cyrilzakka/clinical-trials huggingface dataset:
Surgical Treatment of Peri-implantitis With and Without Systemically Adjunctive Antibiotics

The purpose of this study is to investigate if the use of systemic adjunctive antibiotics in the treatment of periimplantitis is needed.

This study will give the opportunity to draw scientifically based conclusions on the recommendations of the use of adjunctive systemic antibiotics in the treatment of peri-implantitis. This study will also be able to determine the ecological impact on the oropharyngeal and intestinal microflora between different antibiotic treatments. The lack of knowledge in this area has been highlighted by the Food and Drug Administration and The Swedish Council on Health Technology Assessment (SBU)

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18-65 year
2. Patients who has been referred by a general dentist to a specialist clinic in periodontology for treatment of peri-implantitis.
3. Having sign of peri-implantitis around at least one osseointegrated dental implant that has been in function for ≥ one year
4. Peri-implantitis is diagnosed when; PPD of ≥ 6mm can be found at a dental implant in association with BOP and/or suppuration together with the loss of marginal alveolar bone of more than 2 mm detected on intraoral radiographs (giving radiographic exposure of at least ≥ 3 fixture threads).
5. Partially or completely edentulous subjects with healthy or treated periodontal conditions enrolled in a regular supportive program.
6. Full-Mouth Plaque Score (FMPS) ≤ 25
7. Signed informed consent

Exclusion Criteria:

1. Known allergy to amoxicillin, penicillin (PcV), metronidazole or betalactamic
2. Contraindication for dental surgical treatment (i.e. immunocompromised, uncontrolled DM (B-GHb-A1C 8-9 %, 64-75 mmol/mol), osteoporosis, I.V bisphosphonate treatment due to malignancy, pregnant and lactating women).
3. Incapability to perform basal oral hygiene measures due to physical or mental disorders.
4. Received systemic antimicrobial therapy in the past three months.
5. Currently on allopurinol, digoxin, disulfiram, lithium, busulfan, 5-fluorouracil, methotrexate, phenytoin, cyclosporine and warfarin.
6. Known severe chronic peripheral or central disease of the nervous system
7. Known alcohol abuse
8. Known hepatic encephalopathy
9. Known lactose intolerance, galactose intolerance
10. Untreated periodontal condition.
11. Implant showing sign of mobility.
12. Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond any transverse openings in hollow implants.
13. Any medical condition or on any concomitant medication that, in the opinion of the investigator, might interfere with the evaluation of the study objectives or jeopardize patient safety

Patients with xerostomia or having slow bowel motion will be excluded from the group of patients providing salivary and fecal samples.
A Comparison Study of Three Standard Elbow Wrist Hand Orthoses to Limit Forearm Rotation

The Researchers are trying to assess which splint limits forearm rotation the best. These splints are commonly used in hand therapy to limit forearm rotation. This data will help hand surgery and hand therapy provide better outcomes.

Common upper extremity injuries often need to heal with no wrist and forearm range of motion. Forearm range of motion includes supination and pronation. Injuries that necessitate limiting forearm range of motion include fracture patterns involving the distal radioulnar joint (DRUJ), proximal radioulnar joint (PRUJ), triangular fibrocartilage complex (TFCC), both bone forearm fractures, ulnar shortening procedures, radial and ulnar osteotomies, DRUJ instability. Long arm orthoses, sugar tong orthoses and muenster style orthoses can all limit forearm rotation.

Past research has indicated common methods of immobilization to include the following: sugar tongs cast/orthosis, muenster cast/orthosis, long arm cast/orthosis/or short arm cast/orthosis, and an antirotation orthosis.

Currently, there are no research studies that compare the amount of forearm rotation in a traditional thermoplastic orthoses to newer materials such as a Delta Cast orthosis, or prefabricated muenster orthoses such as the Hely and Weber MTC Fracture Brace. The purpose of this study is to assess which orthosis-a traditional thermoplastic ulnar based muenster, a delta cast style muenster and the Hely and Weber MTC Fracture Brace-allows for the least amount of supination and pronation in a healthy population in the dominant extremity.

