cyrilzakka/clinical-trials huggingface dataset:
Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others can find cancer cells and help kill them or carry cancer-killing substances to them. Combination chemotherapy followed by alemtuzumab may be effective in treating chronic lymphocytic leukemia and prolymphocytic leukemia.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy followed by alemtuzumab works in treating patients with T-cell chronic lymphocytic leukemia or prolymphocytic leukemia.

OBJECTIVES:

Primary

* Determine the number of severe adverse events and life-threatening infections in patients with T-cell chronic lymphocytic leukemia or T-cell prolymphocytic leukemia treated with induction chemotherapy comprising fludarabine, cyclophosphamide, and mitoxantrone hydrochloride followed by consolidation therapy comprising alemtuzumab.
* Determine the remission rate in patients treated with this regimen.

Secondary

* Determine the overall and progression-free survival of patients treated with this regimen.
* Determine the quality of remission in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy comprising fludarabine IV and cyclophosphamide IV for 3 days and mitoxantrone hydrochloride IV on 1 day. Treatment repeats every 28 days for up to 4 courses. Patients then receive consolidation therapy comprising alemtuzumab IV 3 times in week 1 and then weekly for up to 11 weeks.

PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of T-cell chronic lymphocytic leukemia (T-CLL) or T-cell prolymphocytic leukemia (T-PLL)
* Previously untreated disease OR patient may have received up to 2 therapies

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy \> 6 months
* No severe organ dysfunction
* No other concurrent or previous neoplasm
* No autoimmune hemolytic anemia or thrombocytopenia

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior fludarabine, mitoxantrone hydrochloride, cyclophosphamide, or alemtuzumab
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes

A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in participants with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.


Eligibility Criteria:
Key Inclusion Criteria:

* Unresectable, locally advanced or metastatic solid tumor and relapsed/progressive disease
* Measurable disease per RECIST v1.1 or modified RECIST v1.1 and PCWG3 (for prostate cancer)
* Have a deleterious mutation (germline or somatic) in BRCA1, BRCA2, PALB2, RAD51C, RAD51D, BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B. Note: Breast cancer patients that are HER2 negative and have germline BRCA1 or BRCA2 mutations AND patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or metastatic castration-resistant prostate cancer with BRCA1 or BRCA2 mutations are ineligible for this trial.
* At least one prior line of therapy extending overall survival or standard of care therapy for advanced disease. Note: Some tumor types have specific inclusion/exclusion criteria for previous treatments.
* ECOG 0 or 1
* Tumor tissue available for genomic analysis, or must be willing to have a biopsy if no archival tumor tissue available
* Adequate organ function
* Life expectancy of 4 months

Key Exclusion Criteria:

* Active central nervous system brain metastases, leptomeningeal disease or primary tumor of CNS origin
* Active second malignancy (Exceptions: Successfully treated malignancy with no active disease for 1 year, surgically cured and/or low-risk tumors, or patients receiving ongoing anticancer hormonal therapy for a previously treated cancer)
* Pre-existing gastrointestinal disorders/conditions interfering with ingestion/absorption of rucaparib
* Prior treatment with a PARP inhibitor
* More than 3 prior lines of chemotherapy in the locally advanced/metastatic setting
* History of myelodysplastic syndrome or acute myeloid leukemia
Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding

Our goal is to design and build a new hearing aid system, which mitigates the most common complaints that hearing aid users have. These include hearing in multi-talker situations, poor sound quality, unwanted whistling resulting from feedback, and a dislike of the sound of their own voice. Current efforts, with limited success, use signal processing methods rather than restoring more closely the normal auditory function. We plan to achieve our goal by reducing to practice three key enabling concepts. The first is to replace the current acoustic transducer with a non-acoustic mechanical output transducer that directly actuates the tympanic membrane (TM). This transducer, called the EarLens, floats on the tympanic membrane in a manner similar to the way a contract lens floats on the eye. The second is to increase the output bandwidth of the hearing aid. The third key concept is to place a wide-bandwidth microphone in the ear canal to capture the pinna diffraction cues similarly to the way the normal ear functions. Our central hypothesis is that a hearing aid that delivers amplified wide-bandwidth mechanical stimuli, directionally dependent cues, in an open canal configuration will perform better than conventional hearing aids when there are competing talkers in the background. First phase includes verification the capability of the system to deliver sufficient maximum equivalent pressure output (MEPO) to treat the degree of hearing loss in the target fitting range.


