cyrilzakka/clinical-trials huggingface dataset:
Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma

Chemotherapy treatment with docetaxel and gemcitabine is a standard treatment for patients with soft tissue sarcoma. This study is designed to explore whether the addition of tyrosine kinase inhibitor pazopanib enhances the anticancer effect of the chemotherapy drugs.

The Phase I component of this study is designed to determine the maximum tolerated dose of pazopanib when given with docetaxel and gemcitabine. The Phase II component is designed to determine the overall response rate of the combination of docetaxel, gemcitabine and pazopanib prior to surgical resection in patients with soft tissue sarcoma.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* chemotherapy naive, histologically high grade soft tissue sarcoma that is considered to be operable
* tumor greater than 5 cm in longest dimension
* life expectancy of at least 6 months
* Zubrod performance status of 0-2
* signed informed consent
* adequate bone marrow function defined by:

  1. absolute peripheral granulocyte count of \>1500 cells/mm\^3
  2. hemoglobin \>8.0 g/dl
  3. platelet count \>100,000/mm\^3
  4. absence of a regular red blood cell transfusion requirement
* adequate hepatic function defined by:

  1. total bilirubin \<1.5 x upper limit of normal (ULN)
  2. AST, ALT and alkaline phosphatase all not more than 2.5 x ULN
* adequate renal function defined by:

  1. serum creatinine \<1.5 x ULN
* negative pregnancy test for women of child bearing potential
* willingness to use effective contraception while on treatment and for 3 months thereafter

Exclusion Criteria:

* Multiple metastases (patients with 5 or fewer oligometastases that could be resectable are eligible)
* Pregnant women or nursing mothers
* concurrent chemotherapy or radiation therapy
* severe medical problems (at the discretion of the investigator)
* history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* symptomatic brain metastases
* cirrhosis
* dermatofibrosarcoma protuberans (DFSP), embryonal rhabdomyosarcoma or alveolar soft part sarcoma (ASPS)
Racial Differences in Vagal Control of Glucose Homeostasis, Chronic Study

Investigators will test the hypothesis that chronic restoration of vagal nerve activity with a central acetylcholinesterase inhibitor improves insulin sensitivity and reduces adipose tissue oxidation in obese African American Women compared to white women.

Investigators will test the hypothesis that chronic restoration of parasympathetic nervous system (PNS) activity with a central acetylcholinesterase inhibitor improves insulin sensitivity and reduces adipose tissue oxidation in obese African American women (AAW) compared to white women (WW). A cross-over study will be performed in matched cohorts of AAW and white women subjected to chronic central acetylcholinesterase inhibition with galantamine versus placebo, given orally over a 4-week period. Insulin sensitivity will be measured using the gold standard hyperinsulinemic-euglycemic clamp. Adipose tissue will be obtained through subcutaneous fat biopsies where F2-isoprostanes will be quantified.

Eligibility Criteria:
Inclusion Criteria

* Female
* African American or white (race will be self-defined, but only subjects who report both parents of the same race will be included)
* 18-60 years old
* BMI 30-45 Kg/m2
* Not pregnant or breastfeeding

Exclusion Criteria

* Pregnant or breastfeeding
* Diabetes diagnosis (defined by the American Diabetes Association (ADA) criteria)38
* Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy.
* Arrhythmia (first-, second-, and third-degree AV block)
* Significant weight change \>5% in the past 3 months
* Impaired hepatic function (AST and/or ALT \>1.5X upper limit of normal range)
* Impaired renal function (eGFR \<60ml/min)
* Users of strong inhibitors of CYP3A4 or CYP2D6
* Users of other acetylcholinesterase inhibitors such as pyridostigmine or bethanechol
* History of alcohol or drug abuse
* Mental conditions rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
* Steroid use within 6 weeks prior to study entry
* Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
* Discretion of the investigator
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)

This is a Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic Sinusitis.

LYR-210 is a drug depot, which contains the anti-inflammatory medication mometasone furoate (MF) pre-loaded in a single use applicator. LYR-210 is intended to be placed bilaterally into the sino-nasal passages by an otolaryngologist. Once in place, each LYR-210 drug depot is designed to gradually deliver sustained topical doses of MF to the inflamed mucosal sinus tissue over 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CS.
* Two trials of medical treatments for CS in the past.
* Minimum CS symptom score.
* Ability to tolerate topical anesthesia.
* Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
* Agrees to comply with all study requirements.

