cyrilzakka/clinical-trials huggingface dataset:
Jinhua Qinggan Granules in the Treatment of COVID-19

The clinical trial is designed to be randomized, double blind, placebo controlled, to evaluate the effectiveness and safety of Jinhua Qinggan granules (JHQG) on mild-category patients of COVID-19 in Pakistani population with the age limit of 18-75 years, at10th day comprehensive follow-up. The informed consent form must be signed by the subjects before their participation in the trial.

The course of treatment is 10 days, and the visit points are set on the 1st and 10th day, in which 10th day is follow-up. Patients will be assessed by using seven-category ordinal scale and clinical signs and symptoms on 1st and 10th day. If the subject recovers and checks out within 10 days, they will be recorded once before checking out. All effectiveness and safety inspection items will be done once before the trial and once at follow-up point i.e. 10th day. In case of any new abnormality or abnormality aggravation after the treatment, should be followed up until normal or stable.

Eligibility Criteria:
Inclusion Criteria:

* 1) Between the ages of 18-75 years, both male and female.
* 2) Confirmed Coronavirus infection by real time RT-PCR.
* 3) Mild cases of Coronavirus having main symptoms with minimum 2 grade (as mentioned in 7.1.6).
* 4) The subject has signed the informed consent form;

Exclusion Criteria:

* 1) Younger than 18 years or older than 75 years.
* 2) Patients with moderate or critical Coronavirus infection confirmed by real time RT-PCR; cases meeting any of the following criteria:

  1. Lung lesions
  2. Respiratory failure and requiring mechanical ventilation
  3. Shock
  4. With other organ failure that requires ICU cares.
* 3) Severe primary health conditions associated with cardiovascular, cerebrovascular, pulmonary, hepatic, renal, endocrine and hematological diseases, hematopoietic system (above grade II of cardiac function; ALT \& AST are 1.5 times higher than the normal value; Creatinine above the upper limit of normal value) and mental illness or serious diseases affecting their survival, such as cancer or AIDS;
* 4) With severe cardiopulmonary dysfunction, cardiopulmonary insufficiency.
* 5) Subjects, who took other antiviral, antibacterial, cough relieving, expectorant and antiasthmatic drugs within 3 days prior to the visit (including β2 receptor agonists, anticholinergic agents, theophylline drugs, glucocorticoids, expectorant and Chinese Medicine.)
* 6) Allergic individuals and those who are known to be allergic to experimental drugs
* 7) Pregnant women, lactating women or fertile women who are ready to conceive in 3 months.
* 8) Subject, who has participated in the past 1 month in another clinical study.
* 9) Subjects who are not suitable for the clinical trial based on investigators' judgment.
Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment

The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.


Eligibility Criteria:
Key Inclusion Criteria:

* Have a diagnosis of RA (2010 American College of Rheumatology \[ACR\]/European League Against Rheumatism \[EULAR\] criteria for RA), and are ACR functional class I-III.
* Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints \[SJC66\]) and ≥6 tender joints (from a tender joint count based on 68 joints \[TJC68\]) at screening and Day 1
* Ongoing treatment with a stable prescription of 1 or 2 csDMARDs
* Have received at least one biologic disease modifying antirheumatic drug (bDMARD) for the treatment of RA to which they have had an inadequate response or intolerance

Key Exclusion Criteria:

* Previous treatment with any janus kinase (JAK) inhibitor

NOTE: Other protocol Inclusion/ Exclusion criteria may apply.
Use of Misoprostol for Intrauterine Device (IUD) Insertion in Nulliparous Women

The purpose of this study is to evaluate if the use of misoprostol can make it easier for a provider, and less painful for a woman, to place an IUD if she has never had a child before.

IUD's are a tremendously effective long acting, reversible method of contraception, and they require little participation from the woman after insertion. Despite these benefits, few women in the US use an IUD. Education is important so that both providers and women understand that IUD's are safe and effective in women even if they have never had a child. Insertion of an IUD in nulliparous patients can be more difficult and uncomfortable. The purpose of this study is to see if use of misoprostol prior to IUD placement in nulliparous women can make it easier and less painful. The goal is that more information on the feasibility and ease of IUD insertion will make it more accessible to more women. The findings from this trial will be used in a prospective meta analysis on this topic.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous, no prior pregnancy beyond 14 week
* Over 18 years of age
* Negative pregnancy test

