cyrilzakka/clinical-trials huggingface dataset:
Laser Assisted Drug Delivery in the Treatment of Superficial Non Melanoma Skin Cancer: a Randomized Controlled Trial

Photodynamic therapy (PDT) is a well established treatment option for superficial non melanoma skin cancer, such as superficial basal cell carcinoma (sBCC) and Bowen Disease (BD). However, a limited uptake of the topically applied photosensitizer methyl aminolevulinate (MAL) may reduce its efficacy. Pretreatment with an ablative carbon dioxide (CO2) laser has recently been studied in order to enhance the skin penetration of this photosensitizer. This study compares the results of a full ablative and a fractional ablative CO2 laser mode as pretreatment of PDT in the management of sBCC and BD. The endpoints efficacy, pain, aesthetics and patient preference are investigated during twelve months of follow up.

Superficial Basal Cell Carcinoma (sBCC) and Bowen Disease (BD) are malignant skin tumors localised in the superficial epidermis. These tumors are highly prevalent in the caucasian population. Diagnosis of sBCC and BD is often delayed because the clinical manifestation may be discrete and lesions are sometimes wrongly diagnosed and treated as eczema. Once the diagnosis is established, the lesions may cover an extensive area, making surgical excision more difficult. At that moment, the physician can make use of less invasive techniques such as photodynamic therapy (PDT). Pretreatment with an ablative carbon dioxide (CO2) laser has recently been studied in order to enhance the skin penetration of the photosensitizer methyl aminolevulinate (MAL). This study compares the results of a full ablative and a fractional ablative CO2 laser mode as pretreatment of PDT in the management of sBCC and BD. Ablation of the upper epiderm of the cancer results in an deeper penetration of MAL. Fractional ablation is known to result in better wound healing compared to full ablative CO2 laser ablation, because only small skin columns are ablated instead of the entire epidermal layer. Patients with non operable sBCC or BD lesions covering an area of at least 5 cm2 or with the presence of two small separated lesions, will be investigated. Lesions greater than 5 cm2 are divided in two. After randomization, the half of the lesions will be pretreated with the full ablative CO2 laser, while the other half with the fractional ablative CO2 laser. Afterwards, the entire surface is treated with MAL-PDT. Such as in our current clinical practice, this treatment modality is repeated after a two week interval. Thus, every subject undergoes both treatment modalities, making within-patient comparison possible. The endpoints efficacy, pain, aesthetics and patient preference are investigated during twelve months of follow up.

Eligibility Criteria:
Inclusion Criteria: patients with the presence of

* non operable superficial Basal Cell Carcinoma or Bowen's Disease lesions
* and the presence of at least two lesions or the presence of one lesion covering an area greater than 5cm2

Exclusion Criteria: pregnancy and/or breast feeding
Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage

The purpose of this study is to decrease the likelihood of composite postpartum hemorrhage (PPH) morbidity, which consists of i) Estimated or quantified blood loss of 1,500 mL or more, ii) transfusion of any blood products or iii) hysterectomy


Eligibility Criteria:
Inclusion Criteria:

* Singletons with a gestational age of 34.0 weeks or more
* Labor (spontaneous or medical induction)
* Medium- or High-risk for PPH, as described by American College of Obstetricians and Gynecologists (ACOG)

Exclusion Criteria:

* Scheduled cesarean delivery
* Multiple gestations
* Delivery at \< 34.0 weeks
* Contraindication to place intrauterine pressure catheter (e.g. HIV)
* Incarcerated subjects
* Major fetal anomalies requiring neonatal surgical intervention
* Stillbirth on admission
Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

The purpose of this double-blind, controlled, randomized study is to investigate the antidepressant efficacy of oral ketamine treatment in patients suffering from a major depressive episode.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a major depressive episode in the scope of a major depressive or bipolar disorder supported by a Structured Clinical Interview for DSM-IV-TR (SCID)
* Hamilton depression rating scale score ≥ 19
* Willingness and competence to sign the informed consent form
* Stable psychopharmacological treatment for 10 days (except benzodiazepines)

Exclusion Criteria:

* Initiation of a new antidepressant or mood stabilizing treatment (pharmacological, physical or psychotherapeutic) with adequate dosage (as defined by the minimum recommended dose in the respective prescribing information) within 4 weeks prior to inclusion
* Prior use of ketamine
* Pregnancy/Breast feeding
* Instable arterial hypertension \>170/110mmHg
* Hepatic dysfunction
* Hyperthyreosis
* History of glaucoma
* Neurodegenerative disorders
* Any unstable medical illness
* History of substance abuse within the past 12 months
* History of psychosis
* Failure to comply with the study protocol or to follow the instructions of the investigating team
* Current treatment with one of the following drugs: clopidogrel, carbamazepine, valproate, barbiturates, memantine, modafinil, disulfiram, amiodarone, ranolazine, phenytoin, verapamil, fibrates, antiretroviral agents, antimicrobial chemotherapeutics, azole antifungals, glucocorticoids, cyclosporine, valeriana/garlic/grapefruit preparations, St. John's wort.
Arrhythmic Manifestations and Management in Hospitalized COVID-19 Patients

Although arrhythmias appear to be common in COVID-19 patients, arrhythmia mechanisms and characteristics, predisposing factors, incidence of sudden cardiac death and predictors, therapeutic strategies employed as well as long term outcomes are not well understood. Hence, we seek to develop a multicenter registry aimed to characterize arrhythmic manifestations, employed treatment strategies and long-term outcomes among hospitalized COVID-19 patients in the US.

The novel coronavirus (SARS-CoV-2) and the resulting respiratory tract infection (Coronavirus Disease 2019 or COVID-19) is a pandemic with over 3 million cases globally and resulting in \>230,000 deaths at the time of this writing. From initial reports in Wuhan, China, viral progression resulted in over 80,000 cases in January/February 2020 in China. The following global spread has involved more than 210 countries. Unfortunately, the United States has been significantly affected, with over 1 million confirmed cases and over 60,000 deaths, the highest in the world. As this global pandemic continues to rage, cardiovascular, especially arrhythmic manifestations associated with COVID-19 have become evident. A recent report from Wuhan, China, noted that 16.7% of hospitalized and 44.4% of ICU patients with COVID-19 had arrhythmias. Although arrhythmias appear to be common in COVID-19 patients, arrhythmia mechanisms and characteristics, predisposing factors, incidence of sudden cardiac death and predictors, therapeutic strategies employed as well as long term outcomes are not well understood. Hence, we seek to develop a multicenter registry aimed to characterize arrhythmic manifestations, employed treatment strategies and long-term outcomes among hospitalized COVID-19 patients in the US.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age
* Hospital admission with COVID-19

Exclusion Criteria:

● Age \< 18 years
Evaluation of the Benefit of Traditional Karate in Heart Failure for Cardiac Rehabilitation

Cardiac rehabilitation is based on physical activity which, usually, associates combination of a cycle ergometer or treadmill completed by gymnastics.

Some studies have been done with complementary physical activities such as tai chi or yoga integrated into the strategy of non-drug therapies. The tai chi study showed a tendency to improve the peak of VO2 in the tai chi group but which was not significant but also a significant improvement on secondary objectives such as quality of life, the increase in the 6-minute walk test and a decrease in the level of natriuretic peptides. A study of the effects of yoga after coronary artery bypass surgery showed at one year an improvement of the ejection fraction, the lipid profile and the state of anxiety of the patients. This study showed that the addition of yoga to conventional cardiac rehabilitation could improve cardiovascular risk factors especially in patients with abnormalities such as low HDL.

The physical activities offered in rehabilitation to improve physical performance are currently limited to cycling, treadmill or gymnastics. Many patients do not like cycling or treadmill, which limits their adherence to a cardiac rehabilitation program. Moreover, one of the main problems of rehabilitation is that after the rehabilitation cycle, a minority of patients continue the physical activity. Strategies for implementing home exercises have been tested to increase the level of physical activity after rehabilitation.

