cyrilzakka/clinical-trials huggingface dataset:
Arnica Montana and Bromelain in Rhinoplasty

The purpose of this study is to assess the perioperative use of Arnica Montana and the combined use of Arnica Montana and Bromelain in aiding the body's wound healing functions during the postoperative period after rhinoplasty. The secondary objective of the study is to determine if there is a reduction in postoperative edema when Arnica Montana and Bromelain are combined. Another secondary objective is to demonstrate increased patient satisfaction with the use of Arnica Montana and the combination Arnica Montana and Bromelain.


Eligibility Criteria:
Inclusion Criteria:

-adults scheduled for outpatient primary rhinoplasty with osteotomies at Boston Medical Center

Exclusion Criteria:

* oral or contact allergies to Arnica Montana or to derivatives from the Ananas comosus or to any other member of the Asteraceae family of plants such as ragweed, chrysanthemums, marigolds, and daisies or Bromelain as determined by self disclosure.
* allergies to pineapple as Bromelain is from pineapple extract
* currently taking antiplatelet medication or anticoagulation medications
* chronic use of NSAIDs meaning those currently using NSAIDS daily for at least 3 months
* taking other homeopathic remedies during the perioperative period
* bleeding disorders as determined by self-disclosure or strong family history, patients in question who would like to participate in the study will have blood work obtained prior to operation
* chronic medical conditions such as significant pulmonary, cardiac, liver, or kidney disease are excluded including poorly controlled hypertension or patients on more than one antihypertensive agent and patients with diabetes
* malignancy, infection, immunodeficiency, metabolic syndrome, infectious, or inflammatory gastrointestinal disease
* severe liver or kidney disease
* significant psychiatric disorders
* females who are breast feeding or pregnant
* history of nasal surgery
* history of head and neck malignancy
* taking oral corticosteroid therapy
* undergoing additional surgery other than primary rhinoplasty
Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children

Vitiligo is a auto immune that impact 2% of the global population, regardless from the phototype. Even though it affects patients in a physical way through loss of pigmentation, it is also impacting them on a mental/emotional way.11-12 Current treatments offer a symptomatic solution to patients, however the response rate can be low and results can be slow.

Pediatric patients in vitiligo deserves special care as frequently (50%), the disease onset is before 20 years of age and, in 25% of the cases, it starts before the age of 10 years.13 Also, the current treatments for children are limited since it can involve pain and claustrophobia. The combination therapy of the study could offer a painless and easy treatment to follow.

If the combination of those two therapies can fasten and improve the response rate, this could be a good option to treat this condition not only in children, but also for adults patients.


Eligibility Criteria:
Inclusion Criteria:

* vitiligo and surface area involved of less than10% who are being followed in the outpatient dermatology clinics of King Abdullah University Hospital (KAUH)
* 6 weeks wash out period from previous treatments will be employed to eliminate any effect from such treatments

Exclusion Criteria:

* Skin dermatoses with Kobner phenomenon
* Lupus erythematous
* Pacemakers
* Hyper-photosensitivity
* Melanoma and non-melanoma skin cancers
* Drugs with photosensitizer side effect
* Radiotherapy
* Pregnancy (by principle, nno study available)
* Diseases that are contagious by contact
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis

Fatigue is the most common symptom reported by end-stage kidney disease patients on maintenance hemodialysis. Unfortunately, there currently is no medical management for this overwhelming feeling of tiredness. As a result, patients continue to suffer with poor quality of life and impaired daily activities. The purpose of this pilot trial is to find out if bupropion (a medicine commonly prescribed for stopping smoking, seasonal mood disorder, and depression) may help lessen fatigue in hemodialysis patients.

In this study, hemodialysis participants will receive bupropion tablet orally three times a week during routine dialysis procedure for consecutive 8 weeks. Study participants will complete a battery of questionnaires to self-report fatigue, cognition, and quality of life. The study team will collect biological specimens. All these procedures will be performed at the dialysis clinic during routine dialysis procedure.

While taking part in this study, participants will be asked to complete study procedures with the researchers or study staff three times a week during routine dialysis visits. Collections of blood, urine (if available) and stool will be collected at different time points over the 8-week intervention. Blood will be analyzed for markers of inflammation, amino acids, and for safety labs as needed. Blood will also be tested for pharmacokinetics of bupropion.

Primary Objective: To evaluate the feasibility and efficacy of bupropion for the treatment of fatigue in patients with end-stage kidney disease on maintenance hemodialysis.

Secondary Objective: To evaluate the effect of bupropion in reducing inflammatory markers in hemodialysis patients with fatigue.

