cyrilzakka/clinical-trials huggingface dataset:
A Study Of GW679769 Compared To Placebo In Women With Overactive Bladder

This is a Phase IIa study to evaluate the efficacy, safety and tolerability of GW679769 vs placebo on symptoms of urgency with urge incontinence, frequency and nocturia associated with overactive bladder in women.

A Twelve-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Forced Titration, Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as well as the Pharmacokinetic Profile of 60 mg and 120 mg of GW679769 administered once daily vs Placebo in Women with Overactive Bladder

Eligibility Criteria:
Inclusion Criteria:

* Female subjects with overactive bladder with symptoms of urgency with urge incontinence and frequency which may be associated with nocturia but without bladder pain.
* Must not be pregnant.
* Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
* Body weight in the range of = 45 kg and \<100 kg.

Exclusion Criteria:

* Stage III/IV pelvic organ prolapse with or without cystocele.
* History of interstitial cystitis or bladder related pain.
* Subjects with stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history.
* History of pelvic prolapse repair (cystocele or rectocele) or urethral diverticulectomy within six months of screening.
* Subjects with urinary incontinence due to causes other then detrusor over activity (e.g., overflow incontinence).
* Nocturnal enuresis only.
* Urinary retention, or other evidence of poor detrusor function.
* History of prior anti-incontinence surgery.
* History of radiation cystitis or a history of pelvic irradiation.
* Electrostimulation, biofeedback, or bladder training therapy (behavioral therapy) during the previous month prior to screening, or the intention to initiate such therapies during the study. Pessaries and implants are also excluded.
* Participated in any clinical trial of an investigation drug that may affect urinary function within 3 months of enrollment into the study.
* Received any investigational product within 30 days of enrollment into the study.
LEVITRA® 20mg Special Drug Use Investigation (Long-term)

This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.


Eligibility Criteria:
Inclusion Criteria:

* This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.
Safety and Performance Study of the NeoChord Device

The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 and \< 80 years
* Candidate for surgical mitral valve repair or replacement
* Isolated posterior leaflet prolapse
* Moderate to severe or severe mitral valve regurgitation that is degenerative in nature

Exclusion Criteria:

* Anterior or bi-leaflet prolapse
* Functional or ischemic MR
* NYHA Class IV
* Complex mechanism of MR (leaflet perforation, etc)
* Significant tethering of leaflets toward LV apex
* Severely calcified mitral valve annulus
* Inflammatory valve disease
* Severe LV dilation
Observational Study on Changing the Quality of Life in Daily Life Activities After Clinical Approach Positioning the Wheelchair

Stemming from the common practice of attribution of the technical helps in the posture in Canada, the multidisciplinary approach of positioning develops in France for more than 10 years old.

To date, no observatory study was led to estimate the impact of such consultation in daily activities, an essential objective conditioning the observance and the acceptance of assistive devices. This study wants to estimate the impact through modification of WHOM scale.


Eligibility Criteria:
Inclusion Criteria:

* persons which are in wheelchair since more than 6 months,
* no recent medical decompensation (\<1 mois)

Exclusion Criteria:

* recent medical decompensation
Comparison of Aripiprazole Versus Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI

The purpose of this study is to compare abdominal weight gain and fat distribution in people taking aripiprazole versus risperidone or quetiapine, to people not taking any of these antipsychotic medications.

Second generation antipsychotic drugs have much greater efficacy for refractory schizophrenia and have much lower propensity to induce motor side-effects. These medications are seeing increased use for indications other than psychosis, and greater use in populations such as adolescents. However, one of the most critical issues in the field of psychiatry today is the overwhelming evidence that chronic use of the second generation antipsychotics can result in metabolic dysregulation, which includes weight gain, hyperlipidemia, and insulin resistance. A recent meta-analysis indicated that switching from other second generation antipsychotics to the antipsychotic drug aripiprazole consistently resulted in significant weight loss and may be an optimal treatment for patients who exhibit drug-induced weight gain. Therefore, we aim to compare metabolic dysregulation (namely abdominal weight gain and fat distribution)in participants taking aripiprazole, to participants who are taking higher-metabolic propensity antipsychotic drugs (such as risperidone or quetiapine), and to healthy participants.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 12+ years for healthy participants or participants with bipolar disorder; or aged 15+ years for participants with non-affective psychosis.
* Recent admission to hospital for psychiatric services related to first-episode psychosis or first-episode bipolar disorder.
* Participants being treated with an antipsychotic medication principally for psychosis or for bipolar disorder.
* Participants taking aripiprazole must be taking a dose of at least 10mg/day for the duration of the study.
* Participants must have received no more than 12 weeks of total lifetime exposure to antipsychotics.
* Participants may be in- or outpatients.
* Participants able to give informed consent, or informed consent through legally authorized representative.

