cyrilzakka/clinical-trials huggingface dataset:
Treatment of Cancer-anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreatic Cancer Patients

Purpose of the study is to compare the effects of megestrol acetate concentrated suspension and placebo on caloric intake for the treatment of cancer-associated anorexia in patients with lung or pancreatic cancer


Eligibility Criteria:
Inclusion Criteria:

* Stage II, III,or IV lung or pancreatic cancer
* Fair, poor, or very poor appetite
* Cancer associated anorexia/cachexia
* Weight loss perceived to be associated with diminished appetite
* Eastern Cooperative Oncology Group Performance score of 0, 1, 2
* Life expectancy \>3 months
* Alert and mentally competent
* Women of child-bearing potential required to use an adequate and reliable method of contraception. Post-menopausal women have to have been so for at least 1 year
* Screening laboratory values must not be clinically significant (some exceptions per protocol)

Exclusion Criteria:

* Brain, or head and neck metastases that may interfere with food consumption
* AIDS-related wasting
* Radiation therapy to the head and neck, abdomen, or pelvis within past 6 weeks, or anticipated during course of the study such that the result may interfere with food consumption
* Conditions that interfere with oral intake, or ability to swallow
* Absence of a normally functioning gut
* Mechanical obstruction of the alimentary or biliary tract, or malabsorption syndrome
* Intractable or frequent vomiting that regularly interfere with eating
* Clinically significant diarrhea
* History of recurrent thromboembolic events, a thromboembolic event in past 3 months, or long-term anticoagulation treatment for thromboembolism
* Uncontrolled diabetes mellitus, or symptomatic hypoadrenalism
* Poorly controlled hypertension, or congestive heart failure
* Pregnant/lactating females
* Use within past 30 days of an appetite stimulant
* Use within past week, or planned use during the study of parenteral nutrition or tube feedings
* Chronic use of steroids within past 3 months (intermittent short-term use allowed)
* Current use of or not willing to abstain from using illicit substances
* Allergy, hypersensitivity, or contraindication to megestrol acetate
Leptin and Endothelial Function

The purpose of this trial was to determine if injections of leptin would improve vascular function in normal-weight, healthy volunteers.

The researchers plan to enroll a total of 15 non-obese (BMI \< 27 kg/m2) otherwise healthy adults into a randomized, double-blinded, cross-over study of the impact of recombinant methionyl human leptin 0.2 mg/kg SC, hereafter called rL, (Amgen Inc, Thousand Oaks, Calif) versus placebo SC (sorbitol and sodium acetate, pH 4.0 of same volume) in 15 non-obese adults. Subjects will have baseline vascular studies performed by brachial artery ultrasonography-flow-mediated dilatation and nitroglycerin mediated dilatation and blood drawn for measures of leptin levels. They will then receive rL SC or placebo SC (randomized order). They will then have vascular studies performed and blood levels drawn every 2 hours for 6 hours total. After completion of day 1, patients will return 1-4 weeks later and repeat the protocol crossed-over to the alternate intervention (rL or placebo).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female ages 18-50.
* BMI \< 27 kg/m2 for lean group

Exclusion Criteria:

* Any CVD risk factor (diabetes or fasting glucose \> 126 mg/dL
* Hypertension or measured BP \> 140/90 mmHg
* Current tobacco smoking within last month
* LDL\>160 mg/dL, HDL\<35 mg/dL)
* Renal insufficiency (creatinine \> 1.4 mg/dL)
* Thyroid abnormalities (abnormal TSH)
* Established CVD (any atherosclerosis, or history of peripheral arterial disease, previous stroke, myocardial infarction, angina, heart failure, aortic aneurysms)
* Usage of medications which impact endothelial function within last month (folate, fish oil, Vitamin C or E, L-arginine, blood pressure or lipid-lowering medications, diabetes medications)
Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing

A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease.

A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease. Patients with hypertension resistant of antihypertensive treatment have a high frequency of non-dipping and obstructive sleep apnoea (OSA). The aim of this project is to analyse the effect of dietary sodium restriction on nocturnal blood pressure and nocturnal pauses in breathing in this patients population.

