cyrilzakka/clinical-trials huggingface dataset:
Rectal Administration of Opioids Using the Macy Catheter in Reducing Pain in Patients With Advanced Cancer

This trial studies how well rectal administration of opioids using the Macy catheter works in reducing pain in patients with cancer that has spread to other anatomic sites or is no longer responding to treatment. Rectal administration of opioids using the Macy catheter may help to reduce the cost of care, resolve the issue of medication availability currently faced in the form of parenteral opioid shortage throughout the country, and provide adequate comfort and symptom relief for patients with smoother transition out of hospital.

PRIMARY OBJECTIVES:

I. Determine the feasibility of using the device 'Macy catheter' for rectal administration of opioids for comfort in cancer patients on palliative care.

SECONDARY OBJECTIVES:

I. To determine the ease of use, level of satisfaction and overall perception of effectiveness of 'Macy catheter' for rectal administration of opioids for pain control in advanced cancer patients, by the hospital bedside nursing staff.

II. To assess patients' (or primary care-giver's) experience of using the 'Macy catheter' 48 hours after discharge from the hospital.

III. To assess the hospice staff (or primary care-giver's) experience of using the 'Macy catheter' after patient's death.

OUTLINE:

Patients undergo placement of rectal catheter and receive opioids through the Macy catheter.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to the inpatient Acute Palliative Care Unit (APCU) at MD Anderson Cancer Center
* Candidate for taking short acting opioids and/or methadone, with or without transdermal fentanyl, for control of cancer related pain
* Impaired oral/gastrointestinal (GI) route for medicine intake (due to, but not limited to, any level of gastrointestinal obstruction, severe nausea and/or vomiting, odynophagia and/or dysphagia due to severe mucositis, tumor, muscle weakness or in-coordination)
* Advanced cancer defined as cancer with no further oncological management and patients are at end of life (EOL) or recommended for best supportive/comfort care (estimated prognosis less than 6 months)
* Able and willing to read and sign in English

Exclusion Criteria:

* Non-English speaking
* Contraindications to use of the Macy catheter (1. Not be used for patients with rectal lesions, tumors, active rectal bleeding and/or compromised rectal mucosa \[i.e. ulceration or ischemic proctitis\], 2. Patients with diarrhea, or more than 1 liquid stool per day, 3. Patients with recent bowel surgery \[less than 6 weeks\], 4. Thrombocytopenia \[platelet count less than 20,000, checked in the last 1 week\])
* Patients who are unable to take oral medications due to severe constipation only, which can be adequately managed by bowel laxative regimen
Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and STN-DBS

The objective is to investigate whether AMPS (Automated Mechanical Peripheral Stimulation) is effective in reduction of FOG measured via the FOG-AC (Freezing Of Gait Assessment Course) in people with Parkinson Disease and STN-DBS (Subthalamic Nucleus Deep Brain Stimulation) in a randomized, double-blind, sham-controlled, cross-over trial

The effects of AMPS treatment (effective vs sham) will be measured using the FOG-AC assessment. Patients will be randomized to receive either AMPS treatment and then sham or sham and then AMPS. Each treatment phase will be 4 weeks of treatment, separated by a 6-week washout period.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* ≥18 years old
* Diagnosis of Parkinson's Disease according to the United Kingdom Brain Bank Criteria
* Bilateral STN-DBS for at least 6 months
* Moderate to severe FOG i.e. FOG-AC ≥8 pts.

Exclusion Criteria:

* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Pregnancy
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* L-Dopa induced-freezing (defined by medical history),
* DBS-induced freezing (defined by medical history),
* Clinically relevant depression
* Clinically relevant cognitive impairments
* Shoe size greater than 46
Influence of Surgical Regional Anesthesia on Postoperative Pain

To compare three Types of anesthetic techniques (Spinal anesthesia, Combined spinal epidural anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain after elective cesarean section.

Regional analgesia is the most effective way of providing analgesia during labor and delivery. By using a combination of local anesthetics and opioids, it is often possible to avoid motor block. Spinal anesthesia is suitable for most elective cesarean sections. Epidural anesthesia and in particular catheter based epidural anesthesia allow a gradual extension of anesthesia and are suitable for prolonged treatment of postoperative pain.

It is unclear which anesthetic technique provides better pain relief after cesarean section.

