cyrilzakka/clinical-trials huggingface dataset:
Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility

The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 12 months or hospital discharge post-transplant.


Eligibility Criteria:
Inclusion Criteria:

* Male or female;
* Aged 18 years or older;
* Informed consent is given for participation in the Study by the patient or patient's designated representative; and
* Patient undergoes lung transplantation.

Exclusion Criteria:

* Patients listed for same-side lung re-transplantation.
* Patients listed for multiple organ transplantation including lung and any other organ.
* Patients listed for live donor lobar lung transplant.
* Patients positive for human immunodeficiency virus (HIV) or Burkholderia cenocepacia infection.
* Patient receives a standard of care (non-EVLP) lung transplant but does not match to an EVLP subject based on the criteria for control matching.
* Participating in another interventional trial
Pulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney Disease

Sirolimus (SIR) has lead to a reduction of overall kidney size, a decrease in cyst density and general tubular cell proliferation in animal models, and to a reduction of the increase in creatinine and blood urea nitrogen by 34 and 39 percent respectively, as well as a reduction of cyst proliferation, expressed by a 30 percent reduction of overall kidney enlargement, a reduction in general cyst volume, and a reduction of the cyst volume density in the renal cortex in humans.

However, despite promising data from animal- and in vivo studies, most mammalian target of rapamycin inhibitor (mTOR-I) studies in patients with autosomal-dominant polycystic kidney disease (ADPKD) produced only subtle if any clinically relevant effects on cyst growth and the preservation of renal function.

In this study we will investigate if pulsed administration of SIR in a fixed weekly oral dose of 3 mg over 24 months compared to placebo significantly reduces cyst growth and preserves excretory renal function in patients with ADPKD and an estimated glomerular filtration (eGFR) rate below 60 mL/min per 1.73m2.


Eligibility Criteria:
Inclusion Criteria:

* ADPKD, as confirmed by history, ultrasound, computed- or magnetic resonance tomography
* Eighteen years of age, or older
* Baseline eGFR below 60 mL/min per 1.73m2
* Negative serum pregnancy test prior to administration of sirolimus and agreement to use contraception throughout the study and three months after
* Written informed consent

Exclusion Criteria:

* Need for renal replacement therapy
* Pregnancy/lactation
* Plans to become pregnant in the near future
* Refusal to use sufficient contraception
* Proteinuria as defined as protein:creatinine ratio \>1000 or \>1g/d, respectively
* History of life threatening complications of ADPKD
* Evidence of active systemic- or localized major infection
* Evidence of infiltrate or consolidation on chest X-ray
* Use of any investigational drug or -treatment up to 4 weeks prior to enrolment and during the study
* Known allergy/hypersensitivity to sirolimus and its derivatives
* Medication that will interfere with the cytochrome P450 (CYP3A4/CYP3A5) system
* Total white blood cell count below or equal to 3000/mm3
* Platelet count below or equal to 100.000/mm3
* Fasting triglycerides above or equal to 400 mg/dL
* Fasting total cholesterol above or equal to 300 mg/dL
* Concomitant glomerular diseases
* Psychiatric disorders and any condition that might prevent full comprehension of the purposes and risks of the study
* History of malignancy, with the exception of adequately treated basal cell- and squamous cell carcinoma of the skin
* HIV positivity
Administration of Kisspeptin in Patients With Hyperprolactinemia

The goal of this study is to learn more about how kisspeptin, a naturally occurring hormone, affects women with high levels of prolactin (also called hyperprolactinemia). Subjects in one group will undergo blood sampling every 10 minutes over two 12-hour periods (one 12-hour period without any intervention and one 12-hour period with intravenous (IV) kisspeptin administration). Subjects in the second group will receive subcutaneous (SC) kisspeptin every 90 minutes for eight days.


Eligibility Criteria:
Inclusion/Exclusion Criteria:

* confirmed diagnosis of elevated levels of prolactin measured via blood test,
* no pituitary adenoma OR a microprolactinoma (\<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded,
* no history of a medication reaction requiring emergency medical care,
* no illicit drug use or excessive alcohol consumption (\>10 drinks/week),
* not currently seeking fertility, breastfeeding or pregnant,
* no history of bilateral oophorectomy,
* willing to complete a dopamine agonist washout and/or oral contraceptive washout,
* normal physical exam and laboratory studies within protocol reference range.
Clinical Validation of a Novel, Accelerometer Based, Continuous Respiratory Rate Sensor

Comparing a wireless accelerometer-based sensor that continuously measure breathing rate with the gold standard capnography. The aim is to evaluate if both methods are equivalent.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the Hospital
* Expected to remain undisturbed for at least one hour

Exclusion Criteria:

* Not able to give informed consent
* Use of high flow oxygen therapy
* Skin disease preventing proper attachment of the sensor
* Implanted electronic medical device.
* Known infection or colonisation with microbes necessitating protective measures above routine care
Two Strategies for Methicillin-resistant Staphylococcus Aureus (MRSA) Infection Prevention in Surgical Patients

The study is a two-arm controlled multi-centre trial of two strategies to reduce nosocomial MRSA transmission and infection among surgical patients. Enrolment and primary analyses will be performed at the hospital level. A total of ten adult surgical departments with at least 3 surgical subspecialties each will participate in the study. Sites of the study are located in 9 countries (UK, France, Spain, Germany, Switzerland, Italy, Serbia, Greece and Israel).