Exclusion Criteria:

* Have undergone previous sinus surgery.
* Pregnant or breast feeding.
* Known history of hypersensitivity or intolerance to corticosteroids.
* History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
* Known history of hypothalamic pituitary adrenal axial dysfunction or having a morning serum cortisol level at screening outside of the normal range.
* Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
* Past or present functional vision in only one eye.
* Has cataracts
* Past, present, or planned organ transplant or chemotherapy with immunosuppression.
* Currently participating in an investigational drug or device study
Drug-Drug Interaction Study in Healthy Subjects

The purpose of this study is to assess the pharmacokinetics and safety of BMS-790052 and BMS-650032 when co-administered and when administered alone

Pharmacokinetics and Safety in Healthy Subjects

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 18 to 49 years
* Females who are not of childbearing potential, pregnant or breastfeeding
* Subject Body Mass Index (BMI) of 18 to 32 kg/m²

Exclusion Criteria:

* Women of child bearing potential
* Male subjects who have sex with women who are unwilling to agree to practice male barrier contraception during study participation and for a least 12 weeks following dosing
* Any significant acute or chronic medical illness
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
* Prior exposure to BMS-650032 or BMS-790052
* Positive for HIV or HCV
Safety and Efficacy of Inhaled Treprostinil in Patients With PAH

To evaluate the effect of inhaled treprostinil compared to placebo on exercise capacity and time to clinical worsening.


Eligibility Criteria:
Eligible subjects must:

* Be between 18 and 75 years of age at Screening (as defined by date of informed consent is signed),
* Have a diagnosis of idiopathic or heritable PAH, PAH associated with connective tissue disease (CTD), PAH associated with repaired congenital systemic-to-pulmonary shunts (at least 1 year since repair) or human immunodeficiency virus (HIV) infection, or PAH associated with appetite suppressant or toxin use.
* Be treatment naïve, or receiving background PAH therapies (e.g., phosphodiesterase type-5 inhibitor (PDE-5i)and / or endothelin receptor antagonist (ERA)) for less than 1 year prior to Screening.
* Have a 6MWD at Baseline (as measured by the mean value of two 6MWT separated by at least 24 hours, but no more than 14 days) that is between 150 - 500 meters, inclusive.
Investıgatıon of Temporomandıbular Dysfunctıon in Patıents Wıth Breast Cancer-Related Lymphedema

This study is the first study to examine temporomandibular joint dysfunction (TMD) in patients with breast cancer. The aim of the study was to investigate the relationship between lymphedema (LÖ) and TMD in patients with breast cancer. Socio-demographic characteristics of 38 individuals included in the study were recorded. Patients were divided into stage 0, 1 and 2 groups according to their LÖ stage and mild, moderate and advanced groups according to their TMD levels. In the evaluation of severity of lymphedema, Symptoms and Signs of TMD, pain threshold and tolerance assessment and normal range of motion, anxiety and depression, posture analysis environmental measurement, Craniomandibular Dysfunction Index for Clinical, Visual Analogue Scale (VAS) and algometer , goniometer and inclinometer, Turkish version of the Hospital Anxiety and Depression Scale (HAD) ,photogrammetric assessment method and inclinometer were used


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 18-75 years who were treated for unilateral breast cancer and developed breast cancer-related LE were included in the study

Exclusion Criteria:

* Patients with general joint diseases affecting the head and neck region that may cause TMD (e.g. rheumatoid arthritis),
* jaw fracture,
* trauma or orthognathic surgery history,
* cervical disc herniation,
* congenital disease,
* facial paralysis,
* patients who have been treated for TMD for the last 3 months and patients who use antidepressant drugs were excluded.
Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts

This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
* Women aged ≥18 years at the time of enrollment;\*
* Women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense;
* At moderately increased or high risk (\>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1:

AND Referred for screening mammography

Exclusion Criteria:

* Have been screened using any breast imaging technology in \<12 months immediately prior to enrollment;
* Exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment;
* Diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment;
* Are currently pregnant as determined per standard clinical practice at the investigational site;
* Present with contraindications to any imaging examination required in the study protocol;
* Have breast implants; OR
* Are lactating.
RDEA3170 PK/PD Study