Eligibility Criteria:
Inclusion Criteria:

* Hearing loss less than 60 dB at any frequency, no conductive hearing loss

Exclusion Criteria:

* Collapsed ear canal, damaged or repaired middle ear, too much sensory hearing loss
Early Discharge Pathway Registry

Despite the year-on-year decrease, coronary artery disease (CAD) still remains one of the leading causes of mortality worldwide. With advances in technology and our understanding of cardiac disease, we can now treat CAD using minimally invasive interventional techniques. This has revolutionised treatment for and improved the lives of many patients with CAD. Although trials have assessed various therapeutic strategies in various populations, real-world evidence of intervention and medical treatment among patients with CAD is increasingly recognised as an important part of providing safety and efficacy data and improving the care we provide.

Regional heart attack services have improved clinical outcomes following ST-segment elevation myocardial infarction (STEMI) by facilitating early reperfusion by primary percutaneous coronary intervention (PCI). Early discharge after primary PCI is welcomed by patients and increases the efficiency of health care.

This data will add to that literature by assessing the characteristics and outcomes of patients with CAD, concentrating on those who are discharged via the early discharge pathway. It will also identify and characterise predictors of outcomes, and improve risk stratification and diagnostic evaluation.

The proposed study includes one of the largest coronary interventional programmes in the UK at Europe's largest cardiac centre (BHC). This has allowed us to accumulate a large number of patients in just over 4 years. All patients admitted with acute coronary syndrome and discharged via the early discharge pathway are included in this study using a clinical database. The database is password-protected and includes demographic, clinical and outcome data.

The database includes patients with simple to complex CAD. We will use this database to test several hypotheses including but not limited to investigating characteristics of patients treated, complications of interventional treatment and outcomes of patients. This research will add substantially to the literature by providing real-world data from a leading coronary centre.

In this registry, we will assess the safety and feasibility of the EHD pathway for patients who were discharged after primary PCI from a high-volume heart attack centre in London.

The impact of this study will have local, regional and global consequences with an emphasis on investigating poorly studied areas (e.g. decompensated aortic stenosis) and providing evidence to improve their management and stimulate further research.

Eligibility Criteria:
Inclusion Criteria:

Informed consent will not be sought for, as patients are automatically included onto a database that we will use for research purposes. No children will be included in this study. Vulnerable adults or those unable to give consent will be included in the study as well if they are referred to the Interventional Cardiology team.

Both male and female patients ≥16 years of age will be included

All patients will have been admitted to BHC with acute coronary syndrome.

Exclusion Criteria:

Patients \<16 years will not be included in this study.
Degarelix in the Treatment of Endometriosis Recurrence

The long acting GnRH antagonist degarelix will be tested for the treatment of women with endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will be the outcomes for establishing which medical treatment is the best in endometriosis recurrence treatment.

Endometriosis is a chronic disease affecting 5-10% of women in reproductive age, showing recurrence after surgery at least in 20-50% after 5 years of follow-up. The long acting GnRH antagonist degarelix, which do not have the flare-up effect at the opposite of GnRH agonist and strongly suppress LH secretion and thecal cell activity may show a better effects on endometrial implants than GnRH agonist.

Eligibility Criteria:
Inclusion Criteria:

* women affected by endometriosis showing recurrence of pain symptoms
* previous surgery for endometriosis

Exclusion Criteria:

* presence of other systemic diseases
Radiological Images for Nasotracheal Tube Size Estimation

This trial is planned to estimate the size of nasotracheal tube (NTT) by calculating the diameter of both nasal cavity in radiological images of nose (CT scan/MRI) at the level below the inferior turbinate and floor of nose in coronal planes. Smallest diameter will be considered to calculate the outer diameter of NTT, hence the size .

