cyrilzakka/clinical-trials huggingface dataset:
Observational Cohort of COVID-19 Patients at Raymond-Poincare

The SARS-CoV-2 infection detected in China in December 2019 is responsible for the current COVID-19 pandemic affecting nearly 1.2 million people worldwide to date. Infection with this virus of the coronavirus family is causing a broad clinical spectrum, the main manifestation of which is an influenza-like condition associated with a pattern of severe hypoxemia pneumonia, and in some cases fatal. Little is known about this pathology, so we propose to carry out an observational cohort of patients treated in our hospital for an SARS-CoV-2 infection.

This cohort should make it possible to clinically, biologically and radiologically characterize the SARS-CoV-2 infections. We will also collect the therapeutic strategies implemented, their possible toxicity and the evolution of the patients.

COVID-19 is a virus belonging to the coronavirus family, which includes a large number of viruses that can cause a wide variety of diseases in humans. The SARS-CoV-2 virus that caused the current COVID-19 pandemic, although widely described in the literature, still has many grey areas. The main clinical manifestation is an influenza-like illness associated with respiratory tract infection that can lead to severe hypoxemic pneumonia with fatal outcomes in 2.3% of cases. The clinical spectrum is not yet very well known, as evidenced by the evidence of anosmia, agueusia, or recent skin manifestations, but also strong suspicion of possible neurological damage. Similarly, it is not yet very well established, apart from certain co-morbidities, which patients are likely to develop serious forms requiring admission to intensive care, as shown by the proportion of patients \< 60 years of age admitted to intensive care for ARDS.

Moreover, the question of how to manage these patients still raises many questions, particularly about the type of molecules to be introduced and at what point in the history of the disease. Some of these molecules, such as the Lopinavir/Ritonavir combinations and the Hydroxychloroquine/ Azithromycin combination, are not free of complications, particularly cardiac complications requiring close monitoring by ECGs and repeated dosing, the effectiveness of which has not yet been clearly demonstrated.

In order to better understand this infection, we propose to set up a cohort of patients treated for CoV-2 SARS infection on our site.

Study scheme:

Longitudinal cohort study of patients with confirmed or strongly suspected CoV-2 SARS infection.

Eligibility Criteria:
Inclusion criteria:

* Patient ≥ 18 years old
* SARS-CoV-2 infection confirmed by PCR or strongly suspected on compatible radio-clinical grounds during an epidemic period.

Exclusion criteria:

* Not able to express their opposition
* Patient under guardianship or curatorship
A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold Versus Everolimus-eluting Metallic Stent in Long Coronary Lesions

PCI of diffuse long coronary lesions still remains challenging because of relatively high risk of in-stent restenosis and stent thrombosis compared to short coronary lesions. The purpose of the study is to compare an incidence of composite of major adverse cardiovascular events (MACEs) at 1 year between Absorb everolimus-eluting BVS and Xience EES after coronary intervention in long lesions.


Eligibility Criteria:
Inclusion Criteria:

* Age 19-85 years
* Patients with ischemic heart disease requiring PCI
* Significant coronary de novo lesion (stenosis \>50% by quantitative angiographic analysis) requiring stent ≥28 mm in length based on angiographic estimation
* Reference vessel diameter of 2.5 to 3.75 mm by operator assessment

Exclusion Criteria:

* Acute myocardial infarction within 48 hours with unstable hemodynamics requiring pharmacologic or mechanical support
* Complex coronary morphology including left main disease and bifurcation lesion requiring two-stent technique
* Contraindication or hypersensitivity to anti-platelet agents or contrast media
* Treated with any metallic stent or BVS within 3 months at other vessel
* Cardiogenic shock
* Left ventricular ejection fraction \<40%
* Pregnant women or women with potential childbearing
* Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
* Inability to understand or read the informed content
HIV Resistance, Molecular Epidemiology and New Treatment Strategies in the Eastern European Region and in Russia

Cohort based prospective monitoring of the spread of HIV drug resistance during a phase when new anti-HIV drugs are introduced.