Exploratory Objective: To examine whether bupropion improves cognitive function.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female ESKD patients between aged 25-74 yrs on maintenance in-center hemodialysis procedure 3 times/week for ≥3 months with an arteriovenous fistula or graft.
2. Blood hemoglobin of ≥10.0 g/dL based on most recent routine laboratory profile.
3. Dialysis adequacy measured with Kt/V of ≥1.2
4. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Currently on bupropion or hypersensitivity/ intolerance to bupropion by history and monoamine oxidase inhibitors.
2. Diagnosis or history of eating disorders (bulimia or anorexia nervosa) and seizure.
3. Pregnant, lactating, childbearing women
4. History of post-acute COVID-19 syndrome
5. Diagnosis of depression and/or on antidepressants and bipolar affective disorder
6. Patient Health Questionnaire (PHQ)-9 score of ≥10
7. Diagnosis of cognitive impairment including dementia
8. Current participation in another interventional trial
9. Scheduled for kidney transplantation in next 6 months
10. Life expectancy \<6 months as judged by the attending nephrologist/primary care physician.
11. Current or history of substance abuse or dependency.
Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

The investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable.


Eligibility Criteria:
Inclusion Criteria:

* age \>15 years
* erythema migrans in 4 months period before neurologic symptoms
* normal CSF cell count
* absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy).

Exclusion Criteria:

* pregnancy
* lactation
* allergy on doxycycline and ceftriaxone
* immune deficiency.
Hydroxychloroquine and Cognitive Function After Surgery

The purpose of this study is to determine whether hydroxychloroquine decreases the relative leakage of the brain barrier after surgery.

Hydroxychloroquine will be administered preoperatively to 30 patients undergoing cardiac surgery. All patients will undergo magnetic resonance imaging (MRI) with gadolinium in the post-operative period before hospital discharge in order to assess blood-brain barrier permeability.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age ≥ 50 years old.
2. Patients scheduled to undergo cardiac surgery (CABG, CABG + Valve, Valve) with CPB.
3. Patient has voluntarily signed and dated the study-specific informed consent form approved by Duke University Health System Institutional Review Board (DUHS IRB)

Exclusion Criteria:

1. Cardiac surgery scheduled to be performed without cardiopulmonary bypass
2. Patients requiring emergent operation
3. Patients with a history of myocardial infarction within 7 days of surgery
4. Patients with a history of porphyria, psoriasis, chronic dermatitis, or retinal disease
5. Patients receiving preoperative digoxin
6. Patients with symptomatic cerebrovascular disease with substantial residual deficit
7. Patients with a history of alcohol abuse within 2 years of screening
8. Patients with a history of psychiatric illness and/or anxiety requiring medical treatment.
9. Patients with impaired liver and/or kidney functions (AST, ALT 2 times the upper limit of normal)
10. Patients with impaired renal functions (GFR \< 30ml/min)
11. Patients with less than a 7th-grade education or unable to read and thus unable complete the neuropsychological testing
12. Patients scoring \< 26 on a baseline Mini Mental State examination (MMSE) or scoring \>27 on the Center for Epidemiological Studies - Depression (CES-D) scale
13. Female subjects of childbearing potential who have had menstrual period within the past two years
14. Patients with bodily implants unsafe for MRI use
15. Patients with a history of claustrophobia
16. Known or suspected hypersensitivity to quinine (chloroquine or hydroxychloroquine)
17. Patient with pre-existing diagnosis of G6PD deficiency
18. Patients who have participated in another interventional clinical study within the previous 30 days
19. Any other concurrent disease or illness that, in the opinion of the investigator, makes the patient unsuitable for the study
20. Major ophthalmologic comorbidities (ex: ruptured globe, retinal vascular occlusive disease, retinal artery occlusion, anterior ischemic optic neuropathy, media opacification due to corneal abnormalities or cataract that prevent ocular and optical coherence tomography examination, glaucoma, age-related macular degeneration, history of intravitreal injections, and macular edema)
21. Patients who have received chemotherapy in the last 12 months
22. Patient with a QTc of 450 msec or greater (or 500 msec or greater in those with known IVCD, RBBB, or LBBB) at baseline will be excluded.
Placement of Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Central Veins

Balloon angioplasty is used to open up a narrowing that forms in hemodialysis fistula. Two areas of particular problems are the terminal portion of the cephalic vein near the shoulder and the central veins in the chest. Although angioplasty is standard of care the treated narrowed segments of vein mostly renarrow within 3 months requiring retreatment to keep your dialysis access functional. Recently there has been introduction of a new technology called a covered stent graft. Initial studies suggest that placing this device across the area of narrowing leads to dialysis access staying open longer and needing less angioplasty treatments.

