cyrilzakka/clinical-trials huggingface dataset:
Early Detection of Endometrial/Ovarian Cancer and Hereditary Predisposition of These Cancers

Early stage high-grade cancer, endometrial and ovarian, has few, if any, symptoms or signs. When symptoms appear, the disease may be in advanced stage as the disease has left the gynaecological organs and metastasized to the pelvic/abdominal cavity. The McGill research group had showed in the DOvEE trial (NCT02296307), that fast-track assessment with transvaginal ultrasound scans (TVUS) and serial CA125 of women with vague symptoms associated with ovarian and endometrial cancer did diagnose these cancers earlier in the disease trajectory, with low-volume resectable disease, but only after the cancer had already become Stage III. One way to detect these cancers earlier is to screen asymptomatic women. Unfortunately, none of the currently available tests, including TVUS and CA-125 have been shown to be useful for screening for ovarian or endometrial cancer.

The McGill team has developed a genomic assay to screen and detect these cancers earlier in the trajectory than is currently the case. The test identifies pathogenic somatic mutations (necessary early steps in the development of these cancers), in an uterine cytological sample. It is able to do so by incorporating a deep machine-learning derived classifier that can discriminate the mutational signature of these cancers from benign disease with a sensitivity of 70% and a specificity of 100% in a population with high background mutational burden. In addition to the intra-uterine cytological sample, the test includes an assay of a saliva sample to identify germline mutations that predispose to hereditary endometrial/ovarian cancers as well as breast and colon cancers.

The test was developed in a retrospective population in whom the assay was done pre-operatively and the diagnosis of malignancy versus benign gynecological disease was confirmed by detailed pathological analysis of the uterus, tubes, and ovaries after surgical resection (NCT02288676). The test is now ready to be tested as a phase III diagnostic test in the general population to see if these results are just as promising in the community at large.


Eligibility Criteria:
Inclusion Criteria:

- Capacity to understand study and provide informed consent

Exclusion Criteria:

* Prior hysterectomy
* Be pregnant
* Be nursing
* Be undergoing any fertility treatment
* Have had recent history of uterine perforation
Telehealth as a Modality to Increase the Uptake of PrEP Services in Black and Latino: "e-PrEP"

To evaluate if utilizing Telehealth medicine for access to HIV PrEP will engage more Black and Latino Men who have sex with Men (MSM)

The goal of this study is to determine whether incorporating a telehealth model that allows for same-day appointments for PrEP delivery with the support of navigation leads to increased uptake and persistence of PrEP in young MSM/transgender of color and individuals in rural communities that have disproportionately not used PrEP. The investigators will accomplish this by using an effectiveness-hybrid design that will allow us to both evaluate the interventions impact on relevant clinical outcomes as well as the effectiveness of the implementation strategy. Our hypothesis is that by removing some of the barriers to care such as transportation, childcare, work schedule and potentially stigma with repeated clinic visits, the investigators will increase the uptake and persistence of PrEP amongst communities who historically have had many barriers to care and have not started PrEP.

Eligibility Criteria:
Inclusion Criteria:

1. HIV negative on any FDA approved HIV test within 10 days of starting PrEP 18 years and older
2. No medical or mental health comorbidity that would preclude participating in a clinical study as deemed by the study investigator
3. Able to understand and sign consent in English or with other language interpreter
4. Able to stay in the state catchment area of the license health care provider
5. No use of PrEP for more than 30 days in the last year

Exclusion Criteria:

1. HIV positive
2. If greater and equal to 50 years of age and Renal Glomerular Filtration Rate (GFR) \<30 mg/g
3. \<18 years of age
4. No access to Internet or devise for telehealth
5. Cis-gender Women
Effects of Teriparatide on Distal Radius Fracture Healing

Effects of Teriparatide on Distal Radius Fracture Healing


Eligibility Criteria:
Inclusion Criteria:

Ambulatory, postmenopausal, women 45 to 85 years of age. Postmenopausal is defined as at least 2 years without regular menses

Sustained a unilateral, dorsally angulated fracture of the distal radius within 10 days

Received conservative treatment of her distal radius fracture, including closed reduction and immobilization device (such as cast, splint, or brace)

Free of severe or chronically disabling conditions other than a distal radius fracture as determined by the investigator

Without language barrier, cooperative, expected to return for all follow-up procedures, and has given informed consent before entering the study and after being informed of the risks, medications and procedures to be used in the study.

