cyrilzakka/clinical-trials huggingface dataset:
Early Tracheostomy in Ventilated Stroke Patients

Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation, have a particularly bad prognosis. If they require long-term ventilation, their orotracheal tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal tube below the larynx. This so called tracheostomy might be associated with advantages such as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth hygiene, safer airway, more patient comfort and earlier mobilisation. The best timepoint for tracheostomy in stroke, however, is not known. This study investigates the potential benefits of early tracheostomy in ventilated critically ill patients with ischemic or hemorrhagic stroke.

Background: Tracheostomy is a common procedure in critical care patients. Advantages of a short tracheal tube compared to a long orotracheal one are the avoidance of laryngeal lesions and sinusitis, facilitation of nursing care and physiotherapy and the reduction of analgosedatives. The optimal point in time for tracheostomy is still unknown, but it is commonly done not later than 2-3 weeks and after one or several failed extubation trials. Studies in different sets of critical care patients have suggested additional advantages of early tracheostomy: less pneumonias and other complications, more patient comfort, less analgosedation, shorter duration of ventilation and of ICU stay. These questions have not been looked at in non-traumatic neurocritical care patients, although these might have a special weaning benefit by early tracheostomy, being mainly compromised in securing their airway, but not in breathing.

Method: Non-traumatic Neurocritical care patients with ischemic strokes, intracerebral hemorrhage or subarachnoid hemorrhage so severly affected that 2 weeks of ventilation need are estimated, are principally eligible for the study. After randomization, one group receives tracheostomy within the first 3 days after intubation. The other group stays orotracheally intubated and is either weaned and extubated or receives tracheostomy within 7 to 14 days after intubation. Tracheostomy is done as percutaneous dilatation by neurologists.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* informed consent from legal representative
* non-traumatic cerebrovascular disease
* Estimated ventilation need for at least 2 weeks

Exclusion Criteria:

* age \< 18 years
* informed consent not obtainable
* intubated for more than 3 days
* death within 3 weeks likely
* severe chronic pulmonary disease
* severe chronic cardiac disease
* emergency situation
* intracranial pressure difficult to control
* need for a permanent tracheostoma
* contraindications for dilatative tracheostomy
* severe coagulopathy
* severe respiration difficulties
* intubation/extubation/tube exchange difficulties
Evaluation of Cognitive and Physical Training on MCI Elders

This study examines the impact of combining cognitive and physical training, recognizing that daily living often requires individuals to perform multiple tasks simultaneously. The inability to execute such dual movements can hinder daily functioning.

The primary goal is to enhance the ability of individuals with mild cognitive impairment (MCI) to perform two tasks concurrently, focusing on both cognitive and physical aspects. This research aims to deepen our understanding of how multitasking affects patients' abilities and to develop effective intervention programs.

The World Health Organization has recognized cognitive impairment as a significant global health issue, encompassing a spectrum of conditions from mild cognitive impairment to various forms of dementia. These conditions are linked to heightened risks of disability and mortality. In the absence of suitable interventions, cognitive functions typically exhibit a gradual decline over time, driven by factors including aging, neurological disorders, traumatic brain injury, and substance abuse.

A thorough literature review indicates that cognitive and physical training can sustain cognitive or physical functions, contingent upon the specific training protocols implemented. Concurrent cognitive and physical training entails the simultaneous execution of multiple cognitive and motor activities, thereby maintaining dual functional control. This innovative training modality integrates motor and cognitive rehabilitation into a cohesive framework.

This clinical trial adopts a randomized controlled design, stratifying participants into four distinct groups: cognitive training, physical training, combined cognitive and physical training, and passive informational activities. The interventions will be administered with a frequency of three times per week over a 12-week period, incorporating task-specific training to enhance both motor and cognitive functions.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be aged 60 years or older and able to communicate in Mandarin or Taiwanese.
2. Mild cognitive impairment, assessed using the Mini Mental State Examination (MMSE) with a score of 14≦MMSE≦25.
3. Self-reported complaints of cognitive decline.
4. In addition to the above criteria, participants must voluntarily agree to participate and sign an informed consent form.

