cyrilzakka/clinical-trials huggingface dataset:
Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer

In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively.


Eligibility Criteria:
Inclusion Criteria:

* no androgen deprivation therapy within the last 2 months prior to RT
* good performance status (Eastern Cooperative Oncology Group, ECOG, 0/1)
* no secondary malignancy
Interleukin-38 Levels in Individuals With Periodontitis

Interleukin (IL)-38 is the newest member of the IL-1 family. It can bind to receptors through various pathways and regulate the formation and function of inflammatory cytokines. Periodontitis is a chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. The aim of this study is to compare the IL-38, IL-1β and IL-10 levels of healthy and periodontitis individuals.

Periodontitis is a destructive chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. More than any other cytokine family, the interleukin (IL)-1 family (IL-1α, IL-1β, IL-18, IL-33, IL-36α, IL-36β, IL-36γ, IL-1Ra, IL-36Ra, IL-37, IL-38) includes key signaling molecules that trigger and perpetuate periodontal inflammation.

Interleukine -1β ( IL-1β ) levels are associated with periodontal destruction in the pathogenesis of periodontal disease. Interleukine-10 (IL-10) has been reported to decrease periodontal disease progression rate.

Gingival crevicular fluid shows the cellular response in the periodontium. The most important host-related ingredients are inflammatory markers, including cytokines, enzymes, and interleukins. Saliva analysis is used in the diagnosis of systemic conditions as well as in the diagnosis of oral pathologies.

In recent studies, IL-38 expression has been reported to be abnormal (abnormal) in chronic inflammatory diseases, especially in rheumatoid diseases such as systemic lupus erythematosus, rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Therefore, this relationship of this inflammatory cytokine with chronic inflammatory diseases draws attention to the regulatory effect of IL-38 in these diseases. The aim of this study is to compare the IL-38, IL-1β and IL-10 levels of healthy and periodontitis individuals.

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy individuals who does not have a disease under treatment,
* individuals without regular systemic medication

Exclusion Criteria:

* smoking
* receiving periodontal treatment in the last 6 months
* pregnancy
* lactation
Facial Demodicosis and Ocular Demodicosis

To understand the association between facial demodicosis and ocular demodicosis, we plan to enroll patients with facial demodicosis, ocular demodicosis, or both, in order to analyze their clinical presentations, the density of Demodex infestation over facial skin and eyelashes, and possible risk factors of the two diagnoses.

Although facial demodicosis and ocular demodicosis are described in a variety of clinical presentations, the association between the two diagnoses is not clearly identified.

Clinically, we plan to enroll 120 patients with facial demodicosis, ocular demodicosis. We will obtain their basic information, medical history, medication, and lifestyle. We will evaluate their clinical features. We will also perform quantitative tests including direct microscopic examination and cilia epilation test:

1. Direct microscopic examination: On glabella and bilateral cheeks, follicular contents in the 1-cm × 1-cm area will be squeezed out. The contents are transferred onto a glass slide, covered with mineral oil and a cover slide, and examined under the microscope.
2. Epilation: Four (4) non-adjacent cilia will be pulled from each upper eyelid and examined under the microscope. The total Demodex counts are recorded.

We will analyze the clinical presentations, the density of Demodex infestation, and possible risk factors of the two diagnoses.

Eligibility Criteria:
Inclusion Criteria:

Patient with a diagnosis of facial demodicosis or ocular demodicosis.

A. Facial demodicosis defined as both 1 and 2:

1. Clinical presentation of facial skin matches any of the followings:

   1. Pityriasis folliculorum.
   2. Papulopustular lesion.
   3. Rosacea.
2. Demodex infestation detected by direct microscopic examination ≥ 5 mites/cm2.

   B. Ocular demodicosis defined as both 3 and 4:
3. Clinical presentation of ocular region matches any of the followings:

   1. Chronic blepharitis.
   2. Eyelash abnormalities: trichiasis, distichiasis, madarosis.
   3. Meibomian gland dysfunction.
   4. Recurrent chalazion.
   5. Ocular rosacea.
4. Demodex infestation detected by cilia epilation test ≥ 1 mite/eyelid.

