cyrilzakka/clinical-trials huggingface dataset:
Sodium Picosulphate/Magnesium Citrate and Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy

Adequate bowel cleansing is essential for effective colonoscopy. Acceptance of colon preparation affects the quality of colon cleansing. The study is aimed at comparing the efficacy, safety and acceptability of sodium picosulphate/magnesium citrate (PMC) and low-volume PEG -ascorbic acid (PEG+ASC)in colon cleansing, and to identify predictors of poor bowel preparation.


Eligibility Criteria:
Inclusion Criteria:

* adult outpatients
* aged 18-85 years
* undergoing elective colonoscopy

Exclusion Criteria:

* previous colon resection
* ileus
* intestinal obstruction
* toxic megacolon
* severe heart failure (New York Heart Association \[NYHA\] Class III or IV)
* acute cardiovascular disease
* uncontrolled arterial hypertension (systolic pressure \> 170 mmHg, diastolic pressure \> 100 mmHg)
* severe liver failure or ascites
* end-stage renal failure
* phenylketonuria
* glucose-6-phosphate dehydrogenase deficiency. Women were excluded from the study if they were pregnant, breastfeeding
Performance in Walking in Osteoarthritis Patients

Few data exist to date on the effect of eccentric muscle building in knee osteoarthritis. No studies have compared the effect of eccentric versus concentric reinforcement in knee osteoarthritis. Our study aims to show the effectiveness of an eccentric reinforcement. This is a randomized, interventional trial.

Few data exist to date on the effect of eccentric muscle building in knee osteoarthritis. No studies have compared the effect of eccentric versus concentric reinforcement in knee osteoarthritis. Our study aims to show the effectiveness of an eccentric reinforcement, the interest of a work supervised by a sports coach to maintain activity over time and to study the effect of this activity at the muscular level. The main objective is to study the effect of an eccentric muscle strengthening program on walking performance in osteoarthritis patients. The secondary objectives are to study: the effect of fatigue on walking, the relationship between fatigue and the level of physical activity, the effect of training on perceived fatigue and the effect of training on the function and at muscular level. This is a randomized, interventional trial. 40 subjects are planned. Inclusion criteria include: age 40-85 years, KL 2 and 3. The subjects are divided into two groups to perform either eccentric or concentric work. 2 sessions per week for 6 weeks. At baseline and at the end of the study a clinical evaluation and MRI will be carried out for evaluation of the criteria of judgment

Eligibility Criteria:
Inclusion Criteria:

* Autonomous subjects aged 40 to 85
* Subjects meeting ACR criteria for gonarthrosis
* Subjects with a score of Kellgren and Lawrence at least one knee greater than or equal to 2
* Signature of consent form
* Subjects affiliated to social security

Exclusion Criteria:

Subject with a Kellgren and Lawrence stadium at 4 for at least one of his two knees

* Subjects with symptomatic femoro-patellar arthrosis
* Subject with a pathology that makes walking testing impossible.
* Non-autonomous subjects, with a pathology impairing walking
* Subjects with symptomatic osteoarthritis of the hip and / or with a hip or knee prosthesis
* Subject incapable of signing consent and unable to understand information leaflet.
Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™)

To investigate the efficacy of treatment with oral trofinetide versus placebo in females with Rett syndrome


Eligibility Criteria:
Inclusion Criteria:

1. Female subjects 5 to 20 years of age, inclusive, at Screening
2. Body weight ≥12 kg at Screening
3. Can swallow the study medication provided as a liquid solution or can take it by gastrostomy tube
4. Has classic/typical Rett syndrome (RTT)
5. Has a documented disease-causing mutation in the MECP2 gene
6. Has a stable pattern of seizures, or has had no seizures, within 8 weeks of Screening
7. Subjects of childbearing potential must abstain from sexual activity for the duration of the study and for at least 30 days thereafter or must agree to use acceptable methods of contraception. Subject must not be pregnant or breastfeeding.
8. The subject's caregiver is English-speaking and has sufficient language skills to complete the caregiver assessments
9. Subject and caregiver(s) must reside at a location to which study drug can be delivered and have been at their present residence for at least 3 months prior to Screening

Exclusion Criteria:

1. Has been treated with insulin within 12 weeks of Baseline
2. Has current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus), renal, hepatic, respiratory or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) or has major surgery planned during the study
3. Has a history of, or current, cerebrovascular disease or brain trauma
4. Has significant, uncorrected visual or uncorrected hearing impairment
5. Has a history of, or current, malignancy
6. Has a known history or symptoms of long QT syndrome

