cyrilzakka/clinical-trials huggingface dataset:
Feasibility of a Mobile Medication Plan Application in CF Patient Care

This is a pilot, multicenter, prospective, randomized controlled study to evaluate the feasibility of an innovative medication adherence intervention utilizing a web-based, mobile medication management application \[MedActionPlan® (MAP)\] to encourage self-management by reinforcing adherence and education about treatment regimens in Participants with cystic fibrosis (CF) (ages 12 years and older).

Outcomes of interest for this study are 1) feasibility of MAP in real-world setting which will be evaluated using patient/caregiver and clinician feedback regarding value, ease of use, and challenges with use, 2) effect of MAP on patient/caregiver knowledge and perception of medication use, 3) effect of MAP on adherence to inhaled and oral medications used in chronic management of CF. Preliminary data regarding outcomes on exacerbations, lung function, and health care system utilization (e.g., emergency department visits, hospitalization) will also be examined as part of this study.


Eligibility Criteria:
Inclusion Criteria:

* CLINICIAN PARTICIPANTS:

  1. A CF care team member from any discipline, designated by the site principal investigator (PI) and CF team
  2. Willing to use MAP as part of CF care
* PATIENT PARTICIPANTS:

  1. Male or female patients ages ≥ 12 years of age at Study Visit 1
  2. Documentation of a CF diagnosis (physician diagnosed)
  3. Ability to understand verbal and written English
  4. Access to mobile device such as a tablet or smartphone (iPhone/iPad/iTouch or Android device)
  5. Willingness to use the MAP application
  6. Currently taking at least one of the following chronic medications and willing to use AdhereTech pill bottles for oral medications and/or eTrack nebulizer for nebulized medications listed below: nebulized agents, dornase alfa, hypertonic saline, inhaled tobramycin, inhaled aztreonam, inhaled colistimethate, oral agents, azithromycin
* CAREGIVER PARTICIPANTS (for Patient Participants age \< 18 years)

  1. Child is consented to participate in the study.
  2. Ability to understand verbal and written English

Exclusion Criteria:

* CLINICIAN PARTICIPANTS:

Previous use of MAP (with patient(s) or self) in the last 12 months - when used with patients, defined as use in 5 or more patients

* PATIENT PARTICIPANTS:

  1. Previous use of MAP in the last 12 months - defined as use for 4 weeks or longer in own care
  2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data including, but not limited to, diagnosis of intellectual or developmental disability (e.g., autism); and/or history of lung transplant
  3. Planned or scheduled hospitalization during study period of up to 36 weeks
* CAREGIVER PARTICIPANTS:

(for Patient Participants age \< 18 years)

1. Previous use of MAP in the last 12 months - defined as use for 4 weeks or longer in child's or own care
Assessing the Maternal Outcome Monitoring Systems

Pregnancy-related death is a growing public health issues, which are of particular concern to minority groups, including African-Americans and Spanish-speaking Latinas. Our proposal aims to improve a patient's ability to detect warning signs of pregnancy related death and seek medical care.

Pregnancy-related death (PRD) rates have risen 120-200% in the United States in the past two decades, and experts estimate that 40-60% of these cases are preventable. Improvement initiatives are predominantly hospital-based and rely on perinatal people recognizing their own symptoms and seeking care without ample support or education. We hypothesize that we can improve patients' self-efficacy and decision-making about when to seek care by helping them to self-monitor symptoms and by providing decision support. We propose to develop a mHealth-based, patient-reported outcome (PRO) and decision-support system to help mothers determine when to seek care for warning signs of PRD. Our project focuses on diverse populations facing postpartum disparities, particularly African- American and Spanish-speaking Latina women. This protocol involves a single-arm pilot trial assessing the feasibility and preliminary effectiveness of MOMS/MAMA for improving knowledge and patient activation among postpartum patients.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 28 weeks pregnant
* Receiving healthcare in the United States
* Age 18 years or older
* \[Identify as Black or African American race AND able to speak and read English, AND preferred language of English\] OR \[Identify as Hispanic/Latino Ethnicity AND Spanish able to speak and read Spanish AND preferred language of Spanish\]
* Planned delivery at the following NewYork-Presbyterian hospitals: Children's Hospital of New York, Allen Hospital, Weill Cornell Medical Center, Lower Manhattan Hospital

