cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.

This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in breast cancer Patients with brain metastases.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).
2. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.
3. Life expectancy ≥ 3 months.
4. Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies.
5. At least one measurable lesion .
6. Laboratory test results meet the relevant requirements for organ function.
7. Subjects who agree to take effective contraceptive measures.

Exclusion Criteria:

1. Inflammatory breast cancer.
2. Patients unsuitable for endocrine therapy at the investigator's discretion.
3. Have a History of other malignancies prior to the start of study treatment.
4. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.
5. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.
6. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.
7. Pregnant or lactating women.
8. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; ≥ NYHA (New York Heart Association) Class II; QTcF≥ 470 ms; left ventricular ejection fraction ≤ 50%.
9. History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
10. Hepatitis B surface antigen positive and HBV (Hepatitis B Virus) DNA \> 2,000 IU/mL or \> 10(4) copies/mL; HCV (Hepatitis C Virus) antibody positive and HCV RNA positive; or known HIV infection.
11. History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product.
12. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment.
13. Presence of uncontrolled infections before the start of study treatment.
14. Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders.
15. Presence of other diseases that the risks of receiving the study treatment outweigh its benefits, as determined by the investigator, or any other reason for which patients are ineligible for the study as assessed by the investigator.
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2

The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days.

Mon/Wed/Fri dosing with the 8 mg buprenorphine/naloxone tablet is as safe and effective as daily dosing and is preferred by patients to daily dosing. Multiple doses of the combination tablet (e.g. 16mg, 24mg) are well tolerated by patients. A 3 day schedule with take-outs is as effective as a 3-day schedule in which all medication is ingested at the clinic

Eligibility Criteria:
Inclusion Criteria:

Individual must be currently dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.

Exclusion Criteria:

Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
Investigation of the Effect of 8-week Controlled High Intense Interval Training in Type 2 Diabetic Patients

The overall objective of this study is to examine the blood flow in the thigh muscles and sugar metabolism before and after 8 weeks of high intensity interval training (HIIT) on a bicycle ergometer in patients with type 2 diabetes (T2D) and matched controls. The following parameters are included in the assessment:

* Sugar Metabolism
* Muscle and fat mass
* The blood flow at rest around the thigh muscles
* Oxygen uptake test on a bicycle ergometer and 5 km time trial

Type 2 diabetes (T2D) can be defined as a bihormonal metabolic disorder characterised by insufficient insulin secretion and abnormal glucagon secretion. It is however well established that physical activity per se improves glucose and may postpone or even slow down in the diabetic population. Glycaemic control may be improved more by high intensity interval training than by intensities from existing recommended guidelines. Additionally, there seems to be accumulating evidence that high intensity interval training induces increased overall fat and abdominal fat mass loss as opposed to traditional continuous endurance training Therefore we hypothesise that 3 weekly sessions of high intensity interval training (10×60 sec. at an intensity inducing 90% of maximal heart frequency with a recovery of 60 sec. between each bout) over 8 weeks improves overall glycaemic control (glucose, insulin and glucagon), inflammatory status (interleukins, cytokines, chemokines and cell adhesion molecules) and blood flow (NO and PGI2 vasodilatory capabilities).

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes or matched healthy controls. T2D subject only : HbA1c \> 7,3. All subjects have an age between 40-65 years and a body mass index between 25-40 kg/m2. Both genders is allowed

Exclusion Criteria:

* Severe diseases /immobility
Determination of Venous Thromboembolism Risk and Nursing Practices in Patients Hospitalized in Medical Services

Together with individual predisposition to form vascular clots and clinical conditions that further increase this risk, venous thromboembolism (VTE) poses a significant additional morbidity and mortality risk for the majority of the world's population. Although VTE causes serious disability and death when undiagnosed, it is a medical condition that can be prevented when diagnosed early. Although all hospitalized patients are at risk of DVT, studies have shown that 75% of hospitalized patients are hospitalized in internal clinics.As a result of this observational study, it was aimed to determine the VTE risk levels of the patients from the time of hospitalization and to determine preventive nursing care for VTE.

