cyrilzakka/clinical-trials huggingface dataset:
Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC)

In this trial, we aim to compare the outcomes of adjuvant chemoradiotherapy with chemotherapy for patients with resected pancreatic cancer who are at high risk of disease progressions.

Pancreatic cancer is a lethal malignancy with the lowest 5-year overall survival rate of 9% and an increasing incidence. In China, the mortality of pancreatic cancer ranked the sixth among all cancers. Although surgical resection is the only radical treatment, only less than 20% patients could receive upfront surgery at the initial diagnosis. Even though patients have surgery, the incidence of disease progressions, including local progression and metastasis, is about 80-90%. In NCCN guidelines and Chinese guidelines, adjuvant chemotherapy is recommended for post-operative pancreatic cancer, while adjuvant chemoradiotherapy could also be used. However, it has not been clarified that which patients may benefit from adjuvant chemoradiotherapy, and no high-level evidence has shown the advantages of adjuvant chemoradiotherapy over chemotherapy. In meta-analyses, it was demonstrated that patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion could achieve longer survival after adjuvant chemoradiotherapy compared with chemotherapy. Therefore, we aim to compare the outcomes of adjuvant chemoradiotherapy with those of chemotherapy in patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion after surgical resection of pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years
* Pathologically confirmed pancreatic ductal adenocarcinoma
* Pathologically confirmed lymph node metastasis, R1 or R2 resection or lymphovascular invasion (one of the risk factors)
* No history of cancer treatment after surgical resection
* No disease progression confirmed by imaging examinations
* ECOG 0 to1 point
* No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10\^9/L, neutrophil count ≥2.0×10\^9, hemoglobin level ≥100g/L, platelet count ≥100×10\^9/L, ALT and AST level \< 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio \<2)

Exclusion Criteria:

* History of cancer treatment after surgical resection
* History of other cancers within 5 years
* Disease progression, including local pprogression or metastasis, confirmed by imaging examinations
* ECOG ≥2 points
* Significant abnormality in blood routine test, liver and kidney function test and coagulation test
* Active inflammatory bowel disease
* Gastrointestinal bleeding or perforation within 6 months
* Infections requiring antibiotics
* Heart or respirotory insufficiency
* Pregnant women or breastfeeding women
A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer

The goal of this Phase 3 clinical trial is to compare efficacy and safety of CT-P51 and European Union (EU) approved Keytruda in combination with platinum pemetrexed chemotherapy in patients with previously untreated metastatic nsNSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Stage IV, non squamous NSCLC
* Have not received any prior systemic anti-cancer therapy for metastatic NSCLC
* Have at least 1 measurable lesion per RECIST version 1.1

Exclusion Criteria:

* Have predominantly squamous cell histology NSCLC.
* Hypersensitivity or contraindication to any component of the study drug, pemetrexed and cisplatin or carboplatin
A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer

This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI.

The study population will consist of patients with mCRC previously treated with an oxaliplatin-based regimen in the first line setting or who have progressed within 6 months of the end of an adjuvant oxaliplatin-based regimen.


Eligibility Criteria:
Inclusion Criteria:

* Advanced colorectal carcinoma.
* Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting.
* Tumor tissue available at time of screening for molecular profiling.
* Adequate performance status.
* Adequate glucose control, bone marrow, kidney, liver, and heart function.

Exclusion Criteria:

* Participation in other studies involving investigational drug(s) (Phases 1-4) before the current study begins and/or during study participation.
* Prior irinotecan treatment.
* Prior radiation to the pelvis or abdomen in the metastatic or locally advanced setting.
* History of Gilbert's syndrome.
* Active brain metastases.
* Deep vein thrombosis in the preceding 2 months.
* History of interstitial lung disease.
* RAS (KRAS/NRAS) wild type mCRC not previously treated with an anti-EGFR containing regimen (unless contraindicated or not considered standard practice per clinical site or country guidelines).
Cranberry Tablets Versus Nitrofurantoin Prophylaxis for Urinary Tract Infection Prevention After Urogynecologic Surgery

We aim to compare the effectiveness of cranberry capsules versus nitrofurantoin prophylaxis in preventing urinary tract infections (UTIs) after urogynecologic surgery by conducting a double-blinded randomized clinical trial involving women with pelvic organ prolapse and/or urinary incontinence scheduled to have surgery with the Urogynecologists who comprise the Brigham and Women's Urogynecology Group.

We plan to conduct a double-blinded randomized clinical trial involving women who undergo surgery for pelvic organ prolapse and/or urinary incontinence.

Participants who need transurethral catheterization postoperatively will be randomized to cranberry capsules or nitrofurantoin prophylaxis. Randomization will be performed the day of discharge. Both participants and surgeons will be blinded to treatment allocation. All participants will receive routine perioperative intravenous antibiotic prophylaxis.

