cyrilzakka/clinical-trials huggingface dataset:
Treatment for Teachers With Vocal Fatigue

Teachers are a population at high risk for voice disorders given their occupational demands. In a teaching career, a common debilitating symptom among all vocal symptoms experienced is - vocal fatigue, impacting teachers' occupational performance and increasing health care costs. It is therefore essential to identify potential treatment options to alleviate the symptom of vocal fatigue. The purpose of this study is to utilize a body-system level cardiovascular training protocol in comparison to traditional voice production training to alleviate the symptoms of vocal fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Female teachers between the ages of 21-60 years Female instructors and college professors between the ages of 21-60 years
* A score of ≥ 15 on factor 1 of the VFI (tiredness and avoidance of voice use) or a score of ≤ 5 on factor 3 of the VFI (improvement of symptoms or lack thereof with rest)
* Sedentary- wherein participants will need to be completing mild intensity cardiovascular exercise less than 150 minutes in less than 5 days per week

Exclusion Criteria:

* Trained athletes
* Trained singers
* Smoking in the past 6months
* Prior history of a vocal fold pathology and current vocal fold pathology
Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg

Healthy male volunteers were administered alone and in combination with dapoxetine 30mg mirodenafil 100mg for three times, respectively and the pharmacokinetic interaction was compared between the two drugs.

Healthy male volunteers were randomized into one group among 6 sequential groups and were administered alone or in combination with dapoxetine 30mg mirodenafil 100mg in each period. Bloods were obtained at each time for pharmacokinetic analysis. Safety evaluation was also done during entire study period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male adults aged between 19 and 55
* Body mass index (BMI) in the range of 19 to 27 kg/m2
* Understand the requirements of the study and voluntarily consent to participate in the study
* Available for the entire study period

Exclusion Criteria:

* Subject has a history such as liver diseases, kidneys, digestive system, respiratory system, endocrine system, nervous psychiatric, blood, cancer, cardiovascular diseases
* Subject with clinically significant vital signs (sitting position blood pressure) (90 mmHg \> systolic blood pressure ≥ 140 mmHg, 60 mmHg \> diastolic blood pressure ≥ 90 mmHg)
* History of drug abuse
* History of caffeine, alcohol, smoking abuse

  * caffeine(coffee,tea,coke)\> 4cups/day
  * smoking \> 10 cigarettes/day
  * alcohol \> 140g/week
* Consumption of any grapefruit or grapefruit-containing juices over 1 cup a day
* Previously donate whole blood within 60 days or component blood within 30 days
* Subject has taken drugs which affects the ADME of investigational products
* Subject with known for hypersensitivity reactions to mirodenafil/ dapoxetine or other drugs
* Inadequate laboratory test result:

  * AST(SGOT) or ALT(SGPT) or total bilirubin \> 1.5 x upper limit of normal range
* Subject considered as unsuitable based on medical judgement by investigators
Gentamicin Treatment Prior to Schwannoma Surgery - Residual Function

The purpose of the study is to determine whether vestibular and postural compensation following schwannoma surgery is improved by ablating remaining vestibular function prior to surgery, through gentamicin injections in the middle ear.

The residual function of the vestibular system before surgery differs considerably between patients, due to extent and influence of tumor growth, resulting in varying spectra of post-surgery illness as well as vestibular symptoms. An acute unilateral vestibular deafferentation (uVD) (if significant vestibular function remains prior to surgery) invariably results in severe nausea and vertigo. The nausea/vertigo induced by surgery and sudden uVD both can impede vestibular compensation processes and in extension, also the need for rehabilitation. The vestibular PREHAB protocol was developed in order to address this problem and to ensure an enhanced and sufficient rehabilitation. The protocol encompass treating patients that have measurable vestibular function before surgery with intratympanic gentamicin injections, thus producing gradually a uVD over a period of 3-4 weeks, whilst performing daily vestibular exercises before and after the gentamicin treatment. Through this procedure the sensory trauma is separated from the surgical trauma, making it possible for vestibular compensation to ensue as the vestibular function gradually decline from gentamicin toxicity, unencumbered by any depression of central nervous function that might result from schwannoma surgery or the acute stages of an uVD.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with vestibular schwannoma and surgical treatment is advised
* remaining vestibular function

Exclusion Criteria:

* impaired decision making
* no remaining vestibular function
* signs of central nervous dysfunction
* neurofibromatosis
* Patients are advised not to participate in the gentamicin arm but encouraged to participate in the 'non-gentamicin' arm:
* when hearing is better than 30decibel (dB) i pure tone average (500, 1000, 2000, 3000/4000 Hz) and speech discrimination better than 70% -when the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin- associated hearing loss
Post-Operative Ambulatory Challenge and Exercise (PACE) Trial

This research study is evaluating the postoperative results in terms of quality of life and functional recovery of elderly patients after cancer surgery.

