cyrilzakka/clinical-trials huggingface dataset:
Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma

Current therapies for Soft Tissue Sarcoma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Soft Tissue Sarcoma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Soft Tissue Sarcoma.

Soft Tissue Sarcoma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Soft Tissue Sarcoma, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with Soft Tissue Sarcoma.
* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed soft tissue sarcoma that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy

  * Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan

PATIENT CHARACTERISTICS:

Age:

* 6 months and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 2 months

Hematopoietic:

* WBC at least 2,000/mm\^3
* Platelet count at least 50,000/mm\^3

Hepatic:

* No hepatic insufficiency
* Bilirubin no greater than 2.5 mg/dL
* SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

* No renal insufficiency
* Creatinine no greater than 2.5 mg/dL
* No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

* No uncontrolled hypertension
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

* No serious lung disease, such as chronic obstructive pulmonary disease

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* No active infection
* No nonmalignant systemic disease
* Not high medical or psychiatric risk

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since immunotherapy
* No concurrent immunomodulating agents

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy:

* Concurrent corticosteroids allowed

Radiotherapy:

* At least 8 weeks since prior radiotherapy

Surgery:

* Recovered from prior surgery

Other:

* Prior cytodifferentiating agents allowed
* No prior antineoplastons
* No other concurrent antineoplastic agents
Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain

This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female outpatients 18 years of age or older.
2. Patients with chronic non-cancer pain that necessitates the use of non-injectable opioid analgesics. The equivalent dose of 300 mg morphine per day is the maximum opioid analgesic dose allowed. In general, patients should be using opioids on a daily basis.
3. Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.
4. Constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain. Opioid-induced constipation (OIC) is defined as follows:

   * less than 3 spontaneous bowel movements per week and at least one of the following on at least 25% of occasions:

     1. hard or very hard stools
     2. sensation of incomplete evacuation
     3. straining while having a bowel movement

Exclusion Criteria:

1. Patients who are receiving opioids for abdominal pain or connective tissue disorders.
2. Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose
3. Patients who underwent major surgery within 3 months prior to screening.
4. Patients with a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.
5. Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.

Other protocol-defined inclusion/exclusion criteria may apply.
The Comparison of the Effect of Pressure-controlled Ventilation and Volume-controlled Ventilation on the Gastric Insufflations in I-gel

The purpose of this study is to investigate whether the pressure controlled ventilation can reduce gastric insufflation compared to the volume controlled ventilation in patients who were mechanically ventilated with the i-gel.


Eligibility Criteria:
Inclusion Criteria:

* adult patients aged over 20 yrs who are scheduled for surgery under general anesthesia

Exclusion Criteria:

* upper gastrointestinal surgery,
* surgery of long duration more than 4 hours,
* anticipated difficult intubation,
* body mass index more than 35 kg/m2,
* pregnancy
Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas

Evaluation of colonoscopy with a specific device for the detection of adenomas: Multicenter, prospective and randomized study

Given the discrepancy in the results of the published studies, the main objective of the present study would be to evaluate, through a multicentric design and with a sufficiently large sample of patients, if there are relevant differences in the ADR and in the MAP between the colonoscopy performed with a device specific (Endocuff visionTM) versus standard colonoscopy.

Secondarily, the number of adenomas, the number of advanced adenomas and the number of serrated lesions in both groups.

Eligibility Criteria:
Inclusion Criteria:

All patients must be adults (≥18 years), give their consent for endoscopic exploration, for the study and meet following inclusion criteria:

1. Patients with positive immunologic fecal occult blood test (IFOBT) for population screening.
2. Patients invited to an opportunistic screening colonoscopy or included regional population screening program.
3. Patients with a family history of CRC and indication of screening colonoscopy.
4. Patients with follow-up colonoscopy indication by personal history of adenomas.

