cyrilzakka/clinical-trials huggingface dataset:
Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml®

This study will evaluate the local control rate, cosmetic results, and complication rates of breast brachytherapy delivered using the MammoSite-ML® when used as the sole method of radiation therapy or as a boost technique for patients with stage I-II carcinoma of the breast (\< 3 cm), (non-lobular histology) treated with lumpectomy with histologically negative surgical margins by at least 2 mm, negative axillary lymph nodes, and DCIS.

Hypotheses:

* For selected patients with stage I breast carcinoma and Ductal Carcinoma In Situ (DCIS), radiation therapy delivered with brachytherapy alone using the MammoSite-ML® is technically feasible and reproducible with acceptable complication rates.
* Cosmetic results after brachytherapy will be similar to that obtained after traditional whole breast external beam radiation therapy.
* Local tumor control rate in the breast after brachytherapy will be similar to that of conventional external beam radiation therapy, with less inconvenience and potentially less cost to the patient, given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy.


Eligibility Criteria:
Inclusion Criteria:

* Women,age of at least 45 years
* Zubrod performance status of 0-2
* AJCC Stage I-II (T1-T2, N0 M0) breast cancer
* Maximum tumor dimension \< 3 cm
* Invasive ductal, medullary, papillary, tubular, colloid (mucinous) histologies
* Unifocal breast cancer
* Unilateral breast cancer (no synchronous or previous contralateral breast cancer)
* Lumpectomy with negative surgical margins by at least 2 mm or re-excision specimen with negative surgical margins by at least 2 mm
* Ductal Carcinoma In-Situ
* Negative axillary lymph nodes for invasive breast cancer (sentinel node biopsy or standard level I-II dissection with \> 6 nodes removed)
* Time interval from final breast surgery to brachytherapy loading less than 8 weeks
* At least 2 mm of breast tissue between the skin and the MammoSite® balloon surface(prefer \> 5 mm)
* If chemotherapy is planned, it must begin no earlier that 2 weeks following completion of radiation therapy. If chemotherapy is first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation therapy.
* Signed study-specific consent form

Exclusion Criteria:

* Invasive lobular histology
* Non-epithelial breast malignancies such as sarcoma or lymphoma
* Multifocal or multicentric invasive carcinoma
* Extensive intraductal component (EIC)
* Paget's disease of the nipple
* Skin involvement by tumor, regardless of tumor size
* Positive axillary lymph nodes
* Distant metastases
* Collagen vascular disease (scleroderma)
* Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females (negative pregnancy test for women of child-bearing age)
* Any previously treated or synchronous contralateral breast carcinoma
* Patients with psychiatric or addictive disorder that would preclude obtaining informed Consent
* Men
Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma

Note: The study data was transferred to zr pharma\& following the divestment of panobinostat to pharma\&. Prior to study completion under the sponsorship of Secura Bio, the study was initiated and conducted in part under the sponsorship of Novartis.

The purpose of this study is to investigate the safety and efficacy of 3 different regimens of panobinostat (20 milligrams \[mg\] thrice a week \[TIW\], 20 mg twice a week \[BIW\], and 10 mg TIW) in combination with subcutaneous bortezomib and dexamethasone and to provide exposure, safety and efficacy data to identify the optimal regimen of panobinostat in a randomized, 3-arm parallel design. This study will also assess the impact of administering subcutaneous bortezomib (in combination with panobinostat and dexamethasone) twice weekly for 4 cycles, and then weekly starting from Cycle 5 until disease progression in participants ≤ 75 years of age. Participants \> 75 years of age will receive subcutaneous bortezomib weekly for the entire treatment period (in combination with panobinostat and dexamethasone) until disease progression.

Participants will be treated until disease progression or until they discontinue earlier due to unacceptable toxicity or for other reasons.

Participants who discontinued study treatment for reasons other than disease progression will be followed for efficacy every 6 weeks.

All participants will be followed for survival until the last participant entering long-term follow-up has completed a 3-year survival follow-up or discontinued earlier.