The primary objective is to determine the effect of an early MRSA detection \& decolonization \& isolation strategy compared to an enhanced standard control strategy on healthcare-associated MRSA isolation rates among surgical patients at risk of MRSA carriage, who are hospitalized for at least 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* Surgical patients with LOS\>24h

Exclusion Criteria:

* Surgical patients with LOS\<24h
Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial

Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has also been reported to be helpful for some pain conditions. The investigators have observed prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin Type A (BTA) in patients with certain types of neuropathic pain. the investigators propose to study if addition of BTA extends pain relief compared to placebo when injected subcutaneously into areas of cutaneous allodynia (the property that a normally non-noxious stimulus is perceived as painful).

Patients with post-herpetic neuralgia, complex regional pain syndrome, and post-surgical neuromatous pain patients have marked cutaneous allodynia. Touching their skin with normally non-painful stimuli results in pain. Injected local anesthetics are often effective in providing temporary relief. In the course of clinical practice the investigators have observed that a number of patients with cutaneous allodynia have had marked persistent benefit from subcutaneous injection of Botulinum toxin Type A.

Rather than killing targeted neurons, Botulinum toxin type A inhibits release of acetylcholine from cholinergic nerve terminals in a prolonged but ultimately reversible manner. Neuropathic pain and its hallmark allodynia are classically difficult to treat. Standard treatment with tricyclic antidepressants, anti-epileptic drugs, opiates and spinal cord stimulation is frequently disappointing leaving patients with refractory pain. Surgical or percutaneous ablation of involved nerves has fallen out of favor among many due to disappointing results.

A pilot study is needed to assess the efficacy of superficially injected Botulinum Toxin type A for treatment of cutaneous allodynia and spontaneous pain among patients with neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe pain (greater than 2/10) of duration more than 6 months despite previous therapy, excluding botox injection
* The patient exhibits at least 80% pain relief following injection of local anesthetic subcutaneously into scar as assessed by change in NRS
* Patient reports more than 3 weeks of greater than 50% pain relief from previous botox injection
* The patient reports the presence of hyperalgesia, allodynia, dysesthesia, or hypoesthesia surrounding the scar in the absence of the botox injection
* Age 18-100
* Ability to read, write, and converse in English, provide informed consent, and follow study procedures

Exclusion Criteria:

* Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular dystrophy
* Any ongoing legal action related to their pain
* Allergy to local anesthetics
* Any ongoing disability claim
* Currently being treated for any severe psychiatric disorder, including anxiety or depression
* History of any adverse reaction to botulinum toxin
* History of botulism
* Untreated infection
* Coagulopathy
* (Females) - positive pregnancy test
* Surgery in the last 6 months
Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana

The Ghana study will hypothesize that both the multiple dose and single dose of mebendazole will achieve effective cure rates against hookworm among children and adolescents. This study is intended to be a pilot study for a planned Phase 3 registration trial of a new drug for hookworm, tribendimidine.

This study will determine the Cure Rates (CRs) of mebendazole regimens to be used as comparator drug regimens in the future pivotal trial of tribendimidine and will provide evidence of the efficacy and safety of mebendazole among children and adolescents infected with hookworm in Ghana. Children and adolescents bear a large burden of morbidity from hookworm infection, so building the evidence base for effective treatments in this population has important public health implications in Ghana and other endemic settings.

Eligibility Criteria:
Inclusion Criteria

All participants must meet all of the following inclusion criteria:

1. Male or female, aged 6 to 18 years, inclusive, at the time of randomization.
2. Written informed consent signed by at least one parent and/or legally acceptable representative (as defined by local law); and assent by participant.
3. Able and willing to be examined by a study health care provider at the beginning of the study.
4. Able and willing to provide one stool sample at the beginning (baseline) and one sample approximately three weeks after treatment (follow-up).
5. Positive for hookworm eggs in the stool (two Kato-Katz thick smear slides with more than one hookworm egg) at baseline.

