cyrilzakka/clinical-trials huggingface dataset:
A Study Assessing the PK, PD, Safety, and Tolerability of SB414 in Psoriasis

The objectives of this study are to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of SB414 in subjects with mild to moderate plaque psoriasis.

This is a phase 1b, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in approximately 36 adult subjects with mild to moderate chronic plaque psoriasis. After obtaining informed consent, subjects will be randomized to active or vehicle treatment arms. Subjects will apply the study product (SB414 6% or Vehicle cream) twice daily to all affected areas of psoriasis on the trunk and/or extremities for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Be male or female, 18-70 years old, and in good general health;
* Have a clinical diagnosis of stable chronic plaque psoriasis of mild to moderate severity based on the PSGA, involving 2-15% BSA (excluding the scalp/face), present for \> 6 months;
* Must have at least 2 target plaques on trunk and/or extremities at least 5 cm2 with a TPSS \> 5 and thickness sub-score \> 2. Target plaques cannot be located on the groin, hands, feet, neck, face, elbows, knees, ankles or scalp;
* Be willing to not use any other systemic agents used to treat psoriasis or apply any other topical products (medicated or over-the-counter) to the treatment sites on the trunk and/or extremities during the study;
* Women of childbearing potential (WOCBP) must have a negative UPT prior to randomization and must agree to use an effective method of birth control during the study and for 30 days after their final study visit.

Exclusion Criteria:

* Have inverse (i.e.: axillae, groin) or facial psoriasis only, erythrodermic psoriasis, guttate psoriasis, pustular psoriasis, drug-induced psoriasis, and /or psoriatic arthritis requiring treatment with disease modifying antirheumatic drugs (DMARDs);
* Concurrent or recent use of topical or systemic medications without a sufficient washout period;
* Are immunocompromised, including those who are known HIV positive or received immunosuppressive treatment within the past 6 months;
* Female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study.
Norursodeoxycholic Acid vs. Placebo in NASH

This is a double-blind, randomised, multi-centre, placebo-controlled, comparative, phase IIb trial. The trial will be conducted with three treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d or 1000 mg/d norUDCA tablets vs. placebo tablets for the treatment of NASH.


Eligibility Criteria:
Inclusion Criteria:

* Must be willing to participate in the study and provide written informed consent
* Male or female patients ≥ 18 and \< 75 years
* Centrally assessed histological evidence of NASH and liver fibrosis
* Women of childbearing potential agree to use a highly effective method of birth control during the entire duration of the trial and for 4 weeks following the last dose of trial treatment

Exclusion Criteria:

* Patients taking prohibited medications
* Presence of liver cirrhosis
* Type 1 diabetes or uncontrolled Type 2 diabetes
* History or presence of any other significant concomitant liver diseases
* History of liver transplantation
* BMI \>45 kg/m\^2
* Any known relevant infectious disease (e.g., active tuberculosis, acquired immunodeficiency syndrome \[AIDS\]-defining diseases)
* Abnormal renal function (glomerular filtration rate estimated from cystatin C \< 30 ml/min) at screening visit
* Any active malignant disease (except for basal cell carcinoma)
* Existing or intended pregnancy or breast-feeding
Oxygen Insufflation To Reduce Postoperative Abscess In Laparoscopic Appendectomy

Oxygen has inherent bactericidal properties. The investigators are testing to see if they can reduce the incidence of postoperative abscesses following laparoscopic appendectomy by insufflating with oxygen at the end of the case.

Intra-abdominal abscess a well-known complication of both open and laparoscopic appendectomy, especially in the setting of perforated and gangrenous appendicitis. The reviewed literature cites an incidence of about 10%. Besides peri-operative antibiotic administration there have been few developments to reduce this inherent risk. Oxygen rich environments are potently bactericidal, and thus it is our hypothesis that establishing an oxygen rich ambience within the abdomen at the conclusion of laparoscopy could curtail bacterial growth and subsequent abscess formation.

In the experimental arm, at the conclusion of all surgical dissection and manipulation, the carbon dioxide insufflate will be exchanged with oxygen to generate a high intra-abdominal concentration. Oxygen will be infused for 15 seconds as CO2 is allowed to escape through the open trocars. In the control arm Co2 will be allowed to escape through the open trocar ports without any oxygen flush. Patients will receive a standardized operation as well as standard post-operative care and follow up.

