cyrilzakka/clinical-trials huggingface dataset:
The Effect of Transcorneal Stimulation in Cases of Central Retinal Artery Occlusion Using a New Waveform

The purpose of this study is to describe the effect of transcorneal electrical stimulation (TES) with a non conventional biphasic bipolar waveform in central retinal artery occlusion

Patients with acute central retinal artery occlusion (CRAO) generally present with a history of painless visual loss that occurred over several seconds. In some instances amaurosis fugax is also present. At the time of initial examination, visual acuity in 90% of patients with CRAO can vary from counting fingers to light perception. Acute CRAO is considered an emergency situation, and therapy must be started as soon as possible. There are different reports where different treatments were proved for the acute phase for example: ocular massage, anterior chamber paracentesis, intravenous mannitol, acetazolamide, hyperbaric oxygenation, microcatheter urokinase infusion, and carbogen 1,2,3. Electrophysiological occlusion of the ophthalmic artery, central retinal artery occlusion, or central retinal vein has a profound impact on the ERG. ERG can provide an objective assessment of severity if occlusion occurs, the b wave is eliminated and a reduction in the "a" wave can be observed.

In addition, a traumatic optic neuropathy, together with retinal ganglion cell death, can induce a loss of vision which progresses rapidly within several hours l. It is known that the visual prognosis following treatment of acute central retinal artery occlusion is not as good as we would like 2; the patient must go to any emergency department to be treated immediately3, in order to preserve maximal visual function. It has been prove that the retinal function recovers after an ischemic event lasting up to 97 minutes, 4 and irreparable damage may occur after 105 minutes. This is why this study intervene during the chronic phase between 4 hrs and 14 days; where demonstrable clinical improvements in the magnitude of retinal damage where seen5, 6, 7 However recently research reports have shown that, electrical stimulation can rescue injured retinal ganglion cells from death cells and can preserve visual function after an optic nerve crush. 8 There is no ideal treatment in the chronic phase of the CRAO. That is the reason why most recent papers suggest different treatment approaches in the chronic phase of this pathology. One of these treatments that were described is the application of electrical stimulation on the patient's cornea who present with CRAO. It has been reported in the literature that transcorneal, retinal 9,10 or cerebral visual cortex 11 electrical stimulation (ES) results in evoked visual sensations (phosphenes),6,9,10,12 however, this intervention requires surgical electrode implantation.

Eligibility Criteria:
Inclusion Criteria:

* central retinal Artery occlusion
* no retinal diseases associated
* visual acuity in other eye better than 20/200

Exclusion Criteria:

* Branch retinal artery occlusion
A Measurement Study of TIS-modNV and AccuGait Force Platform in People With MS

The current project will fill a knowledge gap in the follow-up of people with Multiple Sclerosis (MS) with mild and moderate disability levels, with the purpose to assess the adequacy of measurement tools for trunk control and balance, functions that are pre-requisites for optimal performance in everyday physical activities.

Trunk control and balance, necessary for daily activities, are frequently impaired in people with MS. Adequate measurement tools for clinical- and research purposes are thus warranted. In this study two measurement tools will be explored:

1. The Trunk Impairment scale - modified Norwegian version (TIS-modNV), which has demonstrated high validity and reliability in individuals with stoke (Gjelsvik et al., 2012), however its properties has not yet been assessed in people with MS. Concurrent validity with a balance scale, the Mini-Balance Evaluation Systems Test (Mini-BESTest), will be assessed as well as its inter- and intra-rater reliability.
2. The AMTI Accugait Optimized™ multi-axis force platform (AMTI, Inc., Newton, MA) will be examined as there is a lack of studies measuring its properties within the MS population. A validity assessment of this tool will be included in this measurement study.

This study is two-parted, each with a separate aim:

Aim part 1: To determine the validity and reliability of the TIS-modNV across mild and moderate disability levels in the MS population.

Aim part 2: To determine the concurrent validity of the AMTI AccuGait OptimizedTM force plate system compared to the Mini-BESTest across mild and moderate disability levels in the MS population.