Exclusion Criteria:

1. Patients with absolute contraindications for colonoscopy (suspicion of intestinal obstruction or perforation, acute diverticulitis suspected or confirmed 6 weeks before the colonoscopy, etc).
2. Symptomatic patients with indication of diagnostic colonoscopy.
3. Patients with a personal history of CRC.
4. Patients with a personal history of chronic inflammatory bowel disease (IBD).
5. Patients with a known personal history of hereditary CRC syndrome:

   I. No polyposis (Lynch syndrome). II. Polypic.
6. Patients with suspected attenuated polyposis (\> 20 adenomas) with genetic diagnosis not defined.
7. Patients with total or partial colic resection.
8. Complete colonoscopy with an adequate preparation (total Boston ≥6 with at least score ≥2 per segment) in a period of less than a year
9. Pregnant or breastfeeding mothers.
10. Patients who have expressed their wish not to participate or who do not have the ability to understand and / or sign informed consent.
11. Patients with any serious and uncontrolled medical, psychological, psychiatric, geographic or social problem that could interfere with the participation of the patient in the study or not allow an adequate follow-up and adherence with the protocol and evaluation of the results of the study.
Hairy Cell Leukemia: Harnessing the Full Power of Extracellular Vesicles to Improve Patient Care Management

Check whether patients with Hairy Cell Leukemia (HCL) of different status (at diagnosis, in complete remission \> 2 years or relapsed requiring therapy) have a 'signature' of altered immunity based on extracellular vesicles (EV)

Extracellular vesicles are small particles detected within plasma and recognized as mediators of intercellular communication thanks to their cargo of proteins, lipids, and nucleic acids. However, the composition of vesicles from Hairy Cell Leukemia patients, which may hold the key to unraveling their involvement and function within tumor microenvironment, is totally unknown. The aim of this study is to characterize these extracellular vesicles in order to identify biology-related and disease-specific biomarkers.

Eligibility Criteria:
Inclusion criteria for patients:

* WHO2022-defined diagnosis of Hairy Cell Leukemia.
* age ≥18 years.
* signed informed consent.

Inclusion criteria for Healthy Donors:

* age ≥18 years.
* Volunteers in general good health, free from any disease or serious illness.
* Signed informed consent.

Exclusion criteria

- None
The Effect of Light Emitting Diode Phototherapy on the Rate of Orthodontic Tooth Movement - A Clinical Study

LED Phototherapy will increase the velocity of Orthodontic tooth movement.


Eligibility Criteria:
Inclusion Criteria:

* bilaterally symmetric extraction of premolar teeth with residual extraction spaces large enough to ensure space closure is not complete prior to the subsequent orthodontic appointment
* no medicines or systemic illness
* full banding/bonding of teeth

Exclusion Criteria:

* pregnant
* non-extraction treatment
* systemic illness
* prior orthodontic treatment
Candidemia in a Pediatric Center and Importance of Central Venous Catheter Removal

Candidemia has emerged as an important cause of hospital-associated blood-stream infection in children. The purpose of this study was to identify differences in distribution of candida species, risk factors, treatment, and clinical outcome of candidemia in children. This study in children ≤18 years with blood culture proven candidemia identified between 2004 and 2012. Analyses included the determination of causative candida species, resistance to antifungals and clinical outcome, as well as the identification of potential risk factors associated with candidemia.


Eligibility Criteria:
Inclusion Criteria:

* Presence of growth of any candida species in at least one blood culture

Exclusion Criteria:

* Febrile neutropenic patients who were using empirical antifungal agents
PET-CT and Circulating Tumor Cells in Colorectal Cancer

The purpose of this study is to identify an early indicator of drug efficacy in patients with advanced colorectal cancer - a prospective evaluation of circulating tumor cells, positron-emission tomography scan and RECIST criteria.

1. To determine if measuring both tumor metabolic response (via FDG-PET scan) \& circulating tumor cells (CirTC) at 4 weeks after starting treatment, is a better predictor of clinical outcome than measuring either modality alone in patients with metastatic colorectal cancer (CRC) who are undergoing first-line oxaliplatin-based chemotherapy.
2. To determine if a new method of assessing drug response (measuring tumor metabolic response via FDG-PET \& CirTC at 4 weeks after starting treatment) better predicts clinical outcome than the conventional method (measuring radiological changes in tumor dimensions at 10 weeks after starting treatment via the 'Response Evaluation Criteria in Solid Tumors' - RECIST).

Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal cancer patients not received prior drug treatment for metastatic CRC
* Age \>= 18 years
* (ECOG) performance status of 0-2
* Measurable tumor sites by RECIST criteria
* Adequate bone marrow, renal \& hepatic functions

Exclusion Criteria:

* Patients with diabetes mellitus
* presence of hyperglycemia
* Pregnant or lactating patients
FACE-PC: Family-Centered Care for Older Adults With Depression and Chronic Medical Conditions in Primary Care

Comorbid depression and multiple medical conditions in older adults are a serious public health problem. As an important facilitator of health-related activities, families are already involved in various aspects of self-management of chronic disease in older adults. Despite the benefits they provide, informal caregiving activities currently are organized outside the medical system, which potentially creates redundant or misaligned efforts.The purpose of the mentored research is to examine the feasibility and acceptability of the FACE-PC, a theory-driven, multi- component, technology-assisted interdisciplinary team-based care model that systematically involves family in chronic disease management. It aims to optimize the patient and family's collective ability to self-manage chronic disease.

