cyrilzakka/clinical-trials huggingface dataset:
Trial of BDC-1001 +/- Pertuzumab in Subjects with HER2-Positive Metastatic Breast Cancer

This is an open-label, Phase 2 study to evaluate preliminary anti-tumor activity, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of BDC-1001 administered as a single agent and in combination with pertuzumab in subjects with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC) previously treated with trastuzumab deruxtecan (Enhertu®).

Eligible subjects will be randomly assigned in a 1:1 ratio to receive BDC-1001 as a single agent or BDC-1001 in combination with pertuzumab. Within each treatment arm, a Simon 2-stage design will be applied. Subjects will receive study treatment (i.e., BDC-1001 or BDC-1001 in combination with pertuzumab) for up to 24 months after Cycle 1 Day 1 (C1D1), until disease progression, unacceptable toxicity, or withdrawal for any reason.

Bolt amended the protocol to transition any subjects still receiving BDC-1001 to continue receiving BDC-1001 in the Maintenance Phase. Subjects remaining on BDC-1001 will continue to receive BDC-1001 until a criterion for discontinuation has been met.

Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the breast that is HER2+ (IHC 3+ or gene amplification by ISH or NGS).
* Have received 2 or more prior lines of anti-HER2-directed therapies, at least 1 in the metastatic setting and including trastuzumab deruxtecan.
* Measurable disease as determined by RECIST v.1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Have life expectancy of greater than 12 weeks per the Investigator.
* All subjects must agree to have a biopsy prior to enrollment. If, in the judgment of the Investigator, a biopsy is not safely accessible or clinically feasible an archival tumor tissue sample must be submitted in lieu of a freshly collected specimen.

Key Exclusion Criteria:

* History of severe hypersensitivity to any ingredient of BDC-1001 or pertuzumab.
* Previous treatment with a small molecule TLR7/8 agonist or TLR7/8 agonist that has been conjugated to tumor-targeting antibody such as ISACs within 12 months before starting study treatment.
* Impaired cardiac function or history of clinically significant cardiac disease.
* Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
* Central nervous system metastases with the exception of disease that is asymptomatic, clinically stable, and has not required steroids for at least 28 days before starting study treatment.
Super-Resolution Ultrasound of the Brain in 3D

The goal of this proof of concept study is to determine if the visualization of the middle cerebral artery and its perforators, through 3D transtemporal ultrasound imaging, is possible thanks to an off-line analysis by 3D ultrasound localization microscopy. Visualization of these vessels would allow us to conclude on the presence, or absence, of an ischemic stroke in the region of the middle cerebral artery.

To answer the question asked, 20 participants who suffered a stroke will carry out a transtemporal ultrasound examination specifically for research in the 7 days following his stroke. The data obtained will be analyzed by the CNRS medical imaging laboratory, in order to characterize the presence of a stroke and to compare the data obtained with that of standard examinations (CT and MRI).


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 and over
* Hospitalized patient with ischemic stroke in the deep territory of the middle cerebral artery
* Patient with lesion observable on MRI
* Patient included between 24 hours and 7 days after the ischemic stroke
* Patient with a temporal window which allows soundproofing of the polygon of Willis and the middle cerebral artery
* Patient having signed free, informed and written consent
* Patient affiliated to a social security system (excluding AME)

Exclusion Criteria:

* Contralateral middle cerebral artery territory stroke or contralateral middle cerebral artery occlusion
* Patient with contraindication to Doppler ultrasound with contrast (right-left shunt, severe pulmonary arterial hypertension)
* Patient with hypersensitivity to the active princip of Sonovue (sulfur hexafluoride) or these excipients
* Patient with uncontrolled systemic hypertension
* Patient with respiratory distress syndrome
* Patient under guardianship or curatorship
* Pregnant or breastfeeding patient (positive blood pregnancy test during hospitalization)
* Patient with damaged skin at the temporal level
* Patient having presented in the 7 days preceding inclusion an acute coronary syndrome or suffering from unstable ischemic heart disease
Role of PACAP in Nehprotic Syndrome

This study will identify the role of PACAP (pituitary adenylate cyclase-activating polypeptide) deficiency in patients with nephrotic syndrome. PACAP is a neuropeptide that has a putative role as an inhibitor of megakaryopoiesis and platelet function. Patients with nephrotic syndrome show decreased PACAP plasma levels, due to urinary loss. We hypothesize that in severe nephrotic syndrome, plasma deficiency of PACAP enhances megakaryopoiesis and causes blood platelet activation, which contribute to the increased rate of thromboembolic disease in these patients.

To test our hypothesis, the role of PACAP deficiency on pro-thrombotic state in patients with nephrotic syndrome will be studied using patient blood and urine samples.


