cyrilzakka/clinical-trials huggingface dataset:
Ayurveda for Flu Like Illness During Covid-19 Outbreak

This study aimed to evaluate the efficacy and safety of Ayurveda in reducing symptoms of flu like illness during the Covid 19 outbreak.


Eligibility Criteria:
Inclusion Criteria:

* Patients with fu like symptoms within 48 hours of onset during March2020
* Mild to moderate symptoms who were advised to self isolate at home for 7-14 days
* Flu like symptoms present at least one respiratory symptom (e.g. cough, nasal obstruction, sore throat) and at least one constitutional symptom other than fever (e.g. fatigue, headache, myalgias) of less than 48-hour duration
* Willing to consent and follow up

Exclusion Criteria:

* Pregnant/lactating

  * Participants with chronic pulmonary diseases or critical condition or already developed severe respiratory distress
  * Clinically malignancies, systemic infection, other medical or psychiatric condition which places the subject at unacceptable risk to participate in the study - Known hypersensitivity to any ayurveda herbal substances
* Severe symptoms of respiratory distress patients deemed to require intensive care immediately
Effectiveness of a Care Management System to Reduce Unmet Needs of Informal Caregivers of People With Dementia

The purpose of this study is to test the effectiveness of a computer assisted care management system to identify and reduce unmet needs for and to improve quality of life of informal caregivers of people with dementia.

The identification of care needs of informal caregivers of people with dementia (PwD) at home is of particular importance to provide timely appropriate support and health care services to this vulnerable group. Family doctors and specialists have a key role in identifying the burden and care needs of informal caregivers. However, this often remains a challenge in everyday practice. In addition, the regionally available support and health care offers are often unknown. A computer-assisted care management system (CMS) can support the identification of unmet care needs and suggest individual, regional offers via a constantly updated database. On the basis of a standardized self-assessment, the VMS identifies personal, social, nursing and medical care needs of informal caregivers of PwD. The investigators apply the system in family and specialist practices as well as in memory clinics where it generates modularized recommendations for interventions based on predefined algorithms. The aim of the study is to test the effectiveness of a CMS to reduce the number of unmet care needs and to improve quality of life of informal caregivers of PwD. The study design is a cluster-randomized, controlled intervention study with two arms and two assessment times. The setting includes family and specialist practices for neurology and/ or psychiatry as well as memory clinics. The CMS will be used in the practices of the intervention group. Informal caregivers of PwD answer a self-administered questionnaire on a tablet PC. From the input, the system generates a list of unmet care needs based on predefined algorithms, and assigns these to individual intervention recommendations. The doctor evaluates each recommendation and forwards a validated list and possibly further intervention recommendations to a study assistant (Care Manager, CM). In a subsequent home visit, the care manager systematically collects additional information, specifies and concretizes the intervention recommendations and supports the informal caregivers of PwD in the implementation of the recommendations. In subsequent telephone contacts, the status of the implementation of the intervention recommendations will be discussed and the care manager coordinates the informal caregivers individual support. Patients of the control group will receive Care as Usual (CAU). After 6 months, a blinded, systematic, computer-based follow-up assessment will be conducted in both groups by hitherto uninvolved study assistants

Eligibility Criteria:
Inclusion Criteria:

* 18+ years
* main caregiver of a PwD (Hauptversorgungsperson)
* PwD lives at home
* written informed consent of caregiver

Exclusion Criteria:

* caregiver not living in the study region MV
* not able to provide written consent
* unable to fill out self-administered questionnaire an/or to be interviewed
Text Message Quit Vaping Intervention for Adolescents

This research study, conducted by Truth Initiative, will help us learn how text messaging can help adolescents between 13 and 17 years of age quit vaping.

The Teen Quit Vaping Study (QVS Teen) is a comparative effectiveness trial to evaluate the effectiveness of a quit vaping text message program in promoting abstinence from e-cigarettes among young users aged 13-17. This study is a 3-arm randomized controlled trial conducted among young users aged 13-17 recruited through online channels. Participants will be randomized to a quit vaping text message intervention, an assessment-only control condition, or a waitlist control condition. The primary aim is to examine 30-day point prevalence abstinence at 7-months post enrollment (roughly corresponds to 6-months post-treatment).