Cardiac rehabilitation has several components: correction of risk factors, optimization of treatment, physical activity to improve the physical abilities to exertion that are directly correlated to mortality.

Our hypothesis is that the implementation of a program of physical activity based on traditional karate would improve the physical abilities to effort and the quality of life of patients, to give a better psychological confidence to patients who, after a cardiovascular event such as acute coronary syndrome, bypass surgery or valvular surgery, have marked anxiety or depression. Rehabilitation, and especially physical activity, is one of the therapeutic means proposed. The interest of this study would be to be able to offer an additional activity for rehabilitation centers, to offer patients an activity in post-rehabilitation. In addition, interaction between patients could increase adherence to rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female ≥ 18 years
* Patient with heart failure
* Patient with impaired ejection fraction with Left ventricular ejection fraction ≤ 40%
* Patient affiliated with a health insurance plan
* Patient giving free, informed and express consent

Exclusion Criteria:

* Patient under tutorship or curatorship
* Patient deprived of liberty
* Non-French speaking patient
Antidepressant Discontinuation in Treatment Resistant Depression

The purpose of this study is to compare the effects on depressive symptoms of subjects who discontinue serotonergic antidepressants (a certain type of antidepressant, such as Prozac, that works on serotonin receptors in the brain) with the effects on depressive symptoms of subjects who continue to take serotonergic antidepressants. During this study, subjects will also be presented with the opportunity to undergo genetic testing for the serotonin gene transporter which has a short or long form. This is being done because it has been demonstrated that genetic testing improves outcome while treating treatment-resistant depression.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be a man or woman 18 to 70 years of age, inclusive.
* Subject must meet criteria for a major depressive disorder as confirmed by the Mini International Neuropsychiatric Interview \[MINI\].
* Subjects must have a current Treatment-Resistant Depression as defined below.
* Subjects must have been taking serotonergic antidepressants (serotonin reuptake inhibitor or monoamine oxidase inhibitor) for at least 2 years but not more than 4 years, and have failed 2 previous medication trial for the current episode. Current Montgomery-Åsberg Depression Rating Scale \[MADRS\] score must be equal to or more than 25.
* Subject must be medically stable.
* Female subjects must have a negative urine pregnancy test at screening, and agree to avoid pregnancy during the study.
* Each subject must sign an informed consent form indicating that he/she understands the purpose of the study and the procedures required and are willing to participate in the study.
* Subject must be able to participate in symptom measurement.

Exclusion Criteria:

* Subject has a current Diagnostic and Statistical Manual of Mental Disorders-5 \[DSM-5\] diagnosis of bipolar disorder or has a positive screening for bipolar disorder by Mini International Neuropsychiatric Interview \[MINI\] or Mood Disorder Questionnaire \[MDQ\].
* Subject has a current DSM-5 diagnosis of schizophrenia, schizoaffective disorder, autistic disorder, or intellectual disability.
* Subject has a substance use disorder (except for nicotine or cannabis) within 3 months prior to screening or has a positive drug screen test for any recreational drugs at the time of screening with the exception of Cannabis.
* Subject has evidence of any clinically significant, unstable medical problems that may create a safety risk for a subject, interfere with study participation, or make results difficult to interpret.
* Subject is at imminent risk of suicide according to the investigator's clinical judgment and/or a Columbia-Suicide Severity Rating Scale (C-SSRS) 3 or more at any time in the study.
* Subject is a woman who is pregnant, breast-feeding or planning to become pregnant while enrolled in the study.
* Subject has any condition (according to the investigator) for which participation will not be the best interest for the subject or it can prevent, limit or confound the protocol-specified assessments.
Hand Ligament Reconstructions With Knee Collateral Ligament Allografts

The purpose of this study is to review the clinical outcomes following hand ligament reconstruction surgery using allograft (cadaveric) knee collateral ligaments. Currently, there is no standard procedure or devices used for hand ligament reconstruction surgery, although most techniques use some form of autograft (patients' own tissue) for the reconstruction. We believe that the use of allograft ligaments in reconstruction may eliminate the pain associated with procuring the patients' own tissue for the procedure, and prove to be a viable and preferred alternative to the multiple techniques currently used.

