cyrilzakka/clinical-trials huggingface dataset:
Assessing the Effectiveness of Diabetes Interactive Diary (DID) in Diabetes Management

For people with Type 1 Diabetes, blood glucose control is achieved by matching insulin doses directly to the amount of carbohydrate consumed. We are looking at new ways to help our patients with type 1 diabetes manage their diabetes control more effectively. We are testing if "Diabetes Interactive Diary" (DID), a novel programme designed to be used on a mobile phone, can represent an important tool in carbohydrate counting while avoiding the use of complex calculations and in depth knowledge about the carbohydrate content of their food.

This is randomized control trial aimed to evaluate the effectiveness of a DID compare to the standard education approach in order to help the patients with Type 1 diabetes to estimate the carbohydrate in their food and adjust insulin doses. It involves individuals with Type 1 diabetes who are not habitually using carbohydrate counting. They should be testing their blood sugar levels at least 3 times a day, using multiple daily injections of short-acting and long-acting insulin analogues, with HbA1c between 7.5% and 10% and are familiar with the use of mobile phones and possess a personal SIM card.

Patients will be randomized to the standard education programme run for 4 full days over a 4 week period or to the DID programme run as three 2-hour sessions over a two-week period.

The DID is a novel software programme installed on the patient's mobile telephone. It facilitates the communication between the dietitian and the patient by using SMS text messages, so that the dietitian can monitor glycaemic control and suggest adjustments if necessary. It can be described as a little computer, where the patient can record their blood glucose value, the amount of insulin injected and the amount of carbohydrate consumed.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over
* Not habitually using carbohydrate counting and insulin dose adjustment
* Testing their blood sugar levels at least 3 times a day
* Using multiple daily injections of short-acting and long-acting insulin analogues
* With HbA1c between 7.5% and 10%
* Familiar with the use of mobile phones and possess a personal SIM card.

Exclusion Criteria:

* Mental conditions, depression or high anxiety rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Eating disorders
* Pregnancy
* Any clinically significant major organ system disease or infective diseases
* Any disease or condition or abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator may interfere with the completion of the study
* Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study procedures
Targeting the Optimal Mean Arterial Pressure in Hypoxic Ischemic Brain Injury After Cardiac Arrest

Hypoxic ischemic brain injury (HIBI) is the ensuing brain injury after cardiac arrest and is the primary cause of adverse outcome. HIBI is caused by low oxygen delivery to the brain. The patient's blood pressure is primary determinant of oxygen delivery to the brain. International guidelines recommend maintaining uniform blood pressure targets in all patients, however, this 'one size fits all approach' fails to account for individual baseline differences between patient's blood pressures and extent of underlying disease. Recently, 'autoregulation monitoring', a novel brain monitoring technique, has emerged as a viable tool to identify patient specific blood pressures after brain injury. This personalized medicine approach of targeting patient specific blood pressure (MAPopt) is associated with improved outcome in traumatic brain injury. It has not been evaluated in HIBI after cardiac arrest.

Recently, I completed a first-in-human study demonstrating the ability to identify MAPopt in HIBI patients using neuromonitoring (microcatheters inserted into the brain tissue). The proposed study in this grant is to take the next step and investigate the changes in key brain physiologic variables (brain blood flow and oxygenation) before and after therapeutically targeting MAPopt in HIBI patients. This interventional study will serve as the basis to embark on a pilot randomized control trial of MAPopt targeted therapy versus standard of care in HIBI patients after cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

* We will include any patient 19 years or older who are admitted to the ICU following cardiac arrest with a post-resuscitation Glasgow Coma Scale of 8 or less.

  * Existing arterial line in situ as part of their clinical care.
  * Enrolled within 72 hours of their cardiac arrest
  * Patients must have had more than 20 consecutive minutes of spontaneous circulation following resuscitation
  * Duration of cardiac arrest greater than 10 minutes prior to return of spontaneous circulation. This is to ensure that we will not be placing intra-parenchymal bolts in patients who are likely to have a favourable neurological outcome regardless of monitoring.

Exclusion Criteria:

1. Coagulopathy (INR \> 1.5, PTT \> 40, Platelets \< 100)
2. Cardiac catheterization procedure is anticipated within the next 7 days.
3. Current or anticipated use of anticoagulant or antiplatelet medication. Importantly, subcutaneous heparin or dalteparin for deep venous thrombosis prophylaxis may be used provided it is not administered 12 hours prior to insertion or removal of the bolt. This practice is currently utilized in our TBI population.
4. Undergoing therapeutic hypothermia with a target temperature under 35oC.
5. Known or prior history of severe TBI, intracranial hemorrhage or stroke that would interfere with cerebral oximetry (i.e. significant prior damage to the frontal lobes).
6. No current commitment to ongoing support by the medical team
7. Acute ST elevation myocardial infarction

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Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004

Study 20140114 will continue to follow participants with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up.

