cyrilzakka/clinical-trials huggingface dataset:
The Effect of a Diabetes Action Team in Patients Post Infrainguinal Bypass Surgery With and Without Diabetes

Diabetes is a very common illness. Approximately 4% of British Columbians have diabetes. However, at least 20% of people admitted to acute care hospitals have diabetes. People with diabetes are at a higher risk for developing complications after surgery including infection and prolonged hospital stay, especially if blood sugars are high.

The researchers are testing a Diabetes Action Team to see if their involvement in patient care after surgery improves blood glucose control, duration of stay in hospital, and infection rates.

This trial will randomize subjects with diabetes who plan to undergo elective infrainguinal bypass surgery to receive either standard diabetes care by their admitting physician, or diabetes care under the direction of the Diabetes Action Team post operatively until hospital discharge and post discharge in the community. Subjects without diabetes will have their blood glucose levels monitored while in the hospital. The Diabetes Action team will consist of a nurse coordinator who is a Certified Diabetes Educator (CDE) and a team of physicians specialized in the management of diabetes. The study will not increase the length of the hospital stay.

Eligibility Criteria:
Inclusion Criteria:

Non-Diabetes:

* Fasting blood glucose \< 7.0 mmol/L or a random blood glucose of \< 11.1 mmol/L

Diabetes:

* Poorly controlled type 2 diabetes (fasting plasma glucose greater than or equal to 7.0 or random plasma glucose greater than or equal to 10.0 mmol/L)
* Newly diagnosed type 2 diabetes (fasting plasma glucose greater than or equal to 7.0 mmol/L or random plasma glucose greater than or equal to 11.1 mmol/L)
* Age \> 30
* English-speaking
* Agrees to participate in the study and lives in the Lower Mainland

Exclusion Criteria:

* Scheduled to undergo surgery other than infrainguinal bypass surgery
* Under 30 years of age
* Living outside of Lower Mainland
* Cannot speak and understand English
A Clinical Study of Bacillus Coagulans in Acute Graft-Versus-Host Disease After Hematopoietic Stem Cell Transplantation

To evaluate the preventive effect of Bacillus coagulans on acute graft-versus-host disease (aGVHD) after hematopoietic stem cell transplantation

The study is conducted on patients after hematopoietic stem cell transplantation and the intervention is Bacillus coagulans, aiming to investigate the preventive effect of Bacillus coagulans on acute graft-versus-host disease after hematopoietic stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients are fully aware of the study, voluntarily participate and sign informed consent;
2. Age: ≥18 years old;
3. Patients with hematologic malignancies undergoing allo-HSCT and patients with severe aplastic anemia (SAA) undergoing allo-HSCT were treated with myeloablative conditioning (MAC).

Exclusion Criteria:

1. Refused to participate in this clinical study;
2. Unable to take the drug orally;
3. Allergic to Bacillus coagulans;
4. People take allo-HSCT with reduced intensity conditioning (RIC) and nonmyeloablative conditioning (NMC);lymphoma or multiple myeloma with auto-HSCT; multiple myeloma patients.
Supporting the National Expansion of HPV-based Cervical Cancer Screening in Tanzania Among Women Living with HIV

* Cervical cancer is caused by persistent infections with one of \~13 carcinogenic human papillomavirus (HPV) types and causes substantial morbidity and mortality worldwide.
* Highly effective strategies exist, including HPV vaccination and HPV-based screening for early detection and treatment of precancerous lesions.
* The investigators are proposing an innovative implementation research program and randomized trial evaluating HPV DNA testing as a primary screening tool for cervical cancer screening in HIV Care and Treatment clinics within Tanzania's National Cervical Cancer Prevention (CECAP) program.
* The investigators will combine HPV DNA testing with high quality visual assessment of the cervix for treatment and management of cervical precancerous lesions among HPV+ Women Living with HIV (WLWH).
* At 12-month follow up women will be recalled for repeat screening for HPV and visual assessment of the cervix for treatment combined with a second therapeutic dose of HPV vaccine.
* The investigators propose to recruit 2000 WLWH from 4 HIV Clinics in Kilimanjaro Region. Two clinics will be randomized to the test, treat and vaccinate strategy and two clinics will be randomized to test, treat and re-screen and then vaccinate strategy.
* Currently, there is no Standard of Care (SOC) for vaccination of women who are at risk for HPV in the country. These two arms of the study will allow for treatment and observation to occur that would not be available otherwise.