The researchers will assess the 3 different orthoses using a standard measuring device for pronation and supination. The participants will also be asked questions regarding comfort, fit, and style of each orthosis. 30 Participants data will be collected during the study.

Eligibility Criteria:
Inclusion Criteria:

* No prior wrist or elbow injuries on the dominant side of his/her body
* Ability to complete study in one sitting of 90-120 minutes
* Between the ages of 18 years and 100 years
* Ability to follow directions and speak and read English

Exclusion Criteria:

* Prior wrist or elbow injuries on the dominant side of his/her body
* Subjects with known rheumatoid arthritis deformities of the wrist or any prior wrist surgeries are excluded
Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D

The goal of this observational study is to investigate the changes of LBB EGM during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of ICD/CRT-D patients. The main question it aims to answer is:

• Does the LBBP lead can provide accurate, stable, and valid EGM for ICD/CRT-D sensing and detection of ventricular tachyarrhythmia events? In each patient intracardiac EGMs of LBBP lead will be collected by ambulatory Holter monitor at the time of peri-implantation and up to 6-month follow-up. EGM collection will be collected at resting and walking conditions and overdrive pacing.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>=18 yrs.
* Patients indicated for ICD or CRT-D (primary or secondary prevention)
* Patients who recently (\<=30 days) received ICD/CRT-D implantation with LBBP
* Patients' EGM can be digitally recorded
* Patients are willing to participate in the study and provide signed informed consent

Exclusion Criteria:

* Patients received CIED upgrade or replacement with old pacing leads
* Patients are pregnant
* Patients participate in another study that will confound this study
The Effect of Reiki Therapy in Pediatric Oncology Patients

The study was conducted based on randomized controlled experimental design with double-blind, pre-test-post-test to determine the effect of Reiki applied to pediatric oncology patients aged 5-7 years on pain, vital signs, oxygen saturation (SpO2) and quality of life. While the population of the study consisted of oncology patients aged 5-7 years who were hospitalized in the pediatric oncology services between December 2020 and November 2021, the sample consisted of 66 children diagnosed with leukemia who met the sample selection criteria. The research consists of 3 groups. These groups are Reiki group (n=22), Placebo group (n=22), control group (n=22). The data are collected using Introductory Information Form, Wong-Baker FACES Pain Scale (W-BPS), Vital Signs Follow-up Form, The Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module Child and Parent Form. Reiki was applied to the Reiki group for 20-30 minutes for three consecutive days and Placebo was applied to the sham Reiki group by an independent nurse during the same application period. The children in the control group were like the routine of the ward.

The universe of the study consisted of pediatric oncology patients who met the selection criteria in the pediatric oncology services. The study was planned as a randomized controlled experimental design with double-blind, pre-test post-test to determine the effect of Reiki applied to pediatric oncology patients aged 5-7 years on pain, vital signs, oxygen saturation (SpO2) and quality of life. In order for the groups to be distributed homogeneously, the order produced by a computer program (http://www.randomization.com , Balanced permutation) was used. Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list. The control variable of the study is demographic characteristics of the children. The dependent variables of the study are pain, vital signs, oxygen saturation parameters and quality of life score.

Eligibility Criteria:
Inclusion Criteria:

* Being treated in the pediatric oncology service at the time of the study
* Being between 5-7 years old
* Body temperature being within normal limits
* To have received at least 1 course of chemotherapy
* Absence of visual, auditory problems or mental retardation at a level that can fill the scales,

Exclusion Criteria:

* To have taken analgesic medication in the last 6 hours,
* Have received any energy and body-mind therapy (yoga, reiki, massage, meditation, healing touch) in the last six months
The Origin of Phantom Limb Sensation and Phantom Limb Pain in Amputees

With the far infrared ray applied to the 'phantom limbs' in amputees and the corresponding normal legs in healthy subjects, the sensation of (phantom) limb will be assessed for each subject using the techniques of fMRI and meridian response.

