cyrilzakka/clinical-trials huggingface dataset:
A Phase 1, First-in-Human Study of BMS-986421 in Healthy Participants

The purpose of this study is to assess the safety and tolerability of BMS-986421 in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants are required to remain in the clinical facility from Day -1 (Part 1) or Day -2 (Part 2) until clinic discharge.
* A negative test for COVID-19, which will be performed in the manner mandated by the clinical site where this study is being conducted, at screening and admission.
* All female participants, Women of Childbearing Potential (WOCBP) and women not of childbearing potential, must have a negative highly sensitive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) at screening and on Day -1 (or Day -2 for Part 2).

Exclusion Criteria:

* Participant was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer).
* Vaccination or plans for vaccination with non-live vaccines within 30 days before Day -1 (for Day -2 for Part 2) until the follow-up phone call.
* Donation of blood or blood transfusion within 8 weeks of first study intervention administration.
Y90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver

The purpose of this study is to assess the safety of transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma

The purpose of this study is to assess the peri-operative morbidity and mortality of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Cirrhotic liver demonstrated by typical liver dysmorphy on imaging and/or liver biopsy.
* HCC with at least one lesion measuring more than 1 cm in diameter with a single dynamic imaging technique (CT or MRI), showing intense arterial uptake followed by washout of contrast in the venous-delayed phases, or diagnosed by biopsy.
* Borderline resectable disease eligible for surgical resection or radiofrequency destruction.
* No extra-hepatic dissemination.
* ECOG Performance status \< 2.
* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Signed written informed consent (approved by an Independent Ethics Committee) obtained prior to any study specific baseline procedures.

Exclusion Criteria:

* Decompensated cirrhosis (Child Pugh B, C).
* Extra-hepatic tumour spread.
* Previous or concomitant malignancies within five years other than basal cell carcinoma of the skin.
* Pregnancy, lactation or refusal to use adequate contraceptive measures (hormonal or barrier method of birth control, abstinence).
* Pre-existing other hepatic disease (liver abscess, hepatic sarcoidosis or tuberculosis, sclerosing cholangitis, ...).
* Previous trans-arterial radioembolization (TARE).
* History of allergic reactions attributed to compounds of similar chemical or biologic composition of the administered materials.
* Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
* Major surgery within four weeks.
* Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Uncontrolled Diabetes.
Assessment of Handgrip Strength in Adults With Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a chronic disease, which causes inflammation of the gut. People with this disease are often poorly nourished. Problems caused by poor nutrition such as poor wound healing can be reduced if it is recognised and treated early.

When people with IBD attend outpatients clinic with their IBD specialist they are weighed and their BMI calculated to indicate if they are poorly nourished. Weight and BMI may not always provide a good assessment of how well nourished a person is because it does not describe the amount of muscle in the body in proportion to fat. A person with a low or decreasing amount of muscle but a normal or high BMI is at risk of nutritional problems. Measuring the amount of muscle someone with IBD has in routine practice poses a challenge to clinicians due to time constraints. One-way of measuring the amount of muscle a person has is to measure their muscle strength. This can be measured by recording the strength of a person's handgrip. Handgrip strength can be measured using a hand-held device called a dynamometer.

This study aims to test whether it is possible to measure the handgrip strength of people with IBD attending outpatient's clinic. It also aims to test how the measure obtained compares with other methods of assessing whether someone is malnourished and their health. People with a diagnosis of IBD who are aged 18 or older and who are scheduled to attend IBD outpatients clinic in one hospital will be asked to take part in the study. Their handgrip strength will be measured each time they attend clinic over a nine-month period in addition to other information about their health and nutritional state. This study forms part of a Masters in Research being undertaken with The University of Southampton.


Eligibility Criteria:
Inclusion Criteria:

1. Adult participants with a confirmed diagnosis of IBD (≥18 years of age)
2. People deemed to have capacity to consent
3. People able to understand and read English
4. People attending a gastroenterology outpatient clinic appointment

Exclusion Criteria:

1. People physically unable to complete the study procedures
2. Any person who is currently participating in another research trial in which the principle investigator is not satisfied to sign a 12-week exemption form.
3. People involved in an interventional study.
4. People who are currently an inpatient
Pharmacokinetics of CLG561 in Patients With Advanced Age-Related Macular Degeneration

The purpose of this study is to evaluate the safety, tolerability, and serum pharmacokinetics of CLG561 in subjects with advanced age-related macular degeneration (AMD).

