cyrilzakka/clinical-trials huggingface dataset:
Breath Metabolomics in the Laboring Parturient

This is primarily a feasibility study to determine whether quantitative measurement of volatile organic compounds (VOCs) in the breath of parturients undergoing labor is possible.

Aim A: To determine baseline values of breath metabolites and volatile organic compounds (VOCs) in the breath for term pregnant women.

Aim B: To gather preliminary data to determine breath metabolite and volatile organic compound (VOCs) signature change during labor and delivery.

Aim C: Compare the breath metabolite and volatile organic compound (VOCs) signature women undergoing induction compared to spontaneous vaginal deliveries.

Breath metabolites, also known as volatile organic compounds (VOC's) are produced during periods of increased stress and as a marker of underlying medical conditions. The goal of this project is to collect VOCs within the breath in the initial stages of delivery in otherwise healthy parturients undergoing induction of labor. In addition to a panel of metabolites, we will obtain information on the 3400 compounds which compose the breath metabolome by gas mass spectrometry technology. This is the first step of a larger planned project to develop specialized panels of breath signatures during labor and delivery in parturients.

We will collect breath samples at bedside and measure metabolites in the laboratory. This is a feasibility study which we will use to determine normal values for a term parturient and changes of VOCs during the course of labor. We will also use this data to construct a power analysis and perform a follow-up study to test whether VOCs are associated with different aspects of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy nulliparous women with singleton term (37-41 weeks) pregnant at least 18 years of age.
* Presenting for labor (induction of labor and spontaneous labor) at LPHC.

Exclusion Criteria:

* Participants unable to or refuse to give informed consent
* Participants that do not understand English or are hearing impaired
* Medical History: Chronic disease (HTN, diabetes, asthma)
* Obstetric History during this pregnancy: gestational diabetes, gestational hypertension, pre-eclampsia, Eclampsia
* Multiple gestation
* Any significant fetal anomalies
* Morbid obesity (BMI\>50)
Study to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic Technique

This is a prospective, open-label, exploratory clinical trial designed to investigate the safety and efficacy of HLBLS-200 (an investigational hemostatic agent). The study will recruit approximately 8 subjects.

Patients scheduled for hepatic resection who voluntarily agree to participate the study will be recruited for the screening procedures.

Patients who meet the eligibility criteria will be assigned to the study. Subjects will receive HLBLS-200 as a supplementary hemostatic technique for oozing hemorrhage which can be occurred during hepatic resection.

A dose of HLBLS-200 based on the area of liver resection will be applied and time to hemostasis of blood oozing will be evaluated.

Patients will be followed for 12 weeks after application of HLBLS-200 to monitor any adverse event.

Study objective:

1. To investigate the safety of HLBLS-200 application.
2. To explore hemostatic function of HLBLS-200 in patients receiving hepatectomy.

Eligibility Criteria:
Inclusion Criteria: (during screening period)

* Subject aged between 18 and 80 years old and scheduled for non-emergent hepatic resection.
* Subject is willing to provide written consent and able to comply with study procedures.
* Female subject of childbearing potential who is willing to use an adequate method of contraception or to be abstinent during the course of the study.

Inclusion Criteria: (during hepatectomy)

* Subjects who need to receive additional hemostatic treatment for blood oozing at the resection site after application of primary hemostatic methods.

Exclusion Criteria: (during screening period)

* Subject with a history of bleeding disorder, platelet disorder or bone marrow disorder.
* Platelet count \< 50 X 10\^9/L or International normalized ratio \> 2.
* Subject who received any drug affecting hemorrhage and/or hemostasis such as anticoagulants, antiplatelet agents or thrombolytic agent within 2 weeks prior to hepatectomy.
* Subject with a history of hypersensitivity to the substance of the investigational device.
* Creatinine clearance \< 30mL/min
* Aspartate transaminase or alanine aminotransferase ≥ 3.0 X upper limit of normal.
* Subject with a suspected disorder of decrease in fibrinolytic activity such as disseminated intravascular coagulation.
* Subject with a history of alcohol or drug abuse.
* Pregnant or lactating women
* Subject who have participated in other clinical trial and have received investigation drugs or devices within 4 weeks prior to participation in the study.
* Subject who were judged by the investigator as inadequate for participation in the study.

Exclusion Criteria: (during hepatectomy)

* Subject with following major bleeding (e.g. spurting hemorrhage, hemorrhage from hepatic veins) despite application of primary hemostatic methods
* Subject who is deemed to need anticoagulant treatment within 48 hours of hepatectomy.
* For other reason, subject who were judged by the investigator as inadequate for participation in the study.
Impact of Endogenous E2 on SSI and GH Rebound

Endogenous estrogens maintain growth hormone (GH) secretion in postmenopausal women by potentiating endogenous GH-releasing hormone (GHRH) drive and restraining somatostatin inhibition of GH release.