The main procedures of this study include wrist and hand ligament reconstruction surgery (for wrist scapholunate (SL) ligaments, thumb ulnar collateral ligaments (UCL), and finger proximal interphalangeal (PIP) joint collateral ligaments) using allograft ligament, and subsequent follow up appointments where measurements and questionnaires will be completed to evaluate how hand function is doing after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Have symptomatic injuries to either their finger PIP collateral ligaments, thumb UCL ligaments, or wrist SL ligaments and have failed non-operative management for the above ligament injuries (thus eligible for operative reconstruction)
* Age over 18 years

Exclusion Criteria:

* Presence of any other current injury in that limb
* Presence of advanced arthrosis in that limb
* Presence of fixed joint deformity in that limb
* Presence of instability in that limb due to bony or articular instability
* Presence of instability in that limb due to inflammatory arthrosis
* Is under 18 years of age
* Lacks the capacity to consent
IQP-CL-101 in IBS Management

After 2 weeks of run-in period, subjects are randomized to either IQP-CL-101 or a matching placebo. Over 8 weeks, the subjects are monitored for improvements in IBS symptoms


Eligibility Criteria:
Inclusion Criteria:

* Fulfils Rome-III criteria for IBS diagnosis
* Females' agreement to use appropriate birth control methods during the active study period for females of childbearing potential
* Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply

Exclusion Criteria:

* Known sensitivity to any of the ingredients of IQP-CL-101
* Clinically relevant abnormalities in colonoscopy within the last 2 years prior to randomization
* Other causes of IBS symptoms such as inflammatory bowel disease (IBD), microscopic colitis, celiac disease, history of abdominal obstruction, cholecystitis, pancreatitis, ileus, or any gastrointestinal bleeding
* Use of medications that could influence GI functions (e.g. antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or anti-diarrheals) within 1 month prior to randomization
* Clinically relevant excursions of safety parameters
* Any other conditions deemed relevant by the investigator(s)
Transversus Abdominis Plane Blocks With Abdominoplasty

Comparing morphine consumption and recovery with two different TAP block techniques after abdominoplasty.

TAP blocks have the potential to become an important part of multi-modal analgesia after abdominal surgery (1,2). Originally Dr J McDonnell described a blind double pop technique, trough the triangle of Petit, with up to 48 hours of analgesia (3,4). Dr P Hebbard described an ultrasound based technique with a subcostal (for supra-umbilical analgesia) and an axillary mid-line injection (for sub-umbilical analgesia) in the TAP, with reported analgesia for up to 8 hours (5,6). Recently Dr J McDonnell presented data showing para vertebral spread (up to L5) of the (high dose, low concentration) local anaesthetic explaining the prolonged analgesic effect (7,8). In 2007 Dr Blanco described an ultrasound guided technique for the posterior inﬁltration as performed by McDonnell (9). Our limited observational comparison between both block techniques conﬁrms this difference. We decided to compare both techniques (the ultrasound guided single shot subcostal injection, the aTAP-group (Hebbard is from Australia) and the ultrasound guided posterior injection, the iTAP-group (McDonnell is from Ireland). We will use the same volume and concentration of local anesthetic and we will asses their analgesic efﬁcacy and improvement in quality of recovery.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for abdominoplasty
* ASA 1-2
* Fluent french/dutch/english

Exclusion Criteria:

* History of allergy to local anaesthetics
* Chronic opioids abuse
* Pregnant patients
Registry of Non-primary Angioplasty at Hospitals Without Surgery On-site

This is a simple registry of patients undergoing PCI at hospitals without surgery on-site who were participants in the CPORT-E project. The aim of the registry is simple data collection and reporting to respective State Departments of Health. The registry population consists of patients undergoing diagnostic cardiac catheterization for suspected CAD at hospitals without SOS and who require PCI.


