cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study of SHR-3276 for Injection in Patients With Advanced Malignant Tumors

This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3276 for injection in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to sign a written informed consent；
2. Age 18-70 years old (including both ends), both male and female；
3. Pathologically confirmed advanced malignant tumors that have failed sufficient standard treatment or have no effective standard treatment plan；
4. Existence of measurable lesions；
5. ECOG score: 0-1；
6. Expected survival time ≥ 12 weeks；
7. The functional level of the major organs must meet the requirements；
8. Fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; And must be non-lactating.

Exclusion Criteria:

1. Central nervous system metastasis or meningeal metastasis with clinical symptoms;
2. Spinal cord compression that has not been treated radically by surgery and/or radiotherapy；
3. Patients with uncontrolled tumor-related pain as judged by the investigator
4. A third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator；
5. Systemic antitumor therapy was administered within 28 days prior to treatment in the first study；
6. Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, or elective surgery was expected during the trial period；
7. Serious drug-related adverse reactions during previous immune checkpoint inhibitor therapy；
8. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1；
9. Live attenuated vaccines were used within 28 days prior to administration in the first study or were expected to be required during the study treatment；
10. Systemic immunosuppressive therapy was administered within 14 days prior to the first study
11. Arterial/venous thrombosis events occurred within 3 months prior to initial administration
12. Patients with clinical significant lung disease;
13. Patients with history of autoimmune diseases;
14. The first study studied any other malignancy within 5 years prior to medication
15. A known history of severe allergic reactions to the investigational drug and its principal formulation ingredients；
16. Have a history of immune deficiency or organ transplantation；
17. Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.
Specified Drug-use Surveillance of Fabhalta Capsules

This is a multicenter, single-arm, non-interventional study (NIS) with a central registration system and an all-case surveillance system. The observation period is 48 weeks after the start of treatment with Fabhalta.

The observation period will be 48 weeks after the start of treatment with Fabhalta.

For patients in whom treatment with Fabhalta is discontinued within 48 weeks after the start of the treatment, adverse events occurring by the last day of the treatment + 30 days and concomitant drugs will be monitored and recorded in CRFs.

Eligibility Criteria:
Inclusion Criteria:

All patients who received Fabhalta.

·

Exclusion Criteria:

Patients receiving Fabhalta for an unapproved indication under the Clinical Trials Act or GCP.
Hematopoietic Stem Cell Transplantation With Targeted Busulfan and Fludarabine in Pediatric AML

In this study we plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.

Busulfan is a highly toxic drug with narrow therapeutic window used for the conditioning of hematopoietic stem cell transplantation. High exposure is associated with systemic toxicity such as veno-occlusive disease (VOD) and underexposure is associated with graft failure or relapse. In this study the investigators plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are diagnosed as AML.
2. Patients who need hematopoietic stem cell transplantation with busulfan based conditioning regimen.
3. Age: up to 21 years
4. Performance status: ECOG 0-2.
5. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. Heart: a shortening fraction \> 30% and ejection fraction \> 45%. 2. Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal. 3. Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
6. Patients must lack any active viral infections or active fungal infection.
7. Appropriate donor is available: Matched in 6/6 of A, B, DR loci.
8. Patients (or one of parents if patients age \< 20) should sign informed consent.

Exclusion Criteria:

1. Pregnant or nursing women.
2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
3. Psychiatric disorder that would preclude compliance.
Observational Study on Multiple Sclerosis

This is a multicentre observational study which involves 43 of the major Italian centres that treat MS. The duration expected for the study participation of each subject was exclusively the necessary one for the screening visit and execution of the ecocolor-Doppler test, which could have also been executed on the same day.


Eligibility Criteria:
Inclusion Criteria:

* Group A (MS)

  * Age 18-55 years;
  * Unisex patients diagnosed with MS according to McDonald criteria and successive relapse (38, 39), and subjects with CIS;
  * Course of the disease: RR-SP-PP-CIS;
  * Disease duration (starting from diagnosis): from 1 month to 25 years for subjects with RR, SP, and PP; a maximum of 5 years for subjects with CIS;
  * Not in clinical relapse (at least 30 days after the last clinical relapse);
  * Subjects treated or non-treated with immunomodulatory and immunosuppressive drugs;
  * Signature of the informed consent.

Group B (HC)

* Age 18-55 years;
* Absence of significant diseases and lack of familiarity with MS, ie health check-ups (HC);
* Signature of the informed consent.

