cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants

An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to evaluate pharmacokinetics in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Women not of childbearing potential (WNOCBP), and males, ages 18 to 70 years, inclusive.
* BMI of 20.0 to 38.0 kg/m2 inclusive
* Participants who a history of normal renal function
* Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen
* Healthy subjects to the extent possible matched to four subjects with hepatic impairment with regard to body weight, age and gender, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

* Any nonhepatic significant acute or chronic medical illness that could affect participant safety or data interpretation as determined by the investigator.
* History of recurrent dizziness or fall risk within 4 weeks of study drug administration
* History of primarily cholestatic liver diseases, autoimmune liver disease, metastatic liver disease or active alcoholic hepatitis
* History of known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura)
* Other protocol defined exclusion criteria could apply
Predicting Acute Exacerbations of COPD Using Wearable Devices and Remote Monitoring Technology with AI/ML Models

This study is aimed to collect real-time physiological data using two wearable devices (a biometric ring and a biometric wristband), daily lung mechanical measurements by a handheld oscillometer, and participant-reported symptoms in patients with COPD remotely from their home environment. The data will be used to train and validate artificial intelligence and machine learning (AI/ML) models to predict COPD exacerbations in advance of their actual occurrence. The data will also be used to test the new severity classification system for exacerbations of COPD, as well as to determine important relationships between physiological measurements from the wearable devices, the handheld oscillometer, the self-reported symptoms, and the tests performed at the baseline visit.

A single-site, prospective, observational cohort study to collect high-quality multidimensional data from the wearable/portable devices, as well as symptom and exacerbation data, in high-risk patients with frequent exacerbations in order to develop a COPD exacerbation predictive model.

Eligibility Criteria:
Inclusion Criteria:

* Males/females, age ≥ 40, former/current smokers with ≥10 pack-year smoking history
* FEV1/FVC \< 0.7, with 80% \< FEV1 ≤50% (moderate, 'GOLD 2') 50% \< FEV1 ≤ 30% (severe, 'GOLD 3') or FEV1 \< 30% (very severe, 'GOLD 4') COPD
* History of 2 or more exacerbations in the preceding 12 months requiring corticosteroids, antibiotics, or both
* Ability to provide informed consent
* Ability to access internet at least once daily

Exclusion Criteria:

* No existing COPD diagnosis
* Any medical/cognitive/functional condition which renders inability to operate research equipment/devices, and/or to complete daily symptom response
Exercise During Pregnancy and Urinary Incontinence

The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women

Exclusion Criteria:

-
RESTI Registry: Spanish Registry of Primary Immune Thrombocytopenia and Other Immune Thrombocytopenia

Primary immune thrombocytopenia (PIT), previously referred to as idiopathic thrombocytopenic purpura, is an acquired disease characterized by accelerated platelet destruction and deficient platelet production by megakaryocytes.

Although the existence of PIT has been known for decades, there is no consensus on its triggering mechanisms. On the other hand, this disease presents a very heterogeneous patient profile, both in its characteristics and treatments. In this sense, the diagnosis is still made by excluding other causes of thrombocytopenia.

There is insufficient epidemiological data on the disease, a fact that is especially evident in our country. We have no data on the incidence or prevalence of this pathology in Spain.

For all these reasons, this epidemiological study has been designed to increase the available knowledge about this disease and the detailed characterization of the population of patients with ITP in Spain.

The main objective of this study is to describe the clinical, analytical and treatment characteristics of primary immune thrombocytopenia and other immune thrombocytopenia.

The study is an epidemiological, ambispective, multicenter study carried out in hospitals in Spain.

Information will be collected on the disease under study, as well as on the treatments received, using the patient's clinical history as a source document.


Eligibility Criteria:
Inclusion Criteria:

* Children as young as 2 months of age and adults in follow-up since 2015 (irrespective of date of diagnosis) with the diagnostic presumption of PIT or other thrombocytopenia of probable immune origin defined as a platelet count \< 100 x 109/L.
* Patients who have given written informed consent. In the case of deceased patients, the data will be included in the registry and the investigator will record the impossibility of collecting patient's informed consent form due to death. Only patients deceased after December 31 2015, will be included

Exclusion Criteria:

* Patients who, at the investigator's discretion, do not meet the conditions for inclusion in the study
Safety of Effivia®, a Bevacizumab Biosimilar

This is a post-marketing observational study aimed to evaluated the safety profile of Effivia®, a biosimilar of bevacizumab, in mexican patients with different types of cancer.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, 18 years and older.
* Patients with metastatic colorectal cancer,unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, or epithelial ovarian, fallopian tube, or primary peritoneal cancer naive to bevacizumab therapy (Effivia®).
* Provide written informed consent.

