cyrilzakka/clinical-trials huggingface dataset:
Liposomal Doxorubicin, Vincristine, & Dexamethasone Plus Arsenic Trioxide in Untreated Symptomatic Multiple Myeloma

This study will assess the ability of Doxorubicin, Vincristine and Dexamethasone plus arsenic trioxide to achieve an overall response rate of greater than 60%.

Rationale: The chemotherapy combination of doxorubicin, vincristine and dexamethasone (DVd) has been used with some efficacy in patients with multiple myeloma. However, DVd's efficacy is primarily considered palliative for patients with this condition. The current study adds arsenic trioxide to the DVd combo to assess if all of the treatments together improve patient outcomes. Previous studies suggest that arsenic trioxide may enhance the efficacy of specific chemotherapy agents including those in DVd; however, research in people has not yet demonstrated this improved effectiveness. Because the safety of arsenic trioxide has been tested in this patient population, this phase II study will gather more information about safety and also measure efficacy through various measures.

Purpose: This study will evaluate the safety and efficacy of doxorubicin, vincristine and dexamethasone plus arsenic trioxide in untreated patients with symptomatic multiple myeloma. The biology of the tumor and other molecular changes will also be assessed in patients through collections of blood and marrow samples.

Treatment: Patients in this study will receive arsenic trioxide, doxorubicin, vincristine and dexamethasone. During the first five days of the study, patients will be given arsenic trioxide each day through an intravenous infusion. No treatments will be provided on days six and seven. After this first week, patients will then receive study drugs on the following schedule every four weeks: doxorubicin and vincristine on day one, dexamethasone on days one through four, and arsenic trioxide twice each week. This schedule can be repeated up to four times for a total of approximately four months. Several tests and exams will be given throughout the study to closely monitor patients. Supportive care will be provided to help regulate side effects from study drugs and maintain quality of life in patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Must have Multiple Myeloma
* No prior chemotherapy, thalidomide, or corticosteroids treatments for Multiple Myeloma
* ECOG performance status must be 0-2

Exclusion Criteria:

* Resting left ventricular cardiac ejection fraction ≥50% by echo or MUGA scan.
* QT interval ≥480 msec on baseline ECG.
* No history of cardiac disease.
* Pregnant or breast-feeding.
* No history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil.
* History of prior or concurrent malignancy or myelodysplasia.
Performance Study of SONA Saliva C-19 Rapid Test

The Sona Saliva C-19 Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to a RT-PCR reference method

The clinical performance of the Sona Saliva C-19 Rapid Test will be evaluated in a prospective clinical study conducted at a single (1) investigational site in Toronto, Cananda.

Consenting patients of ages 18+, any gender, or race/ethnicity who presents at the test site with COVID-19 like symptoms during the 2021 COVID-19 season will be asked to take part in the study, will be sequentially enrolled and tested.

Trained operators with laboratory experience who have received training on the use of the Sona Saliva C-19 Rapid Test will conduct the testing and represent the intended users.

A subject's participation in this study will consist of a single visit. Following the completion of the informed consent process, study questionnaire and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number, be asked to provide a sample for testing.

Eligibility Criteria:
Inclusion Criteria:

Up to 500 subjects will be screened, consented, and enrolled to obtain a minimum of 50 eligible candidates. In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Presenting to the Emergency Department at HRH.
2. Receiving a COVID-19 RT-PCR test as per standard pathway of care.
3. Provide written informed consent.
4. Patients must be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 7 days:

   1. Fever as self-described or measured ≥ 38 °C (100.4°F)
   2. Chills
   3. Cough
   4. Shortness of breath
   5. Congestion or runny nose
   6. Difficulty Breathing
   7. Muscle or Body Aches
   8. Vomiting
   9. Diarrhea
   10. New loss of sense of taste or smell
   11. Headache
   12. General malaise
   13. Sore Throat

Exclusion Criteria:

1. Asymptomatic patients.
2. Patients unable to provide a saliva sample.
3. Patients unable to give consent.
4. Patients who will not be receiving a nasopharyngeal RT-PCR test.
The Impact Of Tissue Micro-RNA Profile From EUS-FNA In Pancreatic Adenocarcinoma

Pancreatic adenocarcinoma still represents one of the "hot-topics" worldwide. Endoscopic ultrasonography was a breakthrough, bringing us closer to personalized treatment by getting histopathological samples through fine-needle-aspiration or fine-needle-biopsy. These samples can be analyzed and offer the possibility to detect a micro-RNA profile.