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all pre-specified entry criteria).
Pregnancy Rates in IVF After Ovulation Triggering With Recombinant or Urinary Human Chorionic Gonadotrophin (HCG)

To access whether the ovulation triggering with rec-HCG instead urinary-HCG has any impact on the blastulation rate and pregnancy rate of patients undergoing IVF treatment


Eligibility Criteria:
Inclusion Criteria:

* FSH\<12,
* normal sperm,less than 36y,
* single blastocyst transfer

Exclusion Criteria:

* endometriosis stage 3\&4,
* pco
A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis

A Canadian study to evaluate early use of adalimumab after methotrexate failure in early rheumatoid arthritis. The study hypothesis will verify if adalimumab effectively reduces joint damage in more participants when introduced earlier than in current practice.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has a diagnosis of Rheumatoid Arthritis as defined by the 1987-revised American College of Rheumatology-classification criteria and has disease duration of less than 2 years from diagnosis.
2. Subject must have been on a dose of methotrexate therapy either subcutaneously or orally administered (15-25 mg/week) for at least 3 months prior to baseline visit and has had an inadequate response to treatment defined as having a Disease Activity Score DAS28 \> 3.2 (at Screening visit).
3. Subject must also meet the following three criteria (at screening visit): at least 4 swollen joints out of 66 assessed; at least 4 tender joints out of 68 assessed; subject must have an elevated erythrocyte sedimentation rate \>/= 20 mm/1h or C-reactive protein \> upper limit of normal.
4. Subject must fulfill at least one of the following three criteria: history of rheumatoid factor positive; history of at least one erosion on X-ray or magnetic resonance imaging; history of anti-cyclic-citrullinated protein antibody positive.

Exclusion Criteria:

1. Subject has previous exposure to any biologic therapy including adalimumab.
2. Prior disease-modifying antirheumatic drugs triple therapy with methotrexate.
3. Subject has been treated with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks prior to baseline visit. Inhaled corticosteroids for stable medical conditions are allowed.
4. Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study) of Baseline.
5. Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the Investigator, would put the subject at risk by participating in the study.
Effects of Intensified Sodium Management in Hemodialysis Patients

The primary aim of this study is to investigate whether intensive sodium management by dietary sodium restriction and by preventing positive sodium balance during dialysis can be successfully applied in chronic hemodialysis patients. Secondary aims are to test if sodium restriction has positive effects on the frequency of hospital admissions, blood pressure, fluid overload, quality of life and residual renal function.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory, clinically stable maintenance hemodialysis patients on a thrice weekly HD regimen.
* Willing and able to provide written, signed informed consent after the nature of the study has been explained.
* Willing and able to comply with all study procedures.
* Age ≥18 years.

Exclusion Criteria:

* Simultaneous participation in another clinical study except observational trials.
* Any psychological condition which could interfere with the patient's ability to comply with the study protocol.
* Pregnancy.
* Amputation of a limb.
* Pacemaker, implantable pump, artificial joint.
* Expectation that native kidney function will recover.
* Unable to verbally communicate in English or Spanish.
* Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center within the next 14 months.
* Life expectancy \< 15 months
Vascular Cardiotoxicity of Ponatinib

Pre-clinical studies suggest that the third generation tyrosine kinase inhibitor ponatinib can result in microvascular angiopathy and acceleration of atherosclerosis. This study is intended to examine for myocardial microvascular angiopathy and changes in carotid plaque in patients receiving ponatinib as part of their clinical care.

In this study, we will perform serial echocardiography for ventricular function, myocardial contrast echocardiography for microvascular perfusion assessment, blood analysis for myocardial injury, and carotid US for plaque or IMT progression in subjects receiving ponatinib. This series of tests is intended to provide information on the presence of clinically-evident or subclinical microvascular angiopathy and plaque acceleration.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CML or ALL
* Prescribed ponatinib

Exclusion Criteria:

* pregnancy or lactation
* major medical illness involving the heart or vasculature (CAD, PAD, DCM).
* hemodynamically unstable
* allergy to ultrasound contrast agents.
Non-interventional Open Label Study to Investigate the Effect of Quetiapine XR on Patient Satisfaction and Quality of Life in Patients With Schizophrenia

