cyrilzakka/clinical-trials huggingface dataset:
Mesalazine and/or Lactobacillus Casei in the Diverticular Disease of the Colon

This is a multi-centre, randomised, double blind, double-dummy, parallel groups, placebo-controlled trial was conducted in a population of patients suffering from symptomatic uncomplicated diverticular disease in order to investigate which is the best treatment in preventing relapses of the disease.

Patients were randomly divided in double-blind fashion in one of the following groups:

Group A. Active mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei placebo, 1 sachet/day for 10 days/month;

Group B. Active Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800 placebo, 2 tablets/day for 10 days/month;

Group C. Active mesalazine 800 ng, 2 tablets/day plus Active Lactobacillus casei, 1 sachet/day for 10 days/month;

Group D. Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month.

The main objective was to assess the safety and the efficacy of mesalazine and/or Lactobacillus casei in maintaining remission of symptomatic uncomplicated diverticular disease


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of diverticular disease diagnosed for the first time or established by previous colonoscopy
* symptomatic episode of uncomplicated diverticular disease no more than 4 weeks prior to study entry
* patients who have given their free and informed consent.

Exclusion Criteria:

* acute diverticulitis (both complicated and uncomplicated)
* diverticular colitis
* active or recent peptic ulcer
* chronic renal insufficiency
* allergy to salicylates
* patients with intended or ascertained pregnancy, lactation
* women of childbearing age not using contraceptives
* lactulose-lactitol use in the two weeks before the enrolment and during the study
* presence of diverticulitis complications (fistulas, abscesses, and/or stenoses)
* use of probiotic preparations either prescribed or over-the counter within two weeks prior to study entry
* inability to give a valid informed consent or to properly follow the protocol
* patients with active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment were also acceptable)
* recent history or suspicion of alcohol abuse or drug addiction
* any severe pathology that can interfere with the treatment or the clinical or instrumental tests of the trial
* use of NSAIDS for one week before and throughout the study period (only paracetamol was permitted).
The Practical Use of Transthoracic Echocardiography for Obtaining an Optimal Depth of Internal Jugular Venous Catheters in Infants

To test if transthoracic echocardiography is useful for correct positioning of central venous catheters in infants with congenital heart disease

Patients scheduled for surgery for congenital heart disease younger than 12 months were studied. Following successful catheter insertion, the insertion depth was determined using transthoracic echocardiography. The long axis or short axis images were used.Chest X-ray images were taken postoperatively and distances from the tip to the carina level were measured.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for surgery under general anesthesia

Exclusion Criteria:

* anomaly of the internal jugular vein
* thrombus in the internal jugular vein
Removal Wichita Fusion Nail After Knee Arthrodesis

The purpose of this study is to make clear how difficult it is to remove osteosynthesis materials afterwards, so surgeons will think twice before inserting intramedullary nails. Also it offers an alternative methode to remove the Wichita Fusion Nail after arthrodesis has become.


Eligibility Criteria:
Inclusion Criteria:

* Extraction of Wichita Fusion Nail

Exclusion Criteria:

* All other kinds of intramedullairy nails used to become a solid knee arhrodesis
Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.

Maximum Age:

Part A SAD 65 years

Part B MAD 75 years

Part C MAD Japanese 75 years

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

1. Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
2. Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=Weight (kg)/\[height(m)\]2
3. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men, ages 18 to 75, inclusive

Exclusion Criteria:

1. Concurrent or use within 2 weeks of study drug administration, of marketed or investigational, drugs as specified in protocol
2. Other protocol-defined exclusion criteria could apply
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine Plus Cisplatin Versus Placebo in Combination with Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers.

