cyrilzakka/clinical-trials huggingface dataset:
Kidney and Pregnancy Registry

Maternal physiological adaptation to pregnancy plays an important role in the smooth progress of the pregnancy and the healthy growth of the fetus. This physiological adaptation takes place at the level of several organs, including the kidney. Physiological changes during a normal pregnancy take place at the anatomical, glomerular and tubular level.

In the event of pre-existing kidney damage (glomerular and tubular diseases, stone disease, high blood pressure (hypertension) etc...) these adaptations will not be optimal. This will have implications for:

* the course of the pregnancy with the occurrence of feto-maternal complications: miscarriages, pre-eclampsia, intrauterine growth retardation (IUGR), low birth weight, prematurity. The risk of feto-maternal complications increases with the degree of renal failure or with certain pathologies such as lupus.
* progression of kidney disease

Some maternal complications have long-term implications: preeclampsia is associated with a high risk of subsequent cardiovascular and renal complications. Pregnancies in these patients are high-risk pregnancies and require specialized management by an experienced group of gynecologists and nephrologists.

The creation of a retrospective and prospective register by collecting demographic, clinical, biological, radiological and genetic data concerning patients at each consultation within the CHU Brugmann Hospital will allow:

* to establish the epidemiological and clinico-biological characteristics of the patients followed at the Kidney and Pregnancy Clinic at the CHU Brugmann Hospital
* to analyze the risk factors for feto-maternal complications
* to analyze the risk factors for the occurrence of subsequent cardio-renal pathologies in patients who have had preeclampsia or an event during their pregnancy
* to identify patients who will need specialized genetic testing


Eligibility Criteria:
Inclusion Criteria:

1. Pre-conception consultations

   Woman of childbearing age with:
   * Renal damage (glomerular, tubular disease, renal lithiasis, systemic disease, metabolic diseases, congenital diseases, etc.)
   * Hematological disorders (sickle cell disease)
   * Kidney transplantation
   * High blood pressure (hypertension)
   * Pre-kidney transplant assessment in progress for discussion of contraception and pregnancy after kidney transplantation
   * Preeclampsia
   * Multiple miscarriages
   * IUGR and low birth weight in the fetus
   * Family history of kidney disease
2. Peri-gravid consultations

   Pregnant women with
   * Pre-existing kidney damage
   * De novo renal failure (IR)
   * Proteinuria
   * Hematuria
   * Chronic hypertension
   * Pregnancy hypertension
   * Renal lithiasis
3. Postpartum consultations

Postpartum women with

* Early/late pre-eclampsia
* Eclampsia / Hemolysis Elevated Liver enzymes Low Platelet (HELLP) syndrome
* Pregnancy hypertension
* Postpartum hemorrhage
* De novo renal failure postpartum

Exclusion Criteria:

Male patients Menopausal patients
Sugar Challenge Study

This is a longitudinal study involving use of the January App which collects multiple data streams and employs machine learning techniques to offer personalized lifestyle recommendations and structured food and activity challenges.

The Sugar Challenge Study is a real-world, longitudinal study aimed at understanding the impact of lifestyle (i.e. food choices, physical activity and sleep patterns), genetics and personalized lifestyle recommendations on blood glucose levels, blood pressure, immune system status, stress hormone levels and microbiome composition. The purpose of this 10-day observational study was to primarily elucidate the impact of food choices, physical activity, and sleep patterns on an individual's blood glucose. In addition, we probed if continuous and personalized feedback to participants would improve glycemic control acutely through better decision making. Multiple investigations may be performed over an indefinite period of time to improve the understanding of these interconnected relationships. For example, we will perform studies to understand an individual's blood glucose response to an oral glucose load or mixed meal. We will also perform studies to determine the phenotype (clinical, metabolic, or immunologic) associated with a particular genotype. The data collected will be analyzed using proprietary machine learning methods.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, have pre-diabetes or metabolic syndrome or type 2 diabetes on metformin or GLP-1 or SGLT-2 therapy
* Have access to smart-phone with NFC reader
* Be willing to wear a continuous glucose monitor (CGM) and a smartwatch 24 hours/day for 10-14 consecutive days at a time
* Be willing to limit swimming to a maximum of 30 minutes per session while wearing CGM
* Available for two in-person or remote study visits (study orientation and close-out)
* Willing to provide weight at baseline and comprehensive logging of their activity, food and water consumption for 10-14 days
* Covered by health insurance plan
* Able and willing to give informed consent for study participation

