cyrilzakka/clinical-trials huggingface dataset:
Home Non-Invasive Ventilation Targeting Expiratory Flow Limitation in Severe Hypercapnic COPD.

In this 2-phase pilot study, the BiPAP A40 EFL will be evaluated in patients with severe COPD requiring home non-invasive ventilatory support with respect to patient-related and physiologic outcomes.

Objective phase 1: in patients with COPD already established on home NIV, to assess the effect of 2 months of the A40EFL on ventilator parameters, physiologic and patient-related outcomes (PRO), in comparison to the patients' usual settings as prescribed by their treating physician.

The two primary outcomes will be the nightly duration of NIV use and NIV-related symptoms (S3-NIV questionnaire). Patient preference will be a secondary outcome.

Objective phase 2 : In hypercapnic patients with COPD with a prior hypercapnic exacerbation requiring NIV in hospital, to obtain preliminary data regarding the impact of home NIV using the A40EFL on COPD exacerbations and physiologic and patient-related outcomes.

The primary outcome will be the number of hospitalizations over 12 months on A40EFL.

Secondary outcomes will include descriptive data on number of exacerbations not requiring hospitalization but treated with antibiotics or prednisone.

Additional secondary outcomes, physiologic and PRO, for both phases 1 \& 2, will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Phase 1:

severe COPD with FEV1\<50%, using home NIV successfully for at least 2 months through the Quebec National Program for Home Ventilatory Assistance (NPHVA).

* Phase 2:

severe COPD with FEV1\<50%; pCO2\>= 52 on arterial or capillary blood gas measured 2-4 weeks after acute NIV use and discontinuation

Exclusion Criteria:

* Phase 1

COPD exacerbation requiring treatment (including hospitalization) within the last 6 weeks; surgical procedure or major illness within the last 3 months; kyphoscoliosis, neuromuscular disease, other lung disease (e.g. fibrosis); active cancer; expected survival \< 2 months; listed on the transplant list.

* Phase 2:

any additional condition potentially predisposing to hypercapnia such as: obesity (BMI\> 30kg/m2), kyphoscoliosis, neuromuscular disease, other lung disease (e.g. fibrosis), severe obstructive sleep apnea (AHI\>30/h on prior testing if available, but will not test as part of the study); active cancer; expected survival \< 2 months; listed on the transplant list at start of study.
Desmopressin in Cardiac Surgery

Patients undergoing cardiac surgery could develop excessive perioperative bleeding requiring transfusions of blood products.

Desmopressin (DDAVP), already used for patients with von Willebrand syndrome, could reduce bleeding and transfusion requirements in these patients when administered ev (0.3 mg/kg) in 20-30 minutes postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* undergoing cardiac surgery
* excessive bleeding

Exclusion Criteria:

* age\<18 y
* not signing written consent
Sanfu Herbal Patch and Sanfu Moxibustion for Persistent Allergic Rhinitis: a Controlled Clinical Trial

To observe the efficacy of Sanfu herbal patch and Sanfu moxibustion on persistent allergic rhinitis,and comparing the differences between the combination of these 2 methods with each method alone.


Eligibility Criteria:
Inclusion criteria

Patients recruited to this study must meet the following inclusion criteria:

1. Males or females aged between 5 and 60 years.
2. Each PAR patient must be diagnosed by an otolaryngologist using the following diagnostic criteria: major symptoms of paroxysm rhinocnesmus, continuous sneezing, nasal obstruction, and significant quantities of clear and thin nasal mucus, accompanied by symptoms of hyposmia and itching of the eyes and throat. These symptoms should last for or add up to 1 hour a day. The attacks should occur for more than 4 weeks and at last for at least 4 days each week.
3. One of 2 laboratory results is positive: skin prick test or serum high circulating levels of allergen-specific IgE antibody detected by a specific blood test for allergy called a radioallergosorbent (RAST) test
4. The course of the disease is more than 1 year.
5. Voluntary signing of an informed consent form.
6. No current participation in any other clinical trials. Exclusion criteria

Patients with any of the following conditions will be excluded:

1. Allergies to the herbal medicines, a moxa smoke or adhesive tape applied in this study, and the skin at the specific acupoint has physical scars or breakage.
2. Patients with other allergic diseases, such as allergic asthma.
3. Patients who received acupuncture and moxibustion treatment, Chinese herbal medicine, nasal inhalation of herbal medicine, physical therapy or other external treatment for AR within the last 4 weeks
4. Patients who received immune therapy or systematic hormonotherapy in the past 1 year.
5. Pregnant women, lactating women, or women preparing for pregnancy in 2 years.
6. Patients with serious medical disorders such as congenital heart disease, severe nephropathy, mental diseases, and infectious diseases including tuberculosis, hepatitis, and AIDS.
Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer

This is a randomized, controlled trial on frail elderly patients (aged 65+) with colorectal cancer. The patients will be randomized into two groups. The control group will receive standard surgical treatment. The intervention group will in addition go through a preoperative comprehensive geriatric assessment. The assessment will include evaluation of co-morbidity and medication, social status, nutritional status, cognition, depression and physical performance. This assessment will form basis of an individualized perioperative intervention.