Eligibility Criteria:
Inclusion Criteria:

Patient inclusion criteria are:

Pre-catheterization

1. must be undergoing diagnostic cardiac catheterization for suspected CAD
2. be at least 18 years of age
3. must not be pregnant (negative pregnancy test) or must not be of childbearing potential
4. must be able to give informed consent. Post-catheterization
5. coronary artery disease judged to be clinically and angiographically significant
6. ability to perform PCI with equipment available at the local site (see below)
7. procedure risk judged to be not high (see below)

Exclusion Criteria:

Patient exclusion criteria are:

Pre-catheterization

1. inability to give informed consent
2. ST-segment elevation myocardial infarction
3. pregnancy Post-catheterization
4. high likelihood of requiring a device not available at the hospitals without SOS (see below)
5. no need for PCI
6. need for coronary artery bypass surgery
7. high procedural risk (see below)
Description of the Evolution of Functional Dysphonia Managed by Hypnotherapy

HYPNODYS is a single-center study evaluating the evolution of perceived voice-related disability before and after 3 standardized hypnosis sessions in patients with functional dysphonia.

Functional or psychogenic voice and speech disorders are characterized by various changes in voice (aphonia or dysphonia) or speech (stuttering, foreign accent syndrome, and childish prosody in adults) without organic damage associated. These disorders have a significant functional impact (physical and mental handicap) and a significant cost for society.

Their management, like that of functional neurological disorders in general, is still poorly codified. Different therapeutic strategies are mentioned, especially in the event of speech therapy failure, in particular behavioural and cognitive psychotherapeutic approaches.

The recent explanatory hypotheses of functional neurological disorders are that the processing of sensory and motor information can be modulated, or even inhibited, by cognitive and attentional mechanisms. Different elements (volition, emotions, attention) can exclude certain psychic representations from consciousness.

Hypnosis, by exercising direct control over attentional resources makes it possible to obtain hypoactivation of the medial prefrontal cortex and hyperactivation of the executive and salience networks, making greater use of the buffer of working memory and activate the para-sympathetic system. Thus, one can observe analgesia, amnesia, a loss of the notion of time, plurimodal hallucinations, a detachment from oneself, a distortion of reality and logic.

Hypnosis has been used since the 19th century in the treatment of functional paralysis. To date, there are only presentations and case series evaluating the value of hypnosis in functional disorders of voice and speech. However, from a clinical standpoint, the use of hypnosis seems to show a significant interest in functional speech disorders.

Functional neurological disorders are located at the crossroads of neurological and psychiatric disorders, psychiatric and psychological evaluation of these patients therefore seems necessary in order to measure their impact on the pathological and recovery processes through hypnotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of functional neurological disorder according to the DSM-5
* Supported at the Rothschild Foundation as part of a hypnotherapy protocol
* Mastering the understanding of the French language
* Express consent to participate in the study

Exclusion Criteria:

* Organic etiology of dysphonia
* Decompensation of a psychiatric pathology
* Discovery during study of an organic etiology not initially identified
A Study of BI 853520 in Japanese and Taiwanese Patients With Various Types of Advanced or Metastatic Cancer

The primary objective of this trial is to explore the safety and tolerability of BI 853520 monotherapy and determine the maximum tolerated dose (MTD) for Japanese and Taiwanese patients with advanced or metastatic solid tumours.

Secondary objective is collection of preliminary data on anti-tumour efficacy


Eligibility Criteria:
Inclusion criteria:

* Patients with a confirmed diagnosis of advanced, measurable or evaluable, non-resectable and/or metastatic non-hematologic malignancy, which has shown to be progressive in the last 6 months
* Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options
* Recovery from reversible toxicities (alopecia excluded) of prior anti-cancer therapies (Common Terminology Criteria for Adverse Events grade \<2)
* Age \>= 20 years
* Written informed consent in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation
* Eastern Cooperative Oncology Group (ECOG), performance score 0-1

Exclusion criteria:

* Serious concomitant non-oncological disease/illness
* Active/symptomatic brain metastases
* Second malignancy
* Pregnancy or breastfeeding
* Women or men who are sexually active and unwilling to use a medically acceptable method of contraception.
* Treatment with cytotoxic anti-cancer-therapies or investigational drugs within four weeks of the first treatment with the study medication