Exclusion Criteria:

1. Usage of oral Ivermectin, topical Ivermectin or topical tea tree oil in the past 1 month.
2. Patient who cannot tolerate direct microscopic examination or cilia epilation test.
Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch

This study aims to evaluate if meropenem can be administered in outpatients as a continuous infusion using elastomeric pumps and an isothermal pouch maintaining the anti-infective solution between 10° and 15°C for improved stability.

The Outpatient Parenteral Antibiotic Therapy (OPAT) unit of the University Hospital of Lausanne uses elastomeric pumps for continuous intravenous administration of 6 different antibiotics. This mode of administration is possible for all antibiotics with a time-dependent bactericidal effect.

Meropenem belongs to this class of antibiotics, but is not stable at room temperature in elastomeric pumps. However, this antibiotic is stable at 10°C and 15°C. The investigators have therefore developed an isothermal pouch that allows the anti-infective solution to be maintained at a temperature between 10 and 15°C over 24 hours.

This study aims to evaluate the efficacy and safety of meropenem administration using an elastomeric pump maintained at a temperature between 10° and 15°C by an isothermal pouch.

The possibility of being able to administer meropenem by elastomeric pumps would greatly facilitate the ambulatory management of patients requiring treatment with this anti-infective drug.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the OPAT unit for a anti-microbial treatment with meropenem
* Age ≥ 18 years
* Informed consent signed

Exclusion Criteria:

* Patients refusing a PICC-line
* Pregnancy or desire of a pregnancy
* Patients considered to be not eligible for outpatient treatment by the OPAT team
Establishing the Collaborative Care Model for Pediatric Allergic Rhinitis With Sleep Disorder

The purpose of study is to compared the impact of the integrative care clinic to ordinary western medicine among patients of moderate persistent allergic rhinitis combined with sleep disorder and establishing the collaborative care model of TCM and western medicine for pediatric allergic rhinitis with sleep disorder.

Investigators invited children aged below 18 years old to the integrative care clinic as experimental group, who have persistent moderate allergic rhinitis, more than 60 scores of the OSA-18 sleep questionnaire, and can accept integrative therapy. The controlled group is patients who receive ordinary western treatment. Investigators compare these two groups by questionnaires of OSA-18,SN-5, PADQLQ,SNAP-IV, the dose of nasal corticosteroid , and polysomnography.

In Taiwan, there are many patients suffer from pediatric allergic rhinitis and lead to the medical heavy budget. The persistent symptoms would cause sleep disorder or complicated with pediatric obstructive sleep apnea. It would affect the growth development ,attention deficiency, or psychiatric cognition problems. Obstructive sleep apnea for a long time would result in cardiovascular, endocrine, and metabolic complications if not well-treated.

Patients of allergic rhinitis combined with sleep disorder are classified to moderate persistent type by ARIA, who are intractable to ordinary treatment. Investigators invited them to the integrative care clinic. In addition to the ordinary western medicine, the therapies in the integrative care clinic included herbal medicine, nasal aerosol inhalation, acupuncture, and health care education. The purpose of our study is to compared the impact of the integrative care clinic to ordinary western medicine among patients of moderate persistent allergic rhinitis combined with sleep disorder and establishing the collaborative care model of TCM and western medicine for pediatric allergic rhinitis with sleep disorder.

Investigators invited children aged below 18 years old to the integrative care clinic as experimental group, who have persistent moderate allergic rhinitis, more than 60 scores of the OSA-18 sleep questionnaire, and can accept integrative therapy. The controlled group is patients who receive ordinary western treatment. Investigators compare these two groups by questionnaires of OSA-18,SN-5, PADQLQ,SNAP-IV, the dose of nasal corticosteroid , and polysomnography.

