cyrilzakka/clinical-trials huggingface dataset:
Scalp Hair Estradiol and Progesterone Level Determination in Women (Proof of Concept Study)

The investigators hypothesis is that we can determine estrogen and progesterone levels in the hair by using the immune method and we can show a significant difference in the levels of these hormones in both groups of women: pre- and postmenopausal women. If indeed it would then be possible in future to carry out research that can find a relationship between the levels of these hormones and various diseases

One group will include 20 women under the age 40 years old, with regular menstruation cycles and without any illness or medication including birth control pills or steroidal ointments, and without known diagnosis of polycystic ovaries or fertility disorder. The second group will include 20 women over the age of 60, with no menstruation at least for the last five years, and without hormone therapy or treatment of any Steroidal therapy for the last year.

From all of the participants the investigators will collect hair samples at the crown back of the head (hair will be cut as close as possible to the scalp), the samples will be measured quantitatively about 100 hairs at a length of 2-3 cm. In order to grind the hair samples we will use a mini-Bead beater machine. milled hairs will be incubated overnight in a solution of 1 ml methanol 50, in constant gentle muddling. Afterwards, ethanol will disperse through a stream of nitrogen. The remainder of the suspension will be dissolved at 200 microliter buffer PBS (Phosphate-Buffered Saline) (pH 8.0) and the concentration of estrogen and progesterone will be measured by using the immune method which is available in the endocrine laboratory in Bnai Zion medical center. At the end of the study the investigators will cary out a statistical comparison of progesterone and estrogen levels between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* women under 40 with regular cycles
* Women over the age of 60 in menopause for at least 5 years

Exclusion Criteria:

* pregnant women
* oral contraceptive treatment in the last year
* hormonal replacement therapy in the last year
* 6 month after delivery
* infertile women
* irregular menstruation
* women with progesterone secretion intrauterine device in the last year
* BMI- Body Mass Index- below 25 or above 35
* Polycystic Ovarian Syndrome
* steriodal treatment including inhalers and ointments.
* status post Removal of the ovaries or uterus
* Breast or uterine cancer in the past.
* any pituitary or adrenal disease
Reducing Concurrent Opioid-Benzodiazepine Prescriptions

The purpose of this effort is to use informative e-mails to improve the process of prescribing of opioids and benzodiazepines within the National Capital Region/Military Health System (NCR/MHS), with the aim of decreasing concurrent opioid and benzodiazepine prescribing.

The purpose of this effort is to use low-cost informative e-mails to improve the process of prescribing of opioids and benzodiazepines within the National Capital Region/Military Health System (NCR/MHS), with the aim of decreasing concurrent opioid and benzodiazepine prescribing. Both the VA/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain (2017) and the CDC Guideline for Prescribing Opioids for Chronic Pain (2016) strongly recommend against the concurrent use of opioids and benzodiazepines. Taken together, these drugs could cause respiratory depression, enhanced sedation, and death. The intervention population will be prescribers and primary care managers associated with patients who have recently received concurrent prescriptions of opioids and benzodiazepines. Using a randomized approach, we will allocate the NCR/MHS providers associated with patients with concurrent prescriptions for opioids and benzodiazepines to one of two conditions:

1. E-mail alert - A messaging approach, in which we will send encrypted emails to the patient's opioid and benzodiazepine prescriber(s) and primary care manager that identify the concurrent prescriptions and detail the patient's prescription history, inform them of the VA/DoD guideline and risk to patient, and provide action steps and relevant resources. When multiple providers are involved, the email message will also encourage coordination across providers and provide relevant contact information
2. As-Usual - An as-usual approach, in which providers are not sent messages. These providers can access patient information through the MHS Opioid Registry as before.

Eligibility Criteria:
Inclusion Criteria:

* Patient had an overlapping opioid-benzodiazepine prescription
* At least one of the patient's providers (opioid prescribers, benzodiazepine prescribers, and/or PCM) is in the NCR

Exclusion Criteria:

* Patient has a cancer diagnosis
* Patient is receiving palliative care
* Patient is under 18
* Patient was previously allocated to a study condition
Evaluation Trial of Handheld Urinal for Adult Use

Usability and efficacy evaluation of a prototype handheld urinal for adult use

28 day usability and efficacy evaluation by 154 adults in domestic settings who suffer one or more of nocturia, urge, frequency or functional incontinence.