Exclusion Criteria:

* History of recent surgery or wound healing complications.
* History of gastrointestinal perforations or fistula.
* History of renal injury and proteinuria.
* Recent surgical intervention.
* Pregnant or nursing women.
* History of bevacizumab, monoclonal antibodies, or CHO cells-derived products hypersensitivity.
* Other safety concerns or bevacizumab contraindications.
Radioimmunoimaging of AL Amyloidosis

The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.

To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis without significant cardiac (New York Heart Association class IV) disease and not be on kidney dialysis. Additionally, after testing, their blood must not contain antibodies to mouse proteins. The study requires an intravenous infusion, over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 or 7 days after infusion of the antibody. A 5 ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of AL Amyloidosis

Exclusion Criteria:

* New York Heart Association class IV
* patient on renal dialysis
* serum antibodies to mouse protein
Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults

The primary objectives of this clinical trial are to determine if replacing sugar sweetened beverages with water consumption promote weight loss over 6 months in overweight adults and if replacing sugar sweetened beverages with water consumption promote greater weight loss over 6 months relative to replacement with other non-caloric sweetened beverages or control.

The secondary objective is to identify mediators and moderators of the effect of water replacement including hydration status, glucose metabolism, anthropometrics, physical activity, dietary intake and resting metabolic rate.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age.
* Body mass index (BMI) between 25.0-49.9 kg/m2.
* Subject consumes at least 280 calories per day from caloric beverages.

Exclusion Criteria:

* Report losing \>5% of current body weight in the previous 6 months.
* Report participating in a research project involving weight loss or physical activity in the previous 6 months, as these proximal experiences may impact the results of this study. Additionally, report current participating in any other research studies whose results could be compromised by or in which participation could compromise this research study. (Participation in a research study that would not affect or be affected by this study is allowed.)
* Report pregnancy or lactation during the previous 6 months, or planned pregnancy in the next 6 months.
* Report taking medication that could affect metabolism or change body weight (e.g., synthroid).
* Report hospitalization for psychiatric problems during the prior year.
* Report major psychiatric diagnoses and organic brain syndromes.
* Report heart problems, chest pain, cancer within the last 5 years
* Being treated by a therapist for psychological issues or problems with psychotropic medications.
* Report behaviors that indicate probable alcohol dependence as assessed by the Rapid Alcohol Problems Screen (RAPS4-QF) (Cherpitel CJ, 2002).
* Unwilling to change intake of beverages during the study period.
* Plan to move from the area during the study period, and/or unable to attend monthly group meetings.
* Report not having adequate transportation to the study center that would allow transport of study supplies back to the subject's home.
* Report not being able to attend group meetings on Monday or Tuesday evenings.
Psychosocial Reasons for Transfer to In Center Hemodialysis in Home Dialysis Patients- A Focus Group Study

Patients who start home dialysis take on an added responsibility and that can be challenging. The investigators are interested in studying the patient and care partner perspective on the challenges that the participants faced on home dialysis and what interventions could help support them better by holding focus group discussions.

Home dialysis has many advantages compared to in-center hemodialysis (ICHD) including better quality of life and lower healthcare costs. Transfer from home dialysis to ICHD is disruptive to the patients' lives and in some cases may be preventible. Patients do not infrequently transfer to ICHD due to psychosocial reasons, which may be multi-factorial and hard to capture.

The aim of this study is to explore patients' and care partners' perspectives and experiences of the psychosocial factors that make home dialysis challenging and that ultimately contribute to transfer to ICHD during focus group discussions. The investigators will ask them to describe issues that may compound patient and care partner burnout; for those who have already transferred to hemodialysis, the investigators will specifically ask what factors contributed to their transfer off of home dialysis. the investigators will also ask for feedback on what interventions may have helped to prevent the transfer and/or burnout.

* Understanding patient's perspectives and experiences will help the investigators improve patient experience and identify the gaps in health care delivery.
* Help plan interventions and scale-out a solution to identify patients experiencing challenges that put them at risk of transfer to ICHD.
* Lay the groundwork to develop surveys that can be used in the future.
* To enable a truly patient-centered care model, understanding the issues in more detail is critical.