The patient cohort that has been set up includes both viral sequences and clinical/epidemiological data from diverse geographical regions in Russia and Ukraine, where continued prospective follow-up - both short-term and long-term - is warranted to monitor and investigate drug resistance and its impact on INSTI roll-out. Likewise, continued collection of samples and data is fundamental to study the impact of DRM (Drug Resistance Mutations) in Russia and the Eastern European Region for upcoming new drugs, in order to expand the knowledge and to get a representative pattern.

In particular the promoter aims in the timeframe of 1 year at:

* Cohort based prospective monitoring of the spread of HIV drug resistance during a phase when new anti-HIV drugs are introduced. It requires a long-time follow up to identify any changing PDR (Pre-treatment Drug Resistance) patterns.
* Cohort based prospective exploration of the temporal kinetics of subtypes and sub-subtypes in Russia in order to define the coming molecular epidemiology of HIV-1.
* Expand the description of DRM (natural polymorphisms, pre-existing, acquired and off-target mutations) in a larger number of patients mainly from Russia. The samples and the collected data will be used to study the impact of DRM on the phenotypic sensitivity for INSTI and other already diffused drugs (NRTI/NNRTI).
* Support the implementation and evaluation of the PDR surveillance plan which has been defined in accordance with WHO (World Health Organisation) directives.

Eligibility Criteria:
Inclusion Criteria:

* naïve patients starting 2nd generation INSTI treatment
* first line patients under 2nd generation INSTI treatment with either viral RNA sequence before therapy start, or PBMC available with PBMC sample date not more than 3 years from therapy start date (with reasonably sure history of no failure in the interval from therapy start date to PBMC sample date\]).

Exclusion Criteria:

* patients not having a signed informed consent for the EIDB data repository, if required by local/national legislation in order to have data in the common data repository.
* patients not having Signed Informed consent for the present study, if required by local authorities iii) Persons aged \< 18 at baseline
Phase I Dose-Escalation Study to Evaluate Tolerability, Safety & PK of INO-8875 in Healthy Older-Adult Volunteers

The purpose of this study is to evaluate how tolerable and safe it is to give INO-8875 eye drops at different concentrations to normal older healthy adult volunteers for two weeks.


Eligibility Criteria:
Inclusion Criteria:

* male, or a female with a negative pregnancy test and without childbearing potential
* aged 35 to 65 years
* body weight is ≥50 kg and ≤115 kg

Exclusion Criteria:

* Subject has glaucoma or any active ophthalmologic disease including conjunctivitis
* Subject has a central retinal vein occlusion in either eye at any time in the past
* Subject is currently on any drug that might affect IOP including oral or ocular glucocorticoids or ephedrine
* Subject has history of ocular trauma or surgery (except for non-incisional surgery performed at least 3 months prior to the Screening visit)
* Subject has a prosthetic eye or any ocular abnormality precluding reliable applanation tonometry in either eye including an immobile pupil.
* Subject is not able to refrain from use of contact lenses during the Treatment Period
Study of Chemotherapy Sequenced by or Combined With EGFR-TKIs for NSCLC Patients Failed to EGFR-TKIs Therapy

There are two different treatment modes for NSCLC patients who failed to epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) after initially responding to EGFR-TKI. One is EGFR-TKI combined with chemotherapy and the other is chemotherapy followed by EGFR-TKI. It is unclear which one is more suitable to this group of lung cancer patients. So this phase Ⅱclinical trial is designed to compare the efficiency and safety of these two different treatment modes.

Responses to EGFR-TKIs are quiet dramatic and durable, especially in patients with EGFR gene classic mutations, such as 19 deletion or 21 leucine 858 arginine(L858R). However, most patients with NSCLC who respond to EGFR-TKIs eventually experience progression of disease after approximately 12 months. The lack of an established therapeutic option for NSCLC patients who have progressive disease after EGFR-TKIs failure poses a great challenge to physicians in terms of how best to manage this growing group of lung cancer patients.

