cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess Indices of SNAP vs VISTA on Surgical Patients Undergoing General Anesthesia

Establish the range of index values for the SNAP II corresponding to each anesthetic state studied.

Index values for the SNAP II monitor will be identified with each corresponding anesthetic state studied.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for surgery requiring general anesthesia
* Open or laparoscopic procedures
* Cases anticipated to be less than 4 hours in duration
* In-patient and out-patient subjects
* Patients and cases manageable with LMA. Cases manageable with ET tube are also allowed with the condition that only a minimal dose of short-acting NMBA is used at intubation and not throughout the case.
* Local analgesia at incision site is permitted.
* Males and Females between 18 and 65 years of age, inclusive.
* BMI\<40 and body mass\>41 kg
* Patients who have signed the informed consent.
* Able to receive Informed Consent through subjects native language providing that a native language speaker delivers the Informed Consent.
* ASA Stratification I - III

Exclusion Criteria:

* Any subject failing to fulfill all inclusion criteria
* ASA stratification \>= IV
* Subject is a prisoner.
* Patients presenting with evidence of recent trauma, active infection, neurological disorder, seizure disorder, dementia or have been diagnosed with Alzheimer's disease
* Subjects with cardiac or gastric pace makers
* Pregnant women as identified by institutional SOP for female of child-bearing age
* Patients that will not sign an informed consent form
* Patients with previous adverse incidents with anesthesia, including awareness
* Patients undergoing surgery on the head or neck
* Subjects currently taking psychoactive medications as part of routine medical care within the past 7 days
* Subjects that require and/or receive any of the psychotherapeutic agents or psychotropic drugs below, in the treatment of mental illness, and have taken such treatment within the past 7 days.
* Benzodiazepines
* MAOI inhibitors
* Selective serotonin reuptake inhibitors (SSRIs)
* Tricyclic antidepressants
* Lithium
* Neuroleptic agents
* Central nervous system stimulants.
* Subjects with a known history of alcohol or narcotic abuse within 6 months prior to screening OR subjects reporting narcotic or narcotic medication use with 24 hours prior to surgery.
* Subjects requiring neurophysiologic monitoring
* Subjects requiring TIVA
* Subjects requiring prolonged use of NMBA beyond dose required for intubation
* Subjects requiring ketamine
* Subjects receiving spinal, epidural, or other nerve blocks
* Subjects having any condition or severe illness that to the Principal Investigator's discretion would interfere with study assessments OR other severe acute or chronic medical or psychiatric condition that may interfere with the interpretation of study results and, in the judgment of the investigator, and would make the subject inappropriate for entry into this study.
Community Approach to Reduce the Risks of Diabetes After Gestational Diabetes Mellitus

Objective: The current study examined the effectiveness of a culturally-appropriate adaptation of the diabetes prevention program (DPP) curriculum in reducing type 2 diabetes risk in Latinas with a history of gestational diabetes mellitus (GDM).

Research Design and Methods: Seventy-six Latinas aged 18-45 years with GDM in the past 3 years participated in an 8-week group-based, peer-educator led lifestyle intervention based on the DPP, with adaptations appropriate to Latino culture and recent mothers. Clinical and self-report indicators were assessed at baseline, post-intervention (month-3), and follow-up (month-6).

Hypothesis-The modified culturally tailored DPP will improve risk factors associated with the development of type 2 DM.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old
* Latina
* GDM within the last 3 years
* able and willing to participate in physical activity sessions

Exclusion Criteria:

* current diabetes
* severe illness that would preclude them from coming to the sessions
AZD2281 in Combination With Liposomal Doxorubicin in Advanced Solid Tumours

The study will be an open label, multicenter, dose finding study. Depending on the tolerated dose up to 7 dose levels will be explored in this study, approximately 33 patients (21-54 depending on number of cohorts) may be enrolled into this study. Three patients will be initially dosed in each cohort. The primary objective of this study is to determine the recommended dose (RD) of twice daily oral doses of AZD2281 either as intermittent therapy for 7 days out of a 28-day schedule or given continuously, administered in combination with liposomal doxorubicin to patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent
* Measurable or evaluable disease
* ECOG Performance status 0 - 2
* Estimated life expectancy of at least 12 weeks