Eligibility Criteria:
Inclusion Criteria:

* 24h blood pressure \> 130/80 mmHg under antihypertensive treatment with three agent, one of these being diuretic. Blood pressure measurement completed after observed intake of antihypertensive medication.
* unchanged antihypertensive treatment for three months
* estimated glomerular function \>45 mL/min/1.73 m2

Exclusion Criteria:

* Heart failure assessed from NYHA classification (grade 3-4)
* Presence of clinically significant peripheral edema
* In treatment for obstructive sleep apnea
* Chronic obstructive pulmonary disease (FEV1 \<50%)
* Antihypertensive therapy that can not be taken once daily
* Pregnancy or breastfeeding
* Β-albumin \<34 g / l
* U-albumin creatinine ratio\> 1000 mg / g
* INR\> 1.2 (if marevan treatment: ALAT\> 200)
* Gluten allergy (dietary guidelines are not adjusted to this group)
Early Stockholm Obesity Prevention Program (EarlySTOPP-China)

Early STOPP project promotes good health in children from early age by supporting good habits for the whole family. Our aim is to see if we can prevent overweight and obesity in children in families where parents are overweight or obese. Normal weight parents will also be needed in this study.

Background: Several daily habits lead to less favorable health factors. For example, using the car instead of cycling or walking - leads to less activity in everyday life. Individuals also eat more unhealthy foods in larger portions. In combination with genetics, social in heritage and surrounding factors this contributes to increase overweight and obesity among children not only in adults but also in children.

Good treatment for childhood obesity are lacking, making prevention very important. The earlier good habits are introduced to a child the better it is.

In Early STOPP project we study food, physical activity and sleep habits in the families with a child of one year of age. The height, weight, waist circumference and blood pressure will be recorded in both child and parents. The parents will answer questionnaires about food, physical activity and sleeping habits for both the child and themselves. During the study, the child's physical activity will be measured. Based on our observations we aim to develop the preventive strategies for the families with very young children.


Eligibility Criteria:
Inclusion Criteria:

* one obese or two overweight parents, 1 year old child

Exclusion Criteria:

* weight effecting diseases
Evaluation of Etomidate on Adrenal Function in Trauma Patients

Trauma patients are at increased risk for adrenal function insufficiency. A commonly used agent for rapid sequence intubation (RSI) is known to decrease adrenal function. We want to determine the incidence of adrenocortical insufficiency and its significance during the first 24 hours of resuscitation following RSI in trauma patients.

The study will have two arms. Patients on one arm will be assigned to receive etomidate (0.3 mg/kg) and succinylcholine (1mg/kg) for RSI. Patients on the other arm will receive standard therapy at this institution which consists of Versed (generic name midazolam) (5 mg) plus fentanyl (100 mcgs) as well as succinylcholine for RSI. Both drug regimens have a rapid onset, short duration and short half-life.

Patients will be randomly assigned to one arm of the study. The trauma nurse emergency room responders, intensive care unit staff, or helicopter crew will pull a study envelope which will contain a randomization to either the etomidate arm or standard therapy arm. The numbers will correspond to a log, delineating which medication is given. The nurse will document the medication as RSI Study Drug - etomidate or RSI Study Drug - standard and the randomization packet number (ie, RSI Study Drug, etomidate, #1, RSI Study Drug, standard, #2, etc.) and will document the patient's name and medical record number on the study log in either the helicopter or the ER Resuscitation Bay.

Baseline cortisol level will be drawn prior to RSI. An additional cortisol level will be drawn 4-6 hours later. Following this level, a cortrosyn stimulation test will be performed by giving 0.25 mg cortrosyn IV and rechecking a cortisol level in 60 minutes. Adrenal insufficiency will be defined as a baseline cortisol level of \<15 or an increase in cortisol of \<9 after cortrosyn administration. Patients will be monitored for 24 hours for hemodynamics, IV fluid administration , and use of vasopressors. Patient will be resuscitated to adequate mean arterial blood pressure and urine output. Any patient found to be adrenal insufficient will be treated with hydrocortisone 50 mg IV every 6 hours.