Micro-RNAs are small non-coding RNA molecules that interfere in genic expression. Many studies focused on seric microRNA profile, though there are many implications in tissue micro-RNA profile, thus overexpression or under expression of these molecules might help us not only understand different cellular processes, but also interfere in personalized medicine in the future.

The investigators propose a prospective, multicenter, randomized, cohort study on 60 patients with solid pancreatic masses to evaluate tissue microRNA profile obtained by EUS-FNA.

The primary hypothesis is to correlate the microRNA tissular expression in pancreatic adenocarcinoma with tumor aggressive behavior, survival and response to treatment.

The samples will be obtained from the participants during endoscopic ultrasonography, through fine needle aspiration, after consent was given to be a part of the study prior to the intervention. The probe will be preserved in a special recipient that stabilizes RNA and inhibits RNA-lazes, thus preventing RNA degradation by endogenous ribonucleases.

The analysis of miRNA profile will be made using qRT-PCR array method, by miScript II RT Kit, miScript SYBR Green PCR Kit și miScript miRNA PCR Array Human Cancer Pathway Finder (MIHS-102Z) (Qiagen, GmbH). Thus a kit containing a number of 84 miRNAs will be analysed in every participant.


Eligibility Criteria:
Inclusion Criteria:

* Pancreatic solid mass, with or without a cystic component
* Age over 18 years old
* Signed informed consent

Exclusion Criteria:

* Cystic pancreatic mass with no solid component
* Abnormal coagulation (elevated INR \>1.5, thrombocytopenia\<60 000/mm3, activated partial thromboplastin time\>42 seconds), participant on anticoagulant treatment that cannot stop the treatment
* European Cooperative Oncology Group status 4
* Pregnancy
* Age under 18 years old
* The participant does not want to sign the consent form, or is unable to
* Difficult puncture position during endoscopic ultrasonography: vessels or Wirsung duct positioned in front of the needle (decision of the endoscopist)
Acupuncture for the Treatment of Vulvodynia

A randomized controlled pilot study was conducted to evaluate the effect of an acupuncture protocol for the treatment of vulvodynia.

Hypotheses:

1. Acupuncture reduces vulvar pain and dyspareunia in women with vulvodynia.
2. Acupuncture increases sexual function in women with vulvodynia.


Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed with either generalized vulvodynia, localized vestibulodynia, or both
* Provoked vulvodynia
* Unprovoked vulvodynia
* Women between 18 years of age and menopause

Exclusion Criteria:

* Pregnancy
* Menopause
* Interstitial cystitis
* Irritable bowel syndrome
* Untreated vaginitis
* Cervicitis
* Pelvic inflammatory disease
* Diagnosed with other pelvic pathology causing pain
* Concomitantly receiving physical therapy
* Concomitantly receiving biofeedback,
* Concomitantly receiving massage
* Concomitantly receiving additional acupuncture.
Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study

Idiopathic pulmonary fibrosis (IPF) is a chronic disease, leading to poor lung function with a median survival of 2-3 years. Acute exacerbation of idiopathic IPF is a complication associated with a mortality rate \> 50%. So far, the appearance of an acute exacerbation is unpredictable. Worsening of the IPF accompanies with a decrease of the FVC-value, the lung capacity. So far, studies are missing investigating the correlation between a decrease of the FVC-value and emerging acute exacerbations. Therefore, this study uses daily home spirometry to investigate that correlation. With this study the investigators hope to determine acute exacerbations early and treat patients early.

