cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy

The purpose of this study is to assess safety and efficacy of treatment with pregabalin in patients with idiopathic small fiber neuropathy proven by skin biopsy.This is an enriched enrollment randomized withdrawal study that comprises 4 phases: a screening and selection phase, a washout period from previous pain medication for enriched enrollment, an 8 week single blind pregabalin treatment phase; and a 4 week randomized withdrawal phase.

Patients who show any increase in their pain intensity score during the washout phase will be eligible for the single blind pregabalin treatment phase. Patients who respond to pregabalin, with at least 1 point improvement in neuropathic pain from baseline at the end of the single blind pregabalin treatment phase and meeting all other study requirements are considered eligible for participation in the withdrawal phase. These eligible patients are randomly assigned (1:1) to continue pregabalin or to be switched to placebo for a comparison of pregabalin efficacy and safety. Patients who have a worsening of average pain relative to the last week of the single blind pregabalin treatment period by more than one point and average pain level \> =4 will be considered to have a loss of therapeutic response (LTR).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with idiopathic predominate-small fiber neuropathy
* Subject must have chronic peripheral neuropathic pain for more than 3 months
* A score \>3 and \<8 on Pain intensity scale for pain in prior week at first visit;
* Show increase in pain intensity scores during the wash off period;
* Age older than 18 years;

Exclusion Criteria:

* Subjects with large-fiber predominant neuropathy
* Subjects with HIV infection, trigeminal neuralgia (TGN), toxic neuropathy (e.g. chemotherapy exposure), paraneoplastic neuropathy, mono-gammopathy, inflammatory neuropathy, celiac disease, systemic lupus, peripheral vascular disease, connective tissue disorders, hepatitis C, Fabry disease, and diabetes;
* Subjects with uncontrolled thyroid or B12 disorders
* Subjects with Complex Regional Pain Syndrome
* Allergy to Pregabalin
* Subjects at risk of suicide or self harm
* Subjects with any clinically unstable cardiovascular, hematological, autoimmune, endocrine, renal, hepatic, renal, respiratory, or gastrointestinal disease; epilepsy, symptomatic peripheral vascular disease including intermittent claudication, pernicious anemia, untreated hypothyroidism, venous insufficiency, or spinal stenosis.
* History of known analgesic, alcohol or illicit drug abuse within 12 months of first visit;
* Pregnant females; breastfeeding females.
Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis

The purpose of this study is to determine whether the dry extract BNO 1016 is effective and safe in the treatment of acute rhinosinusitis in adults.

The aim of this clinical study is to investigate the efficacy of a 15-days treatment with the herbal medicinal product BNO 1016 for therapy of acute rhinosinusitis in adult patients. Due to the considerable morbidity and the diminished quality of life experienced by people afflicted with acute rhinosinusitis an important aim of the treatment is to reduce the severity of rhinosinusitis symptoms and the duration of the disease. By grading the severity of the disease on the basis of the 5 main rhinosinusitis symptoms the investigator will assess the efficacy of the treatment.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of acute rhinosinusitis

* characterized by a major symptom score (MSS) ≥ 8 and ≤ 12 points (minimum 0, maximum 15 points)
* individual score for facial pain/pressure ≥ 1 (mild) and ≤ 2 (moderate)
* confirmed by ultrasonography of paranasal sinuses
* with presence of symptoms ≤ 3 days prior to inclusion

Exclusion Criteria:

* Chronic rhinosinusitis
* Polyposis nasi
* Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation/airflow
* Acute symptoms of a known allergic rhinitis
* Patients with asthma who have a history of exacerbations within 30 days prior to study inclusion
* Signs or symptoms of fulminant bacterial sinusitis
* Odontogenic sinusitis
Efficacy and Safety Trial of Pangramin SLIT HDM-mix in Subjects With House Dust Mite Induced Rhinitis

Primary aim is to evaluate the efficacy of specific immunotherapy with Pangramin SLIT HDM-mix compared to placebo in the treatment of House Dust Mite (HDM) induced rhinitis with or without asthma.