Eligibility Criteria:
Inclusion Criteria:

* Patients currently on home dialysis (maintenance peritoneal dialysis or home hemodialysis), preferably identified as high risk of transfer to in center HD at Satellite healthcare by the clinical team, OR their care partner
* Patients who transferred from home dialysis to ICHD in the last 12 (preferably 6) months, preferably those who had transferred mostly because of psychosocial reasons such as nonconducive living conditions, patient preference, the burden of treatment, loss of care partner, etc, OR their care partner.
* Age \>=20 years

Exclusion Criteria:

* Lack of decision-making capacity
* Non English-speaking
The Effects of Passive Gait Training in Complete Motor Spinal Cord Injury (SCI)

The purpose of this study is to determine whether a three times per week, 2 month robotic assisted treadmill gait training program, will beneficially affect the fitness, physical and psychological well-being, and the vascular and metabolic cardiovascular risk factors in individuals with complete motor Spinal Cord Injury (SCI).

Cardiovascular morbidity and mortality are a source of increasing concern among people with SCI and their health providers. The importance of physical activity in reducing the risk of heart disease in this population is indisputable, but exercise opportunities for persons with SCI are limited by physiologic and functional factors. Decreased functional muscle mass, impaired autonomic control of myocardial function, and decreased venous return limits training responses.

Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant non-lactating female
* At least 6 months after injury
* Complete (AIS A-B) cervical (C4-8) or thoracic (T1-T6) spinal cord injury according to American Spinal Injury Association (AIS) guidelines.
* Under 100 kg and between 155 - 200 cm of height

Exclusion Criteria:

* History of severe neurological injuries other than SCI (MS, CP, ALS, TBI etc).
* Severe concurrent medical diseases: infections, heart or lung, pressure sores, etc
* Unstable spine or unhealed limbs or pelvic fractures
* Psychiatric or cognitive situations that may interfere with the trial
* Spasticity above 3 degree according to Ashworth scale
* Reduced range of motion of knee/hip \> 15°
Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer

The purpose of the present trial is to evaluate the safety, tolerability and pharmacokinetics(PK)/pharmacodynamics(PD) of single subcutaneous injection of GW003 in breast cancer patients. Moreover, the efficacy will be assessed preliminary.

This is an single-center, open-label, randomized, active-controlled phase I study evaluating tolerability and pharmacokinetics/pharmacodynamics of single subcutaneous injections of GW003 in the breast cancer patients.GW003 is recombinant human serum albumin/human granulocyte-colony stimulating factor(I)fusion protein .It is a long-acting G-CSF(Granulocyte-Colony Stimulating Factor). In this study, participants will be administered a single dose of GW003. Every subject will only accept one dose. In addition to tolerability and safety, pharmacokinetics/pharmacodynamics, preliminary efficacy and immunogenicity of GW003 will be evaluated as well.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years to 70 years, female
* Patients with histologically-confirmed breast cancer and plan to accept adjuvant chemotherapy(epirubicin plus cyclophosphamide)
* Have an Eastern Cooperative Oncology Group(ECOG) performance status≤2
* Have no clinically significant impairment in cardiac, liver and kidney
* Adequate hematologic, hepatic and renal function which should meet the following requirements:

  1. Absolute neutrophil count(ANC)≥1.5 x 10\^9/L
  2. Blood platelet(PLT)≥100 x 10\^9/L
  3. Serum creatinine(sCr)≤1.5 times the upper limit of normal(ULN)
  4. Total bilirubin(TBIL)≤1.5×ULN
  5. Aspartate aminotransferase(AST) /serum glutamic-oxaloacetic transaminase(SGOT) and/or alanine aminotransferase(ALT)/serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN
  6. Hemoglobin(Hb)\>9 g/dL
  7. Alkaline phosphatase(ALP)≤1.5×ULN
* Expected to comply with protocol
* With urine human chorionic gonadotropin (hCG) negative
* Signed informed consent

Exclusion Criteria:

* With acute infection
* With history of bone marrow transplant and/or stem cell transplant
* With primary hematological diseases, such as myelodysplastic syndromes, aplastic anemia, sickle cell anemia
* Received surgery within 3 weeks before chemotherapy
* Received G-CSF within 4 weeks before involved in this study
* Females who are pregnant or lactating
* Participated in other clinical trials at the same time or within 4 weeks before screening
* Known allergy to chemotherapy drugs,recombinant human granulocyte-colony stimulating factor rh(rhG-CSF) or any other biological products
* With cacoethic addiction such as drug abuse or alcoholism
* With other cases which is not suitable for this study judged by investigator
A Mindfulness-based Intervention for Treatment of Anxiety in ICD (Implantable Cardioverter Defibrillator) Patients

The purpose of this study is to evaluate the feasibility and preliminary efficacy of a mindfulness-based behavioral intervention combining breathing and other relaxation exercises on symptoms of anxiety in patients undergoing the implantation of an implantable cardioverter defibrillator. This study will pilot test the feasibility and preliminary efficacy of a mindfulness-based intervention intended to improve mindfulness and anxiety levels in ICD (Implantable Cardioverter Defibrillators) patients. A randomized controlled study design will be used, in which an 8 session phone-delivered mindfulness intervention will be compared to a usual care condition among consecutive candidates for ICD procedures. The study will be conducted at the Electrophysiology (EPS) Unit at the UMass Memorial Medical Center. Assessments will be performed at baseline and at the end of the intervention (9 weeks after enrollment).

