cyrilzakka/clinical-trials huggingface dataset:
Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With Homozygous Familial Hypercholesterolemia (HoFH)

This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3- LRX for reduction of low density lipoprotein cholesterol (LDL-C) levels in patients with Homozygous Familial Hypercholesterolemia (HoFH).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≤ 35 kg/m2,
* Genetic confirmation of two mutant alleles at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus OR an untreated LDL-C \> 500 mg/dL (13 mmol/L) or treated LDL-C ≥ 300 mg/dL (2.59 mmol/L) together with either cutaneous or tendon xanthoma before age 10 years OR familial medical history of genetically confirmed heterozygous FH in both parents OR untreated elevated LDL-C and TC \> 250 mg/dL consistent with the disease,
* Patients must be on stable LDL-C lowering agents or on regular apheresis

Exclusion Criteria:

* Myocardial infarction, percutaneous transluminal coronary intervention, or coronary artery bypass graft surgery within 12 weeks prior to Screening, or cerebrovascular accident within 24 weeks prior to Screening.
* Diabetes mellitus if newly diagnosed or if HbA1c ≥ 9.0%
Outpatient Treatment of PE and DVT in the Emergency Department

Standardize the approach to outpatient Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT) treatment.

In the current protocol, we will study the outcomes most likely to influence emergency physician behavior, such as improved Emergency Department (ED) throughput, and decreased ED and Emergency Department Observation Unit (EDOU) length of stay. Metrics such as decreased admissions are also very important to hospital administrators so our results will have impact outside the ED as well. At the end of this study we will demonstrate that a carefully planned and data-driven approach to the outpatient treatment of Pulmonary Embolism (PE) is safe, improves operational metrics, and reduces cost.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older at time of enrollment.
* Subject is diagnosed with acute VTE (DVT or PE) in the MGH or BWH ED or transferred to the MGH or BWH ED (e.g from a clinic or outside hospital) with a diagnosis of acute VTE.
* Subject is treated as an outpatient (i.e. discharged) directly from the ED or admitted to the ED Observation Unit/ED Short Stay Unit on the outpatient treatment protocol.

Exclusion Criteria:

* Subjects admitted from the ED to an inpatient service will not be enrolled as study subjects, but will be used as contemporary controls.
* Subjects who are unable to understand or provide informed consent.
* Subjects unable or unlikely to follow up (e.g. prisoners).
A Retrospective Cohort Study to Develop Markers for TB Severity and Treatment Progress

The objective of this study is to compare how accurately the Xpert MTB/RIF assay Ct value at diagnosis and the AI-based tuberculosis activity score predict the treatment outcome of rifampin-susceptible pulmonary tuberculosis patients. As a retrospective observational study, data from patients diagnosed with rifampin susceptible pulmonary tuberculosis through the Xpert MTB/RIF assay performed on sputum in 2019 at the participating institutions will be analyzed (up to 900 people).


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with rifampin-susceptible pulmonary tuberculosis by Xpert MTB/RIF assay with sputum samples between January 1, 2019 and December 31, 2019

Exclusion Criteria:

* None
Resectoscopic Treatment of Atypical Endometrial Polyps in Fertile Women

The study aims to evaluate the long-term efficacy and prognosis of hysteroscopic resection and coagulation of the base of endometrial polyps with focal atypia in fertile women.

The introduction of hysteroscopy in clinical practice changed significantly our knowledge of uterine cavity, but did not stimulate the start of big studies with aim to evaluate the feasibility of conservative treatments for better defined diseases as endometrial polyp. The use of curettage(D\&C) has led the gynecologists to consider diffuse atypical endometrial hyperplasia and atypical polyp as the same disease. The treatment of these precancerous lesions recommended by scientific societies is aggressive (hysterectomy). Surprisingly, regarding hysterectomy we did not observe management modifications after the introduction of endoscopic techniques, as happened in other surgical disciplines.

To evaluate costs and health benefits of operational hysteroscopy we started in our Institute a study protocol in 1998. In a first trial we studied a conservative treatment of postmenopausal woman with high anesthesiologic risk who had endometrial polyps with atypia and no involvement of the base (Scrimin F. Am J Obstet Gynecol 2006;195:1328-30).

The good initial results and the request of conservative treatments by some women, desiring pregnancies, encouraged us to start this preliminary trial to evaluate the long-term efficacy and prognosis of hysteroscopic resection and coagulation of the base of endometrial polyps with focal atypia in a little sample of fertile women. Other studies suggest progestin treatment of well differentiated carcinoma in young women who desired to preserve their fertility. There is no evidence of a correlation between the tendency to develop endometrial polyps and the risk of endometrial carcinoma. The risk of malignant degeneration of endometrial polyps is not well known, but seems to range between 0.5% and 6%. On this background, we decided to study in the same population of fertile women and with a quasi-randomised design the possible additional effect of levonorgestrel-releasing intrauterine device (LNG-IUD).

