cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer

This clinical trial studies ultrasound tomography using SoftVue in diagnosing women with breast cancer. New diagnostic procedures, such as ultrasound tomography using SoftVue, may help find and diagnose breast cancer.

PRIMARY OBJECTIVES:

I. Determine the in-vivo imaging potential of SoftVue through 3-dimensional (3-D) breast imaging.

II. Acquire data for SoftVue evaluation from a cohort of 100 women receiving standard ultrasound (US) evaluation as follow-up to mammographic or palpable abnormalities and construct reflection, sound speed and attenuation images with SoftVue.

III. Evaluate the ability of SoftVue to detect dominant breast findings (i.e. major normal landmark architecture) or masses previously identified with standard diagnostic evaluation (palpation, mammography, standard US) using standard clock position and radial distance measurements from the nipple.

IV. Conduct tomographic (i.e. slice-by-slice) comparison of SoftVue with magnetic resonance imaging (MRI) findings from a subgroup of 50 patients.

OUTLINE:

Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for mammogram, breast ultrasound and/or breast MRI
* Breast size less than 22 cm diameter (ring diameter is 22cm)
* Able to read or understand and provide informed consent
* Weight \< 350lbs (patient bed max weight)
* Non-pregnant and non-lactating
* No open breast or chest wounds
* No active skin infection
* No serious medical or psychiatric illnesses that would prevent informed consent
Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV-1 Infected Patients

This is a prospective, open controlled trial in which naïve HIV-1 patients will be randomized to receive atazanavir / ritonavir or darunavir / ritonavir in combination with tenofovir / emtricitabine. They will be followed up during 96 weeks to determinate the cholesterol levels.

Randomization will be stratified according to the values of the ratio of total cholesterol/HDL cholesterol obtained during the screening visit (as they will be \<4.5 or ≥ 4.5).


Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes aged 18 years or more. Women of childbearing potential must commit to sexual abstinence or use barrier contraceptive methods during the study.
2. Diagnosis of infection by HIV-1 (according to standard diagnostic criteria)
3. Not previously treated with antiretroviral drugs
4. Plasma viral load \> = 1000 copies / ml
5. Clinically stable patients in the investigator's opinion at the time of inclusion
6. Able to meet the schedule of study visits and other protocol requirements
7. Written informed consent to participate in the study and undergo tests and examinations that entails

Exclusion Criteria:

1. ALT, AST levels greater than or equal to 5 times ULN (upper limit of normal)
2. serum creatinine level greater than 2 times ULN
3. Diabetes Mellitus (according to clinical and / or use of anti-diabetic agents)
4. Obesity (BMI ≥ 30 kg/m2)
5. Use of drugs that may affect lipid and / or glucose metabolism for at least 30 days prior to inclusion in the study.
6. Active opportunistic infection requiring intravenous treatment
7. Patients with known hypersensitivity to any of the products under study
8. Use of drugs formally contraindicated in the product information for any of the drugs under study
9. Contraindication to the use of any of the drugs under study
10. Women pregnant or lactating at the time of study inclusion or anticipating pregnancy in the follow-up period provided by the test
Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.


Eligibility Criteria:
Inclusion Criteria:

* were at least 18 years old;
* were experienced contact lens wearers;
* were correctable to at least 20/40 or better in both eyes with contact lenses;
* were in good general health, with healthy eyes (other than requiring vision correction);
* had not worn lenses for at least 12 hours before each baseline visit;
* had a corneal staining score no greater than Grade 1 in either eye at time of enrollment;
* had previously used an MPS or hydrogen peroxide solution successfully.

Exclusion Criteria:

* had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;
* required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;
* had a known sensitivity or intolerance to any MPS, study products or ingredient(s);
* were currently participating in any other clinical study;
* had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.
Clostridium Difficile Infection: the First Report in Southeast Asia by 2010 Nationwide Study

The authors retrieved in-patient medical data, including the expense, from the 2010 Thailand Nationwide Hospital Admission Database, which is part of the National Health Security Office (NHSO). The diagnosis of digestive diseases with any form of colitis listed in the causes, either as principal diagnosis or co-morbidity, coding by the ICD-10 was recorded. The inclusion criteria were: 1) diagnosis of enterocolitis due to Clostridium difficile (ICD10-A07); and 2) age of more than 18 years. If the data was incomplete, the case was excluded. The baseline characteristics, including age, sex, co-morbidity disease and history of endoscopy or surgery, were recorded. The burden of CDI was evaluated by length of hospital stay (LOS), mortality rate, and hospital charge.


