cyrilzakka/clinical-trials huggingface dataset:
Exercise-induced Changes in Exosomes

The proposed study aims to shed light on the function/importance/relevance of exercise-induced changes in exosomes to connective tissues. Exosomes are known to increase robustly in response to exercise. We have previously shown that serum isolated from subjects after they lift heavy weights increases human engineered ligament collagen content and mechanics more than serum from before they lift weight. Further, we showed that exercise-induced changes in hormones could not explain the change in ligament structure or function. These data indicate that there is a significant gap in our understanding of muscle-connective tissue crosstalk. To address this gap, the current proposal seeks to: i) isolate and sequence exosomal RNA (long non-coding, miR, and mRNA) and ii) determine whether exosomes isolated from serum after exercise increase engineered ligament mechanics and collagen content.


Eligibility Criteria:
Inclusion Criteria:

* Young healthy adults (18-35 y)
* Experience with exercise (\>1y)

Exclusion Criteria:

* Pregnancy
* Smoking
* Receiving any medication that may interfere with the study outcomes
Initiation of Cooling by EMS to Promote Adoption of In-hospital Hypothermia in Cardiac Arrest Survivors

This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional post-resuscitation care. The goal of this trial is to increase the proportion of cardiac arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to reach the target body temperature within 6 hours of hospital arrival. The investigators believe that EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system.

This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional post-resuscitation care. The goal of this trial is to increase the proportion of cardiac arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to reach the target body temperature within 6 hours of hospital arrival. The investigators believe that EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system. This study builds on our previous work using large hospital networks hospitals to improve the delivery of evidence-based practice.

The primary research question is as follows: Does pre-hospital initiation of therapeutic hypothermia by EMS providers increase the proportion of comatose out of hospital cardiac arrest patients with return of spontaneous circulation (ROSC) that are successfully cooled to a target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival, compared to usual post-resuscitation care provided in the field? The primary outcome is the proportion of included patients that are successfully cooled to reach target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival.

Eligibility Criteria:
Inclusion Criteria:

* Pulseless OHCA in the study communities (any rhythm, initial rhythm will be recorded)
* Age equal to or greater than 18 years
* Defibrillation and/or chest compressions by EMS providers (including fire fighters)
* Return of spontaneous circulation (ROSC) sustained for greater than or equal to 5 minutes
* Patient is unresponsive to verbal stimulus using AVPU (Alert, Voice, Pain, Unresponsive) scale
* Patient is endotracheally intubated
* SBP equal to or greater than 100 mm Hg (even if needing dopamine)

Exclusion Criteria:

* Trauma (including burns) associated with cardiac arrest
* Sepsis or serious infection suspected as cause of cardiac arrest
* Clinical evidence of active severe bleeding
* Suspected hypothermic cardiac arrest
* Known coagulopathy (medical history or medications; ASA and clopidogrel are permitted)
* Any verbal or written do-not-resuscitate (DNR)
* Obviously pregnant
* Known Prisoner
Misoprostol in Missed Abortion

In this study we compare between the effectiveness of combined Foley's catheter with Misoprostol and intracervical Foley's catheter alone for termination of second trimester abortion.