Since subjective well-being and quality of life (QoL) are increasingly being recognized as important treatment outcomes in patients with schizophrenia (Hofer et al., 2004; Becker et al., 2005), the aim of this study is to investigate the effect of treatment with quetiapine XR on these parameters in the acute hospital and the subsequent ambulant care setting. The study is planned to be conducted in 15 centers all over Austria and, overall, about 150 inpatients with a ICD-10 diagnosis of acute schizophrenia are planning to be enrolled. The duration of the whole trial will be approximately 4 months, whereas 2 visits during hospitalization and two further visits after discharge will be scheduled. At each visit, adverse events and safety parameters, patient satisfaction and effectiveness of the current treatment, as well as concomitant medication and dosing schedules will be assessed and documented.In addition to that, the patients' overall satisfaction with antipsychotic therapy and their current quality of life will be determined using a QoL questionnaire, focussing on the subjective experience with quetiapine XR.


Eligibility Criteria:
Inclusion Criteria:

* Adult schizophrenia patients
* Inclusion according to Summary of product characteristics

Exclusion Criteria:

* Diagnosis other than schizophrenia
* Patients for which Seroquel XR is not registered (pregnant women, children and adolescents...)
Continuous Quality Improvement (CQI) Pilot Study Evaluating the Utility of an Educational Video

The primary aim of this study is to evaluate the effects of prospective patient education on patient satisfaction with administration of topical 5% 5-fluorouracil cream for the treatment of actinic keratosis involving the face, scalp, upper chest, dorsal hands and forearms. Specifically, this study aims to determine if prospective patient viewing of an educational video delineating treatment effects and expectations improves patient satisfaction and treatment completion rates.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a clinical diagnosis of actinic keratoses with at least 6 clinically-diagnosed actinic keratoses on the face, bald scalp, arms, upper chest, OR dorsal hands classified as grade I, mild (slightly palpable actinic keratoses, more easily felt than seen), and II, moderate (moderately thick hyperkeratotic actinic keratoses, easily felt).

Exclusion Criteria:

* Patients using interferon or interferon inducers, immunomodulators, cytotoxic or immunosuppressor drugs, corticosteroids, retinoids, or investigational drugs within 4 weeks prior to enrollment.
* Patients who have been treated with any topical drug for actinic keratoses lesions less than 8 weeks prior to enrollment.
* Patients with invasive tumors within the treated area (e.g. invasive squamous cell carcinoma)
* Patients who have exhibited any dermatological disease within the treated or adjacent (3 cm distance) area at the time of screening.
* Patients who have known allergies to fluorouracil (5-FU).
Optimization of Therapeutic Human Serum Albumin Infusion in Selected Critically Ill Patients

Primary purpose : mortality at Day 28

Secondary purposes :

* Daily SOFA (Sequential Organ Failure Assessment) score lessening within Intensive Care Unit (ICU)
* Duration of increasing doses of norepinephrine infusion to maintain target mean arterial pressure
* Number of care-related infections within ICU

According to currently available literature on therapeutic albumin infusion in critically ill patients, there is room for new approaches to delineate an optimal use of this expansive treatment. Indeed, many authors suggest that the present clinical use of albumin is questionable in critically ill patients as far as changes in morbidity or mortality are concerned and with regards to cost-effectiveness.

It has been reported that protein misfolding and aggregation are a hallmark of several inflammatory diseases. In vitro studies show that very small amounts of albumin are able to restore the physiologic activities of endogenous circulating proteins that had been aggregated in multimeric form during oxidative stress. Recently, the investigators have reported that in vitro albumin restores antimicrobial and anti-inflammatory effects of some chromogranin A-derived peptides. The investigators therefore search to test in vivo, in critically ill patients with severe systemic inflammation requiring norepinephrine infusion, whether therapeutic albumin infused at a low and continuous dosage may modify mortality (primary purpose) and morbidity (secondary purposes) in comparison with intermittent high dosage albumin infusion.

Eligibility Criteria:
Inclusion Criteria:

* circulatory failure requiring norepinephrine support (any dose)
* hospitalization within an Intensive Care Unit
* SIRS
* low plasma albumin (\< 20g/L)
* consent to study

Exclusion Criteria:

* absence of circulatory failure
* absence of SIRS
* chronic low albumin concentration
* absence of consent to study
* inability to tolerate human serum albumin
* Patients under guardianship or curators
* Women pregnant
Effects of Respiratory Rehabilitation by Gender in COPD Patients

Without calling into question the effectiveness of pulmonary rehabilitation in women, the difference in outcome by gender was not established due to insufficient evidence .