This study is a multi-Center study happening on five different sites, Heidelberg, Gießen, Grosshansdorf, München, and Hannover, all in Germany. Each site recuits ten patients for a total of 50 patients.

All patients will receive a tablet and a spirometer for daily home spirometry. Each patient is supposed to do the home spirometry at the same time every morning. The spirometer and the tablet are connected via Bluetooth and data will be transferred to a webpage after the measurement, that team members have access to the data and can see the progress daily. Alerts will be automatically send to team members, if the FVC-value decreases about 5% or more within three consecutive days or if the patient does not do the measurement on three consecutive days. Study period is one year.

In addition to the home spirometry, patients will conduct a survey to measure health related quality of life (K-BILD). This questionnaire will be conducted at baseline and then every 12 weeks. Every 4 weeks the patients are participating in a phone interview to record changes in medication and condition. At baseline and after 3, 6, 9, and 12 months, patients will conduct a 6 minutes walking test, lung function test, blood will be drawn for biomarker analysis, and sputum, nasal swab, and a urine sample will be collected and analyzed.

Aim is to detect and treat an acute exacerbation early.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the study
* diagnosis of IPF
* Age \> 18 years
* FVC \< 70%
* DLCO-SB \<60%
* Ability to work with a tablet and home spirometer

Exclusion Criteria:

* Patient does not understand the study
* Patient cannot participate in study related processes
* pulmonary infection within the last 4 weeks
* acute exacerbation within the last 4 weeks
* obstructive Ventilation disorders
* other respiratory decline within the last 4 weeks
* relevant malignancy within the last 5 years
Teaching Electronic Fetal Monitoring to Midwifery Students With Peer Teaching Method

706 / 5.000 The aim of the study is to examine the effects of Electronic Fetal Monitoring (EFM) (a test that evaluates fetal health during pregnancy) training given to midwifery students through peer education method on the knowledge, skills and self-efficacy levels of the students. It is being conducted as an experimental study with a randomized controlled pre-test-post-test design. Students were given standard training on EFM. Students in the peer teaching group were given peer education. Students continue to be evaluated while applying EFM to pregnant women in clinical practice. Personal information form, achievement test for EFM, skill form and Electronic Fetal Monitoring Self-Efficacy Scale were used in the evaluation of the students.

The aim of the study was to examine the effects of Electronic Fetal Monitoring (EFM) training given to midwifery students through peer education method on the knowledge, skill and self-efficacy levels of the students. It is being conducted as an experimental study with a randomized controlled pre-test-post-test design.

The Electronic Fetal Monitoring Achievement Test and Electronic Fetal Monitoring Skill Form to be used within the scope of the study were created in line with the literature and presented to the opinions of experts in the field. The necessary arrangements were made in line with the opinions of expert instructors and the final version of the achievement test and skill form was created. The Electronic Fetal Monitoring Self-Efficacy Scale is a valid and reliable scale developed by researchers in Turkey in 2023.

After the measurement tools were completed, standard training on EFM was given to the 2nd year students of the midwifery department within the scope of the Prenatal Period I course. After the standard training, the students were informed about the research. The students included in the study were provided with the Personal information formi achievement test and Electronic Fetal Monitoring Self-Efficacy Scale for EFM as a pre-test. The students included in the study were randomized and assigned to Peer Tutoring and Standard Education groups. Then, peer education was given to the students in the Peer Tutoring group.

