cyrilzakka/clinical-trials huggingface dataset:
Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma

This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of follicular lymphoma, according to the Revised European American Lymphoma/World Health Organization \[REAL/WHO\] classification
* Documented CD40+ follicular lymphoma
* Measurable lesion
* Refractory to rituximab
* Prior treatment with at least 1 chemotherapeutic regimen
* 18 years or older
* WHO Performance Status grade 0, 1, or 2
* Life expectancy \> 3 months
* Obtained written informed consent

Exclusion Criteria:

* Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma (i.e. DLBCL)
* History of another primary malignancy that is currently clinically significant or currently requires active intervention
* Prior allogeneic stem cell transplantation
* Prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration
* Impaired cardiac function or clinically significant cardiac disease
* History of acute or chronic pancreatitis, surgery of the pancreas, or any risk factors that may increase the risk of pancreatitis
* History of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 28 days before study treatment.
* Known diagnosis of human immunodeficiency virus (HIV) infection
* Evidence of previous hepatitis viral infection such as hepatitis B or hepatitis C
* Ongoing corticosteroid use (\>10 mg/day prednisone or equivalent)
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply
Study of HLX10, Trastuzumab and Chemotherapy in First-line Treatment of HER2-positive Recurrent/Metastatic Gastric Cancer

Investigators assessed the effectiveness of HLX10, Trastuzumab and Chemotherapy in First-line Treatment of HER2-positive Recurrent/Metastatic Gastric Cancer


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically proven metastatic or locally advanced HER2-positive gastric cancer
2. Documented disease progression after receiving prior line of trastuzumab-containing chemotherapy for gastric cancer
3. Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
4. Eligible male and female subjects aged ≥18 years.
5. Has measurable disease as determined by RECIST 1.1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
7. Has baseline left ventricular ejection fraction (LVEF) ≥ 55%.
8. Adequate organ function as demonstrated by laboratory test results within 14 days prior to first dose of study treatment.
9. Have urinary protein that is \<2 on dipstick or routine urinalysis.
10. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to first dose of study treatment.
11. Female subjects of childbearing potential and male subjects should be willing to use methods of birth control for the course of the study and up to 120 days after the last dose of study treatment.

Exclusion Criteria:

1. Received prior anticancer treatment with targeted agents, chemotherapy, or radiotherapy within 14 days, with monoclonal antibodies within 28 days, has previously received treatment with ramucirumab, or has participated in another clinical trial within 14 days prior to start of study treatment.
2. Has experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to treatment.
3. Has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 3 months prior to treatment.
4. Has history of severe thromboembolism, including deep vein thrombosis and pulmonary embolism within 6 months prior to treatment.
5. Has an active or ongoing infection, symptomatic congestive heart failure, （6）uncontrolled angina pectoris, symptomatic or poorly controlled arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator.

（7）Has ongoing or active psychiatric illness or social situation that would limit compliance with study requirements.

（8）Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

（9）Has evidence of active, non-infectious pneumonitis. （10）Have an elective or a planned major surgery during the course of the trial or has undergone major surgery within 4 weeks prior to enrollment.
Design, Implementation, and Evaluation of Virtual Reality in the Nursing Curriculum

The aim of the study is to determine the effectiveness of an immersive virtual reality learning programme for nursing students, based on virtual glasses, in acquiring the competence (knowledge, skills and attitudes) to care for patients with pressure ulcers, and to compare it with the traditional teaching method.

The design was an exploratory randomised controlled trial. The variables used to measure effectiveness were competence and its attributes: knowledge assessment by a multiple-choice test (Pressure Ulcer Knowledge Assessment Tool, Pukat 2.0 instrument), skill performance by direct observation of procedural skills (simulated cases with standardised patients) and satisfaction and usability assessment (Usefulness, Satisfaction and Ease of Use Questionnaire).