Participants who fail their voiding trial after surgery and require transurethral catheterization upon discharge from the hospital will be randomized to either one cranberry capsule (TheraCran one®, Theralogix, LLC, Rockville, Maryland) or one 100 mg capsule of nitrofurantoin by mouth daily beginning postoperative day #1. Participants randomized to the cranberry capsule group will continue to take one cranberry capsule daily for 28 days. Participants randomized to the nitrofurantoin group will continue to take 100 mg of nitrofurantoin each day transurethral catheterization is needed for up to 28 days. All participants will be scheduled for a repeat voiding trial within 48 hours to 1 week after discharge.

All participants will complete a daily catheterization and medication diary to record the type of catheterization used (indwelling or intermittent) and to confirm they are taking the study medication for the duration of the study period. They will also be asked to record any urinary symptoms they experience and will be encouraged to contact the office immediately if they experience urinary symptoms consistent with a UTI.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* English-speaking
* Plan for pelvic organ prolapse (POP) or urinary incontinence (UI) surgery

Exclusion Criteria:

* Pregnancy
* Urethral diverticulectomy
* Urogenital fistula repair
* Sacral neuromodulation
* Congenital urogenital anomaly
* Allergy to cranberry products
* Allergy to nitrofurantoin
* Dependent on catheterization preoperatively
* Recurrent UTI's (3 or more culture proven UTI's over the past consecutive 12 months)
* Known creatinine clearance \<60 mL/min
* Non-English, Non-Spanish speaking
Exploratory Study of Relationships Between Malodor and Urine Metabolomics

The purpose of this study is to identify metabolic signatures associated with malodor conditions. The investigators will perform state-of-the art metabolomics tests and bioinformatic data mining to explore if conditions leading to malodor can be screened by metabolomic profiling of urine samples.

In this study, metabolite profiling analysis will be carried out on urine samples of individuals with malodor conditions related to metabolism inefficiencies. Metabolic profiles will be identified using the metabolomics equipment located in the NMR, HPLC and MS facilities of the Metabolomics Innovation Centre (TMIC). Multivariate statistical analyses will be used, as well as other approaches to mine complex data from heterogeneous sources.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* unpredictable and uncontrollable episodes of malodor
* willing and able to ship a urine sample (in the kit provided) by an overnight courier to Edmonton, Alberta, Canada
* good general health

Exclusion Criteria:

* serious medical conditions that require treatment
* conditions that, in the opinion of the investigator, would prevent participation
* under the age of 18
* elect not to participate in the study
Soft Tissue Augmentation Using CAF With Either SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession

Compare gingival thickness following CAF With SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession.

Control group (coronally advanced flap and subepithelial connective tissue graft alone) Test group (coronally advanced flap and subepithelial connective tissue graft using microsurgical approach) Same procedure will be executed but with the addition of vitamin C injection. Intraepidermal injection (oral mesotherapy technique) of 1-1.5 ml (200-300 mg concentration) of L-ascorbic acid will be done. It will be locally introduced in relation to the keratinized gingival tissues with extension to the whole target region successively using special syringes (30 gauge). The needle will be introduced parallel to the gingival tissues with the bevel facing upwards. Vitamin C will then be delivered through the attached gingival tissues at the epithelium-connective tissue junction (equivalent to epidermal- dermal junction) till the tissues blanch. Vitamin C will be injected first time immediately postsurgical and then repeated once per week for 3 consecutive weeks for a total of 4 injections.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years or older.
2. Periodontally and systemically healthy.
3. Buccal recession defects classified as Cairo RT1.
4. Presence of identifiable CEJ (Zucchelli et al., 2010).
5. Clinical indication and/or patient request for recession coverage.
6. O'Leary index less than 20% (O'Leary, Drake and Naylor, 1972).

Exclusion Criteria:

1. Cairo RT2 or RT3 recession defects.
2. Pregnant females.
3. Smokers as smoking is a contraindication for any periodontal plastic surgery (Khuller, 2009).
4. Handicapped and mentally retarded patients.
5. Patients undergoing radiotherapy.
6. Teeth with cervical restorations, abrasion and malalignment.
7. Presence of systemic disease that would affect wound healing.
Hemoclin Gel for the Treatment of Hemorrhoids

Post market, single arm, clinical investigation to assess safety and performance of the product.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects.
2. Sex: male or female.
3. Age: more than 18 years old.
4. Symptomatic haemorrhoids stage 1 and 2 (Goligher classification).
5. Episodes of haemorrhoid-related itching experienced at least every other day during the last two weeks before enrolment in the study.
6. Able to attempt bowel movements daily (defined as trying to have a bowel movement while sitting on the toilet for at least a few minutes, at least once daily, whether or not you feel the need to have a bowel movement that day).
7. Able and willing to provide informed consent and comply with study procedures

