cyrilzakka/clinical-trials huggingface dataset:
Impact of Probiotic Preparation VSL#3 on Infants Colics

Infantile colic is one of the most commonly reported medical problems within the first three months of life causing appreciable distress for both parents and pediatricians.

It appears that multiple independent origins might be involved: amongst them infant's difficult temperament, inadequate mother-infant communication or maternal anxiety, transient lactase deficiency, exposure to cow's milk, abnormal gastrointestinal function, maternal smoking during pregnancy or after delivery. Consequently, various treatment approaches have been tried to alleviate this condition.

Recent studies have suggested that changes of intestinal microflora of a newborn may play an important role in pathogenesis of infantile colic. Therefore, dietary supplementation with probiotics has been proposed for the improvement of this condition.

Aim of the study is to evaluate the improvement of colics symptoms by the oral administration of VSL#3 and the difference in the daily average crying time (measured with parental diary) between end of treatment and baseline.

In this study, 62 infants will be enrolled and will receive 10 drops per day of VSL#3 or Placebo according to randomization list. The study product will be supplied as a box containing the oil bottle and a powder stick. The product should be stored refrigerated. On the first day of supplementation, the mother will open the sachet, pour the contents into the bottle and shake vigorously. A dropper is provided to count the drops. The suspension must be shaken vigorously before every use. Compliance will be monitored by filling out a diary.

Eligibility Criteria:
Inclusion Criteria:

* Infants aged between 30 and 90 days
* Breast fed exclusively during length of trial
* Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week but not treated previously for colics.
* Debut of colic symptoms 6+/-1 days before randomization
* Written informed consent from one or both parents
* Stated availability and reliability throughout the study period.

Exclusion Criteria:

* Major chronic disease
* Gastrointestinal disease
* Administration of antibiotics the week before randomization
* Administration of probiotics two weeks before randomization
* Infants with GI malformation, cystic fibrosis, other genetic diseases
* Participation in other clinical trials.
Phase I AZD2171 in Patients With Relapsed or Refractory AML and Elderly Patients With DeNovo or Secondary AML

The study will be conducted across multiple European centres to assess the safety and tolerability of multiple doses of AZD2171 in patients with AML.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Male/female, 18 yrs or over
* WHO performance status 0-2
* Disease not responding to or relapsing after chemotherapy or elderly patients not suited to chemotherapy

Exclusion Criteria:

* Acute myeloid leukaemia arising from previous chronic myeloid leukaemia or acute myeloid leukaemia of type FAB M3
* Previous treatment against new blood vessel formation (anti-angiogenic)
* Chest X-ray showing leukaemia in the lungs
Improving Care for Unhealthy Alcohol Use in Primary Care

In order to improve the quality of alcohol-related care for those with unhealthy alcohol use, the current research will use an evidence-based implementation strategy, practice facilitation, at one VA primary care site to pilot test whether practice facilitation has the potential to improve the quality of primary care-based alcohol-related care . It is hypothesized that primary care providers who take part in the practice facilitation intervention will provide higher quality substance use care to Veterans with unhealthy alcohol use compared to care pre-practice facilitation (e.g., administer evidence-based brief counseling interventions at higher rates, prescribe alcohol use disorder pharmacotherapy at higher rates, increase referrals to specialty substance use disorder clinics).

Alcohol use is a significant risk factor of disability and death for U.S. adults and one out of every six Veterans seen in primary care report unhealthy alcohol use. Based on substantial evidence from randomized controlled trials and the U.S. Preventive Services Task Force, VA/DoD clinical guidelines stipulate that all Veterans screening positive for unhealthy alcohol use should receive evidence-based alcohol care in primary care, including brief counseling interventions (BI) and additional treatment (e.g., pharmacotherapy) for those with alcohol use disorders (AUD). The VA was a pioneer in implementing alcohol screening and BI in primary care, yet substantial implementation gaps remain. In order to improve the quality and fidelity of alcohol-related care, the current research proposes to use an evidence-based implementation strategy, practice facilitation, at one VA to pilot test whether practice facilitation has the potential to improve quality of primary care-based alcohol-related care.

