cyrilzakka/clinical-trials huggingface dataset:
RaGuS Trial by Postoperative Patients

Vasoplegic syndrome is characterized clinically by reduced systemic vascular resistance and normal or increased cardiac output. It is principally observed in cardiovascular and orthopedic interventions and is characterized by a systemic inflammatory response with the inability of the vascular endothelial muscles to contract and a resistance to the action of vasoactive drugs. This event extends the length of stay in the critical care area due to the need of vasoactive drugs.

The investigators aim to assess the standardized application of midodrine in postoperative patients without sepsis and need of vasoactive drugs in order to reduce the length of stay in critical care area and for extension in hospital.

Midodrine is an alpha 1 receptor agonist used usually in cases of hypotension helping to increase blood pressure. The main indication is orthostatic hypotension but there are other clinical conditions where this medicament is often used like hypotension by dialysis, hepatorenal syndrome and after carotid artery stenting.

Vasoplegic syndrome coul be interpreted as a variant of orthostatic hypotension that happens usually after surgical interventions. It produces a loss of systemic vascular resistance due to inflammatory reaction without any signs of infection.

The investigators aim to conduct a randomized, double-blind, single-center, placebo-controlled study of midodrine in patients who present postoperative vasoplegia with no active signs of sepsis but need of vasoactive drugs (Noradrenalin).

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Need of vasoactive drugs after three hours from arrival and adequate volume recovery.

Exclusion Criteria:

* Signs of infection (anamnesis or pro-calcitonin \> 0.2 with leukocytosis, CRP and/or fever)
* Serum lactate \> 2mmol/l
* Mechanical ventilation
* Therapeutic restrictions or comfort measures at arrival
* "de novo" or acute on chronic heart failure (Reduction of known ejection fraction for more than 20 percent, signs of acute lung edema)
* Pregnant
* Patients with digoxin treatment or history of glaucoma.
* History of midodrine allergy, pheochromocytoma, thyrotoxicosis, tachyarrhythmias or ventricular fibrillation.
Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant COCHLESURV

The number of patients with cochlear implants increases every year, constituting an active queue increasingly important (60 new cases per year in Toulouse, active list in 2013: 380 adult patients). The number of approved cochlear implant centers is limited by guardianships, and corresponds to the Hospitals University. It is not possible to create networks of correspondents. Teams of implantation centers must meet the needs of new patients and ensure continuity of care for patients already implanted: speech therapy monitoring, adjustment and rehabilitation.

In case of malfunction of the implant, patients use in first-line reference center. The increasing number of patients leads to a lack of specialized teams that can not meet the demands of patients in a timely manner, while continuing to provide support for new patients. It is therefore necessary to find solutions to improve the service provided to patients who received a cochlear implant system to respond quickly and effectively to the request of troubled patients, while optimizing the workload of the teams . The introduction of a telemedicine platform is expected to achieve these goals, distinguishing minor malfunctions, not requiring a consultation in a center, and the most complex situations requiring consultation in a center.

The strategy of the study is to establish contact with the patient at home in case of problems through the establishment of a daily continuously in service by telephone contact and video calling.

There will be no change in the usual care of the patient. The monitoring center by health professionals (speech therapists, technicians and doctors ORL) in the cochlear implant center will operate a daily permanence of 5 half days on business days, to respond to a patient call.

Are excluded from this research, emergency management such as meningitis, which passes through the usual emergency lane.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\> 18 years), carrying a cochlear implant,
* Familiar with using the Internet and with equipment (computer and computer video camera) at his home
* Agreeing to participate in the study,
* With a social protection system.

Exclusion Criteria:

* Misunderstanding of login procedures,
* Failure to follow procedures,
* Person under a legal protection system (guardianship, curators or safeguard justice)
* Pregnancy or breastfeeding.
Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women

The purpose of this study is to figure out if postmenopausal women find a mindfulness audio recording acceptable for use along with physical activity, and to find out if this tool is helpful in increasing daily physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Patients self-report as being \> 1 year postmenopausal.
* Patients are able to walk without a walking aid.
* Patients own and know how to operate a smart phone or tablet.
* Patients are willing and able to complete the activity monitoring.
* Patients are self-reportedly underactive.

