cyrilzakka/clinical-trials huggingface dataset:
Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.

Acute diarrhea remains being the second most frequent infectious condition in children, producing a high number of admissions yearly. In children below one year of age, rotavirus represents the main etiologic agent, both in developed and developing countries. In Bolivia, acute diarrhea affects about 30% of the group below 5 years of age. Probiotics appear as one of the alternatives currently under discussion. Also, evidence available suggests that probiotics shorten the time of diarrhea and therefore the time of rotavirus excretion. In daily practice, we are often limited by the type and number of probiotics products locally available; moreover, information about combined products is scarce. With this in mind, in this study we compared the efficacy of two commercially available products.

Eligibility Criteria:
Inclusion Criteria:

* Positive stool sample for rotavirus test

Exclusion Criteria:

* Severe malnourishment
* Severe dehydration
* Use of antibiotics, probiotics or nitazoxanide 2 weeks before admission
* Systemic infections
* Severe chronic disease
* Mixed enteric infections besides rotavirus
Optimizing Clinical Outcomes in Patients Undergoing Mitral Transcatheter Edge-to-edge Repair (M-TEER) for Severe Functional Mitral Regurgitation Towards Improved Guideline-directed Medical Therapy

A multi-centre, prospective, observational pilot registry in patients undergoing mitral valve repair for severe functional mitral regurgitation to report the heart failure drug therapy and dosing before the mitral valve procedure and afterwards to assess whether the recommended maximal dose of medication is administered. This maximal dose, although recommended, might not be tolerated well by patients and can cause side-effects. Researchers will determine whether the mitral valve repair procedure might have a possible effect on increasing the drug therapy towards the recommended optimal doses.

Mitral transcatheter edge-to-edge repair (M-TEER) has become an important therapy in the management of severe functional mitral regurgitation (FMR).

These patients often have left ventricular dilatation with associated left ventricular failure and undergo intervention after guideline-directed medical therapy (GDMT) is optimised.

However, many patients cannot tolerate maximal doses of these drugs, some of which are potent vasodilators, due to the potential for hypotension and other side effects.

After M-TEER, with significant reduction of valve regurgitation, and a consequent improvement in systemic blood pressure and left ventricular function, it may be possible to further optimize GDMT and thus improve patients' clinical outcomes.

This pilot registry will be conducted in up to 4 German centres with a minimum annual volume of \~ 50 M-TEER procedures aiming for an environment of 100 patients.

This registry aims to:

* document the extent of suboptimal GDMT in patients undergoing M-TEER for severe FMR and to assess the potential to improve care towards maximal recommended medical therapy.
* compare 6- and 12-months heart failure (HF) hospitalization post-procedure compared to 12- and 6-months historical HF hospitalisation prior the index procedure. Functional status (NYHA class, 6-minute walk test) to be assessed at baseline and at 6 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* mitral transcatheter edge-to-edge repair (M-TEER) patients treated with the PASCAL system (≥ 18 years) as per the current approved indication and local Heart Team decision
* Severe functional and mixed-type mitral regurgitation with LV-EF \< 50%
* Patient with optimized guideline-directed medical therapy (GDMT): A minimum of 3 points in the pre-defined GMDT scoring system
* Provision of written informed consent

Exclusion Criteria:

* Degenerative mitral regurgitation
* Emergency procedure
* Re-do or concomitant (mitral/tricuspid) procedures
* Patients on maximum dose GDMT
* Atrial functional mitral regurgitation (FMR)
* Coronary revascularisation within the last 3 months
* Pregnant woman
Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)

