cyrilzakka/clinical-trials huggingface dataset:
A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma

Raynaud's phenomenon (RP) associated with scleroderma is a difficult problem to treat. Many patients develop ischemic digital ulcers due to severe RP that causes considerable morbidity and adversely affects the quality of life. In an earlier study, we have observed marked improvement in RP attacks and rapid healing of digital ulcers following therapy with phosphodiesterase V inhibitor, Tadalafil. In the present multicentric study we aim to study the efficacy of Tadalafil in patients continuing to have RP attacks despite using at least one or more vasodilators.


Eligibility Criteria:
Inclusion Criteria:

Male or female subjects between the ages of 18 years and 65 years will be selected for the study if they have a clinical diagnosis of Raynaud's phenomenon secondary to systemic sclerosis (scleroderma) despite being on vasodilator therapy. Raynaud's phenomenon is defined as a history of cold sensitivity associated with colour changes of cyanosis or pallor. Patients with a history of at least 4 attacks per week during two-week pre-trial period even with treatment with other vasodilators will be recruited. Patients fulfilling the diagnostic criteria of scleroderma (as per American College of Rheumatology criteria) or having presence of at least 3 of the 5 features of the CREST syndrome (calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, telangiectasias)will be invited to participate in the study.

Exclusion Criteria:

Patients with:

* Symptomatic orthostatic hypotension,
* Evidence of current malignancy,
* History of sympathectomy,
* Upper extremity deep vein thrombosis or lymphedema within 3 months,
* Recent surgical procedure requiring general anesthesia,
* Acute Myocardial Infarction, unstable angina, strokes and transient ischemic attacks within the past three months,
* Smoking,
* Use of any investigational drug within 30 days of the study sessions,
* Use of medications that might interfere with tadalafil like nitrates and alpha adrenergic blockers that have vasoactive effects, and patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole, and itraconazole, erythromycin, itraconazole, and grapefruit juice,
* Patients taking alcohol,
* Patients with bleeding disorders
* Significant active peptic ulceration,
* Current pregnancy,
* Current breast-feeding.
Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg)

This study aims to assess the pharmacokinetic profile of a Fixed Dose Combination nefopam hydrochloride (30 mg) / paracetamol (500 mg) and individual components taken alone or concomitantly after oral single dose.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant female human subjects, age 18 - 45 years.
* Body Mass Index between 18.5-30 Kg / m2 .
* Subjects with normal findings .
* Willingness to follow the protocol requirements

Exclusion Criteria:

* Known history of hypersensitivity to Nefopam, Paracetamol or related drugs.
* Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
* Subjects with a history of convulsive disorders.
* Subject with a moderate or severe renal impairment
* History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
* Female subjects not confirming to using birth control measures,
Doppler Evaluation of Ultrasound-guided Pectointercostal Fascial Plane Block in Cardiac Surgery

The aim of this study was to evaluate the effect of pectointercostal fascial plane block on regional haemodynamic parameters in patients undergoing cardiac surgery.

Perioperative pain management has become an important component of Enhanced Recovery After Surgery (ERAS) protocols in patients undergoing cardiac surgery. Pain is most intense in the first two days after cardiac surgery. Inadequate pain control has been shown to cause an increase in pulmonary complications due to inadequate mobility and coughing, an increase in sympathetic activation, an increase in myocardial infarction and thromboembolic events, delayed wound healing, and prolonged hospital and intensive care unit stay. Non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, opioids, epidural anesthesia and ultrasound-guided fascial plane blocks are widely used for pain management after cardiac surgery. The pectointercostal fascial plane (PIFP) block is an ultrasound-guided, superficial fascial plane block that can be applied as part of multimodal postoperative analgesia, especially after cardiac surgery. PIFB block has been shown to reduce postoperative analgesic consumption and improve pain scores not only in patients undergoing cardiac surgery but also in non-cardiac surgeries and thoracic procedures. The aim of this study was to evaluate the effect of PIFP block on regional haemodynamic parameters in patients undergoing cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* elective cardiac surgery
* over 18 years, adult
* American Society of Anaesthesiology (ASA) I-III

Exclusion Criteria:

* history of cerebrovascular disease
* history of Alzheimer's disease
* mental disorder
* emergency surgery
* re-operated due to surgery-related complications
* allergy to local anaesthetics
* declining to give written informed consent
Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents

To determine if long-term treatment, up to 6 months, with Depakote ER is safe and effective in the treatment of bipolar I disorder in children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Subject and subject's legal representative have voluntarily signed and dated an IRB-approved informed assent form and an IRB-approved informed consent form, respectively, before any study-specific procedures or tests are performed.
* The subject was randomized into Study M01-342 and either completed the study or prematurely discontinued due to ineffectiveness.
* The subject is male or a non-pregnant, non-lactating female.
* Subject is judged to be in general good health based upon the results of a physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory profile (as described in Section 5.3.1)

Exclusion Criteria

* Subject is female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives).
* Subject experienced a serious adverse event in Study M01-342, which the investigator considered "possibly" or "probably related" to study drug.
* Subject is violent, homicidal, or suicidal such that, in the opinion of the investigator, the subject is at significant imminent risk of hurting self or others.
* Subject has any of the following abnormal laboratory results at the last assessment prior to Day 1: Platelet count \</= 100,000/µL; ALT or AST \>/= 2 times Upper Limit of Normal (ULN)
* The subject is taking a protocol allowed medication for ADHD that has not been stable for at least 3 months prior to Day 1, is expected to require a dosage adjustment during the study, or that, in the investigators opinion, may be exacerbating mood symptoms.
* Subject requires treatment with or has taken a protocol-prohibited medication (see Appendix D) within 5 elimination half lives of Day 1.
* Subject has received an investigational drug, other than Depakote ER in Study M01-342, within 30 days prior to Day 1 of this study.
* In the investigator's opinion, long-term treatment with Depakote ER for the subject's mania associated with bipolar disorder is contraindicated.
* For any reason, subject is considered by the investigator to be an unsuitable candidate for this study.
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE W)

The purpose of this study is to determine if the combination of Clopidogrel 75mg once daily (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation therapy with a lower risk of bleeding in patients with atrial fibrillation associated with at least one major cardiovascular risk factor.Primary objectives :The combination of clopidogrel plus aspirin compared to adjusted dose (INR between 2.0 and 3.3) oral anticoagulation (a vitamin K antagonist) will result in the same risk of the composite outcome of stroke, non-CNS systemic embolism, myocardial infarction or vascular death in patients with atrial fibrillation.The secondary objective is to establish whether or not aspirin plus clopidogrel has a lower risk of hemorrhage than standard anticoagulation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of atrial fibrillation either on one current Electrocardiogram (ECG) or on two ECG recorded at two weeks a part during 6 months prior to study enrollment.
* Evidence of high risk of vascular events: at least one of the following risk criteria must be present:

  * are 75 years or greater;
  * on treatment for systemic hypertension;
  * prior stroke, TIA, or non-CNS systemic embolus;
  * left ventricular dysfunction with left ventricular ejection fraction (EF) estimated by echocardiogram or angiogram (radionuclide or contrast) to be \< 45%;
  * peripheral vascular disease (previous peripheral artery revascularization, limb and foot amputation, or the combination of current intermittent claudication and ankle arm systolic blood pressure ratio \< 0.9);
  * age 55 to 74 years; AND
  * either diabetes mellitus requiring drug therapy, or documented previous myocardial infarction, or documented coronary artery disease.

Exclusion Criteria:

* Patients will be excluded from ACTIVE if any of the following are present :

  * requirement for clopidogrel (such as recent coronary stent procedure);
  * requirement for oral anticoagulant (such as prosthetic mechanical heart valve);
  * prior intolerance to ASA or clopidogrel;
  * documented peptic ulcer disease within the previous 6 months;
  * prior intracerebral hemorrhage;
  * significant thrombocytopenia; (platelet count \< 50 x 10(9)/L);
  * psychosocial reason making study participation impractical;
  * geographic reason making study participation impractical;
  * ongoing alcohol abuse;
  * mitral stenosis;
  * pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study;
  * severe comorbid condition such that the patient is not expected to survive 6 months;
  * patient currently receiving an investigational pharmacologic agent; OR
  * requirement for chronic (\> 3 months) non-COX-2 inhibitor NSAID therapy.
A Study to Investigate the Efficacy and Safety of Eribulin in Korean Breast Cancer Participants

The primary objective of the study is to observe efficacy in terms of progression-free survival rate at 6 months in eribulin-treated breast cancer participants retrospectively.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of locally advanced or metastatic breast cancer
* Participants who were treated with Eribulin between 01 June, 2014 and 31 December, 2016

Exclusion Criteria:

* Not applicable
CHARITÉ™ Artificial Disc Compared to Anterior Interbody Fusion for Treatment of Degenerative Disc Disease

The study is designed to evaluate the safety and effectiveness of the CHARITE Artificial Disc compared to anterior lumbar interbody fusion for treatment of degenerative disc disease at one level of the lumbar spine (either L4/L5 or L5/S1).

