissue (FFPE).
* Histologically or cytologically diagnosed HR+, HER2-
* Diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amendable to resection or radiation with curative intent or metastatic disease not amendable to curative therapy
* Must be appropriate candidates for endocrine therapy
* Previously received at least 1 line of endocrine therapy for MBC or had recurrence while on adjuvant endocrine therapy for locally advanced breast cancer
* Discontinued endocrine therapy at least 15 days prior to first dose of PMD-026
* At least 1 measurable target lesion as defined by RECIST v1.1
* Progression on or after treatment with a CDK4/6 inhibitor in combination with endocrine therapy inhibitor in the locally advanced or metastatic setting
* Adequate hematologic, hepatic, and renal function as assessed by laboratory parameters
* Toxicity related to prior therapy resolved to at least Grade 1 (alopecia excepted) or to at least Grade 2 with prior approval of the Medical Monitor

Exclusion Criteria, Combination with fulvestrant (Part 3):

* ≤14 days from prior chemotherapy, biological or investigational therapy
* Prior fulvestrant in the locally advanced or metastatic setting
* Presence of visceral crisis or uncontrolled visceral disease for which chemotherapy would be indicated
* Central nervous system metastases, unless appropriately treated and neurologically stable
* History of leptomeningeal metastases
* Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
* Known hepatitis B or hepatitis C infection
* Known HIV-positive with CD4+ cell counts \<350 cells/μL
* Known HIV-positive with a history of an AIDS-defining opportunistic infection
* History of clinically significant cardiovascular abnormalities, including QTcF interval \>460 msec (using Fridericia's formula)
Two Narrative Medicine Interventions in Type 1 Diabetes

a randomized prospective study aims at comparing the impact of a "living theater" session with a simple "writing workshop " on emotional distress (Problem Areas in Diabetes Questionnaire PAID) and illness perception ( Illness Perception Questionnaire IPQR) during a 5 day education course

This randomized prospective pilot study aims at comparing the impact of a "living theater" session with a simple "writing workshop " on emotional distress (Problem Areas in Diabetes Questionnaire PAID) and illness perception ( Illness Perception Questionnaire IPQR) during a 5 day education course on Functional Insulin Therapy (FIT). Questionaries at T0 (course day 1 ) and T1 (3 months later). qualitative interviews in a sub group of patients random G1 and G2 subgroup at T1, with a general inductive approach to capture all representations

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes

Exclusion Criteria:

* no french language
Effect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction

Monocentric, prospective, randomised, double-blind study of two parallel groups of 66 patients with post-reconstruction ACL hamstring contracture treated with an ultrasound-guided injection at two points on the body of the hamstring

* Group 1: botulinum toxin: 100 units (0.5ml) in 1 injection
* Group 2: placebo: 0.5 ml in 1 injection

The study includes three assessments: one month after ligamentoplasty (inclusion visit) and then at M2 and M5. The therapeutic benefit of the study treatments is based on the evolution of the extension defect at M2.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patient who has read and signed the consent form for participation in the study
* Patient operated on for primary ACL ligamentoplasty with or without meniscal repair
* Patient with reducible flatus \>10° at 1 month post ligamentoplasty

Exclusion Criteria:

* Revision ligamentoplasty
* Multi-ligament knee
* Patient under court protection, guardianship or trusteeship
* Patient not affiliated to the French social security system
* Patient participating in another therapeutic protocol
* Pregnant woman or woman of childbearing age without effective contraception
* Patient unable to understand the informed information and/or to give written informed consent: dementia, psychosis, disturbed consciousness, non-French speaking patient
* Patient with known hypersensitivity to botulinum toxin
* Patient with peripheral neuromuscular dysfunction or pronounced atrophy of the semitendinosus muscle
* Patient treated with anticoagulants, chloroquine (or hydroxychloroquine)
* Patient treated in the previous seven days with antibiotics or muscle relaxants (such as tubocurarine)
A Study of ET-02 in Patients With Relapsed or Refractory B-cell Malignancy(NHL/ALL)

The purpose of this study is to evaluate the safety and efficacy of CD19-UCART in patients with r/r B-cell hematological malignancies.


