cyrilzakka/clinical-trials huggingface dataset:
Changes in Retinal Nerve Fiber Layer Thickness Detected by OCT in Diabetic Retinopathy After Panretinal Photocoagulation

Panretinal photocoagulation reduces the risk of visual loss by 50% in patients with diabetic retinopathy. It is recognized that laser expansion into the retina may be associated with photoreceptor loss, retinal pigment epithelial hypertrophy and visual field loss.

Panretinal photocoagulation can cause alteration in retinal vascular permeability therefore, retinal thickness may be increased including retinal nerve fiber layer. On the contrary, it can damage retinal cells including ganglion cells, which may decrease the retinal nerve fiber layer thickness in the latter follow up period.

Peripapillary retinal nerve fiber layer can be measured by optical coherence tomography which is a non-invasive technique for obtaining high resolution cross sectional images of a tissue.

Pre laser assessment:

* Assessment of medical and family history
* Refraction and best corrected visual acuity
* Anterior segment examination using binocular slit lamp bi-microscopy.
* Posterior segment examination.
* OCT scan of peripapillary area

Post laser assessment ( at 1,3 and 6 months):

* Refraction and best corrected visual acuity.
* Anterior segment examination using binocular slit lamp bi-microscopy.
* Posterior segment examination.
* OCT scan of peripapillary area.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of proliferative diabetic retinopathy.
* Treated by panretinal photocoagulation.
* Age between 40-70 years old.

Exclusion Criteria:

* Patients with densely opaque media (as dense cataract or vitreous hemorrhage).
* Glaucomatous patients.
* Any other associated retinopathy.
The Effect of Resistance Training in Parkinson Disease: A Pilot Study

To investigate if resistance training exercises performed twice a week with or without gym equipment assistance in a 12-week period could improve balance in patients with Parkinson Disease (PD).

Methods: Sixty three patients with idiopathic PD (Hoehn and Yahr stage II - III) and preserved cognitive function will participate in this study. Patients will be randomized among three intervention groups: resistance training with free weights, resistance training with gym equipment and control group. Investigators will use static platform balance variables to assess the primary end-point outcome measures. For the secondary outcomes measures, most common clinical functional balances tests for PD will be applied: Berg Balance Scale (BBS), Mini-BESTest - Balance Evaluation (Mini-BESTest), Timed Up and Go test (TUG) and variables from dynamic posturography.

Parkinson's disease is a progressive neurodegenerative disease that affects motor functions and is characterized by bradykinesia, resting tremor, rigidity, and postural instability. Despite of pharmacological treatments, patients remain with deficits in balance, gait, autonomic system functions and cognition which impact on their quality of life.

The effects of resistance training on PD are still controversial when balance and improvement on functional tests are the targets.

Since the results of previous studies about resistance training on balance are still controversial, more interventions are required to address the question if strengthening exercise may improve or not the balance of PD patients. Our exercises will target the trunk, leg and shoulder muscles because of their contribution on patient's posture.

Eligibility Criteria:
Inclusion Criteria:

* Age between 50 to 75 years old;
* Hoehn and Yahr stages II or III;
* Idiopathic Parkinson disease diagnosed according to the United Kingdom Parkinson's Disease Society Brain Research Centre Criteria, Institute of Neurology, London;
* Ability to walk independently without walking devices aid;
* Absence of orthopedic injuries or pain in joints that could interfere on training program;
* Stable medication regimen for PD treatment at recruitment stage;
* Mini Mental State Examination Scale (MMSE) ≥ to 27 for literate patients and schooling ≥ of 4 years of formal education;
* No cardiovascular instability;
* No pacemaker, decompensated metabolic disease, vestibular dysfunction, and stroke;
* Availability to come to the clinic twice a week;
* Not participating in other physical rehabilitation programs during and six months prior to the study.

Exclusion Criteria:

* Patients will be excluded if they refuse to participate, do not sign the consent form, have a diagnosis of secondary parkinsonism or present cognitive impairment.
Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI

The purpose of this study is to examine the effectiveness of a low carbohydrate diet on increasing dietary adherence and improving cardiometabolic risk factors among adults with spinal cord injury (SCI). Seventy overweight/obese adults with SCI will be randomized to one of two groups: 1) a reduced carbohydrate diet or 2): a "standard" diet (STD). Participants will take part in a 6-month behavioral lifestyle intervention implemented through a novel eHealth platform specially designed for individuals with SCI.