Exclusion Criteria:

* More than 3 prior lines of chemotherapy for advanced disease
* Less than 28 days from active treatment (ie, any treatment used to treat the disease) or high dose radiotherapy (patients may continue concomitant use of stable dose of bisphosphonates if used at least 28 days prior to commencing study treatment and pat
* Prior treatment with \>300mg/m2 cumulative dose of doxorubicin equivalent
* Resistance to anthracyclines defined as progressive disease during anthracycline treatment or within 6 months after the last anthracycline administration.
Physiological Role of KiSS-1/GPR54 System in the Human Ovary

The aim of this project is to study the physiological role of the KiSS-1/GPR54 system in the granulosa cells of the human ovary.


Eligibility Criteria:
Inclusion Criteria:

* Consenting oocyte donors

Exclusion Criteria:

-
A Clinical Study With Aliskiren Alone or in Combination Therapy With Diuretic Hctz in Venezuelan Hypertensive Patients.

This is an open-label, not controlled, sequential, dose escalation study of 16 weeks' duration. The study is composed of two periods: a 0-2 week optional wash-out period depending on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment period. Patients will be evaluated every 4 weeks during period 2. Treatment will start with Aliskiren 150 mg with dose titration to Aliskiren 300 mg, and addition of HCTZ 12,5 mg and 25 if control of BP is not achieved (\< 140/90 mmHg or 130/ 80 mmHg in diabetics patients). All patients who have reached their BP target will be considered as having met the primary endpoint and this visit will be considered as the final visit.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients, with essential hypertension, stage I-II, naïve or not controlled with monotherapy.

Exclusion Criteria:

* BP\> 180/110 mmHg
* Pregnant or nursing women
* Hypertensive encephalopathy or cerebrovascular accident, transient ischemic - cerebral attack, myocardial infarction, unstable angina, coronary bypass surgery, percutaneous coronary intervention within 6 month
* K \<3.5 mEq/L or ≥ 5 mEq/L
* Renal impairment
* Hypersensitivity to HCTZ or Aliskiren or angioedema due to ACE-I or ARB
* Other protocol-defined inclusion/exclusion criteria may apply
Ease of Use Study for the Gambro Polyflux HD-C4 Small Dialyzer

The purpose of the study is to study the ease of use of the Polyflux HD-C4 Small dialyzer under conditions of routine clinical use for hemodialysis

Market evaluation protocol.

This ease of use study involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. This study is strictly aimed at obtaining feedback from the nursing and technical staff regarding the use of the Polyflux HD-C4 Small dialyzer. The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy.

Eligibility Criteria:
Inclusion Criteria:

* n/a routine dialysis patients

Exclusion Criteria:

* n/a routine dialysis patients
Study of the Sensitivity of Manual vs Electric Aspiration to Detect Completed Early Abortion

With sensitive urine pregnancy tests, women are now able to confirm very early pregnancies. However, approximately one third of abortion facilities do not offer abortions at less than six weeks of pregnancy. Providers may be concerned that they will be unable to identify products of conception (POCs) in uterine aspirates after early abortion and about the time, cost and risk associated with following serum hCG levels when completed abortion cannot be confirmed by gross inspection. Many providers believe that manual vacuum aspiration (MVA) causes less destruction of pregnancy tissue and therefore may increase the likelihood of identifying POCs on gross inspection. No published reports specifically compare MVA to electric vacuum aspiration (EVA) for the detection of complete products of conception and none compare MVA and EVA at less than 6 weeks of pregnancy. We, the investigators, propose to conduct a randomized controlled trial comparing the sensitivity of MVA to EVA for the detection of completed abortion in 500 women with pregnancies of less than 6 weeks gestation at a large inner city family planning center. We will measure positive identification of POCs on gross inspection in patients subsequently shown to have completed abortions. We hypothesize that the rate of true positive detection of POCs will be higher in dilation and curettage (D\&C) using MVA than EVA.


