cyrilzakka/clinical-trials huggingface dataset:
A Study of KM602 in Patients With Advanced Solid Tumors

This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and activity of KM602 as monotherapy in patients with advanced solid tumors.

This Phase 1 study is comprised of dose escalation and expansions for KM602 monotherapy. Monotherapy dose escalation is designed with initial accelerated titration followed by a standard 3+3 dose escalation; Patients will remain on study treatment until progression of disease, unacceptable toxicity, or other specified reason for discontinuation.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed, disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments (predominantly melanoma and non-small cell lung cancer)
2. All patients must have at least one measurable lesion at baseline according to RECIST v1.1
3. ECOG performance status of 0 or 1
4. Life expectancy of ≥ 12 weeks
5. Adequate baseline hematologic, renal, and hepatic function

Exclusion Criteria:

1. Patients with meningeal metastasis or symptomatic central nervous system metastasis
2. Any second malignancy active within the previous 5 years
3. Any active, known, or suspected autoimmune disease
4. Active or prior pneumonitis or interstitial lung disease
5. Prior organ allograft or allogeneic hematopoietic stem cell transplantation
6. Treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 4 weeks prior to the first dose of KM602
7. Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab
8. History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation
9. Systemic treatment with corticosteroids (\> 10 mg/day prednisone) or other immunosuppressive medication within 14 days prior to the first dose of KM602 or during the study
10. Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C
11. Known allergies, hypersensitivity, or intolerance to KM602 or excipients in the drug product formulation
12. Active infection requiring therapy at the time of the first dose of KM602
13. Pregnancy or breastfeeding
14. Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.
CERAMENT G As Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure

The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.

The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.

The purpose of this post market prospective cohort study is to obtain longer-term clinical and radiographic data on the safety and effectiveness of CERAMENT G as part of the surgical treatment of Osteomyelitis in a single-stage procedure.

Detailed questions to be answered are:

1. What is the nature, severity, and frequency of incomplete new bone formation?
2. What is the nature, severity, and frequency of the risks of probable adverse events and serious adverse events associated with incomplete new bone formation, including pathologic fractures and reinfection?

Eligibility Criteria:
Inclusion Criteria:

Subjects meeting the following inclusion criteria are to be included in the analysis:

1. Patients receiving CERAMENT G subsequent to surgical excision of osteomyelitis, with Cierny-Mader classification grades III or IV, who require dead-space management of a bone defect following surgical debridement and excision of infection.
2. Symptoms for a minimum of six months with clinical and radiological features accompanied by at least one of the following:

   1. the presence of a sinus
   2. the presence of an abscess or intra-operative pus
   3. the presence of positive supportive histology
   4. two or more microbiological cultures with indistinguishable organisms (defined as cultures resulting in identification of the same microbe (e.g., Staph aureus) with similar antimicrobial sensitivity) Notes: In cases where cultures are negative, a patient will be included in the study only if there is positive supportive histology combined with the presence of a draining sinus or intra-operative pus. Infected non-unions will be included only if the bone loss is \< 1cm after debridement and excision of bone has been performed.

Exclusion Criteria:

The subject will be excluded from the study if:

1. Skeletal immaturity, defined as pre-operative/ screening radiology with evidence of incompletely fused physes. (determined by their previous x-rays which are taken as part of their admission, unrelated to the study)
2. Those unable to give informed consent for inclusion in the trial, or those not willing to be included
3. A known allergy or reaction to gentamicin or calcium sulfate
4. Treatment with a combination of different antibiotic-eluting bone graft substitutes
5. They have a segmental bone defect \> 1cm
6. Infection of the spine
Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)

The purpose of this study is to investigate the effect of Lu AG06466 after multiple doses of 30 milligrams (mg) in participants with PTSD.

The crossover study consists of two treatment periods of 15 days duration. On Day -1 or Day 1 of Treatment Period 1, eligible participants will be randomized (1:1) to a sequence of treatments (either Lu AG06466-placebo or placebo-Lu AG06466) with 15 participants are planned per sequence. Each treatment period will be separated by a washout period of ≥7 and ≤14 days.

