cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Revised WORQ in CI Users

The Work Related Questionnaire (WORQ) is a 59-item questionnaire of which each item represents an International Classification of Functioning and disability category. The WORQ was modified and reduced to include only questions relevant to Cochlear Implant (CI) users. In this analysis, a multicentre retrospective review of the revised WORQ in CI users was performed, with the revised WORQ as part of the questionnaires used in the regular clinical follow-up of CI users. Experienced CI users' responses on the questions will be evaluated to define the qualifiers for the revised WORQ.


Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18 years
* Adults must wear a MED-EL cochlear implant
* Adults may have the following hearing indications and device fitting:

  * Unilateral cochlear implant with severe-to-profound hearing loss
  * Bilateral cochlear implant with severe-to-profound hearing loss
  * Single sided deafness (SSD) where the poorer ear PTA ≥70 dB HL and the better ear PTA ≤30 dB HL with an interaural threshold gap of ≥40 dB HL.
  * Asymmetrical hearing loss using a cochlear implant in the poorer ear and a hearing aid in the better ear (also known as bimodal fitting). The poorer ear PTA ≥70 dB HL and the better ear PTA \>30 dB HL and ≤55 dB HL with an interaural threshold gap of ≥15 dB HL.
* Adults should have a minimum of one year's device experience

Exclusion Criteria

No extra exclusion criteria
Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis

N-Acetyl cysteine (NAC) is an amino acid with strong antioxidant, mucolytic and antibacterial properties, and is produced within the human body.Its effect in biofilms has been tested in several bacteria. Biofilms have recently been observed in 90% of subjects with bacterial vaginosis (BV) with Gardnerella vaginalis being the predominant species. Although a wide range of antimicrobial agents are currently available, treatment options for controlling BV are still limited. Furthermore, the number of relapses are increasing and require alternative treatments. This study is aiming to evaluate the role of NAC in treatment of BV and prevention of recurrence.

Bacterial vaginosis (BV) is the most frequent diagnosis made in women with lower genital tract symptoms. It has recently been observed that 90% of subjects with BV show the growth of bacteria in the form of biofilms,and that Gardnerella vaginalis was the predominant species. The propensity of G. vaginalis to form biofilm is clinically relevant because this form of growth allows it to tolerate higher concentrations of certain antibiotics, thus increasing the possibility of recurrent BV even after apparently curative therapy. So new treatment strategies must be used to insure complete cure and prevent recurrence. NAC is an amino acid with strong antioxidant, mucolytic and antibacterial properties, and is produced within the human body.Its effect in biofilms has been tested in several bacteria.

This study aims to test the efficacy of NAC in treatment of BV either alone or in combination with the traditionally used metronidazole. Also the effect of using NAC in prevention of recurrence of BV will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* patients complaining bacterial vaginosis and proved to have BV using standard diagnostic methods for BV
* patients with age between 20-50

Exclusion Criteria:

* Virgins and menstruating patients.
* Recent douching or sexual intercourse.
* Use of systematic or vaginal antimicrobial therapy or any vaginal suppositories or drugs.

All patients will sign a written consent before starting the treatment
Proton Beam Therapy for Unresectable Liver Metastasis

The investigators performed the present study to evaluate the role of proton beam therapy for liver metastasis which is unresectable and unsuitable for radiofrequency ablation (RFA) in terms of local control and safety.


Eligibility Criteria:
Inclusion Criteria:

* pathologically diagnosed cancer patient
* confirmed liver metastasis via computed tomography (CT) or magnetic resonance imaging (MRI) or biopsy
* unresectable or unsuitable for RFA
* solitary liver metastasis or less than 3 metastatic lesions if the distance is less than 3 cm between metastatic lesions
* case discussed by surgeon, radiologist, and radiation oncologist
* Eastern cooperative oncology group performance status 0 to 2
* optimal liver and renal function (Child-Pugh score 10 or less)
* informed consent
* agree to be contraceptive for the duration of the study and for the next 6 months

Exclusion Criteria:

* uncontrolled ascites or hepatorenal syndrome
* status of pregnancy or breast-feeding
* less than 12 weeks of expected survival
* combined disease known to have high radiation side effects
* serious acute illness that is not treated other than liver disease
Effect of Hypertonic Solutions on Allergic Rhinitis Patients

The purpose of this study is to assess the effectivity of using hypertonic nasal solutions alone on the symptom scores and nasal eosinophil levels of allergic rhinitis patients, retrospectively.