Exclusion Criteria:

* Previous total lifetime exposure to antipsychotics of more than 12 weeks.
* Previously diagnosed with diabetes mellitus, seizure disorders, mental retardation (IQ \< 70), or pregnancy (current or within 3 months postpartum).
* Participants who have been treated/are currently being treated with mood stabilizers (paroxetine, lithium, or valproic acid). Prior or concurrent use of Selective Serotonin Reuptake Inhibitor antidepressants (other than paroxetine) is acceptable.
* Received chemotherapy for cancer treatment in the 4 weeks prior to baseline or 16-week follow-up visit.
* Participants who are not able to fluently communicate in English.
* Contraindicated for MRI scan (i.e., has had major surgery in the last 6 months, morbid obesity, claustrophobia, and/or has metal in their bodies from a surgical intervention or working in metalwork, or is unsure if metal is present in their bodies, etc.).
Effect of Untact Upper Extremity Rehabilitation Using Smart Glove for Late Subacute and Chronic Patients with Brain Disorder

The aim is to clinically validate the clinical efficacy, usability, and safety of home-based upper limb rehabilitation training using the Neofect Smart Glove by comparing the effects between a group using the home-based Neofect Smart Glove and a group performing conventional home-based occupational therapy in patients with upper limb dysfunction in the late subacute and chronic stages of neurological diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patients with brain disorder aged 19 to 85 years old
* patients with hemiparesis lasting for more than 3 months due to neurological diseases (stroke, traumatic brain injury, brain tumor) and impaired upper limb function
* Patients with spasticity of the wrist and finger flexors and extensors on the affected side, with a Modified Ashworth Scale (MAS) score of 1+ or lower
* Participants with sufficient cognitive function to understand the instructions from the researcher and the smart glove, and to perform the tasks (K-MMSE ≥21)

Exclusion Criteria:

* pre-existing significant neurogenic disorders
* major psychiatric disorders such as schizophrenia, bipolar disorder, or dementia
* History of diseases that caused pain or muscle atrophy in the affected upper limb before the onset of the neurological disease, which interfered with rehabilitation
* Severe spasticity of the affected upper limb (Modified Ashworth Scale score ≥3)
* skin disorders or open wounds on the affected upper limb
* Amputation, fractures, or soft tissue-related diseases or injuries on the affected upper limb
* severe pain that interferes with rehabilitation of the affected upper limb (Numeric Rating Scale \> 6)
* Inability to maintain a seated posture for more than 10 minutes
* Significant visual impairment to the extent that the screen cannot be recognized when using the smart glove
Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of patients with confirmed candidemia or invasive candidiasis.

This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.

Eligibility Criteria:
Inclusion Criteria

* Has Candidemia or invasive candidiasis documented by typical clinical signs and symptoms and confirmed by fungal culture or histologic confirmation

Exclusion Criteria

* Has abnormal liver test parameters, e.g., AST or ALT \> 10 times upper limit of normal
* Has life expectancy judged to be less than 5 days
* De novo patients who have received a systemic antifungal agent for the treatment of this episode of candidemia or invasive candidiasis for more than 48 hours prior to the first dose of FK463; or efficacy failure patients who have received =\< 5 days of prior systemic antifungal therapy for the treatment of this episode of candidemia or invasive candidiasis
* Require treatment with topical or systemic antifungal agents for conditions other than candidemia or invasive candidiasis
Is Long-term Use of Amantadine Effective in PD?

The investigator aims to assess whether long-term use of amantadine is effective in patients with Parkinson's disease.

Amantadine is used in the early stages of Parkinson's disease (PD). However, amantadine is known to be relatively weak compared to other antiparkinsonian drugs such as levodopa, dopamine agonist or Mao-B inhibitor and its effects are limited in early months, so it is rarely used than other drugs.

Recently, several studies have identified the long-term effects of amantadine on dyskinesia, but the basis is still insufficient.