In clinical practice some of the initially EGFR-TKI sensitive tumors which progressed evidence a striking increase in tumor volume within several weeks, after being taken off EGFR-TKI. This response is called "rebound phenomenon". Most experts still believe that these tumors continue to be "oncogene-addicted" to EGFR. So it is rational that EGFR-TKI combined with another chemotherapy regimen can be used to treat NSCLC after the failure of EGFR-TKI therapy.

However in some phase Ⅱclinical trials involved a few NSCLC patients who failed to EGFR-TKI therapy, another treatment mode, that is to say, at least one cytotoxic chemotherapy was used firstly then switched to EGFR-TKI therapy until progression of disease, was used and called reintroduction or retreatment of EGFR-TKI. Using this treatment mode, some investigators reported the partial remission (PR) and disease control rate (DCR) were observed in 21.7%-36% and 65.2%-86% NSCLC patients.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* histologically and cytologically proven non-small cell bronchogenic carcinoma (sputum cytology alone was not acceptable)
* clinical stages ⅢB or Ⅳ
* recurrent or refractory disease following previous first-line chemotherapy regimens containing platinum and second-line EGFR-TKIs therapy
* partial remission (PR) or stable disease (SD) at least for 6 months during previous EGFR-TKI treatment
* at least one bidimensionally measurable or radiographically assessable lesion
* Eastern cooperative oncology group performance status (ECOG PS) ≤ 2
* life expectancy ≥ 12 weeks
* adequate hematological, renal, and hepatic functions

Exclusion Criteria:

* additional malignancies
* uncontrolled systemic disease
* any evidence of clinically active interstitial lung disease
* newly diagnosed central nervous system (CNS) metastasis and not treated by radiotherapy or surgery
* pregnancy or breast feeding phase
Evaluation of the Usefulness of a PRN Regimen Using Ranibizumab for Macular Edema Due to Branch Retinal Vein Occlusion

Monthly intravitreal ranibizumab (IVR) during the first 6 month had great effect for macular edema with branch retinal vein occlusion (BVO) both in visual and anatomical outcome. It is expected that similar results could be obtained by less frequent IVR. The purpose of this study is to investigate if IVR by PRN is as effective as by monthly. In addition, the investigators are going to study the relationship between macular edema and the size and location of retinal non-perfusion area.

It was demonstrated in BRAVO study that IVR had great effect for macular edema with BVO both in visual and anatomical outcome. However IVR was done monthly for all patients (except Sham group) during the first 6 months in BRAVO study. It is expected that similar results could be obtained by less frequent IVR, and if so, it will contribute to reduce patient's burden and medical cost. Thus it is necessary to determine the optimal regimen of IVR therapy.

In this study, considering the medical and social circumstances in Japan, the investigators are going to investigate if IVR by PRN is as effective as BRAVO study.In addition, the investigators are going to study the relationship between macular edema and the size and location of retinal non-perfusion area (NPA), because VEGF is thought to be released from non-perfused retinal tissue, and VEGF production may be correlated with NPA size and location. The investigators are going to measure the size of NPA semi-quantatively by ultra wide field fluorescein angiography (UWFA) using Optos 200Tx. Then the relationship with macular edema will be studied. The effect of ranibizumab to NPA is controversial. In this study, it will be investigated, too.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Macula edema secondary to BRVO
* BCVA of 77 to 20 letters assessed with the use of ETDRS charts
* CRT ≧250μm

Exclusion Criteria:

* Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation (study eye)
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for RVO
* Ocular disorders in the study eye that may confound interpretation of study results
* BCVA over 77 letters between screening and Day 0
* The pregnant or lactating woman
Neural and Cognitive Mechanisms of Depression and Anxiety: a Multimodal MRI Study

To explore the neural and cognitive mechanisms of depression (including unipolar depression and Bipolar disorder) and anxiety using multimodal MRI techniques.


