cyrilzakka/clinical-trials huggingface dataset:
Randomized Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma

Principal objective: to evaluate the effect of the combination pravastatin - sorafenib versus sorafenib alone on overall survival in patients with hepatocellular carcinoma developing on Child-Pugh A cirrhosis who are unsuitable for curative treatment.

Secondary objectives: evaluate the effect of this treatment on progression-free survival, the time to progression, the time to treatment failure and quality of life (QLQ-C30 et FACT HEP)


Eligibility Criteria:
Inclusion Criteria:

* Hepatocellular carcinoma diagnosed by:
* either a histological examination
* or if histological evidence cannot be obtained (ascites, coagulation disorders) the diagnosis can be made in cases of cirrhosis according to EASL/AASLD 2005 criteria, by revealing a hepatic focal lesion of more than 10 mm
* on two dynamic imaging techniques (helical CT-scan, MRI, contrast-enhanced ultrasound) for tumours measuring less than 2 cm. The lesion must be characterised by hyperdensity during the arterial phase and wash-out during the delayed portal phase Patients who are not suitable for treatment with a curative intent (transplantation, resection, percutaneous destruction) or by chemo-embolisation or with progressive hepatocellular carcinoma after the failure of specific treatment Prognostic CLIP score 0 to 4 Child-Pugh Class A Transaminases ≤ 5 N and Creatininemia ≤ 1.5 N WHO: 0, 1 or 2 Age more than 18 years Foreseeable survival \> 12 weeks Possibility of regular follow-up Written informed consent

Exclusion Criteria:

* Extra-hepatic disease that could be life-threatening in the short or medium term Another progressive cancer with the exception of in situ cervical cancer, a superficial bladder tumour and treated basocellular carcinoma.

Any other cancer treated with a curative intent in the previous 3 years can be included in the study Heart failure (≥New York Heart Association class 2), uncontrolled AHT or arrhythmia, myocardial infarction in the previous 6 months Digestive haemorrhage in the previous month Patients who are receiving or have already received treatment with statins or sorafenib Pregnancy and breast-feeding. Women of child-bearing age must use an effective method of contraception throughout the trial and for 3 months after the end of the treatment.
Efficacy and Safety of VA106483 in Elderly Males

A double blind, placebo-controlled, dose ranging study in males over the age of 65, who have a history of nocturia. The study will investigate pharmacodynamic outcomes (urine volumes and osmolality, circulating coagulation factors and haemodynamics) and pharmacokinetics, of both single and multiple oral doses of VA106483 at three dose levels, under conditions of controlled hydration.

VA106483 is a selective vasopressin V2 receptor agonist which is currently under development for the treatment of nocturia in males. This study examines the pharmacological action of VA106483 on markers of clinical efficacy (urine volumes and osmolality) and safety markers (coagulation factors and haemodynamics). The study will also assess the pharmacokinetics in the study population. The study design includes both cross-over and parallel phases so that pharmacodynamic and pharmacokinetic parameters can be assessed following both single and repeat dosing. Three dose levels will be given.

Eligibility Criteria:
Inclusion Criteria:

* Males 65 years and above with history of nocturia

Exclusion Criteria:

* Any clinically significant concomitant medical disease, condition or abnormal laboratory test result
* Participation in any other clinical study within 30 days
* Intake of non-prescription medication within 14 days
Strigolactones and Dysplastic Colonic Lesions or Cancer

The purpose of this study is to determine the effects of the plant hormones strigolactones, on cell cultures of colonic polyps and colorectal cancer.

Strigolactones have been shown to anti-proliferative and pro-apoptotic effects in cell cultures of breast and prostate origin, partially by down-regulation of cyclin B1 and induction of cell cycle arrest. In this study the investigators intend to take biopsies from benign colonic polyps and cancer tissue, culture intestinal explants and generate immortalized primary cells as a platform to assess the effect of this plant hormone on cell viability, cell mobility, apoptosis and cytoskeleton modifications.

Eligibility Criteria:
Inclusion Criteria:

* Patients with positive findings during colonoscopy

Exclusion Criteria:

* Patients below 18 years old
* Patients who cannot sign a consent form
Rivaroxaban in Endovenous Laser Ablation With and Without Miniphlebectomy

The purpose of this study is to determine retrospectively if the application of rivaroxaban after endovenous laser ablation with and without miniphlebectomy is safe and if it lowers the risk of venous thrombosis.

Rivaroxaban is an orally active direct factor Xa inhibitor, that is used for thrombosis prophylaxis for example in the setting of orthopaedic surgery.

In the observed situation Rivaroxaban was applied in a dosage of 10mg daily during 5 days after endovenous laser ablation.