The medical records of the patients who admitted to outpatient clinic of otorhinolaryngology department of a tertiary referral center were retrospectively investigated. The symptom scores and nasal eosinophil levels of the patients were recorded. Patients using hypertonic solutions alone or steroid nasal spray alone were compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with positive Prick's test to at least one allergen and diagnosed as having allergic rhinitis were included
* Patients who used hypertonic nasal solution alone for at least one month were included as sthe study group
* Patients who used nasal steroid spray alone or at least one month were included as sthe study group

Exclusion Criteria:

* Patients with a history of asthma, urticeria, eczama, diabetes mellitus, hypertension, COPD and other systemic diseases were excluded
High-Dose Chemotherapy in Treating Patients With Advanced Stomach Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving higher doses may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of high-dose chemotherapy in treating patients with advanced stomach cancer.

OBJECTIVES: I. Determine the response rates in patients with advanced gastric cancer treated with high-dose fluorouracil (5-FU) with vs without high-dose leucovorin (CF) vs high-dose 5-FU/CF/cisplatin. II. Determine the toxic effects of these regimens in these patients. III. Assess the symptomatic improvement in these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, WHO performance status (0 or 1 vs 2), and disease stage (metastatic vs locally advanced). Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive fluorouracil (5-FU) IV over 24 hours weekly for 6 weeks. Arm II: Patients receive leucovorin calcium (CF) IV over 2 hours followed by 5-FU IV over 24 hours weekly for 6 weeks. Arm III: Patients receive CF and 5-FU as in arm II and cisplatin IV over 1 hour on days 1, 15, and 29. Treatment repeats every 7 weeks for a maximum of 4 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 65-135 patients (21-45 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed gastric cancer that is either metastatic or locally advanced and inoperable Bidimensionally measurable disease No CNS metastasis

PATIENT CHARACTERISTICS: Age: 75 and under Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.7 mg/dL Renal: Creatinine no greater than 1.3 mg/dL Creatinine clearance greater than 60 mL/min Cardiovascular: No myocardial infarction within past 12 months No coronary heart disease requiring drug therapy Congestive heart failure or arrhythmia treatable with standard medication allowed Other: No active infection No history of severe mental disorder No other malignancy within past 10 years except carcinoma in situ of the cervix or nonmelanoma skin cancer Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified
A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer

A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab

A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab

Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* 1) Stage IV or recurrent non-Small cell lung cancer
* 2) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* 3) Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization

Exclusion Criteria:

* 1) Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy
* 2) Active, known or suspected autoimmune disease or HIV infection
* 3) Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
* 4) Untreated Central Nervous System metastases

Other protocol defined inclusion/exclusion criteria could apply
Feasibility and Efficacy of PRO-MAMAS

This experimental design will assess the feasibility \& initial effectiveness of PRO-MAMAS (promoting participation, health and wellbeing through meaningful maternal-role activities after stroke) - a novel occupational therapy intervention program to promote participation, health and wellbeing of older mothers with chronic stroke.

Assessments will be conducted at three time points: baseline, pre, post the Pro-MAMA intervention

This study aims to test the feasibility and initial effectiveness of PRO-MAMAS (promoting participation, health and wellbeing through meaningful maternal-role activities after stroke) in improving participation, health and wellbeing among older community dwelling mothers with chronic stroke.

PRO-MAMAS is a group intervention that aims to promote the health and wellbeing of older mothers with chronic stroke by using meaningful maternal-role activities as a motivational mean for participation. The intervention will include group discussions and practice, analysis of facilitators and barriers for participation, and home exercise. PRO-MAMAS will focus on raising awareness to meaningful maternal-role activities, identifying facilitators and barriers for participation and problem solving to enhance meaningful participation.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Aged 70 and older
* Mothers (have at least one live and healthy child)
* With chronic stroke (at lease six months from stroke onset)
* That live at home
* That they can walk independently (with or without a walking aid)
* Without significant cognitive decline (MoCA ≥19)
NIS to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia

The purpose of the study is to monitor the general functional changes among patients with schizophrenia, treated with atypical antipsychotics dosed once daily for a period of 6 months.The primary study objective is to compare general functioning of patients with schizophrenia treated with Seroquel SR between baseline and the last study visit. The secondary study objectives are to compare general functioning of patients with schizophrenia treated with other atypical antipsychotic medicinal products administered once daily between baseline and the last study visit, monitoring of other indicators of clinical improvement, evaluation of patient compliance and assessment of occurrence of adverse effects


