cyrilzakka/clinical-trials huggingface dataset:
Prevalidation of the First German Version of the Vocal Fatigue Index (VFI)

Vocal fatigue has been described as a common complaint in patients with voice disorders, however to date there is no standardized questionnaire in german language to assess specific symptoms. Main aim of this study is to assess the validity of the first german version of the Vocal Fatigue Index (VFI), and english questionnaire developed for voice patients to assess vocal fatigue.

In this study patients with voice disorders will receive the patient based questionnaires "Vocal Fatigue Index (VFI)", "Voice Handicap Index 9 international (VHI 9i)" and "Vocal Tract Discomfort Scale (VTD)", the study information and consent letter together with the standard invitation letter to a voice assessment at the Department for Phoniatrics and Speech Pathology University Hospital Zurich. Data of 93 consecutive volunteering patients will be collected. Furthermore a retest using the VFI will be conducted after 1 week with 10 volunteers. Thereafter construct validity of the VFI as compared to the established voice symptom questionnaires VHI 9i and VTD will be investigated. Further test-retest reliability will be determined.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* voice disorder (all etiologies)

Exclusion Criteria:

* age \< 18 Jahre
* current voice therapy
* psychological disease
* botox injection in the Larynx
* inability to independently fill out the questionnaire
Role of Biomarkers in Muscle Pain and Joint Pain in Patients With Solid Tumors Receiving Paclitaxel

RATIONALE: Learning about pain in patients with cancer receiving paclitaxel may help plan treatment and may help patients live more comfortably. Studying samples of urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to muscle and joint pain.

PURPOSE: This phase I trial is studying the role of biomarkers in muscle pain and joint pain in patients with solid tumors receiving paclitaxel.

OBJECTIVES:

Primary

* To determine the change in urinary prostaglandin E metabolite (PGE-M) level after paclitaxel treatment in patients with a variety of solid tumor malignancies.
* To determine whether a change in PGE-M level correlates with paclitaxel dose.
* To determine whether the change in urinary PGE-M level correlates with patient reporting of pain, as measured by a visual analog scale and the Brief Pain Inventory short form (BPI-SF).

Secondary

* To determine whether leukotriene levels are affected by paclitaxel treatment.

OUTLINE: At baseline (prior to the first dose of paclitaxel), patients complete a questionnaire about their baseline pain symptoms (including the Brief Pain Inventory short form and the visual analog scale); cigarette smoking status and second-hand smoke exposure; and routine use of any pain medications (including NSAIDs, selective COX-2 inhibitors, and opioid analgesics), corticosteroids, or leukotriene antagonists (montelukast or zafirlukast). Patients also complete questionnaires about their pain daily on days 2-7 after paclitaxel administration.

Urine samples are collected at baseline for urinary prostaglandin E metabolite (PGE-M), urinary leukotriene E_4 (LTE_4), and urinary cotinine levels and on day 4 for urinary PGE-M and LTE_4 levels.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Solid malignancy of any type
* Patients must be scheduled to receive their first dose of paclitaxel at Vanderbilt-Ingram Cancer Center

  * Any paclitaxel-containing regimen or dosing schedule is allowed

PATIENT CHARACTERISTICS:

* Not pregnant
* Accessible for follow-up
* Able to submit urine samples
* Able to complete questionnaires

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Safety and Preliminary Efficacy Study of PDS-1.0 in Patients With Neovascular AMD

This study will evaluate the safety and preliminary effectiveness of PDS 1.0 in patients with neovascular AMD.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of CNV secondary to AMD confirmed by fluorescein angiography, not previously treated
* Retinal thickness due to edema of at least 300um in the study eye
* Best corrected visual acuity of 20/80 or worse in the study eye
* Best corrected visual acuity of 20/40 or better in the fellow eye

Exclusion Criteria:

* Evidence of scarring CNV (e.g. geographic atrophy) in the study eye
* Fibrosis \>75% of lesion area in the study eye
The Use of Real Time Ultrasound Feedback in Teaching Abdominal Hollowing Exercises