The study was a prospective, randomized, double-blind controlled trial conducted from March to May 2022 at a Nursing Faculty. The participants were second-year Nursing Bachelor Degree students from a University in the North of Spain. A convenience sample of students in the second year of the nursing program participated in the study. According to the sample size calculation for a two-tailed independent t-test, conducted using the G\*Power 3.1.9 program, with a type I error rate of 0.05, power of 0.80, and an effect size of 0.71, the estimated minimum required sample size was 33. The recommended sample size was 40 participants per group, accounting for a 10% allowance for withdrawals, missing data, and lost follow-up. After registering to enrol in the study, 127 students were screened by the researchers for eligibility. Of these, 99 volunteers met the inclusion criteria and were contacted to schedule the pre-test phase. Following the pre-test assessment, participants were randomly assigned to either the intervention group (50 students) or the control group (49 students) at a 1:1 allocation ratio using a computer-generated assignment. During the study, three participants in the intervention group and two in the control group were excluded due to missing follow-up (refusal to continue in the research), and one student in the control group was removed by statistical analysis. In total, 93 participants were included in the data analysis.

Data was collected from February to May, a period during which the students did not have exams. The demographic information form included fields for age, gender, specific learning related to pressure ulcer care at degree level, and previous experience with virtual reality devices and environments.

Eligibility Criteria:
Inclusion Criteria:

* Students enrolled in the 2rd year of nursing at the Faculty of Nursing of the University of Navarra and who voluntarily agree to participate in the study.

Exclusion Criteria:

* Students who had acquired the skill of caring pressure ulcers in advance.
The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications

This study will be conducted as a randomized, double-blind, placebo-controlled trial to compare routine antibiotic prescription vs. no routine antibiotic prescription in the management of uncomplicated cases of severe acute malnutrition treated in the community in terms of nutritional recovery. The investigators hypothesize that there will be no significant difference in terms of the risk of nutritional recovery among children uncomplicated cases of severe acute malnutrition treated in the community that receive routine antibiotic prescription and those who receive no routine antibiotic prescription.


Eligibility Criteria:
Inclusion Criteria:

* Age from 6 to 59 months
* MUAC \< 11.5 cm or WHZ \< -3
* Absence of bipedal edema
* Absence of current illness requiring inpatient care
* Eligible for new admission for outpatient nutritional therapy for SAM at 3 CRENAS in Madarounfa operated by FORSANI
* Absence of current clinical illness requiring prescription of specific antibiotic therapy and decision by the study physician to use a specific antimicrobial drug on admission
* Written consent of parent or caregiver
* Residence within Niger

Exclusion Criteria:

* Age \< 6 months or \> 59 months
* MUAC ≥ 11.5 cm and WHZ ≥ -3
* Presence of bipedal edema
* Presence of current illness requiring inpatient care
* Decision by the study physician to use a specific different antimicrobial drug on admission
* Presence of any congenital abnormality or underlying chronic disease that may affect growth or risk of infection
* Treatment with any antibiotic within 7 days
* Admission to any nutritional program for the treatment of SAM within 3 months
* Known contraindication / hypersensitivity to amoxicillin
Study on the Protective Effect of RIPC in Patients Undergoing Cardiac Surgery.

To observe the effect of RIPC on the function of vital organs after cardiac surgery, and to explore its possible mechanism.


Eligibility Criteria:
Inclusion Criteria:

* patients with aortic valve, mitral valve, tricuspid valve, ascending aortic disease and coronary atherosclerosis who were admitted to hospital for elective valve repair, replacement, artificial vascular replacement or coronary artery bypass grafting.
* age 18-80 years old.
* No restriction on gender.
* ASA grade II\~III.
* NYHAII\~III level.
* the patient or his family member has signed the informed consent form for the clinical trial

Exclusion Criteria:

* those who are disabled in the selected test.
* less than 5 years of education.
* The preoperative left ventricular ejection fraction ((LVEF)) was less than 40%.
* Myocardial infarction occurred in nearly one month.
* malignant tumor, hematological disease, severe liver and kidney dysfunction, recent severe infection, etc.
* History of nervous system, immune system and mental illness.
* recent operation history of heart, brain, lung, liver, kidney and other important organs
Evaluating QoL and Postoperative Complications Using TEThA Technique in the Treatment of Tributary Veins

Endovenous laser thermoablation is a well-established alternative for the treatment of tributary veins. We believe that it is possible to improve the techniques described in the literature, aiming not only to allocate the laser fiber within the venous lumen, but mainly to transfix the vessel walls - a technique called TEThA (Transfixing Endovenous Thermal Ablation).

