cyrilzakka/clinical-trials huggingface dataset:
Phase I, Dose-Escalation Study of Soluble Beta-Glucan (SBG) in Patients With Advanced Solid Tumors

Soluble Beta-Glucan (SBG) is a compound prepared from commercial active dry Baker's yeast which is then proceeded through a multi-step laboratory processes invented by Prof. Rapepun Wititsuwannakul, Faculty of Science, Prince of Songkla University, Thailand. Based upon pre-clinical data, SBG has been shown to inhibit angiogenesis and probably enhance immune function, leading to shrinkage of tumor size in athymic nude mice injected by hepatocellular carcinoma cells (HepG2) and cervical cancer cells. Therefore, the investigators expect to see the safety and anti-cancer property of SBG in patients with advanced cancer whom no available therapy can be offered.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histologically or cytologically documented, advanced-stage, primary or metastatic solid tumors that are refractory to standard therapy or for which no available standard therapy exists.
* Evidence of measurable or evaluable disease.
* Age must be at least 18 years.
* ECOG performance status must be 0 or 2.
* Received only best supportive care.
* Patient must meet protocol-specified laboratory values.

Exclusion Criteria:

* Second primary cancer diagnosed within 5 years, except cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma which completed curative treatment.
* Concurrent therapy with any other investigational agent.
* Severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study-drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, make the subject inappropriate for this study.
* Allergy to study drug.
Cooperative Adenomyosis Network

To set up a Cooperative Network by enrolling 5000 patients with Adenomyosis(AM) from multiple centers.Based on the Network platform and Database,the investigators try to explore the diagnostic strategies for AM and carry out epidemiological survey on the semeiology of AM.In addiction，the investigators expect to conduct research on the effect and the follow-up fertility outcomes of different medical or surgical treatment, the etiology of AM and endometriosis,the perspective investigation of the malignant transformation of AM ;the high-risk factors of AM,and finally propel the formation of Expert Consensus and Clinical Guidelines about AM which suitable to chinese conditions.

5000 women diagnosed of Adenomyosis(AM) with pathology, transvaginal ultrasonography or magnetic resonance image（MRI）will be enrolled from nationwide multicenters. The investigators would build up Network platform, and database with the registered data within 6 months. 30-month follow-up with an interval of at least once every 6 months will be done for every patient ，and update the database timely.

Based on the Network platform and Database,we try to explore the diagnostic strategies for AM and carry out epidemiological survey on the semeiology of AM.In addiction，the investigators expect to conduct research on the effect and the follow-up fertility outcomes of different medical or surgical treatment,the etiology of AM and endometriosis,the perspective investigation of the malignant transformation of AM ;the high-risk factors of AM,and finally propel the formation of Expert Consensus and Clinical Guidelines about AM which suitable to chinese conditions.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed of adenomyosis by pathology, transvaginal ultrasound or MRI.

Exclusion Criteria:

* Refusal to join the study
Prospective Cohort Follow-up of French Patients With Profound and Multiple Disabilities: Healthcare Pathways and Quality of Life Among Patients and Their Families

The studies conducted so far concerning the medical and paramedical cares provided to patients with profound and multiple disabilities (PMD) often show important limitations: samples are too small or very heterogeneous, generally constituted of children only; studies are mainly cross-sectional and retrospective, focusing on very specific issues instead of assessing health and quality of life from a more global perspective... So far, the investigators found no published data from a prospective cohort study involving a representative sample of patients with PMD. The present project aims to set up such a cohort so as to describe for the first time the natural history of French patients with PMD as well as the cares they receive at home or within the different dedicated structures in France. This cohort will also make it possible to identify the factors responsible for differences in the cares patients are provided, the consequences of these differences on their health and their quality of life (and those of their relatives) as well as the evolutions of these data over time. It will then allow for assessing the effectiveness of the French healthcare system to care for patients with PMD as well as building a frame of reference regarding the best cares to provide to these patients.

The primary goal of this study is to identify the determinants of health among patients with PMD.


Eligibility Criteria:
Inclusion Criteria:

* age \> 3 years old,
* patient with health insurance,
* causal brain injury before the age of 3,
* Intellectual Quotient \< 40 or not assessable,
* motor disability: paraparesis, tetraparesis, hemiparesis, ataxia, neuromuscular disorders, or extrapyramidal motor disorders,
* score at the Gross Motor Function Classification System \> 3,
* score at the Functional Independence Measure \< 55.

