cyrilzakka/clinical-trials huggingface dataset:
Alteration of the Immune Microenvironment in Basal Cell Carcinoma Following Photodynamic Therapy

The purpose of this study is to better understand the immune response to basal cell carcinoma (BCC) treated with Photodynamic Therapy (PDT) in order to develop new methods of treating BCC. Previous research suggests that PDT alters the immune response, possibly in a way that could promote better tumor clearance when combined with other treatments. Overall, participation in this study will help the study team better understand the anti-tumor immune response when BCC is treated with PDT.

PDT is a technique that works by combining a photosensitizing topical agent and an intense light to kill tumor cells. PDT is not currently approved for the treatment of BCC by the Food and Drug Administration (FDA), although it is approved for that purpose in many European countries.

This is an internally (bilaterally) controlled trial that will enroll 24 participants with biopsy-proven BCC who are planning to undergo tumor removal via Mohs surgery. Within this cohort, one tumor will be PDT-treated and the other left as an untreated control. This study is also a cohort-controlled trial, because discarded tissue from fully de-identified Mohs participants will be analyzed after routine Mohs surgery, in order to establish the baseline variability in tumor-infiltrating immune cell parameters in non-PDT-treated participants.

The objectives of this study are:

To determine the time to maximum expression of immune checkpoint molecules in BCC tumors and peri-tumoral stroma after PDT, as compared to untreated tumors.

To determine the ratio of cytotoxic T cells to regulatory T cells in BCC tumors and peri-tumoral stroma after PDT, as compared to untreated tumors.

To determine whether circulating T-cells, collected from patients' peripheral blood, sampled before and after PDT treatment of a BCC tumor, show a higher proportion of tumor-activated CD8+ T-cells after PDT. The hypothesis is that PDT of the localized tumor will trigger a systemic anti-tumor immune effect.

To determine the rate of protoporphyrin IX (PpIX) accumulation and maximal PpIX levels.in tumors To determine the rate of production and maximal levels of singlet oxygen (O2) produced during blue light exposure To assess change in the volume, color, and appearance of tumors at the Mohs surgery visit compared to the PDT visit To assess for distant tumor (abscopal) effects after PDT

Eligibility Criteria:
Inclusion Criteria:

* Adults scheduled to undergo Mohs surgery within the Dermatologic Surgery unit of the Department of Dermatology, Cleveland Clinic
* Must have at least one BCC tumor eligible for removal by surgical excision
* Men and women of any ethnic group are eligible
* Must provide informed consent to participate

Exclusion Criteria:

* Pregnant or breastfeeding
* Currently being treated for other cancers with medical or radiation therapy
* Known hypersensitivity to 5-aminolevulinic acid (ALA)
* History of a photosensitivity disease, e.g.,porphyria cutanea tarda
A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia

Depression with ongoing insomnia is a common clinical presentation with patients. Clinical data suggests that patients with insomnia that receive concomitant treatment with a sleep aid experience a more robust antidepressant response along with a quicker response. The purpose of this clinical study is to compare the effectiveness of the FDA-approved insomnia medication suvorexant, also known as Belsomra®, as add-on treatment to an antidepressant to that of placebo plus antidepressant treatment in patients with depression and residual or ongoing insomnia.

Many patients with depression suffer from residual insomnia. This study is a six week, randomized, double-blind, placebo-controlled, trial to study suvorexant augmentation of continuing antidepressant therapy against placebo with continuing antidepressant therapy. Patient volunteers must be on a stable antidepressant treatment and will remain on this treatment for the duration of the study. Patient volunteers that qualify and enroll in the clinical trial will either receive suvorexant 10 mg/day and may have it adjusted to a dose of either 15 mg or 20 mg/day. Treatment is for a total of six weeks in addition to a clinical follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Provide written Informed Consent
* Diagnosis of depression (MDD)
* Currently on antidepressant
* Healthy and/or stable medically

Exclusion Criteria:

* unwilling to discontinue current use of sedative hypnotics/sleep aids/benzodiazepines or over the counter sleep aids/supplements
* currently using other psychotropics other than antidepressants
* at risk of self harm or a suicide attempt within the past 12 months
* history or presence of psychotic disorders
* known hypersensitivity to suvorexant
* presence of any other sleep disorder other than residual insomnia of depression
Postoperative Pain in Patients Undergoing Scheduled Laparoscopic Intestinal Resection Surgery

This observational prospective study aims to evaluate the postoperative analgesic effect of a regional anesthesia thechnique (TAP block) in patients undergoing scheduled laparoscopic intestinal resection for intestinal cancer. ASA I-III patients operated between May 1 and September 30, 2019 under general anesthesia according to usual clinical practice, will be included. Patients who meet any of the following criteria will be excluded from this study: under 18 years old, language barrier, cognitive impairment or inability to assist in clinical assessment, drug or alcohol abuse, intake of opioids, consumption of analgesics 24 hours before surgery, BMI \<18 or \>35 kg/m2. Subsequently, an analysis will be made evaluating the quality of analgesia and the appearance of postoperative chronic pain and comparing the patients who underwent TAP block with those who did not.