This study is designed to compare angioplasty (standard of care) versus using a covered stent graft. The investigators will then look at the dialysis records and future fistulograms to see if there is decreased flow through the fistula at 3, 6 and 12 months after the initial procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Hemodialysis patient with a mature forearm or upper arm access that was created \> 2 months before enrollment in study.
2. The patient is ≥ 18 years of age.
3. The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
4. The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements.
5. The patient or his/her legal guardian is willing to provide informed consent.
6. The patient has lesions that meet the angiographic inclusion / exclusion criteria and induce clinical, hemodynamic or functional abnormality.

Exclusion Criteria:

1. The patient has a known or suspected systemic infection.
2. The patient has a known or suspected infection of the hemodialysis access and / or bacteremia.
3. The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (\>10 mg per day), cyclosporine, tacrolimus, or cyclophosphamide.
4. The patient has known bleeding disorder (e.g., hemophilia or von Willebrand's disease).
5. The patient has known sensitivity to heparin.
6. The patient is scheduled for a live donor kidney transplant.
7. The patient is enrolled in another investigational study or another access maintenance trial
8. The patient has comorbid conditions that may limit their ability to comply with the follow-up requirements
9. Life expectancy is ≤ 24 months.
10. The patient has an untreatable allergy to radiographic contrast material.
11. The patient is pregnant.
12. In the opinion of the operating physician, the patient's hemodialysis access circuit is unsuitable for endovascular treatment.
13. The patient's access is planned to be abandoned within 1 year.
14. The patient has indwelling catheters (dialysis, pacemakers, ports).
15. The patient has a central vein stent that would lead to jailing of the internal jugular vein.
16. The patient experiences angioplasty-induced venous rupture.
17. The patient has a flow limiting dissection after angioplasty.
18. The patient's hemodialysis access is thrombosed.
Cervical Alignment Changes After Correction of Thoracic Adolescent Idiopathic Scoliosis With Thoracic Hypokyphosis

The sagittal alignment of Adolescent Idiopathic Scoliosis (AIS) curves has attracted growing interest in recent years, to the extent that it has become a pivotal point in the Lenke classification, with the introduction of a sagittal modifier. In particular, thoracic curves, partly due to the theory of anterior overgrowth, are almost invariably characterized by thoracic hypokyphosis, which can be severe (T5-T12 thoracic kyphosis \< 10°, that corresponds to a Lenke - sagittal modifier). However, the development of such a severely abnormal sagittal alignment has consequences that are not limited only to the thoracic region, but it rather results in a disruption of the entire sagittal spinal alignment. In fact, thoracic hypokyphosis tends to shift the C7SVA backward and to decrease the T1 slope. As a compensation, this ultimately leads to the development of a cervical kyphosis in order to translate the head forward and maintain global sagittal balance. While the interplay relationship between thoracic hypokyphosis and the development of cervical kyphosis has been well established in modern literature, the results regarding the amount of spontaneous correction of cervical kyphosis achieved after hypokyphotic AIS correction are conflicting. There are several papers in literature that study the complex relationship between AIS and cervical kyphosis, and they did not report any improvement in cervical lordosis after AIS correction, even when successful restoration of thoracic kyphosis (TK) was achieved. Conversely, other authors did report an improvement in cervical sagittal alignment after AIS correction. The aim of the present paper is firstly to assess the amount of spontaneous change in cervical sagittal alignment after correction of AIS with associated severe thoracic hypokyphosis (\<10°). Secondly, the aim of the study is to seek for any radiographical parameter able to predict the postoperative cervical sagittal alignment in these patients, via a multivariate regression analysis.


Eligibility Criteria:
Inclusion Criteria:

* AIS patients with a major thoracic curve (Lenke 1, 2 , 3 patterns), with associated severe thoracic hypokyphosis (TK \< 10°; Lenke - modifier) who underwent surgical correction at the participating centers was performed.

Exclusion Criteria:

* Non-idiopathic scoliosis, infantile, juvenile, or adult idiopathic scoliosis diagnosis were considered exclusion criteria
Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia

Oropharyngeal dysphagia induces aspirations which could be responsible of aspiration pneumonia and denutrition. It could be present in the majority of central neurological disease (degenerative or vascular disease), which explains that it is the first case of mortality in stroke. Two pilot studies realised by our research group aimed to demonstrate that sensitive transcutaneous electrical stimulation could improve swallowing coordination and reduce aspirations. This technique could be used at home.

The aim of this study is to demonstrate that sensitive electrical stimulation could improve oropharyngeal dysphagia in hemispheric stroke patients. 118 patients should be included in seven centers. Sensitive electrical stimulation will be applied either as active stimulation, either as a placebo. Active electrical stimulation will be realised at 80 hz during 30 minutes, under motor threshold and above sensitive threshold. It will be administrated via surface electrodes over the hyoid bone. Patients will be separated by randomisation.

Patients will be evaluated before and after 6 weeks of use. Methods will evaluation questionnaire, clinical examination and videofluoroscopy. The time of use will also be collected.

