cyrilzakka/clinical-trials huggingface dataset:
Management of Migraine Using Enerumab and Traditional Therapy at the Time of COVID-19

The objective of this study was to assess the efficacy of erenumab on frequency of monthly migraine days in adults at baseline, 3 months and 6 months, disability in patients with chronic migraine and on post covid migraine severity

Migraine is a debilitating disorder that affects 37 million people in the United States. Recently, three new injectables calcitonin gene-related peptide (CGRP) receptor antagonists-erenumab, fremanezumab, and galcanezumab-were FDA approved for prophylactic treatment of migraine in adults, that plays a key role in migraine pathophysiology. By blocking the receptor function of CGRP, these agents can reduce the total number of headache days per month and limit the need for using multiple medications. In clinical trials, these agents, which have no drug interactions and minimal adverse reactions, reduced headache days per month by as much as 50% in patients experiencing multiple migraine days each month. These new biologics, however, are more expensive for the patient compared with other prophylactic treatments

The rational of this study was to assess the efficacy of erenumab on frequency of monthly migraine days in adults at baseline, 3 months and 6 months, disability in patients with chronic migraine and on post covid migraine severity

Eligibility Criteria:
Inclusion Criteria:

* -Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
* Sexes Eligible for Study: All
* History of at least 5 attacks of migraine

  -≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period
* chronic migraineurs with failure to more than 2 preventive treatments
* chronic migraineurs without any preventive treatments
* Naive to anti CGRP monclonal antibodies

Exclusion Criteria:

* Participants are excluded from the study if any of the following criteria apply:

  • unable to understand the study requirements, the informed consent, or complete headache records as required per protocol;
* History of cluster or hemiplegic headache
* Evidence of seizure or major psychiatric disorder Cardiac or active hepatic disease
* pregnant, actively trying to become pregnant, or breast-feeding;
* episodic migraineurs,
* Other headache types
* allergy to latex;
* received nerve blocks or trigger point injections in the previous 8 weeks or plans to receive them during the study;
* prior exposure in the last 6 months to biologics or drugs specifically targeting the calcitonin gene-related peptide (CGRP) pathway;
* a psychiatric condition, that may affect the interpretation of efficacy and safety data or contraindicates the participant's participation in the study
Efficacy of the Athletes for Life Program to Promote Cardiovascular Health

The purpose of this study was to test the efficacy of a fitness- and behavioral-focused intervention, Athletes for Life (AFL), to improve cardiorespiratory fitness (CRF) among 160 underserved families.

The Athletes for Life (AFL) study was a 12-week randomized controlled trial designed to promote cardiorespiratory fitness (CRF) and healthy lifestyle changes among parents and children. The original enrollment target was 160 families. A total of 149 parent-child dyads living in a Southwestern U.S. metropolitan area were enrolled in the study. AFL consisting of 24 structured, twice-weekly 90-min family-based, nutrition and sport/fitness-oriented sessions, and was delivered in a municipal recreation center. Behavior change, including increased physical activity, and adherence were motivated through positive reinforcement techniques. Families were randomized to either the AFL program or a wait-list control group.

Eligibility Criteria:
Inclusion Criteria:

* Parent ages 18 years and over
* Child ages 6-11 years

Exclusion Criteria:

* Presence of a mental or physical condition that was contraindicated to participating in sports/exercise
* Having a chronic condition that limited mobility
* Taking medications that influenced body composition
Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia

The purpose of this study is to determine wether intravenous Phenylephrine, administered as start bolus and following continuous infusion (specific dosage per weight), or optimal lower limb bandaging is more effective in preventing hypotension during caesarean section under spinal anaesthesia in healthy women.

The hypothesis is that the Phenylephrine model is superior to lower limb compression in preventing hypotension.