Study 20140114 will continue to follow participants with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up. Collection of long-term safety information will include adverse events of interest and all treatment-emergent adverse events and serious adverse events

Eligibility Criteria:
Inclusion Criteria:

* Participant was previously enrolled in Study 20062004.
* Participant or participant's legally acceptable representative has provided informed consent/assent prior to initiation of any study-specific activities/procedures.

Exclusion Criteria:

* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
* Females of childbearing potential on denosumab and not willing to continue to use 1 highly effective method of contraception during treatment and for 5 months after the end of treatment
Effect of Heatwaves on Glycemic Control in People With Type 1 Diabetes Treated With Artificial Pancreas

To analyze the effect of heatwaves on interstitial glucose in adult patients with type 1 diabetes mellitus treated with artificial pancreas

Observational retrospective study to analyze the effect of heatwaves on interstitial glucose in adult patients with type 1 diabetes mellitus treated with advanced hybrid closed-loop systems in the Castilla-La Mancha region (southcentral Spain). Main objective is the difference in time in range of intersticial glucose between 3.0-10 mmol/L (70-180 mg/d) measured throught real-time continuous glucose monitoring during the two consecutive greatest heatwave during summer 2024 (5th-26th August) comparted to the following period (27th August to 17th September). Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value \< 0.05 was considered statistically significant. The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Older than 18 years old
* Using advanced hybrid closed-loop systems (AHCL)
* Paired active AHCL data from the heatwave periods and two consecutive weeks

Exclusion Criteria:

* Younger than 18 years old
* Not using AHCL
* Not having active paired AHCL data from the analyzed periods
The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy

The objective of this study is to evaluate the performance and safety of da Vinci Single Port (SP) system on the surgery for extraperitoneal approach radical prostatectomy

Enrolled subjects would receive extraperitoneal approach radical prostatectomy using da Vinci SP system and be assessed at baseline (preoperatively), during hospitalization, and postoperatively (at 1 month +/-4 days, 3 month +/- 7 days, 6 months +/- 10 days, 12month +/-14 days). The preoperative assessment includes any diagnostic tests to confirm the subjects' cancer status and eligibility for the intervention under consideration such as transrectal or transperineal biopsy, image studies for staging including MRI/CT and bone scan, and cardiopulmonary tests to evaluate risks for anesthesia. The hospitalization assessment includes the collection of perioperative and postoperative details, conversions, and complications. The postoperative assessment includes regular follow up studies to evaluate cancer status and functional outcome (For sexual function, the International Index of Erectile Function (IIEF-5) would be recorded before and after the surgery. For continence, the number of pads per day and 24hr total weight of pads would be recorded. No pad used or one safe pad per day with net wet ≤ 50gm would be considered as continent. International Prostate Symptom Score (IPSS) wound be recorded before and after the surgery to access voiding function).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with biopsy-proved prostate cancer
2. Stage clinical T1-T2N0M0
3. Prostate volume ≦ 70cm (by transrectal ultrasound or other image studies)
4. BMI ≦ 35 kg/m
5. Low priority of nerve sparing (pre-op sexual dysfunction or don't care about sexual function)
6. Age between 18 and 78 years old
7. Suitable for minimally invasive surgery
8. Patients willing and able to provide informed consent
9. Patients willing and able to comply with study protocol requirements and follow-up

Exclusion Criteria:

1. Previous abdominal or pelvic major operation history
2. Previous radiation treatment to the pelvic area
3. Patients received transurethral resection of prostate in three months
4. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions

   * Severe heart disease (NYHA functional class III-IV)
   * Severe lung disease (GOLD Group C-D)
5. Anatomy unsuitable for endoscopic visualization or minimally invasive surgery
6. Hemodynamic or respiratory instability after anesthesia
7. Working space restriction (e.g. kyphosis or severe scoliosis)
8. Emergency surgery
9. Untreated active infection
10. vulnerable populations
Return to Sport After Posterior Spinal Fusion

The primary purpose of this prospective study is to determine when adolescent athletes with idiopathic scoliosis are able to return to sports participation after posterior spinal fusion surgery.

The investigators aim to determine at what time subjects return to athletic activity, and how long after surgery they are performing at pre-surgical levels. The investigators will enroll adolescent athletes that meet the inclusion criteria below, and follow their postoperative activity level with standardized activity questionnaires on a monthly basis until the subject reaches their baseline pre-surgical performance level. The investigators primary aim is to determine at what time patients return to sports without any restrictions to contact level or type of play. The investigators secondary aim is to quantitatively assess when patients are able to compete at their prior level of play as determined by self-assessment surveys, as well as identify any post-operative complications in these patients after return to sports.

