cyrilzakka/clinical-trials huggingface dataset:
Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy

The purpose of the study is to determine whether the combination of the the three drugs gabapentin, duloxetine, and donepezil are effective in treating pain in people with diabetic neuropathy or patients with failed low back syndrome (chronic back pain).

Neuropathic pain is a complex and likely heterogeneous disorder, and we recognize that clinically useful agents such as opioids, gabapentin, and antidepressants may be effective precisely because they have multiple mechanisms of action at multiple sites. This study, however, will not only provide important mechanistic information regarding one cascade which can be manipulated for analgesia, but will also provide much needed systematic and practical guidance for multi-drug therapy in patients with neuropathic pain.

This study in patients with diabetic neuropathic pain and patients with failed low back syndrome, culminate in a quantitative description of interactions between activators of descending noradrenergic activity, norepinephrine transporter inhibitors, and cholinesterase inhibitors to exploit the plasticity of analgesia in chronic pain states. We will focus on practical applications, using clinically approved drugs, including gabapentin (Neurontin®) to activate noradrenergic activity, duloxetine (Cymbalta®) to inhibit the norepinephrine transporter, and donepezil (Aricept®), approved for the treatment of Alzheimer's dementia, but not previously tested to treat neuropathic pain, to inhibit cholinesterase.

After the baseline measurements and physical examination patients will be trained to use a Personal Digital Assistant (PDA) to answer questions about their diabetic neuropathic pain or their chronic back pain. Upon successful completion of these tasks the patients will be randomized to receive one of the drug choices or placebo (inactive pill).

The study will last for a total of 16 weeks and includes 5 visits to the research center with each visit lasting approximately 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetic neuropathy
* Age 18-80
* Willing to temporarily discontinue gabapentin or monoamine reuptake inhibitors upon entry into the study

Exclusion Criteria:

* Pregnancy
* Allergy to study medications
* Uncontrolled narrow-angle glaucoma
* Currently being treatment with thioridazine (Mellaril)
* Unstable medical conditions including cardiac, pulmonary, renal or hepatic diseases
* Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization
Methylated DNA Detect in Paraneoplastic Syndrome of Nervous System

The purpose of this study is to verify whether the cell-free DNA of lung cancer in the blood can be used as a biomarker for early diagnosis and prognosis evaluation of patient with paraneoplastic syndrome of the nervous system.

Paraneoplastic neurological syndrome (PNS) is a clinical syndrome that affects the central nervous system, peripheral nerves, neuromuscular junctions and muscles by the distant influence of the tumor. No tumor cells are visible in the neuropathy. The disease is a rare clinical syndrome, and lung cancer is the most common type of tumor that causes PNS.If PNS can be diagnosed when there are no tumor symptoms, not only can the cause of PNS be identified, but early tumors can be found for treatment time, and measures can be taken in the early stages of the tumor to improve survival. Tumor free DNA (cell-free DNA, cfDNA) methylation detection is to determine the cancer condition and cancer type of the subject by detecting the methylation of free DNA released by tumor cells. In normal cells, tumor suppressor genes are expressed and proto-oncogenes are silenced; in tumor cells, tumor suppressor genes are hypermethylated and silenced, and oncogenes are hypomethylated and activated. The release of free DNA into the blood will be quickly cleared in tens of minutes to several hours, which can reflect the body's cell damage in real time, and is of great significance for monitoring the early occurrence and development of the disease. At present, the sensitivity of lung cancer cf-DNA detection technology is close to 100%, and the specificity is 94%, which is an effective detection technology for early detection of lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* The agnogenic typical neurological syndromes (including encephalomyelitis, marginal encephalitis, subacute cerebellar degeneration, strabismus ocular clonic-myoclonus, subacute sensory neuron disease, Lambert-Eaton myasthenic syndrome, skin Myositis, etc.) patient who predisposed to a tumor.
* Pathologically confirmed as lung cancer or suggested as lung cancer patient by imaging (pulmonary CT/Positron Emission Tomography-CT), tumor biomarkers, anti-brain tissue antibodies, etc.

Exclusion Criteria:

* Lacunar infarction
* Aortic atherosclerotic cerebral infarction
* Clear cardiogenic cerebral infarction
* Other related system diseases (arteritis, vascular dissection, migraine and vasospasm, etc.)
Efficacy and Tolerability of MK0533 in Patients With Type 2 Diabetes (0533-005)

A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 to 70 years with Type 2 diabetes who have not been able to adequately control their blood glucose levels
* Note: Only patients who have not been taking any antihyperglycemic medicine for 3 months will be screened

Exclusion Criteria:

* Patients taking any medicines that affect body fluid level such as a diuretic or water pill
* Patients taking niacin or other certain medications
* Patients with any of the following conditions: liver or kidney disease, poorly controlled high blood pressure, heart disease or certain blood disorders
* Patients with abnormal laboratory results from a blood test that will be given before each patient starts the study
Prediabetes and Newly Diagnosed Diabetes in Chronic Heart Failure

The aim the study is to determine the prevalence of prediabetic dysglycemia and newly diagnosed diabetes among individuals with CHF(chronic heart failure) in sohag university hospital patients .