In the opinion of the investigator, the patient is willing to be trained and use the pen-injector daily, is able to satisfactorily use a pen-type injection delivery system, or is willing to receive daily subcutaneous injections from a care partner who has been trained to use the pen injector

Exclusion Criteria:

Increased baseline risk of osteosarcoma

History of a malignant neoplasm in the 5 years prior to visit 2, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated

Have currently known, suspected, or history of other diseases that affect bone metabolism other than postmenopausal osteoporosis or cause secondary osteoporosis that has been clinically active in the 1 year prior to visit 2

Have elevated serum calcium values

Active liver disease or clinical jaundice

History of symptomatic nephro-or urolithiasis in the 2 years prior to visit 2

Previous fractures or bone surgery in the currently fractured distal forearm

Joint disease such as rheumatoid arthritis or disabling osteoarthritis that clearly affect the function of the wrist and/or hand of the injured arm

Requirement for chronic treatment with nonsteroidal anti-inflammatory drugs defined as more than 3 consecutive months of any NSAID treatment

Treatment with:

Oral bisphosphonates for more than 18 months during the prior 3 years, or have received any oral or intravenous biphosphonate therapy within the last 2 months prior to screening.

Oral strontium ranelate for any duration

Systemic corticosteroids for more than 30 days (total) in the 6 months prior to visit 2, or any systemic corticosteroid dose in the 1 month prior to visit 2. Ophthalmic, oric, topical, or nasally inhaled corticosteroid therapy may be used without these restrictions.

Fluoride at therapeutic doses (greater than or equal to 20mg/day) for more than 3 months during the last 2 years or for more than a total of 2 years, or any dosages within the 6 months prior to visit 2.
Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) for Locally-advanced Cervical Cancer

The standard treatment for locally advanced cervical cancer is well established as a combination of chemotherapy and radiation, typically over 25-28 daily fractions with the addition of a brachytherapy boost to the primary tumor. An important component to treatment efficacy is overall treatment time. Prolongation of overall treatment time has been shown to lead to worse local control and overall survival; thus, strategies to effectively deliver radiation efficiently is required.

This is a pragmatic feasibility study to determine the impact of upfront brachytherapy combined with hypofractionated external beam radiation for patients with locally advanced cervical cancer (FIGO 2018 stage IB3-IVA) on late gastrointestinal and genitourinary toxicity, oncologic outcomes including recurrence free survival, and systemic and local immune response.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed biopsy proven FIGO (2018) clinical stage IB3-IVA cervical carcinoma.
* Histological diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix
* Candidate for definitive radiation therapy as determined by treating radiation oncologist.
* At least 18 years of age.
* ECOG performance status ≤ 2
* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representative may sign and give informed consent on behalf of study participants.

Exclusion Criteria:

* Any prior pelvic radiotherapy.
* Any prior gynecologic or other pelvic malignancy.
* Any prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for the trial.
* Evidence of metastatic disease outside of the pelvis or para-aortic nodes.
* Previous hysterectomy or planned hysterectomy as part of initial cervical cancer therapy; this includes patients with a prior history of supracervical hysterectomy.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test day of or within 7 days prior to simulation.
* Major surgery ≤ 3 weeks prior to initiating protocol therapy; if a patient has had major surgery prior to 3 weeks, they must have recovered from any surgical effects.
* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome.
CRP Apheresis in STEMI

Background: In patients with acute ST-elevation myocardial infarction (STEMI), the amount of infarcted myocardium (infarct size) is known to be a major predictor for adverse remodeling and recurrent adverse cardiovascular events. Effective cardio-protective strategies with the aim of reducing infarct size are therefore of great interest. Local and systemic inflammation influences the fate of ischemic myocardium and thus, adverse remodeling and clinical outcome. C-reactive protein (CRP) also acts as a potential mechanistic mediator that adversely affects the amount of irreversible myocardial tissue damage after acute myocardial infarction.

Objective: The main objectives of the current study are to investigate the efficacy of selective CRP apheresis, using the PentraSorb®-CRP system, as an adjunctive therapy to standard of care for patients with acute STEMI treated with primary PCI.

Design: Investigator-initiated, prospective, randomized, open-label (outcome assessors masked), controlled, multicenter, two group trial with a two-stage adaptive design.

