cyrilzakka/clinical-trials huggingface dataset:
An Efficacy and Safety Study of Low-dose Transdermal Therapeutic System (TTS)-Fentanyl D-Trans in Taiwan Participants With Cancer Pain

The purpose of this study is to evaluate safety/tolerability and clinical utility of low-dose transdermal therapeutic system (TTS \[medicated adhesive pad that is placed on the skin to deliver a timed-release dose of medication through the skin into the bloodstream\]) - fentanyl in Taiwan participants with cancer pain. Secondly, to demonstrate the dropout rate that will be decreased by initiating therapy with12 microgram per hour (mcg/hr) instead of with 25 mcg/h.

This is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), single-arm, non-randomized study to evaluate the efficacy and safety of low-dose TTS-fentanyl in Taiwan participants with cancer pain. Eligible participants will be enrolled and scheduled to return at Day 0, 7, 14 and 28. Participants will receive TTS-fentanyl for 28 days at a starting dose of 12 micrograms per hour (mcg/h) (one patch). Dose of fentanyl can increased or decreased as per Investigator's discretion to maintain participant's pain score at 2 or less on the Brief Pain Inventory (BPI) question 6 (that tells how much pain you have right now). Safety will primarily be evaluated by measuring participant's dropout rate due to adverse events. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with cancer; histologically (examination of tissue specimens under a microscope) confirmed malignancy (term for diseases in which abnormal cells divide without control and can invade nearby tissues)
* Participants who are able to communicate effectively with study personnel
* Participants who have intolerable cancer pain (pain score greater than or equal to \[\>=\] 4)
* Participants who have an estimated life expectancy of at least 30 days
* Participants who have given written dated informed consent to participate in the study

Exclusion Criteria:

* Participants who have already received regular treatment with an strong opioid (morphine-like synthetic narcotic that produces the same effects as drugs derived from the opium poppy \[opiates\]), for their pain before entering the study
* Participants who have already received tramadol (a narcotic-like pain reliever used to treat moderate to severe pain) treatment over 200 milligram (mg) for their pain before entering the study
* Participants with significant abnormalities in hepatic or renal function which would, in the opinion of the Investigator, prevent the participants involvement in the study
* Participants with significant clinical abnormalities in central nervous system (CNS), respiratory or cardiovascular function, which in the investigators judgment prevents participation in the study
* Pregnant or lactating females or females of child bearing potential not currently practicing documented, adequate contraception
Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Cisplatin Contained Chemotherapy in NSCLC Patients

Evaluate the efficacy and safety of Monosialoganglioside(GM1) to prevent the neurotoxicity induced by cisplatin

NSCLC patients received a cisplatin-based doublet chemotherapy are included in this trial. Patients are randomly assigned into the experimental group and control group based on segmented block randomized method. After enrollment, patients should complete four or six chemotherapy and GM1/placebo injection. During the 3w per cycle chemotherapy, cisplatin injection is conducted in D1/D1-3, GM1/placebo (80mg+250ml N.S) is injected from D0 to D3. Neurotoxicity evaluation and quality of life (FACT-NTX and EROTC scale) assessment will be conducted every cycle and 3w/11w/19w after the chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Cytological and histological confirmation of non-small cell lung cancer (NSCLC) diagnosis, single sputum cytology diagnosis is not accepted
* Expected survival period is more than 3 months
* Enough blood function reservation: absolute neutrophil count (ANC) 2 x 10E9/L or higher;platelet count 100 x 109 /L or higher;hemoglobin 9 g/dL or higher.
* Enough liver function reservation:the total bilirubin less than upper limit of normal;AST and ALT acuities were less than 2.5 times the upper limit of normal (ULN);Alkaline phosphatase 5 times the upper limit of normal (ULN) or less.
* Clinical doctors identify patients suitable for standard doses of ganglioside drug therapy, and expected time of medication is at least six weeks
* Within 4 weeks before treatment, did not receive other adverse reaction of drugs may cause similar neurotoxicity; 18 weeks before, did not received platinum-based drugs chemical treatment.
* No more than 1 degree of the peripheral nervous system diseases exists before enrollment, also no other symptom or disease could affect the adverse reactions of neurotoxicity pathological.
* Can't accept other adverse reactions may prevent neurotoxicity treatment or care after enrollment.
* Sign the informed consent form.

