cyrilzakka/clinical-trials huggingface dataset:
Evaluating Raised Intracranial Pressure Using MR Elastography

Investigators will compare magnetic resonance (MR) elastography measurements to other forms of noninvasive methods of detecting raised intracranial pressure, including optical coherence tomography (OCT) imaging measurements of the retinal nerve fiber layer (RNFL) and indirect signs of raised intracranial pressure on magnetic resonance imaging (MRI).

The goal of this study is to evaluate the brain elasticity in patients with idiopathic intracranial hypertension (IIH) and other forms of raised intracranial pressure, such as obstructive hydrocephalus. Investigators will evaluate for a correlation between brain stiffness and opening pressure on lumbar puncture. Investigators will also evaluate for changes in brain stiffness after interventions that are aimed at lowering intracranial pressure, including lumbar punctures, medications, and surgical interventions, such as ventriculoperitoneal shunts. Lastly, investigators will compare MR elastography measurements to other forms of noninvasive methods of detecting raised intracranial pressure, including optical coherence tomography (OCT) measurements of the retinal nerve fiber layer (RNFL) and indirect signs of raised intracranial pressure on MRI.

Eligibility Criteria:
All subjects will have the following inclusion criteria:

* Group 1: Papilledema from idiopathic intracranial hypertension and other forms of elevated intracranial pressure, including obstructive hydrocephalus
* Group 2: Patients without raised intracranial pressure.

All subjects will have the following exclusion criteria:

* Age \<18
* Pregnancy (self-reported)
* Individuals for whom MR is contraindicated
Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial (MINT)"

The overarching goal of the MINT trial is to reduce treatment-related toxicity while maintaining efficacy. Patients with HPV-related oropharyngeal squamous cell carcinoma (OPSCC) will undergo resection of the primary tumor site and involved/at risk regional neck nodes.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed HPV-related stages I-III OPSCC (8th edition of AJCC/UICC Staging Manual) or HPV-related neck node with unknown primary. HPV-related may be defined by p16 IHC stain and/or HPV-ISH or PCR using standard definitions of positive and negative test results.
* Primary tumor that will be resected via a transoral oral approach (conventional surgery, transoral laser microsurgery, transoral robotic surgery)
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
* Normal organ and marrow function defined as:

  * Creatinine clearance \> 50 cc/min.
  * ANC \> 1,000/mcL.
  * Platelet count \>100,000/mcL.
* At least 18 years of age.
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Prior curative therapy for HNSCC.
* Patient must not have known distant metastatic disease at presentation.
* History of prior invasive malignancy diagnosed within 2 years prior to study enrollment; exceptions are malignancies with a low risk of metastasis or death (e.g., expected 5-year overall survival (OS) \> 90%) that were treated with an expected curative outcome, such as squamous cell carcinoma of the skin, in-situ carcinoma of the cervix uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b).
* Receiving any other investigational agents.
* Uncontrolled serious inter-current illness or serious psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant and/or breastfeeding. A negative serum or urine pregnancy test is required at screening for all female patients of childbearing potential.
Genetic Linkage Study for Hereditary Pancreatitis

The purpose of this study is to establish linkage in families with hereditary pancreatitis (HP) to the cationic trypsinogen gene or other, as yet unknown, HP gene(s).

Hereditary Pancreatitis (HP) is an inflammatory condition of the pancreas which is usually recurrent in nature and occurs in blood-related persons over two or more generations. It is an autosomal dominant trait with complete penetrance by variable expression. Symptoms are usually present during childhood and it is the second most common cause of chronic or recurrent pancreatitis in children. HP is a primary disorder and can therefore be differentiated from other inherited disorders that cause secondary pancreatitis. The purpose of this study is to establish linkage in families with HP between the phenotype and a chromosomal locus (loci) which contains the responsible gene. Affected families are recruited to donate a blood sample through referral from their primary physician or self-referral. The potential significance lies in the identification of the genetic defect causing HP and understanding the pathophysiologic mechanism of the disease. Typically families with HP have a high incidence of adenocarcinoma of the pancreas and identification of the cause of this disease may provide critical insights into the cause of pancreatic cancer.