Comorbid depression and multiple medical conditions in older adults are a serious public health problem. As an important facilitator of health-related activities, families are already involved in various aspects of self-management of chronic disease in older adults. Despite the benefits they provide, informal caregiving activities currently are organized outside the medical system, which potentially creates redundant or misaligned efforts.The purpose of the mentored research is to examine the feasibility and acceptability of the FACE-PC, a theory-driven, multi- component, technology-assisted interdisciplinary team-based care model that systematically involves family in chronic disease management. It aims to optimize the patient and family's collective ability to self-manage chronic disease.

Eligibility Criteria:
Inclusion Criteria for Patient:

* 60 years of age or older
* Receives primary care
* PHQ-9 score ≥ 5
* Must have at least one medical condition actively managed at the study site.

Inclusion Criteria for Family:

* Age 18 or older
* Identified as family by the patient
* Has a minimum of twice weekly total of 4 hour face-to face contact with the patient
* Is willing and available to participate in the study;
* Has access to internet.

Exclusion Criteria for Patient:

* Inability to understand screening and assessment questions
* Montreal Cognitive Assessment Scores \<18
* Known diagnosis of a severe chronic mental illness such as schizophrenia
* Meeting the criteria for bipolar disorder or schizophrenia in PRIME-MD
* Deemed to be a danger to self or others that may require treatment outside a primary care setting.

Exclusion Criteria for Family:

* Institutionalized at the time of study.
"We Are an Active Family": Promoting Child Physical Activity Through Social Identity Formation in the Family System

The purpose of our study is to explore the effectiveness of physical activity (PA) identity formation in the family system as a promotor of long-term PA. The primary research question is:

Does a family identity formation condition (with education+planning) result in increased child moderate- to vigorous-intensity PA (MVPA) compared to a standard comparison education and planning condition at six months? Hypothesis: Child MVPA will be higher for the identity formation condition in comparison to the more standard PA education+planning condition at six months.

The secondary research questions will include:

1. Does the identity formation condition improve child health-related fitness outcomes compared to the education and planning condition at six months? Hypothesis: Child health-related fitness will be higher for the identity formation condition in comparison to the education and planning condition.
2. Can group differences among behavioural, and health-related fitness outcomes be explained through a mediation model? Hypothesis: The covariance of the assigned conditions (identity formation, planning + education) on child MVPA will be explained by parental support, and through parental support identity (i.e., manipulation check). In turn, the covariance between support and health-related outcomes will be explained by MVPA among conditions. In the case of null outcomes for research question #1, the investigators will instead explore a prediction model of these variables rather than a mediation model.
3. Is there an intergenerational, seasonal, or sex difference across primary outcomes by assigned condition? Hypothesis: Parents in the identity formation condition will show higher physical activity via some activities being performed with their children (as part of social identity) in comparison to the other condition. No differences in child sex or season are hypothesized based on past research.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be at least one parent with at least one child between the ages of 6 and 12 years.
* Families (parents and/or guardians and children) residing in Greater Victoria, Nanaimo, Ladysmith, Duncan, Vancouver, Richmond, Surrey, Burnaby, British Columbia.
* Children that participate in \<60 minutes/day of moderate to vigorous physical activity (MVPA)

Exclusion Criteria:

* If child is meeting the current physical activity guidelines \>=60 minutes a day of moderate to vigorous physical activity per day.
* If participant does not pass Physical Activity Readiness Questionnaire (PARQ)
Immune Profile and Complication Risk in Type 2 Diabetes

The aim of this study is to investigate the relation between individual differences in pattern recognition molecules (PRM's) in the innate immune system and the prevalence and development of vascular complications in patients with type 2 diabetes.

This is based on the hypothesis that pattern recognition molecules (PRM's) in the innate immune system contributes to a chronic low grade inflammation in diabetic patients. Variation in PRM's - at the genome, proteome as well as the functional level - are therefore associated with the degree of chronic low grade inflammation, and probably also with the prevalence of vascular complications.