Venous Thromboembolism (VTE) refers to interrelated diagnoses such as Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). 10-20% of venous thromboembolic events occur in medical patients and 10-80% in intensive care patients. Recognized as a major complication for medical and surgical patients, VTE has been described as the 'silent killer' of hospitalized patients. During the Covid-19 pandemic in recent years, high rates of thrombolytic events have been reported in hospitalized COVID-19 patients. Nurses have an important role in identifying risk factors for VTE, taking precautions and assessing patient compliance with these precautions. The nurse should identify risk factors in the preoperative period, long-term and intensive care hospitalizations by taking a comprehensive history and physical assessment of the patient before hospitalization. There are several risk assessment models developed to assess the risk of VTE for application to inpatient medical patients. There are various risk assessment models developed for application to inpatient medical patients. Padua and IMPROVE VTE risk assessment models are frequently used. In the literature, it is stated that the Padua model gives moderate results and the IMPROVE model gives moderate-good results in predicting risk (1). Therefore, risk levels were not determined with the IMPROVE risk assessment tool in this study.

Eligibility Criteria:
Inclusion Criteria:

* To be conscious,
* Consent of the patient's relatives to participate in the study in unconscious patients
* 24 hours have passed since hospitalization
* The patient admitted to hospitalization has been pre-assessed by the nurse and the pre-assessment form and nurse observation form have been completed

Exclusion Criteria:

* Surgical patients
* Pregnant patients
* Refusing to participate in the study during the completion of the data collection forms.
* In unconscious patients, the patient's relatives did not give consent to participate in the study
* Unconscious patient whose relatives cannot be reached
* The patient admitted to hospitalization was not pre-assessed by the nurse and the pre-assessment form and nurse observation form were not filled out
Imaging During Surgery in Diagnosing Patients With Prostate, Bladder, or Kidney Cancer

This pilot clinical trial studies imaging during surgery in diagnosing patients with prostate, bladder, or kidney cancer. New diagnostic imaging procedures, may find prostate, bladder, or kidney cancer

PRIMARY OBJECTIVES:

I. The primary objective of this pilot study is to assess the ability of fluorescent imaging and photoacoustic imaging (PAI) in a clinical setting to distinguish benign from malignant tissue.

SECONDARY OBJECTIVES:

I. To qualitatively determine the possible benefit of PAI and fluorescent imaging over traditional white light imaging.

OUTLINE:

Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a pathologic confirmation of prostate cancer, bladder cancer, or kidney cancer based on previous biopsies or procedures OR a strong concern for a kidney malignancy based on computed tomography (CT) or magnetic resonance imaging (MRI) imaging
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients with a surgical history or anatomic variant that would preclude robot assisted laparoscopic approaches to their surgery (i.e. history of ventral hernia repair with mesh)
* Patients with medical co-morbidities who cannot tolerate laparoscopic surgery secondary to intra-abdominal carbon dioxide insufflation
* Patients with documented allergy or adverse drug reaction to indocyanine green or baseline serum creatinine greater than 1.5 mg/dL
The Effect of Hyperoxia on Cardiac Output

Rational: Preoxygenation is a standard procedure before (deep) sedation in the ED. However, there is literature suggesting that too much oxygen can be harmful. One potential detrimental effect is a decrease in cardiac output due to coronary vasoconstriction. So far, it is unknown if this effect is rate dependent and if it also occurs after only a short period of hyperoxia, as patients experience during procedural sedation pre-oxygenation.

Objective: To investigate if hyperoxia has a negative effect on Cardiac index (CI) in patients undergoing procedural sedation in the ED.

Methods: In patients needing sedation for a painful condition, non-invasive measurements of CI, stroke volume and total peripheral resistance are performed using the Clearsight non-invasive cardiac output monitoring system.. Measurements will be taken at baseline, after 1,2 and 5 minutes of 15L O2/min, and then after another 2 and 5 minutes of flush rate oxygen and during the subsequent sedation.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting in the ED of the Medical Center Leeuwarden (MCL) who have a painful condition for which procedural sedation is required.

