cyrilzakka/clinical-trials huggingface dataset:
A Safety Study of Dapivirine Vaginal Ring in Africa

This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety of a silicone elastomer vaginal ring containing 25mg dapivirine.


Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 40 years of age inclusive who can provide informed consent
* Available for all visits and consent to follow all procedures scheduled for the study
* Healthy and self-reported sexually active
* HIV-negative
* On a stable form of contraception and willing to continue OR have undergone surgical sterilization at least 3 months prior to enrollment
* In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle defined as having a minimum of 21 days and a maximum of 35 days between menses
* Upon pelvic/speculum examination and colposcopy at the time of enrolment, the cervix and vagina appear normal as determined by the investigator
* Asymptomatic for genital infections at the time of enrolment
* Willing to refrain from use of vaginal products or objects within 14 days from enrollment and for the duration of the study
* Willing to answer to acceptability, adherence and behavioural assessments throughout the study
* Willing to refrain from participation in any other research study for the duration of their participation
* Willing to provide adequate locator information for study retention purposes and be reachable per local standard procedures

Exclusion Criteria:

* Currently pregnant or last pregnancy within 3 months prior to enrolment
* Currently breast-feeding
* Participated in any other research study within 60 days prior to screening
* Previously participated in any HIV vaccine study
* Untreated urogenital infections within 2 weeks prior to enrolment
* Presence of any abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy
* History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, or urethral obstruction, incontinence or urge incontinence
* Pap smear result at screening that requires cryotherapy, biopsy, treatment or further evaluation
* Any Grade 2, 3 or 4 baseline (screening) haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Events
* Any abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrolment
* Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or silicone elastomer
* Any serious acute, chronic or progressive disease
* Any condition(s) that, in the opinion of the investigator, might interfere with adherence to study requirements or evaluation of the study objectives
Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

The purpose of this study is to assess whether either or both nutrition supplements (Impact® Advanced Recovery or Boost® High Protein) ingested prior to and during concurrent chemoradiotherapy decreases toxic side effects of treatment in Stage IIIA-B non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be recruited from the Moffitt Cancer Center Thoracic Oncology Outpatient Clinic when identified by a thoracic oncologist that the patient will undergo all of their chemoradiotherapy at Moffitt.

  * Men and women ≥18 years of age.
  * Diagnosed with unresectable stage IIIA or IIIB non-small cell lung cancer.
  * Patients plan to undergo all cancer treatment at Moffitt Cancer Center with definitive concurrent chemotherapy and radiotherapy.
  * No prior treatment of NSCLC.
  * Able to provide informed consent.
  * Performance status 0, 1 or 2.
  * Life expectancy \>3 months.
  * No esophagitis within 90 days.

Exclusion Criteria:

* Mental incompetence or chronic psychiatric disease.
* Incarcerated individuals.
* Use of antibiotics or probiotic supplements within one month of chemoradiotherapy.
* Allergy to any of the components of Impact® Advanced Recovery or Boost® High Protein.
* Pregnant female or breast-feeding. Any female patient \<45 years old not using appropriate contraceptive measures during the treatment.
* Sepsis or active infection.
* Chronic renal failure stage IV (requiring protein restriction) or stage V requiring dialysis.
* Malnutrition defined as BMI \<16.
* Inflammatory bowel disease (ulcerative colitis or Crohn's disease).
* Severe hepatic dysfunction (baseline prothrombin time off any anticoagulation of international normalized ratio (INR) \>1.8).
* Significant digestive disease with nausea, vomiting or diarrhea, NCI Grade \>1.
* Use of IL-6 inhibitors (tocilizumab or siltuximab) within last 6 months.
Respiratory Variation in Central Venous Oxygen Saturation Predicts Volume Responsiveness in Hemodynamically Unstable Patients Under Mechanical Ventilation : a Prospective Cohort Study

Vascular filling is the main treatment of hypovolemia. Hypovolemia diagnosis can be difficult in some situations and need to be confirmed with other investigations.

Venous oxymetry based on the ScvO2 values represent a valuable way to predict responsivness to fluid filling maneuver in patients with hemodynamic instability.

Vascular filling represent the milestone of the treatment of hypovolemia. Its main objective is to restore vascular volume and correct perfusion issues preventing the deleterious consequences of prolonged shock.

Hypovolemia diagnosis is easy to made in obvious clinical situations such as hemorrhagic shock, deshydratation..., but there still many diagnostic difficulties regarding latent hypovolemia especially if associated with left ventricular dysfunction.

In this situations, diagnostic of hypovolemia is hard to made and other investigations are needed.

Central venous pressure (CVP) and pulmonary occlusion artery pressure (PAPO) are the mainly used parameters for indicating vascular filling but actually many studies underline their low liability in this situation.

