cyrilzakka/clinical-trials huggingface dataset:
Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC.


Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of locally advanced or metastatic RCC with a clear-cell component with or without sarcomatoid features.
* Must not have received any prior systemic therapy for their mRCC.
* Measurable disease based on RECIST v1.1.
* Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion as required.
* Karnofsky performance status ≥ 70%.
* Adequate organ function per protocol-defined criteria.

Exclusion Criteria:

* Use of protocol-defined prior/concomitant therapy.
* Currently receiving or has received an investigational treatment as part of a study of an investigational agent or has used an investigational device within 4 weeks before randomization.
* History of severe hypersensitivity reaction to study treatments or their excipients.
* Active autoimmune disease that has required systemic treatment in past 2 years.
* Known additional malignancy that has progressed or has required active treatment in the last 3 years.
* Known active central nervous system metastases and/or carcinomatous meningitis.
* History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
* History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful.
* Significant cardiac event within 12 months before Cycle 1 Day 1.
Single Ascending Oral Dose Study to Investigate the Effects of OCT461201 in Healthy Volunteers

A study in healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of OCT461201. The study included a screening period, a single dose of study treatment or placebo and a follow up period.

A phase 1, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of OCT461201 in healthy participants following ascending single doses.

The study comprised a screening period (Day -35 to Day -2), a treatment period (Day -1 to Day 3) and a post-study follow-up visit 4 - 8 days following administration of OCT461201 or placebo (i.e., Day 5 - 9). A dose leader design was implemented with 2 participants being dosed on the first dosing day (1 randomised to placebo, 1 to active drug) and the remainder of the cohort dosed at least 24 hours later pending an acceptable safety profile in the dose leader group. Safety and Pharmacokinetic data was reviewed by the Dose Escalation Review Committee before escalation to the next cohort/dose level.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participant, between 15 and 55 years of age inclusive at screening
* Body mass index (BMI) of 18-30 kg/m2
* No clinically significant history of previous allergy/sensitivity to compounds similar to experimental drug or any of its excipients
* No clinically significant results for serum biochemistry, haematology and/or urine analysis within 35 days before first dose of Investigational Medicinal Product (IMP)
* No clinically significant abnormalities in 12-lead ECG within 35 days before dose of IMP
* Available to complete the study including all follow up visits

Exclusion Criteria:

* Clinically significant history of gastrointestinal disorder likely to influence IMP absorption
* Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction
* Participation in a new chemical entity clinical study within the previous 3 months or 5 half-lives, whichever was longer
The Psychosocial and Economic Burden of Genital Warts

Considering the importance of HPV(human papilomavirus) and related diseases in Brazil, and the lack of studies about both the economic and the psychosocial burden of these diseases, BEMFAM, a Brazilian non-governmental organization that provides reproductive health services and technical support to local governments proposes a study to measure the psychosocial and economic burden of genital warts.

Cervical cancer is a public health issue in Brazil. The Cancer National Institute estimates that cervical cancer will be the second most incident among women, with 18.430 new cases in 2010. Human papillomavirus (HPV) is related to cervical cancer and is also responsible for benign lesions, such as genital warts.The Brazilian Ministry of Health estimates the prevalence of genital warts to be 5,7% among pregnant women and 21,5% among women attending sexually transmitted infections treatment clinics.The study will measure the psychosocial burden of genital warts using HPV Impact Profile questionnaire and the economic burden of genital warts among women attending its six reproductive health clinics.

There are two study objectives:

1 - to measure the psychosocial burden of genital warts in women attending six reproductive health clinics in Brazil. 2- to measure the economic burden of genital warts treatment for women attending six reproductive health clinics in Brazil.

Hypothesis testing:

For objective 1, the experiment compare differences on psychosocial burden of Genital Warts among subgroups and therefore does not include any formal hypothesis testing about the psychosocial burden of the disease in agreement with the extant literature on the subject (Xingshu Zhu et al., 2009).

Objective 2 aims to measure differentials in the economic burden of the disease among subgroups with different type of genital warts (newly diagnosed, recurrent and resistant), site of the lesion, age, duration of treatment, number of medical visits, type and number of medical procedures. No formal hypothesis will be tested.

