cyrilzakka/clinical-trials huggingface dataset:
Tick-borne Encephalitis and Positive Borrelial Antibodies

In Slovenia, tick-borne encephalitis and Lyme borreliosis are both endemic diseases with high incidence rates and they are both transmitted by a bite of infected Ixodes ricinus tick. In clinical practice, tick-borne encephalitis is confirmed by demonstration of tick-borne encephalitis antibodies in serum of a patient with compatible clinical presentation and cerebrospinal pleocytosis. Patients with Lyme meningitis or meningoradiculitis also have cerebrospinal pleocytosis, however the presence of borrelial antibodies in serum does not attest Lyme neuroborreliosis.

Patients with tick-borne encephalitis and positive borrelial antibodies in serum, but not fulfilling criteria for Lyme neuroborreliosis, are often being treated with antibiotics in several European countries due to the possibility of double infection. The investigators hypothesise that such patients do not benefit from antibiotics. Such an approach may appear safe regarding the possibility of borrelial infection, however it can also be associated with detrimental consequences such as antibiotic related adverse reactions, negative epidemiological impact on bacterial resistance, and intravenous catheter related complications.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* clinical picture compatible with tick-borne encephalitis,
* clear cerebrospinal fluid,
* cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid \>5 x 106/)L,
* positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against tick-borne encephalitis virus,
* positive serum IgG antibodies against Lyme borreliae.

Exclusion Criteria:

* isolation of B.burgdorferi sensu lato from cerebrospinal fluid,
* positive intrathecal borrelial antibody production index,
* seroconversion of borrelial IgG antibodies,
* presence of erythema migrans and/or borrelial lymphocytoma in the last month,
* Bannwarth syndrome.
Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs

Maintaining treatment engagement is critical for first episode psychosis patients to experience gains possible with coordinated specialty care (CSC). This study is designed to identify CSC participants still receiving care but at high risk for disengagement and to intervene to prevent/delay disengagement.

In Phase 1 of the project, we will confirm a model predicting factors associated with later disengagement from CSC treatment. In Phase 2, we will compare disengagement among high-risk individuals with a CSC Step-down intervention to that with standard CSC care. The Step-down intervention will use web-based telemedicine and a smartphone app, to decrease disengagement likelihood. High-risk participants identified by predictors found in Phase 1 will be offered the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled into a CSC program

Exclusion Criteria:

* None
Follow Up of an Online Hearing Support for First-time Hearing Aid Users

The main questions the research aims to answer are short- and long-term effects on consequences of hearing loss depending on which type of follow-up the participant chooses.

Investigation of the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids. The goal is also to assess changes in use of communication strategies and the emotional consequences, knowledge and acceptance of hearing loss.

Eligibility Criteria:
Inclusion Criteria:

* People who have participated in NCT06051968 are automatically enrolled to participate in the follow-up according to the study protocol.
Fast Track for Wrist and Scaphoid Fractures

This is a mono centric, prospective, randomised trial on the implementation and assessment of a shortened pathway for mono-trauma of the wrist and suspected fracture of distal radius and/or ulna and/or scaphoid bone.

Patients will be randomised into two groups: fast track and normal pathway. At the arrival in the Emergency Department a triage will be performed. In case of met inclusion criteria the patient will sign the informed consent and will be randomised in one of the two study groups.

The fast track group will be straightforwardly evaluated for absence of exclusion criteria (in case of exclusion criteria present the investigators will follow the normal pathway and the patient will not be included in the study). Then, patients will be assessed with an ad hoc checklist and then sent for x-ray performance, if necessary. After the x-ray the patients will be examined by an emergency physician that will have the opportunity to request new x-ray views if necessary.

The normal pathway group will go straight to medical examination as soon as possible, depending on waiting times in the Emergency Department.

Investigators will collect anagraphical data, waiting times, time to x-ray, overall length of stay in the Emergency Department, patients' and staff's satisfaction for the two groups.

Eligibility Criteria:
Inclusion Criteria:

* adults patients presenting at the emergency dept with suspected scaphoid or wrist fracture
* monotrauma
* written informed consent

Exclusion Criteria:

* patients younger than 18 yr
* pregnant women
* either vascular or neural impairment
* signs of open fracture
* multiple trauma patient
Tobramycin Exposure From Active Calcium Sulfate Bone Graft Substitute

This study aimed to assess the systemic absorption and disposition of tobramycin in patients treated with a tobramycin-laden bone graft substitute (Osteoset® T).