Eligibility Criteria:
Inclusion Criteria:

* gestational sac size \<12 mm or no visible sac (with positive pregnancy test) day of surgical abortion
* no medical contraindications to outpatient abortion at study site

Exclusion Criteria:

* not able to consent
* suspected ectopic pregnancy (pelvic mass, unilateral pain, or detection on ultrasound), suspected molar pregnancy, or no sac and vaginal bleeding suspicious for completed spontaneous abortion
* failed medication abortion
Victim Impact Modules for Jail Inmates

The purpose of this study is to evaluate feasibility of modularized delivery of the Impact of Crime (IOC) group intervention with jail inmates, and obtain preliminary data on its effectiveness in reducing post-release recidivism, substance abuse, and HIV risk behavior.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years or older
* Must be male
* Must be currently incarcerated jail inmate
* Must be sentenced
* Sentence must be short enough to serve out sentence at ADC
* Release date must follow projected final session of treatment
* Must speak, read, and write in English with sufficient proficiency to use workbook and participate in group sessions
* Must be assigned to the jail's "general population"

Exclusion Criteria:

* Actively psychotic
* Assigned "keep separate" from other group members
Guideline Recommended Care and Excess Mortality for Non ST-elevation Myocardial Infarction : A National Cohort Study

The aim of the study is to quantify the excess mortality associated with non-adherence to care for non ST-elevation myocardial infarction in England and Wales over the last decade.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or more
* patients hospitalised with non ST-elevation myocardial infarction

Exclusion Criteria:

* patients hospitalised with phenotypes other than non ST-elevation myocardial infarction
Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury

The purpose of the study is to evaluate the outcome of a multidiscplinary telerehabilitation after traumatic brain injury assessed by the patient and the therapists with respect to the overall feasibility of the therapy protocol and the effects on psychological well-being and quality of life..

Patients from 18 to 60 years of age recovering after traumatic brain injury are recruited to participate in a multidisciplinary telerehabilitation containing total of 20 video meetings over a period of 4-5 months. The study design consists of a 3-day visit in rehabilitation ward for the pre-treatment clinical assessments and education on the telerehabilitation protocol. A self-exercise program is supervised and monitored using a health platform application on a tablet computer through weekly video meetings. A digital diary recordings enable the therapists to track on the progress of therapies. The primary goal is to achieve the individual goals set in the Goal Attainment Scaling. The secondary goals are related to the improvement of psychological well-being (BDI) and quality of life (WHOQOL-Bref).

Eligibility Criteria:
Inclusion Criteria:

* sequelae of traumatic brain injury
* capable of doing self exercises at home and participating in video meetings

Exclusion Criteria:

* moderate or severe aphasia
* poor recovery potential for return to school or working life based on clinical assessment
Application of an Electronic Nose in the Early Detection of ASpergillosis

The purpose of this study is to establish the accuracy with which the eNose can discriminate patients with invasive pulmonary aspergillosis from controls.


Eligibility Criteria:
Inclusion Criteria:

Patients that

1. are 18 years of age or older
2. will undergo treatment for a hematological malignancy expected to result in grade 4 neutropenia (according to CTCAE 3.0, i.e. \<0.5 x 109 neutrophils/L) of prolonged duration (i.e., more than 7 days), e.g. hematopoietic stem cell transplantation or induction/consolidation treatment for acute myeloid leukaemia
3. have given written informed consent

Exclusion Criteria:

1. a previously diagnosed invasive mycosis
2. the inability to perform the breathing manoeuvre needed for eNose-analysis of exhaled air
The Functional Profile of People Suffering From Trigger Finger

The purpose of this study is to Characterize the population of people who suffer from trigger finger (TF) in terms of demographic (Gender, age, occupation, etc.); motor skills (hand function); the Consequences of the disease on a person's daily functioning and impact on quality of life.

The study will also attempt to examine the suitability of several common assessment tool for evaluation of hand rehabilitation Patients who suffer from TF.

