cyrilzakka/clinical-trials huggingface dataset:
Trial of Combination Antifungal Therapy (Vori+Mica vs. Vori+Placebo) in Invasive Aspergillosis

The purpose of this study is to evaluate the therapeutic effectiveness of combination antifungal therapy (CAT) of voriconazole plus micafungin versus voriconazole plus placebo equivalent as primary therapy for invasive aspergillosis (IA) in patients with hematological cancer.

Patients will receive either IV micafungin 100 mg or placebo equivalent daily. Intravenous (IV)Voriconazole will be administered at a loading dose of 6 mg/kg every 12 hours for the first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours. Patients may be switched to oral voriconazole 200 mg BID provided aspergillosis response is achieved and gastrointestinal functions are intact.

Eligibility Criteria:
Inclusion Criteria:

1. The patient or legally authorized representative has signed an informed consent/assent.

   Assent will be obtained as required by the UAMS IRB.
2. The patient has a diagnosis of proven or probable invasive aspergillosis and with positive Aspergillus GM index (≥0.5 ng/ml) provide the patient is not receiving antibiotics, such as piperacillin-tazobactam, that are known to cause false positive GMI
3. The patient is 18 years of age or older.

Exclusion Criteria:

1. The patient is being treated with an unlicensed investigational drug for aspergillosis.
2. The patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid formulation of amphotericin B) for \> 7 days immediately prior to randomization for treatment of the Probable, or Proven invasive aspergillosis for which the patient is being enrolled.
3. Patient has invasive aspergillosis but with negative Aspergillus GM index.
4. The patient is pregnant or lactating. If the patient is female and of childbearing potential, the patient must have a negative pregnancy test and avoid becoming pregnant while receiving study drug. A pregnancy test should be performed within 14 days prior to the first dose of study drug.
5. The patient has alkaline phosphatase, ALT, AST or total bilirubin greater than five times the upper limit of normal.
6. The patient has hepatic cirrhosis.
7. Patients with creatinine \> 3 will be enrolled only if able to receive oral voriconazole (specify oral loading dose is 6 mg/kg PO Q 12 hours for 24 hours) then oral maintenance 200 mg PO q 12 hours).
8. The patient is on artificial ventilation, and unlikely to be extubated within 24 hours of study entry.
9. The patient has a history of allergy, hypersensitivity, or any serious reaction to the azole or echinocandin class of antifungal agents.
10. The patient has previously enrolled into this study.
11. The patient has a concomitant medical condition, which in the opinion of the Investigator may create an unacceptable additional risk.
12. The patient has an active microbiologically-documented deep infection due to a non-Aspergillus mold.
13. The patient has a life expectancy of less than seven days.
Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers

To investigate the effect of Dipeptidyl Peptidase 4 Inhibition on wound healing in patients with diabetic foot ulcers, the investigators randomly divided the participants into two groups: saxagliptin with regular treatment group，placebo with regular treatment group. The clinical data are collected at the given time point. This study aimed to observe the potential protective effect of DPP4i on diabetic ulcers.

Groups:

Diabetic ulcers, saxagliptin + Regular treatment.

Diabetic ulcers, placebo + Regular treatment.

Time Point:

Initial treatment;

Post-treatment ( 1w );

Post-treatment ( 2w );

Post-treatment ( 4w );

Completely healed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus according to World Health Organization criteria ( treatment with insulin or an oral hypoglycemic agent, twice random glucose measurements major than 200 mg/dl, or a fasting glucose major than 140 mg/dl)
* Ulcer located on the legs or feet, stage III or IV (Wagner Classification System)
* The subject agrees to comply with study protocol requirements and all follow up visit requirements.

Exclusion Criteria:

* Uncontrolled diabetes
* Ulcer infection
* Non-diabetic ulcers Orthopedic or neuromuscular pathologic conditions
Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring

This pilot study aims to assess the feasibility and safety of using an ILR to identify the incidence of recurrent AF after an episode of newly diagnosed AF. The study further aims to assess the risk of AF recurrence in this low risk population based on left atrial and left atrial appendage anatomic and functional indices in addition to the standardized clinical CHA2DS2-Vasc score.

There is a significant incidence of recurrent AF following initial diagnosis of AF.

Inclusion of left atrial (LA) and left atrial appendage (LAA) abnormalities together with risk prediction of CVA using CHA2DS2-Vasc score will identify patients at low or high risk for adverse cardiovascular events in patients with manifest and silent AF.

Patients requiring cardioversion have higher risk of recurrent AF in follow up.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Newly diagnosed AF
3. Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule

Exclusion Criteria:

1. Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint
2. Patient received an organ transplant, or is on a waiting list.
3. Patient is not able to follow instructions for remote monitoring 4 Prior history of AF
Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL

The purpose of this study is to assess the antitumor effect and safety of fludarabine phosphate tablet in combination with rituximab in patient with indolent lymphoma.