Exclusion Criteria:

1. Pregnant or nursing woman or planning a pregnancy during the study.
2. Subject not able or not willing to provide informed consent and comply with study procedures
3. Subject who had been deprived of their freedom by administrative or legal decision.
4. Major subject who is under guardianship or who is not able to express his consent.
5. Subject in a social or sanitary establishment.
6. Subject suspected to be non-compliant according to the Investigator's judgment. In terms of associated pathology
7. Grade III or IV haemorrhoids (Goligher classification).
8. Other pre-existing anal disorders and diseases including Crohns disease, ulcerative colitis, undefined inflammatory bowel disease, anal fissures, perianal fistulas, perianal rash or eczema, rectal prolapse, rectocele, benign or malignant anal and rectal tumor and perianal infections.
9. Any anal surgery (including surgical or instrumental procedures in the last 60 days). Relating to previous or ongoing treatment
10. Any anal topical medication applied in last 7 days.
11. Known or suspected sensitivity or allergy to ingredients of the investigational product. In terms of COVID pandemic
12. Subject who was abroad in a country with higher incidence rate of Covid-19 than Poland within 14 days before the beginning of the study.
13. Subject presenting following symptoms: cough, shortness of breath, elevated body temperature - equal and above 37.5°C.
14. Subject who had contact with any person infected with COVID-19 within 10 days before the beginning of the study.
15. Subject who is currently during home quarantine recommended by the Sanitary Inspection
Evaluation of Moderate to Severe Influenza Outcomes in Children

The purpose of this study was to determine whether moderate-severe endpoints (including high fever, lower respiratory tract disease, acute otitis media, or serious extra-pulmonary complications) were predictive of hospitalization, intensive care admission, antibiotic use and other complications in children under 8 years of age.

This prospective observational study aimed to determine the risk difference of hospitalization due to moderate to severe influenza compared with mild influenza among children aged 6 months to 8 years who were evaluated at Children's Hospital Colorado emergency department and urgent care during the 2016-2017 influenza season. In addition, the study intended to evaluate the risk difference for other health outcomes such as ICU admission, antibiotic and antiviral use, caregiver and child absenteeism and recurrent (\>1) healthcare visits, and to compare the healthcare costs associated with management of moderate to severe versus mild influenza in children. Children who presented to Children's Hospital Colorado Emergency Department (ED) and urgent care affiliated sites (North Campus urgent care) with an influenza-like illness from December 2016 to April 2017 and during the 2016-2017 influenza season, were eligible for the study. Once enrolled in the study, the investigators collected respiratory samples (nasal swab specimens) for influenza testing by PCR, sociodemographic and clinical data including variables of interest outlined above, and followed the clinical outcome of these children for 14 days after their initial presentation. Some of the variables of interest the investigators collected are shown below.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 months to \< 8 years
* Presentation to one of the study sites with signs and symptoms of influenza-like illness (temperature of \>37.8⁰C and at least one of the following: cough, sore throat, runny nose or nasal congestion)
* Parents or guardians agreeing and consenting to medical information release, respiratory specimen collection and testing, email/phone call follow up and collection of leftover blood samples obtained during routine clinical care
* Patients seen during the 2016-2017 influenza season

Exclusion Criteria:

* Respiratory symptom duration \> 14 days
* Nurse only visit
* Enrollment in the study within prior 14 days
Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients

The aim of this study is to evaluate the use of autologous expanded mesenchymal stem cells intralesional transplantation as a safe and potentially beneficial treatment for patients with spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* American Spinal Injury Association Impairment (ASIA) Scale A, B and C
* Cervical (under C4), thoracic o lumbar spine lesion
* Complete or Incomplete SCI
* Platelet count over 100.000/ul

Exclusion Criteria:

* Acute SCI (less than 3 months)
* Active infectious diseases
* Pregnancy
* Neurodegenerative diseases
* Primary hematologic diseases
* Coagulopathies
* Hepatic dysfunction
* Pregnancy
Local Radiotherapy for Residual Tumor Lesions During the First-line Treatment

This study aimed to confirmed that local radiotherapy for residual lesions can significantly prolong the efficacy of chemotherapy combined with immunotherapy in the initial treatment of advanced non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* ≥18，Advanced Non-small Cell Lung Cancer Confirmed by Histopathology Patients received platinum-based chemotherapy combined with immunotherapy

Exclusion Criteria:

* EGFR/ALK/ROS1 driver gene mutation
* Chemotherapy only
* Concurrent radio-chemotherapy
* Surgery
* Single-agent immunotherapy
* No treatment information available
Behavioral Economic Approaches to Increase Colorectal Cancer Screening

This is an RCT aimed at testing different population-based approaches to increasing colorectal cancer screening through email outreach, including usual email communication, active choice, and active choice + financial incentive.