Exclusion Criteria:

* Use of vitamin C supplements in excess of 200% of the United States Recommended Daily Allowance at least 14 days prior to starting the trial
* Allergy to skin adhesives used in the trial
* Women who are pregnant, lactating, have given birth in the past 6 months, or are planning to get pregnant in the next 6 months
* Individuals deemed unfit for participation by study physician
* Allergy to nuts
* Individuals who are taking any of the following medications:
* Insulin
* Progesterone
* Atypical antipsychotics
* Oral or injectable antidiabetic medications EXCEPT for metformin or Glucagon-like peptide-1 (GLP-1) agonists or Selective sodium-glucose transporter-2 (SGLT-2) inhibitors
* Oral corticosteroid use
* Triphasic oral contraceptives
* Blood thinners
Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C).

The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.


Eligibility Criteria:
Inclusion Criteria:

* Patient meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features:

  1. Relieved with defecation
  2. Onset associated with a change in frequency of stool
  3. Onset associated with a change in form (appearance) of stool
* Patient reports \< 3 bowel movements (BMs) per week (in the absence of any laxative, suppository, or enema use during the preceding 24 hours) and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during \> 25% of BMs
* Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests (some patients may require a colonoscopy per American Gastroenterological Association (AGA) guidelines)
* Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting of BM habits and IBS symptoms

Exclusion Criteria:

* Patient has history of loose or watery stools for \>25% of BMs
* Patient has a structural abnormality of the gastrointestinal (GI) tract or a history of a disease or condition that can affect GI motility
* Patient has any protocol-excluded or clinically significant medical or surgical history or concomitant medication use that could confound the study assessments
Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers

This study will assess whether varenicline (chantix) has antidepressant properties when used in addition to other psychiatric medication. It will also assess whether varenicline improves the inability to feel pleasure (i.e. anhedonia), and if it is well-tolerated when used with psychiatric medications.

Enrolled patients will be assessed for improved mood, improved anhedonia, overall sense of health, side effects as well as tobacco use for 6-8 weeks.

Medication will be provided free of charge.

Outpatient smokers who are depressed despite current stable psychiatric medication regimens will be invited to participate.

They will receive varenicline dosed according to FDA-approved smoking cessation regime; patients will be assessed using QIDS-SR16, snaith-hamilton anhedonia rating scale, SAFTEE and clinical global improvement self-report scales and clinician global improvement scales at the above time intervals.

Concurrent medication, psychiatric and non-psychiatric, will be recorded, as will vital signs (BP, HR, weight) and tobacco use.

Eligibility Criteria:
Inclusion Criteria:

1. Meets DSM-IV symptoms criteria for a mood disorder including major depression \[unipolar or bipolar\], depressive disorder NOS, dysthymia, adjustment disorder with depressed mood, or substance-induced mood disorder.
2. Failed to achieve full symptom remission with previous pharmacotherapy.
3. Current tobacco users.
4. Able to give written, informed consent.

Exclusion Criteria:

1. Past adverse reaction to varenicline.
2. Renal failure or dialysis.
3. Current pregnancy or breastfeeding.
A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma

A study designed to assess the safety of MTX110 in patients suffering with recurrent glioblastoma. MTX110 will be administered directly to the site of the tumour via a catheter which is inserted during a surgical procedure at the beginning of the study.

A two cohort, ascending dose study of intra-tumoral MTX110 in patients with recurrent glioblastoma. With the aim to assess the safety and also the recommended phase 2 dose of MTX110.

The patient will undergo a surgical procedure to insert a programmable pump and catheter system to allow administration of MTX110 directly to the tumour using Convection Enhanced Delivery (CED).

Cohort A patients will receive one of three potential dose levels of MTX110 as a weekly infusion in order to establish recommended phase 2 dose. This will be based on an accelerated dose titration/3+3 design.

Cohort B patients will follow the 3+3 study design with the starting concentration established in Cohort A. They too will receive MTX110 as a weekly infusion and may undergo catheter repositioning and continued treatment following progression.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent glioblastoma.
* Patients must be healthy enough to tolerate surgery and general anesthesia.
* Estimated life expectancy of greater than 3 months.

