cyrilzakka/clinical-trials huggingface dataset:
Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II

The purpose of this clinical investigation is to test the safety and performance of one short- and one long-term Baseplate constructed with different types of biocompatible adhesives.

This clinical investigation intended to test different biocompatible adhesives over time as part of the UNEEG Episight Baseplate construction for UNEEG™ medical A/S.

The two Baseplates reported on in this registration, is a follow-up to an initial testing of four different types of adhesive i.e., four types of Baseplates.

This study is Part II of the protocol. Part I is registered: NCT05111847

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained, and letter of authority signed before any study related activities
* Are at least 18 years of age and have full legal capacity
* Healthy skin behind the ear

Exclusion Criteria:

* Pregnant or breastfeeding
* Known allergic responses to the adhesives
* Treatment with corticosteroids, either as a cream in the area behind the ear or systemically (tablet or injection) within the last month
* Subject is unable or does not have the necessary assistance to properly operate the device system
An Open-label, Phase 1/2 Trial of Gene Therapy 4D-310 in Adults With Fabry Disease

This is a prospective multicenter, open-label, dose-escalation trial to assess the safety, tolerability, and pharmacodynamics of 4D-310 following a single IV administration. The study population is comprised of adult males and females with Fabry Disease.

This is a prospective multicenter, open-label, dose-escalation trial to assess the safety, tolerability, and pharmacodynamics of 4D-310 following a single IV administration. The study population is comprised of adult males and females with Fabry Disease.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years of age
2. Pathogenic GLA mutation consistent with Fabry Disease
3. Confirmed diagnosis of classic or late-onset Fabry disease
4. Individuals on ERT must be on a stable dose for at least 6 months (and a minimum of 12 months total exposure) prior to study enrollment
5. Agree to use highly effective contraception

Exclusion Criteria:

1. Presence of high titer neutralizing antibody to 4D-310 capsid, or presence of high antibody titer to AGA
2. eGFR \<45 mL/min/1.73 m2
3. Undergone kidney transplantation or currently on hemodialysis or peritoneal dialysis
4. HIV, active or chronic hepatitis B or C,
5. Evidence of liver disease, severe pulmonary disease or diabetes with poor glycemic control
6. History of stroke or transient ischemic attack within the last 12 months, or other significant thromboembolic disease history (e.g. pulmonary embolism)
7. Contraindication to systemic corticosteroid therapy or immunosuppressive therapy
8. Chronic steroid use, defined as ≥ 3 months of oral corticosteroid use within the last 12 months.
9. Moderately severe to severe cardiovascular disease or uncontrolled hypertension
10. Left ventricular ejection fraction of \<45% on echocardiogram (ECHO)
11. Currently receiving investigational drug, device or therapy or having ever received gene therapy
12. History of infusion related response to ERT or any adverse reaction leading to ERT discontinuation
13. History of cancer within 2 years (exceptions include non-melanoma skin cancer, localized prostate cancer treated with curative intent)
14. Pregnant or breast-feeding
Addressing Involuntary Movements in Tardive Dyskinesia

The purpose of this study is to determine whether fixed-doses of an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.


Eligibility Criteria:
Inclusion Criteria:

* History of using a dopamine receptor antagonist for at least 3 months
* Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening
* Subjects with underlying psychiatric diagnosis are stable and have no change in psychoactive medications
* Have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months
* History of being compliant with prescribed medications
* Able to swallow study drug whole
* Be in good general health and is expected to attend all study visits and complete study assessments
* Female subjects must not be pregnant and must agree to an acceptable method of contraception throughout the study

Exclusion Criteria:

* Currently receiving medication for the treatment of tardive dyskinesia
* Have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias
* Have a serious untreated or undertreated psychiatric illness
* Have recent history or presence of violent behavior
* Have unstable or serious medical illness
* Have evidence of hepatic impairment
* Have evidence of renal impairment
* Have known allergy to any component of SD-809 or tetrabenazine
* Has participated in an investigational drug or device trial and received study drug or device within 30 days
* Have acknowledged use of illicit drugs
* Have a history of alcohol or substance abuse in the previous 12 months
Assessing the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta®

This is a randomized, double-blind, 2-period parallel study in healthy subjects to assess immunogenicity and safety of two sequential 6 mg subcutaneous (SC) injections of CHS-1701 compared with two sequential 6 mg SC injections of Neulasta®.