Systemic concentrations of testosterone (Te), estradiol (E2), GH, IGF-I and IGFBP-3 decline in healthy aging individuals (1-3). Sex-steroid deprivation accentuates GH and IGF-I depletion, since Te and E2 stimulate GH and IGF-I production in older adults, hypogonadal patients of all ages, and patients undergoing gender reassignment (1,2,4). Tamoxifen blocks the effect of Te, suggesting involvement of E2 in GH's stimulation in men (5). E2 also stimulates GH secretion in women, putatively via the nuclear estrogen receptor (ER-alpha) (1,2,6,7). Because Te, E2 and GH fall with menopause, and Te is converted to E2 by aromatization in the body (8-10), we postulate that diminished Te concentrations, Te→E2 concentrations and low E2 mediate low GH output in older women. What remains unknown is whether the low E2 levels in postmenopausal women retain GH-stimulating effects. To test this notion would require blocking: (i) aromatase-enzyme activity, which mediates E2 synthesis from Te, and/or (ii) estrogen receptor-alpha, which transduces most of E2's stimulation of the GH axis.

Eligibility Criteria:
Inclusion:

1. 60 healthy post-menopausal women (ages 55 to 80 y);
2. BMI 18-30 kg/m2
3. Community dwelling; and voluntarily consenting

Exclusion:

1. Recent use of psychotropic or neuroactive drugs (within five biological half-lives);
2. Obesity (outside weight range above);
3. Laboratory test results not deemed physician acceptable, cholesterol \>250, triglycerides \> 300, BUN \>30 or creatinine \> 1.5 mg/dL, liver function tests exceeding twice upper limit of normal, electrolyte abnormality, anemia;
4. Drug or alcohol abuse, psychosis, depression, mania or severe anxiety;
5. Systemic inflammatory disease;
6. Endocrinopathy, other than primary thyroidal failure receiving replacement;
7. Nightshift work or recent transmeridian travel (exceeding 3 time zones within 7 days of CRU admission);
8. Acute weight change (loss or gain of \> 2 kg in 6 weeks);
9. Systemic illness
10. Unwillingness to provide written informed consent.
11. Allergy to anastrozole or fulvestrant (treatment drugs).
12. History or suspicion of breast cancer.
13. History of carcinoma (excluding localized basal cell carcinoma removed or surgically treated with no recurrence).
14. History of thrombotic arterial disease (stroke, TIA, MI, angina) or deep-vein thrombophlebitis.
15. History of CHF, cardiac arrhythmias, congenital QT prolongation, and medications used to treat cardiac arrhythmias.
16. Pre-menopausal status as determined by screening hormone measurements.
Chronic Low Back Pain and Meditation

The purpose of this research study is to see if and how mindfulness meditation affects pain. Specifically, we are interested in assessing if mindfulness is associated with the release of naturally occurring opiates in the body, in response to intravenous (IV) administration of the opioid antagonist naloxone during a chronic low back pain provoking procedure.

The purpose of this psychophysical and pharmacologic study is to determine if meditation induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during a pain evoking straight leg raise test in response to double-blind intravenous administration (IV) of naloxone/placebo-saline. The aim of this study is to determine if mindfulness-based analgesia is associated with the release of endogenous opioids.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a medical evaluation that demonstrates chronic low back pain that is evoked by lifting the legs. Existing medical records, per physician discretion and low back examinations will confirm diagnosis
* Participants must be between 18 and 65 years of age
* Participants must rate their daily chronic pain intensity at a 3 or higher on 0-10 visual analog scale
* Participants must have experienced their chronic low back pain for at least 3 months
* Participants must have no prior meditative experience
* Participants must be straight leg raise test positive

Exclusion Criteria:

* Participants must not be participating in any new (within 2 weeks prior or anytime after enrollment) pain management procedures during the study period
* Participants must not be taking opioids
* Participants must not be pregnant or nursing mothers
* Participants must have not had back surgery within the last year before their enrollment into the study
* Participants must have not had any other sensory or motor deficits that preclude participation in this study
* Participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, and a personal history of psychosis
* Participants must not have any known allergies to naloxone or similar drugs
* Participants must not have a history of syncope and/or fear of needles/blood
Telerehabilitation Through Serious Games in Virtual Reality in a Stroke Population (AutoRReVi)

After a stroke, individuals present with motor and/or cognitive impairments. These impairments limit activity, restrict participation and affect quality of life. Therefore, rehabilitation programs are provided from the earliest days. However, an important proportion of patients do not achieve the recommended amount of rehabilitation therapy (even in institutional systems). In fact, patients do not always have access to healthcare systems. Moreover, hospital resources and healthcare systems are often limited (especially in poor countries) which has led to the development of new cost-effective rehabilitation methods such as self-rehabilitation and tele-rehabilitation.

