cyrilzakka/clinical-trials huggingface dataset:
Treating Suicidality Remotely

Background: Practical and psychological barriers make it difficult for people with Suicidal Thoughts and Behaviors (STBs) to get professional help. Online interventions have the potential to overcome many of these barriers, but the online interventions to date have produced small or short-lived effects and have only been found to reduce suicidal thoughts, not behaviors. This is a crucial limitation, since previous studies have shown that interventions that reduce suicidal thoughts often do not prevent suicide attempts, and vice versa.

Methods: A fully remote randomized controlled trial will be conducted in which 364 participants of 16 years and older will be recruited through the website of a suicide prevention helpline in the Netherlands and randomized with an allocation ratio of 1:1 to either Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT-SP) or a semi-guided online self-help course that has previously been found superior to waitlist in reducing suicidal thoughts. The primary outcome of the study is the number of suicide attempts, measured with the Columbia Suicide Severity Rating Scale. Secondary outcomes are self-reported suicidal ideation, healthcare utilization, treatment satisfaction, adverse effects, and quality of life. All outcomes will be assessed at baseline, immediately after the treatment and at 18 months follow-up.

Discussion: If remote BCBT-SP proves effective, the findings of this study will add to the evidence base of BCBT-SP as one of very few psychological interventions with replicated effectiveness in preventing suicide attempts and provide the first evidence to date that remote interventions cannot only reduce suicidal thoughts, but also prevent suicidal behavior.


Eligibility Criteria:
Inclusion Criteria:

* 16 years or older
* Currently living in The Netherlands
* Any type of STBs in the past 4 weeks

Exclusion Criteria:

* Insufficient mastery of the Dutch language
* Previously engaged in 113 Suicide Prevention's Online Therapy or Self-help course
* Currently seeing a mental health professional at least once every 3 weeks, other then a general practitioner or general practice based nurse practitioner ('POH-GGZ')
* Not able to engage in online therapy, for instance because of severe mood disorders or psychotic symptoms, based on the clinical impression of the research assistant and a supervisor
Effects of Gonadotropin Replacement Therapy on Metabolic Parameters in Patients With Hypogonadism

Effects of gonadotrophin replacement therapy Lipid Profile and Oxidative Stress Parameters of Patients with Idiopathic Hypogonadotropic Hypogonadism

30 male patients diagnosed with IHH and a control group of 20 healthy cases with similar age and BMI were included in the study. The levels of advanced oxidation protein products (AOPP), thiol, malondialdehyde (MDA), nitric oxide (NO) and 8-hydroxydeoxyguanosine (8-OHdG) and the levels of triglyceride (TG), total cholesterol (TC), high density lipoprotein (HDL-K), low density lipoprotein (LDL-K), Apolipoprotein A1 (ApoA1) and Apolipoprotein B100 (ApoB100) were measured before and after gonadotrophin therapy.

Eligibility Criteria:
Inclusion Criteria:

Serum testosterone concentration \< 300ng/dL Absence of a pituitary or hypothalamic mass lesions, Presence of gonadotropin response to GnRH, -

Exclusion Criteria:

diabetes mellitus, arterial hypertension other hormone deficiencies

-
Xavier Electromyographic Wheelchair Control for Limited Mobility Patients

The purpose of this study is to assess the functional mobility and self-reported satisfaction with the Xavier electromyography hands-free wheelchair control system in comparison with a standard joystick.


Eligibility Criteria:
Inclusion Criteria:

* ALS diagnosis by revised el Escorial criteria (definite, probable or probable laboratory supported)
* Age 18-89
* Limited mobility with use of motorized wheelchair at screening-time
* Impairment of hand function limiting the use of a standard joystick control
* Caregiver willing to assist with transfers into wheelchair and application of controllers
* Ability to attend study visits with a motorized wheelchair
* Ability to communicate and answer patient reported outcome measure questions

Exclusion Criteria:

* Cognitive impairment prohibiting safe independent mobility as defined by an ALS-Cognitive Behavioral Screen (ALS-CBS) score of \<10 or the opinion of the investigator
* A sensory impairment prohibiting safe independent mobility in the opinion of the investigator
* Allergy to adhesives or electrode gels (required for EMG electrodes)
* Skin breakdown over the temporalis muscle that would predispose to further breakdown and/or infection with electrodes
* Severe loss of facial muscle functionality or control that would preclude EMG electrode efficacy
* Subjects who do not have the capacity to consent
Glucose Control in the ICU Using Continuous Glucose Monitoring

Stress hyperglycemia occurs in 50-85% of patients admitted to a medical intensive care unit (MICU) and is associated with increased morbidity and mortality. However, randomized controlled trials examining the effects of strict glycemic control demonstrated conflicting results. A common finding in these trials was the high risk of hypoglycaemia.