This project will investigate two main hypotheses based on our previous studies on phantom limb sensation and phantom limb pain. The first hypothesis states that phantom limb sensation and phantom limb pain both correlate with the 'phantom limb', while the second one maintains that the phantom limb can interact with the patient's body by means of the meridian system. With the far infrared ray applied to the 'phantom limbs' in amputees and the corresponding normal legs in healthy subjects, the sensation of (phantom) limb will be assessed for each subject using the techniques of fMRI and meridian response. By analyzing the data collected from both groups, the investigators expect both hypotheses will be supported by the results of experiments in this project.

Eligibility Criteria:
Inclusion Criteria:

* Amputees: at least one arm or one leg amputated
* Healthy subjects: healthy person under 30 years old

Exclusion Criteria:

* with mental diseases
First-In-Human Study of EOS884448 in Participants with Advanced Cancers.

IO-002 study is a multicenter, open-label, dose-escalation Phase I/IIa clinical study to evaluate the safety and tolerability, PK, PD, and antitumor activity of EOS884448 in participants with advanced cancers.

Multicenter, open-label, dose-escalation Phase I/IIa clinical study to evaluate the safety and tolerability, PK, PD, and antitumor activity of EOS884448 in participants with advanced cancers. The study will consist in a dose-escalation phase to determine the MTD, the RP2D, and the safety of EOS884448 in participants with advanced cancers.

Eligibility Criteria:
Inclusion Criteria:

1. Be willing to provide a signed written informed consent for the trial and consent for biopsies before and during administration of EOS884448
2. Be more than18 years of age on day of signing informed consent.
3. Have histologically or cytologically confirmed advanced or metastatic cancer for whom no standard treatment is further available
4. Have evaluable disease, per RECIST v1.1 for solid tumor escalation or other criteria if indicated
5. Have an ECOG performance status of Grade 0 to 1.
6. Have adequate organ function.
7. Agree to use adequate contraception during the treatment if required.

Exclusion Criteria:

1. Has received any anti-cancer therapy, unless at least 4 weeks (or 5 half-lives, whichever is shorter) since the last dose.
2. Has undergone major surgery within 5 weeks before initiating treatment.
3. Has received prior radiotherapy within 2 weeks of start of IP.
4. Has toxicity (except for alopecia) related to prior anti-cancer therapy, unless the toxicity is resolved, returned to baseline or Grade 1, or deemed irreversible.
5. Has known CNS metastases.
6. Has any condition requiring concurrent use of systemic immunosuppressants or corticosteroids.
7. Has uncontrolled or significant cardiovascular disease.
8. Has received vaccine containing live virus within 4 weeks.
9. Has known active or chronic viral hepatitis.
10. Has any known or underlying medical, psychiatric condition, and/or social situations that, in the opinion of the investigator, would limit compliance with study requirements.
Telenursing and Transitional Care

Post-operative care for Lumbar Disc Herniation (LDH) is important to reduce postoperative complications. The transition from hospital to home after discharge is important for LDH patients, as the transition process is flawless, the necessary care is provided appropriately, and follow-up is important. The aim of the study is to determine the effects of transitional model-based telenursing and mobile application-based follow-up on fall risk, post-discharge recovery, mobility, anxiety, and complications in patients who underwent lumbar disc surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 years of age or older,
* Can speak and understand Turkish,
* Have no hearing, understanding, vision or speech problems,
* Have undergone LDH surgery for the first time,
* Have undergone LDH surgery with the open method,
* Have not been diagnosed with depression or anxiety disorder before surgery and are not taking medication for this purpose,
* Have a smart mobile phone suitable for taking photos or for those close to them,
* Have not developed serious complications that would delay their discharge from the hospital,
* Volunteer to participate in the study will be included in the study.