Termination of pregnancy (TOP) is defined as elective expulsion or extraction of products of conception from uterus instead of spontaneous onset of process irrespectable of duration of pregnancy. Worldwide mid-trimester abortion constitutes 10-15% of all induced abortions but responsible for two-thirds of all major complications Despite the recent advances in prenatal diagnosis in first trimester. Termination of pregnancy in second trimester due to foetal abnormalities and intrauterine foetal death still accounts for large number of abortions, and has increased the demand for rapid termination of pregnancy. In intrauterine fetal death in 2nd trimester, expulsion may take several weeks. This is associated with psychological trauma, coagulopathy and intrauterine infection. Among various methods of second trimester termination, evacuation and curettage induces risk of bleeding, infection, uterine perforation and cervical trauma. The introduction of misoprostol , a synthetic prostaglandin E1 analogue (PGE1) has become an important for cervical ripening and uterotonic action. It is economic, stable at room temperature and is associated with few side effects such as fever, vomiting and diarrhea. There is still debate about doses, routes and regimes of PGE1 for termination of pregnancy during 2nd trimester. It is active orally but more effective and better tolerated when administrated vaginally and has fewer side effects. Vaginal route is preferred in first and second trimester. The use of Foley's catheter has been recommended in many developing countries. The reports from different countries have mentioned excellent results with the use of Foley's catheter either alone or in combination with prostaglandins. The scope of our study: is to compare the use of Foley's catheter combination with Misoprostol versus Foley's catheter alone for pre induction cervical ripening and induction of second trimester abortion.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 - 40 years of age with mid-trimester fetal death inutero.

  * Singleton pregnancies from 18-24 weeks.
  * women with unfavourable cervix (Bishop Score \< 5) at the time of recruitment.
  * Previous one CS and non-previous CS pregnant women.

Exclusion Criteria:

* • Previous 2 CS or more.

  * Medical contraindications for prostaglandin therapy (allergy to prostaglandins or severe asthma).
  * co-morbidities like severe anemia (Hb \< 7g/dl), hypertension, diabetes, or coagulopathy .
  * Women with excessive vaginal discharge or rupture of membrane.
  * Women having any complication in previous caesarean like endometritis, reopening, scar dehiscence etc.
  * Active genital infection e. g. active genital Herpes simplex infection.
Anterior Cruciate Ligament Reconstruction and Plyometric Exercise

This is a single-center, randomized, double-blind (subject/evaluator)study. Enrolled patients had anterior cruciate ligament (ACL) reconstruction and met criteria for advanced rehabilitation. The study included 8 weeks of advanced rehabilitation consisting of low- or high-intensity plyometric exercise. The objective of the study was to determine the effect of plyometric exercise intensity on knee function and knee cartilage in patients with ACL reconstruction.

As part of the study, investigators will insure patients meet the criteria for advanced rehabilitation based on knee motion, pain levels and quadriceps strength.

Participants will be asked to review the informed consent and consent to the study prior to any study procedures. The study will consist of 2 testing sessions and an 8 week intervention (2 visits per week) at the UF\&Shands Orthopaedics and Sports Medicine Institute. The testing sessions will include clinical measures of knee impairments, questionnaires, biomechanical analysis and functional performance testing.

Eligibility Criteria:
Inclusion Criteria:

1. time from injury to ACL reconstruction is no greater than 6 months,
2. pre-injury activity level includes participation in high-demand activities, and
3. meet the criteria for advanced rehabilitation including full active knee extension, active knee flexion within 5 degrees of the contralateral side, pain rating no greater or equal to 1/10 with activities of daily living, and involved side knee extensor strength at least 60% of the contralateral side.

Exclusion Criteria:

1. bilateral knee injury,
2. prior knee ligament injury and/or surgery,
3. concomitant other ligamentous injury \> Grade I,
4. meniscal repair performed in conjunction with ACL reconstruction,
5. cartilage repair procedure performed in conjunction with ACL reconstruction,
6. complications during surgery requiring protocol modification, and
7. renal disease.
Pilot Study of OXP001 and Brufen in Healthy Subjects

Oxford Pharmascience (the sponsor) is developing a new formulation of Ibuprofen (OXP001 - the study drug) which it is proposed will have less of the side effects than are currently reported with standard prescription strength Ibuprofen.

This study will compare the study drug to an already marketed formulation of prescription strength Ibuprofen (the reference product) by looking at how the drug is taken up by the body and also by performing a specialist procedure called an endoscopy (or more specifically a gastroscopy). The safety and tolerability of the study drug will also be assessed.

