cyrilzakka/clinical-trials huggingface dataset:
D-SOLVE Cohorts (Cohort a and B)

Hepatitis D is by far the most severe form of chronic viral hepatitis, frequently leading to liver failure, hepatocellular carcinoma and death. Hepatitis D is caused by coinfection Hepatitis D is caused by co-infection with hepatitis B virus (HBV) and hepatitis D virus (HDV).

This multicenter cohort should enable a comprehensive and unbiased biomarker screening of well-defined HDV-infected patients, followed by mechanistic studies to determine the functional role of distinct molecules. Patient surveillance strategies and antiviral treatment approaches could be personalized which should reduce clinical and social disease burden, improve quality of life and save direct and indirect costs caused by HDV infection.

The D-SOLVE consortium ("Understanding the individual host response against Hepatitis D Virus to develop a personalized approach for the management of hepatitis D"), aims for an unbiased screening of a large multicenter cohort of well-defined HDV-infected patients to better understand individual factors determining the outcome of infection and to identify subjects benefitting from currently available treatments.

The D-SOLVE cohorts will be collected retrospectively as well as prospectively with clinical and virological data and biomaterial for the biomarker analysis. The aim of the cohorts is as following:

Cohort A: To define the demographic, clinical, virological, and immunological features of a large cross-sectional cohort of 750 untreated and treated HDV patients at 4 EU centers. To compare these features among patients with different origin, gender, disease severity and treatment. To collect biological material to generate translational studies, aimed to better understand pathogenesis, natural history and treatment response.

Cohort B: To identify histological and immunological features that are associated with fibrosis progression and clinical complications in patients with chronic HDV infection.

The D-SOLVE consortium has received funding from the Horizon 2020 EU Horizon Call "Personalised medicine and infectious diseases: understanding the individual host response to viruses (e.g. SARS-CoV-2)" of the European Union (grant agreement No 101057917). The consortium is coordinated by Hannover Medical School (MHH) and the Centre for Individualised Infection Medicine (CiiM). Other partners are:

* Helmholtz-Zentrum für Infektionsforschung (HZI), Germany
* Institut national de la santé et de la recherche médicale (INSERM)
* Karolinska Institutet (KI), Sweden
* Karolinska University Hospital / Region Stockholm (KUH), Sweden
* Policlinico of Milan (PFM), Italy
* National Institute for Infectious Diseases "Prof Dr Matei Balș" (INBIMB), Romania
* Helmholtz-Zentrum für Informationssicherheit (CISPA), Germany

The Cohorts and the biomarker screening are part of the EU-funded D-SOLVE Consortium.

Eligibility Criteria:
Inclusion Criteria:

* Anti-HDV positive
* ≥18 years old
* Sex: m/f/d
* Informed consent for prospective procedures

Exclusion Criteria:

* Anti-HDV negative
Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

This is a randomised trial comparing the efficacy of 3 different analgesic strategies in newborns on prostaglandin for ductus dependent congenital heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Full-term newborn
* Under one month of age
* With ductus dependent congenital heart disease requiring prostaglandin infusion and elevated pain score

Exclusion Criteria:

* Contraindication to either morphine, acetaminophen, or nalbuphine
* Other painful condition
* Poor neurological condition
* Cardiac instability requiring urgent surgery
Platelet Rich Fibrin on Root Coverage of Gingival Recessions

Several surgical techniques and various adjunctive agents have been used to covered Gingival Recession (GR) and promote clinical outcomes. The treatment of the GR more used (gold standard) is the root coverage with surgical procedures and connective tissue graft, but it has limitations due to the conditions of the donor graft. Is necessary develop other biomaterials for these cases.

The platelet rich fibrin is a autologous biomaterial that has gained tremendous momentum having been utilized for a variety of dental and medical procedures including periodontal surgeries. However, results remain contradictory and mainly focus on the hard and soft tissue healing, aesthetics and postoperative discomfort.

