cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Azithromycin in Patients With Bronchiolitis Obliterans

Placebo-controlled, double-blind, randomized study. Post-infectious bronchiolitis obliterans (PIBO) patients aged 5 years and older of both sexes were enrolled.

Bronchiolitis obliterans (BO) was defined as the presence of signs and symptoms of chronic obstructive lung disease: A) previously documented acute lower respiratory infection (ALRI) with persistence of airway obstruction and respiratory signs and symptoms, such as: dyspnea, tachypnea, retractions, persistent cough, increased antero-posterior diameter of the chest, persistent wheezing, crackles, exercise intolerance; B) findings such as: hyperinflation, atelectasis, and mosaic oligohemia on CT scan; and C) persistent obstructive pattern on pulmonary function test.

Patients were randomly assigned by pharmacy staff in blocks of 4 to receive either capsules of azithromycin 250 mg (Group 1) or placebo (Group 2) 3 days a week for 6 months. Patients whose weight was less than 40 kg received 250 mg 3 days a week (Monday, Wednesday, and Friday) and those weighing more than 40 kg received 500 mg in the same scheme, according to randomization to active drug or placebo. Pulmonary function and number of exacerbations were evaluated. Spirometry and plethysmography were performed at baseline and at 6 months. Variables analyzed were Forced vital capacity (FVC),Flow expiratory volume at the first second (FEV1), Total lung capacity (TLC),Residual volumen(RV),especific conductance (sGaw). Patients had been clinically stable over the previous three weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of Bronchiolitis obliternas
* older than 5 years
* Ability to perform pulmonary function test

Exclusion Criteria:

* Not being able to perform lung function study adequately
* Other causes of chronic lung disease (bronchopulmonary dysplasia, cystic fibrosis, primary or secondary immune deficiency)
* Previous history of portal hypertension, liver cirrhosis, splenomegaly or chang in normal values of laboratory at the start of the study.
* History of hypersensitivity to macrolides
A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of saxagliptin administered before breakfast for 14 consecutive days in patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet all of the following criteria will be included:

  1. HbA1c level ≥7.0% and \< 9.0%
  2. Fasting glucose level ≥130mg/dL and \<210mg/dL
  3. Patients who are capable of giving informed consent
  4. Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after completion of the study

Exclusion Criteria:

* Patients with type 1 diabetes mellitus; patients with diabetes mellitus due to other specified drugs, mechanisms, or diseases; and patients with gestational diabetes mellitus
* Patients with a medical history of diabetic coma
* Patients with heart failure
* Patients with a complication of active chronic hepatitis or hepatic cirrhosis
* Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
* Patients with a history or complication of malignant tumor
Evaluation of Demonstrations to End Childhood Hunger - KY

The 2010 Child Nutrition Reauthorization provided funding to test innovative strategies to end childhood hunger and food insecurity. Demonstration projects were funded in Chickasaw Nation, Kentucky, Navajo Nation, Nevada, and Virginia. This study focuses on Kentucky.

Households in the treatment group received an extra monthly SNAP benefit amount through two new intervention-related deductions to the SNAP benefit formula: (1) a fixed deduction, depending on county of residence, for transportation costs for six round trips to the grocery store per month; and (2) an earnings deduction equal to 10 percent of earned income for households with at least one employed household member. Households in the control group continued to receive their regular monthly SNAP benefit amounts.

Objective: To reduce child food insecurity in rural households by raising Supplemental Nutrition Assistance Program (SNAP) benefits to offset higher transportation costs and further strengthen SNAP work incentives.

Target Population: SNAP households with: (1) positive net income, (2) at least one child under the age of 18 by the end of the demonstration period, and (3) living in 17 geographically isolated and poor counties in eastern Kentucky.

Intervention: Households were randomly assigned to either a treatment or control group. Households in the treatment group received an extra monthly SNAP benefit amount through two new intervention-related deductions to the SNAP benefit formula: (1) a fixed deduction, depending on county of residence, for transportation costs for six round trips to the grocery store per month; and (2) an earnings deduction equal to 10 percent of earned income for households with at least one employed household member. Households in the control group continued to receive their regular monthly SNAP benefit amounts.

Eligibility Criteria:
Inclusion Criteria:

* SNAP households with: (1) positive net income, (2) at least one child under the age of 18 by the end of the demonstration period, and (3) living in 17 geographically isolated and poor counties in eastern Kentucky.

Exclusion Criteria:

-
Dosing of LT4 in Older Individuals

Our overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.

