cyrilzakka/clinical-trials huggingface dataset:
Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults

This proposal hypothesizes that oral supplementation with sodium nitrite or nitrate will result in in vivo conversion of nitrate to nitrite and nitrite to nitric oxide with limited toxicity in the doses proposed in healthy adult normal volunteers. We utilize a powerful in vivo technique (pharmacokinetic testing) and are the first to design inorganic nitrate and nitrite capsules for cardiovascular disease.

Preclinical and clinical research over the last decade has revealed the important vasoprotective effects of nitrates and nitrites with regards to reduction in blood pressure, vascular inflammation and endothelial dysfunction. New findings suggest an effect of nitrate and nitrite therapy in the regulation of glucose-insulin homeostasis. Development of an oral formulation of nitrate and nitrite salts is attractive, whereby nitrite would ensure rapid acting effects upon absorption, while the nitrate would continuously provide a slow formation of nitrite over a prolonged period of time via the enterosalivary circulation pathway.

For this reason, development of an oral formulation of nitrate and nitrite salts is attractive, whereby nitrite would ensure rapid acting effects upon absorption, while the nitrate would continuously provide a slow formation of nitrite over a prolonged period of time via the enterosalivary circulation pathway. This study aims to establish the pharmacokinetics, metabolism and interconversion of nitrate to nitrite and nitrite to nitric oxide in vivo in healthy adult normal volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years
* Systolic blood pressure ≤130 and diastolic blood pressure ≤85 mm Hg

Exclusion Criteria:

* Positive urine pregnancy test or breastfeeding
* Concurrent use of medications affecting glucose or lipid metabolism
* Recent addition or change in dosing of hormonal contraceptive medications (oral contraceptive pill, intrauterine device, DepoProvera)
* Current use of ≥2 anti-hypertensive agents regardless of blood pressure control or normotensive on a single agent
* Current use of phosphodiesterase 5 inhibitors or organic nitrates
* Not stable on treatments for the prior three months or not planning to remain on current dose of medications for blood pressure, contraception, etc
* Known chronic psychiatric or medical conditions including diabetes, liver or kidney disease or obesity syndromes
* Smoker
Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB)

This is a one-period, double-blind, single-center pharmacokinetic study of linezolid in patients with MDR or XDR tuberculosis treated with linezolid and an Optimized Background Therapy (defined as treatment with \> 4 drugs with activity against tuberculosis to which the patient's isolate is believed to be sensitive by history or based on drug sensitivity testing).

This is a one-period, double-blind, single-center pharmacokinetic study of linezolid in patients with MDR or XDR tuberculosis treated with linezolid and an Optimized Background Therapy (defined as treatment with \> 4 drugs with activity against tuberculosis to which the patient's isolate is believed to be sensitive by history or based on drug sensitivity testing).

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the TBTC Study 30
* Provision of informed consent for the study

Exclusion Criteria:

* Severe anemia as defined by a hematocrit less than 25% (most recent value, measured within 30 days of the PK study).
Observational Study to Evaluate the Safety of Levemir® in Diabetes

This study is conducted in Africa, Asia, Europe, Japan and South America. The aim of this observational study is to evaluate the incidence of serious adverse reactions (SARs) while using Levemir® (insulin detemir) under normal clinical practice conditions.

Study conducted globally in 26 countries. Some countries participated in the study for only 3 months (Austria, Brazil, Denmark, Germany, Israel, Lebanon, Slovenia, Russia, and Turkey), while others extended their participation to 6 (Belgium/Luxembourg, Czech Republic, Greece, India, Italy, Netherlands, Saudi Arabia, South Africa, South Korea, Sweden, Tunisia, and United Kingdom/Ireland) and 12 months (Finland, France, and Japan), respectively.


Eligibility Criteria:
Inclusion Criteria:

* Age according to approved label in each country and physician discretion
* Type 1 or 2 diabetes
* Recently started treatment with insulin detemir at the discretion of the investigator. Before initiation of insulin detemir they should not have been treated with insulin
* Selection at the discretion of the physician

Exclusion Criteria:

* Current treatment with Levemir® (insulin detemir)
* Previously enrolled in the study
* Hypersensitivity to Levemir® (insulin detemir)
An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of Minzasolmin (UCB0599) in Study Participants With Parkinson's Disease

The purpose of the study is to estimate the pharmacodynamic effects of minzasolmin (UCB0599) on brain pathophysiology in Early-start versus Delayed-start participants originally diagnosed with new onset Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria

* Participant completed the Treatment Period of PD0053 (NCT04658186). The Baseline Visit for PD0055 (Visit 2) should be no later than 4 weeks following the end of treatment (EOT) Visit in PD0053 (NCT04658186). Any delay needs to be justified by the Investigator and approved by the Sponsor
* A male study participant must agree to use contraception during the Treatment Period and for at least 90 days after the last dose of the IMP and refrain from donating sperm during this period.
* A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

  ◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 1 month after the last dose of investigational medicinal product (IMP). The study participant must have a negative urine pregnancy test at Screening (Visit 1), which is to be confirmed negative by urine testing prior to the first dose of IMP at PD0055 Baseline Visit. If oral contraception is used, an additional barrier method will be required during the study as an IMP-related gastrointestinal upset or a drug interaction by cytochrome P450 3A4 (CYP3A4) induction could interfere with efficacy
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent form (ICF) and in this protocol.

Exclusion Criteria:

* Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
* A female study participant who tests positive for pregnancy, plans to get pregnant during the participation in the study, or who is breastfeeding
* Study participant had previously participated in PD0055
* Study participant meets any withdrawal criteria in PD0053 (NCT04658186)
* Study participants wearing any kind of implantable active device, including cardiac pacemakers, pumps, and implantable cardioverters, will be excluded from using Digital Health Technology, but may participate in the main study
* Study participant does not agree to refrain from donating blood or blood products or other body fluids
Mobile Self-Management of Irritable Bowel Syndrome for Adolescents

The objective of the proposed research is to conduct user testing of a mobile-based self-management support intervention for adolescents and young adults with Irritable Bowel Syndrome (IBS), a chronic digestive condition. The application (app; BodiMojo Buddy) uses a virtual coach that can serve to increase patient engagement through interactive skill-building, self-care, and mindfulness-based cognitive behavioral activities. If the BodiMojo Buddy mobile app is successful, it will have a significant public health impact by providing a mobile resource to the 10-15% of the US population who suffer from IBS and potentially improving health outcomes and reducing significant costs to the US healthcare system.

Study participation involves participants downloading and using the app for 30 days. During the 30 days, participants will interact with the app by inputting their current mood, receiving supportive feedback from the app, reading messages, and doing brief activities (such as relaxation activities, etc.). Before and after the 30 days of user testing, participants will complete a few brief questionnaires about their behavior, how their symptoms affect their life, and how they receive support from others. These questions will take around 20 minutes to complete at each administration.


Eligibility Criteria:
Inclusion Criteria:

1. Age 13-21 years
2. For adolescents: Parent-reported physician diagnosis of IBS, using pediatric Rome III diagnostic criteria for functional gastrointestinal disorders. For young adults: self-reported physician diagnosis of IBS using Rome III diagnostic criteria, or meeting criteria for IBS or functional abdominal pain as determined during phone screening.
3. Have daily use of an iPhone or iPad that meets the following technical specifications: at least iOS 8; for iPhones, must be iPhone 5 or above.
4. Able and willing to give informed assent/consent and comply with study requirements
5. Have one caregiver willing and able to participate in the study \[only for 13-17 year olds\]

Exclusion Criteria:

1. Inability to provide informed assent/permission/consent
2. Inability to read, speak, and understand English (because the app content/parent guides are written in English, as are the measures being used in the study)
Thoracoabdominal Arortic CTA Study

The purpose of this study is to compare the contrast agents and imaging techniques used for thoracoabdominal aortic imaging in CT. Imaging parameters and contrast volume are changed and adjusted based on the contrast agent, since contrast agents have varying iodine concentrations. If the contrast iodine concentration is higher, it may be possible to adjust the imaging parameters and lower the overall radiation dose to the patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing thoracoabdominal aortic (TAA) CTA
* Able to provide informed consent
* Body Mass Index (BMI) equal to or less than 30

Exclusion Criteria:

* Creatinine greater than 2.0
* Allergy to contrast media
* Pregnant women
Smokefree.Gov Website in Helping United States Federal Employees Quit Smoking

RATIONALE: Stop-smoking information on the smokefree.gov website may help people quit smoking and remain a nonsmoker.

PURPOSE: This clinical trial is studying how well the smokefree.gov website works with an electronic bulletin board in helping United States federal employees quit smoking.