Exclusion Criteria:

* Patients are \< 1 year postmenopausal.
* Patients require a walking aid for daily mobility.
* Patients do not own a smartphone or table, or are unwilling to use such a device for the purposes of the study.
* Patients' primary form of exercise is swimming (the activity monitors are not waterproof).
* Patients are unable or unwilling to complete activity monitoring.
* Patients are unable to provide informed consent independently.
SYV: A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth

The overall objectives of this proposal are to support positive coping strategies that bolster mental health and lead to improved HIV outcomes among Young People Living with HIV (YPLWH). The central hypothesis is that SYV (Sauti ya Vijana, The Voice of Youth) will be effective to improve antiretroviral therapy (ART) adherence and virologic suppression in YPLWH in Tanzania. The rationale for this project is that by targeting mental health, which is strongly associated with medication adherence, that this will effectively improve adherence and thereby HIV viral suppression. The central hypothesis will be tested in three aims in a hybrid type-1 effectiveness-implementation trial.

The rigorous experimental design includes a pilot study followed by a parallel-arm randomized control trial (RCT). The pilot will include approximately eight consenting members of the youth community advisory board (CAB) at each site location prior to the RCT. If a youth CAB does not currently exist at each site, one will be formed. Although the investigators have strong pilot data for the SYV intervention from Moshi, the pilot test proposed herein will help ensure recruitment, enrollment, intervention delivery, supervision, measurement technology and logistics run as expected at each site (Moshi, Mbeya, Mwanza, Ifakara). The pilot study will be comprised of 8 participants recruited at each site. Subsequently, for the RCT, we will individually randomize up to 750 participants to receive the SYV intervention or SOC (standard of care) to achieve 90% power to detect a 10 percentage point difference between arms in the primary outcome of virologic suppression at the two-tailed 5% significance level, accounting for clustering by SYV group in the intervention arm.

The intervention will be rolled out across four main sites, in four different Tanzanian regions, and in four waves separated in time by 6 months. There will be two SYV groups per wave at each site (\~8 groups per site) A study visit for all participants will be conducted baseline and approximately 4 months (T1), 6-, 12-, and 18-months post-baseline (T2, T3, T4) with 6-months post baseline being the primary endpoint. At 12 months post-baseline (T3), those randomized to the SYV intervention will receive a one-session SYV booster to improve content retention and study engagement as has been shown in prior studies.

Eligibility Criteria:
Inclusion Criteria:

* Youth between the ages of 10 and 24 years of age
* Attending the enrolling adolescent HIV clinic
* Are fully disclosed and aware of their HIV status
* Receiving ART for a minimum of 6 months
* If ≥ 18 years, able to understand the project and provide written informed consent
* If \<18 years, a parent or guardian must provide written permission and participant must be able to assent
* All adolescents must also commit to attending the 10 weekly SYV sessions and 2 individual sessions

Exclusion Criteria:

* Active psychosis
* Developmental delay, or cognitive disability that precludes active participation in consent process, intervention, and assessment interviews
Randomized, Controlled Trial to Test the Efficacy of Interferon Beta in the Treatment of Intermediate Uveitis

The purpose of this study is to investigate if interferon beta is superior to the standard treatment with Methotrexate for the treatment of intermediate uveitis and macular edema.

Deuter et al were the first to show the anti-edematous effect of interferon alpha on inflammatory macular edema (Deuter C. M. E., Kötter I., Günaydin I., Zierhut M. Treatment of the Cystoid Macular Oedema in Behçet's Disease with Interferon Alfa-2a, Retina, in press). In an interventional, multi-centric pilot-study we could demonstrate a positive effect of interferon beta on ED associated uveitis, especially in reducing the macular edema. Undesired effects of the treatment were not observed.

Thus we want to test the efficacy and safety of interferon beta compared to standard treatment with methotrexate in a prospective, clinically controlled trial on patients who suffer from intermediate uveitis with inflammatory macular edema who either have associated ED or have no systemic disease association, i.e. primary uveitis. .

