cyrilzakka/clinical-trials huggingface dataset:
Innovative Training Program for Elderly in Need of Care Individuals

The goal of this randomized controlled study was to examine the effects of a 8 weeks innovative training regime (stochastic resonance whole-body vibration \[SR-WBV\] and virtual virtual games \[VG\]) in the skilling up phase on physical performance and strength in elderly in need of care population.

Sensorimotor and strength exercise are methods to increase strength \& power in the field of geriatrics. The question that arise what exercises are best suited to and most effective for elderly in need of care individuals. Such populations are advised first to enter a "skilling up program" before more traditional forms of training exercises are implemented.

Goals in the skilling up phase: improvement in neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity.

The aim of the study in the skilling up phase:

Study the effect on physical performance Study the effects on muscle strength.. The participants will be recruited in Canton Bern - Switzerland and will be randomly allocated to an intervention group or sham group.

Eligibility Criteria:
Inclusion Criteria:

* RAI (Resident Assessment Instrument) \>0
* live in canton Bern
* in terms of training load be resistant.

Exclusion Criteria:

* acut joint disease, acut thrombosis, acute fractures, acute infections, acute tissue damage, or acute
* surgical scars
* seniors with prosthesis.
* alcoholic
* acute joint disease, activated osteoarthritis, rheumatoid arthritis, acute lower limb
* acute inflammation or infection tumors
* fresh surgical wounds
* severe migraine
* epilepsy acute severe pain
Intermittent Automated Devices for Labor Analgesia in Emilia Romagna

The study aims to determine whether the use of automated intermittent devices for labor analgesia could prevent the increase of instrumental deliveries, with same analgesia.

Moreover it will evaluate if automated devices can allow a reduction of health-care burden.

Epidural analgesia is recognized as the most effective technique to control labor pain, although its possible adverse events. Continuous epidural administration of local anesthetics can stabilize the analgesic block and reduce the anesthesiologists' workload but is associated with an increase in operative vaginal delivery.

Epidural intermittent boluses performed by anesthetist are associated to reduction of dosages, but they could provide insufficient analgesia and they involve the constant anesthetist's presence in the operating room.

This is a multicenter randomized controlled trial with two arms, funded by grant of Regione Emilia Romagna, in which we will compare two different epidural analgesia protocols: anesthesiologist's supervised versus intermittent boluses with PCEA.

Eligibility Criteria:
Inclusion Criteria:

1. Nulliparous women at full-term pregnancy single fetus and vertex presentation, hospitalized for harbingers of labor and cervical dilation less than 5 cm
2. Numeric Rate Scale \> 5

Exclusion Criteria:

1. patients aged under 18 years
2. patients with ongoing administration of oxytocin
3. patients with no indications to epidural analgesia
4. patients with inability to place the epidural catheter for technical difficulty
5. patients with parenteral administration of opioids
6. multiparous women
7. patients unable to understand the objectives and procedures of the study
Fournier's Gangrene and the Origin of the Infection as a Prognostic of Morbidity and Mortality, an Analysis of 121 Patients

Background:

Fournier's gangrene it's a necrotizing infection of the genital area, with high morbidity and mortality. The site of infection its the origin of the necrotizing fasciitis. There are 4 well known origins of Fournier's gangrene: Testicular, Intestinal, Urinary and cutaneous, and its prognostic value has not been established yet, that's because the lack of case series with adequate number of patients. This is a retrospective study in which we evaluate the prognostic factors of every patient and its mortality compared with its origin area and multiple scores with their survival rates and hospital stay.

Objective:

To evaluate origins of Fournier's gangrene as a prognostic value in the morbidity and mortality.

Patients and methods:

This is a retrospective study where patients from a single hospital from 2007 to 2016 were included. They were categorized in 4 groups matching the origin of infection. In every group categorizing with the origin of infection and determined severity factors, days of hospital stay, Fournier's gangrene severity index and mortality. A statistic analysis will be done using lineal multivariable analysis.

Eligibility Criteria:
Inclusion Criteria

* Male Patient
* Fournier's Gangrene
* All patients treated with two antibiotics
* All patients undergone with aggressive debridement

Exclusion Criteria

* Female
* Not having Fournier's Gangrene
Preoperative Anxiety's Incidence and Related Factors in Surgical Patients

Preoperative anxiety is often described as an uncomfortable, tense unpleasant mood before surgery, an emotional response to a potential challenge or threat to reality. Data show that adult patients with preoperative anxiety rate of 30-40%. The main reason for the occurrence of patients for surgery, anesthesia and other factors of fear. Preoperative anxiety itself is not a mental illness, but studies have confirmed that the occurrence of preoperative anxiety and postoperative complications were positively correlated, and the existence of preoperative anxiety in patients with conventional postoperative analgesic effect is poor. At present, there are still few studies on the relationship between preoperative anxiety and postoperative complications and analgesia. At the same time, there is a lack of large sample size to study the incidence of preoperative anxiety and its related predictors.