Eligibility Criteria:
Inclusion Criteria:

* Age 13-17
* Past 30-day use of e-cigarettes containing nicotine
* Interest in quitting e-cigarette use in the next 30 days
* US residence

Exclusion Criteria:

* Failure to confirm mobile number after initial sign-up
The Study of AZD8529 for Smoking Cessation in Female Smokers

To evaluate the efficacy and safety of AZD8529 for smoking cessation in female smokers.

This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of two different doses of AZD8529 (1.5 and 40 mg) in smoking cessation. Up to 2 weeks will be allowed for the Screening Period, followed by a 1-week, single-blind run-in period. At the end of Study Week 1 (on Study Day 8), medication compliance will be one of the factors used in a predictive enrichment strategy.

Eligibility Criteria:
Inclusion Criteria:

* Be a female smoker between the ages of 18 to 75 years.
* Want to quit smoking.
* Be currently (last 30 days) smoking 10 or more cigarettes per day and report less than 3 months of consecutive smoking abstinence during the past year.
* Be able, in the opinion of the site investigator (SI), to understand and follow all protocol-specified instructions and understand and provide written informed consent.
* Be willing to provide personal information for entry into a clinical trial registry.
* Agree to use and continue using at least one acceptable contraceptive method (oral contraceptives, IUDs, contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, condoms with spermicide, or abstinence) or, if not of childbearing potential, must fulfill one of the following criteria at screening: post-menopausal defined as amenorrhea for at least 12 months and with follicle stimulating hormone (FSH) levels in the laboratory defined post-menopausal range and/or documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy or tubal ligation verified by the Site Investigator.
* Agree not to use any other smoking behavioral intervention (self-help or formal treatment), acupuncture, or other smoking cessation pharmacotherapy during the study.
* Agree to refrain from using dietary/herbal supplements other than vitamins and minerals for 7 days prior to receiving study drug and throughout the 13-week treatment period.
* Agree to attend all required clinic appointments (including 3 eye exams) during the course of the 19-week study.

Exclusion Criteria:

* Please contact the site for more information
Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women

The purpose of this study is to fulfil regulatory requirements for registration of a new chemical entity in China. Rasagiline is approved for the treatment of Parkinson's Disease (PD) in Europe and the US. Rasagiline is safe and well tolerated in healthy subjects, and the efficacy and safety has been demonstrated in placebo- and active comparator-controlled phase III studies.


Eligibility Criteria:
Inclusion Criteria:

* The subject is a Chinese man or woman
* The subject is, in the opinion of the investigator, generally healthy
* If female, the subject must have a negative pregnancy test at screening and baseline, and agree not to try to become pregnant from Screening until after the Follow-up Visit

Exclusion Criteria:

* The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.

Other inclusion and exclusion criteria may apply.
A Giant Myelolipoma.

48-year-old woman who presented with intermittent left flank pain with incidental findings of adrenal tumor on computed tomography (CT). She underwent laparoscopic tumor resection due to a large tumor of 12 cm in size.

A 48-year-old female presented to our hospital with the following medical conditions: She denies smoking and drug addiction. Type 2 diabetes mellitus under treatment with metfomin, surgical history of abdominal hysterectomy and open cholecystectomy.

The patient started experiencing pain located in the left flank for 2 months, which was intermittent, yielded to the administration of analgesics, she denied hematuria and weight loss.

On physical examination, the abdomen was distended due to adipose tissue, normal bowel sounds were auscultated, and abdominal masses are not palpable.

She underwent a computed tomography (CT) scan. CT features in the anatomical site of the left adrenal gland, a well-defined ovoid tumor is observed, with heterogeneous content with areas of hypodense (5 HU), fat and calcification. It measures 90 x 69 x 92 mm. Upon application of contrast medium, the hypodense parts present enhancement up to 44 HU. (Fig. 1, 2). She was decided for surgical resection of the tumor via laparoscopic transabdominal approach. The surgery went well without any intraoperative and postoperative complications. She was discharged after day 3.