Exclusion Criteria:

* Severe cognitive impairment
* Major psychiatric illness
* Concomitant terminal illness that would preclude participation.
Clonidine in Femoral Nerve Block Surgery in Children

Knee arthroscopy is a common surgical procedure in pediatrics in which the knee joint is visualized through a small camera to help diagnose and treat knee problems. This procedure is commonly accomplished with the use of general anesthesia. Regional anesthesia is commonly completed with a single injection of local anesthetic around the femoral nerve to provide pain relief for several hours following knee arthroscopy. The intent of this study is to examine the effects of clonidine in addition to local anesthetics for femoral nerve blockade in providing children and adolescents post-operative analgesia. The investigators hypothesize the addition of low dose clonidine (1 mcg/kg) provides an additional 4 hours of post operative analgesia following arthroscopic knee surgery and reduces post-operative opiate requirement.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist (ASA) functional status I or II
* Patients scheduled for arthroscopic knee surgery only

Exclusion Criteria:

* Patients with history of chronic opioid therapy, central or peripheral neuropathy, contraindications to regional anesthesia, history of allergy to clonidine or ropivicaine, or anterior cruciate ligament reconstructive surgery in addition to knee arthroscopy
Study of Statin for Reduction of Postoperative Paroxysmal Atrial Fibrillation

The study will select all recruited patients with paroxysmal atrial fibrillation will be randomly allocated to receive oral rosuvastatin 20mg/day or blank control from 7 days before ablation and last for 3 months. To observe the early relapse of atrial fibrillation and the changes of white blood cell count, hs-C reactive protein (CRP), interleukin (IL)-6 and tumor necrosis factor (TNF)-α, and the changes of safety indicators .

This study assumes that the early atrial fibrillation (AF) recurrence will be decreased in patients with paroxysmal AF if rosuvastatin 20mg/d is received from 7 days before surgery in these patients who plan to undergo radiofrequency catheter ablation for consecutive 3 months.

This study is a randomized, open-label, multi-centers, parallel-control study to explore whether rosuvastatin 20mg/d could decrease early AF recurrence in patients with paroxysmal AF after radiofrequency catheter ablation. 346 patients with paroxysmal AF are planned to be enrolled. The patients are randomized to receive oral rosuvastatin 20mg/d or control therapy from 7 days before operation and last for 3 months. The early AF recurrence within 90 days after ablation and the changes of 4 inflammatory markers including white blood cell count, hs-CRP, IL-6 and TNF-α and safety indicators will be observed. The study is aim to evaluate the efficacy and safety of rosuvastatin on decreasing early recurrence in patients with paroxysmal AF and discuss its mechanisms of action.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures;
2. Age from 18 to 75 years old, male or female;
3. The course of paroxysmal AF is more than 3 months and confirmed by ECG;
4. Plan to undergo radiofrequency catheter ablation

Exclusion Criteria:

1. Concomitant with serious organic heart disease such as valvular heart diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardial infarction and unstable angina pectoris;
2. Concomitant with sinoatrial node functional disorder and (or) atrioventricular block;
3. Acute cerebral apoplexy or contraindication of anticoagulant;
4. Thyroid function abnormality;
5. Accepted radiofrequency catheter ablation (RFCA) previously;
6. Being receiving other statins;
7. Be allergic to statins;
8. Pregnancy or women during lactation period;
9. Be not aligning to treatment or follow-up due to mental disorders or other reasons;
10. Be with myopathy or active hepatopathy including agnogenic persistent elevation of serum transaminase and any serum transaminase being over 3 times of upper limit of normal;
11. Be with serious renal dysfunction (creatinine≥3 mg/dL);
12. Need steroid or non-steroid anti-inflammatory drugs to treat inflammation.
CANPOS: Predictive Biomarkers of Tumor Progression in Non-small Cell Lung Cancer