Many patients with ALS experience cramps during the course of the disease. Frequently, cramps occur as the first symptom of the disease, months before the patients notice weakness and wasting. Cramp severity varies from mild, without affecting daily activities and sleep, to disabling, where almost any voluntary muscle activity induces long standing, severely painful cramping. ALS patients who smoke herbal cannabis (marijuana) or drink hemp tea report lessening of cramps and fasciculations. Although, various medications, such as magnesium, quinine sulfate, lioresal, dantrolene, clonazepam, diphenylhydantoin and gabapentin are used for the treatment of cramps in ALS so far, no medication has been of proven benefit. However, a recent pilot study with THC in ALS showed symptomatic effects in "spasms", fasciculations, insomnia and appetite. The aim of the proposed study is to determine the tolerability, safety and efficacy of THC in the treatment of cramps in ALS. The hypothesis is that THC will lessen cramps in ALS.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years of age and have full legal capacity
* Patients must voluntarily give written informed consent
* Patients diagnosed with possible, probable laboratory supported, probable or definite ALS according to the revised El Escorial criteria (Brooks 2000)
* Patients must score severity of cramps on the VAS 5 or more
* Patients must be able to communicate and report adverse events by phone
* Patients must have laboratory parameters within the following limits: Creatinine, Bilirubin,Transaminases less than 3x upper limit of normal
* Patients may take any medication for the treatment of ALS (ALS -specific and -symptomatic) but may not change this medication during the study period
* Patients must not have cannabis or cannabinoids for at least one month prior to the study and agree not to use it at all during the study. They have to have a negative urinary test for cannabinoids at baseline
* Pre-menopausal females must provide negative pregnancy test within fourteen days before beginning of study participation and have to apply adequate (barrier) birth-control methods
* Patients must agree not to drive a vehicle or use dangerous machines during the entire study period

Exclusion Criteria:

* Patients who are not willing or able to sign the consent form. Doubt of investigator concerning compliance of the patient
* Patients who have a history of failure to respond to, or had significant adverse effects from or hypersensitivity to THC or any cannabinoid
* Patients who have significant concomitant illness(-es), or acute, uncontrolled infections, which might make evaluation of treatment and side effects difficult
* Patients with a history of significant psychiatric disorder, explicitly of schizophrenia
* Patients who are current drug abusers, including alcohol abusers
* Patients with severe coronary artery disease or hemodynamically relevant ECG-documented arrhythmia
* Pregnancy or breast feeding
Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

The purpose of this research study is to evaluate if different Enterra® device programming methods active during sleeping hours can maintain gastroparesis-related symptom relief and quality of life measures.

Participants in this study with existing Enterra® devices will be randomly assigned to one of three programming methods that will be active during sleep. Participants will answer daily questions about their gastroparesis symptoms on an application with their phone/tablet. Participants will answer quality of life questionnaires about their gastroparesis symptoms at study visits.

Participants will be involved in the study for up to six months after treatment assignment.

Programming parameters in the study are within currently approved labeling.


Eligibility Criteria:
In order to be eligible to participate in this study, a participant must meet all of the following criteria:

1. Completed informed consent process with signed and dated informed consent form;
2. Stated willingness to comply with all study procedures and availability for the duration of the study;
3. Male or female, aged ≥18 or ≤70 at time of informed consent;
4. Currently implanted with the Enterra® Therapy System (Enterra® II 37800 neurostimulator);
5. High GES output defined as remaining pulse generator expected life of \> 9 months from enrollment and less than 4 years from the time of implant;
6. Stable gastroparesis symptoms, in the opinion of the investigator;
7. On stable medical therapy for gastroparesis symptoms;
8. On stable supplemental nutritional support during the month prior to enrollment;
9. English language comprehension to complete study-required assessments;
10. Reliable access to internet-connected smart device(s) to complete study-required assessments.

A participant who meets any of the following criteria will be excluded from participation in this study:

1. Post-surgical gastroparesis (e.g., fundoplication, Bilroth I or II) or other active stomach or gastrointestinal diseases disorders which could explain symptoms in the opinion of the investigator;
2. Subjects, in the opinion of the investigator, with profound nausea and/or vomiting at night;
3. Subjects, in the opinion of the investigator, with profound gastroparesis symptoms upon waking in the morning;
4. Subjects without a regular and defined sleep schedule;
5. Pregnancy, or subject that intends to become pregnant during participation in the study;
6. Chemical dependency;
7. Enterra lead impedance measurements ≥ 700 Ohms at screening visit;
8. Life expectancy \< 1 year from conditions other than GI diseases;
9. Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications;
10. Participation in other clinical studies;
11. Subjects involved in current or past medical-related litigation;
12. Subjects with cognitive impairment or other characteristic that would limit subject's ability to complete study requirements.
Exercise and Body Composition in Juvenile Idiopathic Arthritis

This research is being done to see if resistance exercise (RE) is safe and has a positive effect on children and young adults with juvenile idiopathic arthritis (JIA).