Investigators will perform a randomized, parallel, double-blind clinical trial of two 6-month dosing strategies of levothyroxine (LT4) in patients aged 65 years and older who are already taking a stable dose of at least 1.2 mcg/kg/day of LT4 therapy, one to maintain a target thyroid stimulating hormone (TSH) level of 0.5-2.0 mU/L (lower TSH group) and another of a lower levothyroxine dose to achieve a target TSH of 5.5-7.0 mU/L (higher TSH group). Investigators will assess the effects of levothyroxine therapy at two different TSH targets on symptoms of hypothyroidism, mood, sleep, measures of memory and executive function, weight, lipids, and a marker of bone turnover.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, community dwelling, aged 65 years or older
4. Diagnosed with hypothyroidism of any etiology for at least 6 months, taking 75-200 mcg per day LT4 and a minimum of 1.2 mcg/kg/day with no dose adjustment since the last TSH test.
5. Ability to take oral medication and be willing to adhere to the medication regimen

Exclusion Criteria:

1. Hypopituitarism
2. History of thyroid cancer requiring suppression of TSH secretion
3. Current use of liothyronine (LT3), thyroid extracts, Tirosint liquid or capsules, and medications that interfere with thyroid function or thyroid function tests
4. GFR \<30 ml/min/1.73 m2 within the prior 12 months
5. Unable to understand and comply with study requirements, as assessed by study staff and the PI, will be excluded.
6. Other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study.
Parkinson's Disease and Movement Disorders Clinical Database

The research database contains demographic and family history information, longitudinal information on the clinical symptoms, neuropsychological profile and treatments, stored biological samples, and brain images of patients with Parkinson's disease and related disorders receiving care at the Parkinson's disease and Movement Disorders Center and the Hospital of the University of Pennsylvania.

The research database contains demographic and family history information, longitudinal information on the clinical symptoms, neuropsychological profile and treatments, stored biological samples, and brain images of patients with Parkinson's disease and related disorders receiving care at the Parkinson's disease and Movement Disorders Center (PDMDC) and the Hospital of the University of Pennsylvania.

The purpose of the research database is to have a comprehensive source of data that can be used for educational, research and patient care projects at the PDMDC. These data may be used for any study examining the relationship between treatment and clinical symptoms of patients with PD and related disorders. The main uses of the data are to:

* Determine the long term effects of Parkinson's disease and related conditions, including predictors of its motor and non-motor symptoms
* Identify genetic and other neurobiological factors related to the risk of developing Parkinson's disease and related disorders and their course
* Improve our understanding of how best to identify, diagnose, and manage motor and non-motor symptoms of Parkinson's disease and related conditions Evaluate biological markers of disease or response to therapy
* Identify patients who may be candidates for participation in trials of new medications.
* Identify patients who may be interested in participating in educational or developmental activities

Participants are seen annually for the first 4 years, biennially thereafter. The participants continue in the study until study end, withdrawal, or death on study.

Eligibility Criteria:
Inclusion Criteria:

Any person who receives medical care for the diagnosis of Parkinson's disease with mild cognitive impairment (MCI) or dementia may be eligible to participate in the research database. There are no limitations for database participation based on age, disease severity or presence of cognitive impairments, as long as the person is able to complete the research assessments.

Exclusion Criteria:

Absence of Parkinson's disease diagnosis. There are no limitations for database participation based on age, disease severity or presence of cognitive impairments, as long as the person is able to complete the research assessments.
A Study of KHK4827 in Subjects With Palmoplantar Pustulosis

Evaluation of efficacy and safety of KHK4827 in Subjects with Palmoplantar Pustulosis


Eligibility Criteria:
Inclusion Criteria:

* Subject has had a diagnosis of palmoplantar pustulosis for at least 24 weeks as of the time of informed consent.
* Subject has a PPPASI total score ≥12 and a PPPASI severity score of pustules/vesicles on the palms or soles ≥2 both at the pre-examination and enrollment examination;
* Subject inadequately responded to any one or combination of the following therapies before informed consent: Topical corticosteroids, Topical vitamin D3, Phototherapy, Etretinate

Exclusion Criteria:

* Subject has a diagnosis of plaque psoriasis, pustular psoriasis, drug-induced palmoplantar pustulosis, or pompholyx;
* Subject has an improvement in PPPASI total score of ≥4 points during the screening period;
* Subject has a history or evidence of psychiatric disorder or alcohol/drug abuse that, in the opinion of the investigator or subinvestigator, may compromise the safety of the subject because of participation in the study or may interfere with assessments and procedures in the study or study completion;
* Subject has a past or current history of suicidal ideation (severity of 4 or 5) or any suicidal behavior at enrollment, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS);
* Subject has severe depression with a PHQ-8 total score of ≥15 at enrollment
A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon

Rationale: Nutrition and lifestyle interventions are currently not implemented in usual clinical care of PAH-patients. Mainly because there is little known on the relation between pathology, nutrition and lifestyle. Patients who suffer from Pulmonary Arterial Hypertension feel insecure about their nutrition and lifestyle. The investigators hypothesize that an intervention on nutrition and lifestyle can improve the patients' quality of life.