Eligibility Criteria:
Inclusion Criteria:

* women aged 18 to 45 years, who had a Pap-smear in the preceding 90 days or were diagnosed with genital warts during physical examination.
* good health

Exclusion Criteria:

* women self reported HIV-positive
* women undergoing antiretro-viral treatment
* illiteracy
* pregnancy
Regimen Switch After Intensive Insulin Therapy

Insulin intensive therapy have traditionally been considered a sequential therapy in type 2 diabetes last choice, a number of guidelines and consensus recommendations insulin intensive therapy can be as obvious hyperglycemia in patients with newly diagnosed T2DM part of a line, a subset of patients after insulin intensive treatment target often need to change to other treatments, especially for senile diabetes patients, due to its self management ability, simplify the insulin solution is more urgent. Current clinical guidelines do not provide specific clinical guidance, such as the timing and method of switch after initial insulin intensive therapy. The purpose of this study was to explore the timing, suitable population and conversion methods of insulin regimens after treatment.

Selecting initial insulin intensive therapy during the period of hospitalization in patients with type 2 diabetes, collect the basic information and biochemical information collection, including gender, age, duration of diabetes, intensive glucose-lowering treatment plan before treatment, diabetes complications, merger disease, smoking, drinking, height, weight, blood pressure, fasting glucose, glycosylated hemoglobin and glycosylated serum protein, insulin, c-peptide, liver and kidney function, blood lipid, blood routine, hypoglycemia is happening almost 1 month. Follow-up was conducted in January, March and June. Endocrinologists decide whether to continue the original hypoglycemic regimen or adjust it according to the glycemic control goals, islet β-cell function, diabetes complications, complications, hypoglycemia and other combination drugs, as well as patients' treatment willingness and compliance. To compare the timing of conversion of treatment regimens, the proportion of conversion to each regimen and the situation of reaching the standard, and to further analyze and compare the characteristics of people who switched to different regimens, in order to establish the basis for the selection of adjustment regimens after insulin treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes;
* Patients who started intensive insulin therapy during hospitalization
* Age ≥18 years old

Exclusion Criteria:

* Type 1 diabetes, special type diabetes
* Acute complications of diabetes (diabetic ketoacidosis, hyperglycemia and hyperosmolarity)
* Severe infection
* pregnancy or planned pregnancy
* Participating in other clinical studies or trials
Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months

The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks or a birth weight of \>2000g.
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

* Planned administration of oral polio vaccine during the period starting from 2 weeks before each dose of study vaccine(s) and ending 2 weeks after.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
* History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B.
* Previous vaccination against diphtheria, tetanus, pertussis, and/or Haemophilus influenzae type b.
* History of allergic disease
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
* Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination)
* Previous confirmed occurrence of RV GE.
* Household contact with an immunosuppressed individual or pregnant women.
* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period
Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women

This is a phase I study to analyze bioavailability and pharmacodynamic of two different variants of oral salmon calcitonin (SMC021) in postmenopausal women


Eligibility Criteria:
Inclusion Criteria:

* Healthy postmenopausal women

Exclusion Criteria:

* Previous treatment with other osteoporosis medication

Other protocol-defined inclusion/exclusion criteria may apply.
Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon Site

The purpose of this study was to demonstrate efficacy, including effects on inflammation by magnetic resonance imaging (MRI) assessments, of secukinumab on Achilles tendon enthesitis for up to 1 year with a primary focus at Week 24, in patients with active Psoriatic Arthritis and axial Spondyloarthritis despite current or previous non-steroidal anti-inflammatory drugs (NSAID) and/or disease modifying anti-rheumatic drug (DMARD) and/or anti-TNFα therapy.

Primary endpoint was at week 24 but there was no interim Clinical Study Report. While Protocol states at chapter 9.7 that a week 24 analysis may be provided (not mandatory as per protocol), all data has been analyzed at week 52.

Some of the secondary endpoints include the whole study period up to week 52 (to address questions on switching placebo to active drug)

Eligibility Criteria:
Key Inclusion Criteria:

- Patients with Psoriatic arthritis: Diagnosis of Psoriatic arthritis as per the Classification criteria for Psoriatic Arthritis (CASPAR criteria) with symptoms for at least 6 months and active Psoriatic arthritis as assessed by ≥ 1 tender joints out of 78 and ≥ 1 swollen joints out of 76 at Baseline (dactylitis of a digit counts as one joint each).

- Patients with Axial Spondyloarthritis: Diagnosis of Axial Spondyloarthritis as per the classification of the Assessment of Spondyloarthritis International Society axial Spondyloarthritis (ASAS) criteria and objective signs of inflammation at Screening (magnetic resonance imaging (MRI) or definite radiographic sacroilitis and/or abnormal C-Reactive Protein) and active disease assessed by total Bath ankylosing spondylitis disease activity index (BASDAI) ≥ 4 (0-10) at Baseline.

