cyrilzakka/clinical-trials huggingface dataset:
Hydroxychloroquine in Cystic Fibrosis

Study levels of inflammatory mediators in induced sputum of patients with cystic fibrosis before and after a 4 week course of oral hydroxychloroquine.

Open label study of effect of hydroxychloroquine on inflammation, bacterial burden and exhaled breath condensate pH in patients with cystic fibrosis. Patients with cystic fibrosis, 16 years or older and with pulmonary function tests with an FEV1 greater than 40% predicted will be eligible for enrollment. Enrolled subjects will undergo collection of exhaled breath condensate and sputum induction and collection following nebulized hypertonic saline, before and following a 4 week course of oral hydroxychloroquine at 200 mg a day. Inflammatory mediators, neutrophil counts, and bacterial density in sputum and exhaled breath condensate pH will be measure at entry and at the end of 4 weeks of oral drug. There will be no placebo group.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female between 16 years and 65 years of age.
2. Confirmed diagnosis of CF based on the following criteria:

   i. positive sweat chloride 60 mEq/liter (by pilocarpine iontophoresis) and/or ii. a genotype with two identifiable mutations consistent with CF, and iii. accompanied by one or more clinical features consistent with the CF phenotype
3. FEV1 50% predicted value (subjects 16- \<18 years of age) or 40% predicted value (subjects 18 years of age)
4. Clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation within the 14 days prior to Visit 1 (Day 0)
5. Ability to reproducibly perform spirometry and peak flow measurements
6. Ability to understand and sign a written informed consent or assent and comply with the requirements of the study

Exclusion Criteria:

1. Use of an investigational agent within the 4-week period prior to Visit 1
2. Chronic daily use of ibuprofen or other NSAIDs, or systemic corticosteroids, or any oral diabetic or hypoglycemic agent within the 4 weeks prior to Visit 1 or acute usage within 72 hours prior to Visit 1
3. History of hypersensitivity to beta-agonists
4. History of hypersensitivity to hydroxychloroquine or chloroquine
5. Oxygen saturation \< 92% on room air at Visit 1
6. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
7. History of hemoptysis 30 cc per episode during the 30 days prior to Visit 1
8. Significant history of hepatic, cardiovascular, renal, neurological, hematologic, or peptic ulcer disease
A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)

This study is open to adults aged 18 years and older with cystic fibrosis bronchiectasis.

The purpose of this study is to find out whether a medicine called BI 1291583 is tolerated by people with cystic fibrosis bronchiectasis. Participants are put randomly into 2 groups. One group takes BI 1291583 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1291583 tablets but do not contain any medicine. Participants in both groups take 1 tablet once a day for 12 weeks. Participants have twice the chance of being placed in the BI 1291583 group than in the placebo group.

Participants are in the study for about 6 months. During this time, they visit the study site 7 times. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 1291583.


Eligibility Criteria:
Inclusion Criteria:

1. Age of patients when signing the informed consent ≥18 years
2. Historical clinical diagnosis of Cystic fibrosis (CF) (symptoms of CF and sweat chloride ≥ 60 mmol/L and/or 2 CF-causing Cystic fibrosis transmembrane conductance regulator (CFTR) mutations)
3. Investigator-confirmed diagnosis of Bronchiectasis (BE) by Computed tomography (CT) scan and clinical history consistent with BE (e.g., cough, chronic sputum production, recurrent respiratory infections). Subjects whose past chest CT records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than 5 years
4. History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either:

   1. at least 2 exacerbations, or
   2. at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \>40 at screening visit 1 For patients on stable oral or inhaled antibiotics as chronic treatment for BE, at least one exacerbation must have occurred while on stable antibiotics.
5. Patients must be able to provide spontaneous or induced sputum samples. Further inclusion criteria apply.