As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CD 20 positive, relapsed/refractory indolent lymphoma. (Regimens of prior chemotherapy are limited to 2; prior rituximab treatments up to 16 times are allowed.)
* Patients with measurable lesions (\> 1.5 cm).
* Patients who have not received any treatment for more than 4 weeks after completing previous therapies (6 months in the case of antibody therapies).
* ECOG performance status: 0 - 1
* Patients with adequately maintained organ functions.

Exclusion Criteria:

* Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency, serious CNS symptoms, fever \</=38 °C, interstitial pneumonia or pulmonary fibrosis, active other malignancies, autoimmune hemolytic anemia or the history of the disease, or glaucoma.
* Patients who are positive for HBs antigen, HCV antibody, or HIV antibody.
* Patients who received G-CSF or transfusion within 1 week before the registration.
* Patients with the history of allergies to purine nucleoside analogue.
* Patients who experienced serious hypersensitivity or anaphylaxis to rituximab or mouse protein-derived products.
* Patients who had ever received prior therapy with fludarabine phosphate injection, pentostatin, cladribine, SH T 586, blood stem cell transplant, or monoclonal antibody therapy other than rituximab to NHL (including radioimmunotherapy).
* Patients who had progressive disease within 6 months of receiving therapy including rituximab.
* Women who are pregnant, of childbearing potential, or lactating.
* Patients who do not agree to practice contraception.
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of the Dayspring Technology for Patients With Breast Cancer Related Lymphedema (BCRL) After Lymphatic Surgery

To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery

To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of age
* Willing to sign the informed consent and deemed capable of following the study protocol
* Subjects must have a diagnosis of upper extremity edema and have or will undergo lymphatic surgery with Dr. Nguyen
* Subjects must have a difference in volume greater than 3% between the limbs.

Exclusion Criteria:

* Individuals with a history or presence of a systemic disorder or condition that could place the patient at increased risk from sequential compression therapy
* Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
* Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
* Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer
* Patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
* Diagnosis of lipedema
* Diagnosis of acute infection. The source of the infection must be treated for 2 weeks prior to admittance into the study
* Diagnosis of acute thrombophlebitis (in last 2 months)
* Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
* Diagnosis of pulmonary edema
* Diagnosis of congestive heart failure (uncontrolled)
* Diagnosis of chronic kidney disease
* Diagnosis of epilepsy
* Patients with poorly controlled asthma
* Women who are pregnant, planning a pregnancy or nursing at study entry
* Participation in any clinical trial of an investigational substance or device during the past 30 days
* Bilateral limb edema
The Effect of Acupressure on Procedural Pain, Anxiety and Hemodynamic Variables During Chest Tube Removal

When the literature was reviewed, many studies were found in which various non-pharmacologic interventions such as reflexology, music therapy, slow and deep breathing exercises, relaxation exercises and cold application were examined in the control of pain associated with chest tube removal. However, a limited number of studies have examined the effect of acupressure on the control of pain caused by chest tube removal; there are no studies in which LI4, LI11 and HT7 acupressure points were used and anxiety level and hemodynamic variables were examined along with procedural pain. Thus, the aim of this study was to investigate the effect of acupressure on procedural pain, anxiety and hemodynamic variables after chest tube removal after open heart surgery.

Before starting the acupressure/placebo acupressure point application, the area around the area where pressure will be applied for 20-30 seconds will be gently rubbed with the palm of the hand. By gently rubbing the surrounding tissue, tension and tissue sensitivity will be reduced and the tissue will be relaxed by heating, relaxing and preparing the point area. Pressure will be applied to the determined points (LI4, LI11 and HT7 or points 1.5 cm away) with the thumb, index or middle finger manually for 5 seconds to create a depth of 1-1.5 cm, and rest for 2 seconds. Each point will be applied for 2 minutes and the application will last 12 minutes.

When acupressure/plesebo acupressure application is completed, the chest tube will be removed by the physician. Procedural pain level, anxiety level and hemodynamic variables of all patients in the acupressure and placebo acupressure groups will be re-evaluated immediately and 15 minutes after removal of the chest tube.