Eligibility Criteria:
Inclusion Criteria:

* Patients age greater than 18 years, informed consent was given.
* Endovenous Laser Ablation (EVLA) of the greater saphenous vein (GSV), autologous saphenous vein (ASV) and/or small saphenous vein (SSV) using 1470 nm wavelength radial laser (ELVeS, Biolitec, Austria) and postinterventional Endothermal Heat Induced Thrombosis (EHIT) prophylaxis with rivaroxaban.

Exclusion Criteria:

Patients are ineligible if they had:

* an endovenous ablation technique other than EVLA,
* other veins than GSV, ASV or SSV treated with EVLA (i.e. perforators),
* postinterventional EHIT prophylaxis other than prophylactic dose of rivaroxaban or
* informed consent was not given.
WiTNNess - TNNT1 Myopathy Natural History Study

WiTNNess is designed to accurately document the natural course and variation of muscle disease caused by pathogenic changes of the TNNT1 gene. The primary aim of the study is to specify meaningful outcome measures for future clinical trials. WiTNNess is open to children and adults worldwide. Participants can choose to include their information once (cross-sectional cohort) or every few months (prospective cohort).

WiTNNess is an observational study that includes prospective and cross-sectional arms, both of which include people diagnosed with autosomal recessive TNNT1-associated muscle disease, commonly described as a form of infantile-onset (NEM5A) or childhood-onset (NEM5B) nemaline rod myopathy. The study's primary objective is to establish the nature and time course of disease outcomes under current treatment, so that these can later be compared to outcomes achieved with novel disease-modifying therapies (i.e., interventional trials).

Participants from all over the world are welcome to enroll in either arm of the WiTNNess study. Following appropriate consent, those in the prospective arm are followed long-term. Recurring assessments are performed at the participant's home, the Clinic for Special Children, or a partnering clinical site, depending on the individual's particular circumstances. Basic assessments include vital signs, a physical exam, documentation of motor milestones, growth measurements, and blood chemistry values. Participant's may also undergo non-invasive ultrasound of the heart (echocardiogram) and one or more chest radiographs.

Participants in the cross-sectional arm are contacted once after consent. Members of the WiTNNess study team partner with healthcare providers and family members to capture pertinent medical history, physical exam findings, growth metrics, and motor milestones at the time of contact.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with biallelic pathogenic variants of TNNT1
* Infantile-onset or childhood-onset proximal weakness without confounding medical conditions that could effect muscle health.

Exclusion Criteria:

* Another known or suspected medical condition (genetic or acquired) that could potentially alter the natural disease course or otherwise interfere with completion of study procedures.
Partner Violence and Anger Management

The purpose of this study is to investigate the effectiveness of the Brøset anger management model in reducing violent behavior amongst clients who are violent in intimate partnerships and who voluntarily seek help.

Violence in intimate partnerships constitutes a serious problem worldwide and there is reason to believe that cognitive behavior therapy has some effect on the reduction of violent behavior. However, there are currently too few randomized controlled studies to conclude about the effectiveness of cognitive behavior therapy for this client group.


Eligibility Criteria:
Inclusion Criteria:

* fluent in Norwegian language
* is in a partner relationship at inclusion. Partner relationship is defined by having an intimate partner at present, or being in regular contact with a former intimate partner so that violence is possible (e.g. they have children)
* admits being violent to his partner (physical, mental and/or sexual)

Exclusion Criteria:

* psychosis
* alcohol- or drug addiction to a level that hinders group participation free from intoxication.
Language Acquisition in the Brain and Algorithms: Towards Systematic Monitoring of the Evolution of Semantic Representations in Biological and Artificial Neural Networks

Speech depends on our ability to recursively combine successive words into a complex sense. Although the order of these putative operations (syntax) has been the subject of extensive examination in the way in which the human brain learns to perform a "Semantic composition" remains largely unknown.

The Rothschild Hospital houses a unit specializing in drug-resistant epilepsy in children from 2 to 20 years old.

The identification of the epileptogenic zone often requires making an iEEG recording for a week (implantation of intracerebral electrodes in depth).

Sometimes this recording has to be repeated, providing a unique opportunity to directly record brain activity at different periods of its development.

Children will listen to pre-recorded phrases and stories such as "The Little Prince of Antoine de Saint-Exupéry" while being recorded with iEEG.


Eligibility Criteria:
Inclusion Criteria:

* Any patient benefiting from a long-term intracranial brain recording.
* Non-opposition to participating in the study (adult patients)
* Non-opposition of at least one of the holders of the exercise of parental authority (minor patients)

Exclusion Criteria:

* Patient with complete deafness
Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy

This study, a nonrandomized open-label safety and exploratory study, will evaluate the safety of topical norepinephrine in post-surgical breast cancer patients who are undergoing radiation therapy.