Eligibility Criteria:
Inclusion Criteria:

Healthy women Elective caesarean section under spinal anaesthesia Informed consent Age 18-40 ASA 1-2 BMI 18-32 prior to pregnancy Height 160-180 cm

Exclusion Criteria:

Any form of disease or anomalities:

Heart or vascular disease Cerebrovascular disease Other somatic or psychiatric disease Hypertension or preeclampsia Contraindication against spinal anaesthesia Anomalities concerning pregnancy and foster
A Biological Study of Resveratrol's Effects on Notch-1 Signaling in Subjects With Low Grade Gastrointestinal Tumors

Resveratrol has been shown to activate a protein called Notch-1. Signaling of Notch-1 has been shown to prevent tumor cell growth. Resveratrol has also been shown to prevent growth of tumors in mice. The purpose of this study is to examine the effects of resveratrol and Notch-1 on neuroendocrine tumor tissue and to examine how people with neuroendocrine tumors who take resveratrol for up to three months tolerate the product.

Patients will be treated with a dose of 5 gm/day of resveratrol orally, in two divided doses of 2.5 gm each without a break in therapy for a total of three cycles. All patients who receive at least one dose of resveratrol will be evaluated for toxicity and tolerability. Toxicities will be assessed every 28 days while the study drug is being taken by the patient. Pill bottles will be reviewed at this visit as well to ensure compliance with the study medication. Toxicities will be graded according to the NCI Common Toxicity Criteria. Blood will be drawn for a complete blood count and comprehensive metabolic panel. In addition, one vial of serum will be stored at the time of each toxicity assessment for later analysis of resveratrol levels. This level must be drawn one hour after the morning dose and the participants will be instructed to alter the time of the morning dose so as to allow proper timing with the scheduled blood draw.

During the third cycle of treatment, a post-treatment biopsy will be obtained for study related purposes and will be processed only for research related purposes.

Eligibility Criteria:
Inclusion Criteria:

1. ECOG performance status of 0-2
2. Age \>18 years old
3. Women who are not postmenopausal must have a negative enrollment blood test and agree to use an effective mode of contraception while taking the study medication
4. Greater than four weeks must have elapsed since any previous therapy was administered for the neuroendocrine tumor, including surgery, radiation, chemotherapy or local liver therapy.
5. Octreotide use is allowed but must be initiated at least four weeks prior to enrollment and to the pre-treatment biopsy
6. Able to give informed consent and willing to undergo the post-treatment research biopsy
7. Must be able to take oral medications and be without GI tract obstructive symptoms
8. Subjects with another malignancy for which they are either undergoing treatment with chemotherapy or radiation, or with a malignancy for which such treatments have been recommended, would be excluded or withdrawn from the study.
9. Must agree to abstain from excessive alcohol, as defined by greater than the equivalent of three glasses of wine per day or one six pack of beer per day

Exclusion Criteria:

1. The principal investigator will review each subject's current medications prior to enrollment of the study to ensure that the administration of Resveratrol will not affect their current medications.
Secondary and Tertiary Digital Prevention of Non-alcoholic and Dysmetabolic Liver Disease

The prevalence of Metabolic dysfunction-associated steatotic liver disease (MASLD) and its severe form, Metabolic dysfunction-associated steatohepatitis (MASH), is high and they are increasingly becoming major causes of cirrhosis, hepatocellular carcinoma (HCC), and the need for liver transplantation. Due to the lack of noticeable symptoms during the early stages, the detection of MASLD is often delayed until the disease has advanced.

Currently, the treatment options MASLD are limited to lifestyle interventions such as dietary changes and physical activity. Despite the increasing prevalence of MASLD, there are no drugs available on the market specifically for this condition.

The goal is to made new model care which integrates the standard clinical procedures with a digital approach, namely a mobile application for patients and a clinical dashboard for healthcare professionals (HCPs), integrated with simple clinical data (anthropometric, laboratory and imaging data).

This study wants to test the feasibility of integrating a digital intervention to improve the patient engagement and linkage to care in order to identify the advanced MASLD at earliest stage (secondary prevention) and mitigate the impact of ongoing advanced liver disease helping patients to manage the long-term effect of disease.