Eligibility Criteria:
Inclusion Criteria:

* The participant has PTSD, diagnosed according to Diagnostic and Statistical Manual Diploma in Social Medicine-5 (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI).
* The participant has a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score ≥28 at screening and baseline.
* The participant has alterations in arousal and reactivity, confirmed on CAPS-5.
* The participant has ongoing sleep disturbances, confirmed on CAPS-5.
* The participant is willing to discontinue all prohibited medications during the study and to complete a washout of psychotropic medication during the washout period.
* The participant does not have any magnetic resonance imaging (MRI) contraindications.

Exclusion Criteria:

* The index traumatic event that led to development of PTSD took place \>15 years or \<6 months before screening.

Other inclusion and exclusion criteria may apply.
Efficacy and Safety Study for PIOLIN® Shampoo

This study aims to demonstrate the therapeutic efficacy and safety of Shampoo PIOLIN ® in the treatment of human pediculosis. Will be treated 212 patients aged 2-60 years with the infestation, along with the people in your family life. All will be submitted to the dosing regimen recommended in the package insert. 100% of the sample shall be subjected to clinical evaluation through comb, pre and post treatment and monitored after thirty days for evaluation of safety and possible adverse effects that may arise related to any of the components of the formula.

The efficacy study is active comparator, non-inferiority.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers healthy female and male ;
* Children between 2 and 17 years ;
* Increased from 18 years;
* Availability of volunteer to maintain a stable weight during the study period (ranging from less than 2 kg) ;
* Displays lice infestation on clinical examination ;
* Voluntary participation ;
* Signing the consent form and / or Free and Informed Consent ;
* Willingness to comply with study procedures ;
* Complying that researchers can make use of all the information nameless , including publication and comply with the use and storage of all information confidential .

Exclusion Criteria:

* Use paint or other chemicals on the hair in the last four weeks that precede the study ;
* Concomitant Therapy ;
* Women who are pregnant or intend to become pregnant during the study ;
* Infants ;
* Volunteers not willing to sign and adhere to the Statement of Consent ;
* Known hypersensitivity to the product ;
* Participation in any other clinical study ;
* Any other condition that the investigator decides that might interfere with the results or involving a risk to the volunteer study
A Clinical Trial of the Administration of Light Therapy to Prevent and Treat Mouth Sores in Children With Cancer

The goal of this clinical trial is to learn if light therapy can prevent and/or treat mouth sores in children with cancer. The main questions it aims to answer are:

Is it reasonable and acceptable to provide light therapy for children with cancer?

Does light therapy prevent and treat mouth sores related to medical treatment?

Researchers will compare children who did not receive light therapy before the clinical trial to children who receive light therapy during the clinical trial to see if light therapy helps to prevent and treat mucositis.

Participants will:

* Tell the nurse their pain score, related to their mouth sores, before receiving light therapy.
* Have picture taken of their mouth to look for mouth sores.
* Receive light therapy every other day while admitted to the hospital on the cancer unit or while admitted to an alternate unit.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to oncology unit, PICU, or on an alternate acute care unit.
* Diagnosis:
* Following diagnoses until achieve count recover (ANC≥500), the patient has no clinical signs of mucositis, or is discharged i. ALL interim-maintenance high dose Methotrexate ii. ALL with trisomy 21 receiving high dose Methotrexate iii. AML iv. Neuroblastoma (excluding admissions for antibody treatment) v. Burkitt lymphoma vi. Osteosarcoma receiving high dose Methotrexate vii. Germ cell tumors receiving Etoposide viii. Rhabdomyosarcoma ix. Ewing sarcoma
* Head/neck cancers receiving radiation
* Able to speak and understand English or Spanish

Exclusion Criteria:

* Unwilling to participate
* Do not meet eligibility criteria outline above
Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing

Introduction: There is currently no long-term study, which compares the outcomes of partial tonsillectomy to conventional tonsillectomy. We hypothesize that there will be little significant tonsillar regrowth with partial tonsillectomy.