This prospective, randomized study compares the effectiveness of three types of regional anesthetic techniques (Spinal anesthesia, Combined spinal epidural anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain after elective cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged greater than or equal to 18 years
* Patients without severe illnesses (American Society of Anaesthesiologists \[ASA\] grade II-III)
* Patients for elective cesarean sections
* Informing patients about risks and complications of anesthesia until 24 hrs before operation

Exclusion Criteria:

* Lacking willingness to regional procedures
* No offered patient information and written informed consent
* Persons without the capacity to consent
* Unability of German language use
* Preterm delivery \< 28 weeks of pregnancy
* Chronic pain or chronic analgesic intake in medical history
* Alcohol, dope and medication abuse
* Psychiatric disease in medical history
* Baby death after delivery
* Anxiolytic medication
* Allergy to local anaesthetics
* History of bleeding tendency
* Eclampsia and HELLP syndrome
* Elective section out work routine time
* Participation in another clinical trial during the trial, one month before screening and three months after screening
Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device in Brain-injured Patients

Clinical pilot study to evaluate a new multi-parameter neuromonitoring device that allows the measurement of regional cerebral blood flow (rCBF), intracranial pressure (ICP), brain temperature monitoring and ventricular cerebrospinal fluid (CSF) drainage in brain-injured patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patient, aged 18 - 75 years
* Brain injured patients with acute intracranial hemorrhage (including aneurysmal subarachnoid hemorrhage (SAH) and spontaneous intracerebral hemorrhage (ICH)) who are admitted to the ICU and have an indication for ICP monitoring and CSF drainage, as per standard patient care
* Informed consent obtained for research in emergency situations according to HRA art. 30 \& 31 at time of inclusion

Exclusion Criteria:

* Known kidney disease, defined as plasma creatinine \> 120 μmol/l
* Known liver disease, defined as AST \> 200 IU/L
* Over-active thyroid or benign tumors of the thyroid
* History of allergic disorders, including allergic reactions, against contrast agents containing iodine, or against ICG
* Patients which have received one of the following medications before being admitted to ICU: Haloperidol, Meperidine, Methadone, Morphine, Phenobarbital and Rifamycin.
* Patients with wounds or scars including the front orbital region.
* Cerebrospinal fluid infection or signs of meningo-encephalitis
* Anemia (hemoglobin \< 10 g/dl) or Thalassemia
* Carbon monoxide poisoning
* Acquired pathological or congenital disorders of the cerebral system, being clinically significant, respectively interfering in the investigator's opinion with the conduct of study
* Documented history of bleeding, clotting or coagulation disorders
* Patients who are not suitable for a CT perfusion
* Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this clinical investigation or will not comply with requirements of the study
* Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation
* Pre-existing disability and/or legal representative
* Patients who are kept lawfully in an institution
* Participation in another interventional clinical investigation within the last 30 days before start of treatment
* History of, respectively diagnosis of pregnancy, or breastfeeding patients
Sexually Transmitted Infections Among African American Women Who Have Sex With Women

The purpose of this study is to determine the rates of sexually transmitted infections (STI) among a group of African American women who have sex with women (AA WSW). The first study hypothesis is that AA WSW are at risk for acquiring and transmitting STI, including the human immunodeficiency virus (HIV). The second study hypothesis is that AA WSW participate in multiple high-risk sexual activities that may facilitate transmission of STIs, including HIV.

Historically, women who have sex with women (WSW) have been thought to be at low risk for acquiring sexually transmitted infections (STI), presumably due to the absence of genital mucosal contact present during vaginal-penile sex or due to the assumption that the vaginal mucosa experiences a lesser degree of trauma during female sex than during heterosexual sex. This assumption has been challenged and debated over the past two decades. In addition, the sexual health risks of WSW are only beginning to be understood.

To date the majority of research regarding STI in women has occurred in heterosexuals. National and local surveillance data that estimate the risk for STI transmission between WSW are limited, especially among African Americans. This is a group of women that may exhibit distinctive behavioral characteristics that may put them at higher risk for sexually transmitted infections STI and HIV than their Caucasian counterparts. This group of women has traditionally been reluctant to discuss their sexual orientation with physicians for fear of being stigmatized. The burden of STIs, including HIV, experienced by this group of women is largely unknown.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18 years or older
* African American race
* Sexual contact with another female within the past 6 months
* Ability to give written informed consent

Exclusion Criteria:

* Male
* Age less than 18 years old
* Race other than African American
* No sexual contact with another woman within the past 6 months
* Pregnant
* Prior enrollment in this study
* Participants who, for any reason, in the opinion of the investigator, do not have the ability to give written informed consent or may not be expected to comply with the requirements of the protocol
Prognostic Perspective of Invasive Hyperemic and Non-Hyperemic Physiologic Indices Measured After Percutaneous Coronary Intervention

Coronary physiologic assessments by the pressure-derived fractional flow reserve (FFR) have become standard methods for identifying hemodynamic deprivation in coronary arterial stenosis for evidence-based percutaneous coronary intervention (PCI). Invasive physiologic indices-guidance enables on-site real time assessment for functional significance of epicardial coronary stenosis and the use of those indices has shown to be effective to guide treatment decision. Several studies further support the role of post-PCI FFR measurement as a functional marker of residual disease after PCI and prognostic indicator of patients. Although optimal cut-off values of post-PCI FFR varied across studies, an inverse relationship between post-PCI FFR and the risk of future clinical events have been reported consistently.

