cyrilzakka/clinical-trials huggingface dataset:
Yoga Therapy in Treating Patients With Malignant Brain Tumors

This clinical trial studies yoga therapy in treating patients with malignant brain tumors. Yoga therapy may improve the quality of life of patients with brain tumors

PRIMARY OBJECTIVES:

I. To estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors.

SECONDARY OBJECTIVES:

I. To obtain estimates of the variability of self-reported fatigue, distress (i.e., depression, anxiety), sleep disturbance, cognitive function, and health-related quality of life from baseline to the end of the intervention at 6 (post-onsite intervention) and 12 weeks (post-full intervention).

II. To obtain preliminary estimates of the efficacy of a yoga intervention in patients with malignant brain tumors on the outcomes of fatigue, distress, and cognitive function.

III. To standardize the cancer-specific yoga protocol for use with brain tumor patients.

OUTLINE:

Patients participate in yoga classes comprising postures, deep relaxation, breathing practices, and meditation twice weekly for 75 minutes during weeks 1-6. Patients then practice yoga at home twice weekly for 45 minutes during weeks 7-12.

After completion of study treatment, patients are followed up periodically for 4-5 months.

Eligibility Criteria:
Inclusion Criteria:

Signed protocol specific informed consent Are diagnosed with a Malignant Brain Tumor (Grades II-IV) Able to start the on-site yoga intervention within 1 week of first radiation treatment Are physically able to attend the intervention classes (Eastern Cooperative Oncology Group \[ECOG\] performance status rating 0-2) Able to understand written and spoken English Have no medical contraindications reported by the attending physician

Exclusion Criteria:

Have practiced yoga on a regular basis (at least once a week) within the past 4 weeks to recruit participants who are not already regularly practicing yoga; given that the benefits of yoga are likely more immediate than long-term, however, we will enroll participants who have previously had a yoga practice
Early-Phase Schizophrenia: Practice-based Research to Improve Outcomes

The goal if the project is to develop a learning health network devoted to the treatment of first episode psychosis.

The RAISE ETP study, designed and conducted by our group, signaled that a Coordinated Specialty Care (CSC) model could be feasibly delivered in community mental health clinics in multiple states and was effective. Since then, with the support of SAMSHA block grants to states, there are CSC programs across the nation.

The goal of this project is to develop a learning health system with sites providing CSC treatment of first-episode psychosis (FEP). Sites are drawn from five states: Connecticut, Florida, Michigan, Oklahoma and South Carolina. They vary in populations served, levels of funding available and research experience. All are committed to advancing the development of CSC using a health learning system model, to implementing a practical assessment strategy to enhance outcome assessment and to conducting research to improve outcomes that will be meaningful to the full range of stakeholders.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in CSC program

Exclusion Criteria:

* none
Phase Out in Tinnitus Patients

Phase shift treatment is a new tinnitus therapy that aims at sound cancelling via complete or partial residual inhibition. This technique is based on the theory by Choy advocating that the induction of a sound wave with a 180 degree phase shift compared to the sound experienced by the patient could result in sound cancelling, likely by negation of the cortical perception of tinnitus.

The aim is to determine the efficacy of the Phase Out treatment in pure tone and narrow band noise tinnitus patients.


Eligibility Criteria:
Inclusion Criteria:

* consult ENT department UZA with tinnitus
* pure tone tinnitus or narrow band noise tinnitus
* unilateral tinnitus, or bilateral tinnitus if both ears pure tone or both ears narrow band noise
* frequency tinnitus \> 1kHz
* cochlear origin tinnitus
* tinnitus duration 3 months or longer
* age 18y or more
* patient being able to cooperate
* patiënt able to fill in VAS
* normal MRI pontine angle

Exclusion Criteria:

* depression: BDI \> 21
* pulsatile tinnitus
* pregnancy
* epilepsy
24-hour Urinary Aldosterone And Endocrine System In Obesity

The study was aimed at investigating the relationship between hormone parameters and urinary aldosterone levels in 24h within a cohort of overweight and obesity.