Background and Significance: Tonsillectomy is the most common major surgical procedure performed on children in the United States with nearly 300,000 procedures performed each year, primarily for the indication of obstructive sleep disordered breathing (OSDB). Conventional (total) tonsillectomy removes the tonsillar capsule, and partial tonsillectomy preserves the capsule by shaving away the tonsils using an endoscopic microdebrider. Partial tonsillectomy results in less pain, fewer days to normal activity and diet, and fewer days of analgesics than total tonsillectomy. There are no significant differences between the techniques in blood loss or postoperative life improved Historical evidence suggests that eventually there will be tonsillar regrowth with partial tonsillectomy. However, in a 2003 follow-up report of 243 children undergoing partial tonsillectomy and 107 undergoing complete tonsillectomy from 1998 through 2002 for OSDB there was no evidence of significant tonsillar regrowth. (1) We will follow-up children undergoing partial or complete tonsillectomies at the Cleveland Clinic from 1998 through 2002. There will be standardized tonsillar examinations by two observers, with a third observer in cases of significant disagreement, and questionnaires evaluating sleep apnea and daytime sleepiness, and number of tonsillar infections.

If there are a large number of children with recurrent tonsillar symptoms post partial tonsillectomy, the procedure should be abandoned. However, if follow-up reveals comparable tonsillar symptoms for partial and the total tonsillectomy, perhaps the partial procedure should replace the total tonsillectomy as the standard operation to relieve tonsillar OSDB. This could eventually result in millions of less lost days of work and school in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing tonsillectomies at the Cleveland Clinic from 1998-2002
SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)

Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.

Randomized, double-blind study comparing Sufenidone (SC1011) and placebo in IPF patients, with interim analysis at 26 weeks to select the optimal dose for a 52-week treatment period followed by 4-week safety monitoring

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and sign written informed consent.
* The diagnosis time of IPF before enrollment was less than 5 years.
* Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF.
* Dlco (corrected for Hb): 30%-90% predicted of normal.
* FVC\>= 50% predicted of normal.

Exclusion Criteria:

* Forced expiratory volume in one second (FEV1)/FVC ratio \<0.7 after administration of bronchodilator at Screening
* Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization.
* Known explanation for interstitial lung disease
* History of asthma or chronic obstructive pulmonary disease
* Active infection
* Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents
* History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months
Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects

The purpose of this study is to determine the effect that telaprevir and boceprevir has on the pharmacokinetics of maraviroc.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
* Total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
* Positive result for HIV-1, HIV-2, Hepatitis B serology (HbsAg, HbcAb) or anti hepatitis C virus serology (as determined by a multi antigen EIA).
Predictive Value of suPAR and hsCRP on Postoperative Mortality in Cardiac Surgery

This study aims to investigate whether preoperative soluble urokinase plasminogen activating receptor (suPAR) and High-sensitivity C-Reactive Protein (hsCRP) are independent markers of death after cardiac surgery. Further, to assess whether suPAR and hsCRP provides increased predictive accuracy of the clinical risk model EuroSCORE II. The purpose of the study is to gain knowledge on whether these inflammatory biomarkers might be able to reveal a pro-inflammatory disease state that represents a significant risk in patients undergoing cardiovascular surgery. Hence, these biomarkers may assist clinicians in selecting compassionate treatment for high risk patients.


Eligibility Criteria:
Inclusion Criteria:

* Planned elective on-pump cardiac surgery (isolated coronary artery bypass graft (CABG), single and multiple valvular procedures, combined CABG and valvular surgery, and others)
* Given informed consent on delivering a blood sample for the biobank.

Exclusion Criteria:

* Peroperatively cancelling the surgery
* Sudden change to off-pump coronary artery bypass (OPCAB) surgery
* Death prior to surgery
* Project blood samples not available.
Ex-Vivo COF Study for Lung Cancer Observation

Accessing nodules located in the most outer part of the lung is challenging. Tissue that will be removed from the lung will be used to see if we can reach and see the nodule with a very small camera. This camera that may reach in the smaller and outer airways is called a composite optical fiberscope (COF).

The purpose of this study is to evaluate insertion ability of the COF and visualization of the lung tumor by the COF. In order to do so, we plan to evaluate 50 patient samples from the University Health Network over the span of 2 years.