Eligibility Criteria:
Inclusion Criteria:

* Trauma mechanism of injury
* Patient requires rapid sequence induction for ventilatory support

Exclusion Criteria:

* \<18 years old
* Prisoners
* Pregnant women
* Patients with a history of adrenal insufficiency
* Patients with adrenal trauma documented by CT scan
* Patients receiving corticosteroids in the previous year
Holiday Season Weight Change During Islamic Holidays

The study involved 30 regular exercisers and 33 non-exercisers. Food records were collected five times: before the holiday season, before Ramadan, during Ramadan, during Ramadan Feast, and after Ramadan Feast, including the Eid al-Adha period. Anthropometric measurements were taken before and after holidays: initially before Ramadan and again after Eid al-Adha. Physical activity was recorded for both groups: once before Ramadan for non-exercisers and twice (on exercise and rest days) for exercisers.

The purpose of this study is to determine the changes in nutrient consumption during the holiday season and to assess the changes in body weight, body composition, and blood pressure of exercising and non-exercising individuals at the end of this season. In the United States of America, the holiday season is the period between Thanksgiving and New Year's Day. In Turkey, the holiday season is defined as the period between the Feast of Ramadan and the Feast of Sacrifice. A total of 30 individuals who regularly exercise and 33 who do not exercise participated in the study. In this study, 3-day food consumption records were taken from the participants five times; before the holiday season, before Ramadan, during Ramadan, during Ramadan Feast, after Ramadan Feast, and during the Eid al-Adha period. The anthropometric measurements of the participants were measured before and after the holidays. The first measurement was taken before Ramadan, and the second was taken after Eid al-Adha. Physical activity was recorded in the pre-Ramadan period, once for non-exercising participants, and twice for exercising participants, on exercise and rest days.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 to 45 years
* Body mass index (BMI) between 18.5-40.0kg/m2
* Observing the Islamic holiday season.

Exclusion Criteria:

* Pregnant or lactating women
* Chronic metabolic diseases including type 1 or type 2 diabetes, any type of cancer, cardiovascular diseases
* 5kg of weight gain or loss in the last 3 months
* Planning to lose weight or following a specific diet
* Exercising \>300min/week
* Medication use that might affect body weight or composition
Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Taiwan

The purpose of the study is to identify the bacterial aetiology of Acute Otitis Media episodes in young children aged \>= 3 months to \< 5 years in Taiwan


Eligibility Criteria:
Inclusion Criteria:

* Age: \>= 3 months and \< 5 years at the time they are seen by the pediatrician or ear, nose and throat specialist. The subject becomes ineligible on the fifth birthday.
* Onset of signs and symptoms of acute otitis media within 72 hours:
* One of the functional or general signs of otalgia (, conjunctivitis, fever and either
* Paradise's criteria or
* Spontaneous otorrhea of less than 1 day.
* Written informed consent obtained from parent or legally acceptable representative prior to study start.

Exclusion Criteria:

* Hospitalized during the diagnosis of acute otitis media.
* Onset of otorrhea greater than 1 day prior to enrolment.
* Otitis externa, or otitis media with effusion.
* Presence of a transtympanic aerator.
* Systemic antibiotic treatment received for a disease other than acute otitis media in the 72 hours prior to enrolment.
* Receiving antimicrobial prophylaxis for recurrent acute otitis media.
* Provision of prescribing antibiotics by ear, nose and throat specialist and Pediatricians for acute otitis media before sample collection.
* Intended or planned prescription of antibiotic by pediatrician or ear, nose and throat specialist prior to the completion of study specified procedures during the enrolment visit.
Evaluation of the Role of Plasma Biomarkers in the Development of Decompensation in Patients With Cirrhosis .

This is a single-center and prospective study to identify specific biomarker in order to predict development of decompensation in cirrhotic patients.

The duration of the study is 36 months and it provides a cohort of 200 patients.

At screening, patient will have taken blood samples and performed hepatic vein pressure gradient.