The main aim of the study is to see if the number of postoperative complications in this group can be reduced by a perioperative geriatric intervention. A study of inflammation markers in serum will also be performed, with focus on identifying potential biological frailty markers.


Eligibility Criteria:
Inclusion Criteria:

* Age 65+
* Elective surgery for colorectal cancer
* Frail

Exclusion Criteria:

* Acute surgery
* Not able to consent
* Does not consent with registration
Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD

Parenteral nutrition-associated cholestasis (PNAC) and liver disease (PNALD) are associated with significant morbidity and mortality in neonates and is felt to be exacerbated by soybean-based lipid emulsions. Much research is currently being directed at identifying ways to reduce this risk. Reduction of the dose of soybean-based lipid given as a component of parenteral nutrition is one possible strategy. In this study we will compare standard dosing of soybean-based lipid (up to 3/kg/day) with a minimized dose (1 g/kg/day) and evaluate for the development of cholestasis and adequate growth between the two groups. Longterm followup will include an assessment of neurodevelopmental outcomes at 12 and 24 months of age.

Funding source - FDA OOPD


Eligibility Criteria:
Inclusion Criteria:

* neonates and infants who are at least 28 weeks corrected gestational age at the time of enrollment who are parenteral nutrition (PN) naive
* current direct bilirubin \<2 mg/dL
* any of the following conditions:
* meconium ileus and peritonitis
* gastroschisis
* omphalocele \>4cm or with liver herniated outside of the abdominal cavity
* necrotizing enterocolitis requiring surgical intervention
* volvulus
* intestinal atresia with \>50% bowel loss

Exclusion Criteria:

* weight \<1 kg
* metabolic pathway defect which is associated with liver dysfunction in the neonatal period, including: hereditary fructose intolerance, galactosemia due to transferase deficiency and neonatal tyrosinemia, and/or disorder of lipid metabolism
* hepatic insufficiency as documented by either a biopsy with cirrhosis and/or marked aberration in synthetic function
* renal failure
* primary or secondary liver disease, regardless of liver function (includes hepatitis)
* use of extracorporeal membrane oxygenation (ECMO)
* suspected congenital obstruction of the hepatobiliary tree
* documented active infection which may be communicable, including infections hepatitis or HIV
* previous receipt of choleretic agents
* currently receiving phenobarbital or other barbiturates
* history of PNAC
* direct bilirubin \>=2 mg/dL at time of enrollment
* congenital or acquired anomaly which will require major cardiovascular surgery
* major congenital or chromosomal anomaly
* hypoxic ischemic encephalopathy
* congenital defect of the brain
* major seizure disorder
Photodynamic Therapy and Periodontal Therapy. A Clinical, Microbiological and Immunoenzymatic Analysis

Residual pockets and furcation defects are challenging sites that require additional periodontal therapy. The aim of this study is evaluate 1)the effect of a single photodynamic therapy (PDT) as monotherapy residual pockets in single rooted teeth and 2) the effect of PDT in association with scaling and root planing (SRP) in class II furcation lesions with probing pocket depth (PPD) \>5mm and bleeding on probing (BoP). A blind randomized controlled clinical trial was conducted in subjects presenting at least three residual pockets in single root teeth and subjects with at least one molar presenting class II furcation defect. To evaluate the effect of a single PDT as monotherapy in residual pockets, the selected sites were assigned to receive: PDT alone, photosensitizer alone or SRP alone. To evaluate the effect of PDT in association with SRP in class II furcation lesions, the selected sites were assigned to PDT+SRP or SRP alone. Clinical, microbiological and immunoenzymatic analyses were assessed at baseline, 3 and 6 months post-therapies.

Residual pockets and class II furcation lesions are challenging sites that require additional periodontal therapy. The aims of this study were to evaluate:

1) the effect of a single PDT as monotherapy residual pockets in single rooted teeth and 2) the effect of PDT in association with SRP in class II furcation lesions.

A blind randomized controlled clinical trial was conducted in subjects presenting at least three residual pockets in single root teeth and subjects with at least one molar presenting class II furcation involvement.

To evaluate the effect of a single PDT as monotherapy in residual pockets, the selected sites were assigned to receive one of following therapies: PDT alone, photosensitizer alone or SRP alone.