Aim: The primary aims of the project are:

1. By use of advanced magnetic resonance imaging to characterize the prevalence of atherosclerosis in the carotid arteries in patients with newly diagnosed type 2 diabetes.
2. To investigate if individual differences in the innate immune system contributes to the prevalence and development of cardiovascular disease in patients with type 2 diabetes.
3. To prospectively observe the cardiovascular morbidity and mortality in a cohort of patients with type 2 diabetes seen in the light of the obtained baseline characteristics.

Background: Type 2 diabetes is a very common disease in the western world. Patients with type 2 diabetes are at risk of a number of complications, including macroangiopathy which involves an accelerated atherosclerosis, that causes most of the increased mortality and morbidity in type 2 diabetics. Mounting evidence suggests that development of vascular complications is associated to a chronic low grad inflammation in type 2 diabetes. Individual differences in the innate immune system might contribute to this chronic low grade inflammation as it has become apparent that in some situations - as after tissue ischemia or in diabetes - a change in the body's own cell glycosylations occurs, which leads to increased affinity of PRM's. This study will focus primarily on two families of PRM's: Collectins and Toll-like receptors.

Methods: The study consists of a prospective observational cohort study of 100 newly diagnosed type 2 diabetic patients with continuous 2-year clinical follow-up and a register-based follow-up of morbidity and mortality study after 5 and 10 years. Furthermore 100 healthy control subjects will be included. Baseline data will represent a independent cross-sectional study of the relationship between the innate immune system, glycemic control and the presence of atherosclerosis in the carotid arteries in newly diagnosed type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* Diabetics: Newly diagnosed (\<5 years since diagnoses) type 2 diabetes due to national diagnosis criteria
* Controls: No diabetes or prediabetes in oral glucose tolerance test

Both:

* Age \> 18 years
* Signed informed consent

Exclusion Criteria:

Both:

* Pacemaker or other magnetic materials in the body
* Severe claustrophobia
* Pregnancy/lactation
* Cancer - former or current
* Acute or chronic infection
* Dialysis-dependent kidney disease
A Clinical Trial to Test the Saftey and Success Rate for a Cerrumen Cleaning Device - "Wondertip".

Wondertip is a silicone single use device with a coil end, designed for the purpose of evacuating impacted cerumen of external ear canals. This trial aims at testing the safety and efficacy of this device. The participating investigators will be ENT doctors with the skill of examining the treating ear problems.

Cerumen is ear wax, a combination of dead skin cells of the external ear canal, sebaceous glands secretions and ceruminous sweat glands secretions. Cerumen exists in a range of people but sometimes it become an obstacle to patients or caregivers. Cerumen may accumulate in the external ear canal and cause discomfort to the patient, sensation ofobtuseness and conductive hearing loss. Patients who use hearing aids may suffer from problems wearing them, and sometimes the cerumen may plug the inner part of the hearing aid or the ventilation channel of the ear phone.

For caregivers, cerumen may poses a diagnostic challenge, by concealing part of the external ear canal and tympanic membrane, thus making it difficult to observe the middle ear. cerumen my affect the results of audiometric tests, ABR tests, Otoacustic Emission tests and in conducting tympanometric tests. All of which may result in false results. The incidence of cerumen is estimated to be betwean 7 to 35% of the general population.

There are few options to evacuate the cerumen, but they usually require skill and the use of otology microscope. It mays casue discomfort or pain, and even trauma to the external ear canal or the tympanic membrane. A device which does not require a special skill or equipment may have a advantage, especially for the general practioner doctor.

The Wondertip is an Israeli patent, made of silicone with a coil like end, targeted to evacuate the cerumen in a safe and effective manner. The coil is gently inserted to the ear canal, grasps and evacuates the cerumen.

The purpose of the trial is to investigate the safety and efficacy of the Wondertip. A second purpose is to messure external ear canal depth.

Each candidate which will present with cerumen impaction will recieve a detailed explanation regarding the trial. If the patient agrees, and signs a concent form, a short interview will take place by the doctor. An evacuation of the cerumen will be attempted by the same doctor with the Wondertip. Further the doctor will document details regarding the safety and efficacy of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 1 year old who have cerumen impaction.

Exclusion Criteria:

* external ear infection
* chronic otitis media with perforation of the tympanic membrane
* past ear surgery
* otorrhea
* inflamation of the auricle or the periauricular region
* temporal bone neoplasm
* deafness in the contralateral ear (single sided deafness).