cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Stellate Ganglion Block in Patients With Parkinson's Disease

The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:

• Can stellate ganglion block improve the dysphagia and activities of daily living in patients with Parkinson's disease.

Participants will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Dysphagia, or swallowing difficulty, is a common symptom associated with Parkinson's disease. It is characterized by weakened chewing and throat muscles, leading to difficulties in eating, coughing, and a sensation of choking in individuals with Parkinson's disease.

The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:

• Can stellate ganglion block improve the dysphagia and activities of daily living in patients with Parkinson's disease.

Participants will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years.
* Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006.
* Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
* Stable vital signs, conscious, able to cooperate with assessment and treatment.

Exclusion Criteria:

* Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
* History of mental diseases or use of antipsychotics.
* Complicated with cognitive impairment or consciousness dysfunction.
* Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers

This study is designed to show bioequivalence between Current and New formulation of Aciclovir cream 5% in keratin layer of the epidermis in Japanese Subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese adult males between 20 and 55 years of age, inclusive.

Healthy subjects are defined as individuals who are free from clinically significant disease as determined by their medical history, physical examination, clinical laboratory examinations, vital sign, 12-lead ECG, immunology tests and urinary drug screen test.

* Bodyweight \>50 kg and body mass index (BMI) between 18.5 and 28.0 at screening.
* Subjects must be capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Baseline QTc interval \<450 msec.
* Non-smoker or ex-smoker having ceased smoking for at least 6 months.
* Clinical laboratory examination (AST, ALT, ALP and GGT) at screening are within the normal range.
* The subject is able to attend all visits and complete the study.

Exclusion Criteria:

* Any clinically relevant abnormality identified on the screening physical examination, vital sign measurement, 12-lead ECG recording and/or clinical laboratory examination that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern.
* History of regular alcohol consumption exceeding, on average, 14 drinks/week (1 drink = 5 ounces (150 mL) of wine or 350 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening.
* Positive for urine drug at screening.
* Positive for syphilis, HIV antibody, Hepatitis B surface antigen, Hepatitis C antibody or HTLV-1 antibody at screening.
* Donation of blood in excess of 400mL within 4 months or 200mL within 1 months prior to at screening.
* History of drug abuse, or current conditions of drug abuse or alcoholism.
* Participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first application of study medication.
* Participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device.
* History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses.
* The subject has an allergy for any drug or idiosyncrasy. This excludes a pollen allergy without current symptoms.
* At the part obtaining keratinized layer, having exanthem, pigment abnormality, the skin symptoms such as wounds and/or an excessive sunburn.
* History of clinically significant itching, erythema and/or rash by any paster.
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy, safety, and tolerability of ISIS-GCGRRx in combination with metformin versus placebo


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 to 75
* BMI ≥ 25.0 kg/m2
* HbA1c ≥ 8.0% and ≤ 10.5%
* Type 2 Diabetes Mellitus and on stable dose of Metformin
* Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion Criteria:

* Clinically significant abnormalities in medical history of physical exam
* Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
* History of solid organ transplant or renal dialysis
* History of liver disease
* History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
* Treatment with any other antidiabetic drug(s) other than metformin within 3 months of screening
* History of diabetic ketoacidosis
* Any other significant illness or condition that may interfere with the patient participating or completing the study
* Inability or unwillingness to comply with protocol or study procedures
The Effect of Saccharomyces Boulardii in Clinical Presentation and Quality of Life Patient With IBS

This study aims to compare the effectiveness of Saccharomyces Boulardii vs Placebo in patient with Irritable Bowel Syndrome

This study aims to compare the effectiveness of Saccharomyces Boulardii vs Placebo in patient with Irritable Bowel Syndrome within timeframe of study 28 days and then will be examined the outcome as the improvement quality of life

Eligibility Criteria:
Inclusion Criterias:

* 18 years or older
* diagnosed with IBS based on ROME IV criteria
* agree to be participant by signing inform consent

Exclusion Criteria:

* patient who does not want to sign the inform consent
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers

The aim of the study is to test the performance and safety of a newly developed intermittent catheter in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent and signed letter of authority
2. Be at least 18 years of age and have full legal capacity
3. Be a male
4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits
5. Have a negative urine multistix - erythrocytes (Microscopic haematuria)
6. Have a negative urine multistix:

   * Leukocytes
   * Nitrite Or if positive, subsequent negative for bacterial growth in urine culture

Exclusion Criteria:

1. Abnormalities, diseases or surgical procedures performed in the lower urinary tract
2. Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
3. Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation
4. Known hypersensitivity toward any of the test products -
An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia

The objective of the present study was to investigate the possibility of using L-lysine, an amino acid that occurs naturally in food and which interferes with nitric oxide (NO) production, for the treatment of schizophrenia. L-lysine, 6 g/day, was administered to ten patients with schizophrenia as an add-on treatment to conventional antipsychotic treatment. The study was designed as a single-blinded, cross-over study where patients were randomly assigned to initial treatment with either L-lysine or placebo and screened at baseline, after four weeks when treatment was crossed over, and after eight weeks when treatment was terminated. The four-week L-lysine treatment regimen caused a significant increased in blood concentration of the amino acid and was tolerated well. The analysis of outcome measures showed a significant decrease in symptom severity as measured by the Positive and Negative Syndrome Scale (PANSS). Furthermore, the patient's ability to solve the Wisconsin Card Sorting Task (WCST) was significantly improved indicating increased problem solving capacity and cognitive flexibility. Subjective reports from three of the patients also indicated decreased symptom severity and enhanced cognitive functioning. In summary, these findings suggest potential beneficial effects of L-lysine treatment on symptom severity and cognitive deficits in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* a stable phase of illness
* a stable dose of antipsychotic medication
* no other major medical conditions or other psychiatric diagnosis
* normal admission laboratory tests and vital signs

Exclusion Criteria:

* substance abuse, apart from smoking
A Pilot Randomized Controlled Trial of Intravenous N-acetyl Cysteine in STEMI

The PANACEA trial is an investigator-initiated prospective, single-center, two-arm, non-blinded pilot randomized controlled trial of high-dose IV N-Acetylcysteine therapy used as an adjunct to pharmaco-invasive reperfusion in patients presenting early after a large STEMI.

Patients presenting with ST-segment elevation myocardial infarction within 3 hours of symptom onset and satisfying all of the inclusion criteria after informed consent would be randomly allocated to either intravenous N-Acetylcysteine or standard treatment using a 1:1 allocation ratio. Those randomized to IV N-Acetylcysteine would be administered a bolus of 1200 mg over 0.5 hours (in 5% Dextrose) followed by 600mg/hour for the remaining 47.5 hours (in 5% dextrose). A total N-acetylcysteine dose of 29.7 grams is administered over 48 hours. The infusion is continued during the primary percutaneous coronary intervention. Patients would be followed up for a minimum of 90 days. The primary clinical endpoint will be myocardial infarct size measured by late gadolinium enhancement CMR imaging at 3-5 days from first medical contact. Primary feasibility outcome will be the rate of recruitment, the number of patients undergoing cardiac MRI within the stipulated time frame, and completeness of the study data collection.

Eligibility Criteria:
Inclusion Criteria:

Patients presenting with STEMI within 3 hours of symptom onset and satisfying all of the following criteria:

1. Patient age ≥ 18 years
2. Have received thrombolysis, with intend to pursue a pharmaco-invasive reperfusion strategy. Onset of chest pain to reperfusion time of \< 3hrs.
3. STEMI involving anterior and/or inferior wall
4. An absence of baseline Q-waves on the initial ECG: The presence of Q waves defined at baseline using the Selvester QRS screening criteria
5. Have a high-risk STEMI ECG defined as:

   * ≥2mm ST-segment elevation in 2 anterior or lateral leads; or
   * ≥2 mm ST-segment elevation in 2 inferior leads coupled with ST-segment depression in 2 contiguous anterior leads for a total ST-segment deviation of ≥4 mm

Exclusion Criteria:

1. Previous myocardial infarction
2. Known to have moderate to severe LV systolic dysfunction (LV EF\< 45%)
3. Known allergy to thrombolytic therapy or NAC
4. Presence of left bundle branch block
5. Cardiogenic shock (defined as systolic blood pressure of \< 90mm Hg, for at least 30 minutes, not responsive to fluid resuscitation)
6. Permanent pacemaker or cardioverter defibrillator implanted previously
7. Patients with contra-indications to thrombolytic therapy
8. Patients with loss of consciousness or confusion
9. Patients with known chronic kidney disease (GFR \< 30ml/min/m2) or on dialysis
10. Current pregnancy
11. Planned therapy with primary PCI
Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.


Eligibility Criteria:
Inclusion Criteria

* Histopathologically proven prostate adenocarcinoma.
* Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

  * Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation for biochemical recurrence after radical prostatectomy

    * PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
  * Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical recurrence after radiation therapy

    * Nadir + greater than or equal to 2 ng/mL rise in PSA
* Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
* Age \>= 18.
* Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria

* Unable to lie flat, still or tolerate a PET scan.
* Concomitant investigational therapy.
* Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
* Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet

All the patients admitted in emergency department for minor traumatized cranial, with antiplatelet therapy, can be included, after checked inclusion and non inclusions criterias. If they are agree, a blood sample for the dosage of S100b will be done.

No other modification of the medical care, all patients will have tomodensitometria, according with recommendations. The aim of the study is to validate the negative predictive value of S100b in this population.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 Years old
* Minor traumatic brain injury measured by a Glasgow score between 13 and 15
* Antiplatelet agent therapy
* Free subject without tutorship or curatorship

Exclusion Criteria:

* Age \< 18 years old
* Glasgow score \<13
* Traumatic brain injury older than 6 hours
* Patient without any social security system
* Patient with renforced protection (tutorship, curatorship, ...)
Liver Enzyme Abnormalities and Risk Factors in Taking Herbal Medicine

Herb-induced liver injury is an important issue in musculoskeletal diseases where herbal medicine is most frequently used. The low prevalence of drug-induced liver injury (DILI) gives rise to the need for large-scale patient studies. We assessed the prevalence of liver injury of 6,894 musculoskeletal disease inpatients taking herbal medicine.

Herb-induced liver injury is an important issue in musculoskeletal diseases where herbal medicine is most frequently used. The low prevalence of drug-induced liver injury (DILI) gives rise to the need for large-scale patient studies. The objective of this study is to report on the incidence of liver injury from herbal medicine in musculoskeletal disease patients as large-scale studies are scarce.

Of 32,675 inpatients taking herbal medicine at 7 locations of a Korean medicine hospital between 2005 and 2013, we screened for liver injury in 6,894 patients with liver function tests (LFTs) at admission and discharge. LFTs included t-bilirubin, AST, ALT, and ALP. We assessed for risk factors for liver injury at discharge.

Participants received the most frequently used complementary and alternative medicine treatment contents (herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation) administered to musculoskeletal disease patients at this hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for at least one day who took herbal medicine and at least 2 LFTs during admittance.

Exclusion Criteria:

* None.
Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy

the investigators will pursue two specific aims: (1) to monitor the extent of heme oxygenase induction (by measuring endogenous CO production) in relationship to the extent of hepatic resection (2) to assess the production of CO in patients following liver resection and correlate these findings to the rate of liver regeneration and liver function.


Eligibility Criteria:
Inclusion Criteria:

* Patient plans to have partial liver resection for primary liver pathology or metastatic disease
* Patient is able to comprehend and willing to sign the written consent form

Exclusion Criteria:

* Patients \< 18 years
* Patients identified as members of a vulnerable population, except women of child bearing potential with negative pregnancy test
Quality of Pediatric Resuscitation in a Multicenter Collaborative

This is a prospective, observational, multi-center cohort study of pediatric cardiac arrests.

The purpose of the study is to determine the association between chest compression mechanics (rate, depth, flow fraction, compression release) and patient outcomes. In addition, the investigators will determine the association of post cardiac arrest care with patient outcomes.