The objective of this study was to evaluate the clinical effects of coronal advanced flap (CAF) and CAF + Platelet Rich Fibrin (PRF) on Root coverage (RC) over a period of 24 month.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Healthy males and females of age 18-60 years old
* Multiple bilateral (maxillary or mandibular) gingival recessions (Miller class І or II)
* Good oral hygiene (O´Leary index ≤ 15%)

Exclusion Criteria:

* Active periodontal disease
* Periodontal surgeries in the last three years
* Pregnancy or lactation
* Smokers or alcoholics
* Platelet dysfunction syndrome or thrombocytopenia
* Coagulation defects
* Uncontrolled diabetes
* Medical contraindications to elective oral surgery procedures
* Severe immunodeficiencies
* Oncological history
* Prosthetic restorations adjacent to gingival recessions
* Mobility II or III
* Occlusal contacts excessive
* Root caries
* Buccal restaurations Class V
Level of Deprivation Assessment in a Population of Short-bowel Syndrome Patients With Intestinal Failure

The association between social deprivation and chronic disease is regularly examined but there are no data available on patients with intestinal failure due to short bowel syndrome (SBS-IF). First, the investigators aim to characterize this population and then to assess if insecurity is associated with some disease criteria.

This exploratory cross-sectional study was conducted on patients affected by intestinal failure in short bowel syndrome and monitored by the certified home parenteral nutrition (HPN) center of Nancy University Hospital.

The investigators included all patients over 18 years old suffering from SBS-IF followed-up by the certified HPN center of Nancy University Hospital between March 1st, 2020, and November 30th, 2023.

The f-EDI (a European ecological index adapted to France) was determined for each participant.

The investigators set the initial date at 2020, as this corresponds to the start of the use of patient-specific formulas in the center. Exclusion criteria were: not living in France, because it's required to use French-EDI and patients under 18 years old because they are monitored by the children's hospital. Investigators also excluded patients with transitory type 1 SBS who would have a bowel length over 2 meters after re-establishment of digestive continuity.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Suffering from Short-bowel syndrome with intestinal failure
* Monitored by the Certified Home Parenteral Nutrition Center of the Nancy University Hospital
* Between March 1st 2020 and November 30th 2023

Exclusion Criteria:

* Patients not living in France
* Transitory short-bowel syndrome with a predicted bowel length \> 200cm after digestive continuity
Birth Rate in Conservative Monitoring of Pregnancy Beyond the Date of Birth.

Pregnant Women beyond the date of birth. will be followed while coming to routine monitoring. physiological parameter of cervical length will be measured as the differential predictor to determine their due date. the cervical length will be measured as part of routine gynecologic examination to women who come for routine over due date follow up.

additional medical data will be collected from the patient medical record.- demographic data, and all the routine prenatal medical care the women will receive up to the delivery.and delivery outcomes.

The clinical part of the study: the first visit of pregnancy monitoring is carried out at 40 full weeks. First visit to make sure the gestational age to receive full medical anamnesis , perform physical examination and vaginal and NST and BPP. Also, assess the clinical weight and when the need arises assessment of weight sonography. monitoring fetal movements . The women are ordered to return for routine check ups every 3 days. from - 41 full weeks the women should come every two days and 42 weeks should be referred for induction. In practice, the women offered induction at 41 weeks + 3 or 4 days.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-50 .
2. Individual fetus
3. The dating of gestational age based on first- trimester ultrasonography or by last menstrual
4. Gestational age between 39 weeks and 0 days to 41 weeks and 6 days .
5. The pregnant women is not in pain ( VAS \<3 ) while signing on consent to participate.
6. Normal fetal monitoring measures and Sonar
7. Expectant mother is in active labor
8. Consent to participate

Exclusion Criteria:

1. Multi-pass Pregnancy
2. Without accurate dating of gestational age based on first- trimester ultrasonography or by last menstrual
3. Indicators for abnormal fetal monitoring and / or Sonar
4. Active labor
5. pain ( VAS \> = 3 )
6. Expectant mother does not agree to participate or delivery if consent was given earlier
Early Initiated Vasopressor Therapy in the Emergency Department

The goal of this pragmatic, multi-center, superiority, randomized clinical trial is to compare early treatment with peripheral (through a vein) infused noradrenaline (a natural hormone that increases blood pressure) with fluid only therapy in patients with hypotensive and shock in the Danish Emergency Departments (ED).

The main questions it aims to answer are:

If early initiated noradrenaline in non-bleeding hypotensive patients presenting in the ED can

* Improve time to shock control.
* Reduce the need for ICU admittance.
* Decrease mortality.

Participants will be included by the clinical staff and treated urgently with either noradrenaline or usual treatment during their Emergency Department stay.

After completion of the treatment in the Emergency Department, patient data will be extracted from the bed-side measurements, electronic health records and national registers.

Patients will be contacted by the research staff 1 year after study inclusion to answer brief questions about their daily physical function and ability to care for themselves.

