cyrilzakka/clinical-trials huggingface dataset:
Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances

The objectives of this study are:

* To assess the effect of ophthalmic phentolamine mesylate in mesopic conditions on the four endpoints:

  1. Contrast sensitivity
  2. Low contrast visual acuity
  3. Wavefront aberrometry
  4. Subjective questionnaire
* To assess the safety of ophthalmic phentolamine mesylate

Double-masked, placebo-controlled, single-dose Phase 2 study in 24 patients experiencing severe night vision difficulties to evaluate ocular and systemic safety and efficacy following administration of one drop of phentolamine mesylate 1.0% QD in each eye for 1 day.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥ 18 years of age
2. Currently experiencing severe night vision difficulty as reported subjectively
3. At least two patches below the normal range at any two frequencies in Contrast Sensitivity done under mesopic conditions with glare
4. Improvement in low contrast visual acuity (LCVA) in dim light during illumination of contralateral eye
5. Good general health
6. Written informed consent to participate in this trial
7. Ability to comply with all protocol mandated procedures and to attend all scheduled office visits

Exclusion Criteria:

1. Patients with untreated cataracts grades 1-4
2. Patients who wear contact lenses
3. Less than 5 weeks post-refractive surgery (LASIK or PRK)
4. Less than 5 weeks post intraocular lens insertion
5. Low blood pressure (systolic \<120 mm Hg or diastolic \<80 mm Hg)
6. A history of heart rate abnormalities
7. Administration of any investigational drug within 30 days of study initiation
8. Use of any eye drops with a pharmacologic effect on the pupil within 7 days of Visit 1
9. Use of any systemic alpha adrenergic antagonists (Appendix 1)
10. Known local or systemic hypersensitivity to adrenergic antagonists
11. For women of childbearing potential: currently pregnant or lactating, or unwilling to use birth control during the study
AbioCor Implantable Replacement Heart

Abiocor is a post market approval study for an Implantable Replacement Heart. This post approval study is currently on hold.


Eligibility Criteria:
Inclusion Criteria:

* Patients in severe biventricular end stage heart disease who are not cardiac transplant candidates and who are adults less than 75 years old, require multiple inotropic support, are not treatable by LVAD destination therapy, and are not weanable from biventricular support if on such support.

Exclusion Criteria:

* Patients with other irreversible end organ dysfunctions that would compromise survival, having in clinical assessment a more than 30% chance of survival beyond 30 days, inadequate psychosocial support, or patients in whom fit is a problem, based on preoperative noninvasive anatomical assessment showing that the thoracic volume is unable to accommodate the device.
Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level

This randomized controlled study evaluates the effect of acupressure application on the anxiety level patients undergoing cystectomy surgery. The hypothesis of this study is that acupressure reduces anxiety levels and stabilizes hemodynamic parameters.

In the study, 60 patients will randomly assigned to acupressure and placebo acupressure groups. To the acupressure group (n = 30), an average of 15 minutes will be applied to the HT7 (heart), LI4 (liver) and EX-NH3 (the point between the two eyes). In the placebo acupressure group (n = 30), the points 1.5 cm away from the HT7, LI4, and EX-NH3 points will be applied for an average of 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the research (signing the Informed Consent Form),
* Conscious and cooperative
* Speaks and understands Turkish,
* 18-65 years old,
* Before surgery,
* Stable general condition,
* No sensitivity in the area where acupressure/placebo acupressure will be applied,
* 15 July 2022 - 15 July 2023 hospitalized in the urology clinic,
* No active COVID-19 infection,
* Patients without any psychiatric diagnosis will be included.

