cyrilzakka/clinical-trials huggingface dataset:
Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic Amyloidosis

RATIONALE: Drugs such as melphalan, thalidomide, and dexamethasone may be effective in treating patients with primary systemic amyloidosis.

PURPOSE: This phase II trial is studying how well giving melphalan together with thalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.

OBJECTIVES:

Primary

* Determine the 2-year and overall progression-free survival of patients with newly diagnosed, previously untreated primary systemic (AL) amyloidosis treated with risk-adapted melphalan followed by thalidomide and dexamethasone.

Secondary

* Determine plasma cell disease response in these patients at 3, 12, and 24 months after treatment with this regimen.
* Determine amyloid-related disease response in these patients at 12 and 24 months after treatment with this regimen.
* Determine the prognostic significance of immunoglobulin light-chain variable-region germline gene expression by AL plasma cell clones in patients treated with this regimen.
* Determine whether there is molecular minimal residual disease at 12 and 24 months in patients achieving a complete hematologic response after treatment with this regimen.

OUTLINE: Patients are stratified according to the extent of amyloid-related disease (low-risk vs high-risk).

* High-risk disease: Patients receive 2 courses of low-dose melphalan IV, dexamethasone, and filgrastim (G-CSF). After 3 months, patients receive thalidomide and dexamethasone if plasma cell disease persists.
* Low-risk disease: Patients receive 1 course of high-dose melphalan IV and G-CSF. Patients then receive thalidomide and dexamethasone as in high-risk disease regimen.

Patients are followed at 3, 12, and 24 months.

PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of primary systemic (AL) amyloidosis within the past 12 months

  * High- or low-risk disease, determined by the extent of systemic organ involvement with disease and patient age

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* SWOG 0-3

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Cardiovascular

* No New York Heart Association class III or IV congestive heart failure
* No restrictive cardiomyopathy requiring oxygen
* No myocardial infarction within the past 6 months
* No symptomatic cardiac arrhythmia within the past 60 days

Other

* No other active malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy for AL amyloidosis

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* No other prior or concurrent therapy for AL amyloidosis
Examining Stress Salivary Biomarkers in Pediatric Patients Undergoing Dental Procedures

Pediatric patients are susceptible to show signs of fear. One of the scenarios that have always been a source of fear is undergoing a dental procedure. Fear of undergoing dental procedure has been addressed as "dental fear", which can lead to avoidance of receiving dental care and may result to a decline in proper oral hygiene.

Fear stimulates multiple cerebral responses and can be often related to an increased stress level. Stress level fluctuations during dental procedures can be examined by blood and salivary biomarkers. Given accessibility and minimal invasiveness, the collection of saliva samples constitutes an easy and cost-effective diagnostic method to investigate a variety of oral and systemic conditions. Cortisol and alpha amylase are present within the saliva and their levels are supposedly influenced by stress. In contrast, salivary IgA is not known to be influenced by stress level and can be used in comparison as a non-stress salivary biomarker.

Fear of dental appointments is a well-known cause of stress and activation of the sympathetic nervous system in adolescents undergoing dental procedure. However, the examination of stress and stress-related factors in young individuals attending their first dental appointment compared to young individuals who present for an orthodontic application is largely understudies.

Therefore, the aims of the study are: 1) to measure stress salivary biomarkers in pediatric patients before undergoing dental and/or orthodontic procedures; 2) assess whether subjective stress to dental treatment (as measured by dental anxiety, stress, and dental fear) is associated with objective stress measurements (as measured by collection of stress salivary biomarkers).


Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 7 and 17
* Ability to read and speak English language
* Patients seen for a first visit at the pediatric or orthodontic departments of the dental institute of the Multispecialty Clinic at Midwestern University with a scheduled future appointment to start treatment in the pediatric or orthodontic department

Exclusion Criteria:

* Older than 17 years of age or younger than 7 years of age
* Unable to read and speak English language
* Have any major health conditions or history of mental illness
* Being a returning patient in the pediatric or orthodontic department of the dental institute of the Multispecialty Clinic at Midwestern University
* Taking any systemic medications that would cause a change in salivary flow (e.g., oxybutynin, protein pump inhibitors)
Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

This study investigates the effect of a combined therapy with gastrectomy and HIPEC in localized advanced gastric cancer.

