cyrilzakka/clinical-trials huggingface dataset:
Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression

This proposed research is aimed to investigate the efficacy and safety of combined cytidine- and creatine-containing drug and dietary supplement in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using magnetic resonance spectroscopy.


Eligibility Criteria:
Inclusion Criteria:

* 19-65 year-old male or female
* Bipolar depression diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV)
* Written informed consent

Exclusion Criteria:

* Present use of drugs for bipolar depression or any psychotropic medication
* Use of psychoactive medication that may affect brain imaging findings
* Diagnosis of any other axis I psychiatric disorder
* Presence of borderline personality disorder or antisocial personality disorder
* Presence of any major physical or neurological illness (e.g., epilepsy, multiple sclerosis, brain tumor, cerebrovascular disease, etc.)
* Hypersensitivity to divalproate, valpromide or diagnosis of porphyria
* Past or current liver disease, current severe liver or pancreas dysfunction
* Currently taking mefloquine
* Presence of alcohol or drug dependence, drug abuse
* Intelligence quotient below 80
* Contraindications to magnetic resonance imaging
* Women who are pregnant, breastfeeding, or planning pregnancy
* Allergy or intolerance to the study drugs
Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1)

This study is a prospective, randomized, double-blind, placebo-controlled evaluation of the safety of a topically applied formulation of rapamycin to cutaneous fibromatous lesions in subjects with Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1). Subjects will apply either a Polyvinylidene fluoride (PVDF) coating (Skincerity) containing rapamycin or the PVDF coating alone nightly to fibromatous lesions for a duration of six months.

The primary goal of this study is to evaluate the safety of the topical product in patients with TSC and NF1. The secondary goal of this study is to evaluate the effectiveness of the topical product for treatment of cutaneous fibromatous lesions.


Eligibility Criteria:
Inclusion Criteria:

* Subject is willing and able to comply with all trial requirements
* Subject is male or female and over 13 years of age
* Subject has a diagnosis of either TSC or NF1 and has visible fibromatous lesions (angiofibromas or neurofibromas)
* Female subjects of child-bearing potential must not be pregnant and must agree to use appropriate contraceptive methods for the duration of the trial

Exclusion Criteria:

* Subject is currently receiving therapy with rapamycin or sirolimus
* Subject is receiving any form of immunosuppression or has previously experienced immune dysfunction
* Subject is currently participating in or has participated within the last 30 days in any clinical trial involving an investigational drug
* Subject has a known hypersensitivity to either the PVDF coating (Skincerity®) or rapamycin
* Subject is a pregnant or nursing female
Effects of LycoComfort™ Supplementation on Symptoms Associated With Lower Urinary Tract Symptoms (LUTS)

This study will evaluate LycoComfort™ supplementation in alleviating symptoms associated with LUTS, BPH, and general prostate concerns.

Inflammation, oxidative stress and androgenic activity in the prostate are proven catalysts of BPH, ultimately leading to increased prostate cell proliferation. The once-daily supplement LycoComfort™, will be under investigation for symptom relief and will be taken by participants for a duration of 12 weeks.

LycoComfort™ is a dietary supplement containing tomato extract and phytosterols, ingredients that have been associated with relief of symptoms associated with general prostate discomfort and Lower Urinary Tract Symptoms (LUTS).

The purpose of this study is to evaluate changes in these symptoms after taking this supplement daily for 12 weeks.

Although it was not until the latter part of the twenties century that investigators began to explore the importance of lycopene, the benefits of this natural carotenoid are well studied. A number of clinical trials have shown lycopene to be effectual for alleviating prostate discomfort, symptoms of BPH and LUTS.

The American Urological Association estimates that 90% of men between 45 and 80 years of age suffer some symptoms of LUTS. Several pathophysiological mechanisms are believed to lead to LUTS and BPH, including oxidative damage, inflammation and sympathetic nervous system issues. High blood lycopene concentrations have been suggested in epidemiological trials to be associated with decreases in oxidative stress and contributions to disease prevention overall. Also, clinical trials have shown that higher levels of lycopene in the blood are associated with a reduced risk of prostate cancer, as well as other inflammatory conditions.