Exclusion Criteria:

* current pregnancy or pregnancy within 6 weeks
* current cervicitis or PID (active or within 3 months)
* undiagnosed abnormal uterine bleeding
* allergy to copper/ Wilson's disease (for Paragard)
* cervical or uterine cancer
* uterine anomaly altering uterine cavity
Study of WPV01 Compared With Placebo in Patients With Mild/Moderate COVID-19 Infection

A randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of WPV01 in patients with mild/moderate COVID-19 infection


Eligibility Criteria:
Inclusion Criteria:

1. Participants ≥18 years of age when signing ICF;
2. Initial onset at least 1 of 11 COVID-19 symptoms within 48 hours before randomization;
3. Within three days before randomization, the RT-PCR test of specimens such as nasal and pharyngeal swabs must be positive for SARS-CoV-2 or the rapid antigen test must be positive, and also the patiets should meet the diagnostic criteria for mild or moderate cases as defined in the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 10) issued by the National Health Commission of China;
4. Fertile participants must agree to take effective contraceptive measures;
5. Participants who understand and agree to comply with planned study procedures，voluntarily participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

1. Known allergy to any ingredient in the study treatment drug;
2. Patients who meet the diagnostic criteria for severe or critical cases of COVID-19 as defined in the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 10) issued by the National Health Commission of China at the time of randomization;
3. Obvious abnormal liver function (ALT or AST ≥ 3ULN, or total bilirubin ≥1.5ULN);
4. On dialysis or combined with moderate to severe kidney injury;
5. Patients with compromised immune system;
6. Patients with acute exacerbation of chronic respiratory disease at screening, including bronchial asthma, chronic obstructive pulmonary disease;
7. Patients with suspected or confirmed concurrent active systemic infection other than COVID-19 at screening;
8. Any comorbidity requiring surgery within 14 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator;
9. Has received or is expected to receive COVID-19 monoclonal antibody or convalescent COVID-19 plasma during study treatment;
10. Has received treatment with antivirals against SARS-CoV-2 within 14 days prior to randomization;
11. Has received any novel coronavirus infection vaccine within 1 week prior to randomization;
12. Current or expected use of strong CYP3A4 inducers, inhibitors or medications that are highly dependent on CYP3A4 for clearance;
13. Difficulty swallowing or a history of gastrointestinal disorders that severely interfere with drug absorption;
14. BMI≥30 kg/m2;
15. Pregnant, lactating women or those with a positive pregnancy test;
16. Previous administration with any investigational drug within 3 months before the study drug administration;
17. Patients who are judged by the investigator to be unsuitable to participate in this study.
Questionnaire of Lower Urinary Tract Symptoms Among Women Before and After Surgical Correction of Uterine Prolapse

. The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire. . The baseline questionnaire included data on age, urinary incontinence, daytime frequency, nocturia, postmicturition dribble, straining, urgency, incomplete bladder emptying, and hesitancy. Women were asked about leakage caused by coughing or sneezing, moving, lifting, sleeping, sexual intercourse, urgency, and rest.

Pelvic organs prolapse (POP) is defined as the downward descent of the pelvic organs resulting in protrusion of the vagina and/or uterine cervix. POP and overactive bladder (OAB) often co-exist. The International Continence Society defines OAB as "urgency with or without urge incontinence, usually with frequency and nocturia" Of women with symptomatic pelvic organ prolapse, 13-39% experience voiding dysfunction (VD).

The aim of the study is to determine the effect of prolapse surgery on voiding function. The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire.

Non-responders will send a reminder after three weeks and if the non-responders still failed to respond were eventually asked to complete a short form comprising questions on urgency and incontinence. This procedure followed guidelines outlined by the local ethical committee. The baseline questionnaire included data on age, urinary incontinence, daytime frequency, nocturia, postmicturition dribble, straining, urgency, incomplete bladder emptying, and hesitancy. Women were asked about leakage caused by coughing or sneezing, moving, lifting, sleeping, sexual intercourse, urgency, and rest. stress incontinence according to the International Continence Society defined as leakage caused by exertion (coughing or sneezing, moving, or lifting) and urge incontinence as leakage associated with urgency.

