cyrilzakka/clinical-trials huggingface dataset:
Genetic Testing in African Americans

This is a pilot/feasibility study to conduct genetic testing using tumor/blood samples of African American and Caucasian patients with ovarian and endometrial cancer following surgery at AU Health Medical Center. The aim of the pilot/feasibility study is to sequence a panel of cancer genes on paired tumor/blood (germline) samples of patients with ovarian and endometrial tumors at a two-week time point following surgery at AU Medical Center. While paired testing of tumor and blood (germline) provides direct clinical value to patients, investigators propose to study whether investigators can define and overcome such minority barriers among the Georgia Cancer Center (GCC)/AU Health Medical Center (AUMC) patient population.

The purpose of this study is to identify genetic mutations using a sequence a panel to detect cancer genes on paired tumor/blood (germline) samples particularly (AA) patients with ovarian, endometrial, fallopian or primary peritoneal carcinoma as AA individuals with cancer are less prone to accept a recommendation to undergo genetic testing. Approximately 30 subjects will participate in this study at Georgia Cancer Center/AU Health Medical Center.

Primary Objective:

To test the feasibility of this approach designed to provide a preliminary statistical analysis among the number of patients to overcome minority barriers among the GCC/AUMC patient population.

Secondary Objectives:

1. Measure attitudes toward early testing.
2. Compare rates of participation based on messaging of benefits between Caucasians and AA

Subjects must meet all inclusion criteria of the study. There are no exclusion criteria.

Patients will be identified by an AU Health gynecologic oncologist (SG, BR, RH). A research coordinator will be deployed to the clinic at the 2-week post-biopsy visit.

All subjects who consent to participate a clinical research coordinator will ask for their permission to provide a matched tumor and blood sample for genetic testing. If consented the subjects will be given a questionnaire regarding their knowledge of genetic testing for germline mutations. Tumor and blood samples will be collected for testing and sent to the Georgia Esoteric and Molecular Laboratory. It is estimated that it will take approximately one year to fully accrue and complete assessments on all participants entered on this study.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years of age.
2. New diagnosis of ovarian, endometrial, fallopian, or primary peritoneal carcinoma.
3. Diagnostic procedure performed at AU Health Medical Center.
4. Adequate tissue is available for the tumor testing component (e.g., cytology and FNA samples are typically not adequate, whereas core biopsies and open biopsies usually are adequate.
5. Consent at first post-biopsy outpatient clinic visit (typically about 2 weeks).
6. Ability to provide informed consent in English.

Exclusion Criteria:

There are no exclusion criteria

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Modified Video-assisted Thoracoscopic Surgery (VATS) Lobectomy for Early-stage Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to modify the surgical technique of VATS (video-assisted thoracoscopic surgery) lobectomy for early-stage non-small cell lung cancer.

VATS (video-assisted thoracoscopic surgery) lobectomy is a relatively new minimally invasive surgical treatment for early-stage non-small cell lung cancer (NSCLC), associated with low morbidity and mortality and effective oncologic results over the standard thoracotomy. However, this surgical procedure has not spread widely in china for several reasons. First , VATS surgery cost more than thoracotomy for thoracoscopic staples; second, the procedure of VATS lobectomy may be more difficult in china as the lack of VATS surgical equipments adjusted for smaller thoracic cavity of chinese, and more common adhesive and calcified lymph nodes due to infection and tuberculosis; Third, the surgical levels of VATS lobectomy are far from equal in china, and the Continuing Medical Education training programs of thoracoscopic surgery seem to be less efficient without major criterion.

The purpose of this study is to modify the surgical technique of VATS (video-assisted thoracoscopic surgery) lobectomy for early-stage non-small cell lung cancer, to examine the feasibility of VATS lobectomy performed by less staples, and to evaluate the feasibility of VATS lobectomy performed by modified surgical equipments designed according to the experience of chinese lobectomy surgery, and to generate a chinese standard operative procedure of VATS lobectomy for technique learning and spread. The investigators will intend to recruit 250 patients each group, for 4 groups. Group A(open group) will undergo radical lobectomy via thoracotomy approach. Group B(standard VATS group) will undergo lobectomy via standard VATS approach introduced. Group C(less staples group) will undergo lobectomy via VATS approach with staples limitation. Group D(modified equipments group) will undergo lobectomy via VATS approach using VATS surgical equipments designed according to the experience of chinese lobectomy surgery. The investigators will compare two groups of patients as followed: A vs. B, B vs. C, B vs. D.

Eligibility Criteria:
Inclusion Criteria:

1. clinically diagnosed with stage I to stage II peripheral non-small cell lung cancer suitable for lobectomy.
2. signed informed consent from patient or legal representative, and allowed adequate follow-up.
3. operators must have experience of VATS lobectomy for more than 50 cases.

