cyrilzakka/clinical-trials huggingface dataset:
Pain in Sickle Cell Epidemiologic Study

To measure the variability in pain and response to pain in sickle cell disease, and to build multivariate models to explain both patients' pain and their response to pain, especially, utilization of health care.

BACKGROUND:

Pain in sickle cell disease is poorly recognized, measured, and treated. Although painful episodes are the most common reason sickle cell patients seek care, studies have seldom directly measured pain in detail. In studies to date, biological and demographic variables alone only partly explain the observed variance in painful episode frequency. Further, little is known about differences in pain responses including home management versus health care utilization.

DESIGN NARRATIVE:

This cohort study is measuring the variability in pain and response to pain in sickle cell disease, and building multivariate models to explain both patients' pain and their response to pain, especially, utilization of health care. The models' outcome variables include mean pain, painful episodes, and various types of utilization episodes, including non-narcotic analgesic use, narcotic use, office visits, emergency department (ED visits, and hospitalization. An additional outcome is the percentage of each patient's painful episodes that result in various types of utilization. Outcomes will be operationalized using daily pain diaries collected over six months. Reflecting on the prior 24 hours, patients will recall on an ordinal (0-9) scale maximum pain, distress, and disability, judge whether they were in a "crisis," and note pain locations and their various types of utilization. Daily pain intensity ratings will be transformed into pain episode counts using a formulaic threshold for a painful episode. The formula calculates each patient's threshold individually, based on his/her pain ratings. The models will measure the effect of several classes of explanatory variables (demographic, disease-related, psycho social, and readiness to utilize care), operationalized using primary data and validated instruments.

Patients will be recruited from the central and Tidewater regions of Virginia, will undergo an initial survey battery, chart review, and a brief final survey, venipuncture and urine sampling, and complete pain diaries daily for six months. This study will advance knowledge of the etiology and influences on pain and pain response in sickle cell disease. By revealing potentially mutable explanatory variables, the study's results will suggest targets of biobehavioral treatment interventions.

Eligibility Criteria:
No eligibility criteria
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II

A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-75 years;
2. The diagnosis of PBC is clear and does not meet the Paris criteria for diagnosing PBC overlap AIH, but it needs to meet 3xULN \< ALT \< 5xULN or 3xULN \< AST \< 5xULN or 1.3xULN \< IgG \< 2xULN, and liver pathological biopsy excludes moderate or higher interface inflammation;
3. Agreed to participate in the trial, and assigned informed consent.

Exclusion Criteria:

1. The presence of hepatitis A, B, C, D, or E virus infection;
2. Patients with presence of cirrhosis;
3. Patients with presence of fulminant liver failure;
4. Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease; Pregnant and breeding women and women of childbearing age in need of reproduction;
5. Severe disorders of other vital organs, such as severe heart failure, cancer;
6. Parenteral administration of blood or blood products within 6 months before screening;
7. Recent treatment with drugs having known liver toxicity;
8. Taken part in other clinic trials within 6 months before enrollment.
9. patients with contraindications of glucocorticoid
Intrathecal Bupivacaine Versus Bupivacaine and Clonidine in Paediatrics Age Group:A Comparative Evaluation

The investigators can summarize intrathecal clonidine can potentiate bupivacaine thereby bringing about better quality and longer duration of analgesia, better sedation and better postoperative outcomes with minimal side effects.

In our Randomized controlled, double blind study involving 30 subjects in two groups; the investigators compared the safety, efficacy and quality of using intrathecal hyperbaric bupivacaine 0.5% and hyperbaric bupivacaine 0.5% with clonidine 1µg/kg in paediatric patients undergoing surgeries below T8 dermatome.

American Society of Anesthesiologists (ASA) Grade I patients aged between 3-10 years were scheduled for the surgeries below T8 dermatome up to two hrs duration. The patients were randomly allocated in - Group A-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for more than 15 kg intrathecally.

Group B-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for more than 15 kg and 1µg/kg preservative free clonidine intrathecally.

The patients studied across the group did not vary much with respect to age, weight and sex distribution.