Recently, non-hyperemic pressure ratios (NHPRs) have been introduced in clinical practice. Although there are several different NHPRs, previous studies consistently indicated that those NHPRs shares similar diagnostic performance and prognostic implications. Nevertheless, few reports were available for clinical relevance of NHPRs in evaluation of post-PCI status.

In this context, we will evaluate the physiologic characteristics and prognostic implication of post-PCI NHPRs and compare with those of post-PCI FFR in patients who underwent angiographically successful PCI with 2nd generation drug-eluting stent implantation (DES).

Patients who diagnosed significant coronary artery disease and treated by 2nd generation DES with post-PCI physiologic evaluation would be enrolled.

Invasive physiologic assessment including recording of resting pressure trecing would be required at the baseline and at the end of index PCI procedure. PCI procedure would be performed upon local routine. Any available 2nd generation DES could be used. Web-based electronic-case record form (CRF) system will be used for collecting data. All data will be handled and analyzed by blind fashion at independent core lab. 2-year clinical outcome after index procedure will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* any patient meets eligible criteria who underwent PCI with DES followed by invasive physiologic assessment at the index procedure
* available both post-PCI resting pressure tracing and FFR

Exclusion Criteria:

* culprit vessel of acute coronary syndrome
* failed achieving TIMI 3 flow at the end of PCI
* left ventricular ejection fraction \<30%
* graft vessel
* collateral feeder
* in-stent restenosis
* primary myocardial or valvular heart disease
* in patient whose life expectancy less than 2 years
* visible thrombus of target vessel segment
* unmeasured post-PCI resting pressure tracings
The Metabolic Effects of Ginseng Oligopeptide Preparation on Non- Alcoholic Fatty Liver Disease With Obesity: a Randomized Controlled Double-blind Trial

To investigate the effect of ginseng oligopeptide on nonalcoholic fatty liver disease with obesity and clarify its intervention mechanism in theory, which will contribute to the prevention and treatment of non-alcoholic fatty liver more scientifically and effectively.The patients were randomly divided into two groups. One group of patients took ginseng oligopeptide orally, and the other group took placebo. The liver function, blood lipid, blood glucose, liver B ultrasound and other indicators were observed to further determine the efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for non-alcoholic fatty liver disease ;
* Aged 18-65 years old;
* ALT, AST, GGT≤2×Upper Limit Of Normal（ULN）;
* BMI≥28Kg/㎡;
* Patients signed the relevant informed consent on a voluntary basis.

Exclusion Criteria:

* Under 18 years old and over 65 years old;
* Allergic to the ingredients of ginseng oligopeptide preparation;
* Serum ALT, AST, GGT\>2ULN;
* Currently taking oral hepatoprotective drugs such as reduced glutathione, polyene phosphatidylcholine, and silibinin, etc.;
* Subjects participating in other clinical trials;
* Pregnant or lactating women;
* Complicated with serious diseases of the digestive system or other systems, such as chronic gastrointestinal diseases and chronic diseases causing digestive malabsorption,Kidney disease, hematological system or autoimmune diseases;
* Other populations that were deemed by the investigators to be ineligible for the trial may reduce or complicate enrollment patients with chemotherapy.
Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury

The aim of this study is to evaluate posterior segment changes in the non-traumatic eye after open globe injury.

Globe injuries can be classified as either closed- or open-globe injuries, based on the integrity of the sclera and cornea. Open-globe injury (OGI) is characterized by a full-thickness wound of the ocular wall.

As one of the most severe forms of ocular trauma, open-globe injury (OGI) causes significant vision loss. Timely and meticulous repair of these injuries can improve patient outcomes.

OGI by rupture often occurs at the weakest point of the eye wall, which may or may not be at the actual injury site. The rupture site is most commonly found in the sclera concentric to the limbus, just posterior to the insertion of the extraocular muscles.

After trauma, changes may occur in the non-trauma eye. Retinal and choroidal circulation may change as a result of adaptation mechanisms. In this study, we evaluated the vascular densities of the control group and post-traumatic non-trauma eye.

