cyrilzakka/clinical-trials huggingface dataset:
Radiofrequency Ablation of Pulmonary Tumors Response Evaluation

The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective treatment for malignant lung tumors.

Image-guided RF ablation is accepted as a viable therapeutic choice for patients with early-stage hepatocellular carcinoma or limited hepatic metastatic disease from colorectal cancer, when surgery is precluded (1, 2). Recently, RF ablation has been proposed as a viable option for the treatment of pulmonary malignancies. Experimental studies in animal tumor models have confirmed the effectiveness of RF ablation in the destruction of experimentally-induced pulmonary malignancies (3). Pilot clinical investigations have suggested that the treatment can achieve high proportions of tumor response (4, 5). We designed a prospective, intention-to-treat, multicenter clinical trial aimed at assessing feasibility, safety and effectiveness of RF ablation in the treatment of lung malignancies.

Eligibility Criteria:
Inclusion Criteria:

1. adult (\> 18 years) male or female patient
2. patient has biopsy-proven NSCLC or lung metastasis
3. patient has been rejected for surgery and has been considered unfit for radiation therapy or chemotherapy
4. patient has as many as 3 tumors per lung, each 3.5 cm or smaller in greatest diameter, by CT scan
5. tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart
6. tumors are accessible by percutaneous route
7. patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
8. patient has platelet count \> 100 x 109 /L and international normalized ratio ≤ 1.5
9. patient has signed written informed consent prior to any study specific procedures.

Exclusion Criteria:

1. patient has undergone previous pneumonectomy
2. patient is considered at high-risk for RF ablation due to major co-morbid medical conditions
3. patient has more than 3 tumors / lung
4. patient has at least one tumor \> 3.5 in greatest diameter
5. tumor is associated with atelectasis or obstructive pneumonitis
6. patient has renal failure requiring hemodialysis or peritoneal dialysis
7. patient has active clinically serious infection
8. patient has history of organ allograft
9. patient has history of substance abuse or any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results
10. patient is pregnant or breast-feeding
11. patient has ECOG performance status \> 2
12. patient has platelet count ≤ 100 x 109 /L or international normalized ratio \> 1.5.
Washed Microbiota Transplantation for Clostridioides Difficile Infection

This is a real-world study to explore the safety and the efficacy of washed microbiota transplantation （WMT） for patients with Clostridioides Difficile Infection （CDI）.

At least 12 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, intestinal symptoms, medicine treatment usage and clinical outcomes will be collected. After treatment, they will enter the follow-up period （at least for 4-week post-WMT）for safety and efficacy evaluation. Subjects with no response and recurrence will receive salvage therapy, and the extended follow-up period will be performed.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to enter the study:

1. At the time of informed consent, male or non-pregnant or non-lactating female.
2. The diagnostic criteria for C. difficile infection are met during screening:

   1. Medical records confirming CDI prior to screening (laboratory tests are positive for Clostridium difficile or its toxin): Clostridium difficile toxin test is positive (determined by EIisa test), or colonoscopy indicates pseudomembranous enteritis; Or Glutamate dehydrogenase positive, toxin negative, there are obvious causes and diarrhea.
   2. CDI-related diarrhea episodes, i.e., defecation ≥3 times/day for at least two consecutive days with unformed stools (Bristol score 6-7).
3. The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria must be excluded from the study:

1. Subjects with immune deficiencies (such as HIV infection, or neutrophils \<0.5×109/L in absolute value, or lymphocytes \<0.5×109/L, etc.), or on immunosuppressants, or on medium to high doses of steroid hormones (≥20g/d of prednisone or equal doses of steroid hormones).
2. There is rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis assessed by the investigator and colonic transendoscopic enteral tubing cannot be performed.
3. Confirmed or clinically suspected infection with pathogenic microorganisms other than Clostridium difficile prior to screening.
4. Have had major abdominal surgery (other than laparoscopic gallbladder or appendectomy), previous partial or total colectomy, previous partial small intestinal resection, or previous gastroduodenal surgery within 6 months prior to screening.
5. At the time of screening, the subject or his/her legal representative refuses to take effective contraception within 3 months after the last treatment.
6. According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.
Correlation of FFR and iFR With Cardiac PET Perfusion in Patients With Severe Aortic Valve Stenosis

