cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Procalcitonin Guided Antibiotic Therapy in Adult Intensive Care Units (ICU's)

This is a randomized controlled trial comparing standard-of-care therapy of infections in critically ill patients with a procalcitonin-guided approach evaluating efficacy (antibiotics consumption) and safety (mortality).

Antibiotics are prescribed widely in intensive care units and are linked with high costs and the occurence of antimicrobial (multi)resistance. The optimal duration of antibiotic treatment is poorly known and often based on consensus guidelines.

SAPS is a multicenter, prospective, randomized, controlled open-label trial evaluating the equivalence/efficacy and safety of procalcitonin-guided treatment of infections in ICU patients versus a standard-of-care approach.

All patients that are admitted to the ICU and for whom systemic antibiotics are prescribed for presumed or proven bacterial infections are eligible for this trial. Patients will be randomized and stratified according to clinical diagnosis of severe sepsis and septic shock. Any patient over the age of 18, admitted to the ICU and receiving antibiotics for an assumed infection can be enrolled into this trial. Informed consent has to be obtained in writing from the patient of his/her relatives prior to inclusion. In the intervention group daily procalcitonin levels be performed and will generate a non-binding stopping advice when predefined stopping-rules have been reached. The ultimate decision to stop antibiotics will be at the discretion of the physician in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* receiving antibiotics for no more than 24 hours for an assumed or proven infection
* Informed consent

Exclusion Criteria:

* Failure to obtain written consent to participate
* Patients receiving prolonged antibiotic therapies (\> 3 weeks, e.g. endocarditis, cerebral/hepatic abscess)
* Patients with severe infections due to viruses or parasites (e.g. Dengue, Toxoplasma gondii, Plasmodium spp.)
* Patients infected with Mycobacterium tuberculosis
* Patients entering the ICU for post-operative observation and/or on antibiotic prophylaxis with an estimated length of stay less then 24 hrs.
* Patients suffering from cystic fibrosis
* Severely immunocompromised patients such as patients with HIV and with a CD4 count of less than 200 cells/mm, neutropenic patients (\<500 neutrophils per mL) or patients with solid organ transplantation
* Moribund patients
Natural History of Types 2 and 3 SMA in Taiwan

The primary objective of this study is to investigate the natural history of spinal muscular atrophy (SMA) types 2 and 3 patients in Taiwan. This study will provide further insights into the clinical course SMA. Several analyses will be conducted regarding overall survival, demographic characteristics, motor function, respiratory and nutritional support, and genotype and phenotype correlation.

As with other rare diseases, individual groups of SMA have therefore opted to share patient information in the form of clinical sites to increase the overall patient cohorts on which clinical outcomes and new assisted-healthcare technologies can be assessed. Using the collaborative and retrospective study of types 2 and 3 SMA patients in Taiwan, the investigators aim to 1) characterize the correlation of genotype and phenotype, 2) correlate the onset, progression, management with disease outcome, 3) depict comorbidity and within type 2 and 3 SMA patients with different SMN2 copy number.

Eligibility Criteria:
Inclusion Criteria:

1. Patients are diagnosed with SMA types 2 or 3
2. Generalized hypotonia and muscle weakness, weakness of the legs is greater than the arms, and the proximal part is weaker than distal part of extremities.
3. SMN1 gene deletion or mutation and/or neurogenic changes in electromyogram and/or muscle pathology.

Exclusion Criteria:

1. Non-5q SMA (no deletion or mutation of SMN1 gene) patients.
2. Type 1 SMA patients.
Learning Curves of Different Devices for Vaginal Birth on Mannequin

Learning curves for residents and specialists for devices applied on operative vaginal birth on mannequin (Odòn, Kiwi, Simpson forceps)

Residents and specialists were exposed to formal lecture having the opportunity of digital evaluation of digital support. After a frontal lecture they will have a formal explanation of mannequin approach for each device (Odòn, Kiwi, Simpson) After one month and after two month they will re-train on mannequin for each device.

Before frontal lecture they will answer to a questionnaire evaluating status of residency (year), elderly of specialization (years after degree) and personal experience in labor ward and on mannequin for training. After each training session they will have a further questionnaire evaluating how the training was working on their knowledge and on retaining of skills.

All training sessions will be recorded in a blind way erasing voice and face and with a ID computer generated code.

