cyrilzakka/clinical-trials huggingface dataset:
Camrelizumab Combined With Apatinib Mesylate

The purpose of this study is to observe the safety of camrelizumab combined with apatinib mesylate in the treatment of solid tumors

According to current studies, the combination of camrelizide and apatinib mesylate has significant efficacy and controllable toxicity in the treatment of solid tumors.

This study adopted camrelizumab combined with apatinib mesylate in the treatment of solid tumors, aiming to further explore the safety of camrelizumab combined with apatinib mesylate in the treatment of solid tumors and provide more research data for the treatment of solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥18 years old, male or female;
2. ECOG score is 0\~2;
3. Patients with solid tumors confirmed by pathology or histology;
4. At least one measurable lesion (according to RECIST V 1.1);
5. For patients who have failed first-line or second-line treatment or who cannot tolerate standard treatment regimens for solid tumors.
6. Estimated survival ≥3 months;
7. Patients who have used immunosuppressants or antiangiogenic drugs in the past are not excluded;
8. For women who have not undergone menopause or surgical sterilization, agree to abstain from sex or use an effective contraceptive method during treatment and for at least 7 months after the last dose given in study treatment;
9. Researchers think they can benefit;
10. Voluntarily participate in the study and sign the informed consent;

Exclusion Criteria:

1. Pregnant or lactating women;
2. Except patients with contraindications to camrelizumab and/or apatinib mesylate, that is, those allergic to camrelizumab and its excipients; Allergic to apatinib mesylate should be prohibited; It should be contraindication for patients with active bleeding, ulcers, intestinal perforation, intestinal obstruction, hypertension beyond drug control within 30 days after major surgery, class III-IV cardiac insufficiency (NYHA standard), and severe hepatic or renal insufficiency (Class 4).
3. Those deemed unsuitable for inclusion by doctors;
4. The researchers determined there was a high risk that the tumor would invade important blood vessels and cause fatal hemorrhages during the follow-up study
Chronic and Acute Effects of Smoking on the Left and Right Ventricular Relaxation in Young Healthy Smokers

Impairment of relaxation, the early phase of ventricular diastole is the first stage of heart diastolic dysfunction. Left ventricular diastolic function can be determined noninvasively by Echo- Doppler - derived mitral valve flow velocities. The addition of pulmonary venous flow pattern enables more accurate assessment of left ventricle diastolic function. The role of the right ventricle in haemodynamic function of the heart is now emphasized. The right ventricle diastolic function can be assess by recording the Doppler tricuspid valve flow pattern. Impaired LV diastolic function usually precedes systolic dysfunction and may cause clinical signs of congestive heart failure. Cigarette smoking is one of the major risk factors for cardiovascular diseases. The aim of the study was to assess left and right ventricular diastolic function in healthy, young and slim smokers before and after smoking one cigarette.

Echocardiographic examination: before and after smoking one cigarette Echocardiographic evaluation of mitral valve flow, pulmonary venous flow, tricuspid valve flow and hepatic vein flow to assess diastolic function of ventricles.

Echocardiographic examination: in left lateral position after 10 minutes rest. The first examination: after a 2-hour non-smoking period, the second: immediately after smoking one cigarette containing 0.9 mg of nicotine. The duration of the second examination: no more than 15 minutes.

Echocardiography equipment: Hewlett-Packard SONOS 2000 (Andover, Massachusetts) imaging system. The transducer's frequency: 2 MHz.

From the apical four chamber view the visualisation of transmitral flow, pulmonary venous flow and transtricuspid flow. From subcostal view the visualisation of right superior hepatic vein and the hepatic vein flow.

Eligibility Criteria:
Inclusion Criteria:

* Smokers smoking over 10 cigarettes per day over the last 5 years
* Body mass index \< 25 kg/m2
* Normal blood pressure and normal parameters of echocardiographic examination (wall thickness, left- and right- chamber size, valvular function and left and right ventricular systolic function)
* Normal results of routine physical examination, chest x-ray, standard rest electrocardiogram and routine laboratory tests.