Sublingual immunotherapy has been used during several years and has been shown to provide benefits compare to traditional subcutaneous treatment. This study will investigate if improvements in rhinitis symptoms and less use of symptomatic medication can be obtained as a consequence of being treated under specific immunotherapy.

This study aim also to contribute to the documentation of tolerability and safety profile of Pangramin HDM Mix.

Extensive clinical experience has been gained due to the widespread use of Pangramin® SLIT and other SLIT products as named patient products, both with respect to the types and the frequencies of the adverse events(AEs) observed. No safety concerns have been found.

The optimal therapeutic dose range regarding SLIT is not fully elucidated. The fate of the allergen after sublingual administration is not known in detail, i.e. to what extent is the allergen absorbed over the mucosa or swallowed and how this is related to volume, excipients etc. The relationship between dose and effect is thus not fully elucidated. The general recommendation is to use a dose inducing a clinical relevant effect in most patients without causing unacceptable adverse events. As Pangramin SLIT HDM-mix has a safety profile that allows a single daily intake by the patient at home, the dosage at this trial will be the same as marketed product.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 5 to ≤ 55 years of age.
* A history HDM induced allergic rhinitis.
* Use of medication for the control of rhinoconjunctivitis symptoms.
* Positive Skin Prick Test (SPT).
* Positive specific IgE.

Exclusion Criteria:

* PEF ≤ 70% of predicted value.
* History of significant symptomatic seasonal or perennial allergic rhinitis and/or asthma caused by an allergen to which the patient is regularly exposed, and sensitized (e.g. pollens, cat, dog, cockroach...except house dust mites).
* Severe asthma.
* Current symptoms of upper respiratory tract infection or other relevant infectious process.
* Current food allergies with oral allergy syndrome.
* A clinical history of chronic sinusitis.
* Current severe atopic dermatitis.
* Concomitant or previous treatment by immunotherapy.
Compassionate Single Subject Use of FG-3019 (FibroGen) in Locally Advanced, Unresectable Pancreatic Cancer

Single compassionate use subject is an 83 year old woman with a history of lymph node positive breast cancer and recently diagnosed pancreatic cancer in May. With an Eastern Cooperative Oncology Group (ECOG) of 2, it is felt that she cannot tolerate more aggressive chemotherapy. The investigators propose to administer FG-3019 on a compassionate pleas basis in combination with gemzar. The patient is currently being treated and is tolerating gemzar.

The FG-3019 treatment will be administered over a 28-day cycle:

* Dose: 35 mg/kg
* Route: IV over one hour following completion of gemcitabine infusion
* Schedule:

  * Days 1, 8, and 15
  * Please note that Day 8 infusion will on be completed during the first treatment cycle

On Drug Evaluation

The patient will be seen prior to every FG-3019 treatment by the treating physician. The following procedures will be conducted at each visit:

* History and thorough symptom assessment
* Physical examination
* Laboratory assessments (these can be collected up to 3 days prior to treatment):
* Complete blood count (CBC) and differential
* Comprehensive Metabolic Panel (Chemistry): bicarbonate, blood, urea, nitrogen (BUN), calcium, creatinine, glucose, potassium, sodium
* Liver Function Tests: Alkaline phosphatase (ALP), Alanine transaminase (ALT), Aspartate transaminase (AST), total bilirubin
* Carbohydrate antigen (CA) 19-9

ECGs will be conducted during the screening and end of treatment visits. CT scans of the chest and abdomen will be done every 12 to 16 weeks.

All of these data will be recorded and stored with their source documents.

