cyrilzakka/clinical-trials huggingface dataset:
Music Therapy and Psycho-behavioral Disorders in the Elderly Population

Since the 1990s, neuroscience, with functional MRI, has made it possible to understand the beneficial neurophysiological effect of music on man and his brain. They have shown that music stimulates brain plasticity and contributes to the reorganization of the affected neural circuits. The concept of cerebral plasticity and cerebral symphony have thus been developed. In March 2008, the HAS (High Authority for Health) proposed in its recommendations good practices concerning the management of neurodegenerative diseases that "Music therapy, aromatherapy, multisensory stimulation ... could improve certain of behavior's aspects ". Music has shown that memory capacity can remain present in people with Alzheimer's disease even in the advanced stages. Music also improves the well-being of patients with Alzheimer's or mixed dementia living in institutions and reduces the suffering of caregivers. It improves communication with others, including those who have lost the usual codes of communication and improves the quality of sleep of elderly people living in institutions.

However, although musical interventions have recently gained popularity as a non-pharmacological treatment for dementia, the scientific evidence warrants further research.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 60 present in the reinforced hospital unit during the study period
* Patients over 60 years hospitalized in follow-up care and rehabilitation with behavioral disorders in the context of a neurocognitive disorder

Exclusion Criteria:

* Unpaired deafness
* Refusal to participate
Nasal Dilator Strips for Rhinoplasty

In this study, the study team will investigate the validity and role of nasal dilator strips (NDS), a novel method to determine the site of nasal valve compromise (NVC), in the pre-operative evaluation. The method involves placing the strip sequentially at the upper and lower lateral cartilage and recording the location of the optimal airway based on patient's subjective symptoms.

Investigators seek to assess surgical outcomes in participants undergoing rhinoplasty based on pre-operative NDS classification. The Nasal Obstruction and Septoplasty Effectiveness (NOSE) instrument will be used to evaluate subjective symptoms of nasal obstruction, before and after the operation and comparing these scores.The results will help determine the effectiveness and predictive value of NDS in isolating the site of NVC.

In this study, the study team will investigate the validity and role of nasal dilator strips (NDS), a novel method to determine the site of nasal valve compromise (NVC), in the pre-operative evaluation. The method involves placing the strip sequentially at the upper and lower lateral cartilage and recording the location of the optimal airway based on patient's subjective symptoms.

Investigators seek to assess surgical outcomes in participants undergoing rhinoplasty based on pre-operative NDS classification. The Nasal Obstruction and Septoplasty Effectiveness (NOSE) instrument will be used to evaluate subjective symptoms of nasal obstruction, before and after the operation and comparing these scores.The results will help determine the effectiveness and predictive value of NDS in isolating the site of NVC.

Additional study aims are to determine the specificity and predictive value of nasal dilator strips in determining the location of obstruction in patients with nasal valve compromise, and to assess the role of nasal dilator strips in supplementing or replacing current approaches for pre-operative evaluation of nasal valve compromise.

The target population for this study is patients at the Emory Aesthetics Center who are undergoing functional rhinoplasty for nasal valve compromise and obstruction.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing functional rhinoplasty for nasal valve compromise and obstruction at the Emory Aesthetics Center

Exclusion Criteria:

* Inability to speak English
* Any disabilities that might prevent patients from completing a survey
Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant Ovarian Cancer

The study is conducted to evaluate the efficacy, safety and tolerability of apatinib (375 mg qd) and etoposide capsule (50 mg/d, d1-14, q3w) in subjects with platinum resistant or refractory ovarian cancer compared with weekly paclitaxel (80 mg/m2, d1, d8, d15, q3w).


Eligibility Criteria:
Inclusion Criteria:

1. 18 Years and older
2. Epithelial ovarian, fallopian tube or primary peritoneal cancer
3. Platinum refractory and resistant disease (disease progression during platinum therapy or within 6 months of platinum therapy)
4. EOCG performance status of 0-1

Exclusion Criteria:

1. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
2. Known hypersensitivity to any of the study drugs or excipients.
3. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
4. Congenital or acquired immune deficiency (e.g. HIV infected)
Immune-Pineal Axis Function in Chronic Tension-Type Headache

The purpose of this study is to determine whether electroacupuncture is effective in the treatment of chronic tension-type headache, measured by Headache Impact Test, Visual Analogue Scale and biomarkers.

Tension-type headache can be defined as a constant sensation of pressure or heaviness, and is a highly-prevalent condition in the health services. The objective of the present study is to investigate the function of the immuno-pineal axis in chronic tension headache, focussed on the neuro-immune regulatory dysfunction. In addition, the effect of neuro-stimulation (electroacupuncture) on the function of this axis will also be studied.