Exclusion Criteria:

1. Moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment) or Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) \> 3.0x Upper limit of normal (ULN) at Visit 1
2. Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula \< 30 mL/min at Visit 1
3. Absolute blood neutrophil count \< 1,000/mm\^3 (equivalent to \< 1000 cells/μL or \< 10\^9 cells/L) at Visit 1
4. Any findings in the medical examination (including blood pressure (BP), pulse rate (PR), or electrocardiogram (ECG)) and/or laboratory value assessed at Visit 1 or during screening period that in the opinion of the investigator may put the patient at risk by participating in the trial
5. Positive serological tests for hepatitis B, hepatitis C (also confirmed with Hepatitis C virus ribonucleic acid (HCV RNA)), or human immunodeficiency virus (HIV) infection, or known infection status.

Further exclusion criteria apply.
Study of Efficacy and Safety of Laparoscopic Intra-abdominal Chemotherapy (PIPAC) Performed in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancer and Primary Peritoneal Tumors

Single center, open label, phase I-II, non-randomized, two-cohort, repeated single dose study to explore the feasibility, efficacy, safety, and Overall Response Rate (ORR) of oxaliplatin, or cisplatin and doxorubicin when given as a pressurized intraperitoneal chemotherapy (PIPAC) to patients (men and women) with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and in primary cancers of peritoneum.


Eligibility Criteria:
Inclusion Criteria:

* Clinical and pathological confirmation of peritoneal carcinomatosis from gastric, colorectal and ovarian cancers or primary peritoneal tumors.
* Patients aged between 18 and 78 years.
* Performance status sec. ECOG ≤ 2
* Disease progression/relapse after at least one line of previous i.v. standard chemotherapy in gastric cancer and primary peritoneal tumors and two lines in colorectal and ovarian cancers.
* Patients with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and primary peritoneal cancers not eligible to cytoreductive surgery +/- HIPEC.
* Blood and electrolyte counts, liver, renal and cardiopulmonary function parameters within 10% of the normal range.
* Written informed consent.
* Tumor mass present on CT-scan in order to allow tumor response assessment with RECIST-criteria.

Exclusion Criteria:

* Extra-abdominal metastatic disease, with the exception of isolated pleural carcinomatosis.
* Bowel obstruction.
* Severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias.
* Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system.
* Creatinine clearance \< 60 ml /min.
* Pregnancy.
* Previous treatment reaching the maximum cumulative dose of doxorubicin, daunorubicin, epirubicin, idarubicin and/or other anthracyclines and anthracenediones.
* Known allergy to cisplatin or other platinum-containing compounds or to doxorubicin.
* Patients of both sexes who do not conduct complete abstinence from heterosexual relationships or agree to use an effective clinically acceptable method (with failure rate \<1%) during the study and the following 6 months after the last treatment.
Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.

Examination of the feasibility of intra-operative pet CT to detect surgical margins in breast conservative surgery to prevent re-excision.


Eligibility Criteria:
Inclusion Criteria:

* • female and 18 years of age or older

  * diagnosed with an early-stage (T1 or T2, and N0 or N1; according to the TNM-classification) invasive breast cancer
  * eligible for breast conserving surgery

Exclusion Criteria:

* • Pregnancy or lactation

  * Diabetes
  * Multifocal tumor disease
  * Diagnosis of inflammatory breast cancer
  * Appointment at the nuclear medicine department for 18F-FDG administration would result in a unacceptable delay of surgery
  * Subject has had exposure to ionizing radiation of more than 1 mSv in other research studies within the last 12 months
  * Subject has recently (\<60 days) or is simultaneously participating in another clinical trial.
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women

The study collected retrospective data from the assumption of combined natural molecules in menopausal women with metabolic syndrome


Eligibility Criteria:
Inclusion Criteria:

* menopause
* diagnosis of metabolic syndrome

Exclusion Criteria:

* pharmacologically-induced menopause
* hormonal therapies
* sensitizing insulin therapies
* cancer patient or ex-cancer patient
Allogeneic Hematopoietic Stem Cell Transplantation With Reduced Intensity Pre-transplant Conditioning for the Treatment of High-risk Hematological Malignancies (V3)

This is study is for patients that have been diagnosed with high-risk hematological malignancies. The main purpose of this study is to confirm previously published results of stem cell transplantation with reduced intensity pre-transplant conditioning. Patients will be assigned to 1 of 3 regimens depending on the patient's diagnosis. Participants will be followed by the transplant team for the remainder of the patient's life. Patient's will visit MUSC daily, then visits will be reduced to frequent visits for up to 6 months. After 6 months, the visits will be reduced more depending on the patient's condition.


Eligibility Criteria:
Inclusion Criteria:

* A proven diagnosis of one of the conditions in Table 1.
* Prior therapy including blood or marrow transplant will not exclude patients for reduced intensity transplant.
* Age \< 75 years. Pediatric patients are eligible from the ages of 1 month to 18 years if the transplant physician believes that co-morbid conditions significantly increase the risk for a standard transplant regimen.
* HIV antibody negative.
* ECOG performance status 0-3, (or equivalent Karnofsky and Lansky performance scores for patients \<18yrs, see appendix 2)
* Availability of an HLA-identical related donor or suitable alternative donor, (≥7/8 allele match at A, B, C and DRB). Syngeneic transplants will not be allowed in this protocol.
* Due to the complexity of the study, all patients prior to enrollment will be assessed by the PI or co-PI.
* Patient with marrow failure states or immune deficiency syndromes undergoing stem cell transplants must be reviewed by one of the investigators to determine eligibility for study.
* Adequate insurance coverage (or financial resources) to cover the costs associated with the patient's transplant and, in the case of patients eligible for cohort C, to cover the costs associated with I 131 Tositumomab treatment.

Exclusion Criteria:

* Active CNS involvement with malignant disease.
* Pregnancy.
* Fertile men or women unwilling to use contraceptive techniques during the study period.
* Creatinine clearance \< 30 ml/min.
* Left ventricular ejection fraction \<30% or clinical cardiac failure uncontrolled by medical therapy.
* Pulmonary disease requiring supplemental oxygen therapy.
* Patients with estimated life span less than 1 year due to medical illnesses other than the condition being treated on the study.

Donor Selection:

Inclusion Criteria

* Major HLA identical relative or genotypically matched unrelated donor (7-8/8 alleles) .
* Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines.

Exclusion Criterion

* Positive anti-donor HLA antibody.
* Identical twin.
Prognostic Values of PET Examination With 11 C-Fe_CIT With Voxel-based Analysis Method in Patients With Sporadic Parkonson's Disease and Parkinsonisms (Prot.PD-diagn).

The role of PET for the in vivo study of the presynaptic dopaminergic system with 11C-Fe-CIT is universally recognized, and its use has also become routine in numerous nuclear medicine centers in Europe. The indication for the examination is provided exclusively by the clinic in the presence of extrapyramidal signs in the suspicion of Parkinson's disease (PD) or for the differential diagnosis of parkinsonisms. The existence of factors that influence the prognosis of patients with PD or parkinsonism associated with other degenerative diseases is known.

Given these premises, the possibility of identifying the disease in the early stages appears fundamental.

For this purpose the following should be considered:

1. an automatic analysis method based on the measurement of radiotracer uptake at the level of individual voxels, following Statistical Parametric Mapping procedures.
2. the analysis based on regions of interest (ROIs) positioned ad hoc by the operator which will give the value of the ROI to reference region ratio. In particular, ROIs on the basal ganglia (caudate, putamen) towards cerebellum.

Both of these methods offer a quantitative measurement of the damage at the level of the structures involved that is absolutely better than the visual investigation of the distribution of radioactivity in the central nervous system.