Exclusion Criteria:

* Body mass index \> 25 kg/m2
* Abnormal blood pressure
* Abnormal parameters of echocardiographic examination (wall thickness, left- and right- chamber size, valvular function and left and right ventricular systolic function)
* Abnormal results of routine physical examination, chest x-ray, standard rest electrocardiogram and routine laboratory tests.
Retrospective Study for Identificatiopn of a Link Between Doxycycline and COVID-19 Treatment

A new coronavirus, the third documented animal-to-human passage, emerged in Wuhan , China in the last quarter of 2019. Acne patients on doxycycline escaped seasonal viruses, showing the interest of this antibiotic as a possible treatment against COVID-19.

The antiviral action of tetracyclines can be explained by different mechanisms. First of all, tetracyclines are modulators of innate immunity by decreasing NF-B expression, inhibiting inflammatory cytokines such as TNF-α, IL-1β and IL-6, inflammatory granulomas and free radical release . This action is obtained at doses lower than those necessary to obtain an antibiotic effect. Another possible action of tetracyclines is their ability to chelate zinc from matrix metalloproteinases (MMPS). The coronavirus family is known to bind to host MMPs, particularly for viral survival. Their chelating activity may help inhibit SARS-CoV-2 infection by limiting its ability to replicate in the host. Finally, tetracyclines could have a direct action by inhibiting the replication of single-stranded RNA virus, such as the SARS-CoV-2 coronavirus.We therefore propose a larger comparative study using data from the French National Health Data System.

DOXY-COVID study is a national, observational, retrospective cohort study to compare the risk of severe COVID-19 in doxycycline-treated patients versus non-doxycycline-treated control patients (so-called case-cohort study).

The patient inclusion period corresponds to the main waves associated with the COVID-19 epidemic in France, i.e. from January 1, 2020 to November 30, 2021. Indeed, the time of data access, expected during 2022, would not allow reasonable follow-up of doxycycline-exposed patients from December 1, 2021.

Data of interest collected on these patients are requested over the period from January 1, 2016, through December 31, 2021:

* From January 1, 2016, in order to be able to define a pre-exposure phenotype over a follow-up period of at least 4 years in the French Health Insurance databases (period 2016-2019 inclusive)
* Until December 31, 2021, in order to have at least one month's hindsight on the risk of occurrence of severe forms of COVID-19

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ≥ 12 years old
* Affiliated with the French social security system or equivalent system
* Having been dispensed oral doxycycline at a dose of 100 mg between January 1, 2020 and November 30, 2021
Sedation Efficacy of Dexmedetomidine Versus Midazolam in Critically Ill Ventilated Children

There is a significant lack of adequately powered randomized clinical trial (RCT) data to determine the comparative safety and effectiveness of sedative treatments in pediatric patients. In many centres the standard of care for sedation in pediatric critical care unit (PCCU) patients includes the use of benzodiazepines despite the known negative effects of increased patient agitation and delirium, which can contribute to longer PCCU and hospital length of stay (LOS). The use of an alternative sedative, dexmedetomidine may reduce negative effects in this population. As such, the investigators plan to conduct a well designed comparative RCT to determine the most effective and safest sedative in this vulnerable population utilizing clinical assessments of sedation levels and delirium instance, electroencephalography (EEG) analysis and patient important outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Age is 1 month to 18 years inclusive
2. The patient is intubated and is expected to remain intubated for at least the next 48 hours
3. The patient has not been receiving mechanical ventilation for more than 72 hours
4. The patient must already be receiving an opioid infusion per PCCU Guidelines for Sedation \& Analgesia for Procedures Outside O.R. and need additional sedation.