Eligibility Criteria:
Inclusion Criteria:

* Patient with myelolipoma

Exclusion Criteria:

* Patient without myelolipoma
VIBE - Virtual Image Guided Brachytherapy Emulation for Locally Advanced Cervical Cancer (LACC)

This study will evaluate the role of SBRT with the aim to reproduce high dose rate brachytherapy (HDR BT) dose distribution by means of external beam radiotherapy in the radical treatment in patients with LACC. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking.

This is a phase I/II feasibility study of hypofractionated, image-guided Volumetric Modulated Arc Therapy (VMAT) Stereotactic Body Radiotherapy (SBRT) to LACC with the aim to reproduce HDR BT dose distribution by means of external beam radiotherapy in the radical treatment in patients with LACC. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking.

Eligible patients who consent to participate in the current study will receive 4 image-guided SBRT sessions to a prescription of 7 Gray per fraction to the LACC (HR-CTV) following whole pelvis external beam radiotherapy.

SBRT will start within one week after whole pelvis external beam radiotherapy. The study will enroll a total of 30 patients. After treatment, patients will be followed-up at 1 month, at 3 months (+/- 1 week), at 6 months (+/- 4 weeks), and then every 6 months (+/- 6 weeks) until the end of the 3rd year, then annually until the 5th year.

The equivalence of outcome and toxicity will be measured by comparing the data obtained in the study to literature data regarding the standard modality of brachytherapy. Patients' oncological outcomes, toxicity and quality of life data will be reported.

Eligibility Criteria:
Inclusion Criteria:

* Cancer of the uterine cervix suitable for curative treatment with definitive radio-chemotherapy
* Biopsy proven showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
* Pelvic MRI.
* MRI and Positron emission tomography (PET-CT) of the retroperitoneal space and abdomen at diagnosis is performed.
* Stage IIB to IVA according to International Federation of Gynecological and Obstetrics (FIGO) and TNM guidelines.
* Planning MRI with the applicator in place for the SBRT boost.
* Para-aortic metastatic nodes below L1-L2 are allowed.
* Study specific signed patient informed consent.

Exclusion Criteria:

* Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin.
* Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix.
* Metastatic disease above and beyond the retroperitoneal paraaortic L1-L2 interspace.
* Previous pelvic or abdominal radiotherapy.
* Previous total or partial hysterectomy.
* Contra-indications to MRI.
* Severe psychiatric condition.
* Severe, active co-morbidity.
Effects of a Metronome on Functional Outcomes in Aquatic Therapy

The purpose of this study is to determine if the use of a pacing device, a metronome, improves functional outcome measures in aquatic therapy when compared to a control group.


Eligibility Criteria:
Inclusion Criteria:

* All patients over the age of 18 assigned to aquatic therapy

Exclusion Criteria:

* Women who identify themselves as pregnant on the clinics intake sheet.
* Anyone unable to hear the beats of the metronome.
Building Access to Food Through Systems and Solidarity

BASIS aims to implement a whole-of-community intervention in Brooklyn for improving diet and the social and /built environments for English-, Chinese-, Spanish-, and Bangla-speaking communities. This is achieved through five main pillars: by 1) improving food access (subsidized, culturally tailored fresh produce box program), 2) providing nutrition education, 3) conducting experiential learning (gardening workshops, cooking demonstrations, farm tours, physical activity sessions, arts-based sessions), 4) assisting with economic security (SNAP/WIC enrollment, workforce development, small business owner engagement), and 5) contributing to policy.