Eligibility Criteria:
Inclusion Criteria:

1. Patients volunteer to participate in the study and sign the ICF;
2. Male or female aged≥18 years old；
3. Patient with relapsed or refractory CD19 positive B-ALL orNHL，as evidenced by 2 or more lines of prior therapy ;
4. Estimated life expectancy≥12 weeks ;
5. ECOG performance status ≤1;
6. Adequate organ function.

Exclusion Criteria:

1. Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive therapy；
2. History of central nervous system (CNS) involvement by malignancy；
3. Women who are pregnant or breastfeeding；
4. Any situations that may increase the risk of patients or interfere with the results of study，which judged by investigator.
Apnea Tests as the Methods of Brain Death Diagnosis.

Apnea test (AT) is the most important clinical test performed usually at the end of brain death (BD) diagnosis procedure. Traditional insufflation apnea test (I-AT) cannot be completed in patients with extremely compromised lung function due to rapid blood desaturation and circulatory disturbances. Therefore the investigators decided to verify alternative AT options such as continuous positive airway pressure apnea test (CPAP-AT) in patients with good and poor baseline oxygenation, before implementing them in currently reviewed Polish BD criteria.

Apnea test (AT) is one of the most important examination during the diagnosis of brain death. It is usually performed at the end of each series of clinical examinations during diagnostic process. The most popular standard insufflation apnea test (I-AT) may be potentially harmful. It may cause some serious complications including pneumothorax, severe hypoxemia, hemodynamic instability and even cardiac arrest. Therefore, the investigators decided to analyze apnea test in CPAP option (CPAP-AT) as a new tool. For safety of the study the investigators analyzed a method after BD diagnosis.

Methods:

I-AT and hypoventilation with 100 % oxygen (if needed) were performed according to Polish guidelines. Two hours after BD diagnosis was performed extra apnea test in CPAP option (CPAP-AT). Before CPAP-AT the patients were ventilated 100% oxygen. After then the ventilator settings were changed to CPAP mode with PEEP 10 cm H2O, PS 0 cm H2O, FiO2 1,0, flow 6L/min. Emergency apnea ventilation was turned off. At the beginning of CPAP mode and 10 minutes after, blood samples for arterial blood gases (ABG) were collected. If were observed rapid desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborted and study was finished.

During routine diagnosis of brain death, pupillary dilation after a neck flexion was observed in one case. Therefore, the investigators decided to use a pupillometer during brain death examination to find out how pupils react after a neck flexion and how often it happens.

Pupil measurements were taken immediately after the diagnosis of brain death. The measurements of pupil diameter were taken twice: A - before neck flexion; B - after neck flexion. We used pupillometer: AlgiScan (Equip Medkey BV).

Eligibility Criteria:
Inclusion Criteria:

* brain death diagnosis

Exclusion Criteria:

* no
A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes

The purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.


Eligibility Criteria:
Inclusion Criteria:

* 6 months to 12 years old
* Ear tubes in one or both ears
* Ear drainage visible by the parent / guardian
* Ear drainage less than 21 days
* Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
* Patient may not have non-tube otorrhea
* Patient may not have had otic surgery other than tube placement in the last year
* Patient may not be a menarchal female
* Diabetic patients are not eligible
* Patient may not have any disease or condition that would negatively affect the conduct of the study
* Patient may not require any other systemic antimicrobial therapy during the study
* Patient must meet certain medication washouts to be eligible
* Analgesic use (other than acetaminophen) is not allowed
* Patient may not be pre-disposed to neurosensory hearing loss
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Age related
* Other protocol-defined exclusion criteria may apply
Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Thoracic Aortic Surgery

Postoperative acute kidney injury (AKI) is still one of the serious complications of thoracic aortic surgery, with incidence of 8 to 50 percent. Postoperative AKI significantly increases the morbidity and mortality of patients undergoing thoracic aortic surgery. Previous studies for AKI after DHCA reported confounding results due to different criteria of AKI. Therefore, the investigators tried to evaluate the incidence and risk factors of AKI after thoracic aortic surgery according to the diagnostic criteria and staging system of AKI reported from acute kidney injury network. The investigators also tried to develop a risk model with scoring system of AKI and evaluate the performance of the risk model.