This randomized controlled trial evaluates the impact of real-time continuous glucose monitoring (RT-CGM) on glycemic control and risk of hypoglycemia in severely ill MICU patients with an APACHE-II (Acute Physiology and Chronic Health Evaluation II) score ≥20.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to a medical intensive care unit
* age: ≥ 18 y , \< 75 y
* APACHE II (Acute Physiology and Chronic Health Evaluation II) score ≥ 20
* expected length of stay in ICU \> 3 days

Exclusion Criteria:

* pregnancy
* patient with a DNR (do not reanimate) code
* surgical patient
* no informed consent
Ovarian Reserve and Ankylosing Spondylitis

The aim of this study was to determine the status of ovarian reserve in patients with ankylosing spondylitis (AS) using anti-mullerian hormone (AMH) level and antral follicle count (AFC). Women with AS and women controls diagnosed according to the classification criteria proposed by the American-European Consensus Group will be included in the study. Ovarian reserve will be evaluated in terms of clinical findings, AFC and serum AMH and reproductive hormone levels.

Researchers predict that the ovarian reserve may be reduced in patients with AS due to the autoimmune process and the pathophysiology of the disease. Serum AMH and ovarian AFC may be useful for assessing ovarian reserve. It is aimed to determine the course of ovarian reserve abnormalities and the best possible biomarkers of reduced ovarian reserve in patients with AS.


Eligibility Criteria:
Inclusion Criteria:

* regular menstruation with intervals of 21-35 days;
* cycle length variations \<4 days;
* both ovaries still present

Exclusion Criteria:

* history of liver failure;
* diagnosed malignancy;
* cigarette smoking;
* chronic renal failure;
* known infertility;
* presence of gynecological abnormalities such as abnormal uterine bleeding or menorrhagia;
* history of ovarian surgery;
* history of hormone preparation (including corticosteroids) use or use of herbal products within 3 months;
* diagnosis of polycystic ovary syndrome.
Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation

This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo orthotopic liver transplantation
* Liver disease classified as Child-Turcotte (Pughs modification) score B or C

Exclusion Criteria:

* Previous liver transplantation
* Scheduled multi-organ transplantation
* Scheduled for living related donor transplantation
* Present renal insufficiency requiring dialysis
* Pregnancy
Clinical Application of Cholangiojejunostomy in the Surgical Treatment of Cholelithiasis With Moderate Dilatation of Common Bile Duct

This study evaluates the clinical application of cholangiojejunostomy in the surgical treatment of cholelithiasis with Moderate dilatation of common bile duct. Half of participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage, while the other half will receive hepatectomy and T-tube Drainage.


Eligibility Criteria:
Inclusion Criteria:

* Hepatic bile duct stone disease, need surgery
* No residual stones in the operation
* Extrahepatic bile duct dilatation, 15-30 mm in diam.
* No relaxation or stenosis of the sphincter of Oddi

Exclusion Criteria:

* Patient involuntary
* Surgical treatment can not be performed because of various reasons.
* Intrahepatic and extrahepatic bile duct stones can not be taken away
* with other biliary tract diseases, such as bile duct cancer
* Oddi sphincter relaxation or stenosis
* loss to follow-up
Concussion Treatment in Older Adults

The purpose of this study is to conduct the first randomized control trial for targeted treatments for concussion in adults 50 years or older. Participants will be enrolled at their first concussion clinical visit (V1) and their second study visit will occur after (up to 7 days) or concurrently with the participant's second concussion clinical visit, typically (but not limited to) between 21-31 days from V1.

Although concussion is a common occurrence in older adults, we know little about the injury in this at-risk population. Certain management tools that might be appropriate for adolescent and young adult populations may not be appropriate for use in older adults who may have sensory, cognitive, and neuro-motor limitations. This study will help to develop initial evidence for targeted treatments for concussion in older adults. The study will utilize a two group design with permuted block random assignment to intervention and usual care/control groups. All participants will complete the following assessments at their initial and follow-up visit appointments: cognitive screening (learning, memory, language, executive functioning), concussion and mood symptom questionnaires, and neuro-motor screening. The primary outcomes for this study will be total symptom severity score (i.e., symptom burden) on the Concussion Clinical Profiles Screening (CP Screen) and Patient Global Impression of Change (PGIC). Secondary outcomes will include: Short Falls Efficacy Scale (SFES), Dizziness Handicap Inventory (DHI), Patient Health Questionnaire-9 (PHQ-9), Patient Health Questionnaire-15 (PHQ-15), Generalized Anxiety Disorder - 7 (GAD-7), Posttraumatic Stress Disorder Checklist (PCL-5), Pittsburgh Sleep Quality Index (PSQI), Neuro-Quality of Life (QOL) v2.0 - Cognition Function (Short version), Headache Impact Test (HIT-6), ID Migraine, Neck Disability Index (NDI), Vestibular Ocular Motor Screen (VOMS), Timed-Up-and-Go (TUG), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). All outcomes will be treated as continuous.

