cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis

The purpose of this study is to determine efficacy of apraclonidine for patients with ocular synkinesis, who are seen in the UAB Facial Nerve Clinic.

UAB has a large Facial Nerve Clinic that treats patients with acquired facial nerve palsies and the associated difficulties of swallowing/speaking, and visual field defects from ptosis (a drooping or falling of the upper eyelid) and synkinesis (unwanted contractions of the muscles of the face during attempted movement.). Commonly, patients will experience involuntary eyelid contraction with oral movements like smiling. For eyelid synkinesis causing significant aesthetic or functional difficulty, surgery or botox is often the first line treatment. However, not all patients desire this, and some are poor surgical candidates due to other comorbidities. Botox has been shown to work well for these patients, but can be only partially effective. In addition, patients experience a wearing off period between treatments.

Several eye drops are available for the medical treatment of ptosis, including apraclonidine and 0.1% oxymetazoline. Both are alpha 2 adrenergic agonists, which stimulates Mullers muscle, causing muscle contraction and upper eyelid lifting. In addition, apraclonidine has been shown to be beneficial in patients with blepharospasm in a pilot study by Vijayakumar et. al.

We hypothesize that patients with synkinesis, similar to patients with ptosis and blepharospasm, could have symptomatic improvement with apraclonidine use.

Our study will initially be a pilot study, designed similarly to the Vijayakumar study. If this shows improvement for these patients, our hope is to pursue a randomized control trial.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Ability to speak and comprehend English
* Ability to consent for themselves
* Diagnosis of synkinesis affecting eye movement

Exclusion Criteria:

* Age less than 18 years
* Unable to speak and comprehend English
* Unable to consent for themselves
* Diagnosis of congenital ptosis, Horner syndrome, myasthenia travis, mechanical ptosis
* Visual field loss from causes unrelated to facial nerve injury
* Currently receiving monoamine oxidase inhibitors
* Known hypersensitivity to apraclonidine or other components of the drug under study
Clinical Trial to Evaluate the Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children

Principal focus is to evaluate the effects of omega 3 fatty acids supplementation on the ADHD children's behaviour during 12 weeks on two years. The secondary focus is to evaluate the effects of omega 3 fatty acids supplementation on the lexical level,intentional abilities, anxiety and depression.

The omega 3 fatty acids don't present adverse side effects. The inclusion to the trial could avoid the intake the methylphenidate and its associated adverse side effects.


Eligibility Criteria:
Inclusion Criteria:

* 6 to 15 years and 11 months of age ADHD children with hyperactivity confirmed dy DSM IV criteria Children and parents' consent

Exclusion Criteria:

* Without methylphenidate treatment Fish or other sea products allergic Intake of sea omega 3 fatty acids supplments more one week during 3 months before the trial Children need quickly to take methylphenidate: social, family, or school risk Intake methylphenidate 30 days before the trial or/and intake it during one consecutive week
Proteomics of Papillary Thyroid Carcinoma

Thyroid carcinoma is the common endocrine system malignant neoplasm. At present it has become the malignant neoplasm of fastest growing incidence rate. More than 85% thyroid carcinoma is papillary thyroid carcinoma. Cervical lymph node metastasis is common in papillary thyroid carcinoma patients. This study aim to reveal protein expression differences between papillary thyroid carcinoma with cervical lymph node metastasis and without cervical lymph node metastasis.

1. Object: Patients aged 18-65 years; newly diagnosed papillary thyroid carcinoma with cervical lymph node metastasis and without cervical lymph node metastasis and undergone thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer.
2. Clinical information, examination data: Information is obtained from medical record abstraction.
3. Samples: Fresh frozen thyroid tissues from each sample group(normal histology, benign disease, papillary thyroid carcinoma with cervical lymph node metastasis, papillary thyroid carcinoma without cervical lymph node metastasis ).

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed papillary thyroid carcinoma.
* Undergo thyroidectomy according to the China thyroid association guidelines forthe Management of thyroid nodule and thyroid cancer.

Exclusion Criteria:

* Current substance abuse/dependence.
* Daily tobacco and alcohol use.
* Whole neck irradiation or surgery.
* Prior cancer diagnosis or chemotherapy treatment.
* Active autoimmune disorder.
* Uncontrolled allergic condition or asthma.
* Chronic use of oral steroid medication.
* Hormone therapy (estrogen, progestin compounds).
Assessment of Neuropathic Pain

Development of neuropathic pain is one of the most disabling sequels after spinal cord injury (SCI) and in peripheral nerve diseases. The functionality of the pain pathway in humans as well as its plastic changes following SCI can be assessed in vivo by surface electrophysiological recordings and functional magnetic resonance imaging after noxious heat stimulation of the skin. Aims: a) establishing a clinically applicable assessment of the pain pathway and characterizing its changes as a consequence of SCI and in peripheral nerve diseases in an objective manner, b) characterizing plastic changes in the pain pathway in SCI patients with neuropathic pain and in patients with peripheral nerve diseases and relating them to the development of neuropathic pain syndromes.