Eligibility Criteria:
Inclusion Criteria:

* The patients with the diagnosis of Clostridium difficile (ICD10-A07)
* Age of more than 18 years.

Exclusion Criteria:

* Data incompleted
Non-operative Treatment Versus Volar Locking Plate in Treatment of Distal Radius Fracture in Patients Over 65 Years

The present collaboration study on the treatment of distal radius fractures is aimed to:

(i) to compare non-operative treatment to volar plating in the treatment of initially malaligned distal radius fractures in patients aged 65 and older in terms of functional outcome measured with PRWE

(ii) to compare non-operative treatment to volar plating in the treatment of distal radius fractures with early instability during follow-up, i.e., loss of reduction at 1 week (range 5 to 10 days) in patients aged 65 and older in terms of functional outcome measured with PRWE

(iii)to compare pain, disability, quality of life, grip strength, and the number of complications after non-operative treatment and the initial and delayed operative treatment of distal radius fracture

(iv) to assess the effect of pain catastrophizing score (PCS) on the functional outcome of non-operatively and operatively treated distal radius fracture

(v) to assess the association between physical activity and the number of wrist movements measured with Axivity accelerometer and functional outcome measured with PROMs of non-operatively and operatively treated distal radius fractures

(vi) to assess the effect of initial as well as the final radiological parameters on the functional outcome

(vii) to assess the correlation of probability of radiological malalignment estimated by clinical prediction rule (EWC) with functional outcome measured with PRWE and PASS


Eligibility Criteria:
Inclusion Criteria:

* low energy intra or extra-articular dorsally displaced distal radius fracture within 3 cm of the radiocarpal joint, diagnosed with lateral and posterior-anterior radiographs in ER
* \>10° dorsal tilt and/or over 2 mm step-off and/or over 3 mm shortening in the radiograph

Exclusion Criteria:

* Refuse to participate the study
* Open fracture more than Gustilo 1 gradus
* Age under 65 years
* Chauffeure's or Barton´s fracture
* Smith´s fracture (volar angulation of the fracture)
* Does not understand written and spoken guidance in local languages
* Pathological fracture or previous fracture in the same wrist or forearm
PET Imaging of Cancer Patients Using [18F]-SKI-249380, a Radiolabeled Dasatinib-Derivative

This study is the first time that a new experimental drug called \[18F\]-SKI-249380 is being used in people. \[18F\]-SKI-249380 is not a therapeutic drug. \[18F\]-SKI-249380 is a drug that will be used with PET scanners to 'see' where \[18F\]-SKI-249380 goes in the body, after its injected. The researchers believe that scans with \[18F\]-SKI-249380 might be able to find tumors in patients.

This study is being done to see how long \[18F\]-SKI-249380 stays in the blood, when it is given to people in tiny amounts by an injection into a vein in their arm, and to see where \[18F\]-SKI-249380 goes in the body. If the results of this trial are good, then the study doctors plan to use \[18F\]-SKI-249380 in another trial to see if scans with \[18F\]-SKI-249380 are better for finding tumors compared to the standard types of scans that doctors use.


Eligibility Criteria:
Inclusion Criteria:

* Patients with history of histologically-confirmed neoplasm of any of the following classifications: solid malignancy, myeloid neoplasm, lymphoid neoplasm.
* Histology confirmed by MSKCC Department of Pathology.
* Disease that is either:

  * Radiologically-measurable or evaluable as defined by tumor response criteria from an MSKCC-IRB approved clinic research protocol.
  * Detectable by biopsy (eg, bone marrow) and/or peripheral blood assays obtained within 6 weeks of study enrollment
* Age between 21-90
* Negative serum pregnancy test for females of child-bearing age (11-55 years) and potential (ie, women who were not postmenopausal before the start of ongoing treatment, if applicable; and who have not had a surgical intervention whose intent or effect is sterilization, such as tubal ligation or hysterectomy.)
* Not breast-feeding, if applicable.