Exclusion Criteria:

1. Individuals with severe psychiatric disorders or behavioral problems, as assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q) with (a) severity score ≥ 6 and caregiver distress score ≥ 7.
2. Participants who have undergone other cognitive or activity training within the past six months.
3. Individuals with sensory impairments, such as visual, auditory, or communication difficulties.
4. People with mobility impairments, such as those who use wheelchairs or mobility aids.
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Myocardial Injury in Elderly Patients Undergoing Thoracoscopic Surgery: a Prospective, Randomized Controlled Study

This research group plans to design a prospective, double-blind, randomized controlled study to explore the effect of taVNS on hs-cTnT in elderly patients undergoing thoracoscopic surgery, and to evaluate the effect on perioperative myocardial injury and postoperative analgesia during thoracoscopic surgery.

A small number of studies based on transcutaneous auricular vagus nerve stimulation have shown that it has good therapeutic effects on patients with cardiovascular disease, and is simple to operate, with few complications and low risks. However, thoracic surgery is closer to the heart and has a higher incidence of perioperative myocardial injury. , and hs-cTnT has become a biomarker that predicts myocardial injury. This research group plans to design a prospective, double-blind, randomized controlled study to explore the effect of taVNS on hs-cTnT in elderly patients undergoing thoracoscopic surgery, and to evaluate the effect on perioperative myocardial injury and postoperative analgesia during thoracoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥60 years old
2. Inpatients scheduled to undergo elective thoracoscopic lobectomy, segmentectomy, or wedge resection
3. ASA score of Ⅰ-Ⅲ
4. Able to communicate with the researcher Communicate and cooperate with patients completing assessment scales.

Exclusion Criteria:

1. Patients with congenital heart disease, coronary heart disease, myocardial infarction, severe heart block or implanted cardiac pacemaker
2. Patients with neurological diseases such as cerebral infarction, cerebral hemorrhage or stroke
3. Patients with pain, damage, infection or unhealed ear trauma in the area near the external auricle
4. Patients with a history of severe mental illness, abuse of analgesia or addiction to psychiatric drugs
5. Patients with severe digestive system diseases
6. Patients and their families who refuse surgical anesthesia or are unable to cooperate in completing the questionnaire
7. Pregnant women.
Analysis of the Molecular Profile of the Mixofibrosarcoma of the Extremities

Single institution case series review with a histological diagnosis of mixofibrosarcoma of the extremities from 01 Jan 1993 to 01 Dec 2017.

The study will exam all the clinical, radiological, histological and immunohistochemical features of this tumour in all samples and in a limited serie of cases the presence of mutation of 50 genes cancer related.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients treated at Rizzoli Institute from 01 Jan 1993 to 01 Dec 2017
2. Diagnosis of mixofibrosarcoma of extremities
3. Histological slides/formalin-fixed paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the histology analysis and molecular analysis
4. Enough tumor biobanked material available for molecular analysis
5. Presence of the biobank signed informed consent
6. Written informed consent prior to any study-specific analysis and/or data collection

Exclusion Criteria:

1) Patients with histological diagnosis different from mixofibrosarcoma of extremities
Radlink GPS Provide a Valid Intra-operative Assessment of Acetabular Inclination and Anteversion

Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb length evaluation during Anterior hip replacement as measured intraoperative with C-Arm visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.

Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb length evaluation during Anterior hip replacement as measured intraoperative with C-Arm visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.

GPS may improve total hip replacement by allowing surgeons to measure the exact position of components placed during surgery and there is a question whether RADLINK helps surgeons place the acetabular cup (the part that goes into the hip bone) component in a precise position. The objective of the study is to determine whether GPS gives surgeons reliable, valid information about the orientation of the cup component. The surgeons need to collect data to help clarify this issue.

Eligibility Criteria:
Inclusion Criteria:

* Both: both female and male participants are being studied.
* Minimum Age: Age of participants is between 20 years - 75 years.
* Accepts: Persons who are in need of a total hip replacement

Exclusion Critieria:

* Has an existing condition that would compromise participation
* Had previous surgery on affected hip
Relationship Between Oral Hygiene in Newborns and Candida Spp.

Little is known regarding the effectiveness of neonatal oral hygiene and its relationship to colonization by Candida spp. in edentulous oral cavities. Thus, the objective of this study is to evaluate whether the oral hygiene of edentulous infants favors colonization by Candida spp. Newborns with up to 48 hours of life will randomly allocated to two groups. The mothers will instructed to clean the oral cavity with gauze and mineral water three times a day, in the test group, and not to clean, in the control group.


