cyrilzakka/clinical-trials huggingface dataset:
Enhanced Care Coordination for Head and Neck Cancer Survivors

The purpose of this study is to evaluate the effect of a multidimensional symptom management intervention on decreasing symptom burden and thus reducing hospital utilization in patients undergoing radiation with or without chemotherapy for head and neck cancer.

The purpose of this study is to evaluate the effect of a multidimensional symptom assessment intervention on identifying symptoms and alerting care team of changes, and thus reducing hospital utilization, in patients undergoing radiation with or without chemotherapy for head and neck cancer. This is a pilot study.

This project is being conducted to 1) examine the symptomatology of head and neck cancer patients undergoing treatment that includes radiation, 2) determine the hospital admission rates of this patient population before, during and post treatment, 3) compare the admission rates of this patient population to historical controls and 4) to examine overall patient compliance.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Diagnosed with primary, head and neck cancer of the paranasal sinuses, nasal cavity, oral cavity, tongue, salivary glands, larynx, and pharynx (including the nasopharynx, oropharynx, and hypopharynx)
* Will include squamous cell carcinoma found in lymph nodes as a result of unknown primary location.
* Prior to the initiation of radiation treatment for qualifying diagnosis
* Treatment occurring at Hillman Cancer Center

Exclusion Criteria:

* Prior radiation treatment of squamous cell carcinoma of the locations listed in inclusion criteria.
Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study.

Study to allow access to everolimus for patients who are on everolimus treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator

This multi-center, open-label roll-over study aimed to better characterize the long-term safety of everolimus in subjects currently being treated in a Novartis-sponsored studies and who were receiving clinical benefit on the current study treatment as judged by the Investigator.

The study was designed to provide continued treatment with everolimus monotherapy to the subjects. Subjects were allowed to continue combination therapy with Sandostatin LAR® Depot if they were receiving this combination therapy on the parent protocol. Subjects were allowed to continue in this roll-over study until they no longer benefitted from the everolimus treatment as judged by the Investigator, discontinued due to toxicities, subject withdrew consent or lost to follow-up, disease progression, protocol non-compliance, or subject death, whichever occurred first. A subject was considered to have reached end of study when everolimus treatment was permanently discontinued.

As per the original protocol, it was designed to collect only serious adverse events (SAEs) and protocol defined adverse events of special interest (AESIs). However, due to the feedback received from health authorities, the protocol was amended in 2016 (3 years after study was initiated) to collect all AEs (non-serious and serious AEs, and AESIs). The protocol was also amended to include an Investigator assessment of clinical benefit at every visit for remaining subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subject enrolled in a Novartis-sponsored, CD\&MA study receiving everolimus or everolimus plus Sandostatin LAR Depot and fulfilled all their requirements in the parent study
* Subject benefiting from treatment with everolimus, as determined by the guidelines of the parent protocol.

Exclusion Criteria:

* Subject was permanently discontinued from everolimus study treatment in the parent study.
* Subject was receiving everolimus in combination with an unapproved or experimental treatment

Other protocol-defined inclusion/exclusion criteria might apply
Lidocaine 5% Patch Supplementation to Intra-articular Bupivacaine Dexmedetomidine After Arthroscopic Knee Surgery

Surgery of the knee is a very common procedure which can be very painful and sufficient postoperative pain treatment is often problematic. The aim of this work was to study the effects of supplementation of intra-articular bupivacaine dexmedetomidine with lidocaine 5% patch after arthroscopic knee surgery under general anesthesia and its role in improving quality of anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* ASA I \& II
* Aged between 18 to 60 years
* Weight between 60 to 100 kg
* Scheduled for elective arthroscopic knee surgery

Exclusion Criteria:

* patient refusal.
* history of cardiac disease.
* impaired renal or hepatic function.
* hypertension treated with α methyldopa, clonidine, or beta-adrenergic blockers.
* if they have used opioid analgesics within the previous 24 hr.
* previous sensitivity to local anesthetics.
Intermittent Fasting in Refractory Epilepsy

This is an open trial of intermittent fasting in a group of patients with refractory seizures. Patients will continue on the diet for 6 months to assess the impact of the diet on seizure frequency.