The study will also provide information about whether topical norepinephrine can prevent or decrease the severity of the radiation dermatitis experienced by these patients.


Eligibility Criteria:
Inclusion Criteria:

Subjects must:

1. be ≥ age 18 years of age with a documented pathological diagnosis of Stage Ia (T1, N0, M0), Stage Ib (T0 or 1, N1mic, M0), Stage IIA (T0-T1N1M0, T2N0M0) or Stage IIB (T2N1M0, T3N0M0) infiltrating ductal or lobular carcinoma of the breast or ductal carcinoma in situ (DCIS).
2. be post-surgical patients scheduled to be treated with at least 50 Gy to the whole breast and axilla using standard radiation techniques (an additional 10-16 Gy boost to the lumpectomy region may also be delivered). All radiation treatment is to be delivered based on standard CT planning.
3. be at higher than average risk for radiodermatitis, as evidenced by a separation at the posterior tangent field border of ≥ 24 cm or a bra cup size of C or greater \[breast size criterion\].
4. have the ability to understand the informed consent document.
5. be able to comply with protocol schedule.
6. have a negative serum pregnancy test (within 7 days prior to starting radiation therapy), if a female of child bearing potential.
7. consent to utilize medically acceptable methods of contraception throughout the study period if of child-bearing potential.

Exclusion Criteria:

Subjects:

1. with unhealed surgical wounds or scars in the study treatment area.
2. with underlying active untreated cardiac disease (e.g. arrhythmia).
3. with generalized skin disorders that have required treatment within the past 6 months.
4. with connective tissue disorders.
5. with rashes, ulcerations, or poorly healed scars in the study drug application area.
6. with a known allergy to norepinephrine.
7. with a known clinically significant abnormal ECG within the past 6 months. If the Principal Investigator feels that the ECG findings are of clinical significance, the patient will excluded or sent for a cardiac consult (insignificant abnormalities such as sinus tachycardia and sinus bradycardia may be allowed at the discretion of the Principal Investigator).
8. receiving MAO inhibitors or antidepressants (triptyline or imipramine types).
9. who are pregnant or breastfeeding.
10. with lymphovascular space invasion on pathology.
11. with dermal lymphatic invasion on pathology.
12. with close proximity of the tumor to the overlying skin within the SDAS (as evidenced by a depth of less than 5 mm on ultrasound or MRI \[if performed\] and a linear distance of less than 2 cm from the SDAS), or a diagnosis of inflammatory breast cancer.
13. receiving concurrent neoadjuvant or adjuvant chemotherapy for their breast cancer.
14. with previous radiation to the breast to be treated.
15. taking β-blockers.
16. with NCI CTC Version 4.0 grade 2 or higher hypertension at the time of study entry.
Open Label Extension of Efgartigimod in Adults with Post-COVID-19 POTS

The OLE study aims to investigate the safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod in participants with post-COVID-19 postural orthostatic.

Study ARGX-113-2105 is a long-term, single-arm, open-label, multicenter extension of the ARGX-113-2104 study, designed to evaluate the long-term safety of efgartigimod IV in adult patients with PC-POTS. Participants will be enrolled from both active and placebo arms of the ARGX-113-2104 study and will receive efgartigimod IV 10 mg/kg in the extension study without knowledge of their prior treatment arm. To be eligible to enroll in this study, participants must have completed the 24-week treatment period of the ARGX-113-2104 study and must not have permanently discontinued the IMP in that study.

Eligibility Criteria:
Inclusion Criteria:

1. The participant has completed the ARGX-113-2104 study without permanent discontinuation of IMP and agrees to directly roll over into the extension study without discontinuation of IMP.
2. The participant signs the informed consent form, and can comply with OLE study (ARGX-113-2105) protocol requirements.
3. The participant agrees to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Contraceptive requirements are provided.
4. Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP.

Exclusion Criteria:

1. The participant has a clinically significant condition, based on the judgement of the Study Investigator, eg, laboratory abnormalities, 12-lead ECG readings, concomitant medical disease(s), etc., which may place them at undue risk or confound interpretation of study data.
2. The participant intends to become pregnant or start breastfeeding during the study.
A Study to Investigate the Safety of AB680 in Healthy Volunteers

This is a double-blind, randomized, placebo-controlled, single- and multiple-ascending dose study to investigate the safety, tolerability, and pharmacokinetic profile of AB680 in healthy volunteers.

AB680 will be administered as single and multiple intravenous doses to the healthy volunteers. In each group of 8 participants, 6 will receive AB680 and 2 will receive matching placebo.

