cyrilzakka/clinical-trials huggingface dataset:
Colposcopy and Dynamic Spectral Imaging (DSI)

This study evaluates the Dynamic Spectral Imaging (DSI) Colposcope (DySIS) in it's ability to diagnose cervical dysplasia. Half of participants with be examined by the DySIS colposcope, there the other half will be examined by standard colposcopy.

Colposcopy has been shown to be a subjective exam, and is dependant on the colposcopists. Sensitivity for colposcopy has been shown to be as low as 50%.

To improve this, different adjunctive technologies have been introduced to add a more objective approach to the colposcopy exam. One of these devices is the DySIS colposcope, which measures the aceto-white reaction that may occur on the cervix uteri after the application of acetic-acid. The device provides the examiner with a colour-coded map indicating areas of interest. Studies have shown promising results indicating that using this device together with the colposcopists own interpretation of the cervix uteri can potentially lead to an increase in the performance of the colposcopy exam.

In Denmark all women referred for colposcopy have 4 biopsies taken, according to the Danish national guidelines.

In our study these 4 biopsies are as following:

1. The area the colposcopists views as the worst before the DSI-map is seen. Colposcopy-Directed Biopsy (CDB)
2. The area indicated as the worst by the DSI-map (DSI-directed biopsy)
3. additional biopsy
4. additional biopsy All biopsies are placed in separate containers and analysed separately by specialized pathologists.

Eligibility Criteria:
Inclusion Criteria:

* Referred for colposcopy due to a cervical smear test of Atypical Squamous Cells of Undetermined Significance (ASCUS), low-grade intraepithelial lesion (LSIL), atypical squamous cells, cannot exclude a high-grade lesion (ASC-H), high-grade intraepithelial lesion (HSIL), Atypical glandular cells (ACG) or carcinoma in situ (CIS)
* Referred for colposcopy due to follow-up of previously diagnosed CIN (If there has been a minimum of 6 months since previous cervical biopsies)

Exclusion Criteria:

* Cervical biopsies taken within the last 6 months
* Previous cone procedure
* Currently pregnant
* Pregnant within the last 6 months
IMR Evaluation in Patients with Coronary Sinus Reducer Implantation (INROAD Study)

The INROAD is an investigator-driven, prospective, study in which patients undergoing coronary sinus reducer implantation (Reducer) for chronic refractory angina undergo evaluation of the index of microcirculatory resistance (IMR) at the time of implantation, and at 4 months follow-up

Refractory angina (RA) is a chronic condition (present for at least 3 months) of moderate-severe symptoms (Canadian class Cardiovascular Society \[CCS\] II-IV) due to coronary artery disease which cannot be adequately controlled by the combination of optimal medical therapy and coronary revascularization. The clinical impact in terms of quality of life, re-hospitalization and socio-health costs is extremely negative. In this context, the therapeutic goals are primarily the management of the symptom and improvement the patient's quality of life. The unpaid therapeutic demand of these patients has brought out a large number of medical and interventional treatments, including the coronary sinus reduction system (REDUCER). Numerous clinical studies and registries have been carried out and they proved both the efficacy and safety in the use of REDUCER. The physiological mechanism that are supposed to be behind the antianginal effect of coronary sinus intervention are essentially two:

1. Redistribution of coronary flow from the subepicardium to the subendocardium.
2. Coronary neoangiogenesis In both cases, the primum movens of the Reducer's therapeutic mechanism is attributable to the increase in venous pressure due to narrowing of the coronary sinus. Nevertheless, this mechanism of action is theoretical and has never been objectively tested. The evaluation of microcirculatory resistance by IMR before and after REDUCER implantation could be the most effective way to confirm this hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Chronic refractory angina refractory to medical and interventional therapies.
* At least one open coronary artery (excluded right coronary artery) where to performs IMR evaluation
* Ability to provide informed written consent
* Life expectancy ≥1 year

Exclusion Criteria:

* Recent (within 3 months) acute coronary syndrome
* Left ventricular ejection fraction of \<30%
* Severe valvular heart disease
* Inability to perform IMR
* Technical contraindications to the implant ( A pacemaker electrode in the coronary sinus, Mean right atrial pressure \>15mmHg, Anomalous coronary sinus anatomy)
Effect of Peri-operative Glucocorticoids on Short-term Functional Outcome After THA

This randomized, single surgeon, placebo controlled, double blind study will be conducted in order to investigate whether or not peri-operative high doses of intravenous glucocorticoids improve short-term functional outcome after direct anterior total hip arthroplasty. So far, it has been proven that high dose glucocorticoids reduce immediate post-operative pain and nausea, but no data exists on functional outcome during the first 6 weeks. Our hypothesis is that patients in the intervention group will follow a so-called "get ahead, stay ahead" principle and that glucocorticoids can be considered an important tool (adjuvant treatment) in the enhanced recovery pathway after THA with significant socio-economic implications.

Patients listed for a direct anterior total hip arthroplasty by a single surgeon will be recruited for this study and allocated to one of two groups:

1. intervention group: 25 grams of iv dexamethasone at induction followed by 10 mg of iv dexamethasone 12 hours later
2. control group: 5 grams of iv dexamethasone at induction followed by placebo 12 hours later Both patients and surgeons will be blinded. Primary outcome measure will be number of steps during the first 6 weeks as measured by a pedometer. Secondary outcome measures will be side effects, complications, Patient Reported Outcome Measures, pain, nausea, stiffness, achievement of clinical milestones and use of analgesia/anti-emetics. This data will be collected using a tailor made application for a smartphone or tablet and data collecting will start one week before surgery until 6 weeks after surgery.

Based on a power analysis both groups will consist of 35 patients each.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing unilateral uncemented THA for primary OA or AVN of the hip under general anesthesia (GA)
* Aged 18 years and above (including women of child bearing age)
* Able to provide informed consent

Exclusion Criteria:

* Younger than 18 years
* Known alcohol or drug abuse
* Known allergy for glucocorticoids
* Administration of any glucocorticoids in the last three months
* Usage of strong analgesia (such as lyrica or oxycodone) as regular medication
* Usage of medication with anticipated interactions with glucocorticoids
* Known gastric ulcer
* Insulin dependent diabetes mellitus
* Severe heart disease (NYHA \> 2)
* Liver or renal failure
* Systemic rheumatoid diseases
* Insufficient understanding of the Dutch language
* Unable to provide informed consent
* Pre-operative use of walking aids
* Gross anatomical deformities
* Significant intra-operative complications such as periprosthetic fracture
A Survey of Breast Cancer Patients With Metastatic Bone Disease Receiving Oral Ibandronate

This observational, multicenter survey is designed to assess the efficacy of oral ibandronate in adults with breast cancer and metastatic bone disease. Data on the use of ibandronate in clinical practice will be collected from Hungarian patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults at least 18 years of age
* Histologically confirmed breast cancer with bone metastasis
* Receiving or indicated for the tablet formulation of ibandronate according to the summary of product characteristics (SmPC) and local labeling

Exclusion Criteria:

* Contraindication to ibandronate according to SmPC
* Ongoing participation in any trial evaluating the efficacy and/or safety of ibandronate
Sun Protection Factor (SPF) - Static and Water Resistant Assay

Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of an age of 18 to 70 years inclusive;
* Fitzpatrick Skin Type I, II and/or III for SPF testing;
* Good health as determined from the CRO Subject History Form (SHF);
* Signed and dated Informed Consent Form;
* Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form;
* An unambiguous minimal erythema dose (MED).
A Retrospective Observational Study on Compliance in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab) in Clinical Practice (REMISSION II)

This multicenter, retrospective observational study will evaluate compliance an reasons for withdrawal in patients with moderate to severe active rheumatoid arthritis on treatment with intravenous RoActemra/Actemra (tocilizumab) in daily clinical practice. Data will be collected from each eligible patient over a period of 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis according to the revised 1987 ACR criteria at baseline
* RoActemra/Actemra treatment must have been initiated 6 months prior to ICF signing
* Patient eligible according to the summary of product characteristics (SPC) and routine clinical practice/European recommendations for the use of biologic DMARDs for the treatment of rheumatoid arthritis