An operation and the constant further development of the surgical techniques can not always prevent the recurrence of a tumor of the stomach or the transition from the esophagus to the stomach. As reason for this recurrence, the investigators assume that the tumor was already present at the time of the surgery and has crossed the boundaries of the stomach or free tumor cells are located in the peritoneal cavity, even if they can't be found with the bare eye or imaging methods. Such free tumor cells have the possibility of developing metastases within the abdominal cavity.

An innovative local treatment method is being tested in Tübingen and applied to remove any remaining free tumor cells or very small and invisible residual tumors. These free tumor cells can be determined prior to the start of treatment by peritoneal endoscopy (diagnostic laparoscopy). If these can be identified by lavage of the abdominal cavity there is an increased risk for the development of peritoneal metastases. Therefore, in patients with detected free tumor cells in the lavage water of the abdominal cavity, after the removal of the stomach, should be used once a chemotherapy in the abdominal cavity, which is warmer than the body (intraoperative hyperthermic chemotherapy, HIPEC). In this study the investigators want to demonstrate, that the single administration of intraoperative HIPEC with cisplatin and doxorubicin in addition to routine surgery delays the onset of peritoneal metastases and the additional therapy with its low risks is reasonable.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of the patient
* Positive lavage cytology in staging laparoscopy
* Intraoperative R0- or R1-gastrectomy (Re-evaluation intraoperative)
* Histologically confirmed locally advanced, resectable Adenocarcinomas of the stomach (incl. AEG II-III): \>cT3 and/or cN+ and cM0 (none existing solid Peritoneal metastases, Re-evaluation intraoperative)
* Neoadjuvant chemotherapy ≥ 2 cycles

Exclusion Criteria:

* \< 18 years
* Existence of contraindications or contraindications against the study medication
* Uncompensated Heart Failure (NYHA III and IV)
* Severe CHD, medically insufficient treatable cardiac arrhythmias, uncontrolled arterial hypertension
* Serum creatinine ≥ 1.5 x the standard value or a Creatinine clearance \< 60 ml/min/1.73 m2
* Severe pulmonary dysfunction (COPD, PAH), Pulmonary function test confirmed (IVC \< 55 %, DLCO \< 40%)
* malignant secondary tumor disease that persists for \< 5 years (Exception: in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin)
* Participation in other interventional studies that at the time of the ProPeC study inclusion, still are not finished
* pregnancy or lactation
Study on the Frequency of de Novo Atrial Fibrillation in Septic Shock in Medical Intensive Care

The aim of this pilot study is to determine, as exhaustively as possible thanks to the continuous and precise recording of heart rhythm, the frequency of de novo atrial fibrillation in septic shock, which is currently unknown, and to identify specific factors that could be associated with the condition. These will be investigated more precisely in a future study. This constitutes the first step in a reflection on the management of Cardiac Arrhythmia by Atrial fibrillation (ACFA) in septic shock in Medical Intensive Care, known as a major prognostic factor for morbimortality, but for which management is uncertain in the absence of reference data.


Eligibility Criteria:
Inclusion Criteria:

* All patients in septic shock (defined as hypotension that is not reversed by fluid resuscitation and requires the use of vasopressor agents) hospitalized in Medical intensive care
* Patients with national health insurance cover
* Age: at least 18 years with no upper limit

Exclusion Criteria:

* Transferred from another intensive care unit for septic shock
* Adults under guardianship
* History of atrial fibrillation
Zoledronic Acid in Cystic Fibrosis

Null hypotheses: zoledronic acid does not improve bone density in cystic fibrosis.

Low bone mineral density (osteoporosis) is prevalent in adults with cystic fibrosis (CF); they have an increased rate of bone fractures in comparison to the general population. CF patients start to lose bone density in adolescence/early adulthood due to an imbalance in bone breakdown and formation. Predicted survival for patients with CF has increased from 16 years in 1970 to 36.5 years in 2009 which has resulted in an increase in comorbidities associated with increased longevity in CF e.g. decreased bone density. Oral and intravenous bisphophosphonates are known to increase bone density in CF; the current licensed oral preparations require daily or weekly dosing which are difficult to maintain. Zoledronate, which is licensed for use, is administered intravenously once a year which should be easier to administer. The current evidence relates to its use in other disease groups e.g. glucocorticoid induced osteoporosis and oncology. The purpose of this study is to ascertain its efficacy in cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis
* Aged at least 18 years
* Bone mineral density score of -1.5 or less at lumbar spine or total hip
* Able to give informed consent