Eligibility Criteria:
Inclusion Criteria:

* Nonpregnant adults 18 or older
* Clinical or image proven appendicitis
* Undergoing Laparoscopic Appendectomy

Exclusion Criteria:

* Any pregnant females
* Anyone under the age of 18
Study to Evaluate the Safety and Efficacy of MEM 3454 as Adjunctive Treatment in Combination With a Preexisting Antipsychotic in Patients With Cognitive Impairment Associated With Schizophrenia

To establish the proof of concept that MEM 3454, used as add-on pharmacotherapy, is a safe and effective treatment in patients with cognitive impairment associated with schizophrenia (CIAS).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia (any subtype), assessed using a structured interview.
* At least one month on the same dose of antipsychotic medication.
* Clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks.
* Able to provide informed consent.
* Fluent in English.
* Smokers and non-smokers.

Exclusion Criteria:

* First 3 years of schizophrenia diagnosis.
* Current risk of suicide, or history of suicidal behavior within the last 6 months.
* Hospitalized for psychiatric symptoms in the past 3 months.
* Other psychiatric diagnoses.
* Substance abuse/dependence (other than nicotine or caffeine) within the last 6 months according.
* Nicotine replacement therapy, smoking cessation medications or remedies, including Varenicline (Chantix).
Oral Carnitine Challenge Test Guides Personalized Nutrition for CV Patients

The investigators plan to use the recently developed oral carnitine challenge test (OCCT) as a tool to exam individual's trimethylamine N-oxide (TMAO) production capacity from their gut microbiota. By using data collected by OCCT, the investigators defined subjects as high-TMAO producer or low-TMAO producer and apply low carnitine/choline diet as dietary intervention for the high-TMAO producers. After dietary intervention for two months, the investigators conducted OCCT for the participants and compare the TMAO production capacity before and after the dietary intervention.

Patients diagnosed with cardiovascular disease at the CV clinics are being recruited to undergo the Oral Carnitine Challenge Test (OCCT) to assess the TMAO production capacity of their gut microbiota. Participants identified as high-TMAO producers will be invited to partake in a two-month vegetarian diet intervention, supervised by a registered dietitian, followed by a three-month period of reverting to their regular diet. The OCCT will be conducted before and after the vegetarian diet intervention, as well as after the diet recovery phase. Fecal samples will be collected and analyzed at the baseline, in the second month, and in the fifth month of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient with risks of cardiovascular disease (CAD) or CAD patients proved by coronary angiography

Exclusion Criteria:

* age \< 20, hx of GI surgery, hx of malignancy, antibiotic or probiotic or carnitine supplement use within one month, liver cirrhosis, end stage chronic renal disease
Effect of Preoperative Aspirin in Patients Undergoing Off-pump Coronary Artery Bypass Grafting

Effect of Preoperative Aspirin in patients undergoing Off-pump Coronary Artery Bypass Grafting. A double-blind, placebo-controlled, randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients undergoing off-pump coronary artery bypass grafting (OPCAB)
* Patients in whom antiplatelet therapy was stopped 5-7 days prior to OPCAB

Exclusion Criteria:

* Patients undergoing on-pump coronary artery bypass grafting
* Patients in whom antiplatelet therapy was not stopped 5-7 days prior to OPCAB
* Intraoperative conversion to on-pump coronary artery bypass grafting
* Patients with inherited blood-clotting disorders
* Patients undergoing other cardiac operations
The Effect of Exercise With Wearable Walking Assist Robot in Various Environments

This single-blinded, randomized, controlled trial includes 60 healthy adults. The participants were randomized to four different groups. The first group performed over-ground walking without GEMS-H, the second group performed over-ground walking with GEMS-H applied resistance mode, the third group performed stair ascent with GEMS-H applied assist mode, and the fourth group were designated as the group that performed inclined gait with GEMS-H applied assist mode on a treadmill. Each group is divided in 15 participants.

At the first visit, the subjects are fully informed of the study if appropriate after determining whether they meet the selection criteria. If the subjects meet the selection criteria, the participants were randomized to four different groups. The first group performed over-ground walking without GEMS-H, the second group performed over-ground walking with GEMS-H with resistance mode, the third group performed stair ascent with GEMS-H with assist mode, and the fourth group were designated as the group that performed inclined gait with GEMS-H with assist mode on a treadmill. Each group is divided in 15 participants. Each group completed 30 minutes exercise at least three times per week (total 10 sessions). All measurements were conducted before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 50 to less than 85 years without a history of central nervous system disease

Exclusion Criteria:

* Those who have difficulty walking independently due to problems such as visual field defects or fractures
* Those with severe arthritis or orthopedic problems limiting passive range of motion (ROM) of the lower extremities (knee flexion contracture \>10°, knee flexion ROM \<90°, hip flexion contracture \>25°, ankle plantar flexion contracture \>15°)
* Those who have difficulty understanding the exercise program due to severe cognitive decline (Korean-Mini-Mental State Examination, K-MMSE≤10)
* Those who have difficulty participating in exercise programs due to adult diseases such as uncontrolled hypertension and diabetes
* Those who are at risk of falling while walking due to severe dizziness
* Those who are less than 140 cm or more than 185 cm in height that is not suitable size for the wearing of the walking assistance robot
* Those who are overweight based on body mass index (BMI) 35 or higher
CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD

The purpose of this study is to determine if CLONICEL (clonidine HCl sustained release) is a safe and effective add-on to psychostimulant therapy in children and adolescents with attention deficit hyperactivity disorder (ADHD).


