cyrilzakka/clinical-trials huggingface dataset:
Teen Asthma Project

Aims of this study are:

1. To determine the feasibility of implementing the intervention using a peer-assisted asthma day camp for adolescents with asthma.
2. To determine patterns of change in knowledge, attitudes toward asthma, self-efficacy, perception of barriers, and self-management behaviors, asthma control and quality of life over time among peer leaders.
3. To test the following hypothesis:

   * Adolescents participating in a peer-assisted asthma camp program will report improved knowledge, attitudes toward asthma, self-efficacy, and self-management behaviors, decreased perception of barriers, and increased asthma control and quality of life at 3-, 6- and 9-months post-intervention compared with the adult-led camp group.
4. To examine the moderating effect of personal factors (e.g., age, sex, socioeconomic status, race, illness status, family support) on intervention outcomes such as self-management behaviors, asthma control and quality of life in adolescents with asthma.
5. To examine the effect of the peer-assisted camp program on self-reported health care utilization including emergency department visits, days of hospitalization, outpatient visits by comparing between baseline and 9-months post-camp data and between the peer-led camp and the adult-camp programs.


Eligibility Criteria:
Inclusion Criteria:

1. age between 13-18 years
2. mild, moderate or severe persistent asthma specified by the NHLBI Asthma guidelines
3. asthma diagnosis \> 1 year
4. no other major chronic/emotional health concerns
5. ability to understand spoken and written English. Participants were recruited from the communities through flyers, newspaper ads, and referrals from clinics and schools.

Eligibility criteria for peer leaders included:

1. age between 16-20 years
2. nomination from school teachers/nurses or health care providers
3. average grade point B or above in the past school year
4. fulfillment of eligibility criteria (2)-(5) prescribed for adolescent participants.

Exclusion Criteria:

* learning disabilities based on reports from parents, teachers or clinicians
Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric IOL Implantation Compared to Monofocal IOL Implantation

The objectives of this study are to assess and compare bilateral uncorrected distance visual acuity and distance spectacle independence post bilateral implantation of AcrySof Toric Intraocular Lenses (IOLs) and monofocal IOLs. Secondary outcomes will include cost of eyeglass purchased and patient vision-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* are willing and able to understand and sign an informed consent;
* are willing and able to attend postoperative examinations per protocol schedule;
* are ≥ 21 years of age, of either gender and any race;
* have bilateral, age related, cataracts;
* have planned cataract removal via phacoemulsification with implantation of an intraocular lens (IOL);
* are available to undergo second eye surgery within 6 weeks of the first eye surgery;
* are in good ocular health, with the exception of cataracts;
* are free of disease(s)/condition(s) listed in the "Precautions" section of the AcrySof Toric and monofocal package inserts: choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, extremely shallow anterior chamber, medically uncontrolled glaucoma, microphthalmos, non-age-related cataract, proliferative diabetic retinopathy (severe), severe corneal dystrophy, severe optic nerve atrophy, irregular corneal astigmatism and color vision deficiencies.
* have regular corneal astigmatism;
* qualify for bilateral AcrySof Toric IOLs on the AcrySof Toric Calculator (www.acrysoftoriccalculator.com)
* are able to obtain pupil dilation ≥ 5.0 mm
* are able to read and understand one of the following languages: Dutch, French, German

Exclusion Criteria:

* previous corneal surgery and/or reshaping
* abnormality, disease and/or conditions of the cornea (i.e. keratoconus, corneal dystrophy, keratitis, corneal scar, etc.), which would clinically contra-indicate the implantation of a toric intraocular lens
* planned multiple procedures during cataract/IOL implantation surgery
* planned limbal relaxing incision (LRI), Excimer laser treatment or similar procedure prior to or during the course of the study
* an ocular disease and/or condition that may compromise visual acuity levels (i.e. glaucoma, diabetic retinopathy, amblyopia, etc.)
* pregnant, lactating or planning pregnancy during course of study. Subjects who become pregnant during the study will not be discontinued; however, data may be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results. Data will be collected on the CRF as observations.
Assessment of Limb Perfusion During Junctional Tourniquet