Eligibility Criteria:
Inclusion Criteria:

* patients have a diagnosis of schizophrenia, as defined by DSM-IV-TR
* patients' symptoms are controlled with Seroquel SR started up to 1 month before the inclusion
* or patients' symptoms are controlled with other atypical antipsychotic in once daily formulation started up to 1 month before the inclusion

Exclusion Criteria:

* patients who are treated with Seroquel SR or other antipsychotic more than 1 month
* patients with prescribed antipsychotic combinations
* pregnant women or women who are breast-feeding
* patients who have been treated with antipsychotics in depot formulations for the last two months
Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions

This study aims to examine the relation between iron status and maternal-child interactions as well as maternal depressive symptoms in mothers from central Pennsylvania.

Investigators aim to follow mothers and their infants from 6 weeks to 6 months in the postpartum to understand the relation between iron status and mother-child interactions and depressive symptoms. During this period, iron deficient anemic mothers will receive an intervention with iron with the scope of improving iron status, reducing their depressive symptoms, and in turn, increasing the quality of parenting behaviors during mother-child interactions. The control group will be iron sufficient mothers who will receive a placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women between 18 - 40 years.
2. Mother expects to be the primary caregiver for the infant for study duration and will allow infant to be enrolled in the study..
3. Mother has no history of gastrointestinal or hematological disorders and not taking medications that interfere with hematopoiesis or absorption.
4. After birth, the mother and baby are healthy, delivery was of one infant only, infant gestational age ≥ 38 weeks, infant weight ≥ 2500 g (5.5 lbs), neither the mom nor the infant received a blood transfusion at or since delivery, and mom agrees to discontinue use of any iron containing medications.

Exclusion Criteria:

1. Maternal age ≤ 18 and \> 40 years
2. Evidence of a history of gastrointestinal or hematological disorders and evidence of taking medications that interfere with hematopoiesis or absorption.
3. Severely anemic (Hemoglobin \< 90 g/L)
4. Iron deficient but not anemic women
5. Non-English speaking
Effects of Different Strategy of Fluids Administration on Acid/Base Disorders and Inflammatory Mediators

Aim of the study is to ascertain whether a different strategy of fluids administration can be responsible of differences in terms of acid/base disorders (Stewart approach), pro-inflammatory and inflammatory mediators. Hence two groups of patients will be treated either with not-balanced solutions (Normal Saline) or balanced solutions


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of large bowel cancer
* Age \> 18 years old

Exclusion Criteria:

Emergency surgery for bowel punch or intestinal occlusion

* Massive bleeding
* Therapy with corticosteroid or nonsteroid antiinflammatory substances
* Renal insufficiency (serum creatinine \> 200 micromol /l)
* Cardiac insufficiency (NYHA III-IV)
* Altered liver function (ALT \> 40 U/l AST \>40 U/l)
* Preoperative anaemia ( Hb \< 10 g/dl )
* Allergy to hydrossietilic starches
* Patient rejection to share the study
Debritom - Micro Water Jet Technology and Wound Healing

This study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers.

This is a prospective cohort, single-center, open-label study in subjects with chronic lower extremity wounds. The study will enroll up to 20 subjects. Subjects will undergo screening evaluations to determine eligibility to enroll in the study. All study subjects will receive micro water jet technology debridement as opposed to other debridement methods as part of their wound care treatment. The other aspects of subjects wound care protocol will remain unchanged. In the case of bilateral limb ulcers, or multiple ulcers, subjects will have the option to receive micro water jet debridement on one or all of the ulcers.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 or older
* The ability and willingness to provide Informed consent
* Presence of a chronic lower extremity ulcer
* Chronic ulcer is defined as that greater than 4 weeks in duration.
* Subject's informed consent for participation prior to proceeding with micro water jet technology debridement
* Patient's ulcer cannot exhibit any gross clinical signs of infection.
* Patient is willing to participate in all procedures and follow up evaluations necessary to complete the study.
* Patient willing and able to comply with having micro water jet technology debridement potentially weekly or biweekly as part of their wound care treatment plan for up to 20 weeks.

Exclusion Criteria:

* Patients with active wound infection, or untreated osteomyelitis
* Patients with dementia, or impaired cognitive function
* Patients who are unable or unwilling to participate in all procedures and follow up evaluations
* Patient has Active Charcot foot
* Patient with malignant wounds
Effectiveness of the Cytokine Hemadsorption on Sepsis

In this prospective study, we aimed to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock.