Eligibility Criteria:
Inclusion Criteria:

* Age 6-17 years, inclusive
* Diagnosis of ADHD
* Currently on a stable psychostimulant regimen for ADHD
* Lack of adequate response to stable psychostimulant regimen
* Ability to swallow tablets

Exclusion Criteria:

* Clinically significant illnesses or abnormalities upon evaluation
* Conduct Disorder
* Intolerance to clonidine
* History of seizures or syncope
A Study of Stem Cells and Filgrastim

To determine the safety of stem cell harvesting after administration of filgrastim ( G-CSF ) to mobilize bone marrow stem cells into the peripheral blood in patients at various stages of HIV-1 infection as well as in HIV-negative volunteers. To determine the surface phenotypic and functional characteristics as well as the viral load in the stem cells obtained following this procedure.

Patients and volunteers receive seven daily subcutaneous injections of G-CSF. On days 5 and 6 of drug administration, patients have peripheral blood mononuclear cells harvested by leukapheresis. HIV-positive patients are stratified into three cohorts based on CD4 count and presence of symptoms. If no increase in number of harvested stem cells and no grade 4 bone pain toxicity occur in two of the first three patients in a cohort, then the last three patients in that cohort will receive a dose escalation. Patients are followed for 24 weeks.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* PCP prophylaxis.
* Antiretroviral therapy in patients with CD4 counts \<= 500 cells/mm3.
* Narcotic analgesics for grade 3/4 bone pain toxicity.

Patients must have:

* HIV infection.
* HIV infected patients with CD4 count \> 500 cells/mm3 must be asymptomatic. Patients with CD4 count 200-500 cells/mm3 may be either asymptomatic or symptomatic but must not have AIDS. Patients with CD4 count \< 200 cells/mm3 may or may not have AIDS-defining conditions.
* No antiretroviral therapy within the past 30 days in patients with asymptomatic disease and CD4 count \> 500 cells/mm3.
* Stable antiretroviral therapy for the past 60 days if CD4 count \<= 500 cells/mm3.
* Suitable venous access.

Prior Medication:

Allowed:

* Prior antiretroviral therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Current malignancy.
* Any medication condition that interferes with study evaluation.
* Known hypersensitivity to E. coli-derived proteins (e.g., insulin, human growth hormones).

Concurrent Medication:

Excluded:

* Acute treatment for serious opportunistic infection.
* Systemic cytotoxic chemotherapy.

Concurrent Treatment:

Excluded:

* Systemic radiation therapy.

Patients with the following prior conditions are excluded:

* Prior malignancy.
* Leukapheresis or lymphopheresis within the past 180 days.
* Significant active CNS disease or seizures within the past year.

Prior Medication:

Excluded:

* G-CSF or GM-CSF within the past 6 months.
* Investigational antiretrovirals within the past 30 days.
* Treatment for opportunistic infection within the past 14 days.

Active alcohol or substance abuse.
Liquid Biopsy to Reduce Time to Treatment for Advanced Nonsquamous NSCLC Diagnosed at Outside Sites

The purpose of this study is to determine if liquid biopsies will reduce time to begin treatment in participants with non-small cell lung cancer (NSCLC). A liquid biopsy is a test done on a sample of blood to look for cancer cells.

Referred patients with newly diagnosed NSCLC who have not had genetic testing for targetable mutations will be considered for this study. The primary objective of this prospective study is to examine if using liquid biopsy can reduce time to treatment (TTT) in external participants with NSCLC. Secondary objectives examined will include time to actionable genetic testing results (ctDNA or tissue), rate of actionable biomarker discovery, and rate of appropriate guideline-directed therapy based upon testing results.

A liquid biopsy is a test done on a sample of blood to look for cancer cells. A traditional biopsy, which requires tissue to be removed from the body, takes 14 days to be tested. A liquid biopsy takes 7 days which significantly shortens the TTT for those diagnosed with NSCLC. By studying this, doctors may be better able to determine if this will be beneficial and result in less time taken to treat cancer.

