cyrilzakka/clinical-trials huggingface dataset:
Vasomotor Symptom Alleviation Through Acupuncture in Patients With Prostate Cancer

A pilot study to assess the acceptability and efficacy of acupuncture in alleviating vasomotor symptoms (hot flushes and night sweats) in Irish patients with prostate cancer receiving androgen deprivation therapy.


Eligibility Criteria:
Inclusion Criteria:

* All participants must have a histologically confirmed diagnosis of prostate cancer and currently be treated with androgen deprivation therapy with or without additional prostate cancer therapies.
* Patients under the care of a Medical Oncologist in either Bons Secours Hospital or Cork University Hospital
* All participants must be experiencing moderate to severe vasomotor symptoms as defined by a score of 4 or more on the Hot Flash Index.

Exclusion Criteria:

* Patients under 18.
* Patients with HFI scores below 4.
* Patients not currently being treated with androgen deprivation therapy.
* Patients with contraindications to acupuncture.
* Patients already receiving acupuncture for vasomotor symptoms.
* Patients unwilling to participate in the study.
IPM Procedures With or Without Fluoroscopy: Outcome Comparison

To determine clinically significant improvement in the patients undergoing procedures under fluoroscopy.

To evaluate and compare the adverse event profile in both groups

For the target delivery of injectate, it is believed that fluoroscopy is mandatory. However, there is a view among some professionals that a procedure may be performed without fluoroscopy as effectively as under fluoroscopy. The outcomes among the two groups of patients have not been studied

Eligibility Criteria:
Inclusion Criteria:

Patients who have undergone the following procedures:

Cervical facet joint nerve blocks, thoracic facet joint nerve blocks, lumbar facet joint nerve blocks, lumbar interlaminar epidural steroid injections, cervical Interlaminar epidural steroid injections

During 1998 to 2001 and 2004 to 2005

-

Exclusion Criteria: Non-availability of appropriate data
Proof of Mechanism in ELT

The purpose of this study is to determine if the administration of GSK958108 can delay ejaculation in patients with primary premature ejaculation as measured by the ejaculatory latency time (ELT) using the masturbation model and sexual visual stimulation, and to evaluate the safety and tolerability of GSK958108 in healthy men with PE


Eligibility Criteria:
Inclusion Criteria:

* Heterosexual male subject with self-reported moderate or severe primary Premature ejaculation with ejaculation occurring on or before penetration, or shortly there after with minimal stimulation
* Baseline Ejaculation Latency time \< 3 minutes
* Subjects must agree to use a contraception methods as per protocol
* Body weight \> or = 50 kg and Body Mass Index within the range 19.0-29.9 Kg/m2
* Subject with normal visual acuity (with appropriate correction if needed)
* Subject able to cooperate in all study procedure including the eye examination with use of mydriatics

Exclusion Criteria:

* Erectile dysfunction
* History of migraine
* Current clinically relevant abnormality
* History of psychiatric illness or suicidal attempts or behaviours
* History of any eye disorder or colour blind, excluding myopia and presbyopia
* Cardiac conduction disorder or other clinically significant cardiac disease
* Positive at pre-study drug/alcohol screen and to Hepatitis or HIV tests
* Regular consumption of alcohol
* History of sensitivity or intolerance to drugs
* Consumption of red wine, seville oranges, grapefruit or grapefruit juice \[and/or pummelos, exotic citrus fruits, grapefruit hybrids\] from 7 days prior to the first dose of study medication
* Subject has received or is continuing to receive any treatment for premature ejaculation in the four weeks prior to the study start
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements prior to the first dose of study medication
* Participation in another clinical trial in the previous month
* Exposure to more than four new experimental drugs within the previous 12 months
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Unwillingness or inability to follow the procedures outlined in the protocol.
Intubation Assist Clinical Study

The Intubation Assist Clinical Study is an observational study of adult patients scheduled for elective surgery under general anesthesia to assess the user interface, assess transthoracic impedance by the ventilation volume and assess transthoracic impedance. Monitoring will begin at the time the patient is pre-oxygenated in preparation for endotracheal intubation and will continue until 30 minutes after intubation is achieved.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Requiring intubation and assisted ventilation
* Patient undergoing elective surgery
* Able to give informed consent

Exclusion Criteria:

* Skin condition that would interfere with electrodes
* Inability/failure to intubate
* Pregnancy
* Surgery that prevents the application of electrodes and monitoring equipment.
* Previous excision of complete or partial lung; congenital lung abnormalities.
Tapentadol vs Tramadol in Total Knee Arthroplasty

Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Total Knee Replacement (TKR).