Aortic valve stenosis (AS) affects 2-7% of persons \> 65 years, symptoms include: angina and dyspnea, dizziness and syncope. Coincidence of coronary artery disease (CAD), also presenting with angina and dyspnea, in patients with AS between 40 - 65% . Angina in AS caused by significant reduction of coronary flow reserve (CFR). CFR is the ratio of maximal flow increase in the coronary vessel bed during maximal hyperaemia (medically or exercise induced). FFR (fractional flow reserve) use in patients with AS potentially invalid due to dysfunctional CFR leading to potential undertreatment of CAD in these patients.CFR disturbance in AS mainly due to myocardial overload causing concentric hypertrophy, increased oxygen consumption and neurohormonal activation leading to increased vascular resistance. Current studies are investigating the validity of FFR and iFR in AS patients. Recent data demonstrate very good correlation between FFR and iFR derived values to PET myocardial perfusion imaging values in patients with no evidence of AS. Our study aims to investigate the diagnostic performance of FFR and iFR in intermediate-grade coronary stenosis in patients with severe aortic valve disease and correlate FFR- and iFR derived values with those extracted from PET-perfusion Imaging.


Eligibility Criteria:
Inclusion Criteria:

* patients with severe aortic Stenosis eligible for transcatheter aortic stenosis
* left ventricular ejection fraction \> 55%
* no intolerance of Adenosin
* no history of bradycardia, atrioventricular Blockade
* intermediate coronary Stenosis with FFR\> 0.8
* Age \>65

Exclusion Criteria:

* intolerance of Adenosin
* left ventricular ejection fraction \< 55%
Sodium Lactate Versus Hypertonic Saline Solution in the Treatment of Intracranial Hypertensive Episodes in Severe Brain Injured Patients

Brain oedema is a major complication of brain injury (TBI). It increases the risk of intracranial hypertension (ICH) and brain hypoxia, leading to an increase in mortality and poor neurologic outcome. Increased water content in the injured brain can be related to a vasogenic or cellular pathway. Osmotherapy, by using mannitol or hypertonic saline (HSS), is recommended and currently administered for the treatment of ICH in this setting. Beside these two usual treatments, sodium lactate (SL), a metabolic and neuroprotective solution, has recently been described as having similar effects on lowering intracranial pressure (ICP). In a previous study, conducted in patients with severe TBI, (1) Ichai et al. reported that a bolus of half-molar SL was as effective than equimolar doses of mannitol to reduce elevated ICP (less refractory ICH and higher and longer reduction of ICH).

Objective(s):

The purpose of the study is to analyze the effect on ICH of SL compared to a hypertonic saline solution (HSS).

Outcome(s):

The primary endpoint is the efficacy in lowering ICH after 4 h. Secondary endpoints were percentage of successfully treated episodes of intracranial hypertension and neurological status at discharge from ICU.


Eligibility Criteria:
Inclusion Criteria:

* Patient with an acute, isolated, severe brain injury (SAH, TBI, ICH)
* Glasgow coma score \<8
* Monitored using ICP device
* Presenting an episode of intracranial hypertension requiring osmotherapy. ( defined as increase in ICP 25 mmHg which persisted for more than 5 min in the absence of noxious stimulations)
* Informed Consent as documented by signature

Exclusion criteria

* Pregnant woman
* Bilateral fixed dilatated pupils
* Initial hypernatremia (\>155 mmol/l)
* Penetrating head injury
* Active participation to another trial (Clin B, C)
Evaluation of TMS Visual Outcome

The goal of this clinical trial is to learn if transcranial magnetic stimulation (TMS) can improve the visual outcomes in patients after cataract surgery. The main question it aims to answer is:

• Does TMS improve the visual outcome in patients after cataract surgery? Researchers will compare TMS to the sham-controlled treatment (exposure to recorded sounds of pulses without real magnetic stimulation) to see if TMS works to improve the visual outcomes of patients after cataract surgery.