Cardiac arrests in children are a major public health problem. Thousands of children each year in the USA are treated with cardiopulmonary resuscitation (CPR) and managed after their cardiac arrest. Neurological outcomes following these in-hospital CPR events are often abnormal. As children with neurological deficits following CPR are a major burden for families and society, improving neurological outcomes through superior chest compression delivery during CPR and optimal care and management after cardiac arrest is an important clinical goal.

Therefore, the objective of this investigation is to obtain evidentiary support to associate the relationship of quantitative CPR quality data (depth, rate, chest compressions (CC) fraction, compression release) during CPR, post-cardiac arrest care (PCAC) and patient survival in those children who suffer an arrest within the study (RES-Q) Network.

Eligibility Criteria:
Inclusion Criteria:

* Patient received chest compressions for at least 1 minute
* Patient between gestational age ≥37 weeks and 17 years of age
* Patient had a quality of CPR measurements device (eg., Zoll Medical chest compression sensor) in place during chest compressions

Exclusion Criteria:

* Patient on extracorporeal membrane oxygenation (ECMO) therapy at beginning of CPR event
Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT

Up to 40 evaluable women with known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer will participate in two different imaging cohorts. The Biodistribution cohort will include up to 4 patients and the Dynamic cohort will include up to 36 patients. Human dosimetry will be calculated from the Biodistribution cohort. The Dynamic cohort date will evaluate preliminary information on uptake of \[18F\]FTT in gynecological cancer and compare with PARP-1 activity in tissue.

Primary Objectives

• Evaluate PARP-1 activity in epithelial ovarian, fallopian tube, or primary peritoneal cancer using measures of uptake of \[18F\]FluorThanatrace

Secondary Objectives

* Evaluate the safety of \[18F\]FluorThanatrace
* Correlate \[18F\]FluorThanatrace uptake measures with BRCA mutation status
* Correlate \[18F\]FluorThanatrace uptake measures with PARP-1 activity in tumor.
* Determine biodistribution of the radioactive investigational drug (\[18F\]FluorThanatrace) in patients and calculate human dosimetry.
* Evaluate change in \[18F\]FluorThanatrace uptake measures after therapy

Eligibility Criteria:
Inclusion Criteria for Dynamic cohort

* Participants will be ≥ 18 years of age
* History of known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer (may have primary or recurrent cancer at the time of study enrollment)
* At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. CT, MRI, ultrasound, FDG PET/CT)

Exclusion Criteria for Dynamic cohort

* Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
* Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
* Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
A Prospective Comparison of Robotic and Endoscopic SMG Resection Via Retroauricular Approach

Traditional transcervical incision of the upper neck is a safe and effective approach for resection of the submandibular gland (SMG). However, external scar at the highly visible area may be a burden for the patients and sometimes may lead to disfiguring hypertrophic scar or keloid. Recently, the investigators reported our surgical technique of 'endoscope-assisted' and 'robot-assisted' SMG resection, which was feasible and showed excellent cosmetic outcomes since the scar was hidden by the auricle and hair. In our previous feasibility study of robot-assisted SMG resection, the investigators proposed that robot-assisted technique may overcome the limitations of endoscopic instruments with rigid and straight nature without articulation and surgical view of two-dimension. In addition, the ergonomically designed operating system was more convenient for the surgeon considering the frequent collision of the endoscopic instruments and reversed hand-eye coordination in endoscope-assisted surgery. However, clinical trial comparing the surgical outcomes of the two techniques has not been reported in the literature.

In this study, the investigators made a prospective comparative study of robot-assisted versus endoscope-assisted SMG resection to determine whether robot-assisted technique has benefits regarding early surgical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as pleomorphic adenoma or chronic sialadenitis from preoperative ultrasound-guided fine needle aspiration biopsy (FNAB)

Exclusion Criteria:

* Past history of neck surgery or radiation
* Possible malignancy expected from FNAB or image study
* Gland with severe adhesion to surrounding tissue on preoperative physical examination