Eligibility Criteria:
Inclusion Criteria:

* Males, age 40 and older
* A score of 8 or greater on a self-administered I-PSS test

Exclusion Criteria:

* Acute or chronic prostatitis
* Acute urinary retention
* Allergy or sensitivity to any of the test product components (tomato \[lycopene\] or beta-sitosterol)
* Cancer of the prostate (PCa) or other cancers, current or a history of PCa
* Chronic diseases of the kidneys and/or liver
* Hematuria of unknown etiology
* Infection or malfunction of the urinary tract
* Inflammatory diseases of the urogenital tract
* Medication, herbal supplementation or other substance use for the treatment of urinary symptoms, BPH/LUTS, or erectile dysfunction, including medications which may affect hormonal status within 30 days before screening. These may include, but are not limited to: Sildenafil/Viagra; Tadalafil/Cialis; Vardenafil/Levitra; "Herbal Viagra"; Alpha-Blockers; Oral Steroids, Spironolactone or Testosterone
* Previous radiotherapy of prostate
* Previous surgery of the prostate, bladder or urethra
VEC-162 Study in Adult Patients With Primary Insomnia

The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of VEC-162 as compared to placebo in male and female patients with primary insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Males and females with a diagnosis of primary insomnia as defined in DSM-IV.
* Habitual bedtime between 9:00 pm and 1:00 am.
* No history or evidence of restless leg syndrome or periodic limb movement disorder or sleep apnea.
* Patients must sign a written consent form.

Exclusion Criteria:

* History of drug or alcohol abuse as defined in DSM-IV.
* History of psychiatric disorders, including Major Depressive Disorder, Generalized Anxiety Disorder and delirium.
* History of chronic obstructive pulmonary disease (COPD), seizures, sleep apnea, narcolepsy, circadian-rhythm sleep disorder, parasomnia or any sleep disorder other than chronic insomnia.
* Recent history of shift work or jet lag.
Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy

to compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic myomectomy.

To compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic myomectomy, by using patient controlled analgesia postoperatively, a randomized, double blind clinical trial. Patients undergoing elective Laparoscopic myomectomy are randomly divided into two groups: nalbuphine and morphine groups. All patients are under general anesthesia with routine methods. The nalbuphine group receive postoperative patient controlled analgesia using nalbuphine 30mg/120ml, while the morphine group receive postoperative patient controlled analgesia using morphine 60mg/120ml. Perioperative parameters are to be collected to compare the two groups.

Eligibility Criteria:
Inclusion Criteria:

* elective Laparoscopic myomectomy patients 24hr post-operative patient controlled analgesia analgesia no mild or severe liver or renal disfunction

Exclusion Criteria:

* can't understand patient controlled analgesia device refuse trial
INtestinal Failure, multiPle Organ Failure ANd CItrulline Assessment

The gastrointestinal dysfunction occurs frequently during the intensive care unit (ICU) stay and is associated with a worse prognosis.

The gastrointestinal failure (GIF) is diagnosed based on symptoms such as bowel distension, ileus, diarrhea, digestive bleeding, or intestinal ischemia. A GIF score based on has been demonstrated to be correlated with outcome, with higher scores indicating higher risk of death. However, GIF may be occult or clinical signs can go undetected in critically ill patients due to the frequent use of analgesic, sedative or neuromuscular blocking agents, acute neurologic diseases, or delirium.

Citrulline is a potential biomarker for small bowel function in critically ill patients with maintained renal function. Normal plasma citrulline levels (12-55 µmol/L) are determined by the balance between gut synthesis and kidney degradation.

GIF is involved in the pathogenesis of multiple organ dysfunctions and failures (MOF) through various mechanisms, and it is often associated with high intra-abdominal pressure (IAP). IAP greater than 12 mmHg, may lead to abdominal compartment syndrome (ACS) and MOF, including cardiac, respiratory and kidney failure. Studies have suggested that GIF can be the consequence rather than the cause of MOF.

The aim of this study is to investigate if plasma citrulline levels is associated with a clinical diagnosis of GIF, and may predict the development of MOF.


Eligibility Criteria:
Inclusion Criteria:

- Intensive Care Unit stay of at least 48 hours

Exclusion Criteria:

* Intensive Care Unit stay less than 48 hours
* abdominal trauma or surgery in the last 6 weeks
* inflammatory bowel disease
* a body mass index (BMI) ≥35
* terminal condition.
Ventilator Trigger Sensitivity Adjustment Versus Threshold Inspiratory Muscle Training on Arterial Blood Gases

The aim of the current study is to compare the effect of ventilator trigger sensitivity adjustment versus threshold inspiratory muscle training on arterial blood gases in mechanically ventilated patients.

Failed extubations are not uncommon in most ICUs, the failure rate ranging from 2 to 20%. Since failed extubation is associated with greater hospital morbidity and mortality and longer length of stay, it is imperative to identify screening techniques that minimize the number of failed extubations.

Many studies have been done on the effect of IMT by threshold IMT and adjustment of mechanical ventilator trigger separately, thereby, it is rational to compare between two methods of training to know which is more effective to help in weaning process through its effect on ABGs.