Exclusion Criteria:

* Patients who wish to withdraw from the study at any stage after voluntarily participating in the study.
VA106483 and Alpha Blocker Interaction Study in Elderly Males

The main purpose of this study is to investigate whether the hypotensive effects of an alpha-blocker are increased when VA106483 is given at the same time.

VA106483 is intended to be used as a treatment for patients suffering from nocturia (defined as waking to urinate at least once per night between periods of sleep). Nocturia is a condition that often worsens as sufferers get older. This may be due to an over-active bladder muscle, the bladder being able to hold less urine at night-time or over production of urine in the bladder at night. Some of the treatments available for nocturia have side-effects which make them unsuitable for elderly patients. These side-effects have not been seen in studies with VA106483, which makes it potentially suitable for treating elderly patients.

Nocturia is commonly associated with Benign Prostatic Hypertrophy (or BPH, a non-cancerous enlargement of the prostate gland, which often results in problems passing water). Of the patients who suffer from BPH, an estimated 40-85% experience the symptoms of waking at night to pass water.

Treatments which are commonly prescribed for BPH include alpha-blockers which work by improving urine flow by a muscle relaxant effect. Alpha-blockers are known to cause hypotension (lowering of blood pressure which can cause dizziness in some patients) . Since it is likely that subjects may be co-prescribed VA106483 and alpha-blockers, the purpose of this study is to determine that giving VA106483 does not increase the hypotensive effects of alpha-blockers

Eligibility Criteria:
Inclusion Criteria:

* Male aged 65 years of age and above
* No clinically important abnormal physical, laboratory or vital sign findings in the opinion of the Investigator
* Provision of written informed consent to participate
* No recent alpha-blocker therapy
* Not taking any concomitant medication known to be a cytochrome 3A4 inhibitor
* Not taking any prescribed or over the counter medications unless agreed with the Investigator and Sponsor
* No evidence of serious pathology or disease including poorly controlled endocrine disorders; active liver or biliary disease or severe kidney problems; syndrome of inappropriate antidiuretic hormone secretion
* No history of orthostatic hypotension or syncope.
* No known hypersensitivity to the IMP or alpha blocker, including severe lactose intolerance.
* No history of drug or alcohol abuse
* Negative for HIV, hepatitis B or C
A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)

This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in the Phase 2 study 3030-202-002 or the Phase 3 study 3030-303-002.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* Male or female participants must be 6 to 17 years of age (inclusive)
* Participants must have completed study intervention in their lead-in study

Exclusion Criteria:

* Participant has an unresolved AE or a clinically significant finding on a physical examination, vital sign assessment, or neurological assessment along with an ECG or clinical laboratory tests (if results are available by the time of enrollment) that; in the opinion of the investigator, could represent a safety concern or a condition that would be exclusionary, could prevent the participant from performing any protocol assessments, or could confound study assessments.
* Participant has known allergies or hypersensitivity to opioids
* Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study.
* Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy).
* Participant has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction
* Participant has a history of pancreatitis; structural diseases of the pancreas, known or suspected pancreatic duct obstruction
* Participant has a history of chronic or severe constipation, or sequelae from constipation, or known or suspected mechanical GI obstruction or pseudo obstruction
* Participant has renal impairment or an unstable hepatic, metabolic, or hematologic condition.
* Participant is a current regular alcohol drinker and/or binge drinker\*, and/or has a history of alcoholism, alcohol abuse (eg, binge-drinking\*), or alcohol addiction, and/or intends to consume alcohol during the study
Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Healthy Subjects

This study evaluates the work of breathing among healthy subjects under various conditions of treatment with high flow nasal cannulas. Ten subjects will be included. The design of this study is a cross over of five treatment periods with different flow settings.