Eligibility Criteria:
Inclusion Criteria:

1. Adult male or female of ages 18 to 50 inclusive
2. Body weight \> 50 kg (110 lb.) and body mass index between 18 and 32 kg/m2 inclusive
3. Medically healthy with clinically insignificant findings based on medical history, 12-lead ECG, and physical examination
4. Negative urine pregnancy test in women of childbearing potential

Exclusion Criteria:

1. Previous exposure to pegfilgrastim or filgrastim, or known allergy to PEG (polyethylene glycol)
2. Chemistry and hematology values outside protocol specified range
3. Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric, or other disorder
4. History of chronic or acute respiratory illness within the past 4 weeks
5. Positive urine drug or alcohol screen or unwillingness to abstain from alcohol or recreational drugs for the duration of study participation
6. No prescription or nonprescription drugs during the study
7. Participation in an investigational clinical study within 30 days prior to screening
8. Known or suspected allergic reaction to latex
Association Between Venous Excess Ultrasound Grading System and Acute Kidney Injury in the ICU Population

Fluid resuscitation is one of the cornerstones of treatment in ICU patients. Nonetheless, excessive fluid administration can lead to fluid overload which has been associated with worse outcomes in the ICU. To prevent this, assessments of fluid responsiveness are commonly employed. However, fluid responsiveness does not take fluid tolerance into account. Fluid tolerance is the idea that a patient might still be fluid responsive but might already be at risk of the detrimental effects of fluid therapy. Recent developments in point of care ultrasound e.g. the Venous excess ultrasound might help identify patients at risk of fluid overload. However its association with patient relevant outcomes in the ICU remains unclear.

This study will investigate the association between the venous excess ultrasound grading system (VExUS) and patient relevant outcomes such as acute kidney injury, mortality and length of stay.

A secondary analysis is planned where the association between VExUS and the lung ultrasound score will be investigated

Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to the ICU 18 years or older expected to stay in the ICU for more than 24 hours

Exclusion Criteria:

* any obstruction between the righ atrium and structures assessed by VExUS
* a medical history of: Major cardiac shunts (e.g. atrial septum defect), Tricuspid regurgitation, dialysis, portal hypertension, pulmonary hypertension, interstitial lung disease, recipients of a kidney of liver transplant.
* patients in whom an ultrasound assesment is unfeasible e.g. a BMI over 40
Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The purpose of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with regard to safety and efficacy.

Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076) will have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight \[bw\]) weekly for up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment. Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.

The treatment duration will be up to 48 weeks, followed by a completion visit (week 49).


Eligibility Criteria:
Inclusion Criteria:

* Subjects having completed the pivotal study IgPro20_3003 (SC Week 25) or successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076).
* Written informed consent for study participation obtained before undergoing any study-specific procedures.

Exclusion Criteria:

* Subject is unable to directly transition from study IgPro20_3003.
* New medical condition and/or social behavior (ie, alcohol, drug, or medication abuse) during participation in study IgPro20_3003 that in the judgment of the investigator could increase risk to the subject, interfere with the evaluation of investigational medicinal product, and/or conduct of the study.
Postoperative Pain and Incidence of Extrusion Following the Use of Two Intra-canal Medications in Retreatment of Single Rooted Teeth

This study aims to compare the postoperative pain and incidence of extrusion of two intracanal medications in the retreatment of single-rooted teeth.

The main question it aims to answer is:

Does the injection of intra-canal medication into the shaped root canal after complete removal of the old obturating material lead to post-operative pain and paste extrusion to periapical tissues or not?


Eligibility Criteria:
Inclusion Criteria:

* Patients with failed endodontic treatment in single root teeth
* Systemic free

Exclusion Criteria:

* Muktirooted teeth
Using Mobile Application for Rehabilitation in Patients With Chronic Neck Pain

The aim of this study is to reduce pain, increase range of motion, increase the endurance of deep cervical flexors muscles, and increase quality of life with mobile application in the treatment of patients with chronic neck pain. Although many benefits of exercises have been proven, the effectiveness, follow-up and continuity of exercise will be investigated with mobile application tracking.

One of the important factors in mechanical chronic neck pain is the decrease in the endurance of the deep cervical flexor muscles. As a result of this decrease, an increase to the activation of M. Scalenus Anterior and M. Sternocleidomastoid muscles is observed. It is known that patients avoid some movements due to pain, and as a result, loss of muscle strength and endurance in the neck, upper back, around the scapula and shoulder occurs. The loss in strength and endurance, combined with the severity of pain, may affect the stability of the upper extremity has been considered.

Patients with chronic neck pain may experience a number of problems due to the predisposition to accompany pain or some problems caused by neck pain. It is known that all these problems affect the quality of life of patients by limiting their daily living activities.