The project will first conduct qualitative interviews assessing Veteran and clinical stakeholders to understand barriers and facilitators to high-quality alcohol care. Results from qualitative interviews will be used to refine and hone the practice facilitation intervention. Clinical stakeholders will then be recruited to participate in focus groups in order to evaluate the acceptability and feasibility of the proposed practice facilitation intervention prior to testing it. Last, a pilot test of the practice facilitation intervention will be conducted within one VA primary care clinic to understand whether practice facilitation improves the quality of primary care-based alcohol-related care.

Eligibility Criteria:
Inclusion Criteria:

Veteran patients:

* Veteran presenting for care at VA primary care site during pilot testing of the practice facilitation intervention, AND
* Age 18 years and older.

Primary care providers:

* Primary care staff who screen for unhealthy alcohol use and providers who practice at the primary care clinic at least 1 day per week.

Exclusion Criteria:

* None.
Efficacy of 8 vs 4 Sessions Mindfulness-based Programs in a Non-clinical Population

The aim of this study was to assess and compare the efficacy of a standard 8-weeks protocol based on the Mindfulness Based Stress Reduction MBSR program versus a 4-week shortened version of the protocol in the improvement of wellbeing variables in a non-clinical population in Spain. The investigators initial hypothesis was that both protocols are efficacious but the standard 8-week performs better that the short one.


Eligibility Criteria:
Inclusion Criteria:

* be adult (18-y or older);
* willingness to participate in the study and signing informed consent;
* ability to understand and write Spanish.

Exclusion Criteria:

* have an acute clinical or psychiatry condition;
* have no previous experience with mindfulness or other type of contemplative or mind-boy practices such as yoga, taichi or chikung.
Pyrophosphate and Arterial Calcification in Chronic Kidney Disease

Arterial calcifications start at early stages of chronic kidney disease (CKD) and are associated to cardiovascular mortality. Pyrophosphate (PPi) is an endogenous compound, which stops the mineralization process in bones and is expected to act at ectopic sites. In uremic rats, low PPi plasma levels are associated with high calcium content in the aorta and peritoneal administration of PPi blocks this process. People on maintenance dialysis or kidney transplant recipients have low plasma levels of PPi and show high scores of arterial calcification. The purpose is to determine the role of low PPi in the development of arterial calcifications in patients with CKD stage 3 or 4. To that aim, 252 patients with eGFR between 59 et 20 ml/min/1,73 m2 will be recruited and will be examined at baseline and three years later.


Eligibility Criteria:
Inclusion Criteria:

* eGFR between 59 et 20 ml/min/1,73 m2 twice at three month interval

Exclusion Criteria:

1. kidney transplantation
2. acute inflammatory disease or active cancer
Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery

Fondaparinux is a synthetic antithrombotic agent with specific anti-factor Xa activity. A population pharmacokinetic model of fondaparinux, based on data obtained in patients included in phase II/III trials, has been described. However, the validity of this model in everyday practice needed to be confirmed. This study was a multicenter, prospective cohort study in consecutive orthopedic patients treated with 2.5 mg of fondaparinux. Anti-Xa activities were recorded in 809 patients. Population parameters and inter-individual variability were estimated using NONMEM VI software. A two-compartment model with first-order absorption best described fondaparinux pharmacokinetics. Covariates partly explaining inter-individual variability were body weight, age and creatinine clearance estimated by the simplified Modification of Diet in Renal Disease formula. A body weight less than 50 kg and moderate renal failure increased drug exposure. These results suggest that fondaparinux pharmacokinetics need to be confirmed in patient populations not fully assessed in phase II/III studies


Eligibility Criteria:
Inclusion Criteria:

* patient who need leg major orthopedic surgery
* age \> 18 years
* patient who need prophylactic doses of fondaparinux

Exclusion Criteria:

* contra-indication to fondaparinux
* renal insufficiency
Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival or overall survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 and ≤ 70 years of age
* Histological confirmed advanced or metastatic adenocarcinoma of the stomach
* Have failed for at least 2 lines of chemotherapy
* Life expectancy of at least 12 weeks.
* Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 1 week before randomization.
* At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan)
* Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
* More than 4 weeks for operation or radiotherapy
* More than 4 weeks for cytotoxic agents or growth inhibitors
* Adequate hepatic, renal, heart, and hematologic functions (HB ≥ 90g/L,platelets \> 80 ×10 E+9/L, neutrophil \> 1.5 × 10 E+9/L, serum creatinine ≤ 1× upper limit of normal(ULN), bilirubin \< 1.25× ULN, and serum transaminase ≤ 2.5× ULN).