Eligibility Criteria:
Inclusion Criteria:

1. Age; greater than or equal to 18 years
2. women with urogenital prolapse grade 3 or more
3. indicated for surgical repair for pelvic organ prolapse
4. Willing and able to sign an informed consent
5. Willing to comply with the study protocol

Exclusion Criteria:

1. Anti-incontinence surgery
2. Lower urinary tract anomaly
3. Active urinary tract infections
4. Bladder tumor.
5. Bladder stones
Paclitaxel in Treating Patients With Ovarian Stromal Cancer

This phase II trial studies the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PRIMARY OBJECTIVES:

I. To estimate the probability of clinical response and toxicity of paclitaxel as second-line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma.

II. To evaluate the value of inhibin for predicting response.

OUTLINE:

Patients receive paclitaxel intravenously (IV) over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, then every 6 months for three years, and then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with histologically confirmed ovarian stromal tumor (granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor \[androblastoma\], steroid \[lipid\] cell tumor, gynandroblastoma, unclassified sex cord stromal tumor, sex cord tumor with annular tubules)
* Patients must have recurrent stromal tumor having received no more than one prior chemotherapy regimen
* Patients must have measurable disease as defined by Gynecological Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* White blood count equal to or greater than 3000/mcl
* Granulocyte count equal to or greater than 1500/mcl
* Platelet count equal to or greater than 100,000/mcl
* Creatinine equal to or less than 2.0 mg%
* Bilirubin less than or equal to 1.5 times normal
* Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 times normal
* Patients with a GOG performance grade of 0, 1 or 2
* Patients of child bearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control
* Patients who have met the pre-entry requirements as specified
* Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria:

* Patients with GOG performance grade of 3 or 4
* Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy
* Patients having received more than one prior chemotherapy regimen
* Patients amenable to cure by surgery
* Patients with prior radiation except for those whose recurrent disease is outside the radiation port
Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers.

A non-randomized, multiple-dose, open-label, single sequence study to evaluate effect of concomitant administration of EDP-305 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy human volunteers.


Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
* Female subjects must be of non-childbearing potential.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease.
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
* A positive urine drug screen at screening or Day -1.
* Current tobacco smokers or use of tobacco within 3 months prior to screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
* History of regular alcohol consumption.
* Participation in a clinical trial within 30 days prior to the first dose of study drug.
Physical Activity and Education Program for Somali Women

There is a significant need for culturally adapted and effective health education programs to address rising rates of obesity and chronic disease concerns for refugee communities. Physical activity has been identified as an important prevention tool to prevent numerous chronic health conditions. This research tests the feasibility and acceptability of a culturally adapted physical activity intervention for sedentary adult Somali women. Study participants will be randomized to a 3-month physical activity program or a wait-list control group. The primary outcome is increases in physical activity between baseline and the end of the program as measured by pedometer.

Participants in the physical activity program will participate in 12 weekly 1.5-hour sessions focused on increasing physical activity. The group sessions will include participating in physical activity as well as group discussions on the barriers and opportunities for increasing physical activity in their daily life. The 12-week program covers educational topics related to physical activity (e.g. overcoming barriers to activity, exercising safely, relapse prevention strategies) and the program gradually increases the amount of physical activity completed during the group sessions over the course of the 12 weeks. Over a 3-month wait period, individuals in the wait-list control group will be offered monthly sessions on health and wellness topics before being offered the physical activity program. Measurement visits will occur at baseline, at the end of the12-week program, and approximately 12-weeks after the end of the intervention. During the measurement sessions participants will complete assessments related to their physical activity and other health behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary (less than 90 minutes per week of moderate or vigorous physical activity)
* Self-identify as Somali
* Planning on living in the area for the next 6 months
* Ability to attend 12-weeks of in-person group sessions at a designated community site

Exclusion Criteria:

* Currently pregnant or within 3 months of delivery
* BMI greater than or equal to 40
* Medical conditions or physical problems that interfere with physical activity or require medical supervision to exercise
* Have another member of the household participating in the study
* Employment by one of the collaborating organizations
Ultrasound to Predict the Prognosis of Rotator Cuff Tears

To predict the prognosis of large-to-massive RCTs and risk of re-tear by ultrasound elastography.