Subjects were divided into 5 cohorts, with the subjects in each cohort being administered a single IVT dose of CLG561 in 1 of 5 concentration levels A-E, where A=lowest and E=highest. All subjects received active CLG561. Progress from one cohort to the next was time-lagged to allow for safety review. Dosing was also time-lagged within each cohort. Only one eye (designated as the study eye) was dosed per subject. Post-dose safety assessments and ocular examination occurred immediately after the IVT injection and continued throughout the outpatient visits at pre-determined timepoints. Collection of post-injection blood samples began after the IVT injection at pre-determined timepoints. Subjects were followed for up to 84 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of age-related macular degeneration in study eye, as specified in protocol.
* Poor visual acuity in study eye, as specified in protocol.
* Willing to receive meningitis and pneumonia vaccinations at least 2 weeks prior to study treatment.
* Females must be post-menopausal and/or surgically sterile.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Treatments to the study eye within 28 days prior to study treatment, as specified in protocol.
* Any disease or medication expected to cause systemic or ocular immunosuppression.
* Participation in another interventional clinical study or use of any experimental treatment for AMD within 12 weeks prior to study treatment.
* Other protocol-defined exclusion criteria may apply.
SOCKNLEG Compression Stocking Kit : User Friendliness

The investigators aim to evaluate the user friendliness of a newly designed leg compression stocking kit, the SOCKNLEG, compared to a standard leg compression stocking of the same compression strength, the SIGVARIS Cotton. The SOCKNLEG is not yet commercially available, whereas the SIGVARIS Cotton has been successfully commercialized for many years.

After an initial screening visit, a computer generated list will allocate the participants in either the SOCKNLEG or the SIGVARIS Cotton group.

All participants will try on both study stockings, in the order of their allocated group, and will rate their donning and doffing success with a questionnaire. The patients will then wear only the assigned study stocking of their allocated group, for a day and rate its comfort again at the end of the day. The donning and doffing success will also be rated by the study investigator. Leg volume measurements of the study leg will be taken at each visit to determine edema prevention.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Male or postmenopausal female patient, aged over 65 years of age
* Diagnosed venous insufficiency stage C3-C6 (according to CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic) -classification for venous diseases)

Exclusion Criteria:

* Venous leg ulcer with a surface \>5cm2
* Peripheral artery disease (PAD) or media calcinosis (Ankle-Brachial-Index \<0.8 or \>1.3)
* Difference in brachial blood pressure \>20mmHg in both arms
* Suspected polyneuropathy with ≥4 sensible test areas, measured with the Semmes-Weinstein-Monofilament-Test
* Inability to reach the forefoot with their hands
* Inability to follow the procedures of the study
* Bed-ridden hospitalized patients who are not able to leave the bed or sit upright for a few consecutive hours
A Study of the Effects of a One-session Mindfulness of the Breath Meditation Practice on State Hope and State Gratitude in the General Population

This study aims to examine whether a brief mindfulness of the breath meditation practice is more helpful than listening to an audio recording in relation to improving hope and gratitude in the general population.

This one-session online study will randomise members of the general public to either 1) a mindfulness of the breath meditation practice lasting 10 minutes or 2) an audio-recording control of the same length. State measures of mindfulness, hope and gratitude will be taken immediately before (baseline) and after the intervention/control. In addition, the study will also measure trait mindfulness at baseline.The primary hypothesis is that engaging in a brief mindfulness practice will result in beneficial changes in state hope compared to control. Other hypotheses are that: engaging in a brief mindfulness practice will result in beneficial changes in state gratitude compared to control; that the effect of mindfulness practice on state hope will be statistically mediated by change in state mindfulness; that the effect of mindfulness practice on state gratitude will be statistically mediated by change in state mindfulness; and that baseline trait mindfulness will statistically moderate the effect of mindfulness practice on change in state mindfulness in the above mentioned mediation models (i.e. that moderated mediation will be observed).

Eligibility Criteria:
Inclusion Criteria:

* Members of the general public.
* Adequate understanding of spoken and written English.
* Internet access.