Eligibility Criteria:
Inclusion Criteria:

* A signed statement of informed consent
* Newborns up to 48 hours of life
* Exclusive breastfeeding
* Edentulous oral cavity

Exclusion Criteria:

* Any feeding other than breastfeeding
* Use of pacifier
* Digit sucking
* Systemic alterations
Garden-fresh Foods and Gut Microbiomes

The purpose of this research is to explore what types of microbes are present on garden-fresh versus store-bought fruits and vegetables, as well as how they might affect the human gut microbiome.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Body mass index (BMI) greater than or equal to 35 or less than or equal to 18.
* Age under 18 or over 45.
* Female who is pregnant or lactating.
* Irregular bowel movements and/or stool consistency.
* Plans to travel, move residences, or other major life change during the study period (August-October 2023).
* Unable to speak, read, and write English.
* Use of any of the following drugs within the last 6 months:
* systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral);
* oral, intravenous, intramuscular, nasal or inhaled corticosteroids;
* cytokines;
* methotrexate or immunosuppressive cytotoxic agents;
* large doses of commercial probiotics consumed (greater than or equal to 108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
* Acute disease at the time of enrollment (defer sampling until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever.
* History of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.
* Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.
* Recent history of chronic alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day.
* Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection.
* Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
* History of active uncontrolled gastrointestinal disorders or diseases including:
* inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis;
* irritable bowel syndrome (IBS) (moderate-severe);
* persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated);
* chronic constipation.
Near-Infrared Autofluorescence With PTH Test Strip as an SOP of Parathyroid in Thyroid Surgery

This is a prospective study aiming to establish near-infrared autofluorescence technology and PTH test strip as a standardized process for finding and identifying parathyroid glands in thyroid surgery.

This is a prospective study aiming to establish near-infrared autofluorescence technology and PTH test strip as a standardized process for finding and identifying parathyroid glands in thyroid surgery.

NIFRA first photographed all specimens from thyroidectomy with or without central neck dissection, and positive tissues under near-infrared light were recorded in a neck map. Then, a senior surgeon examined the parathyroid glands with the naked eye. These suspicious tissues were then identified with the PTH test strip as a gold standard. Finally, the parathyroid glands discovered during the operation that could not be preserved in situ were excluded from the procedure comparison and classified as strategic parathyroid transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with thyroid cancer by FNA
* Scheduled for surgical treatment

Exclusion Criteria:

* Patients with papillary thyroid microcarcinoma who ready for radiofrequency ablation or survival monitoring
The Acute Effect of Coffee Consumption on Stomach, Self-reported Gastrointestinal Symptoms and Stress.

This study investigated the acute effect of the consumption of four different kinds of coffee (hot and cold instant coffee, cold espresso and hot filter coffee) with the same caffeine content on salivary gastrin, cortisol and alpha-amylase concentrations, on self-reported gastrointestinal symptoms and on psychometric assessments in healthy individuals.

Coffee consumption is very common in Greece. Many of the consumers support that certain types of coffee and especially instant coffee cause gastrointestinal symptoms in healthy individuals. Up to now, few studies have investigated the relationship between coffee consumption, gastrointestinal symptoms and stress in healthy individuals with conflicting results.Coffee consumption is related with increased gastric acid and gastrin secretion, however it does not seem to affect stomach or stomach walls. Stress, which characterizes modern lifestyle, also is found to increase gastric acid and gastrin secretion and seems to be exclusively responsible for gastrointestinal symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Stable body weight for at least 1 month prior to study enrollment.