Endovenous laser thermoablation is an alternative for the treatment of tributary veins that is not yet one of the main alternatives in our specialty's consensus. In order to treat tributary veins applying laser, several punctures and the complete placement of introducer catheters are recommended in order to position the endolaser fiber in the lumen of the varicose vein before performing thermoablation of the saphenous veins. However, we believe that it is possible to perform an adequate treatment with a smaller number of punctures, aiming not only to place the laser fiber inside the venous lumen, but mainly to transfix the vessel walls - a technique called TEThA (Transfixing Endovenous Thermal Ablation). Our aim is to carry out a prospective cohort study to assess the Aberdeen score in patients undergoing the TEThA technique for the treatment of tributary veins.

Eligibility Criteria:
Inclusion Criteria:

Patients with varicose veins \> 2mm associated with reflux of great or small saphenous veins with CEAP C2 to C6

Exclusion Criteria:

Patients under 18 years Acute or previous thrombophlebitis or deep vein thrombosis. Pregnant patient. Reject the Informed Consent Form.
Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia

The purpose of this study is to learn if giving 17-hydroxyprogesterone caproate (17 OHPC) to mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby outcomes.

The OBGYN house and attending staff on duty caring for the patient will determine appropriateness for study inclusion. The treating physician will then immediately contact the MFM fellow on call and Research Division personnel to facilitate the initiation of study procedures, including the consent process and baseline blood tests. Once enrolled with informed consent, the participant will receive 17 OHPC, 250mg IM to be given at admission and every 7 days thereafter. Blood sampling of approximately 1-2 teaspoons each will be collected at baseline immediately prior to administration of 17 OHPC, then 24 hours (+-2hrs). After the first 24 hours, blood samples will be collected every 72 hrs until delivery and again 24hrs (+- 2hrs) after delivery. Placentas will be collected at delivery and the investigators will also collect information of the mother and newborn while in the hospital and until discharge including de-identified routine ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* UMMC antepartum patients with preterm PE between 23 0/7ths and 34 0/7ths weeks gestation when initially evaluated
* Willing and able to understand study procedures and to provide informed consent

Exclusion Criteria:

* \>33 weeks gestational age or \<23 weeks gestation
* Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema).
* Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations, minimal to absent fetal heart rate variability).
* Parameters according to current practice guidelines that exclude a patient from expectant management include the following:
* Preterm premature rupture of membranes (PPROM) \> 34 weeks gestation;
* Platelet count \< 100,000/microliter (thrombocytopenia) with evidence of HELLP syndrome;
* Persistently abnormal hepatic enzyme concentrations (twice or more upper normal values);
* Severe fetal growth restriction (ultrasound-estimated fetal weight less than fifth percentile);
* Severe Oligohydramnios (AFI \< 5cm)
* Reversal of end diastolic flow(REDF) in umbilical artery Doppler testing;
* Recurrent (\> 2 readings \> 30 minutes apart) severe hypertension despite antihypertensive therapy;
* Eclampsia;
* Pulmonary edema;
* Abruption placentae;
* Nonreassuring fetal status during daily testing (biophysical profile \<4/10 and/or recurrent variable or late decelerations);
* IUFD
Study to Evaluate the Feasibility of Integrating the Point-of-care Testing for Sexually Transmitted Infections and HIV Into Community-based Clinics for MSM and TGW in Thailand

This will be a prospective study that will enroll up to 2000 MSM and TG from community-based clinics in Bangkok, Chonburi, Chiang Mai, and Songkhla.