Eligibility Criteria:
Inclusion Criteria:

* With only one chest tube after open heart surgery,
* 18 years of age or older,
* Conscious and cooperative,
* Speaks and understands Turkish,
* General condition and hemodynamic variables are stable,
* Planned surgical intervention,
* No previous chest tube experience,
* Acupressure/placebo acupressure without scars, scars, tenderness in the area to be acupressure,
* No active COVID-19 infection,
* Does not have any psychiatric diagnosis,
* Not using psychiatric and/or local neuromuscular blocking drugs,
* Patients who agreed to participate in the study (signed the Informed Consent Form)

Exclusion Criteria:

* No chest tube or multiple chest tubes after open heart surgery,
* Under 18 years of age,
* Conscious and uncooperative,
* Speaking Turkish but not understanding it,
* Unstable general condition and hemodynamic variables,
* Underwent emergency surgical intervention,
* Anyone with previous chest tube experience,
* Wounds, scars, tenderness in the area where acupressure/placebo acupressure will be applied,
* With active COVID-19 infection,
* Has an existing psychiatric diagnosis,
* Psychiatric and/or local neuromuscular blocking drugs,
* Patients who did not agree to participate in the study (did not sign the Informed Consent Form).
Efficacy and Safety of MTX-loaded Nanoparticles to Treat Severe COVID-19 Patients

The aim of this study is to evaluate the efficacy and safety of MTX-loaded nanoparticles in three different doses to treat severe COVID-19 patients.

Patients with acute lung injury caused by COVID-19 disease are experiencing an inflammatory reaction that can be harmful and worsen the severity of the clinical condition. Thus, the use of MTX-loaded nanoparticules in patients with acute lung injury secondary to COVID-19 aims to decrease the exacerbated inflammatory reaction leading to a decrease in cell damage caused by this inflammatory process in patients.

The study will be divided in 3 phases:

Phase A (n=4): IV administration of 20 mg of MTX-loaded nanoparticles. Four doses of Investigational Product (IP) will be administered, once per week. If patients show clinical improvement after 2nd or 3rd administration, the next phase will start.

Phase B (n=12): IV administration of 30 mg of MTX-loaded nanoparticles. Four doses of Investigational Product (IP) will be administered, once per week. If patients show clinical improvement after 2nd or 3rd administration, the next phase will start.

Fase C (n=26): IV administration of 40 mg of MTX-loaded nanoparticules. Four doses of Investigational Product (IP) will be administered, once per week.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent from patient or legal representative.
2. Male or female, aged ≥ 18 years;
3. Acute respiratory distress syndrome; with imminent risk of death, and with chest CT scan with pulmonary impairment greater than 50%;
4. Confirmed or pending diagnosis of COVID-19.

Exclusion Criteria:

1. Pleural effusion \> 150mL or ascites \> 200mL;
2. Chronic liver disease;
3. ALT and AST serum levels \>= three times the upper limit of normality;
4. Renal failure (dialysis)
5. Multiple organ failure

7. Concomitant use or use in the last 7 days of cell therapy with stem cells; 8. Any clinical or laboratory condition or comorbidity that, at medical discretion, 9. Known hypersensitivity to the investigational product; 10. Subject who is pregnant or lactating
The Need of Revisiting to an Outpatient Clinic After the Prescription of Vonoprazan or Esomeprazole

After vonoprazan (20mg/day) or esomeprazole (20mg/day) for 4weeks is prescribed for patients with erosive esophagitis diagnosed by esophagogastroduodenoscopy, the number of patients who will visit our outpatient clinic again due to some reasons without any appointments is compared with vonoprazan group and esomeprazole.

1. Patients who have erosive esophagitis diagnosed by esophagogastroduodenoscopy is enrolled.
2. Vonoprazan (20mg/day) or esomeprazole (20mg/day) is prescribed for 4weeks the patients randomly without next appointments.
3. Some patients may visit our outpatient clinic again due to some reasons without any appointments.
4. The number of the patients who revisit our outpatient clinic again is compared with vonoprazan group and esomeprazole.

Eligibility Criteria:
Inclusion Criteria:

* outpatients belonging to American Society of Anesthesiologists class I or II
* patients have erosive esophagitis diagnosed by esophagogastroduodenoscopy shortly before the prescription

Exclusion Criteria:

* other acid blockers are taken
The Effects of Whole-body Exercise to Improve Swallowing Function in Older Adults With Dementia

Swallowing impairment (dysphagia) is extremely common in older adults living with dementia due to age-related changes in swallowing and other disease-specific impairments. Dysphagia is commonly managed by modifying diet textures rather than engaging in rehabilitative swallowing therapy. This means that countless people with dementia are left to eat pureed foods and drink thickened liquids, which are unpalatable and lead to malnutrition. As the disease progresses, many are transferred to nursing homes. In Canada, speech-language pathologists, who manage dysphagia, are consultants within nursing homes; therefore, swallowing therapy is non-existent. However, exercise therapy is more commonly available. Rodent models have demonstrated that physical exercise strengthens tongue and vocal-fold musculature, which are critical components of swallowing. Therefore, it is possible that whole-body physical exercise, which increases rate of respiration, will help to strengthen swallowing-related musculature in older adults with dementia. In this study, older adults (65+) with early-stage dementia will complete a 12-week physical exercise program to determine improvement of swallowing function.