Eligibility Criteria:
Inclusion Criteria:

* SCI ≥ 1 year post injury
* able to use arms for exercise
* BMI of 22-50 kg/m2
* 19-60 years old
* reliable access to internet and smartphone
* have the ability to converse in English
* ability to prepare own food or have input into person responsible for food preparation

Exclusion Criteria:

* heart disease
* renal disease
* active pressure sore
* persons on medically restricted diets
Irreversible Electroporation of Unresectable Liver Tumors

The aim of this study is to evaluate the safety and feasibility of curative intended irreversible electroporation (IRE) in the treatment of liver tumors neighboring major vessels or bile ducts.

Patients can be included in the study if they have one or more malignant liver tumors unsuitable for resection and thermal ablation (due to proximity of major vessels or bile duct) or other established liver directed therapies.

Prior to inclusion all potential participant will be evaluated by the local multidisciplinary team, to insure fulfillment of the above-mentioned criteria. In general, the included patient will have tumors with \<1 cm of margin to major hepatic vessels or bile ducts, thereby not allowing for conventional treatments because of risk of i.e. hemorrhage, biliary tract damage, liver failure or ineffective ablation due to heat sink.

IRE will be done under general anesthesia as an in-patient procedure. Patients will be observed for at least 24 hours after IRE.

Patients will attend CT scans 1, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post-IRE according to national guidelines (for follow-up after radiofrequency ablation (RFA)). Patients will attend the out-patient clinic after 1, 3, 6, 9, 12, 18 and 24 months. During the follow-up period, patients will be asked to fill out electronic forms monitoring pain, quality of life and nutritional status. After 24 months the patients will only be followed with CT scans in accordance with the mentioned schedule. Data collection for scientific purposes will stop when the last included patient has been followed for at least 24 months or when the study period concludes.

In case of multiple liver tumors, where a conventional treatment approach is not possible due to a single lesion being too close to major vessels or bile ducts, IRE may be used in conjunction to conventional therapy.

Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary cancer of the liver.
* Largest tumor diameter ≤5 cm in any plane.
* Tumor must be deemed as unresectable and unsuitable for other established curative liver directed therapies.
* Treatment must be given with curative intent.
* Patients must be able to give informed consent.

Exclusion Criteria:

* Radiological signs of synchronous intra- or extrahepatic disease, unless curative intended therapy is planned.
* Tumor is inaccessible e.g. due to venous dilation etc. (assessed with preoperative ultrasound)
* American Society of Anesthesiologists (ASA) score \>3
* Eastern Cooperative Oncology Group (ECOG) performance status \>2
* Child-Pugh class C
* International Normalized Ratio (INR)\>1.5
* Pregnancy
* Persistent atrial fibrillation
* Implanted electronic devices e.g. cardiac pacemakers or other electrostimulators.
* Metal stents or other metallic objects near the ablation zone (unless the stent can be replaced with a plastic stent prior to IRE)
* Severe allergies to anesthetic agent, paralytic agent or any of the equipment used during treatment.
* Patient is referred from a hospital outside of Denmark
Endocytoscopy of Upper Gastrointestinal Tract in Acute Graft-versus-host Disease: a Pilot Study

The goal of this clinical trial is to test the assess the diagnostic effectiveness of endocytoscopy in patients with underlying UGI aGvHD. The main question it aims to answer is: the effectiveness of ECS for diagnosing UGI aGvHD. Participants will undergo endoscopy, endocytoscopic evaluation and biopsy simultaneously. If there is a comparison group: Researchers will compare endoscopic, endocytoscopic and pathologic findings of these patients.


Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 14 years
* developed UGI symptoms within first three months after engraftment or during the tapering of immunosuppressive agents

Exclusion Criteria:

* \< 14 year
* with underlying gastrointestinal disease before allo-HSCT
* incomplete medical information
Long-term Adverse Effects After Bariatric Surgery on Oesophagus Epithelium

The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on oesophageal symptoms and disease, including the presence of Barrett oesophagus ≥ 5 years post-surgery.