Exclusion Criteria:

* Previous solid organ transplant
* on solid organ transplant waiting list
* Long trem oral glucocorticosteroids
* CRP \>20mg on day of randomisation
* Hypocalcaemia
* Poor dental hygiene
Safety and Efficacy of RRG001 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

A Phase I/IIa, Dose-escalation and Dose-expansion Study to Evaluate the Safety and Efficacy of Single Subretinal Injection of RRG001 in Subjects With Neovascular Age-related Macular Degeneration

This study adopts a multicenter, single-arm, open-label phase I/IIa seamless study design and comprises two stages, i.e., phase I 3+3 dose escalation study and a phase IIa dose expansion study. Four dose groups are preset for the phase I dose escalation study; 3-6 subjects will be enrolled for each dose group, and it is planned to enroll 12-24 subjects. The phase IIa dose expansion study will be conducted successively at the doses after safety assessments of dose 2 and/or dose 3 in phase I are completed. Twelve subjects are expected to be enrolled for each dose group, with a total of 24 subjects will be enrolled overall. The sponsor will assess whether or not to adjust the dose(s) and sample size for the exploration study based on the results in the phase I exploration study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects that are willing and able to follow study procedures.
* Patinets ≥50 years old.
* Clinically diagnosed with CNV secondary to nAMD.
* BCVA of the study eye is ≥5 letters and ≤73 letters(Snellen 20/800\~20/40), as well as that of the other eye ≥19 letters(Snellen 20/400).
* Responding to anti-VEGF

Exclusion Criteria:

* Presence of any other eye diseases other than nAMD in study eye that would affect the treatment or confusing the interpretation of the study results , as judged by the investigator.
* CNV or macular edema in the study eye secondary to any causes other than AMD.
* Uncontrolled glaucoma.
* Uncontrolled hypertension despite medication.
* Pregnant or lactating women or individuals with reproductive potential who are unwilling to take effective contraception during the study period.
Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fasted Healthy Volunteers

This study aimed to evaluate the pharmacokinetic characteristics of montelukast sodium oral thin films and the bioequivalence between oral thin films and chewable tablets in healthy chinese volunteers under fasted condition.


Eligibility Criteria:
Inclusion Criteria:

* Fully understood and voluntarily signed the informed consent form
* With high compliance
* BMI 18.6-28.5 kg/m\^2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female

Exclusion Criteria:

* Allergic to any component of study drugs, other leukotriene receptor antagonists, sulfonamides, or non-steroidal anti-inflammatory drugs
* With clinically relevantly abnormal vital sign, examination, or clinically relevant disease
* Had drug abuse within 3 months before screening or positive in drug of abuse test
* With any routine use of drugs
* Received major surgery within 6 months before study drug administration or planned to receive major surgery during study period
* With average number of cigarettes smoked \> 5/day within 3 months before screening or refused to suspend smoking from 24 hours before study drug administration throughout study period
* With average alcohol consumption \> 14 units/week within 6 months before screening or refused to suspend alcohol consumption from 24 hours before study drug administration throughout study period
* With average tea, coffee, or other drink with caffeine consumption \> 8\*250 mL/day, or refused to suspend tea, coffee, other drink with caffeine, or grape fruit juice consumption from 24 hours before study drug administration throughout study period
* Lost or donated blood \> 200 mL within 3 months, or donated platelet \> 24 U within 1 months before study drug administration
* Received any drug within 14 days before study drug administration
* Received any drug of other clinical trial within 3 months before study drug administration
* Received any vaccine within 4 weeks before study drug administration
* Planned for pregnancy within 3 months after informed consent form signed or refused to use adequate contraception (excluding contraceptive drug)
* For female, pregnant, breastfeeding, received oral contraceptives within 30 days, or contraceptive injection or implant within 6 months before study drug administration
* For pregnancy-capable female, had unprotected sexual contact within 14 days before study drug administration
SIBS-Intervention for Siblings and Parents of Children With Chronic Illness

SIBS-RCT is a randomized controlled trial comparing the effect of a 5-session group intervention for siblings and parents of children with chronic illness to 12-week waitlist. Participants randomized to waitlist will receive the intervention after waitlist. The main outcome is sibling mental health, and secondary outcomes include family communication, sibling disorder knowledge, quality of life, and adaption. Outcomes will be examined at pre-, post, 3-, 6- and 12- month follow-up.