Subjects were enrolled at the first examination whether they were not taking any medication, including oral contraceptives or drugs for osteoporosis, and free of significant medical illnesses, except obesity. Exclusion criteria were history of endocrinological diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), chronic inflammatory diseases, stable known hypertension, angina pectoris, stroke, transient ischemic attack, heart infarction, congenital heart disease, malignancies, chronic inflammatory diseases, renal and liver failure, angina pectoris, myocardial infarction, heart failure, congenital heart diseases, minor and major stroke, and inherited thrombocytopenias and other major malignancies. Subjects were examined by means of the medical history, hormonal, metabolic and routine hematochemical parameters. The investigators provided for a clinical baseline evaluation that included extemporaneous ambulatory blood pressure (BP) and a physical assessment of body weight, Body Mass Index (BMI) and Waist Circumference (WC) as anthropometric parameters.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obesity (BMI\> 25 Kg/m2)

Exclusion Criteria:

* Any kind of drug
* Hypertension
* Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
* Chronic inflammatory diseases
* Renal failure
* Liver failure
* Angina pectoris
* Myocardial infarction and heart failure
* Genetic heart diseases
* Thrombocytopenias
Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and Risperidone

The primary purpose of this study is to determine whether a combination of ACP-103 (the study medication) with either haloperidol or risperidone will show antipsychotic efficacy and that it is safe and well tolerated. Further purposes of this study are to determine whether ACP-103, in combination with either haloperidol or risperidone, will enhance their antipsychotic effectiveness, demonstrate effectiveness against the negative symptoms, improve motoric tolerability, and is safe and well tolerated.

This is a seven-week study (one week screening and six weeks of study medication) where a total of 400 patients who meet entrance criteria will randomly be assigned to receive one of five groups of study treatments of either low dose haloperidol plus ACP-103, low dose haloperidol plus placebo (a substance similar to a sugar pill), low dose risperidone plus ACP-103, low dose risperidone plus placebo, or high dose risperidone plus placebo. The study will begin with with a three to seven day drug-free period followed by six weeks of a stable daily dosage of study medication. Study subjects will be treated as hospital in-patients during screening and for the first 14 days of the study. Study subjects will be closely monitored throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* male or female subjects ages 18-65 diagnosed with schizophrenia
* experiencing an acute exacerbation of psychosis
* has had prior response to antipsychotic therapy within the previous 3 years
* female subjects must be of non-childbearing potential or must comply with double-barrier protection methods against conception
* ability of subject or caregiver or legally authorized representative to provide informed consent
* subjects must be hospitalized at screening and must be willing to remain in the hospital at least 14 days after baseline and must comply with all study events through completion of the study

Exclusion Criteria:

* inability of the subject or caregiver or legally authorized representative to provide consent
* any female subject who is pregnant or breast feeding
* any subject with concurrent mental illness or disability
* any subject considered to be a danger to themselves or others
* recent use of certain antipsychotics or other medications that might interfere with this study's medication
* abnormal clinical laboratory values
* presence, or recent history, of serious medical conditions or drug abuse
* likely allergy or sensitivity to ACP-103, haloperidol, or risperidone, based on known allergies to drugs of the same class
* any subject who has participated in a prior clinical trial of ACP-103
* any subject judged by the Principal Investigator to be inappropriate for the study
Does Intravitreal Injection of Triamcinolone Acetonide Impairs the Adrenal Function

The use of intravitreal corticosteroids in the management ocular inflammatory diseases has recently gained widespread acceptance. The purpose of this study is to determine if the use of intravitreal triamcinolone is associated with suppression of endogenous cortisol production, as generally admitted for patients treated with oral or parenteral corticosteroid therapy.

