cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat

This is a Phase 1, fixed sequence, open-label study to evaluate the effect of multiple oral doses of rabeprazole on the pharmacokinetics of a single dose of vadadustat 300 mg in healthy male and female subjects.

This is a Phase 1, fixed sequence, open-label study in healthy adult subjects to evaluate the effect of multiple doses of rabeprazole on the pharmacokinetics of a single dose of vadadustat in healthy male and female subjects. Approximately twenty (20) subjects, with at least 30% female subjects, will be enrolled to ensure 18 evaluable subjects. Subjects will be on study for up to 66 days, including a 28-day screening period, 9-day clinic period, and a 30-day follow- up period post last dose. Subjects who are confirmed eligible and receive at least one dose of study drug will be considered enrolled in the study. Blood samples for PK analysis will be collected at pre-defined time points throughout the study up to 48 hours post administration of vadadustat.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Male or female between 18 and 55 years of age, inclusive, at time of informed consent
* Body mass index between 18.0 and 30.0 kg/m2, with a minimum body weight of 45 kg for females and 50 kg for males, inclusive.

Exclusion Criteria:

* Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease. History of cancer (except treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening.
* Positive test results for human immunodeficiency virus (HIV) antibody; Positive test results of hepatitis B surface antigen (HBsAg), or positive hepatitis C virus antibody (HCVab) within 3 months prior to screening , or positive test results for human immunodeficiency virus antibody (HIVab) at Screening
* Taking any prescription medication or over the counter multi-vitamin supplement, or any non-prescription products (including herbal-containing preparations but excluding acetaminophen) within 14 days prior to Day -1.
Clinical Study Phase III, Randomized, Double-blind, Prospective and Comparative to Evaluate the Efficacy and Tolerability of Using APETIVITON BC Compared to Petivit BC in Appetite Stimulate.

Clinical study phase III, randomized, double-blind, prospective, comparative non-inferiority to evaluate the efficacy and tolerability of using APETIVITON BC compared to Petivit BC in appetite stimulate in children, adults and elderly.

Clinical trial phase III, randomized, double-blind, prospective, comparative non-inferiority to evaluate the efficacy and tolerability of using APETIVITON BC compared to Petivit BC stimulation of appetite in children, adults and elderly. A total of 150 patients, distributed as follows:

25 patients treated children Apetiviton BC,25 patients treated children Petivit BC, (2-6 years).

25 adult patients treated with Apetiviton BC,25 adult patients treated with Petivit BC, (18-50 years.

25 elderly patients treated with Apetiviton BC,25 elderly patients treated with Petivit BC. (60-80 years.

Eligibility Criteria:
Inclusion Criteria:

For both groups:

* Patients who have inappetence;
* Patients able to understand and maintain adherence to protocol;
* Wash-out 20 days after ingestion of prior similar drug;
* Patients able to understand the correct use of medication;
* Patients who consent to participate in the study by signing the inform consent;

Children:

* Patients of any ethnic group male and female, aged between 2 and 6 years;

Adults:

* Patients of any ethnic group male and female, aged between 18 and 50 years;
* Female patients in childbearing age, sexually active, make pregnancy test result should be negative and, furthermore, should be using contraceptive methods such as contraception, condom, IUD and diaphragm.

Elderly:

* Patients of any ethnic group male and female, aged between 60 and 80 years.
* Female patients in childbearing age, sexually active, make pregnancy test result should be negative and, furthermore, should be using contraceptive methods such as contraception, condom, IUD and diaphragm.

Exclusion Criteria:

For both groups:

* Patients with glaucoma open or closure angle;
* Patients with predisposition to urinary retention;
* Patients with stenous peptic ulcer or pylorus-duodenal obstruction;
* Debilitated patients or in acute attack of asthma;
* Alcoholic;
* Patients who have loss of appetite caused by any serious disease;
* Patients who make use of any drugs central nervous system depressants;
* Patients who make use of medicines monoaminooxidase inhibitors, tricyclic antidepressants, phenothiazines, probenecid, levodopa, phenytoin, phenobarbital, chloramphenicol, cyclophosphamide, cyclosporine, chlorambucil, corticotropin, mercaptopurine, isoniazid, penicillin, estrogens, contraceptives, haloperidol, ipatrópico, barbiturates, primidone, salicylates;
* Patients with known hypersensitivity to any components of the formula;
* Patient who is participating in another clinical study;
* No able to adhere to protocol;
* Patients who are pregnant or breastfeeding;
* Any condition that in the opinion of the investigator can impossible to include the patient's adherence to the protocol.
Culturally Tailored Mindfulness-Positive Psychological Intervention Using Virtual Reality

This study is to explore the experience of older Korean adults with anti-Asian racism in the U.S. and investigate the feasibility, acceptability, and preliminary efficacy of a virtual reality-based culturally tailored mindfulness-positive psychological intervention. Primary outcome is racism-related stress and secondary outcomes are negative mental health (e.g., anxiety, depressive symptoms, and anxiety) and positive psychological well-being (e.g., positive affect, optimism, life engagement, mindful attention awareness).