Eligibility Criteria:
Inclusion Criteria:

* Signed Consent form
* Have adequate liver function
* Have adequate bone marrow function

Exclusion Criteria:

* History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
* Any medical or surgical condition that may place the subject at increased risk while on treatment
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with treatment requirements
* Current abuse of alcohol or drugs
Single and Multiple Dose Study of Uprifosbuvir (MK-3682/IDX21437) in Healthy and Hepatitis C Virus (HCV)-Infected Participants (MK-3682-001)

This is a multi-part study to evaluate the safety, tolerability, and pharmacokinetics (PK) of uprifosbuvir (MK-3682/IDX21437) in healthy participants and in participants infected with Hepatitis C virus (HCV) genotype (GT)1-GT6. The effect of food on the PK of uprifosbuvir will be evaluated. The antiviral activity of uprifosbuvir will also be assessed in HCV-infected participants.


Eligibility Criteria:
Inclusion Criteria:

All Participants:

* of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug
* must not have consumed grapefruit or grapefruit juice within 7 days of Day -1 and throughout the study

HCV Participants:

* documented clinical history compatible with chronic hepatitis C.
* have not received direct-acting antiviral treatment for hepatitis C infection
* has HCV Genotype 1, 2, 3, 4, 5 or 6

Exclusion Criteria:

All Participants:

* pregnant or breastfeeding
* co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
* decompensated liver disease
* other clinically significant medical conditions or laboratory abnormalities.
Umbilical Cord Mesenchymal Stem Cells Infusion for Diabetes Related Vascular Complications

Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

Diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments.

Stem cell therapy has been a new and effective therapy in recent years for diabetic foot. Combined with the previous studies of the investigators research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus Type 2 or Type 1
* Age between 18-80 years
* Chronic foot ulcer more than 6 weeks
* No sufficient response to best standard care delivered for six weeks.
* PAD up to Fontaine stage III or IV period
* CLI with the ankle brachial index (index ankle-brachial, ABI) \<0.7 and (or) the percutaneous oxygen partial pressure (oxygen tension transcutaneous, TcPO2) \<30mmHg

Exclusion Criteria:

* HbA1c \>12%
* Hemoglobin \<10 mg/dl
* Creatinine clearance rate \<30ml/min
* Systemic bacterial, viral infections (Mei Du, hepatitis, cytomegalovirus infection, - HIV, B19 infection, herpes virus infection) and sepsis
* Have accepted the treatment of stem cells or growth factors
* Have a history of malignant disease
* Pregnancy
* Mental illness history
* Abnormal coagulation function
* Allergic reaction
* Severe cardiac insufficiency (III-IV NYHA)
* Using vasoactive substances
An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery

Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.

This is a randomized, double-blinded, placebo-controlled trial to evaluate fenoldopam and N-acetylcysteine (NAC) individually, and together, as renal protective agents for patients with renal insufficiency undergoing heart surgery. Subjects have chronic renal insufficiency with creatinine clearance (CrCl) \</= 40cc/min but not on pre-operative dialysis, and receive: NAC 600 mg by mouth (po) twice a day (bid) or placebo starting 24 hours pre-operative and continuing through the day of surgery; and/or fenoldopam 0.1 mcg/kg/min intravenous (IV) or saline placebo at anesthetic induction and continuing for 48 hours. Outcome data include: nadir, post-operative day 3 and post-operative day 14 CrCl, time to CrCl nadir, length of Intensive Care Unit (ICU) stay, length of post-operative hospital stay, hospital costs, mortality, and the need for hemodialysis. Intraoperative and post-operative pressor use is being monitored. The enrollment will include 80 patients (20 in each group).

Eligibility Criteria:
Inclusion Criteria:

* Chronic creatinine clearance \</= 40cc/h
* Pre-operative cardiac surgery

Exclusion Criteria:

* Pre-operative ongoing dialysis
* Nausea and vomiting
* Uncontrolled glaucoma
* Allergy to metabisulfite
* Enrollment in another clinical study within 30 days
* Pregnancy
* Acute renal failure
Perceptions of E-Cigarettes and Synthetic Cooling Agents, the ICE Study

This study evaluates how synthetic cooling additives like WS-3 and WS-23 impact e-cigarette perceptions, use behavior, and toxicant exposure.