We wish to demonstrate that transcutaneous electrical stimulation is able to improve oropharyngeal dysphagia in stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years
* No contraindication to electrical stimulation
* Oropharyngeal dysphagia from 8 weeks diagnosed by videofluorosocpy with penetration aspiration scale \> 3 or a residue ≥ 50%
* Due to an hemispheric stroke
* Patients able to understand the videofluroscopy and questionnaires
* For women in age of procreation, to have a contraception, a pregnacy test will be done if not
* Able to swallow (a nasogastric tube is not a contraindication to participate)

Exclusion Criteria:

* Pregnancy or breast feeding
* Psychiatric illnes
* Swallowing disorders before the stroke
* Contraindication to electrical stimulation
Glycophosphopeptical AM3 A Potential Adjuvant in the Treatment of SARS-CoV-2

Introduction: In late 2019, a novel human coronavirus was detected in Wuhan, China, causing an outbreak of the severe acute respiratory syndrome - Coronavirus 2 (SARS-CoV-2). The disease that SARS-CoV-2 causes was named coronavirus disease 2019 (COVID-19). The virus rapidly spread throughout China and beyond, causing a public health challenge of global concern. Today, the availability of safe and effective drugs to treat COVID-19 remains limited, and symptomatic supportive treatments are the foundations of care. A natural glycophosphopeptical, AM3 has been shown to effectively improve the progression of infectious respiratory diseases with no side effects. In this context, AM3 could maintain an adequate immune status and serve as a therapeutic tool against COVID-19.

Study Aim: The effect of AM3 supplementation on the progression of COVID-19 patients. To evaluate the existence of significant differences between control and intervention groups in the progression of severe COVID-19 disease.

Methods: Double-blind randomized controlled clinical trial in collaboration with the Health Care Management of Soria. At the start of the trial, eligible patients will be randomized in a 1:1 ratio into two intervention and control groups. Block randomization with participants based on gender will be used. 120 patients with a confirmed diagnosis of COVID-19 by PCR and/or antigen testing will be randomized to the control group (placebo treatment) or experimental group (AM3 treatment), respectively. Patients will be randomly divided into two groups, the AM3 supplementation group (n=60) and the control group (n=60). The intervention group will be administered 2 indistinct capsules of AM3 (3 g/day of AM3) for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach. The control group will be administered a placebo of identical appearance of 2 indistinct capsules for a single daily intake in the morning, same dose as the experimental group (3 g/day of placebo), for 30 consecutive days.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* Males and females
* Confirmed clinical diagnosis of COVID-19 positive by Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) and/or SARS-CoV-2 Antigen Test performed 120 hours prior to patient inclusion in the study
* LDH 250-400 U/L
* Acceptance of informed consent signature
* IMC: 18.5-30
* Patients not participating in other trials
* No hepatic and renal disorders
* Possession of mental faculties to participate in the study

Exclusion Criteria:

* Patients with rare and specific viral diseases such as HIV
* Patients undergoing chemotherapy during the last 2 months
* Any other condition/pathology diagnosed by the medical specialist that prevents them from participating in the trial
* Intake of vitamin complexes or functional foods
Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL

The purpose of this clinical study is to assess the repeatability of objective refraction using auto refraction on subjects bilaterally implanted (implanted in both eyes) with the Fluid Accommodating IOL (FAIOL).

Subjects will be expected to attend 10 office visits from screening to exit. The total expected duration of participation for each subject in this study is approximately 12 months. The second eye surgery will take place within 7-15 days from the date of the first implanted eye. The primary endpoint will be collected at Month 1, following the 2nd eye implant date.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to attend all scheduled study visits as required per protocol
* 22 years of age or older
* Bilateral cataracts
* Corneal astigmatism ≤ 1.25 D
* Clear intraocular media other than cataract
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential, defined as all women who are physiologically capable of becoming pregnant and who are not postmenopausal for at least 1 year or are less than 6 weeks since sterilization, are excluded from participation if any of the following apply:

  1. are currently pregnant,
  2. have a positive urine pregnancy test result at V0,
  3. intend to become pregnant during the study period,
  4. are breast-feeding.
* Subjects taking medications that may affect accommodation, confound the outcome, or as per the Investigator's opinion may increase the risk to the subject
* Glaucoma
* Significant corneal or retinal abnormalities, per the Investigator's opinion, or other disease or pathology other than cataract expected to reduce postoperative vision
* Monocular patient, significant permanent visual function loss, or binocular vision anomalies as evaluated by specific testing
* Previous corneal procedure (such as LASIK, keratotomy, LRI) or plans to have additional corneal procedures during the study
* Systemic disease that could increase the operative risk or confound the outcome
* Other protocol-specified exclusion criteria may apply