Blood samples are collected from patients and family members. DNA is extracted from the blood and used for genotypic analysis and linkage analysis. Patients do not necessarily receive the results of the genetic testing and the results do not influence the type or duration of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of pancreatitis at age \< 60 OR
2. Diagnosis of pancreatitis at any age and at least one other 1st or 2nd degree relative with a diagnosis of pancreatitis or pancreatic cancer OR
3. Diagnosis of pancreatic cancer and a 1st or 2nd degree relative with pancreatic cancer or pancreatitis OR
4. Diagnosis of pancreatic insufficiency or maldigestion that improves with pancreatic enzyme replacement OR
5. Close family members (parents, grandparents, siblings cousins - anyone related by blood) of subjects who meet criteria 1, 2, or 3 AND
6. Age 3 months up to 100 years

Exclusion Criteria:

There are no general exclusions.
A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes

The main purpose of this study is to evaluate the efficacy and safety of combination therapy with dulaglutide and insulin in Japanese participants with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have had a diagnosis of type 2 diabetes mellitus
* Participants who have been treated with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin regimen) with or without 1 or 2 oral antidiabetics (OADs) at stable dose for at least 3 months before screening
* Participants who have an HbA1c value ≥7.0% and ≤10.5% at screening if the participant is washing out OADs (dipeptidyl peptidase-4 \[DPP-4\] inhibitors, sulfonylurea \[SU\], or glinides) or ≥7.5% and ≤10.5% at screening if the participant is not washing out OADs
* Participants who have stable weight (±5%) ≥3 months prior to screening
* Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m\^2)

Exclusion Criteria:

* Participants who have a diagnosis of type 1 diabetes
* Participants who have previously received therapy with a glucagon-like peptide-1 receptor agonist within 3 months prior to screening
* Participants who have been previously treated with dulaglutide prior to screening
* Participants who have been treated with 2 of the following at screening: DPP-4 inhibitor, SU, and glinide (ie, DPP-4 inhibitor and SU, or DPP-4 inhibitor and glinide)
* Participants who have been treated with continuous subcutaneous insulin infusion (CSII) at screening
* Participants who have clinically significant gastric emptying abnormality, hepatitis, pancreatitis, renal dysfunction, or thyroid abnormalities
* Participants who have a history of clinically significant cardiovascular disease, transplanted organ, or active or untreated malignancy
Measuring Menstrual Iron Loss Using the Iron Isotope Dilution Technique

It is very difficult to quantify menstrual blood loss, the reference method is a tedious one. This is a problem, as it is not conducive to objectively measuring menstrual blood loss and understanding the contribution of menstrual iron loss to iron deficiency anemia. With this study, the investigators aim to investigate iron loss during the menstrual cycle and aim to validate a much simpler technique.

Anemia reduction efforts have largely focused on increasing iron intakes such as improving diet quality, food fortification with iron, iron supplementation, biofortification. There is little information on the contribution of menstrual iron loss to iron deficiency anemia.

Indeed, the accurate measurement of menstrual blood loss volume and iron loss is difficult. Self-perception of heavy menstrual blood loss poorly predicts actual blood loss, and the objective measurement of menstrual blood loss remains a tedious method. Various methods have been used to objectively measure menstrual blood loss volume including radioisotopes, but these methods are invasive. The investigators aim to validate a much simpler technique, namely the stable iron isotope dilution methodology. This is a promising new method for quantifying long-term body iron balance, absorption, and loss which has not been applied previously to measure menstrual iron losses. Validating this new method against the alkaline hematin reference method would be an important step to encourage menstrual blood loss measurements and shed light on the contribution of menstrual blood loss to iron deficiency and iron deficiency anemia.

Eligibility Criteria:
Inclusion Criteria:

* Female, 18-30 years old
* Already labelled with stable iron isotopes at least 12 months prior to study start
* Weight \<70 kg
* Normal body mass index (18.5 - 25kg/m2)
* Regular menstrual cycle (self-reported cycle length between 28 and 35 days in the past 6 months)
* Signed informed consent
* Able to read and understand English

Exclusion Criteria:

* Use of hormonal contraceptives within a 3-month recall period
* Anemia (hemoglobin \< 117 g/L)
* Any known major metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer, or cardiovascular diseases (according to the participants own statement)
* Women with severe menstrual cramps
* Consumption of iron-containing supplements within 1 month prior to the start of study
* Known difficulties with blood sampling
* Pregnancy (serum human chorionic gonadotropin (hCG) \< 5 mIU/mL)
* Current smoking (\>1 cigarette per week over a 1-month recall period)
* Women who are planning to get pregnant
* Inability to follow the study protocol
Oral Contraceptive Efficacy and Body Weight

The purpose of the blood spot validation portion of the study is to test if measuring female hormone levels in the blood is as accurate through a finger stick, as it is by a blood draw from a vein. The purpose of the feasibility study is to evaluate ovulation occurrence in two populations of oral contraceptive users: heavier and lighter women.