Eligibility Criteria:
Inclusion

1. Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
2. Patients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
3. Patient with recurrent disease \>6 months after curative surgery or \>6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.
4. WHO/ECOG PS of 0 or 1

Exclusion

1. History of another primary malignancy
2. Brain metastases or spinal cord compression
3. Uncontrolled intercurrent illness
4. Major surgical procedure within 28 days prior to the first dose of IP.
5. Prior locoregional therapy such as radioembolization
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women Volunteers

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04427429 in healthy women.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy women, of non-child bearing potential, between the ages of 18 and 65 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 35.0 kg/m2; and a total body weight between 50 kg (110 lbs) and 120 kg (265 lbs) inclusive.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, or neurologic, disease. Subjects with asymptomatic, seasonal allergies at the time of dosing will not be excluded.
* Women of childbearing potential.
* History or diagnosis of ocular disease or conditions that would confound the assessment of ocular safety, such as diabetic retinopathy, uveitis, severe wet or dry AMD.
Intelligent Assistive Technologies for Dementia

With the HAAL(HeAlthy Ageing eco system for peopLe with dementia) project, the Netherlands, Taiwan, Italy, Austria, and Denmark combine their strength, co-create, evaluate and share their experiences in supporting dementia care by state-of-the-art AAL bundles.Co-design sessions will take place before developing the dashboard, consisting of (in)formal carers, and older people/clients they care for. The HAAL project will conduct field trials with the first version of the dashboard (Alpha testing) and after Alpha testing, a Beta version of the dashboard will be developed according users' feedback. Then more end-users will be incorporated in Beta testing.The aims of the dashboard are to provide support to reduce the workload of the caregivers and allow psychological relief, which eventually support clients' wellbeing.


Eligibility Criteria:
Inclusion Criteria:

Caregiver

* Principal caregivers of PwD(people with dementia) or organizer or manager of care organization

Care Recipient

* Aged ≥ 65
* Global Deterioration Scale(GDS):2-4 level
* Healthy adult (no skeletal muscle, neurological,eye and hearing disease)
In Vitro Maturation of Human Eggs

CCRM Fertility, a global pioneer in fertility treatment, research and science, is seeking participants for a new study on in vitro maturation (IVM). IVM requires less hormones to stimulate the ovaries than IVF, making it more affordable than IVF with fewer side effects. Participants that qualify for the study will receive a free cycle of IVM treatment at CCRM Fertility and including a new patient consultation, fertility testing, preimplantation genetic testing for aneuploidies (PGT-A), anesthesia and some medication

Patients will undergo a complete IVF workup to qualify for study. Once passing their baseline appointment patients will undergo a three day low dose stimulation followed by egg retrieval 18-22 hours post last medication dosage. Immature oocytes will be retrieved from the ovaries via ultrasound guided TV aspiration and matured overnight in the laboratory. Mature oocytes will be fertilized via ICSI the following day and cultured to the blastocyst stage. Biopsy of the first 14 blastocysts are included with this package, patients have the option biopsy additional embryos if available. Biopsies will be sent for PGTA testing. This study also includes preparation for and the first frozen embryo transfer. Some FET medication is included as well as testing through the first pregnancy test.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women diagnosed with PCOS or polycystic ovaries, or infertile women with good ovarian reserve
* Antral follicle count (AFC) greater than 24
* AMH greater than 3.5 ng/ml
* Body Mass Index less than 35
* Accept to have embryos biopsied for PGT
* Intend to perform embryo transfer within 4 months after completing the IVM cycle
* Paternal (or donor) age \&lt;45, ejaculated sperm collection only (partner frozen and donor sperm acceptable), sperm morphology (strict criteria) \&gt;1%, motility \&gt; 20% and sperm count \&gt; 10 million per ml (so samples can be prepared through standard procedure)

Exclusion Criteria:

* More than 2 failed IVF cycles
Steroids in Bilateral Total Knee Replacement

Inflammation related to cytokine release is known to occur with surgery. The cytokine IL6, a major marker of inflammation is known to increase during total joint replacement surgery. IL6 has been found to be elevated postoperatively in patients with hip fractures and has been linked to mental status changes and possibly other complications. It is known to lead to shock and participate in the inflammatory state seen in sepsis. High levels have further been linked to postoperative fever, confusion, symptoms of depression, acute respiratory distress syndrome (ARDS) and fat embolism syndrome (FES). Previously the investigators found that low dose steroids given in two doses in the initial perioperative period decreased the amount of IL6 released compared to placebo, but this was not sustained past 24 hours.