Bariatric surgery shows impressive results in terms of weight loss and resolution of comorbidities. Still, there are questions as to the frequency of long-term adverse effects: the prevalence and causes of post-operative swallowing disorders and reflux disease are uncertain. Recently, independent study groups described a high incidence of Barrett oesophagus post LSG. Additional research is urgently needed.

The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on oesophageal symptoms and disease, including the presence of Barrett oesophagus ≥ 5 years post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received laparoscopic gastric bypass or laparoscopic sleeve gastrectomy ≥ 5 years ago as a primary bariatric procedure will be eligible for this study.

Exclusion Criteria:

* Patients who received laparoscopic gastric bypass or laparoscopic sleeve gastrectomy as a secondary bariatric procedure (e.g. after gastric banding),
* Patients who received a secondary bariatric operation after laparoscopic gastric bypass or laparoscopic sleeve gastrectomy( e.g. biliopancreatic diversion)
Pharmacogenomic Contributions to Trihexyphenidyl Biotransformation and Response in Children With Dystonic Cerebral Palsy

This study looks at how a medicine called trihexyphenidyl works in children with dystonic cerebral palsy. The study aims to understand how trihexyphenidyl is broken down and used in the body of pediatric patients and whether this is impacted by a person's genetics. Information from this study will also be used to design future clinical trials.

This is a 16-week single-arm nonrandomized pilot study of trihexyphenidyl in children with dystonic cerebral palsy (DCP) to 1) evaluate the pharmacokinetics (PK) of trihexyphenidyl (THP) and variation in PK parameters between CYP2D6 and CYP2C19 genotypes and 2) evaluate the feasibility of a future exposure-controlled clinical trial of THP.

Eligibility Criteria:
Inclusion Criteria:

* Ages 5-17 years of age
* Diagnosis of cerebral palsy and dystonia causing interference
* Parent/legal guardian of a child with a diagnosis of cerebral palsy and dystonia
* Parent/legal guardian is willing and able to provide informed permission/assent for the study

Exclusion Criteria:

* Previously or currently taking trihexyphenidyl
* Patients turning 18 years of age within the study period (16 weeks from Study Day 1)
* A language barrier for the patient that precludes communication and/or the ability to complete study-related requirements
Speech Outcome After Partial Adenoidectomy in Patients With Risk of Hypernasality

Adenoid hypertrophy is a common cause of airway obstruction in children; it may lead to mouth breathing, nasal discharge, snoring, sleep apnea, and hyponasal speech.

Adenoid hypertrophy is a common cause of airway obstruction in children; it may lead to mouth breathing, nasal discharge, snoring, sleep apnea, and hyponasal speech. It also contributes to the pathogenesis of rhinosinusitis and recurrent otitis media. However, the adenoid lies in the posterior nasopharyngeal wall and may act as a pad against the palate facilitating velopharyngeal closure, especially in patients with palatal abnormalities; Its presence can compensate for a short or poorly mobile palate. Following adenoidectomy, compensation is eliminated and velopharyngeal insufficiency (VPI) may result. Therefore, patients with palatal abnormalities (such as poor palatal mobility, short palate, occult submucosal cleft palate, scarred palate after previous tonsillectomy, and repaired cleft palate) are at high risk to develop hypernasality after complete adenoidectomy, and in such situations conservative or partial adenoidectomy is performed

Eligibility Criteria:
Inclusion Criteria:

1. Patient with symptoms of adenoid hypertrophy.
2. High risk to VPI:

   1. Short palate.
   2. Scarred palate after previous tonsillectomy.
   3. Occult submucous cleft.
   4. Deep pharynx.
   5. Repaired cleft palate.

Exclusion Criteria:

* Any neurological deficit, muscular disorder or structural defects of the palate (as cleft palate).
Study of Interest on Cervical Ultrasound Exploration for Association With Difficult Intubation

The purpose of this study is to determine if cervical ultrasound exploration can predict difficult intubation better than main validated clinical criteria.