The planned trial will estimate the size of nasotracheal tube (NTT) by calculating the diameter of both nasal cavity in radiological images of nose (CT scan/MRI) at the level below the inferior turbinate and floor of nose at different levels in coronal planes. Smallest diameter will be considered to calculate the outer diameter of NTT, hence the size. The side of nasotracheal intubation will be decided after view the radiological images and the estimated size of NTT will be used. Finally the ease of intubation and complications will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. patients requiring nasal intubation for oromaxillofacial surgeries

   Exclusion Criteria:
   * 1. Midface instability
2. Coagulopathy
3. Suspected basilar skull fractures
4. Large nasal polyps
5. Suspected nasal foreign bodies
6. Recent nasal surgery
7. History of frequent episodes of epistaxis
8. Prosthetic heart valves (increased risk of bacteremia during the insertion).
9. Patients with deranged liver and renal functions.
Artificial Intelligence-based Mortality Prediction Among Cancer Patients in the Hospice Ward

The purpose of this study is to develop a novel deep-learning-based survival prediction model employing patient activity data recorded by a wearable device.

This study aims to develop a deep-learning-based survival prediction model that utilizes patient movement data upon admission to predict their clinical outcomes: either death or discharge with stable condition. Objective data of the patients are recorded by a wearable device and documented as parameters of physical activity, angle, and spin. In addition to objective data, the investigators also document patients' Karnofsky Performance Status assessed subjectively by clinical doctors. Finally, the investigators aim to explore and describe the applicability, potential, and limitations of the survival prediction model based on patient movement data as a simple prognostic parameter in clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 20 years or older admitted to the hospice care unit at Taipei Medical University Hospital
* Participants diagnosed with at least one end-stage solid tumor diseases
* Participants consented to receive hospice care

Exclusion Criteria:

* Participants aged below 20 years of age
* Participants diagnosed with leukemia or carcinoma of unknown primary
* Participants with evident signs of approaching death upon admission
* Participants with no vital signs upon admission
* Participants who continued to receive aggressive treatment despite admission to the hospice care unit
Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)

This is an efficacy and safety study of desloratadine (MK-4117) in Japanese participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that the change from Baseline in Total Nasal Symptom Score (TNSS) is improved by desloratadine compared to placebo.

This study consists of a one-week Symptom Confirmation Period during which participants undergo a single-blinded placebo run-in, a two-week double-blind Treatment Period and a two-week Follow-up Period.

Eligibility Criteria:
Inclusion Criteria:

* Has at least a 2-year history of seasonal allergic rhinitis with typical symptoms
* Male or female who is unlikely to conceive: a surgically sterilized female, female who has reached natural menopause, or is of reproductive potential and agrees to either remain abstinent or use (or have her partner use) 2 acceptable methods of birth control from study start through 14 days after the last dose of study drug.

Exclusion Criteria:

* Has a lower respiratory tract infection or has a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment
* Has a coexisting infection or systemic mycosis for which there are no effective antibiotics
* Has asthma that is under treatment and/or uncontrolled
* Has nasal septum ulcers, nasal surgery, or nasal trauma which have not healed
* Has vasomotor rhinitis or eosinophilic rhinitis
* Has a history of hypersensitivity to antihistamines or ingredients of study drug
* Has had treatment with corticosteroids (oral, injectable, suppository, depot drugs \[injectable\]) or immunological drugs within 28 days prior to Visit 2
* Is currently receiving treatment with another investigational drug or has received an investigational drug within prior 3 months
* Has started specific desensitization therapy (allergen immunotherapy) or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who has received such therapies within prior 3 months
* Has received coagulation or resection using laser therapy etc. for treatment for nasal symptoms
* Will receive nasal nebulizer therapy and/or thermotherapy during study period
* Has severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor
* Has a history of malignancy or clinically important hematological disorder, except for adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix
* Has a history of severe drug allergy (e.g. anaphylactoid reaction)
* Is pregnant or lactating or may be pregnant
* Is planning a remote trip for more than 1 day during the Symptom Confirmation Period or for more than 2 days during the Treatment Period.
Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping

The purpose of this study is to determine if the planning of radiation treatment of prostate cancer patient can be made more precise by comparing currently planning techniques to an imaging technique called SPECT.

Single photon emission computed tomography (SPECT) uses radioactive tracers and a scanner to record data that a computer constructs into two- or three-dimensional images. A small amount of a radioactive drug is injected into the body and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. Using a gamma camera (a special kind of scanner), we can create a better picture of the lymph node region. We will compare these pictures to images from your CT scan, to help plan your therapy.