Exclusion Criteria:

Subject declaring benefit "psychotropic treatment which" significantly alter the reasoning, discernment or judgment.
Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma

Gamma GBM is a single-arm phase II trial that prospectively measures the progression-free survival time after addition of an early gamma knife boost to areas of residual tumor to standard-of-care (surgery, chemo-radiotherapy, chemotherapy).

Glioblastomas are highly malignant brain tumors that recur about 6 months after treatment. Most recurrences develop at the edge of the surgical margin and a common reason for an early recurrence of a glioblastoma is when tumors are not completely resected. This may be the case when intraoperative neuro-monitoring indicates that further resection would impair certain motor functions. Physicians can identify residual tumor in early (24-72h after surgery) postoperative MRI scans and could treat these regions. However, this treatment would not be a part of the recommended standard of care and thus, any further treatment of this areas will need a clinical trial.

The aim of this trial is to evaluate if the use of another modality to deplete these areas of residual tumor identified in early postoperative MRI scans will provide a relevant benefit in terms of progression-free survival (which means a prolongation of the time that patients do not experience a re-growth of the tumor). The modality is termed "radiosurgery", which is a non-invasive technique to delete cells without using a blade but a highly focused beam of gamma rays.

The machine that focusses these rays (like a magnifying glass that can focus light), is called 'gamma knife'. Gamma knife radiosurgery is a safe and effective treatment for a plethora of malignant and benign brain tumors and the technique is used since the 1950s and there has been a continuous improvement of precision and patient comfort up to now.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Karnofsky performance status score ≥ 60
* histology must be glioblastoma (frozen sections during surgery)
* radiographic proof of residual tumor
* Informed consent
* adequate birth control (e.g., oral contraceptives)

Exclusion Criteria:

* any previous cranial radiotherapy
* histology inconclusive or low(er)-grade astrocytoma
* contraindications for chemo- or radiotherapy
* bleeding or clotting disorders
* contraindications for MRI or CT scans
Can Feedback From a Large Language Model Improve Health Care Quality?

The goal of this study is to learn if computer-assisted advice can help improve patient care in Nigerian health clinics. The main question it aims to answer is: does giving healthcare workers instant computer feedback help them make better decisions about patient care?

Researchers will compare patient care notes written by healthcare workers before and after they receive computer feedback to see if the feedback improves care quality. A doctor who doesn't know if feedback was given will review these notes.

Participants will:

* Be seen by a community healthcare worker who uses the computer feedback system
* Be treated by a fully trained medical doctor
* Get tested for malaria, anemia, or urinary tract infections if they have certain symptoms

This project tests whether Large Language Models (LLMs) can improve patient care in Nigerian primary care clinics by giving customized and instant feedback to the provider in natural language. An LLM-based tool integrated into an electronic patient record management system provides "second opinions" to community health extension workers (CHEWs) at two clinics in Nigeria. These second opinions are intended to mirror what a reviewing physician might advise the CHEWs after seeing or hearing their initial report on a patient.

For the main analysis, this study employs a within-patient comparison of two patient notes created by the CHEW; one during the initial patient consultation, and one after the LLM feedback was received. The patient is also seen by a fully trained medical officer who is in charge of patient care. The MO conducts a blinded review of the CHEW's patient notes to measures changes in the CHEW's care as a result of the LLM feedback. The data comes from the information captured in the electronic medical record (EMR) of the patient and from survey data collected from CHEWs, reviewing MOs, and a panel of reviewing Medical Doctors.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at the clinic for outpatient consultation
* Parent/guardian consent is required for individuals under 18

Exclusion Criteria:

* Patient does not require emergency care
* Patient is not at the clinic for a checkup (e.g. weight, blood pressure, follow up after recovery)
* Patient is not a trauma patient (visit is not for an accident, wound or injury)
* Patient is not at the clinic for a scheduled procedure or a birth
Effect of MgSO4 Pretreatment on Muscle Relaxation

In this study, the effect of magnesium sulphate on the onset and duration of intense and moderate cis-atracurium induced neuromuscular blocking and on the period of no response to nerve stimulation will be evaluated in patients who will recieve magnesium sulphate (intervention group) and patients who will not recieve magnesium sulphate (comparator group).

