cyrilzakka/clinical-trials huggingface dataset:
Effects of Chest Wall Elastance on Pulmonary Mechanics of Acute Respiratory Failure (ARF)

Patients with chest wall elastance increasing could worsen lung function. Increasing of chest wall elastance plays a great role in lung mechanics, and could influence mechanical ventilation settings. Therefore, It could help the physicians to find appropriate indicators and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics changse in the patients with high chest wall elastance.

Mechanical ventilation(MV) is an important treatment for acute respiratory failure(ARF) patients, could improve hypoxemia, maintain lung volume and promote alveolar opening. However, because of barotrauma, volutrauma and biotrauma, MV could cause or aggravate acute lung injury not only in acute respiratory distress syndrome(ARDS) patients, but in patients with normal lung function1,2.

Patients with chest wall elastance increasing could worsen lung function. Increasing of chest wall elastance plays a great role in lung mechanics, and could influence mechanical ventilation settings. Therefore, It could help the physicians to find appropriate indicators and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics changse in the patients with high chest wall elastance.

The present study is set out to examine the effects of high chest wall elastance on changes of lung mechanics and the correlation of airway pressure(Paw) stress index and transpulmonary pressure(PL) stress index.

Eligibility Criteria:
Inclusion Criteria:

* ARF
* mechanical ventilation
* cardiovascular stable

Exclusion Criteria:

* age \< 18y or \> 85y
* pregnancy
* COPD or chronic pulmonary disease
The Relationship Between Muscle Morphology and Muscle Strength

The evaluation of skeletal muscle strength in severly ill or cognitive impaired patients is an unresolved problem especially during the rehabilitation process. The aim of this study is to correlate morphological parameters assessed with muscle ultrasound and isometric muscle strength to establish an objective progression parameter for rehabilitation therapies.


Eligibility Criteria:
Inclusion Criteria:

* group 1: patients between 18 and 35 years
* group 2: patients between 60 and 80 years

Exclusion Criteria:

* neuromuscular diseases
* hip or knee prosthesis in the investigated leg
* any trauma of the hip, knee or ankle of the investigated leg during the last 12 months
* cognitive impairments
* pregnancy
* diabetes mellitus Type II
* acute or chronic pain in the investigated leg
* chronic maligne or non - maligne diseases (of the heart, lung or kidney)
Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System

The objective of the clinical study is to evaluate the AHPV-GT Assay using the PANTHER System in cervical cancer screening.

This objective will be accomplished in the ASC-US Study by evaluating the performance characteristics of the AHPV-GT Assay using the PANTHER System in a sample population of women with ASC-US Pap test results who were 21 years of age or older ("≥21 years of age") at the time of their Pap visit. For the Adjunct Study, this objective will be accomplished by evaluating the ability of the AHPV-GT Assay using the PANTHER System to identify women at increased risk of cervical disease in a sample population of women with negative (NILM)cytology results who were ≥30 years of age at the time of their Pap visit.


Eligibility Criteria:
Inclusion Criteria:

Subjects who were previously enrolled into the prospective, multicenter US clinical study for the APTIMA HPV Assay on the TIGRIS System (protocol 2007HPVASCUS30) will be eligible for inclusion in the study of the AHPV-GT Assay using the PANTHER System described in this protocol. All evaluable ASC-US Study subjects ≥21 years of age will be eligible for inclusion.

Evaluable Adjunct Study subjects ≥30 years of age will be eligible if the following criteria are met:

* the subject attended the colposcopy visit, or
* the subject did not attend the colposcopy visit but the referral Pap sample had a positive APTIMA HPV Assay result in the APTIMA HPV Assay TIGRIS System study (protocol 2007HPVASCUS30) or in the APTIMA HPV Assay PANTHER System study (protocol AHPVPS-US11-003).

Exclusion Criteria:

Eligible subjects will be excluded if they do not have an evaluable sample. This may be due to insufficient volume or because the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions).
Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)

The purpose of this study is to evaluate the safety and effects of repeated intravitreal injections of ICON-1 0.6 mg administered as maintenance therapy or in combination with aflibercept in patients with wet macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Males or females of any race, ≥50 years of age
* Active primary CNV secondary to AMD in the study eye

Exclusion Criteria:

* Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins
* Any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months
* Vitrectomy in the study eye
Study of the Effect of the Auditory Stimulation on Stuttering Symptoms in Patients With a Deficit of Spectral Power in the EEG Beta Frequency Band

In this study, the investigators will research the efficacy of a novel auditory neuro modulating technology that leverages euphonic music tracks with broad-spectrum binaural beats to induce selective EEG spectral power changes.