This is a clinical Trial study, randomised, in parallel, cross-over with a blinded assessor, and with a sham placebo control.

The study will be carried out in the Clinical Research Outpatient Clinic of the Hospital de Clínicas de Porto Alegre (HCPA), with women aged between 18 and 60 years old. The participants will respond to questionnaires at the beginning and end of each therapeutic intervention, with 24-hour urine, blood and saliva collection. The therapeutic intervention will include: 10 electroacupuncture sessions and 10 sham placebo sessions. The measurements taken will be: quality of life, depression, impact of headache on daily life, sleep quality, chronotropic types, immuno-inflammatory mediators, levels of 6-sulfatoxymelatonin, and salivary cortisol.

Through these interventions it is hoped that patients will present an improvement in their pain presentation, quality of life and sleep, as well as central autonomic regulation. Evidence for these hypotheses will support a minimally-invasive treatment, with few side-effects and a low cost.

Eligibility Criteria:
Inclusion Criteria:

* Women,
* Aged between 18 and 60 years old,
* Providing informed consent to participate in the study,
* Literate,
* Clinical diagnosis of Chronic Tension-Type Headache according to the International Headache Society.

Exclusion Criteria:

* Psychiatric or neurologic disorder that unable patient to consent and follow study protocol,
* De-compensated systemic disease,
* Chronic inflammatory disease (e.g. Systemic Lupus Erythematous, Rheumatoid Arthritis),
* HIV.
Role of the Nasal Environment in Obesity

The primary aim of this study is to investigate the nasal environment in obese and lean individuals.


Eligibility Criteria:
Inclusion Criteria:

N=50 adult male and female patients with obesity will be included in this study.

Inclusion criteria:

Inclusion criteria:

* Age 18-55 years
* Written informed consent
* BMI \> 30 kg/m2

N=50 adult lean patients age- and sex-matched to the group of obese patients will be included in this study.

Inclusion criteria:

* Age 18-55 years
* Written informed consent
* BMI 18-25 kg/m2

N=50 adult male and female patients with obesity with scheduled bariatric will be included in this study

Inclusion criteria:

* Age 18-55 years
* Written informed consent
* BMI \> 35 kg/m2

Exclusion Criteria:

* Smoking
* Chronic or acute sinusitis
* Surgical intervention of the nasal cavity or the paranasal sinus
* Use of antibiotics within the last 31 days18
* Current illicit drug abuse including daily marijuana or CBD consumption (≤ 24 g of alcohol per day allowed)
* Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease)
* Use of any kind of decongestant more than twice a week
* Use of cortisone-containing nasal spray within the last 3 months
* Acute allergic rhinitis
* History of neurodegenerative diseases
* History of severe head trauma
* Severe renal impairment (e.g. estimated glomerular filtration rate \<30 ml/min/m2)
Effect of Pregabalin on Immediate Post-operative and Longterm Pain

This study aims to evaluate the incidence of longterm pain after spinal fusion surgery in children and adolescents. In the second part of the study a randomized double-blind clinical trial will be conducted. We compare the effect of pregabalin versus placebo on postoperative pain and oxycodone consumption. We will also be able to evaluate the effect of pregabalin on neurophysiological monitoring during surgery.

Adolescent idiopathic scoliosis is the most common indication for major surgery during adolescence. Postoperative pain is a major concern in these adolescents with major surgical trauma. Spinal cord monitoring is an essential part of spinal deformity correction, but the effects of pregabalin on these measurements are not known.

In order to evaluate the incidence of longterm postoperative pain in children after spinal surgery the first part of our study will be retrospective. We will send a symptom and pain questionnaire to all children, who have been in spinal fusion surgery at our university hospital between the years 2009-2015. The questionnaire will include Oswestry Low Back Pain Questionnaire, pain drawing and SRS-24. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain.

In the second part of our study a randomized double-blind clinical trial will be conducted comparing the effect of pregabalin and placebo on postoperative pain and oxycodone consumption. In addition the effect of pregabalin on neurophysiological monitoring in adolescents undergoing surgery for spinal deformities will be assessed. Finally, the prevalence of persistent postsurgical pain will be evaluated at 6, 12 and 24 months after surgery.

To obtain statistical power of 80% and a type I-error level of 0.05, 60 adolescents (30 in control and 30 in active treatment group) will be recruited according to CONSORT guidelines.

The aim of the study is to evaluate the effect of pregabalin given twice preoperatively and for five days postoperatively on postoperative pain. Pain will be measured using visual analogue scale (VAS). Oxycodone administered using patient controlled anesthesia (PCA) will be used for analgesia. Persistent pain at 6, 12 and 24 months will also be evaluated. In addition, the effect of preoperative pregabalin on motor evoked potentials (latency, amplitude, currency needed to evoke potentials) during spinal cord monitoring as well as perioperative EEG findings and on the consumption of anesthetics.