Exclusion Criteria

Participants must meet none of the following exclusion criteria to be eligible for this study:

1. Presence of major systemic illnesses as assessed by a study health care provider, upon initial targeted clinical assessment.
2. Pregnancy, based on a positive urine rapid test, or breastfeeding in girls after menarche.
3. Recent use of an anthelminthic drug (within the past 4 weeks) or use of anthelminthics not provided by study staff during the study period.
4. Known allergy to mebendazole or albendazole.
5. Participation in other clinical trials during the study.
Continuous Monitoring of Patients in and After the Acute Admission Ward to Optimize Clinical Pathways

Hospitals aim to hospitalize patients when necessary and discharge patients when possible. However, the triage process and discharge management of patients in e.g. the Acute Admission Ward, is not a trivial task. The upcoming technology of wearable monitoring devices, whereby patients can be continuously monitored with an unobtrusive vital signs device, might help getting more insight into patients' health condition and thus help facilitate efficient and effective triaging.

Therefore, the primary objective is to assess the effects of continuous monitoring of patients in the acute admission ward (AAW) on the percentage of patients who can be discharged home. Secondary objectives are to assess the length of stay in the acute admission ward and in the in-hospital wards, as well as the effect on admission to the intensive care unit, rapid response team calls and hospital readmission. The predictive value of algorithms applied to the monitoring data combined with other parameters to detect timely deterioration and predict discharge will be assessed. Facilitators and barriers for implementing such a system will be investigated.


Eligibility Criteria:
Inclusion Criteria:

In order for a patient to be eligible to participate in this study, the following criteria need to be met:

* admitted to the AAW
* Age ≥ 18 years
* Able to speak and read Dutch
* Willing and able to provide written informed consent

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from participation:

* Not able or willing to wear a wearable sensor on the chest continuously for 14 days
* Planned major surgery in the upcoming 30 days
* At the time of AAW admission already known to be discharged home or admitted to the hospital
* Any skin condition, for example prior rash, discoloration, scars, infection, injury or open wounds at the area (Left lower rib) where the sensor needs to be placed
* Known sensitivity to medical adhesives
* Wearing an active implantable device (e.g. ICD, pacemaker)
* Intend to go to the sauna or go swimming in the upcoming 14 days
* Pregnant or breastfeeding
* Use of creams or lotions that are known to influence the skin at the area where sensor is placed (such as medical and non-medical creams or lotions)
New Relapse Model in Psychiatry

The goal of this clinical trial is to learn about risk factors of relapse in patients with alcohol use disorder. The main questions it aims to answer are :

* Among patients with Alcohol Use Disorder, are there clusters of patients with the same characteristics and the same outcome ?
* Which are the risk factors of relapse that are the most predictive ? Do they vary according to cluster?
* Can a feedback-measurment-system (eg : a feedback of the tests' results) be usefull in a detoxification unit ?

Participants will :

* Complete auto-questionnaires
* Pass hetero-evaluations
* Undergo an electrophysiological battery


Eligibility Criteria:
Inclusion Criteria:

* To suffer from AUD
* To be hospitalized
* To speak French fluently
* To be able to give their consent (medically and legally).

Exclusion Criteria:

* To suffer from severe perceptive disabilities (auditory, visual)
* To suffer from severe cognitive impairment
Treatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT

To compare the effect and side effects of photodynamic treatment and traditional topical steroid treatment in female genital erosive lichen planus

To assess the feasibility, efficacy and safety of hexyl 5-aminolevulinate-hydrocloride (HAL)-PDT in GELP in women.

Eligibility Criteria:
Inclusion Criteria:

Women with symptomatically genital ELP, clinically verified by at least one doctor attended to the Vulva clinic.

Untreated for ELP for at least 4 weeks. Written Informed Consent signed Age 18 or above

Exclusion Criteria:

Current pelvic inflammatory disease, genital malignancy, or gynecological infection.

Known or suspected porphyria

Known allergy to hexaminolevulinate or similar compounds (e.g. hexaminolevulinate or aminolevulinic acid) Pregnancy and lactation Participation in other clinical study either concurrently or within the last 30 days
Facial Nerve Morbidity After Superficial Parotidectomy in the Absence of Nerve Conductor

In this single-centre, cross-sectional case series, the investigators aim to evaluate the incidence of facial nerve injury in patients undergoing superficial parotidectomy in the absence of nerve conductor. Data to be collected retrospectively from a prospectively maintained database of consecutive patients, at the Department of Surgery, Liaquat University of Medical and Health Sciences Jamshoro, Pakistan. The sample size was calculated as 101.