The Specific Aims of this pilot study are:

Primary aim:

To determine the feasibility of a randomized clinical trial of a phone-administered, mindfulness-based training program, as measured by recruitment and retention rates, treatment adherence and fidelity.

Secondary aims:

1. To obtain preliminary estimates of the effect of a phone delivered mindfulness-based intervention on mindfulness levels, measured as the difference between baseline and post-intervention Five Factors of Mindfulness scores (FFM) in the intervention and in the control group at the end of the intervention. Hypothesis: Mindfulness levels will improve in the intervention group compared to the control group.
2. To obtain preliminary estimates of the effect of a phone delivered, mindfulness-based intervention on anxiety, measured as the difference between baseline and post-intervention Hospital Anxiety and Depression (HAD) anxiety scores in the intervention and in the control group at the end of the intervention. Hypothesis: Anxiety levels will be reduced in the intervention group, compared to the control group.
3. To collect preliminary data about the number of arrhythmic episodes/administered shocks during the intervention period. Hypothesis: the proportion of patients experiencing arrhythmic events/shocks will decrease in the intervention vs. the control group.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21
2. ICD procedure
3. Ability to understand and speak English
4. Access to a telephone

Exclusion Criteria:

1. Inability or unwillingness to give informed consent
2. Signs of cognitive impairment (Blessed Orientation-Memory-Concentration (BOMS)scores \>10)
3. New York Heart Association (NYHA) functional class\>III, angina Canadian Cardiovascular Society(CCS) III and IV or clinically unstable
4. Awaiting coronary by-pass or heart transplantation
5. Co-morbid life threatening condition
6. Ongoing severe depression or psychosis
Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis (MS), Compared to a Control Group

The investigators want to evaluate ovarian reserve concerning patients with multiple sclerosis, compared to a control group of healthy women. This study will include women from 25 to 35 years old.

Multiple sclerosis is an inflammatory disease of central nervous system, with a prevalence rate in France of 1 case/1000 subjects. The average age at diagnosis is 30 years old and it affects especially women, with a sex ratio of 3 women for 1 men. Multiples sclerosis concerns women at a moment when fertility is a main issue.

Few studies suggest that there is an negative impact of multiple sclerosis on ovarian reserve, with a combined mechanism ( inflammatory and autoimmune mechanism). The investigators can hypothesize that patients with multiple sclerosis are more predisposed to have primary ovarian insufficiency.

Ovarian reserve is evaluated by Anti-Mullerian Hormone (AMH) dosage and antral follicle count (AFC) by ultrasound imaging.AMH levels can be measured at every moment of the menstrual cycle whereas AFC is preferentially performed between the second and the fifth day of the menstrual cycle. The combined use of this two markers is well known to be correlated with ovarian reserve. Only a few studies have evaluated ovarian reserve in patients with multiple sclerosis. Besides, there is only a few number of participants and results are contradictory. A decrease of ovarian reserve identified among patients with multiple sclerosis could lead to an orientation in a fertility preservation center.

This project is a monocentric study realized at Pellegrin Hospital - Bordeaux. Patients with multiple sclerosis belong to a cohort of the neurology center. Healthy women come from a volunteer base contacted by email.The two groups are matched thanks to answers of a short questionnaire.Measure of AMH level is performed at pellegrin Hospital at the medical laboratory. Ultrasound imaging is performed by the center of women imagery at Pellegrin Hospital. Results are communicated by teleconsultation two months later. If there is an anormal result, a specific appointment will be organized with a gynecologist.

Eligibility Criteria:
Inclusion Criteria:

* Reproductive women between 25 and 35 years old ;
* MS Patient : Diagnosis of multiple sclerosis based on McDonald Criteria 2017;
* French-speaking, without comprehension disorders ;
* being affiliated to health insurance ;
* Willing to participate and to sign informed consent.

Exclusion Criteria:

* History of ovarian surgery (cystectomy, annexectomy) ;
* Turner Syndrome ;
* fragile X messenger ribonucleoprotein 1 (FMR1) premutation ;
* Endometriosis with a risk of ovarian reserve alteration ;
* History of chemotherapy or pelvic radiotherapy ;
* Pregnant or breastfeeding women ;
* patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).