Exclusion Criteria:

1. Admission is a consequence of suspected or proven drug overdose
2. Patient is receiving dialysis
3. Known pregnancy or lactation
4. Neuromuscular blockade other than for intubation
5. General anesthesia in the 24 hours prior to study initiation
6. An acquired Central Nervous System (CNS) condition (i.e. encephalitis, traumatic brain injury) resulting in ongoing dysfunction or an acquired condition resulting in ongoing dysfunction
7. Acute hepatitis or severe liver disease
8. Known history of sensitivity to midazolam and/or dexmedetomidine or their constituents
9. Systolic blood pressure (SBP) below 5th percentile for two consecutive measurements
10. Heart rate (HR) below 5th percentile for two consecutive measurements
11. Death is deemed to be imminent or inevitable during the admission and either the intensivist or substitute decision maker is not committed to full active resuscitation
12. Previous enrollment into the study
Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

Multi center, pivotal prospective, randomized clinical trial

The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of DCIS or invasive cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.

ClearEdge is a CE marked device already been used in several hospitals in the UK. It was used in a prospective single arm and 2 phases clinical study. It was demonstrated that surgeons successfully used the device to identify DCIS or invasive cancer involved margins and that it can reduce the need for repeat surgeries by meeting the margins depth criteria to require repeat operations. European Journal of Oncology Surgery. 2016; 42 (12): 1834-1840. In addition, the device was clinically evaluated by several hospitals.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are female (genotype)
2. Patients aged above 18 years, inclusive
3. Patients diagnosed with breast DCIS or invasive cancer recommended for lumpectomy procedure
4. Patients treated with neoadjuvant endocrine therapy may be enrolled

Exclusion Criteria:

1. Patients currently receiving chemotherapy
2. Patients having prior ipsilateral surgical treatment for breast cancer
3. Patients who have had radiation therapy for ipsilateral breast cancer or for other malignancy that includes breast tissue in the radiation field (e.g. Hodgkin's lymphoma)
4. Patients who have breast implants
5. Patients who are pregnant and/or lactating
6. Patients participating in other breast cancer studies involving surgical treatment to the breast in the past 6 months.
Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study

The study involved the administration of pharmacotherapy and cognitive behavior psychotherapy to individuals suffering from erectile dysfunction. The study was randomized controlled trial with two arms involving a control group. The study was conducted with an aim of pilot and feasibility study to evaluate the efficacy and suitability of cognitive behavior psychotherapy with individuals suffering from erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

1. Men diagnosed with erectile dysfunction
2. Must be in the age range of 18 to 39 years
3. Must be in a stable heterosexual relationship
4. Must not be suffering from any medical or psychiatric illness

Exclusion Criteria:

1. Men not meeting criteria of diagnosis of erectile dysfunction
2. Men not in a heterosexual relationship
3. Men of or above the age of 40 years
4. Men diagnosed with any medical or psychiatric illness or obese men
Development of IVF/ICSI Children Born From Different Endometrial Preparation Protocols

The efficacy and safety of endometrial preparation regimens remain controversial. In the most recent meta-analysis, using natural and modified natural cycle protocol to prepare the endometrium in frozen embryo transfer resulted in higher live birth rates. In addition, the natural cycle reduces the risk of gestational hypertension, postpartum haemorrhage, and extremely preterm delivery compared with regimens using exogenous hormones.

Because there are many physiological and endocrinal differences in the frozen embryo transfer cycle with different endometrial preparation protocols, the development of children born from these regimens has received much attention. For example, there is a complete absence of the corpus luteum during the cycle of exogenous hormone administration. Or in the modified natural cycle, the pharmacokinetics is not entirely the same as the natural physiology when using an additional ovulatory injection with hCG. To date, there have been no longitudinal follow-up studies that evaluated and compared the long-term development of IVF/ICSI children born from frozen embryo transfer with different endometrial preparation protocols.

Thus, the investigators conduct a follow-up of our RCT to investigate the IVF/ICSI children born from frozen embryo transfer with different endometrial preparation protocols to give strong evidence about the safety of the three most common endometrial preparation protocols in women undergoing frozen embryo transfer.