Eligibility Criteria:
Inclusion Criteria:

* Uninjured
* Scord injured subjects
* Subjects with peripheral nerve diseases
* Patients resident in Switzerland

Exclusion Criteria:

* Presence of any central psychiatric disorder (that precludes subject from giving informed and voluntary consent)
* For fMRI measurements: "yes" for any item in the MR-risk questionnaire
* Patients resident outside from Switzerland
Assessment of Balance in Patients With Pes Planus

Introduction: Pes planus is a foot deformity with increased contact of the foot with the ground as a result of the decrease or disappearance of the medial longitudinal arch of the foot. The arch of the foot creates an adaptive and flexible support for the whole body, and biomechanical changes in the foot can affect the whole body posture and balance. The results of the studies evaluating balance and plantar pressure analysis in adults with pes planus seem contradictory. The aim of this study is to evaluate fall risk and plantar pressure in adults with pes planus aged 50 -65 years

Materials and Methods: 34 cases with pes planus will be included in the study. Medial longitudinal arch height of all cases will be evaluated by physical examination . Affected foot, presence of "too many toes" sign will be observed. With the fingertip rise test, it will be checked whether the pes planus is flexible or rigid.

Inky foot analysis and plantar pressure analysis will be performed in cases. Chippaux-Smirak index and Staheli arch index of all cases will be evaluated for the diagnosis of pes planus.The risk of falling will be calculated by evaluation of the balance with clinically and with posturography.

Results: Statistical analyzes in the study will be made with the NCSS (Number Cruncher Statistical System) 2007 Statistical Software (Utah, USA) package program.

In addition to descriptive statistical methods (mean, standard deviation) in the evaluation of the data, the distribution of the variables will be examined with the Shapiro - Wilk normality test, one-way analysis of variance in the comparison of the normally distributed variables, Tukey multiple comparison test in the comparison of subgroups, independent t test in the comparison of the paired groups, Chi-square test will be used in comparisons of qualitative data. Results will be evaluated at the level of significance p\<0.05.

Discussion: The results will be discussed according to the recent literature. In the literature, there are conflicting results about the balance and gait of adults with pes planus. In several studies in the literature, it has been found that the risk of falling is increased in elderly individuals with pes planus. The study can contribute to the literature in this perspective.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50 years and above with pes planus according to Staheli Arch Index and Chippaux- Smirak Index

Exclusion Criteria:

* Congenital anomalies of the foot
* Prior lower extremity surgery Inflammatory arthritis
* Neuromuscular diseases
* Diseases that interfere with lower extremity circulation
* Presence of orthostatic hypotension
* Untreated visual impairment
* Neurological and vestibular diseases
* Use of drugs that can cause balance disorders (Antipsychotics, Pregabalin, etc.)
Plasma Glucose Levels With Dexamethasone as Adjuvant to Interscalene Block

The purpose of this study is to determine the Finger Blood Glucose (sugar) when dexamethasone is added to a local anesthetic for a shoulder nerve block procedure. The investigators hypothesize that there is no increase in plasma glucose when 8 mg of dexamethasone is used as an adjuvant with local anesthetic to interscalene regional anesthesia. By performing finger stick blood glucose measures pre/peri and post operatively the investigators will be able to determine if any such increase exists.

Patients receiving regional anesthesia for orthopedic surgeries are provided with significant pain relief in the post-operative period. Dexamethasone as an adjuvant to local anesthetic has been shown to provide increased duration of block without adverse effects. Use of steroids as adjuvants are restricted to non-diabetics due to concern for increased plasma glucose from systemic absorption. The investigators hypothesize that there will be no difference(increase) from patient baseline(preoperative plasma glucose) in plasma glucose levels up to 4 hours post nerve block in patients who receive 8 mg of dexamethasone used as an adjuvant with local anesthetic to interscalene regional anesthesia. Research has demonstrated the safety and efficacy of dexamethasone as an adjuvant to local anesthetic in peripheral nerve block. Currently there are no studies which document any plasma glucose effects(or lack of effects) from dexamethasone used as an adjuvant to regional anesthesia. Currently dexamethasone is used clinically off label by anesthesiologists as an adjuvant in association with local anesthetic for nerve block anesthesia. Once studies are completed, the investigators hope to allow diabetics to also receive the prolongation of pain relief associated with the use of steroid as an adjuvant. In addition, the increased educational and pharmacological data gleamed from the data can potentially be utilized for future studies with dexamethasone utilized perineurally.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1 or ASA 2 male or female non pregnant patients undergoing elective shoulder arthroscopy for surgical repair.