Recently, physical therapists have begun treating people who have mechanical low back pain, hypothesized to be caused by segmental instability in the lumbar spine, with a very specific exercise program consisting of trunk stabilization exercises. The theory behind the use of trunk stabilization exercises to treat lower back pain is that active contraction of the trunk local segmental muscles helps to control inter-segmental movement in the spine. The initial trunk stabilization exercise that physical therapists teach patients is an abdominal drawing in maneuver often called an abdominal hollowing exercise (AHE). A challenge for physical therapists is to establish the most effective means of teaching people to contract the relevant muscles needed to perform the AHE. The purpose of this study is to examine if supplementing the typical clinical instruction for teaching the AHE with visual ultrasound feedback to the patient is effective at reducing the length of time it takes an individual to learn to perform an AHE.

Three groups of research volunteers will be taught how to do the AHE while receiving different kinds of feedback about their performance in order to determine which type of feedback is most effective in assisting people to learn the AHE. Group 1 will not receive any feedback about performance; Group 2 will receive feedback from palpation and verbal descriptive alone; and Group 3 will receive feedback from palpation, verbal descriptive feedback, and real time ultrasound. For the initial test when subjects are learning the AHE, the number of trials until the subject demonstrates his/her third correct AHE will be the outcome variable. For the retention test, the outcome variable will be the percentage of trials (out of ten) of correctly performed AHEs in the absence of visual, verbal or palpation feedback.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
Treatment of Anal Fistulas With Obsidian RFT®

The study conducted a retrospective analysis from January 2018 to December 2022 on patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna.

Anal fistulas present a significant challenge in colorectal surgery, featuring abnormal passages between the anal canal and surrounding tissues. Traditional treatments, while effective, may risk damaging the anal sphincter complex and subsequent fecal incontinence. Sphincter-preserving techniques like autologous compound platelet-rich fibrin foam have gained popularity, offering potential for better functional outcomes in anal fistula treatment. In this context, our retrospective study aims to evaluate the efficacy and safety of autologous compound platelet-rich fibrin foam, specifically Obsidian RFT®, analyzing its success in fistula closure and functional outcomes, thus contributing to the advancement of sphincter-preserving methods in anal fistula management.

The study conducted a retrospective analysis from January 2018 to December 2022 on patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna.

Clinical diagnosis, complemented by radiographic imaging, was employed to confirm inconclusive cases.

Demographic, comorbidity, fistula characteristics, and postoperative data were collected from electronic records.

Eligibility Criteria:
Inclusion Criteria:

* patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna

Exclusion Criteria:

* unclear documentation
Escalating Multiple-Dose Safety and Tolerance of WR 6026 Hydrochloride in HIV-Infected Subjects

To determine the maximum tolerated dose (MTD) of WR 6026 in HIV-infected patients. To determine whether any unexpected toxicities are caused by WR 6026 in HIV-infected patients. To determine whether there is additional toxicity when WR 6026 is given for 21 days rather than 14 days. To further investigate the pharmacokinetics and pharmacodynamics of WR 6026, and in particular to examine potential correlations between the area under the concentration-time curve and methemoglobinemia or other toxicities.

In recent animal studies, WR 6026 demonstrated inhibitory activity against Pneumocystis carinii pneumonia (PCP). This study will assess the safety and tolerance of this drug in HIV-infected patients who do not have PCP.

In recent animal studies, WR 6026 demonstrated inhibitory activity against Pneumocystis carinii pneumonia (PCP). This study will assess the safety and tolerance of this drug in HIV-infected patients who do not have PCP.