To evaluate the effect of PDT in association with SRP in class II furcation lesions, the selected sites were assigned to receive PDT+SRP or SRP alone. Microbiological, immunoenzymatic analyses and clinical parameters: probing pocket depth (PPD), position of the gingival margin (PGM), relative clinical attachment level (RCAL), full mouth plaque (FMPS) and bleeding score (FMBS), will be assessed at baseline,3 and 6 months post-therapies.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic periodontitis (according to the criteria of the 1999 international classification)
* at least three contralateral single rooted teeth with residual PPD \> 5mm with bleeding on probing (BoP) in supportive periodontal therapy or with at least one molar presenting class II furcation defect.

Exclusion Criteria:

* pregnancy
* lactation
* current smoking and smoking within the past 10 years
* antibiotic therapies in the previous 6 months
* use of mouth rinses containing antimicrobials in the preceding 2 months
* systemic conditions that could affect the progression of periodontitis
* orthodontic appliances
* use of long-term administration of anti-inflammatory and immunosuppressive medications
Comparison of Different Frames of Numerical Information in Cochrane Plain Language Summaries

Participants will be randomly given one of two formats containing descriptions of health interventions. In one format, participants will have to read short summaries where results of the intervention are presented as frequencies and the side effects of health intervention are presented as percentages, while in another format the frames will be reversed (results will be presented as percentages and side effects as frequencies). After reading, participants will be asked several questions about the content of the summary and its conclusions.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are visiting their family doctor, and are at least 18 old. Students of biomedical studies at University of Split School of Medicine, who are at least 18 years old.

Exclusion Criteria:

* Participants younger than 18 years.
A Clinic-based Prevention Program for Families of Depressed Mothers

This study will assess the effectiveness of the "Keeping Families Strong" program (KFS) in avoiding or delaying the onset of psychiatric disorders among children with depressed mothers.

Children of depressed mothers are at high risk for developing serious psychiatric disorders. While genetics can account for about 34% of cases of childhood psychiatric disorders, children of depressed parents are at an even greater risk of developing mental disorders. The "Keeping Families Strong" program, or KFS, was built from evidence-based prevention programs. Its goal is to provide educational, cognitive, and behavioral interventions. These interventions are meant to enhance understanding about depression and its effects on families, improve communication within families, enhance social support, increase positive and consistent parenting, and improve child coping. This will likely improve the children's mental health, as well as positively affect the short- and long-term outcomes of parents recovering from a depressive episode. This study will evaluate the effectiveness of the KFS program in avoiding or delaying the onset of psychiatric disorders among children with depressed mothers.

This 10-week, open-label program will involve 12 meetings, lasting 2 hours each. The parents and the children will attend separate meetings each week on the same nights. Children are prone to take on their parents' responsibilities to prevent them from becoming depressed. In order to avoid this, the children's meetings will focus on clarifying role responsibilities. There will be two additional follow-up meetings in the 3 months following completion of the program. All caregivers are encouraged to participate, including depressed fathers.

Eligibility Criteria:
Inclusion Criteria:

* Parent in treatment for depression
* Parent in maintenance phase of treatment

Exclusion Criteria:

* Active substance abuse
* Substantial cognitive impairment
* Psychosis
Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)

Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in both the chronic kidney disease (CKD; pre-dialysis) and end stage renal disease (ESRD; on hemodialysis) populations, and several lines of evidence point to their contribution in the development of atherosclerosis. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and death in these two populations. The uremic state is characterized by retention of oxidized solutes including reactive aldehyde groups and oxidized thiol groups. It has recently been demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the atherosclerotic uremic metabolic state. In this study we hypothesize that administration of antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress in patients with Stage III and IV CKD.


Eligibility Criteria:
Inclusion criteria:

1. Patients with Stage III-IV chronic kidney disease measured by MDRD formula.
2. age \> 18 or \< 75 years.
3. Life expectancy greater than one year.
4. Ability to understand and provide informed consent for participation in the study

Exclusion criteria:

1. AIDS (HIV seropositivity is not an exclusion criteria)
2. Active hepatitis C or B
3. Active gout
4. Other active inflammatory diseases.
5. Active malignancy excluding basal or squamous cell carcinoma of the skin.
6. Gastrointestinal dysfunction requiring parental nutrition.
7. History of functional kidney transplant \< 6 months prior to study entry.
8. Anticipated live donor kidney transplant over study duration.
9. Prisoners, patients will significant mental illness, pregnant women, and other vulnerable populations.
10. Patients taking Vitamin E supplements \> 60 IU/day, vitamin C\> 500mg/day over the past 30days.
11. Patients taking anti-inflammatory medication except aspirin \< 325mg/day over the past 30 days.
12. Patient taking any prednisone therapy.
13. More than two hospitalizations within the last 90 days or one hospitalization within the last 30 days.
14. On experimental drug protocols.
15. Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin.
16. Hypersensitivity to vitamin E or alpha lipoic acid.
17. Pregnant women
Titan Spine Endoskeleton TT/TO Study

This is a prospective, multi-center controlled observational clinical study. All subjects will receive Titan Endoskeleton TT/TO acid etched titanium implant for the planned procedure. Each site will have a predetermined bonegraft extender to be used in all enrolled subjects at that site.


