cyrilzakka/clinical-trials huggingface dataset:
Breast Cancer With Over-expression of erbB2-BRAINSTORM

This retrospective cohort study aims to improve our understanding of the current paradigm for treatment of brain metastases in erbB2+ breast cancer patients in the Asia Pacific region. We aim to identify approximately 300 erbB2+ breast cancer patients with brain metastases diagnosed between 2006-2008 in 6 countries. Medical records will be analyzed to determine the treatment pattern for brain metastases, including anti-erbB2 therapy. Additional objectives are to understand the impact of anti-erbB2 therapy on survival after brain metastases and to investigate the relationship between anti-erbB2 therapy for brain metastases and: 1) the time interval between diagnosis of erb2+ breast cancer and brain metastasis, and 2) the occurrence of brain metastasis as the first site of disease progression.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients diagnosed with erbB2+ breast cancer. ErbB2 positivity will be as determined by respective institutional standards, and will be based on medical history only.
2. Brain metastasis diagnosis made between January 2006 - December 2008.

Exclusion Criteria:

1. Women who have another primary cancer diagnosed between the time of breast cancer diagnosis and brain metastasis..
2. Patient has leptomeningeal metastases only without parenchymal brain involvement (since this pattern of the disease requires a different treatment approach.)
Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?

The investigators hypothesize that the dry eye caused by SS may include the evaporative type, resulting from the MGD. Furthermore, the investigators hypothesize that both pSS and sSS are associated with MGD.To test our hypothesis, we conducted a prospective clinical study in patients with SS (both pSS and sSS) and MGD, and the normal population All subjects were matched for both age and gender and assessed for tear function and ocular surface signs and symptoms.


Eligibility Criteria:
Inclusion Criteria:

* All the subjects are female and age between 50-60 years
* Patients with primary SS fulfilled the criteria established by the European Study Group
* Patients with SLE and RA met the criteria set by the American College of Rheumatology

Exclusion Criteria:

* The control history of autoimmune disease
Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe COVID-19 Patients

This clinical trial is set out to evaluate the safety and efficacy of allogeneic human dental pulp mesenchymal stem cells in the treatment of severe pneumonia caused by COVID-19; to explore the effects of human dental pulp mesenchymal stem cells in the treatment of severe pneumonia of COVID-19 in terms of reducing mortality and improving clinical prognosis; and to discover a new therapeutic strategy for COVID-19 using allogeneic human dental pulp mesenchymal stem cells.

This clinical trial is set out to evaluate the followings:

1. the safety and efficacy of allogeneic human dental pulp mesenchymal stem cells in the treatment of severe pneumonia caused by COVID-19;
2. to explore the effects of human dental pulp mesenchymal stem cells in the treatment of severe pneumonia of COVID-19 in terms of reducing mortality and improving clinical prognosis; and
3. to discover a new therapeutic strategy for COVID-19 using allogeneic human dental pulp mesenchymal stem cells.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-65 years;
2. Voluntarily participate in this clinical trial and sign off "informed consent form";
3. Diagnosed with severe pneumonia of COVID: respiratory distress, RR \>30 times / min; resting oxygen saturation of 93% or less; arterial partial pressure of oxygen / oxygen concentration 300mmHg; SARS-CoV-2 nucleic acid test was positive.
4. Chest imaging confirm COVID-19 featured lesions in lung.

Exclusion Criteria:

1. Receive any clinical trial drug treatment for COVID-2019 within 30 days before the screening assessment;
2. Severe liver disease (e.g., Child Pugh score \>=C or AST\> 5 times of the upper limit);
3. Patients with known severe renal insufficiency (estimated glomerular filtration rate \<=30mL / min/1.73 m2) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis;
4. Co-infection of HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;
5. Female patients who have no sexual protection in the last 30 days prior to the screening assessment;
6. Pregnant or lactating women or women using estrogen contraception;
7. Patients who are planning to become pregnant during the study period or within 6 months after the end of the study period;
8. Other conditions that the researchers consider not suitable for participating in this clinical trial.
Impact of Switching to Non-Menthol Cigarettes Among Smokers

This pilot study will investigate within-person changes in smoking behavior when current adult smokers are systematically switched from smoking menthol cigarettes to non-menthol cigarettes.

The goals of this project include evaluating the feasibility of a cigarette switching paradigm to examine how switching adult smokers from menthol to non-menthol cigarettes impacts smoking behavior and satisfaction. Smoking behavior will be measured by self-reported total number of cigarettes and time to first cigarette in the morning, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3). Smoking satisfaction will be measured by self-reported ratings of the cigarettes, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3).