The blood spot validation portion of the study tests the hypothesis that progesterone assays from self-collected daily blood spots are equivalent to serum samples, and that the values obtained can identify women that ovulate. After validating collection methods, enrollment will begin for the feasibility portion of the study looking at thin and heavy women on birth control pills. All women in this portion of the study will take a very-low dose birth control pill that is normally available through a doctor's office. During each month of the study, women will have their blood pressure and weight recorded, and have their blood drawn twice per week or use a finger stick kit daily at home to check for the natural hormones and brain chemicals that tells if an egg develops. During the last week of each menstrual cycle (period week), women will also have their blood drawn to measure the levels of hormone found in the birth control pill. Women will also need to report in a written diary that they have taken their birth control pill for the day.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 35
* single baseline hematocrit ≥ 36%
* single progesterone level of 3 ng/mL or greater during the luteal phase (days 18 to 25) in the menstrual cycle prior to treatment with OCs.

Exclusion Criteria:

* any absolute contraindications to ethinyl estradiol and levonorgestrel
* smoking
* actively seeking or involved in a weight loss program (must be weight stable)
* pregnancy, breastfeeding, or seeking pregnancy
* diagnosis of Polycystic Ovarian Syndrome
* recent (8 week) use of OC (patch or ring included), intrauterine, or implantable hormonal contraception
* DepoProvera use within six months
* current use of drugs that interfere with metabolism of sex steroids.
Prognostic Role of Free Psa Ratio at Biochemical Recurrence After Radical Treatments for Prostate Cancer

Measurement of Free PSA ratio in patients after definitive radical treatment for prostate cancer, and assessment of whether post-treatment free PSA ratio can function as a biomarker for advanced disease in prostate cancer patients.

Prostatic specific antigen (PSA) circulates mostly in complex with protease inhibitors, but 10-30% circulates as inactive free-PSA (FPSA). In patients with prostate cancer (PCa), pretreatment FPSA is lower and used to risk-stratify patients for biopsy. However, posttreatment FPSA ratio (FPSAR) is rarely quantified, with an unexplored clinical value.

Methods The institutional database was queried to identify patients following radical prostatectomy (RP cohort) or radiotherapy (RT cohort) between 2000 and 2017. For validation, the investigators identified an independent prospective cohort with biochemical recurrence (BCR) after RP, using biobank samples (biobank cohort). All patients had at least one posttreatment FPSAR test. Kaplan-Meier (KM) method was used to compare the metastasis-free (MFS), castration-resistant PCa (CRPC)-free, and cancer-specific-survival (CSS) rates. Multivariable Cox models determined the association between posttreatment FPSAR, metastases, and CRPC.

Eligibility Criteria:
Inclusion Criteria:

For the two retrospective cohorts:

1. All patients that older than 18 treated for localized adenocarcinoma of the prostate between 2000 and 2017 with either radical prostatectomy or radiotherapy
2. All treated patients had a rising post-treatment PSA, with at least one post-treatment free PSA blood test.

For the biobank validation cohort:

1. All patients treated with radical prostatectomy for localized prostate cancer between 2000 and 2017 who had biobank samples taken when developing biochemical recurrence.

Exclusion Criteria:

1. Patients that were younger than 18,
2. Patients with prostate cancer other than adenocarcinoma, such as small cell and neuroendocrine cancer
3. Patients with prostate adenocarcinoma that did not develop biochemical recurrence.
4. In the retrospective cohorts - patients that did not have at least one post-treatment free PSA blood test.
ACE2 Chewing Gum on SARS-CoV-2 Viral Load (COVID 19)

A randomized double-blind, placebo controlled clinical trial of the safety, tolerability, and antiviral activity of angiotensin-converting enzyme 2 (ACE2) chewing gum over a 3-day period in non-hospitalized subjects with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide informed consent prior to initiation of study procedures.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged 18 years to 65 years.
4. Had a positive PCR or antigen test for SARS-CoV-2 within 72 hours of enrollment.
5. In the opinion of the investigator, has the ability to comply with study procedures including chewing the study products (gum).
6. Stated willingness to refrain from brushing, eating or using any oral health care products, including mouth rinses at least one hour prior to first saliva sample.
7. Stated willingness to abstain from eating mints or other chewing gums during the duration of the study.
8. Stated willingness to abstain from using mouth rinse/gargling solutions at the time of enrollment and for the duration of the study.
9. Stated willingness to use an acceptable method of birth control throughout duration of the study. Acceptable methods include hormonal contraceptives, barrier methods, abstinence, or other effective methods approved by the PI.
10. Stated ability and willingness to store saliva samples at approximately 40° F for 3 days.

