cyrilzakka/clinical-trials huggingface dataset:
Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial

The aim of the study is to investigate if iv iron formulation improve recovery after surgery with blood loss.

Post-operative anaemia is a common debilitating condition after major surgery due to a combination of preoperative iron deficiency anaemia (IDA) and per-operative blood loss. Median blood loss following hepatopancreatobiliary (HPB) and complex aortic surgery typically range between 500-1000 ml. Bioavailability of iron may be a rate limiting factor in erythropoiesis in anaemia secondary to blood loss. For the IRIS trial, it is hypothesized that intravenously (iv) administered Ferric Carboxymaltose after a per-operative blood loss of 400-4000 ml, improves post-operative recovery and reduces the RBC transfusion.

Patients scheduled for elective HPB surgery or complex aortic surgery will be screened for eligibility and recruited into the study.

By the end of the surgical procedure, if blood loss is estimated to 400-4000 ml, the patient is randomized 1:1 to iv 1000 mg Ferric Carboxymaltose or placebo.

The primary endpoint is a composite of death, number of RBC transfusions, post-operative severe anemia (Hb \<80 g/L) and FACT-An Quality of life (QoL) five weeks after surgery, assessed by win ratio.

The trial will also examine effects on; a) levels of Hb; b) markers of erythropoiesis and iron bioavailability; c) post-operative complications; d) post-operative recovery; e) performance status; f) subgroups based on type of surgery and degree of anemia and iron deficiency; g) re-admissions; h) long term outcome based on patient medical records and i) how post-operative recovery differs between those with low (\<400 ml), high (400-4000 ml) and very high (\>4000 ml) per-operative blood loss.

Recruitment will continue until 338 patients are randomized or 304 have completed the five week follow up

The coordinating center of the trial is the Department of Surgery at Uppsala University Hospital. Participating sites are also Linköping University Hospital and Lund University Hospital, all in Sweden. Other sites may be added.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent
2. Male and female patients
3. Weight \> 50 kg
4. \> 18 years of age
5. Scheduled for complex aortic surgery, liver resection or pancreatic resection

Exclusion Criteria:

1. Short expected survival (less than six months)
2. Intra-venous iron therapy within one month prior to surgery
3. Severe anaemia (B-Hb \<80 mg/L) prior to surgery
4. Contraindication to Ferric Carboxymaltose according to SmPC
5. Iron overloading disorder, i.e. hemochromatosis
6. Risk of small for size future liver remnant
7. Pre-operative renal replacement therapy
8. Enrolled in another drug or medical device study within 30 days prior to enrolment of the current study
9. Another planned major surgical procedure before the five week follow up
10. Unsuitable for inclusion according to the investigator
11. Pregnancy
Registry of Pediatric Patients Diagnosed With Crohn's Disease in Belgium

A registry of pediatric patients (under 18 yrs of age) diagnosed with Crohn's disease was created in Belgium. Over a 2 year period 257 patients are included. These patients will be follow up prospectively during 5 years. Demographic data, family history, disease presentation and disease course including medication are registered in CRF's.


Eligibility Criteria:
Inclusion Criteria:

1-18 yrs old belgian Crohn s disease informed consent

Exclusion Criteria:

no informed consent
S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)

The aim of this study is to investigate clinical effects (liver biochemistries, health-related quality of life, liver stiffness) and underlying mechanisms of hepatoprotection of S-adenosylmethionine in patients with primary sclerosing cholangitis. The study will be performed in a randomized and placebo-controlled fashion.

The study is designed as a randomised, double-blind, placebo-controlled trial.

Eighty participants will be randomized in 1:1 ratio to one of two arms of the study: Intervention or Placebo. Participants in Intervention Group will be treated with S-adenosyl-L-methionine 1200 mg/daily in tablets in two divided doses (800mg in the morning and 400mg midday) over the period of 6 months. Patients in Placebo Group will receive a placebo of identical appearance, smell and taste, with the same schedule.

Participants will be monitored in out-patient clinic at baseline, interim visits at weeks: 4, 12, end of treatment at 24 weeks and follow-up visit after 4-6 weeks wash-out period. Treatment adherence, adverse events, serum biochemistry and health related quality of life will be assessed at each visit. Liver fibrosis will be measured with transient elastography at baseline and at the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* primary sclerosing cholangitis fulfilling EASL criteria;
* age: 18 - 75 years;
* treatment with ursodeoxycholic acid (UDCA) in a dose of 13-15mg/kg b.w. for at least 6 months.