This study aims :

1. to develop and validate relevant self-assessments tools in virtual reality
2. to propose auto-adaptative virtual reality-based therapies based on the link between motor and cognitive functions.


Eligibility Criteria:
Inclusion Criteria:

* Stroke patients (with hemiparesis or cognitive impairment such as apraxia, aphasia or hemineglect) OR healthy subjects
* Able to undersand simple instructions

Exclusion Criteria:

* Other disease that could affect upper limb motor function or cognition
NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal Surgery

The aim of this study is to prove that Novosyn Quick and Monosyn Quick are equivalent in early wound healing in adult patients undergoing resective periodontal surgery.

In order to show equivalence between Novosyn Quick and Monosyn Quick EHS, which is composed of 3 parameters: clinical signs of reepithelization, clinical signs of haemostasis and clinical signs of inflammation, will be calculated for each suture 10 ± 5 days postoperatively and cannot differ more than 2 points.

Furthermore, complications, the handling of the suture material, pain, satisfaction of the patient and bacterial contamination of the thread (optional) will also be assessed as secondary objectives.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient undergoing resective periodontal surgery abd one of the incisions below has been performed:
* Crestal incision
* Vertical incision
* Intrasulcular incision
* Submarginal incision
* Written informed consent regarding the data collection for the RCT

Exclusion Criteria:

* Emergency surgery.
* Pregnancy.
* Breastfeeding
* Patients taking medication that might affect wound healing.
* Patients having a condition that might affect wound healing.
* Patients with hypersensitivity or allergy to the suture material
Sex and Female Empowerment

This study will develop and initially evaluate Sex and Female Empowerment (SAFE), an intervention designed to increase acceptance of and adherence to contraceptive practices among opioid-agonist-maintained women of childbearing age. The intervention will be delivered in one of two formats: a face-to-face brief intervention approach or a novel computer-adaptive platform. To the extent that either version of SAFE is found to be efficacious compared with usual care, it has the potential to reduce the number of unintended pregnancies and consequently decrease the need for and the costs of child protective services.


Eligibility Criteria:
Inclusion criteria will be:

1. ages 18-40 years old for women;
2. able to provide informed consent;
3. currently enrolled in a opioid-agonist-maintenance program;
4. currently not pregnant (urine testing confirmation);
5. report heterosexual orientation;
6. no tubal ligation or other sterilization;
7. no plans to become pregnant in the next 6 months; and
8. provides verifiable locator information.
One Point Versus Two Point Fixation of Tripodal Zygomatic Fractures

The zygomatic bone defines the anterior and lateral projection of the face and articulates with the frontal, sphenoid,temporal, and maxillary bones. The zygomatic complex is responsible for the protection of the orbital contents and the mid-facial contour. Fracture of the zygomatic complex is one of the most common facial injuries in maxillofacial trauma and predominately appears in young adult males. The etiology of zygomatic complex fractures primarily includes road traffic accidents, violent assaults, falls and sports injuries. The main clinical features of zygomatic complex fractures include diplopia, enophthalmos, subconjunctival ecchymosis, extraocular muscle entrapment, cosmetic deformity with depression of the malar eminence, malocclusion and neurosensory disturbances of the infraorbital nerve. Diagnosis of zygomatic complex fractures is usually clinical with confirmation by computed tomography (CT) scan. Zygomatic complex fractures with no or minimal displacement are often treated without surgical intervention, whereas fractures with functional or esthetic impairments often necessitate surgical intervention. Various surgical approaches and treatment strategies have been proposed to obtain successful treatment outcome, including the Gilles temporal approach, eyebrow, upper eyelid, transconjunctival, infraciliary lower eyelid, and intraoral vestibular approaches. The surgical approach for adequate reduction of zygomatic complex fractures must ensure a good functional and cosmetic result. Surgical reduction of zygomatic fractures by an intraoral surgical approach was first described in1909 by Keen, and several studies have subsequently documented the treatment outcome after open reduction of zygomatic complex fractures by an intraoral surgical approach.

This study is a prospective clinical intervention study where the admitted patients do lab investigation as CBC, coagulation profile ,Kidney function test and Imaging as CT maxillofacial with axial and coronal cuts. Patients will be assigned randomly into either one of the two groups under the study using concealed envelope. Under general anaesthesia with oral or naso-tracheal intubation, open reduction and internal fixation of tripod zygomatic fractures will be done using miniplates and screws at one point (zygomaticomaxillary area) or at two points (zygomaticomaxillary and frontozygomatic areas).

Eligibility Criteria:
Inclusion Criteria:

* (a) Adult patients with maxillofacial fractures including tripodal zygomatic fractures as determined on clinical and radiological finding (b) Isolated tripodal fracture zygoma

Exclusion Criteria:

* patients with Le Fort I/II/III fractures
Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients

Objective: to evaluate the bioavailability of subcutaneous granisetron.Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle.

