cyrilzakka/clinical-trials huggingface dataset:
Electromagnetic Stimulation of the Phrenic Nerve in Critically Ill Mechanically Ventilated Patients (STIMIT-II)

Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. A non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it is currently unclear if that is feasible.

In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction in critically ill ICU patients via an external electromagnetic stimulation of the phrenic nerve, leading to an inspiration (i) with a sufficient tidal volume (3-6 ml/kg ideal body weight) and (ii) with verifiable muscular diaphragmatic contraction through ultrasound imaging.

During the time of first spontaneous breathing trial 60% of mechanically ventilated patients present with diaphragmatic weakness or also know as ventilator-induced diaphragmatic dysfunction (VIDD). The damage to the diaphragm in terms of muscle atrophy has been shown as early as 12 hours after initiation of mechanical ventilation. Recently, a correlation between diaphragmatic atrophy and mortality could be established.

Induction of diaphragmatic contractions via stimulation of the phrenic nerve would be a possible method to prevent or treat VIDD. A possible modality would be the non-invasive electromagnetic stimulation but feasibility has not been established.

In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction in critically ill ICU patients via an external electromagnetic stimulation of the phrenic nerve, leading to an inspiration (i) with a sufficient tidal volume (3-6 ml/kg ideal body weight) and (ii) with verifiable muscular diaphragmatic contraction through ultrasound imaging.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 60 years old, hospitalized in ICU
* Mechanical ventilation \< 36 h
* Prone to stay ventilated \> 72 h

Exclusion Criteria:

* Known neurological condition affecting motor neuron or muscle (e.g. ALS)
* Known paralysis of the phrenic nerve
* Proven or suspected spinal cord injury that contraindicates weight bearing on the spinal cord
* Conditions that limit diaphragm movement (high intra-abdominal pressure, ascites, obesity)
* Not able to read and understand the national language German
* Patients with Implanted cardiac support systems (pacemaker, implanted defibrillator)
* Patients with implanted medical pumps
* Pregnant patients
* Patients with skin lesions, infections or strictures in throat/neck area
* Patients with metallic implants
Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers

To Estimate Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting Conditions with 40% Ethanol Compared with Water in Healthy Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* History of moderate alcohol consumption
* Total body weight exceeding 64 kg

Exclusion Criteria:

* Evidence or history of clinically significant disease.
* Positive urine drug test
* History of alcoholism or heavy alcohol consumption
Open-Label Study of Long-Term Safety and Efficacy of Intravenous Trappsol Cyclo (HPβCD) in Niemann-Pick Disease Type C

The purpose of this study is to provide continued access to treatment for NPC-1 after participation and completion of the Phase I trial CTD-TCNPC-101, when administered at doses of 1500 mg/kg and 2500 mg/kg by slow IV infusion over a period of 8 to 9 hours every two weeks.

This is an open-label extension study of intravenous HP-β-CD (administered as Trappsol® Cyclo(TM)) in patients with NPC-1 to evaluate long-term safety and efficacy by providing continued access to treatment following completion of study CTD-TCNPC-101. Patients will receive medication at their home or local site under the supervision of a home nurse professional or at the parent site under the supervision of the site principal investigator. Patients will visit the parent site for safety and efficacy evaluations after receiving treatment for 3 months in the extension protocol.

Thereafter, visits to the parent site will be every 6 months until cessation. The study will continue until Trappsol® Cyclo (TM) becomes commercially available or study/site/patient discontinuation. All patients who complete study CTD-TCNCP-101 and pass the screening criteria will be eligible for this study. The study will be directed from parent site in the US. Vital signs, AEs Adverse Events (AEs) and concomitant meds will be recorded by the home nurse professional or deputy at the local site and reported immediately to the parent site for entry into the Electronic Data Capture (EDC) and reporting to the sponsor.

For logistical reasons home infusions will be permitted as long as AEs, infusion details and concomitants medications are reported directly to the parent site by an authorised deputy according to local guidelines. A Safety Review Committee (SRC) consisting of an independent advisor, the medical monitor, and the principal investigator will be established to review AEs and laboratory data throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Completion of study CTD-TCNPC-101 with no safety concerns at the final visit
* Negative urine pregnancy test for females of child bearing potential
* Patients must be legally resident in the USA with access to healthcare
* Written, informed consent

Exclusion Criteria:

* Inability to comply with the proposed protocol assessments or any uncertainty about their ability to give meaningful, informed consent (legal guardian may give consent with subject assent)
* Concurrent medical conditions representing a contraindication to any of the study medications
* Grade 3 renal impairment or worse as indicated by estimated Glomerular filtration rate (eGFR) \< 60mL/min/1.73m2
* Clinical evidence of acute liver disease including symptoms of jaundice or right upper quadrant pain or International Normalised Ratio (INR) \>1.8
* Male patients and female patients of childbearing potential who are not willing to use appropriate birth control (i.e. double barrier birth control) from enrollment until the follow-up visit
Brain Study of Patients With Frontal Lobe Dementia and Parkinsonian Disorders

The Cognitive Neuroscience Section of the National Institute of Neurological Disorders and Stroke proposes to continue its cross-sectional and longitudinal studies of cerebral metabolism in frontal lobe dementias and atypical basal ganglia disorders. These studies include repeated assessments of neuropsychological and brain anatomical and metabolic function in subjects with these important and possibly related brain disorders.