To achieve this goal the study will leverage on a mobile app named OpenTele in order to test the adherence to lifestyle changes in patient with MASLD and on the connected clinical dashboard.

The app aims at integrating the standard clinical practice with digital technologies able to guide and support patients in order to seamlessly integrate secondary prevention strategies in their everyday life with 2 main aims:

* to implement a strategy for delay progression of liver disease;
* to reduce the effect of cirrhosis (tertiary prevention).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with MASLD and LSM\>= 10 kPa
* Age \>= 18 years old
* Sufficient digital literacy or supported from a caregiver with sufficient digital literacy
* Smartphone (Android or iOS) able to download and run the App
* Able to understand and communicate in Italian
* Able to sign the informed consent

Exclusion Criteria:

* Major psychiatric disorder
* Not able to use digital technologies
Frail Elderly Subjects - Evaluation and Follow-Up

This was a prospective multicenter cohort study of elderly people admitted to medical wards via emergency departments. Subjects were followed up to 36 months. It aimed to study the inhospital pathways and adverse geriatric outcomes. In all, 1306 subjects were included : 85+/-5 years, and mainly women (65%).

The SAFES cohort was formed within a National Research Program (funded by the French Ministry of health) into the recruitment of emergency units in nine teaching hospitals. All nine centres had a geriatric ward. The inclusion of subjects ran from March 1st 2001 to January 17th 2002. To be eligible, patients were to be 75 or over, to have been hospitalised in a medical ward in the same hospital as the emergency unit to which they were initially admitted. Subjects were not eligible if hospitalisation was into intensive care or surgery, or if admission did not occur after admission to the emergency unit. Every day in each centre, patients admitted to the emergency unit were registered. From the list thus obtained, patients were selected by random draw stratified at two levels: in each week, 5 days were selected randomly, and for each of these days, two patients were chosen randomly. Next, each patient was visited by a specialist in geriatrics familiar with the survey procedures. In the course of this interview, patients were informed about the study, prior to signing the consent form. If the clinical status and/or the cognitive status of the patient did not enable informed consent, the interviewer referred to the subject's representative. Follow-up was by telephone interview after the 1st, 8th and 21st month and by face-to-face interviews after the 5th, 12th, 18th, and 24th month following the initial hospitalisation. Several outcome have been studied.

Eligibility Criteria:
Inclusion Criteria:

* Age of 75 years or over
* Admitted to medical ward via emergency department
* Consent to participate

Exclusion Criteria:

* Not hospitalised after emergency department stay
* Admitted to surgery or intensive car unit
* Died before signing informed consent form
Effect of Supragingival Irrigators Containing Chlorhexidine on Oral Health in Blood Dyscrasia

in this study , effectiveness of supragingival irrigators containing chlorhexidine is compared with routine oral health measures in patients with blood dyscrasia whom can not use effective oral health measures(e.g brushing ) due to their systemic condition(e,g,neutropenia ,thrombocytopenia,..)

Since some patients with hematologic malignancies cannot brush effectively and are at increased risk of bleeding and infection due to severe neutropenia and thrombocytopenia we want to access whether a none invasive method ( water jet systems containing chlorhexidine ) Can help this patients to get better oral health indexes in comparison with routine oral health measures in these type of patients.

Eligibility Criteria:
Inclusion Criteria:

patients with a blood dyscrasia, severe neutropenia and thrombocytopenia, absence of periodontitis, absence of any oral mucosal lesion in onset of study, patient consent

Exclusion Criteria:

diabetes mellitus, observation of any side effect (resulted from the device), severe oral mucositis in intervention group(grade 3 and4 WHO), edentulousness, intolerance of device in severely malaise patients, patient death
Efficacy of Various Treatments for Acute Acoustic Trauma.