5-HT3 antagonists are one of the mainstays of antiemetic treatment and they are administered either intravenously or orally. Nevertheless sometimes neither administration route is feasible, such as in patients unable to admit oral intake managed in an outpatient setting. Our objective is to evaluate the bioavailability of subcutaneous granisetron.Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle. Pharmacokinetics of SC and IV granisetron will be prospectively compared.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients receiving platinum-based chemotherapy
* adequate bone marrow, hepatic and renal function, respectively defined by: platelets \>100000/mm3 and absolute neutrophil count \>1500/mm3; bilirubin, AST and ALT \<2 times x upper limit of normality; and creatinine \<1.5 mg/dl.
* ECOG performance status \<2 and body mass index from 20-28 kg/m2.

Exclusion Criteria:

* Pregnancy
* Serious concomitant diseases, in the invesgator´s criteria
Effectiveness of Functional Electrical Stimulation Versus Spencer Technique in Patients With Adhesive Capsulitis

This study focus on the rehabilitation of patients with frozen shoulder through a manual technique called "Spencer MET".The purpose of this approach is to reduce the pain and improve the ROM and quality of life.

By comparing the effectiveness of functional electrical stimulation versus the Spencer technique in patients with adhesive capsuilitis is to determine which treatment approach will yields better outcomes in order to reduce the detrimental effects of disease process.Spencer METs consist of series of seven steps taken in order to decrease pain and stiffness in sholder regiegionn.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetic frozen shoulder
* Patients having frozen shoulder after stroke
* Subjects having stiff shoulder for at least 3 months
* Subjects with bilateral/unilateral frozen shoulder
* Subjects with idiopathic frozen shoulder

Exclusion Criteria:

* Bone fracture within past 12 weeks
* Patients with hyper mobile joints
* Subjects with Rotator cuff pathology
* Dislocated shoulder
* Subjects who had shoulder arthroplasty
Building Closer Friendships in Social Anxiety Disorder

This study assesses whether a 4-week computerized intervention can be used to decrease fear of intimacy, and loneliness and improve perceived social support in people with Social Anxiety Disorder.

This study hopes to assess whether a month long computerized intervention aimed at giving people skills to form closer friendships. Participants will be randomized into an active treatment condition or a wait list control. We hypothesize that 1) participants in the treatment condition will have lower fear of intimacy at post treatment than those in the waitlist condition 2) participants in the treatment condition will have lower levels of loneliness than those in the waitlist condition 3) participants in the treatment condition will have higher perceived social support than those in the waitlist condition.

Eligibility Criteria:
Inclusion Criteria:

* Social Anxiety Disorder Diagnosed by the Mini International Neuropsychiatric Interview
* Social Phobia Inventory Score \>19
* Stable psychotropic medication for the past month and kept stable for duration of study

Exclusion Criteria:

* Currently participating in therapy
* Current Substance Dependence
* Bipolar Disorder or psychotic illness
* Current suicidality (imminent risk)
Pathways to Vocational Rehabilitation: Enhancing Entry and Retention

This study will examine the barriers and supports for entering and receiving work-related services for veterans with a serious mental illness. It will also determine the effectiveness of a brief motivational interviewing intervention designed to help veterans receive these services.

Randomized clinical trials and naturalistic studies show that among patients meeting criteria for chronic mental illness, those participating in vocational rehabilitation (VR) have significantly reduced days of inpatient hospitalization. Unfortunately, the majority of eligible adults fail to enter VR and almost half of those who do, drop out or are involuntarily discharged. The reasons for nonparticipation and drop out and their impact on rehabilitation outcomes are poorly understood.

The study will provide needed naturalistic data documenting:

1. the way in which barriers function to reduce entry to services and contribute to the high rate of dropout,
2. the outcomes associated with different patterns of participation, and
3. relative rates of entry and retention in a non-VHA VR exemplar of the Intensive Placement and Support (IPS) model at the Manchester Mental Health Center in Manchester, New Hampshire.

While we need to know more about these "barriers" in order to develop the range of appropriate interventions, the enhancement of client motivation for work and rehabilitation is likely to have a positive impact both on entry and sustained compliance. We are proposing a random assignment single blind trial of a brief Motivational Interviewing (MI) intervention designed to address the low entry and retention rates of veterans with Serious Mental Illness (SMI) in Veterans Health Administration's (VHA) VR services.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of serious mental illness, present for at least 2 years
* Is unemployed or underemployed
* Current episode of un/underemployment is at least 3 months
* Enrolled to receive services at study site

Exclusion Criteria:

* Over the age of 55
* Non-English speaker
* Mini-Mental score of less than 20
* Planning to move more than 30 miles from study site in the next 18 months
* Previously screened for this study
* Currently or previously involved in other research studies which may impact variables relevant to this study