Exclusion Criteria:

1. pregnant or breastfeeding women.
2. severe complications or infections.
3. no prior chemotherapy or radiotherapy for this malignancy.
4. medical history of mediastinal or hilar lymphadenopathy.
5. current participation in another study involving an investigational device or drug.
Effect of Tumor Micronecrosis on Postoperative Transcatheter Arterial Chemoembolization in Patients With Hepatocellular Carcinomas

Micronecrosis is a novel pathological feature of hepatocellular carcinoma (HCC). This study was aimed at evaluating the effect of tumor micronecrosis on postoperative transcatheter arterial chemoembolization (TACE) in patients with hepatocellular carcinomas, and further exploring the value of micronecrosis for guiding TACE in HCC management.


Eligibility Criteria:
Inclusion Criteria:

* (1) pathologically confirmed HCC (2) achievement of R0 resection.

Exclusion Criteria:

* (1) simultaneous presence of other tumors ; (2) receipt of preoperative anti-tumoral treatments; (3) concurrent treatment with other antitumoral therapies in combination with TACE; (4) tumor necrosis that could be observed by gross examination; (5) a lack of necessary preoperative laboratory test results.
Assessing the Impact of "Super-whey" vs. Isonitrogenous Whey on Muscle Protein Synthesis

Skeletal muscle accounts for approximately 45-55% of total body mass in healthy adults and plays a pivotal role in whole-body metabolic health, locomotion and physical independence. Undesirable loss of skeletal muscle mass (atrophy) is, however, a common feature of many diseases and scenarios including ageing, bed rest/immobilisation, cancer and physical inactivity. Despite the exact mechanisms causing muscle atrophy being not yet fully understood, "anabolic resistance" (reduced muscle building in response to protein feeding and exercise) is thought to be key, especially for age-related skeletal muscle losses (known as sarcopenia). As such, the search for optimal strategies (e.g., exercise and/ or nutritional interventions) to combat this anabolic blunting remains a hot-topic in scientific research.

Leucine, an essential and branched chain amino acid (EAA/BCAA), is thought to be the most potent AA for stimulating muscle protein synthesis (MPS; the muscle building process). Although, as a stand-alone supplement, leucine is unlikely to provoke a robust and prolonged state of MPS, low doses of leucine-enriched mixed-EAAs can elicit similar increases in MPS as compared to a large dose of whey protein. As reduced appetite and increased satiety (feeling fuller) are common with advancing age, supplementation of a low-dose protein (i.e., leucine-enriched) that can adequately stimulate MPS may contribute to muscle health maintenance in older adults and reduce satiation following a meal.

This study aims to examine whether a novel whey protein with greater leucine content ("super-whey") has superior muscle building properties compared to a regular whey protein, at rest and after a single bout of exercise, in both young and older adults


Eligibility Criteria:
Inclusion Criteria:

* Participant is in the desired age-ranges (young adults: 18-35 years; older adults: 65+ years).
* Participant is willing and able to give informed consent for participation in the study.
* Participant is physically able to perform resistance exercise

Exclusion Criteria:

* A BMI \<18 or \>35 kg/m2
* Active cardiovascular, cerebrovascular or respiratory disease: e.g. uncontrolled hypertension (BP \> 160/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event, COPD, pulmonary hypertension or recent (6 mo) stroke
* Any metabolic disease
* Clotting dysfunction
* A history of, or current neurological or musculoskeletal conditions (e.g. epilepsy)
* Lactose intolerance
* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection

Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19

This is a randomized, doubled-blind and placebo-controlled phase II study that will evaluate the efficacy of the early use of ivermectin plus losartan in cancer patients who present with recent diagnosis of COVID-19.

The trial will enroll 176 patients with previous diagnosis of active cancer (88 in each arm) and the aim of the study is to assess the efficacy of these drugs combination to decrease the incidence of COVID-19 severe complications. Patients will receive single dose ivermectin of 12mg after the confirmed diagnosis of COVID-19, followed by 15 days of losartan.

We believe that the association of anti-viral activity of the ivermectin plus the extracellular blockade of the receptor used by the virus will decrease the overall viremia and subsequently improve clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years of age
* Ability to understand and sign informed consent
* Biopsy-proven diagnosis of previous cancer (solid or hematologic disease)
* Participants must be diagnosed with active malignancy, defined as the presence of metastatic disease; or patient undergoing curative treatment during cancer treatment, regardless of the therapeutic modality.
* Confirmed diagnosis of COVID-19 by the presence of a positive PCR test or positive serological test and / or diagnosis presumed by the presence of flu-like symptoms associated to suggestive findings on CT scan.
* ECOG performance status 0 to 2
* Patients must have an assessment of adequate organ function within 28 days prior to enrollment, evidenced by:

  * Hemoglobin ≥ 9.0 g / dL
  * Leukometry\> 2,000 / mm3
  * Absolute neutrophil count ≥ 1,500 / mm3
  * Platelet count ≥ 100,000 / mm3
  * Creatinine clearance ≥ 30 mL / min. Creatinine clearance (CrCl) should be calculated according to the Cockcroft-Gault formula.
  * Total bilirubin \<3 x the upper limit of normal (ULN), except for patients with known Gilbert's syndrome.
  * Aspartate aminotransaminase (AST) \<3.0 x LSN.
  * Alanine aminotransaminase (ALT) \<3.0 x ULN.