Exclusion Criteria:

* Pregnant or lactating women
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg).
* Any factors that influence the usage of oral administration; Evidence of Central Nerves System(CNS) metastasis
* Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure and proteinuria ≥ (+)
* International Normalize Ratio (INR) \> 1.5 and activated partial thromboplastin time（APPT） \> 1.5 × ULN
* Abuse of alcohol or drugs
* Certain possibility of gastric or intestine hemorrhage
* Less than 4 weeks from the last clinical trial
* Prior VEGFR inhibitor treatment
* Disability of serious uncontrolled intercurrence infection Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc.
Measuring Quality of Life of Versacryl Relined Dentures

Resilient liners were introduced in the1950s and have been used since then as a gold standard material to increase the tolerance, retention and comfort of complete dentures. Due to drawbacks of conventional resilient liners, their longevity is questionable and they require replacement which is time consuming and costly for the dentist and patient respectively. Versacryl is a biocompatible intraoral thermo-elastic material. So versatile, it can be used to improve esthetics, retention and comfort for the patient. It softens with heat and when it is inserted to patient's mouth, it cools to body temperature providing desired rigidity. This process can be repeated many times to ensuring the comfort for the patient. Versacryl has a reported predictable long term performance, durable bonding to acrylic denture bases, high fatigue endurance, excellent wear characteristics and solvent resistance with almost no free monomer in the processed material .

The investigators' trial is done in order to improve the longevity and oral health related quality of life of soft liners in comparison to silicone-based soft liners.


Eligibility Criteria:
Inclusion Criteria:

1. Completely edentulous patients wearing complete dentures.
2. Flat mandibular residual ridge.
3. Mandibular denture indicated for relining.
4. Patients with minimum of 2 years and maximum of 5 years complete denture usage.
5. Angle's class I maxillary-mandibular relationship

Exclusion Criteria:

1. Drug or alcohol abuse.
2. Inflammatory changes in the oral cavity.
3. Candidiasis.
4. Any intra-oral soft tissue hyperplasia.
5. Physical reasons that could affect follow-up.
6. Psychiatric problems.
7. Heavy smokers.
8. Dentures indicated for remake.
Molecular Characterization of Advanced Stage Melanoma by Blood Sampling

Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies.

In this context, molecular characterization of a tumor material flowing (circulating tumor DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.

The main objective of this study will be to define the diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood.

The secondary objectives of this study will be:

* Study the concordance between mutations in circulating tumor DNA and mutations in tumor tissue - Study the associations between mutational profiles and clinical and histological features of melanoma.
* Study the prognostic impact on survival of the identified genetic profile from the circulating tumor DNA

Eligibility Criteria:
Inclusion Criteria:

* patient with melanoma confirmed histologically
* patient with metastatic melanoma (stage III unresectable or stage IV)
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
* patient older than 18 years

Exclusion Criteria:

- Metastatic tumor whose origin is doubtful (uncertain melanoma)
Analysis of Headache Chronification with Imaging, Deep Phenotyping, and Proteomics

Study is aimed at determining why some patients with episodic headache proceed to chronic daily or near daily headaches. The Investigators seek to discover differences in brain anatomy and function, composition of cerebrospinal fluid, blood products, genetics, and patient phenotypes that might help explain this process.

The purpose of our study is to better understand disease processes and risk factors involved in onset of chronic daily headaches/Chronic Migraines. Further, The Investigators hopes to learn more about the etiology and disease mechanisms to optimize treatment strategies and determine prophylactic measures.

Participation in this research study, will include online questionnaires, a blood sample, a lumbar puncture, and a magnetic resonance imaging (MRI) scan without contrast to measure brain activity. Participant may select to participate in a magnetic resonance imaging (MRI) scan and/ or lumbar puncture. participating in atleast 3 procedures is required (blood draw, online questionnaires , MRI and/or Spinal Tap.