Stuttering is a speech disorder that affects more than 70 million people worldwide, limiting their ability to communicate and socialize. During recent decades, several studies have demonstrated a link between stuttering and a deficit of β EEG spectral power.

In this study, the investigators will research the efficacy of a novel auditory neuro modulating technology that leverages euphonic music tracks with broad-spectrum binaural beats to induce selective EEG spectral power changes. Participants are adults with stuttering and without speech disfluencies from the control group will expose to euphonic binaural stimuli for 5 minutes. The brain electrical activity patterns (EEG) and ECG bio-signals will record prior to, during, and after exposure.

Eligibility Criteria:
Inclusion Criteria:

* Adults with stuttering (stammering) symptoms;

Exclusion Criteria:

* Hearing disabilities;
* Applying other drugs or devices simultaneously;
Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency

This is an open-label, 2-part, dose-escalating, Phase 1 study of INBRX-101 (rhAAT-Fc). Part 1 will consist of single ascending dose (SAD) administration of INBRX-101 and Part 2 will consist of multiple ascending dose (MAD) administrations of INBRX-101. The planned dosing schedule is IV every 3 to 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Documented alpha-1 antitrypsin (AAT) serum concentration \<11 μM.
* Diagnosis of alpha-1 antitrypsin deficiency (AATD) with any allelic combination with exception of the null/null genotype.
* For subjects in Part 2 80 and 120 mg/kg cohorts ONLY: post-bronchodilator FEV1 of at least 40% of predicted normal value.
* For subjects in Part 2 80 and 120 mg/kg cohorts ONLY: subjects eligible for bronchoscopy per judgment of investigator.
* Nonsmoker for at least 6 months prior to study and must remain nonsmoking for the entire study duration.
* Adequate hepatic and renal function as defined per protocol.
* Willing to undergo current augmentation therapy washout (if applicable) and refrain from initiating augmentation therapy, other investigational drug trials for AATD, therapy with IV immunoglobulins or monoclonal antibodies during the entire study, including follow-up.

Exclusion Criteria:

* Known or suspected allergy to components of INBRX-101 (AAT or human IgG) or pdAAT.
* Participation in any investigational drug trial within 30 days prior to this trial, or subjects receiving IV immunoglobulins or monoclonal antibodies within 30 days prior to this trial.
* History of and/or on the waiting list for lung or liver transplant, lobectomy, or lung volume reduction surgery.
* Acute respiratory tract infection or COPD exacerbation that required antibiotic treatment and/or increase in systemic steroid dosage within the 4 weeks prior to screening. Subjects are permitted to continue to receive steroids if the investigator judges the subject to have a history of stable dosing.
* Subjects with ongoing or history of unstable cor pulmonale.
* Infection with hepatitis A, B, or C or human immunodeficiency virus (HIV).
* Active autoimmune disease or documented history of autoimmune disease that 1) required systemic steroids or immune-suppressive medications and 2) tested positive for auto-antibodies. Exception: Endocrinopathies managed with hormone replacement therapy (HRT).
* Current substance and/or alcohol abuse with protocol defined exceptions.
* Current narcotics abuse with protocol defined exceptions.
Diagnostic Efficiency of Artificial Intelligence for Surgical Neuropathology

This is a multi-center, prospective, self-controlled, diagnostic accuracy comparative study of Artificial Intelligence Diagnostic System for Surgical Neuropathology. The investigators will compare the diagnostic efficiency of Artificial Intelligence with that of practicing pathologists, and suppose that the diagnostic efficiency of artificial intelligence in prospective clinical data is no less than that of pathologists.

In this study, 141 patients will be recruited. After being enrolled, the patients will accept surgery and specimens for pathological analysis will be taken according to the routine treatment process.

The histopathologic slides will then be digitized by a whole-slide scanner. The images will be reviewed by gold standard committee for evaluation of ground truth. And then be separately diagnosed by Artificial Intelligence Diagnostic System and practicing pathologists. So the investigators can compare the diagnostic efficiency of Artificial Intelligence with that of pathologists, thus understand the gap between artificial intelligence and actual clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Patients or their guardians understand the research process, agree to use their data, and sign the informed consent form;
2. Aged \>=18 years;
3. MRI shows intracranial spaceoccupying lesions;
4. The clinical diagnosis is glioma, metastasis or lymphoma thus requiring surgical treatment;
5. The patient is willing to accept the surgery.

