cyrilzakka/clinical-trials huggingface dataset:
A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies

This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose (MTD), maximum administered dose (MAD), recommended Phase 2 dose (RP2D), and pharmacokinetic profile of the drug. Additionally, preliminary antitumor activity will be characterized. The study is divided into 2 main parts: Part 1 "Monotherapy Dose Finding" and Part 2 "Monotherapy Dose Expansion."


Eligibility Criteria:
Inclusion Criteria

1. Confirmed diagnosis (per World Health Organization \[WHO\] guidelines, unless otherwise noted) of one of the following:

   Cohort A1 and Cohort A2:
   1. R/R DLBCL
   2. R/R FL
   3. R/R MZL
   4. Transformed B-cell NHL
   5. Richter's transformation to DLBCL
2. Measurable disease by computed tomography/magnetic resonance imaging.

Exclusion Criteria:

1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer
2. Known central nervous system involvement by lymphoma/leukemia
3. Prior autologous stem cell transplant \< 3 months before the first dose of study drug. Or prior chimeric antigen receptor T-cell (CAR-T) therapy \< 3 months before the first dose of study drug
4. Prior allogeneic stem cell transplant.
5. Major surgery \< 4 weeks before the first dose of study treatment

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome

To investigate the long-term safety and tolerability of clobazam when administered for 1 year as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.


Eligibility Criteria:
The inclusion and exclusion criteria for the patients who participated in lead-in Study 14362A will be transferred from the 14362A study and for the patients who did not participate in lead-in Study 14362A the inclusion/exclusion is separately listed below.

Inclusion Criteria:

1. The patient has a diagnosis of Dravet Syndrome supported by:

   1. onset of seizures in the first year of life
   2. history of fever-induced prolonged seizures as determined by the Investigator

      * these may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures
   3. multiple seizure types which may include:

      * generalised tonic-clonic (required for inclusion)
      * clonic (required for inclusion)
      * myoclonic jerks/seizures
   4. history of normal development prior to seizure onset followed by development delay or regression after seizure onset
   5. abnormal EEG consistent with Dravet Syndrome
2. The patient is currently receiving a stable dose of clobazam of at least 0.5 mg/kg/day (maximum 20 mg/day) for at least 3 months

Other protocol-defined inclusion and exclusion criteria may apply.
Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects

This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male, age 18-55 years, both inclusive, at the time of signing informed consent
* Body Mass Index (BMI) 18.5-30 kg/m\^2, both inclusive
* Good general health based on assessment of medical history, vital signs, physical examination, ECG (electrocardiogram), and laboratory data at screening, as judged by the investigator

Exclusion Criteria:

* Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the investigator
Phase 3 Study of Acupression's Bracelets in Nausea and Vomiting Induced by FEC100 Chemotherapy's Sort.

The purpose of this study is to demonstrate a betterment of the digestive symptomatology by the anti-emetic acupression's bracelets's use associated with hygiene and dietetic advices.


Eligibility Criteria:
Inclusion Criteria:

* Woman
* Age \> 18 years
* Well-informed written consent, signed by the patient before the beginning of the study
* Breast cancer's diagnosis (operated or not)
* Forecast of a treatment by FEC100 chemotherapy's sort (D1=D21) during at least 3 cycles.
* Patient affiliated at a welfare or beneficiary from it
* Investigator estimates that the patient is able to conform with protocol's conditions and to respect them

Exclusion Criteria:

* Operated arm's lymphedema
* Wrist's morphology which cannot permit the bracelet's wearing (20 cm)
* D1=D15 FEC100's treatment
* Psychic incapability to sign a well-informed consent
* Refusal to give a written consent
* Patient under tutelage or guardianship
* Pregnant or breast-feeding woman
* Any clinical trial's participation which would impose nausea and vomiting's treatment modalities
BioButton Among Nursing Home Residents

This pilot study will explore the use of the BioIntellisense BioButton, a remote wearable multi-parameter monitor, to identify gait disturbances that occur as a side effect of polypharmacy.

By 2030, an anticipated seven adults over 65 years old are projected to die every hour from a fall in the United States. This highlights the growing percentage of the elderly in our population and the impact of falls on them. Nationally, over 25% of older adults report falling each year and falls are the leading cause of fatal and non-fatal injuries. In Pennsylvania, 30% of older adults report falling each year, an underreported value that can be as high as 60%. The cost of care for falls is over $50 billion annually in the United States according to the Centers for Disease Control (CDC). Nursing home residents are especially at risk; among nursing home residents, the risk of falling is 2x greater than community residents.

Nursing home residents who take multiple medications especially antidepressants, anxiolytics, and blood pressure drugs have an increased risk for falling. Polypharmacy especially the use of five or more medications is significantly associated with a 21% increase of falls. Unfortunately, gait data is not routinely collected or available to geriatric clinicians for making medication decisions. Empowering clinicians with gait data can be a powerful piece of the puzzle; this information may help them decide whether the benefit of starting a new anti-hypertensive or mood medication is worth the risk.