Eligibility Criteria:
Inclusion Criteria:

1. Difficult to wean Guillain barre patients who have been on MV for at least 48 hours. Difficult to wean subjects have been defined as those who fail the first spontaneous breathing trial (SBT)and may require up to 3 SBTs or up to 7 d from the first attempt to achieve successful weaning (B´eduneau G. et al.,2017) and (Annia F. et al.,2019).
2. Age: \>18 years.
3. Both sexes will be included.
4. Ventilator mode: Pressure support mode with FiO2≤ 0.5, positive end expiratory pressure (PEEP) will be\<8-10cm/H2Oand respiratory rate \< 25.
5. Conscious oriented patient with Glasgow coma score ≥13.
6. Alertness will be titrated to a Riker Sedation Agitation Score of 4.
7. PH\>7.25, arterial oxygen saturation \>90%.
8. Cardiovascular stability.
9. Maximal inspiratory pressure from 15 to 30 cm H2O and able to trigger spontaneous breaths on ventilator.

Exclusion Criteria:

1. Persistent hemodynamic instability as life threatening arrhythmias, acute heart failure.
2. Severe breathlessness, when spontaneously breathing.
3. Any progressive neuromuscular disease that would interfere with responding to inspiratory muscle training (non-stationary course).
4. Spinal cord injury.
5. Skeletal pathology (scoliosis, flail chest, spinal instrumentation) that would seriously impair the movement of the chest wall and ribs.
6. Patients on heavy sedation and respiratory muscle paralysis.
7. High peak airway pressure (barotraumas).
8. BMI ≥ 40.
Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia

The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia.

The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Primary Fibromyalgia (2010 ACR criteria)
* Male or female 18-75 years old
* Patients currently receiving pharmacologic treatment for depression should have been clinically stable for at least 3 months prior to randomization, and on stable doses of antidepressants during this 3 month time frame.
* Willing and able to withdraw specific therapies (ask PI)
* If female, medically acceptable form of contraception or not of child bearing potential.
* Provide written informed consent to participate.
* Willing and able to comply with all protocol specified requirement.

Exclusion Criteria:

* Arthritis, lupus and other systemic auto-immune diseases
* Regional or persistent pain that could interfere with assessment of fibromyalgia pain
* Bipolar and psychotic disorders
* Increased risk of suicide
* Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
* Inability to wash-out specific medications (ask PI)
* Known hypersensitivity to cyclobenzaprine
* Others: seizure disorders, severe/untreated sleep apnea, BMI\>45
Perioperative Ostomy Self-Management Telehealth for Cancer Patients and Family Caregivers

This phase II trial studies how well Perioperative Ostomy Self-Management Telehealth (Periop-OSMT) provides patients and their caregivers information about ostomy and ostomy care. Periop-OSMT may help to understand patient preparedness to do ostomy self-care, confidence in doing ostomy self-care, knowledge of ostomy self-care, quality of life, mood, use of medical services, and financial burden.

PRIMARY OBJECTIVE:

I. Assess the feasibility and acceptability of the Periop-OSMT as measured by the percentage of patients and support persons/family caregivers (FCGs) who agree to participate; complete \>= 80% of the intervention; and report satisfaction with the intervention (through structured exit interviews).

SECONDARY OBJECTIVES:

I. Examine the patterns and trajectories for patient outcomes pre- and post-intervention, including patient activation, self-efficacy, ostomy-related knowledge, health related quality of life (HRQOL), medical care utilization, and financial burden.

II. Examine patterns and trajectories for support person/FCG outcomes pre- and post-intervention, including quality of life (QOL).

III. Using qualitative methods, evaluate the acceptability of the intervention as reported by participants.

OUTLINE:

Patients and/or support persons/family caregivers complete Periop-OSMT session in-person or via telephone over 20-40 minutes before surgery and before hospital discharge, and group telehealth session over 1.5-2 hours at weeks 1-3, 4, 5, 6, and 7 post discharge.

After completion of study intervention, participants are followed up for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* PATIENT: Scheduled to undergo a surgical procedure that includes the creation of an intestinal stoma (fecal or urinary).
* PATIENT: Able to read and understand English.
* PATIENT: Patients scheduled for temporary ostomy procedures
* SUPPORT PERSON/FCG: Family member/friend identified by the patient as the primary caregiver before and after surgery.
* SUPPORT PERSON/FCG: Able to read and understand English.
* Patients with all stages of disease are eligible for the study.
* The study is open to anyone regardless of gender or ethnicity. Efforts are made to extend the accrual to a representative population.

Exclusion Criteria:

* Subjects, who in the opinion of the principal investigator (PI), may not be able to comply with the requirements of the study.
Fed Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg

The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsules to Ortho-McNeil's Topamax® Sprinkle 25 mg capsules following a single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study
Post- End- Expiratory Pressure Affect the Alveolar Heterogeneity in Moderate and Sever ARDS Patients

This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.

