cyrilzakka/clinical-trials huggingface dataset:
A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors

This trial is an open and multicenter phase I/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

This is an open, multicenter Phase I/II clinical trial of LBL-033 in the treatment of patients with advanced malignant tumors，which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

The trial is divided into 2 parts: Phase 1 and Phase 2

Phase I study:

Dose-escalation and PK expansion.The PK expansion study will be judged on the basis of dose escalation data.

Phase II study:

Dose expansion included 4 cohorts that required patients with MUC16-positive malignancies.Blood samples will be collected from all subjects in this trial.

Phase I and Phase II studies are expected to recruit 113-468 patients

Eligibility Criteria:
Inclusion Criteria:

1. Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;
2. Age ≥ 18 years old when signing the informed consent form;
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1;
4. The expected survival time is at least 12 weeks;
5. According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable Target lesion;
6. Subject has adequate organ and bone marrow function，Conforming to laboratory test results:
7. Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets，etc）; Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.

Exclusion Criteria:

1. Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
2. Patients with active infection and currently requiring intravenous anti-infective treatment；
3. Those who have clinically uncontrollable pleural effusion, pericardial effusion , requiring repeated drainage or medical intervention;
4. The patient has a Medical history of immunodeficiency, including HIV antibody positive；
5. Women during pregnancy or lactation;
6. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules

Osteoporosis is a common senile disease with a high incidence. The Chinese medicine differentiation treatment has small side effects and can be taken for a long time, which has certain advantages. This project adopts the experience of the person in charge of the project-Xulin Jiangu Granules and clinically collects patients with postmenopausal osteoporosis (kidney deficiency and blood stasis syndrome).

Randomized control method was used to observe the clinical efficacy of the treatment of postmenopausal osteoporosis (kidney deficiency and blood stasis syndrome) with jiujian jiangu granules, combined with the gene expression of bone metabolism markers BALP, PINP, TRACP and S-CTX, and RANK, RANKL and OPG Detection, compared with the control group of ossification trihydrate capsules, to explore the mechanism of the treatment of postmenopausal osteoporosis by the continued Xulin Jiangu granules, and lay the foundation for the development of new drugs.

Eligibility Criteria:
Inclusion Criteria:

* at least 2 years prior and met the diagnostic criteria for osteoporosis according to the "clinical practice guidelines of traditional medicine for primary osteoporosis
* met the CM diagnostic criteria according to "Syndrome Differentiation in Modern Research of Traditional Chinese Medicine

Exclusion Criteria:

* patients who did not meet the diagnostic criteria for osteoporosis or CM standards
* patients with rheumatoid arthritis, diabetes, secondary osteoporosis due to hyperthyroidism, and severe cardiovascular or cerebrovascular diseases
* patients with abnormal liver and/or Shen function test results
* patients with osteoporosis who had received treatment with CM within the last month, hormone replacement therapy and calcitonin within the past three months, or bisphosphonates for 15 consecutive days within the past 6 months.
The Paired Donation Consortium Paired Donation Program

The purpose of the protocol is to increase the number of living donor transplants by eliminating immune incompatibilities between donors and recipients through paired donation.

The purpose of the protocol is to increase the number of living donor transplants by eliminating immune incompatibilities between donors and recipients through paired donation.

To increase the number of patients transplanted by paired donation by establishment of regional paired donation programs.

To develop educational programs for potential living donors and their recipient, as well as the opportunity for transplant professionals to increase acceptance of the PDC to maximize the opportunity for organ donation.

To identify and evaluate ethical and psychological factors that may influence the effects of paired donation on living kidney donation.

Eligibility Criteria:
Inclusion Criteria:

* Persons capable of providing written informed consent.
* Each recipient must have one or more medically suitable donors who are either ABO-incompatible or HLA-incompatible.

Exclusion Criteria:

* Persons with eligible, compatible donor.
Prediction of Hypotension During Induction of General Anesthesia

Post induction hypotension is closely related to postoperative complications. Patients are at high risk of hypotension due to preexisting hypovolemia and the vasodilatory effects of induction agents. Ultrasonographic measurement of the Carotid artery corrected flow time and internal jugular vein collapsibility index may predict post induction hypotension.

* Type of Study: Observational Prospective Cohort Design.
* Study Setting and ethical consideration: The approval of the Scientific Research Ethics Committee of the Faculty of Medicine, Ain Shams University will be obtained before starting work on the study. This study will be conducted in operating theatres of Ain Shams University Hospitals. Informed written consents to participate will be obtained from the patients.
* Study Period: One year (October 2023-October 2024)
* Study Population: Adult patient undergoing elective surgeries.

