cyrilzakka/clinical-trials huggingface dataset:
Adenomyosis in Fertile Women in MUSA Criteria

1. To estimate the prevalence of adenomyosis in fertile women aged 18-30 years using the revised MUSA ultrasound criteria.
2. To evaluate clinical risk factors that are associated with adenomyosis diagnosis in this population

Adenomyosis is a benign condition characterized by the presence endometrial glands and stroma within the myometrium. Its prevalence varies from 5-70%. The definitive diagnosis of adenomyosis is based mainly on histological assessment of hysterectomy specimens. This led to a concept that adenomyosis affects only parous women between 35-50 years who complain of dysmenorrhea and heavy menstrual bleeding. Magnetic Resonance Imaging (MRI) can detect adenomyosis with a sensitivity of 80%. Transvaginal ultrasound using the revised Morphological Uterus Sonographic Assessment (MUSA) criteria can detect adenomyosis non-invasively at a lower cost. Such advancements in imaging techniques allow studying the prevalence of the disease in wider range of population including young women.

Eligibility Criteria:
Inclusion Criteria:

* women with regular menstrual cycle attending outpatient clinic for contraception counseling
* age 18 -30 years old

Exclusion Criteria:

* Women on hormonal contraception
* Infertile women
* Associated pathologies like endometriosis, uterine fibroids. and ovarian cysts
MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier

This is a study to determine if Magnetic Resonance Imaging (MRI) techniques can detect early changes in white matter (in the brain) and the blood-brain barrier resulting from radiation therapy.

Patients will be assigned to one of two groups based on the type of radiation they will be receiving: whole brain irradiation or partial brain irradiation. Patients will undergo Magnetic Resonance Imaging (MRI) assessments, neurocognitive testing (Quality of Life and Neuropsychological assessments), and clinical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving partial brain irradiation for malignant or benign brain tumors (including low-grade gliomas, high-grade gliomas, malignant meningioma, pituitary adenomas, supratentorial meningioma, or craniopharyngiomas); or patients receiving whole brain irradiation for brain metastases.
* Patients must be 18 years of age or older
* Patients must sign a study specific consent form approved by the Institutional Review Board (IRB) of the University of Michigan prior to study entry.
* Patients must have a neurological function class 1 or 2 with a Karnofsky performance status (a scoring system used to quantify general well being and quality of life on a scale of 100 to 0) of greater than or equal to 70.
* Patients must have an expected life expectancy of greater than 6 months.

Exclusion Criteria:

* Patients with a history of major medical illness or psychiatric impairment which, in the investigator's opinion, will prevent administration of the protocol.
* Patients who have had prior external beam irradiation to the brain or head/neck area that will lead to overlap of the radiation field.
* Patients should have no contraindications to having a contrast enhanced Magnetic Resonance Imaging (MRI) scan.
* Prisoners are excluded.
* Pregnant women are excluded.
NOTUS Feasibility Study: Reducing Chronic Low Back Pain with Mobile App Intervention

This feasibility study will investigate the feasibility of screening, recruiting, and delivering a mobile app intervention that involves pain education and clinical hypnosis to people seeking treatments for chronic low back pain (chronic LBP) in general practices in Australia.

This study aims to assess the recruitment strategy, the willingness of participants to be included in the proposed treatments, whether the intervention can be delivered as intended within the health care system and clinical setting, the adherence of participants to the proposed treatment, response rates to questionnaires, loss to the short-term follow-up, and the appropriateness and acceptability of the interventions. This feasibility study will inform possible modifications in the recruitment and treatments for the main clinical trial.

A total of 60 participants will be randomised into two treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* Experiencing chronic LBP, defined as pain in the area between the 12th rib and buttock crease accompanied or not by leg pain for a minimum duration of 12 weeks.
* LBP with or without leg pain (in case of leg pain, LBP is worse than leg pain).
* Currently attending general practice across Australia.
* Mean pain intensity score on the NRS ≥ 3/10 in the past week.
* A score of at least moderate on question 8 of the physical functioning component of the SF36 questionnaire.
* Access to a mobile device with minimal requirements to download the study app (300MB).
* Internet connection to access the mobile app functionalities.
* Able to understand English via reading and audio materials.
* Individuals who reported interest in participating in a clinical trial involving digital interventions after consultation with their general practitioners.
* Individuals whose general practitioners permitted them to receive information about the trial after the general practice consultation.