JIA is an inflammatory autoimmune disease that can cause severe impairment and disability. JIA can cause bone loss and decreased muscle strength. The medications used to treat JIA can also have negative effects on growth and development, strength, and ability to function. RE is performing movements in a slow and controlled fashion (i.e., no speeding up or using force in the lifting and lowering of the weight) to lessen force on the joints and tissues. This study will be using Ren-Ex exercise equipment to perform RE.

Currently the American College of Rheumatology recommends exercise for patients with arthritis. This exercise includes range of motion exercise to protect joint mobility as well as low resistance and aerobic exercise (AE) to protect muscle mass, bone health, and fitness. However, a recent study showed no major differences in functionality or quality of life between patients who performed AE and those who did not perform AE. There is a need for more data on the impact of RE on children with JIA. Children and young adults aged 10 to 21 with juvenile idiopathic arthritis may join.


Eligibility Criteria:
Inclusion Criteria:

* American College of Rheumatology criteria for polyarticular JIA
* Stable medical therapy

Exclusion Criteria:

* Non-English speaking
* Pregnancy
* Currently breast feeding
* Cognitive impairment as determined by PI (patient is not responsible for making their own health care decisions)
Long-term Mortality in Diabetics Undergoing Major Surgery

Patients with CAD and diabetes mellitus have a better prognosis than patients with CAD and no diabetes mellitus. In acute coronary syndrome patients with an insulin therapy had a better survival than patients with oral antidiabetics. But there is not known wether perioperative therapy with insulin or oral antidiabetics is associated with higher risk for higher perioperative cardiac morbidity and mortality and worse long-term survival.

Diabetes mellitus is an important risk factor for arteriosclerosis in general and for coronary artery disease. Patients with CAD have a worse prognosis if they have diabetes mellitus. But it is not known whether the treatment of Dm has an influence on mortality or morbidity.

In face of the high number of patients with Dm and the therapeutic consequences this prospective study wants to compare short-time and long-time morbidity in Patients with Dm undergoing major non-vascular surgery. Inclusion criteria are medically treated Dm (insulin or oral antidiabetics) and major non cardiac surgery.

The "normal" perioperative treatment of the study is not changed by the study itself.

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus with insulin or oral antidiabetics
* proven coronary artery disease or very high risk for it
* major non-vascular surgery

Exclusion Criteria:

* emergency
* no consent
Use of Essure® Micro-inserts in Women With Hydrosalpinx Prior to In Vitro Fertilization: A Prospective, Multicenter, International Feasibility Study

The purpose of this study is to gather safety data related to the use of Essure® micro-inserts in women with hydrosalpinx prior to in vitro fertilization and during pregnancy and to collect data with regard to implantation rates, clinical pregnancy rates, and pregnancy outcomes.


Eligibility Criteria:
Inclusion Criteria:

Women age 21-38 (unless women in ovum donor cycle then age will be included up to 43) who:

Are willing to participate in this clinical study Are able to comprehend and give informed consent for participation in this study Have read, understood and signed an informed consent form Have been unable to achieve pregnancy after trying for 1 year or greater and who have unilateral or bilateral hydrosalpinges as evidenced by laparoscopy or ultrasound or HSG Have a Day #3 serum FSH\<10, and Day #3 Estradiol\<80 Recipient women undergoing a ovum donor cycle the donor must have a Day 3 serum FSH \< 10 and Day 3 Estradiol \< 80 Have an antral follicle count 10 or greater for both ovaries combined, if women using ovum donor (follicle count) will be based on eligible donor Have a desire to receive treatment for their HS Are willing to undergo a hysterosalpingogram (HSG) 3 months after Essure placement to confirm proximal tubal occlusion