In this study the investigators want to compare results provided by methods 1 and 2 in the populations under examination to evaluate the data relating to the specificity and sensitivity of the test.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with initial PD or parkinsonism;
* signature of informed consent.

Exclusion Criteria:

* patients \< 18 years
Performances of a Fast Test for the Detection of Helicobacter Pylori Antigens in Child Stool

The diagnostic tests used to detect Helicobacter pylori (H. pylori) infection are either direct and invasive, as in culture, histology and the rapid urease test (RUT) or noninvasive, such as serology, the 13C-Urea breathe test or the stool antigen test. However, there is no single reference method to detect the H. pylori infection reliably and accurately. The specificity of gastric biopsy cultures is 100%, but the sensitivity is lower. Histology and RUT provide excellent diagnostic accuracy, but the detection of H. pylori is decreased in cases of bleeding peptic ulcers or gastric atrophy. Therefore, it is recommended that at least two tests should agree when defining the H. pylori infection in children. Quantitative real-time polymerase chain reaction (qPCR)-based methods have been shown to be the most reliable for H. pylori detection in adults and in children. In children, the reference method for H. pylori infection detection is invasive, namely upper digestive endoscopy with gastric biopsy for histology, culture, RUT and qPCR. A noninvasive alternative to detect H. pylori antigen in stools could use a quick one-step immuno-chromatographic technique.

The aim of this study was to assess the performance of a new quick, noninvasive, one-step immuno-chromatographic, stool antigen test (ALERE Inc, Jouy-en-Josas, France) for the detection of H. pylori infection in children.


Eligibility Criteria:
Inclusion Criteria:

* Children \<18 years old
* All children undergoing a high digestive endoscopy with per-endoscopic gastric biopsies.
* Informed consent of parents and children

Exclusion Criteria:

* Children having received an antibiotic treatment 4 weeks before inclusion
* Children having received Proton pump inhibitors 2 weeks before inclusion
* Children having received Bismuth salts 2 weeks before inclusion
Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis

The purpose of this study is to assess the safety and efficacy of Nicotinamide riboside (NR) for treatment of patients with progressive multiple sclerosis.

The main question it aims to answer is:

• Does NR delay disability progression in progressive multiple sclerosis?

Participants will be treated with NR or placebo for 30 months,

After being informed about the study and risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry.

At baseline patients who meet the eligibility requirements will be randomised in a double- blinded manner (patient and investigator) in a 1:1 ratio to nicotinamide riboside (1000 mg daily) or placebo (once a day)

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of progressive MS (secondary; SPMS or primary; PPMS) according to the 2013 revisions of clinical course of multiple sclerosis and the 2017 revisions of the McDonald criteria.
* Aged 18-65 years.
* EDSS 3-6.5
* Able to perform T25FW test
* The participant must have documented evidence of disability progression observed during the 24 months before screening.
* With or without a stable disease modifying therapy during the last three months.
* Written informed consent for study participation.

Exclusion Criteria:

* A diagnosis of relapsing MS according to the revisions of the McDonald criteria
* Neoplastic disease at baseline
* Previous history of malignant melanoma or breast cancer
* Stable phase of a progressive disease course
* Pregnancy or lactating female patients
* Dementia or other neurodegenerative disorder at baseline visit
* Comorbidity (psychiatric or somatic) that precludes study participation
* Use of high dose vitamin B3 supplementation within 30 days of enrolment
* Genetically confirmed mitochondrial disease or metabolic disorder
Bedtime ACEIs/ARBs Versus Morning ACEIs/ARBs for Reverting Non-dipping Hypertension

Background: Non-dipping (ND), defined as a \<10% decrease in blood pressure (BP) during sleep, is an independent significant predictor of cardiovascular outcome in hypertensive patients. A few anti-hypertensive medications, including angiotensin receptor blockers (ARBs) and angiotensin converting enzyme inhibitors (ACEIs), may normalize dipping if administered at night. Chinese data are scarce and there are no prospective studies on cardiovascular outcomes in Chinese patients.