After vascular filling, outcome measurment is needed to evaluate the efficacity of the treatment.

Outcome measurment based on hemodynamic criteria is still insufficient. In fact, tissue hypoxia persists if the cardio - respiratory system did not adapt to the metabolic needs, that's why a pathway based on therapeutic objectives like venous oxymetry is needed.

Theorically, a filling maneuver is beneficial if associated with a ScvO2 amelioration. It reflects the amelioration of cardiac output and predicts the positive responsivness to the filling test.

Eligibility Criteria:
Inclusion Criteria:

* patients aged above 18 year old
* hemodynamic instability (hypotension or shock)

Exclusion Criteria:

* intra cardiac shunt
* severe arrythmia
* valvular regurgitation
* pacemaker
* pulmonary oedema
Financial Coaching and Lifestyle Intervention for Diabetes Prevention in Low-income Families

The purpose of this study is to compare the effect on weight and metabolic outcomes of an enhanced intervention, comprised of evidence-based financial coaching plus a lifestyle intervention vs. the lifestyle intervention alone


Eligibility Criteria:
Inclusion Criteria:

* English speaking parents
* BMI\>25.0 at baseline
* must have a child participant in the Brighter Bites program at study enrollment
* own a smartphone (Android 6 and iPhone 12.4 or later)
* must able to participate in study activities

Exclusion Criteria:

* medications known to affect appetite or body composition (e.g., corticosteroids, antidepressants, beta blockers, sulfonylureas, insulin)
* currently diagnosed with conditions known to affect body composition or fat distribution (e.g., Cushing's syndrome, hypothyroidism)
* diagnosis of an eating disorder
* currently pregnant.
Comparison of the ID NOW and Accula Point-of-Care Assays for Detection of COVID-19

This study is a comparison of the ID Now COVID-19 (Abbott) assay to the Accula SARS-CoV-2 (Mesa Biotech) assay to assist in the identification of infection with COVID-19. The tests will be compared for sensitivity, specificity, positive predictive value and negative predictive value.

In response to the pandemic, the Food and Drug Administration (FDA) approved several platforms under emergency use authorization (EUA). These platforms do not have full FDA approval and may be used for COVID-19 testing temporarily in a clinical laboratory until the manufacturer receives full FDA clearance for use in the U.S.

Two point of care (POC) platforms with current EUA approval are the ID NOW COVID-19 (Abbott) and the Accula SARS-CoV-2 tests (Mesa Biotech). Both tests are designated as clinical laboratory improvement amendments (CLIA) waived complexity. POCs play a vital role in the diagnosis of COVID-19, especially in laboratories and clinics where testing including molecular assays and serology is not available.

The purpose of this study is to compare SARS-CoV-2 results from clinical specimens on the ID NOW and the Accula systems. If the Accula system is comparable or demonstrates superior test parameters including sensitivity, then this assay may potentially assist in improving turnaround times for COVID-19 results and facilitate reinstating elective procedures.

Patients with orders for rapid Covid-19 testing and who have consented to participate will be included. For these patients one additional clinical specimen, a nasal specimen will be collected from the patient at the same time as the initial specimen for the ID NOW. If there is a discrepancy between the ID NOW and Accula test results, an additional specimen (nasal) will be collected from the patient, if possible (i.e. if the patient remains in-house) to confirm the COVID-19 results. We will also include patients who did not have an initial swab but tested positive by PCR. They will be swabbed by both systems.

This study will evaluate accuracy by comparing Accula results to the ID NOW, precision (reproducibility) by repeating select specimens with different users and on different analyzers, limit of detection by diluting commercial SARS-CoV-2 controls with a known concentration and cross-reactivity by testing known respiratory viruses (including influenza A, B and RSV) on the Accula.

Eligibility Criteria:
Inclusion Criteria:

* Covid-19 testing has been ordered in the Emergency Dept. or for inpatients in the hospital or patient has already tested positive via PCR.
* Adult patients
* Consent obtained

Exclusion Criteria:

* Testing not ordered or tested negative via PCR.
* Children
* Do not consent
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients

The purpose of this study is to investigate safety and tolerability after high Single Ascending Oral Doses of AZD1656.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures.
* Male, T2DM patients aged 20-60 years
* Treatment with 1 to 2 OADs as Therapy for T2DM for at least 30 days prior to enrollment
* Patients should not have been treated with glitazones within 6 months prior to enrollment
* Male T2DM patients without known cardiovascular disease, with the exception of Grade 1 hypertension without secondary organ involvement (eg. grade 1 HT is allowed if no eye, kidney disease or LVH has been documented).