Comparison: women assigned to odd numbers underwent polyp resection and endometrial surveillance with insertion of levonorgestrel intrauterine system (IUD group), women assigned to even numbers underwent polyp resection and endometrial surveillance without insertion of levonorgestrel intrauterine system (no IUD or control group).

Eligibility Criteria:
Inclusion Criteria:

* women in fertile age desiring to preserve their uterus
* atypical polyps, without atypia in the base. The hysteroscopic and histologic criteria for inclusion in the study were: proliferative, secretive, dysfunctional endometrium or simple hyperplasia in 4 random biopsies.

Exclusion Criteria:

* women with adenomatous or atypical hyperplasia in the random biopsies
Safety, Tolerability and Pharmacokinetics of Increasing Doses of BIBN 4096 BS in Healthy Male and Female Volunteers

The objective of the present study was to obtain information about safety, tolerability and pharmacokinetics of BIBN 4096 BS after oral administration of increasing doses in healthy male and female volunteers. With respect to pharmacokinetics, it was of particular importance to investigate whether therapeutic plasma levels (for treatment of migraine) could have been achieved by oral administration of a BIBN 4096 BS formulation.


Eligibility Criteria:
Inclusion Criteria:

* Participants should be healthy males and females
* Age range from 21 to 50 years
* Broca Index: within +- 20% of their normal weight
* Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead Electrocardiogram (ECG). Hematopoietic, hepatic and renal function test will be carried out in the laboratory. The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance. In accordance with Good Clinical Practice (GCP) and local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\>24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study (exclusion: substitution therapy regarding thyroid gland and/or ovaries)
* Use of any drugs which might influence the results of the trial (within one week prior to administration or during the trial)
* Participation in another study with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (\>= 100 ml) within four weeks prior to administration or during the trial
* Excessive physical activities (within the last week before the study)
* Any laboratory value outside the reference range of clinical relevance

For female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g. oral contraceptives, sterilization, intrauterine pessary (IUP)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
A Virtual Arm to Stop Smoking

The investigators reported in a pilot study presented at last year's Cybertherapy Conference (Girard \& Turcotte, 2007) that using an action-cue exposure strategy in virtual reality (ACE-VR; crushing virtual cigarettes) might be useful in the treatment of tobacco addiction.

The investigators are pursuing research in this area with a randomized control trial based on 90 smokers who will receive a brief psychosocial smoking cessation program (25 people are enrolled so far and we expect to finish the study before the conference). During the first four weeks of an eight-session psychoeducational and motivational program, all participants will be immersed in VR. During the immersions in VR, 45 of the participants will use a virtual arm to catch and crush virtual cigarettes. The other half of the sample will use the virtual arm to catch virtual fruits (control condition).

The smoking frequency, and abstinence, will be assessed with a daily diary and exhaled carbon monoxide tests (the CO2 tests will provide an objective confirmation of the abstinence reported in the diaries). The success the program will be compared based on the number of subjects who quitted or reduced their smoking frequency. The severity of addiction will be assessed with two questionnaires, the Fagerstrom and the Horn tests. Craving and withdrawal effects will be measured with the Minnesota Nicotine Withdrawal Scale (MNWS) and the Brief Questionnaire of Smoking Urges (QSU-Brief) at the baseline and at the visits from weeks 1 through 4, 6, 12 and at the end of the program. Before the VR immersion, the Immersive Tendencies Questionnaire will be administered and after each VR session participants will fill two questionnaires addressing presence and cybersickness. The comparative impact of both treatments will be tested with repeated measures ANOVAs (and planned contrasts) with sufficient power to detect medium effect sizes.

The main goal of our study is show that crushing virtual cigarettes can boost the impact of a behavioural program dedicated to cigarette addiction.

A detailed description is available, in French, by contacting stephane.bouchard@uqo.ca.

Eligibility Criteria:
Inclusion Criteria:

* adult smoker
* aged 18 - 65
* willing to stop smoking
* at least 10 cigarettes per day in the last year

Exclusion Criteria:

* receiving concomitant treatment for smoking (e.g., patches or varenicline)
* weight problems : Body Mass Index \< 15 kg or \> 45.5 kg
* suffering from a mental disorder, such as major depression, schizophrenia, etc.
Intervention Study to Enhance Patients' Pain Management After Cardiac Surgery

The main objective of this randomized controlled trial is to evaluate the effect of an intervention formed as a pain booklet provided to patients at discharge from hospital following cardiac surgery.