With the developing technology, mobile health applications have started to be used more and more in our lives. In addition to preventing disease, reducing risk factors, increasing physical activity and quality of life, mobile applications are used in many different areas such as diagnosis, treatment, feedback and monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Having chronic neck pain in the past 6 months
* No communication problem
* Be Literate,
* Individuals who speaks Turkish and can use developed mobile application

Exclusion Criteria:

* Previous neck or shoulder surgery,
* Shoulder pain due to any reason,
* Having tumor or inflammatory disease underlying neck pain
* Having mental disorder,
* Individual with sequestered disc level or root compression,
* Individual with uncontrolled diabetes mellitus and hypertension
* Patients received additional treatment
* Patients who did not complete physical therapy sessions
Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children

Acute lower respiratory tract infections are a leading cause of morbidity and mortality in sub Saharan Africa. The World Health Organisation (WHO) still recommends intravenous chloramphenicol for the treatment of severe pneumonia in children aged less than five years. However, up to 20% of children fail treatment due to the emergence of resistance by bacteria. Several centers now use ceftriaxone, a third generation cephalosporin, which is reported to be efficacious in the treatment of severe pneumonia. However the high cost of ceftriaxone is too prohibitive to allow for its routine use in resource constrained countries. The purpose of this study is to compare chloramphenicol and ceftriaxone in the treatment of severe pneumonia in children under five.

We hypothesize that 92.7% of children who receive once daily intravenous ceftriaxone (75 mg/kg body weight)for 7 days, will recover from severe pneumonia compared to 80.2 % of those who receive intravenous chloramphenicol (25mg/kg body weight/dose every 6 hours for 7 days).

A recent report from the World health Organization showed pneumonia was the leading cause of death in children less than 5 years. WHO recommends intravenous Chloramphenicol 25mg/kg six hourly as the first line drug for the treatment of severe pneumonia in these children. Ceftriaxone 75mg/kg daily is the second line drug.

The efficacy of chloramphenicol for the treatment of severe pneumonia ranges from 80%-84%, while that of ceftriaxone ranges from 85% to 97%. However the high cost of ceftriaxone is too prohibitive to allow for its routine use in resource constrained countries. A study comparing penicillin G plus chloramphenicol and ceftriaxone in the treatment of severe pneumonia in Turkey found that both drugs were equally effective in normalization of the outcome parameters. A recent Cochrane review found no randomized controlled trials comparing both drugs in the treatment of severe forms of pneumonia.

The objective of this study it to compare the efficacy of Ceftriaxone versus Chloramphenicol in the treatment of severe pneumonia in the children under five years of age admitted to Mulago hospital.

This will be a double- blinded randomized controlled trial. Three hundred forty eight children with severe pneumonia will be randomized to receive either intravenous ceftriaxone 75mg/kg/day for seven days or intravenous chloramphenicol 100mg/kg/day for seven days. The primary outcome will mortality and secondary outcomes will be time taken to normalization of respiratory rate, temperature and oxygen saturation.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months to 59months with cough, difficult breathing and lower chest indrawing
* Consent from parent/carer

Exclusion Criteria:

* Children with severe Asthmatic attack
* Allergy to any of the study drugs
* Diagnosis of Pneumocystis JiroveciPneumonia on therapeutic treatment
Combined Laser-surgical Technology of RRD Treatment

Purpose: to assess the efficacy and safety of combined laser-surgical technology of RRD treatment

The study takes place in the S.N. Fyodorov "Eye Microsurgery" Federal State Institution located in Moscow, Russian Federation.

The study will include 50 patients with rhegmatogenous retinal detachment due to a horseshoe-tear. In addition to the standard ophthalmological examination, all patients will undergo wide-field optical coherence tomography to determine the extension and localization of the vitreoretinal traction zone. The obtained data will be used to planning the 1st step of laser-surgical treatment. All patients will undergo a combined laser-surgical technology, which includes 3 steps: 1) Nd-YAG laser excision of the vitreoretinal traction zone 2) pneumatic retinopexy (10% C3F8) 3) barrier laser photocoagulation around retinal break after retinal attachment.

The patients are going to be followed up for at least 1 year, the main outcome measures are postoperative primary and final anatomic outcome, BCVA and complications.

Eligibility Criteria:
Inclusion Criteria:

1. Rhegmatogenous retinal detachment extending from the 9-o'clock to the 3-o'clock meridians.
2. Superior retinal break from 9 o'clock to 3 o'clock
3. Single retinal break not greater than 1 clock hours in size
4. Physically and mentally co-operated in post-operative head positioning
5. No (or minimal) proliferative vitreoretinopathy
6. None or mild vitreous hemorrhage.

