cyrilzakka/clinical-trials huggingface dataset:
Observation of Clinical Consistency of Organoid-chips Drug Sensitivity in Chemotherapy for PCa With Visceral Metastasis

This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans.

This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans;The final medication regimen for patients is determined by doctors based on their experience and in vitro drug sensitivity results. The actual clinical efficacy of medication is tracked for patients, and the organoid chip drug sensitivity detection model is analyzed as a predictor of the sensitivity, specificity, and accuracy of anti-tumor chemotherapy drugs, providing data reference for clinical applications.At the same time, analyze the accuracy of drug sensitivity testing results and clinical empirical medication.If patients are treated with a chemotherapy combined with immunotherapy regimen, the in vitro sensitivity of immune drugs will be determined using organoid-immune co-culture technology, and exploratory research on the predictive performance of immune models will be conducted in conjunction with clinical medication.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with visceral metastasis of prostate cancer diagnosed clinically or pathologically;
2. Age ≥ 18 years old;
3. ECOG score ≤ 2 points or ECOG score 3-4 points due to tumor progression;
4. Normal liver and kidney function, serum transaminase ALT\<66 U/L, AST\<36 U/L, total bilirubin\<22 umol/L, creatinine\<106 umol/L, urea nitrogen\<6.1 mmol/L; Normal bone marrow function: neutrophil count ≥ 1800/mm3 and platelet count ≥ 100000/mm3;
5. Can obtain surgical or biopsy samples;
6. Patients voluntarily join this study and sign an informed consent form.

Exclusion Criteria:

1. Patients with severe heart, liver, kidney, and peripheral nervous system diseases, as well as autoimmune diseases such as hyperthyroidism and hypothyroidism; Systemic lupus erythematosus, etc;
2. Patients who are unable to obtain tissue samples;
3. Subjects with active pulmonary tuberculosis (TB);
4. Subjects who are preparing for or have previously undergone tissue/organ transplantation;
5. Exclusion criteria are not listed, but the researchers believe that patients who are not suitable to participate in this clinical study.
Pattern Of Use Of Belatacept In US Transplant Recipients

* The prevalence of Belatacept use
* The characteristics of Belatacept users and the temporal trends in these characteristics
* Characteristics of adult kidney-only transplant recipients who are treated with Belatacept vs. who are treated with Calcineurin inhibitors (CNI)-based regimens at the time of transplantation, and the temporal trends in these characteristics during 7 years post approval of Belatacept.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* The cohort for the analyses of all transplants includes all organ transplant recipients who are reported with Belatacept at transplant

Exclusion Criteria:
Sorin Universal REgistry on Aortic Valve Replacement

Multi-center, International, Prospective, Non comparative, Non randomized, Open label.

5,000 patients to be enrolled approximately worldwide.

The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU).

This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.

SURE-AVR objective is to collect post market safety and performance data collected along the procedure and the relevant follow-up with Sorin Group aortic valve devices in accordance with the IFU to further evidence the safety and efficacy in a post-approval environment. All current and future Sorin Group aortic valve devices that have obtained CE-mark or other local regulatory and/or commercial approvals may be included in the registry. During the duration of the registry,other aortic valve replacement products or current devices might receive modifications and might become commercial available. This registry allows extensions for the inclusion of new products.

This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry following the local applicable regulations.

The data collection shall be performed as per the local standard of care and without exposing the patient to any additional risk to the treatment (s)he would normally receive.

The registry is an open-ended project:

* Inclusions phase: open-ended
* Follow-up phase: annually throughout 5 years (7 and 10 years are optional).

The study shall be completed after the 10-year follow-up of the last patient.

Eligibility Criteria:
Inclusion Criteria:

* All patients must provide written or oral informed consent to participate in the registry depending on the local regulations.
* Patients having received a Sorin Group aortic valve device in accordance with the IFU

Exclusion Criteria: NA
Intestinal Microbiota and Antimicrobial Resistance in Hong Kong Residents After Travel

International travel is well reported to be associated with acquisition of multidrug-resistant organisms, however, the impact of colonization of these multidrug-resistant organisms is currently uncertain. As colonization of multidrug-resistant organisms had been demonstrated to be associated with distinct intestinal microbiota composition and travellers constitute a generally healthy population with minimal antibiotics exposure; by evaluating serial stool samples before and after travel, the investigators can delineate a potential causal relationship between host intestinal microbiota and subsequent risk of acquisition of multidrug-resistant organisms.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or above
* Chinese ethnicity
* Planning to visit any places outside of Hong Kong within the next three months
* Able to provide informed consent

Exclusion Criteria:

* Use of antibiotics within 4 weeks prior to the time of recruitment (Except for antimalarial prophylaxis)
* Hospitalization within 3 months
* Underlying gastrointestinal diseases, including gastrointestinal malignancy, inflammatory bowel disease, resection of small or large bowel
* Pregnancy
EYLEA Age-Related Macular Degeneration (AMD) Post-marketing Surveillance in Japan

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received EYLEA for Age-Related Macular Degeneration (AMD).