Peripheral pulmonary lesions (PPLs), which include pulmonary nodules and masses, are a common problem in pulmonology practice. The incidence of PPLs will likely increase given the growing adoption of chest CT screening for lung cancer. There are several guidelines available for management of PPLs. If bronchoscopy is selected as the method of diagnosis, conventional bronchoscopy has been one platform used for decades to diagnose PPLs. However, conventional bronchoscopic techniques have significant limitations and overall low diagnostic yield for most PPLs. As a result, innovative bronchoscopic techniques and technologies have evolved over the last decade to diagnose PPLs more accurately. However, accessing to PPLs located in the most peripheral part is still challenging.

As a new method to diagnose and localize cancers, photodynamic diagnosis (PDD) has been gaining attention. PDD is a new technique where a photosensitizer injected intravenously accumulates in the abnormal lesion, then its fluorescence can be detected by a detector. To conduct PDD for PPLs, we collaboratively developed a parallel-type composite optical fiberscope (COF) with an outer tip diameter of 0.97 mm with OK Fiber Technology (Kyoto, Japan). Its small size and flexibility of the tip enable it to be inserted into animal ultrasmall airways. The outer membrane of the fiberscope is made from polytetrafluoroethylene in the COF's insertable section and is hydrophilic coated, which reduces frictional forces when in the contact with the bronchial wall resulting in smooth insertion of the fiberscope. As the COF has illumination fibers and a laser fiber inside, simultaneous white-light and fluorescence imaging with real-time monitoring can be performed to confirm the tip position of the fiberscope during laser irradiation. In this study, we want to evaluate the COF regarding the quality of white-light images and the accessibility of lung tumors located in the peripheral area of the lung.

Eligibility Criteria:
Inclusion Criteria:

1. Any patients scheduled for lobectomy or anatomical segmental resection for malignant lung tumors.
2. 18 years of age or older.

Exclusion Criteria:

1) Any patients with inability to give informed consent.
Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients

The primary objective for this retrospective Electronic Health Record (EHR) analysis is to evaluate the clinical outcomes associated with the utilization of a pulmonary artery catheter (PAC), for monitoring purposes, within patients undergoing cardiac surgeries (isolated coronary artery bypass graft \[CABG\], valve, aortic surgery, multi-procedures, other complex nonvalvular procedures and heart transplants). The study will be conducted using prospectively collected hospital inpatient data over a duration of over 5 years (Jan. 1, 2010 - June 30, 2015) using a large US electronic health database (Cerner HealthFacts; Kansas City, MO).

A retrospective study will be conducted using prospectively collected hospital inpatient data over a duration of over 5 years (Jan. 1, 2010 - June 30, 2015) using a large US electronic health database (Cerner HealthFacts; Kansas City, MO). Patients who underwent a qualifying cardiac surgery (verified through use of selected valid International Classification of Diseases-9 procedure codes and/or Current Procedural Terminology \[CPT\] codes) will be included. Each patient's cohort designation will be defined based upon whether he/she did or did not receive a pulmonary artery catheter (PAC) for monitoring purposes. Propensity scores, which take into account patient and hospital demographics, patient comorbidities, surgical type (isolated coronary artery bypass graft \[CABG\], valve, aortic surgery, multi-procedures, other complex nonvalvular procedures and heart transplants), and pre-operative condition (via an adapted EuroSCORE II) will be utilized to "match" patients who received a PAC for monitoring purposes with those who did not, to form a matched study cohort. Clinical outcomes will be monitored through index visit discharge and up to 90 days post index visit discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoes a qualifying cardiac surgery between Jan 1, 2010 and January 1, 2015. If multiple qualifying surgeries are present, the first in database will be utilized
* Inpatient with a LOS of at least 48 hours
* Treated arm receives a PAC for monitoring purposes within admission date and qualifying cardiac surgical day plus one via specified ICD-9 or CPT-4 codes, or EHR recorded PAC readings

Exclusion Criteria:

* Cardiac surgery patients with age \<18 years on index procedure date
* Non-treated arm derived from an institution which does not have database documented use of ICD-9 or CPT-4 PAC placement codes for monitoring purposes \[Lessens the likelihood that the untreated arm is indeed treated by ensuring that the patient would likely be coded if he/she had a PAC in place for monitoring purposes\]
* Patient record must have the demographics populated of age, gender, and race. ICD-9 diagnosis and procedure codes must be present in record for index visit, as well as medications administered over index visit
* Patient must be treated at a hospital which performs a minimum of 100 qualifying cardiac procedures per year