This is an RCT aimed at testing different population-based approaches to increasing colorectal cancer screening. The investigators will randomize a cohort of employees between the ages of 50-64 to 3 arms of email communications: a.) Usual email communication; b.) Active choice- usual care + the ability to pre-commit directly through a web form; c.) Financial incentive- usual care + active choice + financial incentive for completion.

Eligibility Criteria:
Inclusion Criteria:

* Male and female employees of the University of Pennsylvania Health System who live within 30 miles of a health system endoscopy center.
Expanded Access of Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload

This is an open-label, non-randomized, multi-center trial designed to provide expanded access of deferasirox to patients with congenital disorders of red blood cells and chronic iron overload from blood transfusions who cannot adequately be treated with locally approved iron chelators.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients greater than or equal to 2 years of age
* Documented congenital disorder of red blood cells (e.g., β-thalassemia major, sickle cell anemia, diamond-blackfan anemia) requiring ongoing blood transfusions
* Cannot be adequately treated with a locally approved iron chelator due to one of the following reasons:

  * Documented non-compliance, defined as having taken less than 50% of the prescribed chelation therapy doses in the 12 months prior to study entry
  * Contraindications, unacceptable toxicities and/or documented poor response to locally approved iron chelators despite proper compliance
* History of at least 20 blood transfusions (equivalent to 100 mL/kg of packed red blood cells (PRBC\])
* Serum ferritin value greater than or equal to 1000 µg/L
* Ability to comply with all study-related procedures, medications, and evaluations

Exclusion Criteria:

* Ongoing treatment with another iron chelator (Any other iron chelation therapy must be discontinued at least 24 hours prior to study entry.)
* Patients who meet the eligibility criteria for any other ongoing Novartis sponsored clinical study protocol with deferasirox and who have geographic access to these sites
* Patients unable to tolerate (or who have unacceptable toxicities to) prior treatment with deferasirox
* Serum creatinine above the upper limit of normal at screening.
* Patients with ALT ≥ 500 U/L at screening.
* Evidence of chelation-related cataracts or hearing loss within 4 weeks prior to baseline
* Pregnancy (as indicated by serum β-HCG pregnancy test at screening for all female patients with the potential to become pregnant) and patients who are breastfeeding
* Patients treated with systemic investigational drug within 4 weeks prior to or with topical investigational drug within 7 days prior to the baseline visit

Other protocol-defined inclusion/exclusion criteria may apply.
Heart Rate Variability At the Emergency Department

In this study investigators want to examine if heart rate variability at hospital entry predicts prognosis in participants with severe disease.

Predictive parameters that can predict the outcome are very scarce. Vital parameters such as heart rate, blood pressure, saturation, etc. can be normal for a long time or only slightly changed, even in seriously ill patients. Heart rate variability is a parameter that can be used as a measure of autonomic dysfunction. Lower heart rate variability is associated with increased mortality and morbidity according to recent studies. Heart rate variability could thus be used to identify the need for intervention and treatment more quickly.

In this study, we want to investigate whether there is indeed a relationship between heart rate variability at admission to the emergency department and eventual mortality and morbidity in critically ill patients.

Therefore, heart rate variability will be determined in patients admitted to the emergency department who were triaged in red or orange according to the Manchester Triage System (internationally validated triage system that is also used in the emergency department at UZ Gent). Subanalyses will be made for patients with trauma, sepsis, pneumonia, CVA and acute myocardial infarction. Determination of heart rate variability will be done by EKG monitoring during the first 5 minutes and after 3 hours. There are several parameters that can reflect heart rate variability. Both frequency domain measurements and non-linair measurements will be determined. Use will be made of the Kubios programme, a free programme that can determine these different parameters on the basis of EKG monitoring. Patients who are resuscitated on arrival will be excluded, as well as patients in VKF, as the heart rate variability on arrival cannot be determined for these two groups. Demographic data (age, sex,...), history and home medication, vital parameters (heart rate, blood pressure, saturation, temperature, respiratory rate) and some lab data (lactate, CRP) will also be collected. The primary outcome will be mortality after 30 days. Secondary outcomes that will be studied are the total duration of hospital stay and the duration of stay in the intensive care unit, as well as the need for life-saving interventions (need for surgery, ventilation, inotropics, PCI or thrombolysis).

By collecting these data, we want to find out whether heart rate variability is a good predictor of outcome, and thus the need for ICU admission, faster invasive interventions,... During this study, the patient's management will remain unchanged.

Eligibility Criteria:
Inclusion Criteria:

Patients with (possible) sepsis, myocardial infarction, cerebrovascular accident, polytrauma or Covid 19 pneumonia who were triaged red or orange following the Manchester triage system

Exclusion Criteria:

Patients with cardiac arrest or arrhythmia at arrival