Participants will

* Undergo TMS treatment or a sham-controlled treatment for consecutive 5 days.
* Visit the clinic once every 2 weeks for checkups and tests.


Eligibility Criteria:
Inclusion Criteria:

* Post cataract surgery
* Best-corrected visual acuity less than 0.1logMAR

Exclusion Criteria:

* Diagnosed with cognitive impairment or mental disorders and unable to cooperate with treatment;
* Diagnosed with significant opacity of refractive media that affects observation of visual function;
* History of epileptic seizures;
* Long term use of psychotropic drugs；
* Metal implants in the body.
Activity Levels and Rehabilitation Outcomes of Patients Post-stroke

Patients admitted to the in-patient rehabilitation center with a diagnosis of stroke will be recruited into the study. The participants will wear two activity monitors (one commercial grade and one research grade) for the duration of their rehab stay. Data from the monitors will be correlated with rehab outcomes, therapy units billed, and length of stay.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of stroke
* patient at the Brookdale Center for Healthy Aging \& Rehabilitation
* not greater than maximum assistance to walk 10 feet
* walking re-training included in the therapy plan of care

Exclusion Criteria:

* primary diagnosis other than stroke
* allergy or reaction to the wrist bands of the activity monitors
Water Immersion and Polyp Detection: A Randomized Controlled Trial

We plan to conduct a randomized trial of tandem colonoscopies comparing water infusion and air insufflation for inspection of mucosa on withdrawal. In one randomized group, water infusion will be employed as the first method for mucosal inspection while in a second group, CO2 insufflation will be used first. This study will be different than usual care since the participants will receive two successive or tandem colonoscopies versus one


Eligibility Criteria:
Inclusion Criteria:

* all adults 50 years or older who present for colonoscopy at White River Junction VAMC and Indiana University

Exclusion Criteria:

* includes co-morbid status of ASA III or higher, Inflammatory Bowel Disease (IBD), surgical resection of the large bowel, as well as the use of anticoagulants. Finally, potential subjects who do not report a clear effluent in the most recent bowel movement will be excluded from the study.
The Role of Spreader Flaps in Preventing of Nasal Obstruction

Nasal obstruction is a preventable complication of rhinoplasty, for which the spreader graft is the gold standard. More recently, the spreader flap technique has been espoused as an alternative to spreader grafting. Herein we evaluated the efficacy of this technique in a randomized trial setting.

Rhinoplasty is a common facial plastic surgery procedure, one complication of which is nasal vault narrowing and consequent nasal obstruction. Recently, researchers have paid much attention to nasal valve area and especially to the role of upper lateral cartilage (ULC) in preserving of nasal patency, since a possible consequence of destructive techniques was permanent functional problems for patients. In addition to functional problems, it can cause some aesthetic problems such as the inverted-V deformity . Accordingly, reconstruction of the midvault after dorsal reduction has been advocated and widely adopted.

The gold standard for midvault reconstruction after dorsal reduction has been the spreader graft, first advocated by Sheen . Subsequently, its usage has been widened to include repair of the valve in the unoperated nose, and its efficacy well-documented. However, it can be a time-consuming procedure that requires the harvest of septal cartilage. Therefore, some authors proposed the spreader flap as an alternative technique. While the results of the above mentioned articles proposed the efficacy of spreader flaps, none of them was a randomized trial and subjective methods were used for measurement of nasal breathing after rhinoplasty.