Eligibility Criteria:
Inclusion Criteria:

* Adult (\> or =18 years old) patients
* Treatment with Osteoset® T

Exclusion Criteria:

* Intravenous tobramycin
Multifunctional Magnetic Resonance Imaging in Predicting Breast Lesions in Women Undergoing Mastectomy for Breast Cancer

RATIONALE: Diagnostic procedures, such as multifunctional magnetic resonance imaging, may help doctors learn the extent of disease and plan the best treatment.

PURPOSE: This clinical trial is studying how well multifunctional magnetic resonance imaging works in predicting breast lesions in women undergoing mastectomy for breast cancer.

OBJECTIVES:

* To determine the accuracy of multifunctional magnetic resonance (MR) in detecting, localizing, and characterizing satellite lesions in relation to an index breast tumor in order to improve definition of clinical target volume after local excision.

OUTLINE: Patients receive an injection of gadolinium chelate and undergo multifunctional magnetic resonance (MR) imaging, including dynamic contrast-enhanced MR, hydrogen-MR spectroscopy, and diffusion-weighted MRI, of the ipsilateral breast within 4 weeks before surgery. Patients undergo a mastectomy as planned. The resected specimen is photographed, and a histopathological analysis is performed consisting of the size and grade (if pre-invasive or invasive disease) of each satellite lesion, classification of benign satellite lesions, dimensions of each lesion, distance from the edge of the index tumor to the center of each satellite lesion, and the distance from the center of the surface of the nipple to the center of each lesion.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biopsy-confirmed invasive ductal carcinoma of the breast
* Unifocal disease as defined by clinical examination, mammography, and ultrasound
* Patient must be proceeding to mastectomy
* Hormone receptor status unknown
* No T4d or multifocal disease (as defined on conventional imaging)
* Index tumor ≤ 4 cm in diameter

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Female
* No claustrophobia
* No cup size of DD or greater

PRIOR CONCURRENT THERAPY:

* No prior surgery to ipsilateral breast
* No prior neoadjuvant chemotherapy
* No prior ferromagnetic implants
Three Combinations Of Docetaxel And Irinotecan For Recurrent Or Metastatic Non Small Cell Lung Cancer

A multicenter randomized phase II study evaluating the activity and tolerability of three different combinations of docetaxel (taxotere) and irinotecan (campto) as second line therapy for recurrent or metastatic non small cell lung cancer (NSCLC)


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven NSCLC
* Recurrent or metastatic NCSLC

Exclusion Criteria:

* Prior malignancies; except for cured non melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer adequately treated an with non evidence of disease for at least 5 years
* History or presence of brain or meningeal metastases
Alveolar Cleft Grafting by Double Iliac Bone Blocks Versus Iliac Spongy Bone From Anterior Iliac Crest

Reconstruction of Alveolar Cleft Using Double Iliac Corticocancellous Blocks in comparison with the gold standard technique ( cancellous bone ) both from anterior iliac crest.

This study will compare two techniques for the proper alveolar cleft reconstruction with adequate bone bridge formation of maximum bone quality, contour, and minimal resorption. One of them is packing autogenous particulate spongy bone from the anterior iliac crest (gold standard). While the other technique would be reconstruction of the cleft with two iliac corticocancellous bone blocks with cancellous bone in between. which benefits of the rapid revascularization and healing of cancellous bone and the strong mechanical properties of cortical bone that will aid in obtaining a proper reconstruction and form for the defect and can be applied to defects of any size.

Eligibility Criteria:
Inclusion Criteria:

* Patients with complete maxillary alveolar cleft either unilateral or bilateral at the age of mixed dentition (between 7 and 13 years old).

  * repaired cleft lip.
  * Patients with cleft lip and palate who have not undergone alveolar grafting procedure.
  * Patients with unerupted maxillary permanent canine in the cleft region.
  * Patients with medical history that did not hinder surgical intervention and have adequate proper oral hygiene.
  * Both genders males and females will be included

Exclusion Criteria:

* General contraindications to surgical intervention of the area. Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft.

  * Patients with associated syndrome.
  * Patients requiring concomitant Orthognathic surgical procedure.
  * Subjected to irradiation in the head and neck area less than 1 year before surgery.
  * Untreated periodontitis.
  * Poor oral hygiene.
  * Uncontrolled diabetes.
  * Immunosuppressed or immunocompromised.
  * Treated or under treatment with intravenous amino-bisphosphonates.
  * Active infection or severe inflammation in the area intended for graft placement.
  * Patients participating in other studies, if the present protocol could not be properly followed.
A Trial of NS/GEMOX Chemotherapy in Patients With Untreated Pancreatic Cancer ( HZ-NS/GEMOX-PC )

This is a Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With untreated Pancreatic cancer.