Eligibility Criteria:
Inclusion Criteria:

* U.S. Korean Americans/immigrants
* ≥ 60 years of age
* Korean fluency
* no medical history of cognitive impairments (e.g., dementia or Alzheimer-related diseases)
* self-reported direct experience of discrimination as per the Everyday Discrimination Scale

Exclusion Criteria:

* severe cognitive impairment denoting dementia
* other ethnicities rather than Korean Americans/immigrants
* younger than 60 years of age
* cannot speak and read Korean
* have not experienced any discrimination
* serious sensory problems negating the use of virtual reality
* medical history of epilepsy, seizures, or vertigo
* experience in mindfulness or meditation-based programs
Dynamic MRI Evaluation Post Operative Stapled Trans Anal Rectal Resection (STARR) Procedure

The purpose of this study is to assess the effects of the Stapled Trans Anal Rectal Resection (STARR) procedure for patients with obstructive defecation syndrome. This involves a dynamic pelvic MRI and obstructive defecation score (ODS) at 6 month post STARR procedure.

The use of dynamic pelvic MRI has greatly impacted our preoperative evaluation of pelvic floor disorders, both anatomically and functionally. The STARR procedure is a new approved procedure for patients with obstructive defecation, who have failed conservative therapy of medications and aggressive pelvic floor retraining. Most patients have also been screened for colonic transit problems. The traditional study for evaluating these patients was defecating proctograms. With the advent of the dynamic pelvic MRI, we are now beginning to understand the interaction of the entire pelvic structure in the complex act of defecation. This study is providing us a different view of the pelvic structures to better understand the pathophysiology of this disorder. The defecating proctogram, though informative in certain cases, lacks information outside the rectum. We wish to evaluate and compare our preoperative dynamic pelvic MRI with a six month dynamic pelvic MRI in 10 patients. We also will compare pre and post op obstructive defecation scores (ODS). We expect this small sample to direct us to a much more pointed evaluation of this disorder.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing to have a follow-up with a dynamic pelvic MRI and complete an obstructive defecation score (ODS) at 6 month post STARR procedure at Mayo Clinic - Jacksonville

Exclusion Criteria:

* Patients with medical devices/implants or who cannot have follow-up dynamic pelvic MRI
New Quantitive MRI Parameters in Assessing Kidneys of Autosomal Dominant Polycystic Kidney Disease

The purpose of this study is to establish normal Magnetic Resonance quantitative values (tissues stiffness, Apparent Diffusion Coefficient values and Blood Oxygen Level Determination values for both renal cortex and medullary tissues and total renal blood flow) for young Autosomal Dominant Polycystic Kidney Disease patients with normal renal function, and normal young adult controls without Autosomal Dominant Polycystic Kidney Disease and normal renal function.

Hypothesis: Newer Magnetic Resonance quantitative imaging parameters (tissue stiffness, Apparent Diffusion Coefficient, Blood Oxygen Level Determination levels, Magnetization Transfer and renal blood flow) will have different values in young adult ADPKD patients as compared to normal volunteers.


Eligibility Criteria:
Inclusion criteria ADPKD participants

* Male and female subjects between 18-30 years of age
* Diagnosis of ADPKD
* Glomerular Filtration Rate (GFR) of \> or = to 60 mL/min (Chronic Kidney Disease-Epidemiology Collaboration equation)
* Ability to provide written, informed consent

Exclusion criteria for ADPKD participants

* Clinically significant concomitant systemic disease
* Subjects with Diabetes Mellitus
* Urinary protein excretion
* Abnormal urinalysis suggestive of concomitant glomerular disease
* Subjects having contraindications to, or interference with MRI assessments
* Subjects with supine blood pressure higher than 140/90 mm Hg or taking blood pressure medications

Inclusion criteria for Normal Volunteers

* Male and female subjects between 18-30 years of age
* Glomerular Filtration Rate (GFR) of \> or = to 60 mL/min (Chronic Kidney Disease-Epidemiology Collaboration equation)
* Ability to provide written, informed consent

Exclusion criteria for Normal Volunteers

* Previous personal or family history of kidney disease
* Clinically significant concomitant systemic disease
* Subjects with Diabetes Mellitus
* Urinary protein excretion
* Abnormal urinalysis suggestive of concomitant glomerular disease
* Subjects having contraindications to, or interference with MRI assessments
* Subjects with supine blood pressure higher than 140/90 mm Hg or taking blood pressure medications
Serial Exhaled Breath pH Monitoring

This study will seek to determine the amount of acids a person with a chronic cough that is suspected to be related to acid reflux breathes out after coughing. The study will also seek to determine if this measurement can predict the best treatment for the cough.