Eligibility Criteria:
Inclusion Criteria:

* multiple myeloma per International Myeloma Working Group 2014 definition
* requiring treatment for relapsed or relapsed/refractory disease
* measurable disease based on central protein assessment
* received 1 to 4 prior lines of therapy
* prior immunomodulatory agent(s) exposure
* acceptable lab values prior to randomization

Exclusion Criteria:

* primary refractory myeloma
* refractory to bortezomib
* concomitant anti-cancer therapy (other than bortezomib/dexamethasone and bisphosphonates)
* prior treatment with pan-deacetylase inhibitors
* clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months prior to randomization)
* unresolved diarrhea ≥ Common Terminology Criteria for adverse events grade 2 or presence of medical condition associated with chronic diarrhea (such as irritable bowel syndrome and inflammatory bowel disease)

Other protocol-defined inclusion/exclusion criteria may apply.
Individual Patient Compassionate Use of Nirogacestat

This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee, and applicable competent authority approval.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a serious, debilitating or life-threatening medical condition that cannot be treated satisfactorily with an authorized medicinal product or other available standard treatment options, or all other treatment options have been exhausted.
* Patient does not qualify to participate in an ongoing clinical trial.
ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past

The purpose of this study is to see if ABT-378/ritonavir plus efavirenz is safe and effective in lowering the amount of HIV in the blood of patients who have been treated with more than 1 protease inhibitor (PI).

All patients take ABT-378/ritonavir and efavirenz; there are no placebos in this study. Patients take study medications for 48 weeks, during which time there will be 15 study visits. There is a possibility of a study extension after 48 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a viral load (level of HIV in the blood) of at least 1,000 copies/ml.
* Have been receiving stable (no changes) anti-HIV treatment that includes at least 1 PI for at least 8 weeks prior to study entry.
* Have received more than 1 PI for at least 12 weeks each at some time in the past.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have had any active opportunistic (AIDS-related) infections within the past 30 days.
* Have ever received nonnucleoside reverse transcriptase inhibitors (NNRTIs), such as delavirdine, nevirapine, or efavirenz.
* Have received certain medications.
* Are pregnant or breast-feeding.
* Abuse alcohol or drugs.
Evaluation of The Effect of Virtual Reality Glasses

The study was planned as a randomized controlled study to evaluate the effect of virtual reality glasses used on anxiety and treatment compliance in outpatient cancer patients receiving chemotherapy. The sample of the study consisted of a total of 30 patients, including 15 experimental and 15 control groups, who received intravenous chemotherapy treatment every 21 days between April 1 and September 31, 2023, in the outpatient chemotherapy unit of a research hospital. Research data will be collected using the Patient Information Form, Beck Anxiety Scale (BAI) and Chronic Disease Adaptation Scale (CCDS). In evaluating the data, it was planned to analyze the differences between the rates of categorical variables in independent groups with Chi-Square tests. It was planned to use t tests to compare quantitative continuous data between two independent groups. Dependent groups t-test will be used to compare measurements within groups. After being informed about the research, patients in both groups will be given a pre-test. Patients in the experimental group will be shown 3 different videos with virtual reality glasses during 3 cycles of chemotherapy treatment, and a final test will be administered to both groups at the end of the 3rd cycle..


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Knowing Turkish, agreeing to participate in the research
* Being diagnosed with cancer, regardless of the type of cancer
* Starting an intravenous chemotherapy treatment regimen after diagnosis
* Those who receive their treatment in 21-day periods to ensure equality in application frequencies.
* Able to use virtual reality glasses
* People without hearing or visual impairment are included

Exclusion Criteria:

* Anyone with any visual or hearing impairment
* The patient does not know the diagnosis of cancer, has been diagnosed with cancer but has not received treatment or has completed the cure.
* Those with brain tumor or brain metastasis are not included.
Cumulative Irritation Test

The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.

Healthy, adult volunteers of either sex will be patched on his/her back with AN2690 Solution 2.5%, AN2690 Solution 5%, AN2690 Solution 7.5%, AN2690 Solution Vehicle and Sodium Laurel Sulfate 0.5% over the course of 21 consecutive days. After 24 hours, the patches are to be removed and the site evaluated using a five-point scale for irritation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, volunteers of either sex, at least 18 years of age or older
* Females of childbearing potential submitted to a urine pregnancy test and had negative results at Day 1 and at the final visit and also was using an effective method of birth control (e.g. abstinence, implants, injectables, oral contraceptives, intrauterine contraceptive devices or double barrier) or agreed to use an effective method of birth control prior to becoming sexual active
* Subjects were of any skin type or race providing their degree of pigmentation did not interfere with making readings of skin reactions
* Subjects were willing to follow the study procedures and complete the study
* Written informed consent was obtained

Exclusion Criteria:

* Subject with any skin disease that would have in any way confounded interpretation of the study results. Atopic dermatitis/eczema, psoriasis or chronic asthma were excluded
* Subject was pregnant or nursing
* Subject had a history of sensitivity to any component of any of the formulations
* Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study
UVA Protection Factors of SPF 50 and 50+ Face Sunscreens

The goal of this observational study is to use the International Organization for Standardization (ISO) 24442:2011 in vivo method for assessment of the Ultraviolet A Protection Factor (UVAPF) of topical sunscreen products in healthy adults. The main question it aims to answer is to determine the degree of UVA-protection against UVA radiation.