Most symptomatic large-to-massiverotator cuff tears (RCTs) should be operated, but the prognosis and postoperative risk of re-tear depended on the quality of rotator cuff muscles. Preoperative evaluations were usually done by magnetic resonance imaging (MRI). MRI was used in recent studies to predict the surgical outcome of large-to-massive RCTs and postoperative re-tear, but the clinical availability was not as good as ultrasound. The investigators hypothesize that ultrasound elastography can predict the prognosis of large-to-massive RCTs and risk of re-tear.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are diagnosed with rotator cuff tear by an orthopedist.
2. The large-to-massive rotator cuff tears need to be confirmed by magnetic resonance imaging or ultrasound. The definitions of this diagnosis include a tear over 3 cm or any full-thickness of tears in more than two rotator cuff muscles.
3. Being willing to cooperated with the arranged examinations before the operation.

Exclusion Criteria:

1. Patients who are only diagnosed with partial-thickness rotator cuff muscle tears or small- to large- sized full-thickness tears.
2. Patients who have acromioclavicular arthritis that needs distal clavicle resection.
3. Patients who had serious glenohumeral arthritis, pseudoparalysis, or any other shoulder trauma history.
Contrast Enhanced Mammography or Breast Magnetic Resonance: Which Choice for Optimal Diagnostic Performance?

This study compares the diagnostic performance of Contrast-Enhanced Mammography (CEM) and Breast MRI in evaluating breast lesions. It aims to assess sensitivity, specificity, and diagnostic accuracy to identify the optimal imaging modality for clinical scenarios such as dense breast tissue and high-risk populations.

Search differences and performance of MRI and CEM

Eligibility Criteria:
Inclusion Criteria:

* Age: Women aged 18 years and older.
* Indication for Advanced Imaging: Patients referred for Contrast-Enhanced Mammography (CEM) or Breast MRI due to suspicious findings or high-risk factors for breast cancer.
* Dense Breast Tissue or Inconclusive Findings: Patients with dense breast tissue or inconclusive results from standard mammography.

Informed Consent: Ability to provide written informed consent for participation in the study.

- Presence of Breast Tissue: Female or transgender women who have breast tissue suitable for imaging.

Exclusion Criteria:

* Contraindications to MRI: Patients with contraindications to Breast MRI (e.g., implanted pacemakers, severe claustrophobia, or metallic implants that cannot be removed).
* Contraindications to Contrast Agents: Patients who have allergies or contraindications to iodinated contrast agents used in CEM.

Severe Renal Impairment: Patients with severe renal impairment (eGFR \< 30 mL/min/1.73 m²), as they may not safely undergo contrast-enhanced imaging.

* Pregnancy or Breastfeeding: Women who are pregnant or breastfeeding, as the use of contrast agents may pose risks to the fetus or infant.
* Already Confirmed Primary Tumor: Patients with a confirmed primary breast malignancy or another primary tumor site (e.g., gastrointestinal, lung) that has already been diagnosed.
* Other Medical Conditions: Patients with serious medical conditions that may interfere with participation in the study or may affect the safety of the imaging procedures.
Carotid Artery Corrected Flow Time and Fluid Responsiveness in Geriatric Patients

Carotid blood flow and corrected carotid flow time (Carotid Flow Time (FTc)) provide information about left ventricular preload and inversely correlate with systemic vascular resistance. The reliability in assessing fluid responsiveness has been demonstrated in studies involving invasive cardiac output measurements. In the elderly patient population where arterial elasticity can be compromised, there is no existing data in literature that determines the reliability and predictive value of FTc after general anesthesia induction.

Doppler ultrasound of the common carotid artery has begun to be used as a potential non-invasive tool for assessing hemodynamic status. Its non-invasive nature, ability to be applied independently of the patient's position, ease of application due to the superficial location of the carotid artery, and resistance to intrathoracic pressure changes are among its advantages. Carotid blood flow and corrected carotid flow time (Carotid Flow Time (FTc)) provide information about left ventricular preload and inversely correlate with systemic vascular resistance. Additionally, the velocity time integral (VTI) measuring blood flow through the carotid artery during systole, when multiplied by the cross-sectional area of the carotid artery, allows for the determination of flow within the carotid artery. The reliability in assessing fluid responsiveness has been demonstrated in studies involving invasive cardiac output measurements. In the elderly patient population where arterial elasticity can be compromised, there is no existing data in literature that determines the reliability and predictive value of FTc after general anesthesia induction.

Eligibility Criteria:
Inclusion Criteria:

* geriatric patient (older than 65 years of age) having surgery under general anesthesia

Exclusion Criteria:

* Common carotid artery stenosis, common carotid artery disease