All videos will be evaluated by three different specialists of known experience on the three devices

Eligibility Criteria:
Inclusion Criteria:

* residents
* specialists

Exclusion Criteria:

* none
Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency

Open-label, Uncontrolled, Multicenter Observational Study on the Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency

There is a need to increase the body of data on treatment effectiveness and safety in the ultra-rare setting of congenital fibrinogen deficiency. Real-world evidence (RWE) derived from non-interventional studies can describe product utilization, demonstrate value, and facilitate benefit-risk assessments; RWE can only be fully assessed once a product is launched and used in a real-life setting.

This post-marketing, observational study is designed to collect information concerning safety, efficacy, and outcomes of Fibryga administration in routine clinical use in patients of any age with congenital afibrinogenemia or hypofibrinogenemia. Documentation of the administration of Fibryga in clinical practice for the treatment of both minor and major bleeding events (BEs) will not only enhance the knowledge on the efficacy and safety profile of Fibryga, but will also gather information that cannot be obtained in the same way in controlled clinical studies. These observational data will support the safety and efficacy data generated with Fibryga in good clinical practice (GCP) clinical studies, providing benefit for both physicians and patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any age with a documented diagnosis of congenital afibrinogenemia or hypofibrinogenemia expected to require on-demand in-hospital treatment for BEs with Fibryga

Exclusion Criteria:

* Bleeding disorder other than congenital fibrinogen deficiency
* Patients with acquired fibrinogen deficiency or dysfibrinogenemia
* Suspicion of an anti-fibrinogen inhibitor as indicated by previous in vivo recovery, if available, of \<0.5 (mg/dL)/(mg/kg); there is currently no standard test for inhibitors
* Participation in an interventional clinical study at the time of or within 4 weeks prior to enrolment
Intubating Conditions During Rapid Sequence Induction in Elderly With Either Suxamethonium 1.0 mg/kg or Rocuronium 1.0 mg/kg

The aim of this study is to determine the proportion of excellent tracheal intubation conditions at 60 seconds after administration of either rocuronium 1.0 mg/kg or suxamethonium 1 mg/kg in patients with age ≥ 80 years during rapid sequence induction.

Elderly patients are frail and susceptible to complications in the perioperative period. They are at higher risk of major morbidity and mortality and are characterized by a reduction in cardiac output, liver function and renal function. These physiological changes influence pharmacodynamics and pharmacokinetics of drugs administered during anesthesia as for example neuromuscular blocking agents (NMBA).

The number of elderly patients (\>80 years) is increasing and a large proportion of these patients will require surgery and anesthesia with employment of rapid sequence induction (RSI) within the next decades. RSI and intubation is performed when there is an increased risk of pulmonary aspiration of gastric contents. Because of its fast onset time succinylcholine is often used to facilitate tracheal intubation during RSI. However, succinylcholine has certain side effects such as cardiac arrhythmia, hyperkalemia, muscle soreness, short duration of action and shorter time to desaturation.

It is therefore unknown if succinylcholine 1.0 mg/kg provides better intubating conditions compared to high dose rocuronium (1.0 mg/kg) in the elderly. In this matter, there remains a need for a study to investigate the optimal muscle relaxant during rapid sequence induction for facilitating tracheal intubation in the elderly.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 80
* Scheduled for surgery under general anesthesia with indication for rapid sequence induction
* American Society of Anesthesiologists physical status classification (ASA) I to IV
* Informed consent (see appendix 1)
* Body mass index (BMI) \< 35 kg/m2
* Read and understand Danish

Exclusion Criteria:

* Neuromuscular disease
* Known allergy to rocuronium and/or suxamethonium
* Known hyperkalemia \> 5 mM
* Previous malignant hyperthermia
* Known homozygote plasmacholinesterase gene mutation variant a or s
* Known impaired kidney function defined as estimated glomerular filtration rate (eGFR) \< 30
Cognitive Inhibition, Psychosocial Interactions and Suicide Attempt in Elderly

The study aims to determine the correlation between the cognitive inhibition impairment and the history of suicide attempt in elderly depressed patients.

2 groups of patients will be studied: in the first group, depressed patients with a history of suicide attempt will be included whereas in the second group, depressed patients without a history of suicide attempt will be included.

For each group, the cognitive inhibition will be assessed trough an eye tracker task (antisaccade).

Both groups will also be compared on their neuropsychological characteristics and the quality of social interactions of participants.

Eligibility Criteria:
Inclusion Criteria:

* major depressive disorder according to Diagnostic ans Statistical Manual (DSM) V
* group 1: with a history of suicide attempt
* group 2: without a history of suicide attempt

Exclusion Criteria:

* other psychiatric disease
* guardianship
Reducing Preoperative Anxiety in Parents of Surgical Patients

Aims and objectives: To investigate preoperative anxiety in parents of paediatric surgical patients, testing whether the provision of information (using video and story books) regarding the surgical process can impact on reducing anxiety. Analyse if some personal factors influence the reduction of anxiety.