Eligibility Criteria:
Inclusion Criteria:

1. Adolescent (10-21 years) undergoing spinal fusion for idiopathic scoliosis, spondylolisthesis or Scheuermann kyphosis.
2. Posterior spinal fusion
3. No contraindication for Pregabalin use
4. ASA I-III
5. Written informed consent

Exclusion Criteria:

1. Other spinal pathology or other associated medical condition
2. Major neurologic developmental delay
3. Need for anterior surgery or for vertebral column resection.
4. Preoperative opioid use
5. Inability to use PCA
The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors

The rate of adequate bowel preparation is one of important quality indicators of colonoscopy. Inadequate bowel preparation negatively affects the outcomes of colonoscopy. If patients with inadequate bowel preparation were identified before the procedure, enhanced strategy could be offered to achieve better bowel cleaning. Currently, there were three predicting models of inadequate bowel preparation established based on patient-related factors. So far, none of predictive models have been tested in other than their validation cohort populations, and no study has attempted to apply a different regimen to patients presenting with risk factors for inadequate colon cleanliness. In previous studies, we established a prediction model based on procedure-related factors, which has better accuracy and can better predict the quality of bowel preparation.

The aim of this study is to compare the quality of bowel preparation by using a predictive model based on procedure-related factors versus the criterion group in unsedation patients


Eligibility Criteria:
Inclusion Criteria:

* Age: 18\~75 years
* Patients undergoing morning colonoscopy

Exclusion Criteria:

* colon resection;
* suspected bowel obstruction;
* moderate or severe complications related to drinking the 1st or 2rd dose of PEG
* hemodynamically unstable;
* lactating or pregnant women;
* no need to reach the ileocecal segment
* unwilling to provided informed content.
Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.

The purpose of the study is to demonstrate consistent results in 3 production lots of Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a single injection, with respect to immunogenicity, safety and reactogenicity. Tritanrix™-HepB/Hiberix™ given alone and Wyeth Lederle's meningococcal C conjugate vaccine (Meningitec™), given concomitantly with Tritanrix™-HepB/Hiberix™ will be used as benchmark vaccines for all antigens except for MenA. The immunogenicity of MenA will also be evaluated.

Randomized study with five groups to receive one of the following vaccination regimens after a birth dose of hepatitis B vaccine: One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HBV (3 different groups) GSK Biologicals' Tritanrix™-HBV/Hiberix™ GSK Biologicals' Tritanrix™-HBV/Hiberix™ +Meningitec™

Eligibility Criteria:
Inclusion criteria:

• Healthy infants 56-83 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks and received a birth dose of hepatitis B vaccine within the first 72 hours of life.

Exclusion criteria:

* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history \& physical examination.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV).
* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration (\>14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
* Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.
Evaluating Pegfilgrastim and a Multi-Day Topotecan Regimen in Subjects With Relapsed or Refractory Ovarian Cancer

This trial will provide data on the safety and efficacy of pegfilgrastim, in terms of duration of grade 4 neutropenia, when administered on the last day or the day after a multi-day, myelosuppressive chemotherapy regimen for ovarian cancer.


Eligibility Criteria:
Inclusion Criteria: - Subjects with histologically confirmed primary peritoneal carcinoma, epithelial ovarian cancer, or tubal carcinoma relapsed after or refractory to 1 or 2 prior regimens of therapy - Measurable or evaluable disease - GOG Performance Status of 0 to 2 - Subjects must be at least 2 weeks from major surgery and recovered from all associated toxicities or sequelae - At least 2 weeks from radiation therapy and recovered from all associated toxicities - Adequate hemopoietic function evidenced by: \*ANC greater than 1.5 x 10\^9/L, \*platelets greater than 100 x 10\^9/L and \*hemoglobin greater than or equal to 10 g/dL - AST and ALT less than 1.5 x ULN; total serum bilirubin less than or equal to 2.0 mg/dL; serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than or equal to 60 mL/min Exclusion Criteria: - Epithelial ovarian tumors of low malignant potential - Prior therapy with topotecan - Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of chemotherapy - Prior malignancy within the last 5 years, with the exception of surgically cured basal/squamous skin cell carcinoma, and/or carcinoma of the cervix in-situ - History of impaired cardiac status (e.g., severe heart disease, cardiomyopathy, or congestive heart failure) - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukemia - Subject is pregnant (e.g., positive HCG test) or breast feeding - Subject is of child-bearing potential and does not agree to using adequate contraceptive precautions - Any psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with study protocol procedures - Other investigational procedures are excluded. Subject is currently enrolled in, or has not yet completed at least 30 days since ending another investigational device or drug trial(s) or is receiving other investigational agent(s)
Mortality Follow-Up and Analyses of Men in the MRFIT

To extend mortality followup through 25 years for two cohorts of men in the Multiple Risk Factor intervention Trial (MRFIT): the 361,662 men screened and the 12,866 men randomized, and to pursue the general aim of elucidating unresolved research issues on the epidemiology, natural history, etiology, prevention, and control of major chronic diseases, particularly cardiovascular and neoplastic diseases and diabetes.