Objective: To explore the effect of a nutrition and lifestyle intervention on quality of life for patients suffering from PAH.

Study design: Investigator initiated intervention study with control group. Study population: investigators aim to include 70 patients (18 - 80 years) with idiopathic, hereditable or drug related PAH, who have been stable for at least three months and are self-sufficient and/or have a family who's willing to participate in the lifestyle changes.

Intervention (if applicable): Nutritional status, - education, - intervention and - compliance.

Main study parameters/endpoints: This is an intervention study in which the investigators will asses the effect of a nutrition and lifestyle intervention on quality of life measured by SF-36 overall outcome with a significant difference of 6.35.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for the patient exists of 12 extra visits to the hospital and contact moments, over a period of 11 months, as well compliance to the diet and lifestyle. There is minimal risk in participation.

Baseline nutritional assessment

Nutritional education:

8 online lessons containing information about nutrition, lifestyle and general health with complementary tips regarding PH. All participants recieve workbook with assignments.

Nutritional intervention:

Group A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Group B: MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids) Control group: no diet.

Follow-up:

Patients in intervention arm followed for a period of 6 months to assess compliance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic PAH, hereditable PAH or drug related PAH
* Age between 18 and 80
* NYHA II or III and stable for at least 3 months, determined by a stable 6minute walk test with a difference of \<10%.
* Self-sufficient and/or compliance from partner and/or family
* Creatinine \> 30 ml/min
* Able to understand and willing to sign the Informed Consent Form

Exclusion Criteria:

* - Pregnant subjects
* Fat percentage \< 10% \> 50 %
* One or more of the following comorbidities: diabetes mellitus type one or two, clinically relevant thyroid disease
* Known history of noncompliance considering therapies
Cytolytic Vaginosis Multicentre Registry

The goal of this registry is to learn more about cytolytic vaginosis, a little known and controversial condition. The main questions the registry aims to answer are:

* What are risk factors of cytolytic vaginosis?
* Are there defining symptoms of cytolytic vaginosis?
* What features on wet mount should be used to diagnosis cytolytic vaginosis?
* Are baking soda vaginal irrigations an effective treatment for cytolytic vaginosis?
* Do characteristics of cytolytic vaginosis vary between sites/countries?

Cytolytic vaginosis is a largely unknown, debated, and equivocal vaginal condition. It is unclear whether cytolytic vaginosis is a variant of normal vaginal microbiome or should be considered a vaginal dysbiosis condition, similar to bacterial vaginosis. This multicentre registry will enroll women that have signs/symptoms consistent with cytolytic vaginosis to better characterize it.

Women at participating sites diagnosed with cytolytic vaginosis and that provide consent will be consecutively enrolled in the registry. The registry will capture data on risk factors, symptoms, test results (eg, wet mount) and treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Vaginitis symptoms
* Predominately lactobacilli or/and elongated lactobacilli on wet mount
* Cytolysis on wet mount

Exclusion Criteria:

* Unable to consent or decline consent
* Pregnant
* Positive for yeast (culture or PCR)
Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC

This study aims to observe and explore the efficacy and safety of Penpulimab combined with chemotherapy for neoadjuvant and adjuvant therapy in patients with resectable head and neck squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients voluntarily joined the study, signed the informed consent, and had good compliance;
* Patients with 18 Years to 75 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-1;
* Patients with untreated head and neck squamous cell carcinoma who were pathologically confirmed and determined to be suitable for surgical treatment were classified as stage III, IVa according to AJCC (8th Edition), including oral, oropharyngeal, hypopharyngeal, and laryngeal cancers
* Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study.