The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses


Eligibility Criteria:
Inclusion Criteria:

* Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
* Subject has a Screening serum urate level 4 to 7 mg/dL
* Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion Criteria:

* Subject has a history or suspicion of kidney stones.
* Subject has undergone major surgery within 3 months prior to Screening.
* Subject donated blood or experienced significant blood loss within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1.
* Subject has clinically unacceptable physical examination, per the Investigator's judgment.
* Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment.
* Subject has Screening clinical safety laboratory parameters (serum chemistry \[other than serum creatinine and serum urate\], hematology, coagulation or urinalysis) that are outside the normal limits and are considered clinically significant by the Investigator.
* Subject has a serum creatinine value above the upper limit of normal at the Screening visit.
* Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment.
* Subject has a history of cardiac abnormalities
* Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.
Long-term Follow-up Study of COVID-19

The goal of this observational study is to learn the long-term prognosis of patients and the clinical characteristics of complications, which is of great significance for treatment of novel coronavirus infection pneumonia.

This trial plans to include 5700 inpatients with positive SARS CoV-2 nucleic acid test results. This trial does not involve the use of specific drug. Participants's health and psychological status will be observed at the preset time points. The blood, feces, urine samples of patients will be collected for relevant tests.

After the patients are enrolled, record the patient's treatment regimens, blood routine results, blood biochemistry results, cytokines results, lung imaging results, and cranial imaging results, understand the patient's current clinical manifestations, evaluate the patient's psychological status and quality of life, and collect samples of the patients' blood, feces, urine, and other related tests.

Collection of clinical samples: collect blood, urine, throat swabs and other samples from patients with confirmed novel coronavirus pneumonia (Nucleic acid test positive), and collect samples for relevant tests at 3 months, 6 months, 12 months, 18 months, 24 months and 36 months after discharge of patients, and record the clinical manifestations of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed COVID-19

Exclusion Criteria:

* Combined infection with influenza virus, mycoplasma, and chlamydia.
Online, Guided Interventions to Reduce Generalized Anxiety Disorder Among Indian University Students

This controlled, three-arm, randomized (1:1:1), multi-site trial will evaluate the efficacy, feasibility and acceptability of cognitive-behavioral therapy (CBT)-based online guided and unguided self-help intervention to reduce Generalized Anxiety Disorder (GAD) in Indian university students. The investigators aim to assess if these novel electronic health (eHealth) interventions can be integrated into Indian university systems to increase access to efficacious, less stigmatized, and cost-effective mental healthcare.

Students from three Indian colleges will be invited to complete an online, self-report survey. Based on their answers, they are categorized into clinical, subclinical, and asymptomatic for Generalized Anxiety Disorder (GAD). Those who meet the diagnostic criteria for GAD as detailed in the Diagnostic and Statistical Manual of Mental Disorders (DSM), 4th Edition are classified as clinical. Those who score a 5.7 or above using dimensional scoring of the GAD-Q-IV but are not "clinical" are classified as subclinical. All others are asymptomatic. After ruling out those with a clinical PTSD diagnosis (scoring 38 or above on the PCL5) and those currently receiving mental healthcare treatment, those who are clinical and subclinical are offered the opportunity to use one of the online programs. Those who accept are randomized between a guided self-help program, a self-help program, and a waitlist control group. Each student who enrolls will be reassessed at post-intervention (3 months) and followup (6 months later, or 9 months after completing baseline). Additionally, those who are classified as asymptomatic are invited to complete additional followup surveys at 3 and 9 months to provide data on anxiety symptom change over time.

Eligibility Criteria:
Inclusion Criteria:

* Current student of one of the 3 college sites
* Subjects must have a clinical or subclinical diagnosis of Generalized Anxiety Disorder (GAD); clinical diagnosis is met by self-reporting DSM-IV criteria for GAD; subclinical diagnosis is met by scoring a 5.7 or above using diagnostic scoring of the GAD-Q-IV

Exclusion Criteria:

* Unable to give informed consent.
* Is currently receiving mental health treatment.
* Has clinical PTSD (a score of 38 or above on the PCL5)
Semi-blunt Needles: is Outcome Better?