Eligibility Criteria:
Inclusion Criteria:

* Suffers from nocturia urge, frequency, or funnctional incontinence

Exclusion Criteria:

* Suffers only from stress UI
Predictive Parameters for Efficacy of Sitagliptin and Metformin Combination

It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose levels in both fasting and postprandial states and preserves pancreatic beta cell function in patients with type 2 diabetes. Their mechanism of action is derived from increased incretin (GLP-1) levels, which stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas. Recent studies reported that combination therapy with DPP-IV inhibitors and metformin have additive or synergistic effects in lowering glycose level, preserving beta-cell mass and function as well as enhancing insulin sensitivity. However, there have been few studies about the difference of glucose lowering effect of combination therapy of DPP-IV inhibitors and metformin according to the secretory capacity of pancreas.

The researchers hypothesized that combination therapy with DPP-IV inhibitor and metformin may have more favorable glucose lowering effect in type 2 diabetic patients who have preserved pancreatic secretory function. The researchers plan to investigate the difference of glucose lowering effect of 24 weeks treatment with sitagliptin (DPP-IV inhibitor) in combination with metformin according to basal c-peptide and glucagon level in type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* HbA1c ≥ 7%
* Age ≥ 18

Exclusion Criteria:

* Contraindication to sitagliptin or metformin
* Pregnant or breast feeding women
* Reproductive-age women who refuse contraception
* Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
* Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT \> 3-fold the upper limit of normal)
* Renal failure (Cr \> 2.0)
* Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment)
* Not appropriate for oral antidiabetic agent
* Medication which affect glycemic control
* Disease which affect efficacy and safety of drugs
* Other clinical trial within 30 days
Ontological Coaching Among Nurses (OCN)

This study aims to develop and evaluate ontological coaching among novice nurses in Singapore. The specific aims of this project are: (1) to develop theory based Ontological Coaching among Nurses (OCN) intervention for novice nurses; (2) examine its effectiveness on nurses' psychological wellbeing (primary outcome), help-seeking behavior (social support), goal setting, resilience, intention to leave and job satisfaction (Secondary outcomes); and (3) examine the perceptions of nurses in receiving this intervention.

The specific research questions we plan to answer in this project are:

* How the OCN will influence psychological wellbeing of the new nurses?
* How the OCN will enhance the new nurses social support and goal setting for their reality and future?
* How the OCN will influence new nurses' resilience, intention to leave and job satisfaction?
* What are the changes in psychological well-being, social support, goal setting, resilience, intention to leave and job satisfaction after receiving OCN over time (pre-test and post-test)?
* Are there any strengths, weaknesses and area of improvements (overall experience) for the use of OCN among new nurses?


Eligibility Criteria:
Inclusion Criteria:

Nurses:

* 21 years old and above
* are able to read and speak English,
* have 0-10 years of working experience after the registration with Singapore Nursing Board (SNB)
* currently working at the study venues with the valid registered nurse license with the SNB
* who are willing to be audio-recorded if invited for an interview

Facilitators:

- who hold an Ontological Coaching certification and a minimum of 50 hours of Coaching experience

Exclusion Criteria:

Nurses:

* have physical or mental disorders which would interfere with their ability to participate in the study
* have refused to participate in this study

Facilitators:

- who does not hold an Ontological Coaching certification or who do not have a minimum of 50 hours of Coaching experience
Assessing the Potential Role of the Gut Microbiome in Modulating Physical Abilities in Humans

The intestinal microbiome is a microbial system that is influenced by host genetics and environmental exposures such as nutrition, stress and medications. There is a growing body of evidence indicating the significant contribution of the gut microbiome to host health and disease. Furthermore, it has been shown that exercise may modify the microbiome composition. However, important mechanistic questions related to the possible associations between exercise and the human gut microbiome remain unanswered.

In this study, the investigators are using advanced state-of-the-art measurements of physical activity level and related metabolic parameters whether there is a connection between the microbiome and physical abilities in healthy participants and whether antibiotics consumption can influence host physical abilities and glycemic responses through changes induced in microbiome composition and function.

During all days of the study, participants will be connected to a continuous glucose monitor (CGM).

In the second segment of the study, participants will be randomized into two groups: antibiotics or placebo, which will be consumed for 7 days.

The third segment of the trial, participants will undergo an FMT/placebo administration for three consecutive days according to their randomization: participants who received antibiotics will receive FMT and participants who received placebo pills will receive placebo capsules in this segment as well.

During the study, participants will collect stool and buccal samples which will be used for microbiota profiling.

Furthermore, participants will undergo physical abilities test, anthropometric measurements, medical history questioners, blood and urine samples and Dual X-ray absorptiometry (DXA) test.

Eligibility Criteria:
Inclusion Criteria:

* BMI\<28
* Age - 20-35
* Are used to exercise in aerobic sports (running, swimming, Zumba, ball games, functional training, surfing, tennis, wrestling ext.).
* Exercise at least twice a week, for a minimum duration of the last 6 months.