The goal of this study is to use contrast enhanced ultrasound to determine the degree to which flow is reduced during application of a junctional tourniquet (JT). Contrast enhanced ultrasound is performed to quantify thigh and calf perfusion at baseline and during application of the JT


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject
* Age 19-50

Exclusion Criteria:

* Peripheral artery disease
* Known heart failure
* Right to left shunt
* Pregnancy
* Presence of femoral artery aneurysm
Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis

Rational of study : 3,4-diaminopyridine is suspected to improved the fatigue associated in patient's multiple sclerosis.

In order to confirm this hypothesis, a randomized, controlled versus placebo, double blinded study is performed.

We proposed a randomized controlled trial between 3,4-diaminopyridine and placebo .

The main objective : improvement of fatigue by diminution of EMIF-SEP score between the arm treatment and placebo arm. The hypothesis tested is that the 3,4-DAP is efficacy in the fatigue of multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years and = \<60 years
* Patients with multiple sclerosis clinically defined and with MIFS-SEP score \> 44, without deficit sleep and without depression.
* Patients without treatment by 3,4-DAP since 3 months
* EDSS score \< 6

Exclusion Criteria:

* ASAT/ALAT \> 2 x ULN
* MADRS \>= 20
* Abnormality cardiac rhythm
* Pregnancy
* Asthma
* Evolutive affection
* Renal failure
Study of Trilaciclib and Lurbinectidin

Lung cancer is by far the leading cause of cancer death among both men and women worldwide and the second most common cancer in terms of new cases. Small cell lung cancer (SCLC) is the deadliest form of lung cancer. The standard first-line treatment is the combination of carboplatin, etoposide, and atezolizumab. While response rates for this regimen are high (roughly 60%), the duration of response is short, typically 4 months. Following progression after the 1st line treatment of SCLC, there is no consensus regarding subsequent therapy. Lurbinectedin is FDA approved and is increasingly preferred in clinical practice. Toxicity was significant, but appeared favorable compared to historic results with topotecan, leading to the adoption of this therapy for second-line SCLC. The toxicity profile was dominated by myelosuppression.

This study investigates the effect of Trilaciclib on myelosuppression rate in subjects with platinum refractory extensive stage (ES)- SCLC receiving Lurbinectedin as well as the clinical synergy of Trilaciclib and Lurbinectedin combination.


Eligibility Criteria:
In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Age ≥ 18 years at the time of consent.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Measurable disease according to RECIST v1.1 within 28 days prior to start of treatment.
* Previous treatment with a platinum agent, PD1 or PDL1 agent.

Exclusion Criteria:

* Active infection requiring systemic therapy.

  * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
  * Treatment with any investigational drug within 4 weeks prior to start of treatment.
  * A known allergy or sensitivity to either study drug or its excipients.
  * Subject is receiving prohibited medications or treatments as listed in the protocol.
Lung Health of Early COPD: a Multi-center Cohort Study

This is a multi-center, prospective, cohort study in early COPD patients. This study aims to elucidate the lung function decline and its association with smoking and other risk factors. Other biomarkers and image markers from chest CT scan are also analyzed to investigate the lung function in early COPD patients.


Eligibility Criteria:
Inclusion Criteria:

1. Gender: male or female
2. Age: 35-75 years old
3. post-bronchodilator spirometry: FEV1/FVC \< 0.8 and FEV1%pred ≥80%

Exclusion Criteria:

1. Other diseases may affect lung function, like lung cancer, bronchiectasis, interstitial lung disease or chest surgery.
2. BMI \> 35 kg/m2
3. Dementia or other severe neurological disease
4. Pregnancy
5. Conditions that contraindicated lung function test
Patient-Reported Outcome and Safety Between Preoperative and Postmastectomy Radiotherapy in DIEP Flap Reconstruction