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age 18 and over
* Active uni- or bilateral non-infectious intermediate uveitis of at least 1 year duration
* Visual acuity on the worse eye at least 0.1 (20/200) and maximally 0.6 (20/30) caused by macular edema, defined by foveal thickness ≥ 250 µm
* Either primary uveitis or diagnosis of Multiple Sclerosis
* Previous treatment with oral corticosteroids in a dose of 0.5 mg per kg bodyweight of prednisone equivalent without sufficient success
* Previous treatment with other immunosuppressive drugs is facultative

Exclusion Criteria:

* Exclusively anterior uveitis
* Absence of macular edema
* Optic nerve atrophy after neuritis nervi optici
* Peri-or intraocular injection of corticosteroids in the previous 3 months
* Allergies against any interferon
* Depression diagnosed by a psychiatrist
* Hepatic disease
* Infectious Uveitis
* Other auto-immune diseases but MS
* Pregnancy, Lactation
* Lack of reliable contraception
* Patients with metabolic, psychiatric or neoplastic diseases
* Active diseases like asthma, psoriasis or inflammatory bowel disease who have to be treated with corticosteroids
* primary or secondary immune deficiency
* Tuberculosis or other infectious lung diseases
* Hepatitis B or C
* Life vaccination during the trial duration
Patient Specific Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures

The aim of the current study is to evaluate and assess the clinical stability and efficacy of patient specific computer guided titanium plates versus the conventional titanium mini plates regarding accurate reduction and fixation of mandibular body fractures, reducing the operating time, achieving precise bone alignment and reducing the plate palpability.

The study will be conducted on two groups:

Intervention group: patient specific three-dimensional titanium plates CBCT or CT scan will be performed for the patient, the dicom files will be imported into a surgical planning software , plates will then be designed virtually and sent for three-dimensional (3D) printing.

Control group: Conventional miniplates:

In this group two miniplates of titanium Mini-System 2.0 mm will be used. The plate has profile height 1.0 mm whereas the screw length varies according to the site of the plate. According to Champy osteosynthesis lines for fixation of the posterior mandibular fracture ,the first plate will be placed at the inferior border from the buccal side, using bicortical screws engaging the buccal and lingual cortices to achieve rigid fixation, while the second plate will be placed at about 5mm superior to the inferior plate in the subapical region, using monocortical screws engaging only the buccal cortex to avoid injuring the teeth roots.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral mandibular body fractures, not associated with other mandibular and maxillofacial fractures

Exclusion Criteria:

* Patients with bilateral mandibular fractures
* Patients with other mandibular or maxillofacial fractures
* Comminuted fractures
* Medical problem that may interfere with the procedure such as bleeding disorder and pregnancy.
Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer

The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy.

Image-guided transperineal permanent prostate brachytherapy (PI) is an accepted curative treatment option for patients with early stage prostate cancer. The most severe side effect of PI is urinary retention requiring intermittent self-catheterization (ISC). This study will assess the ability of pharmacologic intervention to ameliorate the post-operative side effect of PI. The use of both tamsulosin and dutasteride is proposed to have benefit in reducing urinary symptom score and in reducing the rate of intermittent self-catheterization for patients with prostate adenocarcinoma after prostate implant.

Eligibility Criteria:
Inclusion Criteria:

* Patient is eligible for a prostate implant
* Patient is greater than 18 years of age
* Patient is able to give informed consent
* Patient does not currently take Flomax, Dutasteride or Finasteride
* Patient does not have a known hypersensitivity reaction to Flomax or Dutasteride

Exclusion Criteria:

* Patients who have a known hypersensitivity reaction to tamsulosin, dutasteride or finasteride and those patients who are already on any prior to prostate implantation
* Patients who are taking a PDE-5 inhibitor including sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra) are ineligible to participate unless they are willing to discontinue using those drugs one week prior to their implant and for three months after the implant
Comparison of Monitors of Fluid Therapy

The investigators want to correlate different methods to guide fluid therapy. The investigators know that guidance by esophagus doppler technique has improved outcome and want to correlate other already used techniques to esophagus doppler.

Fluid therapy before and under surgery can be guided by measurement of the hearts ability to eject blood (cardiac output). By doing this it has been shown that the occurrence of nausea,vomiting and complications generally can be reduced. The function of the heart has been measured with a probe in the esophagus in in earlier studies. We want to correlate these results with other techniques by which fluid therapy also is guided in daily practice. These are: SVO2, modelflow (finapres)and NIRS.

These methods are noninvasive except SVO2 measurement which requires a central venous catheter (CVK). Therefore we have chosen a population in which CVK is standard in our institution. We thereby don´t apply any further risks than daily practice and the project is considered as a quality assessment of used standards.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Elective urological surgery in which a central venous catheter is routinely administered
* Informed consent

Exclusion Criteria:

* Age 70 years or older
* No informed consent
* Pathology in the esophagus that contraindicates use off gastric tube and esophagus doppler
* ASA III or above
Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo controlled, pediatric study conducted in three phases.