As the population ages and becomes more active, the demand for TKR surgery is expected to increase. However, the treatment of TKR pain remains a challenge.

Postoperative pain is associated with longer hospital stays, lower satisfaction, increased opioid consumption, and transition to chronic pain. In TKR, the risk of chronic pain can be as high as 20%.

A suggested method of anesthesia and pain relief is the use of spinal anesthesia along with multimodal analgesia that includes an adductor canal block.

In our hospital, the multimodal analgesia protocol consists of intraoperative sedation with dexmedetomidine, a low dose of ketamine, paracetamol, NSAIDs, and magnesium. Dexamethasone and droperidol are preferred as antiemetics as they can improve the analgesic outcome.

To minimize the use of opioids, the administration of tramadol used to be the standard of care. Tapentadol is an opioid that can be equally effective in the treatment of postoperative pain and reduces the incidence of chronic pain after TKR.

Eligibility Criteria:
Inclusion Criteria:

* Patients for elective TKR
* ASA PS I - III

Exclusion Criteria:

* Patient refusal
* Cognitive disfunction
* Severe psychiatric disease
* Under medication with MAO inhibitors, tricyclic antidepressants, serotonin reuptake inhibitors
* Not speaking Greek
* Known allergy to the study drugs
* Contraindications for any of the study drugs
* Chronic renal failure (GFR \< 50 ml/h)
* Liver failure
* Known regular use or misuse of opioids
* Pregnant women
* Patients undergoing general anesthesia
Laterally Rotated Flap for Soft Tissue Augmentation Around Maxillary Loaded Osseointegrated Dental Implant

Peri-implant mucositis is one of the most common peri-implant diseases. It was reported in more than 20% of the subjects rehabilitated with dental implants (Lee et al. 2017; Rodrigo et al. 2018; Wada et al. 2019). Furthermore, a significant association was found between peri-implant mucositis, and smoking, implant maintenance and peri-implant soft tissue characteristics (Wada et al. 2019).

Soft tissue quality and volume of the peri-implant mucosa are considered important factors in the prognosis of osseointegrated implants. Linkevicius et al. showed that if its soft tissue thickness was less than 2 mm, crestal bone loss might occur (Linkevicius et al. 2009). In addition, when soft tissue width was evaluated, a wider soft tissue band was related to minimal bone remodeling (Linkevicius et al. 2015). Lin et al. reported in a systematic review and meta-analysis that a lack of keratinized tissue (KT) around osseintegrated implants was associated with plaque accumulation, peri-implant tissue inflammation, soft tissue recession and attachment loss (Lin et al. 2013). Moreover, recent studies established the need of a minimal band of 2 mm of KT around osseointegrated implants, and showed that a band less than 2 mm was associated with more brushing discomfort, plaque accumulation, tissue inflammation and marginal bone apical displacement, concluding that a KT\>2 mm had a protective effect on peri-implant tissues (Souza et al. 2015, Perussolo et al. 2018, Monje et al. 2019). Furthermore, peri-implant tissue diseases have also been related to an irregular compliance in situations of lack of KT (Monje et al. 2019).

In the presence of peri-implant horizontal and/or vertical soft tissue deficiencias, soft tissue augmentation has been considered a priority, even prior or instead of bone augmentation (Burkhardt et al. 2008, Zucchelli et al. 2013).


Eligibility Criteria:
Inclusion Criteria:

implant with soft tissue recession Plaque index score less than 30% No relevant systemic disease Smokers (Less than 20 cigars/day)

Exclusion Criteria:

Pregnancy-Lactation Relevant systemic disease
A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease

The purpose of this study is to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of probable Alzheimer's disease(DSM-IV and NINCDS-ADRDA criteria)
* MRI within the last 12 months consistent with a diagnosis of AD
* MMSE score of 10 to 26 and CDR of 1 or 2
* AChEI or memantine was not taken at least 3 months prior to screening

Exclusion Criteria:

* Other central nervous disease
* Hypothyroidism, Vitamin B12/ Folic acid deficiency, Hypercalcemia, Neurosyphilis, AIDS
* T.I.A or Major infarction within the last 12 months
* Any serious disorder that could limit the ability of the patient to participate in the study
* COPD or asthma
* Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study
Carvedilol for Psychostimulant Dependence

This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine dependent participants.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old
* Cocaine dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV.
* At least weekly self-reported cocaine use during a preceding three month period
* Urine toxicology screen positive for cocaine or cocaine metabolite
* Women of childbearing age must have a negative pregnancy test, agree to adequate contraception to prevent pregnancy during the study, agree to monthly pregnancy testing and not be nursing

Exclusion Criteria:

* Suicide attempts within the past 12 months or suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician.
* Current opioid, alcohol or sedative physical dependence or amphetamine dependence.
* Major cardiovascular disorder that contraindicates study participation (e.g., history of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia, significant hypertension \[i.e., \>170 SBP or \>110 DBP\] or an unstable medical condition (e.g., untreated bacterial infection) as determined by the study physician.
* Asthma or chronic obstructive pulmonary disease.
* History of schizophrenia, or bipolar type I disorder.
* Use of medications that would be expected to have major interaction with carvedilol (e.g., rifampin, cimetidine, digoxin, diuretics).
* Medical contraindication to receiving carvedilol (e.g., diabetes, severe bradycardia, bronchial asthma or other bronchospastic condition, 2nd or 3rd degree AV block, sick sinus rhythm, severe hepatic impairment, documented hypersensitivity to carvedilol).
* Patients currently taking selective serotonin re-uptake inhibitors, antipsychotics and antidepressants (e.g., amitriptyline and imipramine).
* Liver function tests (i.e., liver enzymes) greater than three times normal levels.
* Systolic blood pressure \> 170 mmHg or \< 90 mmHg, diastolic blood pressure \> 110 mmHg or \< 60 mmHg, or heart rate of \> 110 beats/min or \< 55 beats/min. Supine blood pressure of 100/65 mm Hg or lower, a seated blood pressure of 90/60 mm Hg or lower, or an orthostatic change of \>20mm Hg systolic or 10 mm Hg diastolic on standing.
* Participants with estimated glomerular filtration rate \< 30 ml/min.
* Pregnant or nursing female.
A Study of Siliphos in Adults With Non-alcoholic Steatohepatitis (NASH)

The purpose of this study is to evaluate the dietary supplement Siliphos, which comes from milk thistle, to determine whether it is safe and well-tolerated in adults who have non-alcoholic steatohepatitis (NASH). An additional aim of this study is to determine whether Siliphos may be beneficial in treatment of NASH as indicated by improvement in liver enzymes (ALT and AST). The study hypothesis is that Siliphos will be safe and well-tolerated in people with NASH and will result in a decrease in the liver enzymes ALT and AST.

Non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of liver conditions characterized by fat accumulation in the liver. Non-alcoholic steatohepatitis (NASH) is one form of NAFLD that may progress to cirrhosis in some people. Currently, there are no medications that are approved for the treatment of NASH. Milk thistle is sold over-the-counter as a dietary supplement. Milk thistle has been used for hundreds of years as a supplement to support liver function, and is commonly taken by people with a variety of liver conditions. Milk thistle may help to reduce inflammation and fibrosis (scar tissue) in the liver, so it may be beneficial in the treatment of NASH. As NAFLD is very common in the population, there are probably many people with NAFLD taking milk thistle supplements. However, there are no published studies of milk thistle in NAFLD. Therefore, this study is designed to provide preliminary evidence of the safety, tolerability, and efficacy of milk thistle in people with NASH.

Comparison: The milk thistle supplement (called Siliphos) will be compared to a placebo (sugar pill) in this study.

Eligibility Criteria:
Inclusion Criteria:

* Liver biopsy within 12 months demonstrating NASH
* Abnormal ALT

Exclusion Criteria:

* Uncontrolled diabetes
* Hepatitis B, hepatitis C, or other chronic liver conditions
* Abnormal kidney function
* Excess alcohol consumption
Suture vs Staples for Skin Closure After Liver Resection

Closure of the skin after liver resection (surgery to remove part of the liver) may be achieved by one of several methods. The standard method at our institution is to use stainless steel staples to adjoin the two sides of skin. Alternatively, a continuous absorbable suture may be used to "sew" the skin together.