Exclusion Criteria:

Active or recent upper or lower pelvic infection Known hypersensitivity to nickel as confirmed by skin test Known allergy to contrast media Pregnancy or suspected pregnancy Delivery or termination of pregnancy less than six weeks prior to Essure micro-insert placements BMI \> 35 Abnormal pap smear (CIN2 or greater abnormality) within the past year Pelvic malignancy Severely retroverted uterus Evidence of intrauterine abnormalities such as submucous fibroids, polyps, intrauterine adhesions or presence of a uterine septum Abnormal Clomid Challenge Test or abnormal lab values on Day #3 serum FSH and Estradiol Antral follicle count less than 10 (both ovaries combined) Poor general or gynecologic health Inability or refusal to provide informed consent

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Luminal Fructose Kinetics (MARTINI Study)

In this study the investigators aim is to explore the dynamics of (small) intestinal fructose catabolism in humans and ethanol production in relation to small intestinal signalling pathways and changes in pH, using 13C fructose isotope tracing techniques complemented with direct luminal sampling via small intestinal catheter in biopsy proven MASLD/MASH patients vs healthy (BMI\<25) subjects. Additionally the investigators will repeat the experiment after four weeks of administering omeprazole at a dose of 40 mg twice daily. Omeprazole is a proton pump inhibitor, known to elevate pH from 2-6.

The investigators will perform a non blinded single centre intervention study in 2x 11 participants

Participants will be either healthy volunteers with a BMI \< 25 and Age 18-65 or patients with MASLD with a BMI \>25, Age 18-65

The objective of the investigators is to study the fructose host/microbial kinetics in humans and to establish the role of (small) intestinal pH on fructose fermentation and endogenous ethanol production in a MASLD/MASH population versus healthy subjects

Subjects will be given omeprazole orally given twice a day 40mg for four weeks

At baseline and after four weeks of omeprazole, a fructose challenge test with labelled fructose and fomepizole and a gastroscopy will be performed, during which a nasal-intestinal catheter will be placed to allow for luminal sampling during the fructose challenge test.

Eligibility Criteria:
Inclusion Criteria:

In case of the healthy subject group:

* Adult individuals, age \> 18 \<65 years
* Male or postmenopauzal females
* BMI \<25
* Ability to give informed consent In case of the MASLD/MASH group
* Adult individuals, age \> 18 \<65 years
* Male or postmenopauzal females
* BMI \> 25
* Biopsy proven MASLD/MASH
* Ability to give informed consent

Exclusion Criteria:

* History of sustained excess alcohol ingestion: daily consumption \>30g/day (3 drinks per day) for males and \>20 g/day (2 drinks per day) for females
* Patients with diabetes
* Bariatric surgery
* Other forms of liver disease (e.g. Hepatitis B,C, Wilson disease, hemochromatosis)
* Proton-pump inhibitor usage one year prior to study participation
* GLP1, SGLT2i or insulin use
* Antibiotic use for the past 3 months
* Probiotic or symbiotic usage
* Pregnant women
* Chronic illness (including a known history of heart failure, renal failure (eGFR \<30 ml/min), pulmonary disease, gastrointestinal disorders, or hematologic diseases), or other inflammatory diseases
* Active infection
* Use of ascal, clopidogrel or other platelet inhibition
* Smoking
* Blood thinners
* Heart failure
Radiomics of Immunotherapeutics Response Evaluation and Prediction