Nasal obstruction can be evaluated in different methods, both quantitative and subjective, the validity of each debated. For example, while the numeric form of Visual Analogue Scale (VAS) is commonly used, it is ultimately related to patients' subjective perception. Alternatively, objective evaluation of nasal patency is also of common interest to many researchers, and various methods for objective measurement exist. Among these different methods, acoustic rhinomanometry is an effective tool. However, some researchers debate the reliability of these results. Herein we examine the efficacy of the spreader flap in preventing nasal obstruction after dorsal reduction using a randomized trial with both objective and subjective measures.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent rhinoplasty

Exclusion Criteria:

* revision rhinoplasty
* congenital malformations
* severe allergic rhinitis
* nasal polyposis
* sinusitis
* deviated nose
Effect of SGLT2i on Diabetic Retinopathy in Type 2 Diabetes Mellitus Patients

A prospective, randomized, open-label, controlled clinical trial will be conducted at the endocrinology department - Ain Shams University (ASU) hospital. Sixty patients will be enrolled into the study. 30 of which will receive dapagliflozin 10mg tab once daily and the other thirty will receive their standard antidiabetic therapy for 12 weeks.

All type 2 diabetes mellitus patients presenting to the endocrinology department, ASU Hospitals, who were diagnosed with mild to moderate non-proliferative diabetic retinopathy will be assessed for eligibility.

Eligible patients will be randomly assigned to one of the following 2 arms:

1. Group 1 (Control group) (n= 30): type 2 diabetes mellitus patients who will receive their oral antidiabetic for 12 weeks.
2. Group 2 (Test group) (n= 30): type 2 diabetes mellitus patients who will receive their oral antidiabetic along with dapagliflozin at a dose of 10 mg daily for 12 weeks.

A total of four visits one for baseline evaluation and one for end of study evaluation and two intermediate visits, the following will be performed in the visits:

1. Clinical Evaluation

   1. Systolic and diastolic blood pressures recording.
   2. Plasma glucose measurement.
2. Report any adverse effects that may appear
3. Blood samples will be taken at baseline and at 12-week visits
4. Follow up

Eligibility Criteria:
Inclusion Criteria:

1. Female or male aged between 40 and 70 years old.
2. Glomerular filtration rates \> 60 mL/min.
3. Normal aspartate and alanine transaminase levels.
4. Controlled systolic and diastolic blood pressures

Exclusion Criteria:

1. Patients using insulin or more than one oral anti-diabetic drug.
2. Patients who have HbA1c level ≥10% (86 mmol/mol) or a fasting plasma glucose level \>240 mg/dl.
3. Patients with a history of cardiovascular events within six months before enrolment.
4. Patients suffering from cataract or glaucoma.
5. Patients with volume depletion clinical signs.
6. Body mass index (BMI) \>40 kg/m2
7. Infectious or inflammatory diseases.
8. Neoplasm, or hematological disorders.
9. Pregnant or breast-feeding patients.
10. Active participation in another clinical study.
Can the Electronic Nose Smell COVID-19 Antibodies?

Corona Virus Disease (COVID-19), spread worldwide and has become an emergency of major international concern. In March 2020, the WHO declared the COVID-19 outbreak a global pandemic. Accurate and fast diagnosis is crucial in managing the pandemic. Current diagnostic approaches raise several difficulties: they are time-consuming, expensive, invasive, and most important lacking high sensitivity. The gold standard diagnostic test for COVID-19, reverse transcription polymerase chain reaction (RT-PCR), is highly dependent on adequate deep sampling of the swab in the naso- and oropharynx. A new diagnostic test that can correctly and rapidly identify infected patients and asymptomatic carriers is urgently required to prevent further virus transmission and thus reduce mortality rates.

Aim: This proof-of-principle study aims to investigate if an electronic nose (Aeonose) can distinguish individuals with antibodies from individuals without antibodies against COVID-19 based on analysis of volatile organic compounds (VOCs).