The objective of this study is to assess safety and effectiveness of EYLEA using in real clinical practice.

A total of 4,000 patients are to be enrolled and assessed in 3 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received EYLEA for AMD

Exclusion Criteria:

* Patients who have already received EYLEA
Ultrasound-guided Thoracic Spinal Level Identification

Typically, the rhomboid minor muscles rise from the C7-T1 spinous process and run downward to touch the upper inner corner of the scapula, and the rhomboid major muscles rise from the T2-T5 spinous process and run downward to reach the lower middle inner corner of the scapula. In anatomical research articles, it has been reported that the rhomboid muscle's anatomical variations are rare. Considering the characteristics of these rhomboid muscles, the investigators planned a study on the utility of rhomboid muscles as a landmark for identifying thoracic spine levels.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing thoracic nerve root block due to herpes zoster, postherpetic neuralgia, complex regional pain syndrome, post traumatic pain syndrome, or compression fracture of vertebra.

Exclusion Criteria:

1. Previous T-spine surgery
2. Patient refusal
3. Coagulopathy
4. Generalized infection or localized infection at injection site
5. Anatomical abnormality of T-spine
6. Allergic reaction to local anesthetics
Chronic Obstructive Pulmonary Disease (COPD) and Osteoporosis

The main objective is to study important factors in the patho-physiology of osteoporosis in patients with COPD. Therefore, the investigators will study biological markers in plasma and urine and correlate them to markers of bone turnover and clinical data.

Rationale:

Chronic obstructive pulmonary disease (COPD) is defined as a preventable and treatable disease with significant extrapulmonary effects. Osteoporosis is recognized as one of these extrapulmonary consequences. It results in increased risk of fracture and thereby an increased morbidity and mortality. Nowadays it is believed that the patho-physiology of osteoporosis is multi-factorial. However, which factors are most important in patients with COPD is still not clear.

Objective:

The main objective is to study important factors in the patho-physiology of osteoporosis in patients with COPD. Therefore, we will study biological markers in plasma and urine and correlate them to markers of bone turnover and clinical data.

Study design:

The present study will be an observational, cross-sectional study.

Eligibility Criteria:
Inclusion Criteria for the COPD patients:

* Aged 50 years or older;
* Women have to be postmenopausal (amenorrhea for 12 months or more)
* COPD Global initiative of Obstructive Lung Disease (GOLD) I, II, III and IV according to the American Thoracic Society (ATS) guidelines;
* ≥ 12 pack years;
* No respiratory tract infection or exacerbation of the disease for at least 4 weeks before the study;
* No use of oral corticosteroids for at least 4 weeks before the study;
* No use of anti-osteoporotic medication (calcium, vitamin D, biphosphonates) before inclusion;
* Capable to provide informed consent.

Exclusion Criteria for the COPD patients:

* Malignancy in the last 5 years;
* Lung fibrosis;
* Inflammatory bowel disease;
* Rheumatoid arthritis;
* Alcohol abuse;
* Bronchiectasia;
* Auto immune diseases;
* Hypothyroidism or hyperthyroidism based on blood sampling for thyroid hormone (TSH, fT4).
A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging

The purpose of the study is to assess the effects of selexipag on right ventricular (RV) function in participants with Pulmonary arterial hypertension (PAH).