Eligibility Criteria:
Inclusion Criteria:

* Gender: person with an intact cervix
* HIV type 1 (HIV-1) positive status and receiving care at one of the study CTC sites randomized for the trial
* Not pregnant and utilizing contraception if sexually active and willing to undergo a urine pregnancy test prior to enrolment
* Residence in the study-defined catchment area
* Willing to consent to receive follow-up phone calls from the health provider to provide reminders and counselling about follow-up visits required for the study procedures
* Willing to receive HPV Vaccination in a 2-dose strategy
* Language: able to speak/understand English or Kiswahili (if the participant cannot read, the consent will be read to her, and thumbprint will suffice for consent as per the Tanzanian National Institute for Medical Research Ethical Guidelines for Informed Consent Processes)

Exclusion Criteria:

* Women will be excluded for a prior history of invasive or microinvasive cervical, vaginal, vulvar, or anal cancer; prior hysterectomy; cervical treatments within 1 year prior to study; cervical, vaginal, or vulvar lesions suspicious for cancer; prior HPV vaccination; receipt of anticoagulants; known sensitivity to vaccine components; hemophilia or bleeding diathesis; use of antineoplastic or immunomodulatory treatment; breastfeeding; and \<3 months postpartum. Any potential participant who appears unable to provide informed consent or does not want to participate in the research study will be excluded.

Women that do not want to receive the vaccine will be excluded.
Role of Volatile Anesthetics for Hepatic Protection

This study aims to evaluate the attenuation of ischemic-reperfusion injury in the liver after sevoflurane preconditioning. In the presence of sevoflurane, an attenuation of liver injury is hypothesized (diminished increase of liver enzymes, reduced production of inflammatory mediators).

Organ protection; preconditioning; volatile anesthetics; ischemia reperfusion

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years of age
* Patients undergoing liver resection (benign or malignant tumors)

Exclusion Criteria:

* Laparoscopic liver resection coagulopathy (platelets \< 50,000/ml, Quick \< 50%)
* Liver cirrhosis
Sugars-sweetened Beverages and Exercise on Glycaemic Response and Subjective Appetite in Children

The purpose of the study is to understand the role chocolate milk compared to a fruit drink, with and without exercise, on glycaemic regulation and subjective appetite in children. The investigators hypothesize that chocolate milk in combination with exercise will have the greatest effect attenuating glycaemic response. Blood glucose will be measured by finger prick following drink consumption (0 min) and exercise or sitting (15 min), and at 65 minutes. Subjective appetite will be measured at 0, 20, 35, 50 and 65 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, boy, born at full term and normal birth weight

Exclusion Criteria:

* Girls, have significant learning, behavioral, or emotional difficulties
Effects of Collagen Peptide Supplementation on Muscle and Tendon Damage and Function

The aim of the study is to investigate the acute and short-term effects of collagen peptides (Collagen Peptan) on muscle and connective tissue during an eccentric overload training period. Currently, all studies investigating the effects of post-exercise collagen supplementation did this in the absence of whey proteins, which are part of the standard recommendations for post-exercise recovery. The investigators will therefore investigate whether the combined intake of whey proteins and collagen peptides ensures a better recovery of exercise performance and whether it can prevent or reduce symptoms of muscle and tendon overload during a three-week eccentric overload training period (n = 22).