Exclusion Criteria:

* If one volunteer consumed breakfast more than three days a week, their daily caffeine intake was over 500 mg caffeine, was taking medication, their psychological state was strongly influenced by some exogenous factor (e.g. moving to a new house, new job, divorce e.t.c.), was on hypocaloric diet for weight loss, was smoking more than five cigarettes a day, was an athlete with very vigorous physical activity (\> 4 hours vigorous exercise a day), had a history of gastrointestinal disorders (e.g. gastroesophageal reflux disease (GERD), irritable bowel syndrome, diarrhea, ulcers e.t.c.), depression, diabetes, kidney disease, hypertension, blood disorders, liver disease, unregulated hyper - or hypothyroidism, arrhythmia, heart disease, cancer, vascular disease, recent surgery, or severe psychiatric disorders was automatically excluded from the study.
A Study of ZN-c3 in Patients With Ovarian Cancer

This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of ZN-c3 in combination with other drugs.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed high-grade serous epithelial ovarian carcinoma, fallopian tube, or peritoneal carcinoma.
* Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting.
* Measurable disease per RECIST version 1.1.
* Adequate hematologic and organ function as defined by the following criteria:

  1. ANC ≥ 1.5 × 10\^9/L; excluding measurements obtained within 7 days after daily administration of filgrastim/sargramostim or within 3 weeks after administration of pegfilgrastim.
  2. Platelet count ≥ 100 × 10\^9/L; excluding measurements obtained within 3 days after transfusion of platelets or within 3 weeks after administration of platelet growth factors.
  3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastases, AST and ALT ≤ 5 x ULN.
  4. Total serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of Gilbert's disease.
  5. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min.

Exclusion Criteria:

* Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
* Any of the following treatment interventions within the specified time frame prior to Cycle 1 Day 1:

  1. Major surgery within 28 days.
  2. Radiation therapy within 21 days.
  3. Autologous or allogeneic stem cell transplant within 3 months.

A serious illness or medical condition(s) including, but not limited to, the following:

1. Brain metastases that require immediate treatment or are clinically or radiographically unstable.
2. Myocardial impairment of any cause.
3. Significant gastrointestinal abnormalities.
4. Active or uncontrolled infection.
5. Any evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for small bowel obstruction within 3 months prior to Cycle 1 Day 1, or recurrent paracentesis or thoracentesis within 6 weeks prior to Cycle 1 Day 1.

   * Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
Effects of Hypericum Perforatum Oil on Promoting Skin Recovery in Different Human Skin Damage Models

Saint John's wort (Hypericum perforatum) was recognised as a traditional, folk medicine used topically for the treatment of wounds, abrasions, burns, sunburns and inflammatory skin disorders.

Its use in wound healing could be justified with its anti-inflammatory, antimicrobial and astringent effects. It also stimulated tissue growth and cell differentiation, as one of Hypericum perforatum's main ingredients, hyperforin, was shown to activate TRPC6 channel which had been recognised as an activator of keratinocyte differentiation. Another potentially useful activities could be its inhibitory effects on epidermal Langerhans cells.

Furthermore, in vivo research showed its potential with improved wound healing in different rat models. Finally, several clinical studies were performed testing its effects in atopic dermatitis treatment, wound healing after caesarean section and episiotomy, as well as healing of post-surgical scalp wounds, bed sores and venous ulcers.

The aim of the study will be to determine the effectiveness of ointment containing Hypericum perforatum oil on promoting skin recovery in different human skin damage models on healthy volunteers, in comparison to placebo.

Chosen test sites will be the forearms. One forearm will be treated will the formulation containing Hypericum perforatum oil while the other will be treated with the placebo formulation. Four test sites will be marked on each forearm with skin barrier damage induced on three areas while the fourth will be left intact. Treated forearm and test sites sequence on forearms will be prospectively randomized (double randomization).

First skin damage model used in the trial will be sodium lauryl sulphate (SLS) induced irritation. The SLS solution will be placed on the skin of participants under the occlusion for 24 hours. Second model will be the tape-stripping procedure with defined TEWL value set as an endpoint. The final model will be damage by the UV radiation. UV irradiation will be performed under strict conditions with use of the necessary safety equipment. Only the defined test areas will be irradiated with the defined dose of radiation.


Eligibility Criteria:
Inclusion Criteria:

- young, healthy volunteers who gave written informed consent

Exclusion Criteria:

* skin disease, skin damage on measurement sites
* use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
* use of drugs that may cause photosensitivity
* use of emollients three days prior the inclusion in the trial
* non-adherence to the trial protocol
* exposure to artificial and excessive natural UV radiation
* pregnancy and lactation
* skin cancer
* history of vitiligo, melasma and other pigmentation and photosensitivity disorders
* immunosuppression
* allergic or irritant reactions to the constituents of the two ointments (active and placebo) and similar chemicals (e.g. salicylic and benzoic acid)