Exclusion Criteria:

* Patients who have previously used PD-1/PD-L1/CTLA-4 antibody therapy;
* Patients who require systemic treatment with corticosteroids (\> 10mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days prior to administration or during treatmentIn the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone at doses \>10mg/ day equivalent to prednisone and adrenocortical hormone replacement at therapeutic doses not exceeding 10mg/ day prednisone are permitted;
* A history of any active immune or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
* Active or uncontrolled severe infection within 4 weeks prior to enrollment (CTCAE grade 2 infection);
* Abnormal function of major organs
* Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.
Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)

This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in Alaska natives with alcohol dependence. The study will also examine whether a combination of naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone. Alaska Native individuals will be recruited into a 16 week outpatient study.


Eligibility Criteria:
Inclusion Criteria:

* Alaska Native having biological Alaska Native ancestry.
* Meets criteria for alcohol dependence.
* Prior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment.
* Stable residence to ensure that subjects can be located during the study.

Exclusion Criteria:

* Currently meets criteria for abuse or dependence on substances other than alcohol or nicotine.
* Current use of disulfiram.
* Psychotic or otherwise severely psychiatrically disabled.
* Use of other psychotropic medications including antidepressants and anxiolytics.
* Medical conditions that would not permit the use of sertraline or naltrexone, such as a history of unstable or severe hepatic, cardiovascular, metabolic, endocrine, gastrointestinal or kidney disease.
* Hepatocellular disease or elevated bilirubin levels.
* Females who are pregnant, nursing, or not using a reliable method of birth control.
* Probation or parole requirements that might interfere with participation in the study.
* Involvement in alcohol treatment other than provided by the study or AA.
* Use of monoamine oxidase inhibitors in the past month.
* Current use of Type 1C antiarrhythmics propafenone and flecainide.
Ventricular Arrhythmias in Uremic Cardiomyopathy

There is a certain gene called sarcoplasmic reticulum gene (SERCA2a), which is found in heart muscle. This gene is also found in blood vessels and skin tissue. When active this gene builds a crucial protein inside the heart muscle called SERCA2a protein. This is responsible for regulating calcium levels inside your heart muscle. When this gene is not activated, studies have shown that it can lead to abnormal electrical currents in the heart that can lead to death. The investigators are conducting this study to prove that SERCA2a gene is inactive in patients with kidney disease. Scientists found that patient at risk for abnormal electrical currents in the heart can be tested by what they called "microvolt Twave alternans." This is a very delicate machine much more sensitive than a regular electrocardiogram that you do at the cardiology office.

This study will test the hypothesis that patients with uremic cardiomyopathy have reduced levels of SERCA2a protein compared to those with normal kidney function. We propose that such a correlation will provide convincing evidence that these patients,have a defective redistribution in intracellular calcium handling as an explanation for their increase risk in sudden cardiac death an fatal arrhythmias. To achieve our specific aims: 1) we will screen patients with end stage renal disease (ESRD) going for certain vascular procedures. 2) obtain an echocardiogram on these patients including only those with isolated diastolic dysfunction or LVH. 3) Patients who has diastolic dysfunction or LVH will be assessed for underlying microvolt (TWA) 4) vessel and skin tissue on these patients will be collected for SERCA2a quantification.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* Patients with stage 5 CKD or ESRD and those with normal CKD will be considered as possible candidates if admitted for one of the following vascular procedures
* coronary artery bypass grafting, or vascular bypass surgery, or arteriovenous fistula creation, or arteriovenous graft surgery.
* The aforementioned patients will be included if they have LVH or diastolic dysfunction and a normal LVEF on echocardiogram within one year of their scheduled surgery.

Exclusion Criteria:

1. Age less than 18 ;
2. Pregnancy;
3. Dilated cardiomyopathy;
4. left ventricular ejection fraction (LVEF) less than or equal to 50%;
5. Patients on digoxin.
6. antiarrhytmic medications;
7. baseline electrolyte abnormalities;
8. Atrial fibrillation;
9. Bundle branch block
Hesperidin and Diosmin Effect on Metabolic Syndrome

The components of metabolic syndrome (MetS), particularly obesity and dyslipidemia, are linked to peripheral neuropathy (PN) among patients with diabetes or even without diabetes. Several studies revealed that complementary and herbal medicine could provide a potential for PN management and MetS components. Thus, designing clinical trials with interventions combinations to achieve a considerable improvement is highly recommended. Hesperidin and diosmin, citrus-derived flavonoids, have been reported to possess anti-hyperlipidemic, anti-inflammatory, analgesic, antioxidant, antidiabetic, and anti-hypertensive effect with high tolerability and safety profile


Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes adult patients who meet metabolic syndrome criteria and with diabetic neuropathy

Exclusion Criteria:

patients without any parameter of inclusion criteria