Exclusion Criteria:

* - Cardiogenic shock (SBP\<90 mmHg)
* Procedural sedation for cardioversion
* Pregnancy
* General contra-indications for the procedural sedation according to local sedation protocol of the MCL.
* Hypoxia (sat \<90% or pO2 \<8)) despite oxygen suppletion
* Age \< 18 years
* Non-invasive ventilation (NIV) or intubation
* No informed consent
* Use of bleomycin
* COPD GOLD III of IV
* COPD GOLD I of II with hypercapnia (PCO2 \> 6,4 kPa)
* Patients in whom no reliable signal for Clearsight measurement can be obtained
the Effect of Different Wound Dressing on Prevention of Pressure ınjury Related to NIMV Mask

This study is aimed to examine the effect of different wound dressings on the prevention of pressure injury in the face area related to noninvasive mechanical ventilation mask. The study was completed out with 102 patients who were followed up in Chest Diseases and Thoracic Surgery Hospital between October 2019 and August 2020 and met the inclusion criteria of the study. In the study, hydrocellular and hydrocolloid wound dressing was applied to the pressure areas under the mask of noninvasive mechanical ventilation in the intervention groups, while the routine treatment process was followed in the control group. Wound dressings were obtained from HARTMANN. Study data were collected with the "Individual Characteristics Form" and "Pressure Injury Rating Scale".

In the hospital where the study was conducted, patients with respiratory failure receive NIMV treatment with an oro-nasal mask. In the study, hydrocolloid and hydrocellular wound dressings were placed on the pressure areas under the mask of the patients in the intervention group. NIMV treatment was applied to the face area of the patients in the control group with an oronasal mask without using any barrier cover. The pressure areas of the patients in the intervention and control groups were evaluated with the pressure injury scale before and after the NIMV treatment. Follow-up was carried out twice a day for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years, receiving NIMV therapy for at least 6 hours a day, on the first day of hospitalization and followed up for at least 7 days, receiving NIMV treatment with an oro-nasal mask, tolerant of mask,

Exclusion Criteria:

* patients with pre-treatment pressure injuries in the facial area, patients with diabetes mellitus, patients with mental or psychological problems
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 18-65
* Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, and now meet criteria for a major depressive episode.
Fitball Program Versus Task-oriented Motor Program on Improving Postural Control in Developmental Coordination Disorder

Children with developmental coordination disorder (DCD) often have poor postural control and motor skills that affect their activities of daily living and participation in school activities. The aim of this randomized controlled trial is to compare the effects of fitball training versus task-oriented motor training for children with DCD.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of DCD according to DSM-IV criteria
* Poor motor skills (Movement Assessment Battery for Children score \<15 percentile, or any two or more of subtests in BOT II \< 1.5 SD)
* aged between 6-12 years old

Exclusion Criteria:

* have attended treatment for motor problems in the previous 6 months
* any major co-morbid medical / neurological / sensory problems such as moderate to severe mental disability, profound visual or hearing impairment, severe sensory problems, or had any major behavioral problems.
Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial

Analgesia after cesarean section is still not satisfactory for many women. Even if pain reduction is sufficient with the technique of intrathecal morphine injection, side effects such as nausea and pruritus are common.

Since several years, an alternative technique has been studied, the "transversus abdominis plane (TAP)"-block. Here a local anesthetic is injected in the abdominal wall muscles, and this has been shown to give a similar analgesic effect compared to intrathecal morphine, with potentially less side effects.

With this study, we want to evaluate if the TAP-block yields indeed less side effects when compared with intrathecal morphine.

The study will be a prospective study with the patients randomized to either a group with intrathecal morphine or a group with TAP-block.