Siblings' wellbeing is at risk when one's brother or sister has a neurodevelopmental disorder. Neurodevelopmental disorders are enduring somatic and/or mental conditions affecting the central nervous system, such as autism, intellectual disability, and cerebral palsy. The mechanisms behind the wellbeing risk for siblings are linked to siblings' lack of disorder knowledge, poor parental mental health due to extra care responsibilities, and impaired family communication. No evidence-based interventions to improve sibling wellbeing exist. To address this gap, we propose examining a group intervention for siblings and parents of children with neurodevelopmental disorders in a randomized controlled trial (SIBS-RCT). SIBS-RCT compares a 5-session manual-based sibling-parent group intervention delivered over two weeks, to 3-month "treatment as usual" waitlist. The planned sample is 288 siblings and 288 parents. Recruitment and intervention will take place in specialist and municipal health services. Inclusion criteria are being the sibling (aged 8-16 years) of a child (aged 0-18 years) who is diagnosed with neurodevelopmental disorder and who receives specialist or municipal health services. Participants will be randomized in blocks of 6 to intervention or waitlist. The primary outcome is sibling mental health. Secondary outcomes include quality of life, disorder knowledge, and family communication. Predictor measures include biological stress levels, parent mental health, disorder impairment, and group leader adherence to the SIBS-manual. Measures will be electronically rated by siblings, parents, and teachers at pre-intervention, post-intervention, and 3, 6, and 12 months follow-up. Main effects of the intervention will be measured as the mean mental health change difference between intervention and waitlist from pre-intervention to 3-month follow-up. We will also apply growth curve models to examine trajectories of outcomes from pre-intervention to 12-month follow-up. Expected outcomes include improved sibling wellbeing, improved health services for siblings and families of children with neurodevelopmental disorders, and better integration between municipal and specialist services.

Eligibility Criteria:
Inclusion Criteria:

1. Being the sibling of a child diagnosed with chronic illness who is aged 0 to 18 years and receives specialist and/or municipal health services.
2. One parent able to attend the intervention.

Exclusion Criteria:

1. Being enrolled as primary patients in specialist health services;
2. Chronic illness diagnosis.
Comprehensive Voice Rehabilitation Program Compared With Vocal Function Exercises

The purpose of this study is to evaluate the effectiveness and safety of the Comprehensive Voice Rehabilitation Program compared with Vocal Function Exercises in behavioral dysphonia.

Introduction: Voice therapy is the best indication for the most voice disorders, with a strong degree of recommendation based on systematic reviews and randomized clinical trials, with a predominance of benefit over risk. Some speech therapy techniques are specific, others are organized principles or with eclectic approaches, that use a combination of strategies. So far, few studies have tested the effectiveness of treatment for dysphonia due to time spent, safety and improved quality of life more comprehensive as they are made in clinical. Objective: To evaluate the effectiveness and safety of the Comprehensive Voice Rehabilitation Program compared with Vocal Function Exercises in behavioral dysphonia. Methods: 106 professional of voice with dysphonia behavior, between 18 and 50 years old and vocal complaints for more than six months. These professionals have been evaluated by an otolaryngologist, randomized to participate of Vocal Function Exercises arm or Comprehensive Voice Rehabilitation Program arm. Both arms were follow for six sessions with speech therapists and reassessed when finish the period and after one month. The primary outcomes assessed are: reduction of VHI score, improved voice quality in the CAPE-V and improves the larynx condition. Conclusions: The Comprehensive Voice Program has an eclectic approach and follows the philosophy of what is practiced in clinics in Brazil. We believe this program can demonstrate the power of voice therapy effectiveness more organized to solve problems, with shorter duration of treatment, benefit patient health and funding agencies such as Unified Public Health System (SUS) and health insurance.

Eligibility Criteria:
Inclusion Criteria:

* voice professionals with behavioral dysphonia, with or without larynx lesions, with otorhinolaryngologist's indication;
* over 6 months with vocal complain;
* 3 or more signs and symptoms in the questionary.

Exclusion Criteria:

* Other kind of vocal disorder, speech or language disorder, malignant lesions, hormonal disturbances related by the patient, laryngeal papilloma, etc.
* Singers;
* neurological problems;
* acute larynx problem.