Information obtained from the study will enable a deeper comprehension of the consequences of TF on the patient and will be the first step in developing a protocol assessment and evidence-based treatment in this population.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 and above.
* Men and Women.
* diagnosed with Trigger Finger.

Exclusion Criteria:

* Trauma in upper Extremity.
* Cognitive difficulties that are blocking the ability to answer the questionnaires (dementia, head injury).
* Pregnant women.
* participants who didnt completed all Assessments.
A Study of Residual Curarization Incidence in China

The purpose of this study is to determine the incidence of residual curarization in PACU and relevant risk factors.

In the last twenty years, residual curarization in PACU (Post Anesthesia Care Unit) has become a common problem in clinical practice and poses high risk to patients. The residual curarization incidence of Neuromuscular blocking agents (NMBA) varies very much between different studies. These differences indicates the necessity of further study. In China, there is no common view of the harmfulness of residual curarization and its complications. The consensus on the necessity of neuromuscular transmission monitoring and neuromuscular blockade antagonist has not been reached yet. There is also no similar large-scale survey in China. In this case, the investigators conduct this large scale multicentre study, which is designed to learn the incidence of residual curarization and its complications. Further analysis of risk factors will also been made. All these efforts are hoped to fill the data gap and provide reliable evidences for rational use of NMBA.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or older
* Nondepolarized NMBA will be given during surgery and tracheal extubation will be performed after surgery
* Willing to comply with all study procedures and provide signed and dated informed consent

Exclusion Criteria:

* Allergic reaction to gel electrode
* Neuromuscular disorders and hepatic or renal dysfunction
* Scheduled to receive mechanical ventilation therapy
* Involved in other clinical trials
* Body position and surgical procedure affecting TOF-Watch SX normal function
Malnutrition Screening in Acute Aged Care

The purpose of this study is to determine the impact of malnutrition screening and nutrition intervention on acute aged care patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* admitted under a geriatrician into one of 2 acute geriatric medicine wards of the hospital

Exclusion Criteria:

* expected length of stay less than 72 hours
* palliative (not for active treatment)
* unable to be nutritionally assessed (non english speaking, severe dementia/confusion and non cooperative/refused)
* already seen by dietitian during current admission
* enrolled in the study during previous admission
Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia

Hyperbilirubinemia is the most common problem seen in neonates, owing to severe complications in their lifetime. The study design of the study is pretest - a posttest experimental design. Criterion-based purposive sampling will be used for recruiting the neonates. In the study neonates will be selected according to the selection criteria and will be allocated into two groups using computer-based randomization.The Intervention group - neonates will receive tactile and kinesthetic stimulation for 15 minutes for 3 consecutive days, 1 hour after feeding twice daily along with Phototherapy, Control group - Phototherapy alone will be given along with conventional NICU care. Total serum bilirubin will be assessed as outcome measures daily once. Transcutaneous bilirubin will be assessed after every intervention.


Eligibility Criteria:
1. New born in Neonatal Intensive Care Unit
2. Stable vitals
3. Full Term and Preterm neonates
4. Gestational age 34 weeks to 40 weeks
5. Birth weight -1800 - 3000 g
6. APGAR Score at birth of 8 -10
7. Total serum bilirubin levels \> 10 mg/dL
Tai Chi Training on Hand Grip Strength and Functional Fitness in Post COVID

to evaluate the effects of participating of Tai Chi program on hand grip strength and Functional Fitness in post Covid

evaluate the effects of Tai Chi and aerobic training on improving hand grip strength, fatigue, and functional fitness in patients with post COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* post covid

Exclusion Criteria:

* medically unstable
* post stroke
* obese
* mentally unstable
Single-Dose Study of Black Cohosh and Red Clover

This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose of one botanical preparation. The observation period will be one week. Drug toxicity, absorption, distribution, metabolism and elimination data will be collected, and dosages to be utilized in a Phase II clinical trial will be determined.