Therefore, this study aims to investigate the long-term effectiveness of amantadine in patients with PD. Participants who have used amantadine since the early stages of diagnosis undergo clinical evaluations including the Montreal Cognitive Assessment (MoCA), Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Freezing of Gait-Questionnaire (FOG-Q), Non-motor Symptom Scale (NMSS) and Parkinson's Disease Questionnaire-39 (PDQ-39). Then, participants stop taking amantadine. To investigate the long-term effect, clinical evaluations except MoCA are repetitively assessed at 4- and 8-week follow-ups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been taking amantadine since the beginning of diagnosis
2. Patients who have taken amantadine for more than five years
3. Patients with Parkinson's disease who are aged 40 years or older

Exclusion Criteria:

1. Patient who stops amantadine or is hypersensitive to amantadine
2. Patients who have undergone brain surgery, including deep brain stimulation
3. Patient identified as atypical parkinsonism
4. Patients with psychiatric conditions such as dementia, major depression or bipolar disorder who are difficult to assess
5. Patients who are currently unable to follow up at our hospital
ACB Versus IA Analgesia in Knee Arthroscopy

Reconstruction of the anterior cruciate ligament (ACL) of the knee is a painful procedure, and effective postoperative analgesia is important for early return of patient activity.

Reconstruction of the anterior cruciate ligament (ACL) of the knee is a painful procedure, with postoperative analgesia providing patient comfort, early mobilization, and discharge within 24 hours.

Various methods for postoperative analgesia management are available, such as systemic opioids, epidural local anesthetic, peripheral nerve block and local anesthetic infiltration analgesia. Use of systemic opioids can cause adverse effects that may affect functional rehabilitation, such as nausea, vomiting, pruritus, sedation and respiratory depression. Hypotension, urinary retention, and pruritus are more common in patients with epidural analgesia. In addition, use of long-acting intrathecal opioids causes adverse effects such as bilateral motor block, tremor and hypotension. Systemic and intrathecal methods for postoperative analgesia are gradually being abandoned because of these negative effects.

The saphenous nerve is the largest contributor to sensory perception around the knee, while the adductor canal contains the nerve to the vastus medialis, the medial femoral cutaneous nerve, the medial retinacular nerve, articular branches from the posterior division of the obturator nerve and occasionally the anterior branch of the obturator nerve. Although adductor canal block (ACB) can contribute towards motor blockade of the periarticular musculature, its effect on functional weakness of the quadriceps has been reported to be minimal, compared with femoral nerve block (FNB).

Intra-articular (IA) local anesthetic agents have been used either alone or in combination with other agent. However, it was observed that use of combination of drug is better than single drug for prevention of postoperative pain, providing synergistic effect and reducing side effects compared to high dose of single drug.

Dexamethasone is a potent and highly selective glucocorticoid with minimal mineralocorticoid effect. It blocks the nociceptive impulse transmission along the myelinated C fibers. Dexamethasone prolongs the duration of regional blocks, when combined with local anesthetics.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective arthroscopic reconstruction of the anterior cruciate ligament (ACL) under spinal anesthesia, aged from 18 to 65 years old

Exclusion Criteria:

* Contraindications to peripheral nerve block (e.g. allergy to local anesthetics, coagulopathy, infection in the area)
* History of cardiovascular, cerebrovascular, and respiratory diseases
* Preexisting neuropathies
* Chronic pain syndrome
* Opioid dependence
* Patients with diabetes mellitus, sever hypertension, hepatic or renal dysfunction
* Pregnancy
* Not willingness to participate.
The Role of Salivary Alpha Amylase in Sepsis

Critical illness may be induced by different underlying life-threatening diseases, such as infection, sepsis, trauma, respiratory insufficiency or hypoxia and severe neurological status. The associated endocrine, nervous, metabolic and immunological changes are defined as acute stress syndrome. Salivary alpha-amylase is secreted from the salivary glands mainly in response to beta-adrenergic stimuli. Salivary alpha-amylase (sAA) has gained rapid popularity as a non-invasive marker of sympathetic nervous system (SNS) activity.

Critical illness may be induced by different underlying life-threatening diseases, such as infection, sepsis, trauma, respiratory insufficiency or hypoxia and severe neurological status. The associated endocrine, nervous, metabolic and immunological changes are defined as acute stress syndrome.

Although sepsis is one of the oldest syndromes in medicine, it is a challenging healthcare problem even nowadays. In spite of the era of modern an¬tibiotics and intensive therapy sepsis is still one of the leading causes of morbidity and mortality.

Based on the novel results and advances of pathobiology, management and epidemiology of sepsis, the definitions of the syndrome have been changed recently. Sepsis-3 consensus de¬fines sepsis as a life-threatening organ dysfunc¬tion caused by a dysregulated host response to infection.

The diagnosis of sepsis is most often not easy especially in newborns or in patients whose im¬mune response is not adequate. Therefore, it is of most importance to introduce diagnostic biomarkers which can predict or verify systemic inflammation as early as possible. These tests should also be applicable for monitoring of the disease progression and efficacy of therapy as well.