Exclusion Criteria:

* Rheumatic autoimmune disease other than RA
* Participation in interventional clinical trials during the observational period
Stereotactic Intracerebral Injection of IPSC-DAPs in Patients with Parkinson's Disease

Parkinson's disease is a progressive neurodegenerative disorder characterized by high morbidity due to the limited regenerative capacity of dopaminergic neurons in the brain. Current drug treatments primarily manage symptoms but do not halt or reverse neuronal loss. Cellular replacement therapy has emerged as a potential strategy to restore dopaminergic function and address the underlying neuronal deficits. This study aims to evaluate the safety, feasibility, and efficacy of transplanting dopaminergic neurons into the brain to improve motor function and quality of life in patients with advanced Parkinson's disease.

Patients with Parkinson's disease will be treated with autologous induced pluripotent stem cell-derived dopamine progenitor cells (iPSC-DAPs). These cells will be transplanted directly into the striatum to restore dopamine-producing capacity. Patients will be evaluated at 1, 3, 6, 9 and 12 months after transplantation for safety, feasibility, and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Able to sign informed consent and comply with the study protocol
* 39-75 years of age, at the time of signing informed consent
* Diagnosed to be Parkinson's disease patients over 5 years
* Taking levodopa, but with complications of therapy such as wearing off and/or dyskinesia
* At least 3 hours accumulative "off" time per day
* Hoehn and Yahr Stage 2.5 - 4 in the off state at screening
* Dopamine drug responsiveness demonstrated by a positive "on/off" test with at least a 30% improvement on UPDRS III (motor) scale

Exclusion Criteria:

* Patients with the following concomitant conditions or disorders: Epilepsy；Multiple sclerosis；Unable to give consent due to dementia；Atypical Parkinsonism；Genetic Parkinson's disease；Suicidal ideation associated with intent or plan in the past 12 months；History of psychosis；History of subarachnoid hemorrhage；History of stroke or transient ischemic attack
* Patient with unstable vital sign at screening and/or prior to the surgery:
* Estimated Glomerular Filtration Rate (eGFR) \< 60 ml/min/1.73m2
* Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
* Hematologic abnormality: hemoglobin \<10 mg/dL or platelet count \< 100,000/mL
* International normalized ratio (INR) ≥ 1.3 not due to a reversible cause
* Patients with autoimmune disorders
* Patients with HIV and/or active HBV or HCV
* Patients who are unable to undergo MRI and PET/CT
* Patients with an expected life expectancy of \<1 year
* Patients who have had active malignancies
* Patients currently receive levodopa-carbidopa intestinal gel or apomorphine treatment
* Patients who have history of pallidotomy or thalamotomy or deep brain stimulation (DBS) surgery
* Received cell or gene therapy (autologous or allogeneic) within the previous 12 months
* Participation in an investigational therapeutic or device trial within 30 days of consent
* Women who are pregnant or breast-feeding
* Other conditions that researchers consider not suitable to participate in this study
Group Treatment for Hoarding Disorder

This study assesses the effectiveness of a novel group treatment for hoarding disorder.

The primary aim of this study is to investigate the effectiveness of a novel group treatment for hoarding disorder. Participants will be randomized to receive either treatment as usual (cognitive behavioral therapy: CBT) or treatment as usual augmented by interpersonal psychotherapy (IPT). It is hypothesized that group CBT with IPT will result in greater decreases in hoarding symptoms, as compared to standard group CBT. It is further hypothesized that CBT with IPT will result in greater reductions in object attachment and maladaptive beliefs about relationships with others, as well as greater increases in interpersonal attachment.