Eligibility Criteria:
Inclusion Criteria:

* 50 years of age or older
* Diagnosed concussion within the last 4 days - 12 months
* Must be recruited at their initial concussion appointment
* Ability to read/write to complete study assessments/testing

Exclusion Criteria:

* Diagnosed neurological disorder (stroke, dementia, epilepsy)
* Diagnosed major psychiatric disorders other than depression/anxiety (e.g., schizophrenia)
* Diagnosed with moderate to severe brain injury or past brain surgery/malformations
Efficacy of Sodium Thiosulfate and Mannitol in Reducing Ototoxicity in Adult Patients Receiving Cisplatin Chemotherapy

One common side effect of cisplatin chemotherapy is ototoxicity. The drugs sodium thiosulfate and mannitol may protect against cisplatin-induced hearing loss. Specifically, sodium thiosulfate has been found to protect the cells in the inner ear, and may therefore prevent hearing loss. Mannitol can help sodium thiosulfate enter the inner ear, and ponteially increase the effectiveness of sodium thiosulfate. This study aims to assess the efficacy of sodium thiosulfate and mannitol to reduce the hearing impairment caused by cisplatin chemotherapy.

Randomized phase II clinical trial: with 1:1 randomization between cisplatin alone, and cisplatin + sodium thiosulfate and mannitol. Participants will first be recruited into a 2-year pilot feasibility study of 24 patients (12 in each arm). The pilot study will be performed to evaluate the feasibility of the trial as defined by the following factors: treatment outcomes, occurrence of adverse events, logistics of treatment delivery, as well as dropout and recruitment rates. The results from the pilot study will support the safety, efficacy, and effectiveness of the sodium thiosuldate and mannitol treatment, confirm feasibility using the factors mentioned above, and serve as an earlier-phase developmental function to enhance the probability of success of the subsequent clinical trial. Participants will complete various pre-treatment hearing tests. Participants will receive sodium thiosulfate and mannitol 4 - 8 hours following chemotherapy treatment. The control group will not receive the experimental intervention. Follow-up hearing tests will be performed at select time intervals following completion of their cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients undertaking systemic cisplatin therapy as part of their cancer treatment
* Age ≥ 18
* Willing to provide informed consent
* ECOG performance status 0-2
* For female of child-bearing potential, a negative pregnancy test (beta-HCG) prior to study treatment is required
* Any patient who is of reproductive age should provide written agreement to use adequate contraception for the duration of the trial

Exclusion Criteria:

* Age less than 18
* Preexisting severe to profound sensorineural hearing loss (unilateral or bilateral) (speech reception threshold \>70dB, or word recognition score \<50%) as confirmed with an audiogram
* History of Meniere's or fluctuating hearing loss
* Asymmetrical hearing loss (bone conduction threshold difference of: (a) 20 dB threshold difference at a single frequency, (b) 15 dB threshold difference at 2 frequencies, (c) 10 dB threshold difference at 3 frequencies
* Abnormal renal function (creatinine clearance \<60 ml/min)
* Abnormal liver function (liver function tests (ALT and ALP) \>2.5 times upper limit of normal without liver metastasis and \>5 times upper limit of normal with liver metastasis
* Previous hypersensitivity to STS or mannitol
* Pregnant and/or nursing women
* Patient unable to follow the protocol for any reason
Comparative Study of Diagnostic and Prognosis Biomarkers of Prostate Cancer in Liquid Biopsy

Constitution of a biological collection within the framework of the establishment of a diagnostic, prognostic and active surveillance test for prostate cancer from long non-coding RNA biomarkers, in 3 cohorts of patients, with cancer of the prostate, with suspected cancer without biopsy confirmation or with prostatic hyperplasia and healthy donors.

This biological collection will also be used as a support for further researches on the identification of biomarkers and genetic markers to improve the prognosis and diagnostic management of patients with prostate pathologies.

Multicenter, RIPH 2 study, evaluating on 3 patient cohorts the feasibility of setting up a diagnostic test, prognosis and active surveillance of prostate cancer using long non-coding RNA biomarkers.

For patients agreeing to participate in the study and having signed a consent form, during their routine care consultation in the urology department, will have a blood sample and a urine sample after prostate massage as part of the study, and if necessary, a tissue sample as part of the treatment.

Patients with prostate cancer will be followed as part of their care at least annually, and their follow-up data will be collected as part of the study, without additional sampling.