Aim: To determine if the bedtime administration of ACEIs and ARBs is more effective at normalizing ND than morning administration. As a pilot project, the feasibility of recruiting hypertension patients in primary care for ambulatory blood pressure monitoring (ABPM) and conducting a clinical trial will be evaluated such that future larger randomized trials can be planned to determine treatments for ND.

Method: Fifty patients diagnosed with essential hypertension who are receiving either ACEIs or ARBs and diagnosed with ND will be randomized to take ACEIs or ARBs either early morning or before bedtime. A follow-up 48-hour ABPM will be performed after 4-6 weeks to examine post-treatment changes in BP and ND status.

Outcome: The primary outcome of this proposed study is the proportion of ND at 6 weeks; secondary outcomes will include (i) mean awake and asleep SBP/DBP of 48-hour duration (ii) feasibility of this pilot study will be assessed by recruitment and dropout rates during the study period.

Potential: This pilot study will provide the basis for a future larger randomized controlled study to further examine the treatment for ND in primary care.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are taking an ACEI or an ARB
* \>18 years of age
* Chinese and
* Received a diagnosis of primary HT.

Exclusion Criteria:

* Severe HT as defined by a clinic systolic BP ≥180 mmHg and/or diastolic BP ≥ 110 mmHg
* allergic reaction or intolerance to the current ACEI or ARB
* unable to provide consent
* pregnancy
* night-time worker
* occupational drivers since patients will be asked not to move during BP measurements, which may induce potential danger in driving
* taking anti-coagulants to avoid causing bruises when using ABPM
* known atrial fibrillation since ABPM use has not been validated in this group
* known hyperkalemia
* ABPM discovered hypotension (mean SBP \< 100 and/or mean DBP \< 60) because these patients may need to stop their medications
* Reported sleep time of \<4 hours per night (at least seven readings are recommended during sleep for an ABPM recording to be valid, and a sleeping time \< 4 hours is unlikely to generate valid results).
Feasibility of Online MR-guided Radiotherapy on a 1.5T MR-Linac

This study investigates the feasibility of imaging and treatment on a novel 1.5 T MR-Linac radiotherapy hybrid device.

Novel hybrid devices combine magnetic resonance imaging (MRI) and a linear accelerator in a single device. The superior soft tissue contrast compared with cone-beam computed tomography based treatment and the possibility for daily plan adaptation promise a higher precision of treatment, better target volume coverage and normal tissue sparing. In a first step the present study will test the feasibility of imaging and treatment on the 1.5 T MR-Linac.

Eligibility Criteria:
Inclusion Criteria:

* existing indication for radiation therapy
* minimum age 18 years, no upper age limit
* capacity for consent
* Informed consent

Exclusion Criteria:

* contraindication for MRI (claustrophobia, metallic implants not applicable for MRI
* pregnancy
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)

The purpose of this extension study is to determine the long-term safety and tolerability of an investigational treatment (LUM001 also known as Maralixibat) in children with ALGS who have completed participation in a core LUM001 treatment protocol. Efficacy will be assessed by evaluating the effect of LUM001 on pruritus, biochemical markers of pruritus, as well as biochemical markers of cholestasis and liver disease.


Eligibility Criteria:
Participation for an individual patient is expected to be approximately 72 weeks.

Patients who complete 72 weeks of treatment may be eligible to receive treatment for up to 52 weeks during the follow-up treatment period and patients who completed the 124 weeks of treatment may be eligible to enter the additional long-term follow-up period.
Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma

To characterize the safety profile of acalabrutinib in subjects with relapsed or refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age.
* Pathologically confirmed de novo ABC DLBCL
* Relapsed or refractory disease
* Subjects must have ≥ 1 measurable disease sites

Exclusion Criteria:

* A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or LVEF \< 50%
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
* Breast feeding or pregnant