cyrilzakka/clinical-trials huggingface dataset:
Efficacy of the Sit to Stand Test in the Decision to Hospitalize a Patient Consulting the Emergency Dept for COVID 19

As part of the Coronavirus Infectious Disease 2019 (COVID19) pandemic, the hospital care system is facing a major strain. Patients with SARS-Cov2 (severe acute respiratory syndrome coronavirus 2 ) infection can worsen very quickly, possibly presenting, within hours, severe respiratory failure requiring urgent specialized care. Therefore, it is essential to develop emergency assessment tools to assess relevant criteria to decide which patients must be kept under hospital monitoring and which patients can be treated on outpatient care.

The aim of this study is to assess the efficacy of STST in the decision to hospitalize patients consulting emergency department for a SARS-Cov2 infection. The investigators wish to show that the addition of this test to the usual hospitalization criteria reduces the proportion of patients hospitalized 48 hours after their first visit to the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years old)
* Admit to emergency department for suspected SARS-Cov2 infection
* SARS-CoV2 infection confirmed by Real Time Polymerase Chain Reaction (RT - PCR) before the first discharge of emergency department
* Patient affiliated or beneficiary of a health care insurance
* Effective contraception in women of childbearing age. For postmenopausal women, amenorrhea for at least 12 months before the inclusion visit

Exclusion Criteria:

* Patient presenting criteria for admission to intensive care: signs of acute respiratory distress , respiratory rate\> 30 / min, oxygen dependence \> 6L / min on face mask for an SpO2 ≥ 95% or an arterial oxygen pressure \>8kPa, neurological disorders, systolic blood pressure (SBP) \<90mmHg despite fluid resuscitation, lactates\> 2mmol / L, bradycardia, or heart rate disorders
* Patient with SpO2 \<90% in spontaneous ventilation in room air at rest
* Patient with functional impairment or deterioration of the general condition leading to the inability to perform STST
* Patient with a resting SBP\> 180 mmHg or resting diastolic blood pressure (DBP)\> 100 mmHg or resting heart rate (HR)\> 120 / min
* Patient with decompensated or unbalanced cardiac pathology
* Patient previously included in the study following a previous admission to emergency department
* Patient deprived of liberty, unable to consent freely
* Patient non affiliated or beneficiary of a health care insurance
Efficacy and Safety of Dacomitinib in the Treatment of Skin Squamous Cell Cancer

This is an open label, monocentric, uncontrolled phase II trial with Dacomitinib, a pan-HER inhibitor, in unresectable or metastatic skin SCC.

HER2 expression is common in skin SCC, being reported with high rates, even if in small studies.

Coexpression of EGFR, HER2 and HER3 is present in skin SCCs but not in normal skin and it could be associated with the malignant phenotype. In this frame Dacomitinib could play a role in the increase of the response rate.

The patients will assume Dacomitinib 30 mg daily for the first 2 weeks. If the highest skin toxicity will be of grade \<2, then the patients will start dacomitinib at 45 mg once daily and they will be clinically assessed every cycle (i.e. every 28 days).

If the highest skin toxicity will be grade \>2, then the patient will interrupt the treatment following the criteria for dose reduction.

Tumor evaluation will be performed at baseline and every other cycle. Response will be assessed according to RECIST 1.1. The patient will continue to assume the study drug until disease progression, unacceptable toxicity or any medical condition that will suggest to stop the treatment for patient's safety

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent to treatment
* Histological diagnosis of squamous cell carcinoma of the skin not amenable to surgical treatment with curative purposes or with clinical contraindication to surgery (examples of medical contraindications to surgery include but are not limited to: skin SCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely; anticipated substantial morbidity and/or deformity from surgery (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation); anticipated difficulty in obtaining a curative resection due to the location of the tumour, the size of disease; anticipated difficulty in reconstructing the area that will be surgically removed; significant comorbidities that preclude the feasibility of a radical surgery
* Presence of measurable disease according to RECIST 1.1
* ECOG performance status 0-2
* Age≥ 18 years
* For men and women in the fertile period: the use of birth control systems during treatment

Exclusion Criteria:

* Previous treatment with tyrosine kinase inhibitors or monoclonal antibodies directed against EGFR
* Any toxicity CTC grade\> 2 from previous treatments not yet resolved
* Pregnant or breastfeeding
EndoRings Colonoscopy for Adenoma Detection

Adenoma detection rate (ADR) in colon cancer screening is most important for avoiding colon cancer development. Recent studies suggest a benefit of endoscopic devices attached to the distal tip of the colonoscope for improving the ADR. This work is the first GERMAN randomized controlled trial comparing standard colonoscopy with EndoRIngs-assisted colonoscopy.