CANPOS is a non-interventional study aiming at evaluate at the time of initial surgery the value of new serum markers to predict the occurrence of metastases in patients with early-stage non-small cell lung cancer. This would represent a rational to develop personalized follow-up and prevention strategies


Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis or suspected for a diagnosis of lung cancer, non-small cell lung cancer
* age over 18 years
* patient naïve of any oncology treatment (excluding surgery alone) within the past 5 years
* patient who signed the informed consent by the study protocol

Exclusion criteria were:

* any ongoing treatment for cancer
* any history of cancer within 5 years before the diagnosis of lung cancer
* any psychological, sociological or geographical conditions that would not allow the study follow-up
Morbidity and Mortality in Solo Adult Traumatic Brain Injury Patients in Minia University Hospital

Tracking post-traumatic brain injury sequale


Eligibility Criteria:
Inclusion Criteria:

* Solo non penetrating neurotrauma victims

Exclusion Criteria:

* 1- Penetrating head trauma. 2- Polytrauma patients. 3- Coexist of Psychiatric disorders or history of neuronal disorders. 4- Refusal of patient relatives to participate in the assignment. 5- Pregnant females with TBI. 6- Patients who died during 24 hours from admission to ICU . 7- Patients more than 65 years of age .

  8- combined abdominal or orthopedic trauma.
A Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers

This study is designed to evaluate the potential for a PK drug-drug interaction between FV-100 and ritonavir. The study is a single-center, open-label, randomized, 2-way crossover design in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Capable of giving written informed consent
* Non-tobacco user for at least 3 months prior to selection
* Healthy on the basis of physical examination, medical history, ECG and clinical laboratory testing at screening

Exclusion Criteria:(must NOT meet the following)

* Infected with Hepatitis A, B, C, or HIV
* History of or any current medical condition which could impact safety of the participant
* A positive urine drug test
* Consumption of more than 2 units of alcoholic beverages per day or more than 14 per week
* Received an investigational drug or vaccine or used an investigational medical device within 3 months or 5 half-lives before the planned start of treatment or prior treatment with FV-100
* Subjects who have used any drugs or substances known to inhibit or induce cytochrome(CYP) P450 enzymes and/or P-gp within 28 days prior to the first dose and throughout study
* Subjects who have, within 2 weeks prior to the first dose of study drug, ingested grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family or charbroiled meats
Effect of Virtual Reality Glasses as a Distraction Method on Child's Anxiety During Dental Treatment

The aim of the study is to evaluate and compare the effect of virtual reality glasses (VR) to conventional behavior management techniques as a distraction method on child's dental anxiety during dental treatment

The study to be conducted will be a randomized controlled clinical trial .The sample will consist of forty children presented to the Department of Pediatric Dentistry and Dental Public Health, 20 preschoolers of age ranging from 4-5 years old and 20 schoolers of age ranging from 6-8 years old. The eligible participants will be randomly divided into a study group where virtual reality glasses distraction will be used for child behavior management and a control group where conventional behavior management techniques (tell-show-do, distraction, and positive reinforcement) will be used.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children (ASA category I).
* Frankl behavior rating score 2 or 3.
* Requiring pulpotomy in one of their primary molars.

Exclusion Criteria:

* Children taking medications that interfere with measures of salivary cortisol.
* Presence of any systemic or mental disease.
Dance-movement Therapy Programme in Fibromyalgia.

Fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with generalized hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. This condition is very prevalent. It has been reported to be about 2-5% of the general global population. Fibromyalgia is associated with balance problems and increased fall frequency. The objective of this study was to examine the effects of an 8 weeks dance-movement therapy programme on balance, strength, flexibility and quality of life in patients with fibromyalgia.