Eligibility Criteria:
Inclusion Criteria:

* \> 59 years of age
* able to walk independently with or without an assistive device for a distance of at least 10 meters
* able to be active for 60 minutes with rest breaks
* abe to independently follow directions
* not involved in active rehabilitation
* a diagnosis of a progressive neurologic disease
* a maximum value for tongue strength \<40 kPa

Exclusion Criteria:

* neurological conditions other than a progressive neurologic disease
* significant cardiovascular conditions
* severe aphasia
* pain, other medical conditions or behavioural issues that would limit safe participation in the exercise program
* individuals with known structural causes of dysphagia
* individuals with known allergies to latex
* individuals receiving swallowing rehab
Long Term Follow up Investigation of Endobronchial Valves in Emphysema

This is an observational prospective single arm multicentre study to observe the effect over 5 years of Zephyr endobronchial valve therapy for emphysema.

Primary objective is pulmonary function as assessed by FEV1 and secondary objectives are health related quality of life as assessed by the modified MRC dyspnea score and by the COPD assessment test, and survival at five years. 2000 patients will be enrolled in the study from approximately 200 referring centres in Germany. Patients will be followed up at 3, 6, and 12 months, and then yearly up to 5 years. The study will observe normal clinical practice. No investigations beyond those performed in normal clinical practice will be required with the exception of two short questionnaires. Patients will only be enrolled in the study if they have provided informed written consent for their anonymised data to be used in the study. Zephyr Endobronchial Valve has CE mark and is fully reimbursed in Germany and will not be provided by the sponsor for this study but will be obtained through normal commercial channels in accordance with normal clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders of at least 18 years of age
* Understand and voluntarily sign an informed consent form.
* FEV1 \> 15% predicted and \< 45% predicted
* RV \>180% predicted
* Diagnosis of emphysema with CT evidence of hyperinflation . Absence of collateral ventilation according to Chartis Assessment System

Exclusion Criteria:

• Active pulmonary infection
Rehabilitating Overweight People Back to Working Life

Obesity may have implications on the individual's participation in working life through different mechanisms such as comorbidity and loss of functional level. The investigators also know that when exiting the working force, it is difficult to get back later. As rehabilitation back to working life is often not a very focused aim with weight loss treatment, this study sets this as a primary aim by involvement in a 4 week stay at a rehabilitation clinic followed by 48 weeks work practice programme at one of three different companies.


Eligibility Criteria:
Inclusion Criteria:

* BMI 30-47
* 19-67 years

Exclusion Criteria:

* Pregnancy
* Significant reduced physical function
* Drug use
* Serious mental illness
Safety Profile Following Td Vaccination in Indonesian Pregnant Woman

To assess any serious systemic reaction within 30 minutes after Td immunization in pregnant woman

Any local and systemic reaction after Td immunization in pregnant woman (as a routine immunization program)

Eligibility Criteria:
Inclusion Criteria:

* Healthy Pregnant Woman aged 18-39 years old
* 27-36 weeks of pregnancy
* Subject have been informed properly regarding the study and signed the informed consent form
* Subject will commit to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria:

* Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination
Rhinoplasty and Quality of Life

Quality of life and satisfaction in aesthetic surgery is still under-evaluated. It is a prospective and multicenter study with a 4 months follow-up of patients under rhinoplasty or rhinoseptoplasty procedure. They will answer to the FACE-Q and NOSE questionnaires before surgery, one week later and 4 months after the procedure. The aim of the study is to show a significant augmentation of the quality of life scores. At this occasion, the FACE-Q questionnaire has been translated and validated in French

The main objective of this study is to show the efficiency of the rhinoplasty or rhinoseptoplasty procedure on the quality of life in a French population. There are many Patients reported outcomes questionnaire in aesthetic surgery but none of them is perfect. The FACE-Q rhinoplasty modules questionnaires is a recent test which has been validated in English but not in French. It is able to evaluate different areas of the quality of life and patient satisfaction. After French validation of the FACE-Q, this study will compare patient satisfaction before and after rhinoplasty or rhinoseptoplasty procedure. There is a lack of studies in the French population about rhinoseptoplasty surgery and quality of life or satisfaction. The goal is to show the interest of a surgery procedure on the feeling of the patients, concerning very different domains of appearance. This could help us to define the preoperative patients who are able to be really improved by this surgery

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old,
* patient engaged for surgery procedure of rhinoplasty or rhinoseptoplasty

Exclusion Criteria:

* patient with nose surgery medical history,
* mental or physical incapacity to answer the questionnaires
* antecedent of cervico facial cancer