Escalating doses of WR 6026 will be studied in successive patient cohorts. Four patients will be randomized to active drug or placebo in a 3:1 ratio at each dose level until moderate toxicity is demonstrated. If one patient at a given dose level experiences WR 6026-related moderate or worse toxicity, the sample size for all subsequent dose levels will be doubled. If two or more patients at a given dose level experience moderate or dose-limiting toxicity, an additional four patients (randomized in the same 3:1 ratio) will be entered at that level, and sample size at all subsequent dose levels will be doubled. Dose escalation will continue until three of six patients receiving active drug at a given dose level experience dose-limiting or worse toxicity, or until two of six patients at a given dose level experience life-threatening toxicity. The MTD will be defined as the dose immediately below the highest dose studied. Eight additional patients will be studied at the presumed MTD to confirm tolerance.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV antibody positive.
* CD4 cell counts less than 500/mm3.
* Adequate general health.
* No significant deterioration in performance status within the past month.
* Prior treatment with a stable regimen of antiretroviral medication for at least 4 weeks prior to study.

Prior Medication:

Required:

* Stable regimen of antiretroviral medication for at least 4 weeks prior to study entry.

Allowed:

* Aerosolized pentamidine for PCP prophylaxis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Intercurrent infection.
* Clinically significant abnormality on EKG.
* Known hypersensitivity to quinolines.
* Known hemoglobin M abnormality.
* Known NADH methemoglobin reductase deficiency.
* Positive test for G6PD deficiency.
* Fever.

Prior Medication:

Excluded:

* Other systemic medication (other than AZT, ddC, ddI, methadone, acyclovir, and NSAIDs) within 3 days prior to study entry.
Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty

Randomized, controlled, single center observational study to compare the safety and performance of navigation-assisted OrthoPilot Elite and robotic-assisted MAKO total knee arthroplasty (TKA). The aim of the study is the comparison of the clinical outcome between navigated and robotic-assisted TKA. The hypothesis of the study is that both treatments achieve similar results regarding functional and clinical aspects.


Eligibility Criteria:
Inclusion Criteria:

* Indication for a TKA with a fixed-bearing total knee endoprosthesis
* Written informed consent for participating in the clinical study

Exclusion Criteria:

* Patient age \<18 years and \>90 years
* Patient not willing to participate at the follow-up
* Pregnancy
* retropatellar arthrosis requiring patella resurfacing
* American Society of Anaesthesiologists (ASA) Classification \>3
Telotristat With Lutathera in Neuroendocrine Tumors

This trial will test the hypothesis that Telotristat treatment increases the antitumor efficacy of Lutetium Lu 177 Dotatate therapy in neuroendocrine tumors (NETs).

Neuroendocrine tumors (NETs) are a very heterogeneous group of tumors that develop predominantly in the gastrointestinal and pulmonary systems. Clinical detection and diagnosis are more reliable at late stages when metastatic spread has occurred. Patients with advanced disease may suffer from complications of uncontrolled hormone secretion and usually succumb due to tumor progression.

This trial tests the hypothesis that inhibition of serotonin production with Telotristat will lead to cytostatic effects on neuroendocrine tumors and will complement the anti-tumor activity of Lutetium 177 Dotatate. The proposed combination may result in improved treatment efficacy as reflected by improved 20-month progression-free survival (PFS) as compared to historical control.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic, or unresectable, histologically confirmed well-differentiated grade 1 and 2 neuroendocrine tumor with a positive gallium 68 Dotatate scan within 6 months prior to study enrollment
* Baseline CT scan or MRI with measurable progressive disease based on RECIST Criteria
* Failure of at least one prior systemic cancer treatment for this diagnosis
* Recovered from Adverse Events of previously administered therapeutic agents to Grade 2 or less toxicity according to CTCAE version 5.0
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* normal organ and marrow function

Exclusion Criteria:

* Prior exposure to Lutetium Lu 177 Dotatate
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Telotristat or Lutetium Lu 177 Dotatate.
* Presence of unstable angina or myocardial infarction
* New York Heart Association (NYHA) Class III or IV heart failure
* uncontrolled angina
* history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities
* Pregnant or lactating women
* Women of childbearing potential or male patients of reproductive potential
* Any other significant medical or psychiatric condition, currently uncontrolled by treatment, which may interfere with completion of the study
Effects of Disrupting Prolonged Sitting With Different Physical Activity Protocols on Metabolic Risk Factors in Sedentary Adults