* Diagnosis of Achilles tendon enthesitis according to swelling and tenderness at the insertional site of the Achilles tendon into the calcaneus.
* Onset of heel pain ≥ 1 month at Baseline.
* Heel enthesitis that is magnetic resonance imaging (MRI)-positive according to the investigator's judgement.
* Patients who have been exposed to up to two TNFα inhibitors.

Key Exclusion Criteria:

* Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
* Previous exposure to secukinumab or other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor.
* Ongoing use of psoriasis treatments / medications (e.g. topical corticosteroids, ultraviolet (UV) therapy) at randomization.
* Patients who have previously been exposed to more than two Tumor necrosis factor (TNF) inhibitors (investigational or approved).
* Patients who have ever received biologic immunomodulating agents (investigational or approved), except those targeting Tumor necrosis factor (TNF) inhibitors.
* Pregnant or nursing (lactating) women.
* History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.
Value of Heart Rate Lowering Therapy in Acute Myocarditis

To study the value of heart rate lowering therapy "pharmacological rest" on the short term in cases of myocarditis without LV dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Adults: ≥18 years of age.
* Presentation: at least one of the following:

  * Myopericarditis/ACS-like
  * MINOCA
  * Arrhythmias: brady or tachyarrhythmias.
  * Unexplained compensated acute cardiomyopathy (excluded ischemic, valvular, hypertensive, metabolic, and toxic causes of cardiomyopathy as indicated clinically).
* TTE: LVEF\>40%
* CMR-confirmed myo(peri)carditis (Lake Louise criteria)

Exclusion Criteria:

* • Rheumatic carditis.

  * Connective tissue diseases (-ve ANA).
  * Cancer chemotherapy.
  * Toxicity from immunotherapy.
  * Vaccine-related myocarditis.
  * Presence of coronary artery disease.
  * Peripartum (occurring during the last month of pregnancy or within 5 months after delivery)
  * ECG: atrial fibrillation/flutter.
  * Resuscitated sudden death.
  * Early/initial phase of decompensated heart failure.
  * Tamponade complicating pericarditis unless successfully managed.
Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide

A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes ≥ 3 months.
* Stable regimen of diet and exercise in combination with a stable treatment of liraglutide ≥1.2 mg/day and metformin ≥1000 mg/day.
* HbA1c ≤9.5%.
* Stable body weight ≥ 3 months.
* Body mass index (BMI) ≥25 to ≤45 kg per meter squared.
* Calcitonin \<50 ng/L (50 pg/mL) at the Screening Visit.

Exclusion Criteria:

* History of type 1 diabetes.
* Recent use or of anti-diabetic medications other than liraglutide or metformin.
* History of significant/severe nausea and/or vomiting due to liraglutide.
* Significant symptomatic hyperglycemia.
* History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.
* History or evidence of acute or chronic pancreatitis.
* History of liver disease.
* History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2.
* Poor thyroid, liver, or renal function.
* Serum creatinine levels \>1.5mg/dL (132 μmol/L) for male patients, or \>1.4 mg/dL (123 μmol/L) for female patients.
* Weight loss surgery or requires weight loss medications.
* History of malignancy (not including basal or squamous cell carcinoma of the skin with past 5 years).
* History of active alcohol or substance abuse.
* Treatment with medications that affect GI motility.
* History of hypersensitivity to exenatide or liraglutide.
* Women that are pregnant, lactating, or planning to become pregnant.
A Phase 2 Study of Intravitreal AVD-104 in Diabetic Macular Edema

A Phase 2 study to determine the safety and preliminary efficacy of intravitreal injections of AVD-104, a novel glyco-mimetic nanoparticle, in reducing macular edema associated with diabetic retinopathy.

The primary objective is to evaluate the tolerability and treatment effect of intravitreal injections (IVT) of AVD-104 in participants with diabetic macular edema (DME). Participants will receive either three intravitreal injections of low-dose AVD-104 (1.0 mg) each 28 days apart or two intravitreal injections of AVD-104 at a high-dose (2.0 mg) 56 days apart. Serial optical coherence tomography (OCT), ultra wide-field fluorescein angiography, and OCT-angiography (OCT-A) will be performed to evaluate the treatment effect on central subfield thickness (CST) and areas of non-perfusion. All participants will be followed-up for safety until day 84.