Eligibility Criteria:
Inclusion Criteria:

* New patient with nephrotic syndrome of patient during relapse of nephrotic syndrome
* Under 16 years old
* Treatment for nephrotic syndrome not yet started by first sample collection

Exclusion Criteria:

* None
ALIGN for Older Adults With Cancer in SNFs

The goal of this clinical trial is to learn if it is possible to deliver a palliative care intervention called ALIGN (Assessing and Listening to Individual Goals and Needs) to hospitalized older adults with advanced cancer who are discharged to a skilled nursing facility and their caregivers. The main questions it aims to answer are:

* Can the investigator successfully deliver the ALIGN intervention in different skilled community nursing facilities?
* Can the investigator successfully collect information from participants throughout the study?
* How can the investigator best prepare caregivers to make medical decisions for loved ones that become unable to do so themselves?

Researchers will compare ALIGN to care as it is usually delivered.

Participants will:

* Visit virtually with an ALIGN palliative care social worker every 1-2 weeks during their skilled nursing facility stay and up to 45 days after discharge from the facility or will see a palliative care clinician if recommended by their oncologist or other involved clinician.
* Participants will provide information about how they are doing 1 month, 3 months, and 6 months after enrolling in the study.


Eligibility Criteria:
Patients

Inclusion Criteria:

1. Adults between 18-98 years
2. Stage II-IV solid tumors
3. Discharging from an acute care hospital to a SNF in Colorado
4. English speaking
5. Receiving or establishing care at the University of Colorado Cancer Center
6. If a patient lacks capacity, a legal surrogate decision-maker will be approached to provide proxy consent.
7. Must have access to the technology needed to complete consenting visit and subsequent intervention visits. This includes internet access through a computer, tablet, or smartphone OR cellular service with adequate allowance of cellular minutes to allow virtual visits (by participant\&#39;s assessment).

Exclusion Criteria:

1. Discharging with hospice care
2. Age less than 18
3. Lacking capacity without a legal surrogate decision maker or proxy. Patient with limited English

Caregivers

Inclusion Criteria:

1. Patient-selected
2. Age ≥ 18
3. English speaking
4. Able to complete baseline measures.

Exclusion Criteria:

1. Discharging with hospice care
2. Age \&lt; 18
3. Caregivers with limited English proficiency will be excluded as ALIGN intervention content and documents have only been validated in an English-speaking population.

SNF Staff

Inclusion Criteria:

1. One of 25 interdisciplinary clinicians from the 5 most common community SNFs
2. Staff must be employed by on of the 5 most common community SNFs named above. (care managers, social workers, nurses, physical therapists, occupational therapists, advanced practice providers, and physicians)

Exclusion Criteria:

1. Not employed by one of the top 5 community SNFs patients were discharged to during the pilot trial

PCSW

Inclusion Criteria:

1. PCSWs who conducted the ALIGN intervention and consent to an interview
Incisive CT Clinica Trial Protocol

The purpose of this study was to evaluate whether the new features of Incisive CT: Precise Image, (PI) and Precise Cardiac (PC) had the expected effectiveness


Eligibility Criteria:
Inclusion Criteria:

* The original data of the images are from the patient base in the age range of 18 to 75 years (18≤ age ≤75 years)
* Original image data are collected in Incisive CT (version 4.5) and traceable;
* Time range for inclusion of original image data: from the start of the clinical trial to the completion of collection in compliance with this protocol;

Exclusion Criteria:

- The investigator deemed it inappropriate to include the original image data for this clinical trial
Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency

30 adolescent girls and young women between 13 and 26 years with central adrenal insufficiency and a grand shortage of DHEA are recruit. The clinical trial is double-blind to show that the substitution of the hormone DHEA stimulates secondary hair growth, enhances well being and mood of the patients. It should also normalize the serum content of DHEA, aldosterone and testosterone.

30 adolescent girls and young women between 13 and 26 years with central adrenal insufficiency and a grand shortage of DHEA are recruit. After randomization they either get DHEA or placebo for 12 months daily. The clinical trial is double-blind to show that the substitution of the hormone DHEA stimulates secondary hair growth, enhances well being and mood of the patients. It should also normalize the serum content of DHEA, aldosterone and testosterone.

Eligibility Criteria:
Inclusion Criteria:

* female gender
* age between 13 and 26 Years
* breast developement minimal Tanner stage 3
* serum content of DHEAS less than 400 ng/ml
* central hypocortisolism
* 2 additional pituitary hormon deficiencies (growth hormone, TSH, FSH, LH, prolactin, ADH)
* no scheduled change of the auxilliary medication during the clinical trial

Exclusion Criteria:

* initial diagnosis of a cerebral tumor less than one year
* constitution after cerebral exposure with over 30 gray
* craniopharyngioma with hypothalamic defect syndrome or relapse
* blindness
* mental retardation or psychiatric disorder
* systemic disorder, diabetes mellitus, cardiovascular disease, liver disease requiring treatment
* elevated liver enzyme levels
* pregnancy
* in case of no hypogonadism: no secure contraception
The Effects of a Ruminococcus Torques Strain Bacterium in Healthy Adults.