This study aims to investigate the feasibility and efficiency of CT radiomic analysis which serves as a high through-put analytical strategy applied to image big-data resource in evaluating and predicting the response of immunotherapeutics. A multi-center retrospective diagnostic test has been designed for this aim to compare the predictive performance of clinical model, qualitative model incorporating semantic CT features and image-based quantitative radiomic model. The reference standard of therapeutic effect is determined by the latest evaluation result utilizing iRECIST within 365 days after recruited. This study intends to enroll 400 participates who had been diagnosed with advanced somatic solid tumor confirmed by histo- or cyto-pathological examination and were planning to receive immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histopathological or cytopathological confirmed solid tumor (including metastatic solid tumor).
2. Patients ≥ 18 years of age on the day of baseline CT scan.
3. Patients received immune checkpoint inhibitors (ICI) monotherapy or combined with chemotherapy in any line of treatment.
4. Patients with at least one measurable target lesion of which minor axis was greater than 15mm and without any local treatment.
5. Female with a negative pregnancy test, or male who agree to use barrier methods of contraception through the therapy period.
6. Patients with a Eastern Cooperative Oncology Group(ECOG) performance status score of 0 or 1.
7. Patients underwent follow-up CT scans with an 6-9-week interval until 365 days after baseline CT scan.
8. Patients with baseline and follow-up CT scans which meet the following conditions: a) Spiral computed tomography device of General Electric Healthcare or Siemens with greater than 16 rows of detectors ; b) Peak kilovoltage: 120kV; c) Dose: auto or fixed; d) Slice resolution: not less than 512 pixels multiply 512 pixels; e) Scanning range: from supraclavicular region to 2cm below the costophrenic angle for thorax, and from diaphragm to pubic symphysis for abdomen; f) contrast-enhanced scan utilizing nonionic low- or iso-osmolar contrast agent and including arterial phase, venous phase and delayed phase at least.

Exclusion Criteria:

1. Patients received any kinds of cytotoxic drugs or experimental drugs 2 weeks before enrollment.
2. Patients meet the contraindications of contrast-enhanced CT scan.
3. Patients who were not suitable for continuous follow-up CT scans.
4. Patients with severe myocardial infarction confirmed by ECG or left ventricular ejection fraction(LVEF) less than 40% or glomerular filtration rate(GFR) less than 45ml/min.
5. Patients who cannot tolerate immunotherapy or with serious immune-related adverse response.
6. Patients with severe interstitial pneumonia confirmed by baseline CT scan.
7. Patients who cannot complete follow-up examinations scheduled by study design.
8. Patients with AIDS or positive serum HIV antibodies.
9. Patients with a CT scan presenting extremely low signal noise ratio or too much artifacts at any timepoint.
Respiatory Viral Infections in Patients with Multiple Myeloma

Respiratory viruses are known to be a major cause of morbodity in multiple myeloma patients but prospective long-term sudies are lacking. We analysed 219 multiple myeloma patients that had 554 nasopharingeal swabs with 58 documented viral episodes. Respiratory viruses studied were rhinovirus, enterovirus, parainflienza, respirator, syncytial virus, metapneumovirus, coronavirus, bocavirus, influenza A, influenza B. Clinical data were extracted from a prospectively entered database, medical records were reviewed. We have prospectively studiend patients until May 2019 when we gathered survival data. Lastly because of Covid-19 pandemic when almost no other viral infections were isolated, we analysed clinical course of respiratory infections in patients with multiple myeloma after the pandemic.


Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple myeloma

Exclusion Criteria:Other hematological malignancies

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Advance Care Planning Individualised Approach and Research Projec

The study will investigate the effect of a palliative approach in the out-patient management of patients with COPD.

Randomised control trial. A total of 90 patients will be randomise 1:1 to either palliative intervention or standard care.

The intervention group will receive follow up in a newly established outpatient clinic for COPD in the specialized palliative united and the control group will receive standard follow up in the respiratory out-patient clinic.

Eligibility Criteria:
Inclusion Criteria:

* • Diagnosis of COPD by spirometry

  * Patients followed in Herlev and Gentofte hospitals' respiratory out-patient-clinics or admitted to Herlev or Gentofte hospital for acute exacerbation
  * 2 or more admissions for acute exacerbation of COPD within the last 12 months
  * CAT \> 20
  * Cognitive and linguistic able to understand and give informed consent

Exclusion Criteria:

* • Expected remaining life time less than 6 months due to other disease than COPD e.g. active cancer

  * Participating in other studies