cyrilzakka/clinical-trials huggingface dataset:
Maxillary Sinus Elevation and Simultaneous Implant Placement

using gel foam \[ absorbable gelatin \] in maxillary sinus elevation which act as a space maintainer and alternative to bone filler for new bone formation in the maxillary sinus and its advantages for patients undergoing maxillary sinus elevation with simultaneous implant placement as regards the implant stability and amount of bone height gain compared to conventional maxillary sinus elevation by xenograft.

One of the main problem for posterior maxilla it becomes atrophic after extraction of the teeth and this followed by Pneumatization of the maxillary sinus, the atrophy of the alveolar process is a common reason for the limited availability of alveolar bone for implant placement in the posterior maxilla.

Numerous techniques designed to increase bone volume in the maxillary sinus region have been proposed. They were mostly based on the insertion of various materials into a void created between the sinus (Schneiderian) membrane and the bony walls of the maxillary sinus. (Sohn et al 2008) reported simultaneous placement of implants, and insertion of gelatin sponges demonstrate new bone formation through clinical and radiographic evaluations. New bone formation was verified by stabilization of the elevated sinus membrane from the tenting effect of placement of dental implants and absorbable gelatin sponge without any bone graft material. This study shows that there is great potential for new bone formation in the maxillary sinus without the use of additional bone grafts. Systemic review showed that the survival rate for implants utilizing xenografts was statistically the same as for implants placed in particulate autogenous bone grafts .

Eligibility Criteria:
Inclusion Criteria:• Patients with atrophic maxilla and pneumatization of the maxillary sinus with residual bone height from 3 to 5mm .

* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:• Sinus pathology.

* Heavy smokers more than 20 cigarettes per day .
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems.
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
The Combination Therapy With Ra-223 and Enzalutamide

This study is to evaluate preliminary efficacy of Ra-223 in combination with Enzalutamide in progressive CRPC patients with bone metastasis


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed as CRPC
2. Surgical or those who will be treated with luteinizing hormone-releasing hormone (LHRH) agonists throughout the study period,
3. Patients who had \>30% of PSA response to enzalutamide prior to enrollment,
4. Interval between PSA progression and enrollment is up to 3 months,
5. With bone metastases (≥ 2 hot spots) on bone scintigraphy within previous 24 weeks,
6. No intention to use anti-cancer chemotherapy within the next 6 months,
7. Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-1,
8. Life expectancy ≥ 6 months,
9. Laboratory requirements within 30 days before enrollment:

   * Absolute neutrophil count (ANC) ≥ 1.5 x 10e9/L,
   * Platelet count ≥ 100 x 10e9/L,
   * Hemoglobin ≥ 10.0 g/dL,
   * Total bilirubin level ≤1.5 institutional upper limit of normal (ULN),
   * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 ULN,
   * Creatinine ≤ 1.5ULN, and estimated glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2,
10. Age ≥ 20,
11. Ability to understand and the willingness to sign a written informed consent (IC).

Exclusion Criteria:

1. Prior chemotherapy or planned treatment with chemotherapy,
2. PSA progression within 3 months after initiation of enzalutamide
3. Prior treatment with corticosteroids, estramustine or abiraterone acetate,
4. Any systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bone metastases,
5. Had history of gastrointestinal bleeding or ulcer within 3 months prior to study entry,
6. History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations,
7. History of or known brain metastasis,
8. Malignant lymphadenopathy ≧1.5 cm in short axis,
9. Imminent or established spinal cord compression based on clinical findings and/or MRI (Magnetic Resonance Imaging),
10. Any other serious illness or medical condition
11. Substance abuse, medical, psychological, or social conditions that might interfere with the subject's participation in the study or evaluation of the study Results
12. Those who judged to be inappropriate by the principal investigator or co-investigator.
The Turkish Version of the Late Life Function and Disability Instrument

The aim of this study is to investigate the Turkish validity and reliability of the Late Life Function and Disability Instrument (LLFDI) and to provide a measurement tool for researchers who wish to work in this field within the Turkish literature.

Short Physical Performance Battery (SPPB), Timed Up and Go Test (TUG), Functional Independence Measure (FIM), and Barthel Index of Activities of Daily Living (MBI), among others. However, these tests were designed without a clear theoretical or conceptual framework, and their utility and applicability are limited by the physical and cognitive condition of the individuals being assessed. There is a need for practical, adequate, tolerable, and reliable tests that provide consistent results and allow for a comprehensive evaluation of functional status and the effects of treatment.