Eligibility Criteria:
Inclusion Criteria:

* Be over 18 years old
* Unilateral eye injury

Exclusion Criteria:

* Be under the age of 18
* Usage of systemic drugs or topical ocular drops
* Bilateral eye injury
* Having systemic disease, having ocular pathology that may decrease visual acuity
Piriformis Syndrome; Extracorporeal Shock Wave Therapy and Dry Needling

This study is being conducted on patients with piriformis syndrome. Patients are divided into two groups by list randomization method: Extracorporeal shock wave therapy (ESWT) group and Dry neddling (DN) group. Both groups of patients agreed to perform basic stretching exercises. The ESWT group received 3 sessions of radial ESWT, 1 session per week. The DN group received 3 sessions of ultrasound-guided needling, 1 session per week. Clinical evaluations of the participants were performed at the beginning of treatment, 1 month, and 3 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Complaint for more than 3 months

Exclusion Criteria:

* disc pathologies according to radiological imaging
* hip joint and soft tissue pathologies
* recent history of trauma, history of surgery in the lumbar and hip region
* history of rheumatologic disease
* history of polyneuropathy
* history of sciatic nerve injury
* history of malignancy
* opioid analgesia or corticosteroid intervention for pain in the last month
* patients receive another treatment during the study
* Having a contraindication for DN treatment or ESWT treatment
Treatment of PED With AMT and Autologous Serum

Patients with persistent corneal epithelial defects who have not responded to conventional therapy will be randomized to treatment with either amniotic membrane transplantation or autologous serum 20%. Outcome measures will be (1) presence or absence of complete re-epithelialization within 28 days and (2) retention of intact epithelium for at least 90 days.


Eligibility Criteria:
Inclusion Criteria:

* Corneal epithelial defect of more than 14 days that has not responded to conventional therapy

Exclusion Criteria:

* Under age 18
* Pregnant/lactating females
* Patients with hemoglobin levels \< 12 mg/ml
* Patients with limbal stem cell deficiency
Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study

Patients with bilateral heterogeneous pulmonary emphysema benefit to differing degrees from unilateral ELVR with complete lobe closure in comparison with incomplete bilateral treatment.

Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 20 patients with bilateral heterogeneous pulmonary emphysema. All patients will undergo treatment at one study centre in Heidelberg. Patients will be considered for both unilateral and bilateral treatment with intrabronchial valves (IBV) on the basis of their emphysema distribution. Patients will be randomised to two treatment arms. 10 patients receive unilateral or bilateral treatment in each case.

Eligibility Criteria:
Inclusion Criteria:

* age \> 40 inhomogeneous emphysema FEV1 between 20-40% DLCO between 20-40% 6MWT \> 150 m

Exclusion Criteria:

* pregnant homogeneous disease FEV1 \< 20%
A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection

To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test using known anti-HCV seropositive and seronegative specimens.

Registration for license application

To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test using known anti-HCV seropositive and seronegative specimens.

To evaluate the effect and applicability of different sample types on RIBA test results through the tests of the investigational product on serum and plasma collected from the same donors.

The specimens with HAV IgG positive, or HBsAg positive, or HEV IgG positive, or anti-HIV positive will be collected and tested for potential interference in the investigational product when used for testing the specimens infected by viruses other than HCV.

This clinical trial is for registration purpose, the study data will be submitted to Regulatory Authority (SFDA) for license application for CHIRON®RIBA®HCV 3.0 SIA reagent.

Eligibility Criteria:
Inclusion Criteria:

* Residual serum or plasma specimens after routine clinical testing; fresh specimens or frozen specimens stored at -20°C or lower within 2 years after collection, with sufficient volume (≥0.5 mL) to complete all the study tests ; 2) Residual serum or plasma specimen is acceptable; matched serum and plasma with EDTA, heparin or citrate used as the anticoagulant. The collection and preparation of the specimens should comply with the standard laboratory operation procedures and the instruction for use (IFU).

Exclusion Criteria:

* Severely hemolytic or turbid specimens; 2) Bacterial contaminated specimens; 3) Specimens that are improperly collected, prepared, or stored or not in accordance with package insert instructions.

Elimination criteria:

1. Errors arising during testing in which the specimen cannot be repeated shall be excluded;
2. Test results that do not pass routine quality control will not be used
3. Any specimen in which the case report form has incomplete data, or the case report form is missing the principal investigator's signature will not be used in the study. Case report forms with missing data will have an explanation for the missing data and should be signed by the principal investigator.
4. Use of unqualified reagents for specimen testing.