The normalcy of hypothalamic- pituitary- adrenal axis (HPA axis) of enrolled subjects will will be assessed before intravitreal injection of 4mg of triamcinolone and again after one day, one week and two weeks. Patients with abnormal HPA axis will be re-tested after four weeks and later until the HPA axis function return to normal. The HPA axis will be assessed with low dose (1mcg) intravenous corticotropin(ACTH) stimulation test, in which cortisol levels will be sampled before , 30 minutes and 60 minutes after 1mcg ACTH IV injection.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving intravitreous injection of triamcinolone 4mg

Exclusion Criteria:

* patients receiving steroids in any form, except by intravitreous administration
Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology

This study will assesses the efficacy of buprenorphine/naloxone vs buprenorphine on maternal withdrawal symptoms and drug cravings.

This is a randomized controlled trial to a cohort of pregnant women seeking medication-assisted treatment for opioid use disorders. Half of participants will receive buprenorphine, while the other half of participants receive a combination of buprenorphine/naloxone

Buprenorphine and Buprenorphine/naloxone each are used to treat opioid use disorders in pregnancy.

Buprenorphine has many preferential characteristics over methadone including decreased risk of maternal overdose, lower incidence of preterm labor, less frequent clinical visits, shorter duration of neonatal hospital stay and treatment for neonatal abstinence syndrome. Recent studies have found that increasing the dosing frequencies of buprenorphine is more efficacious to prevent maternal withdrawal symptoms, improve compliance, and theoretically produce better pregnancy outcomes.

Buprenorphine/naloxone, a combination opioid of buprenorphine and naloxone, has also been investigated as an alternative to treatment and maintenance for opioid use disorder. The advantage of the combination of buprenorphine with naloxone is that it reduces the potential for abuse. As a partial mu opioid agonist, buprenorphine alone has the capacity to induce typical opioid effects such as euphoria, which are enhanced when the drug is taken intravenously. By combining buprenorphine with naloxone, an opioid antagonist, the capacity for buprenorphine to be abused is reduced.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* With a confirmed viable intrauterine pregnancy
* Opioid Use Disorder
* Care in a Stony Brook Medicine OBGYN clinical office sites
* Medication-assisted treatment through Stony Brook Medicine OBGYN office sites

Exclusion Criteria:

* Known or suspected allergy to buprenorphine or buprenorphine/naloxone
* Carrying a fetus with known aneuploidy or anomaly
A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3

To determine the effectiveness of oral paromomycin sulfate for 21 days compared to placebo in the treatment of cryptosporidiosis in patients with HIV infection. To evaluate the safety of oral paromomycin at two different doses. To explore whether paromomycin administered over a longer period provides additional benefit.

In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy.

In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy.

Patients are randomized to receive either placebo or paromomycin for 3 weeks. After the initial double-blind phase, all patients receive open-label paromomycin for 3 weeks. Following 6 weeks of therapy, patients who do not achieve a complete response receive a higher dose of paromomycin for an additional 3 weeks, while complete responders continue receiving the original dose for an additional 3 weeks. Complete or partial responders after 9 weeks may receive 16 additional weeks of optional maintenance therapy at the dose at which their response was achieved. Treatment continues for up to 25 weeks total. Patients are followed at weeks 1, 3, 4, 6, 7, and 9, and then at 2-4 week intervals.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretroviral therapy.
* Macrolides for disseminated Mycobacterium avium.
* Atovaquone for toxoplasmosis.
* Other antimicrobials for concurrent infections.
* Lomotil, Imodium, or deodorized opium tincture in a standardized regimen for diarrhea.

Patients must have:

* Advanced HIV disease.
* Diarrhea presumptively caused by Cryptosporidia.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Hypersensitivity to aminoglycosides.
* Inability to swallow capsules.
* Active infection due to other enteric pathogens. Previous diagnosis of CMV or MAC infection permitted if patient is currently stabilized on a therapeutic regimen (clarithromycin up to 500 mg bid or azithromycin up to 600 mg daily).
* Other known causes for diarrhea (e.g., malabsorption syndrome, gastrointestinal Kaposi's sarcoma).