Exclusion Criteria:

* Those who do not agree to participate in the research (who do not sign the Informed Consent Form)
* Conscious and uncooperative,
* Not speaking or understanding Turkish,
* Not between the ages of 18-65,
* No surgical intervention planned,
* The planned emergency surgical intervention,
* Unstable general condition,
* Sensitivity in the area where acupressure/placebo acupressure will be applied,
* Active COVID-19 infection,
* 15 July 2022 - 15 July 2023 who did not stay in the urology clinic,
* Patients with current psychiatric diagnosis will not be included in the study.
Evaluation of Using Iliac Crest With and Without Platelet-Rich Fibrin in Repair of Congenital Alveolar Cleft

A randomized clinical trial aims to evaluate the clinical and radiographic outcomes of the repair of congenital alveolar clefts using Iliac crest graft with and without mixing with platelet-rich fibrin

Alveolar clefts occur in response to deviations from normal development in the growth, exposure, and fusion of the frontal eminence. The most common alveolar portion of the cleft is located between the central incisors and canines. The treatment of alveolar clefts is multidisciplinary and aimed at restoring normal ridge contour and functionality. Surgical wound closure is insufficient to repair bony defects, Additional materials are needed for these types of defects, such as bone grafts. Aim: The aim of this study is to evaluate the efficiency of using iliac crest bone graft with and without platelet-rich fibrin in repair of alveolar clefts. Methodology: This study will be conducted on 16 patients with alveolar clefts. The patients will be divided equally and randomly into 2 groups: Group 1 : 8 patients will be treated with iliac crest bone graft only (control group).Group 2: 8 patients will be treated with iliac crest bone graft with platelet-rich fibrin (study group).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with congenital alveolar cleft who need secondary alveolar cleft repair.
2. Patients who are medically fit for surgery under general anaesthesia

Exclusion Criteria:

1. ASA 4 OR ASA 5 patients
2. Uncooperative patients
Time to Lose the Weight? Comparison of Weight-based and Non-weight-based Vasopressors for Septic Shock

At present, there is conflicting evidence regarding outcomes in patients with septic shock receiving weight-based vasopressor (WBVP) versus non-weight-based vasopressor (NWBVP) dosing strategies. At MCMC, a weight-based strategy is in place whereas MDMC, MMMC and MRMC currently utilize a non-weight-based dosing strategy. Obese patients (BMI \> 30) receiving either strategy may potentially be receiving substantially more or less vasopressor exposure compared to their non-obese (BMI \< 30) counterparts. Determining total vasopressor exposure and assessing clinical outcomes would benefit our institution and others by providing optimal vasopressor dosing strategies in obese and non-obese patients. There is a difference in clinical outcomes between patients receiving weight-based and non-weight-based vasopressor dosing strategies. There is a difference in total vasopressor exposure between obese and non-obese patients utilizing WBVP and NWBVP strategies.

Vasopressors are a mainstay of therapy for patients with septic shock to achieve and maintain hemodynamic stability.1 Both weight-based and non-weight-based dosing recommendations exist with no clear evidence that one is better than the other.3-10 However, in light of the obesity epidemic and emerging evidence regarding the dangers of excessive catecholamine exposure, an evaluation of dosing practices is warranted. The aim of this study is to determine whether clinical outcomes differ between patients receiving weight-based and non-weight-based vasopressor dosing strategies for septic shock. This is a multicenter, retrospective chart review. Patients admitted to MDMC and MCMC from 4/1/2017-8/31/2019 will be identified through the electronic medical record utilizing ICD codes for sepsis and septic shock. Patients meeting study inclusion criteria will be analyzed as described below. Outcomes will be assessed between patients receiving WBVP and NWBVP with planned subgroup analysis in each group between patients with BMI \< 30, 30-49, and \> 50.

