cyrilzakka/clinical-trials huggingface dataset:
Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer

This study explores the effectiveness of combining electroacupuncture with olanzapine-containing four-drug antiemetic therapy to mitigate chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer. The research aims to assess the adjunctive benefits of electroacupuncture in enhancing the antiemetic effects of conventional medication, particularly in the context of highly emetogenic chemotherapy regimens. By investigating the synergistic potential of these modalities, the study seeks to provide insights into optimizing supportive care strategies for patients with breast cancer undergoing intensive chemotherapy treatment.

This study is a randomized controlled trial conducted in parallel groups, with blinding implemented. It aims to assess the effectiveness of combining electroacupuncture with standard quadruple antiemetic drugs for patients with breast cancer undergoing HEC.

Both study arms will be administered Olanzapine, Neurokinin-1 receptor antagonists, serotonin receptor antagonists, and dexamethasone at the commencement of HEC on Day 1. Subsequently, participants will be randomly assigned to receive either electroacupuncture or sham acupuncture.

Participants will be responsible for recording all instances of nausea and vomiting, as well as documenting the use of rescue antiemetic medications.

The study will evaluate primary and secondary outcomes, as well as monitor adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 75 years, inclusive, from any nationality.
2. Patients diagnosed with early-stage breast cancer.
3. Eastern Cooperative Oncology Group performance status ranging from 0 to 2.
4. All patients must undergo highly emetogenic chemotherapy (HEC).
5. Adequate organ function.
6. Adequate contraception required for premenopausal women.

Exclusion Criteria:

1. Scheduled to undergo chemotherapy between days 2 to 4 following HEC.
2. Received or is planned to receive abdominal radiation therapy within 1 week before Day 1 in cycle 1.
3. Significant medical or psychological conditions.
4. Presents with symptomatic primary or metastatic central nervous system malignancy causing nausea and/or vomiting.
5. Experiencing ongoing vomiting or nausea of grade 2 or higher according to Common Terminology Criteria for Adverse Events (CTCAE).
6. Any known allergies to the study drug, antiemetics, or dexamethasone.
7. Patients who have fear of electroacupuncture stimulation or are allergic to stainless steel needles.
8. Received acupuncture treatments for any conditions within 8 weeks prior to HEC.
Iris Tissue in Primary Congenital Glaucoma

To present the histopathological features of the iris tissue in primary congenital glaucoma which may play a role in pathogenesis

Primary congenital glaucoma etiology still remains obscure . originally barkan , and later Worst , proposed that a membrane covered the anterior chamber angle and blocked aqueous outflow , but the presence of that membrane has not been established histopathologically to date . Now most authors believe that the site of obstruction is the trabecular meshwork rather than an overlying membrane . Maldevelopment of the anterior segment is present in all forms of congenital glaucoma . this maldevelopment may involve the trabecular meshwork alone or the trabecular meshwork in combination with the iris or cornea or both. In approcimately 50% of patients , isolated trabeculodysgensis is the only developmental ocular anomaly found .This is the classic defect found in primary congenital glaucoma .These eyes have no developmental anomalies of iris or cornea present except abnormal insertion of the iris into the angle

Eligibility Criteria:
Inclusion Criteria:

1. Typical symptoms of epiphora , photophobia and blepharospasm
2. corneal diameter \> 13 mm
3. Increased ocular tension \> 25 mmHg UGA using schiotz tonometer

Exclusion Criteria:

1. Infants with history of previous surgery
2. Secondary glaucoma
3. Glaucoma associated with other congenital anomalies
Fructooligosaccharides in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant

This pilot phase I trial studies the side effects and best dose of fructooligosaccharides in treating patients with blood cancer who are undergoing donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Nutritional supplements such as fructooligosaccharides may reduce the incidence of graft-versus-host disease in patients with blood cancer undergoing donor stem cell transplant.

PRIMARY OBJECTIVES:

I. Conduct a dose escalation trial to determine the tolerability of the fructo-oligosaccharides prebiotic in allogeneic hematopoeitic stem cell transplant (HSCT) patients.

OUTLINE: This is a dose escalation study.

Patients receive fructooligosaccharides (FOS) orally (PO) twice daily (BID) for 21 days starting at 7 days before allogeneic hematopoietic stem cell transplant in the absence of disease progression or unexpected toxicity.