An area of each subject's skin is exposed to UVA light without any protection and another (different) area is exposed after application of the sunscreen product under test. One further area is exposed after application of a reference UVA sunscreen formulation (S2), which is used to validate the procedure.

The objective of the study conducted in accordance with the Declaration of Helsinki and national regulations regarding human studies is to evaluate the UVA protection factor of the investigational products against UVA, according to the ISO 24442:2011 methodology comparatively to a standard product (Standard S2) in healthy adult subjects.

Standard reference S2 sunscreen formula is used in a study if any test sample has an expected UVAPF of 12 or above. The mean UVAPF for the reference sample S2 is 12,7. The test result of the reference S2 UVAPF must be between 10,7 and 14,7 or the test is invalid and shall be repeated. The reference S2 may be used to validate any product test.

In order to determine the number of subjects, the 95 % confidence interval (CI) shall be taken into account. The 95 % confidence interval should lie within ±17 % of the mean UVAPF, and a minimum of 10 subjects is required.

Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick skin phototype: II, III or IV
* colorimetric Individual Typology Angle (ITA°): 20° to 41°
* intact skin on test site

Exclusion Criteria:

* pregnant or lactating women
* subjects using medication with photo-sensitizing potential
* subjects receiving chemotherapy or radiotherapy
* subjects who have had UV exposure on the back area in the four weeks prior to UVAPF testing
Artichoke and Bergamot Phytosome

According to WHO data, about 50% of deaths each year are caused by cardiovascular disease. One of the strategies for prevention of cardiovascular diseases, in addition to a correct lifestyle, is to implement therapies that reduce the level of cholesterol in the blood and at the same time control the glycemic levels, which are closely related in the maintenance of metabolic homeostasis. The aim of this clinical study is to confirm the potential broader activity as hypocholesterolemic agent in bergamot poor-responders subjects with mild hypercholesterolemia. The study was a 8-week randomized double-blind placebo-controlled trial. Participants were randomized to either the supplement based on dry extract from artichoke leaf and bergamot phospholipid (31) or placebo arm (29).


Eligibility Criteria:
Inclusion Criteria:

* mild hypercholesterolemia (220 - 280 mg/dl)
* subjects were not taking any medication likely to affect lipid metabolism (such as statins)
* subjects were bergamot poor-responders

Exclusion Criteria:

* liver, renal and thyroid diseases
* history of cardiovascular disease (CVD)
ClinicaI Observation of Induced Abortion With Disposable Tissue Suction Tube

The purpose of this study is to explore the clinical effect of disposable tissue suction tube set for induced abortion and make comparison with traditional metal instruments．


Eligibility Criteria:
Inclusion Criteria:

* premedical abortion diagnosed by ultrasound diagnosed
* pregnancy for the first time
* 7-9 weeks of pregnancy
* voluntary termination of pregnancy
* without surgical contraindication

Exclusion Criteria:

* refuse this clinical trial
* with systemic disease such as hypertensive disease, heart disease, diabetes
* refuse to terminate the pregnancy
Nursing Intervention in Weight and Metabolic Syndrome Management in First-episode Psychosis (MetaKOP)

The goal of this clinical trial is to evaluate if a nursing intervention based on the carbohydrate-insulin model can effectively reduce weight and manage the risk of metabolic syndrome (MetS) in individuals with first-episode psychosis. The main questions it aims to answer are:

Will the intervention lead to a clinically significant weight loss (≥5%)? Can the intervention improve metabolic parameters, psychopathological state, physical activity level, and quality of life? Researchers will compare participants receiving the specialized nursing consultations to those receiving routine care to see if the former group experiences greater improvements in weight loss and metabolic risk reduction.

Participants will:

Attend a series of 8 nursing consultations focused on dietary habits based on the carbohydrate-insulin model and physical activity.