Eligibility Criteria:
Inclusion Criteria:

* World health organization functional class (WHO FC) II or III. Enrollment will be stratified by WHO FC II or III. Proportion of participants with WHO FC II and WHO FC III are expected to be approximately 40 percent (%) and 60%, respectively
* Pulmonary arterial hypertension (PAH) etiology belonging to one of the following groups according to 6th world symposium of pulmonary hypertension (WSPH) classification: a) Idiopathic PAH, b) Heritable PAH, c) Drugs or toxins induced d) PAH associated with connective tissue disease, e) PAH associated with congenital heart disease, with simple systemic-to-pulmonary shunt at least 1 year after surgical repair
* Patients already receiving PAH-specific oral mono or dual therapy (that is, phosphodiesterase type 5 inhibitors \[PDE-5i\] or soluble guanylate cyclase stimulators \[sGCs\] and/or endothelin receptor antagonist \[ERA\]) or patients who are not candidates for these therapies
* N-terminal-pro-hormone brain natriuretic peptide (NT-proBNP) greater than or equal to (\>=) 300 nanograms per liter (ng/L) (greater than or equal to \[\>=\] 300 picograms per milliliter \[pg/mL\]; \>=35.5 picomoles per liter \[pmol/L\]) at screening
* Women of childbearing potential must meet the following criteria: a) Have a negative serum pregnancy test during screening and a negative urine pregnancy test on Day 1, b) Agree to use acceptable methods of contraception from Day 1 to at least 30 days after study intervention discontinuation, c) If only using hormonal contraception, have used it for at least 1 month (30 days) before Day 1, and d) Agree to perform monthly pregnancy tests to at least 30 days after study intervention discontinuation
* 6-minute walking distance (6MWD) \>=150 meter (m) during screening period

Exclusion Criteria:

* Prior use of Prostacyclin (IP)-receptor agonist, prostacyclin, or prostacyclin analog. Use of such treatments for vasoreactivity testing is not exclusionary; intermittent use of such treatments for digital ulcers or Raynaud's phenomenon is not exclusionary if stopped \> 6 months (180 days) prior to Day 1
* Treatment with strong inhibitors of CYP2C8 (example, gemfibrozil) within 4 weeks (28 days) prior to Day 1
* Treatment with another investigational drug planned or taken within 12 weeks (84 days) prior to Day 1
* Severe coronary heart disease or unstable angina
* Cerebrovascular events (example, transient ischemic attack, stroke) within 3 months (90 days) prior to Day 1
Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)

The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT.

Patients (N=600) with surgically resected (R) brain tumors of any pathology who have undergone STaRT are eligible. Data collected will include local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation associated AE's. Data will be collected at 1, 3, 6, 9,12, 18 and 24 months, then every 6 months through 5 years. RESULT: Data will be used to benchmark clinical outcomes of STaRT therapy and allow for comparisons to existing standard-of-care treatments. This will be the first observational registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. The outcome measures captured will allow for evaluation of the potential risks and benefits of this treatment approach for patients in a real-world setting.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
2. Willing and able to provide informed consent and to participate in all evaluations.

Exclusion Criteria:

1. Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.
2. Major medical or psychiatric illness, which, in the investigator's opinion would prevent completion of treatment, ability to complete assessments at the time of enrollment, and/or interfere with follow ups.
3. Lack of English language fluency sufficient to allow for completion of neurocognitive and QOL tests (which are in English).
Randomized Trial of Trust in Online Videos About Prostate Cancer

The study team will evaluate the impact of video characteristics on health consumers' trust in online videos. Participants will be randomized to watch a video by one of four speakers about prostate cancer screening or clinical trials and complete a questionnaire (approximately 15 minutes total).


Eligibility Criteria:
Inclusion Criteria:

1. US adult age 40+
2. Enrolled in Dynata online survey panel

Exclusion Criteria:

1. Children
2. Individuals living outside the U.S.
Lactobacillus in Preventing Infection in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Myelodysplastic Syndrome

RATIONALE: Probiotics, such as Lactobacillus, may be effective in preventing infections in patients with suppressed immune systems.

PURPOSE: This phase I trial is studying the side effects and how well giving enteral nutrition, including Lactobacillus, works in preventing infections in patients undergoing donor stem cell transplant for hematologic cancer or myelodysplastic syndrome.

OBJECTIVES:

* To determine if patients who are treated with a probiotic-containing diet develop infection with one of the probiotic microorganisms while undergoing allogenic hematopoietic stem cell transplantation for a hematologic malignancy or myelodysplastic syndrome.