Concurrent Medication:

Excluded during the first 9 weeks of study:

* Agents with putative anticryptosporidial activity (such as spiramycin, diclazuril, letrazuril, or bovine colostrum).
* Octreotide acetate (Sandostatin).
* Antidiarrheals other than those specifically allowed.
* Clarithromycin if initiated at 500 mg or higher or azithromycin if initiated at 600 mg or higher.

Prior Medication:

Excluded:

* Paromomycin at \> 1 g/day for \>= 14 days prior to study entry.

Excluded within 14 days prior to study entry:

* Agents with putative anticryptosporidial activity (such as spiramycin, diclazuril, letrazuril, or bovine colostrum), with the exception of macrolides that are permitted for other indications.
* Octreotide acetate (Sandostatin).
Cisplatin With Alimta or Gemcitabine in Long Infusion for Mesothelioma

This is a randomised Phase II clinical trial to assess and compare efficacy and safety profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine in long infusion.

Combination of pemetrexed and cisplatin is now considered the standard systemic treatment for mesothelioma. Three arguments against such a position are: 1. Pemetrexed in combination with cisplatin was registered for mesothelioma on the basis of superiority over cisplatin alone, a clearly suboptimal control arm; 2. Several Phase II trials of gemcitabine in standard doses or as low-dose in long infusion in combination with cisplatin have shown at least comparable activity; 3. Due to high cost, pemetrexed is not available to many patients in countries with limited health care resources. During the past five years, our research team in Ljubljana conducted a Phase II trial of low-dose gemcitabine (250 mg/m2) in 6-hours infusion and cisplatin for patients with mesothelioma. In an unselected population of patients including those in poor performance status, elderly, patients with advanced extrathoracic disease and patients in progression after previous chemotherapy, the response rate was 54%, and median survival was 16.5 months. On the basis of this favourable experience and in search of cost-effective treatment for mesothelioma, we here propose a randomised Phase II clinical trial to compare efficacy and safety profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine in long infusion. The primary endpoints are response rate and time to progression; secondary endpoints are survival, toxicity and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven mesothelioma. While local histopathology exam is sufficient to register a patient for the trial, all biopsies will be subject to central review (please see Section 5.3.)
* no history of other malignancy; or in complete remission for \> 3 years if previously treated for other malignancy;
* chemo-naive;
* performance status ≥ 70% (Karnofsky); or ECOG 0 - 2 ;
* no peripheral neuropathy grade 2 or more (common toxicity criteria - CTC, NCI), unless mechanical in origin;
* no vascular disease grade 2 or more (NCI CTC ver.3);
* hemoglobin \> 100 g/L;
* neutrophils \> 2.0 g/L;
* platelets \> 100 x 109 /L;
* kidney function: creatinine within normal limits + ECC \> 60 mL/min; or ECC \> 100 mL/min;
* liver function: bilirubin \< 1.25 x UNL; AST/ALT \< 2 x UNL;
* cardiac compensation;
* no active infection or other serious concomitant disease;
* women are not pregnant
* patient's understanding of the disease and treatment and written informed consent.

Exclusion Criteria:

• significant medical co-morbidity
Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF

The objective of this interventional study is to evaluate the safety and functional performance of the Nephronyx System in patients with ADHF, presenting clinical signs of volume overload and compromised response to diuretics.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to the hospital with a primary diagnosis of ADHF
* Patient has signs of volume overload as evidence by a score of ≥ 4 on the EVEREST score
* Patient with Left Ventricular Ejection Fraction LVEF \>15%
* Patient has compromised response to diuretics
* NT-proBNP \>450 pg/mL if aged \<55 years, \>900 pg/mL if aged between 55 and 75 years and \>1800 pg/mL if aged \>75 years