Considering the existing tests, the Late Life Function and Disability Instrument (LLFDI) was developed by professors in the Department of Physical Therapy at Boston University to assess meaningful changes in both function and disability categories. The LLFDI has been translated into Hebrew, Swedish, French, Korean, Spanish, Canadian Portuguese, and Brazilian Portuguese, with its reliability and validity confirmed. This instrument is widely used in many countries worldwide.

However, there is currently no study on the Turkish version, validity, and reliability of the Late Life Function and Disability Instrument (LLFDI).

The aim of this study is to investigate the validity and reliability of the Turkish version of the Late Life Function and Disability Instrument (LLFDI) and to provide a measurement tool for researchers in this field to be used in the Turkish literature.

Eligibility Criteria:
Inclusion Criteria:

* over 65 years old,
* being willing and volunteer to participate in the study,
* having reading and writing skills,
* being able to read and write in Turkish,
* having a diagnosis of gonarthrosis, and
* scoring above 20 points on the Mini-Mental Test.

Exclusion Criteria:

* Having a neurological problem
SCI Pain App Intervention Study

The purpose of this study is to find out if using an app is a feasible and acceptable treatment for chronic pain in persons with spinal cord injury. Participants will have a 50% chance of being asked to listen to 10 minutes of audio-guided meditations using an app each day for six weeks, and a 50% chance of being asked to listen to 10 minutes of engaging and distracting presentations about topics of interest to the individual (TED Talks) for six weeks. All participants will be asked to complete three online surveys about their emotional and physical health lasting 20-30 minutes (one when the participant first enters the study, one six weeks later, and another six weeks later). Additionally, participants will be asked to complete brief (\<5 minute) online surveys once a week during the first six weeks of their participation. Participation in this study is very low risk, and participants may not experience any personal benefit from their participation. Participation in this study is entirely voluntary.


Eligibility Criteria:
Inclusion Criteria:

1. are at least 18 years of age
2. have a traumatic SCI of at least 6 months duration
3. have chronic pain \[defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale\]
4. understand spoken and written English sufficiently to understand the goals, procedures, time involved, and the time involved in participation, participate in the intervention and complete study surveys.

Exclusion Criteria:

1. have a significant visual or hearing impairment that limits their ability to participate in the app/computer-based intervention
2. lack access to and the ability to use a smart phone or smart tablet (e.g., iPad)
3. are unable to provide or obtain an email address for communication
4. practiced any kind of meditation more than once a week in the past 3 months
Observation Study an Immunogenicity Modified TRC-ID Regimen With CPRV With or Without Rabies Immunoglobulin in Children

To determine Immunogenicity and Safety Study of Modified TRC-ID Regimen with A New Chromatographically Purified Vero Cell Rabies Vaccine (SPEEDA®) as post exposure rabies intradermal regimen with or without Rabies Immunoglobulin in Children

post exposure rabies vaccination with modified Thai red cross intrademal regimen has been proven to be immunogenic and effection when using purified vero cell vaccine (PVRV) In present, new chromatographically purified vero cell rabies vaccine (SPEEDA), chromatography purifed vero cell derived rabies vaccine, is manufactured by the Liaoning Chengda Biotechnology is available This study has a goal to determine the immunogenicity of speeda when using with post exposure rabies intradermal vaccination with or without rabies immune globulin in children

Eligibility Criteria:
Inclusion Criteria:

* they are 1-15 years healthy children
* give signed informed consent from their parents
* willing to participate in this study and be able to receive the vaccination and collect blood sample as the study plan.

Exclusion Criteria:

* they have prior history of rabies vaccination or any equine/human serum administration such as snake antivenom and tetanus antiserum or vaccine allergy
* Persons who have immunosuppressive conditions such as known HIV infection, transplantation, chronic renal failure, receiving of steroid or immunosuppressive drugs
* person received anti-malarial drugs within the previous two months or any blood products within previous three months were excluded
* Urine pregnancy test must be done in all female adolescents to exclude the pregnancy in first visit
Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

The purpose of this study is to evaluate DAILIES TOTAL1® Multifocal (DTl MF) contact lenses in current multifocal contact lens wearers with symptoms of end of day discomfort compared to their habitual multifocal contact lens correction.