Eligibility Criteria:
Inclusion Criteria:

Subjects must satisfy all of the following criteria to be enrolled into the study:

* American Society of Anesthesiology (ASA) physical status less than 3 Able to read and understand the information sheet and to sign and date the consent form
* Scheduled for elective C-section planned with spinal anaesthesia
* Age\>18

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

* Complicated pregnancy defined as having preeclampsia or placenta accreta, increta and percreta.
* Drug addiction.
* Contraindication to spinal anaesthesia (history of clotting disorders, septicemia, local infection at the injection site, spinal malformation, elevated intracranial pressure)
* Contraindication to TAP block (skin infection, abdominal wall muscle defect such as hernia and previous abdominal wall mesh).
* BMI\>40 kg/m2
* Weight less than 50 kg the day of the C-section.
* Height less than 150 cm or more than 175 cm.
* Allergy/contraindication to any medication used in the study.
* Previous median abdominal incision. Necessity to perform the C-section urgently before the scheduled date (with less than 24h preparation time).
Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health

The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
* Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
* Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.
* Willing and able to discontinue use of any topical ocular medicine other than the study medication for the duration of the study, including artificial tears.
* Best corrected visual acuity of -0.6 logMAR or better in each eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
* Use of contact lenses within 30 days of Visit 1.
* Use of contact lenses during the study.
* Participation in an investigational drug or device study within 30 days of entering this study.
* Other protocol-defined exclusion criteria may apply.
A Phase I Study of Modified Vaccinia Virus Ankara (MVA-B) in Healthy Volunteers at Low Risk of HIV Infection

The purpose of this clinical trial is to study a modified pox viral vector considering:

1. HIV subtype B accounts for the most frequent virus strain in Europe and North America, as well as in many parts of the world.
2. This novel vaccinia construct expressing HIV subtype B gag, pol, env and nef antigens is to be studied in humans for the first time.


Eligibility Criteria:
Inclusion Criteria:

* male or female
* age between 18 and 55 years on the day of screening
* available for follow-up for the duration of the study (52 weeks from screening)
* able to give written informed consent
* at low risk of HIV and willing to remain so for the duration of the study low risk of HIV infection defined as: no history of injecting drug use in the previous ten years no gonorrhoea or syphilis in the last six months no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months no unprotected anal intercourse in the last six months no unprotected vaginal intercourse outside a relationship with a regular known/presumed HIV negative partner in the last six months
* willing to undergo a HIV test
* willing to undergo a genital infection screen
* if heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; IUCD; consistent record with condoms if using these; physiological or anatomical sterility in self or partner) from 14 days prior to the first vaccination until 4 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination
* if heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination

Exclusion Criteria:

* positive for hepatitis B surface antigen, hepatitis C antibody, antibody responses to vaccinia or serology indicating active syphilis requiring treatment
* pregnant or lactating
* clinically relevant abnormality on history or examination including history of grand-mal epilepsy, severe eczema, immunodeficiency or use of immunosuppressives in preceding 3 months
* receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment
* receipt of blood products or immunoglobin within 4 months of screening
* participation in another trial of a medicinal product, completed less than 30 days prior to enrolment
* history of severe local or general reaction to vaccination defined as local: extensive, indurated redness and swelling involving most of the front-lateral thigh or the major circumference of the arm, not resolving within 72 hours general: fever \>= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal
* HIV 1/2 positive or indeterminate on screening
* positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
* grade 1 routine laboratory parameters
* unlikely to comply with protocol
Relationship Between NLR and Prealbumin Levels With Diaphragm Thickness

A study to find the relationship between neutrophil to lymphocyte ratio (NLR) with diaphragm thickness of critical patients in ICU.

Weaning from ventilator sometimes can be failed and it happened due to several factors. One of the causes was Ventilator Induced Diaphragm Dysfunction (VIDD). This VIDD process occurred due to thinning process of the diaphragm thickness or decreased diaphragm muscle mass. The whole process happened due to inflammatory reaction that usually appeared on patients in Intensive Care Unit (ICU). Thus, this study was aimed to find the relationship between neutrophil to lymphocyte ratio (NLR) with diaphragm thickness of critical patients in ICU.

Eligibility Criteria:
Inclusion Criteria:

* Critical patients treated in intensive care unit using mechanical ventilation from day 0.
* Patients are clinically predicted to be treated for more than 5 days (qSOFA and clinical assessment)

Exclusion Criteria:

* History of suffering from neuromuscular disease and or diaphragmatic malformations
* Used non-invasive ventilation before starting to use mechanical ventilation
* History of tracheostomy
* Patients admitted to ICU within 12 months before this study