Fibromyalgia is a chronic condition associated with balance problems and pain. It has been previously described that fibromyalgia may affect peripheral and/or central mechanisms of postural control. Balance or postural stability is a very complex task that involves the integration of multiple sensory inputs to execute appropriate neuromuscular activity needed to maintain balance.

Patients with fibromyalgia have also muscle weakness. Muscle strength depends on both the cross-sectional area of the muscle and the neural activity. Range of movement and quality of life have also been reported to be affected.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed of Fibromyalgia attending to the Fibromyalgia Association of Granada.
* Women who can complete the assessment battery of tests at the beginning and at the end of the study

Exclusion Criteria:

* Auditive and visual disturbances.
* Cognitive problems.
* Psychiatric pathology.
* Traumatic pathology of lower limbs.
Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns

The purpose of this study is to assess the effect of banana blossom in increasing breast milk volume


Eligibility Criteria:
Inclusion Criteria:

* Postpartum women of preterm newborns

Exclusion Criteria:

* Postpartum women with contraindication for breast feeding such as HIV, herpes zoster at breast, infected wound at breast.
* Postpartum women with preeclampsia, diabetes mellitus, postpartum hemorrhage.
* Postpartum women with allergy to banana blossom.
* Postpartum women with previous breast surgery or nipple surgery.
* Postpartum women who smoking.
* Preterm newborns with unstable conditions.
AGE Levels in ER+ Metastatic Breast Cancer Patients Receiving Endocrine Therapy

The purpose of this study is to look at the effects that the study drug (OPC) has on AGE levels in patients with ER+ metastatic breast cancer.

AGEs are a type of metabolite, or substance, found in the food. The AGE content in food is determined by the types of food you eat and also how you prepare your food. The researchers helping conduct this study have found a potential link between AGE levels and cancer. The purpose of this study is to see if certain drug (OPC) has an effect on the AGE levels in your blood and to see if those AGE levels have an effect on your cancer.

Eligibility Criteria:
Inclusion Criteria:

* Must have ER+ breast cancer
* Metastatic disease; protocol does allow for bone-only disease
* Must be receiving endocrine therapy
* Must have completed at last 2 months of current endocrine therapy prior to registration
* Must have adequate hematologic, renal and hepatic function
* Prior/concurrent radiation therapy is allowed
* Prior chemotherapy is allowed, but last dose must have been at least 2 months prior to enrollment
* May have diabetes, but must not be taking metformin
* Must be able to swallow and retain oral medication
* Performance status of 0-2
* Treated stable brain metastases are allowed, as long as patient does not require steroids or anti-seizure medications
* Must be informed of the investigational nature of this study and must have the ability to sign informed consent.

Exclusion Criteria:

* Known allergy to grapes or grape seed
* More than two prior endocrine therapy regimens for the treatment of metastatic ER+ breast cancer.
* Concurrent use of restricted agents outlined in section 4.5.
* History of alcohol abuse within 2 years of registration.
Gastric and Duodenal Microbiota in Dyspeptic Subjects

The composition of gastric microbiota is determined by the status of Helicobacter pylori infection. In subjects who have never been infected by H. pylori, gastric microbiota includes various bacteria, creating ideal microbial diversity. This ideal microbial diversity is destroyed by H. pylori infection at low intragastric pH. Since it is difficult for most bacteria to proliferate within an acidic stomach, relative H. pylori abundance gives rise to microbial dysbiosis. Conversely, unideal microbial diversity is often observed in infected individuals with impaired gastric secretory ability at hypochlorhydric condition. Bacteria producing carcinogenic N-nitrosamine compounds are often detected in individuals with past or chronic H. pylori infection at high intragastric pH. Nonetheless, microbial imbalance that occurs in the earlier phase before gastric carcinognenesis is uncertain.