Objective

To continue the cross-sectional and longitudinal studies performed by the Cognitive Neuroscience Section of NINDS on the neuroanatomy, cerebral metabolism, neuropsychology, and genetics of frontotemporal dementia, corticobasal syndrome, and related brain disorders.

Study population

Frontal lobe dementias and atypical basal ganglia disorders including frontotemporal dementia, corticobasal syndrome, and related brain disorders.

Design

A cross-sectional assessment of neuropsychological, brain anatomical and metabolic function, and genetic measures in subjects with these disorders.

Outcome measures

MRI, FDG-PET, neuropsychological and clinical tests, genetics, and neuropathology.

Eligibility Criteria:
* Subjects will be recruited from the NIH referral center, neurological and psychiatric clinics, from self or family referral in response to advertisements or from private physicians. Healthy volunteers will include subjects who are considered at-risk for the development of FTD or CBS and subjects who serve as normal controls matched for key characteristics with the patients.

INCLUSION CRITERIA FOR PATIENTS:

* Diagnosis of possible / probable FTD or CBS
* Caregiver willing and able to accept the responsibilities involved in the study

EXCLUSION CRITERIA:

* Pregnant women. Women of childbearing potential will be screened by history for the possibility of pregnancy and undergo a urine pregnancy test. These women will be excluded from the imaging portions of the protocol.
* Behavioral symptoms that would preclude the gathering of data for the study
* Other medical or social condition that would preclude participation in the opinion of the investigators
Osseodensification Drills Versus Piezoelectric Surgery

implant stability is the first requirement for implant success. the aim is to assess whether different implant site preparation technique may impact the value of the primary stability.

Impianti stability represents one of the most fundamental issue for implant success. Different techniques of implant site preparation are available such as twist drill, osteotome, piezosurgery and lastly, osseodensification. Due to their different approach an biological rationale, piezosurgery and osseodensification might show diverse impact on implant first and secondary stability, therefore the aim of the present study was the assessment of primary and secondary stability changes of values between implant sites prepared with piezoelectric bone surgery and with specific osseodensification drills.

Patients with bilateral single maxillary edentulism will randomly receive implant site preparation with piezoelectric approach or with osseodensification drills. standardized implants will be therefore inserted and primary stability will be assessed at the time of implant insertion and during the subsequent timepoints.

Eligibility Criteria:
Inclusion Criteria:

* bilateral single maxillary edentulism

Exclusion Criteria:

* smoking habit
* history of periodontal disease
* uncontrolled diabetes
* pregnancy or breastfeeding
* head and neck radiotherapy or chemotherapy
* bone antiresorptive therapy
* coagulopaties
The Difference in Preoperative Evaluation That is Given by a Senior Physician, a Specialist, and a Computer Program

There is an increasing need and interest in being able to empirically estimate customized, patient-specific risks for virtually all surgical operations in a user-friendly format.

The ACS (American College of Surgeons) surgical risk calculator is a decision-support tool based on reliable multi institutional clinical data, which can be used to estimate the risks of most operations.1 The aim of this study is to compare the assessment provided by the The ACS Surgical Risk Calculator with the assessment provided by a senior and a resident anesthesiologist, and by that comparison to establish the need for the ACS calculator

Understanding the risks of surgery is clearly important for both patients and surgeons in the shared decision making process. Informed consent requires that patients have a thorough understanding of the potential risks of surgery. Moreover, clinicians and patients also need information regarding surgical risks in order to make decisions on the type of operation or whether surgery should be performed at all.

Therefore, there is a need to discuss the risks derived empirically with a specific patient before any action to guide both surgical decision-making and informed consent.

However, predicting postoperative risks and identifying patients at a higher risk of adverse events have traditionally been based on individual surgeon experience and augmented by published rates in the literature, either from single institution studies or clinical trials. Unfortunately, these estimates are typically not specific to an individual Patient's risk factors. The ACS (American College of Surgeons) Surgical Risk Calculator estimates the chance of an unfavorable outcome (such as a complication or death) after surgery. The risk is estimated based upon information the patient gives to the healthcare provider about prior health history. The estimates are calculated using data from a large number of patients who had a surgical procedure similar to the one the patient may have.