Eligibility Criteria:
Inclusion Criteria:

* ICU admission
* Medical admission type
* Received NE, epinephrine (EPI), phenylephrine (PE), or dopamine (DA) for septic shock
* Received NE/EPI/PE/DA for \> 24 hours
* Age ≥ 18 years

Exclusion Criteria:

* Non-sepsis indication for vasopressors
* Surgical or trauma admission type
* ICU length of stay \< 24 hours
* Pregnant
Shoe Inserts for Treating Osteoarthritis of the Knee

This trial will test shoe inserts for the treatment of knee osteoarthritis, the most common form of knee arthritis. Those with disease on the inner (medial) aspect of the knee will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Medial knee osteoarthritis
* Pain
* No foot problems
* Lives in Boston, Massachusetts Metro area
Metronomic Oral Vinorelbine Combination With Tislelizumab in EGFR/ALK-negative Advanced NSCLC

To evaluate the efficacy of metronomic chemotherapy combination with tislelizumab in EGFR/ALK-negative advanced NSCLC patients intolerant to first-line standard chemotherapy.

This study is a clinical intervention study. The patients who comfirm the criteria will be treated with tislelizumab plus metronomic oral vinorelbine. The patients will be followed up until the tumor progressed, and the efficacy (PFS, ORR, DCR) of tumor therapy were evaluated. Drug administration regimen: tislelizumab 200mg intravenous drip once every 3 week3; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.

Eligibility Criteria:
Inclusion Criteria:

* Has a histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b-American Joint Committee on Cancer \[AJCC\] 8th edition) squamous NSCLC or non-squamous NSCLC without sensitising EGFR or ALK alterations.
* Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment.
* Has not received prior systemic treatment for metastatic NSCLC.
* Has a life expectancy of at least 3 months.
* Has fully understood this study and voluntarily signed a written informed consent form.
* Deemed unsuitable by the investigator for any platinum-doublet chemotherapy due to poor performance status (ECOG performance status of 2-3)；\>= 75 years of age；substantial comorbidities; contraindication(s) for any platinum-doublet chemotherapy.

Exclusion Criteria:

* Histological or cytological confirmation of small cell lung cancer.
* Has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has disorders of oral medication.
Clinical Trials of Continuous Oxygen Therapy Combined With Blue Light Deprivation in the Treatment of Retinitis Pigmentosa

The purpose of this study is to investigate the role of continuous oxygen therapy combined with blue light deprivation in prevention and control of retinitis pigmentosa, in order to find a new strategy of treatment for retinitis pigmentosa.

Retinitis pigmentosa (RP) is one of of the major causes of blindness in ocular diseases.Up to now, the etiology of RP remained unclear, and there are no effective therapeutic methods. Several studies had showed that the retina of RP may be anoxic, and oxygen therapy, such as hyperbaric oxygen (hyperbaric oxygen, HBO) treatment, had shown a definite effect on RP. The investigators' previous researches also found that the retinal vessel oxygen saturation in patients with RP who were older than 40 years were significantly lower than normal controls, suggesting that oxygen may play an important role in the development of RP. Besides, many studies have revealed that blue light could damage retina pigment epithelium cells and photoreceptor cell specially. Therefore, investigators will combine continuous oxygen therapy and blue light deprivation therapy in the treatment for RP in this study, in order to find a new strategy of treatment for RP.

Eligibility Criteria:
Inclusion Criteria:

1. Severe patients with RP who meet the following criteria: (1) the EDTRS visual acuity of the good eye \< 0.3 (low vision);(2) the radius of central visual field\< 10 °(low vision)
2. Age range from 18 to 60 years old, sex unlimited
3. Able to adhere to treatment for more than 12 months
4. Willing to participate in this trial, and sign the informed consent

Exclusion Criteria:

1. Serious opacity of cornea, lens or vitreous body which can't have clear fundus examination
2. Patients with severe systemic diseases who was unable to tolerate the examinations, such as heart failure, respiratory failure, sepsis, severe anemia, kidney disease, history of eye surgery and so on
3. Patients who was unable to tolerate oxygen treatment, such as severe pulmonary edema, deformity of the respiratory tract, respiratory tract infection, tuberculosis, patients with pregnancy, and so on
Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL

The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).


Eligibility Criteria:
Inclusion Criteria:

* Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation.
* 50\~75 years of age
* \<1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.