The subjects included in this group could be, for example, unrelated relatives or spouses of those affected by MS or other diseases in the study or linked to these by affinity restrictions (such as, the father-in-law with the son-in-law, the husband with his wife's brother, etc.) or accompanying persons or operators of other centres.

Group C (OND)

* Aged 18-55 years;
* Subjects with other non-inflammatory neurodegenerative disease (OND), for example Parkinson, ALS, ataxy.

Group D (ONDi)

* Age 18-55 years;
* subjects suffering of other inflammatory neurodegenerative diseases (ONDi), for example optical neuromielitys, ADEM, encephalitis, neuro lupus, neurological complications of systemic autoimmune diseases;
* Signature of the informed consent.

Exclusion Criteria:

* • The presence of acute or chronic disease which are disabling or interfere with the design and objective of the study;

  * Clinically proven cardiopathy (NYHA ≥ I class);
  * Previous episodes of venal thromboembolism (including either deep venal thrombosis or pulmonary embolism);
  * Neoplasms;
  * Thrombophilia from an anamnestic definition;
  * Diabetes;
  * Primary or secondary pulmonary hypertension and in treatment for it;
  * Concurrent systemic steroid treatments or in the last 30 days;
  * Cerebrovascular diseases current or previous;
  * Episodes of global transitory amnesia;
  * Pregnancy.
PEG by Introducer Method Via EG Scan

Percutaneous endoscopic gastrostomy(PEG) by introducer method has been proven to be safe and easy to perform. However, it is limited by its need to be performed in an endoscopy unit. E.G. ScanTM is an new portable ultrathin endoscope, capable of being performed in any hospital setting and introduced via nasal approach. Our aim is to prove that PEG by introducer method via E.G. ScanTM is feasible and safe. This will allow PEG to be done at hospitals and medical facilities without endoscopic units.


Eligibility Criteria:
Inclusion Criteria:

* Require percutaneous endoscopic gastrostomy placement due to inability to achieve oral feeding for at least one month

Exclusion Criteria:

* Patients with esophageal ulcers or strictures
* Patients with prior esophageal/gastric surgery (excepting gastric wedge resection)
* Patients at high risk of gastric bleeding, mechanical ileus or gastrointestinal perforation
* Other patients in whom the study investigators consider unfit for inclusion
Quantification of Hepatic Steatosis With Different Ultrasound Frequency

The objective of this study is: (1) to compare the feasibility (technical successes rate and reliability) in measuring attenuation coefficient between two different frequencies (3MHz, 4MHz) of ultrasound beam; (2) to evaluate and compare the diagnostic performance of attenuation coefficient for steatosis using two different frequencies (3MHz, 4MHz) of ultrasound beam by comparison with the pathologic results acquired by liver biopsy or surgery.

Investigators measure the distance between the skin and liver capsule on B-mod images.

Investigators place a region of interest (ROI) avoiding reverberation artifacts and acquire attenuation coefficient for five times.

For participants who require a liver biopsy, investigators try to target the same area in the liver, where ROI was placed.

Investigators evaluate hepatic steatosis, lobular inflammation, and fibrosis of tissue of the liver using a scoring system suggested by Nonalcoholic Steatohepatitis Clinical Research Network.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are candidates for liver donation and scheduled liver biopsies for assessment of hepatic steatosis
* Participants suspected of nonalcoholic fatty liver disease and scheduled for liver biopsy or surgery

Exclusion Criteria:

* Participants with a BMI of less than 23
* Participants underwent liver transplantation or right hepatectomy
* Participants who have a large mass in the right liver
* Participants who have a bleeding tendency (platelet count \< 80000, prothrombin time and international normalized ratio \> 1.5)
Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.

Healthy subjects will take study drug by mouth twice a day for 7 consecutive days, blood and cervicovaginal samples will be taken most mornings around the AM dose. Two visits, \~14 hrs in length will be required on Day 1 and 7. The purpose of this study is to measure how much raltegravir is found in the genital tract after taking it orally.

