cyrilzakka/clinical-trials huggingface dataset:
Diaphragm Function in Low Back Pain People

Pathomechanism of nonspecific low back pain is not clear for the researchers yet. Our aim is to evaluate the function of one of the stabilizer muscles of the low back area. Diaphragm's postural function is evident. However, we do not understand its changes of function in low back pain. Postural function of diaphragm was screened in supine position and in sitting too in a relaxed and in a contracted state. The thickness of diaphragm was measured and contraction ratio was calculated. Additionally, the stability limits of the trunk were measured. We were curios about the differencies in contraction ratio between asymptomatic and low back pain individuals.

Pathomechanism of nonspecific low back pain is not clear for the researchers yet. Our aim is to evaluate the function of one of the stabilizer muscles of the low back area. Diaphragm's postural function is evident. However, we do not understand its changes of function in low back pain. The postural function of diaphragm was screened with Zonare Zone Ultrasound System in supine position and in sitting too in a relaxed and in a contracted state. The thickness of diaphragm was measured by using an elecric caliper of the ultrasound device and the contraction ratio was calculated. Additionally, the stability limits of the trunk were measured with sitting functional reach and sitting lateral reach tests. We were curios about the differencies in contraction ratio between asymptomatic and low back pain individuals.

Eligibility Criteria:
Inclusion Criteria:

* capable to get the scene of the measurements
* age is over 18

Exclusion Criteria:

* serious neurologycal disorder, which affects the performance on the functional tests
* previous surgical intervention which has been affected the trunk
* intensive pain, which prevent the individual to perform the needed positions (supine and sitting)
* serious lung disease or breathing disorder
Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery

Desflurane and its effect on postoperative morbidity and mortality in patients undergoing thoracic surgery.

Halothane, enflurane, isoflurane, sevoflurane, and desflurane are volatile anesthetics, a group of general anesthetics. Because of the hypnotic effects of these agents, attention has mainly focused on the central nervous system. In the last 10 years, however, numerous studies have reported that volatile anesthetic agents interact with membrane structures of the myocardium and thereby attenuate cardiac mechanical dysfunction and limit ultrastructural abnormality on reperfusion after prolonged ischemia in the myocyte. Anesthetic-induced preconditioning has become a main topic in cardiac research worldwide

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria: • Elective thoracic surgery (thoracotomy, thoracoscopy)

* Lung resection
* One-lung ventilation
* Adults (18-80 years of age)
* ASA classification I - III
* Written consent (signature from patient)

Exclusion criteria:

* Known hypersensitivity or suspected allergy to propofol, soja or egg proteins
* Known hypersensitivity to volatile anesthetics (malignant hyperthermia)
* Medication with high dosage of statins
* Therapy with cyclosporin
* Severe renal impairment (GFR \< 30 ml/min)
* Oral steroid treatment at present or stopped less than 3 months before surgery
* Inflammatory processes (non-pulmonary or pulmonary): elevated C-reactive protein level (\> 20 mg/l) or leukocytosis (leukocytes \> 10x103/?l) or body temperature \> 37°C)
* Pregnancy
* Breast feeding
* The subject must not be involved in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion
Septic Pseudarthrosis Of Long Bone : Experience In A Regional Reference Center

Description of septic pseudarthrosis with chirurgical treatment in two steps (first step : Implementation of cement, second step : bone reconstruction, with or without device)


Eligibility Criteria:
Inclusion Criteria:

* patients having septic pseudarthrosis of long bone treated at the CRIOAc LYON

Exclusion Criteria:

-
Study to Find Out How Symptoms Severity Changes During the Standard Course of Treatment With the Cream Relief Pro and Suppositories Relief Pro (Active Ingredients Are Fluocortolone + Lidocaine) in Patients Suffering From Twisted and Bulging Veins in the Rectal Area (Acute Hemorrhoids)

In this study researcher wanted to learn more about the changes of biggest twisted and bulging veins in the rectal area (hemorrhoids) and changes of symptoms during a treatment period with the cream Relief Pro and suppositories Relief Pro. The study collected information on the treatment satisfaction of patients and their physicians with the prescribed treatment by using questionnaires. There were 3 visits at the physician's clinic for this study: one initial visit and 2 follow-up visits over a period of 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male \& female patients 18 to 65 years old;
* Patients with acute hemorrhoids 1 and 2 stage (with thrombosis (external, internal, mixed), including cases with bleeding);
* Prescription of fluocortolone + lidocaine as a part of routine clinical practice.