Exclusion Criteria:

* inability to give informed consent;
* patients with other forms of chronic liver diseases;
* decompensated liver cirrhosis (Child-Pugh class B-C);
* patients with PSC who underwent stenting of their biliary tree within 6 months;
* other diseases or states that can affect quality of life and mood: decompensated diabetes mellitus, renal insufficiency requiring dialyses, malignancy, heart failure ≥ New York Heart Association (NYHA) II, organ transplantation, known HIV infection, rheumatoid arthritis, asthma, psychiatric disorders;
* treatment with: steroids, statins, rifampicin, antidepressants;
* pregnant or breastfeeding women;
* history of hypersensitivity reactions to S-adenosylmethionine;
* any other condition, which in the opinion of the investigators would impede the patient's participation or compliance in the study.
Role of Parenting Skills and Parenting Style in Pediatric Weight Loss Programs

The purpose of this study is to evaluate the role of different parenting skills and parenting styles in the success of children enrolled in a family-based behavioral weight control program and to compare these skills and styles to those used by families with normal weight children.

Pediatric overweight has nearly tripled in the past several decades and while family-based behavioral weight control programs are the mainstay of treatment, there is considerable variability in their outcomes. Parents play an important role in the success of their children, particularly by implementing new behavioral skills. However recent evidence has also suggested that parenting style, or the way a parent interacts with their child and provides emotional support and discipline, may be another key element in pediatric weight control. Our goal is to evaluate the role of specific parenting (behavioral) skills and parenting style in the success of children enrolled in a standard family-based behavioral weight control intervention. Our goal is to examine whether specific parenting (behavioral) skills and parenting style change during the intervention and whether or not this change is related to changes in the child's BMI z-score.

Eligibility Criteria:
Inclusion Criteria:

* children between and including the ages of 8-12 years old
* child BMI \>= 85th percentile
* parent willing to attend all treatment meetings
* parent and child must be able to speak, read, and understand English

Exclusion Criteria:

* a family member who is participating in another weight loss program
* the child has any serious medical problem that would limit his/her participation in the study, for example, gastrointestinal diseases, cardiac disease, immune compromised state, chronic steroid use or other medication that impacts weight, developmental delays.
* child with serious food allergies that would compromise adherence to dietary recommendations
* any family member has a major psychiatric disease or organic brain syndrome
* family is going to move outside the metropolitan area within the time frame of the study
Identification of New Prognostic Markers in Psoriatic Arthritis

Identification of possible markers associated with the onset and / or progression of psoriatic arthritis through comparison in patients with psoriasis alone (Ps) and patients with psoriasis with joint involvement (PsA), plasma levels of a panel of cytokines referable to the Th17 pathway , together with serum levels of MMPs, TIMPs and markers of bone remodeling.

The primary objective of this study is to verify whether the arthropathy component has an effect on the metabolic activity of osteoblasts. This will be determined through the study of the differences in serum concentrations, between Ps and PsA subjects, of "CTx", the parameter best characterized in terms of analytical variability and intra- and inter-individual variability, in the field of bone metabolism.

The secondary objective is the verification of the differences in serum concentrations of the series of parameters specified above, in order to define a complete pattern of variations that can identify the molecular pathways involved in the definition of psoriatic arthropathy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* For Ps group:

plaque psoriasis no previous treatment with biological drugs

- For PsA group: plaque psoriasis with arthropathy no previous treatment with biological drugs but in treatment as per clinical practice or, alternatively, last treatment with drug suspended by a number of days double compared to the half-life of the drug

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Neoplasia in progress or previous (\<5 years)
* Other acute or chronic inflammatory diseases
* Other rheumatological diseases
* Metabolic diseases of the primitive bone
* Recent bone fractures (\<6 months)
* Anxiety, psychosis, depressive disorders
* Inability to understand the information provided by the recruiter doctor
* For Ps group:

treatment with biological drugs
An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection

The TARGET-HBV study engages an observational research design to conduct a comprehensive review of outcomes for patients with CHB infection. The initial phase of the study that enrolled patients treated with tenofovir alafenamide (TAF) was successfully completed. The current protocol (Amendment 1) describes the second phase of the study that will engage research activities for patients being managed for CHB in usual clinical practice in the US and Canada. The study addresses important clinical questions regarding the management of CHB by collecting and analyzing data from patients at academic and community medical centers. TARGET-HBV creates a robust database of real-world data regarding the natural history, management, and health outcomes related to antiviral treatments used in clinical practice.


