cyrilzakka/clinical-trials huggingface dataset:
Objective Measures of Cochlear Implant Electrode Position and Function

Recruit adult patients eligible for cochlear Implant surgery. During routine surgery monitor electrode placement with new 'SCINSEV' technique and complete 'PECAPs' on patient to identify if any of the electrodes have misplaced.

Follow up with patient after surgery for post operative appointment with same measurements.

Cochlear implants (CIs) restore hearing to deaf patients by electrically stimulating the auditory nerve using an array of electrodes inserted into the cochlea (inner ear). All electrodes should be successfully inserted in the cochlea, with each electrode exciting a discrete range of auditory nerve fibers.

Our research investigates two exceptions to this ideal situation, both of which impair the participant's ability to clearly hear sounds such as speech. One exception occurs when some electrodes are located outside the cochlea, limiting the amount of information that is conveyed to the brain and potentially causing unwanted side effects.

Our research will identify these extra-cochlear electrodes during the CI operation, by stimulating each electrode in turn and recording from all other electrodes.

This "SCINSEV" technique then uses a sophisticated computational method to identify which if any electrodes are out of the cochlea. Even when all electrodes are in the cochlea, however, some may produce broad current spreads, which will "blur" the perception of sounds. Our second "PECAP" method measures these instances by stimulating pairs of electrodes and recording the neural responses. It also uses a new computational method, this time so as to calculate the neural spread from each electrode.

Both methods use fast, non-invasive, objective measurements that use the built-in capabilities of the implant .The interventions used are very similar to those employed in standard clinical practice, and the results will pave the way for better identification and management of poor hearing by CI patients

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing or able to consent to participation in the study
* Meets normal candidacy requirements for cochlear implantation
* At least 18 years of age at time of consent being given
* Patent cochlea as verified by CT or MRI scan
* No additional complex needs that would prevent study procedures being followed
* Agreement to participate in the study

Exclusion Criteria:

* Using medication in a manner that might affect hearing levels
Matrix Metalloproteinases in Patients With Critical Limb Ischemia Undergoing Surgical Revascularization

In the present study the investigators will evaluate MMPs. serum levels variations in patients affected by critical limb ischemia, before and after lower limb surgical revascularization through venous or prosthetic bypass.

Recent clinical studies showed an association between Peripheral Artery Disease (PAD) and circulating levels of Matrix Metalloproteinases (MMPs), especially MMP-2, MMP-9, MMP-8 and MMP-10, compared with healthy controls. A recent study showed the association between MMP-10 serum levels and severity and poor outcome in patients affected by Critical Limb Ischemia (CLI).

Also, MMPs seems to be involved in intimal hyperplasia and constrictive remodeling, both responsible of restenosis after surgical treatment of atherosclerotic lesions.

Intimal hyperplasia is a thickening of the tunica intima resulting in narrowing of the vessel lumen.

Elevated tissue levels of MMP-2 and MMP-9 have been identified in pig models of vein bypass grafts, temporally coinciding with the period of Smooth Muscle Cells (SMC) migration and neointimal formation.

In the present study the investigators want to evaluate MMP-1; MMP-2, MMP-9, MMP-8 and MMP-10 serum levels variations in patients affected CLI, before and after lower limb surgical revascularization through venous or prosthetic bypass in order to assess their role in predicting the surgical outcome of these procedures.

Patients with CLI will be randomized to receive lower limb surgical revascularization through autogenous venous (Group I) or prosthetic bypass (using synthetic polytetrafluoroethylene - PTFE- ) (Group II).

Patients enrolled in the present study will be followed through clinical and ultrasonographic examination at 1, 3, 6, 12 and 24 months. At the same time points MMPs plasma levels (by means of blood sampling through venipuncture) will be evaluated. Clinical, Instrumental and Laboratory data then will be matched.

Eligibility Criteria:
Inclusion Criteria:

* patients with CLI stage III-IV according to the Fontaine's classification

Exclusion Criteria:

* Patients with evidence of systemic sepsis, known neoplastic disease or any established generalized inflammatory disease
A Registered Cohort Study on Color Discrimination Deficit Associated With Neurodegenerative Disorders.

Color discrimination deficit is a common manifestation of Alzheimer's disease (AD). However, the pathophysiology of this dysfunction remains poorly understood. The aim of the present study was to evaluate color discrimination using the Farnsworth-Munsell 100 hue test in patients with AD and mild cognitive impairment (MCI), compared with age-matched control subjects. As a secondary aim, we evaluated whether the outcomes of these visual tests were associated with cognitive.