This study is looking at blood and cervicovaginal fluid (CVF) samples of healthy volunteers taking raltegravir. The purpose of this study is to measure the extent that raltegravir penetrates into other body compartments, such as the genital tract. Subjects will take the study drug for 7 days, a total of 10 visits to the research center will be required. A screening visit will occur on no more than 28 days On Days 1 and 7 the subject will stay in the research center for approximately 12 hours for scheduled blood and CVF sampling. Days 3-6 and 8-9 will involve a short visit to the research center for one pre-dose blood and CVF sample before the morning dose. A follow up visit will occur about 7-10 days after last dose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pre-menopausal female subjects
* Between the ages of 18 and 49 years
* With an intact uterus and cervix

(Healthy is defined as no irregular menstrual cycles or clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Exclusion Criteria:

* Negative serum pregnancy test at screening and should be using at least one method of contraception
* Body Mass Index (BMI) of approximately 18 to 30 kg/m\^2
* And a total body weight \> 50 kg (110 lbs)
Torsion of the Tibial Tuberosity, a New Factor of Patellar Instability?

Patellar instability (recurrent patellar dislocation) can occur at any age. It is most often seen in young subjects, especially among adolescents. It is commonly accompanied by anatomical factors. A new factor not described in bibliographic sources and characterized by an external torsion of the tibial tuberosity is frequently found in patients with patellar instability thanks to MRIs. This does not seem to be the case when there is no patellar pathology. A statistical study is needed to assess this rotary anomaly. Validate the predictive benefits when measuring the torsion of tibial tuberosity in cases with recurrent patellar dislocation.

Patellar instability (recurrent patellar dislocation) can occur at any age. It is most often seen in young subjects, especially among adolescents. It is commonly accompanied by anatomical factors known to be driving: Dysplasia of the trochlea, patella alta, lateralisation of the tibial tuberosity, patellar torsion and misalignment, tearing of the Medial Patello Femoral Ligament... The assessment of these factors is essential to evaluate the instability and guide the procedures of the surgical treatment. MRIs have become an important test for the analysis and measurement of these factors. A new factor not described in bibliographic sources and characterized by an external torsion of the tibial tuberosity is frequently found in patients with patellar instability thanks to MRIs. This does not seem to be the case when there is no patellar pathology. A statistical study is needed to assess this rotary anomaly. It will be necessary to take it into account in the future regarding indications and techniques for tibial tuberosity osteotomies, often used to correct patellar instability.

Eligibility Criteria:
Inclusion Criteria:

* Men or women
* Subjects who have not expressed opposition to the use of the data for research purposes

Clinical criteria:

* Unstable group:

  * Medical history with 2 patellar dislocations or more,
  * with or without requiring surgical treatment after an MRI Control group: Men or women over 18 years old
  * Subjects who have not expressed opposition to the use of the data for research purposes
* Control group:

  * Patients showing meniscal injury on MRI who may or may not have been treated (meniscectomy or stitches)

Exclusion Criteria:

* Unstable group:

  * MRI performed on one knee operated for patellar instability
  * Associated tearing of the ligament (ACL, PCL)
* Control group:

  * Patients with a medical history of patellar pathology
  * Patients with associated ligament injury (ACL, PCL)
Pulsed Electromagnetic Field Treatment for Painful Periods

A single-centre, randomised controlled, double blind study comparing use of the Allay pulsed shortwave therapy treatment versus a placebo device or no treatment for management of primary dysmenorrhea.

Women participating in the trial will be randomly allocated to any of the three arms of the study.

* Treatment for 2 menstrual cycles using the PSWT Allay device (BioElectronics Corp, Frederick USA)
* Treatment for 2 menstrual cycles using a placebo device
* No treatment. If they are allocated to a device both the participant and the clinician will be blinded at to weather they are using the active device or the placebo.

Primary Outcome measures are:

* A reduction in dysmenorrhea as measured by the highest pain score on a 10cm visual analogue scale.
* A reduction in average pain score on a 10cm visual analogue scale
* A reduction in use of analgesia as recorded in a pain diary
* Improvement in quality of life as measured through a validated quality of life assessment tool (SF-36 questionnaire)

  - Improvement in menstrual symptoms as recorded through a validated questionnaire (the Modified Menorrhagia Multi-attribute Scale (MMAS)).
* Device acceptability as measured on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable".
* Impact upon associated cyclical symptoms as recorded in a patient symptom diary

Eligibility Criteria:
Inclusion Criteria:

* Female with persistent (\>3months) cyclical period pain associated with menstruation (defined as 5 or more on VAS).
* Able to give written, Informed consent
* Able to wear device and keep up-to-date records of use
* Agrees to attend follow up
* If currently using hormonal contraception agrees to continue on the same dose for the duration of the trial.