The ideal method of closure should be safe, effective, associated with minimal patient discomfort and have a good cosmetic result. At present, there is no scientific evidence to describe which method is most suitable following liver resection.

The primary aims of this study is to investigate which method (subcuticular sutures vs staples) offers the best result in postoperative rate of (1) skin infection, (2) skin dehiscience (separation of skin) and (3) time taken to perform skin closure. In addition, we are interested in which method is best for patient satisfaction and cosmetic appearance and which method is most cost effective.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing liver resection surgery for benign or malignant aetiology
* All patients undergoing surgery as a living liver donor.

Exclusion Criteria:

* Any patient with an active wound infection
* Any patient with an active incisional wound hernia from previous surgery
* Synchronous bowel/liver surgery
* History of keloid formation
Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident

This will be a prospective trial comparing the perspective gross morphological of bladder tumor assessment done by outpatient flexible cystoscopy performed by resident, inpatient rigid cystoscopy done by senior staff and their prediction of the degree of invasion of bladder tumor plus the prediction of the grade compared with the standard pathological result.

Also, assessment of the patient reported outcomes after both flexible and rigid cystoscopy will be done.

In the long run of the study, the prognostic gross morphology with recurrence, progression and cancer specific survival will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years or older
* Denovo or recurrent NMIBC
* Bladder mass discovered in hematuria investigation
* Willing to share in study

Exclusion Criteria:

* inability to cooperate with flexible cystoscopic evaluations
* cystoscopies for other kind of intervention (e.g., removal of a ureteral stent)
* Untreated infections
* Other causes of storage or voiding symptoms as untreated benign prostatic hyperplasia (BPH) or interstitial cystitis
* Unpassable urethral stricture
GDT by Cardiac Index Trending Via a Radial Arterial Line in General Surgery

This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients

This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients Clinical outcome of patients undergoing major abdominal surgery is explored in two different groups. In one group hemodynamic management is guided by the internal standard of the anesthesiological department. In the other group fluid management is goal directed by by continuous cardiac index trending via a radial arterial line and pulse pressure variation.

Eligibility Criteria:
Inclusion Criteria:

* major abdominal surgery
* duration of surgery \> 2 hours

Exclusion Criteria:

* age \< 18 years
* scheduled postoperative icu treatment
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.

PGL4001 will be administered daily to all subjects in an open-label manner with no control group. The three months open label treatment period will be followed by a ten day double blind treatment with progestin or matching placebo. Subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.
* Subject with a Body Mass Index ≥18 and ≤40.
* Subject with myomatous uterus size \< 16 weeks.
* Subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound.
* Subject complained of strong uterine bleeding.
* Subject is eligible for hysterectomy or myomectomy.
* Females of childbearing potential have to practice a non-hormonal method of contraception.

Exclusion Criteria:

* Subject has a history of or current uterus, cervix, ovarian or breast cancer.
* Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy.
* Subject has a known severe coagulation disorder.
* Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate.
* Subject has abnormal hepatic function at study entry.
Protocol for Anatomopathologic Analysis of Biopsies Using Hot Clamps

A cross-over study of the impact of histologic results of bronchial biopsies performed using hot clamps compared to bronchial biopsies using standard clamps


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Patients with no known hemorrhage risk, with an indication of endobronchial biopsy
* Patients with no contra-indication for bronchial endoscopy
* Patients with or without endobronchial tumors
* Patients who have provided written informed consent
* Patients with health insurance coverage

Exclusion Criteria:

* Refusal to be examined
* Contraindication for electrocoagulation (Pacemaker or metallic endobronchial prosthesis)
* Pregnant women
* Patients unable to provide voluntary informed consent, under (tutelage) or guardianship, or unable to come to the center
Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity

Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales

Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales

Eligibility Criteria:
Inclusion Criteria:

* CP patients with therapy-resistent spasticity
* Patients with sufficient body weight in relation to the volume
* Oral medication has failed: insufficient effect or too many side-effects
* The patient and family understand the objectives of the treatment and accept those objectives
* Informed Consent

Exclusion Criteria:

* Contra-indications for surgery (e.g. infection)
* Hypersensitivity to oral Baclofen