Exclusion Criteria:

* Refusal or inability to discontinue medications or other substances (eg, foods or dietary supplements) that may affect \[18F\]-SKI-249380 metabolism. Notably, as dasatinib metabolism is CYP3A4-dependent, the metabolism of \[18F\]-SKI-249380 may be altered by inhibitors and inducers of cytochrome P450 isoenzyme CYP3A4. The acceptability of medications and other substances used by the patient will be determined by the study investigators.
* Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of \[18F\]-SKI-249380 injection and blood draws.)
* Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
* Hepatic: from assays obtained \<2 weeks prior to study enrollment
* Bilirubin \> 1.5 x institutional upper limit of normal (ULN)
* AST/ALT \>2.5 x ULN
* Albumin \< 2 g/dl
* GGT \> 2.5 x ULN IF Alkaline phosphatase \> 2.5 x ULN.
* Renal: Creatinine \>1.5 x ULN or creatinine clearance \< 60 mL/min, from assays obtained \<2 weeks prior to study enrollment
* Acute major illness (e.g., unstable cardiovascular condition, etc.)
Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults

This is a randomized, active-controlled, observer-blinded, dose-escalation multi-center trial of 2 doses of an investigational HZ vaccine (Z-1018) in approximately 440 healthy adults.


Eligibility Criteria:
Inclusion Criteria:

A subject must meet all of the following criteria to be eligible for enrollment (defined as receiving any study vaccine) in the study:

1. Male or female, 50 to 69 years of age
2. Be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
3. Must be able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
4. Seronegative for human immunodeficiency virus (HIV)

Exclusion Criteria:

A subject with any 1 of the following criteria is not eligible for enrollment (defined as receiving any study vaccine) in the study:

1. History of HZ
2. Previous vaccination against varicella or HZ
3. If female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
4. Known history of HIV (HIV 1/2 antibodies)
5. Has a history of sensitivity to any component of study vaccines
6. Has received any blood products or immunoglobulin within 90 days prior to study injection, or is likely to require infusion of blood products during the study period
7. Has received the following prior to the first injection

   * 14 days: any non live vaccine
   * 28 days:
   * Any live vaccine, including a COVID-19 vaccine
   * Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids
   * Granulocyte or granulocyte-macrophage colony-stimulating factor
   * Any other investigational medicinal agent, including a COVID-19 vaccine
8. Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose
9. Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous cell or basal cell carcinoma of the skin
10. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
11. History of autoimmune disease
Qualitative Exploration of Head & Neck Cancer Patient Reported Experience of Radiotherapy

The study aims to explore the experience of patients with Head and Neck Cancer, who are preparing for and/or completed radiotherapy treatment.

This is a non-interventional study using interviews to explore head and neck cancer patients' experience of preparing for and completing radiotherapy utilising an immobilisation mask.

The study will be conducted in 2 stages:

The first stage is Item generation. Approximately 20 interviews will be conducted with head and neck cancer patients who have completed or partially completed radiotherapy. The interviews will capture their experiences and views pertaining to mould making, scans and radiotherapy, reported associated fear of restriction, suffocation, loss of control and fear of public embarrassment during treatment.

The data from the interviews will be used to develop potential items for a screening tool for identification of those patients likely to experience anxiety and claustrophobia before they start their treatment.

The second stage is cognitive interviews. Approximately 5 patients included in Stage I will be invited to take part in a further interview to review the themes and potential questionnaire items identified from interviews.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 (no upper age limit)
* Completed or partially completed radiotherapy treatment utilising a mask ≥ 6 weeks previous to study entry

Exclusion Criteria:

* Unable to understand and communicate in the English language
* Unable to provide written informed consent
Visual Performance of Pseudophakic Patient With Different Intraocular Lenses

This retrospective study comprised patients with cataract, corneal astigmatism, and motivation for spectacle independence. In all cases, a multifocal and monofocal Intraocular Lens was been implanted in the capsular bag. Three months postoperatively, distance, intermediate, and near visual acuities; spherical equivalent; residual refractive astigmatism; defocus curve; and contrast sensitivity was evaluated. A patient-satisfaction and visual phenomena questionnaire was also been administered.

Postoperative evaluation was performed at 3 months. The uncorrected and corrected distance visual acuity were assessed using the 100% contrast Early Treatment Diabetic Retinopathy Study chart, uncorrected intermediate visual acuity at 70 cm, and uncorrected near visual acuity at 40 cm; a binocular defocus curve was constructed using the ETDRS chart at 4 m and adding to the patient's manifest refraction +2.50 to -5.00 D sphere in 0.50 increments. The cylinder axis of the Intraocular lens (IOL) was measured at the slitlamp using the beam protractor after full mydriasis. The mean of the absolute values of degrees the intraocular lens was off axis was determined.

Contrast sensitivity was measured using the CSV-1000 HGT instrument (VectorVision, Inc.), which presents a translucent chart divided into 4 cycles with spatial frequencies of 3, 6, 12 and 18 cycles per degree. The background illumination of the translucent chart does not depend on room lighting. All measurements were obtained under mesopic (5 cd/m2) and photopic (85 cd/m2) conditions. The examinations were performed unilaterally at a distance of 2.5 m with Best-corrected visual acuity (BCVA) and an undilated pupil. All measurements were performed under the same conditions.