Great controversy exists with respect to the optimal or the minimum volume, intensity, and frequency of physical activity capable of attenuating the hazards of prolonged sitting on the metabolic profile. Thus, our study aims to comprehensively investigate the effects of disrupting prolonged sitting with different physical activity protocols on metabolic risk factors in sedentary males.

Ten sedentary males will take part in this randomized cross-over trial consisting of four 27-h conditions. All conditions will be identical except for the physical activity: prolonged sitting intervention (SIT) participants will sit continuously for 9 hours; prolonged sitting+interval standing intervention (STAND), participants will stand for 15 min every 30 minutes (total 270 min) during the 9 hours of sitting; prolonged sitting+moderate-intensity exercise bout (MVPA) participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will sit for the remaining time; and prolonged sitting+moderate-intensity exercise bout +interval standing intervention (MVPA-STAND), participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will stand for 15 min every 30 minutes (total 240 min) during the remaining 8 hours of sitting. Blood glucose, insulin, lipids and cytokines will be determined.

The investigators expect that disrupting prolonged sitting with intermittent standing and a moderate-exercise bout will positively affect the metabolic profile of the participants. Furthermore, we will investigate if combined, these strategies will have an additive effect.


Eligibility Criteria:
Inclusion Criteria:

* Males,
* age 25-55 y,
* BMI \>18 and \<35 kg/m2

Exclusion Criteria:

* Clinically diagnosed diabetes,
* dyslipidaemia,
* hypertension,
* use of glucose- and/or lipid-lowering medication,
* smoking,
* evidence of thyroid, liver, lung, heart or kidney disease,
* non-sedentary occupation and primary means of commuting to work (i.e., cycling) in the last 4 months,
* VO2max levels above the considered average fitness according to age,
* contraindication to increased levels of physical activity.
Comparison of Humidification Devices During Non Invasive Ventilation, in Acute Respiratory Failure

Comparison of humidification devices during non invasive ventilation, in acute respiratory failure.

The hypothesis was, due to dead space, lower humidification, a reduced efficiency of the technique (NIV) when HME are used in comparison with HH.

Comparison of humidification devices during non invasive ventilation, in acute respiratory failure.

The hypothesis was, due to dead space, lower humidification, a reduced efficiency of the technique (NIV) when HME are used in comlparison with HH Several physiological previously performed showed that 1) with HME, because of its working principles, humidification was reduced because of leaks 2) work of breathing was increased with HME because of dead space and 3) alveolar ventilation was reduced with HME because of additional technical dead space.

For these reasons, the hypothesis was an improvement of NIV tolerance, of efficiency to clear te CO2 with HH in comparison with HME and finally to reduce the intubation rate with HH.

The patients were included when requiring NIV (see inclusion and exclusion criteria) and randomisation was performed with stratification according to presence or absence of respiratory acidosis.

The number of patients to include was baszd on the hypothesis that intubation rate would be reduced from 40 with HME to 25% with HME. A total of 250 patients was required with alpha risk of 0,05 and beta risk of 0,2 (power 80%). Intubation criteria were predefined according to the litterature. The expected duration was 18 months. The official support was institutional (DRRC of AP-HP). HH were furnished free of charge, as well as HME. Masks used were the same in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years
* Exacerbation of dyspnea lasting less than two weeks

TWO OR THREE following criteria :

* Respiratory rate higher or equal to 25 b/min
* SaO2 lower or equal to 90% (breathing room air or oxygen)
* Arterial pH \< 7.35

Exclusion Criteria:

* immediate need for intubation
* cardiac arrest or RR\< 10 breaths/min.
* systemic hypotension (SAP \< 80 mmHg ) with no response to 500 ml of macromolecules
* coma defined by GCS \< 8.
* high probability of surgical procedure
* major facial deformity
* pneumothorax
* bad short-term prognosis
* refusal of intubation by the patient or do not intubated order.
PET and MRI Imaging of Brain Tumors Using [18F]PARPi

This study is to collect data about how 18FPARPi can be used together with PET/positron emission tomography and MRI/magnetic resonance imaging scans to take pictures of brain cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with new or suspected recurrent brain tumors (including suspected recurrent brain tumors showing growth from any preceding scan)
* Age \>/= 18 years
* Minimum at least one brain lesion size \>/= 1.5cm diameter
* Scheduled to undergo treatment at MSK
* Willingness to sign informed consent
* Able to receive intravenous gadolinium contrast per MSK Department of Radiology guidelines

Exclusion Criteria:

* Any contraindication to 3T MRI (PET/MR scanner is 4.0 Tesla)
* Pregnancy or breast-feeding women
How do I Perform a Laparoscopic Removal of a Pelvic Retroperitoneal Schwannoma

Schwannomas are mainly benign tumors, which develop mainly in the skull or in the cervical region. Retroperitoneal location is rare, since it represents between 0.5 and 5% of scwhanomas. The malignant retroperitoneal form is, however, more common than in other locations.

Retroperitoneal schwannoma is often discovered during the exploration of unexplained lumbo-pelvic pain, or in the face of compression of nearby organs. Abdominopelvic CT and magnetic resonance imaging are essential to characterize the mass and verify its extension. The precise diagnosis is based on the pathological examination of the part, and complete surgical excision is the standard treatment.

Acquiring the surgical techniques and skills necessary to carry out these types of procedures is essential to providing optimal patient care.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥18 years old)
* suffering from symptomatic deep pelvic endometriosis
* having received treatment at the Strasbourg University Hospital during 2021 for a retro-peritoneal pelvic carcinoma
* having not expressed, after information, the reuse of their data for the purposes of this research.

Exclusion Criteria:

* Patient who expressed her opposition to participating in the study
Application of Palliative Treatment in Children With Brain Stem Glioma and Recurrent High-grade Tumors in the Central Nervous System With the Nanomaterial NPt-Ca

This Protocol is a pilot, clinical interventional study to selected patients between five and fourteen years of both sexes, carriers of the diagnosis of glioma brain stem and high grade recurrent in the central nervous system tumors, in whom there has been no response to conventional-based surgery/radiation/chemotherapy treatment or whose location does not allow treatment with conventional measures, and that already have an indication for a neurosurgical palliative procedure. It will be a close pharmacovigilance on possible adverse effects related to the nanomaterial based on the profile of cisplatin (chemotherapeutic platinum derivative), since documented toxicity data are not counted for NPt-Ca. Quality of life will be documented with PedsQL Cancer Module© and tumor size by magnetic resonance brain images.


Eligibility Criteria:
Inclusion Criteria:

* Histopathological diagnosis or MRI of the brain stem or tumor of recurrent high-grade glioma.
* Indication of palliative surgical treatment by neurosurgery.
* Good general condition, enabling the realization of surgical treatment.
* Scale Lansky \> 20)
* conventional treatment (surgery, radiotherapy, and chemotherapy) failed or not applicable to the patient.

Exclusion Criteria:

* Patients with emerging infectious diseases or fever in the last 72 hours prior to placement of the NPt-Ca.
* Patients whose parents/carers do not authorize expressly the realization of procedure with knowledge of its experimental nature, are not agreed or established their commitment to meet follow-up parameters established by this Protocol.
* Patients with surgical complications prior to placement of the NPt-Ca.
* Patients in which the size and location of the lesion do not allow their surgical approach or an increase in volume by infiltration of the lesion with 3 ml of volume of NPt-Ca.
* Patient whose neurological condition do not allow the implementation of MRI without anesthesia.