Studies demonstrating the effectiveness of pulmonary rehabilitation include a majority of men, which no longer corresponds to the sex ratio of the disease. The impact of gender on pulmonary rehabilitation outcomes was not established due to insufficient evidence.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years old
* No opposition filed
* Patient with COPD
* Completed participation in respiratory rehabilitation program

Exclusion Criteria:

* Refusal of participation
* Patient under tutorship or curatorship
* No final assessment
* Patients with sex changes in marital status
A Study in Healthy People to Compare How 3 Different Formulations of Survodutide Are Taken up in the Body

The main objective of this trial is to investigate relative bioavailability of BI 456906 formulation B and BI 456906 formulation C vs. BI 456906 formulation A.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests.
* Age of 18 to 55 years (inclusive).
* Body mass index (BMI) of 20 to 29.9 kg/m² (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.

Further inclusion criteria apply.

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm).
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator.

Further exclusion criteria apply.
Efficacy and Safety of ASAQ and PD for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania

The World Health Organization recommends regular surveillance of antimalarial efficacy to monitor the performance of different drugs. The Tanzanian National Malaria Control Programme (NMCP) in collaboration with its partners have been implementing therapeutic efficacy studies (TES) to monitor the performance of different antimalarials in the country. Most of the studies conducted in recent years focused on artemether-lumefantrine which is the first line antimalarial for the treatment of uncomplicated malaria in Mainland Tanzania. However, data on the performance of other artemisinin based combination therapy (ACTs) is urgently needed to support timely review and changes of treatment guidelines in case of drug resistance to current regimen. This study was undertaken in the same NMCP framework to assess the efficacy and safety of alternative ACTs used or with potential use in Tanzania. The study assessed the efficacy and safety of artesunate-amodiaquine (ASAQ) and dihydroartemisinin-piperaquine (DP) for the treatment of uncomplicated malaria in Tanzania. The study was undertaken at two NMCP sentinel sites of Kibaha and Ujiji from July to December 2017.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 6 months to 10 years.
* mono-infection with P. falciparum detected by microscopy;
* parasitaemia of 250 - 200,000/μl asexual forms;
* presence of axillary temperature ≥37.5 °C or history of fever during the past 24 hours
* ability to swallow oral medication;
* ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
* Informed consent from the parents or guardians of children.

Exclusion Criteria:

* mRDT negative
* presence of general danger signs in children aged 6 months to 10 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);
* weight under 5 Kg
* mixed or mono-infection with another Plasmodium species detected by microscopy;
* presence of severe malnutrition (defined as a child who has symmetrical oedema involving at least the feet or has a mid-upper arm circumference \< 110 mm in children ≤ 59 months; or BMI of \<16 in children aged 5 years and above)
* presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
* regular medication, which may interfere with antimalarial pharmacokinetics;
* history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
Synovial Sarcoma Registry / Biospecimen Repository

The purpose of this study is to collect and store data and samples for future research to attempt to improve outcomes for patients with synovial sarcoma. The future research will involve various types of genetic testing.

Participants will be asked to allow access to medical records and leftover tumor tissue and may be asked to give a blood or saliva sample. Participants will also be asked to completed questionnaires about their medical history and may be contacted every 6 to 12 months for updates for up to 10 years.

This study will enroll patients with a diagnosis of Synovial Sarcoma.

Following consent, demographic, clinical, treatment and outcome data will be collected from an interview and/or online survey. This will include a request for contact information for the subject's treating hospitals/physicians and a release of records request to obtain medical records.

At approximately 6-12 month intervals for up to 10 years after initial diagnosis and/or relapse, subjects and/or their treating hospitals may be contacted to provide updates on treatment and outcomes.

Tumor samples may be collected from residual material obtained during clinically indicated procedures occurring before or after consent to this study. No additional material will be collected or procedures performed solely for the purpose of this study.

Blood may be collected at the participant's local institution at the time of a clinically indicated blood draw and/or saliva or a buccal swab may be collected as a germline sample and for analysis of circulating free DNA (cfDNA) and/or circulating tumor cells (CTCs).

Genetic testing may be performed on tumor and germline samples submitted by subjects. Results will only be returned if deemed clinically significant.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females of any age
2. Reported diagnosis of synovial sarcoma
3. Informed consent from subject (aged ≥18 years) or parent/guardian

Exclusion Criteria:

1. Individuals with sarcomas that do not fit the definition of those considered for this registry
2. Individuals who are unwilling to participate
3. Individuals who are unwilling or unable to provide written consent