Patient satisfaction and quality of life were assessed by a simple questionnaire. Patients were interviewed 3 months postoperative. Patients were asked about visual disturbances, visual lifestyle activities, spectacle use, and satisfaction with the procedure.

Eligibility Criteria:
Inclusion Criteria:

Cataract Any race Either gender Diagnosis of cataracts both eyes Pre-existing physical conditions that could skew visual results, such as Diabetes, Retinal detachment, Macular degeneration, or Cancer Subjects must have \> 1.00 diopter of astigmatism

Exclusion Criteria:

Central endothelial cell count less than 2000 cells/mm2 glaucoma or intraocular pressure greater than 21 mmHg amblyopia Retinal abnormalities Diabetes mellitus steroid or immunosuppressive treatment Connective tissue diseases
Functional and Structural Outcomes Following Childhood Bone or Soft Tissue Sarcomas of the Lower Extremity

Soft tissue and bone sarcomas of the lower extremity pose significant challenges for affected individuals, often associated with considerable burden. Chemotherapy, load restrictions, and surgery frequently result in long-term physical limitations, causing structural and functional deterioration. These challenges are particularly pronounced in childhood and adolescence, as they affect physiological development, resilience, and autonomy. Yet, it remains unclear whether these deficits can be fully compensated after treatment or if they result in long-term limitations, as this has not been sufficiently studied.

This bicentric study includes children and adolescents undergoing follow-up care for soft tissue or bone sarcoma of the lower extremity within 1 to 5 years since end of therapy. The cohort did not receive any specific prehabilitative training during neoadjuvant therapy. Participants will be divided into two subgroups based on the study site: (1) participants who participated in a non-specific exercise program during acute therapy and (2) participants who did not receive any exercise promotion during acute therapy. Target sample size is n=16. The study has been consented by the local ethics committee.

Several structural and functional parameters are measured to document the natural status of muscular structures and functional abilities after the treatment of a solid tumor in the lower extremities, with a focus on identifying specific deficits and the associated long-term limitations in daily life. The measurements include psoas muscle area, body composition, strength, mobility, balance ability, gait analysis, two questionnaires on physical activity and quality of life, and quantitative measures of the clinical course during acute treatment (days of hospitalization, infection rates, etc.).

For children and adolescents, daily functionality and the experience of autonomy are crucial for physiological development and contribute significantly to quality of life. Therefore, these factors should be investigated and supported in this cohort, a group that is currently underrepresented in scientific research.


Eligibility Criteria:
Inclusion Criteria:

* Cessation of treatment for a bone tumor or soft tissue sarcoma of the lower extremity 1-5 years ago
* Age Range of 6 to 18 years
* Treatment has been conducted at one of the two designated study sites

Exclusion Criteria:

* Medical contraindications for testing (e.g. injury, pain, dizziness, lack of orthopedic clearance for weight-bearing in the tumor region, other acute orthopedic limitations unrelated to the underlying condition, etc.)
* Language barriers that prevent understanding of the instructions for study participation
* Cognitive impairment or developmental delay that hinders comprehension of the instructions in the testing situation, thereby preventing standardized diagnostic data collection
Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult Subjects

Drug drug interaction study between PF-05221304 and PF-06865571

A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects

Eligibility Criteria:
Inclusion criteria:

1. Healthy female subjects of nonchildbearing potential and/or male subjects.
2. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
2. Any condition possibly affecting drug absorption.
3. A positive urine drug test.
4. Screening supine BP 140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest.
5. Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval \>450 msec or a QRS interval \>120 msec.

   -
Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

In a randomized clinical trial of 114 women undergoing Treatment for condyloma acuminata, two surgical methods, the carbon dioxide laser Ablation and the excision by electrocoagulation, will be compared. The primary outcome of the study is the cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step visual analogue scale (VAS), secondary outcomes are intervention time, operative complications, subjects and users satisfaction, postoperative pain and recurrence of genital warts.


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* women with anogenital affection of condyloma acuminata

Exclusion Criteria:

* significant language barrier
* pregnancy
* unwillingness to participate
* the use of blood thinner or known coagulation disorder
* the use of immunosuppressive medicament
* HIV-Infection
* malignant diseases
* local therapy within 8 weeks before Treatment
* wound healing disorder