Exclusion Criteria:

* Patients scheduled to undergo or are undergoing re-irradiation for the recurrent tumour.
* Patients with a history of glioblastoma treatment with carmustine or Gliadel® wafers.
* Patients who cannot undergo MRI.
* Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks, or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week) prior to starting the study drug.
* Patients may not have received treatment with tumor treating fields ≤ 1 week prior to starting the study drug.
* Patients may not be less than 12 weeks from completion of radiation therapy for the primary tumor.
* Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord; radiological evidence of active; multifocal disease; extensive subependymal disease (tumor touching subependymal space is allowed); tumor crossing the midline or leptomeningeal disease.
* Posterior fossa location of the tumor, regardless of its morphology.
* Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin (treatment with tamoxifen or aromatase inhibitors or other hormonal therapy that may be indicated in prevention of prior cancer disease recurrence, are not considered current active treatment).
Effects of an Oral Nicotine Product in Smokeless Tobacco Users

The purpose of this research study is to find out how three different nicotine pouches and participant's own brand of smokeless tobacco affect blood nicotine levels and how participants feel.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (determined by self-report)
* Between the ages of 18-55
* Willing to provide informed consent, attend the lab sessions and abstain from tobacco/nicotine as required
* Agree to use designated products according to study protocol
* Smokeless tobacco users and must report using smokeless tobacco daily. Smokeless tobacco users must have a 'positive' cotinine cassette result to verify nicotine use

Exclusion Criteria:

* The following self-reported current, diagnosed medical condition(s): heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures
* Other self-reported current, diagnosed medical conditions (e.g., diabetes, thyroid disease, Lyme disease) may be excluded after consultation with the PI and medical monitor: any medical condition/medication that may affect participant safety, study outcomes, or biomarker data will be excluded based on these consultations
* Self-reported current, diagnosed psychiatric conditions, and who are currently under the care of a physician for psychiatric conditions, or who report current psychiatric treatment or psychotropic medication use
* Not providing answers to questions related to inclusion/exclusion criteria
* Breast-feeding or pregnant women (pregnancy tested by urinalysis at screening
* Weigh less than 110 pounds
* Intend to quit tobacco/nicotine use in the next 30 days
Anomalous Self-Experience in First Episode Psychosis - A Six-Year Follow-Up Study

The objective of this study is to explore the longitudinal course of self-disturbances (SD) in schizophrenia. The main aim of the study is to investigate, in a 6-7-year follow-up of a representative sample of patients with first-episode schizophrenia, bipolar disorder and other psychoses. The overall aim is to expand our knowledge about the role of SDs in psychotic disorders. Increased knowledge here will aid diagnosis and treatment. The current study is a seven year follow-up of this representative cohort, with baseline measures of SDs and a comprehensive clinical and neurocognitive assessment battery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who participated and completed base-line part of the study,
* Patients with concurrent substance use disorder are included, but have to demonstrate at least one month without substance use, or clear signs that the psychotic disorder had started before the onset of significant substance use.

Exclusion Criteria:

* Patients with brain injury,
* Patients with on going substance use,
* Unable to provide informed consent statement.
* Not able to be interviewed.
To Assess Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses.

A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after single ascending doses in healthy male.

A phase I, single-blind, randomised, placebo-controlled, single centre study to investigate the safety, tolerability and pharmacodynamics of intravenous MEDI8111 after single ascending doses in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures, Healthy male subjects aged 18-40 years with suitable veins for cannulation or repeated venepuncture, Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weight at least 50 kg an no more than 100 kg inclusive, Male subjects should be willing to avoid fathering a child by either true abstinence or the use of two effective means of contraception from the day of dosing until 3 months after dosing with the IP. They should also be willing to use barrier methods from the day of dosing until 3 months after dosing.

Exclusion Criteria:

* Prothrombotic mutation such as factor V Leiden, or deficiencies of protein C, protein S, prothrombin, antithrombin or APC, Antibodies to coagulation FII, History or family history of venous or arterial thromboembolic event, and/or myocardial infarction before age of 50 years, ETP level at baseline \>2000nM/min, FII level (by clot) at screening and/or at baseline outside 50-250% of the normal range
Treatment Satisfaction of Using OmniPod System Compared With Conventional Insulin Pump in Adults With Type 1 Diabetes

Randomized, two arms, open study in order to evaluate treatment satisfaction of using OmniPod system compared with conventional insulin pump in adults with type 1 diabetes.

The study will include two consecutive 12 weeks treatment periods. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with OmniPod system and than 12 weeks with patient's previous insulin pump or vice versa.

A Randomized, two arms, open, crossover study in order to evaluate treatment satisfaction of using OmniPod system compared with conventional insulin pump in adults with type 1 diabetes.