Eligibility Criteria:
Inclusion Criteria:

* Sports participation, including general fitness training, between 2 and 5 hours max per week
* Body mass index between 18.5 and 25

Exclusion Criteria:

* Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise - Intake of any medication or nutritional supplement that could impact muscle protein synthesis and/or exercise performance during the period of the study
* Intake of any whey protein, casein of branched-chain amino acid (BCAA) supplements from 1 month prior to the start of the study
* Blood donation within 3 months prior to the start of the study
* Smoking
* Current participation in another research trial
* Any other argument to believe that the subject is unlikely to successfully complete the full study
Coronary Computed Tomography (CT) to Measure Coronary Calcification in Spinal Cord Injury (SCI)

Although conventional risk factors for coronary heart disease (CHD) have been identified and routinely used to determine risk for CHD in the general population, a systematic approach to determine population-specific risk for CHD has not been performed prospectively in those with SCI. CHD is a leading cause of death in spinal cord injury, occurring at younger ages than in the able-bodied population. Conventional risk factors for CHD are high serum concentrations of low-density lipoprotein (LDL), low serum concentrations of high-density lipoprotein (HDL), diabetes mellitus (DM), positive smoking history, and positive family history of premature CHD.

Coronary calcification (CAC) is a commonly occurring phenomenon that does not necessarily indicate significant obstructive disease. Studies have shown that a strong association exists between coronary calcification and coronary heart disease. The purpose of this study is to compare the CAC scores in persons with SCI with a historical control group of able-bodied persons from a national data base who will be matched for conventional risk factors for coronary artery disease (CAD) and to determine the relationship between CAC scores and conventional and emerging risk factors for CAD.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 to 70 years of age;
2. Chronic (e.g., duration of injury at least 6 months), stable SCI (regardless of level of lesion or completeness of injury);
3. Concurrently participating in or previously completed protocol # 0454-06-073, "Risk Factors for Coronary Heart Disease in Spinal Cord Injury: conventional and emerging".

Exclusion Criteria:

1. Acute medical illness;
2. Pregnancy (as determined by a pregnancy test \< 1 week of the study); and
3. The presence of a chronic disease (i.e., heart disease, pulmonary disease, etc.);
4. Inability to comply with breathing instructions.
Modalities of Surgical Treatment of Chiari Malformation Disease : Clinical Study and Outcomes

Evaluation of postoperative outcomes of Chiari type I Malformation Patients at Department of Neurosurgery Assiut University Hospital .

Chiari malformation is a group of craniocervical malformations involving the brain stem, cerebellum, upper spinal cord, and surrounding bony structure, encompassing a series of hindbrain herniation symptoms. The Austrian pathologist Hans Chiari ﬁrst described the malformation in 1891 and such abnormality is frequently identiﬁed in both young adult and pediatric patients.

There are four main types of chiari malformations with other subtypes. Chiari I malformation (CIM), in which the caudal poles of the cerebellar tonsils extend into the upper cervical spinal canal, is a common clinical type. Common clinical symptoms, including headache, altered sensation, weakness, dysphagia, sleep apnea.

Between 70% and 80% of patients with CIM have accompanying syringomyelia. Surgical treatment is widely accepted and is the only treatment chosen for symptomatic patients with Chiari malformations.

The aim of this study is to elucidate the most favorable procedures for CIM in terms of radiological and clinical outcomes.

Independent and dependent variables will be identiﬁed for analysis. The independent variables will include patient diagnosis, surgical techniques, patient age, patient chronic diseases and identified dependent variables including improvement of symptoms and signs, rates of intraoperative and postoperative adverse events, and perioperative mortality.

Different surgical modalities will be applied ,examples include bony decompression with or without duraplasty with the possibility of cerebellar tonsils resection (RT) .

Common complications include meningitis, CSF leak, pseudomeningocele, hydrocephalus, respiratory failure, hemorrhage, craniocervical instability, and/or death.

The outcome will be measured by reduction / increase of symptoms and signs using the Chicago Chiari outcome scale (CCOS).