Clinicians informed with gait data can make better medication decisions for their elderly patients; they will be able to consider gait disturbance and fall risk in their clinical judgement. As a result, gait data from continuous wearable technology can adjust medication practices, and reduce medication-induced falls. Moreover, the concept for gait-informed prescription practice complements the 4Ms (what matters, medication, mentation, and mobility) employed by age-friendly health systems. Continuous gait data can inform the implementation of the 4Ms by (1) engaging patients and their families about their care priorities related medications and their impact on gait, (2) adjusting medications that affect mobility, and (3) addressing depression treatment with behavioral modifications instead of medications. Results from this project can inform future studies that will move the needle towards implementing care practices consistent with the 4Ms.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18yrs
* Presence of gait documentation in EMR

Exclusion Criteria:

* Age \<18yrs
* Non-English-speaking patients
* Patients who cannot provide consent due to cognitive status
* Bedbound, unable to stand
Effects of Medium Chain Triglyceride Oil, Versus Olive Oil, for Weight Loss

The primary aim of this research project is to determine whether the incorporation of food products containing medium chain triglyceride (MCT) oil in a weight-loss program results in a different degree of weight-loss and total and regional fat mass loss than the incorporation of extra light olive oil. The secondary goals are to test whether there are differences in in metabolic risk profile changes between the 2 diets. We hypothesize that men and women who consumed MCT oil as part of their weight loss program will lose more weight and body fat than those who consume olive oil in their weight loss diet.


Eligibility Criteria:
Inclusion Criteria:

* body mass index 27-33 kg/m2
* pre-menopausal women
* weight stable for at least 6 months
* normal score on Brief Symptoms Inventory questionnaire

Exclusion Criteria:

* chronic disease
* weight loss treatment
* medication known to affect body weight
* unstable blood pressure, glucose, lipid levels
My Smart Age With HIV: Smartphone Self-assessment of Frailty

Understanding the complexity of aging and frailty in chronic HIV infection motivated Italian team members to begin to build a frailty index (FI) including 37 health variables at the Modena HIV Metabolic Clinic (MHMC). The validation of FI in HIV patients have been recently published, and more data comparing FI in HIV infected vs un-infected people, have been presented at international meeting and are at present submitted for publication.

The research consortium (MHMC, HCC and HHMP) of this study was motivated to begin preliminary work in consideration of the similar multidisciplinary approach in Ageing care and capacity to address health status in ageing HIV patients using shared definitions of co-morbidities, multi-morbidity and measures of Physical Function and Cognition impairment, disability and quality of life. The investigators wanted to overcome the major criticism intrinsic in the FI, that is the needs to collects many variables not easily available in most HIV centres. The the investigators approach is to make patient living with HIV (PLWH), be the source of health variables taking advantage of information and communication technologies available with smart phones and fitness tracking device, collecting physiological parameters and patient related outcomes.

In this study the investigators plan to empower elderly HIV patients via health promotion, assessing reduction in health deficit and improvement in quality of life using My Smart Age (MySAwH) application.

MySAwH is an interactive mobile application designed to empower elderly HIV patients in health promotion through self assessment of ageing transition using a FI. FI is generated from health variables which include physical function data routinely collected by fitness tracking devices, Ecological momentary assessment data collected with smart phones and Physician health data collected during patient visits. The change in frailty index over time describes health transition. Although health generally worsens with age, the relationship between aging and health is dynamic and periodic improvement and stability in frailty index may be the result of the patients engagement in health promotion and improved life style.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection on ART
* HIV1-RNA\<40 c/mL for at least 6 months
* Age stratification:

  * 50 pts (per centre) aged 50-64 years
  * 50 pts (per centre) aged ≥ 65 years
* Routine access to a smart phone and willingness to use the fitness tracking device
* Willingness to be trained to use an interactive mobile application

Exclusion Criteria:

-
Lactulose for the Prevention of Nosocomial Infections in Children

The purpose of this study is to assess the ability of lactulose, a prebiotic agent, to prevent hospital acquired infection in children

Despite the adoption of norms regarding enteric isolation, nosocomial infectious diarrhea is common in children(1;2). Viral pathogens, especially rotavirus are responsible for most of the cases. Depending on population, type of hospital, and standard of care, the reported incidence rate ranges from 8 to 33 episodes per 100 admissions(1). Infants and toddlers are at the highest risk of acquiring nosocomial viral gastroenteritis(1;2).

Probiotic bacteria have been shown to be beneficial in the prevention and treatment of gastrointestinal infections as well as reduction of viral shedding(3;4). A recent study by Szajewska et al. (2) showed a significant reduction of nosocomial infections from 33% to 7% by prophylactic treatment with LGG during the hospital stay. Another study however, did not show any difference(1).