Exclusion Criteria:

* Patients with poor general condition, PS score more than 2 points
* Women in pregnancy or lactation
* Patients (male or female) have fertility possibility but not willing to or not to adopt effective contraception
* With other neurological dysfunction which can cause inaccurate record of the occurrence of neurotoxicity and severity
* Known or assignment of any of these products to test drugs allergic agent composition
* Doctors think inappropriate for patients with ganglioside medication or estimated time of less than 6 weeks
* Active infection (determined by the researcher)
* According to the researcher's judgment, there is serious disease to endanger the safety of patients, or may prevent the patients from completing the study
* Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia
The Parietal Peritoneum as a Substitute Graft for Venous Reconstruction in HPB Surgery

To evaluate the safety and outcome of the parietal peritoneum for venous reconstruction HPB surgery. Although the parietal peritoneum had already been used and published for the reconstruction of the vena cava, however this one was never described or described in HPB surgery

Improvements in surgical techniques, perioperative management and effective chemotherapy regimens, have increased the resectability of malignant hepatobiliary and pancreatic tumors when associated with vascular invasion. Therefore, simultaneous vascular resection is increasingly required to obtain an adequate resection margin and improve patient definite survival. Although most vascular resection associated with pancreatectomy can be reconstructed by simple venorraphy or end-to-end anastomosis, a segmental or lateral vacular graft (VG) can be necessary in 8-12 % of cases. Vascular reconstruction can be planned preoperatively if the vascular invasion is evident and an appropriate VG can be prepared. Differents sources of VG are available including autogenous veins , synthetic such as polytetrafluoroethylene (PTFE) , cryopreserved and veins from the resected liver. However the decision to perform vascular resection may be made during dissection due to vascular invasion or injury and even occasionnally taken while the mesentericoportal vein (MPV) or vena cava (VC) are occluded. In this emergency situation, an urgent and easily available graft is necessary to prevent prolonged ischemia. The difficulty of anticipating the need for these vascular resections during HPB surgery, has lead certain authors including those in our group to use either the veins from the resected liver, the umbilical vein or the parietal peritoneum (PP) for vena cava reconstruction. The aim of our study is to evaluate the safety and outcome of the parietal peritoneum as a substitute patch for venous reconstruction during HPB surgery in emergency and elective situations.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to HPB unit and schudeled for major liver or pancreatic resections with suspected venous invasion. Venous invasion is suspected on CT scan (vein narrowing or disappearance of the fat plane between the vein and the tumor) performed within 1 month of surgical resection. Informed consent will be obtained and the parietal peritoneum will be used as a substitute graft for resection-reconstruction in these patients if intra-operative exploration confirmed this venous invasion

Exclusion Criteria:

* Patients who refuse to participate and patients with suspected peritoneal carcinomatosis or if intra-operative exploration confirmed the presence of peritoneal carcinomatosis
Perioperative Intravenous Lidocaine in Liver Surgery

This is a randomized double blinded placebo-controlled study, conducted in Lund, Sweden. Patients will be randomized in two groups, with a ratio of 1:1. The experimental arm will receive intravenous Lidocaine perioperatively, and the Control arm will receive placebo, i.e. normal Saline. Postoperative both arms will get routine pain Control with PCA, Patient Controlled Analgesia with an intravenous Oxycodone-infusion. Outcome-measures will include patients pain intensity scoring, and opioid consumption.

Patientes will be randozied in blocks of eight.

The experimental arm will receive a bolus of 1,5mg/kg before induction of anesthesia, immediately followed by an infusion of 1,5mg/kg/h until 1 hour post surgery. The placebo arm will receive the same amount of normal Saline instead. Pain intensity scoring, measured by Numerical Rating Scale, NRS, will be conducted at 1, 2, 4 hour postoperatively, and each morning and night until discharge, or for a maximum 5 Days.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 yy
* Patient planned for minor hepatectomy
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Cirrosis
* ASA\>3
* Elevated liver enzymes
* AV-block \>1, without pacemaker
* WHO class \>2
* Allergy against Lidocain or other amid-type local anasthesia
* Heart failure
* Epilepsy
* Treatment with class III anti-arythimic medication
* Preoperative ongoing opioid usage
* Use of : Erythromycin, clarithromycin, Fluvoxamine, Cimetidine, ciprofloxacin, antivirala-HIV-läkemedel or imidazol the week before surgery.
Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair

The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life, recovery from surgery and frequency of recurrencies in the three groups


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years
* unilateral primary hernia
* open surgery

Exclusion Criteria:

* Recurrent Hernia
* Bilateral Hernia
* laparoscopic surgery
* Female
A Phase I Pharmacologic Study of CYC116, an Oral Aurora Kinase Inhibitor, in Patients With Advanced Solid Tumors

This is a phase I study of an investigational cancer drug, CYC116, in patients with advanced solid tumors.