Eligibility Criteria:
Inclusion Criteria:

* All patients underwent extensive clinical examination including thorough neurological and somatic examination by a specialized neurologist or geriatrician and extensive neuropsychological examination by a trained psychologist. AD was diagnosed according to the NINCDS-ADRDA criteria.

Exclusion Criteria:

* We excluded individuals with noncompensated somatic illnesses, a history of a psychiatric disorder, color blindness, ophthalmological pathology, severe cranial trauma, focal neurological signs or magnetic resonance imaging examinations suggestive of cerebrovascular disturbances.
The Effect of Probiotics on Microbial Translocation and Inflammation in HIV-infected Patients

Objective:

In this study the investigators aim at investigating:

1. probiotics ability to modulate the microbiome and microbial translocation,
2. if probiotics affect the level of cholesterol, triglycerides as markers of cardiovascular risk factors and
3. if a reduction of microbial translocation is associated with a reduction of inflammation in the gastro-intestinal tract.

Design:

The study is a prospective clinical intervention trial of 40 HIV-infected patients.

Method:

The investigator will administer the bacteria Lactobacillus Rhamnosus in capsular form to each patient 2 times a day in 8 weeks. At baseline and at the 8th week of the intervention, the investigators will collect blood samples, feces samples and make a positron emission tomography-magnetic resonance scans.


Eligibility Criteria:
Inclusion Criteria:

* age over 18
* confirmed HIV
* no HIV treatment
* cluster of differentiation 4+ cell count over 350

Exclusion Criteria:

* antibiotic or probiotic in last 2 month
* drugs that influence gut motility
* diabetes
* Inflammatory bowel disease
* cancer
* autoimmune diseases
Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients With Colorectal or Breast Cancer

A multicenter, randomized, open-label, three-period, and reference-replicated crossover study was conducted in 48 patients with colorectal or breast cancer under fed conditions to assess the bioequivalence between two formulations of capecitabine.

This was a multicenter, open, random, balanced, three-period, three-sequence and semi-repetitive cross study with 48 subjects. Eligible subjects were randomly assigned in a 1:1:1 ratio to receive one period of test formulation or two period of reference formulation, followed by a 1-day washout period and administration of the alternate formulation. Serial blood samples for pharmacokinetic assessment were collected at 0 hours (predose) up to 8 hours postdose. The plasma concentrations of capecitabine were analyzed by LC/MS-MS. Pharmacokinetic parameters (non-compartmental model) were assessed with WinNonlin software. The pharmacokinetic parameters assessed were area under the plasma concentration-time curve from time 0 to the time of last measurable concentration (AUC0-t), AUC from time zero to infinity (AUC0-∞), the peak plasma concentration of the drug (C max ), time needed to reach maximum concentration (Tmax), the elimination half-life (t1/2), and terminal elimination rate (λz). All were analyzed using an ANOVA model after logarithmic transformation of the data. For establishing bioequivalence (BE) for capecitabine， reference-scaled average bioequivalence (RSABE) acceptance criteria and average bioequivalence (ABE) acceptance criteria were used. Safety and tolerability was assessed during the entire study period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically conﬁrmed colorectal or breast cancer receiving capecitabine monotherapy or combination chemotherapy.
* Eligible patients were within 18-70 years of age.
* ECOG score was 0-2.
* Left ventricular ejection fraction (LVEF) \> 50%.
* There was no serious persistent toxicity to capecitabine treatment before screening (laboratory tests ≤ grade 1 (NCI CTCAE 5.0 standard)
* Hand-foot syndrome ≤ grade 2 after recovery from the previous treatment period).

Exclusion Criteria:

* Patients were known allergy to fluorouracil or 5-fluorouracil.
* Patients with complete lack of known dihydropyrimidine dehydrogenase (DPD) activity.
* Patients with abnormal hepatic and renal function (serum creatinine≤ 1.5 ×ULN; CLcr ≥ 51 mL/min; bilirubin≤ 1.5 ×ULN; AST, ALT≤2.5×ULN)
* Needed to accept phenytoin, warfarin, other coumarin derivatives anticoagulants, folic acid, and CYP2C9 substrates during the research.
* Patients with brain metastases or other metastases of the central nervous system (except those who were treated at least 6 months prior to the start of the study and were stable and asymptomatic).
Vinorelbine Metronomic Plus Bevacizumab as Salvage Therapy for Breast Cancer

To evaluate the efficacy of metronomic oral vinorelbine taken three times a week without break plus bevacizumab as salvage treatment in patients with metastatic breast cancer.