Eligibility Criteria:
Inclusion Criteria:

* Level of play: high school or club level
* Frequency of play at above level: \>3mos/year
* Age: 10-18 years of age (inclusive)
* Sports: at least one sport, contact, non-contact, or collision. No sports exclusion criteria
* Spinal deformity criteria: Adolescent idiopathic scoliosis, curve size 40-75 degrees

Exclusion Criteria:

* Play at recreational/intramural level
* Non-English Speaking Patient
* Sports participation \<3 mos/year
* Non idiopathic etiology or curves \>75 degrees
* Treatment outside of Children's Hospital Colorado provider care network
COVID-19 Infection and Epithelial Cell Markers

To assess if TSLP expression by airway epithelial cells following COVID-19 infection regulates viral load and disease severity.

The study aim is to determine the relationship between COVID-19 infection and epithelial cell expression of TSLP. Two cohorts will be used. Cohort One will include 100 hospitalized patients with Covid-19, and 100 hospitalized patients without Covid-19. Cohort 2 will include mild/moderate asthmatics and healthy controls with bio-banked biopsy material used from donors who have previously consented for samples to be used for future research.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and above;
* Able to give informed consent;
* Clinically tested for SARS-CoV-2 (as completed by standard laboratory testing e.g. RT-PCR) and with a positive result and clinical features in keeping with COVID-19 illness. The control group will be patients with a negative RT-PCR COVID-19 test and without any clinical features to suggest COVID-19 illness. In addition, the control group should have NO known or current features of respiratory infection, COPD, asthma, interstitial lung disease, other respiratory inflammatory conditions or lung cancer.
* Able to provide a breath sample (as based on clinical judgement).

Exclusion Criteria:

- none
Gemcitabine With Curcumin for Pancreatic Cancer

The study hypotheasis is that curcumin, a natural compound with a potent antiproliferative effect, can improve the efficacy of the standard chemotherapy gemcitabine in patients with advanced pancreatic cancer. That is why the patients are given a daily oral dose of 8 gr of curcumin along the chemotherapeutic protocol of weekly gemcitabine.


Eligibility Criteria:
Inclusion Criteria:

* locally advanced or metastatic adenocarcinoma of the pancreas
* no prior chemotherapy
* performance status 0-2
* adequate hematology and chemistry

Exclusion Criteria:

* serious concurrent medical condition
Study to Evaluate Your Super's Moon Balance and Its Impact on Premenstrual Syndrome

This is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common PMS and menstrual symptoms, as well as health-related biomarkers.

It is hypothesized that the dietary supplement marketed as "YOUR SUPER Moon Balance" will improve subjective wellbeing in trial participants by alleviating common symptoms of PMS and menstrual symptoms, such as pain, cramps, bloating, and lack of energy. Further, the ability of the supplement to reduce biomarkers of inflammation (CRP) and stress (cortisol), and promote sleep, will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a regular menstruation
* Age 18-40
* Moderate self-reported discomfort during menstruation-related to bloating, cramps, fatigue, mood swings, or other PMS-related symptoms
* Must be in generally good health - no unstable, uncontrolled health condition
* BMI under 35
* Self-reported sleep-issues
* Willingness to refrain from ibuprofen or naproxen sodium (such as Advil, Aleve, Motrin or Midol) during each period (pill bleed) during the study
* Agree to not change their diet significantly during the duration of the study
* Agree to not change the intensity of their workouts for the duration of the study
* Must get their period regularly

Exclusion Criteria:

* Severe chronic conditions, including oncological and psychiatric disorders
* Known to have any severe allergic reactions
* Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study
* Participants unwilling to follow the study protocol
* Have used a similar product (ingredients) in the 6 weeks prior to the study
Developing an In-vitro Diagnostic Risk-Stratification Test for Oral Cancer

The purpose of this study is to verify the discriminatory value of previously identified salivary transcriptome and proteome markers for oral squamous cell cancer in an intended use population of patients with oral lesions suspicious for cancer.

Saliva samples are collected from patients before clinically driven oral biopsy for lesions suspicious for cancer. Specimens are processed by laboratory personnel blinded to the tissue diagnosis. Six pre-specified mRNA markers (IL1b, IL8, SAT, DUSP1, OAZ1 and S100P) are measured by polymerase chain reaction. Markers are compared in cancer and control by raw Ct values as well as by delta Ct after adjustment for housekeeping gens. Appropriate housekeeping genes are identified in a random subset of cancer and control patients and then verified in the remaining subjects. Predictive models are generated by a pre-specified method and robustness evaluated by bootstrap analysis. The model is then further validated in a second cohort. Three pre-specified protein markers (IL8, IL1B, and M2BP) are a secondary endpoint and will also be compared in cancer and control patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for biopsy of an oral lesion suspicious for squamous cell cancer

Exclusion Criteria:

* Patients with known prior oral malignancy in last 2 years or other cancer in last 5 years other than non melanoma skin cancer or with immune deficiency
Knowledge Translation for Patients With Acute Coronary Syndromes

Cluster randomized open-label experimental study multi-center of 24 hospitals to either knowledge translation vs usual care to improve care of patents hospitalized for acute coronary syndromes.