The research in this study involves seeing if it is feasible to use SPECT scanning procedures for the purpose of planning your radiation treatment. We hope that doing so will allow us to more accurately and precisely plan radiation treatment to potential sites of cancer, and avoid delivering too much radiation to normal

Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy proven adenocarcinoma of the prostate
* Patients with at least one of the following high risk clinical features at the time of presentation:
* Extra-prostatic extension (on palpation or radiographic imaging)
* PSA ≥ 20
* Gleason Score ≥ 8
* Patients scheduled to receive prostatic and pelvic IMRT with ACCULOC® target localization
* Age \> 18 years
* ECOG Performance Status ≤ 2
* Willing and able to sign informed consent document.-

Exclusion Criteria:

* History of radical prostatectomy
* History of prior pelvic radiation-
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis

This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in children with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 24 months - 12 years
* Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria, whose affected BSA is over 5% and IGA score is 2 (mild) to 3 (moderate).
* Who has applied stable amount of emollients daily before baseline visit
* Who voluntarily agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

* Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.
* Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychial disorder that can affect study results.
* Who has used systemic steroids, antibiotics, immunosuppressants, or received photochemical therapy within 28 days before study drug administration.
* Who has used topical steroids, immunosuppressants or antibiotics to treat atopic dermatitis within 14 days before study drug administration.
* Who has used or is expected to inevitably use prohibited concomitant medications during the study.
* Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
* Who has dosed other study medications within 30 days before screening.
* Who is determined ineligible for study participation by investigators for any other reasons.
Dynamic-orthosis Programs for Stroke Hand Function

This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors.

This study is a randomized controlled intervention trial. Participants are recruited from two medical centers in Taiwan and undergo a continuous 6-week intervention for post-stroke movement rehabilitation. The control group receives traditional stroke occupational therapy rehabilitation. The experimental group, in addition to traditional treatment, supplements their therapy with the use of modular 3D printed dynamic orthoses developed by the research team for home training. Both groups undergo two effectiveness follow-up assessments, one month and two months after the intervention.

Eligibility Criteria:
Inclusion criteria:

1. Onset of stroke at least three months ago;
2. Upper limb Brunnstrom stage II\~IV;
3. Shoulder can actively flex at least 45 degrees.

Exclusion criteria:

1. Affected hand has regained autonomous grasping function, able to grasp and release a tennis ball 10 times within 2 minutes;
2. Joint deformity or stiffness in the affected hand that prevents the use of the dynamic orthosis;
3. Diagnosis of other neurological disorders affecting motor control, such as neglect, Parkinson's disease, etc.;
4. Inability to follow therapist guidance;
5. Currently undergoing other specific treatments affecting motor function recovery (such as rTMS and BTX).
Predicate and Lay User-HCP Comparison Study of a Multi-Level Urine HCG Pregnancy Test

Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial center and provide a sample of urine from the same void for further testing.

Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site.

Eligible volunteers will be recruited into the study and provide informed consent.

Volunteers will then test their urine sample with the investigational HPT according to the device Instructions For Use, and their results will be recorded. A sample of urine from the same void will be obtained for further testing by the healthcare provider (HCP) study technicians.

The HCP technician will then test the volunteer's sample with a second investigational HPT, a professional use pregnancy test and a HPT, the results of which will be used to provide the volunteer with her pregnancy test result. During technician testing, the volunteer will complete the device usability and leaflet comprehension questionnaires.

True pregnancy status will be determined by laboratory tests and clinical information.

Eligibility Criteria:
Inclusion Criteria:

* Females (persons assigned female at birth and not sterile) willing and able to provide written consent to Study participation
* Able to read and write in English or Spanish

Exclusion criteria:

* Persons employed in a healthcare or laboratory setting and/or with professional experience who conduct point of care urine tests
* Previous or current enrollment in a Clara™ Study
* Visually or otherwise impaired to a degree they are not able to readily read and follow instructions, or visualize the faint pink lines.
* Unwilling or unable to provide at least 12mls of urine specimen and any urine testing they are expected to receive as a part of their non-Study related care.