Complete assessments at the start, 6 months, and 12 months, including weight, metabolic parameters, and psychological evaluations.


Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to the Early Intervention Program (EIP).
2. First-episode psychosis (FEP) within the last 5 years.
3. Diagnosis of psychosis from the F2 spectrum or an affective disorder with psychotic symptoms according to ICD-10.

Exclusion Criteria:

1. Cognitive inability to learn or comorbid intellectual disability that interferes with study procedures.
2. Comorbid diagnosis of neurological pathology.
3. Language or comprehension impairments preventing accurate data collection.
4. Use of hypoglycemic medication before or during the study.
5. Refusal to participate
Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

To evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD).

The total duration of the study was 32 weeks and the study consisted of Periods A, B, and A+. Patients entered the study in Period A and were treated open-label with one of six commercially available antidepressant treatments (ADTs) for 8 weeks. Patients who met the blinded response criteria at the Week 6 Visit, were deemed early responders and were withdrawn from the study. At Week 8, patients with inadequate response to placebo + ADT, as per the randomisation criteria, entered Period B and were randomised to received double-blind brexpiprazole + ADT or placebo + ADT for 24 weeks. Non-randomised patients continued in Period A+ and received placebo + ADT until the end of the study. The primary objective was to compare the efficacy and safety of brexpiprazole with placebo. This comparison occurred Period B; therefore, the focus is Period B.

Eligibility Criteria:
Inclusion Criteria:

* The patient is an outpatient consulting a psychiatrist.
* The patient has an MDD diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
* The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressant treatments.
* The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

* The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than MDD.
* The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypical or histrionic personality disorder.
* The patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology in the current MDE.
* The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
* The patient, in the opinion of the investigator or according to Columbia-Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
* The patient has had neuroleptic malignant syndrome.
* The patient has any relevant medical history or current presence of systemic disease.
* The patient has, at the Screening Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.
* The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for \>5 years prior to the first dose of IMP.
* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.
Quit Smoking With Nicotine Patch and Exercise/Health Education (Females Only)

This research study is for FEMALE cigarette smokers who want to quit smoking.

Participants will be provided with brief quit-smoking education at the beginning of the study and will receive the nicotine patch for 10 weeks, free of charge.

Participants will be assigned to either an exercise program or a general health education program. The exercise and health education programs will take place over 14 weeks, with follow-up appointments 3, 6, and 12 months after the end of the 14-week program.

There is no fee for any part of this study and participants will be compensated for their time.

Participants must complete telephone screening process first.

All eligible participants must attend an orientation session when the investigators will explain the study in detail. After this session, interested participants will complete a consent form and the investigators will collect blood pressure, resting heart rate, body mass index (height/weight), and a carbon monoxide sample to confirm eligibility. The investigators will then explain the physician consent process (all eligible and interested participants must obtain consent from a physician or clinic that they have seen in the past year to confirm that it is safe for them to participate).

Eligibility Criteria:
Inclusion Criteria:

* Current smoker

Exclusion Criteria:

* Ineligible after telephone screen.
* Each participant's personal physician/clinic determines it is unsafe to participate.
A CT-BASED Deep Learning Model for Predicting WHO/ISUP Pathological Grades of Clear Cell Renal Cell Carcinoma (ccRCC) :A Multicenter Cohort Study

This study aims to establish an effective deep learning model to extract relevant information about renal tumors and kidneys from computed tomography (CT) images and predict the pathological grades of clear cell renal cell carcinoma (ccRCC).

Retrospective data were collected from 483 ccRCC patients across three medical centers. Arterial phase and portal venous phase CT images from the dataset were segmented for renal tumors and kidneys. Three convolutional neural networks (CNNs) were employed to extract features from the regions of interest (ROI) in the CT images across multiple dimensions including 3D, 2.5D, and 2D. Least absolute shrinkage and selection (LASSO) regression was used for feature selection. The models were evaluated using receiver operating characteristic (ROC) curves and decision curve analysis (DCA).


Eligibility Criteria:
Inclusion Criteria:

* Patients with a single kidney tumor have complete imaging and clinical data
* Contrast-enhanced CT scan within 30 days before surgery
* No treatment was performed before CT examination

Exclusion Criteria:

* Patients with tumor recurrence
* Obvious artifacts on CT images
* The tumor is cystic
* Multiple cysts on the affected kidney affect the delineation of renal parenchyma