The transverse abdominal plane (TAP) block is a regional anesthesia technique that blocks the afferent nerves of the anterolateral abdominal wall. This observational prospective study aims to evaluate the postoperative analgesic effect in patients undergoing laparoscopic intestinal resection. ASA I-III patients operated on a scheduled basis, between May 1 and September 30, 2019, by laparoscopy for intestinal cancer resection under general anesthesia according to usual clinical practice, will be included. Patients who meet any of the following criteria will be excluded from this study: under 18 years old, language barrier, cognitive impairment or inability to assist in clinical assessment, drug or alcohol abuse, intake of opioids, consumption of analgesics 24 hours before surgery, BMI \<18 or \>35 kg/m2. Subsequently, an analysis will be made evaluating the quality of analgesia and the appearance of postoperative chronic pain and comparing the patients who underwent TAP block with those who did not.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Operated on a scheduled basis for laparoscopic intestinal cancer resection

Exclusion Criteria:

* Under 18 years old
* Language barrier
* Cognitive impairment or inability to collaborate in clinical assessment during the study
* Drug or alcohol abuse
* Habitual intake of opioids
* Consumption of analgesics 24 hours before surgery
* BMI \<18 or \>35 kg/m2
Hypertension Patients on Drug Medication Adherence and Rational Medication Use

This research will be conducted to determine the effects of education and telephone counseling given to hypertension patients on drug treatment compliance and rational drug use.

This research will be conducted to determine the effects of education and telephone counseling given to hypertension patients on drug treatment compliance and rational drug use.

Research Hypotheses H0: Education and telephone counseling given to hypertension patients do not affect drug treatment compliance.

H1: Education and telephone counseling given to hypertension patients increase drug treatment compliance.

H0: Education and telephone counseling given to hypertension patients do not affect rational drug use.

H1: Education and telephone counseling given to hypertension patients increase rational drug use.

This study was planned as a single-blind randomized controlled experimental study.

Eligibility Criteria:
Inclusion Criteria:

* - Diagnosed with hypertension,
* Hypertension disease duration of at least 6 months,
* Using at least one drug due to hypertension,
* 18 years old and over
* Literate,
* Living in the town centre,
* Owns a phone
* Open to communication and cooperation,
* Patients willing to participate in the study will be included in the study.

Exclusion Criteria:

* Having a psychiatric illness
* Hearing loss,
* Can't understand or speak Turkish and
* Patients who do not wish to continue the study will be excluded from the study.
Different Treatment Modalities for Oral Lichen Plan

The goal of applications of Low-Level Laser and Topical Steroid in the Management of Oral Lichen Planus is to learn if intervention can by relieve pain, decreasing inflammation, and facilitating tissue healing in20 patients who were suffering from erosive oral lichen planus. The main questions it aims to answer are which is better and more effective as treatment modality. The erosion size (mm2) measured on the first day and 4 weeks later. Oral Health-Related Quality of Life questionnaire manipulated. Researchers will take Low-Level Laser and Topical Steroid in the Management of Oral Lichen Planus to see if it could be used as separate treatment option or as combination.


Eligibility Criteria:
Inclusion Criteria:

* patients who were monitored for OLP.
* clinical and histopathological finding of OLP in accordance with van der Meij 2003.
* being over 18 years old.

Exclusion Criteria:

* Patients with systemic disorders, pregnancy, using drugs, smoking, lesions in contact with dental amalgams, and cutaneous or other mucosal involvement at the time of treatment were excluded.
Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

The purpose of this trial is to compare the performance of two different contact lenses for contact lens wearers with astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* Have a current spectacle prescription, preferably within 6-9 months.
* Currently wearing toric soft contact lenses in both eyes with at least 1 month experience wearing current brand for daily wear.
* Be correctable to at least 20/40 distance visual acuity in each eye while wearing trial lenses in the parameters available for this trial.
* Have acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
* Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
* Currently enrolled in any Clinical Trial.
* Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* Currently wearing soft toric contact lenses as extended wear.
* Currently wearing either of the products to be worn in the study.
* Other protocol-defined inclusion/exclusion criteria may apply.
Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN)

This project is a pilot study of an adapted intervention of an existing Opioid Use Disorder (OUD) treatment retention intervention called Recovery Management Checkups (RMC). This intervention has been adapted to better fit the experiences and unique issues of those that have been hospitalized with serious injection related infections (SIRI) based on the findings from a prior qualitative study from the principal investigator. This project plans to test the adapted intervention within a smaller group of participants to assess feasibility, acceptability, and calculate early findings of intervention efficacy.