The purpose of this study is to determine if cervical ultrasound exploration can predict difficult intubation better than main validated clinical criteria in general surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* patient consent

Exclusion Criteria:

* patient nonconsent
* age under 18
* cervical surgery
Pain Inhibitory Effects of Other Pain Induced by Mechanical Pressure at Different Intensities

The objective is to estimate the effects on pain thresholds of a painful mechanical stimulus on the upper trapezius at moderate intensity compared to mild intensity or non-painful.

The mechanical stimulus produced in manual therapy (MT) techniques elicits neurophysiological responses within the peripheral and central nervous system responsible for pain inhibition. Almost all types of MT elicit a neurophysiological response that is associated with the descending pain modulation circuit. But it has not been demonstrated whether this inhibition occurs through a conditioned pain modulation mechanism induced by painful mechanical stimulation that is carried out with manual therapy techniques.

Eligibility Criteria:
Inclusion Criteria:

* healthy male or female between 18 and 65 years
* Free of pain and with no history of chronic pain

Exclusion Criteria:

* Pregnant or having given birth within the last year
Low Dose Aspirin Alerts in High-Risk Pregnancies

The goal of this study is to assess the effect of an electronic health record (EHR) clinical decision support tool, also known as a best practice alert (BPA), on healthcare provider recommendations for low dose aspirin use in a high-risk pregnant patient population. The investigators hypothesize that the implementation of the EHR BPA tool will increase the healthcare provider's recommendation for low dose aspirin compared to current standard care.

Low dose aspirin (LDA) has been found to reduce the incidence of preeclampsia in high-risk pregnant patients. At a health system serving central and northeastern Pennsylvania, electronic health record data reveal that clinicians recommend an LDA regimen to only 60% of eligible high-risk pregnant patients, suggesting the need and opportunity for increased LDA recommendation. This study will assess the efficacy of an electronic health record based clinician-facing interruptive clinical decision support tool/best practice alert (BPA) aimed at increasing LDA recommendation for pregnant patients who are at high risk of preeclampsia.

Up to 704 patients will be randomized to account for possible 10% miscarriage and early termination rate as we require outcome data on a total of 640 patients for adequate power. Eligible patients will be randomized to a control group, where the clinician receives no BPA, and one experimental group, where the provider receives a BPA noting the patient is at high-risk and recommend the provider order LDA. If LDA is not recommended, there will be a required acknowledgment reason from the provider noting a rationale for not initiating a LDA regimen.

Eligibility Criteria:
Inclusion Criteria:

* Receiving prenatal care within Geisinger
* Initial prenatal visit prior to 28 weeks gestation
* Determined to be high risk for preeclampsia based on the modified United States Preventive Services Task Force and American College of Obstetrics and Gynecology criteria (at least 1 high risk factor)

Exclusion Criteria:

* Not pregnant
* No prenatal visit prior to 28 weeks gestation
* Maternal-Fetal Medicine only visits
* Not meeting the modified USPSTF high-risk criteria
* Contraindication to aspirin, including allergy
Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19

The aim of the study is to investigate the effect of cranial electrotherapy stimulation (CES), for one hour a day over 3 weeks pulmonary rehabilitation (PR) program on symptoms of anxiety in post-Covid patients.

Many patients recovering from Covid-19 develop sequelae related to the disease. In addition to lung issues, symptoms of Post-Covid/Long-Covid Syndrome include fatigue, brain fog, amyosthenia, insomnia, anxiety and depression. These symptoms play a major role in post-Covid patients recovery.

CES (Cranial electrotherapy stimulation) is a non-invasive therapy using low intensity alternating current applied through electrodes attached to the ear lobe.

CES has been used to improve the condition of non covid patients suffering from depression, anxiety, fatigue and cognitive disabilities. This is thought to be due to a change in electric waves of the brain with an increase of alpha-waves and a decrease of beta- and delta-waves, as well as a change of concentration of neurotransmitters, e.g. beta-endorphin or serotonin.

Therefore, this study aims to investigate the effect of CES in addition to normal PR, compared to PR alone on symptoms (e.g. anxiety) in post-Covid patients.