Eligibility Criteria:
Inclusion Criteria:

* Must sign an informed consent document;
* Current daily wearer of soft multifocal contact lenses for at least 6 months with symptoms of contact lens discomfort as defined by the prescreening Eligibility Questionnaire;
* Requires a near spectacle add of +0.50 to +2.50 diopters (D) (inclusive);
* Requires lenses within the power range of study lenses to be fitted;
* Best corrected VA (BCVA) of 20/30 (0.2 logarithmic minimum angle of resolution \[logMAR\]) or better in each eye at distance;
* Willing to wear study lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any eye condition that contraindicates wearing contact lenses as determined by the Investigator;
* Any use of medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* Monocular (only one eye functional) or fit with only 1 lens;
* Fitted with monovision;
* Prior refractive surgery (e.g., laser vision correction, photorefractive keratectomy, etc.);
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Currently wearing DT1 MF contact lenses;
* Other protocol-defined exclusion criteria may apply.
Psoriatic Immune Response to Tildrakizumab

This study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the IL23 blocker, tildrakizumab.

This is a one-arm, open-label study to examine the effect of Tildrakizumab on cutaneous and blood immune cells of psoriatic patients. Ten subjects with moderate to severe psoriasis will be enrolled. Biopsy and blood samples will be collected before and during treatment and undergo molecular profiling to assess for tildrakizumab-corrected signatures.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patients with moderate-severe psoriasis or \> 5% body surface area affected.

Exclusion Criteria:

* taking systemic immunosuppressives in the last 4 weeks
* pregnancy
* severe immunodeficiency (either from genetic or infectious causes).
* tuberculosis or other active serious infection
* active systemic malignancy.
* breast-feeding
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Detecting the Influence of Cataract Surgery on the Development of Diabetic Retinopathy in Patients With Diabetes Mellitus Type 2 With and Without Diabetic Retinopathy Using OCT Angiography

Detecting the influence of cataract surgery on the development of diabetic retinopathy in patients with diabetes mellitus type 2 with and without diabetic retinopathy using OCT angiography.

Patients with diabetes mellitus type 2 with and without without diabetic retinopathy (on biomicroscopy examination) who need cataract surgery, will undergo OCT angiography examination prior to their cataract surgery. Average vessel density (%) in superficial capillary plexus, deep capillary plexus and choriocapillaris, parafoveal vessel density (%) in the superficial and deep plexuses, FAZ area (mm2) in the superficial capillary plexus, FAZ circularity, retinal thickness, microaneurysms and capillary non-perfusion will be taken into analysis.

Patients will be examined on the first day after the cataract surgery with phacoemulsification and in the bag posterior chamber lens implantation.

All patients will undergo OCT angiography examination four weeks after their cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes mellitus type 2 with and without diabetic retinopathy who needs cataract surgery.
* Patients who need cataract surgery without any intravitreal injections.
* Absence of any ocular disease other than diabetes mellitus.
* Cataract density allowing good visualization of the fundus by OCT angiography.
* Patients with uneventful cataract surgery with phacoemulsification.

Exclusion Criteria:

* Patients who fail to comply with the follow-up schedule.
* Very dense cataract not allowing good visualization of the fundus by OCT angiography.
* Patients with complicated cataract surgery with phacoemulsification.
* Patients who need cataract surgery with any intravitreal injection.
Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV

The purpose of this study is to determine whether oral fecal microbiota transplantation (FMT) is safe for people with human immunodeficiency virus (HIV) infection.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection, documented by any licensed HIV test
* Male subjects ≥ 18 years of age
* Identify as MSM (men who have sex with men)
* Currently on continuous ART for ≥24 weeks prior to study entry with no change in the ART regimen within the 12 weeks prior to study
* Ability and willingness of the participating subject to sign the informed consent form
* No plan to change ART regimen for the study duration
* Screening CD4+ cell count \>350 cells/mm3 obtained within 45 days prior to study entry
* HIV RNA \< 20 copies/ml for ≥12 weeks (1 blip of \< 500 copies/ml will be permitted)
* Absolute neutrophil count ≥ 1000 cells/mm3

Exclusion Criteria:

* Initiation of ART during acute/early HIV infection (within 6 months of HIV seroconversion)
* Co-infection with Hepatitis B (positive HBsAg or positive HBcAb total with detectable HBV DNA levels) or Hepatitis C (positive HCV IgG with detectable HCV RNA levels)
* Use of antibiotics 60 days prior to the study entry
* Use of investigational therapies or vaccines 60 days prior to the study entry
* Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry
* Cirrhosis, inflammatory bowel disease, total colectomy, colon or rectal anastomosis, bowel resection, or current colostomy
* Diabetes mellitus
* Any episode of acute or persistent diarrhea within 60 days prior to study entry
* Use of any of the following medications/products for more than 3 consecutive days within the 60 days prior to study entry: Immunosuppressives, Immune modulators, Antineoplastic agents (except for topical agents for skin cancer), Probiotics and prebiotics (supplements and products).
Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

This project will develop and refine a computer-delivered integrated Personalized Feedback Intervention (PFI) that directly addresses smoking and anxiety sensitivity (AS). The PFI will focus on feedback about smoking behavior, AS, and adaptive coping strategies.

The primary goal of the research study is to investigate the efficacy of a brief, personalized computer-delivered transdiagnostic intervention (PFI) that addresses smoking and anxiety sensitivity (AS) to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, reduce AS and negative affective symptoms, and increase adaptive coping skills compared to a smoking information only control. To address this aim, we will implement a randomized controlled trial that will employ a longitudinal experimental design and involve three stages: (a) phone-screener (pre-screener); (b) baseline appointment consisting of a pre-intervention assessment (eligibility), random assignment to a one-session computer-delivered intervention (PFI versus smoking information control with no personalized feedback), and a post-intervention assessment; (c) 1-month follow-up. Assessments will include a multi-method approach, including biological, behavioral, and self-report methods.

Eligibility Criteria:
Inclusion Criteria:

* Elevated anxiety sensitivity defined as an ASI-III score of at least 17
* Daily smoking for at least one year (minimum of 5 cigarettes per day and biochemically confirmed via Carbon Monoxide \[CO\] analysis at least 4 ppm)
* Not presently engaged in a quit attempt
* Not currently engaged in mental health treatment
* Capable of providing informed consent
* Willing to attend all study visits and comply with the protocol

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Students for whom you have direct access to/influence on grades
* Use of other tobacco products
* Currently suicidal or high suicide risk
* Currently psychotic or high psychotic risk
* Insufficient command of English to participate in assessment or treatment
ERAS in Liver Surgery

Enhanced Recovery After Surgery (ERAS) Program (EP) is widely applied to obtain a reduction in post-operative length of hospital stay and a faster restoration of pre-operative patient conditions. However, in Western countries, adherence to EP in liver surgery is still difficult to achieve due to deep-rooted traditional practices. In our Institute, since 2019, EP has been applied pursuing 18/23 items identified by 2016 guidelines. At all consecutive patients who underwent elective liver surgery in our Institution, EP was proposed and their adherence to ERAS items was measured before, during and after surgery. Data were retrospectively collected and analysed, particularly focusing on EP items. Primary outcome was compliance to EP, defined as at least 80% of accomplished items per patient. Secondary outcome was adherence to each ERAS item, while tertiary outcome was detecting the variables associated with program drop out.


Eligibility Criteria:
Inclusion Criteria:

* patients candidates to surgery for benign or malignant liver disease
* liver resection with curative intent

Exclusion Criteria:

* refusal to participate at the EP
* incapability to acquire informed consent
* cognitive impairment that can prejudice the patient comprehension of the EP
* liver surgery with palliative or diagnostic intent or non-resective liver surgery
* emergency surgery
Chronic Postsurgical Pediatric Pain. Evaluation Risk Factors to Develop Chronic Postsurgical Pain in Children and Adolescents Undergoing Surgery in a First Level Hospital

Chronic postsurgical pain had number of prevalence on 20%. Its derivates from risk factors, but recent research provide new potential risk factors to develop chronic postsurgical pediatric pain.

To increase the body of knowledge, an observational study is proposed in pediatric patients undergoing surgical intervention.

A cohort of pediatric patients undergoing surgery will be followed at the Maternal and Child Hospital October 12, Madrid. The group of patients that develops post-surgical chronic pain and the group that does not develop it will be observed, and risk factors will be studied.

Before the surgical intervention, the risk factors described in the literature will be analyzed. Children will be followed up to 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Children with age from 4 years to 18 years. Undergoing surgery for any surgical specialty. ASA Status (American Society of Anesthesiologist) from I to III.

Exclusion Criteria:

* Children who do not understand and speak Spanish correctly. Children with verbal communication problems.