Innovation: Selective CRP apheresis offers potential to decrease infarct size and consequently improve outcome after PCI for STEMI. This is the first randomized trial investigating the impact of selective CRP apheresis on infarct size in post-STEMI patients. In perspective, the study design allows furthermore to collect robust evidence for the design of a definitive outcome study.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of first acute STEMI in accordance with the European Society of Cardiology (ESC) Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation
2. Symptoms consistent with STEMI with beginning greater than 30 minutes but less than 12 hours prior to primary percutaneous coronary intervention (PCI)
3. CRP elevation of ≥7 mg/l measured between 6 to 16 hours after primary PCI
4. Eligible for primary PCI
5. Age ≥18 years
6. Written informed consent

Exclusion Criteria:

1. Prior acute myocardial infarction, coronary artery bypass surgery or PCI.
2. Persistent hemodynamic instability (Killip class \>2 including cardiogenic shock) or resuscitated cardiac arrest not allowing a CMR scan.
3. The patient is febrile (temperature \>38°C) or has experienced an acute infection with fever in the last 14 days.
4. CRP \>15 mg/l at time of hospital admission.
5. Chronic inflammatory disease.
6. Known history of severe hepatic failure
7. Chronic kidney disease with a creatinine clearance \<30ml/min./1.73m²
8. Contraindication to CMR.
9. Pre-STEMI life expectancy of \<1 year
10. Participation in another interventional trial
11. Limited possibility to join the follow-up examinations (e.g. patient lives abroad)
12. Pregnancy
Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry

The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.

The primary objective of the Accuryn Registry Study is to is to track and analyze changes in physiologic data streams using the Accuryn Monitoring System and correlate these changes to the occurrence of acute kidney injury (AKI) following cardiac surgical intervention(s).

The secondary objective is to determine the incidence of intraoperative and postoperative intra-abdominal hypertension in the cardiovascular surgery population, analyze what factors may contribute to the development of intra-abdominal hypertension (IAH) in this patient population, and analyze associations of IAH with organ dysfunctions such as acute kidney injury and other clinical outcomes (e.g. ICU length of stay, required hemodialysis, readmission).

Eligibility Criteria:
Inclusion Criteria:

1. Signed or Verbal Informed Consent as required by IRB (if applicable).
2. Adult (age ≥ 18).
3. Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment).
4. Patient is undergoing cardiac surgical intervention(s).

Exclusion Criteria:

1. Known history of advanced chronic kidney disease defined by an estimated glomerular filtration rate (eGFR) \<20 mL/min/1.73m2 within 30 days prior to procedure.
2. The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as pregnant women, prisoners ,or those detained in a penal institution.
Association Between Mitochondrial DNA Content and Risk of Gastric Cancer

Compelling epidemiological evidence indicates that alterations of mitochondrial DNA, including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with the initiation and development of gastric cancer.The aim of this study was to explore association between mtDNA content in peripheral blood cells could be used as a risk predictor for gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1.histological confirmed gastric adenocarcinoma; 2.receiving surgical resection; 3.no preoperative anticancer treatment; 4.alive at least 1 months after surgery.

Exclusion Criteria:

* 1.history of other malignancy; 2.blood transfusion within one month or prior bone marrow transplantation; 3.patients who reluctant to sign informed consent.
Study of Safe Blood Transfusion Volumes to Correct Acute Severe Anaemia

Greater volume of whole blood(30mls/kg compared to 20mls/kg) following standard calculations, given to children with severe anaemia will be beneficial in haematological correction and can be given safely since respiratory distress and haemodynamic changes result from acidosis and compensation in these children rather than from biventricular failure.

Severe anemia (SA, hemoglobin \<6 g/dl) is a leading cause of pediatric hospital admission in Africa, with significant in-hospital mortality. The underlying etiology is often infectious, but specific pathogens are rarely identified. Guidelines developed to encourage rational blood use recommend a standard volume of whole blood (20 ml/kg) for transfusion, but this is commonly associated with a frequent need for repeat transfusion and poor outcome. Evidence is lacking on what haemoglobin threshold criteria for intervention and volume are associated with the optimal survival outcomes.

We evaluated the safety and efficacy of a higher volume of whole blood (30 ml/kg; Tx30: n = 78) against the standard volume (20 ml/kg; Tx20: n = 82) in Ugandan children (median age 35.5 months (interquartile range (IQR) 12.5 to 52.5)) for 24-hour anemia correction (hemoglobin \>6 g/dl: primary outcome) and 28-day survival.

Eligibility Criteria:
Inclusion Criteria:

* Severe anaemia(HB less than 6g/dl)at admission
* Guardian or parent willing/able to provide consent

Exclusion Criteria:

* Malignancy
* Surgery
* Acute trauma
* Severe malnutrition
Non-motor Symptoms, Balance, Muscle Strength, and Functional Mobility in Patients With Parkinson's Disease

The purposes of this study is to examine balance, muscle strength, and mobility in relation with non-motor symptoms (NMSs) in patients with Parkinsosn's Disease (PD).