Investigators hoped to prove the effect of integrative care clinic and to upgrade the quality and efficacy of the treatment among persistent moderate allergic rhinitis children.

Eligibility Criteria:
Inclusion Criteria:

1. age \<18 years old
2. ARIA (2014) diagnostic criteria belong to moderate, persistent
3. OSA-18 score ≥60

Exclusion Criteria:

1. cranial-facial anomaly
2. secondary obstruction sleep apnea due to muscle weakness of upper airway, such as Down syndrome or cerebral palsy
3. psychiatric disease or behavior disorder
4. allergy to TCM or ordinary western medicine treatment
5. asthma
YAG Laser Vitreolysis for Vitreous Floaters

The purpose of this study is to measure how the quality of life, the structure of eye, and vision change after treatment for the opacities in the gel (vitreous) that fills the center of eye which cause vision disturbances commonly called "floaters".

In this study the vitreous floaters are treated using a Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser. The FDA has approved the use of this laser to treat membranes in the eye.


Eligibility Criteria:
Inclusion Criteria:

* Only one eye per patient will be included in this study
* Able and willing to give informed consent
* Age ≥18 years
* Suffering from symptomatic vitreous floaters
* Floaters arising from either/both:

  * myopic vitreopathy
  * posterior vitreous detachment
* Floaters meeting the following characteristics:

  * Present for ≥3 months
  * One single or more dense and well-defined vitreous opacities,
  * A Weiss Ring or opacities which are within the safety area, at least 3mm away from the retina and 6mm away from the lens
  * Visible on contact lens biomicroscopy

Exclusion Criteria:

* Patient presenting with vitreous opacities outside of the described safety area (within 3mm of the retina or 6mm from the lens)
* Have clinically significant cataract (lens opacification) in one or both eyes which are in the opinion of the examining doctor more significant in impacting vision as compared to that caused by vitreous opacities; or cataract expected to need cataract surgery during the duration of the study
* Present with untreated retinal tears or retinal holes requiring treatment at the discretion of the study investigator
* Have high risk of peripheral lesions requiring treatment at the discretion of the study investigator
* Have synchysis scintillans (unusual vitreous opacities from old blood)
* Have asteroid hyalosis (unusual vitreous opacities from cholesterol)
* Have vitreous hemorrhage (fresh blood in the center of the eye)
* Have active photopsia (flashing lights)
* History of previous YAG laser vitreolysis treatments, or vitrectomy for any condition (retinal detachment, proliferative diabetic retinopathy, etc.)
* Have Posterior Vitreous Detachment (separation of vitreous away from the retina lining the inside of the back of the eye) within the past 3 months
* Are unable to attend study appointments
* Have any other significant ocular or non-ocular condition that, at the discretion of the study investigator, puts the subject at risk or influences the results of the study
* History of intraocular surgery within 6 months from study entry
* History of retinal laser within 2 months from study entry
Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke

Stroke is a major cause of adult disability. Currently approved reperfusion therapies are provided to only a small percentage of patients in the U.S. New therapies are needed that improve outcome and that can be accessed by a majority of patients. Animal studies suggest that bone marrow-derived mesenchymal stem cells, administered intravenously days after a stroke, safely improve long-term behavioral outcome. A large human experience suggests the safety of allogeneic bone marrow-derived mesenchymal stem cells. The current study aims to assess the safety of this therapy in patients with recent ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* 1. Ischemic stroke in the middle cerebral artery territory, with onset 24-72 hours prior to the time that the therapy transfusion is initiated, radiologically confirmed, and with either diameter \>15 mm or volume \> 4cc.
* 2. The index stroke has clinical deficits that are moderate-severe (NIHSS score 7-20), did not require hemicraniectomy or invasive intracranial pressure monitoring, and was not associated with a concomitant STelevation myocardial infarction.
* 3. Age 18-80 years, inclusive
* 4. Reasonable likelihood of receiving standard post-stroke medical care, as well as standard physical, occupational, and speech therapy.