Exclusion Criteria:

1. Severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole, traumas); OR
2. Ocular media opacities
3. Previous ocular surgeries
4. Age \<18 years
5. Previous retinal detachment (index eye)
Retrospective Study in FFPE Samples From Younger Patients With Rhabdomyosarcoma

This retrospective study is looking into mechanisms of drug therapy resistance in FFPE samples in recurrent and refractory Rhabdomyosarcoma (RMS) in pediatric patients who have experienced lung recurrence. The study employs advanced techniques such as single-cell transcriptomics and spatial transcriptomics to gain a comprehensive understanding of these mechanisms.

This research seeks to enhance our understanding of drug resistance mechanisms in recurrent and refractory RMS in pediatric patients, particularly in the context of lung recurrence. The utilization of cutting-edge techniques like single-cell transcriptomics and spatial transcriptomics allows for a more in-depth and comprehensive analysis of the molecular and spatial aspects of drug resistance in this challenging pediatric cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric Patients: Participants in this study should be pediatric patients, typically defined as individuals aged from infancy to 18 years old, who have been diagnosed with recurrent and refractory Rhabdomyosarcoma (RMS).
2. Lung Recurrence: Included patients must have a documented history of lung recurrence of RMS as a specific clinical manifestation.
3. Availability of FFPE Samples: Patients for whom formalin-fixed paraffin-embedded (FFPE) tissue samples are available for analysis are eligible for inclusion.

Exclusion Criteria:

1. Other Histological Types: Patients with RMS of histological subtypes other than those relevant to the study focus are excluded.
2. Incomplete Clinical Data: Patients with incomplete or insufficient clinical data necessary for the study's objectives may be excluded to ensure robust analysis and interpretation of results.
Evaluation of the Stinging Potential in Human Eyes

The objective of this study was to compare the human eye stinging potential of experimental formulas and an industry standard shampoo mixture. The study was conducted under the supervision of a Board Certified Ophthalmologist.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged 18 to 60 years
* No medical conditions of the eyes as determined by the subjects' medical history and confirmed by ophthalmologist
* Subjects do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the day of and day after the study
* Subject is willing to have the test materials instilled into the eyes and follow all protocol requirements
* Subject is willing to refrain from using false eyelashes of any type or any topical prescription, OTC or cosmetic products on their eyes, eyelids, eyelashes or the peri-orbital areas of the face on the day of the study.
* Subjects should refrain from use of make-up on testing day
Immunological Parameters Between MRONJ Stages

This study aims to conduct a detailed analysis of the immunological response profiles that emerge at different clinical stages of medication-related osteonecrosis of the jaw (MRONJ). The research seeks to understand how these responses influence the pathogenesis, staging, and treatment of MRONJ. Throughout the study, cytokine levels, inflammation markers, and other immunological parameters observed at various stages will be comprehensively assessed. The results of these analyses are expected to provide insights into how stage-specific immunological variables could play a role in the diagnosis and treatment of MRONJ.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 and over
* Both male and female participants
* Individuals who apply to the Oral and Maxillofacial Surgery Clinic at Marmara University Faculty of Dentistry due to medication-related osteonecrosis of the jaw during the study period
* Individuals or their legal representatives who have provided written consent to participate in the study

Exclusion Criteria:

* Non-drug-related osteonecrosis/osteomyelitis
* Osteoradionecrosis
* Metastasis to the oral region
* Individuals who have not given written consent to participate in the study
Efficacy Evaluation of the Probiotics Containing Skincare Products on Skin

Previous studies on skin health with Lactic acid bacteria (LAB) have been published for many years, including prevention of skin diseases and improvement of skin conditions. In this clinical study, the investigators researched the benefit effects of heat-killed Lactobacillus plantarum cream on skin health.

To evaluate the efficacy of applying probiotic cream in the ameliorationof the whole face skin conditions such as moisturizing, whitening, anti-wrinkle and so on.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between the ages of 20-60.

Exclusion Criteria:

* Subjects with photosensitivity (Sun allergy).
* Subjects are undergoing medical therapy for skin diseases.
* Subjects with severe hyperpigmentation.
* Subjects with diabetes.
* Subjects with cosmetics allergy.
* Subjects who have recently participated laser therapies or other treatments are not suitable for sun.
Evaluation of Quality of Life in Women

300 women will be evaluated in this study. Their quality of life, level of physical activity, Social Functioning, levels of depression and musculoskeletal status will be assessed.

Many factors affects quality of life in women. In the literature, factors affecting the quality of life such as diseases, working conditions and psychological factors of women have been investigated in different diseases. However, there was no study investigating the factors affecting quality of life for a sample of adult female individuals. Therefore, the aim of our study is to investigate the effect of social, psychological and physical variables that we think may affect the quality of life in women.

Eligibility Criteria:
Inclusion Criteria:

* To be a volunteer

Exclusion Criteria:

* having severe musculoskeletal system disorders