The primary objectives are to:

1. Develop and implement a pain booklet to improve pain management after cardiac surgery
2. Evaluate the effect of the pain booklet compared to a group of patients given usual care


Eligibility Criteria:
Inclusion Criteria:

* undergoing their first elective CABG, valve surgery or a combination
* receiving the standard preadmission information
* able to take care of themselves after discharge
* able to read and write Norwegian and fill in the questionnaires
* able to be contacted by telephone

Exclusion Criteria:

* more than 12 hours at the intensive care unit after surgery
Epidermal Growth Factor Receptor Mutations in the Blood of Patients With Advanced Non-Small Cell Lung Cancer

RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations in the blood of patients with advanced non-small cell lung cancer.

OBJECTIVES:

* Determine if epidermal growth factor receptor (EGFR) mutation exists in the peripheral blood of patients with advanced non-small cell lung cancer (NSCLC).
* Estimate the frequency of EGFR mutation in these patients.
* Correlate the presence of EGFR mutation in blood with EGFR mutation in primary or metastatic NSCLC tumor block.

OUTLINE: Patients undergo blood collection for analysis of epidermal growth factor receptor mutation by DNA sequencing.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed advanced non-small cell lung cancer
* Must have available tumor tissue block

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Dual PET/CT Imaging in Lung Cancer

The purpose of this study is to compare conventional PET/CT scan performed 1 hour after injection of the radioactive tracer FDG (PET/CT\[1\]) with PET/CT performed after 3 hours (PET/CT\[3\]) in a group of patients with biopsy verified lung cancer or high suspicion of lung cancer after initial work-up (chest x-ray and CT of thorax/upper abdomen), who are potentially operable.

The investigators also want to:

* To find the sensitivity, specificity and accuracy in PET/CT 1h and 3 h in the staging of lung cancer (N-/M-stage). Our gold standard is pathology, when not possible - follow-up (se Gold Standard 6.1.1)
* To compare SUVmax with the expression of GLUT1 and G-6-Pase in tumors
* To compare the expression of GLUT1 with the activity of G6Pase
* To compare SUVmax, RI, tumor/liver ratio, GLUT1 and G-6-Pase with the occurrence of relapse within a year after curative surgery

Eligibility Criteria:
Inclusion Criteria:

* Cytologic/histologic-verified lung cancer or high suspicion of lung cancer after initial work up
* Candidate to curative intended surgery after initial work up (usually chest x-ray, CT of chest/upper abdomen and if needed spirometry).

Exclusion Criteria:

* Former lung cancer
* Contraindications for PET/CT: Pregnancy, recent chemoradiotherapy
* Diabetes mellitus.
the Effect of Danhong Injection on Microcirculation in the Treatment of Patients With STEMI After the PTCA Surgery.

This study focused on the effect of Danhong injection on microcirculation in the treatment of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.

Research Topic.

* A randomized, double-blind, placebo-controlled, multi-center clinical trial of the effect of Danhong Injection on microcirculation in the treatment of patients with STEMI(ST- elevation myocardical infarction) after the PTCA surgery.

Research Purpose.

* This study focused on the effect of Danhong injection on microcirculation in the treatment of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.

Research design.

* A randomized, double-blind, placebo-controlled, multi-center clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Clinically definite or laboratory-supported diagnosis of STEMI ,with the indication of PTCA surgery.
* 18≤Age≤75;
* Agreed to join in the study and signed the inform consent form.

Exclusion Criteria:

* Cardiogenic shock , Killip III-IV degree , papillary muscle rupture , septal perforation , episodes of ventricular tachycardia and ventricular fibrillation after electrical cardioversion , temporary pacemaker implanted AVB III degree.
* Past history of PCI and CABG
* Acute or chronic infectious diseases(for example severe pneumonia);
* Recent history of hemorrhagic stroke(within six months)
* Combined with liver and kidney dysfunction;
* History of valvular heart disease;
* Congenital heart disease or Pulmonary hypertension;
* All kinds of history of cardiomyopathy;
* Bleeding and other thrombotic diseases;
* Severe anemia , thrombocytopenia , Other diseases of the blood system;
* Cancer , Autoimmune disease , All kinds of the patients who use the glucocorticoid and immunosuppressor;
* Menstrual period women, pregnant women and lactating women, pregnancy test positive or recent family planning.
Study on Skin Toxicities Induced by Cancer Treatments

The skin toxicities will be evaluated on patient (male or female) with an indication of cancer treatment in the case of solid tumor of the breast, or lung.


Eligibility Criteria:
Inclusion Criteria:

1. Patient, male or female, aged 18 years and older, with a solid tumor breast or lung, localized, locally advanced or not, metastatic or not;
2. Patient in medical oncology consultation requiring systemic anti-tumor therapy (chemotherapy, targeted therapy, hormone therapy, immunotherapy) in neo-adjuvant, adjuvant or metastatic;
3. Treatment planned for a minimum period of 3 months (from the date of inclusion);
4. Having a social security protection;
5. Signed informed consent form of the study.