Acute acoustic trauma is a growing concern in the IDF. there is currently no accepted treatment. The present retrospective study is intended to evaluate the efficacy of different treatment modalities in the IDF between 01/01/2010 and 15/06/2020.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with acute acoustic trauma.
* Hearing exam performed at least 24 hours after acute acoustic trauma.
* There was a reduction of at least 30dB in the 3,000-8,000 Hz frequency range in the first hearing exam performed.

Exclusion Criteria:

* A known hearing impairment prior to acute acoustic trauma.
* Subjects lost from follow up.
* Another diagnosis is more likely than hearing loss due to acute acoustic trauma.
Development of Early Diagnostic Techniques and Setup of Local Therapeutic Guidelines and Standards

End-stage renal disease (ESRD) is a healthy, social and economic threat worldwide. In the past ten years, the incidence and prevalence of ESRD patients have tremendously increased, ranking at the top in the world. The reasons for such high incidence and prevalence are multifactor. Early diagnosis and closed monitor of the patients with chronic kidney disease (CKD) may be beneficial, but not confirmed yet.The advising mechanisms for non-doing or withdraw long-term dialysis. All these studies will be performed in a multicentered project. Three medical centers in which CKD researches have been conducted for many years will provide a large cohort and share the data collected from their own hospitals. We expect that the results will provide an excellent guideline for CKD care, achieve cost-effectiveness of dialysis therapy and better life quality of ESRD patients.

Purpose: Development of early diagnostic techniques and setup of local therapeutic guidelines and standards.

Design: The group plans to host the co-operation of hospitals, based on the geographical distribution of co-operation of several hospitals to choose the renal physician interviews the doctor and patient received a total of 30 objects was conducted qualitative in-depth interviews.

Time:2008/9/1\~2011/8/31

Inclusion criteria): To withdraw from dialysis treatment of chronic kidney disease, qualitative research, to-depth interviews, field observation, video recording, and public hospitals at the same time the collection of literature.

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease patients with the end of dialysis to withdrawal.
Risk of Bacterial Exposure to the Anesthesiologist's Face During Intubation and Extubation

The practice of intubation and extubation is not without risks to the anesthesiologists. Especially, the face of health care worker is the body part most commonly contaminated by splashes and sprays of body fluids. The aim of this study is to determine the incidence of unrecognized exposure to the anesthesiologists' face during endotracheal intubation and extubation. We will perform face shield swab before and after the endotracheal intubation and extubation. All swabs will be cultured for 48 hours and the number of colony forming units before and after the procedures (intubation/extubation) will be compared.


Eligibility Criteria:
Inclusion Criteria:

* anesthesiologists who perform endotracheal intubation and extubation for patients scheduled for endotracheal intubation for elective surgeries

Exclusion Criteria:

* none
Efficacy Assessment of the Cell Therapy Medicine NC1 in Patients With Post-traumatic Syringomyelia

The objective of the study is to determine if the cell therapy NC1 administered in the spinal cord is effective for the treatment of a post-traumatic syringomyelia. The post-traumatic syringomyelia is the development and progression of cyst filled with cerebrospinal fluid (CSF) within the spinal cord. The cell therapy NC1 consist on cells obtained from the bone marrow of the patient, that are cultured in vitro and administered in the spinal cord of the same patient.

Phase II, Open, prospective, not controlled, not randomized clinical trial in patients affected by post-traumatic syringomyelia. The trial evaluates the efficacy of the cell therapy NC1 administered via intrathecal in the location of the injury. After the administration of the cell therapy, patients will undergo physiotherapy during the follow-up period (6 months). Patients will be evaluated at month 3 and month 6 after the NC1 administration.

Eligibility Criteria:
Inclusion Criteria:

* Patients with traumatic medullar injury (levels A, B, C or D of the ASIA scale) and associated syringomyelia in at least three spinal segments, and with neurological deficit clinically stable at least 6 months prior to treatment.
* Previous studies in Neurophysiology, MR, Urology (if data on neurogenic bowel exists), defecatory function (if data on neurogenic intestine exists)
* Age between 18 and 70 years old.
* Presence of syringomyelia based on a neuro-image (MR)
* Patients will compromise to use anticonceptive measures from the cell extraction until 6 months after the administration of the treatment.
* Patients will compromise to a clinical follow-up and to perform physical therapy, one hour daily five days per week during the treatment period.
* Patients should sign an written informed consent.
* Haematological and creatinin parameters, SGOT and SGPT into the normal ranges.