PRIMARY OBJECTIVES:

I. Assess the abuse liability of e-liquids with and without the presence of synthetic cooling agents.

II. Determine the impact of synthetic cooling agents and flavor on EC puffing behavior (topography).

III. Determine the exposure ranges (harmful and potentially harmful constituents \[HPHCs\], other toxicants) from vaping e-liquids with and without the presence of synthetic cooling agents.

OUTLINE:

Participants attend 4 sessions where they receive 1 of 4 randomly assigned flavored e-cigarettes. Participants use the e cigarettes for vaping followed by ad libitum vaping. Participants also complete surveys and undergo biosample collection throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21-29 years
* Current exclusive e-cigarette (EC) user (defined as ≥ weekly use over the past 3 months)
* Willing to provide informed consent and abstain from using their EC at least 12 hours prior to the four lab sessions
* Read and speak English

Exclusion Criteria:

* Recently COVID-19+ (defined as positive test in the past 30 days) or a recent COVID-19 hospitalization (defined as a hospitalization within the past 6 months)
* Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
* History of cardiac event or distress within the past 3 months
* Are currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test)
* Have suffered from any serious lung disease or infection (e.g. , tuberculosis, cystic fibrosis, or lung cancer) in the past 30 days
* Have hemophilia or another type of bleeding disorder
* Are blind, severely visually impaired, deaf, hard of hearing, or have a severe motor disability
Etravirine Pharmacokinetics and HIV Viral Load in Breast Milk and Plasma

HIV positive pregnant women who receive potent combination antiretroviral therapy over at least the last trimester of pregnancy, and who have proper obstetric interventions and are able to avoid breast feeding, decrease the risk of having an infected infant to about 1%. Breast milk HIV-1 RNA (cell free) viral load is significantly associated with breast milk transmission, and a 2-fold increased risk of transmission associated with every 10-fold increase in breast milk viral load has been reported. In addition, cell associated virus (HIV DNA) was associated with a significant increase in risk of transmission independent of the level of cell-free viral RNA.

However, multiple studies of HIV positive women giving birth have shown that exclusive breast-feeding carries a much lower risk of HIV transmission than mixed breast-feeding (defined as breast milk along with complementary food, other milk, and/or infant formula). The proposed study will measure the antiretroviral (ARV) drug etravirine concentrations in blood and breast milk in postpartum HIV positive women on HAART therapy. The short-term goal is to determine how much etravirine penetrates into breast milk, and whether it leads to undetectable HIV viral load in the breast milk and therefore has the potential to decrease the risk of transmission of HIV through breast milk. The long term goal is to see if breast milk HIV levels can be lowered sufficiently to prevent maternal to child transmission (MTCT) of HIV in infants receiving only breast feeding in resource poor areas.


Eligibility Criteria:
Inclusion Criteria:

1. HIV+ pregnant women on HAART for the prevention of MTCT w/ undetectable viral load at time of delivery (w/i 30 days of delivery).
2. 18 years and older
3. Only women who are deemed by the physician as being capable of understanding that HIV positive women should not breastfeed will be approached.
4. Life expectancy greater than 6 months
5. No known allergies to etravirine
6. Willingness of subject to adhere to protocol requirements.

Exclusion Criteria:

1. Pregnant women with medical or psychological contraindications to breast milk expression.
2. Requirements for prohibited medications:

   * ARV: Tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir, and protease inhibitors administered without ritonavir, nonnucleoside reverse transcriptase inhibitor (NNRTIs).
   * Alternative/CAM: St. John's wort
   * Anticonvulsants: Phenobarbital, carbamazepine , phenytoin
   * Anti-infectives: Rifampin
Vagal Nerve Stimulation for the Treatment of Persistent AF

The goal of this clinical trial is to answer the question whether a transcutaneous stimulation of a certain nerve (Nervus vagus) with a dedicated device reduces the recurrence of the heart rhythm disorder atrial fibrillation.