BACKGROUND:

MRFIT was initiated in 1972 as a randomized, multicenter primary prevention trial designed to determine whether a special intervention consisting of smoking cessation, cholesterol reduction and control of high blood pressure, would result in a significant reduction in coronary heart disease (CHD) mortality, compared to usual care. Follow-up and analysis has continued on the 361,662 men screened and the 12,866 men randomized.

DESIGN NARRATIVE:

The National Death Index (NDI) will be used for continued follow-up of the MRFIT cohorts. An additional assay to establish IGF-1 and IGF binding protein will be added to the data set as a potential prognostic factor. The effort will focus on three primary aims related to long-term mortality. Aim 1 will relate nutritional-dietary data to twenty-five year mortality from coronary heart disease (CHD), stroke, cardiovascular disease (CVD), colon cancer, prostate cancer, and all causes for the 12,866 men randomized. Aim 2 will relate age, ethnicity, socioeconomic position, geographic location, major risk factors, low risk status, prior diabetes, and prior myocardial infarction to twenty-five year mortality for the 361,662 men screened. Aim 3 will relate insulin-like growth factor 1 (IGF-1), IGF binding protein, and fasting and one-hour glucose measurements from frozen baseline sera to mortality for the 12,866 men randomized.

Eligibility Criteria:
No eligibility criteria
An Alternative Dose Interval Study in Participants With Hidradenitis Suppurativa Receiving Brodalumab

Phase 0 Study of an alternative dosing interval of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa to identify biomarkers of disease activity and clinical response.

Phase 0, Open Label study of an alternative dosing interval of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa. Consisting of n=10 patients receiving 210mg subcutaneously every week for 24 weeks. Patients will be followed for a period of 36 weeks (12 weeks after last dose of Brodalumab) to assess for safety.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed Diagnosis of Hidradenitis Suppurativa by the PI
* Age 18 or older
* Moderate to Severe Hidradenitis Suppurativa as determined by the PI
* Previously enrolled in JFR-0989

Exclusion Criteria:

* Inflammatory Bowel Disease
* HIV Positive
* Active Hepatitis B or C Infection
* Pregnant or Breastfeeding
* no concurrent use of any systemic antibiotics/retinoids/imunosuppressants (require washout period of \>5 half lives)
* Any medical, psychological or social condition that, in the opinion of the investigator, would jeopardize the health or well being go the participant during any study procedures or the integrity of the data
* High Suicide Risk as determined by the Columbia Suicide Severity Rating Scale
Neo-RT: A Study Investigating Whether Changing the Sequence of Treatments (Starting Radiotherapy Followed by Hormone Therapy Before Surgery) is Feasible

Four in 10 women diagnosed with breast cancer undergo mastectomy with or without breast reconstruction and less than half are satisfied with how they look unclothed. Breast conservation (removing the area with the lump only) can offer less extensive surgery and improved breast appearance, which can therefore increase well-being.

Intensity-modulated radiotherapy (IMRT) closely shapes the radiation beam to the cancer and is currently given after breast surgery. A new combination of IMRT followed by hormone treatment given before surgery, may increase the possibility of breast conservation.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to participate
* Female
* Aged 18 years and older
* ECOG performance status 0-2
* Histology confirmed invasive breast cancer
* ER positive (Allred score 6-8)
* HER2 negative
* Palpable size ≥20mm
* Grade I-II (or grade III if considered not suitable for neo-adjuvant chemotherapy)
* Considered that radiotherapy will make breast conserving surgery easier
* No evidence of non-breast malignancy if treated with curative intent unless the patient has been disease free ≥5 years
* Unifocal or multifocal disease, i.e. tumour in the same quadrant and breast conserving surgery still feasible

Exclusion Criteria:

* Contraindications to breast radiotherapy or neo-adjuvant endocrine therapy
* Bilateral breast cancer
* Metastatic cancer
* Multicentric disease
* Concomitant medical/psychiatric problems preventing completion of study treatment or follow-up
* Pregnancy
* Breast feeding