Eligibility Criteria:
Inclusion Criteria:

1. ASA grade-1 physical status.
2. weight 5-35kg
3. age-3 to 10 yrs

Exclusion Criteria:

1. patients with known sensitivity to drugs to be used.
2. gross spinal deformity
3. patients in whom regional anesthesia is contraindicated.
4. patients with peripheral neuropathy.
5. patient with hemodynamic instability.
Bright IDEAS - Young Adults Problem-Solving Skills Training

The purpose of this project is to evaluate efficacy of Bright IDEAS, an evidence-based problem-solving skills training (PSST) program, as a supportive care intervention for young adult (YA) cancer patients compared with enhanced usual psychosocial care with 344 young adult patients newly diagnosed with cancer.

Bright IDEAS-YA is a personalized approach to increase problem-solving ability by fostering positive appraisal of problems as solvable challenges that can be overcome and enhancing rational problem-solving skills to systematically work through any problem. Bright IDEAS-YA intervention consists of six 45-minute one-on-one sessions with a trainer who teaches the participant the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach.

Up to 344 young adult patients newly diagnosed with cancer will be recruited to participate in this multi-site randomized controlled trial, where the Bright IDEAS-YA intervention will be compared with enhanced usual psychosocial care. Efficacy will be evaluated by examining changes in psychosocial outcomes from baseline to post-intervention (3 months) and follow-up (6, 12 and 24 months). The extent to which changes in aspects of problem-solving ability mediate the intervention effects will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Current age 18-39
* Within 4 months of first diagnosis of any cancer
* Cancer being treated with chemotherapy and/or radiation therapy and/or hematopoietic stem cell transplant
* No documented or self-reported cognitive delay or impairment that would prevent completion of survey measures
* English-speaking

Exclusion Criteria:

* Medical crisis or not receiving curative therapy per physician/treatment team report
* Treatment involves surgery only
Efficacy of Umbilical Cord Mesenchymal Stem Cells in Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is a genetic disorder caused by an absence of dystrophin and characterized by progressive muscle degeneration. There is no cure for DMD at present but, there are several strategies under-researched for treatment of DMD such as steroid treatment, gene theraphy, exon skipping, stop codon read through and gene repair, cell theraphy and theraphy with drug that help to produce utrophin protein.

The aim of this study is investigate the eficacy of human umblical cord mesenchymal stem cells on DMD and understanding if wild type gene can be transfered to the patient.


Eligibility Criteria:
Inclusion Criteria:

- Patients with diagnosis of DMD that is proven clinically and genetically Age between 7-20 Patients need partial respiratory support, during the day Patients have less than or equal to stage I NIH, Liver, renal and cardiac function Patients without cancer Patients without allergic disease Patients without bleeding diathesis,

Exclusion Criteria:

Patients need complete respiratory support Patients have more than to stage II NIH, Liver, renal and cardiac function Patients have bleeding diathesis and allergic disease
The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam

This is a multi-center, open-label, drug-drug interaction study in postmenopausal women with osteoporosis.

Approximately 27 subjects (Group A: 18; Group B: 9) will receive a 2 mg oral dose of midazolam on day 1 followed by a 24 hour PK collection. Subjects randomized to Group A will receive a single 60 mg subcutaneous (SC) dose of denosumab on day 2 administered in the abdomen. On study day 16, another 2 mg oral dose of midazolam will be administered to all subjects (Groups A and B) followed by a 24 hour PK collection. The primary analysis to determine the effect of denosumab on the PK of midazolam will be based on data from subjects in Group A only.