Eligibility Criteria:
Inclusion Criteria:

* the patients were the available data of clinical and laboratory diagnosis of sepsis and septic shock
* detection of gram-negative bacterial agent in blood or sputum culture.
* patients who had the shock symptoms such as hypotension, tachycardia or fever during the course of sepsis.

Exclusion Criteria:

* had uncontrolled hemorrhage,
* diagnosed with cardiac failure at stage 4 or renal failure at stage 4 or hepatic liver failure at stage 4
* cancer at the end stage or admitted with acute coronary syndrome.
Sunscreen RV 2457C in Photoinduced CLE

Lupus erythematosus (LE) is characterized by a large clinical spectrum, and sunligt is a well established factor in the induction and exacerbation of this disease. In all subsets of LE, skin lesions occur preferentially in sun-exposed areas.

Previous studies have demonstrated that the lesions in LE patients reproduced in controlled experimental conditions. The initial reports suggested that the action spectrum for the LE was in the UVB range (290 to 320 nm), but more recent studies have demonstrated that UVA (320 to 400 nm) can contribute to the induction of LE skin lesions.

Antimalarial agents and topical steroids are the main treatments of chronic LE. The second line therapies include retinoids, sulfones, immunosuppressor agents, systemic corticosteroid and thalidomide. Moreover, patients are advised to avoid sun, to wear sunprotective clothing and to apply sunscreen.

The aim of this study was to assess the efficacy of a sunscreen milk with high protection factor against UV-B and UV-A, used exclusively, in the photoinduced LE.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects
* Patient aged of 18 years or more
* Documented medical history of chronic cutaneous lupus erythematosus (lupus erythematosus tumidus, discoid lupus erythematosus, subacute lupus erythematosus) without any sign of systematic involvement
* patients who have a history of positive provocative phototestimg using a standardized protocol during a previous photobiologic exploration
* informed consent

Exclusion Criteria:

* Pregnant women, nursing mothers
* subjects with lupus erythematosus with systematic involvement
* subjects with a medical history of another photodermatosis
* subjects with sun erythema, residual pigmentation, dermatological lesion, abnormal skin pigmentation which might interfere with a study evaluation on test sides
* subjects who had sun solar simulator exposure on their backs within 12 weeks prior to enter to the study
* subjects with a known intolarance to one of the formula compounds
EXercise Continuation Incorporating Technology Enhancements (EXCITE) Study

The purpose of this study is to inform the integration of mobile and social media components into larger interventions aimed at increasing adherence and maintenance of physical activity. Nearly half of the US population do not meet physical activity recommendations of ≥150 minutes of moderate activity per week. The use of smartphones to "self track" data and upload that data to an online social network is becoming increasingly common and may be an effective way to motivate physical activity adherence and maintenance. We are proposing a two phase study to develop and evaluate a mobile health ("mHealth") intervention that includes the use of two existing technologies: 1) the RunKeeper mobile app to collect and upload exercise data (distance, pace, time), and 2) the RunKeeper.com online social network as a place to analyze uploaded data and engage with a coach and online community. Phase 1 (n=10) will iteratively develop the mHealth intervention and phase 2 (n=30) will pilot the mHealth intervention (participants will be randomized to either mHealth intervention (n=20) or control (n=10)) to collect feasibility, acceptability and preliminary efficacy data. All participants will attend a day-long ChiWalk/Run training to help them avoid potential injuries and meet their coach and community in-person. All participants will also be asked to wear a FitBit accelerometer from one week before the beginning of the intervention through one week after the end of the intervention to collect total physical activity data. This data will be uploaded automatically to the study data base. Primary outcomes will be total physical activity as collected by the FitBit accelerometer (and the RunKeeper mobile app for the intervention group) and secondary outcomes will be changes in psychological factors that may mediate adherence to physical activity.


Eligibility Criteria:
Inclusion Criteria:

* healthy underactive adults interested in using mobile and web based technologies to increase their physical activity
* low risk of cardiovascular disease
* comfortable reading and communicating in English
* owns a smartphone and is does not regularly use a fitness tracking mobile app
* has regular access to the internet and a wireless connection for data uploading.

Exclusion Criteria:

* currently meeting/exceeding recommend 450 MET min per week
* previous condition that would contraindicate regular moderate to vigorous physical activity