After randomization, patient will be seen at follow up every 3 months to do blood sample and every 12 months to undergo hepatic vein pressure gradient , according to the guidelines.

In addition, metabolomics analysis will be performed at screening and every 3 months. The results will be analyzed in relation to emergence of decompensation during follow up period, in order to identify specific metabolomics characteristics that may be able to predict decompensation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of liver cirrhosis
* Aged between 18 and 75 years
* Obtaining written informed consent
* Absence of exclusion criteria

Exclusion Criteria:

* Diagnosis of hepatocellular carcinoma
* Presence of portal vein thrombosis
* HIV
* Liver transplantation
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices

To monitor post-market performance through evaluation of short and long-term performance via:

* Efficacy
* Safety
* Patient reported outcomes

As this is a post-market registry on market approved devices, there will be no formal hypothesis testing. However, points of evaluation will include:

* Characterize the efficacy of the AMS market approved female pelvic health products using standard of care outcome measures and validated quality of life questionnaires
* Characterize the type, severity, and rate of adverse events related to each AMS market approved female pelvic health product
* Collect concomitant procedural data related to the pelvic floor area

Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all of the following criteria to be considered for inclusion in the registry.

  * Have a signed Informed Consent Form
  * Have a signed HIPAA Authorization Form or equivalent Patient Privacy Form if required outside of the US
  * Is a female at least 18 years of age
  * Is scheduled to receive at least one (1) AMS market approved female pelvic health implantable product.
  * Is able and willing to participate in the registry

Exclusion Criteria:

* Patients will be excluded from the registry if any one of the following criteria is met.

  * Patients are contraindicated to receive the target AMS market approved female pelvic health product per the product's IFU
Health Needs of Patients With Kallmann Syndrome

Kallmann syndrome (KS), also known as congenital hypogonadotropic hypogonadism (CHH), is a rare endocrine disorder that is characterized by failure to undergo puberty combined with infertility. KS/CHH patients face a number of psychosocial burdens related to delays in diagnosis, inadequate access to expert care, and lack of information about the condition. As such, there is some evidence to suggest that KS/CHH patients have unmet health needs. This study aims to identify the needs of patients and understand the issues that must be overcome to achieve improved health and quality of life.

This study aims to examine the experiences of patients diagnosed with Kallmann syndrome (KS)/congenital hypogonadotropic hypogonadism (CHH).

The study includes two parts:

* online survey (less than 30 minutes to complete)
* focus groups with KS/CHH patients

The aim of this project is to better understand what health needs are not presently being met for these patients and to identify targets for improving the care of patients diagnosed with KS/CHH

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with congenital hypogonadotropic hypogonadism: i.e. Kallmann syndrome or idiopathic hypogonadotropic hypogonadism
* Primary language is English/capable of responding to a written questionnaire in English
* Consenting to participate in the study

Exclusion Criteria:

* other diagnosis of hypogonadism: i.e. hypergonadotropic hypogonadism (Klinefelter syndrome), adult onset hypogonadism, etc.
Blood Collection Study From COVID-19 Convalescents Previously Hospitalized to Identify Immunogenic Viral Epitopes

The COVID-19 pandemic is a global emergency threatening to take millions of lives in the United States and around the world. There is no current vaccine strategy against COVID-19 infection caused by a novel coronavirus named SARS-CoV-2. Studies with a related coronavirus called SARS-CoV-1 that caused the SARS outbreak in 2003 indicated that memory CD8+ T cells recognizing viral epitopes persisted for more than 6 years post infection while neutralizing antibodies and memory B cells were short-lived and were undetectable after a short period of time (Tang et al., 2011; Peng et al., 2006; Channappanavar et al., 2014). Thus, including viral epitopes that are recognized by memory CD8+ T cells is imperative for vaccines that can provide long-term immunity against SARS-CoV-2. In this study, blood samples from COVID-19 patients who have recovered from the infection will be used to identify the viral epitopes recognized by their memory CD8+ T cells. This will be accomplished using a genome-wide, high-throughput screening technology developed at Harvard Medical School (Kula et al., 2019) and licensed by the study sponsor, TScan Therapeutics. A 24,000-member library that tiles across all \~100 viral isolates of SARS-CoV-2 that have been sequenced so far has already been synthesized at TScan. Blood samples from convalescent patients are urgently needed to identify T cell receptors and immunogenic viral epitopes on SARS-CoV-2. It is the hope that these data will inform development of a vaccine with the potential for long-lasting protection against SARS-CoV-2.