ARDS(Acute respiratory distress syndrome )is common in patients suffering Sepsis, trauma, burning and other sever condition and characterized by diffuse alveolar damage and alveolar heterogeneity.ARDS patient need MV(mechanical ventilation )to maintain oxygenation and need unique MV tragedy to avoid VILI(Ventilator induced Lung injury ).PEEP(post-end-expiratory pressure) is crucial to maintain oxygenation and avoid VILI according to researches. But there are also some other research different voice. This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 or\<80；
2. Moderate or sever ARDS in 2012 \<Berlin definition\>;
3. Applied mechanical ventilation;
4. Consent signed.

Exclusion Criteria:

1. Asthma or COPD；
2. Cardiogenic edema；
3. Sever neutropenia(\<500/mm3)；
4. Hemodynamic astatic: DOPA or Dobutamine \>15 µg/kg/ min; NE \> 15ug /min；
5. GCS coma score ≤12；
6. Thoracic injury or surgery patients contradict EIT ；
7. Refuse to join in trail；
8. Included in other clinical trail。
Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)

The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC.

The IDMC recommended discontinuation of the study, and, the protocol was amended to end study treatment.

Eligibility Criteria:
Inclusion Criteria

* Histologic or cytologic diagnosis with unresectable or metastatic HCC
* Child Pugh Class A
* ECOG performance status 0-1
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria

* Prior systemic (administered intravenously or orally rather than locoregionally) treatment for HCC
* Prior local therapy (including liver-directed therapy) within 4 weeks from entry
* Untreated brain or meningeal metastases
* Current treatment on another clinical trial
* Pregnancy or breastfeeding
Magnetic Resonance Imaging (MRI) for Early Diagnosis of Cystic Fibrosis (CF)

In patients with Cystic Fibrosis (CF) the clinical course of lung disease is crucial for individual prognosis and life expectancy.

Imaging modalities are important in the assessment of follow up of structural lung changes and monitoring of pulmonary complications in CF. Although high resolution computed tomography (HRCT) is the accepted gold standard for evaluation of morphological lung changes in CF, chest-X-ray is widely used as standard imaging procedure for assessment and follow up in these young patients due to less radiation exposure.

Magnetic resonance imaging (MRI) has not been used for lung imaging in CF so far. Studies from the 80's and early 90's were not able to show any impact for the use of MRI in CF. Due to recent technical developments MRI of the lung became possible.

Our study group was able to show that MRI is a competitive imaging modality for evaluating changes of the CF-lung in comparison to the gold standard (HRCT).

So far only patients from the age of 6-7 years were examined. According to recent studies CF is a disease which starts in utero. Therefore it can lead to extensive pulmonary changes even in infants and young children. In this age group lung function testing is difficult and not broadly available. An early optimized therapy is crucial for the long term course and outcome of the pulmonary disease.

The aim of this study is to evaluate morphological and functional MRI for early diagnosis of lung changes in children (0-6 years) with CF.

Month 1-2: Protocol adaptation for infants and small children Month 3-14: Patient examinations (20 Patients with sedation) Month 15-18: Data evaluation

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed by the parents or a legal guardian
* Sedation as necessary
* Conventional clinical indicated diagnostic procedures (lung function test, chest-X-ray, CT)

Exclusion Criteria:

* Study exclusion in case of contra indications for MRI:

  * Patients with cardiac pace maker, metallic implants (e.g. cerebral vessel clips) as well as other conditions that prohibit the exposition of a patient to a strong magnetic field.
  * No informed consent
  * Dyspnea, which disables the patient to follow breathing instructions during the study.
An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)

The aim of this study is to quantify how infliximab therapy is being used in the UK and the consequent impact on health care resources, which will help to inform budget holders and payers on the costs associated with the treatment of Crohn's Disease.

All interested hospital physicians across the UK who prescribe infliximab as part of their treatment of Crohn's Disease patients. will be included. It is assumed that the physician population will consist primarily of gastroenterologists, though general physicians (hospital-based) with an interest in Crohn's Disease may also be included.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Crohn's Disease.
* Over the age of 18 years.
* Must have received the first infusion of infliximab on or after 1st January 2003 (when the maintenance therapy license was granted).
* Must have received at least one infusion of infliximab.
* A minimum of 12 months data prior to, and 24 months data post infliximab exposure should be available in the medical records.
* Must have been under the care of the participating center for the entirety of the study period.

Exclusion Criteria:

* Should not have been involved in any clinical trial during the observational period (ie, a minimum of 12 months before and 24 months after first receiving infliximab).
* Should not have received any biologic therapy prior to infliximab.