Hospitalizations for SIRIs are a unique entry point for patients to start their recovery journey with medications for OUD (MOUD), but many people do not remain on long-term treatment, despite evidence that indicates MOUDs reduce death and re-hospitalization after SIRIs.

The study objectives are to:

* Assess the implementation feasibility of the adapted RMC model for patients with SIRI and OUD.
* Establish preliminary estimates of intervention efficacy.
* Make further adaptions to the intervention that will reduce both known and unknown barriers to care and increase effectiveness in future larger scale trials.

Findings from this pilot study will result in further intervention refinement to better fit the target population, and serve as the basis for a larger randomized control trial that will have aims focused on more in-depth analysis of the efficacy of this program


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 65 years of age
* Able to provide Informed Consent
* Admitted to Boston Medical Center on any inpatient unit for an active serious injection related infection (SIRI) such as endocarditis, osteomyelitis, bacteremia, septic arthritis, epidural abscess or other serious infection in which two weeks or more of antibiotics are recommended

Exclusion Criteria:

* Not able to give informed consent
* Cognitive ability (defined through Research Assistant (RA) determination)
* Inability to complete assessments in English or Spanish (defined through RA determination).
* Exclusion for any reason under PI discretion
* Unable to provide names and contact information for at least two verifiable locator persons who will know where to find them in the future.
* In police custody or expecting incarceration
Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block

Delirium is common in the elderly after orthopedic surgery and is associated with worse outcomes. Continuous femoral nerve block is frequently used for postoperative analgesia after total knee arthoplasty. The investigators hypothesize that dexmedetomidine, when combined with ropivacaine for continuous femoral nerve block, can reduce the incidence of delirium and improve the long-term outcome in elderly patients after total knee arthroplasty.

A growing number of elderly patients undergo total knee arthroplasty. Delirium is a common complication in these patients after surgery and is associated with worse outcomes, including prolonged hospital stay, poor functional recovery, decreased cognitive function, increased health care costs, and elevated mortality rate. Dexmedetomidine has been shown to prolong the duration of nerve block without neurotoxicity and improve postoperative sleep quality. The investigators hypothesize that dexmedetomidine, when combined with ropivacaine for continuous femoral nerve block, can reduce the incidence of delirium and improve the long-term outcome in elderly patients after total knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients (≥ 65 years but \< 90 years);
* Scheduled to undergo single total knee arthroplasty;
* Planned to receive continuous femoral nerve block for postoperative analgesia.

Exclusion Criteria:

* Refuse to participate in this study;
* Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
* Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;
* Preoperative hemorrhagic disease or coagulopathy (platelet count, prothrombin time and/or activated partial thrombin time below the lower limit of normal);
* Preoperative obstructive sleep apnea (diagnosed as obstructive sleep apnea, or STOP-Bang score ≥3);
* Preoperative sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker;
* Severe hepatic dysfunction (Child-Pugh class C);
* Severe renal dysfunction (requirement of renal replacement therapy before surgery);
* ASA classification ≥ IV or unlikely to survive for more than 24 hours after surgery.
A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients

The purpose of this study is to compare the efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with schizophrenia or schizoaffective disorder
* At least a 6th grade reading level
* Males or females, between 18 and 70 years of age at the time of consent
* Subjects must have been hospitalized for no more than 14 consecutive days immediately prior to screening

Exclusion Criteria:

* Psychiatric disorder other than schizophrenia or schizoaffective disorder
* History of arrhythmia, heart attack, or heart failure
ADL-PDT Under Routine Clinical Conditions in Patients With Actinic Keratosis

The objective of this non-interventional study (NIS) is to gain comprehensive insights into the practicability of ADL-PDT with Metvix® in patients with actinic keratoses under real-world conditions.

The objective of this non-interventional study (NIS) is to gain comprehensive insights into the practicability of ADL-PDT with Metvix® in patients with actinic keratoses under real-world conditions. Furthermore, this NIS will document the efficacy, satisfaction, safety and tolerability of ADL-PDT with Metvix® in routine use according to the label.

The observational study is designed as a multicenter study, covering all parts of Germany. Participating investigators are dermatologists experienced in ADL-PDT with an adequate pool of patients with actinic keratoses. The observation time per patient will comprise up to 6 months, including up to 4 visits.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to participate in the study
* Age ≥18 years
* Thin or non-hyperkeratotic and non-pigmented actinic keratoses (AK) on the face or scalp (Olsen grade 1 or Olsen grade 2)
* The decision to undergo ADL-PDT with Metvix® was made independently of this study
* No contraindication (according to the SmPC)

Exclusion Criteria:

* Hypersensitivity to the active substance or to one of the other ingredients listed in section 6.1 of the SmPC or other ingredients, including peanut oil, peanut or soy.
* Morpheaform basal cell carcinoma
* Porphyria
* Pregnancy
Equine-assisted Therapy for Therapy-resistant Adolescents With Autism Spectrum Disorders, a Replicated AB-design

The purpose of this study is to assess the (cost)effectivity of Equine assisted Therapy in adolescents with Autism Spectrum disorders.