OUTLINE: Patients receive oral Lactobacillus rhamosus GG (Culturelle DS) once daily beginning when blood counts have recovered without filgrastim (G-CSF) or sargramostim (GM-CSF) support for 3 consecutive days and continuing for 1 year after transplantation.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Currently undergoing allogeneic stem cell transplantation from a related or unrelated donor for a hematologic malignancy or myelodysplastic syndrome
* Hematopoietic engraftment as evidenced by recovery of the absolute neutrophil count \> 1000/μL for \> 3 days without filgrastim (G-CSF) support within 30 days of transplant

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Serum creatinine ≤ 2.0
* AST or ALT ≤ 3 times upper limit of normal (ULN)
* Total bilirubin ≤ 2.0 times ULN
* No clostridium difficile enterocolitis diagnosed during the transplant hospitalization in the peri-transplant period
* Able to take medications by mouth
* No evidence of graft-vs-host disease
* No history of inflammatory bowel disease or other chronic diarrheal illness
* No history of hypersensitivity to milk proteins

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 3 months since prior use of probiotics supplements, excluding yogurt and cheeses with live cultures
* No concurrent over-the-counter medications or herbal remedies
Evaluation the TECNIS IOL in Both Eyes VS the ReZoom IOL in One and TECNIS IOL in the Opposite

The purpose of this study is to evaluate the visual performance of two cohorts of patients who received multifocal intraocular lenses following cataract and clear lens extraction surgeries. Comparing visual outcomes of patients who were implanted with TECNIS Multifocal IOLs in both eyes versus patients implanted with TECNIS Multifocal in one eye and ReZoom Multifocal IOL in the opposite eye.

Stable post operative cataract and clear lens extraction patients who have been implanted with either the TECNIS Multifocal IOL in both eyes or TECNIS Multifocal IOL in one eye and theReZoom Multifocal IOL in the opposite eye.

Study Design-A retrospective chart review to collect visual outcomes to determine lens performance. Patient satisfaction questionnaire will be administered to determine spectacle independence.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone surgery and received either the TECNIS Multifocal Intraocular lens in one eye and the ReZoom Multifocal Intraocular lens in the other will be evaluated. Males and Females with ages ranging from 42 years to 86 years old.

Exclusion Criteria:

* Patients who have subsequently developed any visual limiting problems (e.g. corneal, retinal, infection) which could potentially limit their post operative visual potential.
Very Early Medical Abortion

The research question begin addressed by this study is "Is Very Early Medical Abortion (VEMA - before a pregnancy is visible on ultrasound scan) as effective as medical abortion when performed later and an intrauterine pregnancy can be visualised with ultrasound?".

This is important to patients and public, because delays to abortion care can cause mental distress, and pain and bleeding are worse at later gestations.

The study is examining whether earlier or delayed administration of abortion medications affects the efficacy and side effects of the medical abortion process, in women with very early pregnancies.

Any women who had a positive pregnancy test, requesting abortion, but did not have a visible pregnancy on ultrasound scan could take part in the study. Women with signs, symptoms or ultrasound findings suggesting ectopic pregnancy would not be included.

This study will be conducted at a community sexual and reproductive health centre that provides abortion care.

The participants will be involved in the study for a maximum period of 4 weeks. They will be randomly allocated to either immediate abortion care or delayed abortion care. In each arm of the study they will receive clinical care that they would otherwise routinely receive. In addition to this, they will receive a telephone call follow up with a short questionnaire to complete over the phone.

This study is being conducted in Scotland but the results will be combined with findings from similar research groups across Europe as part of a consortium of researchers. This consortium is coordinated by the Karolinska Institutet in Sweden under the EuDRACT ID: 2018-003675-35


Eligibility Criteria:
Inclusion Criteria:

1. Women 18 years old or above opting for medical abortion with a pregnancy estimated by gynaecological history and Last Menstrual Period (LMP - if known) to be less than 6 weeks
2. No signs of ectopic pregnancy, miscarriage or other pathological pregnancy
3. Transvaginal ultrasound (part of the clinical protocol at the abortion visit) shows no confirmed Intrauterine Pregnancy (IUP see definitions below)
4. Willing and able to return to the clinic for possible delayed treatment and at 1 to 2 weeks after the start of treatment for follow up
5. Capable of giving their informed consent to participate.

Exclusion Criteria:

1. Women with visible (confirmed) IUP
2. Women with contraindications to medical abortion including diagnosed pathological pregnancy at the initial examination.
3. Inability to give informed consent.

The following definitions will be used according to the consensus statement on nomenclature, definitions and outcomes in pregnancy of unknown location (Barnhart et al, Fertil Steril. 2011;95:857-66):

1. Confirmed IUP: Ultrasound shows an intrauterine yolk sac or fetal structure with or without cardiac echo.
2. Not confirmed IUP: This group includes cases where:

   1. ultrasound shows an empty uterine cavity (frequently referred to as PUL: Pregnancy of Unknown Location) or
   2. ultrasound shows a gestational sac, or sac like structure, but without a yolk sac.