NMSs have been shown to be the key determinant of health-related quality of life (HRQoL) and have a greater effect on HRQoL compared to motor symptoms.Despite a growing literature on NMSs, there are few data on the association between NMSs and motor phenotypes of PD, and they have usually focused only on specific domains of NMSs, such as cognition, mood/anxiety issues, or sleep disorders.

When literature is examined, there is no study which examines balance, muscle strength, and mobility in relation with NMSs in patients with PD.For all these reasons, we think that balance, muscle strength, mobility, and NMSs in patients with PD are worse than those of the healthy individuals and that there is a relationship between NMSs and motor symptoms.


Eligibility Criteria:
Inclusion Criteria:

* being diagnosed with PD by a neurologist, being in Hoehn \& Yahr Stage 1-3, having no musculoskeletal system problems in the previous 6 months, having a score of 24 or more in the Mini-Mental State Examination (MMSE), and being volunteer.

Exclusion Criteria:

* Healthy individuals of similar age and sex, without neurological problems, and who did not experience any musculoskeletal system problems in the previous 6 months were included in the control group.
Proteomic Assessment of Preterm Birth

The purpose of this study is to to collect and store blood samples that will be utilized to develop a multimarker test to predict preterm delivery.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years or older.
* Subject has a singleton pregnancy.
* Subject is able to provide consent.

Exclusion Criteria:

* Subject is pregnant with more than one fetus.
* There is a known or suspected fetal anomaly.
Comparison of 2 Laryngoscopes for Endotracheal Intubation in Children Younger Than 2 Years Old

This is a prospective randomized clinical study to be performed in pediatric patients under the age of 2 years who are undergoing surgical procedures requiring endotracheal intubation. Time to endotracheal intubation will be compared between patients intubated using a GlideScope® video laryngoscope, those intubated with a Storz DCI® video laryngoscope, and those intubated by standard direct laryngoscopy. The study hypothesis is that the time to endotracheal intubation will be decreased in the Storz DCI® video laryngoscope group when compared to the GlideScope® video laryngoscope group and standard laryngoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients under the age of 2 years undergoing surgeries requiring endotracheal intubation at LLUMC will be eligible for participation in this study

Exclusion Criteria:

* Children with increased pulmonary aspiration risk;
* Prior documentation of difficult endotracheal intubation;
* Those that lack legal representative consent
Melatonin Use for Sleep Problems in Alcohol Dependent Patients

A double blind Randomized Controlled Trial with two arms will be used. Subjects with Alcohol use disorder and sleep problems will be recruited and assigned randomly to the active treatment Melatonin or Placebo arms. All subjects will be assessed at baseline for demographics. Sleeping problems will be the primary outcome of the study, and it will be measured by the Pittsburgh sleep quality index (PSQI) scale.

A double blind Randomized Controlled Trial with two arms will be used. Subjects with Alcohol use disorder and sleep problems will be recruited and assigned randomly to either Melatonin or Placebo arms. All subjects will complete some forms on the REDCap system such as contact information list, concomitant medication, Time Line Follow Back (TLFB), Fagerstrom test for nicotine dependence (FTND), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), AUD criteria, and Alcohol use disorder identification test (AUDIT). Sleeping problems will be the primary outcome of the study, and it will be measured by the Pittsburgh sleep quality index (PSQI) scale where score 5 or more indicated a sleeping problem. Women in child-bearing period will be asked to do a urine pregnancy test to exclude pregnancy. After verifying eligibility, the participants will come to pick up the medication (Melatonin or placebo) blister together with a sleep hygiene document and will start taking the medication for 4 weeks. All subjects will then be followed-up at the end of 1 month of treatment and PSQI score will be measured. This step will be completed either online by sending an email link through or the participants can come to a personal visit to complete the second PSQI form. Also, this last visit/email will contain side effects questionnaire, TLFB, BDI, BAI. All the participants will be required to bring/send back the medication blister pack to do a pill count and check all the missing pills.

Eligibility Criteria:
Inclusion Criteria:

* Age: 19 or older
* AUD in any stage
* Sleep problems in the past month
* PSQI score \> 5 at baseline
* Participants must agree not to use other sleep aid during the study
* Women capable of becoming pregnant must agree to use contraceptives during study

Exclusion Criteria:

* Pregnancy, lactation or plans to become pregnant during the study timeline.
* Use of other sleep aid in the past month (either prescribed or over the counter remedies)
* Use of benzodiazepines and/or Z- drugs: (zaleplon, zolpidem and zopiclone) in the past month
* Known allergy to melatonin
* Participants taking immunosuppressive drugs.