Eligible participants will be followed up until the completion of a 12-month period. All participants will be followed up every 3 months. An additional follow up visit at month 1 will be made for participants who PrEP is initiated at entry visit (those who already received PrEP prior to the study will not need the additional visit).

Study Sites

The study will take place at the following community-based clinics:

1. SWING DIC, Bangkok, Thailand
2. RSAT DIC, Bangkok, Thailand
3. SWING DIC, Chonburi, Thailand
4. Sisters DIC, Chonburi, Thailand
5. Mplus DIC, Chiang Mai, Thailand
6. RSAT DIC, Songkhla, Thailand

Eligibility Criteria:
Inclusion Criteria:

1. Thai nationality
2. Age ≥ 18 years old
3. Men or transgender women who have sex with men
4. Have at least one of the following risks for HIV acquisition in the past 6 months:

   * Any unprotected receptive anal sex
   * More than 5 sexual partners, regardless of condom use and serostatus
   * History of syphilis, chlamydia or gonorrhea diagnosed or treated
   * Any stimulant drug use
5. Have signed the consent form

Exclusion Criteria:

* None
ASKB589 in Combination With CAPOX and Sintilimab in Patients With Advanced, and Unresectable G/GEJ Cancer.

This was an open-label, phase 1/2 study to evaluate safety, tolerability, pharmacokinetics, and antitumor activity of ASKB589 in combination with CAPOX and Sintilimab in first-line treatment of patients with locally advanced, recurrent, or metastatic gastric and esophagogastric junction adenocarcinoma.

A two-part, dose-escalation and expansion study of ASKB589 was initiated to determine the MTD, PK, PD, and efficacy in combination with chemotherapy and Sintilimab.

Eligibility Criteria:
Inclusion Criteria:

1. Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic adenocarcinoma of the gastric and gastroesophageal junction currently ineligible for surgery and radical radiotherapy.
2. Investigators determined that the present situation of the patient justifies chemotherapy plus immunotherapy as first-line treatment.
3. Tumor tissue samples are CLDN18.2 positive detected by central laboratory
4. ECOG performance status 0-1.
5. The results of the laboratory tests must meet all criteria
6. Life expectancy of at least 3 months.

Exclusion Criteria:

1. Known active central nervous system metastasis or suspected cancerous meningitis;
2. There are moderate to large amounts of abdominal and pleural fluid.
3. The presence of clinically uncontrollable third interspace fluid；
4. Patients with any other malignant tumors within the past 5 years.
5. Applicable to anti-HER-2 drug therapy；
6. Anti-CLDN18.2 antibody, anti-PD-1 antibody, or drug therapy at any time in the past；
7. Patients have received antitumor therapy during the first 4 weeks before study drug use;
8. Pregnant or lactating women; or women of childbearing age who have a positive blood pregnancy test during screening period; or women of childbearing age and their spouses who are unwilling to take effective contraceptive measures during the period of this clinical trial and within 6 months after the end of the clinical trial;
Efficacy and Safety of Irlanda-2 Association on the Treatment of Common Cold

The purpose of this study is to evaluate the clinical efficacy of the drug associations in the treatment of common cold

Double blind,randomized, multicenter; Maximal experiment duration: 7 days; 03 visits; Safety and efficacy evaluation

Eligibility Criteria:
Inclusion Criteria:

* Participant within 48 hours of the onset of common cold symptoms: headache, sneezing, sore throat, nasal obstruction, cough, coryza and body pain;
* Signed consent.

Exclusion Criteria:

* Patients with any clinically significant disease that, in the investigator opinion, can´t participate in the study;
* Patients with any laboratory finding or image finding that, in the investigator opinion, can´t participate in the clinical trial;
* Patients with history of hypersensitivity to any of the formula compounds;
* Participation in clinical trial in the year prior to this study;
* Patients with vaccine reaction;
* Patients who have uncontrolled asthma. However, participants in use of pulmonary corticosteroids (alone or in combination with other products) will be allowed if they are in stable dose and diagnosed with controlled asthma;
* Patients with gastroesophageal reflux, gastric or duodenal ulcer or other serious disease of the gastrointestinal tract;
* Patients with diabetes mellitus type I and II;
* Pregnancy or risk of pregnancy and lactating patients;
* Patients in use of drugs that can interfere with flu symptoms evaluation.
Clinical Trial of AVL-3288 in Schizophrenia Patients

Single-center, outpatient, randomized, double-blind, placebo-controlled, 3-treatment-phase, cross-over study to evaluate the safety, tolerability and efficacy of two oral doses of AVL-3288 each compared to placebo, in patients with schizophrenia.