This is a pilot study, designed to collect data on steps walked (ambulation) per day of lobectomy patients after surgery. While the investigators know ambulation improves outcomes after surgery, there is no institutional policy, set of patient goals, or method for deciding which patients require further resources, such as physical therapy. Data collected will be used to set up a hospital-wide strategy for patients to achieve post-operative ambulation milestones more readily.

Eligibility Criteria:
Inclusion Criteria:

* Patients Aged ≥ 18 years
* Who underwent or who will undergo lung resection at Brigham and Women's Hospital (BWH)
* With diagnosis of malignant or benign disease

Exclusion Criteria:

* Patients with baseline immobility (i.e. wheelchair-bound, use of any walking assistance device, or gait alterations)
* Patients with cognitive deficits
A FIH Study to Assess the Safety and Tolerability of NS Intravenous NS101 Infusion

Up to 80 healthy adult males, ≥ 18 and ≤ 55 years of age, are planned to be enrolled in the study.

The study will consist of 8 cohorts (Cohorts 1 to 8, 1 cohort per dose level). Each cohort will include 8 subjects (6 subjects receiving a single dose of the study drug NS101 and 2 subjects receiving a single dose of a matching placebo), for a total of 64 subjects planned for evaluation. A total of 21 blood samples will be collected in each cohort for PK analysis and a total of 14 blood samples will be collected in each cohort for PD analysis.

The study will consist of 8 cohorts (Cohorts 1 to 8, 1 cohort per dose level). Each cohort will include 8 subjects (6 subjects receiving a single dose of the study drug NS101 and 2 subjects receiving a single dose of a matching placebo), for a total of 64 subjects planned for evaluation.

For each dose level, the dose to be administered to each subject for a single infusion will be calculated based on subject's body weight, measured on Day 1.

In each cohort, subjects will receive a single infusion of NS101 or matching placebo under fasting conditions over a period of approximately 60 minutes at the target dose level. A total of 21 blood samples will be collected in each cohort for PK analysis and a total of 14 blood samples will be collected in each cohort for PD analysis. A total of 6 immunogenicity blood samples will be collected for ADA and NAbs. For each subject in cohort 5 to 8 only, one single CSF sample will be collected via lumbar puncture over the study, for PK and PD analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Male, non-smokers (no use of tobacco or nicotine products within 6 months prior to screening), ≥18 and ≤55 years of age, with BMI \>18.5 and \<30.0 kg/m2 and body weight ≥50.0 kg for males.
2. Healthy as defined by:

   1. the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
   2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
3. Subject's score on the Sheehan Suicidality Tracking Scale (S-STS) at screening must be 0.

Exclusion Criteria:

1. Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C found during medical screening.
2. Positive urine drug screen or alcohol breath test at screening or admission.
3. History of asthma, allergic rhinitis or urticaria, anaphylactic reactions, or any other clinically significant allergic reactions to any medication, including biologics, or food, or allergy to any excipient in the formulation.
Medium-Dose UVA1 Versus Narrow-Band UVB in Atopic Dermatitis

Atopic dermatitis (AD) is a very common disorder that is characterized by pruritic inflammatory skin lesions, with patients usually having an individual or family history of atopic diseases in their background. Phototherapy is among the first-line approaches in the management of AD. In this context, a variety of studies have shown a beneficial effect of natural or artificial UV radiation in atopic dermatitis (AD). The past ten years have seen the introduction of new phototherapeutic regimens for AD, including UVA1 and NB-UVB.UVA1 seems to be more effective than the above mentioned broadband spectra, in particular in acute severe AD. The aim of the present study is the comparison of UVA1 and NB-UVB phototherapy in the treatment of AD. Additionally, the course of several cytokines, human beta-defensins, and SMAD-proteins will be evaluated during the course of treatment.

Atopic dermatitis (AD) is a very common disorder that is characterized by pruritic inflammatory skin lesions, with patients usually having an individual or family history of atopic diseases in their background (e.g., allergic asthma and rhinitis). Defective skin barrier, immunological dysfunctions (type I and IV allergy), genetic disorders, and psychological factors contribute to the pathogenesis of AD. However, among these factors, CD4+ Th cells are reported to play a particularly crucial role in the pathogenesis of AD. Phototherapy is among the first-line approaches in the management of AD. In this context, a variety of studies have shown a beneficial effect of natural or artificial UV radiation in atopic dermatitis (AD). Different broadband UV spectra (BB-UVA, BB-UVB, BB-UVA/BB-UVB) and combined treatment modalities such as balneophototherapy and PUVA have previously been proven to be effective in AD. However the past ten years have seen the introduction of new phototherapeutic regimens for AD, including UVA1 and NB-UVB.UVA1 seems to be more effective than the above mentioned broadband spectra, in particular in acute severe AD. The aim of the present study is the comparison of UVA1 and NB-UVB phototherapy in the treatment of AD. Additionally, the course of several cytokines, human beta-defensins, and SMAD-proteins will be evaluated during the course of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic AD (Hanifin and Rajka, 1980); moderate to severe disease with SCORAD-index \> 30 (maximum = 102).
* Age \> 18 years
* No topical steroids (except 1% hydrocortisone) or topical/systemic antibiotics or antihistamines within the last 2 weeks, no systemic glucocorticosteroids or other immunosuppressive agents within the last 8 weeks, no phototherapy within the last 12 weeks before inclusion