Another approach is to use prebiotic treatment. Prebiotics are defined as non-digestible substances that, when ingested, selectively promote the growth and establishment of beneficial probiotic-like bacteria normally present in the gut(5).

Lactulose is a semi-synthetic disaccharide made from lactose by a chemical reaction which was first described in 1930(6).

In contrast to other prebiotics, lactulose has up to now been mainly used as a medicinal drug for constipation and hepatic encephalopathy(6). In 1957 Petuely published the basic work about lactulose as "the bifidus factor" which was confirmed by MacGillivray et al(6).They found that the composition of the colonic microflora of bottle-fed babies is very much like that of adults while if lactulose is added to the formula milk such babies have the same composition as breast-fed babies.

Lactulose has been used for 40 years in the treatment of constipation \[10\] and for more than 30 years for encephalopathy.The dosages used in PSE are up to four times higher than those usually applied in constipation. No putative or definite evidence of mutagenic, genotoxic or teratogenic effects of lactulose has been obtained in human use. Animal studies in rats and rabbits also did not reveal any teratogenic or reproduction-toxicologic effects, and even high dosages have had no deleterious effects(6)

Our hypothesis is that lactulose, with its proven prebiotic properties, given to children during their hospital stay, would be beneficial in reducing nosocomial infections.

Eligibility Criteria:
Inclusion Criteria:

* All children aged 2 to 36 months who are admitted to the hospital for reasons other than diarrhea will be eligible for the study.

Exclusion Criteria:

* Children with a history of probiotics or prebiotics use within 7 days before admission, acute gastroenteritis within 3 days before admission, vomiting, treated chronic constipation, known anatomic problem in the gastrointestinal tract will be excluded from the study.
Immediate Neurophysiological Effects of PENS on Radial Nerve in Patients With Lateral Epicondylalgia

Lateral epicondylalgia is a common musculoskeletal condition that approximately affects 1-3% of the general population. Several authors have found greater mechanical pain sensitivity in the radial nerve when compared with healthy subjects. Radial tunnel syndrome exhibits a similar clinical presentation to lateral epicondylalgia. Percutaneous electrical stimulation has shown reduce pain in several conditions. Percutaneous electrical stimulation on the radial nerve could cause an important relief in lateral epicondylalgia.

Hypothesis: Percutaneous electrical stimulation on radial nerve plus in patients with lateral epicondylalgia is better than sham percutaneous electrical stimulation

Randomized, double-blind, placebo controlled clinical trial, using Percutaneous Electrical Nerve Stimulation (PENS). PENS is technique to provide a transcutaneous electrical nerve stimulation current throughout needling filaments place close to the nerve.

Study Aims:

Aim #1: The primary aim of the study is to compare the immediate effect of a single session of PENS on pressure pain sensitivity as measured by pressure pain threshold in patients with lateral epicondylalgia with random assignment to two treatments: PENS or Sham PENS

Aim #2: The secondary aim of the study is to compare the immediate effect on pain free grip strength, on intensity of pain as measured by visual analogue scale (VAS) in patients with lateral epicondylalgia with random assignment to two treatments: PENS or Sham PENS.

Eligibility Criteria:
Inclusion Criteria:

* Lateral epicondylalgia symptoms confirmed with at least 2 of the 4 following test:

  1. pain during palpation of lateral epicondyle
  2. pain on resisted wrist extension
  3. pain on resisted middle finger extension
  4. pain during hand-grip

Exclusion Criteria:

* History of fractures, luxations, surgery and/or musculoskeletal disorders in upper limb.
* Neurological disorders, inflammatory and/or degenerative diseases.
* Having received as treatment techniques that involve needles on the previous 6 months to study enrollment, or having received percutaneous electrical stimulation as a treatment before.
* Cervical pathology, fibromyalgia, unstable cardiovascular diseases, pregnant women or under suspect of pregnancy.
* Contraindications of needle's insertions: anticoagulant therapy, needle phobia, diabetes, hypothyroidism, lymphoedema, muscular diseases).
* Contraindications of electrical current application
The Effectiveness of 18F-fluorocholine Positron Emission Tomography (PET) in Detecting, Staging and Following-up Prostate Cancer

Choline is one of the components of phosphatidylcholine, an essential element of phospholipids in the cell membrane. Some malignant cells show their ability to actively incorporate choline to produce phosphocholine and phosphatidylcholine to facilitate tumor cell duplication. The efficacy of 18F-fluorocholine (18F-FCH) for localizing primary or metastatic prostate cancer has been recently reported in limited studies. This study will be conducted to delineate the effectiveness of 18F-FCH PET in (1) differentiating benign prostate hypertrophy (BPH) from prostate cancer, (2) staging prostate cancer, (3) following-up patients with prostate cancer after initial curative therapy.