Exclusion Criteria:

* Patients under 18 or above 70 years old
* Pregnancy or breastfeeding
* Neoplasia in the last 5 years
* Patients with systemic diseases that increase the risk of the surgical intervention
* Genetics alterations that could conduct to cellular transformation during the cellular expansion phase.
* Patients not really sure of their cooperation to follow the physical therapy or clinical controls during the study.
* Additional neurodegenerative diseases
* Drug consuming, psychiatric disease or allergy to proteins used during cellular expansion
* HIV or syphilis positive serologies
* Active Hepatitis B or c, based on serologies
* Any other reasons according to the investigator criteria.
Myo-inositol Plus Melatonin in Perimenopausal Women

Menopause is the milestone of a more broaden condition that can last up to 10 years. The first menopausal symptoms usually appear around the age of 42 and are characterized by a gradual decline in thyroid and gonadal function with a progressive increase of plasmatic luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels.

Recent studies have shown that myo-inositol and melatonin play a major role in ovarian homeostasis. In particular, it has been demonstrated that myo-inositol and/or melatonin supplementation lead to an increase of oocyte quality.

Additional studies focused on postmenopausal women have shown that myo-inositol is able to ameliorate the metabolic syndrome that often affects these patients, thus reducing the risk of cardiovascular diseases (CVDs).

The aim of the present study is to evaluate whether myo-inositol and melatonin might play a positive role in regulating hormonal levels during menopausal onset.


Eligibility Criteria:
Inclusion Criteria:

* FSH between 15 and 50 IU/ml on the 5th day of the menses
* Oligomenorrhea

Exclusion Criteria:

-
Effect of the Hands- on McKenzie Program on Low Back Pain

Low back pain (LBP) is one of most prevalent types of musculoskeletal pain and is strongly related to disability. The McKenzie method is one of most popular treatment options for LBP.

The objectives of this study are to determine the effect of the hands-on McKenzie program on pain, disability, spine mobility, and posture deviations in subjects with derangement low back pain.

Thirty eight patients with sub-acute and chronic LBP will be randomly assigned to the McKenzie group (MG) or the control group (CG). The MG will perform exercises with the hands-on procedure (three sessions per week) for two weeks, while the CG will perform only exercises for two weeks. Both groups will do a home exercise program. The outcome assessments will measure pain by the Pain Numerical Rating Scale (NPRS), the level of disability through the Oswestry Disability Index (ODI), spine mobility by range of motion (ROM) for the lumbar spine, and the centralization of symptoms and the postural alternation by postural analysis grid (PAG). By using SPSS version 20, a paired t-test will be use to study the effect of the McKenzie program before and after treatment. An independent t-test will be used to study the significance between the two groups.

Eligibility Criteria:
Inclusion Criteria:

- The patients will be age from 18 to 60 years old, and have LBP with or without leg pain, lasting from seven weeks to 12 weeks or more. Additional criteria include recurrent LBP, demonstrating a DP during the mechanical assessment , The subjects have a BMI of normal (17 to 23.9) or overweight (24 to 28.9). Patient is Eligible.

Exclusion Criteria:

Participants who are underweight (BMI \< 18.5) or obese (BMI ≥ 30) will be excluded . Those with contraindications to physical exercise according to the guidelines of the American College of Sports Medicine , such as those with serious spinal pathologies (fractures, tumours, and inflammatory diseases, such as ankylosing spondylitis), nerve root compromise (e.g., cauda equine syndrome), severe cardiopulmonary diseases,SCD, or pregnancy will be excluded.

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