Hypothesis: Three weeks of PR including daily use of CES for one hour will have a positive effect on symptoms of anxiety.

Trial: 40 patients post-Covid reffered to inpatient PR will be recruited and allocated to one of two different groups. Group1: Anxious participants, Group 2: Non anxious participants. Within groups particpants will be randomized to intervention or control/sham. Intervention group will be using a functional device, and the other using a non-functional, SHAM device.

Anxiety is evaluated using the Beck anxiety inventory on admission and at discharge from PR.

Questionnaires to evaluate fatigue, depression and insomnia are the Fatigue Assessment Scale, PHQ-9, PSQI).

A diary will be kept by each participant with a log of general health and mood over the PR program.

Eligibility Criteria:
Inclusion Criteria:

Group with anxiety:

* high Beck Anxiety Inventory Score
* ≥18 years
* post SARS-CoV-2 infection
* written consent

Group without anxiety:

* low Beck Anxiety Inventory Score
* ≥18 years
* post SARS-CoV-2 infection
* written consent

Exclusion Criteria:

* acitve implants (cardiac pacemaker,...)
* pregnancy, lactation period
Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome

The specific hypotheses are:

Gluten supplementation for four weeks increases small intestinal permeability and accelerates colonic transit in patients with irritable bowel syndrome with diarrhea (IBS-D) or functional diarrhea (FD) who are HLA-DQ2 positive.

The study design is a double-blind, randomized, controlled, parallel-group, 6-week study comparing the effects of gluten rich versus gluten free diets in diarrhea or diarrhea predominant IBS patients. All participants will keep a daily bowel pattern diary throughout the study. All participants will have negative serum tissue transglutaminase (TTg) assay, and anti-endomysial antibody test, if TTg is positive or equivocal. All participants will have the following studies performed both before and after the 4-week dietary intervention:

1. Stool samples to check markers of inflammation such as fecal calprotectin.
2. Blood samples to check markers of inflammation and for genetic testing.
3. After ingestion of the mannitol, lactulose and sucralose sugars, urine samples to indirectly measure small intestinal and colonic permeability.
4. After sedation, upper gastrointestinal endoscopy and flexible sigmoidoscopy to obtain 6 mucosal biopsies from the small bowel and sigmoid colon for immunohistochemical analysis.
5. Scintigraphy to measure gastrointestinal transit.

Eligibility Criteria:
Inclusion criteria:

1. Diarrhea or diarrhea predominant IBS patients
2. Age 18 to 65
3. BDQ confirms presence of IBS-D or functional diarrhea, positive by Rome III criteria
4. No restrictions on Hospital Anxiety Depression score
5. No abdominal surgery (except appendectomy and cholecystectomy)

Exclusion criteria:

1. Serum tissue transglutaminase IgA or IgG positive or medical record of small bowel biopsy suggestive of celiac disease
2. Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
3. Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability)
4. Use of oral corticosteroids within the previous 6 weeks
5. Ingestion of artificial sweeteners such as SplendaTM (sucralose), Nutrasweet TM(aspartame), lactulose or mannitol 2 days before the study begins, e.g., foods to be avoided are sugarless gums or mints and diet soda
6. Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins.
7. Any females who are pregnant or trying to become pregnant (due to radiation exposure)
8. Bleeding disorders or medications that increase risk of bleeding from mucosal
Comparison of Surgical Outcomes Between Pre Sympathetic Plexus and Post Sympathetic Plexus Approach

There would be no difference in the risk of sympathetic plexus damage between the pre sympathetic plexus approach and the post sympathetic plexus approach.

Compare the incidence of sympathetic chain injury between front and back of sympathetic approach in oblique lumbar interbody fusion

Eligibility Criteria:
Inclusion Criteria:

* Patients with lumbar degenerative disease needs a lateral lumbar interbody fusion of 1-2 segments between L2 to S1.

Exclusion Criteria:

* Patients who had previously had lumbar surgery
* Patients with muscle weakness of motor grade III or lower
* Patients with neuropsychiatric diseases such as depression
* Patients with musculoskeletal disease, inflammatory musculoskeletal disease, or infection
* Patients with cancerous disease
* Patients who do not want to participate in the study