Eligibility Criteria:
Inclusion Criteria:

* Patients candidates for surgery
* Signed informed consent by patient

Exclusion Criteria:

* None
Ketoprofen Lysine Salt as Mouthwash in Acute Phlogosis of the Pharyngeal Cavity Versus Benzidamine Hydrochloride

A study to in order to verify any differences between the 2 treatment groups in terms of duration of analgesic effects after the first drug intake and time to remission of symptoms and signs of pharyngitis


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients, aged 18 to 70 years, suffering from acute pharyngitis, pharyngolaryngitis
* Moderately or severely intense pain in the pharyngeal region (score ≥ 70 mm) from the "visual analogue scale" (VAS)
* At least 1 of the 2 inflammation signs (edema and hyperemia) to be moderately or severely intense (score ≥ 2) from the scoring scale from 0 to 3
* Release of written informed consent by the patient

Exclusion Criteria:

* Patients suffering from a microbial infection requiring specific antimicrobial treatment
* Patients who have taken the trial drugs during the week before enrolment
* Patients who have taken corticosteroids or antibiotics during the week before enrolment
* Ascertained or suspected hypersensitivity to trial drugs or to chemically correlated drugs or to other non-steroidal anti-inflammatory drugs or to mouthwashes in general
* Patients who are unable to properly fill in the diary every day as provided for by the protocol
* Ascertained or presumed pregnant or lactating women
* Inclusion in any other clinical trial during the study
Pelvic Floor Disorders Among Sexual Minoritized Women

The investigators aim to perform cognitive interviews to assess how pelvic floor disorders impact sexual functioning in women who have sex with women (WSW). As a secondary objective there will be cognitive interviews to assess perceptions of sexual function questionnaires such as Female Sexual Function Index (FSFI) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-IUGA Revised (PISQ-IR) in WSW.

There is a paucity of data regarding care of women who have sex with women (WSW). While some cohort studies are being performed in general gynecology, no studies document the reasons as to why WSW seek urogynecological care, or how pelvic floor disorders (PFDs) affect sexual function in this population. Another detrimental gap in current knowledge and a barrier to care for WSW is the lack of understanding of what would drive WSW to seek care, if there are special considerations for care, or if the commonly used condition specific questionnaires adequately reflect their concerns. The Investigators aim to perform qualitative interviews to understand how PFDs affect sexual function, and if commonly utilized sexual function questionnaires are inclusive to WSW.

Eligibility Criteria:
Inclusion Criteria:

* WSW who have a PFD (pelvic organ prolapse, urinary incontinence, fecal incontinence)
* Age \>18
* Able to provide consent
* Able to read/write in English

Exclusion Criteria:

* WSW who have not been sexually active in the past 6 months
* Incarcerated patients
* Pregnant or lactating patients
* Unable to consent with study procedures or guided discussions
* Unable to speak English
* No sexual activity in the past 6 months
A Study of the Safety of PAZ-417 in Healthy Elderly Adults

This is study to determine the safety of PAZ-417 in healthy adults over 65.


Eligibility Criteria:
Inclusion:

1. A signed and dated IRB-approved informed consent form before any study specific screening procedures are performed.
2. Ability to read English or Spanish.
3. Men or women greater than or equal to 65 years of age on study day 1. Women must be either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than or equal to 1 year (with estradiol less than or equal to 25 pg/mL\[92 pmol/L\] and FSH greather than or equal to 38 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound.
4. Subjects should have a hemoglobin level greater than or equal to 12 g/dL at the screening visit.

Exclusion

1. Any significant unstable or uncontrolled cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
2. History of vascular disorders (peripheral, coronary, venous), chronic inflammatory disorders (eg, rheumatoid arthritis), hematologic disorders, or bleeding disorders (eg, hemophilia, idiopathic thrombocytopenic purpura, VonWillebrand disease).
3. Presence or history of symptomatic vertigo, significant cardiac valvular disease, congestive heart failure, angina pectoris significant cardiac arrhythmia, or seizures.
Metabolic Availability of Metionine From Lentils in Adult Men

The research study is being done so we can determine the quality of the protein present in Canadian lentils. Amino acids are the building blocks of protein and protein quality is determined by the amount of amino acids present and by their bioavailability (their absorption and use by the body). Some amino acids are essential which means they must be obtained from the diet. If any one of the essential amino acids is missing in the diet, the body cannot make proteins that are used to repair tissue build bone, teeth, etc... Lentils as a food source contain low amounts of the essential amino acid methionine which makes its protein incomplete. The amino acids in lentils are also affected by cooking. Our objective is to determine the amount of methionine in lentils that the body can use. We will test lentils by studying them after cooking them in a stew, on their own and by combining the lentil stew with rice in a mixed meal to make a more complete protein.

This research is being done in order to bridge the gap between knowledge of protein requirement and the amount of food needed to meet that requirement. Results from this study will be important for recommendations guiding food choices of lentils as a major protein source in the diet.