- Prospective study to:

1. study the differences in the prevalence of Prediabetes and newly diagnosed diabetes among the patients with HFrEF and HFpEF
2. The effect of dysglycemia on prognosis of patients with chronic heart failure.
3. The effect of early discover of diabetes mellitus on prognosis of patients with chronic heart failure

Eligibility Criteria:
Inclusion criteria:

* All patients presented by heart failure
* 18 years or older
* Classified according to NYHA " New York Heart Association" classification from NYHA class 2 and more

Exclusion Criteria:

* Overt diabetes
* Rheumatic Heart Disease
* Congenital heart disease
Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis

The primary objective of the trial is to investigate the survival time (the time from randomization until death or date of end of the study) compared between control group and experimental group.

This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind trial comparing placebo with high caloric fatty diet for drinking as add-on therapy to 100 mg riluzole in amyotrophic lateral sclerosis (ALS) in 200 enrolled patients. For entry, the El Escorial Criteria for the diagnosis of ALS will be used. The patients have to be stable on riluzole at least 4 weeks prior to randomization.


Eligibility Criteria:
Inclusion Criteria:

* Possible, probable (clinically or laboratory supported) or definite ALS according to the revised version of the El Escorial criteria (Brooks et al. 2000)
* Disease duration \< 36 months
* Vital capacity of more than 50% of normal (defined as slow vital capacity, best of three measurements)
* Age ≥18 years
* Continuously treated with 100 mg riluzole daily for at least four weeks
* Capable of thoroughly understanding all information given and giving full informed consent according to GCP
* Willing to complete a diet questionnaire throughout participation in the study

Exclusion Criteria:

* Simultaneous participation in another interventional clinical study
* Previous participation in a drug clinical trial where last intake of the trial drug was within the last 12 weeks
* Known sensitivity or intolerance to rape oil or sunflower oil, or components thereof
* Tracheostomy
* Patients with gastrostomy
* Pregnancy or breastfeeding
* Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
* Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment.
* Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms.
* Liable to be not cooperative or comply with study requirements as assessed by the investigator, or unable to be reached in the case of emergency.
The Cuff Pressure of an Endotracheal Tube After Supine-to-lateral Position Change

To compare the cuff pressure in lateral position between barrel-shaped cuff and taper-shaped cuff

The position of endotracheal tubes depends on the position of the patients. The change of the tube's position is known to influence the pressure of tube's cuff. The shape of the cuff (barrel-shaped versus tapered-shaped) may affect the tube's migration degree because of the difference of the frictional force.

The investigator try to compare the the cuff pressure after supine-to-lateral position change between barrel-shaped cuff and taper-shaped cuff.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for nephrectomy in lateral decubitus position

Exclusion Criteria:

* Pregnancy
* Patients with difficult airway
* Patients with neck motion disorder
* Patients with history of neck surgery
* Patients with history of oral and pharyngeal surgery
* Patients with body mass index \> 35
* Patients without teeth
Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer

The purpose of this study is to look at the clinical benefit of carboplatin and paclitaxel and correlate response to study treatment with biologic parameters (i.e. lab studies of blood, urine, or tissue). It is hoped that this will allow researchers to gain insight into the underlying biology of prostate tumor progression and perhaps predict which patients may benefit from this chemotherapy regimen.

Docetaxel/prednisone is the standard of care in patients with metastatic, castrate-resistant prostate cancer (CRPC) but duration of response is limited, with median time to prostate-specific antigen (PSA) progression of 6-8 months. There is currently no standard second-line therapy for patients who have progressed after receiving docetaxel. Carboplatin and paclitaxel have demonstrated activity, but prospective clinical trials evaluating this regimen are limited. In addition, correlative studies investigating why some patients respond are lacking.

Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of prostate carcinoma.
* Subject must have progressive metastatic prostate cancer despite adequate medical or surgical castration therapy. Furthermore, if applicable, medical castration must be maintained for the duration of the protocol.
* Serum testosterone \< 50 ng/ml.
* Subjects who have received anti-androgen therapy with a resulting PSA decline must demonstrate progression following discontinuation of anti-androgen therapy.
* Subjects capable of fathering children must agree to use an effective method of contraception for the duration of the trial.
* Must have previously received docetaxel for prostate cancer
* ECOG performance status 0-2
* Willing and able to give informed consent

Exclusion Criteria:

* Platelet count \<100,000/mm3
* Absolute neutrophil count (ANC) \<1,500/mm3
* Hemoglobin \< 8 g/dL
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 x upper limit of normal
* Bilirubin (total) \>2 x upper limit of normal. Subjects with known Gilbert's syndrome are eligible if direct bilirubin is within normal limits
* For subjects with serum creatinine \> 1.5 x ULN, calculated creatinine clearance \< 30 ml/min are excluded; subjects meeting this exclusion criterion are eligible if a measured clearance is \> 30 ml/min
* Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
* Prior investigational therapy within 4 weeks of treatment. Furthermore, other investigational anti-cancer therapy is not permitted during the treatment phase.
* Grade \> 1 peripheral neuropathy
Video-based, Patient-Focused Opioid Education in the Perioperative Period

This is a pilot study designed to assess the feasibility of using a novel, video-based opioid education tool for opioid naïve ambulatory surgery patients in the perioperative period.

Patients will be randomized to a video or no video prior to surgery then administered a phone questionnaire at post-op day 7, 30, and 90. The Arkansas Prescriptions Drug Monitoring Database will also be accessed for information on opioid prescription refills. The overall goal of the study is to evaluate the effect that video-based opioid education has on narcotic intake after outpatient surgery. The duration of the study will be approximately 3 months, plus a single 1-hour long focus group if desired by the patient.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years or older
* Not chronically receiving opioid analgesics
* Patients who have not taken opioids 30 days pre-operatively
* Undergoing surgical procedure not requiring overnight hospital stay

Exclusion Criteria:

* Non-English speaking
* Legally deaf or blind
* On opiate contract
* Has taken oral narcotic in the past 30 days
* Unable to operate a telephone
Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in China

Neonatal sepsis remains one of the most important cause of mortality and morbidities in China. This study will establish a prospective registral cohort of all infants with culture-proven neonatal sepsis in Chinese NICUs participating in the Chinese Neonatal Network (CHNN). The microbiology, antimicrobial resistance patterns and neonatal outcomes will be described in detail for this cohort.

All infants with culture-proven sepsis in NICUs of CHNN will be enrolled in the study. Detailed data on microbiology, resistance pattern, neonatal mortality and morbidities will be collected and described. Risk factors for multi-resistant bacteria infections and for sepsis-related mortality will be identified.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to CHNN NICUs from 2022.1.1 to 2023.12.31
* Diagnosed with culture-proven sepsis

Exclusion Criteria:

* None
Effect of Soy Protein and Colorado Diet on Weight Loss and Maintenance

Dietary protein is a key element of most effective weight loss regimens. This study will investigate the effects of consuming soy protein on body composition and cardiometabolic health within the context of an effective weight loss and maintenance program called the Colorado Diet.

This is a randomized study involving 60 study subjects (30 per arm). Investigators plan to enroll 72 subjects (36 per arm) in order to allow for any potential drop outs with the goal of 60 study completers. Investigators will compare the efficacy of inducing weight loss of two treatment arms all based on the Colorado Diet. Subjects will be randomly assigned to one of two study arms and instructed to follow the Colorado Diet by participating in weekly Colorado Diet group classes (State of Slim class). There will be 4 classes of 18 subjects each (two classes for each treatment group). Subjects will be followed in the study for 12 months. Subjects will be randomized into one of two treatment groups as follows:

* Group 1 will participate in a State of Slim group class, receive a State of Slim book (describing the Colorado Diet), and will then purchase food items allowed in the Colorado Diet from the lists of acceptable foods in the State of Slim book.
* Group 2 will participate in a State of Slim class, receive the State of Slim book, and be provided soy protein foods to be consumed as part of the Colorado Diet (subjects will receive up to 3 foods with approximately 20g of soy protein each, per day).

Eligibility Criteria:
Inclusion Criteria:

1. Males and females ages 18 - 55 years
2. BMI between 27-40
3. Weight stable (have not lost or gained more than 10 pounds in the last 3 months)
4. Generally healthy
5. Able to exercise 70 minutes per day at moderate intensity
6. Willing and able to participate in a State of Slim group class for the first 16 weeks of the study and willing to participate in 5 study visits over the 12 month study period.