This study is the first prospective randomized study assessing the patient-reported outcomes and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction of deep inferior epigastric perforator(DIEP) flap. Radiotherapy before mastectomy and autologous free-flap breast reconstruction can avoid adverse radiation effects on healthy donor tissues and delays to adjuvant radiotherapy. We aimed to explore the feasibility of preoperative radiotherapy followed by DIEP flap reconstruction in patients with breast cancer requiring mastectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histological proven invasive breast cancer;
* Clinical T0-3, T4b and N0-3a disease who require neoadjuvant chemotherapy;
* No distant metastasis;
* Adjuvant radiotherapy and who are suitable for DIEP flap reconstruction at the time of mastectomy.

Exclusion Criteria:

* Patients enrolled in other clinical trial which may as influence the outcome;
* Patients received neoadjuvant therapy without radiotherapy indications；
* Disease progression during neoadjuvant chemotherapy；
* Patients of pregnancy or lactation；
* Previous history of diabetes；
* Previous history of heavy smoking.
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma

This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.


Eligibility Criteria:
Criteria for Inclusion:

1. Presence of unilateral, progressive vestibular schwannoma.
2. Vestibular schwannoma larger than 2 mm.
3. Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the affected ear.
4. Able and willing to comply with all trial requirements, including willingness to participate in a separate long term follow-up study after completion of this trial.

Criteria for Exclusion:

1. Prior diagnosis of NF2 and/or bilateral vestibular schwannoma.
2. Prior surgery or radiation therapy for vestibular schwannoma.
3. Clinical history consistent with endolymphatic hydrops (documented fluctuating sensorineural hearing loss and/or episodic vertigo) in the affected ear.
4. Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the unaffected ear.
5. Prior participation in a clinical trial with an investigational drug within six months prior to administration (Day 0), or any prior participation in a gene therapy clinical trial.
Wearables for the Bladder: an In-home Treatment Feasibility Pilot Study

The goal is to investigate the feasibility and effects of adding "wearables for the bladder" devices to conventional pelvic floor physical therapy (PFPT) to bladder function, in people with multiple sclerosis (MS).

The participants baseline pelvic floor and bladder function will be assessed by a pelvic floor physical therapist as per standard care, and online MS-symptom questionnaires (i.e., quality of life, bladder bother/symptoms, falls, fatigue, depression). Participants will be trained on the maintenance and use of "wearable for the bladder" (WeB) devices. Participants will receive standard PFPT intervention care, and will be asked to further train using the WeB devices. 8-10 sessions will be conducted over telehealth or in person as per standard protocol. At 12 weeks, participants will return to clinic for pelvic floor and bladder function assessment.

A control group will receive standard PFPT intervention care as well as online MS-symptom questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* MS diagnosis
* Assigned Female at birth and whose sex is currently Female
* Mild/moderate bladder dysfunction (bowel/bladder functional systems scores = 0-2 or Bladder control scale \>0)
* California residents
* Wifi in the home and personal smartphone (using Apple operating system)
* Able to walk with or without assistive device
* Manual muscle test score of 2 or more.

Exclusion Criteria:

* Undergone treatment for bladder dysfunction symptoms within 3 months
* Current urinary tract infection
* Recent (\~30 days) relapse
* Any cognitive, dexterity or visual impairment so severe that it precludes use of the wearables for the bladder tool or ability to use a smartphone
* Pregnancy
"Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules"

Thyroid Feasibility Study

This is an early R\&D Feasibility study to assess Imagio OA/US's ability to optimize the device algorithm specific to thyroid in order to detect the difference between benign and malignant thyroid nodules

Eligibility Criteria:
Inclusion Criteria:

1. Have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities;
2. Have an undiagnosed suspicious solid or mostly solid thyroid nodule.;
3. 18 years of age or older at the time of consent;
4. Are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and,
5. Have received recommendation for and are scheduled for an ultrasound guided FNAB, ultrasound guided core biopsy, excisional biopsy, lobectomy or complete thyroidectomy of at least one thyroid nodule.