After the peer education was completed, all students began to be evaluated while performing EFM on pregnant women in clinical practice. Students are evaluated with a skill form by the researcher while performing EFM on pregnant women. After the application is completed, students complete the EFM achievement test and Electronic Fetal Monitoring Self-Efficacy Scale as a post-test. Evaluation of students continues in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* volunteers to participate in the study,
* those taking the Prenatal Period-I course for the first time,
* those who have not received any EFM training before,
* those who are second year Midwifery students

Exclusion Criteria:

* Students who are absent on the day the EFM topic is taught.
Costs of Lost Productive Time Among Korean Workers With Panic Disorder and Effect of Treatment With Paroxetine Controlled Release

Panic disorder(PD)is a disabling psychiatric condition associated with significant impairment in psychosocial, occupational functioning and quality of life, as mentioned by mogotsi et al. So, most patients with panic disorder suffers from the consequences of the impairment in occupational function. This impairment is not only individual problem, but also social one. Since productivity is very important item required to employees, lost productive time among workers with psychiatric illness should be reduced by the proper management. But few data were reported in this field by now.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female outpatients aged 20-50 years
2. In female, is eligible to enter this study if she is if

   * Non-childbearing potential(note:women who are 6 months post-menopausal are not considered women of child-bearing potential)
   * child-bearing potential, has a negative urine dipstick pregnancy test, and is practicing a clinically acceptable method of contraception such as oral contraception, surgical sterilization, I.U.D.,systemic contraception, or double barrier contraception(any two of diaphragm/spermicidal foar/condom)
3. Subject currently meets the diagnosis for PD according to korean version of Anxiety Disorder Interview Schedule for DSM-IV(ADIS-IV) through a comprehensive psychiatric evaluation and not being treated currently.
4. Subject must have the ability to comprehend the key components of the consent form and provide informed consent.

Exclusion Criteria:

1. Subject who has a history of any other major medical or psychiatric illnesses except PD or PD with major depressive disorder.
2. Subject who retired or left his job or who plan to retire within two years.
3. is a current homicidal or suicidal risk in the investigator's judgement.
4. is currently pregnant, lactating or planning to become pregnant within the next 3 months
5. is currently participating in any other clinical trial or taking any non-approved or experimental medication.
Yoga, Mindfulness and Cognitive Psychotherapy as Treatment for Stress and Burnout

The purpose of this study is to investigate if treatment with yoga or mindfulness has a more profound and longstanding effect on stress and burnout than treatment with cognitive psychotherapy alone.


Eligibility Criteria:
Inclusion Criteria:

* On sick leave at least 50% at the beginning of the study.
* Sick leave for a maximum of 1 year if on full-time sick leave at the beginning of the study or for a maximum of 3 years if on part-time sick leave at the beginning of the study.
* Speak Swedish well enough to participate in the study interventions.
* Body mass index (BMI) of between 18 and 30.
* Meet the diagnostic criteria for burnout syndrome from the Swedish National Board of Health and Welfare.

Exclusion Criteria:

* Medication, including all medication or topical skin preparations with cortisone in any form. Exceptions: Antidepressants, contraceptives, hormone replacement therapy for hypothyroidism if hormone levels were within the normal range, and hormone replacement therapy to treat menopausal symptoms. To receive an exception for medication, a participant had to take the same medication at the same dose at both blood tests.
The Balance Influence of Shoe Inserts on Motor Development Delayed Children

Flatfoot, one of the most common foot problems experienced by preschool-aged children, characterized by the collapse of the foot's medial longitudinal arch. Children with motor developmental delay often have flatfoot, according to clinical observation, and research indicates that preschool age is the main stage of the medial longitudinal arch development period. There flatfoot symptoms due to poor arch shock effect, poor walking endurance, likely to cause gait problems while growing up. The lack of a stable foot structure to support and maintain posture may lead to delayed motor development. Early training intervention and help to balance stability is the main rehabilitation goal for motor developmental delayed children. With understanding of the foot development of motor development delayed children, proper intervention can be provided to improve the movement and stability of the lower limbs. The possible deformation of the foot structure and resultant pain in the future can also be prevented.

The investigators designed a prospective cohort study to long-time follow up of preschool aged children with delayed motor development and to establish standard data, including the foot shape, footprint and balance development. The investigators also discuss the influence of the shoe insert with balance and flatfoot correction. Flatfoot leads to poor gross motor balance and the balance improvement after flatfoot correction has never been studied. The investigators findings should provide direct evidence as a reference for clinical workers.