Background: Attending a surgical theatre generates anxiety in all types of patients, especially in the case of children. The effect of different preoperative intervention procedures in children that attempt to reduce their anxiety level have been studied a great deal. However, although their parents also suffer high anxiety levels, potential intervention to reduce their levels have not received the same attention.

Study design: Randomised Clinical trial Methods: One hundred and twenty-five parents of children (8-12 y.o.) undergoing surgery in Hospital Universitario Central de Asturias hospital (Oviedo, Spain) were randomly assigned to the control group (34 individuals) or one of the 3 experimental groups (91). After the pre-anaesthesia consultation, children and parents of the experimental groups were provided with a story book, a video with additional information of nursing, or both. In the antechamber of the operating room and prior to the surgical intervention, the State Anxiety and Trait Anxiety of the parents and children were measured using the STAI and STAIC questionnaires respectively. The data collection, including different demographic variables was carried out for 12 months starting in October 2016


Eligibility Criteria:
Inclusion Criteria:

* Undergoing surgery at Asturias Central Hospital

Exclusion Criteria:

* Children not in the age range,
* Emergency surgery,
* Children not able to understand or read
* Parents not present or refused to participate.
A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection

The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of PF-00868554 in combination with current standard of care therapy, pegylated interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).


Eligibility Criteria:
Inclusion Criteria:

* Treatment naive (no prior treatment with IFN-a +/- RBV regimens.
* Subjects who have discontinued IFN-a containing regimens after \<2 weeks of therapy due to tolerability issues are considered treatment naive.
* HCV RNA \> 100,000 IU/mL at screening.
* Genotype 1.
* A diagnosis of chronic HCV infection for at least 6 months.

Exclusion Criteria:

* Evidence of acute or chronic infection with HIV or HBV.
* Exposure within the previous three months to an investigational anti-HCV agent.
* Evidence of severe or decompensated liver disease.
* Subjects with liver disease unrelated to HCV infection.
Human Phototoxicity Test

To determine the phototoxic potential of a topically applied article in human subjects


Eligibility Criteria:
Inclusion Criteria:

* Be male or female between the ages of 18 and 60 inclusive;
* Be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* Have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164;
* Be in general good health as determined by the subject's medical history and in the discretion of the investigator;

Exclusion Criteria:

* Have a visible sunburn;
* Have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
* Must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.
* Have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products
EPIDEMIOLOGY AND ITS RESULTS IN HIP FRACTURES FOLLOWED IN POSTOPERATIVE INTENSIVE CARE

Type of study: Observational study Goal of this : We conducted a retrospective evaluation of patients with HF who received postoperative ICU, with a focus on 30-day, 90-day and 1-year mortality outcomes.

Participant population/health conditions:Patients over the age of 18 who are hospitalized in the intensive care unit of our hospital after hip fracture operation.

The proportion of elderly individual aged 65 and over in the global populatin is currently %9 and hip fractures (HFs) are a leading injury in this population worldwide. We conducted a retrospective evaluation of patients with HF who received postoperative ICU, with a focus on 30-day, 90-day and 1-year mortality outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with postoperative hip fractures hospitalized in the intensive care unit of our hospital

Exclusion Criteria:

* Patients who do not have a hip fracture operation will not be included.
Effects of Seminal Plasma on Pregnancy Rate With IVF

All couples planned for IVF will be asked to participate. After information and received informed consent they will be randomized into two groups.

At the time for ovum pick up during an IVF procedure either half of the amount of seminal plasma or the same amount of physiological NaCl solution will be installed around the external cervical opening in vagina. The syringe with seminal plasma or physiological NaCl solution will be prepared according to a prearranged randomization list by a technician.

The success rate will be the number of diagnosed pregnancies and live births.

All couples planned for IVF will be asked to participate. After information and received informed consent they will be randomized into two groups.

At the time for ovum pick up during an IVF procedure either half of the amount of seminal plasma or the same amount of physiological NaCl solution will be installed around the external cervical opening in vagina.

Normally we do not use the seminal plasma but now half of it will be installed and the other half analysed regarding a number of cytokines possibly involved in the immunological preparation of the female internal genitalia.

The syringe with seminal plasma or physiological NaCl solution will be prepared according to a prearranged randomization list by a technician.