Exclusion Criteria:

-Currently experiencing very severe problems with their mental health.
Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure

This study will assess the hemodynamic effect of RLX030 infusion in subjects with acute heart failure. In addition safety and effects on renal function and biomarkers will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized or requiring admission to hospital for management of acute heart failure within the previous 48 hours.
* Pulmonary wedge pressure above or equal to18 mmHg determined by right heart catheterization

Exclusion Criteria:

* Systolic blood pressure below 115 mmHg
* Significant valvular diseases or arrythmias
* Acute coronary syndrome in previous 45 days
* Treatment with mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
* Impaired renal or hepatic function

Other protocol-defined inclusion/exclusion criteria may apply
Physical Therapy for In-patients With Severe Anorexia Nervosa

In-patients with severe anorexia nervosa (AN) often drop out of treatment, because of ambivalence towards treatment and anxiety for weight gain. However, physical therapy has shown some positive effects on symptoms of AN. This study aims to investigate the feasibility of a randomized control trial (RCT) of a standardized physiotherapeutic program for patients with severe AN with compliance to nutritional therapy as the primary outcome measure.

Anorexia nervosa (AN) is a serious and complex disease with unknown etiology. It is characterised by disturbed body image and extreme and devastating fear of gaining weight. The illness leads to a considerable and sometimes dangerous weight loss because of the limited food intake and often an exaggerated exercise behavior. AN can affect people of all ages and of both sexes, but girls or young women are more at risk. The prevalence among young women in Denmark is estimated to be between 0.4% and 1%. AN is associated with a high rate of comorbidity and mortality.

The treatment of AN consist of re-feeding and psychotherapy. Different therapeutic methods and theories have been applied, but none have shown to be superior. The patient alliance and motivation for treatment seem to be essential for a successful treatment. Drop-out is a common challenge. Hence, attention must be directed to how the therapeutic alliance and the patient's motivation can be optimized in order to secure a better treatment effect.

Studies have shown that physical therapy, including supervised exercise and bodily focused interventions, may have a positive effect on symptoms of AN. It may reduce the distorted body image and anxiety. However, it is unknown whether physical therapy can affect compliance and drop out rate to the nutrition therapy. The objective of this study is to investigate the feasibility of a RCT design in this group of patients with severe AN at a specialized unit. The intervention is supervised, standardized physical therapeutic exercises mainly consisting of light strength training. The development of the intervention is based partly on the literature, and partly on interviews and observations with two patients with severe AN.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the specialized nutrition section at Odense University Hospital and are fulfilling Diagnostic and Statistical Manual (DSM)-5 criteria for AN.
* 18 years of age or older
* Patients who can be included within the first two weeks of hospitalization

Exclusion Criteria:

* Patients who can not fill in a Danish-language questionnaire.
* Patients who are not able to be in standing position.
* Patients who are not respiratory and circulatory stable.
Air Pollution and Physical Activity: A Randomized Controlled Trial

This is a small pilot intervention trial in which we will collect preliminary data to demonstrate the feasibility of an intervention study.

This is a pilot randomized, control, clinical trial.

We will recruit 24 adults in Buffalo and randomize them to the physical intervention groups. The intervention group will be provided with physical activity courses.

We will follow up all participants until the end of the study.

We will collect their baseline information via questionnaire, and at the end of the follow-up we will collect the exit questionnaire and biospecimen.

The study aims to demonstrate our ability to recruit eligible participants and provide data of the compliance of participants to the intervention.

Eligibility Criteria:
Inclusion Criteria:

* 1) age 35-55 years old; 2) plan to stay in Buffalo most of the time in the next three months; 3) no adverse conditions

Exclusion Criteria:

* those with unstable or life-threatening medical conditions. The pilot study will also demonstrate our ability to recruit the modified study population.
Diet and Aggression: Reducing Aggression Among Chronic Psychiatric Inpatients Through Dietary Supplementation

The overall goal of this study is to investigate whether the daily administration of multivitamins, minerals and n-3 fatty acids will reduce aggression in long-term psychiatric inpatients and will thereby reduce costs of care.