Eligibility Criteria:
Inclusion Criteria:

* MS diagnosis (McDonalds criteria)
* EDSS= 0-6.5
* Ability to walk minimum 6 meters

Exclusion Criteria:

* People will be excluded if not being able to follow test instructions
The Randomized Controlled Clinical Trial of Kushen Injection

The randomized controlled multicenter clinical study of compound Kushen Injection to reduce the radiotherapy related adverse reactions in lung cancer is a phase Ⅳ clinical trials，The main purpose is to evaluate the effect of compound Kushen Injection in preventing and reducing the radiotherapy related adverse reactions. The participants of the clinical trials are patients with lung cancer who need thoracic radiotherapy. In clinical trials, one group of participants is given compound Kushen Injection with chemoradiotherapy, while another group is only given chemoradiotherapy. The period of trials is 18 months.

Patients with lung cancer who need thoracic radiotherapy will be enrolled in the trial, then seprated randomly in two group,the KS injection group treated with chemoradiotherapy plus KS injection; the contral group treated with chemoradiotherapy only. After 6 months observation, The rates of incidence and the degree of adverse reactions caused by redioterapy; the completion rate of radiotherapy; clinical Symptoms; Qof and pulmonary function tests etc. will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Before the start of the study, All patients have been fully understood the reseach and the must sign the informed consent
* To be aged from 18 to 75 years old, both gender
* The lung cancer diagnosis must be proved by pathology
* According to RECIST (version 1.1), At least 1 objectively measurable Tumor lesion (iconography: CT, MRI), the assessable lesion can be measured accurately, maximum diameter more than at least 10mm (Malignant lymph nodes on CT scans short diameter less than at least 15 mm)
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Lung function FEV1 more than at least 1Land more than 50% A normal value
* The function of each organ is basically normal :ANC more than 1.5\*10\^9/L, Platelet count more than 100\*10\^9/L, Hb more than 9.0g/dl, BIL at normal level or less than 1.5\*ULN, AST (SGOT), ALT (SGPT) less than 2.5\*ULN(less than 5\*ULN, if with liver metastases), SCr less than 1.5\*ULN
* The expected survival tme must more than 6 months.

Exclusion Criteria:

* Lung or mediastinal have received radiotherapy before or ever treated with Compound Kushen Injection within 2weeks
* Pregnancy or lactation women
* Patients with severe, uncontrolled organic lesions or infection, such as decompensated heart, lung, kidney failure can lead to tolerance of chemotherapy - Participating or within the last 30 days participated in other clinical trials
* Hypersensitiveness to any kind of trial regime
* Had a history of serious Psychological or Psychiatric disorders, Drug addiction or Alcohol dependence
* Estimating the compliance of patients to participate in this clinical trial is insufficient.
Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN

This is an ancillary study conducted as part of the BASALT trial \[NCT00495157\].

The overall hypotheses are: 1) an indirect airway challenge procedure using mannitol can safely characterize asthma phenotypes, predict asthma control and exacerbations, predict responses to interventions, and perform more specifically than a direct methacholine challenge and; 2) PX27 pore function in whole blood correlates with measures of airway hyperresponsiveness induced by methacholine and/or mannitol challenges


Eligibility Criteria:
Inclusion Criteria:

* all subjects randomized to the BASALT protocol

Exclusion Criteria:

* positive urine pregnancy test
* requirement for more than two albuterol treatments for reversal of the methacholine bronchoprovocation challenge procedure at visit 4 in the BASALT parent trial
Feasibility and Acceptability of an Internet-based Cognitive-behavioral Treatment for Insomnia in Adults With Asthma

The purpose of the proposed study are to explore changes in sleep and asthma outcomes from baseline to post-treatment in adults with asthma and comorbid insomnia who underwent Internet-based cognitive-behavioral treatment for insomnia (CBT-I).