Eligibility Criteria:
Inclusion Criteria:

* Age range from 16 to 55 years old.
* All patients were interviewed by two experienced psychiatrists using the Structured Clinical Interview for DSM-IV (patient edition)

Exclusion Criteria:

* Schizophrenia, mental retardation or personality disorder, any history of loss of consciousness, substance abuse, serious medical or neurological illness.
* Subjects with contraindications to MRI
Acute Metabolic Effects of Pre-meal Consumption of Whey in Women at Risk of Gestational Diabetes Mellitus

The main objective of our study is to investigate the metabolic effects of whey protein (whey protein isolate, WPI, (Lacprodan® ISO.Water. from Arla Foods Ingredients) compared to placebo when consumed by women in risk of gestational diabetes mellitus (GMD) 30 minutes prior to an oral glucose tolerance test (OGTT). We will also investigate any changes in substrate metabolism and energy expenditure using indirect calorimetry. Differences in hunger and satiety parameters as well as rate of gastric emptying will also be assessed. Furthermore, we will investigate the glucose response when the women consume the intervention at home in their own environment 30 minutes before breakfast in various doses (placebo, 10, 15, 20, 30 g whey). The women will be monitored with continuous glucose monitors, activity monitors and all meals will be provided.

The two study days in the laboratory will be repeated 3-9 months after pregnancy. The purpose of this is to be able to compare the metabolic response of pre-meal whey during pregnancy with the response in a not-pregnant state. The study days at home will not be repeated after pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Referred to screening for Gestational Diabetes Mellitus by week 24-30 or GDM
* BMI 20-35
* Normal blood pressure
* Age \> 18 years

Exclusion Criteria:

* Special dietary regimes \> 1 month at time of inclusion e.g. ketogenic diet
* Daily intake of protein supplements
* Milk allergy or phenylketonuria
* Celiac disease
* Medication with effect on glucose metabolism e.g. steroid
* Do not speak or understand Danish
* Gemelli
* Polycystic Ovarian Syndrome
* PI finds the patient unfit (like mental illness, too nervous or other)
* Anemia (hemoglobin \<6 mmol/l)
* Severe chronic illness
* Depression
* Severe nausea/vomiting
* Non-breakfast eaters
Comparison of Brugger's Exercise With and Without Kendall Exercises in Sterno-Symphyseal Syndrome

Sterno-symphyseal syndrome is a natural result of prolonged sitting work, especially with computers .In actual it is the approximation between pubic symphysis and sternum. The aim of study will be to compare the effects of Brugger's exercise with and without Kendall exercises on Pain, Craniovertebral angle and Range of motion in patients with Sterno-Symphyseal Syndrome. Group A will be treated with Kendall exercises and Brugger's Exercise and Group B will receive Brugger's Exercise only. Standard treatment will be provided to both groups. Outcome measures will be conducted at baseline, after 3 weeks and by the end of 6 weeks of treatment. Data will be analyzed using SPSS software version 25.

Sterno-symphyseal syndrome is a natural result of prolonged sitting work, especially with computers. It is basically the approximation between the sternum and pubic symphysis. This syndrome has been given several names including posterior cervical-dorsal syndrome and more commonly Computer back or Student syndrome. This posture is associated with increased muscular tension and faulty respiration habit. The aim of study will be to compare the effects of Brugger's exercise with and without Kendall exercises on Pain, Craniovertebral angle and Range of motion in patients with Sterno-Symphyseal Syndrome.

A Randomized Clinical Trial will be conducted at Umar Hospital Lahore through convenience sampling technique on patients which will be allocated using simple random sampling through computer generated method into Group A and Group B. Group A will be treated with Kendall exercises and Brugger's Exercise and Group B will receive Brugger's Exercise only. Standard treatment will be provided to both groups. Outcome measures will be conducted through pain, Craniovertebral angle and neck range of motion at baseline, after 3 weeks and by the end of 6 weeks of treatment. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria: • Age Group between 18-35 years old

* Gender: Male and Female both included (23).
* Subjects with slumped posture with Craniovertebral angle less than 50 degree (12).
* Subjects having distance from xiphoid process to pubic symphysis less than 28 cm (11 inches).
* Subjects sitting more than 4 hours a day (12).
* Subjects with upper back pain with \< 7 score on Numeric Pain rating scale

Exclusion Criteria: • Subjects with Untreated fractures on cervical and upper thorax spine.