Eligibility Criteria:
Inclusion Criteria:

* Chiari I Malformation patients who suffer from clinical symptoms and radiological manifestations.
* Patients fit for surgery

Exclusion Criteria:

* Other types of Chiari malformations
* Patients with multilevel cervical disc herniation .
* Patients with segmental instability .
* Patients unfit for surgery
A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled study evaluating the efficacy and safety of faricimab in patients with myopic choroidal neovascularization (CNV). This non-inferiority study will compare 6.0 mg faricimab versus 0.5 mg ranibizumab administered at a pro-re-nata (PRN) dosing regimen after an initial active IVT treatment administration at randomization (Day 1).


Eligibility Criteria:
Inclusion Criteria:

1. Treatment-naïve choroidal neovascularization (CNV) secondary to myopia
2. Diagnosis of active myopic CNV in the study eye:

   1. Presence of high myopia, worse than -6 diopters of spherical equivalence
   2. Antero-posterior elongation measurement greater than or equal to 26.0 mm
   3. Presence of posterior changes compatible with pathologic myopia (e.g., tessellated fundus, lacquer cracks, etc.)
   4. Presence of active leakage from CNV on FFA (determined by Central Reading Centre \[CRC\])
   5. Presence of intraretinal or subretinal fluid or increase of CST on OCT (determined by CRC)
3. BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol on Day 1
4. Overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests
5. Ability to comply with the study protocol, in the Investigator's judgment
6. Other protocol-defined inclusion criteria apply

Exclusion Criteria:

1. Any major illness or major surgical procedure within 1 month before screening
2. Pregnancy or breastfeeding, or intention to become pregnant during the study or within 3 months after the final study treatment administration
3. Uncontrolled blood pressure (systolic \>180 millimetres of mercury \[mmHg\], diastolic \>100 mmHg)
4. Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
5. History of systemic or ocular disease that would contraindicate treatment with the investigational drug or comparator
6. Uncontrolled glaucoma in study eye
7. Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities, including, but not restricted to, intravitreal, periocular or laser interventions in study eye
8. Prior or concomitant periocular or intravitreal pharmacological treatment, including anti-VEGF medication, for other retinal diseases (e.g. geography atrophy, nAMD, DME etc.) in study eye
9. Other protocol-defined exclusion criteria apply
Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis

The JIA-ED study is a pilot project. Based on experience in another inflammatory disease, a 4-week period was extrapolated as sufficient to assess the effectiveness of the experimental intervention. This observation is supported by literature data showing that, halfway through phase I of the CDED (Crohn Diseasse Exclusion Diet), it is already possible to identify a subset of patients with Crohn's disease who are responsive to the dietary treatment and who also have a higher likelihood of achieving clinical remission by the end of the first phase of the diet itself.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of juvenile idiopathic arthritis (JIA) in the forms of enthesitis-related arthritis and oligoarticular forms according to the ILAR 2001 criteria (https://medicalcriteria.com/web/reujia/);
* Age between 6 and 18 years (not yet 18);
* Active disease of mild to moderate severity, assessed through the Juvenile - Arthritis Disease Activity Score (JADAS10) tool (Trincianti C. et al., American College Rheumatology, 2021);
* For study groups 2 and 3: failure of ongoing pharmacological therapy at the time of screening, defined as a failure to achieve at least a 20% reduction in JADAS10 values after 3 months of initiating DMARD therapy or biologic medication, or if the disease is inactive on such therapy, a 20% increase in those values;
* Signed informed consent.

Exclusion Criteria:

* Patients requiring systemic immunosuppressive therapy for active uveitis;
* Patients undergoing therapy with systemic corticosteroids (defined as prednisone equivalent \>0.5 mg/kg for \>7 days) or intra-articular corticosteroids in the 3 months prior to enrollment;
* Patients with fecal calprotectin values \> 250 mcg/g at the time of screening;
* Use of antibiotics in the month prior to enrollment.
Reverse Axillary Mapping in Breast Radiation Treatment Planning

The goal of this prospective study is to investigate the role of axillary reverse mapping (ARM) in radiation therapy planning of patients with breast cancer. Lymphedema is a common side effect after surgery and radiation therapy for breast cancer. The use of ARM is becoming more routine in surgery to differentiate the upper extremity lymphatics (UELs) from the breast axillary drainage to preferentially spare the UELs and reduce the rates of lymphedema.