Previously the quality of dietary protein for human consumption was studied in animals. This study is being done in humans because studies in animals are not directly applicable to humans. Excessive animal protein consumption is also linked to cardiovascular disease. Plant protein sources like lentils are important alternatives shown to "enhance ecosystem resilience, and improve human health.

If you agree to take part in this study, you will receive 3 different amounts of lentils which will contain different amounts of the essential amino acid methionine as well as 3 different amount of lentils complemented with rice. The lentils will be cooked in a stew served on its own or served with the rice. The quality of the protein in the lentils will be compared to the quality of a reference protein (egg protein) by giving you 4 reference diets containing amino acids make up like the amino acids in egg protein. The amount of lentils you receive will be provided in a random order.

Breath samples will be collected after the 4th meal in 15 min intervals for 1 hour. Breath collection will resume again two and a half hours after the 5th meal every 15 minutes until 30 minutes after the last meal. A total of 52 breath samples will be collected during each of the 3rd study day.

Eligibility Criteria:
Inclusion Criteria:

* Male, age 18 - 49 yrs, Healthy with no known clinical condition which would affect protein or AA metabolism, ex. Diabetes, Stable Body Weight (no more than 5 lb weight loss or gain in the past 3 months) Not on any medications that could affect protein or amino acid metabolism e.g. steroids

Exclusion Criteria:

* Unwillingness to participate or unable to tolerate the diet Recent history of weight loss within the last 3 months or on a weight reducing diet Inability to tolerate study diets (ex. Allergy to ingredients).
Treatment of Post-partum Depression Using an Behavioral Intervention Called ROSE (Reach Out, Stay Strong, Essentials for Mothers of Newborns) Delivered Using an Electronic App

A randomized trial of pregnant people at risk for postpartum depression comparing the InBloom app (n = 76) to ROSE (n = 76; weekly scheduled group), and two control groups. We will assess Depression at baseline and 1, 2 and 3 months, ROI at 3 months, Satisfaction at 1 and 3 months and Perceived Access at 1 and 3 months. Subject participation will last up to 8 months (minimum 17 weeks pregnant through 3 months postpartum).


Eligibility Criteria:
Inclusion Criteria:

* 17-32 weeks pregnant
* enrolled for prenatal care in one of the five identified practices
* English speaking
* able to use an app (audio/visual/dexterity)
* have one or more of the following PPD risk factors: Medicaid eligible; anxiety (GAD-7 \> 10) during pregnancy; mild to moderate depressive symptoms (PHQ-9 = 10-19); self-reported history of depression treatment; gestational diabetes; and/or young age (18-21 years).

Exclusion Criteria:

* patients with acute mental health needs
* cannot communicate in English
* demonstrate significant cognitive impairment
* are planning to place the child for adoption
* PHQ-9 depression score \> 19
* younger than age 18
Biomarker Study for Prediction of aGVHD

This is a prospective study in patients receiving allogeneic stem cell transplantation. The blood samples on Day-14, -7, 0 and every 7 days until D100 were collected together with clinical data. In the final analysis, cytokines and biomarkers analysis will be carried out and compared between patients in No aGVHD and grade II-IV aGVHD.

This is a prospective study, observation study in patients receiving allogeneic stem cell transplantation in 4 BMT centers in Shanghai. The blood samples (on Day-14, -7, 0 and every 7 days until D100) and clinical data will be collected. In the final analysis, a panel of cytokines and biomarkers analysis of serial blood samples will be carried out and compared between patients with no aGVHD and grade II-IV aGVHD.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing allogeneic stem cel transplantation
* with informed consent
* patients survived without aGVHD or relapse and patients with development of grade II-IV aGVHD

Exclusion Criteria:

* patients with blood sample and clinical data not available
A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients

This study is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient.


Eligibility Criteria:
Inclusion criteria:

* Listed kidney, heart, lung and/or pancreas patients who are negative for chronic hepatitis C infection
* Willing to accept and consent for accepting hepatitis C positive graft

Exclusion criteria:

* Existing chronic liver disease (liver cirrhosis)
* Concomitant infection with HIV or Chronic hepatitis B
* Patient or any member of patient family or care giver team who does not understand or accept the risk of an acquired HCV infection
* Pregnancy (Pregnant patients do not undergo solid organ transplants)
Influence of SLCO2B1 Polymorphism on the PK of Voriconazole in CYP2C19 PM

A clinical trail to investigate the influence of SLCO2B1 polymorphism on the pharmacokinetic characteristics of voriconazole in CYP2C19 poor metabolizers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteer who is a CYP2C19 Poor metabolizer with rs3781727 SNP wild or variant genotype

Exclusion Criteria:

* History of clinically significant respiratory, cardiovascular, renal, hepatic, hematologic, neurological disorder