Exclusion Criteria:

* History of ischemic heart disease , heart failure, stroke, transitory ischemic attack or peripheral vascular disease.
* Prolonged QTcF\>450 msec or shortened QTcF\<350 msec or family history of long QT syndrome.
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
* Systolic BP\>159 mmHg or diastolic BP\>99 mmHg at screening and on Day-1
Changes in Gut Hormones, Body Composition and Energy Expenditure After Roux-en-Y

The purpose of this study is to gain a better understanding of the mechanism of weight regain through gut hormone (substances in the gut that control various functions of the digestive organs) and energy expenditure (the amount of energy a person uses to complete bodily activities).

Our hypothesis is that gut hormone response might be different among subjects who are able to maintain weight loss and subjects with weight regain.

For this study, investigators will measure fasting and postprandial (happening after a meal) gut hormones, bile acid, amino acids, vitamin B, vitamin D, myokines and adipokine levels in obese individuals who are at least 2 years after a Roux-en-Y gastric bypass (RYGB). Investigators will also measure resting metabolic rate (RMR) (the amount of energy expended daily) and body composition (the proportion of fat, muscle, and bone of an individual's body). The subjects body composition will be analyzed, including fat mass and fat free mass, by a Dual-Energy X-ray Absorptiometry (DEXA). This study will provide more information regarding the effect of RYGB on gut hormones, adipokines, bile acids, amino acids, and energy expenditure and body compositions.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-65 years of age
2. Ability and willingness to provide informed consent

Exclusion Criteria:

1. Surgical/anatomical failure such as pouch enlargement, anastomosis dilation, formation of a gastrogastric fistula,
2. Currently on medication that might affect weight gain including GLP-1 analog
3. Inability to provide informed written consent.
4. Any known history of abnormal thyroid function.
5. Females who are pregnant.
Prediction of Hepatitis C Recurrence in Liver Transplant Recipients

The purpose of the study is to look at cells of the immune system to see if the cells are different among people with different risk factors that have received a liver transplant. We will enroll 50 patients receiving liver transplant and their donors. Both donor and recipient must participate in the order for the recipient to participate in the study. We will take blood samples from these patients and their donors.

To establish whether in-vitro donor-specific immune reactivity patterns can differentiate between those liver transplant recipients who are positive for the Hepatitis C virus (HCV) who are at high risk and those who are at low risk for graft loss secondary to early recurrence of HCV.

An assessment of the recipient's donor-specific immune status can be achieved by measuring T-cell activity, specifically alloreactive primed (donor-specific) T cell activity. It has been shown that detection of IFN-y in short-term enzyme-linked-immunosorbent-spot (ELISPOT) assay is consistent with the presence of primed memory T cells (6). In the transplantation setting, T cells of an allograft recipient that secret IFN-y after short in-vitro exposure to donor cells represent a prior sensitization of recipient to donor antigens in vivo. Clinically interpreted - this priming event may signify the presence of an up-coming, or an on-going, rejection episode. Our limited preliminary data suggest an additional potential clinical value for the in-vitro assessment of donor-specific IFN-y production in predicting those liver transplant recipients at higher risk for recurrence of Hepatitis C.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be \>18 years of age
* Chronic HCV infection (and cirrhosis) - group 1
* HCV RNA positive pre-transplant - group 1
* Liver cirrhosis not due to HCV infection - group 2

Exclusion Criteria:

* All patients \< than 18 years of age
* Patients with hepatitis C infection
* Candidates receiving multi-organ combined transplantation
* Patients who have received a previous liver transplantation
* Patients who are unable to understand English
[18F]Fluoro-PEG-folate PET/CT Imaging in Epithelial Ovarian Cancer

The pre-operative assessment of intra-abdominal tumor load in patients with epithelial ovarian cancer (EOC) remains unreliable with standard imaging modalities. The use of tumor targeted imaging, such as folate receptor (FR)-targeted positron emission tomography (PET) imaging could aid in the preoperative assessment of metastatic tumor load.

This study aims to evaluate the safety and tolerability, and pharmacokinetics of the \[18F\]fluoro-PEG-folate PET tracer and to assess the sensitivity and specificity of a \[18F\]fluoro-PEG-folate PET/CT scan for the preoperative detection of intra-abdominal metastatic lesions in patients with advanced stage epithelial ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

Patients with radiologically FIGO stage IIIB/IIIC EOC based on the conventional CT scan who are:

* scheduled to undergo primary cytoreductive surgery and

  1. in whom EOC is histologically proven, or
  2. in whom EOC is cytologically suspected and a serum CA125/CEA ratio \> 25 is found

or

* treated with neoadjuvant chemotherapy (NACT) and are scheduled to undergo interval cytoreductive surgery and

  1. in whom EOC is histologically proven, or
  2. in whom EOC is cytologically suspected and a serum CA125/CEA ratio \> 25 was found before NACT
  3. and with radiologically FIGO stage IIIB/IIIC EOC based on the response evaluation CT scan after NACT