Exclusion Criteria:

1. Patient treated for lymphoma, leukemia or inflammatory breast cancer ;
2. Patient with a solid tumour which location is other than breast or lung;
3. Patient with a tumor wound ;
4. Patient with a general condition \> 2 at baseline (ECOG classification) ;
5. Patient receiving anti-tumor treatment with radiotherapy exclusively or associated with concomitant radiotherapy ;
6. Patient unable to receive information about the study and to give consent ;
7. Persons deprived of liberty or guardianship ;
8. Impossible submission to study procedures for geographical or psychological reasons.
Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy

The purpose of this study is to explore the safety and efficacy of ranibizumab to treat non-arteritic ischemic optic neuropathy based on clinical and anatomical findings.

Nonarteritic anterior ischemic optic neuropathy (NAION) is the most common acute optic neuropathy in people older than 50 years. It is characterized by sudden partial loss of vision in one eye and has an increased risk of vision loss in the fellow eye. Although cause has not been determined, NAION is thought to occur following an idiopathic ischemic event involving the short posterior ciliary arteries that supply blood to the most anterior part of the optic nerve. A complete loss of vision is rare, but partial loss of visual field or acuity can result from NAION in the affected eye(s).

Patients who have a 'disc at risk' or 'crowded disc' (small cup: disc ratio) are at increased risk for developing NAION. Other risk factors for NAION include age \> 50 years and white race (estimated 95% of cases). Hypertension and diabetes also predispose to NAION development. Other factors that have been associated with NAION include high cholesterol, arteriosclerosis, stroke, cardiac and intraocular surgery, tobacco use, nocturnal hypotension, blood loss, glaucoma, elevated homocysteine and sleep apnea. The association between NAION and hypertension, high cholesterol and diabetes is stronger in individuals younger than 50 years than in older persons.

Patients with NAION caused by ischemia leading to swelling of the optic nerve and rapidly progressing visual loss have had limited results with therapy such as corticosteroids, brimonidine, levodopa or surgery, such as optic nerve sheath decompression, in the past. Currently, there is no standard of care for these patients.

Although the role of vascular endothelial growth factor (VEGF) in NAION has not been established, ischemic conditions may lead to VEGF production which could be the cause of edema and swelling. This possibility suggests that VEGF may be a target for therapeutic intervention by ranibizumab. Ranibizumab has demonstrated an effect on edema and vascular permeability. In animal studies it has shown a concentration- dependent effect of blunting the vascular permeability induced by VEGF. Of the more than 5,000 subjects with age-related macular degeneration in current and completed clinical trials, vascular permeability and edema have decreased with the use of ranibizumab.

Eligibility Criteria:
Inclusion Criteria:

* provide written informed consent
* 21 years of age or older
* new onset, within 14 days, of ischemia and vision loss
* Best Corrected Visual Acuity (BCVA) 20/40 or worse

Exclusion Criteria:

* pregnancy or lactation
* proliferative diabetic retinopathy,
* diabetic macular edema,
* uveitis,
* history of ocular trauma,
* severe glaucoma,
* age-related macular degeneration.
* prior or concomitant treatment of oral steroids within 30 days,
* participation in any studies of investigational drugs within 30 days,
* participation in a ranibizumab clinical trial or,
* prior treatment intravitreally or intravenously of Avastin or steroids.
Effect of Bio-mechanical Awareness and Core Stability Exercises on Mechanical Low Back Pain

investigate the effect of bio-mechanical awareness and core stability exercises on mechanical low back pain among Egyptian Physiotherapists

The aims of this study are:

1. to investigate the effect of bio-mechanical awareness and core stability exercises on the intensity of low back pain among Egyptian Physiotherapists.
2. to investigate the effect of bio-mechanical awareness and core stability exercises on and back muscle endurance among Egyptian Physiotherapists.
3. to investigate the effect of bio-mechanical awareness and core stability exercises on level of function (disability) associated with low back pain among Egyptian Physiotherapists.
4. to investigate the effect of bio-mechanical awareness and core stability exercises on fatigue among Egyptian Physiotherapists.
5. to investigate the effect of bio-mechanical awareness and core stability exercises on psycho-social factors at work among Egyptian Physiotherapists.

Eligibility Criteria:
inclusion criteria:

* Egyptian Physiotherapists with non-specific low back pain.
* Physiotherapy graduate who worked for at least two years (Khairy et al.,2019).
* Age range from 25 to 40 years old (Pellissier et al., 2023).
* Male and female.
* Normal BMI ranges between 18.5:24.9 kg/m2.

exclusion criteria:

* Physiotherapists outside the target range age an BMI.
* Students of physical therapy or Physiotherapists who worked for less than two years.
* Physiotherapists who had lumbar spine surgery.
* Physiotherapists who had history sever lumbar problem spondylolisthesis, tumor, fracture.
* Physiotherapists who suffers from vertigo.