Exclusion Criteria:

* Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB).
* Patients who presents with severe conditions at the time of diagnosis requiring ICU admission.
* Prior reaction or intolerance to an ARB or ACE inhibitor.
* Blood pressure less than 110/70 mmHg at presentation
* Potassium greater than 5.0 mEq / L
* Pregnancy or breastfeeding
* Prior reaction to Ivermectin.
* Patient currently enrolled in another research protocol
AZD6244 Versus Pemetrexed (Alimta®) in Patients With Non-small Cell Lung Cancer, Who Have Failed One or Two Prior Chemotherapy Regimen

The purpose of this study is to assess the effect and safety of AZD6244(ARRY-142886)versus pemetrexed in the second or third line treatment of advanced Non-Small Cell Lung Cancer. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or pemetrexed. Treatment will be continued for as long as patients receive clinical benefit.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with non-small cell lung cancer
* Previously received one or two chemotherapeutic treatments

Exclusion Criteria:

* Previous therapy with MEK inhibitor or pemetrexed
* Any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases
Optimal Insertion Depth of FOB for Oral FOB Intubation

For oral fiberoptic intubation, the preliminary insertion depth of the fiberoptic bronchoscope should be important because the excessive insertion depth or too shallow depth might be the reason why the clinicians cannot perform oral fiberoptic intubation completely.

The purpose of the study is to find out the optimal preliminary insertion depth of the fiberoptic bronchoscope for visualization of glottic opening in oral fiberoptic intubation.

For oral fiberoptic intubation, the preliminary insertion depth of the fiberoptic bronchoscope should be important because the excessive insertion depth or too shallow depth might be the reason why the clinicians cannot perform oral fiberoptic intubation completely.

The purpose of the study is to find out the optimal preliminary insertion depth of the fiberoptic bronchoscope for visualization of glottic opening in oral fiberoptic intubation.

The investigators will enroll the subjects of the present study after obtaining the written consent.

After enrollment, the investigators will measure some anatomical distance, such as patient height.

After induction of anesthesia and muscle relaxation for tracheal intubation, An investigator who has experiences of numerous fiberoptic intubation will measure the optimal preliminary insertion depth of the fiberoptic bronchoscope from the philtrum, the upper lip, or the incisors for oral fiberoptic intubation, with the aid of assistants. Then, tracheal intubation with a laryngoscope as a routine manner of our institute.

The investigators will calculate the mean value of the optimal depth and find out an formula for that from our data.

Eligibility Criteria:
Inclusion Criteria:

* patients requiring tracheal intubation for general anesthesia

Exclusion Criteria:

* do not agree to participate in the study
* emergency surgery
* predicted difficult intubation
* very weak teeth (especially central teeth)
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis

The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or treatment-experienced.

This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), multicenter study. The study will consist of a screening phase up to 6 weeks, open-label treatment phase of 8 weeks or 12 weeks, and post-treatment follow up phase up to 24 weeks after end of treatment. Approximately 300 participants will be randomly allocated in a 1:1 ratio to receive 150 mg simeprevir in combination with 400 mg sofosbuvir once daily either for 12 weeks (Arm 1) or 8 weeks (Arm 2). Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examination. The maximum study duration for each participant will be approximately 42 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Hepatitis C virus (HCV) genotype 1a or 1b infection confirmed before randomization
* Documentation of the presence or absence of a NS3 Q80K polymorphism in HCV genotype 1a infected participants before randomization
* Documentation of the IL28B genotype before randomization
* HCV ribonucleic acid level greater than 10,000 IU/mL at screening
* Treatment-experienced participants must have at least 1 documented previous course of interferon-based regimen with or without ribavirin
* Absence of cirrhosis in participants

Exclusion Criteria:

* Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy)
* Infection/co-infection with HCV non-genotype 1a or 1b
* Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening)
* Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen positive)
* Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection
Sarcopenia in Children

Juvenile idiopathic arthritis (AJI), is a frequent inflammatory disease in children, characterized by pain, arthritis, and deformities. Chronic inflammation leads to physical inactivity and can be associated with muscle weakness around affected joints, low bone strength, and mass(3). To our knowledge, no study has focused on the prevalence of sarcopenia in JIA and the data on the muscle disorder are lacking. The purpose of the present study is to detect sarcopenia and identify associated factors in children with JIA


Eligibility Criteria:
Inclusion Criteria:

* children with juvenile idiopathic arthritis fulfilling the ILAR criteria

Exclusion Criteria:

* We excluded patients who have a prosthesis, nutritional problems, inflammatory bowel disease, coeliac disease, temporomandibular involvement, or another chronic disease.
Improving Decision Making About Feeding Options for Dementia

This study is a randomized trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia.