EndoRings is a new FDA approved device that is attached to the distal tip of the colonoscope. Better Polyp detection is suspected by flattening the mucosal folds during withdrawal


Eligibility Criteria:
Inclusion Criteria:

* indication for colonoscopy (screening, surveillance, diagnostic)
* age ≥ 45 years
* ability to give informed consent

Exclusion Criteria:

* pregnancy
* age \<45 years
* known colonic strictures
* chronic inflammatory bowel disease
* active inflammation
* s/p colonic resection
* bleeding disorder
Perioperative Pregabalin in Ureteroscopy: a Pilot

The investigators propose a pilot clinical trial on the use of perioperative pregabalin in order to decrease ureteral stent related symptoms and decrease opioid usage after ureteroscopy with stent placement. Patients undergoing ureteroscopy with stent placement will receive a single dose of 300 mg pregabalin PO in the preoperative area. This work will assess safety and feasibility of studying this regimen at our institution, with the aim of performing a randomized, placebo-controlled, double-blinded study in the future.


Eligibility Criteria:
Subject Population Undergoing elective ureteroscopy with stent placement by Dr. Murray at University of Missouri Hospital and affiliated facilities

Subject Inclusion

Age \>= 18 years

Subject Exclusion

* Renal insufficiency (eGFR \< 30 mL/minute/1.73 m2)
* Chronic indwelling ureteral stent
* Chronic opioid use
* History of opioid abuse
* Chronic gabapentinoid use
* Plan for inpatient hospitalization
* Pregnancy
* Inability of the patient to consent for themselves in English
* Allergy to gabapentinoid
* Liver failure or hepatic dysfunction
Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens

The purpose of this clinical study is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

Subjects will be expected to attend 4 office visits: Screening/Baseline/Dispense, Week 1 Follow-up, Month 1 Follow-up, and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3-4 months in this daily wear clinical study.

Eligibility Criteria:
Key Inclusion Criteria:

* Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day;
* Manifest cylinder equal to or less than 0.75 diopter (D) in each eye;
* Best spectacle corrected visual acuity (using manifest refraction) of 20/20 or better in each eye;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Habitually wearing Biofinity lenses;
* Monovision or multifocal contact lens wearers;
* Other protocol-defined exclusion criteria may apply.
A Pilot Study of Xifaxan to Treat Patients With PSC

In the current protocol, we propose the assessment of potential beneficial effects of the antibiotic Xifaxan on liver biochemistries, liver related symptoms and Mayo risk score in 15 adult and 5 pediatric patients with PSC. Adult patients will receive Xifaxan, 550 mg twice daily over a 12-week period. Pediatric patients with PSC whose weight is greater than or equal to 40 kg will receive Xifaxan, 550 mg twice daily.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of PSC established by all of the following criteria:

  * Alkaline phosphatase \>1.5 times upper limit of normal for at least 6 months duration
  * Gamma-glutamyl transferase (GGT) \>1.5 times upper limit of normal in pediatric patients
  * Cholangiography demonstrating intrahepatic and/or extrahepatic biliary obstruction, beading, or narrowing consistent with PSC
  * Liver histology in the past (if available for review) with features consistent with or diagnostic of PSC
* Both genders
* Adults: Ages 18-75 years.
* Pediatric: Weight \> 40 kg
* Patient's informed consent for study participation

Exclusion criteria:

* Treatment with systematic antibiotics, Azulfidine, ursodeoxycholic acid, corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, tacrolimus, vitamin E or prednisone in the preceding three months
* Active drug or alcohol use
* Prior history of allergic reaction to the antibiotics which will be used in the study
* Any condition that, in the opinion of the investigator, would interfere with the patient's ability to complete the study safely or successfully
* Evidence of decompensated liver disease such as recurrent variceal bleeding, refractory ascites or spontaneous hepatic encephalopathy
* Anticipated need for transplantation in one year (Mayo survival model \<80% one-year survival without transplant)
* Findings highly suggestive of liver disease of other etiology such as chronic alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's disease, 1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis or secondary sclerosing cholangitis
* Treatment with any study medications in the preceding three months
* Pregnancy or current lactation; subjects becoming pregnant during the study despite all the precautions will be withdrawn and referred to their primary physicians
LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)

LITALHICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable perihilar cholangiocarcinoma (pCCA) after treatment with standard of care chemotherapy, in terms of overall survival and quality of life. Additionally, the study aims to identify pre-transplant biological markers and clinical factors that can stratify patients with the best post-transplant prognosis. Finally, the study aims to investigate the role of preoperative PET-MRI, especially in relation to lymph node locations, by correlating the results with histological examination after hilar lymphadenectomy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pCCA (transcatheter biopsy or brush cytology, CA 19-9 \> 100 mg/mL and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography, or biliary ploidy with a malignant appearing stricture on cholangiography)
* Disease considered unsuitable for hepatic resection based on tumor location and extent or underlying liver dysfunction
* Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes detected on radiological study
* No evidence of extrahepatic metastatic disease after chest-abdomen-pelvis CT and PET-MR (or PET-CT)
* Unresectable tumor above cystic duct (pancreatoduodenectomy for microscopic involvement of CBD) or resectable pCCA arising in PSC
* Radial tumor diameter \<3 cm
* At least six months have passed since the first diagnosis of pCCA to the date of inclusion on the liver transplant waiting list
* The patient has received at least six months of standard of care (SOC) chemotherapy, achieving disease stability or partial response (according to RECIST criteria version 1.1) at the time of listing for transplantation
* Absence of medical or surgical contraindication to liver transplantation
* Signed informed consent, and expected patient cooperation for treatment and follow-up, must be obtained and documented according to good clinical practice and national/local regulations

Exclusion Criteria:

* Diagnosis of intrahepatic cholangiocarcinoma (iCCA)
* Uncontrollable infection
* Prior radiotherapy or chemotherapy
* Prior biliary surgical resection or attempted surgical resection
* Diameter of tumor \>3cm
* Presence of intra-hepatic metastases
* Present or past evidence of extrahepatic metastatic disease
* Transperitoneal biopsy (including percutaneous ecography-guided FNA)
* Prior neoplasms, except those treated curatively for more than 5 years without recurrence
* Substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study or with the evaluation of study outcomes
* Pregnant or breastfeeding women
* Medical-surgical contraindications for liver transplantation
* Any reason for which, in the investigator's judgment, the patient should not participate in the study
Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy

Passive video capsule endoscopy is the criterion standard for small-bowel diseases but cannot be used for the large gastric cavity.This blinded prospective study investigates the accuracy of the magnetic-controlled capsule endoscopy compared to gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with gastric symptoms and indicated for Upper GI endoscopy
* Age of 18 years to 70 years

Exclusion Criteria:

* Patients with impaired bowel movement from ileus or organic digestive diseases
* Patients with known large and obstructing tumors of the upper GI tract
* Patients after upper GI surgery or abdominal surgery altering GI anatomy
* Patients under full anticoagulation
* Patient in poor general condition
* Patients using equipment that may be affected by radio transmission
* Patients using equipment that may be affected by magnetic field
* Pregnancy or suspected pregnancy
Blood Flow Regulation in Glaucoma

Glaucoma is one of the leading causes for blindness in industrialized countries. It is characterized by a progressive loss of retinal ganglion cells, morphological changes in the optic nerve head and a characteristic loss of visual field. Although increased intraocular pressure has been identified as the major risk factor for the development and the progression of the disease it has been speculated for a long time that impaired ocular blood flow may contribute to the pathogenesis of the disease. This concept has been supported by several epidemiological studies showing that low ocular perfusion pressure and small retinal vessel caliber are associated with the disease.

The proposed study tests the hypothesis that patients with glaucoma have reduced total retinal blood flow as compared to healthy subjects. Additionally, autoregulation of blood flow will be investigated during an increase in ocular perfusion pressure. This is of importance because it may clarify the degree of vascular involvement in glaucoma.


Eligibility Criteria:
Inclusion Criteria:

Patients with open angle glaucoma:

- Diagnosis of manifest open angle glaucoma as defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and/or untreated intraocular pressure ≥ 21 mmHg on at least three measurements in the medical history. Mean deviation in the visual field test \< 10 decibel

Healthy control subjects:

* normal ophthalmic findings and intraocular pressure \< 20 mmHg on at least three measurements
* no evidence of increased intraocular pressure in the medical history
* no signs of glaucomatous damage in the optic disc or the glaucoma hemifield test

Exclusion Criteria:

* Presence or history of a severe medical condition as judged by the investigator
* Abuse of alcoholic beverages
* Participation in a clinical trial in the 3 weeks preceding the study
* Exfoliation glaucoma
* Pigmentary glaucoma
* Secondary glaucoma
* Ocular hypertension
* History of acute angle closure
* Intraocular surgery within the last 6 months
* History of epilepsia
* Diabetes mellitus
* Ocular inflammation or infection within the last 3 months
* Untreated hypertension with systolic blood pressure \>160 mmHg, diastolic blood pressure \>95 mmHg
* Pregnancy or lactating
An Exploratory Clinical Trial to Evaluate and Compare Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers

This study aims to Evaluate and Compare Safety and Pharmacokinetic Characteristics after Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers.