Exclusion Criteria:

* Consumption of antibiotics (PO) or probiotics 3 months prior to the first day of the experiment.
* Diagnosis of type 1 or type 2 diabetes.
* Pregnancy, fertility treatments, breastfeeding women six months prior to enrollment and during the study.
* Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism etc.)
* Cancer and recent anticancer treatment
* Psychiatric disorders
* Coagulation disorders
* Gastrointestinal disorders
* Bariatric surgery
* Alcohol or substance abuse
* BMI\>28
* Any physical condition precluding the completion of a routine effort test
Circulating Biomarkers to Identify Thyroid Cancer

This study aimed to identify the potential circulating biomarkers of protein, mRNAs, and long non-coding RNAs (lncRNAs) to diﬀerentiate the papillary thyroid cancers from benign thyroid tumors. Methods: The study population of 100 patients was classified into identification (10 patients with papillary thyroid cancers and 10 patients with benign thyroid tumors) and validation groups (45 patients with papillary thyroid cancers and 35 patients with benign thyroid tumors). The Sengenics Immunome Protein Array combined data mining approach using the Open Targets Platform was used to identify the putative protein biomarkers, and their expression validated using the enzyme-linked immunosorbent assay. Next-generation sequencing by Illumina HiSeq was used for the detection of dysregulated mRNAs and lncRNAs. The website Timer v2.0 helped identify the putative mRNA biomarkers, which were significantly over-expressed in papillary thyroid cancers than in adjacent normal thyroid tissue. The mRNA and lncRNAs biomarker expression was validated by a real-time polymerase chain reaction.

Novel biomarkers identification from liquid biopsy samples is in great demand for the diagnosis for malignant diseases. Generally, blood sampling is less invasive and could be carried out repeatedly. In addition to protein markers, circulating nucleic acids are promising sources of cancer biomarkers , since circulating nucleic acids provide information on the genome or gene expression , and harbor wealth of health and disease status information. The long non-coding RNAs (lncRNAs) are the transcripts longer than 200 nucleotides in length and act as prominent regulators of gene expression. Accumulating evidence demonstrated the involvement of lncRNA dysregulation in a variety of cancers, and their expression is associated with cancer development and metastasis. This study was designed to identify the potential protein and RNA biomarkers in the blood for diﬀerentiating a malignant thyroid tumor from a benign thyroid nodule. In this study, only patients with papillary thyroid carcinoma, the most common type of thyroid cancer, were chosen for comparison with those with benign thyroid tumors to simplify the comparison.

Eligibility Criteria:
Inclusion Criteria:

* Patients with thyroid nodules who received total or subtotal thyroidectomy
* Patients aged 20 years and above

Exclusion Criteria:

* Patients with any other type of cancer, immunocompromised disease, or autoimmune disease.
Development and Validation of a Driving Simulator for Evaluating the Residual Effects of Drugs on Driving Performance - Sensitivity Analysis Using Zopiclone As a Positive Control

The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 at screening inspection
* No visual impairment (enable to correct the vision with eyeglasses or contact lens)
* Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* History of drug and food allergy
* Hypersensitivity to zopiclone
* Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
* Other protocol defined inclusion criteria could apply
An Evaluation of the Effect of the AmnioFix Amniotic Membrane Allograft in Patients Undergoing Posterior Instrumentation Removal

The objective of this study is to evaluate the clinical effectiveness of AmnioFix™ in the reduction of the tenacity and frequency of soft tissue adhesions during the removal of segmental posterior lumbar instrumentation.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older)
* Diagnosed with lumbar pathology requiring elective lumbar interbody fusion
* Willingness to comply to follow-up examinations and diagnostic imaging procedures
* Ability to give full written informed consent

Exclusion Criteria:

* Previous surgical procedure performed at same site
* Sign or symptoms of other disease which could result in allograft failure
* Require a corpectomy
* Participating in another drug or device clinical trial
* Pregnant or may become pregnant during the study
* Prisoner
* Involved in workmen's compensation or other litigation relative to a spine injury
* Past medical history of allograft implantation which resulted in graft failure
* Any condition requiring treatment above the normal standard of care
* Currently taking medications which could affect graft incorporation (supervising physicians discretion)
* Auto-Immune disease
* Renal failure
* Failure to sign or understand informed consent information
* History of drug and/or alcohol abuse
* Allergic to aminoglycosides
Efficacy of an Oral Stimulation Protocol in Preterm Infants to Shorten the Period Between Enteral and Oral Nutrition

Oral feeding in the neonatal period requires an accurate coordination between suction, swallowing and breathing. In premature new-borns and, depending on their gestational age, the coordinated work of those processes becomes jeopardised, being necessary to begin with an artificial enteral feeding. This situation results in lengthen their stay at the hospital until they are able to respond in a reliable way to their nutritional requirements orally, maintaining an adequate daily weight gain and without endangering their cardiorespiratory system.

