cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Effect of a Strong CYP3A Inhibitor, on Surufatinib in Healthy Subjects

This study will be a 2-period study conducted with 14 healthy male or female subjects. Subjects will be administered surufatinib alone in Period 1 and in combination with itraconazole in Period 2.

This study will be a single center, open label, fixed-sequence crossover, 2-period study conducted with 14 healthy male or female subjects. Subjects will be administered surufatinib alone in Period 1 and in combination with itraconazole in Period 2. PK samples will be collected through out both study periods.Subjects will be confined in the clinic from check-in on Day -1 through the end-of study visit on Day 15.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking, healthy male or female between the ages of 18 and 55 years old (inclusive).
* Body mass index (BMI) \> 18 and ≤ 29 kg/m2.
* Females must be of non-childbearing potential, or of childbearing potential and agree to use a medically acceptable method of contraception.
* Males who have not had a successful vasectomy and are partners of women of childbearing potential must use, or their partners must use, a highly effective method of contraception starting for at least one menstrual cycle prior to and throughout the entire study period, and for 2 weeks after the last dose of study drug. Those with partners using hormonal contraceptives must also use an additional approved method of contraception. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation.

Exclusion Criteria:

* Evidence of clinically significant cardiovascular, hepatic, GI, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities or had a known history of any GI surgery or cholecystectomy.
* Clinically significant illness within 8 weeks or had a clinically significant infection within 4 weeks prior to the first dose.
* Clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations.
* Systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg.
* The subject has a clinically significant ECG abnormality, or had a family history of prolonged QTc syndrome or sudden death.
* A history of smoking or use of nicotine-containing substances within the previous 2 months.
* A history of drug or alcohol misuse in the previous 6 months.
* Has been diagnosed with acquired immune deficiency syndrome (AIDS) or are positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
* Has participated in a clinical trial of other drug before screening, and the time since the last use of other study drug is less than 5 times the half-life or 4 weeks, whichever is longer, or the subject is currently enrolled in another clinical trial.
* Has received blood or blood products within 4 weeks, or donated blood or blood products within 8 weeks.
* Has used any over-the-counter (OTC) medications or prescription drugs within 2 weeks.
A Study of a Live Intranasal Influenza Vaccine in Children With Cancer

Eligible research subjects will be randomized to receive either FluMist or inactivated influenza vaccine then stratified by age and necessity to receive either one or two immunizations. Subjects requiring one immunization will be immunized at Day 0. Subjects requiring two immunizations will be immunized at Day 0 and Day 28. Subjects will be observed for 30 minutes following vaccination and given a diary card to record symptoms after each vaccination.

The secondary objectives of this study are to:

1. Describe the safety of FluMist and inactivated influenza vaccine.
2. Describe the incidence and duration of viral replication following immunization with FluMist.
3. To examine the association between immunization response (seroconversion or seroprotection) and baseline clinical factors (age, type of malignancy, absolute neutrophil count, absolute lymphocyte count, serum IgA, IgG and IgM levels).

Eligibility Criteria:
Inclusion Criteria:

* Age 2 through 21 (not yet reached their 22nd birthday) at the time of entry into the study
* Participant or participants parent/legal guardian available by telephone during the course of the study;
* Written informed consent (and assent, if applicable) obtained
* Currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or have received chemotherapy in the past 12 weeks;
* If the participant's underlying cancer is a solid tumor, current status must be stable disease, partial response, or complete response to therapy; if the participant's underlying disease is a hematological malignancy, current status must be in remission, and if receiving chemotherapy, must be in the "continuation" or "maintenance" phase of therapy or equivalent;
* Estimated life expectancy of \> 1 year

Exclusion Criteria:

* History of hypersensitivity to any component of FluMist or TIV, including egg or egg products, gelatin, or monosodium glutamate;
* History of hypersensitivity to gentamicin;
* Close contact with a severely immunocompromised patient (e.g., a hematopoietic stem cell transplant patient, during those periods in which the immunocompromised patient requires care in a protective environment
* History of Guillain-Barre´ syndrome;
* History of asthma;
* Female who is breastfeeding or lactating;
Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma

This is a Phase 3b, multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of tezepelumab (210 mg subcutaneous \[SC\] every 4 weeks \[Q4W\]) on antibody responses following seasonal quadrivalent influenza virus vaccination in the fall/winter 2021-2022 in the USA.