The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202108, DWC202109) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated crossover study

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers aged 19 years old to under 55.
* BMI 18.0≥ and ≤30 kg/m² with body mass ≥50 kg
* Those who have no congenital or chronic disease requiring treatment and have no pathological symptoms or findings as a result of medical examination.
* Those who have no clinically significant abnormalities in general physical examination, laboratory assessments and 12-lead electrocardiogram (ECG).
* Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.

Exclusion Criteria:

* Known history or presence of any clinically significant medical condition. Participation in a clinical drug study or bioequivalence study 6 months prior to the present study.
* Refusal to abstain from smoking or consumption of tobacco products 72 hours before drug administration and during each study period.
* Refusal to abstain from caffeine or grapefruit containing food or drinks for 72 hours before drug administration and during each study period.
* Refusal to abstain from strenuous activities for 72 hours before drug administration and post-study visit, before and during each study period.
A Study of LY3316531 in Healthy Participants

The purpose of this study is to assess study drug activity by giving LY3316531 or placebo into a vein in the arm and then measuring blood flow of the skin, after capsaicin is applied to skin's surface. The study will last about 16 weeks inclusive of the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Must be healthy males
* Must be abstinent or use condoms with spermicide as well as 1 additional highly effective method of contraception or effective method of contraception during the study and for 5 months following dosing of study drug
* Must have a body mass index between 18 to 32.0 kilogram per meter square (kg/m²), inclusive, and a minimum body weight of 50 kilogram (kg)
* Must have suitable skin characteristics for the dermal capsaicin challenge and have demonstrated at least a 100 percent (%) increase in dermal flow following capsaicin challenge as part of the screening procedures and measured through laser Doppler imaging (LDI)

Exclusion Criteria:

* Must not have evidence of clinically significant active infection, fever of 100.5 degrees Fahrenheit (°F) (38 degrees Centigrade (°C)) or above, at baseline
* Must not show evidence of active or latent tuberculosis (TB)
* Must not have received live, attenuated live, or non-live vaccine(s) within 28 days of screening or intend to receive during the study
* Must not be immunocompromised
* Must not have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
* Must not have significant allergies to humanised monoclonal antibodies
* Have a history of multiple or severe allergies or has had an anaphylactic reaction to prescription or nonprescription drugs or food
* Must not have had any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin
* Must not have eczema, scleroderma, psoriasis, dermatitis, keloids, tumors, ulcers, burns, flaps, or grafts on their forearm or other abnormality of the skin that may interfere with the study assessments
* Must avoid excess tanning throughout the study and cannot cover forearms for 24 hours prior to each treatment period
* Must not have excessive hair growth on the volar surface of the forearm or currently using lotions, oils, depilatory preparations, or other topical treatments on a regular basis that cannot be discontinued for the duration of the study; participant must not have used any topical treatments within 7 days of the start of the study
Pain and Smoking Study - Interactive Voice Response

PASS2 aims to expand upon the recently completed study (PASS intervention), which tested the telephone delivery of a cognitive behavioral intervention (CBI). This study will use Interactive Voice Response (IVR) to optimize the intervention's effectiveness for smoking cessation among Veteran smokers with chronic pain.

Veterans with chronic pain represent an important population in which to focus smoking cessation efforts. Smoking cessation among patients with chronic medical illnesses substantially decreases morbidity and mortality; yet, many patients (\>50%) with chronic pain continue to smoke.

This study aims to:

1. Determine whether the existing integrated pain and smoking cessation (PASS intervention) augmented with IVR (PASS-IVR) is superior to treatment as usual (e.g., referral to standard VA smoking cessation clinic) enhanced with pharmacotherapy tele-consult (E-TAU) at 6 (primary endpoint) and 12 months on cigarette abstinence rates among non-depressed Veterans with chronic pain.
2. Determine whether PASS-IVR is superior to E-TAU at 6 (primary endpoint) and 12 months on pain interference.
3. Examine critical components of the intervention process to inform future program implementation.

Eligibility Criteria:
Inclusion Criteria:

* being an enrolled Veteran at VACHS;
* current tobacco use;
* willingness to make a quit attempt;
* significant chronic pain defined as \>/=4 on the pain intensity portion of the Brief Pain Inventory (BPI) for more than 90 days.

Exclusion Criteria:

* active diagnosis of dementia or psychosis in medical record;
* severely impaired hearing or speech;
* lack of telephone access;
* enrollment in concurrent research study that might affect main outcomes of this study;
* terminal illness;
* non-English speaking;
* pregnancy;
* provider advising against exercise;
* planned surgeries; and
* clinically significant depressive symptoms (\>10 PHQ-9).