General anesthesia is a drug-induced reversible state consisting of unconsciousness, amnesia, anti-nociception, and immobility, with maintenance of physiological stability. Balanced general anesthesia, the most common management strategy used in anesthesia care, entails administering a combination of different agents to create the anesthetic state. There is evidence that balanced general anesthesia uses less of each drug than if the drug were administered alone. This approach is believed to increase the likelihood of a drug's desired effects and reduce the likelihood of its side effects. With addition of adjuvants, Alpha-2 adrenoceptor agonists, such as dexmedetomidine, are known to possess amnesic, analgesic, sympatholytic, and antinociceptive properties, and therefore, can reduce the requirement of anesthetics and opioids intraoperatively. Administration of MgSO4 has also shown significant reduction in the perioperative requirement of propofol, opioids, and muscle relaxants. Magnesium sulphate has gained prominence as an adjuvant drug in multimodal anesthesia and pain medicine. It has several clinical indications including attenuation of the adrenergic response to tracheal intubation and improved peri-operative analgesia. Magnesium sulphate also enhances the action of non-depolarizing neuromuscular blocking drugs, resulting in potentiation of neuromuscular blockade (NMB).The site of magnesium potentiation of neuromuscular blocking drugs is the motor end plate, where magnesium reduces the release of prejunctional acetylcholine, thereby decreasing the muscle membrane excitability. However, limited data exist concerning the effect of magnesium sulphate on the duration of deep or intense NMB and on the period of no response to nerve stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Age group 18-60 years old
* Both genders
* Patients who will be scheduled to undergo elective otorhinolaryngological surgery.
* Patients with BMI between 18.5 and 24.9 Kg/m2.
* Patients with American Society of Anesthesiologist physical status classification of 1 or 2

Exclusion Criteria:

* Patients who are less than 18 years old or more than 60 years old.
* Patients on medications that interfered with muscle activity.
* Allergy to medications used in this study.
* Pregnancy or suspected pregnancy.
* Neuro-muscular diseases.
* Renal or hepatic impairment.
* Hypermagnesemia (\>2.5 mmol) or hypomagnesemia (\<1.7 mmol).
* Patients refusing to study
Equine Human Interaction With Veterans

This study has two components. The first component (Aim 1) is a randomized trial of a novel equine therapy intervention that was developed for research purposes. The second component (Aim 2) is an evaluation of outcomes from Veterans participating in an adaptive horsemanship program that is not conducted for research purposes.


Eligibility Criteria:
Inclusion Criteria:

For Aim 1:

* Currently enrolled for services at the VA Salt Lake City Health Care System
* At least one mental health service encounter within the preceding 12 months
* Diagnosed with PTSD by a clinician within the preceding 24 months
* Have a doctor release to participate in equine activities

For Aim 2:

* Currently enrolled for services at the VA Salt Lake City Health Care System
* Have a doctor release to participate in equine activities

Exclusion Criteria:

* Pregnancy
* Diagnoses of a psychotic spectrum illness and/or cognitive impairment
* Physical disability that would prevent horseback riding
* Weight \>= 250 lbs.
* Potentially the severity of and psychological and/or behavioral symptoms will be considered
A Study of BG-C477 in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.

This new study will check how safe and helpful a potential anticancer drug called BG-C477 is. This drug will be tested by itself or combined with other anticancer agents. The purpose of this study is to test if BG-C477 is safe and if it works in people with your disease when it is given on its own and in combination with other anticancer agents.

Eligibility Criteria:
Inclusion Criteria:

* Participants must sign the informed consent form (ICF) and be capable of giving written informed consent
* Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy
* Phase 1a (Dose Escalation); Histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, who were previously treated with at least 2 lines of standard systemic therapy or for whom no standard treatment is available in the medical judgment of the investigator
* ≥ 1 measurable lesion as assessed by RECIST v1.1
* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
* Adequate organ function
* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 8 months after the last dose of BG-C477 and for ≥ 6 months after the last dose of chemotherapy, whichever comes later
* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 5 months after the last dose of BG-C477, and for ≥ 3 months after chemotherapy, whichever comes later.

Exclusion Criteria:

* Prior treatment with any carcinoembryonic antigen (CEA)-targeted ADCs or ADCs containing topoisomerase 1 (TOP1) inhibitor as payload
* History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics
* Active leptomeningeal disease or uncontrolled, untreated brain metastasis
* Any malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
The Risk of Falls Index for Patients With Neuromuscular Disorders

The combination of short quantitatively assessing muscular function and balance in combination with short clinical scores, can be a new valid approach to evaluate the patient risk of fall and help to create a quick checkup test to prescribe an appropriate assistive device.

The primary goal of this project is to provide a short battery of clinical assessments used to determine risk of falling for patients with neuromuscular diseases (NMD) based on correlation between clinical assessments between two groups of NMD patients and scales used to assess risk of falling for patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18- and 65-year-old
* Patients with adequate cognitive and communication function to fill out the scales assessing risk of falling
* The neuromuscular disease needs to be confirmed by genetic report and/or disease deepening neurophysiological examination.