OBJECTIVES:

* Determine the perception of utility of the current, publicly accessible version of the smokefree.gov website and the addition of an electronic bulletin board and its features, including open-ended comments, in promoting smoking cessation among United States federal employees who are currently smokers.
* Determine the use of this tool, in terms of average length of time spent on the website, number of page clicks, most popular page clicks, and key interest areas, among these participants.
* Determine the changes in smoking habits, in terms of smoking reduction and short- and long-term abstinence, among these participants.

OUTLINE: This is an open-label study.

Participants are encouraged to use the smokefree.gov website as frequently as needed for support and resources while trying to quit smoking and become, and remain, nonsmokers. Participants are invited to provide feedback on the usefulness of self-help guidelines and several other tools. Participants complete questionnaires evaluating the website at study entry and at 1, 3, and 6 months after study entry.

PROJECTED ACCRUAL: A total of 4,200 participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Currently smokes \> 1 cigarette daily by self reporting
* Planning to quit smoking in the next 90 days by self reporting
* Must be a federal employee or federally employed

PATIENT CHARACTERISTICS:

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY: Any prior or concurrent therapy allowed
Study of NGM438 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors

Study of NGM438 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
* Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for their tumor type for which the patient was eligible and willing to receive.
* Adequate bone marrow, kidney and liver function
* Performance status of 0 or 1.
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for AEs not constituting a safety risk by Investigator judgement.

Exclusion Criteria:

• Prior treatment targeting LAIR1
IV Methadone Vs EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Idiopathic Scoliosis Correction

The goal of this pilot study is to assess the feasibility of conducting a randomized controlled trial at a single institution comparing erector spinae plane blockade (ESPB) with liposomal bupivacaine (LB, Exparel) to intravenous (IV) methadone for managing pain in pediatric subjects undergoing adolescent and juvenile idiopathic scoliosis correction. Specifically, the goal is to enroll 15 subjects in each group and to complete data collection for all subjects. If this pilot study is successful, we plan to then design a larger scale study powered to compare specific outcomes between the two groups.

Enrolled subjects will be randomized to one of two groups: one group will receive intra-operative IV methadone as the primary means of controlling post-operative pain while the other group will instead receive intra-operative erector spinae plane blocks (ESPB) with liposomal bupivacaine (LB, Exparel) and bupivacaine hydrochloride as the primary means of controlling postoperative pain. All other aspects of peri-operative management will be standardized. Subjects and the post-operative care team will be blinded to which intervention was performed in order to reduce bias. Upon discharge, subjects will receive a wearable activity monitor and a daily journal in order to record post-discharge data. Subjects will receive weekly phone calls for data collection and then will have a final in-person clinic visit, at which point participation in the study will conclude.

Eligibility Criteria:
Inclusion Criteria:

* Subjects whose parent(s) or guardian(s) has/have signed and dated the informed consent form (ICF) for the subject to participate in the study
* Patients with a diagnosis of juvenile idiopathic scoliosis (JIS) or adolescent idiopathic scoliosis (AIS) who will have posterior spinal fusion surgery
* Male or female patients 11 to less than 18 years of age on the day of surgery.
* American Society of Anesthesiologists (ASA) Class 1-2.
* Able to adhere to the study visit schedule and complete all study assessments.

Exclusion Criteria:

* Body mass index ≥35 at the time of screening
* Contraindication to regional anesthesia (e.g., abnormal coagulation, infection at site)
* Current opioid use at the time of screening
* Current diagnosis of chronic pain
* Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications
* Administration of liposomal bupivacaine (LB, Exparel)
* Subject/parent/guardian primary language other than English or Spanish
* Inability of patient to verbally express symptoms such as pain and side effects (as in moderate to severe developmental delay)
* A prolonged QTc on preoperative EKG (QTc longer than 450 milliseconds)
* History of Torsades de Pointes
* Renal or hepatic impairment
* Diagnosed active seizure disorder
* Any other condition that causes patient to be ineligible for surgery, i.e. pregnancy.
Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy

The investigators have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. The investigators wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy.

We have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. We wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy in terms of biopsy adequacy, the time taken to obtain a biopsy and patient experience.

Eligibility Criteria:
Inclusion Criteria:

* Indication to carry out diagnostic hysteroscopy
* Agrees and is suitable for outpatient/office hysteroscopy

Exclusion Criteria:

* Failed outpatient/office hysteroscopy
Balance Training To Enhance Stability And Athletic Performance During The Menstrual Cycle

This study was done to investigate the effect of balance training on improving balance and athletic performance during menstrual cycle in young athletic females Does balance training improve balance and athletic performance during the menstrual cycle? 60 athletic females will participate in the study. They will be randomly assigned into two groups. Group A will receive balance training on biodex, while group B will be the control group.