Eligibility Criteria:
Inclusion

1. Male or female patients, age ≥18 years
2. Being managed for chronic hepatitis B (CHB), including patients who have achieved functional cure and patients with concurrent delta hepatitis

Exclusion

1. Inability to provide written informed consent
2. Known history of Human Immunodeficiency Virus (HIV)
3. History of liver transplantation
Sintilimab Combined With Chemotherapy as Adjuvant Treatment for Phase III GC and GEJ

This study is a prospective, single-arm, phase II clinical study. Screening patients with stage III GC/GEJ adenocarcinoma after D2 or broader radical resection. After enrolling in the study, the subjects receive Sintilimab combined with oxaliplatin+Tegafur, Gimeracil and Oteracil Potassium Capsules (SOX) or oxaliplatin+Capecitabine (XELOX) , in which the combined chemotherapy is up to 8 cycles, and the total course of treatment was 16 cycles. The following-up of subjects includes adverse events、disease status、living conditions and the quality of life.

This study is a prospective, single-arm, phase II clinical study. Screening patients with stage III GC/GEJ adenocarcinoma after D2 or broader radical resection that meets the criteria for group entry and does not meet the exclusion criteria. After signing the informed consent, the subjects entered the trial group to receive adjuvant treatment with Sintilimab combined with chemotherapy (SOX or XELOX ), in which SOX or XELOX chemotherapy was up to 8 cycles, and the total course of treatment was 16 cycles. The efficacy is evaluated every 4 cycles during the study treatment. The frequency of follow-up after treatment is defined as: once every 3 months within 2 years after surgery, every 6 months for 2 to 5 years, and once a year after 5 years. The follow-up interval can be adjusted according to the clinical need. Safety follow-up is from the beginning of the first treatment to 30 days after the last medication.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18.
2. Patients with histopathological confirmed gastric/GEJ adenocarcinoma.
3. The pTNM is confirmed between IIIA-IIIC and the PD-L1 CPS\>=1.
4. Patients treated with D2 surgery.
5. ECOG is 0 or 1.
6. Patients who could tolerate chemotherapy combined with immunotherapy.
7. Patients who are not pregnant and have no willing to get pregnant within 6 months after the treatment is over.
8. Patients who are willing to offer their postoperative tumor tissue and their peripheral blood samples.
9. Patients who are volunteer to sign the ICF.

Exclusion Criteria:

1. Patients who had received neoadjuvent treatments before surgery.
2. Patients who have discovered tumor relapse or metastasis before adjuvent treatment.
3. Patients who have other malignant tumors.
4. Patients who could not swallow the tablets and capsules.
5. Other conditions which the researchers think are not suitable for participate the study.
The Role of an Optical Probe in Thyroid Cancer Diagnosis: Pilot Study

This study will investigate the usefulness of an optical probe in the differentiation of thyroid cancer from normal thyroid tissue in a thyroidectomy specimen.

The optical real-time readings will be compared to the histological analysis from the same area. Subjects undergoing thyroid surgery for thyroid disease including thyroid nodules, thyroid cancer and thyroid goiter with nodules will be eligible to participate. After the removal of the thyroid gland, optical readings will be taken from the ex vivo thyroid gland and these same areas will then be analyzed in the usual standard fashion. The reading will then be correlated with the histological results. In addition, if lymph nodes are removed as part of the surgery they will also be tested prior to histological standard processing. All specimens and data will be de-identified.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing thyroid surgery for thyroid nodules, thyroid cancer, and thyroid goiter with nodules.

Exclusion Criteria:

* Subjects whose thyroid specimens have been put in formalin
Studies in Amyotrophic Lateral Sclerosis (ALS) and Other Neurodegenerative Motor Neuron Disorders

The purpose of this study is to collect, from patients with sporadic and familial ALS and their family members, clinical data and blood samples for extraction of DNA, RNA, preparation of lymphocytes, plasma and serum to establish a repository for future investigations of genetic contributions to ALS pathogenesis. Blood samples for DNA extraction also would be collected from control subjects with no personal or family history of ALS phenotypes.


Eligibility Criteria:
Inclusion Criteria

ALS or Suspected ALS Patient

* Clinical diagnosis of possible, laboratory-supported probable, probable or definite ALS according to modified EL Escorial criteria, suspected ALS according to original El Escorial criteria, or diagnosis of a neurodegenerative disorder with evidence of ALS plus extramotor features; OR
* Blood relative (first, second or third degree) with history of ALS or neurodegenerative disorder with evidence of ALS plus extramotor features; OR:

  * A clinical suspicion or referral for ALS;
  * \> 18 years of age;
  * Willing and able to give signed informed consent or assent that has been approved by the Institutional Review Board (IRB).