Surgical patients often have varying degrees of preoperative anxiety.The aim of this study was to determine the incidence of preoperative anxiety and related predictors, and to evaluate the effect of anxiety on anesthesia and postoperative pain and prognosis. The study also showed that prostaglandin, catecholamines, cortex Effects of alcohol and inflammatory cell level on postoperative pain in patients with preoperative anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years old
* Sign that informed consent is willing to participate in the study
* Education: primary school and above
* 1 days after elective general anesthesia surgery
* ASA score grade I-III

Exclusion Criteria:

* Emergency surgery
* Severe mental illness patients (such as anxiety, depression, schizophrenia, etc.)
* Taking anti-anxiety or antidepressants (benzodiazepines, tricyclic antidepressants, selective serotonin inhibitors, monoamine oxidase inhibitors, etc.)
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789

This Phase 1 clinical study is a double-blind, randomized, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics (PK), food effect, and drug interaction potential of ACHN-383 and ACHN-789 co-administered orally as separate capsules in healthy subjects


Eligibility Criteria:
Key Inclusion Criteria:

* Females of child-bearing potential must not be breast feeding, must have a negative serum pregnancy test, and must use a highly effective method of contraception or be abstinent from sexual activity prior to the first dose of study, during the study and for a specified period following the last dose of study drug
* Males must be willing to use a condom for the duration of the study and for a specified period following the study, unless surgically sterile. In addition, their female partner must use a highly effective method of contraception, for the same period of time, unless surgically sterile
* Body mass index (BMI) of ≥19 kg/m\^2 to ≤32 kg/m\^2 and weight ≥50 kg to ≤125 kg
* Normal renal function as determined by creatinine clearance (CLcr) rate

Key Exclusion Criteria:

* Pregnant women
* History of any hepatic or biliary disorder or disease
* Any condition that could possibly affect oral drug absorption
* Unstable cardiovascular disease
* Uncontrolled hypertension, asthma, diabetes, thyroid disease, or seizure disorder
* HIV positive
* Active malignancy
Nitrocamptothecin or Fluorouracil in Treating Patients With Recurrent or Refractory Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether nitrocamptothecin is more effective than fluorouracil for pancreatic cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with that of fluorouracil in treating patients who have recurrent or refractory pancreatic cancer and who have been treated previously with gemcitabine.

OBJECTIVES: I. Compare survival of patients with recurrent or refractory pancreatic cancer after treatment with nitrocamptothecin versus fluorouracil. II. Compare the clinical benefit and objective response rate to these treatment regimens in these patients. III. Compare and evaluate time to treatment failure in these patients with these treatment regimens. IV. Compare the toxicities of these treatment regimens in these patients.

OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive nitrocamptothecin orally on days 1-5. Arm II: Patients receive fluorouracil IV over 30 minutes on day 1. Treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with tumor regression or stabilization may receive additional courses of treatment. Patients with disease progression or unacceptable toxicity may crossover to the alternate treatment arm. Patients are followed every 3 months for one year.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 15 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory adenocarcinoma of the pancreas Must have received prior gemcitabine and progressed

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 50-100% Life expectancy: At least 2 months Hematopoietic: Granulocyte count greater than 1,500/mm3 Hemoglobin at least 9 g/dL Platelet count greater than 100,000/mm3 Hepatic: SGOT and SGPT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if tumor involves liver) Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 2 weeks since prior gemcitabine and recovered No prior chemotherapy except gemcitabine No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids or hormones Radiotherapy: No concurrent radiotherapy Surgery: At least 2 weeks since prior major surgery No major surgery within 8 weeks following initiation of study treatment
Intradermal Tozinameran for Patients With Immune-mediated Dermatologic Diseases

This is a randomised controlled trial conducted to prove that the immunological performance of intradermal tozinameran (i.e., Pfizer-BioNTech COVID-19 vaccine) is no worse than the standard intramuscular route in patients with immune-mediated dermatologic diseases. The side effects profile and disease activity post-vaccination will also be assessed.