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of moderate-severe persistent asthma
* Not well controlled asthma (score ≤ 19 on the Asthma Control Test)
* Age 18-75 years
* Meets criteria for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Insomnia Disorder
* At least moderate insomnia severity (score ≥ 10 on Insomnia Severity Index)
* Telephone number, email address, and reliable Internet access

Exclusion Criteria:

* History of bipolar or psychosis
* Substance abuse disorder within past 3 months
* Dementia or probable dementia diagnosis
* Plans to move or leave present source of care during the following 6 months.
* Non-English speaking, illiterate, or possesses sensory deficits
Effect of Implant Driver Facilitated Micro-osteo Perforation on the Rate of Tooth Movement.

we have conducted a split-mouth randomized clinical trial to study effects of implant induced micro-osteoperforations on the rate of tooth movement during canine retraction.

The experimental group will receive implant driver facilitated microosteoperforation on one side of the mouth( according to split mouth design) decided by random allocation.

After 3 months of extraction of upper first premolar ( according to planned orthodontic treatment), 3 microosteoperforation will be done with implant in an implant driver distal to canine. Surgical procedure will be done in local anesthesia, no flap will be raised. Alginate impressions will be taken before the procedure and 28 days after canine retraction has started, to measure the difference between rate of canine retraction on both sides. Measurement was done by a digital vernier caliper,

Eligibility Criteria:
Inclusion Criteria:

* • Male and female

  * Age 18- 45 years
  * Class 2 div 1
  * No systemic disease
  * No radiographic evidence of bone loss
  * No history of periodontal therapy
  * No current active periodontal disease
  * No smoking
  * No gingivitis or untreated caries
  * Probing depth \< 4mm in all teeth
  * Gingival index \< 1mm
  * Plaque index \< 1mm

Exclusion Criteria:

* Long term use of antibiotics, phenytoin,cyclosporine, anti inflammatory drugs, systemic corticosteroids and calcium channel blockers.
* Poor oral hygiene for more than 2 visits.
* Extreme skeletal class 2 malocclusion, overjet \> 10mm, anb\> 7
* Systemic disease
* Evidence of bone loss
* Past periodontal disease
* Current periodontal disease
* Smoking
* Gingivitis and caries
* Probing depth \> 4mm
Overcoming High On-Treatment Platelet Reactivity (HPR) During Prasugrel Therapy With Ticagrelor

The primary objective is to determine the pharmacodynamic effect of ticagrelor dosing (180mg LD/ 90mg BID) at 2, 4 hours and 14 days in stable Coronary artery disease (CAD) patients who exhibit high-on prasugrel platelet reactivity defined as Vasodilator Stimulated Phosphoprotein-Phosphorylation (VASP-P) \>50%.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female; age ≥ 18 and \< 75 years
2. Weight ≥ 60 kg
3. Currently on ASA therapy and eligible to reduce ASA dose to 81 mg daily if on higher dosing
4. On stable prasugrel maintenance dose for ≥1 month
5. Stable CAD patients defined as: subjects with documented evidence of a history of atherosclerotic coronary artery disease/surgical revascularization (defined as either a prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft surgery). A minimum of 1 month must have elapsed between a subject's enrolment and any acute event, revascularization procedure or hospitalization for chest pain for that subject.
6. If female, may be enrolled if one of the following 3 criteria are met: 1)Had a hysterectomy or tubal ligation at least 6 months prior to signing ICF, 2)Post-menopausal for at least 1 year, 3)If of childbearing potential, will practice 1 of the following methods of birth control throughout the study: oral, injectable, or implantable hormonal contraceptives; intrauterine device; diaphragm plus spermicide; or female condom plus spermicide. Methods of contraception that are not acceptable are partner's use of condoms or partner's vasectomy.
7. Able and willing to provide written informed consent before entering the study

Exclusion Criteria:

1. Subject plans to undergo coronary revascularization at any time during the trial
2. Presence or history of any of the following: ischemic or hemorrhagic stroke; transient ischemic attack (TIA); intracranial neoplasm; arteriovenous malformation, or aneurysm; intracranial hemorrhage; head trauma (within 3 months of study entry)
3. History of refractory ventricular arrhythmias with an increased risk of bradycardic events (eg, subjects without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree atrioventricular (AV) block or bradycardic-related syncope)
4. History or evidence of congestive heart failure (New York Heart Association Class III or above ≤ 6 months before screening
5. Severe hepatic impairment defined as ALT\> 2.5 X ULN
6. Uncontrolled hypertension, or systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg at screening
7. Severely impaired renal function (glomerular filtration rate \< 30 mL/minute) or on dialysis
8. Concomitant use with parenteral or oral anticoagulants
9. Platelet count \<100 X103
A Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer

Virulizin is an immunotherapy drug preparation that is thought to stimulate the patient's immune system, which in turn may slow the growth of tumors. It is presented in vials as a sterile preparation for IM injection. The purpose of the trial is to investigate if Virulizin in combination with gemcitabine provides better efficacy than gemcitabine alone (with placebo) against pancreatic cancer.Virulizin® efficacy will continue to be assessed if chemotherapy is changed to 5-Fluorouracil.

A Phase III, Double-blind, Multicenter, Randomized Study in Chemonaive Patients with Locally Advanced or Metastatic Pancreatic Cancer to Compare a Combination Therapy of Virulizin® plus Gemcitabine versus Placebo plus Gemcitabine; Optional Secondline Therapy may Include Continuation of Virulizin® or Placebo, Alone or in Combination with 5-Fluorouracil.

Patients who have not received any prior chemotherapy will be randomized to receive Gemcitabine plus Virulizin® versus Gemcitabine plus placebo in a double blind fashion. On disease progression patients may be switched to 5-Fluorouracil and continue to receive Virulizin® or placebo. Patients may continue Virulizin® alone, if clinically indicated when 5-Fluorouracil is discontinued.

Eligibility Criteria:
* Patients with advanced (unresectable or metastatic) pancreatic adenocarcinoma (TNM stages II, III or IV)
* No previous systemic chemotherapy(unless given as a radiosensitizer).
* ECOG Performance Status 0-2
* Life expectancy equal to or greater than 12 weeks
* Adequate laboratory and organ functions
* Stabilizable pain (stable analgesic intake)
* No radiotherapy during 4 weeks prior to trial entry
* No evidence of ascites, pleural effusion or third space fluid accumulation
* Not currently using, and have not used in 4 weeks prior to entering trial, systemic steroids or hormonal therapy
Smell in Covid-19 and Efficacy of Nasal Theophylline

Evidence of COVID-19 related anosmia and dysgeusia continues to accumulate daily.

Currently, up to 80% of patients report subjective olfactory dysfunction (OD), and prevalence using objective olfactory testing could be even higher.

We propose a phase II single-site, double-blinded, placebo-controlled randomized clinical trial to determine the efficacy and safety of intranasal theophylline, a known phosphodiesterase inhibitor in the treatment of asthma, as a possible treatment for COVID-19 related OD. Theophylline has shown benefit in similar clinical trials for post-viral OD.

Post-viral olfactory dysfunction has numerous known adverse effects such as loss of cortical gray matter and decrease in quality of life. COVID-19 related olfactory dysfunction has already been shown to be correlated with depression and decreased quality of life, so finding an effective treatment is imperative.

Intranasal and oral corticosteroids as well as olfactory training are currently used to treat post-viral OD; however they have demonstrated limited efficacy and there is no current gold standard of care. There is no current consensus on the pathogenesis of COVID-related anosmia; however evidence for post-viral olfactory dysfunction suggests sensory axonal regeneration and olfactory signaling may rely on elevated levels of secondary messengers cAMP and cGMP, a known effect of theophylline. In this phase II treatment trial, patients will be allocated 1:1 to receive either intranasal theophylline irrigation or placebo for six weeks. Various smell surveys and scratch-and-sniff tests will be utilized to capture changes in smell ability.

Due to COVID-19, this study will be conducted virtually, except for the first ten enrolled patients who will undergo one serum theophylline test. This study is limited to patients living in Missouri or Illinois.