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* Able to read English
* Cigarette smoker

Exclusion Criteria:

* Seeking smoking cessation treatment
* Serious psychiatric or medical condition
* Use of other drugs
* Unable or unwilling to complete study protocol
Impact of Sleep Education Program on Glycemic Control in Hong Kong Chinese Type 2 Diabetic Patients

This is a randomized controlled trial with 12 month sleep education as intervention, followed by a 12 month observational period, to study whether sleep education would improve glycemic control and cardiometabolic profile of sleep deprived type 2 diabetic patients and evaluate the neurohormonal changes associated with sleep education.

Patients will be identified from the Diabetes Mellitus and Endocrine Centre of Prince of Wales Hospital and Yao Chung Kit Diabetes Assessment Centre, The Chinese University of Hong Kong. All participants will have diabetes complications screening and comphrensive evaluations for glycemic control and cardiometabolic risk factors.Eligible subjects will be randomized to 2 groups (usual or conventional care versus intervention with sleep education program) for 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-65 years
2. Type 2 diabetes mellitus
3. Chinese ethnicity
4. Able and willing to give informed written consent
5. Sleep deprived, defined as subjective sleeping time \<6 hours per day

Exclusion Criteria:

1. Type 1 diabetes mellitus
2. Known history of psychiatric disorders (e.g. depression, anxiety, dementia)
3. Sleep disorders secondary to another medical condition (e.g. obstructive sleep apnoea (OSA), circadian rhythm sleep disorder)
4. Concomitant chronic medical condition that was likely to be the cause of sleep problem (e.g. benign prostatic hypertrophy, chronic pain)
5. Concurrent use of hypnotic drugs, psychotic medications and any drugs that are known to affect sleep.
6. Any condition, as judged by the investigators, as ineligible to participate in this study
Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants with EPP

This is a Phase 2, multi-center, double-blind, placebo-controlled, parallel group study of bitopertin to evaluate the safety, tolerability, efficacy, and PPIX concentration change in participants with EPP. Participants may roll over to an open label extension portion after completing the double-blind treatment period.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older at the time of signing the informed consent form (ICF).
2. Diagnosis of EPP, based on medical history by ferrochelatase ( FECH) genotyping or by biochemical porphyrin analysis.
3. Body weight ≥50 kg.
4. Washout of at least 2 months prior to Screening of afamelanotide and dersimelagon, if applicable.
5. Aspartate aminotransferase (AST) and alanine transaminase (ALT) \<2× upper limit of normal (ULN) and total bilirubin \<ULN (unless documented Gilbert syndrome) at Screening. Albumin \>lower limit of normal (LLN).

Exclusion Criteria:

Medical History:

1. Major surgery within 8 weeks before Screening or incomplete recovery from any previous surgery.
2. Other than EPP, an inherited or acquired red cell disease associated with anemia.
3. A history or known allergic reaction to any investigational product excipients or history of anaphylaxis to any food or drug.
4. History of liver transplantation.
5. History of alcohol dependence or excessive alcohol consumption, as assessed by the Investigator.
6. Human immunodeficiency virus (HIV), active Hepatitis B, or C.
7. Other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgment of the Investigator or Sponsor, would put the participant at unacceptable risk or otherwise preclude the participant from participating in the study
8. Condition or concomitant medication that would confound the ability to interpret clinical, clinical laboratory, or participant diary data, including a major psychiatric condition that has had an exacerbation or required hospitalization in the last 6 months.

   Treatment History:
9. Concurrent or planned treatment with afamelanotide or dersimelagon during the study period.
10. Treatment with opioids for any period \>7 days in the 2 months prior to screening or anticipated to require opioid use for \>7 days at any point during the study.
11. New treatment for anemia, including initiation of iron supplementation, in the 2 months prior to Screening.
12. Current or planned use of any drugs or herbal remedies known to be strong inhibitors or inducers of CYP3A4 enzymes for 28 days prior to the first dose and throughout the study.

    Laboratory Exclusions:
13. Hemoglobin \<10 g/dL at Screening.
Autonomic Adaptations to Hydration and Brain Functioning

The influence of relatively small decreases in hydration status have been little studied. On two occasions subjects will be allowed to lose about 0,5% of their body weight and one occasion 300ml of water will be consumed. Functional MRI will be used to monitor brain functioning when performing a mental arithmetic task. Heart rate variability will be monitored and related to differences in brain functioning when water has and has not been drunk

On two mornings twelve male participants will be exposed to a temperature of 30oC for four hours and either drink or not drink two 150ml glasses of water during that time. The subjects the participate in an fMRI protocol during which they complete a modified version of the Paced Auditory Serial Addition Test (PASAT): a challenging arithmetic task designed to elicit autonomic arousal.