Continuous administration of oral vinorelbine, given three times a week (metronomic) is feasible and exceptionally well tolerated at doses up to 50 mg. Early results show activity against refractory tumors and provide evidence towards clinical proof of efficacy for metronomic chemotherapy. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone.

Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
* At least one previous chemotherapy regimen for metastatic breast cancer
* Age 18-75 years
* Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
* Performance status (WHO) 0-2
* Adequate liver function(serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases), adequate renal function (serum creatinine \<1.5 times the upper normal limit) and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
* No radiation of measurable disease (except brain metastases)
* No progressive brain metastases according to clinical or radiological criteria
* No brain metastases without prior radiation therapy
* Written informed consent

Exclusion Criteria:

* Patient unable to take oral medication
* Active infection
* History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* History of stroke
* Anticoagulation therapy (except of low dose aspirin \<325mg)
* Other invasive malignancy except nonmelanoma skin cancer
* Psychiatric illness or social situation that would preclude study compliance
* Pregnant or lactating women
Rehabilitation for Head and Neck Cancer

Patients treated for head and neck cancer (HNC) suffer from severe side-effects such as pain and difficulties in swallowing, often leading to weight loss. More than 70 % of the weight loss is attributed to lean muscle wasting that is associated with decline in physical function, substantial fatigue and significantly decreased quality of life. Rehabilitation that includes physical exercise, nutritional counselling and oral nutritional supplements (ONS) can potentially reduce or prevent muscle wasting. The primary aim of this pilot randomised trial is to assess feasibility, evaluate patient experiences and assess preliminary effects on muscle mass, physical function, nutritional status and quality of life of rehabilitation interventions during and after radiotherapy (RT). Newly diagnosed HNC patients referred for curative RT with or without chemotherapy, will be randomised to a) rehabilitation during RT or b) rehabilitation after RT. Rehabilitation during RT will be carried out at an outpatient facility during the treatment period (6-7 weeks) and rehabilitation after RT will be carried at a rehabilitation centre and last for 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of squamous cell cancer (SCC) originated in the head/neck (naso, oro, hypo pharynx, larynx and oral cavity)
* Due to commence curative radiotherapy (RT) or chemoradiotherapy (CRT)
* All baseline assessments can be completed within 4 weeks prior to first cycle of RT or CRT
* Written informed consent is present
* willing to comply with study procedures

Exclusion Criteria:

* stage T1N0M0 laryngeal cancer
Partner Notification Intervention for STD Clinics.

To help public health professionals (DIS) in interviews of patients infected with STD for the names of their sex partners, this project used a computer-based partner elicitation program before the actual DIS interview. The main outcome was the mean number of partners named by those who had the intervention versus those those who did not.

The primary goal of this project is to develop and evaluate an intervention that will increase the number of people who, having been exposed to a sexual partner with chlamydia, gonorrhea or syphilis, (a) are notified and (b) receive evaluation and treatment. The intervention program will be presented entirely by an automated multimedia computer system with touch screen interface. The intervention will be tailored to user, based on demographic and recent sexual history factors. The intervention is designed to (a) motivate and prompt STD clinic clients to recall and identify sexual partners, (b) teach clinic clients a set of social skills for minimizing negative reactions while informing partners that they may be infected with an STD; (c) increase client's self-efficacy relative to disclosing partners names and informing them of their STD exposure, and (d) provide clients with tools for motivating their partners to seek treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 or older AND
* Anglo, Hispanic, or Black AND
* STD diagnosis positive

Exclusion Criteria:

* Non-English speaker
A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs

The purpose of this study is to compare the safety and effectiveness of emtricitabine and stavudine when given with didanosine plus efavirenz to HIV-infected patients.


Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 18 years old at the time of screening.
* Have plasma HIV-1 RNA loads (level of HIV in your blood) of 5,000 or more copies/ml at the time of screening.
* Have not used any anti-HIV therapy for more than 2 days.
* Have a negative pregnancy test within 22 days of starting study drugs.
* Can be reached by telephone.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are pregnant or breast-feeding.
* Use alcohol or illegal drugs that, in the opinion of the principal investigator, may interfere with the patient's ability to follow the dosing schedule and protocol evaluations.
* Are being treated for active tuberculosis.
* Are using astemizole, cisapride, midazolam, triazolam, ergot derivatives, St. John's wort, or drugs for a mental disorder.
* Have a history of a serious mental disorder.
* Are unwilling to use an effective barrier method of birth control during the study (for women who can get pregnant).
* Have a history of opportunistic infections and cancers (Mycobacterium avium complex, cytomegalovirus, toxoplasmic encephalitis or disseminated toxoplasmosis, cryptosporidiosis, Isospora belli, progressive multifocal leukoencephalopathy, visceral Kaposi's sarcoma, and lymphoma). Patients with past episode of pulmonary tuberculosis, Pneumocystis carinii pneumonia, or isolated cutaneous Kaposi's sarcoma are allowed. Medication for the prevention of PCP (TMP/SMX, nebulized pentamidine, and atovaquone) is allowed.
* Have peripheral neuropathy (a painful condition affecting the nervous system) or history of peripheral neuropathy.
* Cannot take medicine by mouth or have severe chronic diarrhea within 30 days before beginning the study.
* Cannot eat 1 or more meals a day because of chronic nausea, vomiting, or abdominal or esophageal discomfort.
* Have had a serious illness or injury within 30 days of screening. Treatment must have been completed for 14 days prior to study entry.
* Have a history of AIDS-defining opportunistic infection, except for tuberculosis or infection of the stomach or intestines.
Comparison of Superior vs Nasal/Temporal Laser Peripheral Iridotomy in Primary Angle Closure

The purpose of this study is to determine if location of laser peripheral iridotomy (LPI) that is the standard of care treatment for angle closure glaucoma is related to changes in post-operative intraocular pressure (IOP), endothelial cell count,anterior chamber angle morphology and onset of new visual disturbances.

Study hypothesis: Location of laser peripheral iridotomy affects occurrence of post-operative dysphotopsia symptoms, intraocular pressure, anterior chamber angle morphology and corneal endothelial cell count Study design: Multicenter randomized, prospective, single masked trial Trial setting: Hospitals Trial type: Treatment

Interventions: South Indian subjects aged 30 years or greater, with primary angle closure suspect (PACS) or primary angle closure/ primary angle closure glaucoma(PAC/PACG) will be randomized to either bilateral superior or nasal/temporal laser peripheral iridotomy. Subjects will undergo noninvasive testing and imaging studies to measure IOP, anterior chamber angle morphology and endothelial cell count and asked to answer a questionnaire at baseline and again at 2 weeks and 6 months after treatment Primary outcome measures: Occurrence of new self-reported general eye or dysphotopsia symptoms.

Secondary outcome measures: intraocular pressure, anterior chamber and anterior chamber angle morphology, endothelial cell count.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PACS or PAC/PACG in at least one eye

Exclusion Criteria:

* bilaterally pseudophakic
* prior iridotomy, iridoplasty, or incisional glaucoma surgery in either eye
* signs or symptoms consistent with acute angle closure at time of enrollment
Infections After Renal Transplantation: Diseases Pattern in Hong Kong

Infections are the most feared complications developing in patient who had had kidney transplantation. The aim of this study is to document the local disease pattern among this group of patients.


Eligibility Criteria:
Inclusion Criteria:

* All living-related or cadaveric renal transplantation episodes (including preemptive ones) performed in the Hong Kong Special Administration Region (HKSAR), Mainland China or overseas during the period 1/1/2000 to 30/6/2005

Exclusion Criteria:

* multiple organ recipients, incomplete records and lost to follow-up, including those cases who have been taken over by other renal centres
Safety and Pharmacokinetics of a Novel Niclosamide Solution in Combination With Camostat

Niclosamide is a well-established substance that is a promising candidate for a repurposing approach to treat COVID-19. Niclosamide is currently marketed as a chewing tablet for the treatment of intestinal worm infections. The marketed formulation is optimized for minimal drug substance absorption. A niclosamide solution has been developed that is expected to release the drug substance more readily and more reproducibly.

Camostat is approved for oral treatment of chronic pancreatitis and reflux oesophagitis in Japan. Camostat has been shown to effectively block viral replication in a SARS-CoV-2 animal model. Since the mechanisms of actions are different, it was hypothesized that a combination of both substances might have an additive or even synergistic effect in the treatment of COVID-19 patients.

This 3-part study is designed to investigate (1) safety and pharmacokinetics of single ascending doses of the new niclosamide solution after fasted and fed conditions, (2) the relative bioavailability of the niclosamide solution compared to the chewing tablet, and (3) safety and pharmacokinetics of the combination of niclosamide solution and camostat after multiple doses in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects in good health as determined by past medical history
* physical examination, vital signs and safety lab at screening
* between 18 to 45 years of age

Exclusion Criteria:

* Significant illness
* pregnant or lactating women