Eligibility Criteria:
Inclusion Criteria:

* 1- Patients of American Society of Anesthesiologists (ASA) physical status I to II of both genders.

  2- Aged 18-65 years. 3- Elective surgeries under general anesthesia. 4- BMI less than 40.

Exclusion Criteria:

* Patients with

  1. Renal diseases.
  2. Hepatic diseases.
  3. ASA scores of 3-4.
  4. The presence of a left ventricular ejection fraction less than 50%.
  5. Age under 18 years old.
  6. Patient refusal.
  7. Coronary heart disease.
  8. Cardiac disease including cardiomyopathy and mild to severe valve disease.
  9. Pulmonary hypertension.
  10. Peripheral arterial disease.
  11. Preoperative cervical vascular ultrasound abnormalities including plaque, stenosis and anatomical variation.
  12. Any previous neck surgery or trauma.
Gamification in the University Classroom.

This article aims to demonstrate the results of a study on the implementation of Kahoot as a gamification tool in university education. The objectives of this article are: to promote teaching by integrating the use of Kahoot to motivate students and increase their degree of interest and know the students' abilities. opinions on the implementation of this Gamification tool to teach grammar. The study uses a quasi-experimental research design over a four-month period observing variables such as attention, concentration and creativity, as well as social and personal skills.


Eligibility Criteria:
Inclusion Criteria:

* University participants who were enrolled in the second year of the Physiotherapy Degree at the University of Jaén will be included.
* Study Period: Those participants who were available and participated in the study from September to December 2022 were considered.

Exclusion Criteria:

* University students who did not provide informed consent according to the study's ethical guidelines.
* Enrolled in at least one subject from another academic year.
Lung Cancer Mutation Consortium Protocol

The primary objective of this protocol is to determine the frequency of oncogenic mutations in 1000 patients with advanced adenocarcinoma of the lung. The linked clinical and mutational analyses will be used to determine the frequency of each mutation, its association with clinical features and outcome, and its association with other mutations. As future therapeutic protocols specific for these mutations are developed, patients may be notified of their eligibility for these studies. Future translational studies may be used to: a) unravel the complex biology of lung cancer; b) identify prognostic markers; c) define predictive markers of response/resistance to new therapies; d) identify new targets. A secondary goal is to establish a consortium of sites that have the capability of conducting multiple mutation testing in a Clinical Laboratory Improvement Amendments (CLIA) certified lab.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects (=\> 18 years of age) who are undergoing further evaluation for the diagnosis or treatment of advanced adenocarcinoma of the lung.
2. Diagnosed May 2012 or later
3. Oral and written informed consent.

Exclusion Criteria:

1. Lung cancer histologies other than adenocarcinoma
2. Lack of adequate tissue.
Progesterone and Second Trimester Bleeding

Working hypothesis and aims:

To investigate whether progesterone treatment affects the incidence of preterm labor compared to placebo, among women with 2nd trimester bleeding.

The participants will be allocated through randomization to a study or control group. Women in the study group will receive micronized progesterone 200 mg (Utrogestan, company) with an intra-vaginal tablet once daily while the control group will receive placebo. Both women and medical staff will be blinded to group allocation. Treatment will commence on the day of inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation. Data will be collected after the conclusion of pregnancy regarding the maternal and neonatal outcome.


Eligibility Criteria:
Inclusion Criteria:

* Viable pregnancy
* Gestational age between 13 to 26 weeks
* Vaginal bleeding from uterine origin
* Singleton pregnancy
* Normal clotting tests
* Hemodynamically stable woman

Exclusion Criteria:

* Water leak
* Signs of preterm labor
* Fetal malformations incompatible with life
* Uterine malformations and other maternal conditions, i.e. liver disease, breast cancer, active thromboembolic state
* Past preterm birth
Electronic Post-Treatment Surveillance Program for Prostate Cancer Survivors (eHealth)

The purpose of this single institution pilot study is to determine the feasibility of implementing an eHealth prostate cancer surveillance program through the eVisit electronic medical record patient portal. The investigators will assess patient compliance and satisfaction with eVisit follow up care in lieu of in person clinic visits.