This study aims to evaluate the safety and efficacy of Sequential GEMOX/NS Chemotherapy as a first-line treatment of untreated Pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate in the trial and sign the informed consent form
2. 18 years old \<age \<75 years old
3. Histopathological or cytologically confirmed (inoperable) locally advanced or recurrent metastatic pancreatic ductal adenocarcinoma with lesions measurable according to RECIST criteria
4. ECOG score 0-1
5. Life expectancy \> 3 months
6. There must be a CT or MRI examination within a week
7. at least one lesion that can be measured by the RECIST v1.1 standard
8. No chemotherapy has been performed (the interval between postoperative adjuvant chemotherapy must be more than 6 months)
9. without radiation therapy (unless there is at least one measurable target lesion in the non-irradiated area)

Exclusion Criteria:

1. pregnant or lactating women; or those who have fertility but refuse to take contraceptive measures;
2. Severe active infections requiring intravenous antibiotic treatment during enrollment;
3. those who are allergic to the test drug;
4. There is ≥2 neuropathy (CTCAE 4.0);
5. uncontrolled, symptomatic brain metastases or those with a history of uncontrollable psychiatric disorders; severe intellectual or cognitive dysfunction;
6. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack;
7. Have other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin that has been basically controlled;
8. Patients who are unable to follow the protocol or who are unable to follow up;
Randomized Trial of Continuous Versus Intermittent Cefotaxime Infusion on ICU.

This study evaluates target attainment after either intermittent intravenous bolus or intravenous continuous infusion of cefotaxime in critically ill patients. Critically ill patients will be randomized to intermittent infusion or continuous infusion of cefotaxime.

Critically ill patients have other pharmacokinetic/pharmacodynamic profiles than healthy volunteers. Suboptimal, both under- and overdosing of antibiotics is an important threat in this patient category. Given the time-dependent character of beta-lactam antibiotics continuous dosing as opposed to traditional intermittent dosing is likely to render better target attainment and maintenance and might improve clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to intensive care
* Able to give informed consent by themselves or informed consent can be obtained via next of kin
* Indication for treatment with cefotaxime (as judged by treating physician) in the context of our standard treatment protocol of Selective decontamination of the digestive tract (SDD).

Exclusion Criteria:

* Renal replacement therapy
* Contra-indication for cefotaxime, including known or suspected allergy to cefotaxime
* No indication for an arterial line; an arterial line will not be placed solely for the purpose of this study; thus, only patients with an indication for an arterial line outside this protocol are eligible.
Lesser Tuberosity Osteotomy for Subscapularis Repair

The primary objective of this study is to assess the clinical effectiveness of two different techniques used for subscapularis tendon repair during total shoulder replacement. The investigators hypothesize that participants who receive a newer repair technique called a lesser tuberosity osteotomy will have lower rates of postoperative subscapularis muscle dysfunction and rupture as compared to those who receive the traditional tenotomy repair.

The subscapularis tendon is mobilized during total shoulder arthroplasty in order to gain anterior access to the glenohumeral joint. Postoperative subscapularis dysfunction is being recognized more frequently and has been reported in \>65% of patients following shoulder arthroplasty with a soft-tissue repair. Subscapularis dysfunction has been associated with poor functional outcomes including tendon rupture and anterior instability, a major indication for revision surgery. Recent studies suggest that a standard subscapularis tenotomy with primary tendon repair may lead to failure of the repair and decreased functional outcomes as compared to a more novel lesser tuberosity osteotomy technique. The investigators study aims to validate the results of the current literature in a prospective randomized controlled trial, which to their knowledge has not been reported on this topic.Investigators will compare clinical outcomes following these two techniques during total shoulder arthroplasty. Participants undergoing total shoulder replacement will be randomized to receive either a lesser tuberosity osteotomy or tenotomy with primary subscapularis tendon repair. All other procedures conducted in this study are considered standard of care except for ultrasounds, which are conducted for research purposes in the subscapularis tenotomy group. Postoperative outcomes will be monitored objectively and subjectively at routine postoperative office visits using physical exam, imaging (X-rays and ultrasounds), and questionnaires. If the hypothesis is proven to be true, the investigators will establish gold-standard evidence for the use of the newer osteotomy technique to improve patient satisfaction and mobility following shoulder arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Patients already scheduled for total shoulder arthroplasty

Exclusion Criteria:

* Unable to provide information throughout postoperative recovery and attend subsequent office visits thereafter (a minimum of one year).
Evaluation of an Advanced Lower Extremity Neuroprostheses

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.