Exclusion Criteria:

* severe lung disease
* contralateral diaphragmatic paralysis
* coagulopathy
* pregnancy
* pre-existing neuropathy involving the surgical limb
* systemic use of corticosteroids for 2 weeks or longer within 6 months of surgery
* chronic opioid use (30 mg oral oxycodone equivalent per day)
* diabetes I or II
* diagnosis of "pre-diabetes"
* currently prescribed any of the oral glucose medications :sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, or DPP-4 inhibitors.
Echocardiography in Cardiac Resynchronization Therapy (Echo-CRT)

The present observational prospective study aims at identifying echocardiographic parameters (based on the Left Bundle Branch Block (LBBB)-like contraction of the left ventricle (LV) ascertained using new methods of echocardiography including speckle tracking strain) that are linked to Cardiac Resynchronization Therapy (CRT) response and a better outcome following CRT

The Cardiac Resynchronization Therapy (CRT) reduces mortality of patients with heart failure and reduced LV ejection fraction. The clinical benefit of CRT is mediated by LV reverse remodelling (decrease in LV end-systolic volume over time). However, 30 to 50 % of these patients will not experience LV reverse remodelling following CRT.

Classical parameters of dyssynchrony obtained by conventional methods of echocardiography (including doppler tissue imaging) have a limited value in predicting CRT response. Meanwhile, patients with a Left Bundle Branch Block (LBBB) on the electrocardiogram experience more frequently LV reverse remodelling than those without a LBBB.

LBBB is responsible for specific LV contractile abnormalities that can be identified by speckle tracking strain echocardiography (early septal contraction, stretching of late contraction of the postero-lateral wall). The predictive value of these abnormalities remains to be studied.

Thus, it has been hypothesised that these LBBB-related contractile abnormalities may be independent predictors of LV reverse remodelling and outcome following CRT.

The present observational prospective study aims at identifying echocardiographic parameters (based on the LBBB-like contraction of the LV ascertained using new methods of echocardiography including speckle tracking strain) that are linked to CRT response and a better outcome following CRT.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure with left ventricular ejection fraction less than 35 %
* QRS duration over than 120 ms
* Clinical indication for CRT

Exclusion Criteria:

* Rythmologic indication of CRT for atrial fibrillation control
* Rythmologic indication of CRT for left ventricular ejection fraction between 35% and 45%
Specified Drug Use Results Survey of Ipragliflozin Treatment in type2 Diabetes Patients

The objective of this survey is to confirm the safety of Suglat Tablets

The objective of this survey is to confirm the safety and efficacy of Suglat Tablets for long-term use over 3 years.

Specify the effects of Suglat Tablets on the cardiovascular system, incidence rates of malignant tumor, and their risk factors.

Investigate the occurrence of adverse drug reactions. Specify factors that may possibly influence the safety and efficacy of Suglat Tablets.

\<Items of interest\>

* Hypoglycemia
* Genital infection
* Urinary tract infection
* Polyuria and pollakiuria
* Adverse events related to a decrease in body fluids (dehydration, etc.)
* Malignant tumor
* Cardiovascular diseases

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes who first use Suglat Tablets during the period from July 17, 2014 to July 16, 2015

Exclusion Criteria:

* off-label use patients
Feasibility of Stress Management Education Delivered Via Virtual Classroom in Nursing Homes: a Pilot Study of a RCT

The aim of this cluster-randomised pilot study is to assess the feasibility of a remote stress management programme to reduce occupational stress in healthcare workers in specialised care units of nursing homes. Secondary aims are to assess the effectiveness of the programme in reducing stress in care workers and reducing behavioural and psychological symptoms of dementia in residents.

Participants randomised to the experimental cluster will follow the stress management programme delivered in a virtual classroom. Participants randomised to the control cluster will be placed on a waiting list.

The primary outcome measure will be the participation rate in the study. Other secondary outcomes will include measures of heart rate variability (as a marker of physiological stress) and scores on specific questionnaires for stress, anxiety and risk of burnout in nursing staff in the specialised care units, and behavioural and psychological symptoms of dementia and quality of life in residents in the specialised care units.