Participants with moderate to severe asthma will enter the screening period of a minimum of 2 weeks to allow adequate time for all of the eligibility criteria to be evaluated. They will be randomized 1:1 to receive tezepelumab 210 mg or placebo SC Q4W, administered at Weeks 0, 4, 8 and 12. Randomization will be monitored to ensure at least 50% of the randomized participants are between the ages of 12 to 17 years.

Participants will receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention.

Serum samples for evaluation of antibody response will be drawn at Week 12 (pre-vaccination) and at Week 16 (4 weeks post-vaccination) when humoral response to the vaccination is expected to be fully developed.

The End of Treatment (EOT) Visit will be conducted at Week 16 and a final Follow-up Visit and the End of Study Visit will be conducted at Week 28.

Eligibility Criteria:
Inclusion Criteria:

* Documented physician-diagnosed asthma for at least 12 months prior to Visit 1.
* Morning pre-bronchodilator FEV1 (Forced expiratory volume) of \> 50% predicted normal value at Visit 1 or Visit 2.
* Body weight ≥ 40 kg.
* For women of childbearing potential, a negative urine pregnancy test is required prior to administration of study intervention at Visit 3.
* Must have 'not well-controlled' asthma.

Exclusion Criteria:

* Clinically important pulmonary disease other than asthma.
* Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment.
* Life-threatening asthma
* History of cancer.
* Allergy to eggs, if egg based influenza vaccine will be administered.
* History of anaphylaxis to any biologic therapy.
* Current smokers or participants with smoking history ≥ 10 pack-years and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of \< 10 pack-years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.
* History of alcohol or drug abuse within 12 months prior to the date of informed consent.
* Major surgery within 8 weeks prior to Visit 1 or planned surgical procedures during the conduct of the study.
Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1

The purpose of this study is to evaluate modafinil, a cocaine treatment medication, and its interactions with intravenous (IV) cocaine.

Placebo-controlled, escalating dose drug interaction study using a total of 12 cocaine users at a single site. Study duration will include four infusion sessions: 1) screening/baseline; 2) baseline; 3) 400mg/day steady-state modafinil; 4) 800 mg/day steady state modafinil. Infusion session will be 2 days in duration.

Eligibility Criteria:
Inclusion Criteria:

Dependent on cocaine; non-treatment seeking; male or female; DSM-4 criteria for cocaine abuse or dependence; at least 18 years of age but no older than 45 non-pregnant females using adequate birth control; capable of providing written informed consent; able to comply with protocol requirements.

Exclusion Criteria:

Additional criteria available during screening at the site
Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)

PSSc-001 (LOTUSS)

This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in participants with systemic sclerosis-related interstitial lung disease (SSc-ILD).


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of systemic sclerosis-related (SSc) confirmed by the American College of Rheumatology classification criteria of systemic sclerosis (Masi 1980); duration of diagnosis less than (\<) 7 years
2. Diagnosis of SSc-ILD based on an high-resolution computed tomography (HRCT) scan
3. Screening forced vital capacity (FVC) greater than equal to (\>=) 50 percent (%) of the predicted value, and screening carbon monoxide diffusing capacity (DLCO) \>=40% of the predicted value
4. At study entry, the participant either was not taking SSc-ILD medication or was taking cyclophosphamide or mycophenolate

Exclusion Criteria:

1. Clinically significant pulmonary hypertension
2. Known underlying liver disease
3. Clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux
4. History of clinically significant asthma or chronic obstructive pulmonary disease
5. Active infection
6. Diagnosis of another connective tissue disorder
7. Evidence of a malignancy that is likely to result in significant disability or require significant medical or surgical intervention
8. History of unstable or deteriorating cardiac or pulmonary disease (other than SSc-ILD)
9. Pregnancy or lactation
10. Creatinine clearance \<40 milliliters per minute (mL/min)
11. Prior use of pirfenidone
12. Unsuitable for enrollment or unlikely to comply with study requirements
Telehealth Nursing Intervention for Children With Complex Health Care Needs (CCHCN)

The overall objective of this study is to evaluate the effectiveness of a telehealth care coordination and case management nursing intervention for children with complex special health care needs.