Eligibility Criteria:
Inclusion Criteria:

* Olfactory dysfunction that has persisted for \>3 months following suspected COVID-19 infection
* Residing within the states of Missouri or Illinois.
* Can read, write, and understand English.

Exclusion Criteria:

* History of olfactory dysfunction prior to COVID-19 infection
* Use of concomitant therapies specifically for the treatment of olfactory dysfunction
* History of olfactory dysfunction longer than 12 months
* Known existence of nasal polyps, prior sinonasal, or anterior skull-based surgery
* Dependence on theophylline for comorbid conditions such as asthma and COPD
* History of an allergic reaction to theophylline or other methylxanthines
* History of neurodegenerative disease (ie. Alzheimer's dementia, Parkinson's disease, Lewy body dementia, frontotemporal dementia)
* Pregnant or breastfeeding mothers
* Current use of medications with significant interactions with theophylline, which include cimetidine, ciprofloxacin, disulfiram, enoxacin, fluvoxamine, interferon-alpha, lithium, mexiletine, phenytoin, propafenone, propranolol, tacrine, thiabendazole, ticlopidine, and troleandomycin.
* Pre-existing arrhythmias or seizures
Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Folinic Acid, and Bevacizumab to adult participants to treat unresctable metastatic colorectal cancer.

ABBV-400 is an investigational drug being developed for the treatment of unresectable metastatic colorectal cancer. Fluorouracil, folinic acid, and bevacizumab is an drug approved for the treatment of unresectable metastatic colorectal cancer. Study doctors put the participants in groups called treatment arms. Each treatment arm receives a different dose of ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab (FFB) in escalating doses on two different schedules (safety lead in), followed by low or high doses of ABBV-400 in combination with FFB or fluorouracil, folinic acid, irinotecan, and bevacizumab (standard of care \[SOC\]) \[dose optimization\] on its own. Approximately 206 adult participants with unresectable metastatic colorectal cancer will be enrolled in the study in 65 sites worldwide.

In the safety lead in, participants will receive escalating intravenous (IV) ABBV-400 in combination with IV FFB on two different schedules. During the dose optimization participants will receive IV ABBV-400 in combination with FFB at low or high doses determined in the safety lead in. The dose optimization arm will also include a comparator cohort in which participants will receive SOC. The study will run for a duration of approximately 3 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC).
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria:

* Harbor the BRAF V600E mutation.
* dMMR+/MSI-H.
* Progressed on only one first-line (1L) systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy.
* Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400.
Biopsychosocial Education and Chronic Low Back Pain

The purpose of this study is to examine whether the biopsychosocial educational program could improve patients' health-related quality of life at 3-6-12-18-24-30 and 36 - month follow up.

Little information exists on biopsychosocial educational program as a multidimensional and interdisciplinary program in which Quality Of Life is as an outcome measure. Thus this educational Program designed in this study is a an outpatient program that used a health education approach to empower participants through a process of assessment, education and skill building in three dimensions of physical,mental and social that leading to improved quality of life. The purpose of this study was to examine to what extent this educational Program could improve low back pain patients' HRQOL.

Eligibility Criteria:
Inclusion Criteria:

* Low Back Pain lasting more than 12 weeks with or without pain radiating to the legs.
* age 18-70 years.

Exclusion Criteria:

* Osteoporosis
* Newly operation on the back up to 2 years before the beginning of the study
* Fresh vertebral fracture
* Malignancy
* Infection in the back
* spondylolisthesis
* Problem in understanding Farsi Language
Effectiveness of an Exercise Protocol on Alteration of Knee Joint Position Sense in Futsal Players

This research presents a randomized clinical trial which evaluates the effectiveness of an exercise protocol on the knee-joint repositioning in futsal players related to a post-match muscle fatigue. Our hypothesis is the improvement of sensation in a knee in joint position before and after the match when performing our exercise program.


Eligibility Criteria:
Inclusion Criteria:

Must have three years of experience in futsal Must be Licensed players

Exclusion Criteria:

lower limb injuries