Treatments for disc degeneration have historically included conservative modalities, such as rest, heat, electrotherapy, physical therapy, and analgesics to surgery. Currently, there are two main surgical techniques for treatment of disc degeneration: (1) nucleotomy or diskectomy, i.e., excision of part or all of the degenerated disc, which is typically performed for treatment of radicular syndrome in the case of disc herniation; and (2) spinal fusion, i.e., grafting bone between the vertebrae adjacent to the degenerated disc to eliminate articulation at the damaged segment, which is typically performed for treatment of degeneration together with instability and reduction of the intervertebral space. Rigid internal fixation may also be used to promote fusion.

The CHARITÉ Artificial Disc is designed to provide a new therapeutic option for treatment of degenerative disc disease as an alternative to spinal fusion to preserve function in the lumbar vertebral region. Each institution participating in the study was to treat the first 5 consecutive study participants with the CHARITE to as it involves a modification to the technique used for anterior fusion. Data will be collected on these "training" cases but will not be included in the comparison with the control (fusion) treatment.

Comparison: Outcomes for patients treated with the CHARITÉ Artificial Disc will be compared to outcomes for patients treated with anterior lumbar interbody fusion.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 60 years of age inclusive
* symptomatic degenerative disc disease confirmed by provocative discogram
* single level disease L4/L5 or L5/S1
* leg or back pain without nerve root compression
* VAS pain score \>= 40
* Oswestry Disability Index score \>= 30
* six months prior conservative treatment
* appropriate for anterior surgical approach

Exclusion Criteria:

* previous lumbar or thoracic fusion
* other spinal surgery at target level
* symptomatic multiple level degeneration
* non-contained or extruded nucleus pulposus
* compression or burst at L4, L5, or S1 due to trauma
* mid-sagittal stenosis \< 8mm
* osteoporosis, osteopenia, or other metabolic bone disease of the spine
* spondylolisthesis \> 3mm, scoliosis \> 11 degrees
* facet joint arthrosis
* isthmic spondylolisthesis
* positive straight leg raise for radiculopathy
Elucidating the Symptomatic, Explanatory and Prognostic Characteristics of GERIAtric Patients Hospitalized for COVID-19

Statement :

* The emerging Coronavirus 2019 (COVID-19) disease, linked to the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) pathogen, has been spreading worldwide since December 2019, affecting millions of people and causing hundreds of thousands of deaths, particularly among the elderly.
* The first epidemiological evidence available reveals a different expression of the disease in the elderly, associated with a high risk of delayed diagnosis and implementation of protective measures and a particularly high morbidity and mortality, especially among the frailest.
* To date, there is no effective model for predicting the severity of COVID-19 in an individual.

The investigators hypothesize that there are specificities of COVID-19 in the elderly, both etiological, diagnostic and prognostic, all of which are not yet known and understood.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization in the Geriatric unit of the University Hospital (UH) of Angers from 15/03/2020 and until the closure of the COVID-19 geriatric sector

Exclusion Criteria:

* Opposition to the use of the information collected for research purposes.
A Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for Treating Low Rectal Cancer

In this study, the investigators assessed the difference in efficacy and safety among robotic-assisted versus laparoscopic abdominoperineal resection for patients with low rectal cancer.

Patients will be eligible for inclusion if their primary tumors is low rectal cancer.

Eligible patients will be randomly assigned to robotic-assisted (arm A) versus laparoscopic (arm B) abdominoperineal resection.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven rectal adenocarcinoma
* Inferior edge of the tumor located within 5 cm from the anal verge as determined by colonoscopy withdrawing and digital rectal examination
* No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc) according to ultrasound, CT, PET-CT, etc
* Tumor assessed as cT1-T3 or ycT1-T3 after preoperative neoadjuvant chemoradiotherapy by pelvic MRI
* No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
* Suitable for both robot-assisted and laparoscopic surgery
* American Society of Anesthesiologists (ASA) class I - III
* No other preoperative treatment except neoadjuvant chemoradiotherapy
* Informed consent

Exclusion Criteria:

* Tumors assessed as cT1N0 and suitable for local excision
* Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
* More than one colorectal tumor
* Familial Adenomatosis Polyposis, Lynch Syndrome, acute inflammatory bowel disease
* Schedules need for other synchronous colon surgery
* Absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class \> III)
* Pregnancy or lactation
* Patients and/or family members can not understand and accept this study
* Patients received chemoradiotherapy or other anti-tumor therapy before surgery
A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition

This study will develop and evaluate the effectiveness of a self-management program for adults living with both schizophrenia and a co-occurring medical condition.

Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, and believe that others are controlling their thoughts. People with schizophrenia also experience increased rates of concurrent medical conditions, such as diabetes, respiratory illness, and heart disease. This can make holding a job or even caring for oneself very difficult. The purpose of this study is to develop and evaluate a self-management program for adults living with both schizophrenia and a concurrent medical condition.

Participants in this open-label study will attend 10 to 16 group sessions led by two group leaders. Group sessions will meet each week for an hour during which participants will learn new skills to help them take responsibility for the daily management of chronic medical conditions. In addition to learning how to communicate more effectively with medical providers, participants will learn about healthy eating, the importance of physical activity, addictive behaviors that can worsen health conditions, and proper use of medications. Homework will be assigned weekly for participants to review skills learned in each session. After each session, participants will complete a survey to evaluate the session's effectiveness. At the end of the study, participants will attend one additional group meeting and an individual interview to discuss the overall effectiveness of the intervention and their experiences in the group sessions. The results of this study will be used to evaluate and improve the self-management program for future use.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
* Current documented chart diagnosis of at least one chronic medical condition
* Received clinic services for a minimum of 3 months prior to study entry
* English-speaking
* Willing to use an effective form of birth control throughout the study if sexually active

Exclusion Criteria:

* History of a serious neurological disorder or head trauma with loss of consciousness
* Diagnosed with mental retardation or dementia
* Diagnosed with end stage organ disease
* Currently receiving chemotherapy and/or radiation treatment for cancer
* Received psychiatric hospitalization less than 3 months prior to study entry date
* Blind and/or deaf
* Pregnant
* Infected with HIV with a CD4 count under 350
* Diagnosis of AIDS
* Diagnosis of anorexia
* Problematic substance use, as defined by a mental health provider
* Psychiatric instability, as defined by a mental health provider
Support Strategies for Parents During the First Year Following Their Child's Diagnosis of Sickle Cell Disorder

Background: Sickle cell disorder (SCD), the commonest genetic (faulty gene inherited from both parents) condition in the UK, affects mainly underserved groups. Babies with SCD must start treatments soon after birth to prevent them becoming unwell. Stigma, fear and inequalities can make it difficult for parents to accept their child's diagnosis and access appropriate treatment and support.

Aim: Develop strategies to improve support for parents during their child's first year of life following a SCD diagnosis to encourage early engagement with health services.

Method: Comprises two stages: (i) Determine why parents choose to engage with support or not (ii) Use this information to co-design strategies to ensure greater accessibility of support for parents during their child's first year of life.

Patient and Public Involvement: We are working with Sickle Cell Society and parents of children with SCD. Dissemination: Findings will be shared with support groups, charities, health professionals and academics.


Eligibility Criteria:
Inclusion Criteria:

* Parents whose children have been diagnosed with SCD via screening in the last 36 months
* Health professionals involved in the care of children with sickle cell disorder

Exclusion Criteria:

* Parents whose inclusion may be contradicted on psychosocial grounds or who are unable to give informed consent.
* Health professionals who do not have experience of caring for children with sickle cell disorder.
Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension

The primary purpose of this study is to investigate the safety and efficacy of bilateral DWT in subjects with POAG or OHT compared to active and sham controls. The secondary purpose of the study is to investigate the durability, repeatability, and does response of the same.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 18 years or older.
* Subjects diagnosed with either POAG or OHT in both eyes. The diagnosis of POAG must include evidence of:

  1. Optic disc or retinal nerve fiber layer structural abnormalities (substantiated by OCT); and/or
  2. Visual field abnormality (substantiated with the Humphrey automated perimeter using the SITA Standard 24-2 testing algorithm. Mean deviation (MD) score must be -15dB \< MD \< 0dB.
* Subjects with a 9:00AM (+/- 1 hour) median IOP in both eyes that is:

  1. Greater than or equal to 18mmHg at the Screening Visit or have documented history of IOP being greater than or equal to 22mmHg;
  2. Greater than or equal to 22mmHg at both Eligibility Visits.
* Subjects currently using one or more topical medications to control their IOP.
* Subjects able and willing to comply with the protocol, including randomization assignment and all follow-up visits.
* Subjects that sign the informed consent form.

Exclusion Criteria:

* Subjects who are pregnant, lactating, or planning to become pregnant during the course of the study.
* Subjects with any form of glaucoma other than primary open-angle glaucoma (e.g., pseudo exfoliation or pigmentary glaucoma).
* Other exclusion criteria apply