Eligibility Criteria:
Inclusion Criteria:

-Clinical diagnosis of HD

Exclusion Criteria:

* Evidence of a severe mental illness or substance use disorder that would impede the completion of the treatment
* Current receipt of CBT for HD
* Initiation of new psychotropic medications for symptoms of HD
Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201

This clinical trial will enroll subjects with HER2+ solid tumors and is conducted in two phases, which are phase 1a and phase 1b. The primary objective of phase 1 is to determine the safety and tolerability of AB-201 in subjects with advanced HER2+ solid tumors.

This is a Phase 1, multicenter study designed to evaluate the safety, tolerability, and efficacy of AB-201 in subjects with advanced HER2+ solid tumors (specifically, breast and gastric/GEJ cancers).

The Phase 1 will be conducted in two parts, an initial dose escalation stage followed by a dose expansion stage.

Study participation for each subject begins with up to 28 days (1 month) of screening following written informed consent, then lymphodepletion treatment, followed by AB-201. Up to 3 doses of AB-201 may be administered. All subjects will be monitored for a total duration of 18 months of follow up from the first dose administration of AB-201.

Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status 0 to 1.
* Histologically confirmed HER2 expressed breast or gastric/GEJ cancer IHC ≥ 2+ within 6 months prior to study entry.
* Confirmed diagnosis of an advanced/unresectable or metastatic HER2+ breast or gastric/GEJ cancer that is refractory to, or intolerable of standard treatment, or for which no standard treatment is available.
* Must have received prior cancer therapy: Subjects with breast cancer must have received ≥ 3 prior systemic therapies; subjects with gastric/GEJ cancer must have received ≥ 2 prior systemic therapy(ies); subjects with IHC 3+ or IHC 2+/ISH+ cancers must have received previous treatment with a HER2-targeting therapy.

Exclusion Criteria:

* Known past or current malignancy other than inclusion diagnosis.
* Known clinically significant cardiac disease.
* Active central nervous system (CNS) metastases, or involvement of the CNS, unless there is a history of at least 3 months of sustained remission.
* Unresolved toxicities from prior anticancer therapy.
* Ongoing uncontrolled systemic infections requiring antibiotic, anti-fungal, or anti-viral therapy.
* History of sensitivity or intolerance to cyclophosphamide or fludarabine.
* Currently Pregnant or lactating
* Severe disease progression or health deterioration within 2 weeks prior to lymphodepletion regimen.
Prospective Evaluation of a Smartphone Application, GoCheckKids™, to Detect Amblyopia Risk Factors in Young Children

The objective is evaluation of GoCheck Kids, a smartphone application ('App'), for use as a photo screening device in a pediatric population to detect amblyopia risk factors (ARFs).

Detection of amblyopia risk factors using photo screening app in children of ages from 12 months to 8 years

Eligibility Criteria:
Inclusion Criteria:

* Age 12 months to 8 years inclusive.
* Informed consent given by parent or legal guardian.

Exclusion Criteria:

- History of ocular surgery and any condition that would preclude the ability of the investigator to obtain a reliable image and measurement
Studying Fentanyl in Patients With Cancer

RATIONALE: Studying blood samples from cancer patients undergoing pain treatment in the laboratory may help doctors learn more about how pain drugs work in the body. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at fentanyl in patients with cancer.

OBJECTIVES:

* To describe the pharmacokinetics of prolonged intravenous infusions of fentanyl citrate in adult patients with cancer.

OUTLINE: Patients undergo blood sample collection before and after discontinuation of fentanyl citrate therapy (10 days total). Pharmacokinetic analysis is performed on the samples.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of cancer
* Inpatient at the Johns Hopkins Hospital Cancer Center undergoing pain treatment with continuous infusion fentanyl citrate for ≥ 5 days

PATIENT CHARACTERISTICS:

* Willing to change to an alternative opioid

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 72 hours since transdermal fentanyl citrate administration
* At least 12 hours since transmucosal fentanyl citrate administration
* No known requirement for continued opioid therapy with any fentanyl citrate products after discontinuation of fentanyl citrate therapy
Multicomponent FIBROWALK Therapy Plus Unified Protocol for Emotional Regulation in Individuals With Fibromyalgia

Fibromyalgia is a chronic condition characterized by widespread pain, fatigue, sleep disturbances, and cognitive dysfunction. Although the FIBROWALK multicomponent program improves physical functionality and pain, its impact on emotional regulation remains limited. This study aims to integrate the Unified Protocol (UP), a cognitive-behavioral therapy (CBT) approach, to enhance emotional and physical distress tolerance in fibromyalgia patients and explore participants' satisfaction, difficulties, and barriers to treatment.