This study will be in 24 non-smoking outpatients with schizophrenia or schizoaffective disorder. Subjects will complete three treatment phases, each involving 5 straight days of taking AVL-3288 (10 mg or 30 mg study drug or placebo) followed by a 16 day washout period in which subjects do not take the study drug to ensure that the drug is completed eliminated from the body before the next phase.

Eligibility Criteria:
Inclusion Criteria:

* DSM-V diagnosis of schizophrenia or schizoaffective disorder
* RBANS Total Scale Score \>62
* Willing to provide informed consent
* Medically stable for study participation
* Taking an antipsychotic medication other than clozapine at a stable dose for at least 4 weeks
* Judged clinically not to be at significant suicide or violence risk

Exclusion Criteria:

* Substance abuse (excluding nicotine) within last 90 days
* ECG abnormality that is clinically significant
* Current clozapine use
* Participation in a study of investigational medication/device within 4 weeks
* Pregnancy, lactation, or lack of use of effective birth control
* Active tobacco use
* Presence or positive history of significant medical or neurological illness, including cardiac illness, WBC \<3500/mm3, absolute neutrophil count \<1500/mm3, ALT or AST values \>1.5 times upper limit of normal. Hemoglobin less than 130 g/L (13 g/dL) in males or 120 g/L (12 g/dL) in females or known HIV +
* Contraindication to MRI scanning, including metal implants or claustrophobia
* Medicinal patch, unless removed
Benzodiazepine Discontinuation in Opioid Agonist Therapy

The proposed study is a clinical trial, designed to pilot test a Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention for patients on opioid agonist therapy who currently use benzodiazepines. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use. The goal of the study is to assess the applicability and feasibility of this intervention through treatment retention and qualitative interviews with four participants who are receiving opioid agonist treatment and who regularly use BZDs.

This study pilots a 13-week psychosocial intervention paired with a benzodiazepine taper with the aim of assisting individuals receiving OAT discontinue benzodiazepine use. All participants will receive the same benzodiazepine (BZD) discontinuation protocol. The Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention consists of 14 study visits: the first visit consists of the baseline assessment and the first therapy visits, 4 subsequent weekly therapy visits, then a 9-week BZD taper. Some participants may be prescribed non-benzodiazepine medications to treat the underlying conditions for which they were using BZDs \[e.g. selective serotonin reuptake inhibitors (SSRI) for anxiety or hypnotics for insomnia\]. Data collection will occur starting at the baseline assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Receiving OAT (methadone or buprenorphine) confirmed by toxicology testing for at least 90 days and on a steady dose for 2 consecutive weeks
3. Regular BZD use defined by BZD use 3 or more times per week in past month by self-report and positive urine screen at time of recruitment
4. Provides permission to contact current BZD prescriber if being prescribed BZDs
5. Speaks English
6. Wants to discontinue BZD use

Exclusion Criteria:

1. Pregnant, confirmed by urine pregnancy test
2. Cognitive impairment, as indicated by a score of \< 23 on the Mini Mental Status Exam
3. Any past month illicit opioid, barbiturate, z-drug, cocaine, unprescribed amphetamine, or synthetic cannabinoid use determined by self-report or urine drug test
4. Receiving ongoing psychosocial treatment for BZD use disorder
5. Uncontrolled seizure disorder (i.e. seizure in prior 90 days), or past BZD withdrawal seizure
6. Current suicidality or homicidality
7. Current psychotic symptoms