Methods: between April and July 2020, persons undergoing RT-PCR and a serology test for COVID-19 were recruited at Maastricht UMC+ for breath analysis. All participants had to breathe through the Aeonose for five consecutive minutes. The VOC pattern in their exhaled breath was then linked to the matching RT-PCR and serological test results.


Eligibility Criteria:
Inclusion Criteria:

* Participants of whom an oropharyngeal and nasopharyngeal swab was collected for RT-PCR and on whom serology testing for the detection of antibodies was performed.

Exclusion Criteria:

* Participants who where experiencing dyspnea or needed supplemental oxygen.
A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1

This is a 96 week study to determine if UK- 453,061 in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor is as efficacious, safe and tolerable as etravirine in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor in HIV-1 infected patients who have been previously treated with antiretroviral drugs and have NNRTI resistance mutations.

The trial was terminated on 12 April, 2012 due to lack of efficacy at the Week 24 analysis. The decision to terminate the trial was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.
* HIV 1 RNA viral load of greater then 500 copies/mL.
* Negative urine pregnancy test.

Exclusion Criteria:

* Suspected or documented active, untreated HIV-1 related opportunistic infection or other condition requiring acute therapy at the time of randomization.
* Subjects with acute Hepatitis B and/or C within 30 days of randomization.
* Previous use of Darunavir or etravirine
Home-based Transcranial Direct Current Stimulation for Pain Management in Persons With Alzheimer's Disease and Related Dementias

The purpose of this project is to evaluate the preliminary effects of home-based M1-SO applied tDCS (that is, tDCS with the anode over the primary motor cortex and the cathode over the contralateral supraorbital area) on clinical pain in persons with early-stage Alzheimer's disease and Related Dementias (ADRD), to evaluate the preliminary effects of home-based M1-SO applied tDCS on pain-related cortical response in persons with early-stage ADRD, and to evaluate the feasibility and acceptability of home-based M1-SO applied tDCS for pain management in persons with early-stage AD.


Eligibility Criteria:
Inclusion Criteria:

* early-stage Alzhimer's disease and related dementias (ADRD)
* have caregiver-reported chronic pain (average pain in the past 3 months ≥ 3 out of 10),
* have a caregiver willing to participate in the study who sees the participant at least 10 hours/week
* can speak and read English
* have no plans to change medication regimens during the trial

Exclusion Criteria:

* history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
* alcohol/substance abuse
* severely diminished cognitive function (i.e., MiniMental Status Exam score ≤ 15)
* hospitalization within the preceding year for neuropsychiatric illness
Interest of ß 1-3 D Glucan Assays in Screening for the Onset of Invasive Aspergillosis in Neutropenic Patients With Acute Leukaemia.

In the context of screening for infectious fungal diseases in patients with malignant haemopathy, and particularly patients with acute leukaemia, the investigator aims to evaluate the performance of an already commercialized but little used serum screening test (Fungitell® test) and to determine its place in the management strategy for invasive aspergillosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been informed about the study
* Patients over 18 years
* patients with acute myeloblastic leukaemia (AML) or lymphoblastic leukaemia (ALL) who have undergone cytotoxic chemotherapy with curative intent

Exclusion Criteria:

* Adults under guardianship
* Patients without national health insurance cover
* Pregnant or breast-feeding women
* allografts and autografts of Haematopoietic Stem Cells (HSC)
Improving Treatment-Related Symptom Management in Adolescents and Young Adults With Cancer

This study will test the acceptability and feasibility of a telehealth intervention to improve communication between patients and medical providers in adolescent and young adult (AYA) cancer patients receiving chemotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer undergoing active treatment and who have received at least two cycles of chemotherapy
* Access to Epic MyChart (we will facilitate access to MyChart for interested patients who are not yet signed up)
* Access to a smartphone or tablet to access EPIC MyChart telehealth appointments

Exclusion Criteria:

* Non-English or non-Spanish speaking patients
* Potentially completing therapy during study period (including follow-up period) or plans to leave UCDCCC during study period