Exclusion Criteria:

* Known or suspected back-specific (e.g., radiculopathy, fracture) or non-back-specific (e.g., tumour, infection) serious spinal pathology.
* Less than six months post-spinal surgery.
* Scheduled for major surgery during the program or the follow-up period.
* Known or suspected serious psychiatric condition not being treated by a health professional that would impact the adherence to the trial activities.
* Known or suspected sight or hearing problems that would limit access to the intervention components (reading and listening using headphones).
Study to Enhance Motor Acute Recovery With Intensive Training After Stroke

Stroke often results in limitation of arm movements, from which many people do not fully recover. We believe that early and intensive therapy is important to enhance recovery of arm movements after stroke. We are doing this research study to see how much arm movements improve with intensive therapy in patients have had a stroke in the past 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Age over 21 years
2. Ischemic stroke confirmed by CT or MRI within the previous 6 weeks
3. No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no motor symptoms is allowed)
4. Residual unilateral arm weakness with Fugl-Meyer Upper Extremity (FM-UE) score 6-40 at time of enrollment.
5. Ability to give informed consent and understand the tasks involved.

Exclusion Criteria:

1. Space-occupying hemorrhagic transformation or associated intracranial hemorrhage.
2. Arm impairment that is too severe or too mild on day of baseline testing just prior to beginning of the study intervention.
3. Recent botox injection to upper limb or planned botox injection over the course of the 7-month study duration.
4. Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20.
5. History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease).
6. Inability to sit in a chair and perform upper limb exercises for one hour at a time.
7. Participation in another upper extremity rehabilitative therapy study during the study period.
8. Terminal illness
9. Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments.
Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico

The immunomodulatory effects of vitamin D are known to be beneficial in viral infections, it is also known that its deficiency is associated with a worse prognosis of COVID-19. This study aimed to determine the baseline vitamin D serum concentrations in asymptomatic or mildly symptomatic COVID-19 outpatients, as well as to evaluate the effects of supplementation with 10,00 IU/daily of vitamin D3 and its relationship with biochemical parameters and clinical features.


Eligibility Criteria:
Inclusion criteria:

* Intervention group: Patients with positive PCR for COVID-19 of both sexes supplemented with vitamin D
* Control group: Patients with positive PCR for COVID-19 of both sexes
* Both groups: Mexican individuals, after signing the informed consent letter and over 18 years of age.

Exclusion criteria:

• Diseases that compromise the absorption of Vitamin D; Crohn's disease, cystic fibrosis, and celiac disease.
Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program

This is an expanded access treatment protocol to treat up to 100 patients with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma.

This is an expanded access treatment protocol to treat up to 100 subjects with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma. Subjects will receive 1-2 units (200-400 mL per unit, not to exceed 550 mL total) of ABO compatible, low isohemagglutinin titer, COVID-19 convalescent plasma. Plasma will be administered one unit per day for up to two days. The duration of infusion will usually take 1 to 2 hours (rate of 100 to 250 mL/hr). The infusion should not exceed 4 hours. Plasma infusions will be administered following standard institutional procedures, including the use of premedications (e.g. acetaminophen, diphenhydramine, etc.) as necessary.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* 18 years of age or older
* Laboratory confirmed COVID-19 via SARS-CoV-2 RT-PCR testing
* Patients currently hospitalized with severe or life-threatening COVID-19 or patients the treating physician deems to be at high-risk for progressing to severe or life-threatening COVID-19.

  * Severe disease, defined as one or more of the following:

    * dyspnea,
    * respiratory frequency ≥ 30/min,
    * blood oxygen saturation ≤ 93%,
    * partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or
    * lung infiltrates \> 50% within 24 to 48 hours
  * Life-threatening disease, defined as one or more of the following:

    * respiratory failure,
    * septic shock, and/or
    * multiple organ dysfunction or failure
* Patients or their legally authorized representative must provide informed consent.

Exclusion Criteria:

* Female patients with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
* Patients who have received pooled immunoglobulin in past 30 days
* Contraindication to transfusions or history of prior reactions to transfusion blood products
Quantitative Imaging and Proton Spectroscopy in Multiple Sclerosis

The primary purpose of this study is to detect changes in the brain that may be associated with multiple sclerosis. Results will be compared to age matched controls. Investigators will assess lesions by measuring T2 and T1 enhanced lesion volumes and magnetization transfer ratio histogram parameters (MTRHP) in patients with relapsing-remitting and secondary-progressive disease. This data will be correlated to total brain parenchymal volume as well as identifying the effect of MS lesions on the gray and white matter, volumetric disability, including Kurtzke Expanded Disability Status Scale (EDSS) and a specific battery of neuropsychological tests. Quantitative analysis of whole brain N-acetylaspartate (WBNAA), a reproducible measure of viable neuron number, using 1H MRS and compare the results to age-matched controls over duration of 5 years.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with known MS diagnosis
2. Age 7-110 years
3. Males or females

Exclusion Criteria:

1. Medically unstable
2. Artificial implants in the body
3. Pregnant

Normal Controls
Tezepelumab Treatment in Korean Severe Asthma Patients

There is no study that systematically evaluated the effect of Tezepelumab on cough, and based on this background, the present researchers aimed to evaluate the effect of Tezepelumab treatment in patients with severe asthma who complain of cough using the Leicester Cough Questionnaire, a cough-related quality of life measurement tool.