Exclusion Criteria:

* 1. No substantial pre-stroke disability (pre-stroke modified Rankin Scale score 0-2).
* 2. Females of child-bearing potential will be excluded unless (1) a negative urine pregnancy test is obtained and (2) the patient has been effectively using contraceptive method with known failure rate \<1 % for at least 90 days.
* 3. Lactating mothers
* 4. If thrombolytic therapy has been administered, at least 24 hours have passed between completing thrombolytic dosing and initiating the current study's transfusion.
* 5. Known allergy to penicillin or to fetal bovine serum
* 6. Active co-existent major neurological or psychiatric disease that could significantly interfere with patient compliance or study assessments, including drug or alcohol abuse.
* 7. Any diagnosis that makes survival to 1-year post-stroke unlikely.
* 8. Participation in any other experimental therapeutic clinical trial concurrently or in the prior three months.
* 9. Contraindication to undergoing MRI scanning.
Cervicogenic Headache Dose-Response

This study will determine the number of visits to a chiropractor for spinal manipulation and light massage necessary for the optimal relief of cervicogenic headache (headache with associated neck pain). Effectiveness of care will also be determined.


Eligibility Criteria:
Inclusion Criteria:

* chronic cervicogenic headache
* threshold pain level
* threshold headache frequency
* independently ambulatory
* English literate
* candidate for spinal manipulation

Exclusion Criteria:

* contraindication to thrust spinal manipulation or massage
* most other headache types
* Recent manual/exercise therapy from licensed provider for head/neck
* threshold pain medication use
* pregnancy
* involvement with another pain study
* suspicion of unmanaged depression
* most cancers
* hypertension (at least stage II)
* complicating neurological/spinal conditions
* pre-randomization noncompliance or cannot/will not comply with protocols
* health-related litigation, claims, or disability compensation
AST-021p Study in Advanced Solid Tumors

The purpose of this study is to evaluate the safety, tolerability and optimal Immunogenic dose of therapeutic cancer vaccine (AST-021p) in patients With advanced solid tumors

A phase 1 study

Recurrent or advanced solid cancer patients without applicable standard treatments will be included in the 4 dose groups (4 cohort groups- 1.2mg, 2.4mg,3.6mg and 4.8mg) of AST-021p. Participants in each cohort group will be treated 3 times in each dose (3 priming immunications)

This study will apply a modified 3+3 design for dose-escalation.

1 participant will be registered in the lowest dose cohort group(1.2mg) and when the safety and tolerance of the AST-021p(1.2mg) are identified in the the first group, dose will be increased sequentially and accordingly, the safety and tolerance will be assessed for six participants in the other cohort groups (group2(2.4mg), group3(3.6mg) and group4(4.8mg)).

Participants receiving priming immunization only will be assessed up to End of Treatment(EOT) and participants who recive boosting immunization will be evaluated until the end of study(EOS).

Eligibility Criteria:
Inclusion Criteria:

* has recurrent or metastatic solid cancer that has been proven histologically or cytologically and cannot be treated with surgery or radiotherapy for the purpos of complete remission
* does not have a standard treatment that can be applied clinically according to the investigator's judgment
* has an expected life expectancy of more than 3 months
* adults aged 19 or older based on screening day
* ECOG performance status : 0\~1

Exclusion Criteria:

* Has a history of hypersensitivity or other contraindications to rhGM-CSF and Montanide ISA 51 VG
* Has a history of other primary malignant tumor
* Has autoimmune diseases or inflammatory diseases
* Has a history of active primary immunodeficiency disease
* Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
* Is pregnant or breastfeeding or expecting to conceive children
* has a history of immune suppression therapy ≤4 weeks prior to the screening day
L-Gastrectomy With the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System

This study aims to evaluate the safety, efficacy, and feasibility of the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System in patients with gastric cancer.