Eligibility Criteria:
Inclusion Criteria:

* Between 45 to 75 years of age
* Postmenopausal women
* Osteoporosis

Exclusion Criteria:

* Use of any known inhibitors of cytochrome P450 3A4/P-gp (CYP3A4) within 14 days or 5 half lives, whichever is longer; or grapefruit juice or grapefruit containing products within 7 days prior to investigational product administration
* Use of any known CYP3A4 inducers within 30 days or 5 half-lives, whichever is longer, prior to investigational product administration
* Use of any herbal medicine with a known impact on CYP3A4 (eg, St. John's wort) within 30 days prior to investigational product administration
* Current use of medications prescribed for osteoporosis treatment
* Use of midazolam within 14 days prior to investigational product administration
* Influenza or other vaccination within 28 days of screening
* Previous exposure to denosumab
Dementia Care Challenges Among a Sample of Informal Caregivers in Egypt

Dementia is a widespread incapacitating mental syndrome that carries a significant challenge for healthcare systems, persons with dementia, and their caregivers. The world health organization estimates that there is "more than 55 million persons live with dementia worldwide, and there are nearly 10 million new cases every year"

In Egypt there are many studies had investigated caregiver burden with chronic ill elderly as physical or psychiatric diseases; however, studies focusing on caregiving Patients With Dementia (PWD), especially the psychological aspect, has been raised just few years ago. Some focused on psychiatric comorbidities of care givers, others correlated caregivers' quality of life with dementia staging. Other research groups designed educational programs and psychosocial interventions for training informal caregivers with significant psychological burden reduction at the end of the studies , also another group focused their study on the negative emotions expressed by caregiver towards PWD. Still there are many aspects of caregiving not explored considering the financial burden, lack of formal educational resources, stigma, cultural and religious values related to caregiving.

our study aims:

1. To assess challenges of dementia-related knowledge among a sample of dementia informal caregivers
2. To assess the needs of persons with dementia and their informal caregivers
3. To assess the burden of caregiving among a sample of dementia informal caregivers
4. To assess possible culturally related challenges of caregiving among a sample of dementia informal caregivers

The study will be carried out through face-to-face interview, telephone interview, and online survey from community sources, including support groups in social media, memory clinics, outpatient clinics (Geriatric medicine, neurology, or psychiatry), and social support groups of non-governmental organizations.

Eligibility Criteria:
Inclusion Criteria:

* Informal Caregivers aged 18 years or older
* Informal Caregiver in daily contact for care with the person with dementia for at least one year.

Exclusion Criteria:

* Informal caregivers who are unable or unwilling to communicate.
* Formal caregivers
ENERGI-F701 for Female Hair Loss Treatment

The objective of this study is to evaluate the efficacy and safety of ENERGI-F701 Solution in female subjects with hair loss.


Eligibility Criteria:
Inclusion Criteria:

1. Female, aged at least 20 years old
2. With hair loss over 100 hairs/day
3. Willing to maintain the same hair style, color, shampoo and hair products used, and approximate hair length starting from signing ICF and throughout the study
4. The subject of childbearing potential must show a negative urine or serum pregnancy test at Screening Visit
5. Have signed the written informed consent form

Exclusion Criteria:

Any subject meeting any of the exclusion criteria will be excluded from study participation.

1. With alopecia areata or cicatricial alopecia
2. With other scalp or hair disorders
3. With prior hair transplant
4. Use wigs or hair weaves
5. Plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study
6. Have taken any topical or systemic prescription of OTC medications for treating hair loss, hair regrowth and/or hair volume
7. Have used medications known to cause hair thinning, such as Coumadin and anti-depressants/anti-psychotics
8. Have received chemotherapy/cytotoxic agents as well as radiation/laser/surgical therapy of the scalp
9. Have initiated or terminated the use of hormones for birth control or hormone replacement therapy within 6 months. Subject will also be excluded from the study if she plans to initiate or terminate the use of hormones for birth control or hormone replacement therapy during the study.
10. With known or suspected hypersensitivity any ingredients of study product and active control
11. Any hematologic abnormalities.
12. Any serum chemistry abnormalities.
13. Pregnant, lactating, or premenopausal with childbearing potential but not adopting at least one form of birth control.
14. Enrollment in any investigational drug trial
15. With any condition judged by the investigator that entering the trial may be detrimental to the subject
Idylla EGFR Lung Trial

This retrospective, observational study will compare the results of a BioCartis' EGFR mutation test on the Idylla platform with test results from SoC pathology results from tissue biopsies in the same setting. A comparable rapid testing platform for EGFR may serve as a more accessible means to diagnose, and overall, more patients treated successfully with targeted therapies. Up to 150 samples will be tested and compared with existing results.