After completion of study treatment, patients are followed for 100 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in the study will have a hematologic malignancy (any stage or grade) for which they are undergoing preparation for allogeneic HSCT; participants in the study will be restricted to those undergoing HSCT under reduced-intensity protocols 9924 and 9907
* No limitations exist for type or amount of prior therapy
* No restrictions or requirements will be placed on race
* No restrictions will be made based on life expectancy
* Patients will not be evaluated based on Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status (KPS)
* No restrictions will be made based on organ or marrow function
* Patients will be included only if they have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients with a history of gastric bypass surgery or inflammatory bowel disease
* Patients with a history of or current bowel obstruction
* Patients actively enrolled on any other GVHD prevention trial
* Patients with known fructose intolerance
* Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures
* Subjects may co-enroll on other investigational studies except for investigational studies whose primary aim is the prevention of GVHD
* No additional restrictions exist regarding co-morbid disease or incurrent illness
* Patients will be excluded from the trial if they have had a history of allergies or intolerance to fructooligosaccharides or the components of FOS including fructose and glucose
* No exclusion is necessary based on the use of other concomitant medications; specifically there is no prohibition of concomitant antibiotic, antiviral or antifungal therapy; subjects may co-enroll on other investigational studies except for investigational studies whose primary aim is the prevention of GVHD
* Pregnant or nursing patients will not be included in the study
A Clinical Study of SHR-9539 in Patients With Multiple Myeloma

This study is a multicenter, open-label, dose-escalation/dose-expansion clinical Phase I trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy profile of SHR-9539 Injection in patients with multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years on day of signing the Informed Consent Form;
2. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale；
3. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria ；
4. Have a life expectancy of at least 3 months；
5. Male and female subjects with fertility must agree to use efficient contraceptive measures with their partners within 3 months after the last administration of the test drug from the time of signing the informed consent form, and have no fertility plan and avoid donating sperm / eggs. The pregnancy test during the screening period must be negative.

Exclusion Criteria:

1. Central nervous system (CNS) involvement of MM；
2. Diagnosis of amyloidosis, plasma cell leukemia, Wahl's macroglobulinemia, or POEMS syndrome;
3. Prior Grade 3 or higher CRS (Per ASTCT standards) related to any T cell redirection (eg, CD-3 redirection technology or CAR-T cell therapy).
4. Have other factors that may force the termination of the study, e.g., non-compliance with the protocol, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory abnormalities, associated family or social factors, which would affect the safety of the subjects or the collection of data and samples, as determined by the investigator.
Evaluation of a Desipramine Ceiling in Cocaine Abuse - 1

The purpose of this study is to confirm whether a blood level ""ceiling"" exists on desipramine effect in cocaine abuse.


Eligibility Criteria:
Please contact site for information.
Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients

Prospective study of an electromyography (EMG) based seizure detection and warning system for detecting generalized tonic-clonic (GTC) seizures.

This study "A Pivotal, Phase III Trial of Detecting generalized tonic-clonic seizures with a Seizure Detection and Warning System in Epilepsy Patients " is a phase III, pivotal, prospective study of an electromyography (EMG) based seizure detection and warning system (tentatively named Brain Sentinel™ Seizure Detection System) for detecting generalized tonic-clonic (GTC) seizures. The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity. This is to facilitate a faster intervention to the GTC seizure, and to more accurately document GTC seizure frequency in a home, skilled nursing, or inpatient setting.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
2. Is being admitted to a hospital for routine vEEG monitoring related to seizures.
3. Male or female between the ages of 2-99.
4. Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
5. If female and of childbearing potential, has a negative pregnancy test.
6. Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
7. Subject and/or Primary Caregiver must be competent to follow all study procedures.
8. Is able to read, speak, and understand English.

Exclusion Criteria:

1. Does not have a documented history of generalized seizures.
2. Has not had a GTC seizure within the last year AND is not expected to have a reduction of anti-epileptic drugs during their hospital admission.
3. Intracranial EEG electrodes are being used
4. The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm).
5. Pregnant female.
6. Subject/Caregiver is unable to provide consent.
Perioperative Lactate Kinetics in Patient Undergoing Major Liver Surgery

Major liver surgery is associated with increased incidence of perioperative complications and increased mortality if these are not addressed quickly in a high dependency intensive care unit. Of these, posthepatectomy liver failure (PHLF) represents one of the most important cause of postoperative unfavourable outcome. The present study investigates the correlation between lactate levels and PHLF. Lactate levels were collected at six specific timepoints: preoperative, pre-dissection phase, post-dissection phase, end of surgery and 24-hours and 48-hours in the postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing major liver surgery for primary or secondary tumours