The standard intramuscular tozinameran is widely used as a COVID-19 vaccine booster dose, although the fractionated-dose intradermal route of the vaccine has emerged as a dose-sparing and cost-effective alternative. However, before implementing the intradermal vaccine in patients with immune-mediated dermatologic diseases, its immunogenicity should be confirmed, as many of them use long-term immunosuppressive medications, which may alter their immune responses to the vaccine. This prospective open-labelled single-blinded randomised-controlled parallel-grouped non-inferiority trial aims to determine non-inferiority in the immunogenicity of fractionated-dose intradermal tozinameran in comparison with the standard intramuscular tozinameran as the fourth COVID-19 vaccine dose in patients with immune-mediated dermatologic diseases and compare vaccine-related adverse effects between the two.

Eligibility Criteria:
Inclusion Criteria:

1. Aged equal to or more than 18 years
2. Diagnosed with psoriasis or autoimmune bullous diseases
3. Completed two-doses of the primary vaccine series and the third booster dose lasted for more than three months
4. Agree to receive the fourth COVID-19 vaccine dose as tozinameran

Exclusion Criteria:

1. History of previous COVID-19 infection
2. Positive result of COVID-19 rapid antigen test (tested upon recruitment prior to vaccination)
3. Uncontrolled disease activity
4. Non-dermatologic immune-mediated diseases
5. Congenital or acquired immunodeficiency syndrome
6. Cancer
7. Pregnant women
8. Allergy to components of tozinameran
9. Inability to give written informed consent to participate in the study
Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection

The primary purpose of this study is to establish a maximum tolerated dose (MTD) through a dose-escalation trial using intraoperative radiotherapy (IORT) following neurosurgical resection for large brain metastases, and to determine the progression-free survival rate as in the recurrence rate of treated brain metastasis.

The potential for delivering ablative doses of radiation to the tumor bed while simultaneously sparing normal brain parenchyma from significant doses of radiation and reducing the potential for tumor repopulation has led to interest in the use of intraoperative radiotherapy (IORT) for brain metastasis.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be ≥ 18 years of age.
2. Participants must have a Karnosfky performance status of ≥ 50%.
3. Participants must not have had prior intracranial radiation.
4. Participants must have a life expectancy greater than 3 months.
5. Participants must have a preoperative MRI Brain T1-Gadolinum enhanced scan demonstrating a non-dural based lesion with greatest diameter ≥ 2.5 cm.
6. Sufficient distance (≥ 2cm) of the intracranial lesion from optic structures (optic chiasm and bilateral optic nerves) and brainstem to meet established normal structure dose limits.
7. Subject or subject's legal representative to provide signed/written informed consent to participate in the study protocol.
8. Surface of balloon applicator must be ≥ 1cm from skin overlying closest portion of calvarium.
9. Participants may remain on systemic therapy if they are receiving immunotherapy (anti-PD1, anti-PDL1, anti-CTLA-4), capecitabine, temozolomide, etoposide, vinorelbine, pemetrexed, lapatinib, traztuzumab, bevacizumab, mTor or ALK targeted agents with no break prior to initiating IORT.

9.1 Participants receiving cisplatin, methotrexate, taxanes, tyrosine kinase inhibitors, or BRAF targeted agents must have a seven day washout period prior to receiving IORT.

9.2 Participants receiving doxorubicin, T-DM1, or antibody-drug conjugates must have a fourteen day washout period prior to receiving IORT.

9.3. Participants receiving all other concurrent systemic agents will undergo consideration for a washout period prior to receiving IORT at the discretion of the study principal investigator.

Exclusion Criteria:

1. Participants may not be pregnant or breast-feeding.
2. Patients must not have dural lesions or leptomeningeal disease.
3. Patients must not have psychiatric or social conditions limiting adherence to protocol guidelines.
4. Patients must not have contraindications to anesthesia, surgery, or MR imaging with Gadolinium injection.
5. Patients must not have a frozen section diagnosis of small cell carcinoma, lymphoma, germinoma or non-malignant histology.
6. Patients with additional unresected brain metastases must have a limited number of lesions/or volume of intracranial disease amenable to stereotactic radiotherapy at the discretion of the study principal investigator.
7. Patients deemed to require postoperative whole brain radiotherapy should be excluded.
Trial Comparing Proximal Tibia and Proximal Humerus Infusion Rates Using the NIO Intraosseous Device

The investigators sought to compare the intraosseous access success rates of the proximal tibia and the proximal humerus using new Intraosseous access device "NIO" in an adult cadaver model during simulated resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* paramedics
* without previous experience in intraosseous devices

Exclusion Criteria:

* not meet the above criteria
Evaluation of Lofexidine for Treatment of Opiate Withdrawal - 10

The purpose of this study is to assess the safety of lofexidine in the treatment of opiate-dependent individuals.