Eligibility Criteria:
Inclusion Criteria:

* Participants with newly diagnosed, advanced nonsquamous NSCLC referred to the Cleveland Clinic Taussig Cancer Center from outside centers without prior testing results available for targetable genetic alterations
* Plan to receive systemic therapy at the Cleveland Clinic, OR plan to receive systemic therapy at an outside site while maintaining either intermittent follow up at Cleveland Clinic or with electronic health record access through Care Everywhere.

Exclusion Criteria:

* Prior therapy for this diagnosis of NSCLC
* Prior adequate molecular testing done for the current diagnosis of NSCLC
Intraoperative Identification and Stimulation of the Glossopharyngeal Nerve

Published data suggest that the glossopharyngeal nerve innervates pharyngeal musculature important for maintenance of upper airway patency. The investigators propose a study examining the anatomic variation of the glossopharyngeal nerve and the effect of electrical stimulation on muscle recruitment and upper airway patency.

This is a single-arm physiology study. Consenting patients undergoing parapharyngeal space (PPS) surgery for tumor extirpation will undergo dissection of the glossopharyngeal nerve branches to the stylopharyngeus and pharyngeal constrictor muscles. Fine-wire electrodes will be placed on these nerve branches. For each patient, if the target nerve branches can be identified and electrodes successfully placed, they will additionally undergo drug-induced sleep endoscopy (DISE) immediately following PPS surgery.

Per routine care, an incision is made across the neck to provide surgeons access to parapharyngeal space for tumor extirpation. During this dissection, the branch(es) of the glossopharyngeal nerve innervating the stylopharyngeus (SP) and pharyngeal constrictor (PC) muscles are exposed. For this study, measurements and photos/videos of the nerve will be taken. A fine-wire electrode will be placed on either or both successfully identified nerves and stimulated to assess muscle activation and changes in upper airway patency.

Eligibility Criteria:
Inclusion Criteria:

* Consenting adults with BMI ≥ 25 and ≤ 40 kg/m2
* Planned resection of parapharyngeal space (PPS) mass without clinical evidence of cranial nerve function deficits based on physical examination
* History of moderate-to-severe Obstructive Sleep Apnea (OSA) as confirmed by previous polysomnogram OR high risk for OSA based on STOP-BANG criteria (STOP-BANG score ≥ 3)

Exclusion Criteria:

* Unable to consent for research due to a pre-existing neurologic condition or language barriers as determined by PI
* History of other primary sleep-related breathing disorder (e.g., central, or complex sleep apnea).
* Previous pharyngeal surgery excluding tonsillectomy (e.g. cleft palate repair, uvulopalatopharyngoplasty)
* Prior history of head and/or neck chemoradiation therapy
* Existing indwelling neurostimulation device (e.g. pacemaker; spinal, vagal, or hypoglossal nerve stimulator)
Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer

This study is to evaluate the benefits of investigational drug, NRX 194204 in slowing down/stopping/reversing progression of the castration resistant and taxane resistant prostate cancer.

Numerous studies in pre-clinical models and in human clinical trials have clearly established the potential for the use of rexinoids in the treatment and prevention of cancer. NRX 194204, a second generation rexinoid, is a highly potent and specific activator of RXRs (retinoid X receptors). Because NRX 194204 is significantly more selective for the RXRs relative to the RARs (retinoic acid receptors) than a first generation approved drug, it is associated with fewer adverse events in clinical use. This study seeks to investigate NRX 194204 monotherapy in patients with castration- and taxane- resistant prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed prostate cancer
* Documented progression on at least one prior hormone treatment, AND at least one taxane based chemotherapy regimen, or patient's refusal of chemotherapy treatment
* Male, Age \> 18 years
* ECOG (Eastern Cooperative Oncology Group) performance score of 0-2
* Adequate bone marrow, renal and hepatic function
* Men of childbearing potential must consent to use barrier contraception while on treatment and for 90 days thereafter

Exclusion Criteria:

* Prior treatment with NRX 194204 or bexarotene (Targretin)
* Presence of parenchymal brain metastases
* History of prior malignancy within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder or other stage I or stage II cancer in complete remission for at least 12 months
* Patients with a history of unstable or newly diagnosed angina pectoris, documented history of current serious arrhythmia or congestive heart failure or myocardial infarction within 6 months of enrollment
* Known HIV or hepatitis B or C infection
* Life expectancy \< 3 months
* Patients with any history of thyroid disease, pituitary disease or treatment with thyroid replacement hormone
* Patients with a history of pancreatitis or at significant risk of developing pancreatitis