A randomized, placebo controlled crossover study investigating the potential metabolic effects of the naturally occurring gut microbe Ruminococcus torques in healthy, overweight adults.

By analyzing blood samples, indirect calorimetric as well as thermographic assessment of clavicular temperature we want to investigate whether or not the commensal gut bacterium Ruminococcus toqrues strain ATCC 27756 has any metabolic effects in healthy adults. The subjects will recieve the intervention with the live bacterium given through a duodenal feeding tube. The trial is double blinded and placebo controlled using a crossover design. Subjects will be given an intervention with either placebo or Ruminococcus on two different study days with up to six weeks of wash-out between each study day.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40 years
* Self-reported good health
* Caucasian
* Body Mass Index \> 27 kg/m\^2

Exclusion Criteria:

* Any known disorder/disease that could interfere with study results or is seen as compromising to the study (as assessed by the investigator), for example diabetes, cancer or cardiovascular or kidney disease.
* Use of any daily medication as well as p.r.n. (pro re nata; not taken regularly) medication that cannot be discontinued during the trial
* Use of antibiotics during the recent three months
* Acute or chronic gastrointestinal symptoms
* Lactose intolerance
* Pregnancy - ongoing or planned
* Smoking
* Alcohol or drug abuse
* Use of creatine as dietary supplement during study period
* Plasma creatinine above the normal range (\>105 μmol/L for men and \>90 μmol/L for women)
* Known significant liver disease or plasma alanine transaminase concentration ≥ 3 × normal value
* Values for hemoglobin, leukocytes, or thrombocytes outside of the normal ranges
Clinical Impact of HOME Oxygen SATURation Measurement (SATURHOME)

The use of saturometry at home is more and more widespread in patients suffering from interstitial pulmonary diseases (IPD), the patients seeing it as reassurance and a concrete way to follow the evolution of their disease. However, there are no studies evaluating the real clinical benefit of taking saturation at home in this population. In addition, clinical experience seems rather to demonstrate an increase in the anxiety level and the number of clinically unnecessary consultations related to the use of this measure.

The secondary objectives are to determine the impact of this measurement on: (1) the health care use (telephone calls, medical consultations and hospitalizations), (2) dyspnea score, (3) the anxiety and depression score (HADS score) and (4) the physical activity level. The exploratory objectives will be to determine if the measurement of saturation at home makes it possible to (1) predict the occurrence of acute exacerbations of fibrosis, (2) effectively predict the decline in respiratory function tests and (3) 1-year mortality. The investigator will also assess whether this measure makes it possible to screen patients with oxygen therapy needs at home. The investigator hypothesize that measuring oxygen saturation at home will lead to a significant deterioration in quality of life, an increase in the use of health care, a significant increase in the rate of anxiety and depression, dyspnea and a decrease in the physical activity level.

Measurement tools

1. Quality of life: King's Brief Interstitial Lung Disease
2. Anxiety and depression score: HADS score
3. Dyspnea score : UCSD questionnaire
4. Physical activity level during 7 days: MoveMonitor by McRoberts
5. Home base saturation: Nonin Ny vantagr 9590
6. Disease evolution : complete lung function (plethymography, sprimoetry, DLCO), 6-minute walking test (following the ATS recommandation)

Eligibility Criteria:
Inclusion Criteria:

* Fibrosing interstitial lung disease
* Saturation below 90% during the 6-minute walk test
* Clinically stable

Exclusion Criteria:

* Oxygen dependent at rest
ASTHMA-Educator Mobile Application Manage Asthma

Through this study, the investigators developed the ASTHMA-Educator mobile application, and evaluated its use among adult asthma patients at Montefiore.

Through this study, the investigators developed the ASTHMA-Educator mobile application, and evaluated its use through 2 phases: 1) Phase 1 = process outcomes evaluation with 30 patients); and 2) Phase 2 (longitudinal clinical evaluation with 40 patients receiving the intervention at baseline, 2 months, 4 months, and 6 months). The study's primary outcome is asthma control.

Eligibility Criteria:
Inclusion Criteria: Adults (\>18 years) with: (a) severe asthma (i.e. at least one asthma-related ED visit and/or hospitalization in the previous year); (b) access to a smartphone with short message service (SMS) capability; (c) English speaking; (d) able to give informed consent.

Exclusion Criteria: (a) use of oral corticosteroids in the 2 weeks prior to the baseline visit; (b) pregnancy; (c) severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol; and (d) patients that previously received the ASTHMAXcel application.
Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer

The study will be conducted as an open label, single-dose, explorative study with patients with histologically proven cancer and, preferably, tumor positive lesions in previously performed nuclear medicine imaging examinations.