There will be a planned enrollment up to 30 participants.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus (type 1 or 2), as defined by the World Health Organization and/or American Diabetes Association
* Decreased visual acuity (VA) due to DME, with BCVA letter score of 75-20 letters on ETDRS-like charts (20/32-20/320 Snellen equivalent)
* DME represented by macular thickening on SD-OCT involving the center of the macula: CST ≥325 μm

Exclusion Criteria:

* Any IVT anti-vascular endothelial growth factor (VEGF) treatment within 3 months before randomization
* Any history of pan-retinal photocoagulation (PRP) treatment
* Any use of Iluvien® (Alimera Sciences, Inc., Alpharetta, GA) in the last 3 years; or Ozurdex® (Abbvie, Chicago, IL) or Xipere (Bausch \& Lomb, Vaughan, Ontario, Canada) in the last 6 months
* History of macular laser photocoagulation
* Any signs of high-risk proliferative diabetic retinopathy (PDR)
Orofacial Functions in Individuals With and Without Molar Incisor Hypomineralization

Molar incisor hypomineralization (MIH) is a qualitative developmental defect of the enamel with a complex, multifactorial nature and a significant genetic component that predominantly affects the permanent first molars and, occasionally, the permanent incisors. Individuals with MIH have a compromised stomatognathic system manifested by muscle hyperactivity under postural and dynamic conditions. However, there is a gap in knowledge on the specific functional abnormalities that these individuals experience. Early identification and intervention, with a focus on the prevention of orofacial dysfunctions and deviations in facial growth and development, are aspects of the utmost importance. Therefore, the aim of the proposed study is to perform a comparative analysis of orofacial functions with an emphasis on breathing and chewing patterns in individuals with and without MIH. Methods and Analysis: Assessments will be performed using the Nordic Orofacial Test - Screening (NOT-S). Descriptive statistics will be performed and comparisons will be made using the chi-square test, adopting a 5% significance level.


Eligibility Criteria:
Inclusion Criteria:

* Children 6 to 12 years of age with a complete mixed dentition with all first molars present and in occlusion;
* Having all first molars erupted, without caries or previous treatment;
* Inclusion criteria for the MIH group: at least one permanent molar with indices compatible with MIH (code 2, 21, 22 and 3 - Ghanim criteria).

Exclusion Criteria:

* Children with amelogenesis and dentinogenesis imperfecta;
* Children undergoing orthodontic treatment;
* Children with a genetic syndrome;
* Children with the premature loss of deciduous teeth;
* Children with acute respiratory problems;
* Children in treatment.
Study to Evaluate the Safety and Efficacy of Pazopanib, in Subject With Refractory Solid Tumors

This study is a single arm, pilot study of pazopanib in patient with FGFR2 amplification Refractory solid tumor and/or specific sensitivity to pazopanib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.

To investigate the efficacy and safety of pazopanib in patient with Refractory solid tumor.


Eligibility Criteria:
Inclusion Criteria:

* Provision of fully informed consent prior to study specific procedures.
* Patients must be \>= 19 years of age
* FGFR2 amplification ,Refractory solid tumor and/or specific sensitivity to by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
* ECOG Performance status0-2
* Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
* Adequate Organ Function Laboratory values

  * Absolute neutrophil count \>= 1.5 x 109/L, Hemoglobin \>= 9g/dL, pazopanibPlatelets\>=100 x 109/L Bilirubin \<= 1.5 x upper limit of normal AST/ALT \<= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine\<= 1.5 X UNL
* Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
* Adequate heart function

Exclusion Criteria:

* Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for \<= 5 years.
* Has known active central nervous system(CNS) metastases
* Has an active infection requiring systemic therapy
* Pregnancy or breast feeding
* Patients with cardiac problem
* Any previous treatment with pazopanib
To Investigate the Event Related Potentials (ERPs) of Patients With Brain Lesions

Event-related potentials (ERPs）has the advantage of excellent temporal resolution on measuring real-time neural activities that reflect to higher level cognitive processes. A research project related to lesion studies in which patients with cognitive function impairment and communication disorder will be recruited as participants to examine their impairment as well as residual abilities by using ERPs. Hopefully, expected findings will provide further analysis based on the patterns of neural activities revealed by both patients and normal controls should be able to provide important evidence toward building the cross-linguistic theory. The findings also have applications on diagnostic and evaluation for patients with brain lesions for clinical application with communication disorder.


Eligibility Criteria:
Inclusion Criteria:

* patients with new brain lesions confirmed by imaging study

Exclusion Criteria:

* patients with recurrent brain lesions