The study will involve approximately 44 healthy male and female subjects. Subjects will be randomly assigned to receive either the study drug or reference product for 8 days. On Day 1, subjects will receive a single 800 mg dose of ibuprofen. On Days 2 to 9, subjects will receive 800 mg ibuprofen three times a day.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Aged 18-55 years
* Normal, healthy upper gastrointestinal tract

Exclusion Criteria:

* History of or concurrent gastric irritation or ulcers
* History of allergy to non-steroidal anti-inflammatory drugs (NSAIDs)
Trial of Two Central Venous Catheter (CVC) Flushing Schemes in Pediatric Hematology and Oncology Patients

The purpose of this study is to determine whether flushing Central Venous Catheters (CVCs) with Normal saline once per week is not inferior to flushing with 10U/ml heparin 3 times per week, in preventing CVC occlusions.

Tunneled central venous catheters (CVCs) are now used routinely in pediatric hematology and oncology patients. Flushing with heparin solution is routinely recommended to prevent occlusion of long term CVCs, although the concentration of heparin used, and frequency of its use varies between centres. Once weekly Normal saline is also used successfully in some pediatric enters. There is little evidence to support one method over the other.

The investigators have designed a randomised crossover trial to directly compare once weekly Normal saline flushing with 3 times per week 10U/ml heparin flushing, to determine whether Normal saline is not inferior to heparin.

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of any malignant or nonmalignant disease that requires a single lumen Broviac or double lumen Hickman-type CVC for the purpose of chemotherapy, blood product support or hematopoietic stem cell transplantation.
* CVC is planned to remain in situ for 6 months from study entry

Exclusion Criteria:

* Thrombophilia (e.g. Factor V Leiden mutation, antiphospholipid syndrome) or previous thrombosis requiring anticoagulation (e.g. enoxaparin, unfractionated heparin)
* Bleeding disorder (e.g. von Willebrand's disease, hemophilia)
* Previous CVC that was removed due to any complication
Trial of Nonpharmacologic Interventions in Elderly (TONE)

To test the efficacy of weight loss and sodium restriction, alone and combined, in maintaining the normotensive state following withdrawal of antihypertensive medications in an elderly cohort. Conducted in collaboration with the National Institute on Aging.

BACKGROUND:

An estimated 30 to 40 percent of elderly persons are treated with blood pressure medications. The efficacy of blood pressure drug therapy in older patients with diastolic or combined diastolic/systolic hypertension is well proven, but such therapy can adversely affect quality of life and biochemical profile. In 1992 when the study started, there was a compelling rationale to identify what proportion of medicated, well-controlled elderly hypertensives could be maintained long-term or greater than 30 months in the normotensive state following withdrawal of blood pressure medications. There was also a need to determine whether nonpharmacologic therapy could significantly increase the proportion with a successful outcome.

DESIGN NARRATIVE:

Randomized. A total of 585 overweight subjects were assigned in a 2 x 2 factorial design to weight loss, sodium reduction, combined weight loss and sodium reduction, or usual life-style control. The remaining 390 subjects of normal weight were assigned in a 2-armed design to a sodium reduction or an attention control group. The control groups were engaged in a series of non-blood pressure related health encounters designed to control for non-specific effects of groups contacts. Withdrawal of antihypertensive medication was attempted following three months of intervention. The primary endpoint was a blood pressure of 150/90 mm Hg or greater, resumption of antihypertensive drug therapy, or the occurrence of a blood pressure-related clinical complication during two to three years of follow-up. Recruitment ended in June, 1994. Follow-up ended in December, 1995. NHLBI support for the trial ended in March, 1997. The NIA supported the Coordinating Center and two clinical centers through February 1998.

The study completion date listed in this record was obtained from the "Completed Date" entered from the old format in the Protocol Registration and Results System (PRS).