Eligibility Criteria:
Inclusion Criteria:

* Their age will be ranged from 18 to 22. Their BMI will be from 18.5 to 25 kg/cm2 - Athletes

Exclusion Criteria:

* free of musculoskeletal or neurological diseases that could affect balance/ taking any medications that affect sex hormones
Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer

The aim of this double-blinded prospective randomised trial is to explore the potential benefits of early postoperative administration of Synbiotics (combination of prebiotics and probiotics) to patients who have undergone colectomy for cancer. The patients are randomised to either synbiotics or placebo administration at the day they are able to tolerate po liquid diet and for 15 days thereafter.

Primary end points of the study will be:

Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively by the use of the validated questionnaire GIQLI (Gastrointestinal Quality of Life Index)

Secondary end points will be:

-Assessment of functional bowel disorders (diarrhea, constipation, etc) at 1, 3 and 6 months postoperatively based on the respective domains of the validated instrument EORTC QLQ-C30

The study patients are randomized before surgery to receive either synbiotics (Synbiotics group) or placebo (Control group). Equal randomization is accomplished using a computer-generated random allocation schedule. The method of allocation concealment is sequentially numbered sealed opaque envelopes technique. Both synbiotics and placebo preparations are in foil-sealed sachets stored in identical numbered containers. Both study products are white powders, identical in weight, smell, and taste. Thus, the identity of the specific product is blind to participants, support staff and investigators for the entire duration of the study period.

Eligibility Criteria:
Inclusion Criteria:

* Colectomy for histologically proven colorectal adenocarcinoma

Exclusion Criteria:

* Pregnancy,
* hereditary cancer,
* history of inflammatory bowel disease,
* metastatic disease at presentation,
* emergency operation,
* major postoperative complications
Association of Keratinised Mucosa Around Implants and Teeth With Peri-implant/Periodontal Disease and Soft Tissue Conditioning

Lack of keratinised mucosa around dental implants and teeth is associated with plaque accumulation and worse tissue conditions. However, there is lack of data on the influence of the presence/lack of keratinised mucosa on the periodontal condition. Hence, soft tissue conditioning by grafting with a gingival graft is aimed at improving the quality of the peri-implant conditions


Eligibility Criteria:
Inclusion Criteria:

* Partial edentulous patients with adjacent teeth
* Lack of keratinised mucosa
* Healthy patient

Exclusion Criteria:

* Pregnancy
* Complete edentulous patients
* Patients taking any medication
* Smokers
A Study of ABT-384 Levels and Pharmacodynamic Activity Measured in Cerebrospinal Fluid

The objectives of this study are to assess the cerebral spinal fluid (CSF) pharmacokinetics and the plasma/CSF pharmacokinetic/pharmacodynamic relationship of ABT-384 in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age is between 18 and 55 years
* Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

Exclusion Criteria:

* Use of protocol-prohibited medications within 2 weeks prior to study drug administration.
* Positive urine drug screen for non-prescribed drugs of abuse including alcohol.
* Receipt of any drug depot by injection within 30 days prior to study drug administration.
* Receipt of any investigational product within 6 weeks prior to study drug administration.
* History of significant sensitivity or allergy to any drug.
* History of drug or alcohol abuse.
* Positive test result for HAV, HBsAg, HCV or HIV.
* Donation or loss of 550 mL or more blood volume or receipt of any blood product within 3 months prior to study drug administration.
* Contraindication for lumbar puncture (e.g., lumbar scoliosis, coagulopathy, infected skin at puncture site)
* Current enrollment in another clinical study.
A Phase 1 Feasbility Study Of Volume Intracardiac Echo In Assessment Of Patients With Structural And Valvular Heart Disease Undergoing Percutaneous Transcatheter Therapy

This study will compare 3 dimensional intracardiac echo (ICE) with 2 dimensional ICE or transesophageal echo in patients with structural and valvular heart disease who are already scheduled to undergo a percutaneous intervention. Specifically those patients would be those scheduled for a PFO or ASD repair, mitral balloon valvuloplasty, diagnostic cardiac catheterization assessment of aortic stenosis and those undergoing transcatheter aortic valve replacement.


Eligibility Criteria:
Inclusion Criteria:

* patients in the study population referred to the cardiac catheterization laboratory for a percutaneous procedure to treat structural or valvular heart disease

Exclusion Criteria:

* Class IV CHF, inadequate femoral access, coagulation abnormalities, intracariac thrombus or DVT