This project is an experimental, prospective, blinded, randomized study, aimed to determine whether the application of a manual oral stimulation protocol in premature infants, hospitalized in a neonatal unit, reduces the transition time from enteral feeding to oral full feeding, while improves quality of feeding and shortens hospitalization time.


Eligibility Criteria:
Inclusion Criteria:

* Babies between 25 + 0 to 30 + 6 weeks of gestation according to the last menstruation, with adequate weight and size for their gestational age, who are receiving orogastric tube feeding, presenting clinical hemodynamic and cardiorespiratory stability and without any associated pathology.

Exclusion Criteria:

* Babies with congenital anomalies that affect feeding (chromosomopathies, craniofacial anomalies, severe esophageal or tracheal atresia, or any other that affect feeding),
* Babies with abnormalities that alter digestive function such as "necrotizing enterocolitis".
* Babies with other abnormalities that alter hemodynamic or cardiorespiratory stability, that present severe sepsis or positive meningitis culture, that suffer from chronic medical complications such as severe bronchopulmonary dysplasia, grade III or IV intraparaventricular hemorrhage, periventricular leukomalacia, etc.,
* Inability to to assign an exact gestational age.
Effect of Tulsi (Ocimum Sanctum) on Biochemical Parameters in Young Overweight and Obese Subjects

This is a study to investigate the effect of Tulsi (Ocimum sanctum Linn.) on metabolic and biochemical parameters in young overweight and obese subjects. Thirty overweight/obese volunteers will be divided into two groups. The first group will receive no intervention. The second group will be supplemented with one capsule of Tulsi orally every morning and evening in empty stomach for 60 days. The metabolic parameters and liver enzymes will be evaluated before and after the intervention.

This is a randomized, parallel group, open label pilot study to investigate the effect of Tulsi (Ocimum sanctum Linn.) on metabolic and biochemical parameters in young overweight and obese subjects. Thirty overweight/obese volunteers will be divided into two groups. The first group will receive no intervention. The second group will be supplemented with one capsule of Tulsi orally every morning and evening in empty stomach for 60 days. The metabolic parameters and liver enzymes will be evaluated before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese volunteers of both genders from age 17 to 30 years

Exclusion Criteria:

* Addiction to tobacco and/or alcohol.
* Not on drugs like fluoroquinolones, anticonvulsants, antihypertensives, corticosteroids, hormonal contraceptives, hypolipidemic agents, anti psychotics, protease inhibitors and isotretinoin.
* Not suffering from liver disease, malabsorption, nephrotic syndrome, thyroid disorder, allergy or any other chronic disease.
Developing an Utstein-style Danish Drowning Registry: Nationwide Fatal and Nonfatal Drowning Data Since 2016

This nationwide, registry-based study aims to link Danish Prehospital Drowning Data data with inhospital data to develop a Utstein-style Danish Drowning Registry. This study will report mortality and neurological outcomes 30 days after a drowning incident since 2016.

Purpose

The purpose of this study is to establish recommendations towards specific educational, preventative, rescue, or treatment strategies to reduce the number of fatal and non-fatal drowning incidents in Denmark (e.g., campaigns targeting high-risk groups, or fencing, allocating rescue equipment, or establishing lifeguard stations in high-risk areas).

Objectives

The primary objective is to estimate 30-day mortality of drowning incidents in Denmark treated by the Emergency Medical Services from 2016. The secondary objective is to explore risk factors associated with 30-day mortality.

Study design

A nationwide registry-based study linking data from the Danish Prehospital Drowning Data with data from the inhospital electronic medical records. from 2016 and follow-up on mortality 30 days after the drowning incident. Neurological outcomes will be assessed by trained observers through the inhospital electronic medical records.

Eligibility Criteria:
Inclusion Criteria:

* Drowning
* Being registered in the Danish Prehospital Drowning Data with a valid civil registration number to allow for linkage with the inhospital electronic medical records

Exclusion Criteria:

* Obvious signs of irreversible death (decapitation, decomposition, post-mortem lividity, post-mortem rigidity).
* Declared dead on scene.
* A valid Do-Not-Attempt-Resuscitation order or other code status orders limiting life-sustaining therapies.
* An invalid civil registration number.