Aggressive incidents are highly prevalent among chronic psychiatric inpatients. Previous studies have demonstrated the potential of multivitamin-, mineral-, and n-3 fatty acids (n-3FA) supplementation to reduce aggression in adolescent and forensic populations. To test the hypothesis that multivitamin-, mineral-, and n-3FA supplementation reduces aggression among chronic psychiatric inpatients, we designed a pragmatic, randomised, double-blind, placebo controlled, multicentre intervention study among psychiatric inpatients residing in long-stay psychiatric wards. During 6 months, one group receives 2 supplements daily from Orthica: one containing vitamins and minerals (vitamins \[B1, B2, B3, B5, B6, B11, B12, C, D, E, Beta Carotene; Calcium, Iodine, Copper, Magnesium, Selenium, Iron, Zinc, Potassium, Chrome, Manganese\]) and one containing fish fatty acids (n-3FA: eicosapentaenic acid \[EPA\] and docosahexaenic acid \[DHA\]) and the other group receives 2 placebo capsules.

The main study parameter is the number of aggressive incidents from baseline (t0) to endpoint (six months post baseline, t3). Patients who wish to participate enter a 2-week run-in phase in which they take 2 placebo capsules daily. After positive evaluation of this run-in phase patients are randomized to the active or the control condition. Participants will then start the daily use of 2 supplement capsules or 2 placebo capsules, which will continue for 6 months. At 3 time points (at baseline \[t0\] and at 2 and 6 months post-baseline \[t2 and t3\]), three questionnaires measuring feelings of aggression, quality of life, and psychiatric symptoms will be administered. Also, at t0 and t3 (micro)nutrient status will be determined. Finally, at 4 time points (t0, 2 weeks post baseline \[t1\], t2 and t3), nursing staff will report on observed levels of aggression and social dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* residing at a facility for long-term psychiatric inpatient care
* age 18 or over

Exclusion Criteria:

* pregnancy
* breastfeeding
* known contra-indication for using the supplements used in this study
* expected discharge or transfer within the next 8 weeks
* current use of dietary supplements and refusal to stop using these for the duration of the study
* failure to complete run-in phase
* contra-indication for the use of pork-gelatin
Big Data and Text-mining Technologies Applied for Breast Cancer Medical Data Analysis

Primary purpose :

To develop a method to automatically extract and structure the information included in numerous medical records from breast cancer patients.

Secondary purpose :

With this procedure we can analyze the content of ten thousand anonymized textual medical records.

This information should enable us to explore many subjects, such as:

* The impact of certain therapeutic procedures
* The characteristics of sub-groups of patients
* Pregnancy associated breast cancers
* Risk factors


Eligibility Criteria:
Inclusion Criteria:

* Majority (age \> 18)
* Malignant breast tumors
* signed informed consent

Exclusion Criteria:

* Benign breast pathology
* Patients not initially treated at the Hôpitaux Universitaires de Strasbourg
Congenital Athymia Patient Registry

This Congenital Athymia Patient Registry is an observational exposure-based registry study. It uses a prospective cohort design to follow patients who have been treated with RETHYMIC.

Clinical studies conducted with investigational RETHYMIC showed that treatment can result in immune reconstitution and prolong life. This treatment-based registry is being conducted to learn more about the reconstitution process following treatment and the impact of treatment on longer-term survival and the occurrence of adverse events of special interest (AESI).

This Congenital Athymia Patient Registry is an observational exposure-based registry study. It uses a prospective cohort design to follow patients who have been treated with RETHYMIC.

Clinical studies conducted with investigational RETHYMIC showed that treatment can result in immune reconstitution and prolong life. This treatment-based registry is being conducted to learn more about the reconstitution process following treatment and the impact of treatment on longer-term survival and the occurrence of adverse events of special interest (AESI).

Currently, there is a single site where patients are being treated with RETHYMIC. The Investigator will be responsible for recruiting patients who have recently had (i.e., within the past 60 days) or are scheduled to have this treatment within 30 days and obtaining signed informed consent (and assent as applicable). The Investigator will collect baseline medical history and clinical data information for each enrolled subject. The start of follow-up (day 1) begins on the day following treatment surgery. Clinical data and flow cytometry test results (when conducted) will be abstracted from the medical records by Clinical Staff at baseline and during follow-up at predefined intervals.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients diagnosed with Congenital Athymia:

  * Who are scheduled for implantation with RETHYMIC within the next 30 days, or who were treated with RETHYMIC within the previous 60 days.
  * Who have provided written informed consent directly, or written informed consent has been provided by the patient, the parent, or legal guardian.

Exclusion Criteria:

* Written informed consent cannot be obtained.