Eligibility Criteria:
Men and women with a systolic blood pressure of less than 145 mm Hg and diastolic blood pressure of less than 85 mm Hg on single-drug therapy.
Interest of Follicular Helper Lymphocytes / Regulatory Follicular Helper Lymphocytes Ratio in IgA Nephropathy

This study aims to investigate the relevance of the Tfh/Tfr (Follicular helper T cells/ Follicular regulatory T cells) ratio in patients with IgA nephropathy:

* To identify a differential expression of the Tfh/Tfr ratio in patients considered stable or progressive
* To predict, at diagnosis, the clinical evolution of the disease (progressive or stable form) in the first year.


Eligibility Criteria:
Inclusion Criteria:

* IgA nephropathy histologically proven on renal biopsy according to KDIGO criteria, with 8 permeable glomeruli (patients diagnosed from 2009 with a minimum follow-up for their nephropathy of 5 years (arm 1) or patients diagnosed during the study (arm 2))

Control patients: Lupus or ANCA-associated vasculitis or polycystic kidney disease (arm 3)

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Subjects with no social security coverage.
* Pregnancy / No effective contraceptive method
MRI and PET-CT for Radiotherapy Planning for Head and Neck Cancer

Radiotherapy is commonly used to treat advanced cancers of the head and neck, aiming for cure while preserving patients' quality of life including their ability to speak and swallow. In order to reduce the potentially major side effects of treatment, it is essential that the highest doses of radiotherapy are targeted to the main bulk of the tumour. At present a computerized tomography (CT) scan is used by the cancer specialist to identify the tumour for planning the radiotherapy treatment. The investigators know that other types of scan including magnetic resonance imaging (MRI) and positron emission tomography (PET) scans are better than CT scans at showing areas involved by the cancer. However, radiotherapy cannot be directly planned on these types of scans. The aim of this study is to explore whether PET and MRI scans can be combined with CT scans to more accurately identify the tumour target. In addition, this study will explore whether PETCT and MRI scans may used to adjust radiotherapy to how well a tumour is responding during a course of radiotherapy. If the radiotherapy planning process can be improved in these ways, the investigators hope future patients will benefit by more chance of cure with a reduction in the side effects of treatment. The study aims to recruit 16 patients. All patients within the study will undergo a PETCT and an MRI scan prior to starting treatment as part of the study. A subgroup of 8 patients will undergo additional imaging at two timepoints during the course of their radiotherapy. The study is noninterventional and patients' standard treatment will not be affected by their participation in the study.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* WHO Performance status 02
* Histologically proven squamous cell carcinoma of the head and neck region
* Clinical decision made to proceed with a course of radiotherapy of curative intent of 6670Gy in 3335 fractions over six and a half to seven weeks with or without concurrent chemotherapy
* Measurable primary tumour and/or locoregional metastatic lymph nodes on preradiotherapy imaging
* Able to provide fully informed written consent
* Able to lie flat for 1 hour
* Not be pregnant or breast feeding. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal.

Exclusion Criteria:

* Hypersensitivity to fluorine-18 FDG
* Hypersensitivity to iodinated contrast media or Gadolinium
* Poorly controlled diabetes
* Acute renal failure or moderate renal impairment (estimated glomerularb filtration rate \< 30 mL/min)
* Contraindication to MRI imaging, including cardiac pacemaker or presence of MRI incompatible metalwork
* Claustrophobia precluding MRI imaging
* Uncontrolled pain
* Urinary incontinence
* Female patients must not be pregnant and if of child bearing age using adequate contraception
* Breast feeding
* Serious psychiatric comorbidity
Double-Blind Randomized Controlled Trial for the Evaluation of a Novel Adaptive Attention Training in Healthy Adolescents

This project will evaluate the neuro-cognitive outcomes of a novel, adaptive attention training in a healthy adolescent population.