This study investigates the efficacy of integrating the Unified Protocol (UP), a transdiagnostic intervention based on CBT, with the multicomponent FIBROWALK therapy for individuals with fibromyalgia. The trial seeks to enhance emotional regulation, reduce anxiety and depression, and improve quality of life. Additionally, it will gather qualitative feedback from participants to identify challenges, barriers, and potential improvements to the therapeutic intervention.


Eligibility Criteria:
Inclusion Criteria:

* Adults diagnosed with fibromyalgia, according to the 2011 American College of Rheumatology (ACR) modified criteria.
* Aged 18 or older.

Exclusion Criteria:

* Individuals with psychotic disorders, substance abuse, or severe cognitive impairment (based on medical evaluation).
Role of Provider-at-Triage on ED Efficiency and Quality of Care

The United States spends over $8,000 per capita annually on health care and its health care system is more expensive than other developed countries. Even with high per capita costs and a high proportion of physician specialists, the US lags in health care performance from patients' perspectives.

The hospital emergency department (ED) is often the portal of entry for patients seeking health care services and is therefore an ideal setting for initiatives to improve efficiency of care delivery and patient satisfaction. Reduction in wait times, enhanced information delivery and ED staff service quality all have a positive influence on patient perception of health care quality and satisfaction.

Prior studies have attempted to increase patient satisfaction by improving staff communication and courtesy, implementing a patient satisfaction team in triage, and delivering information to patients in a timely manner. Another strategy to increase the efficiency of ED operations is adding a physician to triage to perform brief medical screenings and initiate necessary patient testing and treatment. This contrasts to usual practice in which physicians evaluate patients only following registration and nurse assessment of illness or injury severity.

This study will assess the impact of early patient assessment by a physician at Emergency Department (ED) triage on patient perception of information delivery, overall patient satisfaction and ED efficiency. ED efficiency will be assessed by ED length of patient stay, ED left-without-being-seen and ED left during treatment rates.

Participants who decide to take part in this study, will be asked questions by research staff, who will document responses on a secure iPAD device. The survey will ask participants how they feel about their health condition, the emergency department wait, the care they received in the emergency department and how satisfied the participant was with the care received.

Eligibility Criteria:
Inclusion Criteria:

Participants are eligible to participate in the study if they are:

* English speaking
* Without hemodynamic or respiratory compromise
* Do not have a nurse-assigned triage severity score of Emergency Severity Index 1 (most severe illness or injury score).

Exclusion Criteria:

Participants will be excluded if they are:

* Unwilling or unable to sign an informed consent
* In police custody
* Too ill to participate in study.
Quantification of Respiratory-induced Prostate Motion

Patient anatomy and position during the course of radiation therapy can vary from those used for treatment planning; a function of patient movement, uncertainty in positioning system, and organ motion. Traditionally, treatment margins are designed to compensate for interfraction prostate setup variability. This approach has the potential to lower the overall effectiveness of treatment because the prostate gland is a continuously moving target whose motion cannot be accurately accounted for solely on the basis of interfraction movement. More recently, the dosimetric relevance of intra-fraction prostate motion has been recognized, and may be compensated for by continuous real-time adaptive radiation therapy afforded by the Calypso 4D Localization System™. In the current study, the investigators propose to characterize intrafraction prostate motion. The investigators hypothesize that intrafraction prostate motion is correlated with respiratory motion.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage I-III adenocarcinoma of the prostate gland
* Age \> 18 years. Males of all races and ethnic groups
* Scheduled to receive radiation for definitive therapy
* Three (3) electromagnetic transponders implanted into prostate gland

Exclusion Criteria:

* Does not satisfy inclusion criteria