The participants will be closely observed to monitor the general tolerability of AB680.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 55 years, inclusive, at screening
* Body mass index 18 to 30 kg/m2
* Willing and able to sign informed consent
* Negative tests for hepatitis B surface antigen, anti-hepatitis C virus, and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening
* Healthy as determined by pre-study screening

Exclusion Criteria:

* History of clinically significant drug and/or food allergies
* Positive drug and alcohol screen at screening and (each) admission to the clinical research center.
* Participation in a drug study within 60 days prior to (the first) drug administration in the current study. Participation in more than 4 other drug studies in the 12 months prior to (the first) drug administration in the current study
* Participants who have significant infection or known inflammatory process on screening or admission
Ultrasound Guided Median Nerve Hydrodissection Using Dextrose

to compare the efficacy of dextrose 5% with steroid hydrodissection in patients with carpal tunnel syndrome

in some cases there is prohibition to use steroid with example the patient rejection to use steroid the maneuver planned median nerve hydrodissection using ultrasound and 10 mld of dextrose 5%, unleash the median nerve for the surrounding structure and short follow up planned to be 2 weeks

Eligibility Criteria:
Inclusion Criteria:

severe carpal tunnel syndrome failed medical management -

Exclusion Criteria:

previous failed surgery previous failed injection previous failed trial of hydrodissection cervical or brachial nerve entrapment wrist osteoarthritis or rheumatoid pregnant diabetes mellitus

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Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia

This was a long term follow on study to assess the continued long term safety and efficacy of lomitapide in patients with homozygous familial hypercholesterolemia.

This was a phase III open label clinical trial to evaluate the long-term efficacy and safety of lomitapide at the maximum tolerated dose (for each patient) established during the clinical trial 733-005/UP1002. Subjects completing the 78-week treatment period in study 733-005/UP1002 who have not met any of the stopping criteria will be eligible to participate in 733-012. The treatment period continued until a decision was made by the local competent authority regarding marketing authorization. Lomitapide will be given orally once daily. Patient specific doses will be carried forward from 733-005/UP1002, but will not exceed the maximum tolerated dose the patient received during 733-005 /UP1002. The maximum dose for any patient was 80 mg/day. There was no reference therapy in this trial. The effects of the study drug were compared to baseline data (from 733-005/UP1002). Concomitant lipid-lowering therapy including plasmapheresis or LDL apheresis is permitted.

Note that hereafter, Week 0 in Study 733-005/UP1002 will be referred to as Baseline and Week 48 in Study AEGR-733-012 will be referred to as Week 126 (of overall treatment).

Eligibility Criteria:
Inclusion Criteria:

1. Completed UP1002 or 733-005.
2. Willing and able to provide consent and comply with the requirements of the study protocol.

Exclusion Criteria:

1. Met any of the stopping rules for study discontinuation at the final visit of study UP1002 or 733-005.
Hydrating Efficacy and Tolerance Evaluation of a Face Cream

Aim of the study was to evaluate by non-invasive instrumental evaluations tolerance and hydrating activity of a face topic product, to be applied twice a day, morning and evening, for an uninterrupted period of 8 weeks, by volunteers of both sexes, aged 45-60, who meet the inclusion and exclusion criteria required by the study procedure .

It was also aim of this study to evaluate the hydrating activity of a single product application on the skin damaged by repeated stripping corneum (short term evaluation versus untreated control area).


Eligibility Criteria:
Inclusion Criteria:

* both sexes,
* age 45-60 years,
* caucasian subjects,
* agreeing to present at each study visit without make-up,
* accepting to follow the instructions received by the investigator,
* accepting to not change their habits regarding food, physical activity, face cleansing and make- up use,
* agreeing not to apply or take any product or use face massages or other means known to improve skin wrinkle and skin qualities during the entire duration of the study,
* accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study,
* no participation in a similar study currently or during the previous 3 months
* accepting to sign the Informed consent form.

Exclusion Criteria:

* Pregnancy (only for female subjects),
* lactation (only for female subjects),
* sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit),
* subjects whose insufficient adhesion to the study protocol is foreseeable.
* presence of cutaneous disease on the tested area as lesions, scars, malformations,
* recurrent facial/labial herpes,
* clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).
* endocrine disease,
* hepatic disorder,
* renal disorder,
* cardiac disorder,
* pulmonary disease,
* cancer,
* neurological or psychological disease,
* inflammatory/immunosuppressive disease,
* drug allergy.
* anti-inflammatory drugs, anti-histaminic, topic (application on the face) and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of hormonal treatment starting more than 1 year ago),
* using of drugs or dietary supplements able to influence the test results in the investigator opinion.
Intraoperative Hemodynamics in CABG

The study is to determine the effects of the intraoperative hemodynamics in patients undergoing coronary artery bypass graft on the short-term and long-term outcomes.


Eligibility Criteria:
Inclusion Criteria:

* age18-80 for CABG surgery only

Exclusion Criteria:

* Emergency surgery atrial fibrillation using ECMO/VAD