This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose of one botanical preparation. The observation period will be one week. Drug toxicity, absorption, distribution, metabolism and elimination data will be collected, and dosages to be utilized in a Phase II clinical trial will be determined. The Phase II trial will examine the efficacies of red clover and black cohosh for the reduction of menopausal symptoms in healthy menopausal women. The study will be randomized, double-blinded, and placebo-controlled. Study duration will be one year.

Eligibility Criteria:
Inclusion Criteria:

* Healthy menopausal women
* Average body weight
* Able to give informed consent

Exclusion Criteria:

* Smoker
* Use of any prescription medicine within the last 2 months
* Obesity \> 30% above ideal body weight
* Previous history of breast or reproductive cancer
* Alcohol abuse or consumption above 5 glasses of wine per week or equivalent
* Chronic disease such as diabetes or hypertension
* Concurrent non-dietary phytoestrogens or hormone use; Vegans (vegetarians who tend to consume greater than average dose of phytoestrogens)
* Concurrent participation in other clinical trial(s)
* Unavailable for followup
Screening for Liver Fibrosis by Using Non-invasive Methods ( Fibro Scan) in Patients With Elevated Liver Enzymes

BACKGROUND: Fibrosis assessment by Transient Elastography or Fibro scan is validated in chronic hepatitis C, however limited data are available in chronic hepatitis B and in non alcoholic fatty liver disease (NAFLD). AIMS: Document the prevalence and severity of fibrosis in patients with different chronic liver disease (elevated liver enzymes) who are being followed up in the liver unit and to find associated factors with significant fibrosis and cirrhosis at ziv medical center, Safed,Bar Ilan University. Israel. METHODS: Fibro scan will be performed to all patients with abnormal liver enzymnes who attend the liver clinic. Liver stiffness measurement, age, gender, BMI, will be measured. Questionaire on soft drink consumption, Coffee drinking, use of herbs, and a history of cancer or heart disease will be distributed. Expected RESULTS: we expect that the liver stiffness (normal 1-6 Kpa) will be higher in NAFLD patients than in viral hepatitis patients for the same age ,same BMI, and the same duration of disease. More over, we expect serum aspartate aminotransferase (AST) values will emerge as the most important independent predictive variable of fibrosis and not serum ALT. A significant correlations between soft drink and coffee consumption with the extent of liver fibrosis is also expected. CONCLUSIONS: This prospective study will confirm that screening patients with elevated liver enzymes is beneficial and detect earlier the presence of liver fibrosis mainly in patients with NAFLD.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects
* More than 18 years of age
* Patients with elevated liver enzymes
* Written informed consent

Exclusion Criteria:

* Patients refusing to participate to the study and to provide written informed consent
* clotting disorder
* ongoing treatment with anti-coagulant or anti-aggregant
* advanced or decompensated cirrhosis (Child-Pugh class C)
* hepatocellular carcinoma
* other cancer
* history of surgery for brain aneurysm
* pace maker or defibrillator
* ocular metal foreign body
The Family of Heroes: an Evaluation of an Online Educational Tool

The purpose of this study is to evaluate the effectiveness of a unique web based educational tool called "Family of Heroes," which is designed to educate families about Post Traumatic Stress Disorder (PTSD) and provide them with practical tools for interacting with affected veteran family members. The study includes veterans and a family member of their choosing. Participants are randomly assigned to a group which takes the online training or a group that does not take the training. Both groups complete a baseline questionnaire and a follow up questionaire 60 days later. The study will examine the number of Veteran Affairs (VA) mental health visits.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Operation Iraqi Freedom/ Operation Enduring Freedom (OIF/OEF) veteran
* Positive for PTSD, based on PTSD Checklist (PCL) score greater than or equal to 50
* Availability of a family member who is both willing to participate in the study AND has contact with the veteran 3 or more times per week
* Ability to access a computer with internet access to take educational training and surveys

Exclusion Criteria:

* Not and OIF/OEF veteran
* Negative for PTSD, based on PCL score less than 50
* Unavailability of a family member who is both willing to participate in the study or has contact with the veteran 3 or more times per week
* Inability to access a computer with internet access to take the educational training and surveys