Background:

Prostate cancer is a leading cause of cancer death for male in Taiwan. Although 18F-FDG PET has been shown to be an effective tool in diagnosing many malignancies, previous studies have shown that 18F-FDG is not a suitable PET tracer for detecting prostate cancer. Choline is one of the components of phosphatidylcholine, an essential element of phospholipids in the cell membrane. Some malignant cells show their ability to actively incorporate choline to produce phosphocholine and phosphatidylcholine to facilitate tumor cell duplication. The efficacy of 18F-fluorocholine (18F-FCH) for localizing primary or metastatic prostate cancer has been recently reported in limited studies.

Purpose:

This study will be conducted to delineate the effectiveness of 18F-FCH PET in (1) differentiating benign prostate hypertrophy (BPH) from prostate cancer, (2) staging prostate cancer, (3) following-up patients with prostate cancer after initial curative therapy.

Patients and Methods:

This study will include

1. Group 1: 50 patients with BPH
2. Group 2: 50 patients with newly diagnosed prostate cancer and
3. Group 3: 50 patients who have received curative treatment for prostate cancer and are suspicious of recurrence/metastases because of a persistent increase in their serum PSA.

18F-FCH whole-body PET will be performed for each patient

Expected Results:

To evaluate the effectiveness of 18F-FCH in the diagnosis, staging and follow-up of prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

Group 1: 50 patients with BPH

1. Age above 35 years old
2. Histologically confirmed BPH
3. Informed consent signed

Group 2: 50 patients with newly diagnosed prostate cancer and

1. Age above 35 years old
2. Histologically confirmed prostate cancer
3. Informed consent signed

Group 3: 50 patients who have

1. Age above 35 years old
2. Histologically confirmed prostate cancer and had received curative treatment for prostate cancer
3. suspicious of recurrence/metastases because of a persistent increase in their serum PSA
4. Informed consent signed

Exclusion Criteria:

* Patients with other known malignancies will be excluded.
Establishing of an Early Warming System of Premature Ovarian Insufficiency

Premature ovarian insufficiency (POI) is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. The POI guideline development group of ESHRE recommends the following diagnostic criteria: oligo/ amenorrhea for at least 4 months and an elevated follicle stimulating hormone (FSH) level \>25 mIU/mL on two occasion \>4 weeks apart. Some clinicians and researchers proposed that POI was a progressive disease and there were three stages of POI: occult POI, biochemical POI, overt POI. However, there is lack of reliable indicators to assess the different stages of POI. The present study is to explore the change of menstruation condition, basal follicle-stimulating hormone, anti-müllerian hormone and antral follicle count during the development of POI, and whether those marks can assess the different stages of POI.


Eligibility Criteria:
Inclusion Criteria:

* Serum FSH levels ≥10mIU/ml/ serum AMH levels ≤1.0pg/ml/ AFC ≤5, on at least two occasion \>4 weeks apart

Exclusion Criteria:

* Polycystic Ovarian Syndrome
* other causes of amenorrhea
Adverse Events Related to Low Dose Atropine

Progressive myopia can lead to severe vision loss and is associated with retinal detachment, glaucoma, and other comorbidities. Several studies have shown that off-label, low-dose atropine eye drops slow the progression of myopia. Many eye care providers are now prescribing off-label atropine eye drops for their myopic patients, with the prescribed concentrations varying amongst providers.

The purpose of this study is to determine if low-dose atropine eyedrops used daily, cause adverse effects to the eyes. Patients currently using 0.01%, 0.03%, or 0.05% atropine eye drops obtained from compounding pharmacies will be assessed for associated adverse effects.

Eligibility: Myopic patients currently using 0.01%, 0.03%, or 0.05% atropine eye drops, prescribed by the investigator(s).

Patients that meet the eligibility criteria will be given the parental consent form and child assent form (if applicable) during their regularly scheduled office visit. After consent forms are signed and at each follow-up visit, the investigator or study coordinator will begin by querying for adverse events by asking each patient general, non-directed questions, such as "How have you been feeling since the last visit?" Directed questioning and examination will then be done as appropriate. All reported adverse events will be documented on the appropriate CRF. The patients will then continue with their regular eye exam.

Patients enrolled in the study will be assessed for adverse events at each regularly scheduled office visit for the duration of the study (up to 5 years), unless they choose to withdraw from the study.

The study will assess 148 patients using either 0.01%, 0.03%, or 0.05% atropine eye drops (prescribed by the investigator), over a five-year period.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with myopia
* patients must be currently using 0.01%, 0.03%, or 0.05% atropine eye drops daily
* low-dose atropine eye drops must be prescribed by the principal investigator and obtained from a compounding pharmacy

Exclusion Criteria:

* patients without myopia
* patients with myopia, but not using low-dose atropine eye drops