In this single-centre, cross-sectional case series, the investigators aim to evaluate the incidence of facial nerve injury in partcipants undergoing superficial parotidectomy in the absence of nerve conductor. The institutional Research Ethics Committee has approved the study. Data to be collected retrospectively from a prospectively maintained database, at the Department of Surgery, Liaquat University of Medical and Health Sciences Jamshoro, Pakistan. The data period to be over a period of nine years that is from 1st January 2012 till August 2020. The sample size was calculated using the WHO sample size calculator and taking disease prevalence as 7.1 with CI 95%, which turned out to be 101. All the patients with pleomorphic adenoma irrespective of age and gender were included. To control any chance of bias, one of the members of researchers as part of the team who operated upon these patients. The primary outcome was the incidence of temporary or permanent facial nerve injury, while secondary outcomes were wound infection, seroma, hematoma, Frey's syndrome, salivary fistula and disfigured scar. Temporary facial nerve injury was defined as a feature of facial nerve palsy with full recovery to regular activity within six months. Permanent facial nerve injury was defined as any facial nerve dysfunction lasting beyond six months of operation. The data was recorded on a predesigned Performa, and patients' confidentiality was maintained assigning codes to each case known only to researchers. The data was calculated using SPSS version 23. Values of mean and standard deviation were calculated for continuous variables, whereas frequencies were calculated for categorical data.

Eligibility Criteria:
Inclusion Criteria:

* All the patients with pleomorphic adenoma irrespective of age and gender were included

Exclusion Criteria:

* Patients with recurrent disease or unwilling for participation were excluded
The Role of Genetic Factors in the Development of Idiopathic Scoliosis in the Kazakh Population

The purpose of this study is to identify genetic determinants of susceptibility to idiopathic scoliosis . It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of idiopathic scoliosis


Eligibility Criteria:
Inclusion Criteria:

1. Persons with a doctor-confirmed diagnosis of idiopathic scoliosis;
2. Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs;
3. Hereditary history of scoliosis;
4. Persons who are able and willing to provide written informed consent;

Exclusion Criteria:

1. Patients diagnosed with idiopathic scoliosis under 4 and over 40 years of age;
2. Representatives of the Kazakh ethnic group less than 3 generations;
3. No family history of bilateral idiopathic scoliosis;
4. Patients with an acute period of the inflammatory process (laboratory and clinical signs);
5. Persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;
6. Pregnant or lactating women;
7. Tuberculosis of any localization in the active phase and in history;
8. Severe and decompensated diseases of the liver and kidneys, cardiovascular system;
9. Severe and decompensated course of endocrine diseases;
10. Autoimmune diseases;
11. Systemic diseases;
12. Oncological diseases;
Anesthesiological Strategies in Elective Craniotomy

This protocol, NeuroMorfeo, aims to assess equivalence between volatile and intravenous anesthetics for neurosurgical procedures.

NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for a elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state evaluated with the ASA (I-III) and Glasgow Coma Scale (GCS) equal to 15, will be randomly assigned to one of three anesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil). The equivalence between intravenous and volatile-based neuroanesthesia will be evaluated by comparing the intervals required to reach, after anesthesia discontinuation, a modified Aldrete score ≥ 9 (primary end-point). Two statistical comparisons have been planned: 1) sevoflurane + fentanyl vs. propofol + remifentanil; 2) sevoflurane + remifentanil vs. propofol + remifentanil.

Secondary end-points include: an assessment of neurovegetative stress based on (a) measurement urinary catecholamines and plasma and urinary cortisol and (b) estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded during anesthesia; intraoperative adverse events (i.e. hypotension, hypertension, requirement of osmotic agents or/and hyperventilation for controlling brain swelling); evaluation of surgical field; postoperative adverse events (as seizures, cough, shivering, agitation, postoperative hematoma and postoperative pain); patient's satisfaction and an analysis of costs.

411 patients will be recruited in 14 different Italian centers during an 18-month period.

The recruitment started December 20th, 2007 and up to 11th March 2009.

Eligibility Criteria:
Inclusion criteria:

* Patient scheduled for elective intracranial surgery under general anesthesia for a supratentorial mass lesion in the next 24 hours;
* Physical state, evaluated with the ASA (American Society of Anesthesiologists ) classification I (normal healthy patient), II (patient with mild systemic disease), or III (patient with severe systemic disease);
* Age 18-75 years;
* Normal preoperative level of consciousness, i.e. Glasgow Coma Scale (GCS) = 15;
* No signs of intracranial hypertension.

Exclusion criteria:

* Severe cardiovascular pathology, as uncontrolled arterial hypertension, documented reduced coronary reserve.
* Renal or liver disease precluding the use of either anesthetic technique.
* Pregnancy .
* Known allergies to any anesthetic agent.
* Reduced preoperative level of consciousness, i.e.
* Glasgow Coma Scale (GCS) \< 15.
* Body weight greater than 120 kg.
* History of drug abuse or psychiatric conditions.
* Documented disturbance of the hypothalamic region.Refusal to sign consent form.
* Participation in other clinical trials.
* Delayed awakening, because, due to the location or size of the lesion, postoperative sedation and mechanical ventilation are planned.