Telehealth offers the opportunity to transform cancer surveillance into a patient-centered effort with shared leadership between patient and oncologist. Peer-to-peer electronic communications can improve the collaboration between oncologist and primary care provider (PCP) as patients transition back to primary care as their primary health provider. The investigators propose to test a patient-centered eHealth surveillance program utilizing novel asynchronous telehealth tools to provide patient-reported outcome symptom monitoring using the electronic medical record's patient portal (eVisit).

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old with histologically confirmed prostate cancer
* Completed curative intent treatment to the prostate +/- pelvis
* Deemed to be "without evidence of active disease" by treating provider with at least 1 follow up visit 3 or more months after treatment completion
* MyChart account or willingness to open account
* Access to the internet

Exclusion Criteria:

* Documented extrapelvic metastases
* PSA meeting definition of recurrence (\>0.2 ng/ml for prostatectomy patients or nadir + 2 ng/ml for radiation patients) and rising with doubling time less than 1 year
Prediction of Blood Pressure Outcomes Following Renal Denervation (PREDICT-RDN)

Prospective, single arm trial to assess the effects of renal denervation on day-by-day blood pressure measurements and time in blood pressure target range, as well as establish a multivariate prediction model for blood pressure reduction after renal denervation.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed arterial hypertension with systolic or diastolic blood pressure \>140/90 mmHg in standardized office blood pressure measurement
2. Treatment with 3 to ≤5 antihypertensive drug classes
3. Age \>18 years
4. Written informed consent

Exclusion Criteria:

1. Age ≤ 18 years
2. anatomy unsuitable for renal denervation (i.e. renal artery stenosis, single functioning kidney)
3. pregnancy
4. patients under legal supervision or guardianship
5. participation in other trials that might interfere with the study outcome according to the opinion of one of the investigators.
Study of Lumateperone in the Treatment of Patients With Bipolar Mania

This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

The study will be conducted in 3 phases:

* Screening Period (up to 1 week) during which patient eligibility will be assessed.
* Double-blind Treatment Period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio.
* Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up visit

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide written informed consent before the initiation of any study specific procedures;
2. Male or female inpatient, between the ages of 18 and 75 years, inclusive;
3. Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria for bipolar I disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT);
4. YMRS total score ≥ 20 and a score of at least 4 on two of the following YMRS items: irritability, speech, content, and disruptive/aggressive behavior at Screening and Baseline;
5. Hospitalized voluntarily before Screening or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not \> 14 days before Screening. Hospital admission must be a result of the current manic episode.

Exclusion Criteria:

1. Has a current primary DSM 5 psychiatric diagnosis other than bipolar disorder. These include:

   1. Schizophrenia, schizoaffective disorder, or other psychotic disorders;
   2. Dementia or other cognitive disorders;
   3. Intellectual disability;
   4. Moderate or severe substance use disorder (excluding for nicotine);
2. Experiencing first manic episode;
3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or

   1. At Screening, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening; or
   2. At Screening, the patient has had 1 or more suicidal attempts within 2 years prior to Screening; or
   3. At Baseline, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or
   4. At Screening or Baseline, scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or
   5. Considered to be an imminent danger to himself/herself or others.
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA

This is an expanded access program in the USA to enable eligible patients with previously treated small cell lung cancer to access lurbinectedin treatment prior to FDA approval. Sites must apply to participate in the program. A medical doctor must assess whether the potential benefit outweighs the risk of the investigational therapy considering the program eligibility criteria and the individual patient's medical history.


Eligibility Criteria:
Inclusion Criteria:

* Legally competent adult
* Confirmed and unresectable Small Cell Lung Cancer (SCLC)
* Patients must have received one prior chemotherapy containing line
* Adequate organ, hematological, kidney, metabolic and liver function
* Recovery from toxicities related to previous treatment(s)
* Pregnancy must be excluded, medically acceptable contraception method

Exclusion Criteria:

* Prior treatment with lurbinectedin
* Certain concomitant diseases/conditions
* Symptomatic, steroid-requiring or progressive CNS involvement.
* Pregnant or breast-feeding women.
Blinatumomab for Treatment of Refractory Myasthenia Gravis

The goal of this clinical trial is to evaluate the efficacy and safety of Blinatumomab in the treatment of refractory myasthenia gravis, with the expectation of offering a new therapeutic option for refractory patients. The main questions it aims to answer are:

* Does Blinatumomab improve patients' clinical symptoms?
* Is Blinatumomab safe for the treatment of myasthenia gravis?