Subjects with a chronic cough which is suspected to be related to acid reflux for which their doctor has prescribed a proton pump inhibitor medication will be enrolled in this study.

Acid reflux has been considered to be a key contributor to cough, particularly in patients with obstructive lung diseases. However, diagnosis has relied upon either responsiveness to high dose twice daily administration of proton pump inhibitor therapy or by 24 hour esophageal pH probes. This study is designed to provide information for the development of a clinically useful diagnostic (exhaled breath condensate pH) to identify the contribution of acid reflux to cough.

Exhaled breath condensate (EBC) pH has been well documented to reflect airway acidification. Acid reflux to the level of the hypopharynx, which is a key common trigger of acid reflux induced cough, acidifies the airway sufficiently to be identified with EBC pH assays. The association of low EBC pH with an immediately preceding cough strongly suggests an association of the cough with an airway acid event, and even if the acidity is not prolonged, acid reflux becomes highly suspect.

This study will examine the ability of EBC pH measurements to prognose the likelihood of a positive response to acid blockade with proton pump inhibitor therapy in subjects with chronic cough.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient
* 5 years of age and older
* Cough lasting a minimum of 3 weeks
* Has been prescribed a proton pump inhibitor as a single therapeutic and diagnostic effort to control the cough

Exclusion Criteria:

* Inability to perform serial exhaled breath condensate collections at home
* Unwillingness to initiate proton pump inhibitor therapy as prescribed by physician
* Other changes planned in therapy, such as initiating or discontinuing cough suppressant therapy, initiating or augmenting antibiotic therapy, initiating or augmenting anti-inflammatory therapy
* Previous treatment of respiratory symptoms with proton pump inhibitor therapy
* Current treatment with angiotensin converting enzyme inhibitor medication or H2 antagonists
* Regular exposure to an environmental irritant
Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study

Treatment of vascular malformations requires the placement of a needle within anatomically non well defined, pathological vessels, which may be as small as 1 mm, with the current state of the art relying exclusively on two dimensional fluoroscopy images for guidance. The investigators hypothesize that the combination of stereotactic image guidance with existing targeting methods will result in faster and more reproducible needle placements.

This prospective study aims to investigate the feasibility of the utilization of stereotactic image guidance technology for the needle based percutaneous treatment of peripheral vascular malformations. The specific device to be utilized is the CAS-One IR system, CE marked for use with needle based procedures in combination with medical image data including MRI data, as required by this study.

Utilizing feedback from the stereotactic image guidance system, the interventionalist will attempt to place the needle within the malformation. The position and orientation of the needle relative to the anatomy will be displayed on 2D slices from the MRI, as well as relative to a 3D volume rendering of the patient anatomy constructed from MRI data. The position of the needle relative to the desired position within the malformation will be evaluated utilizing fluoroscopy.

If necessary the position of the needle will be adjusted, this adjustment can be performed utilizing navigated feedback or standard fluoroscopy feedback at the discretion of the physician. The final position of the needle will be confirmed on intra-operative DSA imaging and the sclerosant will be applied according to standard clinical protocols.

This single-centre pilot study will involve a total of 10 patients suffering from peripheral vascular malformations. Only non-emergency adult patients will be considered for inclusion in this trial. Inclusion will be at the discretion of the treating physician and patient. As the study is designed as a pilot trial, no comparator is considered and no blinding performed. The trial will be performed over a period of nine months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with venous or mixed venous-lymphatic malformation
* Patients which are regular scheduled for a percutaneous treatment of a vascular malformation
* Informed Consent as documented by signature

Exclusion Criteria:

* Age \< 18 years
Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer

This is a Phase II research study that is designed for patients who have small cell lung cancer (SCLC) that is no longer responding to treatment. Patients will receive picoplatin, a new platinum-based agent that is currently under investigation, in 21-day cycles.