Eligibility Criteria:
Inclusion Criteria:

* De novo presentation of post-operative (lumpectomy or mastectomy) female breast cancer patients to receive radiation to the whole breast or chest wall and the regional nodes. Patients who have received a sentinel lymph node (SLN) biopsy or an axillary lymph node dissection (ALND) will be eligible.
* Greater than or equal to 18 years of age (no upper age limit).
* Informed consent obtained.

Exclusion Criteria:

* Prisoners.
* Patients with metastatic breast cancer.
* Documented allergy to iodinated contrast
* Prior breast or axillary surgeries or radiation.
Clinical Study of Autologous Erythrocytes Derived MPs Packaging MTX Peritoneal Perfusion to Treat Malignant Ascites

This study makes an observation over the objective response rate of autologous erythrocytes derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy combination in the treatment of malignant ascites. All the participants will randomly receive the treatment of autologous erythrocytes derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy combination or convention drugs peritoneal perfusion and systemic therapy combination.

As a drug carrier, erythrocytes have their own advantages, such as high biocompatibility, high immune compatibility, simple structure and easy access. In this study, microparticles released from erythrocytes are used as the carrier of chemotherapy drugs and effectively kill tumor cells in malignant ascites. These microparticles can easily reach the tumor site and bring the drug into tumor cells, which can overcome the two main problems in normal chemotherapy: damage to normal cells and drug resistance of tumor cells.

Eligibility Criteria:
Inclusion Criteria:

* 18 and ≤ 80 years of age
* Histological confirmed gastric cancer, colorectal cancer, or ovarian cancer, tumor cells were detected by exfoliative cytology of peritoneal effusion, refractory or recurrent ascites of ovarian cancer were required, other kinds of cancer were not limited
* Vital signs were stable, Karnofsky ≥ 70, life expectancy of more than 3 months
* The hematopoietic function of bone marrow was normal without bleeding tendency (INR \< 1.5), blood routine examination: HGB ≥ 90 g/L, WBC \> 4.0 × 10\^9/L (NEU ≥ 1.5 × 10\^9/L), PLT ≥ 80 × 10\^9/L
* Liver function: STB ≤ 1.5 ULN, AST and ALT≤ 2.5 ULN (if the abnormity of liver function was mainly caused by tumor invasion, AST and ALT ≤ 5 ULN), ALP ≤ 1.5 ULN
* Renal function: BUN and Cr ≤ 1.5 ULN, CCr ≥ 50mL/min
* ECG and blood glucose level were normal
* Patients or family members agreed to participate in the study and signed informed consent
* No other serious heart and lung disease, etc.

Exclusion Criteria:

* Pregnant or lactating women
* Allergic constitution and multi-drug allergy
* Serious heart, lung, liver and kidney dysfunction, decompensated heart, lung, kidney, liver and other major organs dysfunction or failure, poor blood glucose control, chemotherapy intolerance, combined intestinal obstruction
* Concurrent severe infection
* HIV positive, HBsAg and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/mL), chronic hepatitis C blood screening positive (HCV antibody positive)
* Cognitive impairment or poor chemotherapy compliance determined by investigator
* Less than 4 weeks from the last clinical trial
* Unsuitable for clinical trials determined by investigator
The Influence of Oxytocin on the Processing of Social Contact

Social touch can convey the most potent and salient of socio-emotional signals. While the hypothalamic peptide oxytocin (OXT) has been identified as a key neurochemical mediator of grooming in some other social species, its modulatory influence on human interpersonal touch is unknown. The investigators expect that OXT augments the hedonic value of touch and that this behavioral effect is paralleled at the neural level by an increased response in brain areas mediating rewarding aspects of social touch.


Eligibility Criteria:
Inclusion Criteria:

Healthy male volunteers

Exclusion Criteria:

Current or past psychiatric disease Current or past physical illness Psychoactive medication Tobacco smokers