Throughout the morning subjects will their heart rate variability (HRV) monitored. At periodic intervals subjects will rate their thirst and mood by visual analogue scales and at the end of the PASAT task they rate its difficulty. Changes in body temperature and fluid loss (perspiration and urine) and urine osmolality will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Self declared as healthy and not taking any medication

Exclusion Criteria:
Osteopathic Manipulative Treatment for Back Pain

This study will investigate if Osteopathic Manipulative Treatment (OMT) is beneficial for patients presenting with back pain.

Low back pain is the most common cause of disability in people under age 45 and accounts for 20% of all physician visits. Osteopathic manual treatment (OMT) has been used to manage patients with acute and chronic back pain. These treatments are often reported as beneficial by patients.

This study will examine the effect on functional status, range of motion, quality of life, and pain with Osteopathic Manipulative Treatment (OMT). Baseline will be defined as someone who has never had OMT, chiropractic, or massage, or has not received such treatments in the last 90 days. Back pain will be specific to pain presenting in the lumbar or thoracic regions of the spine.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years of age or older
* Back pain
* Able to arrange transportation and arrive to three study appointments.

Exclusion Criteria:

* May not have had manual treatment (massage, chiropractic, or OMT) in the last 90 days
* May not have any labs or imaging for their back pain recommended by their physicians the subject has not yet completed
* May not have had back surgery in past 60 days
* May not be pregnant or have given birth in the last 30 days
* May not have be unable to tell a member of the study team their name, city they live in and the current year.
Study on Plasmablastic Lymphoma Patients

This is an observational, multicenter, international and retrospective study, that aims to collect data on clinical and pathological characteristics, treatment regimens, outcome, and prognostic factors (clinical, biomarkers and/or radio-metabolic) in patients affected by PBL.

This study is an International, multicenter, observational, retrospective trial on patients affected by PBL. The information collected aim to obtain data from the real-life diagnosis, staging, management and treatment and outcome of PBL patients. A centralized pathological review of pathological samples is planned to define the rate of accurate diagnosis and to define a recommended immunohistochemical diagnostic panel for PBL. In addition, exploratory analysis will be performed to better characterize PBL.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of plasmablastic lymphoma (PBL) between Jan 1st 2000, and Dec 31st 2022
* Histologically confirmed plasmablastic lymphoma (PBL) diagnosis according to local pathological report
* Age \> 18 years old
* Availability of complete medical records
* Availability of histopathological material requested by the study

Exclusion Criteria:

* Any other histology than PBL
* Lack of complete medical records
* Lack of histopathological material requested by the study
Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma

The purpose of this study is to determine whether ulipristal acetate is effective in the treatment of females with anemia associated with uterine leiomyomas. The safety of this product will also be evaluated.

This is a randomized, placebo controlled, multicenter study with parallel groups in order to evaluate the efficacy and safety of ulipristal acetate in female subjects with anemia associated with uterine leiomyomas. The objective of this study is to determine if daily ulipristal acetate with iron is more effective than iron alone.

Eligibility Criteria:
Inclusion Criteria:

* Is a pre-menopausal female, 18 - 50 years;
* Has documented leiomyoma(s);
* Has leiomyoma-related anemia;
* Has an endometrial biopsy within the screening period prior to the first dose of the test article which shows no endometrial hyperplasia;
* Is willing and able to provide written informed consent and authorization to disclose protected health information.

Exclusion Criteria:

* Has a history of uterine surgery that would interfere with the study;
* Has a condition requiring immediate or intermittent blood transfusions;
* Has a known coagulation disorder;
* Has a history of uterine, cervix, ovarian, or breast cancer;
* Has used a selective progesterone receptor modulator or a gonadotrophin releasing hormone agonist in previous 6 months;
* Has received blood transfusion within 8 weeks before the screening visit;
* Has abnormal liver functions;
* Is pregnant.
A Clinical Trail of Acupuncture and Liu-Zi-Jue Exercise for Dysphagia in Post-stroke

The traditional Chinese medicine rehabilitation for post-stroke dysphagia impairment will be intervened, which can promote the recovery of dysphagia function of stroke patients, reduce the disability rate and improve the quality of life.

This study will collect inpatients from April 2020 to December 2022 who from the third affiliated hospital of Zhejiang university of traditional Chinese medicine, Jiaxing hospital of traditional Chinese medicine, Hangzhou hospital of traditional Chinese medicine.this study sets strict time window (stroke recovery, 30-180 days), use multi-center, large sample, randomized controlled study method and the objective recognition rehabilitation evaluation criteria and efficacy evaluation system to evaluate the clinical effect and analysis of health economics.