Participants will:

* Receive two cycles of intravenous Blinatumomab infusion, each lasting 5 days, with a 1-week interval between cycles.
* Visit the clinic once every 4 weeks for checkups and tests.
* Keep a diary of their symptoms and the types and dosages of medications.


Eligibility Criteria:
Inclusion Criteria:

* Age at onset \> 18 years old
* The diagnosis of MG was based on the presence of typical myasthenic symptoms and supported by positive autoantibodies, electrophysiological studies, and/or the neostigmine test.
* Positive or negative for anti-AChR, and/or anti-MuSK, and/or anti-LRP4 antibodies.
* Refractory myasthenia gravis (MG) patients are defined as those who meet any of the following criteria: For patients with ocular MG, the condition is defined as having no significant improvement in disease symptoms (QMG score improvement \<25%) after adequate dosing and duration of existing immunosuppressive drugs and targeted biologics, with no change or worsening in the post-intervention status (PIS), or if the PIS improves but disease symptoms worsen or relapse during the regular tapering of immunosuppressive treatment, severely affecting daily quality of life. For generalized MG, the patient must meet the following conditions: no improvement or worsening in PIS after adequate dosing and duration of existing immunosuppressive drugs and targeted biologics; improvement in PIS, but with an MG-ADL score ≥6 persisting for at least six months; remission or improvement in PIS, but with ≥2 episodes of disease exacerbation (MG-ADL ≥6) per year during tapering of immunotherapy medications; patients who, after experiencing a myasthenic crisis, undergo multiple immunotherapies including intravenous efgartigimod, eculizumab, immunoglobulin, plasma exchange, and high-dose intravenous methylprednisolone, and active infection control, but still cannot be weaned off the ventilator due to respiratory muscle weakness from MG for more than 14 days. (Note: This includes patients who cannot tolerate existing treatment drugs due to contraindications, comorbidities, or adverse drug reactions.)
* Receiving stable doses of medication prior to enrollment
* Written informed consent

Exclusion Criteria:

* Patients who have thymoma or have undergone thymectomy within six months
* Patients who have used other biologics prior to enrollment that may affect the efficacy assessment of blinatumomab.
* Severe cardiovascular, hepatic, renal, respiratory, or endocrine diseases, malignancies, or uncontrolled acute or chronic infections
* Pregnancy or lactation, unwillingness to avoid pregnancy
* Patients with other diseases that may affect the assessment of muscle strength
* Other conditions that would preclude participation
Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System

An international multicentre, open, comparative, parallel group, prospective clinical investigation with a single 5 year follow up visit.

Two implant products, the standard implant and abutment and the novel implant and abutment, both developed by Cochlear Bone Anchored Solutions AB were tested in the CAG5173 clinical investigation that was completed in December 2012. The primary objective was to show superiority of the novel implant compared to standard implant in terms of implant stability quotient (ISQ) as as measured by resonance frequency analysis1. Results after 6 and 36 months after implantation showed that the new design, the novel implant and abutment, provided statistically significantly higher stability at the time of insertion and over time compared to the standard Baha implant2,3,4. In the investigation, sound processor fitting was performed from 6 weeks post-implantation. No reduction in implant stability following sound processor fitting was recorded, suggesting that it is safe to load the implant 6 weeks after implantation. The investigation also showed improved soft tissue outcomes, in terms of lower Holgers index5 scores for the novel implant and abutment compared to the standard implant and abutment.

After initiation of the 3-year CAG5173 investigation, Cochlear Bone Anchored Solutions AB launched the Cochlear Baha BIA300 Implant and Abutment, which in all critical aspects are identical to the novel implant used in the investigation.

The 36-month visit was the last visit of the investigation. Hence, no further visits were planned or scheduled for the subjects participating in that investigation.participating subjects. It is of clinical and scientific interest to evaluate the clinical performance and safety data of the implants in these subjects after an additional two-year period, in order to gain additional understanding of how implant stability and soft tissue status evolves over time with the two implant and abutment designs, and in order to evaluate long-term implant survival. No randomised controlled investigation of Baha implants with a 5-year follow-up has been conducted to date.

The rationale behind this clinical investigation is to collect long term stability, survival and tolerability data of a novel Baha implant system 5 years after implantation in a population that previously have been followed in a completed controlled investigation during a 3 year period. The collected data will enable comparison with the data gathered in the previous completed CAG5173 clinical investigation.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the CAG5173 investigation
* Signed informed consent

Exclusion Criteria:

* Unable to follow investigational procedure
* Any factor, at the discretion of the investigator, that is considered to contraindicate participation