Eligibility Criteria:
Inclusion Criteria include, but are not limited to, the following:

* Patients aged 4 to less than 21 years who meet the criteria for active SJIA
* Must have been on a stable dose of non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks prior to the screening visit

Exclusion Criteria include, but are not limited to, the following:

* Use of certain medications prior to the baseline visit
* History of recurrent infections
A Phase I Study of AG-348 in Healthy Volunteers

This is a dose escalation study that will be conducted in healthy volunteers. Multiple cohorts of volunteers will receive ascending oral doses of AG-348 to evaluate the safety and tolerability of a single oral dose of AG-348, the pharmacokinetics (PK) of a single dose of AG-348, and the pharmacodynamic profile of AG-348 with specific biomarkers assessed in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male or female subjects 18 - 60 years, in good general health who are able to understand consent and complete all study procedures.
* Female subjects of non-child bearing potential (surgically sterile or post-menopausal as confirmed by age \[over 50 years\], amenorrhea for 12 consecutive months and FSH).
* Male subjects who are not vasectomized must agree to use contraception up to 30 days after dosing.
* Subjects with body weight ≥50 kg; BMI ≥18.5 and ≤32 kg/m2.
* Subjects who are non-smokers and have not used nicotine containing products for at least 3 months prior to screening.
* Subjects must be willing to refrain from caffeine- or xanthene containing products (chocolate) prior to dosing through 72 hours after dosing.
* Subjects must agree to refrain from strenuous exercise prior to admission through final visit.
* Subjects must refrain from use of alcohol starting 7 days prior to admission through final visit.
* Subjects must agree not to donate blood products for duration of study participation.

Exclusion Criteria:

* Subjects who have previously received AG-348.
* Subjects with clinically relevant screening laboratory tests.
* Female subjects of childbearing potential.
* Male subjects with QTcF interval ECG \> 450 msec,or female subjects with QTcF interval ECG \> 470 msec.
* Subjects with a history of a serious mental illness.
* Subjects with a clinically relevant medical history or pre-existing medical condition that would interfere with the absorption, metabolism or excretion of the study drug.
* Subjects with a history of any primary malignancy (cancer). Exceptions are certain skin cancers, cervical cancer in situ or other cancers that have been curatively treated without evidence of disease for a minimum of 1 year.
* Subjects with glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
* Subjects who are positive for hepatitis B, hepatitis C or HIV.
* Subjects who have undergone surgery 6 months prior to screening.
* Subjects who have a history of illicit drug use or alcoholism within the last year.
* Subjects who are participating in other concurrent clinical trial of an investigational drug, or have received another investigational agent within the last 2 months.
* Subjects with any conditions which would make the subject unsuitable for enrollment, or could interfere with the subject's participation in or completion of the study.
Comparing Telepsychiatry and In-person Outcomes

Psychiatric consultation and short-term follow-up will produce equivalent clinical outcomes and be less costly when provided via videoconferencing (telepsychiatry) than when provided in-person.

We predict that patients referred by their family physician for a psychiatric consultation and, if needed, short-term follow-up will have equivalent clinical outcomes when seen via telepsychiatry as compared to those patients seen in-person. We also predicted that telepsychiatry will be cheaper than in-person care.Study Design: a single-centre equivalence trial.We will use a sample size calculation and analytical methods that are specifically tailored for equivalence trials.

Eligibility Criteria:
Inclusion Criteria:

* patients referred by their family physicians for psychiatric consultation
* scores in the dysfunctional range on the Brief Symptom Inventory

Exclusion Criteria:

* patients incapable of consenting to the research
* patients referred for medico-legal or insurance reports
A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury

The purpose of this study is to determine whether sivelestat will reduce the amount of time a patient must spend on a ventilator and/or increase the chance of survival of patients with acute lung injury.

Acute lung injury often develops as a result of severe infection, sepsis, severe injuries, inhalation of foreign substances into the lungs, or pneumonia. The tissues and blood vessels in the lungs become inflamed, and the body does not receive enough oxygen. Patients with this condition are placed on a ventilator to assist with breathing.

Patients entered into this study will be randomly assigned to one of two treatment groups: a sivelestat group or a placebo group. Once entered into the study, patients are monitored for up to 6 months.

Eligibility Criteria:
Inclusion Criteria

* show evidence of acute lung injury
* be on mechanical ventilation

Exclusion Criteria

* have undergone certain organ transplants
* have severe underlying medical problems
* be unlikely to survive
* be pregnant or breast-feeding