Background: Lymphadenectomy in laparoscopic gastrectomy can significantly improve the long-term survival and accuracy of the tumor staging of patients with gastric cancer. The retrieval of more lymph nodes has gradually become a trend among surgeons. However, lymphadenectomy is currently performed without the aid of visual instruments which might lead to an unknown pathological outcome and influence the prognosis of gastric cancer patients. And none of the indocyanine green (ICG) fluorescent imaging systems applied in clinical practice now is equipped with ultra-high definition (4K) or three-dimensional (3D) lens. To explore the advent of minimally invasive surgery with a conveniently switchable high-quality imaging system, we designed a new laparoscopic navigating technique that combined all the three characteristics.

Aims: This study aims to evaluate the safety, efficacy, and feasibility of the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System in patients with gastric cancer.

Methods/design This is a prospective, one-arm, single-center, single-set target value clinical trial to investigate the clinical value of the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System on laparoscopic gastric surgery. The trial will recruit a total of 67 participants.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with gastric cancer require surgery;
2. Without a history of abdominal surgery;
3. BMI ≤ 30 kg/m2;
4. Preoperative ECOG score is 0\~1 and ASA score is I\~III;
5. Having signed the Medical Informed Consent.

Exclusion Criteria:

1. Patients with metastasis or invasion of surrounding tissues;
2. Undergoing emergency operation (perforation, hemorrhage, obstruction);
3. Patients with serious medical co-morbidity (heart, lung, liver and kidney diseases) and could not tolerate laparoscopic surgery;
4. With poor incorrigible physical condition before surgery;
5. The patient who underwent gastrojejunostomy or jejunostomy;
6. The patient who refuses to accept standardized postoperative systemic therapy according to the guidelines.
Effect of Recombinant Human Bone Morphogenetic Protein-2 With an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study.

Effect of Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study.

The Primary outcome will be measuring the effect of rhBMP- 2/ACS in improving the secondary stability of dental implant by using RFA in comparison to control group.

Secondary outcome association of the effect of other factors (ridge dimension, bone density) on dental implant stability.

Eligibility Criteria:
Inclusion Criteria:

* Patients have good oral hygiene.
* Systemic healthy individuals ,Age more than18 years.
* Healed edentulous area for at least 6 months after tooth extraction (delayed implant protocol).
* Patients have at least two missing teeth in the jaw (canine to 1st molar area) indicated for the dental implant.

Exclusion Criteria:

* Presence of systemic diseases preventing implantation.
* Previous implantation or augmentation of the same region.
* The need for additional bone augmentation procedures (such as maxillary sinus augmentation)
* Partial or total edentulous ridge associated with a severe knife-edge ridge .
* Acute infection or any pathological lesion a the implant site.
* Allergy to one of the materials to be used during operation.
* Pregnancy.
* Radiation therapy, bisphosphonate drugs , Osteoradionecrosis.
Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia

This is a single site, open label study with a single arm designed to assess the feasibility of use of caloric vestibular stimulation (CVS) in patients with post-stroke aphasia. CVS is delivered via a portable, non-invasive device. Both language and movement assessments are made.


Eligibility Criteria:
Inclusion Criteria:

* \>6 months post-stroke (ischemic or hemorrhagic)
* receptive or expressive aphasia
* little or no improvement in language ability in the preceding 3 months

Exclusion Criteria:

* persons under the age of 18 or over the age of 75
* patients with pure receptive aphasia
* co-morbid CNS disease
* primary motor/oral apraxia
* pregnant or nursing women
* have a history of unstable mood disorder or unstable anxiety disorder or psychosis
* use of a hearing aid
* have a cochlear implant
* have a diagnosed vestibular dysfunction
* abuse alcohol or other drugs
* have had eye surgery within the previous three months or ear surgery within the previous six months
* have active ear infections or a perforated tympanic membrane
* have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
* Though not excluded, patients taking anti-histamines or anti-nausea drugs will be encouraged not to take such medications within four hours prior to a CVS treatment. The Investigator should review other medications taken by the patient with properties that mimic anti-nausea or anti-dizziness drugs as these may reduce responsiveness of the vestibular system to caloric stimulation.