Phase I study of an investigational cancer drug, CYC116, an Aurora kinase inhibitor, in patients with advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Incurable advanced solid tumors that did not respond to conventional therapy or for which no effective therapy exists
* Age \>=18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy ≥ 3 months
* Evaluable disease
* Adequate bone marrow function
* Adequate renal function
* Adequate liver function
* At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
* Able to swallow capsules
* At least 3 weeks from major surgery
* Agree to practice effective contraception

Exclusion Criteria:

* Previously untreated CNS metastasis or progressive CNS metastasis documented by MRI scan performed at 4 weeks or longer after the last treatment for CNS metastasis
* Currently receiving radiotherapy, biological therapy, or any other investigational agents
* Uncontrolled intercurrent illness
* Pregnant or lactating women
* Known to be HIV-positive
* Known active hepatitis B and/or hepatitis C infection
The Effect of Exercise by Mechanical Hippotherapy Device on Postural Stability and Balance in Stroke

Stroke,one of the leading cause of death, is caused by ischemia or hemorrhage. It results in neurological deficits such as hemiplegia. Hemiplegia show disability characterized loss of motor, sensory and cognitive function. Reduced postural control and balance stability results gait disturbances such as asymmetric weight bearing, risk of falling and imbalances. It also shows increased energy expenditure, decreased independence on quality of life and limited mobility. Physical therapy can be effective method for solving these problems. Hippotherapy, also known as horseback riding therapy, is a form of physical therapy strategy that uses equine movement. The concept of hippotherapy is to use a horse as a therapeutic tool, and it is based on similarities in gait between the human and horse. The horse's gait provides patients having motor disabilities with rhythmic and repetitive movements similar to human walking, thereby giving them training opportunities to improve posture, balance, and strength. Even though it has many effect on solving these problems, hippotherapy centers are not enough. Due to climate and environmental situations, hippotherapy devices were improved and had similar effects on patients with stroke. In literature, these device mostly used on cerebral palsy, but investigator wants to use hippotherapy device on patient with Hemiplegia. For these reasons, the effects of exercises by mechanical hippotherapy device on postural control and balance will be investigated.

Investigator will randomly allocate 30 patients with hemiplegia to two groups; Control group (n=15), experimental group(n=15).The control group will receive conventional rehabilitation for 45 min/day, following by postural control exercises 15 min/day 5 times/week for 4 weeks, while the experimental group receive conventional rehabilitation for 45 min/day following by use of a hippotherapy device for 15 min/day, 5 times/week for 4 weeks. Assessment procedure will be held at the beginning and 4th week of study. Assessment procedure will be held at the beginning and 4th week of study. All subjects will be assessed by berg balance scale and BIODEX primarily while Timed up and go test, SF-36, Functional reach test, functional independence measurement(FIM), Trunk Impairment Scale (TIS), Trunk Control Test (TCT), motricity index, Fugl-meyer will be held secondarily.

Eligibility Criteria:
Inclusion Criteria:

* Mini Mental Test score more than 24
* Ability to stand and sit independently
* Ability to follow and understand verbal instructions.

Exclusion criteria:

* Musculoskeletal problems
* Neurologic deficits such as unilateral neglect, hemianopsia, and apraxia
4D-150 in Patients with Neovascular (Wet) Age-Related Macular Degeneration

Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment

This Phase 1/2 trial is a prospective, multicenter, Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment who have demonstrated a clinical response consistent with anti-VEGF activity. The trial consists of Dose Escalation, Dose Expansion, Steroid Optimization and Population Extension Cohorts.

After receiving one time administration of 4D-150 by intravitreal injection, subjects will undergo assessments at monthly intervals for 24 months to assess safety and efficacy outcomes. Only subjects that received 4D-150 will then enter a long-term follow-up (LTFU) period to assess long-term safety of 4D-150 gene therapy and duration of clinical activity through year 5 (60 months).

Eligibility Criteria:
Inclusion Criteria:

* ≥50 years of age
* Diagnosed with macular CNV secondary to AMD
* BCVA ETDRS Snellen equivalent for dose escalation between \~20/32 and \~20/320, or for dose expansion and population extension between \~20/25 and\~20/200, for steroid optimization between \~20/25 and \~20/640
* Currently receiving anti-VEGF treatment in the study eye and has demonstrated a clinical response consistent with anti-VEGF activity within 12 months prior to screening

Exclusion Criteria:

* Any condition preventing visual acuity improvement in the study eye
* Prior treatment with photodynamic therapy or retinal laser in the study eye
* History of uveitis in either eye
* Any other pre-existing eye conditions or surgical complications that would preclude participation in an interventional clinical trial or interfere with the interpretation of study endpoints
Immediate vs Delayed Placement of Straumann BLX Implants in Molar Extraction Sockets

The aim of this study is to clinically and radiographically compare the success and survival of implants immediately placed in molar fresh extraction socket to delayed implant placement at least 12 weeks post molar extraction. The secondary aim is to evaluate the peri-implant tissue response around implants with immediate vs. delayed placement.