Eligibility Criteria:
Inclusion Criteria:

* Dysphagia

  * Meet the diagnostic criteria of stroke in traditional Chinese medicine;
  * Meet the diagnostic criteria of ischemic stroke in western medicine;
  * meet the diagnostic criteria of pseudobulbar palsy;
  * Age is 18-85, gender not limited;
  * The course of disease is 30 to 180 days;
  * Water test level 3 and level 3 above;
  * Meet the requirements for indications of acupuncture and moxibustion techniques; Volunteer to participate in this project, the patient has no serious complications, can accept acupuncture treatment and good compliance;
  * Sign informed consent
  * MOCA（Montreal Cognitive Assessment） score above 15.

Exclusion Criteria:

* Dysphagia

  * Patients with true bulbar palsy caused by brainstem encephalitis, motor neurone disease, pontine tumor, multiple sclerosis, myasthenia gravis, medulla bulbar cavity;
  * Cerebral hemorrhage caused by cerebrovascular malformation, trauma, aneurysm and other causes;
  * Pregnant or lactating women;
  * Patients with severe primary chronic diseases, severe dementia and cognitive impairment, serious language understanding disorders, and mental illness, including heart, liver, kidney and other viscera, as well as the endocrine system and hematopoietic system;
  * Suffered from a variety of bleeding tendency diseases;
  * The patient to swallow contrast drug allergy;
  * Patients who do not meet the inclusion criteria, do not have poor treatment compliance as prescribed, cannot judge the efficacy or incomplete data affect the judgment of efficacy and are not suitable for clinical observation;
Comparison of Transbronchial Cryobiopsy and Forceps Biopsy in Lung Transplant Recipients

CLAD is defined as loss of lung function after other factors, particularly infections have been excluded. Readily accessible diagnostic procedures to detect acute cellular rejection at the earliest possible occasion is crucial for posttransplant survival. Serial lung function tests, laboratory testing and pulmonary imaging are only clinical indicators of chronic allograft dysfunction in lung transplant recipients. Since forceps biopsy to detect acute cellular rejection in lung transplant recipients has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryoprobe.

Eventually, histopathological confirmation is indispensable to establish the diagnosis of acute cellular rejection. The current gold standard for diagnosis and grading of acute cellular rejection in order to initialize the optimal treatment, with particular regard to adjusting immunosuppression, is forceps biopsy to obtain ≥ five samples. Forceps biopsy has a reasonable risk profile in experienced centers and is performed 2, 4, 6 and 12 months posttransplant and when indicated. Given these concerns about diagnostic yield in forceps biopsy and unjustifiable risks after surgical lung biopsy, cryobiopsy has arisen as promising alternative diagnostic procedure. The value of cryobiopsy to obtain a conclusive diagnosis of ACR is discussed controversially due the lack of safety and efficacy data in lung transplant recipients

Eligibility Criteria:
Inclusion Criteria:

* routinely performed surveillance bronchoscopy and when indicated including serial FB and CB in the same session in patients wo had undergone lung transplant
* male or female subject of at least 18 years of age
* written informed consent after participant's information signed by patient

Exclusion Criteria:

* age \< 18 years
* Lacking ability to form an informed consent (including impaired judgement, communication barriers)
* Contraindication against bronchoscopy (e.g. co-morbidities)
* INR \> 2 or Thrombocytes \< 50000
* Double antiplatelet drugs (e.g. ASS and Clopidogrel) within 7 days before biopsy
* Anticoagulation with NOAK within 48 hours before biopsy
* Moderate or severe pulmonary hypertension (mPAP \> 30 mmHg, RV/RA \>30 mmHg)
Adaptation of Perioperative Satisfaction Scale in Regional Anesthesia and Investigation of Its Psychometric Properties

The aim of the study is to determine the psychometric properties of Perioperative Satisfaction Scale in Regional Anesthesia. In the Turkish version of the scale, a blind reverse translation method will use. And validity and reliability analyses will conduct.

The aim of the present research is to contribute to the international literature determining and describing the factor structure and psychometric qualities of the Perioperative Satisfaction Scale in Regional Anesthesia. An additional aim is to contribute to the national literature regarding the performance of the instrument in cross-cultural adaptation. The following steps will be taken: (a) translation of the scale from English into Turkish, (b) data collection, and (c) checking validity and reliability evidence for the adapted Perioperative Satisfaction Scale in Regional Anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the research
* Participants are over 18 years of age
* Provided regional anesthesia
* Postoperative second day
* No cognitive problems in self-expression

Exclusion Criteria:

* Lack of Turkish literacy
* Use of anesthesia technique other than regional anesthesia