Platinum drugs work by binding to DNA and preventing the rapid cell division of tumors. However, many tumors demonstrate a resistance to platinum drugs. Results from preclinical studies indicate that picoplatin (previously called AMD473 or ZD0473) may be able to overcome or partially overcome platinum resistance. More than 500 patients have received picoplatin in previous Phase I or Phase II clinical trials.

Eligibility Criteria:
Main inclusion criteria:

1. Diagnosis of small cell lung cancer.
2. Patients must have had one prior chemotherapy regimen which must have included either cisplatin or carboplatin.

\[Additional eligibility criteria apply.\]

Exclusion Criteria:

* Prior radiotherapy that included \> 30% of the bone marrow (i.e., the whole of the pelvis or half of the spine).
* Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
* Significant heart disease.
* Uncontrolled, untreated, unstable, or symptomatic brain tumors or central nervous system disease.
* Grade 2+ peripheral neuropathy (a condition caused by damage to the nerves in the peripheral nervous system).

\[Additional exclusion criteria apply.\]
Cold Plasma for the Reduction of Lymphoceles Following PLND

This study protocol will evaluate the efficacy of Bovie Medical's J-Plasma® helium based plasma technology in the reduction of lymphoceles following pelvic lymph node dissection (PLND) during robotic assisted radical prostatectomy (RARP). The J-Plasma® handpiece will be used during the PLND by dissecting the lymph nodes and sealing the lymphatic channels to prevent lymph leakage.

Participants evaluated and scheduled for a PLND during Robotic Assisted Radical Prostatectomy who have met the study inclusion criteria and who have also given informed consent will be enrolled. Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. An abdominal-pelvic ultrasound will be completed at a follow-up period ranging from 4-12 weeks post operatively to determine if a lymphocele is present. The occurrence rate of lymphoceles in this trial group will be compared to retrospective data from the principal investigator's practice and other published data to determine if the occurrence rate has been reduced.

Eligibility Criteria:
Inclusion Criteria:

1. Primary diagnosis of Prostate Cancer (ICD-10:C61)
2. Prostate Specific Antigen (PSA) level =/\> 10ng/mL
3. Gleason score =/\> 7
4. Planned Elective Robotic Assisted Radical Prostatectomy with planned pelvic lymph node dissection.
5. Willing and able to return to clinic for standard of care abdominal ultrasound within 12 weeks post operatively.
6. Able to provide informed consent

Exclusion Criteria:

Must answer no to all:

1. Patient is unwilling or unable to sign or understand informed consent
2. Patient resides outside of the United States
3. Performance of Lymph node dissection was aborted.
The Embodied Cognition: Exploratory Study of Automatic and Controlled Processes in Anorexia Nervosa.

Anorexia nervosa (AN) is a common psychiatric illness, with severe prognosis (5% mortality) that has changed little over in half a century. One of the forms is the restrictive anorexia nervosa (ANR). It consists of a phobia of weight gain and food with a massive food restriction. This pathology is studied in psychology but not using the theories of embodied cognition in which "perception and action" interact through sensorimotor processes. They are the source of attitudes (unconscious) towards certain stimuli and influence our interpretation (conscious).

The investigators hypothesis is that food restriction behavior is the result of two processes. One automatic and not conscious, which is an attraction toward food and manifests itself in the motivational attitudes of approach, and the other controlled and conscious, which prevents attraction to this type of stimuli and is manifested by motivational attitudes avoidance. These processes of attraction and avoidance are observed in embodied cognition paradigms because the answers induce movement of approach or avoidance of stimuli. The validation of these assumptions could lead to reconsideration of the respective roles of automatic and controlled processes in food behaviors of anorexics patients and to complete or refocus psychological techniques of care.

Eligibility Criteria:
Inclusion Criteria for patients:

* Restrictive anorexia nervosa according to Diagnostic and Statistical Manual of Mental Disorders Text Revision (DSM IV-TR)
* BMI\> 16 to avoid the effects of undernutrition
* Start disorders \<10 years
* Right handed
* Having given free and informed consent prior to study participation
* Subject affiliated to the French National Health Insurance

Inclusion Criteria for control group:

* BMI between 18,5 and 25
* Right handed
* Of school level paired in that of the patients (+/-1 the year)
* Having given free and informed consent prior to study participation
* Subject affiliated to the French National Health Insurance

Exclusion Criteria for patients and control group:

* Patients with at the beginning or during the study form of purgative anorexia nervosa
* Control with disorders of current or past eating behavior.
* Control making a restrictive diet during the study period
* Participants with depressive table
* Participants with a somatic problem restricted movement or a problem of uncorrected visual acuity annoying reading of the screen.