Exclusion Criteria:

1. Are prisoners;
2. Have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of view (within one probe length or 4 cm of the nodule),
3. Previous or on-going radioactive iodine treatment.
4. Nodule to be biopsied is greater than 3.0 cm in maximum diameter;
5. Is pregnant;
6. Have an acute or a chronic hematoma and/or acute ecchymosis of the thyroid;
7. Is experiencing photo-toxicity or photo-sensitivity or is undergoing treatment for a photo-sensitive condition such as porphyria or lupus erythematosus;
8. Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU;
9. Have had previous image guided FNAB or surgical biopsy of the target nodule of interest within the 45 days of baseline Imagio Scan;
10. Patient has participated in a clinical study of an investigational drug or device within 3 months prior to screening CDU that may have an impact on clinical outcomes; and,
11. Patient has previously participated in this study.
Expression of NIS Protein and mRNA in Thyroid Tumors

The uptake of iodide by thyroid cells requires the expression of sodium iodide symporter (NIS). Thyroid benign and malignant tumors have low iodide uptake activity. Previous studies of NIS expression with RT-PCR and immunohistochemistry showed divergent data. NIS protein was overexpressed in thyroid cancer. The aim of this study was to investigate the NIS transcript levels and its presence and localization in 30 samples of thyroid tumors (14 benign and 16 malignant) and in their surrounding non-tumoral tissues (NT), by real time RT-PCR and immunohistochemistry, respectively. Our results revealed lower gene expression in 78.6% of the benign tumors and 100% of the carcinomas when compared with the NT samples, using GHPDH as a housekeeping gene. Immunohistochemical staining revealed presence of NIS protein in 100% of the non-tumoral samples, 100% of the benign tumors and 93.75% of the malignant tumors. NIS protein was identified at basolateral membrane in 23.3% of non-tumoral samples, 14.3% of benign and 12.5% of malignant tumors. Stronger cytoplasmatic immunostaining of NIS protein was detected in 64.3% of benign tumors and in 87.5% of malignant tumors when compared to NT. Association between low gene expression and strong cytoplasmatic immunostaining was found in 50% of benign tumors and 87.5% of malignant tumors. We concluded that the reduced NIS gene expression in thyroid tumors associated with strong intracytoplasmatic staining may be due to its incapacity to migrate to cellular membrane.

The aim of this study was to quantify NIS transcript levels by real time PCR and to determine the presence and cellular localization of NIS protein by immunohistochemistry, in benign and malignant thyroid tumor cells and to compare with their paired surrounding non-tumoral cell. NIS expression was also compared to that of the TSHR

Eligibility Criteria:
Inclusion Criteria:

* PAtients with thyroid tumors undergoing surgery for total or partial thyroidectomy

Exclusion Criteria:

* Pregnancy
High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis

Primary biliary cirrhosis is a chronic cholestatic autoimmune liver disease with a progressive course that can lead to liver cirrhosis. There are few studies on dietary management in primary biliary cirrhosis and most of them have focused on micronutrients specifically vitamin D intake to prevent osteoporosis, and lipid control to prevent hyperlipidemia, but few recommendations have been made regarding a complete dietary approach. Fiber has been proven to increase the excretion of nitrogen products and consequently reduce its blood levels, and an adequate protein intake (1- 1.5 g per kg) has shown to decrease endogenous catabolism in cirrhotic patients.

The purpose of this study is to evaluate the impact of a high-protein, high-fiber diet in the nutritional status of patients with primary biliary cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Controls

Diagnose of primary biliary cirrhosis:

* Biochemical evidence of cholestasis: based mainly on alkaline phosphatase elevation
* Presence of antimitochondrial antibodies (AMA)
* Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts.

Ambulatory patients

* Cases

Diagnose of primary biliary cirrhosis:

* Biochemical evidence of cholestasis: based mainly on alkaline phosphatase elevation
* Presence of antimitochondrial antibodies (AMA)
* Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts.