Exclusion Criteria:

* Patients with pre-existing conditions that could skew the results.
* Any of conditions before and during surgery specified in the product information.
Proteasomal Inhibition for Patients With Mis-sense Mutated Dysferlin

Dysferlin is a protein with an important role in the repair of muscle surface membranes. Mutations in dysferlin cause different forms of muscular dystrophies. Dysferlinopathies are inherited in an autosomal recessive manner, and many patients with this disease harbor mis-sense mutations in at least one of their two pathogenic DYSF alleles. These patients have significantly reduced or absent dysferlin levels in skeletal muscle, suggesting that dysferlin encoded by mis-sense alleles is rapidly degraded by the cell's quality-control system. In a series of in-vitro experiments we showed that mis-sense mutated dysferlin can be salvaged from degradation by proteasomal inhibition. This resulted in an increase of functional dysferlin protein and a subsequent repair of plasma membranes of cultured patient-derived muscle cells. In this proof-of-concept study we would like to test wether proteasomal inhibition can salvage mis-sense mutated dysferlin in patients harboring certain dysferlin mis-sense mutations.


Eligibility Criteria:
Inclusion Criteria:

* must carry at least one allele of a salvageable mis-sense mutation of dysferlin
* Age ≥ 18 years
* Written informed consent

Exclusion Criteria:

* Bleeding disorder
* Acute or chronic kidney failure (CCL \<50 ml/min)
* Advanced liver disease or active hepatitis
* Congestive heart failure NYHA III and IV
* Pregnancy or nursing
* Immunosuppression (prednisolone doses below 20 mg/d are allowed)
* Therapy with strong inhibitors of cytochrome P450 3A4
* HCV or HIV infection
* Regular alcohol consumption (\>14 drinks a week)
* Drug addiction
A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers

This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place over approximately two and a half months and will consist of three phases: a screening visit to determine eligibility for the study, a 5-dosing period treatment phase, and an end-of-study visit.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects between 18 and 55 years of age (inclusive)

Exclusion Criteria:

* Evidence or history of clinically significant disease;
* History of obstructive sleep apnea;
* Positive urine drug test.
STOP OVarian CAncer; Implementation of the Opportunistic Salpingectomy in the Netherlands

The aim of this study is to optimize implementation of the opportunistic salpingectomy throughout the Netherlands.

The investigators aim to optimize implementation of opportunistic salpingectomy throughout the Netherlands. The investigators will evaluate the implementation by enrolling patients in a database to evaluate healthcare experiences and to register EOC diagnosis and vital status through yearly PALGA (the nationwide network and registry of histopathology and cytopathology in the Netherlands) and municipal administration searches. In addition, the investigators will perform medical record check to assess which percentage of eligible women have been offered OS.

The investigators expect that a decision aid will be a necessary tool for the decision whether women opt for an OS or not, based on their personal values. After development of the tool(s), the investigators will evaluate the implementation process.

Eligibility Criteria:
Inclusion Criteria:

* Age from 30 years
* Undergoing gynaecological surgery in which currently both ovaries and fallopian tubes would be preserved
* Childbearing completed
* Able to understand the written or spoken Dutch language
* Consent for enrolment in database
* Consent for yearly checks of PALGA database and municipal administration

Exclusion Criteria:

* Age under 30 years
* Undergoing surgery without residual ovarian tissue
* Child wish
* Unable to understand the written or spoken Dutch language
* Previous bilateral salpingectomy
* Previous bilateral salpingo-oophorectomy
Immune Biomarkers Related to Bone Pathology in Patients With Type 1 Gaucher Disease

Bone-related problems represent the principal unmet medical need in Gaucher disease (GD). 75% of GD type 1 patients develop skeletal complications, including bone remodeling defects, osteopenia, osteoporosis, marrow infiltration, avascular necrosis, and osteolysis. However, the underlying cellular/molecular basis of bone involvement and related complications in GD are not fully known. Neither are there any bone-specific markers associated with individual bone pathology. Early diagnosis of bone disease is the key issue for planning individual therapy to prevent and reverse bone disease in GD.