The study has a mixed-methods strategy consisting of three elements: a randomized, multiple-baseline single-case design (n=35), a qualitative study (n=8-10) and a cost-effectiveness study (n=6). After obtaining written informed consent, participants will be randomly assigned to one of the five pre-defined baseline lengths (2-6 weeks) to increase the internal validity of the design.

Eligibility Criteria:
Inclusion Criteria:

* between 11-18 years old;
* a clinical diagnosis of autism spectrum disorders according the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) as diagnosed by a Beroepen in de Individuele Gezondheidszorg (BIG) registered healthcare professional;
* insufficient emotion regulation after regular therapy for at least 1,5 years as indicated by a score above clinical cut-off (T-score = 65) on the EDI;
* comorbidities are allowed except for those interfering with safety.

Exclusion Criteria:

* unable to respond to questions (parents or adolescents);
* no access to an Internet connection;
* insufficient mastery of Dutch language in parents or adolescents;
* physically incapable to work with the horses;
* unstable medication use;
* total intelligence quotient (IQ) equal to or below 80 on the Wechsler Intelligence Scale for Children (WISC-III-R or WISC-V);
* allergic or phobic to horses;
* insufficient regulation to safely handle the horses;
* therapy with horses within the last two years.
Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease

This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. Patient and physician assessments completed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dry eye disease
* Currently using artificial tears daily
* Male or female of legal age of consent
* Normal lid position and closure

Exclusion Criteria

* Patients currently using cyclosporine ophthalmic emulsion 0.05%
* Participation in other investigational drug or device study
* Any current or previous topical ophthalmic or oral cyclosporine use within the last three years
Aortopathy in Persons With Bicuspid Aortic Valve, Turner and Marfan Syndrome

The study aim is:

1. To examine aortic tissue by light microscopy
2. To examine aortic tissue by electron microscopy
3. To study changes in the epigenome and transcriptome of the X chromosome specific to aortic tissue.
4. To examine aortic tissue using biochemistry including proteomics.
5. To establish the karyotype of fibroblasts with standard chromosome examination on 10 meta-phases as well as by fluorescent in situ hybridization (FISH) with probes covering the X and Y chromosome. Using the latter 200 meta-phases will be examined.

30 controls who did not die from aortic dissection or dilation will be recruited from The Department of Forensic Medicine at Aarhus University Hospital.

The investigators will subject samples of aortic tissue from women undergoing prophylactic aortic surgery due to either Marfan syndrome or bicuspid aortic valve to the same panel of examinations (except karyotyping). Lastly the investigators will compare the results from the three groups (Turner syndrome, Marfan syndrome and Bicuspid aortic valve).

Turner syndrome is a congenital complete or partial lack of one of the female sex chromosomes affecting 1 of 2000 live born girls. The syndrome is characterized by an increased prevalence of ischemic heart disease, aortic dilation and dissection, hypertension, stroke and autoimmune diseases in general.

Eligibility Criteria:
Turner syndrome (TS).

A. Inclusion

* TS verified by genotyping
* Age \> 18 years
* Awaiting operation due to aortic dilation

B. Exclusion - Previous aortic dissection or operation of the aorta (per-cutaneous or open surgery)

Marfan syndrome (MS)

A. Inclusion

* Females with MS verified clinically or by genotyping
* Age \> 18 years
* Awaiting operation due to aortic dilation

B. Exclusion

- Previous aortic dissection or operation of the aorta (per-cutaneous or open surgery)

Bicuspid aortic valve

A. Inclusion

* Females with Bicuspid aortic valve
* Age \> 18 years
* Awaiting operation due to aortic dilation

B. Exclusion - Previous aortic dissection or operation of the aorta (per-cutaneous or open surgery)

Controls

A. Inclusion

* Men/females who died from conditions other than aortic dilation or dissection.
* Age 20-60 years.

B. Exclusion

- Previous aortic dissection or operation of the aorta (per-cutaneous or open surgery)
The Cervical Trident Study

This observational retrospective study evaluates the efficacy of RF with the three-tined expandable electrode needle compared to before treatment in the treatment of chronic cervical facet joint pain.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Patients with neck pain
* Patient who had two diagnostic medial branch blocks with significant (\>50%) improvement on both injections.

Exclusion Criteria:

- No patient related outcome measures available in hospital's patient charts