The study recruits participants with headache ( any type of headaches), and patients with no headaches ( or less than 2/year). Participants do not need to have a specified headache type. All participants are asked to complete an on-line survey to characterize a number of phenotypic features felt to be relevant by the Investigators. Three independent study groups (imaging, proteomics/genetics, and phenotyping) analyze data independently and stratify the data. Then, by group analysis, correlation among the different modalities is sought to identify features that distinguish common elements that might help elucidate features that could predict which patients with episodic headache are likely to progress to chronic, and which patients without headache might be at greater risk to develop new daily persistent headache.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must agree to sign informed consent.
* Subject must be able to or at least with some help willing to complete online questionnaires in English .
* Willing to comply with study instructions.
* must speak and understand English

Exclusion Criteria:

\*Any neurological condition, at the discretion of the Principal Investigator (PI)
Perceptions of Illness Severity, Treatment Goals and Life Expectancy

This study is exploring symptom burden, health experiences and expectations of treatment and survival of seriously ill dialysis patients and their physicians.

Sharing and communicating information with patients is an integral part of medical care, yet research has shown that disparities exist between physicians and patient perceptions of illness severity. In renal medicine, along with many other specialties, expected prognosis can affect treatment offered.Thus appreciating and understanding one's prognosis can influence patients and relatives' expectations for treatment and guide discussions regarding quality of life.

Previous work has highlighted disparities in the United States between expectations of survival of seriously ill haemodialysis patients and their physicians. The investigators plan to repeat this study within the United Kingdom, to see whether similar issues occur and to elucidate current practice on discussions of prognosis, symptom burden and transplant candidacy. The investigators hope to identify where care can be improved and to enable patients to better make informed decisions on treatment and goals of care.

Part one of the study is to repeat this study in haemodialysis patients in the United Kingdom. This has been completed and published (2021) at https://www.kireports.org/article/S2468-0249(21)00103-0/fulltext.

Part two of the study is to extend the study to peritoneal dialysis patients in the United Kingdom.

Eligibility Criteria:
Inclusion Criteria:

* Haemodialysis patients 18-100 years old, with a predicted mortality risk of \>20% in the next year, their close person and staff members (nurse and doctor) caring for the patient.
* Peritoneal dialysis patients 18-100 years old, with a predicted mortality risk of \>20% in the next year, their close person and staff members (nurse and doctor) caring for the patient.

Exclusion Criteria:

* Patients on home haemodialysis
Effect of Selenium Intervention on Inflammation in Older Adults

Serum levels of inflammatory mediators increase with age and are strongly associated with the most common and the most devastating health conditions found in older adults including frailty, chronic disease, disability and increased mortality. Even though the processes that contribute to increased inflammatory mediators are likely not completely reversible in older adults, the development of a safe and effective intervention that modulates inappropriate inflammatory responses could be a very important component of prevention against frailty and other adverse health outcomes. As part of an ongoing effort to identify molecular and physiologic triggers of inflammation in older adults, the investigators recently identified a highly significant inverse relationship between the anti-oxidant micronutrient selenium and the inflammatory mediator IL-6, as well as a significant relationship between selenium and all cause mortality in a population of community dwelling older women with selenium levels well below the mean for the overall American population. Based on our findings in older adults and on data from other studies that suggest that selenium interventions are effective in targeted populations with inflammatory conditions, the investigators hypothesize that selenium supplementation targeted to a population of older adults with increased inflammatory markers and low normal selenium levels will in the short term reduce inflammation as measured by serum IL-6, and in the long term will reduce the incidence and prevalence of inflammation associated poor health outcomes of frailty, disability, and mortality in vulnerable older adults.


Eligibility Criteria:
Inclusion Criteria:

* 70 years of age or older
* Able to provide written informed consent for screening and participation in the study

Exclusion Criteria:

* Taking a multi-vitamin containing 60 ug or more of Selenium more than once a week
* Have evidence of an active, untreated, acute inflammatory disease state such as rheumatoid arthritis, gout, or malignancy
* Taking any corticosteroids or the medications prednisone or methotrexate