Exclusion Criteria:

1. The patient has serious underlying diseases thus is not suitable for surgery;
2. After further clinical evaluation, surgical treatment was not the best choice;
3. The patient participate in clinical research of other drugs or devices;
4. The researchers believe that there are other factors that will make the patients unable to complete the study.
Athlete Needs Assessment & Focus Groups

The overall objective of this study is to investigate various physical and mental health needs of collegiate athletes and how they differ in and out of sport. Researchers aim to identify facets of support that athletes may need when transitioning out of sport. To achieve this objective, the study is broken down into two specific parts: 1) an online, anonymous survey assessing 200 athletes to evaluate support needed both during and post sport, quantitatively; and 2) focus groups with 50 athletes who are about to retire or have retired from sport recently to evaluate support needed both during and post sport, qualitatively.


Eligibility Criteria:
Inclusion Criteria:

* Current and previous collegiate athletes over the age of 18 and within two years before leaving sport or within five years after leaving sport.

Exclusion Criteria:

* Athletes under the age of 18 and not within two years before or five years after leaving sport will be excluded.
Clinical Evaluation of a Bulk Fill Resin Composite

The purpose of this clinical trial is to measure the clinical outcomes of Tetric PowerFill Class I and II restorations cured in 3 seconds with the Bluephase PowerCure curing unit.


Eligibility Criteria:
Inclusion Criteria:

* Each subject must need at least 1 restoration in a vital posterior tooth
* Must have given written consent to participate in the trial
* Replacement of defective restorations (i.e. fractured, stained, unaesthetic) with or with-out caries are acceptable
* Must be available for the required follow-up visits over 3 years
* Restored teeth must have occlusal contact with opposing teeth or restored teeth
* Restoration width should be equal to or greater than 1/3 the distance from buccal to lin-gual cusp tips
* 75% of the restorations Class II (minimum) and 25% Class I
* Each Class II will have at least one proximal contact
* 75% in molars (minimum) and 25% in premolars
* All restored teeth must have at least one occlusal contact in habitual closure
* Must have 20 or more teeth

Exclusion Criteria:

* If they have an allergy to ingredients of the materials under investigation (monomers)
* Do not meet all inclusion criteria above
* Have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or are immunocompromised) or disabilities meaning they may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene
* Have xerostomia either by taking medications known to produce xerostomia or those with radiation-induced xerostomia or Sjogren's syndrome - as dry mouth increases tooth and restoration wear as well as the development of caries.
* Have teeth with advanced or severe periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored
* Present with any systemic or local disorders that contraindicate the dental procedures included in this study
* Have unstable occlusion
* Have severe grinding/bruxing or clenching or need TMJ-related therapy
* Have tooth with exposed pulp during preparation or caries removal
* Teeth that are non-vital or that exhibit signs of pulpal pathology for restoration
* Teeth that require cuspal build-ups involving more than one cusp
Study of the Combination of CM082 With Everolimus in Patients With mRCC

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CM082 in Combination with Everolimus in Chinese Patients With Advanced Renal Cell Carcinoma.

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CM082 in Combination with Everolimus in Chinese Patients With Renal Cell Carcinoma (RCC). After the maximum tolerated dose (MTD) or the optimal biological dose is identified, an expansion cohort of \~10 advanced renal cell carcinoma patients will be enrolled to further characterize the safety and tumor response by CT.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma
* Progressed on at least one standard therapy
* Measurable disease per Recist1.1
* Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1
* Life expectancy of at least 12 weeks
* No abnormal bone marrow function
* Adequate heart, lung, liver, kidney organ system functions, and meet the following requirements:

  * Total bilirubin ≤1.5 times the upper limit of normal (ULN)
  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5x the upper limit of normal (ULN) if no liver involvement or ≤5x the upper limit of normal with liver involvement.
  * Creatinine ≤ 1.5 x ULN
  * Urine protein \<1+
  * QTcF \< 450 ms
  * LVEF ≥ 50%
* At least 4 weeks after receiving cancer therapy (i.e., chemotherapy, radiation therapy, biologic therapy, hormonal therapy); 3 months after surgery and recovered
* Willingness and ability to comply with trial and follow-up procedures
* Ability to understand the nature of this trial and give written informed consent

Exclusion Criteria:

* Currently receiving anti-cancer treatment
* Other tumors in addition to renal cell carcinoma
* Have taken strong cytochrome P450 3A4 inhibitors or inducers in the last 2 weeks
* Concomitant use of drugs with a risk of causing prolonged corrected QT interval and/or Torsades de Pointes
* Patients with a history of intolerance to, or significant toxicity with VEGFR tyrosine kinase inhibitor(s) (TKI) or everolimus
* Females who are pregnant or breastfeeding
* Those in reproductive ages who refuse to use contraception
* Those with concurrent condition(e.g. psychological, neuronal, cardiovascular, respiratory conditions or infections) that in the investigator's opinion would jeopardize compliance with the protocol
* Patients with known central nervous system (CNS) metastases
* Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082 or everolimus
* Patients with known severe lung disorders such as asthma, chronic obstructive pulmonary disease (COPD)
* Patients who are HIV positive
* Drug or alcohol abuser
PV Reconnection After PVAI at Different Power Settings and Adenosine Provocation

In this prospective randomized study, we aim to compare the rate of PV reconnection following PVAI performed at different energy settings (30 Watts vs 40 Watts) where dormant PV conduction will be unmasked by adenosine-provocation.

Background:

The efficiency of catheter ablation in drug-refractory atrial fibrillation (AF) is compromised by high incidence of post-ablation AF recurrences requiring multiple ablation procedures (1). Post-PVAI (pulmonary vein antrum isolation) AF recurrence is mostly due to reconnection of the previously isolated PVs (2). Earlier studies have revealed that elimination of dormant PV conduction revealed by adenosine-provocation ensures better outcome as reconnection mostly happens due to presence of incompletely ablated tissue and identification and complete ablation decrease chance of recurrence (1). Adenosine is specifically chosen for induction of triggers because it is known to transiently or permanently re-establish left atrium-pulmonary vein (LA-PV) conduction after apparently successful PV isolation (3). Datino et al have demonstrated in the canines that adenosine selectively hyperpolarizes the PVs by increasing inward rectifier potassium (K+) current and restores excitability (4). As incompletely ablated tissue can potentially cause AF recurrence, the depth and extension of the lesion are crucial factors in determining the success-rate of ablation; these in turn are directly influenced by catheter type and the radio-frequency (RF) energy settings (5). In a previous study, Matiello et al have reported cooled-tip catheter at 40w setting to be more effective in preventing recurrence than that with 30w setting (5). However, none of the earlier studies have examined the rate of PV reconnection when AF ablation is done at different power settings using open-irrigated catheters after the dormant sites are revealed by adenosine-challenge.

Hypothesis:

Use of higher wattage during ablation before and after adenosine-challenge is associated with lower rate of PV reconnection.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Patients presenting with drug-refractory PAF undergoing first ablation
3. Ability to understand and provide signed informed consent

Exclusion Criteria:

1. Previous catheter ablation or MAZE procedure in left atrium
2. Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc
Probiotic Implementation as Help in Solving Vaginal Infections

Over recent years, a growing interest has developed in microbiota and in the concept of maintaining a special balance between Lactobacillus and other bacteria species in order to promote women's well-being. The aim of the study was to confirm that vaginal Lactobacilli long-lasting implementation in women with HPVinfections and concomitant bacterial vaginosis or vaginitis might be able to help in solving the viral infection, by re-establishing the original eubiosis.

A total of 117 women affected by bacterial vaginosis or vaginitis with concomitant HPV infections were enrolled at Department of Gynecological Obstetrics and Urological Sciences, La Sapienza University, Rome, Italy between February 2015 and March 2016. Women were randomized in two groups, standard treatment (metronidazole 500 mg twice a day for 7 days or fluconazole 150 mg orally once a day for 2 consecutive days) plus short-term (3 months) vaginal Lactobacillus implementation (group 1, short probiotics treatment protocol group, n=60) versus the same standard treatment plus long-lasting (6 months) vaginal Lactobacillus rhamnosus BMX 54 administration (group 2, treatment group, n=57).

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years
* documented BV or yeast vaginitis associated with HPV-infection documented as PAP-smear abnormalities (ASCUS, L-SIL or H-SIL histologically demonstrated as CIN1) and/or positive for HPV-DNA

Exclusion Criteria:

* pregnancy or breastfeeding
* previous abnormal PAP-smear
* CIN2-3
* concomitant malignancies
* immunological diseases
* severe comorbidities
* prolonged corticosteroid treatment.