High flow oxygen therapy (HFOT) is a promising technique increasingly used in the management of acute respiratory failure. In hospitalised hypoxemic patients, recent clinical evidence showed that HFOT can reduce endotracheal intubation and reduce mortality. Physiologically, the HFOT causes a decrease in respiratory rate and minute-ventilation and may be associated with a decrease in carbone dioxyde arterial pressure. It is possible that these effects are associated with decreased work of breathing, which could explain some of the benefits in terms of comfort and efficiency.

The objective of this research is to evaluate the impact of a wash-out of anatomical dead space by high flow nasal cannulas on respiratory parameters and on the work of breathing among healthy subjects. The investigators will evaluate the baseline status in room air, and then compare it with four different levels of flow. The primary endpoint will be the work of breathing.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Written and informed consent

Exclusion Criteria:

* Pregnant or breastfeeding women;
* Subject enrolled in another study excluding co-enrolment;
* Cardio-vascular or respiratory disease;
* History of ear nose and throat disease (i.e. surgery, epistaxis, trauma), eso-gastric disease (i.e. esophageal varices, digestive haemorrhage), rheumatologic or neurologic disease possibly interfering with the design of the study;
* Subject feeling nauseous or under recent fed condition (\<1h).
Comparison Between Different Techniques for Carotid Artery Endarterectomy

the goal of this interventional study is to compare between the conventional and the Eversion techniques in performing carotid endarterectomy in patients with carotid artery stenosis the main question it aim to answer is which technique is much more safe and effective the participants will have carotid endarterectomy by one of the two techniques the researcher will compare the group subjected to conventional carotid endarterectomy and the group subjected to Eversion carotid endarterectomy to see which technique is more effective and safe

Carotid endarterectomy (CEA) is widely recognized as the gold standard approach for the prevention of major cerebral events in patients with significant carotid stenosis as it is considered as cerebral revascularization. The procedure entails removing the plaque from the common carotid artery (CCA) and internal carotid artery (ICA) to improve blood flow, prevent potential embolic material and therefore restoring proper cerebral blood flow.

Carotid endarterectomy (CEA) has proven to be a safe and durable operation to decrease the risk of stroke in both symptomatic and asymptomatic patients with extracranial carotid artery stenosis. it is recommended for most symptomatic patients with 50%-99% ICA stenosis. It's considered for asymptomatic patients with 60% - 99%.

There are two main techniques of CEA, conventional carotid endarterectomy (C-CEA) and eversion carotid endarterectomy (E-CEA). More often used is conventional carotid endarterectomy (C-CEA) which is consists of a vertical arteriotomy begun on the CCA and continued through the carotid bifurcation into the ICA beyond the full length of the plaque and closure by patch angioplasty.

As regard comparison between (C-CEA) and (E-CEA) Several studies showed that C-CEA and E-CEA are equally effective surgical approaches for extracranial carotid occlusive disease and studies that compared the influence of E-CEA and C-CEA on postoperative results had varied conclusions some studies have reported no difference in restenosis rates while others have reported less restenosis in eversion endarterectomy. more studies are needed to approve such results, Therefore, it remains difficult to choose the optimal endarterectomy technique.

the study will include 40 patients divided into two groups 20 patients for each group, each group will be subjected to one technique to compare safety and efficacy of each one.

Eligibility Criteria:
Inclusion Criteria:

* Patients having carotid artery stenosis with cerebral events (recent stroke).
* Patients having high grade carotid artery stenosis with increasing symptoms.
* Patients underwent previously CEA presented with carotid restenosis.

Exclusion Criteria:

* Non atherosclerotic carotid artery stenosis e.g., vasculitis, collagen vascular diseases and hypoplastic ICA.
* patients with recently thrombosed ICA.
* High carotid bifurcation to the extent makes CEA not accessible in easy or safe way e.g., increased risk of cranial nerve injury.
* acute ischemic stroke within less than 2 weeks before the procedure.