Salivary alpha-amylase is secreted from the salivary glands mainly in response to beta-adrenergic stimuli.

Salivary alpha-amylase (sAA) has gained rapid popularity as a non-invasive marker of sympathetic nervous system (SNS) activity. sAA is a digestive enzyme that breaks down starch into glucose and maltose, and enzymatic activity (in Units/ml) is used as a proxy for sAA concentration.

The use of salivary alpha amylase as a marker of sympathetic activity seems justified. Salivary alpha amylase release from the salivary glands is under strong control of local sympathetic nerves. Its salivary concentration rapidly increases during acute stress, and its use as a marker of sympathetic activation is also validated by pharmacological studies.

Eligibility Criteria:
Inclusion Criteria:

* The newly diagnosed patients with sepsis according to Sepsis-3 consensus definition using SOFA score
* The newly diagnosed patients with septic shock according to Sepsis-3 consensus definition using SOFA score
* aged more than 18 years old.

Exclusion Criteria:

* Evidence of an immunocompromised as malignancy,
* received corticosteroids,
* recieved chemotherapy,
* recieved radiotherapy
* recieved cytotoxic drugs
* advanced hepatic disease
* renal disease
* pregnancy.
SuperSeton Pilot Studie

Rationale: Perianal fistulas are a common incapacitating problem. Many patients are treated by seton drainage to prevent recurrent abscess formation. Nowadays, vessel loops or sutures are used for drainage. The knot of these seton drains can cause complaints of pain or tenderness if it presses against the external opening of the fistula or even slides in to the fistula tract. Medishield B.V. designed a knotless seton drain, the SuperSeton. This could decrease the pain complaints caused by the knot.

Objective: The aim of this study is to determine the feasibility of SuperSeton placement in patients with perianal fistulas.

Study design: The design of the study is a feasibility study.

Study population: Patients (≥ 18 years) with perianal fistulas (ever) treated with a knotted seton are eligible.

Intervention: The SuperSeton will be placed at the outpatient clinic in patients that already have a seton in situ. This seton will then be exchanged by the SuperSeton. In case patients do not have a seton in situ, the SuperSeton can be placed at the operating theatre in day care setting instead of a regular seton.

Main study parameters/endpoints: The primary outcome is seton failure (loosening of the seton). Secondary outcomes are time of procedure, complications and quality of life measured by the PDAI ('Perianal Disease Activity Index').

Nature and extent of the burden and risks associated with participation: The SuperSeton will be placed in patients with perianal fistulas (ever) treated with a conventional knotted seton. There are no additional risks involved. The seton will be placed at the outpatient clinic in patients with a seton in situ, or at the operating theatre in day care setting in patients with a perianal abscess without a seton. The material that is used for the Setons is of medical grade polyurethane, this is the same material of catheters that are already used in clinical practice (instech BTPU 027). The Setons including the insert (BTPU) are supplied sterile (Synergy Health). Sample size calculation: A group of 60 patients will be included to determine feasibility of the SuperSeton. The proposed treatment protocol is considered feasible if at least 70% of the SuperSetons stay in place.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Written informed consent
* Perianal fistula with a seton in situ or a recurrent perianal fistula for which a new seton will be placed

Exclusion Criteria:

* Patients with a pacemaker or an ICD in situ
* Rectovaginal fistula
* Patients with a stoma
* Life expectancy \< 2 years
* The inability of reading/understanding and filling in the questionnaires
* Dementia or altered mental status that would prohibit the understanding and giving of informed consent
* Participation in another trial
Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

The purpose of this study is to describe visual outcomes, in particular spherical equivalent by manifest refraction and visual acuity across a range of distances, 6 months post implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with corneal astigmatism. Additionally, patient reported outcomes will be assessed.

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 5 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1, Month 3, and Month 6 after the second implantation). The second implantation generally occurred within 30 days of the first.

Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent;
* Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes;
* Able to undergo second eye surgery within one month (30 days) of first eye surgery;
* Able to attend postoperative examinations per protocol schedule;
* Qualify for a AcrySof IQ Toric IOL in both eyes;
* Preoperative astigmatism of ≥0.75 to ≤2.5 diopters (D) in both eyes;
* Residual refractive cylinder of ≤0.5 D in both eyes;
* Good ocular health;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Planned multiple procedures, including LRI, during cataract/IOL implantation surgery;
* Amblyopia;
* Previous corneal surgery;
* Clinically significant corneal endothelial dystrophy;
* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
* History of retinal detachment;
* Pregnant or planning to become pregnant during course of study;
* Other protocol-defined exclusion criteria may apply.