Exclusion Criteria:

* Pregnancy or lactation
* Skin cancer or dysplastic naevi, photosensitive skin diseases, autoimmune diseases or relevant cardiovascular diseases
* Photo-skin type I according to Fitzpatrick
Normal Oxygenation Versus Hyperoxia in the Intensive Care Unit (ICU)

Oxygen administration is a common practice in intensive care units, although concern is growing about oxygen toxicity. The aim of the study is to access whether a rigorous maintenance of a state of normal oxygenation in critically ill patients could obtain better outcomes, such as mortality, infections and organ failures, in comparison to conventional oxygen therapy practice.


Eligibility Criteria:
Inclusion Criteria:

* all patients admitted in a post-operative and medical intensive care unit with expected admission of at least three days. Informed consensus as soon as possible

Exclusion Criteria:

* minority
* patient discharged from ICU and successively re-admitted
* patient enrolled in other studies
* expected survival shorter than 24 hours
Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease

The goal of the study is to assess the impact of treatment with dietary supplement containing Saccharomyces boulardii (used as an addition to standard therapy), on quality of life of patients with mild forms of ulcerative colitis and Crohn disease, as well as those in remission fulfilling criteria for irritable bowel syndrome.

Patients included will be randomly assigned in two groups and subsequently administered with formulation containing Saccharomyces boulardii or placebo for 4 weeks. Patient's quality of life will be assessed by questionnaire at the enrolment and 4 weeks after initiating the therapy.

Saccharomyces boulardii has been reported to have positive impact on intestinal epithelial barrier as well as immune system. It has been proven to be efficient in treatment and prophylaxis of travellers diarrhoea, HIV associated diarrhoea, antibiotics associated diarrhoea and Clostridium difficile infection. However there is a limited data available on effect of therapy with Saccharomyces boulardii (as add-on to standard therapy) in patients with inflammatory bowel disease. Nevertheless, knowing the effect Saccharomyces boulardii has on intestinal flora, intestinal epithelium and immune system it can be hypothesised that Saccharomyces boulardii used as add-on to standard therapy in IBD patients can lead to improvement in symptoms and therefore in quality of life.

Eligibility Criteria:
Inclusion Criteria:

* histological diagnosis of ulcerative colitis or Crohn disease
* colonoscopy in last six months confirming mild disease form according to endoscopic criteria (Mayo score, simple endoscopic score)
* colonoscopy in last six months confirming endoscopic remission with fulfilled clinical Rome IV criteria for irritable bowl syndrome
* patients
* patients with mild disease form are eligible only if treated with mesalazine only
* patients in remission eligible for inclusion if treated with mesalazine, biologics, azathioprine or methotrexate
* signed informed consents

Exclusion Criteria:

* no colonoscopy in last six months
* moderate to severe disease according to colonosopy findings (Mayo score, simple endoscopic score)
* indeterminate colitis
Evaluation of the Comprehensive Family Support Program (PAIF)

The goal of this study is to evaluate the effectiveness of positive parenting programs targeted to parents of toddlers, children and adolescents carried out in Cantabria (Spain).

We will collect information from the participants before the intervention, in the last session of the program and some months after, to verify if there have been some changes in the family dynamics of these parents, and if these changes continue after some time. Besides, we will compare these results with information from other families that are not taking part in the program. The main caregivers of the participating families and the practitioners in charge of the intervention will provide the information for the study.

We expect that families participating in the programs will improve their parenting competencies and their family dynamics, and that these change will stay after the program.

A quasi-experimental design will be followed, with three evaluation moments (pretest, posttest and follow-up) and with a non-randomized comparison group.

The positive parenting programs will be advertised by social media, schools and high schools. The participants will be parental figures interested in joining these programs.

The participants will answer a series of questionnaires by an app, where they will give information related to sociodemographic data and parenting competencies. The app will not allow the participants to leave any question with no answer or with an incorrect answer.

To analyze the data, we will use the softwares Mplus and Statistical Package for the Social Sciences (SPSS).