A proportion of people with epilepsy continue to have seizures despite all conventional treatment options. The classical ketogenic diet and its variants have been shown to help some of these people. However, these diets require significant medical and dietician supervision,and is frequently not well tolerated. There is a need to develop other diet therapy that is easier to administer and more acceptable to the patient. This trial undertaken in adult overweight UCLH outpatients examines the effect of an intermittent fasting diet on seizures. Subjects may consume their normal diet for 5 days a week. On 2 days in a week, they consume only 25% of their daily calorie requirement. Subjects will continue on the diet for 6 months. Intermittent fasting has been shown in animal studies to activate a number of signalling pathways which are thought to reduce seizure thresholds. Has intermittent fasting in humans might be expected to reduce seizures.

Eligibility Criteria:
Inclusion Criteria:

* Experiencing at least 2 seizures per month
* .BMI of 25 or over

Exclusion Criteria:

* Current/previous eating disorder
* Pregnancy
Using EEG to Predict Depression Treatment Response to rTMS in Patients With Major Depression

Repetitive Transcranial Magnetic Stimulation (rTMS) is a promising, novel, non-invasive therapy for depression. The study is looking at changes in specific electroencephalogram parameters in depressed patients treated with rTMS can serve as predictors of depression treatment response among cancer patents undergoing rTMS treatment of depression.

The study will be a prospective, single arm trial in which a set of patients who will be treated for major depression using Repetitive Transcranial Magnetic Stimulation (according to FDA approved rTMS standard care practices) also will undergo EEG recording before Repetitive Transcranial Magnetic Stimulation treatment begins, and at the completion of treatment. The Hamilton Depression Rating Scale will be given to participants by the neuropsychiatrist at baseline and weekly intervals till the completion of treatment.

The neuropsychiatrist investigators expect to see about 12 patients per year who meet treatment criteria for Repetitive Transcranial Magnetic Stimulation. Therefore, it is expected to recruit 24 subjects into the research study over a two-year period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cancer
* Comorbid diagnosis of major depressive disorder
* Age ≥ 18 years
* Baseline Hamilton Depression Rating Scale (HDRS) score ≥ 18
* Failed one or more adequate antidepressant trials (including selective serotonin reuptake inhibitors or SSRIs, selective norepinephrine reuptake inhibitors or SNRIs, tricyclic antidepressants or TCAs). A failed treatment response may be due to lack of antidepressant efficacy or intolerable side effects.

Exclusion Criteria:

* History of seizure or epilepsy
* History of concussion
* History of bipolar disorder
* Comorbid psychotic disorder
* Primary brain tumor or metastasis to brain
* Active comorbid substance use disorder
* History or current diagnosis of dementia
* Current pregnancy
* Unable to attend regular treatment sessions
* Any other condition in which a physician investigator feels may subject the participant to undue risk
Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants

Randomized double-blind clinical trial to compare the incidence of microbiological proven late onset sepsis in extremely preterm infants (\<1000 grams) that are supplemented with donor milk pasteurized by High Temperature Short Time (HTST) method versus the Holder method.

Donor milk pasteurized by an innovative High Temperature Short Time (HTST) system (patented by researchers) retains more immune and trophic compounds than pasteurized milk by traditional Holder method. These compounds are related to the protection conferred by breast milk against nosocomial sepsis and necrotizing enterocolitis in preterm infants, so it would be of interest to study if there is a clinical benefit in these patients when health professionals are supplementing with donor milk pasteurized by both methods.

The purpose of this study is to compare the incidence of microbiological proven late onset sepsis in newborns under 1000 grams that in the first 28 days of life need to be supplemented with donor milk pasteurized by HTST method versus the Holder method.