Exclusion Criteria:

* Age under 16 years.
* Trying to conceive or \<6 weeks post partum
* Currently participating or planning to participate in another clinical trial
Screening Brief Intervention Referral to Treatment (SBIRT) in New Mexico

The purpose of this study is to compare the effectiveness in reducing drug use and its associated problems of a brief intervention for drug use delivered by a behavioral health counselor as compared to a brief intervention delivered by a computerized intervention.

Drug use is a significant cause of morbidity and mortality in the United States. Efforts to develop and rigorously evaluate methods to provide Screening, Brief Intervention and Referral to Treatment (SBIRT) for drug users are needed. Computerized screening and brief interventions in particular have the potential to circumvent some of the potential problems of integrating SBIRT delivered by a counselor into busy primary care settings. These interventions may reduce drug use among individuals who are using drugs but are not yet drug dependent.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Moderate risk category on the ASSIST scores

Exclusion Criteria:

* planning to move out of New Mexico in the next year
* receipt of formal drug abuse treatment or a brief intervention for drug use in the past month.
Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension

The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.


Eligibility Criteria:
Inclusion Criteria:

1. patients aged at least 18 years at the date of signing the consent form
2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the study
3. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
4. able to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's decision)
5. willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation).

Exclusion Criteria:

1. are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
2. known or suspected secondary hypertension
3. mean seated systolic blood pressure (SBP) over 200 mmHg and/or mean seated diastolic blood pressure (DBP) over 120 mmHg at Visit 1 or 2 or mean seated SBP over 180 mmHg and/or mean seated DBP over 120 mmHg at the end of the run-in period (Visit 3)
4. any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency)
5. severe renal impairment (e.g. serum creatinine \>3.0 mg/dL or \>265 mcmol/L, known creatinine clearance \<30mL/min or clinical markers of severe renal impairment)
6. bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
7. clinically relevant hyperkalaemia
8. uncorrected volume or sodium depletion.
9. primary aldosteronism.
10. hereditary fructose or lactose intolerance
Varenicline for Treatment of E-cigarette Dependence

Varenicline is used to treat tobacco use dependence. It helps reduce cravings for tobacco use and decreases the pleasurable effects of cigarettes and other tobacco products. Varenicline has been proven to reduce the desire to smoke cigarettes. This study aims to test whether it shows a similar benefit for individuals who vape and are interested in quitting.

Varenicline is a highly efficacious FDA-approved smoking cessation pharmacotherapy. The aim of this study is to examine the effectiveness of varenicline for e-cigarette cessation medication for mono- e-cigarette use in combination with a minimal, self-guided behavior change booklet. This booklet will include general tips for e-cigarettes cessation and information about the free web-based e-cigarette cessation program sponsored by The Truth Initiative and Mayo called "This is Quitting". This study will have an 8-week treatment period and a 4-week follow-up phase. Participants will be randomized to receive an 8-week supply of varenicline or matching placebo (gel capsule filled with cellulose powder) in combination with the self-change booklet. The investigators hypothesize that participants who receive varenicline will have higher rates of e-cigarette cessation.

Eligibility Criteria:
Inclusion Criteria:

* daily use of an e-cigarette containing nicotine (defined as use for at least 25 days out of the past month)
* use of an e-cigarette containing nicotine\> 6 months
* have desire to quit e-cigarettes, are willing to set a quit date and maintain e-cigarette abstinence
* have daily access to a smartphone or have regular (daily) access/use of email
* live in South Carolina or Connecticut

Exclusion Criteria:

* Vulnerable Populations: Not be enrolling vulnerable populations, specifically pregnant women, children, prisoners, or institutionalized individuals
* The investigators will not enroll participants incapable of providing their own consent. The rationale will be provided to the individual as well as his or her family members.

Referrals for further evaluation, including urgent or emergent evaluation, will be made as needed and clinically warranted.

* exclude individuals with medical contraindications for varenicline use (i.e., severe renal impairment)
* exclude anyone currently using smoking cessation medications.
* Individuals will also be excluded if another household member is currently enrolled in the study.
* Individuals will be excluded if not proficient in English.
* Individuals will be excluded if they have smoked any combustible cigarettes in the past 6 months.
* Verification of Non-Pregnancy: Females ages \<55 will be mailed a commercially available pregnancy test to verify non-pregnancy. Written confirmation of negative pregnancy test via REDCap will be required prior to enrollment in the trial. Participants are also informed that they should let us know if they become pregnant during the trial. Medications will not be sent until this verification is in place. These procedures are based on the Medical University of South Carolina Internal Review Board approved STARS protocol.