Exclusion Criteria:

* Patients participating in an investigational program with interventions outside of routine clinical practice;
* Hemorrhoid with stage ˃ II;
* Contraindications for use of Relief PRO in the approved product label;
* Anemia and/or severe/profuse hemorrhoid bleeding;
* Surgery in perianal region in anamnesis;
* Concomitant treatment with antibiotics/antiseptics, antithrombotics, antineoplastic and/or immunosuppressant;
* Inflammatory bowel disease;
* Hepatic diseases in severe and acute stages;
* Colorectal cancer;
* Purulent-inflammatory diseases of the perianal region and anal canal;
* Chronic pulmonary diseases in severe and acute stages.
Evaluation the Impact of Self-Stigma Reduction Program on Psychosocial Outcomes Among People Diagnosed With Schizophrenia

Backgrounds: Research evidence suggests that people diagnosed with schizophrenia (PDwS) experience higher level of stigma compared with other forms of mental illness, and they are prone to internalize stereotype, which exacerbates severity of psychiatric symptoms, reduces their psychosocial treatment adherence. The purpose of the study to evaluate the effectiveness of stigma reduction program on the perceived stigma, psychiatric symptoms, compliance with psychosocial intervention and self-efficacy.

Methods: A randomized controlled trial was conducted from November 2017 to December 2018 with 278 PDwS. Participants aged 18 years or older with DSM-IV schizophrenia or schizoaffective disorder, from four outpatient mental health clinics in Jordan, were randomly assigned to receive 13 sessions of a booklet form of stigma reduction program (n = 140) (psycho-education, cognitive behavioural therapy and social skills training), and treatment as usual \[TAU\] (intervention, n = 140), or TAU (control, n = 138). Participants were assessed at baseline, immediately post-intervention (post-treatment1) and at six months follow-up. The primary outcome measure was change in stigma perception. Secondary outcomes were psychiatric symptoms, compliance with psychosocial interventions and self-efficacy.


Eligibility Criteria:
Eligibility Criteria

* Adults aged 18 or over diagnosed with schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) (American Psychiatric Association, 2013).
* All participants had to be able to read and write English or Arabic
* Willing and able to consent.

Exclusion criteria were:

- People diagnosed with schizophrenia who had a learning disability, with known organic mental disorder, substance abuse
Efficacy and Safety of RTH258 Versus Aflibercept - Study 1

The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection at two dosage levels (3 mg and 6 mg) to aflibercept ophthalmic solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.

Subjects were randomized to brolucizumab 3 mg, brolucizumab 6 mg,and aflibercept 2 mg in a 1:1:1 ratio. Subjects in all treatment arms received 3 monthly loading doses (Day 0, Week 4 and Week 8), followed by a maintenance regimen, until the end of the study (Week 96/Exit). All subjects attended pre-specified visits every 4 weeks.

Subjects in the brolucizumab 3 mg and brolucizumab 6 mg arms followed a q12w/q8w maintenance regimen. Within the q12w/q8w regimen, the initial treatment after the loading phase was q12w (1 injection every 12 weeks). If disease activity was identified by the masked investigator at any of the disease activity assessments, dosing was adjusted to q8w (1 injection every 8 weeks) ("q12w/q8w regimen"). Once subjects were adjusted to the q8w interval, they stayed on that interval until the end of the study.

Subjects in the aflibercept 2 mg arm followed a q8w maintenance regimen until the end of the study.

Results reported up to Week 48 are based on the database locked for the primary analysis at Week 48. Results reported after Week 48 are based on the database locked at the end of study (final analysis).

Eligibility Criteria:
Key Inclusion Criteria:

* Provide written informed consent
* Active choroidal neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD) that affected the central subfield in the study eye at Screening;
* Total area of CNV comprising \>50% of the total lesion area in the study eye at Screening;
* Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at Screening;
* Best Corrected Visual Acuity (BCVA) between 78 and 23 letters, inclusive, in the study eye at Screening and Baseline using Early Treatment Diabetic Retinopathy Study (ETDRS) testing.