This study will compare the results of a BioCartis' EGFR mutation test on theIdylla platform with test results from standard of care (SoC) pathology results from tissue biopsies. The Idylla™ EGFR Mutation Test, performed on the BioCartis Idylla™ System, is an in vitro diagnostic test for the qualitative detection of exon 18, exon 20, and exon 21 mutations. Additionally, exon 19 deletions and exon 20 insertions in the EGFR oncogene. A rapid testing platform for EGFR may serve as a more accessible means to diagnose, and overall, more patients treated successfully with targeted therapies.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with primary lung cancer
* Data from primary diagnosis must be included in pathology report or data entry.
* Detailed pathology report included for all samples

Exclusion Criteria:

* Limited or no tissue available
* Only tissue available is from fine needle aspiration
* Tissue blocks older than 5 years old
Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI)

Diffusion tensor imaging (DTI) is a non-invasive MRI technique offering a functional approach that provides morphological information about the microstructures of the nerve roots. DTI is a widely used neuroimaging technique and is a current topic of research in the field of peripheral nerve imaging. The aim of this work is therefore to improve DTI sequences by specifically evaluating the contribution of the multiband technique in healthy volunteers.

For every healthy volunteer will be acquired:

* a morphological sequence
* a reference diffusion tensor sequence covering three lumbar stages (reference DTI),
* a diffusion tensor sequence acquired in multiband technique, covering three lumbar stages (optimized DTI),
* a diffusion tensor sequence acquired in a multiband technique, covering a lumbar stage, of higher spatial resolution (centred DTI)

Eligibility Criteria:
Inclusion Criteria:

* Person without history of lumbar surgery
* Person who has previously consented

Exclusion Criteria:

* MRI contraindications (pace maker, cardiac defibrillator,...)
* Claustrophobia
* Pregnant woman
* Person without social security
* Person with a guardianship
* Person carrying metallic surgical material (spine, pelvis, abdomen)
Characteristics of the Anosmic Olfactory Mucosa

The present study aims to describe the structural tissue and cell characteristics of the olfactory mucosa in patients with persistent anosmia (≥2 years) due to COVID-19 or head-trauma, in comparison to healthy individuals with intact olfactory function. In order to avoid possible age-related degenerative changes in the neuro-epithelium, both patients and controls are between 25 and 35 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Legally competent to vouch for their own study participation.
* Informed and written consent for participation in this study.
* Study group 1 (Post-COVID anosmia)

  1. Diagnosed with persistent anosmia for approximately two years concurring with positive SARS-CoV-2 PCR-test between 2019 and 2020.
  2. Sniffin'sticks test with a threshold-discrimination-identification-score(TDI)≤16
  3. Between 25 and 35 years of age.

Study group 2 (Post-trauma anosmia)

1. Diagnosed with persistent anosmia for approximately two years concurring with head trauma.
2. Sniffin'sticks test with a threshold-discrimination-identification-score(TDI)≤16
3. Between 25 and 35 years of age.

Study group 3 (Controls):

1. Between 25 and 35 years of age.
2. Undergoing reposition of a nasal fracture in general anaesthesia

Exclusion Criteria:

* \<25 years of age.
* \>35 years of age.
* Chronic rhinosinusitis with/without polyps.
* Nasal cancer.
* Presence of viral or bacterial rhinosinusitis.
* Uncontrolled allergic rhinosinusitis.
* Coagulation deficiencies, e.g. haemophilia.
* Use of anticoagulants.
* Not able to undergo general anaesthesia.
* Pregnancy.
* Any use of nasal detumescence drugs ≤2 weeks before biopsy.
* Any use of nasal steroids ≤3 months before biopsy.
* Use of nasal inhaled recreational drugs ≤3 month before biopsy.
* Participants not able to communicate in Danish or English.
* Major Depression Inventory (MDI) score ≥27 \[49, 50\]
* Mini Mental State Examination (MMSE) score ≤ 26 \[51\]
* Study group 1 (Post-COVID anosmia)