Eligibility Criteria:
Inclusion Criteria:

* Being caregiver of at least one child under 18 years of age
* The child to be in the developmental stage appropriate for the corresponding arm
* If participating in a targeted program, meet the requirements: (1) be a father; (2) presenting bad health habits in the family according the evaluation of the pediatrician
* Motivated to improve parenting competences

Exclusion Criteria:

* Not having sufficient command of the Spanish language to be able to communicate
* Experience family crisis that prevent for participating in a group intervention
* Experience mental health issue that prevent for participating in a group intervention
Engaging Patients in Weight Loss Tools

The overall aim of this study is to evaluate the acceptability and feasibility of a primary-care based approach to facilitating engagement in online behavior tracking and community support networks for weight loss ("facilitation condition") over 12 weeks among adults with obesity.


Eligibility Criteria:
Inclusion Criteria:

* PCPs:

  1. Employed as a PCP at a clinics in the UF health care system.
  2. Has practiced at current clinic for ≥1 year (self-report)
  3. Is employed ≥ 0.5 FTE (self-report)
  4. Has a patient panel that is majority adult (self-report)
* Patients: EHR-based criteria:

  1. Age 18-75
  2. Last BMI in EHR ≥30 kg/m2
  3. Has an appointment scheduled ("index appointment") with an enrolled primary care PCP 7-30 days after electronic data pull.
  4. Is enrolled in MyChart or has an email address in the IDR system.

     Self-report criteria:
  5. Self-reported BMI \> 29 kg/m2 (to account for under-reporting)
  6. Response yes to question: "Would you be interested in learning strategies to help you lose weight?"
  7. Ability to read and understand English without assistance.
  8. Has either (a) a phone or tablet with a data plan OR (b) reliable access to Wi-Fi (via computer, phone or tablet) in their home.

Exclusion Criteria:

* PCPs:

  1. Planning to move out of the Gainesville or Jacksonville area in the next 12 months.
* Patients:

  1. Currently enrolled in formal weight loss program or a research study focused on changing diet, physical activity, or weight.
  2. In past month, has tracked the majority of their food intake on an app, website, or paper log an average of 3 or more days per week.
  3. Self-reported to be pregnant, breastfeeding, or planning to become pregnant in next 6 months.
  4. Currently undergoing radiation or chemotherapy for cancer.
  5. Self-reported cardiac event in past 6 months.
  6. Self-reported Heart Failure (also known as chronic heart failure or CHF).
  7. Planning to move out of the Gainesville or Jacksonville area (depending on which clinic they are recruited from) in the next 6 months.
FAPI PET for Response Evaluation and Prognosis Prediction in Liver and Biliary Cancer Patients Treated With PD-1 Combination Therapy

The purpose of this study is to explore the ability of positron emission tomography (PET) with \[68Ga\]FAPI to detect, evaluate treatment response, and predict prognosis in advanced liver and biliary cancer patients treated with anti-PD-1 antibodies-based combination therapy.

Hepatocellular carcinoma (HCC) and bile tract cancers (BTC) are major health issue worldwide, particularly in Eastern Asia. Anti-PD-1 antibodies-based combination therapy has shown considerable efficacy in advanced HCC and BTC. However, an objective response is only achieved in a portion of patients. Thus, there is an urgent need for better patient selection before immunotherapy as well as accurate evaluation of treatment response.

PET is a noninvasive imaging technique which might be an effective tool for evaluating anti-PD-1 antibody-based combination treatment in liver and biliary cancer. 68Ga-FAPI has been developed as a novel agent targeting fibroblast activation protein (FAP) that is overexpressed in cancer-associated fibroblasts in liver and biliary cancer. Prior studies have shown that FAP-expressing CAF suppresses anti-tumor immunity while suppressing FAP can overcome stromal barriers to immuno-oncological responses. Meanwhile, 68Ga-FAPI PET showed a high detection rate in primary and metastatic lesions in liver and biliary cancer. The aim of this study is to evaluate the ability of positron emission tomography (PET) with \[68Ga\]FAPI to detect, evaluate treatment response, and predict prognosis in advanced liver and biliary cancer patients treated with anti-PD-1 antibodies-based combination therapy. Our hypothesis is that baseline \[68Ga\]FAPI PET parameters can predict response and clinical benefit of anti-PD-1 antibodies-based combination therapy and overall survival; that effects of anti-PD-1 antibodies-based combination therapy in liver and biliary cancer can be detected and quantified by \[68Ga\]FAPI PET after treatment in correlation with other radiological findings and clinical endpoints; that such effects are more prominent with \[68Ga\]FAPI PET than with the traditional \[18F\]FDG PET.

Eligibility Criteria:
Inclusion Criteria:

* locally advanced or metastatic and/or unresectable HCC or BTC
* Child Pugh A or B liver function status
* an ECOG performance status score of 0-2

Exclusion Criteria:

* intolerance to anti-PD-1-based combination therapy
* active or prior autoimmune disease
* concurrent use of immunosuppressive medicaments