This clinical observational study is designed to identify specific biomarkers for bone involvement in patients with GD1 with decreased bone density and/or bone structural abnormalities

Aims:

1. Identify novel immune cell surface and biochemical markers in peripheral blood correlating with bone involvement in GD.
2. Assess the correlation between cytokine levels in peripheral blood and the severity of bone involvement in GD.
3. Assess the relationship between glycosphingolipids accumulation and macrophage activation with specific bone markers and GD severity.

Eligibility Criteria:
Inclusion Criteria:

* To be enrolled in this study the subject must meet the following criteria

  1. Subject is greater than 16 years old but not older than 90 years
  2. Signed Informed Consent/Assent
  3. Subject is able and willing to sign informed consent or assent
  4. If the subject has GD1, the must have a confirmed diagnosis of Gaucher disease by

     * GCase enzyme activity
     * DNA analysis demonstrating pathogenic variants in the GBA gene

Exclusion Criteria:

* a) Have evidence of hepatitis B, hepatitis C infection or any other chronic infectious disease b) Be pregnant or breastfeeding
Prediction of 3D Effect of Brace in Idiopathic Scoliosis Treatment Using EOS Imaging System and "Anatomic Transfer".

In this study, the accuracy of a new numerical method is evaluated for predicting the 3D effect of brace on idiopathic scoliosis. This method results from the combination of several innovative technologies: the EOS imaging system and the anatomical transfer developed by Anatoscope. This is an essential step in validating a digital tool that can be used in routine clinical practice.

The whole process of brace production remains unchanged. In this study, the simulation software will not be used to influence the medical decision or the manufacture of the brace. In parallel with conventional production, anatomical transfer will be used in the deformed digital model of the trunk to simulate the effect of conventional brace on the spine. This modeling will be used to compare the correction of the conventional brace observed on the spine with EOS imaging system, with that simulated by the software.

EOS Tranfert study is a observationnal, prospective, monocentric, unrandomized and controlled study. This research doesn't modify care of the patient

Eligibility Criteria:
Inclusion Criteria:

* patients aged 9 to 15 years;
* with idiopathic scoliosis (left lumbar and / or right chest);
* with moderate scoliosis: Cobb angle evaluated between 15 ° and 35 °;
* requiring brace placement or renewal;
* having signed a non-objection form
* affiliated with, or receiving, social security

Exclusion Criteria:

* patient/parents who refuse to sign a non-objectiont form
* with unstable medical condition
* person deprived of liberty by judicial or administrative decision
* person under legal protection or unable to express their consent
* person hospitalized for psychiatric care
Strokecopilot: A Precision Medicine Tool in the Stroke Emergency

Ischemic stroke or cerebral infarction (CI) is an immediate emergency affecting approximately 100,000 - 150,000 patients each year in France and is managed in the neurovascular intensive care unit (NICU). Recanalization treatments can prevent disability, but patients must be carefully selected. Knowledge in this field is evolving rapidly, which tends to make management more complex and personalized. In addition, the permanence of thrombolysis channels involves neurologists of all expertise. Decision support tools are desirable to enable precision medicine in stroke. Strokecopilot is a web application developed by the principal investigator. Its algorithm contextualizes the patient in a set of evidence-based medicine references (recommendations and clinical trials) and gives the result of their cross-referencing to the user to indicate theoretical indications for intravenous thrombolysis and mechanical thrombectomy.


Eligibility Criteria:
Inclusion criteria:

- Adult patient (\>18 years old) admitted to the thrombolysis unit of the University Hospital of Strasbourg from January 01, 2017 to December 31, 2021

Exclusion criteria:

- Subjects who have expressed their opposition to the use of their data for scientific research purposes.