  1. Anosmia for less than two years or more than two and a half years.
  2. No positive SARS-CoV-2 PCR-test concurring with olfactory dysfunction.
  3. History of olfactory dysfunction before COVID-19 infection.
* Study group 2 (Post-trauma anosmia)

  1. Anosmia for less than two years or more than approximately two-three years.
  2. Anosmia without concurring with head trauma
  3. History of prior olfactory dysfunction before head trauma.
* Study group 3 (Controls) 1. Known olfactory dysfunction.
Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis

This interventional study aims to evaluate the efficacy of Cyclosporine eye drop treatment in preventing relapses of Vernal Keratoconjunctivitis (VKC) and in treating the acute phases of the disease.

Vernal keratoconjunctivitis (VKC) is a severe allergic disease, characterised by chronic ocular surface inflammation with seasonal relapses. Active phases of VKC require treatment with topical steroids to control inflammation and corneal damage that may lead to impairment of visual function and severe ocular discomfort. To date, safe and effective therapies in preventing relapses and controlling active phases of VKC are not available. Few controlled trials have used topical Cyclosporine A (CsA) for the treatment of VKC. The present multicenter, double-masked, randomised, controlled clinical trial will allow to obtain further data on the safety and efficacy of topical treatment with Cyclosporine in patients affected by VKC. Moreover, this study will evaluate the efficacy of topical CsA in both preventing the relapses of VKC and controlling the active phases of the disease. It is important to highlight that Cyclosporine eye drops are not currently commercially available in Italy and must be custom-made by specialized pharmacies. As VKC mostly affects young patients, it influences their daily life and their social interactions. Moreover, the severe signs and symptoms of the disease result in frequent ophthalmologic controls, influencing school activities of children and working days for their parents with a relevant economic cost for the National Health System.

Comparisons: Efficacy of Cyclosporine A 0.05% eye-drops in preventing VKC relapses compared to standard antiallergic (Ketotifen fumarate 0.025% eye-drops) treatment, and efficacy of Cyclosporine A 0.1% eye-drops in controlling acute phases compared to antiinflammatory (Desametasone 0.15% eye drops) treatments.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by VKC will be enrolled by the three Centres involved in the project
* Diagnosis of VKC will be performed on the basis of personal and family history of systemic allergic diseases, clinical examination (presence of conjunctival tarsal and/or limbal papillae) and presence of eosinophils in the conjunctival scraping

Exclusion Criteria:

* Contact lens wearers
* Patients affected by other ocular diseases
* Patients subjected to ocular surgery in the preceding 6 months
* Patients under eye drop or systemic treatments for other diseases, or
* Patients enrolled in experimental trials in the preceding 6 months
Efficacy and Safety of Zolmitriptan by Sublingual Administration

The purpose is to evaluate the effectiveness and safety profile of zolmitriptan by Sublingual administration for the acute treatment of Cluster headache.

Cluster headache is a primary neurological disorder characterized by intensive attacks and severe sharp headache, can cause a range of symptoms such as conjunctival congestion, runny nose, miosis, forehead sweat. The disability resulting from cluster headache can be severe imposing a considerable health burden upon the sufferer and society. The purpose of this study, using oral zolmitriptan as the control, is to evaluate the effectiveness and safety of zolmitriptan by sublingual administration for the acute treatment of cluster headache. Patients are asked to maintain a headache diary throughout the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than or equal to 18 years and less than 70 years;
* The diagnosis of cluster headache is made according to The International Classification of Headache Disorders: 3rd edition (beta version)(ICHD-III β);
* Consent form signed by the participant or his/her authorized surrogate.

Exclusion Criteria:

* Patients had primary or secondary headache disorders other than cluster headache;
* Female subjects of childbearing age will be excluded if they were pregnant, lactating or planning a pregnancy in the next year or if they were not using an adequate form of birth control;
* Patients will be excluded if they had significant medical or psychiatric disease;
* Patients will be excluded if they had coronary heart disease or not suitable for the treatment of zolmitriptan.