This is a single-site program that will be evaluated over a period of 5 years using a multi-level, mixed methods approach. Each year, culturally appropriate produce will be provided weekly for 20 weeks to community members in Sunset Park and surrounding neighborhoods. Brooklyn Grange in Sunset Park will grow and provide Chinese specific produce and Angel Family Farm will grow and provide Mexican specific produce. Brooklyn Grange's CSA produce box will be valued at $25 and available on a sliding scale (for a fee ranging from $7 to $31 depending on the participant's self-identified situation). In a sliding scale model, each participant contributes the same percentage of income on food but participants can choose the price point they want to pay based on their individual situation and financial resources. Angel Family Farm's subsidized CSA produce box will be valued at $30 and available for a fee of up to $15, which was determined to be acceptable by community members. Participants that receive SNAP benefits can use their EBT card to cover their produce box fees. Education will be offered in the form of nutrition education, cooking tutorials, and farming information provided by staff at Brooklyn Grange.

There will be 3 comparison communities of Mexican and Chinese American individuals in NYC as part of the study's evaluation. Individuals from these communities will not be participating in the CSA produce box. For the Mexican community, we will focus on South Bronx where there are dense pockets of Mexican communities. For the Chinese community, we will focus on Chinatown, Manhattan and Flushing, Queens.

Eligibility Criteria:
Inclusion Criteria:

CSA:

* Adult age 18 years and over
* Resides in Zip codes: 11204, 11209, 11214, 11215, 11217, 11218, 11219, 11220, 11228, 11232
* Speak English, Mandarin, Cantonese, Spanish, or Bangla
* Willing and able to provide consent

Comparison Communities:

* Adult age 18 years and over
* Currently living in South Bronx (Zip codes 10454, 10455, 10451, 10456, 10459), Chinatown (Zip codes 10038, 10002, 10013, 10012), or Flushing (Zip codes 11354, 11355, 11356, 11357, 11360, 11359, 11358, 11365, 11367, 11368)
* Speak English, Mandarin, Cantonese, or Spanish
* Willing and able to provide consent

Exclusion Criteria:

• Unable to complete the baseline survey in English, Mandarin, Cantonese, Spanish or Bangla
Mass Balance Study of [14C]RAY1216 in Healthy Adult Male Subjects in China

This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of \[14C\]RAY1216 in healthy Chinese male participants, revealing the overall pharmacokinetic characteristics of RAY1216.


Eligibility Criteria:
Inclusion Criteria:

1. Males and female participants between 18-45 years (Both inclusive);
2. Body weight≥50kg.Body mass index (BMI) 18\~28 kg/m2 (Both inclusive); BMI is determined by the following equation: BMI = weight/height2 (kg/m2);
3. Participants who voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.

Exclusion Criteria:

1. Any clinically significant abnormality upon physical examination or in the clinical laboratory tests. History or presence of a clinically significant gastrointestinal, renal, hepatic, neurologic, hematic, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular disorder(s) (but not limited to above disorders).
2. Presence of human immunodeficiency virus (HIV), viral hepatitis(including hepatitis C virus (HCV) or hepatitis B virus (HBV) ,treponema pallidum antibodies at screening.
3. Participants who donated blood or bleeding profusely(\> 400 mL)in the 3 months preceding study screening.
4. Participants who have undergone surgery within 6 months before the screening period or whose surgical incision is not completely healed; Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, or an open biopsy or significant traumatic injury;
5. Workers engaged in conditions requiring long-term exposure to radioactivity; Or have significant radiation exposure (≥2 chest/abdomen CT, or ≥3 other types of X-ray examinations) within 1 year before this study or have participated in the radiopharmaceutical labeling test;
6. Participants who smoked an average of \>5 cigarettes per day in the previous 3 months or habitually used nicotine-containing products and were unable to quit during the trial period;
7. Substance abuse or use of soft drugs (e.g., marijuana) in the 3 months prior to the screening period or use of hard drugs (e.g., cocaine, amphetamines, etc.) in the 1 year prior to the screening period; Or screening for positive urine drug abuse (drug) tests;
8. Participants who have special dietary requirements and cannot comply with a uniform diet;
9. History of allergic conditions or allergic diseases, or a history of allergic reactions attributed to RAY1216 or any of the ingredients of its formulation or similar drugs.
Treating Nocturnal Hypertension and Nocturia in African American Men