The AMI-OPTIMA study was a cluster randomized controlled trial of 24 hospitals to one-year knowledge translation (KT) vs usual care. Prior to randomization, we reviewed charts of 100 consecutive acute coronary syndromes (ACS) patients at each participating hospital in 2009. During one year, hospitals randomized to KT completed: 1) revision of the most recent American Heart Association Guidelines of ACS management, 2) focus groups to identify and solve local care gaps, and 3)local champion team to promote evidence-based medical therapy (EBMT). At the end of 12-month of KT/usual care, we reviewed discharge prescriptions of 100 consecutive ACS patients at each participating hospital (year 2012).

EBMT was pre-defined as in-hospital anticoagulation and discharge prescription of dual anti-platelets, beta-blockers, statins, and angiotensin pathway modulating agents (for patients with impaired left ventricular systolic function). Refusal, impaired cognitive function, allergy or intolerance of patients to any of EBMT were considered valid reasons for withholding EBMT.

Eligibility Criteria:
Inclusion Criteria:Had a final discharge diagnosis of one of the following categories:

1. Myocardial infarction with ST-segment elevation
2. Myocardial infarction without ST-segment elevation
3. Unstable angina
4. Acute coronary syndromes -

Exclusion Criteria:

1. Non-atherosclerotic coronary artery disease (as confirmed by coronary angiograms or other non-invasive tests such as stress test, coronary CT-scan, nuclear scans)
2. Hospital stay of less than 48 hours -
Oxytocin, Trauma Disclosure and Intrusions

Severe traumatic experiences such as falling victim to assault, torture, or rape have deleterious effects. Clinical manifestations include intrusions, avoidance behavior, and hyperarousal, which are associated, at a circuit level, with hyperfunction of the amygdala and hypofunction of prefrontal cortex (PFC) subregions. In up to 50 % of the cases, resilience is not sufficient and trauma-exposed individuals develop posttraumatic stress disorder (PTSD). Oxytocin (OXT) is a hypothalamic peptide hormone that exerts anxiolytic effects. Recent clinical trials provide preliminary evidence that post-trauma administration of OXT could be effective as a preventive intervention for PTSD in a subsample of individuals exhibiting early PTSD symptoms prior to the onset of the disorder. However, the underlying neurobiological mechanisms are unclear. Therefore, the rationale of the present project is to expose a sample of healthy participants to experimental trauma in order to explore the circuit mechanisms by which OXT influences, and interferes with, traumatic experience. Functional magnetic resonance imaging (fMRI) will be employed in order to elucidate the long-term effects of intranasal OXT on trauma-induced intrusions, amygdala and PFC responses during an emotional face matching task and resting state functional connectivity.

Participants will be exposed to an experimental trauma (i.e. a highly aversive movie) at days 1 and 4 of the study. After the first experimental trauma and after the first functional magnetic resonance imaging (fMRI) measurement, the participants will receive intranasal OXT or placebo in three different groups (1. OXT for six days, 2. OXT for three days and then placebo for three days, 3. placebo for six days). The same fMRI tasks will be used after the first and second trauma exposure (i.e. one measurement before the treatment and one measurement after three days of treatment).

Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers
* Right-handed

Exclusion Criteria:

* Current or past psychiatric disease
* Current or past physical illness
* Psychoactive medication
* Hormonal contraception
* MRI contraindication (e.g. metal in body, claustrophobia)
Study to Find Maintenance Dose for Periodic Administration of ASP3550

To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.

ASP3550 is administered periodically to patients with prostate cancer. The primary efficacy variable is the effect of ASP3550 on the maintenance of serum testosterone suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven prostate cancer (adenocarcinoma) of all stages
* A patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention
* Serum testosterone level above 2.2 ng/mL
* An ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2
* Serum PSA level above 2 ng/mL

Exclusion Criteria:

* Previous or present endocrine treatment for prostate cancer.

However, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months

* Treated with a 5α-reductase inhibitor
* A candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
* Concurrent or a history of severe liver disease
* Abnormal ECG such as long QTc
* A patient receiving ASP3550 in past times
* Administered drug in another clinical study or a post-market clinical study in the 28 days prior to the study