Diagnose of liver cirrhosis by two or more of the following criteria:

* Albumin \< 3.4 g/dL
* INR ≥ 1.3
* Total bilirubin ≥ 2 mg/dL
* Portal hypertension (esophageal varices, splenomegaly, ascites, etc.)
* Liver biopsy Ambulatory patients

Exclusion Criteria:

* Overlapping syndrome with predominant autoimmune hepatitis
* Hospitalized patients
* Acute or chronic renal failure
* Hepatocellular carcinoma
* Pregnancy
* Neuropsychiatric disorders (Schizophrenia, bipolar disorder, dementia and attention-deficit hyperactivity disorder)
BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis

This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to the RLD.

Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female, at least 18 years of age.
* Female subjects of childbearing potential (excluding women who are or premenarchal, surgically sterilized or postmenopausal for at least 2 years).
* A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp and clinical signs of psoriasis vulgaris on trunk and/or limbs.
* Scalp psoriasis consistent with at least moderate disease severity (grade ≥ 3) using the Physician's Global Assessment (PGA) of disease severity.
* Plaque elevation of at least moderate severity (grade ≥ 3) at the scalp target lesion site using the Psoriasis Area Severity Index (PASI). The most severe lesion at Baseline will be identified as the scalp target lesion.
* Agree to stop use of all other topical or systemic antipsoriatic treatments, corticosteroids, immunosuppressive drugs, calcium supplements and Vitamin D supplements or Vitamin D analogs at a dose \> 400 IU/day during the study.
* Currently in general good health and free from any clinically significant disease, other than scalp psoriasis and psoriasis vulgaris, that may interfere with the study evaluations.
* Willing and able to understand and comply with the requirements of the study, apply IP as instructed, attend required study visits, comply with study prohibitions, and be able to complete the study.

Exclusion Criteria:

* Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
* Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (eg, atopic dermatitis, contact dermatitis, tinea capitis).
* History of hypersensitivity to any component of TEST or RLD.
* Current or past history of hypercalcemia, hypercalciuria, vitamin D toxicity, severe renal insufficiency, or hepatic disorders.
High-protein and High-carbohydrate Diets' Effect on Urinary Concentrating Ability

We wanted to test urinary concentrating ability and AQP-2 expression in kidney during high-protein and high-carbohydrate diet.


Eligibility Criteria:
Inclusion Criteria:

* (1) Genders; both mal and female
* (2) Age; 18- 65 years old
* (3) BMI; below 30
* (4) Females had to bee in oral contraceptive treatment

Exclusion Criteria:

* (1) Clinical signs or history of disease in the heart, lungs, kidneys or endocrine organs
* (2) Abnormal laboratory test (blood haemoglobin, white cell count, platelets, plasma sodium, plasma potassium, plasma creatinine, plasma albumin, plasma bilirubin, plasma alanine aminotransferase, plasma cholesterol and blood glucose)
* (3) Albuminuria or glucosuria
* (4) Cancer
* (5) Arterial hypertension
* (6) Alcohol abuse
* (7) Use of tobacco
* (8) Medical treatment, except oral contraceptives
* (9) Pregnancy or breast feeding
* (10) Medicine abuse
* (11) Donation of blood less than 1 month before the study.
Epidemiological and Clinical Characteristics of Hospitalized Patients Under 5 Years Old With RSV Infection in Central China, Wuhan

The study will be a multicenter, hospital-based retrospective study. We plan to collect the clinical and laboratory data among all hospitalized ARTI cases in three hospitals in Wuhan from June 1, 2020 to May 31, 2023 and then analyze the epidemiological and clinical characteristics of RSV infection, clarify the gene types of epidemics under 5 years old children after the outbreak in Wuhan, China.


Eligibility Criteria:
Inclusion Criteria:

①Admission age \<5 years old

②Clinical diagnosis of acute respiratory tract infections

Exclusion Criteria:

Hospital acquired ARTI