Blood Relative of ALS Patient

* Family history (first, second or third degree blood relative) of ALS or other motor neuron disease;
* \> 18 years of age;
* Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).

Healthy Control

* No personal or family history (first, second or third degree blood relative) of ALS or other motor neuron disease;
* \> 18 years of age;
* No personal history of other neurodegenerative disease (i.e., Alzheimer disease, Parkinson disease);
* Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).

Exclusion Criteria:

ALS or Suspected Patient • Limited mental capacity rendering the subject unable to provide written informed consent or assent or comply with standard phlebotomy procedures.

Blood Relative of ALS Patient

• Limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures.

Healthy Control Subject

* Personal or family history of dementia or other neurodegenerative disease (Parkinson disease, Alzheimer disease, etc.);
* Limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures.
A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)

This was a multi-center, multi-national, double-blind, randomized, comparator-controlled study of plazomicin administered intravenously compared with levofloxacin, a standard approved intravenous therapy for complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).


Eligibility Criteria:
Key Inclusion Criteria:

* Documented or suspected cUTI/AP with clinical signs and symptoms
* Normal kidney function defined as creatinine clearance (CLcr) of ≥60mL/min using Cockcroft-Gault formula

Key Exclusion Criteria:

* Acute bacterial prostatis, orchitis, epididymitis, or chronic bacterial prostatis
* Gross heanaturia requiring intervention other than study drug
* Urinary tract surgery within 7 days of randomization or during the study period
* A known nonrenal source of infection diagnosed within 7 days of randomization
* A corrected QT interval \> 440 msec
* History of hearing loss with onset before the age of 40 years, sensorineural hearing loss, or family history of hearing loss
* Pregnant or breastfeeding women
Visual Arts Interventions With Older Adults

The present study investigates the feasibility, acceptability, and preliminary effects of a novel visual arts-based intervention in an older adult population. In a randomized controlled design, two arts-based interventions will be evaluated with a group of 50 participants.

A two-arm randomized controlled study will be conducted to obtain within-group ratings of feasibility and acceptability, as well as between-group differences in drawing skills after training. In the drawing intervention, participants will learn and train drawing skills through exercises that target attention, perception, and visuospatial reasoning. In the active control condition, participants will navigate virtual art galleries. Both interventions will be completed remotely and at home. Participants will complete in-lab assessment sessions before and after the training.

Each intervention consists of 6 weeks of training for up to 2 hours a week, including up to 1 hour of a self-guided lesson and prompted daily drawing practice adding up to 1 hour in the drawing intervention and 2 1-hour sessions of virtual gallery exploring per week in the arts appreciation intervention. The pre-test is administered within one week of the start of training and the post-test is administered within one week of training completion.

Eligibility Criteria:
Inclusion Criteria:

* 55-85 years of age
* Able to understand and speak English and follow study procedures
* Does not have a psychological or neurological condition that would prevent from being able to give consent to participate
* Less than 2 years of formal visual arts training

Exclusion Criteria:

* Formal diagnosis of dementia or other neurological disease, including Mild Cognitive Impairment
* A final score below 17 on the Montreal Cognitive Assessment - Blind (phone) version
* Abnormal visual acuity prohibitive of tablet-based training
* Physical handicap (motor or perceptual) that would impede training procedures
* Medical illness requiring treatment and/or significant absences during the study timeline
Tobacco and Socioeconomic Disadvantage

Randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers.

The investigators propose a randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers. Participants will be randomly assigned to receive a) A brief motivational interviewing intervention, b) A nicotine replacement therapy sampling intervention, or c) A referral-only intervention.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be between the age of 19 and 65
* Participants must self-report being a daily smoker and provide biochemical verification of smoking status (expired breath carbon monoxide reading \>5)
* Participants must be at socioeconomic disadvantage, defined as receiving services at a New Brunswick, New Jersey based social services agency (i.e., living in New Brunswick Housing Authority-run public housing units or requesting social services from the community social service agency, "Elijah's Promise")
* Participants must be able to speak and read English.

Exclusion Criteria:

* Participants may not be taking FDA approved smoking cessation or anti-psychotic medications
* Participants may not reported medical issues of potential concern to nicotine replacement users (e.g., unstable angina pectoris, myocardial infarction, or significant cardiac arrythmia (including atrial fibrillation) in the past 30 days)
* Participants may not report pending legal issues with potential to result in incarceration.
* Participants may not be pregnant or nursing, planning on becoming pregnant in the next two months, and must be using effective birth control.