Eligibility Criteria:
Inclusion Criteria:

* Laboratory-confirmed diagnosis of COVID-19 performed by The Centers for Disease Control and Prevention (CDC) at a hospital using an FDA Emergency Use Authorized molecular assay for COVID-19
* Age =\>18 years at time of diagnosis of COVID-19
* Time since discontinuation of isolation of =\>14 day following CDC criteria
* Ability to understand and willingness to sign an informed consent document
* No anti-pyretic use for =\>17 days
* Ability to undergo blood draw for 4 tubes of blood containing approximately 7.5 mL of blood each
* Ability to travel to an assigned lab for blood draw
* Ability to waive any claim to blood samples or data obtained for this study's purpose

Exclusion Criteria:

* Any serious medical or psychiatric disorder that would interfere with the subject's safety
* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
* Known blood disorder that would increase the risk of infection or bleeding from a simple phlebotomy
Blocking Tumor Necrosis Factor in Ankylosing Spondylitis

The Division of Rheumatology at University of California San Francisco is conducting a research study on the treatment of ankylosing spondylitis (AS) with a new therapy currently used for people with other forms of arthritis. The drug, called Enbrel (or etanercept), is a protein that is given twice weekly by injection underneath the skin. It blocks the action of tumor necrosis factor-alpha (TNF-alpha), a substance that may be involved in AS, rheumatoid arthritis, and other inflammatory conditions. We will randomly assign patients to receive either the drug or a placebo (inactive treatment) for 4 months. The results we will monitor include morning stiffness, spinal mobility, activities of daily life, and safety of the drug.

In this Phase II clinical trial we will use tumor necrosis factor receptor p75 fusion protein (TNFR:Fc, or etanercept) to treat patients with ankylosing spondylitis (AS). TNFR:Fc is an antagonist of tumor necrosis factor (TNF), a cytokine that researchers have shown to play a possible role in disease pathogenesis of ankylosing spondylitis, rheumatoid arthritis, and vasculitis, as well as other inflammatory conditions.

TNFR:Fc consists of two molecules of the extracellular portion of the p75 receptor, each consisting of 235 amino acids. The two receptors are fused to the Fc portion of human IgG1, which consists of 232 amino acids. The gene fragments encoding the truncated TNFR and the Fc portion of human IgG1 are expressed in a Chinese hamster ovary cell line.

Recent observations from animal and human studies suggest that tumor necrosis factor-alpha (TNF-alpha) may play a role in disease activity in AS and other seronegative spondyloarthropathies. This study aims to test the efficacy of TNFR:Fc used in conjunction with standard medications in the treatment of AS. We will give patients either 25mg of TNFR:Fc or placebo subcutaneously twice a week for 4 months. Outcome measures will include measures of function, pain, morning stiffness, patient global assessment, and swollen joint count, as well as safety measures.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Ankylosing spondylitis
* Acceptable stable treatments during study: oral glucocorticoids (less than or equal to 10 mg/d) and/or NSAIDs at recommended doses and/or one of the following options: methotrexate (less than or equal to 20.0 mg/week); sulfasalazine (less than or equal to 3 grams/d); azathioprine (less than or equal to 2 mg/kg/d); methotrexate and sulfasalazine combination at doses listed above; 6-mercaptopurine (less than or equal to 1.5 mg/kg/d)

Exclusion Criteria:

* Diagnosis of psoriatic arthritis, inflammatory bowel disease, reactive arthritis, or Behýet disease
* Significant medical problems, such as diabetes mellitus
* History of active or recurrent infections
* Complete ankylosis of the entire spine