Exclusion Criteria:

1. Pregnant or trying to become pregnant.
2. Diagnosis of type 1 or type 2 diabetes
3. Individuals following a vegetarian only diet
4. Food allergies (to soy, dairy, wheat/gluten, eggs, or peanuts)
5. Taking medications that could cause weight loss or weight gain or alter plasma lipids (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over-the-counter weight loss agents, statins, fibrates, niacin, etc). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Multivitamins containing niacin can be used as long as subject agrees to not change use of these during the study.
6. Known renal disease
7. hypothyroidism
8. Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included).
9. Any medical condition for which following a diet and/or 70 minutes of exercise daily would be inadvisable
10. LDL cholesterol levels above 190 mg/dl or triglycerides above 400 mg/dl.
Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients

Evaluating the safety, tolerability and efficacy of Aromasin® when used in routine clinical practice, evaluating adherence to prescribed Aromasin® treatment and to understand reasons for early discontinuation.

This study was terminated on 01-Aug-2011 due to very low potential to enroll planned number of patients or any sufficient number of patients for complete statistical analyses. This study is not being terminated because of safety or efficacy concerns.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal females.
* Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
* Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.
* Patients whose tumour was estrogen receptor positive (ER+).
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Patients for whom Aromasin® treatment is contraindicated (see SPC).
* Presence of metastasis or a contra lateral tumour.
* Other adjuvant endocrine therapy.
* Another concomitant antineoplastic treatment.
* Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
MIVetsCan: Cannabidiol (CBD)-Care Trial

This research is studying the effects of cannabidiol (CBD), an active component from cannabis (a.k.a. marijuana), on Veterans' chronic pain. The purpose of this study is to better understand if CBD can improve pain symptoms in Veterans with chronic pain.

Eligible participants will be randomly assigned to receive either placebo medication (not active) or CBD during the study period.

The study hypotheses:

- CBD would improve overall pain symptoms compared to placebo


Eligibility Criteria:
Inclusion Criteria:

* Ability to read and speak English sufficiently to allow for written informed consent and patient-reported outcomes measures
* Armed Services Veteran
* All participants must have been enrolled in the MIVetsCan Pain Registry (HUM00223894) for at least 4 weeks and agree to continue participation in that study.
* Reports moderate to severe chronic pain defined by protocol
* Currently using or interested in using cannabis for pain management
* Self-reported willingness to refrain from or not increase current Tetrahydrocannabinol (THC) or other cannabis product use (including CBD) during the study intervention or other cannabinoid use during the study intervention
* Individuals of reproductive potential must agree to use acceptable birth control per protocol
* Participants must also agree not to donate sperm or eggs during study drug administration
* Willingness to attend all study visits (may be done virtually)
* Ability to take and to swallow the study medication and be willing to adhere to the treatment regimen
* Willingness to wear Fitbit or other similar sensor for passive-data collection
* Willingness to fill out daily diary via smartphone to assess symptom status, study drug use, and other cannabis use

Exclusion Criteria:

* Not an Armed Services Veteran
* Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English)
* Participant reports pregnancy or are nursing
* Planning to move out of a state with legal recreational marijuana use during course of study
* Risk for imminent harm - Suicidal ideation or wish to die as assessed per protocol
* Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol
* Participation in any other clinical trials over the course of this study
* Medical or psychiatric conditions that in the judgment of study personnel would preclude participation in this study (e.g., psychosis, suicidal ideation; note that stable anxiety and depression are not exclusions)
* Having a serious or unstable hepatic disease (e.g., non-alcoholic fatty liver disease or liver cirrhosis)
* Individuals with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, and seizures
* Recent/new diagnosis of cancer within the past 3 years (other than localized melanoma, localized basal cell carcinoma, localized squamous cell carcinoma treated or untreated)
* Current valproate and clobazam use per self-report or medical records
* Self-reported allergies to sesame oil or cannabis/cannabinoids
Natural History in CCFDN and IBM Syndromes

So far, only limited data is available regarding the natural course in Congenital Cataract Facial Dysmorphism Neuropathy Syndrome (CCFDN) and sporadic and hereditary inclusion body myopathies (IBM). Several criteria and outcome measures have led to contradicting results. The investigators want to retrospectively assess the natural course of the disease in CCFDN and IBM patients according to the data recorded during clinical routine visits.

We wanted to assess the natural course in Congenital Cataract Facial Dysmorphism Neuropathy Syndrome (CCFDN) and sporadic and hereditary inclusion body myopathies (IBM) over 10 years to gain new insights in both conditions.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and/or genetic diagnosis of Congenital Cataract Facial Dysmorphism Neuropathy Syndrome (CCFDN) and sporadic and hereditary inclusion body myopathies (IBM)

Exclusion Criteria:

* Additional neuromuscular diseases