Eligibility Criteria:
Inclusion Criteria:

1. Severe asthma patients aged 19 or older and 79 or younger
2. Cases diagnosed as asthma by an expert and classified as severe asthma according to the 2014 ATS/ERS guidelines

   - Patients who require the use of high-dose inhaled steroids and additional control agents or systemic steroids for more than 50% of the year to control symptoms. Or, if asthma is not controlled even with the medication. Here, uncontrolled asthma means that any one of the following is satisfied.
   1. ACT score less than 20 or 'not well controlled' according to GINA guideline
   2. frequent exacerbations; Requires systemic steroid administration (over 3 consecutive days) more than twice in the previous year If you did
   3. severe exacerbation; A condition that required hospitalization, admission to an intensive care unit, or application of a ventilator in the previous year If you have been angry at least once
   4. airflow restrictions; FEV1 \< 80%
3. If a cough is due to asthma according to a doctor and the cough onset scale (cough visual analogue scale, cough VAS) satisfies 30 or more points out of 100.
4. If a positive result is confirmed in the methacholine (or mannitol) bronchial challenge test (if the bronchial challenge test result is not available or the test is difficult to proceed, it can be replaced with a positive bronchodilator response test)

Exclusion Criteria:

1. Minors under 19 years of age, senior citizens over 79 years of age
2. If there is a history of use of other biological agents within 3 months prior to study registration
3. Cases where there was an acute exacerbation requiring a steroid burst (total 90mg prednisolone or more) during the 4-week screening period before study registration (possible for long-term prednisolone users)
4. Cases accompanied by clinically serious respiratory disease in addition to severe asthma
5. When accompanied by hypereosinophilic syndrome, ABPA, EGPA
6. When it is difficult to evaluate asthma alone due to severe respiratory disease
7. Pregnant women
The Expert System VoiceDiab in Children With Diabetes

The purpose of this study to conduct the preliminary investigation on the efficacy and safety in terms of postprandial glucose value and the rates of hypoglycaemia when expert VoiceDiab system supports patient's decision on prandial insulin programming in insulin pump therapy.

In children with type 1 diabetes glucose deterioration occurred every day and night leading into low satisfaction with treatment. Unstable glycemic profile resulting in high glycemic variability depends on the adjustment of insulin dosing to the current needs of the organism. The calculation of prandial insulin dosing is a complex process which involves such factors as preprandial blood glucose level, the amount of food taken, the glycemic index of carbohydrates, the insulin/carbohydrate exchange ratio, the active insulin level following the previous bolus. Currently, in patients treated with continuous subcutaneous insulin infusion (CSII) insulin pumps are equipped with bolus calculators which help to calculate prandial insulin dosing and thus contribute to improve post-prandial blood glucose levels.

The aim of the study was to determine whether the patient's support expert VoiceDiab system have stabilised diurnal glucose profile in children with type 1 diabetes treated with insulin pumps.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed type 1 diabetes at least 12 month prior screening visit
* Current treatment with basal-bolus regime and insulin pump for at least 12 weeks prior screening visit.
* HbAc \< 11%
* Ability and willingness to adhere to the protocol including self-management and dealing with mobile device.

Exclusion Criteria:

* Multiply daily injection modality,
* Treatment with regular insulin,
* Use of any anti-diabetic agent,
Reducing Farmworkers Exposure to Agricultural Chemicals

The goal of this project is to develop and test the effectiveness of a Lay Health Advisor program to teach migrant and seasonal farmworkers about pesticide safety in their homes. This is a community-based collaborative research project in which we first conduct in-depth interviews with farmworkers to learn about their knowledge and beliefs relative to pesticide exposure in the home, and, second, develop the content of the Lay Health Advisor program based on this formative information. We will evaluate this program by conducting pre- and post-test interviews with farmworkers, and comparing safety and knowledge to a control group who receive other important health education.