This is a protocol to obtain pilot data to submit a new NIH grant on Nocturnal Hypertension and Nocturia. In the diversity supplement to Dr. Victor's current NIH grant (Cut Your Pressure Too: The Los Angeles Barbershop Blood Pressure Study) the results show that uncontrolled systolic hypertension is an independent determinant of nocturia in African American men.

the investigators now want to pursue this correlation by designing a new NIH grant proposal to determine whether replacing short acting with long acting drugs and dosing them at bedtime rather than in the morning will: A. Lower systolic blood pressure during sleep B. Improve nocturia and result in better sleep quality

Aims and Significance of pilot data

Determine:

1. The feasibility of the Southern California Healthy Heart and Blood Pressure registry as an effective method to recruit African American men to participate in a new research program
2. If participants are willing to comply with the study procedures including wearing an activity monitor, sleep study device, and ambulatory blood pressure monitor
3. The within subject variation for repeated measures of nocturnal blood pressure by ambulatory blood pressure and activity monitoring
4. If nocturnal systolic blood pressure is higher in men with self-reported nocturia ≥2 than in men with 0-1 nocturia
5. If use of long-acting antihypertensive medication as well as nighttime dosing of medication can lower nocturnal systolic blood pressure and reduce nocturia

Purpose:

Obtain key pilot data to show feasibility and document the reproducibility of the proposed measurements.

Eligibility Criteria:
Inclusion Criteria:

* African American Men
* Age 35 to 59 years-old
* Able to give informed consent
* Willing to wear the activity monitor, ambulatory blood pressure monitoring (ABPM), and sleep study device
* Uncontrolled hypertension: both a sleeping average systolic blood pressure of ≥ 125 mm Hg and an awake average systolic blood pressure of ≥ 135 mm Hg

Exclusion Criteria:

* Severe Sleep Apnea (Apnea Hypopnea Index (AHI) of \> 30 on home sleep study) or history of sleep apnea diagnosis and use of Continuous Positive Airway Pressure therapy
* Uncontrolled Diabetes Mellitus (a random glucose of ≥ 200 mg/dL)
* History of diagnosis or symptoms of either prostate disease or overactive bladder (urinary urgency or frequency during the daytime)
* Chronic kidney disease (Glomerular filtration rate of \< 60 mL/min/1.73 m2 based on the MDRD equation)
* Renal transplant recipient
* Loop diuretic use
* Night shift work
* On chemotherapy for cancer
* Orthostatic hypotension

  o After 2 minutes of standing: a drop in blood pressure of \> 20/10 mm Hg, a standing systolic blood pressure of \< 100 mm Hg, or tachycardia with an increased heart rate of \> 20 beats/minute
* Other reasons deemed unsafe for study participation by Principle Investigator
The Impact of Family Integrated Care on Extrauterine Growth Restriction at Discharge in Very Low Birth Weight Infants

To explore the influence of multi-angle factors, including family integrated care, on extrauterine growth restriction at discharge of very low birth weight infants.

To explore the influence of multi-angle factors, including family integrated care, on extrauterine growth restriction at discharge of very low birth weight infants.Very low birth weight infants admitted to 17 neonatal intensive care units in 8 provinces and cities in southeast China from February 2021 to November 2023 were retrospectively included, which were divided into case group and control group according to whether there was extrauterine growth restriction (defined as the weight below the 10th percentile of children of the same age at discharge). The general situation at birth, the length of hospital stay, the incidence of complications during hospital stay, the feeding situation, the length of family participation care and the perinatal situation of the mother were compared between the two groups. The generalized linear mixed model was used to analyze the influencing factors of extrauterine growth retardation at discharge, and the results of influencing factors were visualized by GraphPad Prism 9.0 software.

Eligibility Criteria:
Inclusion Criteria:

1. Newborns admitted to 17 units in 8 provinces from February 2021 to November 2023;
2. Birth weight \< 1500 g, gestational age \< 32 weeks;
3. admitted in NICU within 24 hours after birth;
4. premature infants without complications (including bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, intraventricular hemorrhage and late-onset septicemia) at the time of admission.

Exclusion Criteria:

1. death occurred during hospitalization;
2. Incomplete outcome data (lack of EUGR data at discharge).