Significant improvement of morbidity and mortality has been achieved during last three decades since developing deep hypothermic circulatory arrest (DHCA). However,postoperative acute kidney injury (AKI) is still one of the serious complications of thoracic aortic surgery, with incidence of 8 to 50 percent. Postoperative AKI significantly increases the morbidity and mortality of patients undergoing thoracic aortic surgery. Previous studies for AKI after DHCA reported confounding results due to different criteria of AKI. Therefore, the investigators tried to evaluate the incidence and risk factors of AKI after thoracic aortic surgery according to the diagnostic criteria and staging system of AKI reported from acute kidney injury network (2007). The investigators also tried to develop a risk model with scoring system of AKI and evaluate the performance of the risk model.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent thoracic aortic surgery during 1994 to 2010 period

Exclusion Criteria:

* patients who had previous renal failure before aortic surgery
Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects approximately 10-20% of women of reproductive age, Management strategies for PCOS include lifestyle modifications such as diet and physical activity that are the first-line approach to treatment; however, they are reported to be minimally effective in reducing weight or treating PCOS-related symptoms.Pharmacological options are also available; however, they are not explicitly approved for PCOS treatment as they have been primarily used to treat other conditions such as T2DM


Eligibility Criteria:
Inclusion Criteria:

-Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.

Exclusion Criteria:

* Patients with history of diabetes mellitus (Type 1 or 2).
* Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months
* Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors
* Eating disorders (anorexia, bulimia) or gastrointestinal disorders
Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial

This randomized controlled trial (RCT) is designed to evaluate the new generation Exalt Model disposable duodenoscope compared to the reusable scope in terms of feasibility, ease of use, adverse events, number of crossover events, and infection rates.

To ensure a safe and high-quality endoscopy, there are multiple disinfection protocols for endoscopes. Side-viewing duodenoscopes with an adjustable accessory device (elevator) contain potential blind spots for debris and bacteria that require specialized cleaning and disinfection methods beyond standard protocols for other endoscopes. It is thought that the duodenoscope's design, persistent postprocedural microbial contamination and biofilm formation make it more prone to cross-contamination5. Gromski et al, found there are documented pathogenic transmissions, which led to harm in multiple patients and centers3. Infection control was likely related to two major components, reusable duodenoscopes and procedural factors related to how the reusable duodenoscopes were reprocessed3. Multidrug-resistant organisms, such as carbapenem-resistant Enterobacteriaceae, that were associated with reusable duodenoscopes lead the FDA to mandate the transition to improved cleaning and disinfection methods or single-use platforms to eliminate infection transmission. One such single-use platform is the Exalt Model D (Boston Scientific, Marlboro, MA), which received FDA approval in 2020 for use of single-use duodenoscopes. Early iterations of the Exalt were used on a case-by-case basis per institution-specific protocols, mainly due to the learning curve involved with using the scope. A new version of Exalt has been released to market in 2023 with modifications that may make it more feasible to use in all settings requiring a duodenoscope. This randomized controlled trial (RCT) is designed to evaluate the new generation Exalt Model disposable duodenoscope compared to the reusable scope in terms of feasibility, ease of use, adverse events, number of crossover events, and infection rates.

Eligibility Criteria:
Inclusion Criteria:

* All patients \> 18 years old who have biliary or pancreatic duct disorder, based on clinical symptoms and radiological findings at CT or magnetic resonance cholangiopancreatography
* Native papilla

Exclusion Criteria:

* Patients with altered pancreaticobiliary anatomy
* Pregnancy
* Patients with percutaneous transhepatic biliary drainage
* Prior history of ERCP
* Inability to provide informed consent