Children with complex special health care needs are those children who have multiple, complex, chronic health conditions who require health and related services of a type or amount beyond that required by children generally. When these children are hospitalized, they receive services as part of an integrated system that provides centralized record keeping and care orders, clearly identified roles and methods of communication for health professionals involved in their care, an established method to obtain equipment and supplies, and regular monitoring of the child's condition. However, when the same child is cared for at home, services are often fragmented, and rarely accessed and delivered in a coordinated system. The task of coordinating services and sharing information between providers almost always becomes the responsibility of the parent or guardian. Families report that their greatest challenges are the stress of coordinating multiple providers, and the disconnect and lack of communication between services and providers. This study will address these issues, using an advanced practice nurse (APN) program of telehealth care coordination and case management in support of these families. Either the telephone or telephone plus interactive video are used by an advanced practice nurse to provide care coordination and case management. Goals of the program are to (1) reduce the number of crisis or unplanned uses of health care services and increase the number of non-crisis or planned health care service usage, (2) improve the QL (quality of life) for these children and their families, and (3) reduce the deficit between help needed and help received for the families in caring for these children. The study objective will be accomplished using a three armed randomized controlled trial. Children will be randomized into a control group receiving usual care that includes LPN (Licensed practical nurse)-delivered care coordination and RN (registered nurse)-delivered telephone triage, an intervention group receiving APN-delivered telephone care coordination and case management, and another intervention group receiving APN-delivered telephone + video care coordination and case management services. It is hypothesized that as the level of telehealth use in coordination and management increases the utilization of unplanned, or crisis, health care service utilization will decrease, that families will receive more of their needed care, and quality of life for the children and their families will improve

Eligibility Criteria:
Inclusion Criteria:

* Children with complex health care needs, in the patient population of the Special Needs Clinic, St Paul Children's Hospital

Exclusion Criteria:

* Healthy children
* CCHCN children not seen in the Special Needs Clinic at St Paul Children's Hospital
Comparative Effectiveness of Direct Admission & Admission Through Emergency Departments for Children

At a national level, emergency departments (EDs) serve as the portal of hospital admission for 75% of hospitalized children. The remainder occur via direct admission, defined as admission to hospital without first receiving care in the hospital's ED. The overall goals of this research are to: (i) implement pediatric direct admission systems at 3 hospitals, (ii) compare the timeliness of healthcare delivery for children who are admitted directly and through emergency departments, (iii) determine which patient populations achieve the greatest benefits from direct admission, and (iv) identify barriers and facilitators of successful implementation.

The Specific Aims of this research are to: (i) Determine the effect of a pediatric direct admission system on timeliness of healthcare provision (the investigator's primary outcome), family experience of care, and rates of clinical deterioration compared to hospital admission beginning in the ED; (ii) Identify the pediatric populations and conditions that experience the greatest benefits from direct admission; and (iii) Through interviews with key informants, identify barriers to and facilitators of implementing standardized direct admission processes.

To achieve these Aims, a stepped-wedge cluster randomized controlled trial at three geographically diverse hospitals in the United States will be conducted, randomizing primary and urgent care practices in the hospitals' catchment area to cross over to the direct admission intervention at four time points. Linear models with random effects for clusters and time period fixed effects will be used to evaluate outcomes associated with the direct admission intervention. To examine for heterogeneity of treatment effects, interactions between direct admission and a priori-specified subgroups will be examined.

Eligibility Criteria:
Inclusion Criteria

Child has one of the following presenting diagnoses:

* gastroenteritis
* dehydration
* skin and soft tissue infection
* urinary tract infection/pyelonephritis
* pneumonia
* viral infection not otherwise specified
* influenza

Exclusion Criteria

Ineligible children include those:

* with planned admissions (i.e., chemotherapy)
* admitted to non-pediatric hospital medicine services (i.e., intensive care)
* transferred from other hospitals
Feasibility of Treatment of Cancer Involving the Liver With High Dose Radiation

A study is being conducted by the University of Rochester Cancer Center (URCC) in which patients with liver cancer will be treated with high dose conformal radiation therapy. This type of radiation uses new techniques which aim the radiation to the sites of disease allowing the tumor to receive a high dose and the surrounding normal liver tissue to receive a low enough dose that the normal tissue should remain free from injury.