Desmosine is a stable breakdown product of elastin from lung tissue that can be measured in urine samples. It is considered to be a marker of lung injury and is found to be elevated in patients with ARDS, congestive obstructive pulmonary disease and FES. Previously, the investigators have found that urine desmosine levels rise with bilateral total knee replacement compared to unilateral total knee replacement indicating possible lung injury.

Therefore the investigators hypothesize:

Continued low dose steroids given three times over a 24 hour period will:

1. Significantly decrease peak IL6 cytokine release during bilateral total knee replacement and maintaining this reduction in IL6 beyond 24 hours.
2. Decrease urinary desmosine levels, and hence be protective of lung injury.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for bilateral total knee replacement
* Between 50-90 years of age

Exclusion Criteria:

* Patients on steroid therapy
* Patients that require stress-dose steroid pre-operatively
* Patients that smoke
* Patients that are diabetic
* Patients younger than 50 or older than 90 years
Medication Reconciliation for Patients Over 65 Years Old : Cost Analysis of the Process Implemented in the Polyvalent Internal Medical Unit of Rennes University Hospital

Among the strategies to secure the patient's care path, medication reconciliation is a powerful approach for the prevention and interception of medication errors.

All medication errors are not serious. Nevertheless 4 studies show that respectively 5.6%, 5.7%, 6.3% and 11.7% of the medication errors intercepted by medication reconciliation (MR) could have had major, critical or catastrophic consequences for patients. If the consequences of a medication error have a clinical or institutional translation for the patient, they can also directly impact the hospital or caregivers, for example by extending the average length of stay or by increasing the number of consultations or readmissions.

The efficiency of the medication reconciliation approach has never been evaluated in France in comparison with standard care. Before initiating cost-effectiveness studies, we propose to conduct a micro-costing study to evaluate the production costs of this conciliation approach.

The costs are almost exclusively related to human resources and the present study will assess the time spent by the different actors involved in the process.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 years old
* Patient non-institutionalized at entry
* For MR :

  * Entry : patients admitted at UMIP between 09/04/2017 and 10/31/2017
  * Discharge : patients returning home or going to a rehabilitation service between 04/09/2017 and 31/10/2017 and having received MR evaluation

Exclusion Criteria:

* Patients not returning home
* Refusal of participation
* Major persons subject to legal protection (safeguard of justice, guardianship), persons deprived of their liberty
Long-term Follow up Local Registry Study of Kymriah in South Korea

This study is multicenter, primary data collection, non-interventional registry study to assess long-term safety, secondary malignancy risk, and effectiveness of tisagenlecleucel in patients with B-cell malignancies in a routine clinical practice setting in Korea.

This study will inform on long-term real-world safety and effectiveness of tisagenlecleucel. The primary objective is to evaluate the long-term safety and the risk of secondary malignancies in patients with B lymphocyte malignancies treated with tisagenlecleucel in a real-world setting. The main secondary objective is to evaluate the longterm effectiveness of tisagenlecleucel.

All participants enrolled in this study will be followed up for 15 years from the time of Kymriah® infusion.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who receive tisagenlecleucel infusion in the commercial setting, treated under a managed access program or other pathway, e.g., when product was manufactured for the commercial setting but turned out to be out of specification (OOS).
2. Consented to data collection.

Exclusion Criteria:

1. Patients who are enrolled or will be enrolled in the Novartis long term follow-up protocol CCTL019A2205B.
Evaluation of the Performance of Y-STRUT® Medical Device to Strengthen Pre-fractural Tumour-induced Lesions at the Level of the Proximal Femur

HIPPON 100 is a national, multicentre, prospective, retrospective, descriptive and non-interventional study, in patients having a Y-STRUT® medical device implanted to prevent a high risk of impending pathological fracture.

The primary objective of this study is to evaluate the performance of the studied medical device by measuring the frequency of patient with a fracture at the implantation site within 1 year after implantation.

A total of 100 patients from France will be enrolled (until November 2018) and followed up to 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* Patient with information form signed to participate in the study;
* Patient presenting a cancer with bone metastases at the level of the proximal femur and having a Y-STRUT® medical device implanted;
* Patient able to complete a questionnaire.