Both clusters will complete the same assessments. Participants in the experimental cluster will follow a three-course programme with a psychologist via videoconferencing over a period of 2 months. After the study's final evaluation visit, which will take place one month after the programme, participants in the control cluster will be offered the opportunity to follow the same programme.


Eligibility Criteria:
Inclusion Criteria:

* Having a caring relationship with residents (e.g. nurses, nursing assistants)
* Working in the specialised care unit of the nursing home
* Working in the nursing home for at least 3 months on the date of inclusion and whose employment contract does not end within 3 months of the date of inclusion.
* Obtaining express written informed consent, after a period of reflection

Exclusion Criteria:

* Person in a period of relative exclusion in relation to another protocol
* Person who is not affiliated to or does not benefit from a social security scheme.
* Pregnant or lactating woman
* Participant unable to give consent
* Person deprived of liberty by judicial or administrative decision
* Person unable to understand, speak, read and write French
Long Antagonist Protocol for IVF With Single Luteal Dose of Degarelix

A prospective study of three different doses of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF

A prospective study of three different doses of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF:Single dose of Degarelix 24mg, 16mg and 12 mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.

ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.

On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.

On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.

On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.

Eligibility Criteria:
Inclusion Criteria:

* primary infertility
* age 18-39 years; body mass index (BMI) 18-29kg/m2;
* regular menstrual cycle of 26-35days,
* presumed to be ovulatory;
* early follicular- phase serum concentration of FSH within normal limits (1-12 IU/l).

Exclusion Criteria:

* women with diabetes and other metabolic disease
* women with heart disease, QT prolongation,heart failure
* elevated liver enzymes, liver failure, hepatitis
* women with inflammatory or autoimmune disease
* abnormal karyotype;
* polycystic ovarian syndrome,
* endometriosis stage III/IV;
* history of being a 'poor responder',
* defined as \>20 days of gonadotrophin in a previous stimulation cycle, or any previous cancellation of a stimulation cycle due to limited follicular response, or development of less than 4 follicles 15 mm in a previous stimulation cycle; history of recurrent miscarriage; severe OHSS in a previous stimula- tion cycle or any contraindication for the use of gonadotrophins.
Characterization and Differential Diagnosis of Postneurosurgical Meningitis

Meningitis is a rare complication following neurosurgical procedures and is associated with high morbidity and mortality. The aim of this study is to describe the clinical characteristics and microbiological characteristics in patients who develope meningitis following neurosurgical operations, and investigate the useful tips for the differential diagnosis of postneurosurgical meningitis.

Besides description of characteristics of patients with postneurosurgical patients, we also will investigate the usefulness of prolonged cerebrospinal fluid (CSF) culture, and profiles of blood and CSF inflammatory markers for the differential diagnosis of meningitis. CSF culture will be extended upto 2 weeks. Serum procalcitonin and C-reactive protein, CSF adenosine deaminase levels will be monitored and analyzed for the differential diagnosis of meningitis.

Eligibility Criteria:
Inclusion Criteria:

* Cerebrospinal fluid corrected WBC \>6/mm\^3 and/or fever (\> 38℃) and/or neck stiffness

Exclusion Criteria:

* Patients already treated more than 48 hours for meningitis before cerebrospinal fluid examination
A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma

This randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment arms. The anticipated time of study treatment is until disease progression or unacceptable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Diagnosis of recurrent glioblastoma multiforme (Grade IV)
* Previous treatment with temozolomide and radiotherapy
* First recurrence after standard adjuvant treatment (surgery, followed by radiotherapy and chemotherapy)
* Adequate hematological, biochemical and organ functions

Exclusion Criteria:

* Previous treatment with Avastin or other anti-angiogenic drugs
* Residual relevant toxicity resulting from previous therapy
* Radiotherapy within the 3 months prior to the diagnosis of disease progression
* Chemotherapy in the previous 4 weeks
* Other active or inactive malignancies (except for carcinoma in situ of the cervix, of the prostate or basal cell carcinoma)
* Clinically significant cardiovascular diseases
Adjuvant Chemoradiation Following Radical Resection of Pancreatic Ductal Adenocarcinoma, a Prospective Cohort Study

This is a prospective observation cohort study to evaluate efficacy of different types of adjuvant therapy strategies, including chemoradiotherapy, chemotherapy alone, or no adjuvant treatment, for pancreatic ductal adenocarcinoma patients who received surgical resection of primary cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 90 years.
2. Received surgical resection of primary tumor.
3. Histological diagnosis of pancreatic ductal adenocarcinoma.
4. Signed informed consent.

Exclusion Criteria:

1.Active concomitant malignancy (Malignancy other than pancreatic cancer).