Study Population To be included in the study, the subjects must be 22 years of age or older and in good general health. They must have at least one nonrestorable more indicated for extraction and immediate or delayed implant placement. Subjects who are unable to undergo oral surgery procedures, smokers, and women who are (or become) pregnant (or are breastfeeding) will be excluded from this study. Additionally, subjects with bone infections or compromised health that may affect the ability of the patients' tissues to heal (e.g., uncontrolled diabetes, bisphosphonate use, current glucocorticoid use) will not be included in this clinical study.

15 implants in each group are necessary to provide 90% power with a type I error of 0.05. Each subject will be randomly assigned into one of two treatment groups:

Test Group (n=15):

The test group will receive immediate molar implant placement in fresh extraction socket with nonocclusal loading immediate provisionalization (Straumann BLX 6.5mm).

Control Group (n=15):

The control group will receive delayed molar implant placement at least 12 weeks post molar extraction with nonocclusal loading immediate provisionalization (Straumann BLX 5.0mm).

Subject Recruitment Methods and Privacy:

Subjects who seek implant treatment in University of Kentucky, College of Dentistry clinics. Implant clinics is referral base clinic. Once a subject is referred to extract a nonrestorable molar tooth and be replaced with an implant, potential subjects will be informed with the study. If subjects decide to be part of the study, informed consent will be signed prior to screening visit.

Informed Consent Process:

The research study will be conducted at the facilities of University of Kentucky, College of Dentistry after approval by the Institutional Review Board. All members of the research team received training in human subject protection. After each patient has been given verbal and written information describing the nature of the study, informed consent will be obtained before he or she can enter the study. A copy of the consent form will be given to the patient and another retained by the investigator. Patients will not be screened until an informed consent has been obtained.

Eligibility Criteria:
Inclusion Criteria:

* 22 years of age or older
* good general health.
* at least one nonrestorable more indicated for extraction and immediate or delayed implant placement

Exclusion Criteria:

* undergo oral surgery procedures
* smokers
* women who are (or become) pregnant (or are breastfeeding)
* subjects with bone infections or compromised health that may affect the ability of the patients' tissues to heal (e.g., uncontrolled diabetes, bisphosphonate use, current glucocorticoid use)
EEG Monitoring in the Emergency Department

This study seeks to investigate whether drug effects in suspected overdose patients could be identified using the electroencephalogram (EEG). From previous work it is known that different classes of anesthetic drugs have specific "EEG signatures" related to the drug mechanisms. Many of the drugs of abuse that are frequently encountered in overdose patients are similar or identical to anesthetic drugs. The hypothesis for this study is that the EEG could be used to characterize the brain effects of intoxicants using EEG in the ED setting. Such monitoring could one day help clinicians and first responders at the point-of-care make more informed decisions to improve the care of overdose patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years and older who present to the ED with suspected use of a potential drug of abuse

Exclusion Criteria:

* Hemodynamic instability or other acute medical condition for which the primary treating team does not thing it would be appropriate or safe for the study staff to approach the patient
* The patient has an overt head trauma or deformity of the face which would preclude application of the forehead EEG monitoring lead
* The patient has dermatological issues or skin conditions on the forehead
* The patient has known dementia and/or mental impairment
* The patient is a prisoner
* The patient is an employee or student at one of the study sites.
Intravenous Immunoglobulins for Post-Polio Syndrome

Postpolio syndrome is a condition that affects many polio survivors years after the acute infection and causes symptoms to increase or new symptoms to develop. Proinflammatory cytokine production within the central nervous system (CNS) indicates an underlying inflammatory process, amenable to immunomodulatory therapy. In this study the investigators sought to confirm that antiinflammatory treatment with intravenous immunoglobulin improves the disease.


Eligibility Criteria:
Inclusion Criteria:

* a history of acute poliomyelitis
* increased muscle weakness, muscle fatigue and pain in muscle groups previously affected by poliomyelitis
* a diagnosis of postpolio syndrome according to the criteria of Halstead and Rossi

Exclusion Criteria:

* clinically relevant systemic disease
* malignancy
* hypothyroidism
* diabetes mellitus not fully controlled by medical therapy
* medical or orthopedic disorders that could give rise to symptoms mimicking post-polio syndrome
* conditions associated with prolonged coagulation time
* serum IgA deficiency
* previous allergic reaction to IVIG
* body-mass index greater than 30
* immune-modulating treatments other than IVIG within the preceding 6 months