The purpose of the study is to determine if the conformal radiation therapy is safe, tolerable and effective in treating liver cancer and to determine the side effects caused by this treatment. A second objective is to determine if the levels of a special type of protein (called cytokines) found in the blood are related to this treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have new hepatic lesions suggestive of metastasis, or otherwise biopsy proven disease if there is no previously negative scan.
* Patients with chemotherapy responsive or resistant disease are acceptable. Primary hepatobiliary tumors are also acceptable. In each case, the patient must be deemed unresectable by a hepatic surgeon.
* Patients with multiple hepatic lesions may be included if they meet the volumetric criteria for dose specification. Likewise, patients with metastases to organs other than the liver, or patients with residual primary disease may be included if it is judged that longevity will be determined by the hepatic disease.
* KPS ≥70
* Age ≥ 18 years
* Bilirubin \<2.0 mg/dl, AST \< 2.5 x normal, ALT \< 2.5 x normal, Platelets \> 80,000/mm3
* Chemotherapy treatment before or after radiation will be allowed
* Informed consent must be obtained., Patient must be judged unresectable by a hepatic surgeon, or must have refused surgery
* Patient must be able to tolerate radiation treatment as judged by the Principal Investigator or co-PI.
* Previous Liver resection is allowed
* Active disease outside the liver is allowed.
* Liver lesion should be visible on CT or MRI.

Exclusion Criteria:

* No active hepatitis or radiographic evidence of diffuse macro-nodular cirrhosis. Patients with lesser degrees of cirrhosis, not associated with portal hypertension or hepatic failure, are eligible but radiation schedule and total dose will be appropriately modified.
* Women who are pregnant
TCM Etiological Study on the Theory of XuSunShengJi in Liver Cirrhosis

To Elucidate and Confirm the Theory of XuSunShengJi in the Traditional Chinese Medicine Etiological Pathogenesis of Liver Cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* With 6 month of chronic liver disease history, and positive serum HBsAg

Exclusion Criteria:

* Other chronic hepatitis and liver cirrhosis of non-hepatitis B
Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate

The aim of colonoscopy is to visualize the inside of the entire large bowel. Several factors can make the procedure difficult, and sometimes a complete examination is not possible. Complicating factors include poor bowel preparation and technical challenges such as differences in anatomy (long, redundant colonic segments), post-surgical adhesions, strictures and diverticulosis. A special endoscope with two inflatable balloons, originally designed to examine the small bowel, has been used for several years with success in such technically difficult colonoscopies. More recently a modified double-balloon instrument was designed specifically for colonoscopy, but the documentation of the performance of this instrument is limited. The aim of the present study is to investigate the performance of the double-balloon colonoscope in cases where conventional colonoscopy have failed due to technical difficulties.

This is a prospective cohort study to investigate the performance of the test instrument. The test instrument consists of a slim, flexible colonoscope with an overtube and an inflatable balloon on the tip of the colonoscope and the tip of the overtube. Patients are eligible for inclusion if conventional colonoscopy fails due to technical difficulties such as loop formation, long colonic segments or suspected adhesions. Written informed consent is required. The study procedures will be performed immediately after the failed conventional colonoscopy, or on a rescheduled appointment within four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Failed cecal intubation during conventional colonoscopy due to technical difficulties

Exclusion Criteria:

* Failed cecal intubation due to insufficient bowel preparation
* Stenotic colonic lesions
* Patients decline
* Pregnancy
* Persons younger than 18 years
* Persons unable to comprehend the information given
Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion

Failed fusion and failure to relieve back pain following spinal fusion are still frequent, irrespective of the type of procedures or grafts used by the surgeon. Moreover, revision surgeries are unfortunately associated with higher procedure-related complication rates, technical difficulties, longer operative time, and quite disappointing and unreliable success rates for both fusion and clinical results.

The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in rescue interbody fusion.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
* Failed lumbar fusion of 15 months minimum requiring a revision surgery at one or two levels between L1 and S1

Exclusion Criteria:

* More than two failed interbody fusions at the involved lumbar level(s)
* Instrumentation failure requiring revision surgery
* Local active or latent infection at the involved lumbar level(s)
* Positive serology for hepatitis B, hepatitis C, HIV
* Current or past medical disease that could interfere with the evaluation of the safety and efficacy, as judged by the investigator