Exclusion Criteria:

1. Women younger than 30 years of age (in accordance with the guidelines of the Netherlands Commission on Radiation Dosimetry \[23\], as the total radiation dose will be 7.2 mSv)
2. Patients who previously underwent primary laparotomy and in whom complete or optimal cytoreduction was not considered feasible.
3. Contraindication for PET (pregnancy, lactating or severe claustrophobia)
4. Thrombocytopenia (platelet count \< 100 x 10\^9/L) and/or INR \> 2
5. Impaired renal function (defined as eGFR \< 50 mL/1.73 m2)
6. Impaired liver function (ALT, AST or total bilirubin \> 3x upper limit of normal)
7. Clinically significant abnormalities on ECG and/or clinically laboratory test
8. Inability to tolerate lying supine for the duration of a PET/CT examination (\~110 minutes)
9. Patients with concomitant malignancy (except basal cell carcinoma of the skin) or any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient
10. Patients not able to comply with the study procedures
11. Patients who did not give informed consent
Effects of Physical Exercise on Blood Glucose and Pain From the Musculoskeletal System in Patients With Type 2 Diabetes

The aim of this study is to investigate the effects og physical exercise on bloodglucose and pain from the musculoskeletal system in patients with type 2 diabetes.

The patients will be recruited to 12 weeks of exercise twice weekly. The outomes are long term bloodglucose (HbA1c) and pain reported in questionaires. In data analyses the patients will be stratified to patients with a high or a low degree of complications related to diabetes.

Design: Uncontrolled intervention study Patients: Type 2 diabetes from Nordsjællands Hospital, Denmark Inclusion critera: adults, type 2 diabetes, not participating in an ungoing exercise program, able to conduct exercise training Exclusion criteria: unable to understand Danish, psychiatric disorder, dementia Intervention: two times one hour exercise training for 12 week. The training will be combined aerobic and resistance training supervised by physiotherapists Outcome: bloodglucose, pain (questionaire) Sample size: 80 participants

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Type 2 diabetes
* Must be able to perform physical exercise

Exclusion Criteria:

* Participation in structured exercise program within the past three months
* Dementia
* Unable to understand Danish language
A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.

This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetic patients who have completed studies BM18248 or BM18249;
* patients considered by the investigator to be suitable for long term treatment with GK Activator (2).

Exclusion Criteria:

* type 1 diabetes mellitus;
* women who are pregnant, breast-feeding or not using adequate contraceptive methods.
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study

The preferences of pregnant women for postpartum thromboprophylaxis are largely unknown. The aims of this transversal study are to elicit the preferences of pregnant/postpartum women about postpartum thromboprophylaxis in semi-structured interviews, and to estimate the utility of the relevant health states (pulmonary embolism, deep vein thrombosis, postpartum hemorrhage, subcutaneous injections). In this second aim, the investigators will also compare the effect of 2 different techniques to estimate utilities (standard gamble vs. time trade-off), using a randomization of these techniques.


Eligibility Criteria:
Inclusion Criteria:

* women
* ongoing pregnancy or within 7 days of delivery
* fluency in French or English

Exclusion Criteria:

* fetal or neonatal death
Arm Training in Standing After Stroke

This study will examine the feasibility of providing task-oriented arm training in standing or during walking in individuals with movement deficits due to stroke. Participants will received 24 sessions of arm training in standing over an 8-week period that focus on arm and hand function.

Residual motor deficits are common after stroke and often have a negative impact on the performance of functional activities and overall quality of life. A frequently reported contribution to these functional limitations is an inability to incorporate the weaker arm and hand into daily activities. While rehabilitation interventions can improve arm functional capacity, these improvements often do not translate into increased real-world arm use which is often reduced after stroke.

The performance of skilled arm and hand movements in standing requires precise coordination between upper extremity movement and balance control. Many everyday functional tasks that require the arm are performed in standing (e.g. opening a door or meal preparation at the kitchen counter), however, training of arm function in rehabilitation is often done in sitting. An important rehabilitation approach may be to create a training environment that resembles the way the arm is used in everyday life (i.e. standing). This study will examine the feasibility of providing task-oriented, functional arm training in standing and during walking in individuals with motor deficits due to stroke.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Had a stroke at least 6 months prior to enrollment
* Show evidence of continued arm and hand weakness
* Have some ability to move the arm and hand that is weaker from the stroke
* Be able to stand with minimal assistance or less without support of the weaker arm for at least 2 minutes
* Be able to follow two-step commands.

Exclusion Criteria:

* Acute medical issues that would interfere with participation
* Another neurologic diagnosis that may impact movement (e.g. Parkinson's Disease)
* Severe apraxia or hemispatial neglect
* Pain that interferes with arm movement or standing