Eligibility Criteria:
Inclusion Criteria:

* preschool aged children with delayed motor development

Exclusion Criteria:

1. lower limb injury case in six months.
2. other neurological history such as cerebral palsy, traumatic brain injury, spina bifida to cause of developmental delay.
3. have been or are receiving insoles correction or treatment.
4. can not be completed with the instruction by foot measurement and balance measurement.
Applicability of the Ottawa Ankle Rules

The aim of this prospective study was to compare outcomes in patients handled by emergency physician according to OAR versus by an orthopedic resident.

92 consecutive patients with ankle injuries attending our emergency department were divided in two groups. The study group comprised 32 patients who arrived during the morning shift and were examined by an emergency physician according to OAR. Patients discharged without an x-ray were followed in the clinic or by telephone communication. The control group constituted 60 patients who were examined during the evening and night shifts by orthopedic residents unaware of this study.

Objective. Ankle and midfoot injuries are common orthopedic complaints, both in general medicine and orthopedic practice. The percentage of fractures among these injuries is small, however many will undergo x-ray. Ottawa ankle rules (OAR) are clinical guidelines for determining whether to use radiography in such cases. The aim of this prospective study was to compare outcomes in patients handled by emergency physician according to OAR versus by an orthopedic resident. Also, we validated the applicability of OAR in an emergency department in our country.

Methods. 92 consecutive patients with ankle injuries attending our emergency department were divided in two groups. The study group comprised 32 patients who arrived during the morning shift and were examined by an emergency physician according to OAR. Patients discharged without an x-ray were followed in the clinic or by telephone communication. The control group constituted 60 patients who were examined during the evening and night shifts by orthopedic residents unaware of this study.

Eligibility Criteria:
Inclusion Criteria:

* ankle trauma

Exclusion Criteria:

* unwilling to participate
Multitissular Effect of Vertical Mobilization Using the Exoskeleton AtalanteTM in Neurological Chair- or Bed-bound Patients

Background and aim: Sustained bed rest impairs many bodily functions. Verticalization restores gravitational challenge and the use of several organs. The Atalante™ exoskeleton (Wandercraft) is the only self-balanced exoskeleton, which allows walking without canes. We assessed multi-tissular effects of mobile reverticalization using Atalante™ in neurological bed- or wheelchair-bound patients.

Methods: Observational cohort study. Inclusion criteria: bed- or wheelchair-bound for \>2 weeks and \<1 hour per day of stance, due to a central neurological disorder. Sessions with exoskeleton were 3/week, integrated in routine care. Data collected at baseline and after eight weeks (W8) included: cardiovascular (echocardiography, EKG, blood pressure lying and standing), pulmonary (spirometry), bone (densitometry, biochemical markers), bowels (daily stool frequency, Bristol Stool Scale), urinary (urinary flow, postmictional residual volume, urinary symptom profile questionnaire, USP), cognitive (trail making test, TMT-B), anxiety and depression (HAD), and quality of life (SF12).

Results will be presented at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* inpatient in neurorehabilitation
* neuroligical lesion
* chair or bed bound more than 23h/24h and more than 2 weeks
* over 18 years old

Exclusion Criteria:

* spasticity over 3 on MAS
* any porotic fracture
* heel pressure sore
* Height \> 150 cms, \> 190 cms
* Weight \< 30 kgs \> 90 kgs
* recent thoracic or abdominal surgery
* pregnancy
* range of motion aloud to use the exoskeleton
Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients

The primary purpose was to evaluate the efficacy of SKP FlutiForm HFA MDI compared to placebo or fluticasone and formoterol administered concurrently or alone in asthma patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with documented history of mild to moderate asthma currently taking a stable dose of inhaled corticosteroid

Exclusion Criteria:

* Smoking history within the last 12 months
* No history of respiratory tract infection within 4 weeks
* No history or evidence of any clinically significant disease or abnormality