Developing further from a previous randomized controlled clinical trial (MONART study - NCT04804020), the investigators decided to assess the physical, mental, and motor development of children up to 24 months after birth, with the aim of providing additional information on the safety of these regimens on the long-term health of the IVF/ICSI children.

Eligibility Criteria:
Inclusion Criteria:

* All live IVF/ICSI babies born from frozen embryo transfer following the natural cycle, modified natural cycle, and artificial cycle from MONART study
* Parents agree to participate in the study.

Exclusion Criteria:

* Babies died under or at 24 months
Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)

This study will be conducted to assess the maximum tolerated dose (MTD) of panobinostat given 3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination with induction chemotherapy (idarubicin and cytarabine) in newly diagnosed patients with a cytopathologically confirmed diagnosis of high-risk AML, and to investigate the safety of the combination in this regimen.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed adult patients = 65 years old with a cytopathologically confirmed diagnosis of high-risk AML
* = 20% bone marrow blasts via bone marrow aspiration or biopsy
* The patient has not yet been treated for AML
* 1º or 2º AML patients with high-risk category features
* ECOG PS = 2
* Renal function and liver function limits.

Exclusion Criteria:

* Patient with a 'favorable' or 'better-risk' cytogenetic profile = t(15;17); t(8;21); or inv(16) or t(16;16)
* Patient has clinical symptoms suggestive of CNS leukemia and/or CSF findings for CNS leukemia
* Prior treatment with deacetylase inhibitors (DACi) including, panobinostat
* Impaired cardiac function
* Female patient who is pregnant or breast feeding
* Male patient who is not willing to use a barrier method of contraception

Other protocol-defined inclusion/exclusion criteria may apply
Radial Extracorporeal Shock Wave Treatment (rESWT) of Myofascial Pain Syndrome in Low Back Pain

The purpose of this study is to evaluate the efficacy of treatment of radial shockwave in myofascial pain syndrome in the lumbar region compared to placebo through questionnaires and imaging exams.

BACKGROUND: Extracorporeal shockwave treatment has been used widely for musculoskeletal conditions, however no randomized controlled trial are available about its use for chronic low back pain with myofascial pain syndrome (MPS).

HYPOTHESIS: Radial extracorporeal shockwave treatment (rESWT) improves pain intensity and functional disability compared with placebo in patients with chronic low back pain due to MPS.

STUDY DESIGN: Randomized controlled clinical trial METHODS: A prospective, randomized, double-blind, placebo-controlled study will be carried out on 40 patients who has moderate to severe pain (VAS \> 4) for more than 6 months, despite 6 weeks of conservative treatment with antidepressants associated with rehabilitation. Six interventions of rESWT (3-4 bar; 1000 impulses per trigger point (TP) or 2500 impulses per muscle) will be compared with placebo. The outcome measures were pain visual analogue scale (VAS), Oswestry Disability Index, Short-form McGill Pain Questionnaire, Roland Morris Disability Questionnaire and the temperature of the treated area will be evaluated with Thermography. The assessments will be apply before treatment, after conservative treatment, 6 and 12 weeks after rESWT.

Eligibility Criteria:
Inclusion Criteria:

* Presenting clinical complaints of lumbar and / or gluteal pains for 3 months or more
* Display pain of moderate to severe intensity: visual analogue scale (VAS)\> 4
* Diagnosis of myofascial pain syndrome in the lumbar and / or gluteal
* Authorize in writing the term of free and informed consent to participate in the study
* Availability of frequent attendance at hospital

Exclusion Criteria:

* Organic or psychological disorders that contraindication participation of patients in study
* Metabolic, infectious, oncological or rheumatologic disorders
* Fibromyalgia
* Labor dispute
* Indication for surgery in column
* Contraindications to therapy of shock waves:

  * Coagulopathy and / or anticoagulant
  * Pregnancy
  * Acute infection in soft tissue or bone
  * Systemic Infections
  * Presence of ulcers at treatment sites
  * Presence of larger vessels or nerves at treatment sites
  * Polyneuropathies
  * Malignancies
  * Cardiac arrhythmias or use of pacemaker
  * Epilepsy
Attitudes & College Experiences

High volume drinking by young adults has proven resistant to long term change, so new approaches are needed. Given strong associations between alcohol-related attitudes and drinking behavior, the investigators adapt a theory-based attitude change strategy for use in alcohol prevention. This research tests the impact of a brief counter attitudinal advocacy activity on subsequent drinking and negative consequences.

The persistence of risky drinking among young adults in college calls for continued efforts to prevent harms related to alcohol. Current prevention interventions have achieved some success, but rely on a single mechanism of change: correcting exaggerated drinking norms. The investigators propose to test a novel prevention strategy targeting another mechanism of change: creating attitude-behavior dissonance. To date, changing alcohol-related attitudes and the resulting attitude-behavior discrepancy has been underutilized as a behavior change strategy for alcohol abuse prevention. Informed by an extensive literature showing strong and consistent associations between alcohol attitudes and drinking behavior, the investigators adapted a brief counter-attitudinal advocacy (CAA) manipulation to the alcohol prevention context.

Eligibility Criteria:
Inclusion Criteria:

* 18-24 years of age
* Enrolled in the university's undergraduate four-year degree program
* Past month heavy episodic drinking (for men, \>5 drinks in one day, for women \>4 drinks in one day)
* At least two self-reported negative consequence from drinking in the past month

Exclusion Criteria:

• Status as a graduating senior
A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With a Tumour in the Brain That is Positive for DLL3

This study (1438-0003) is open to adults with a tumour in the brain that is positive for the tumour marker delta-like 3 (DLL3). This study is in people with advanced cancer for whom previous treatment was not successful.

The purpose of this study is to find out the highest dose of BI 764532 that people with a brain tumour that is positive for DLL3 can tolerate. BI 764532 is an antibody-like molecule that can attach and link together the cancer cells and T-cells of the immune system (DLL3/CD3 bispecific). This may help the immune system fight cancer.

Participants get BI 764532 infusions into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is continued. During this time, participants visit the study site at regular intervals. The total number of visits depends on how they respond to and tolerate the treatment. The first study visits include staying to monitor participants' safety. Doctors record any unwanted effects and regularly check the general health of the participants.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the first informed consent form (ICF1).
2. Signed and dated written informed consent (ICF1 and ICF2) in accordance with International Council for Harmonisation-Good clinical practice (ICH-GCP) and local legislation prior to admission to the trial.
3. Patients with histologically confirmed primary progressive diffuse glioma who have failed standard of care therapies.
4. Availability of archival tumour tissue for Delta-like 3 (DLL3) expression by central assessment.
5. Tumours must be positive for DLL3 expression by immunohistochemistry (IHC) on archived tumour tissue according to central pathology review.
6. Documented unequivocal progression after radiotherapy and/or chemotherapy with measurable disease by response assessment in neuro-oncology (RANO) criteria.
7. Karnofsky performance score ≥70. Further inclusion criteria apply.

Exclusion Criteria:

1. Previous treatment in this trial.
2. Current enrolment in another investigational device or drug trial.
3. Presence of extracranial metastatic or leptomeningeal disease.
4. Previous treatment with therapies targeting DLL3.
5. Prior treatment with bevacizumab or other anti-vascular endothelial growth factor (anti-VEGF) or anti-angiogenic treatment within 6 months prior to first administration of BI 764532.
6. Recent anti-cancer therapy: treatment with any other anticancer drug within 21 days or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532.
7. Radiotherapy within the 3 months prior to the diagnosis of progression; unless tumour progression is clearly outside the radiation field or tumour progression is unequivocally proven by surgery/biopsy.

Further exclusion criteria apply.