This is a randomized double-blind clinical trial with parallel assignment. A total of 305 premature babies with a birth weight of less than 1000 grams will be recruited, admitted to the Neonatology Services of the Hospital 12 de Octubre and the Hospital de La Paz and meet the inclusion criteria. Half of the patients will be supplemented exclusively with donor milk pasteurized by the HTST system and the other half with pasteurized milk by the Holder method. Linear generalized models will be used for longitudinal data analysis.

Eligibility Criteria:
Inclusion Criteria (all criteria are necessary) :

* Infants weighing 1000 grams or less at birth
* Infants born or transferred before the third day of life to the participating centers
* Start enteral feeding in the first week of life
* Receive any amount of donor milk in the first 28 days of life
* Informed consent signed by parents or legal guardians

Exclusion Criteria:

* Language barrier
* Infants with chromosomopathies
* Infants with major congenital malformations
* Infants with severe asphyxiation (cord pH or first arterial pH \<7)
* Infants included in another clinical trial that modifies nutritional management
* Infants who previously fed with formula

Post-randomization exclusion criteria:

- Randomized infant who do not fulfill inclusion criteria
Intradialytic Inspiratory Muscle Training at Different Intensities and Functional Capacity

Investigate the effects of Inspiratory Muscle Training (IMT) performed during hemodialysis (HD) procedures in patients with end stage kidney disease (ESKD). With intervention of thirty-six IMT sessions, performed three times a week, at an intensity of 50%, 30% and 10% (sham) of the maximum inspiratory pressure (MIP).

Introduction: Chronic kidney disease (CKD), especially in its final stage (ESKD), is associated with an increased risk of cardiovascular complications and mortality. Part of this risk can be attributed to the fact that patients with ESKD adopt sedentary behavior.

Objectives: To investigate the effects of Inspiratory Muscle Training (IMT) performed during hemodialysis (HD) procedures in patients with ESKD.

Methodology: Randomized double-blind clinical trial, controlled by sham. Location: Nephrology Sector, Hospital de Clínicas de Porto Alegre (HCPA) Participants: three groups of 12 patients with ESKD on HD randomized to three IMT intensities.

Intervention: Thirty-six IMT sessions, performed three times a week, at an intensity of 50%, 30% and 10% (sham) of the maximum inspiratory pressure (Pimax).

Main outcomes: Functional capacity, diaphragm hypertrophy, respiratory muscle strength, lung volume, blood pressure and quality of life.

Statistical Analysis: Presentation of data in absolute and relative numbers, and through means and standard deviations. To compare the groups, ANOVA will be used, with significance less than 0.05.

Eligibility Criteria:
Inclusion Criteria:

* CKD patients who have been on HD for at least three months;
* In physical conditions to perform the tests proposed by the study;
* With stable CKD for at least 30 days (with no hospitalization);

Exclusion Criteria:

* Patients with a recent history of arrhythmias;
* Recent hospitalization (\<3 months);
* Recent acute myocardial infarction (\<6 weeks);
* HD routine less than 2X / week;
* Muscle or respiratory changes (eg, chronic obstructive pulmonary disease (COPD));
* Unstable angina;
* Severe valve disease;
* Uncontrolled hypertension;
* Hemoglobin concentration \<10 g / dL;
* Participation in a study with intradialytic exercise in the six months preceding this study;
* Refusal to participate in the study.
Bracing During Infantile Scoliosis: Airways Study

Idiopathic juvenile thoracic scoliosis is a tridimensional deformation of the spine which may impact on the intrathoracic organs. Bracing is one of the oldest treatments of spinal deformities. It relies on the indirect manipulation of spinal curvatures in order to prevent curve progression, which may affect respiratory function.

The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave giving the longitudinal cross-sectional area profile of the examined cavity. It is noninvasive and harmless.