Protocol Outline: Patents undergo surgery in which electrodes are implanted into muscles of the trunk and legs. Electrode leads are connected to an stimulator/telemeter. Following implantation, patients undergo training in standing, transfers and other advanced mobility skills using the functional electrical stimulation system. A prescribed course of exercise, functional training and rehabilitation with the implanted stimulation system, followed by laboratory assessments of strength, balance and functional abilities with and without the system, as well as the technical performance of the implanted components. Home-based training follows prior to discharge for home use of the system.

Patients are followed at 6 and 12 months after discharge and then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Low cervical or thoracic spinal cord injury (C6-T12) or other paralyzing condition
* Skeletal maturity
* Ability to understand and sign informed consents
* Disability equivalent to ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing) or C (motor and sensory sparing)
* Intact and electrically excitable lower motor neurons
* Greater than 6 months since injury or onset
* Range of motion within normal limits

Exclusion Criteria:

* Pacemaker
* Cardiac arrythmia
* Pregnancy
* Contractures of any major joint of upper or lower extremities
* Uncontrolled seizure disorder
* Obesity
* Untreated substance abuse
* Immunodeficiency
* Frequent urinary tract infections
* Presence of decubitis ulcers
* Acute or chronic psychological problems
* Acute orthopaedic problems
* Pulmonary compromise
* Renal compromise
* Circulatory compromise
* History of spontaneous fractures or insulin dependent diabetes
Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women

This clinical trial, a double blind randomized controlled trial, is conducted to determine the effects of daily topical visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel on sexual function in postmenopausal women with vulvovaginal atrophy within 8-week of treatment. We compare the active ingredient in emulgel to the emulgel only. We also evaluate the improvement of the vulvovaginal atrophy symptoms in postmenopausal women, the safety and the tolerability of visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel. This study is conducted in the Menopause Clinic and the Gynecology Clinic, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.

Topical visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel is a cosmetic product. Visnadin is an active ingredient which has the vasodilator effect and improve blood flow to female vulvovaginal area. This will improve lubrication from increase Bartholin's gland secretion. As the clitoral blood flow increase, the sexual response could be improved. The ethyl ximeninate, coleus barbatus and millet are plant extract which have moisturizer, anti-inflammation and antioxidant effects. Our hypothesis is a daily topical visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel could improved sexual function and vulvovaginal atrophic symptoms in postmenopausal women with vulvovaginal atrophy.

Eligibility Criteria:
Inclusion Criteria:

* Women age 45-65 years old
* BMI 19-29 kg/m2
* Menopause or removal of both ovaries more than 1 year
* Has moderate to severe vulvovaginal atrophic at least 1 symptom
* Has sign of vulvovaginal atrophy
* Vaginal pH ≥ 5
* Has sexual intercourse at least 1 time/month

Exclusion Criteria:

* Hormonal use within 3 months
* Use vaginal estrogen/ moisturizer within 3 months
* Use aromatase inhibitor/tamoxifen within 3 months
* Has vaginal bleeding within 6 months
* Acute or chronic urinary tract infection
* History of radiation therapy at vulvovaginal and pelvic area
* History of Diabetes mellitus or Cardiovascular disease
* History of neurosis or psychosis
* History of vulvovaginal cancer
* History of smoking more than 20 cigarettes/day
* History of alcoholic drink/ drug abuse
* History of visnadin, ethyl ximeninate, coleus barbatus and millet allergy
* Has disease of vulva
Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery

Dexmedetomidine induces analgesic and sedative effects and is reported to decrease agitation during emergence after general anesthesia in various surgeries. For patients undergoing cranial aneurysm surgeries, a calm anesthesia and emergence is important. In this study, the investigatorstend to observe the effect of dexmedetomidine on maintenance and recovery of patients undergoing cranial aneurysm surgeries.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cerebral aneurysm embolism under general anesthesia

Exclusion Criteria:

* patients with bradycardia or atrioventricular heart block
* patients with ASA(American Society of Anesthesiologists) status over 3
* patients with body mass index(BMI)≥30kg/m2
* patients with difficulty in communication
* patients with ruptured aneurysm
* patients suspected or proved to be pregnant