The investigational drug will be given as a single administration in a dose of \</= 0.1 mg BAY94-9392 (300 MBq, +/- 10%). The total duration of the study for each patient will be approximately 8 days.


Eligibility Criteria:
Inclusion Criteria:

* Males/females \>/= 18 years
* Patients with a diagnosis of primary prostate cancer (biopsy proven) and scheduled for radical prostatectomy or patients with prostate tumor recurrence (Patients with advanced tumor disease and a high likelihood to display lymph node metastasis are to be preferably included.)
* ECOG (Eastern Cooperative Oncology Group) performance status of 0-2, determined within one week prior to treatment with BAY94-9392
* Patient had an \[18F\]-fluorodeoxyglucose (FDG) PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty for a cancer such as melanoma, or colorectal cancer, or head \& neck cancer for which FDG-PET/CT is used in clinical routine, and the primary cancer disease is histologically confirmed. In case of recurrent disease confirmation of the primary tumor is sufficient
* No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.

Exclusion Criteria:

* Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY94-9392, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
* Known sensitivity to the study drug or components of the preparation
* Previous treatment with BAY94-9392 in this study
Impact of the Time of Oral Nutritional Supplements (ONS) Consumption on Daily Alimentary Intakes of Malnourished Elderly

Malnutrition is a severe comorbidity in hospitalised patients, especially in elderly. The consumption of Oral Nutritional Supplements (NOS) is one of several tools for fighting against malnutrition. Their use is easy, and framed by recent French recommendations suggesting to propose NOS at end of meals or as snacking . Nevertheless, there is no scientific data to affirm which is the best of these two hypothesis in elderly hospitalised in Long Term Care Unit(LTCU) . Moreover, a preliminary survey of NOS consumption in LTCU in Limoges university hospital showed some problems about the mode of supplying NOS, partially linked with an insufficiency for paramedical staff in realizing importance of NOS. However, the effect of time of supplying NOS on total food consumption had not been evaluated in this first study. The new one will include 48 malnourished elderly patients in two LTCU and having a prescription of NOS. They will receive them at the same quantity during the whole study either firstly at end of meals (10 days) and secondly as snackings (10 days), or conversely. Order of choice will be randomised. Total daily alimentary intakes will be noted by paramedical staff of the two units, and translated by dieticians in daily energy, protein, carbohydrates and lipids intakes. The time of supplying NOS will be confronted with these intakes, in order to precise the best one.

Malnutrition is a severe comorbidity in hospitalised patients, especially in elderly. The consumption of Oral Nutritional Supplements (NOS) is one of several tools for fighting against malnutrition. Their use is easy, and framed by recent French recommendations suggesting to propose NOS at end of meals or as snacking . Nevertheless, there is no scientific data to affirm which is the best of these two hypothesis in elderly hospitalised in Long Term Care Unit(LTCU) . Moreover, a preliminary survey of NOS consumption in LTCU in Limoges university hospital showed some problems about the mode of supplying NOS, partially linked with an insufficiency for paramedical staff in realizing importance of NOS. However, the effect of time of supplying NOS on total food consumption had not been evaluated in this first study. The new one will include 48 malnourished elderly patients in two LTCU and having a prescription of NOS. They will receive them at the same quantity during the whole study either firstly at end of meals (10 days) and secondly as snackings (10 days), or conversely. Order of choice will be randomised. Total daily alimentary intakes will be noted by paramedical staff of the two units, and translated by dieticians in daily energy, protein, carbohydrates and lipids intakes. The time of supplying NOS will be confronted with these intakes, in order to precise the best one.

Eligibility Criteria:
Inclusion Criteria:

* Malnourished elderly (age \>=70 y) hospitalised in LTCU
* having a NOS medical prescription o

Exclusion Criteria:

* Non malnourished patients in LTCU,
* age \<70.
An Open-labeled Trial of Ramipril in Patients With Migraine

Physiology of migraine involving renin-angiotensin systems (RAS) has been implicated. Ramipril is a broadly-used angiotensin-converting enzyme inhibitor. The investigators attempt to test the efficacy of ramipril on the prophylaxis of migraine attacks.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic migraine are included in this study. Migraineurs should be aged 20 to 70 years old with the ability to read and understand the self-report scales, including the headache diary, used in this study.

Exclusion Criteria:

1. Medication overuse headache are excluded in this study.
2. Treatment with other ACEI or medication that may affect ARS
3. Treatment with migraine prophylactic medications or anti-hypertensive agents including β adrenergic receptor or calcium channel blockers
4. Past history of hepatic or renal dysfunction; an abnormal electrocardiography; a psychiatric disorder; a history of substance abuse; pregnancy or lactation; use of anti-psychotics, antidepressants, or anti-anxiety drugs.