Eligibility Criteria:
Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
Cholinergic Anti-inflammatory Pathway in Prevention & Treatment of the SIRS in Patients With Jaundice After Operation.

RATIONALE:Anticholinesterase drugs and cholinergic M receptor antagonist are applied to patients who have obstructive jaundice after operation.

PURPOSE:This clinical trial was designed to lower the incidence and mortality of operation complications in patients with obstructive jaundice .

OBJECTIVES:

Ⅰ.Judge whether it has the effect of inhibiting inflammation, anti oxidative stress and anti apoptosis when the alpha 7 nicotinic acetylcholine receptors are activated .

Ⅱ.Judge whether it has the effect of reducing the incidence and mortality of operation complication when using Cholinesterase inhibitors and M cholinergic receptor blocking agent in Patients with obstructive jaundice after operation。

OUTLINE:Patients are assigned to 1 of 2 groups according to order of enrollment.

Group 1:Patients receive neostigmine methylsulfate and raceanisodamine hydrochloride on days 0,1,2 after operation.

Group 2:Patients do not receive any special treatment after operation.

All patients should be monitored the observed indexes on the day before the operation and one day, three days, five days after the operation.

Eligibility Criteria:
Inclusion Criteria:

Ⅰ.Accompanied by obstructive jaundice and plans to implement the liver resection of hilar bile duct carcinoma.

Patients with carcinoma of head of pancreas and plans to implement pancreaticoduodenectomy.

Ⅱ. Drugs which were used in the clinical trials is safe for patients.

Ⅲ.The patients did not occur the complication which would affect the experimental observation seriously after the operation.

Ⅳ.The patients agreed to participate in this clinical trial and sign the informed consent.

Exclusion Criteria:

Ⅰ.Patients are unwilling to accept the clinical trials or researchers believe that patients can not in compliance with the requirements of clinical research.

Ⅱ.Patients with tumor metastases widely or can not accept a predetermined operation scheme.

Ⅲ. The postoperative complications or other therapeutic measures take will affect the experimental observation seriously.
Comparison of Change of Tissue Oxygenation During a Vascular Occlusion Test Using Two Different NIRS (O3TM vs. INVOS®)

This study evaluates the change of tissue oxygenation during a vascular occlusion test using two NIRS ( O3TM and INVOS®). NIRS probe will be attached on volunteer's forearm during vascular occlusion test and tissue oxygenation change will be recorded

Near-infrared spectroscopy (NIRS) has been used to measure regional hemoglobin oxygen saturation of tissue. Recently, it also has been used to monitor peripheral tissue oxygen saturation, and micro-vascular reactivity using vascular occlusion test (VOT).

O3 TM is recently developed NIRS and there are only two clinical trials using this device, until now. In one study, this device could adequately predict cerebral regional oxygen saturation. And in the other study, peripheral tissue oxygenation was measured during ischemic pre-conditioning in heart surgery and it showed correlation between O3 TM and other NIRS ( EQUANOX) which has been used to monitor peripheral tissue oxygenation. But in this study, study group was patient with heart disease and the deoxygenation and reoxygenation rate during VOT was not not measured, which reflects tissue oxygen extraction and micro-vascular reactivity.

In NIRS devices, there are assumed cerebral arterial-venous ratio upon which oximetry values are calculated. In INVOS®, assumed arterial-venous ratio is 25/75. In other NIRS, assumed arterial-venous ratio is 30/70. But unlike other NIRS, O3 TM can change its preset arterial-venous ratio between 25/75 and 30/70, and there are no studies compare oximetry values between these two different settings.

In this study, the investigators try to compare INVOS®, which has been used widely for monitor tissue oxygenation, and two different settings of O3 TM ( arterial-venous ratio; 30/70 and 25/75). Three probes will be attached at same site simultaneously and the investigators will measure change of tissue oxygenation, deoxygenation rate and reoxygenation rate during vascular occlusion test

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult without known disease

Exclusion Criteria:

* Patients with previously known cardio-vascular disease
* Patients with body mass index \>30kg/m2
* Patients on vasoactive drug
* Patients with skin pigmentation on probe attachment site
* Patients who is pregnant
* Patients with chronic anemia