Dominant colonization of a specific microbiota leading to dysbiosis may lead to inflammation of the mucosa. We hypothesized that the degree of inflammation depend on the composition of microbiota. This study was aimed to define gastric and duodenal microbiota leading to abnormal histopathology. We further tried to elucidate whether the composition of duodenal microbiota is altered by gastric microbiota.

Among the dyspeptic subjects who visited for upper gastrointestinal (UGI) endoscopy, subjects with drug intake (antibiotics, PPIs, laxatives, antidepressants, statins, metformin) within 3 months will be excluded. Three biopsies will performed at the greater curvature side of the mid-antrum, greater curvature side of the mid-body, and at the duodenum, respectively. Next generation sequencing analysis will be performed for 16S rRNA variable regions using the biopsied samples.

Primary study endpoint is 16S rRNA sequencing findings of gastric and duodenal microbiota.

Secondary endpoints are microbiota linked with higher degrees of inflammation, activity, atrophy and intestinal metaplasia based on the updated Sydney classification. Furthermore, correlation between the microbiota and endoscopy finding will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Dyspeptic subjects who visited for evaluation including upper gastrointestinal endoscopy and biopsies
* Age \>20 years old

Exclusion Criteria:

* Underlying disease(s) that requires managements
* Recent intake of drug(s)
* History of gastrectomy
RElugolix VErsus LeUprolide Cardiac Trial

This phase IV clinical trial investigates the impact of prostate cancer treatment, specifically androgen deprivation therapy (ADT), on the heart and coronary vessels among men with localized, non-metastatic prostate cancer undergoing definitive radiation therapy and concomitant ADT. Recently, cardiovascular toxicity from hormone therapy that is routinely used for prostate cancer (e.g. leuprolide) has emerged as a concern, yet studies identifying who is at risk and the mechanism of cardiac damage are lacking. Additionally, a new hormone therapy drug, relugolix, has recently been Food and Drug Administration (FDA)-approved and may reduce toxicity to the heart. This trial intends to investigate the mechanism of cardiovascular toxicity from ADT, investigate the mechanism by which relugolix reduces cardiovascular toxicity, and identify predictive biomarkers to improve individualized risk-assessment for cardiovascular toxicity from ADT.

PRIMARY OBJECTIVES:

I. Identify and compare the association of gonadotrophin releasing hormone (GNRH)-agonist leuprolide versus GNRH-antagonist relugolix with coronary atherosclerosis and progression in men with prostate cancer.

II. Determine the relationship between leuprolide versus relugolix with downstream immune effector response that is implicated in atherosclerosis.

II. Determine how pre-existing genomic alterations associated with proinflammatory immunity impact development of CV toxicity following GNRH-agonist (GNRHa) versus relugolix.

III. Identify imaging biomarkers associated with increased risk of CV toxicity from ADT

OUTLINE: Patients undergoing radiation therapy alone as part of their standard treatment are assigned to Arm I. Patients undergoing radiation therapy and ADT as part of their standard treatment are randomized to Arm II or Arm III.

ARM I: Patients undergo definitive radiation therapy in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo radiation therapy as in Arm I and receive leuprolide subcutaneously (SC) or intramuscularly (IM) every 3 or 6 months. Treatment continues for 6 to 24 months (depending on cancer risk) in the absence of disease progression or unacceptable toxicity.

ARM III: Patients undergo radiation therapy as in Arm I and receive relugolix orally (PO) once daily (QD) for 6 to 24 months (depending on risk) in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Men \>= 18 years old
* Non-metastatic prostate cancer
* Non-metastatic, biochemically recurrent prostate cancer
* Plan to undergo curative-intent pelvic radiation therapy with or without ADT

Exclusion Criteria:

* Metastatic prostate cancer requiring \> 24 months of ADT
* Prior exposure to androgen deprivation therapy
* Prior exposure to chemotherapy or immunotherapy
* History of cardiac bypass surgery or percutaneous coronary intervention