The aim of this observational study in patients chronically hemodialyzed by a native arterio-venous fistula is to determine the impact of the use of semi-blunt needles on the quality of the punction. The investigators have observed that cannulation with blunt needles (button-hole method) is sometimes difficult and the use of a sharp needle may be necessary, with consequently more hematomes and infections. Our hypothesis is that canulation with semi-blunt needles would be easier than with classical blunt needles, and consequently the use of sharp needles would become less frequent.

Inclusion criteria and study design are detailed below.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis patients
* Aged 18 years or more
* Dialyzed by a native arterio-venous fistula
* Cannuled by buttonhole method with blunt needles

Exclusion Criteria:

* Acute hemodialysis
* Puncture with 14G needles
* Puncture with a sole needle
* Arterio-venous grafts
* Patients transferred from another centre
Multi-modality Imaging in Peritoneal Carcinomatosis of Colorectal Origin

Intraoperative tumor localization and resection can be enhanced using intraoperative fluorescence imaging and radiodetection. Labetuzumab specifically recognizes CEA which is is expressed on \> 95% of colorectal cancers.. Therefore Indium-111-DOTA-labetuzumab-IRDye800CW is a perfect dual-labeled antibody for dual-modality image-guided surgery in peritoneal carcinomatosis of colorectal cancer.

In oncologic surgery complete tumor resection is important for treatment outcome and patient survival. When performing cytoreductive surgery (CRS) for peritoneal carcinomatosis of colorectal origin it can sometimes be difficult to distinguish tumor deposits from adhesions and scar tissue. Intraoperative tumor localization and resection can be enhanced using intraoperative imaging techniques (e.g. targeted radioguided or fluorescence guided surgery). A powerful synergy can be achieved by combining radiotracers (e.g. Indium-111) and optical tracers (e.g. IRDye 800CW) conjugated to an antibody against a tumor-associated antigen. Labetuzumab specifically recognises CEA which is expressed on \> 95% of all colorectal cancers. Therefore Indium-111-DOTA-labetuzumab-IRDye800CW is a perfect dual-labeled antibody for dual-modality image-guided surgery in peritoneal carcinomatosis of colorectal origin. The concept has been shown in preclinical studies with mice and the investigators will translate this to the clinic.

Eligible patients with peritoneal carcinomatosis of colorectal origin scheduled for CRS + HIPEC will receive dual-labeled labetuzumab 6-7 days before surgery. At day 4 or 5 a SPECT/CT of the abdomen and thorax will be obtained. Cytoreductive surgery at day 7 will be extended with the use of a near-infrared fluorescence camera and a gamma probe.

The aim of this study is to assess the feasibility and safety of intraoperative dual-modality imaging with Indium-111-DOTA-labetuzumab-IRDye800CW in peritoneal carcinomatosis of colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of peritoneal carcinomatosis of colorectal origin
* Scheduled for cytoreductive surgery and HIPEC.
* Age over 18 years
* Signed informed consent

Exclusion Criteria:

* Any medical condition present that in the opinion of the investigator will affect patients clinicals status
* Administration of a radionuclide within 10 physical half-lives prior to study enrollment
* Pregnancy or lactation
* Patients with very high (\>500ng/ml serum CEA levels
* Known CEA negative tumor
The Optimization and Evaluation of the Extremism and Intolerance Curriculum for the Kingdom of Bahrain.

Researcher from UNC Greensboro have partnered with Prevention Strategies and key stakeholders from the Kingdom of Bahrain to conduct a study using the innovative, engineering-inspired methodological approach, the Multiphase Optimization Strategy (MOST), to optimize and evaluate the Peaceful Coexistence and Anti-Extremism middle and high school curricula. No other curriculum targeting tolerance and/or extremism has been optimized using the state-of-the-art MOST methodology. The overall goal of the project is that the optimized versions of Peaceful Coexistence and Anti-Extremism curricula will be used across the Kingdom of Bahrain and translated for use in other countries to combat the spread of extremism and intolerance. Additionally, the D.A.R.E. keepin' it REAL (kiR) and D.A.R.E. myPlaybook high school programs will be evaluated as part of the Peaceful Coexistence and Anti-Extremism evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Public or private Bahraini middle or high school students.
* In addition to the main evaluation questions, the following groups will also be included to make programmatic improvements.
* Parents of above mentioned middle or high school students.
* D.A.R.E. Officers teaching middle school and high school D.A.R.E. in Bahrain.

Exclusion Criteria:

* None