Key Exclusion Criteria:

* Any active intraocular or periocular infection or active intraocular inflammation in either eye at Baseline;
* Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis \>50% of the total lesion in the study eye at Screening;
* Subretinal blood affecting the foveal center point and/or \>50% of the lesion of the study eye at Screening;
* Any approved or investigational treatment for neovascular age-related macular degeneration (nAMD) in the study eye at any time;
* Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline;
* Pregnant or nursing women; women of child-bearing potential;
* Stroke or myocardial infarction in the 90-day period prior to Baseline.
PET-MRI Imaging in Patients With Symptomatic Carotid Artery Stenosis

Ischaemic stroke is a major cause of death and disability worldwide. In patients with recent stroke, the 18F-fluoride positron emission tomography-computed tomography highlights high-risk culprit carotid plaque and is more discriminatory than 18F-fluorodeoxyglucose. Using hybrid positron emission tomography-magnetic resonance imaging investigators propose to build upon these findings by prospectively assessing 18F-fluoride uptake in a broad range of patients with acute transient ischaemic attack or ischaemic stroke. Investigators will specifically examine the association of 18F-fluoride uptake with multiparametric magnetic resonance imaging assessments of atherosclerotic plaque, especially the role of thrombus and lipid. Finally, using transcranial Doppler and diffusion-weighted magnetic resonance brain imaging, an assessment of the functional consequences of 18F-fluoride-positive atherosclerotic plaque will be performed. If successful, this technique has a number of valuable translational applications including the better selection of patients for carotid intervention.

The ability to identify the culprit carotid plaque represents a key goal in carotid artery imaging. Although an array of non-invasive imaging techniques can detect a wide spectrum of complementary high-risk characteristics, no single modality can reliably identify vulnerable plaques associated with future stroke development. Substantial histological data suggests that specific plaque components identify patients at high-risk for future ipsilateral stroke and cardiovascular events. This implies that investigators need to look beyond the traditional paradigm where the basis for carotid endarterectomy were formulated by an invasive imaging modality that provided no information on the arterial wall composition. Alternative imaging strategies are therefore required targeting not only in vivo carotid morphology but also plaque biology and disease activity. This is fundamental to optimal risk-stratification and appropriate selection of patients for high-risk vascular intervention. One new approach is to use non-invasive molecular imaging targeted at plaque biology using hybrid systems such as positron emission tomography-magnetic resonance imaging.

Eligibility Criteria:
Inclusion Criteria:

• Patients with carotid artery stenosis (\>50% for men and \>70% for women, by NASCET criteria) above 40 years of age.

Exclusion Criteria:

* Patients with new stroke and a modified Rankin score \>3
* Chronic kidney disease with an estimated Glomerular Filtration Rate (eGFR) of \<30 ml/min/1.73 m2
* Atrial fibrillation
* Pregnant women
* Prior ipsilateral carotid intervention
* Prior neck radiotherapy
* Inability to tolerate the supine position
* Participation in the study would result in delay to surgery
* Psychiatric illness/social situations that would limit compliance with study requirements
* History of allergic reaction attributed to 18F-fluoride
* History of allergic reaction to gadolinium contrast media
* Metal implants and devices including pacemakers and defibrillators
The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study

D-ribose, a natural occurring pentose carbohydrate, has repeatedly shown to enhance high-energy phosphates and improve function following ischemia, states of congestive heart failure, and recently in subjects with lung disease. An initial preliminary, open label pilot study demonstrated a positive benefit of D-ribose in "Baby-Boomer" subjects aged 50 to 65 years old complaining of persistent fatigue. The objective of this study will build on the previously collected data to evaluate oral D-ribose vs. dextrose (administered as a supplement) in relatively healthy, yet fatigued subjects with a goal of improving their state of fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Presents with complaint of fatigue with duration longer than one month
* Males/Females between the ages of 50 and 65 years of age
* No previous clinical diagnosis of pulmonary, cardiac or metabolic disorders based on history
* Capable of performing a sub-maximal incremental treadmill exercise using cardiopulmonary analysis methods
* Normal blood pressure or those with mild, untreated pre-hypertension (\>120/70 or \< 140/90 mmHg)
* Able to be compliant with the supplement regimen, repeat clinical visits and completion of the study questionnaires
* Must be able to understand the consent form, agree to participate, and to execute their signature

Exclusion Criteria:

* Not presently taking any adenine nucleotide enhancing supplements
* History of non-compliance in previous studies
* Known to be pregnant
* Uncontrolled cardiac arrhythmias causing symptoms or unstable hemodynamics
* Moderate to severe gout
* A diagnosis of arthritis of the lower extremities
* Mental impairment, inability to cooperate
* History of acute non-cardiopulmonary disorder that may affect exercise performance, (e.g. infection, renal failure, thyrotoxicosis, etc.)
* Any disorder or condition that in the opinion of the study physician would render exercise unsafe or would impact exercise performance
* Any person who is incarcerated, or on a work release program

Additional Exclusions observed and sequelae during initial baseline evaluation:

* Drop in systolic blood pressure of \>10 mm Hg from baseline despite an increase in workload, when accompanied by other evidence of ischemia
* Moderately severe angina
* Increasing nervous system symptoms (e.g. ataxia, dizziness, or near syncope)
* Signs of poor perfusion (cyanosis or pallor)
* Technical difficulties monitoring the ECG or systolic blood pressure
* Subject's desire to stop
* Sustained ventricular tachycardia
* Electrocardiographic ST elevation (+1.0 mm) in leads without diagnostic Q-waves (other than V1 or aVR)
Chinese Medicine Treat for Hypertensive Renal Injury

This study evaluates whether the traditional chinese medicine (Qianyangyuyin formula) could prevent and treat early renal injury in patients with hypertension and microalbuminuria (defined as a urinary albumin to creatinine ratio between 30 and 300 mg/g) based on standard antihypertensive treatment.

Hypertension is the main cardiovascular disease and the most important risk factor for severe lethal and disabling diseases such as stroke, myocardial infarction, heart failure, and chronic renal insufficiency. The higher the blood pressure level, the higher the risk of these diseases. Antihypertensive drugs can control blood pressure, and effectively reduce the risk of these serious complications. A multi-center, randomized, parallel, placebo-controlled clinical study was designed to explore the effectiveness and safety of early intervention of Chinese medicine (Qianyanguuyin formula) in improving urinary albumin to creatinine ratio (ACR), based on standard antihypertensive treatment (losartan 100mg qd, if necessary combined with calcium channel blockers). Patients were recruited if they were (1) age between 35 and 55 years old, (2) primary hypertension (grades 2-3 ), (3) microalbuminuria (ACR of 30-300 mg/g) and eGFR of at least 60 ml / (min∙1.73m2), (4) ascendant hyperactivity of liver Yang or Yin deficiency in TCM syndrome. It's intented to form a standardized plan for the prevention and treatment of early renal injury in hypertensive patients.

Eligibility Criteria:
Inclusion Criteria:

* Subject has primary hypertension(grades 2-3)
* Subject has microalbuminuria \[defined as a urinary albumin/creatinine ratio (UACR) between 30 and 300mg/g, and a eGFR at least 60ml/(min∙1.73m2)\]
* Subject has ascendant hyperactivity of liver Yang or Yin deficiency in TCM syndrome
* Subject voluntarily participates in the trial and signs informed consent

Exclusion Criteria:

* Subject has secondary hypertension
* Subject with pregnancy or lactating
* Subject has serious life-threatening diseases, such as acute myocardial infarction, stroke, heart failure (NYHA IV), and malignant arrhythmia
* Subject's liver function (AST or ALT) is 2 times greater than normal value
* Subject has history of mental illness
* Subject currently participates in other drug clinical trials
Phase 1/2 Study of HS-10375 in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)

HS-10375 is an oral, highly selective, small molecular inhibitor of EGFR C797S. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10375 in Chinese advanced or metastatic NSCLC.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women greater than or equal to 18 years.
2. Locally advanced or metastatic NSCLC patients confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable .
3. Pathological, NSCLC tissue samples can be used to test EGFR C797S mutation by central laboratory for Phase 1b and Phase II subjects.
4. At least one measurable lesion in accordance with RECIST 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status: 0\~1.
6. Estimated life expectancy \>12 weeks.
7. Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.
8. Females must have the evidence of non-childbearing potential.
9. Signed and dated Informed Consent Form.

Exclusion Criteria:

1. Treatment with any of the following:

   * Previous or current treatment with EGFR C797S inhibitors.
   * Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10375.
   * Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10375.
   * Local radiotherapy for palliation within 2 weeks of the first dose of HS-10375, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose of HS-10375.
   * Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10375.
2. Inadequate bone marrow reserve or serious organ dysfunction.
3. Uncontrolled pleural, ascites or pericardial effusion.
4. Known and untreated, or active central nervous system metastases.
5. Active autoimmune diseases or active infectious disease.
6. Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications.
7. History of hypersensitivity to any active or inactive ingredient of HS-10375 or to drugs with a similar chemical structure or drugs belonging to the same category of HS-10375.
8. The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator.
9. The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator.
10. Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.
11. History of neuropathy or mental disorders, including epilepsy and dementia.
A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab

The primary purpose of this study is to investigate the characteristics of amyloid related imaging abnormalities (ARIA) and investigate the treatment continuation status (e.g., continuation, interruption) after the onset of ARIA in routine clinical practice in participants treated with lecanemab.


Eligibility Criteria:
Inclusion Criteria:

* All participants who are treated with lecanemab in routine clinical practice

Exclusion Criteria:

* None