The study will include two consecutive 12 weeks treatment periods. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with OmniPod system and than 12 weeks with patient's previous insulin pump or vice versa.

Study will consist of 4 clinic visits taking place at -2,0,12 and 24 weeks and additional 4 telephone visits taking place at 4,8,16 and 20 weeks. In addition, patients will be invited one week prior to visit 5 and visit 8 in order to insert a continuous glucose sensor. Patients will complete DTSQ and Comfort \& Function questionnaires at weeks 0, 12 and 24, before and at the end of each study arm.

On each clinical visits the following parameters will be evaluated: vital signs, HbA1c, 4 and 7 points glucose profile, hypoglycemia events, hyperglycemia events and pump related technical problems.

The telephone visits will include pump related technical problems solving and AE/SAE reporting.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 diabetes diagnosed at least 1 year prior to study entry
2. Use of continuous subcutaneous insulin infusion therapy for at least one year
3. Age: 18-35 years old
4. HbA1c \>8.0
5. At least 4 self blood glucose measurements per day
6. No more than one severe hypoglycaemic or ketoacidosis episode within the past year and none within the past month
7. Capable of reading pump screen in English
8. Able to understand and sign subject informed consent forms

Exclusion Criteria:

1. Any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator are likely to effect subject compliance or the subjects ability to complete the study.
2. Patients participating in other device or drug studies
3. Clinical diagnosis of hypoglycaemic unawareness
4. Known dermal hypersensitivity to products that contain medical adhesive
5. Taking prescription medications that could complicate the management of glycemic control.
6. Inability to understand/complete the Treatment satisfaction questionnaire
Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)

This Phase III study will be conducted to evaluate the efficacy and safety of YH25448 as first-line treatment in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with EGFR mutations

YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) that targets both the T790M mutation and activating EGFR mutations while sparing wild type EGFR.

This is a Phase III, Randomized, Double-blind study evaluating the efficacy and safety of YH25448 (240 mg orally, once daily) versus Gefitinib (250 mg orally, once daily) in patients with locally advanced or metastatic NSCLC that is known to be EGFR sensitizing mutation (EGFRm) positive, treatment-naïve and eligible for first-line treatment with an EGFR-TKI.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed adenocarcinoma of the lung
* Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
* At least 1 of the 2 common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations
* Treatment-naïve for locally advanced or metastatic NSCLC
* WHO performance status score of 0 to 1 with no clinically significant deterioration over the previous 2 weeks before randomization
* At least 1 measurable lesion, not previously irradiated and not chosen for biopsy during the study Screening period

Exclusion Criteria:

* Symptomatic and unstable brain metastases
* Leptomeningeal metastases
* Symptomatic spinal cord compression
* History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
* Any medical conditions requiring chronic continuous oxygen therapy
* History of any malignancy other than the disease under study within 3 years before randomization
* Any cardiovascular disease as follows:

  * History of symptomatic chronic heart failure or serious cardiac arrhythmia requiring active treatment
  * History of myocardial infarction or unstable angina within 24 weeks of randomization
Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation

Neutropenia is very common in patients received hematopoietic stem cell transplantation, with median duration of about 14 days. Almost all neutropenia will suffer from febrile without prophylactic antibiotics. IDSA recommended fluoroquinolones as prophylaxis in neutropenia patients of high risks, while in China, major pathogens possess high resistance to fluoroquinolones. It is not clear whether prophylaxis is of benefit, nor the appropriate prophylaxis regimen.

The current study will evaluate the three different regimen:

1. No prophylaxic antibiotic
2. Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas activity.
3. Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam has highest susceptibility rate among common anti-pseudomonas antibiotics.

1. Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.
2. Randomize the neutropenia patients into 3 groups.
3. Receive 3 regimen.
4. Full record of clinical data, including background diseases, previous antibiotics within 90 days, febrile or not at the TOC.
5. For patients developed febrile, imipenem will be prescribed, even if the patient received no prophylaxis. At the same time, the follow-up ended.

Eligibility Criteria:
Inclusion Criteria:

* Age 13-65 years
* Received Autologous or Allogeneic hematopoietic stem cell transplantation.
* ECOG score 0-1.
* ICF is available.

Exclusion Criteria:

* Allergic to any therapy drug.
* Documented infection before neutropenia.
* Renal dysfunction.
* Suffering from central nervous system or mental disease.