Aspects of cognitive control, such as attention and working memory, are critical for successful goal-directed behavior. Importantly, variability in cognitive control abilities can influence real-world functioning, such as scholastic success in children and adolescents. The primary goal of this project is to examine the outcomes of a novel, adaptive attention training that primarily targets aspects of sustained attention and secondarily targets delayed gratification in adolescents. As such, the investigators will validate the feasibility and efficacy of this novel training in a randomized controlled trial (RCT) study. Specifically, healthy adolescents (age 12-16 years old) will be recruited for a longitudinal experiment in which they are randomly assigned to the adaptive attention training group ('Engage') or one of two expectancy-matched control groups. Depending on the assigned group, participants will complete 1 hour (low-dose control group) or 15 hours ('Engage' and active control groups) of training as well as pre-, post- and follow-up assessments of cognitive, neural, and behavioral measures. We hypothesize that completion of 'Engage' training will result in enhancement of fronto-parietal control functions that underlie sustained attention and suppression of ventral-striatal reward impulses, ultimately improving these abilities in a healthy adolescent population.

Eligibility Criteria:
Inclusion Criteria:

* Healthy right-handed children, age 12-16 years old
* No ADHD status (verified with the Vanderbilt ADHD Parent form)
* Willing and able to undergo MRI and EEG procedures

Exclusion Criteria:

* Current psychotropic medications
* Current diagnosis of any axis I psychiatric disorder
* History of seizure disorder or seizure episodes over the last 2 years
* Motor/perceptual handicap that prevents computer use
Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women

Primary Objective: To determine the bioequivalence between the clinical batch process and the new processes for manufacturing LNG/EE.

Secondary Objective: To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women.


Eligibility Criteria:
Inclusion Criteria:

* Women 18 - 35 years of age
* Non-smokers

Exclusion Criteria:

* History of thromboembolic disease
* Prior adverse experiences with oral contraceptives
Safety Study of CTX-100 Inhalation Solution (Formerly ETX-100)

The purpose of the study is to evaluate the safety of administering repeated doses of CTX-100 (formerly ETX-100) to subjects with smoking-related chronic obstructive pulmonary disease.

The study primarily aims to establish safety and evaluate biochemical activity of CTX-100 (formerly ETX-100) with respect to elastin breakdown, but will also concurrently gather data that may point to efficacy. The preliminary efficacy results will be used to assist in the design of subsequent phase 2b clinical studies of longer duration to examine both efficacy and safety of CTX-100 as a therapy for chronic obstructive pulmonary disease.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide written informed consent and comply with study requirements.
* Men or women aged 40 through 75 years at the time of consent.
* At least 10-pack years (average packs/day x number of years) of cigarette use, and either current smoker or ex-smoker.
* Diagnosis of COPD at screening consistent with National Institutes of Health guidelines.
* Evidence of emphysema on chest x-ray.
* A ratio of prebronchodilator FEV1 to forced vital capacity (FVC) of ≤ 70% at screening.
* FEV1 ≥ 50% (prebronchodilator) and ≤ 79% (postbronchodilator) of predicted normal at screening.
* Clinical laboratory tests (complete blood count, serum chemistry, and urinalysis) within normal limits or clinically acceptable to the PI/sponsor at screening.
* Women of childbearing potential and men who are sexually active must agree to use an adequate method of contraception (oral contraceptives, depot progesterone, condom plus spermicide, or IUD) during the study and for 1 month after the final dose of study drug.

Exclusion Criteria:

* Subjects with a measured DLCO of ≤ 50%, or unable to perform a reproducible DLCO.
* Subjects unable to perform 3 reproducible spirometry tests after 5 attempts.
* Upper or lower respiratory tract infection within 2 weeks prior to screening and baseline (day 1).
* Presence of clinically relevant abnormality on chest x-ray (other than evidence of emphysema) at screening or within the previous 12 months.
* Use of supplemental oxygen therapy.
* Requirement for ventilatory support within the last year.
* Exacerbation requiring treatment with systemic corticosteroids within the last 3 months.
* History of lung transplant.
* Presence of clinically relevant abnormality on electrocardiogram (ECG).
* Any medical condition that, in the investigator's judgment, would compromise study participation or the evaluation of the study drug.
* Women who are pregnant or breastfeeding.
* Receipt of an investigational drug within 30 days prior to screening (including subjects who participated in the first phase of this study).