Exclusion Criteria:

1. Individuals receiving antiviral medications that are thought to be active against SARS-CoV-2 in the opinion of the investigator.
2. Individuals receiving oral or injectable antimicrobial medications (antibacterial, antiviral, antibiotics, including hydroxychloroquine) at time of enrollment.
3. Currently undergoing cancer treatment.
4. Pregnant or breastfeeding women.
5. Participation in any other clinical trial within the past 14 days that used an investigational drug product.
6. Admitted to the hospital or other medical facility or in the opinion of the investigator expected to require admission to a medical facility for the duration of the study.
7. Taking chronic immunosuppressive medications at time of enrollment, defined as immunomodulatory agents or a prednisolone dose greater than 10 mg a day.
8. Uncontrolled hypertension, defined as ≥160 mmHg systolic or ≥100 mmHg diastolic.
9. Allergy/hypersensitivity to lettuce, gelatin (plant based), stevia, or unwillingness to consume genetically modified plant material.
Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture

Insertion of a hemiarthroplasty is a well established treatment for a dislocated medial hip fracture in elderly patients. The purpose of this study is to compare unipolar and bipolar hemiarthroplasty as a treatment for patients aged 70 years or above with a dislocated medial femoral neck fracture. The study is prospective and randomised, and will be based on questionnaires, clinical examinations, registration of complications and radiographic evaluation at follow up at 3 months, 1 and 3 years postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Patients ages 70 years or above
* Dislocated medial femoral neck fracture (garden type 3-4)
* Residence in the county of Northern Jutland, Denmark

Exclusion Criteria:

* Pathologic fracture
* Failed formerly internally fixed fracture of the affected hip
* Degenerative joint disease of the affected hip or rheumatoid arthritis
* Dementia
* Terminal neoplastic disease
* No informed consent
Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors

This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle intervention and metformin (a drug used to treat diabetes) to investigate how these treatments, alone or in combination, affect biomarkers associated with breast cancer survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast cancer survivors. After completing the screening process and baseline measures, participants will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle intervention and placebo, or (4) lifestyle intervention and metformin. The intervention was powered on the main effects and the planned analyses are to compare: Metformin to Placebo and a separate comparison of Lifestyle intervention to control. The interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* BMI at least 25.0 kg/m2
* Diagnosed with Stage I, II, or III breast cancer within past 5 years
* Treatment with total mastectomy or breast-sparing surgical removal of cancer with clear macroscopic margins, and axillary dissection, followed by adjuvant breast radiation
* Not scheduled for or currently undergoing chemotherapy
* Accessible geographically and by telephone
* Able to communicate dietary and physical activity data via telephone
* If taking statins, tamoxifen, or aromatase inhibitors; able and willing to remain on treatment for 6-month study period
* Post-menopausal at diagnosis

Exclusion Criteria:

* Preliminary bloodwork outside of specified ranges
* Evidence of renal insufficiency, liver disease, or congestive heart failure
* Currently taking corticosteroid pills or steroid hormone therapy (including vaginal estrogen creams)
* Recent initiation (\< 3 months ago) of thiazides or β-blockers
* Taking insulin or other antidiabetic drug
* Other primary or recurrent invasive cancer in past 10 years
* Unable to commit to study requirements
National Multicenter Registry for Pediatric End-Stage Heart Failure in China

To establish a multicenter pediatric end-stage heart failure (ESHF) specialized disease data platform and promote its adoption across major children's medical centers nationwide. Based on this platform, conduct a national multicenter cohort study on specialized treatments for pediatric ESHF (including pharmacotherapy, ventricular assist devices, heart transplantation, etc.). This initiative will provide a foundational platform for advancing national clinical research on pediatric end-stage heart failure.


Eligibility Criteria:
Inclusion Criteria:

Patients who meet any of the following criteria despite receiving optimal guideline-directed medical therapy (GDMT):

Severe and persistent heart failure symptoms \[New York Heart Association (NYHA) Class III (advanced) or IV\];

Significant cardiac dysfunction, defined as:

Left ventricular ejection fraction ≤30%

Isolated right ventricular failure

Non-operable severe valvular or congenital abnormalities

Persistently elevated B-type natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP) levels

Severe diastolic dysfunction or left ventricular structural abnormalities (based on ESC definitions for heart failure with preserved ejection fraction \[HFpEF\] and heart failure with mildly reduced ejection fraction \[HFmrEF\]);

Requirement of:

High-dose intravenous diuretics (or combination diuretic therapy) for pulmonary/systemic congestion, OR

Inotropic/vasoactive agents for low cardiac output, OR

Management of malignant arrhythmias Resulting in \>1 unplanned hospital visits or admissions within the past 12 months;

Severely impaired mobility due to cardiac causes with either:

Inability to ambulate, OR

6-minute walk distance \<300 m, OR

Peak oxygen consumption (PvO₂) \<12-14 mL/kg/min. -

Exclusion Criteria:

Concurrent life-limiting systemic disorders

Structural cardiac lesions with indication for surgical/interventional correction -