The EOS™ device allows a double incidence, full body, and low-dose X-ray acquisition with thoracic 3D reconstruction.

The aim of the study is to evaluate the impact of bracing on the upper airways patency (by means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles assessment), and on the thoracic penetration index (by means of the EOS™)


Eligibility Criteria:
Inclusion Criteria:

* children with evolutive juvenile thoracic scoliosis
* with a Cobb angle ≥ 30°
* requiring either a Milwaukee or a Cheneaux brace
* in a stable respiratory state

Exclusion Criteria:

* history of spine surgery
Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults

The purpose of this Phase I study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule (domain 1) of T-lymphocytes and monocytes, is safe and well tolerated when administered to asymptomatic HIV-1 infected adults by intravenous infusion and to assess pharmacokinetic parameters of the antibody in blood and on cells. The neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1 infection.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic, treatment-naive, HIV-1 seropositive
* CD4+ T cell count \>350 cells/cubic millimeter
* HIV-1 viral load \>5,000 copies/mL
* Other inclusion criteria apply

Exclusion Criteria:

* Active infection requiring immediate therapy (except HIV-1)
* Prior participation in any HIV vaccine trial
* Previous exposure to a monoclonal antibody
* Use of immunomodulating drugs or systemic chemotherapy
* Other exclusion criteria apply
Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya

The aim of the study is to examine the efficacy of ceramic water filters to reduce the burden of waterborne diarrheal illness among infants in selected villages in Kenya. In Kenya very young children are given drinking water or water is used in reconstitution of their food. We hypothesize that ceramic water filters will remove Cryptosporidium from drinking water reducing infection in infants.

Diarrhea is a major cause of illness among children in Africa. Cryptosporidium is a protozoan waterborne diarrheal pathogen resistant to chlorine. Ceramic filters are effective at improving drinking water quality, including removal of protozoa. In a recent preliminary analysis of \>22,000 children \<5 years enrolled in the Global Enterics Multi-Center Study (GEMS) case-control study of moderate-to-severe diarrhea, Cryptosporidium was identified as a leading cause of diarrhea in infants across all four participating African sites. This pilot is the first Cryptosporidium specific intervention trial of household ceramic water filters to reduce the burden of cryptosporidiosis acquired through drinking water in rural Kenya.

Eligibility Criteria:
Inclusion Criteria:

Children 4-10 months old living in selected villages in the Asembo Health and Demographic Surveillance System (HDSS) study area in Kenya whose primary caretakers consent on their behalf to be visited weekly for 6 months to carry out weekly illness surveillance, and have a follow up home visit one year after initial enrollment into the trial. The household in which the child resides must be a consenting participant in the HDSS. As the children included in the trial are infants, the child's primary caretaker will be invited to participate and be administered questionnaires. Random selection will be at the compound level. Only one household per compound will be eligible for selection.

Exclusion Criteria:

Children 4-10 months old whose households are not active consenting participants in the HDSS will not be eligible for inclusion. Only the subset of children 4-10 months old who are randomly selected in the sample will be eligible for participation.

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Randomized Clinical Trial of an Exposure-based Cognitive Therapy for Depression

The purpose of this study is to investigate, if exposure-based cognitive therapy (EBCT) is at least as effective as the established cognitive-behavioral therapy and more effective in its long-term efficacy. Moreover the mechanisms of change of the EBCT are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Disorder according to DSM-IV as main diagnosis
* minimum standardized depression scores (BDI \>= 17; HAMD \>=13)
* minimum age of 18 years
* informed consent to participate voluntarily in the study
* sufficient German language skills

Exclusion Criteria:

* acute suicidality
* depressive disorder with mood-incongruent psychotic features
* chronic depressive disorder
* organic cause of depression
* drug-induced depression
* bipolar disorder
* diagnosis of schizophrenia, schizophreniform, schizoaffective disorders, and/or psychosis NOS
* comorbid dysthymia, psychotic disorder (acute or anamnestic), dementia, substance dependence, schizotypal/ borderline/ or antisocial personality disorder
* psychopharmacological treatment other than antidepressants
* antidepressant medication, if it is changed within one month prior to the beginning of psychotherapy
* other simultaneous psychological treatments
The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer

The extent of hepatic resection for gallbladder cancer can be done from a wedge resection to 4b/5 bisegmentectomy. This study aims to compare the recurrence rates and survival rates between wedge resection group and bisegmentectomy group. Patients with T2 or T3 gallbladder cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy were enrolled. All patients are randomly assigned to wedge resection or bisegmentectomy group. Number of patients in each group is 44. Primary endpoint is recurrence-free-survival rates and overall survival rates.

The extent of hepatic resection for gallbladder cancer has a wide range. A partial hepatectomy involving the gallbladder fossa is a critical part of the resection but can range from a wedge resection to an anatomic resection of segments 4b and 5 to an extended right hepatectomy. This study enrolls Patients with T2 or T3 gallbladder cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy. Eighty eight patients are randomized to wedge resection group or bisegmentectomy group. Except the extent of hepatic resection, all the procedures including hepatoduodenal,common hepatic, posterior pancreatic lymph node dissection are same.

Primary endpoint is recurrence-free-survival rates and overall survival rates.

Eligibility Criteria:
Inclusion Criteria:

* Patients with T2 or T3 gallbladder cancer on preoperative CT exam
* Patients who are pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy

Exclusion Criteria:

* Peritoneal seeding or distant metastasis
* Impossible to resect the cancer radically
* Pathologically diagnosed to other malignancy such as adenosquamous carcinoma, sarcoma, etc.
* R1 or R2 resection were pathologically diagnosed.
A Study of 25-hydroxy Vitamin d Levels in Non-itching Hemodialysis Patients

Hypothesis:

25-hydroxy vitamin D levels in non-itching hemodialysis (HD) patients will be higher than those in HD patients with itching

25-hydroxy vitamin D levels will be measured in non-itching hemodialysis patients and compared to levels previously measured in a previous study of 25-hydroxy vitamin D levels of patients complaining of itching.

25-hydroxy vitamin D levels from non-itching HD patients in this study will be compared to 25-hydroxy vitamin D levels from our ongoing study in HD patients with itching. The primary endpoints for both studies are continuous variables. Student's t test will be used to test for statistical significance. Multiple regression analysis will be used for controlling covariates and testing the interaction among covariates.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis treatment for \> 3 months No complaints of itching within 1 month prior to study enrollment

Exclusion Criteria:

* Age \< 18 years
* Failure to provide informed consent
* Intact PTH \< 70 pg/ml or \> 1,000 pg/ml
* Serum phosphorus \> 7.0
* Serum calcium (adjusted for albumin)\> 11
* Active malignancy
* Likelihood of imminent renal transplantation
* Current ergocalciferol treatment
Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old

To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to \< 48 months of age


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject, male or female, 6 through \< 48 months of age at the time of enrollment, who has never previously received an influenza vaccine
* Individual who has a parent or guardian that can give written informed consent after understanding the nature of the study and are available for follow-up

Exclusion Criteria:

* Individuals recently vaccinated against influenza
* Subjects with contraindications to receive influenza vaccine
PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy

The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lymphoma receiving chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with age ≥ 18 years
* diagnosis of lymphoma(Hodgkin's lymphoma and non-Hodgkin's lymphoma) patients
* Karnofsky Performance Status Z70
* life expectancy of at least 8 months
* normal white blood cell count and platelet count
* Written informed consent are acquired

Exclusion Criteria:

* uncontrolled infection
* pregnancy
* Have accepted any other anti-tumor drug within 4 weeks before anticipated the study
* Other situations that investigators consider as contra-indication for this study