Exclusion Criteria:

* unsigned patient consent
* death within 24 hours
* need for perioperative renal replacement therapy
* underlying liver disease (e.g. liver cirrhosis)
* other causes of raised lactate levels (e.g. shock)
Systematic Support for Relatives of Palliative Care Patients

The primary purpose of this study is to validate the prognostic screening tool from The Aarhus Bereavement Study (TABS) and to implement a systematic support for relatives of palliative care patients in order to prevent the development of prolonged grief disorder. Depending on their identified support needs, the relatives are offered different interventions. It is evaluated whether this procedure of screening and intervening are able to reduce the risk of developing prolonged grief disorder.

PRIMARY OUTCOME: identification of the support needs of relatives of palliative care patients

SECONDARY OUTCOME: evaluation of the initiated interventions and whether these are able to reduce the risk of developing prolonged grief disorder

PARTICIPANTS: Relatives (age 18-90) of patients affiliated with specialized palliative care in The Capital Region of Denmark.

The relatives will complete a survey and prognostic screening tool at respectively 2 weeks (T1) and every 6 months (T2) from the time that the patients is affiliated to the specialized palliative care and until the death of the patient. This will happen regardless the status of the patient - that is, whether or not the patient continues being affiliated with specialized palliative care, or the patient is being referred to another palliative care units or doesn't need palliative care anymore.

Furthermore the relatives will complete a follow-up survey and the diagnostic questionnaire PGD-13 at respectively 6 months (T3) and 18 months (T4) after the death of the patient (post loss). It will be evaluated whether there are any diffences in the grief symptoms of relatives of patients with a malign versus non-malign disease. It will also be evaluated whether there is an association between the intervention the relatives received from the palliative care unit at Rigshospital and their grief symptoms post loss.

Eligibility Criteria:
Inclusion Criteria:

* relatives of palliative care patients with relation to Department of Palliative Care, (Rigshospitalet)
* relatives identified by the patient

Exclusion Criteria:

* relatives who do not read or understand danish
* relatives who are cognitive disabled
Optimizing the Diagnosis of Pneumocystis in Immunocompromised Patients

Evaluate new diagnostic methods using qPCR on non-invasive samples, compared with reference techniques for the positive diagnosis of pneumocystis (PcP) in immunocompromised patients


Eligibility Criteria:
Inclusion Criteria:

* adult patients with suspected pneumocystis
* with an indication for bronchial fibroscopy for BAL or induced sputum
* no opposition to the research from the adult patient or his or her next of kin research for patients unable to express their non-opposition

Exclusion Criteria:

* Pneumocystis treated for more than 72 hours
* pregnancy/breast-feeding
* adult patients deprived of liberty, protected
Informing American Muslims About Living Donation

The purpose of this projects is to test the effectiveness of a tailored educational intervention in increasing knowledge about organ donation among Muslim Americans. More specifically, using the theory of planned behavior (TPB) as a conceptual framework, the workshop's goal is to enhance attendee knowledge of the benefits and risks (behavioral beliefs and attitude), understanding of religious arguments for and against (normative beliefs and subjective norm), and procedural knowledge about the process and types of (control beliefs and perceived control) living organ donation.

The study consists of two workshops (control and experimental) and an optional follow-up interview.

The study contains 2 intervention arms based on the order in which the organ donation workshop is delivered at the mosque: early and late. The early arm will receive the experimental organ donation workshop first, followed by the control workshop (on end-of-life care). The late arm will receive the workshops in the opposite order (end-of-life care workshop followed by the organ donation workshop).

To address varied adult learning styles, the workshops will incorporate didactic teaching, moderated panel presentations, and facilitated small group discussions led by a trained peer educator. Workshops will also involve self-administered surveys.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified Muslim men and women
* Fluent in English
* Adult
* Availability to attend workshop sessions

Exclusion Criteria:

* No personal or immediate family history of organ transplant
Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia

Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.


Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female, aged ≥18 and \<50.
* The subject is in good general health with no evidence of any medical problems.
* The subject has both wrist circumferences between 14 and 22cm.
* The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

* The subject is obese (BMI\>30).
* The subject has a known history of heart disease, lung disease, kidney or liver disease.
* Diagnosis of asthma, sleep apnea, or use of CPAP.
* Subject has diabetes.
* Subject has a clotting disorder.
* The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample that in the opinion of the investigator, would make them unsuitable for study participation.
* The subject has any other serious systemic illness.
* The subject is a current smoker.
* The subject has piercings that may cause air leaks during the test
* The subject has any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
* The subject has a history of fainting or vasovagal response.
* The subject has a history of sensitivity to local anesthesia.
* The subject has a diagnosis of Raynaud's disease.
* The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
* The subject is pregnant, lactating or trying to get pregnant.
* The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
* The subject has a resting heartrate over 120, Systolic BP is over 150, diastolic BP is over 90 or room air SpO2 is less than 94%.
* The subject has carboxyhemoglobin over 3% as measured by Lab blood gas analysis.
* The subject has any other condition, which in the opinion of the investigators' would make them unsuitable to participate.
Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors

To evaluate CAN1012(Selective TLR7 agonist) when administered by IT injection to subjects with advanced solid tumors who are not candidates for standard therapy.

This is a Phase 1, open-label, first-in-human, single-arm, multicenter, dose escalation study of IT CAN1012 in subjects with advanced solid tumors who are not candidates for standard therapy.

Subjects will be enrolled in cohorts of 3 at each dose level using a 3+3 dose escalation design Approach.

Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide written informed consent and willing to comply with the study's requirements.
2. Male or female age \>18 years at screening.
3. Metastatic or locally advanced solid tumor that has progressed on, is refractory to, or for which there is no efficacious standard of care therapy.
4. Demonstrate adequate organ function as defined below. All screening laboratory assessments should be performed within 14 days of treatment initiation.
5. Performance status of 0 or 1 on the ECOG Performance Scale.
6. Life expectancy \>12 weeks at Baseline.
7. Women of childbearing potential must have negative serum pregnancy test within 3 days prior to receiving the first study drug administration.
8. For women of childbearing potential, must be willing to use an adequate method of contraception from 30 days prior to the first study drug administration and 120 days following last day of study drug administration.
9. Male subjects of childbearing potential must be surgically sterile or must agree to use adequate method of contraception during the study and at least 120 days following the last day of study drug administration.

Exclusion Criteria:

1. Received prior TLR7/8 agonists (excluding topical agents).
2. Has untreated or uncontrolled central nervous system (CNS) involvement.
3. Will receive concurrent chemotherapy, immunotherapy, biologic, hormonal therapy, or other therapies for cancer.
4. Received systemic interferon alfa (IFNα) prior to enrollment.
5. Unresolved toxicities from prior therapy, defined as having not resolved to CTCAE v5.0 Grade 0 or 1, with exception of endocrinopathies from prior therapy, alopecia, and vitiligo.
6. Treatment with systemic corticosteroids.
7. Concomitant or planned use of sensitive substrates of major cytochrome P450 enzymes.
8. Has an active infection requiring systemic therapy.
9. Has known active infection with the human immunodeficiency virus,
10. Unstable/inadequate cardiac function.
11. Uncontrolled concurrent illness.
12. A history of interstitial lung disease.
13. A history of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders.
14. Participated in a clinical study of an investigational agent within 30 days of screening.
15. Has known psychiatric, substance abuse, or other disorders that would interfere with cooperation with the requirements of the study in the opinion of the investigator.
16. Is pregnant or breastfeeding.
Adenomyosis and Pregnancy: Levonorgestrel vs. GnRH for Blastocyst Transfer

Adenomyosis is a condition where endometrial tissue grows into the uterine muscle, causing symptoms like pelvic pain, heavy bleeding, and infertility. This abnormal growth can lead to a variety of reproductive issues, including a higher risk of miscarriage and early pregnancy loss.

While there are treatments available for adenomyosis, they are often limited due to the lack of precise diagnostic criteria. One common approach is the use of gonadotropin-releasing hormone agonist (GnRHa), which can improve pregnancy rates in infertile women with adenomyosis. However, it's important to note that GnRHa may not restore pregnancy rates to baseline levels.

Another potential treatment option is the levonorgestrel-releasing intrauterine system (LNG-IUS). This device releases a hormone called levonorgestrel into the uterus, which can help control the symptoms of endometriosis and adenomyosis. Studies have shown that the endometrial concentration of levonorgestrel from the LNG-IUS is significantly higher than in other tissues like the myometrium, fallopian tubes, and fat tissue.


Eligibility Criteria:
Inclusion Criteria:

* Women who have adenomyosis diagnostic characteristics and underwent ICSI that resulted in good-quality FE.

Exclusion Criteria:

* Women Women who have adenomyosis diagnostic characteristics and underwent ICSI that resulted in Poor-quality FE.