?La Familia! extends collaboration between the North Carolina Farmworkers' Project (NCFP), a grassroots community based organization, and environmental health researchers at Wake Forest University School of Medicine to evaluate a Lay Health Advisor (LHA) model to reduce pesticide exposure among farmworker families. The proposed research builds on PACE, Preventing Agricultural Chemical Exposure among North Carolina Farmworkers (R21 ES08739), a highly successful workplace intervention to reduce migrant and seasonal farmworker pesticide exposure. With ?La Familia!, the PACE focus shifts to exposure of farmworker families, particularly children, and expands work with the North Carolina farmworker community to workers in the western region of the state. ?La Familia!'s specific aims are to: (1) document and assess farmworker knowledge, beliefs and perceptions of pesticide exposure of all family members, particularly as they relate to exposure of children; (2) identify pathways for environmental exposure of farmworker children to pesticides; (3) develop, implement, and evaluate a culturally appropriate LHA intervention to reduce pesticide exposure of children (aged 18-48 mo) in farmworker homes; and (4) compile and disseminate the final intervention program to other farmworker communities and farmworker service providers. A model of community participation will be implemented throughout the 5 project years. Formative research (in-depth interviews; pathway exposure assessment) will be completed in Years 1 and 2. Using the formative results in a PRECEDE-PROCEED framework, the content and format of the LHA intervention will be developed in Year 2. This intervention (and a revision) will be evaluated in Years 3 and 4 using a group randomized design. End-points will include change in knowledge of pesticide exposure routes for children and ways to reduce their exposure; change in exposure-related behaviors; and changes in household dust levels. In the final year, support will continue for the LHA program as part of the process of NCFP developing its health outreach mission in western NC., while the results of the project are disseminated to regional and national farmworker groups, to those providing health care to farmworkers, and in the research literature.

Eligibility Criteria:
Inclusion Criteria

* Adults
* At least household resident employed in farmwork
* At least one coresident child

Exclusion Criteria

* None
The Impact of Emergency Physician Empathy on Litigation Propensity

The purpose of this study is to observe whether people would report being less likely to sue a physician who shows more empathy when giving a patient potentially bad news regarding their medical condition.

The investigators hypothesized that patients will have less propensity to sue emergency physicians after a poor outcome if the physician demonstrated empathy by verbalizing that they recognize the patient is concerned about their symptoms, and that the patient knows their typical state of health better than a physician seeing them for the first time. Accordingly, the investigators will assess whether the presence or absence of emergency physician empathetic statements in videotaped simulated encounters will alter patient propensity towards litigation. Secondary objectives are to assess whether the presence or absence of empathetic statements alters patient perceptions of discharge instruction clarity, physician expertness, physician caring, and physician desirability.

Eligibility Criteria:
Inclusion Criteria:

* Emergency Room Patient

Exclusion Criteria:

* Non-English speaking
* Not healthy enough to be in waiting room
Growth Hormone Treatment in Infants Aged 1 to 2 Years With Chronic Renal Insufficiency (CRI) and Growth Retardation.

This trial is conducted in Europe. Objective(s): To evaluate the effect of human growth hormone on infants aged 1 to 2 years with chronic renal insufficiency (CRI) and growth retardation despite an adequate dietary intake.

Trial Design: This is an open, parallel group clinical trial with a duration of one year, in which period 50% of patients will receive GH treatment and the other 50% will act as a control group, without treatment.

Trial Population: The trial will involve a total of 16 infants aged from 12±3 to 24 months suffering chronic renal insufficiency (Glomerular Filtration Rate less than 60 ml/min/1.73 m2), and growth failure and undergoing conservative treatment or peritoneal dialysis. Include the key inclusion and exclusion criteria.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be infants of both sexes aged 12 ± 3 months with chronic renal insufficiency and growth retardation.
* To be included in the trial, patients must meet all of the following inclusion criteria a.)-c.):
* a.) Male or female infants with a chronological age of 12 ± 3 months
* b.) Chronic renal insufficiency with Glomerular Filtration Rate less than 60 ml/min./1.73m2, according to the method used routinely in each participating center
* c.) Growth retardation documented at the start of the trial, according to the following criteria: Length less than -2 SDS by chronological age and sex and linear growth velocity \<P50 according to the Hernández standards and to Lubchenko in the case of infants born prematurely (\<37 weeks)
* Conservative treatment or chronic peritoneal dialysis
* Euthyroid
* The parent or guardian must give informed consent to the child's participation in the study before any trial related activities. Trial related activities are any procedures that would not have been performed during the normal management of the subject
* Optimal nutritional management criteria met
* Appropriate metabolic control for severe hyperparathyroidism, hydroelectrolyte balance, acid-base balance and calcium-phosphorus balance

Exclusion Criteria:

* Any primary endocrinological disorder and severe renal osteodystrophy.Other causes, apart from CRI, giving rise to growth retardation.Hydrocephalus.
* Known or suspected allergy to the trial product or related products.
* Treatment with corticosteroids within the last six months.
* Renal disease due to the Fanconi syndrome or to oxalosis (except if not under dialysis).
* Known or suspected malignancy.