Eligibility Criteria:
Inclusion Criteria:

1. Be 18-75 years of age, and skeletally mature
2. Have clinical and radiological evidence of degenerative disc disease at one or two levels of the lumbar spine between L2-S1. May also have spondylosis, spinal stenosis, or spondylolisthesis at these levels.
3. In the opinion of the treating surgeon, must already be a qualified candidate for lumbar fusion surgery including 6 months of conservative care prior to surgical intervention.
4. Psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up schedule.
5. Subject must understand and sign the written Informed Consent.

Exclusion Criteria:

1. Previous history of fusion surgery at the index level(s).
2. Clinical, laboratory and/or radiological evidence of back pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.)
3. Osteoporosis defined as a DEXA bone density measurement T score ≤ 2.5 (Necessity for DEXA scan will be determined by investigator's standard of care)
4. Any terminal or autoimmune disease including but not limited to HIV infection, rheumatoid arthritis or lupus.
5. Any other concurrent medical disease that might impair normal healing process.
6. Morbid obesity (BMI ≥ 40 kg/m2).
7. Investigational drug or device use within 30 days.
8. Currently a prisoner.
9. Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.

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Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection

This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without Ribavirin (RBV).


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C virus (HCV) infection
* Non-cirrhotic subjects
* Screening laboratory results showing HCV Genotype 1a (HCV GT1a) infection
* HCV treatment-naïve or if treated previously, only with interferon (IFN) or pegylated interferon (pegINF) with or without ribavirin (RBV)

Exclusion Criteria:

* Pregnant or breastfeeding women
* Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
* HCV genotype of any subtype other than GT1a or unable to subtype
* Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN or RBV. Subjects with previous participation in trials of investigational direct-acting antiviral agents (DAAs) may be enrolled if they can produce documentation that they received only placebo.
* Current enrollment in another interventional clinical study or receipt of any investigational product within 6 weeks prior to study drug administration.
Efficacy of Repetitive Transcranial Magnetic Stimulation in Adult Attention Deficit Disorder

The purpose of the current open-lable study was to use low-frequency repetitive transcranial magnetic stimulation (rTMS) to improve the attention deficits in a sample of adult patients suffering from attention deficit disorder. Participants received 10 sessions of rTMS over Fz (located using the EEG 10-20 international system) and underwent assessments of their attentional capacity using the gradCPT task in an fMRI scanner, before and after the intervention. Other behavioral assessments of their attention symptoms have also been conducted.


Eligibility Criteria:
Inclusion Criteria:

* Normal intelligence level (\>90)
* Diagnosis of ADD by a psychiatrist using the ADHD-RS-IV with Adult Prompts

Exclusion Criteria:

* Scores of 21 or more on BDI and/or BAI
* History of head trauma
* History of a major psychological or neurological condition
* Presence of metal in the head
* History of seizures
* Serious cardiovascular disease
* Use of medications with an impact on cognitive functions during the treatment window (patients with a constant and stable dose were included)
* Recent use of alcohol or substance abuse
Intervention for Pre-Frailty and Frailty in Thoracic Surgery Patients

Frailty has been associated with poor acute and long-term outcomes after major surgery. We recently determined that nearly 70% of patients undergoing major thoracic surgery are pre-frail or frail. We are interested in assessing whether a strength training intervention for frail or pre-frail patients has an impact on surgical decision making and on surgical outcomes.


Eligibility Criteria:
Inclusion Criteria: • Age ≥60 years, • Qualified to consent for participation in a research study, •Thoracic disease that may require major surgery (major anatomic lung resection, esophagectomy, repair of giant paraesophageal hernia, chest wall resection, extended pleurectomy/decortication, thymectomy or major surgery for other mediastinal process),• No obvious contraindications to surgery (end-stage heart disease, end-stage lung disease, severe dementia, other specific comorbidity that would prevent surgery), • Ability to participate in physical therapy and an independent exercise program for frailty mitigation, •No need for induction chemotherapy or radiation therapy, • Recent evaluation including computed tomography of the chest or chest/abdomen.

Exclusion Criteria:• Age \<60 years, •Unable to provide informed consent, • No indication for major thoracic surgery, •Obvious contraindication to major thoracic surgery (end-stage heart disease, end-stage lung disease, severe dementia, other specific comorbidity that would preclude surgery),• Inability to participate in physical therapy and/or an independent home exercise for frailty mitigation, •Need for induction chemotherapy or radiation therapy