Participants will receive a dedicated nerval stimulation device and will treat themselves on a daily basis for at least an hour per day. Treatment will last for 3 months. Researchers will compare this group with a similar group that uses an ineffective device. Both researcher and patients will be blinded so they do not know which device they will be using.

This study is an investigator-initiated, monocentric, randomised, controlled and blinded trial. Patients with persistent atrial fibrillation and planned electrical cardioversion will be included. The participants are randomised to one of two groups - the verum-group or the sham-group. Both groups receive a dedicated stimulation device that stimulates transcutaneously the Ramus auricularis of the Nervus vagus at the area of the Tragus. The verum-group will receive an effective stimulation and the sham-group an ineffective one. The aim of this trial is to evaluate whether this stimulation could reduce the recurrence of atrial fibrillation or not. Therefore daily stimulation of at least one hour will be performed for overall three months. After that period the stimulation will be withdrawn and both groups will be compared. Then, after another three months without stimulation both groups will be compared again to evaluate if a potential effect of the initial stimulation persists.

Eligibility Criteria:
Inclusion Criteria:

* Persistent atrial fibrillation
* Planned electric cardioversion
* Sufficient oral anticoagulation for at least four weeks or
* Absence of thrombus in transoesophageal echocardiography
* Oral anticoagulation possible
* Able to sign informed consent
* Estimated life expectancy \>1 year

Exclusion Criteria:

* Permanent atrial fibrillation
* Ablation therapy of supraventricular arrhythmias in the past
* Missing anticoagulation respective missing rule out of thrombus
* Inability to treat with oral anticoagulation
* Latent or manifest hyperthyroidism
* Acute infection with relevant clinical signs (temp \> 38°C, significant elevated C-reactive protein or white blood cells)
* Inability to sign informed consent
* Preexisting pacemaker or implantable cardioverter defibrillator
* Recent vagal stimulation for other causes
* Recent intolerance of transcutaneous vagal stimulation
* Estimated life expectancy \<1 year
* Acute coronary syndrome
* Haemodynamic instability
* Valvular atrial fibrillation
* Pregnancy
Monitoring Patients With Uncontrolled Epilepsy

This study is designed to evaluate patients with uncontrolled seizures. Seizures can be associated with and monitored by abnormal electrical activity in the brain.

In this study researchers will use video-electroencephalography (EEG) to monitor patients with uncontrolled or suspected seizures. EEG works by measuring electrical activity in different areas of the brain. The video-EEG allows researchers to examine changes in the EEG along with the clinical features of seizures as they occur.

In addition to monitoring electrical activity of the brain, researchers will take frequent antiepileptic drug blood levels. These measures will allow researchers to learn more about how each drug is absorbed and metabolized in the body.

The information collected in the study will be used to place patients into other scientific studies testing new therapies for epilepsy.

In this study we will use standard clinical studies, including simultaneous Video-EEG monitoring, to evaluate patients referred for uncontrolled or suspected seizures. The protocol will be used to screen patients for inclusion in other protocols, follow the natural history of seizure disorders, and train fellows in the evaluation and treatment of epilepsy. Both inpatients and outpatients will be studied.

Eligibility Criteria:
History of uncontrolled seizures, at the present time, at least during 6 months of the past 3 years, and preferably a continuous pattern of seizures during the few months prior to admission.

Seizure frequency, by history, must be sufficient to make video monitoring effective. Priority will be given to patients whose seizures occur once or more per day.

Patients of any age may be accepted.

Patients (and parents or guardians, if applicable) must express willingness to cooperate with the entire protocol, to be willing to undergo further diagnostic tests if needed, and to return for follow up evaluation at intervals as needed.