A blood sample and a urine sample after prostate massage will be carried out during a single consultation at the CIC Henri Mondor for

Eligibility Criteria:
Inclusion Criteria:

Concerning patients:

1. / Patient with suspected prostate cancer or prostatic hyperplasia with a PSA level ≥ 4 ng / ml
2. / Patient diagnosed by prostate MRI in the course of treatment
3. / No infectious episode in the week before the visit (in particular no urinary tract infection) documented by dipstick and absence of fever
4. / Information of the patient and signature of informed consent or his legal representative.
5. / Participant affiliated to a social security scheme

Regarding healthy volunteers:

1. / Male from 50 to 70 years old
2. / PSA level \< 4 ng / mL
3. / No infectious episode in the week before the visit (in particular no urinary tract infection), documented by dipstick and the absence of fever
4. / Absence of cancer and history of haematological pathologies \< 5 years (in particular leukemia, lymphoma).
5. / Patient information and signature of consent

Exclusion Criteria:

1 / Participants who refused to participate in the biological collection 2) Persons deprived of their liberty or under guardianship. 3) Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine

The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP\~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule.

The primary objective is:

* To demonstrate that the pentavalent DTaP-HB-PRP\~T combined vaccine does not induce a lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age.

The secondary objectives are:

* To describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6, 10, and 14 weeks of age; and
* To evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.


Eligibility Criteria:
Inclusion Criteria:

* Six week old infants (42 to 50 days old) on the day of inclusion; of either gender.
* Mother tested as seronegative for hepatitis B surface antigen (HBsAg) between 28 weeks of pregnancy and up to 4 days after delivery
* Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
* Informed consent form signed by one parent or other legal representative if appropriate (independent witness is mandatory if parent is illiterate)
* Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid therapy.
* Chronic illness at a stage that could interfere with the conduct or completion of the trial
* Blood or blood-derived products received since birth
* HB vaccination since birth
* Any vaccination in the four weeks preceding the first trial vaccination
* Any planned vaccination (except trial vaccines and bacillus Calmette-Guerin (BCG) during the trial
* Documented history of pertussis, tetanus (T), diphtheria (D), polio, or Haemophilus influenzae type b (Hib) infection(s) (confirmed either clinically, serologically, or microbiologically)
* Known personal or maternal history of HIV, HBsAg or hepatitis C seropositivity
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
* History of seizures
* Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Impact of Etomidate vs. Propofol on Infectious Complications Post Cardiac Surgery

The aim of this retrospective before-after-study is to evaluate the potential association of etomidate vs. propofol as an induction agent for major cardiac surgery on infectious post-operative complications.

The investigators hypothesize that etomidate increases the rate post-operative infectious complications in cardiosurgical patients.

Etomidate had been a standard induction agent as it results in increased hemodynamic stability compared to propofol. This is seen as a major advantage in patients that frequently have a fragile haemodynamic situation.

A major side effect of Etomidate is the resulting adrenal dysfunction, which hampers the bodies stress response and has been shown to cause a higher mortality in infectious contexts such as sepsis. It remains unclear to what extend this attenuated stress response has an impact on the post-operative context in cardiosurgical patients. First preliminary data show that patients receiving Etomidate as an induction agent are more prone to infection than those receiving a different agent, a definitive correlation is nevertheless still lacking.

This is a retrospective before-after-study comparing the rate of infectious complications in patients receiving either valve and/or coronary cardiac surgery at the Charité - Universitätsmedizin Berlin between October 1st, 2012 and January 31th, 2015. On October 1st, 2013 the standard operating procedures for anesthesia for cardiac surgery were amended and the induction agent at the Charité - Universitätsmedizin Berlin was switched from Etomidate to Propofol. The investigators are therefore comparing patients undergoing cardiac surgery between October 1st, 2012 and September 30th, 2013 as the Etomidate group with patients undergoing surgery between February 1st, 2014 and January 31st, 2015 as the Propofol group. The gap in between the two groups (October 1st, 2013 - January 31st, 2014) was defined as a washout phase to account for a potential delay in implementation of the renewed standard operating procedures. Patients will be investigated unmatched as well as matched according to (Age, Body Mass Index, American Society of Anesthesiologists physical status classification system (ASA), New York Heart Association Functional Classification (NYHA), Surgical Mode and Diabetes). The data for both groups will be acquired from the 2 electronic patient data management systems at our hospital (COPRA System, Sasbachwalden, Germany, and SAP, Walldorf, Germany).

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Valve and/or coronary artery bypass graft surgery

Exclusion Criteria:

* Surgery during washout period (October 1st, 2013 - January 31st, 2014)
* Resurgery
* Endocarditis
* Known immunosuppression:
* Corticosteroid therapy
* Solid organ transplant
* Stem Cell therapy
* HIV diagnosis