Eligibility Criteria:
Inclusion criteria:

* subjects have given informed consent
* infertility for at least 1 year
* the couple wishing IVF
* subjects aged between 20 - 40 years

Exclusion criterion:

* azoospermia
Salvage Chemotherapy of Vinorelbine Plus Oxaliplatin in Metastatic Triple-negative Breast Cancer:a Prospective Trial

The purpose of this study is to evaluate the efficacy and safety of vinorelbine plus oxaliplatin in pretreated metastatic triple-negative breast cancer.

Triple-negative breast cancer is associated with less treatment choices and shorter overall survival. Both vinorebine and oxaliplatin are effective in metastatic breast cancer. The investigators designed this trial to evaluate the combination of these two drugs in pretreated metastatic triple-negative breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Females with age between 18 and 70 years old
2. ECOG performance between 0-2
3. Life expectancy more than 3 months
4. Histological proven unresectable recurrent or advanced breast cancer
5. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (IHC) test. For patients with ER negative, PR negative, Her2 two plus, a negative Her2 gene amplification should be verified with FISH test. Her2 one plus may consider FISH verification.
6. No more than 2 chemotherapy for metastatic breast cancer.
7. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1)
8. No anticancer therapy within 4 weeks
9. No neuropathy more than grade I
10. Adequate hematologic, hepatic, and renal function,No serious medical history of heart, lung, liver and kidney
11. Provision of written informed consent prior to any study specific procedures

Exclusion Criteria:

1. Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound)
2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study
3. Treatment with an investigational product within 4 weeks before the first treatment
4. Symptomatic central nervous system metastases
5. Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
6. Patient having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
7. Uncontrolled serious infection
8. Previous administration of vinorelbine
9. Patients with bad compliance
A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa

The purpose of the study is to assess the PK of bimekizumab following subcutaneous (sc) administration in study participants with moderate to severe hidradenitis suppurativa (HS)


Eligibility Criteria:
Inclusion Criteria:

* Study participant must be 12 to \<18 years of age at the time of informed consent/assent, at Tanner stage 2 or more, for the first 8 participants only, followed by also including participants ≥9 to \<18 years of age at Tanner stage 2 or more.
* Study participant must have a diagnosis of HS for at least 6 months prior to the Baseline Visit.
* Study participant must have moderate to severe HS, defined as a total of ≥5 inflammatory lesions (ie, the sum of abscesses and inflammatory nodules), as assessed at both the Screening and Baseline Visits.
* Study participant must have HS lesions present in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or III, as assessed at both the Screening and Baseline Visits.
* Study participant must have had a history of inadequate response to a course of a systemic antibiotic for treatment of HS
* Study participant must weigh ≥30kg at the Screening Visit.

Exclusion Criteria:

* Study participant has a draining tunnel count of \>20 at either the Screening or Baseline Visits.
* Study participant has experienced primary failure (no response within 12 weeks) to 1 or more IL 17 biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR primary failure to more than 1 biologic response modifier other than an IL-17 biologic response modifier.
* Study participant has previously participated in this study or has received previous therapy with bimekizumab.
* Study participant has a history of IBD or symptoms suggestive of IBD.
* History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated
* Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)
* Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments
* Study participant has the presence of active suicidal ideation, or positive suicide behavior,
* Study participant diagnosed with severe depression in the past 6 months prior to the Screening Visit.
* Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study.
The Effect of Semi-quantitative Procalcitonin Assay to The Adequacy of Empirical Antibiotics and Mortality in Septic Patients

Sepsis is a serious clinical condition with a considerable morbidity and mortality. Procalcitonin (PCT) is a good biomarker for early diagnosis and infection monitoring. The present study aimed to investigate the effect of semi-quantitative PCT test to the empirical antibiotic initiation time, the appropriateness of empirical antibiotics and mortality in septic patients.

The hypothesis of the study are :

* There is an effect on mortality between septic patients who do and do not do semi-quantitative PCT examination
* There is an effect on empirical antibiotic initiation time between septic patients who do and do not do semi-quantitative PCT examination
* There is an effect on appropriateness of empirical antibiotic between septic patients who do and do not do semi-quantitative PCT examination

Study design is randomized diagnostic trial which is also a pragmatic trial.


Eligibility Criteria:
Inclusion Criteria:

* aged more than 18 years old
* have at least two concomitant systemic inflammatory response syndrome criteria
* have focal infection
* with or without sign of organ hypoperfusion or dysfunction

Exclusion Criteria:

* post operative patient
* trauma patient
* have obtained prior antibiotic
* refused to participate