Exclusion Criteria:

* Patient who refuse to participate to this study;
* Patient already enrolled in a clinical study, excluding his participation to HIPPON100.
Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children

To determine the efficacy of tacrolimus in the management of NS(nephrotic syndrome) , the investigators designed this prospective study. The investigators will enroll 100 children with NS(frequent relapse steroid dependent NS, steroid resistance NS) who will be treated with tacrolimus (0.1-0.2 mg/kg/day in two divided doses over 12 h adjusted to a trough level between 5 and 10 ng/ml) for 12 months in combination with low-dose steroids. Other therapies will be included angiotensin-converting enzyme inhibitors, antihypertensive drugs, multivitamins and lipid-lowering agents.

Follow-up is every second week for the first 4 weeks, then monthly. After initiation of tacrolimus therapy, blood was drawn each visit to determine tacrolimus trough levels.

Subsequently , monthly measurements were made until stable levels of tacrolimus were achieved. Urine was analyzed for proteinuria at each visit. Serum creatinine, glucose, albumin and alanine aminotransferase were measured and complete blood counts were obtained at each visit during the study.

Eligibility Criteria:
Inclusion Criteria:

* Frequent relapse nephrotic syndrome
* steroid resistance nephrotic syndrome

Exclusion Criteria:

* secondary nephrotic syndrome
* estimated glomerular filtration rate \< 60 mL/min/1.73m2
* with active hepatitis
Diagnostic Properties of Aldosterone-Renin Ratio in Primary Aldosteronism Among Hypertensives.

This study aims to evaluate the diagnostic value of the Aldosterone-Renin Ratio (ARR)as a screening test for primary aldosteronism among hypertensives. The test characteristics will be studied. Furthermore, the effect of eplerenone, a selective aldosterone-receptor antagonist will be studied.

Although primary aldosteronism (PA) was formerly seen as a rare cause of hypertension, this condition is now thought to be the commonest cause of secondary hypertension, with the prevalence ranging up to 10-15 % of all hypertensives. Identification of patients with PA allows for specific treatment, for instance unilateral adrenalectomy in case of an aldosterone-producing adenoma or the administration of an aldosterone-receptor antagonist in case of bilateral adrenal hyperplasia.

Since the introduction of the aldosterone-renin ratio (ARR) as a screening tool for PA in 1981, there has been considerable debate about the diagnostic value. The values for aldosterone and renin are highly dependent on many factors, including posture, time of day and medication. Also, the cut-off values for the identification of PA remain controversial.

This study aims to evaluate the test characteristics of the ARR in a population of patients with therapy-resistant hypertension, the dependence of the ARR on medication type and the predictive value on the response on eplerenone, a selective aldosterone-receptor antagonist.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years
* blood pressure above 140 mmHg systolic and above 90 mmHg diastolic
* use of at least 2 antihypertensive drugs

Exclusion Criteria:

* known cause of hypertension, including white-coat hypertension
* severe renal failure (kreat \> 200 umol/l)
* BMI above 32 kg/m2
* poorly regulated diabetes mellitus (HbA1C \> 8.0 %)
* heart failure
* stroke or myocardial infarction within 6 months before inclusion
* angina pectoris
* pregnancy
* neoplastic disease, within 5 years before inclusion
* alcohol abuse
Validation of a Novel Thoracic Neoplasm Radiotherapy Image Guidance Technique: A Pilot Study

The overall, broad objective of this study is to pilot the BSD technique. The specific purpose of this particular study is to generate pilot data to validate several crucial steps of the BSD technique, in particular steps 1, 2, and 4. Radiation treatments will proceed per standard of care, and will not be modified in any way during this protocol. This study is a non-treatment protocol.


Eligibility Criteria:
Inclusion Criteria:

* Any thoracic neoplasm scheduled to undergo radiation therapy
* 18 years or older
* Must be treated with radiation as part of standard of care
* Able to tolerate the mouthpiece for spirometry and video glasses
* Ability to provide written informed consent

Exclusion Criteria:

* None