Exclusion Criteria:

- Patients which are not able to perform motoric functional assessments without assistive gait device.
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668

This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-21668 in solid tumor patients. In dose escalation phase, biomarker status is not required, but in dose expansion phase patients are required to harbor PIK3CA mutation.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤70 years, male and female patients;
2. Life expectancy ≥ 12 weeks;
3. ECOG performance score 0-1;
4. Locally advanced or relapsed/metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy or for whom no standard therapy exists, PIK3CA mutation status is required for dose expansion phase;
5. Evaluable lesion required for dose escalation phase and measurable lesion as per RECIST 1.1 required for dose expansion phase;
6. Adequate organ function;
7. Signed informed consent.

Exclusion Criteria:

1. Prior use of PI3K、mTOR or AKT inhibitor;
2. Prior other malignant tumor;
3. Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases ;
4. Type I or type II diabetes;
5. Inadequate wash-out of prior anti-cancer therapies;
6. Cardiac disorders;
7. Instable systemic diseases;
8. Acute or chronic pancreatitis;
9. Pregnancy or lactation;
10. Other protocol specified criteria.
Effect of Aerobic Training on Oxidative Stress Markers in Patients With Parkinson's Disease

Parkinson's disease is a chronic, neurodegenerative disorder characterized with the loss of dopamine-producing neurons. This loss is likely to be related with several environmental and genetic factors. One of the most important factor that is responsible for the initation and progression of the disease is oxidative stress. Exercise training, especially aerobic training, can change the levels of oxidative markers because exercise can lead to decrease oxidative stress in patients with Parkinson's disease. Therefore, this study aims to investigate (1) the effect of aerobic training on total antioxidant status, total oxidant status, glutathione, oxidative glutathione, and zonulin levels, (2) the relationship between the change of motor symptoms and disease severity and the change of total antioxidant status, total oxidant status, glutathione, oxidative glutathione, and zonulin levels.


Eligibility Criteria:
Inclusion Criteria:

* at least 40years of age
* diagnosed with Parkinson's Disease
* Hoehn and Yahr stage of 1 and 3

Exclusion Criteria:

* any other neurologic disorders,
* any cardiovascular, orthopedic, vestibular or rheumatic conditions that impact exercise training
* visual, auditory, and perception problems.
Preliminary Tissue Monitoring During Endovascular Intervention Study

Tissue perfusion assessment is key to more accurate measurement of foot ischemia, which is in turn an important factor in appropriate treatment decisions. In practice though, tissue perfusion measurements are not routinely undertaken as few practical solutions exist that are easy to use and fit in everyday clinical practice. Pedra has developed a novel easy to use, non-invasive device that can be used in practice to better inform treatment decisions.

Tissue perfusion assessment is key to more accurate measurement of foot ischemia, which is in turn an important factor in appropriate treatment decisions. In practice though, tissue perfusion measurements are not routinely undertaken as few practical solutions exist that are easy to use and fit in everyday clinical practice. Pedra has developed a novel, easy to use, non-invasive device that can be used in practice to better inform treatment decisions.

This is a feasibility study to demonstrate the ability of the Xauron system to track tissue perfusion changes in patients undergoing endovascular intervention for the treatment of peripheral artery disease (PAD). The findings of this study are for research purposes and will also be used to help with the future education of physicians about the potential use of the Xauron system. In addition, this early pilot data will be used to help power larger, more definitive studies relating to the intra-procedural use of the Xauron system.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is undergoing endovascular intervention for the management of their PAD.
2. The subject is between 40 to 90 years of age.
3. Documented lower limb arterial occlusive or stenotic disease (using ankle-brachial index / pulse volume recording, duplex ultrasound or CT angiogram) within the last 8 weeks.
4. In the opinion of the Investigator, the subject is willing and able to comply with the protocol and complete all protocol assessments.
5. The subject has been informed of the nature of the study, agrees to its provisions and has willingly provided written informed consent, approved by the appropriate Institutional Review Board (IRB)

Exclusion Criteria:

1. Subjects on an investigational drug or being treated with an investigational therapeutic device, within 30 days of the study visit, that in the view of the Investigator might interfere with the study outcomes.
2. Presence of a condition that the Investigator considers will compromise the subject's ability to participate in the study.
3. Subjects on renal replacement therapy
4. Signs of active infection causing localized inflammation on the plantar or dorsal surfaces of the foot.
5. Lack of intact skin, or pathological skin conditions, at the proposed sensor pad positions that may impair or prevent the adherence of medical adhesives in general.
6. Diabetic subjects with a Charcot neuropathic osteoarthropathy