This research study is a cluster randomized controlled trial of a decision aid to improve decision-making about feeding options for patients with advanced dementia. Surrogate decision-makers in the nursing homes randomized to the intervention will review the decision aid and be prompted to discuss it with the primary health care provider, while those in the control sites receive usual care. We measure the immediate, 1 and 3 month effects of the decision aid on the quality of surrogate decision-making for nursing home residents with advanced dementia.

Eligibility Criteria:
Inclusion Criteria:

* dementia diagnosis
* advanced cognitive impairment
* feeding problem
* age \>= 65
* surrogate decision maker

Exclusion Criteria:

* feeding tube decision made
* hospice
* BMI \> 26
* major psychosis or developmental delay
Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain

The purpose of the study is to investigate the effects of non-invasive invasive vagal nerve stimulation on diabetic peripheral neuropathic pain in people with diabetes.

The study is a randomized, double-blinded, sham-controlled, parallel-group clinical trial, which will include participants with diabetic peripheral neuropathic pain.

Participants are randomized to receive either active non-invasive transcutaneous vagal nerve stimulation (tVNS) or inactive sham stimulation.

The study will investigate the effects of short-term, high-intensity tVNS treatment on peripheral pain.

The primary outcome is subjective patient evaluation of pain symptoms by the use of validated questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 diabetes mellitus \> 1 year
* Patients experiencing neuropathic pain

Exclusion Criteria:

* Patients with co-morbidities such as chronic pain from other conditions
* Patients with serious complications of diabetes such as nephropathy and retinopathy
The Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2001 and HGP2001 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* 19 kg/m\^2 ≤ BMI \< 28 kg/m\^2, weight \>60kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<900 mmHg
* agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.

Exclusion Criteria:

* A history of hypersensitivity reactions or clinically significant hypersensitivity reactions
* A history of gastrointestinal diseases or surgery that may affect the absorption of clinical trial drugs
* A history of substance abuse or who test positive for drugs of concern for abuse in the urine drug screening test
* Positive results of serological tests
* Have taken other investigational drugs or bioequivalence drugs within 6 months before the first administration of the investigational drug
* Donated whole blood within 60 days prior to the screening date or donated components within 30 days or received a blood transfusion within 30 days
* Have drank more than 210 g/week of alcohol within 30 days before the screening date
* Have smoked more than 10 bills/day within 30 days before the screening date
* AST, ALT value is more than 2 times the UNL or bilirubin level is more than 1.5 times the UNL, eGFR \< 50 mL/min/1.73m2, Prothrombin (INR) \> 1.31 INR or aPTT \> 39.7 sec
* 12-ECG QTc \>450 ms
Prevalence of Corneal Astigmatism Before Glaucoma Surgery in Chinese Patients With Primary Angle-closure Glaucoma

Clear-lens extraction has been considered as first-line therapy for primary angle closure glaucoma(PACG) and application of toric intraocular lens (IOLs) leads to better postoperative visual acuity, yet little is known about the prevalence of corneal astigmatism in PACG patients. We intend to make biometry examination for Chinese PACG patients, to obtain keratometry (K) , axial length (AL) and so on, and demographics data will also be recorded. We will study the prevalence of corneal astigmatism before glaucoma surgery in Chinese patients with PACG. Furthermore, differences of corneal astigmatism between primary angle-closure glaucoma and cataract patients will be explored. Finally, the prevalence of corneal astigmatism before glaucoma surgery in Chinese patients with PACG will be portrayed and can be instructive to the IOLs' manufactering.

Biometry examination contains keratometry (K) , axial length (AL), central anterior chamber depth, visual field loss(mean deviation, MD), choroidal thickness(CT), range of goniosynechia, and stage of PACG.

Demographics data contains age, gender, and eye.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are phakic and aged 40 years or older , and had newly diagnosed primary angle closure with intraocular pressure 30 mm Hg or greater or primary angle-closure glaucoma, will be recruited during preoperative screening at Zhongshan Ophthalmic Center.

Exclusion Criteria:

* Patients with corneal disease, irregular astigmatism, previous corneal or intraocular surgery, or a history of ocular inflammation will be excluded.