Exclusion Criteria:

* Patient with active DVT or history of DVT
* Patient has documented or evidence of Renal artery stenosis
* BMI\>35 Kg/m\^2
* Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization
* Patient is in Cardiogenic shock
* Patient has blood dyscrasia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy
* Temperature \> 38°C, or sepsis, or active systemic infection requiring IV anti-microbial treatment
* Patient has shown liver cirrhosis or has signs of liver damage
ProspEctive Cohort Study on Multidisciplinary Approach to Femur FRactures' manAgement in Over 65 Population

Hip fractures are an increasing public health concern as the population continues to age. The increased morbidity and mortality in the 12-month period after hip fracture is largely related to decreased mobility. However, very few studies have analyzed the radiographic factors associated with gait impairment after intertrochanteric hip fractures. This study evaluates gait and mobility after surgical fixation of IT fractures in elderly population with Gait Analysis in combination with clinical and radiographic information.

Hip fractures are an increasing public health concern as the population continues to age. The increased morbidity and mortality in the 12-month period after hip fracture is largely related to decreased mobility. However, very few studies have analyzed the radiographic factors associated with gait impairment after InterTrochanteric (IT) hip fractures. Improving gait and mobility after surgical fixation of IT fractures is one important target of research efforts.

All the patients with IT hip fractures (AO/OTA 31) treated between October 2017 and April 2018 were enrolled. Inclusion criteria consisted of age older than 65 years, previous walking ability, no neurological disease and no other musculoskeletal disorders. The study was approved by the institutional review board of the Local Ethical Committee (reference number 5559). All patients provided written informed consent for participation in the study.

All patients were treated with intramedullary nailing (IMN) or hemiarthroplasty (HA) according to the current international guidelines and to their clinical history.

Radiographs were analyzed at the time of surgery and at each follow-up visit. Clinical outcomes were assessed according to the Harris Hip Score (HHS) and Western Ontario and Mc Master University (WOMAC).

At 6- and 12-months follow-up appointments, gait parameters were measured and recorded in our Gait Analysis Laboratory (BTS Bioengineering SpA, Italy) located in AOUC Policlinico di Bari (Rehabilitation Unit). All participants performed several walking trials at their natural speed. All patients were fitted with full-body external reflective markers placed according to Davis' procedures. A static video trial was recorded with subjects positioned in a neutral standing posture to create a reference for defining neutral joint angles.

In addition, at 12-months follow-up, dual energy X-ray absorptiometry (DXA) has been acquired in order to collect T-score data.

Statistical analyses were performed using IBM SPSS version 23. A p value of \<0.05 was considered to be statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* age older than 65 years
* previous walking ability
* surgical procedure (intramedullary nailing or hemiarthroplasty)

Exclusion Criteria:

* neurological diseases
* musculoskeletal disorders
* cardiovascular diseases
Clinical Study of Titrating PEEP of Different Methods on Right Heart Function

To observe the influence of different methods titrating PEEP on right heart function and pulmonary artery pressure in ARDS patients .

30 patients who diagnosed as ARDS were included in this study.Then set PEEP with respectively ARDS net 、EIT and Esophageal Pressure in Breathing Machine . Recorded diameter of right and left ventricular TAM TAPSE pulmonary artery pressure.Objective to evaluate the correlation between the level of PEEP in three methods and the right heart function and pulmonary artery pressure in ARDS patients .

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to ICU diagnosed of modecate to severe ARDS (Berlin criteria)
* Patients age between 18 years old and 80 years

Exclusion Criteria:

* Patients with chronic respiratory diseases such as COPD.
* Ventilated because of oesophageal surgery in the previous 12months.
* Patients who cannot obtain clear ultrasound images due to thoracic surgery ,massive pleural effusion.
* Oesophageal bleeding in previous 30 days history of oesophageal varices.
* Facial trauma and surgery.