Researchers will compare with patients receiving fluid therapy only, as this is the usual standard of care in Danish Emergency Departments.

Please refer to the full protocol.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Signs or suspicion of hypotension or shock (of any type such as septic, vasodilatory or hypovolemic not included in the exclusion criteria) defined as:

  1. SBP \< 100mmHg or MAP \< 65 mmHg combined with lactate \> 2.0 mmol/L,
  2. Physician defined blood pressure for the individual patient combined with a lactate \> 2.0 mmol/L
  3. Either SBP \< 100mmHg or MAP \< 65mmHg with obvious signs of shock with any lactate level evaluated by either two non-specialist physicians (e.g. registrar medical doctors) or a specialist physician.
* Received at least 500ml of intravenous fluid before study inclusion (Including prehospital administration) within the first 4 hours of ED arrival.
* Clinical Frailty Score (CFS) of ≤4. If CFS is ≥5 and the treating physician find the patient suitable for ICU admittance, the participant can be enrolled, if the on-call ICU doctor would accept the patient for ICU admittance. If the treating physician is unsure of ICU eligibility, regardless of CFS score, the patient should be consulted with the ICU consultant before study inclusion.

Exclusion Criteria:

* Cardiogenic, anaphylactic, haemorrhagic, or neurogenic shock suspected by the treating physician.
* Fertile women (\<60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG or women breastfeeding.
* Patient deemed terminally ill or with a severe co-morbid status resulting in non-eligibility for ICU admittance decided by either the treating physician or ICU consultant.
* Known allergy to noradrenaline.
Capecitabine in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

OBJECTIVES: I. Determine the efficacy of capecitabine in terms of PSA response, PSA response duration, and time to PSA progression in patients with metastatic hormone refractory prostate cancer. II. Evaluate the toxicity of this treatment in these patients. III. Evaluate the correlation between PSA response and quality of life in these patients.

OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days 1-14. Treatment continues every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed on days 1 and 8 of the first course of treatment, on day 1 of each course thereafter, and at treatment failure. Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic hormone refractory prostate cancer Disease progression after orchiectomy or during hormonal therapy Measurable or evaluable disease At least 2 consecutive increases in PSA At least 1 week between reference value and first increase OR Third value must be higher than second if second value is less than reference value PSA at least 5 ng/mL No leptomeningeal or brain metastases

PATIENT CHARACTERISTICS: Age: 18 to 85 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 OR Granulocyte count at least 2,000/mm3 Hemoglobin at least 9.0 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No other prior malignancies in past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin No other significant disease that would preclude study No concurrent active severe infections

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior gene therapy and antibody therapy allowed Chemotherapy: No prior cytostatic chemotherapy, including estramustine Endocrine therapy: See Disease Characteristics At least 1 month since prior antiandrogen therapy (e.g., flutamide or bicalutamide) without tumor response OR Concurrent antiandrogen therapy allowed if clinically unacceptable to discontinue use If disease progressed while receiving hormonal agents (e.g., goserelin, leuprolide, diethylstilbestrol), therapy must continue during study Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiotherapy to lesions to be evaluated No concurrent radiotherapy to more than one area Surgery: See Disease Characteristics Other: Prior noncytostatic therapy allowed At least 1 month since prior investigational drugs
Prucalopride in Pediatric Subjects With Functional Constipation

To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to \< 18 years. A 16-week open-label comparator (PEG) controlled part will follow, to document safety and tolerability up to 24 weeks.


Eligibility Criteria:
Main Inclusion Criteria:

1. Boys and girls, aged ≥ 6 months and \< 18 years.
2. Subjects with a confirmed diagnosis of functional constipation as defined by the Rome III criteria.

Main Exclusion Criteria:

1. Children with underlying GI abnormalities and causes for defecation disorders.
2. Constipation is thought to be drug-induced.
3. Subjects suffering from secondary causes of chronic constipation.
Survey of Adherence to Immunosuppression and Other Medications in Kidney Transplant Patients

Goal:

To define the causes and issues associated with nonadherence in our population

Hypothesis:

There is a difference in the rates and patterns of adherence to transplant medications versus other medications also taken by transplant patients

Methods:

1. A standardized interviewer-administered confidential survey exploring levels of adherence to transplant medications and other medications as well questionnaires on a variety of cognitive and other factors known to be associated with adherence.
2. A brief review of demographics and pertinent laboratory information at the same encounter

Objectives:

1. To determine the prevalence of nonadherence in our population
2. To assess possible causes of nonadherence and correlate those causes with demographic information and clinical findings
3. To assess for differences between adherence with immunosuppressive regime versus adherence with other medications (for hypertension, diabetes, hypercholesterolemia)

Methods:

1. A standardized interviewer-administered confidential survey exploring levels of adherence to transplant medications and other medications as well questionnaires on a variety of cognitive and other factors known to be associated with adherence
2. A brief review of demographics and pertinent laboratory information at the same encounter

Eligibility Criteria:
Inclusion Criteria:

* All renal transplant recipients with a working transplant who are currently attending the transplant clinic and who have been transplanted 6 months to 4.5 years ago are eligible. Patients are recruited at random from the transplant clinic waiting area

Exclusion Criteria:

* Less than 6 months post-transplant
* More than 4.5 years post transplant
Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis

Surgical procedures for complex intestinal neonatal and paediatric diseases may require the use of an ostomy, in order to discharge the upper intestine. The traditional loop ileostomy has recently be challenged by ileostomies in continuity, either the Santulli or the Bishop-Koop one, that both decompresses the proximal dilated bowel and allow intestine fluid to pass through the underlying ileal anastomosis. Nevertheless, to date, no evaluation of their indications, complications and potential benefits has been made.

The aim of this study is to retrospectively compare the outcomes of loop ileostomies and ileostomies in continuity in a paediatric population.

It is thus expected to better define the specific indications for these different types of ileostomies in the paediatric and neonatal population.

The methodology used will be a retrospective non interventional study of the cohorts of paediatric patients having had one or more ileostomies performed in one of the surgical centers participating in this study, between 2007, january the 1st and 2019, august the 31th.

The main outcome will be the duration (days) between full refunctionalization of the bowel in the groups of conventional ileostomy or ostomy in continuity, as assessed by the end of parenteral nutrition or the closure of the stoma.

Secondary outcomes will include (1) the number and type of complications directly related to the stoma and/or to intestinal complications; (2) the comparison of the results obtained by Santulli and Bishop-Koop ileostomies; (3) a sub-group analysis of the outcomes in the different underlying pathologies.

Eligibility Criteria:
Inclusion Criteria:

* all patient aged 16 or less having had one or more ileostomy created as part of its care for an intestinal obstruction, between 2007/01/01 and 2019/08/31. If a patient requires more than one ileostomy, each new stoma will be analysed as a new entry in the study.
* patients having been operated in one of the paediatric surgical department participating in this study.

Exclusion Criteria:

* refusal or absence on consent of the patient and/or their legal representative to participate to the study.
* patient who had an ileostomy created in another center than the ones participating in the present study.
A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia.


Eligibility Criteria:
Inclusion Criteria:

* Receiving stable maintenance hemodialysis 3 times a week.
* Dialysis patients with hyperphosphatemia

Exclusion Criteria:

* Patients having history of a pronounced brain / cardiovascular disorder.
* Patients having severe gastrointestinal disorders.
* Patients having severe hepatic disorders.
Video Telehealth Exercise Training in Cystic Fibrosis

The purpose of this research study is to begin an exercise program for patients with a cystic fibrosis (CF) exacerbation.

The study will enroll 25 patients with CF during an introduction visit and initiate an ambulatory 1) tailored exercise regimen and 2) behavior change techniques focused on adherence and sustainability of exercise. The intervention will be delivered via a data-enabled smartphone with video capabilities facilitating live and interactive two-way video-conferencing using a HIPAA compliant app. Participants will receive supervised exercise paired with coaching on behavior change techniques over 12 weeks in 3 weekly 1-hour sessions, and will have monthly phone follow-ups and clinic follow-ups at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

Diagnosed with Cystic Fibrosis 18 years old and older clinically stable with no exacerbation within 6 weeks

Exclusion Criteria:

any comorbidity that precludes exercise

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A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects

The purpose of this study is to investigate the safety of YM543 in type 2 Diabetes Mellitus patients and to investigate whether this study drug is effective in these patients


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naive subjects diagnosed with T2DM
* Stable diet and exercise program for at least 6 weeks
* Inadequate glycemic control indicated by HbA1c and FPG level at Visit 1

Exclusion Criteria:

* Any known complication of T2DM indicating a late disease state, clinical manifestations of macro- and/or micro vascular disorders
* Use of insulin or oral blood glucose lowering drugs in the last 3 months