* Neoplasm on spine.
* Cervical disc prolapses.
* Subject with psychological disorder.
* Vertebro basilar insufficiency and Migraine are excluded (12).
IOP Changes Associated With SICS and Phako

Prospective randomized trial in patients requiring cataract surgery in which IOP, angle anatomy and other demographic and clinical data are compared. Subjects randomized to both MSICS and phakoemulsification

Prospective, randomized, double masked, parallel assignment clincal trial. Five hundred eyes of 500 participants between 40 - 70 years with normal IOP, gonioscopically open angles and age related cataract. Eyes underwent phacoemulsification or MSICS following a 1:1 randomization and allocation code. Best corrected vision (BCVA), IOP, comprehensive slit lamp evaluation and anterior segment optical coherence tomography (ASOCT) were performed at baseline and at 1, 3 and 6 months follow up.

Eligibility Criteria:
Inclusion Criteria:Age over 40 requiring cataract surgery -

Exclusion Criteria: inability to follow up, lens not suitable for phacoemulsification, prior intraocular surgery, glaucoma

-
Comparison Between Ultra-low-dose Computed Tomography and Lung MRI in Cystic Fibrosis

The purpose of this study is to compare the performances of ultra-low dose computed tomography (CT) and lung magnetic resonance imaging (MRI) for morphological assessment of cystic fibrosis-related lung disease and to compare their performances to conventional low dose CT

Cystic fibrosis (CF) is a recessive autosomal disease caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that encodes for an epithelial chloride channel involved in ion and fluid transport. CF is the most common inherited disease in Caucasians and disease severity mainly depends on the degree of lung involvement, which can lead to terminal respiratory failure Disease monitoring of CF-related lung disease rely on functional assessment and complimentary morphological assessment. Conventional low-dose chest computed tomography (CT) is currently the gold standard for the morphological assessment of CF-related lung disease but ultra-low dose chest CT and high-resolution magnetic resonance imaging (MRI) of the lung using UTE sequences have been recently developed and allow important radiation reduction of radiation dose exposure. However the performances of these 2 competing imaging methods remains to be compared.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 year-old
* Diagnosis of cystic fibrosis provided by genetic and swear test
* Chest CT acquisition performed as part of the standard follow-up
* Patient with social security or health insurance
* Informed consent

Exclusion Criteria:

* MRI contraindication
* Orthopnea
* Inability to hold breath for 17 seconds
* No spirometry planned the same day
* Lung transplant patient
Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit

Patients with constipation often have bloating and abdominal distension. It is unclear if this is related to intestinal bacteria. Hypothesis: treatment for constipation may reduce small bowel and colon bacteria colonization, a change in the balance of stool microorganisms, and improve the symptoms of dyspepsia and constipation.

This is an open-label study to collect data on upper and lower GI symptoms, hydrogen breath test, stool PCR, and serum before and after 4 weeks of lubiprostone 24 mcg by mouth twice a day for 4 weeks.

Eligibility Criteria:
Inclusion Criteria: Functional constipation by Rome III criteria

Exclusion Criteria:

1. History of esophageal or gastric surgery (including vagotomy, antireflux, and obesity surgery)
2. History of small bowel or colon resection (excluding appendectomy and cholecystectomy)
3. History of gastric outlet, small bowel, or colon obstruction
4. History of surgery for small bowel adhesion lysis
5. History of surgery for gastroparesis
6. Diagnosis of diabetes requiring daily medications
7. Diagnosis of connective tissue d/o (including scleroderma, lupus, mixed connective tissue disorder)
8. Diagnosis of neuromuscular disorder (including multiple sclerosis, Parkinson, muscular dystrophy, dysautonomia, dystonia)
9. Disorders of small bowel pseudo-obstruction or dumping syndrome
10. Untreated or poorly controlled hypothyroidism
11. Taking an opiate medication daily
12. Taking a medication daily that can cause constipation (calcium channel blocker, anticholinergic, iron supplements, etc.)
13. Active cancer being treated
14. History of significant liver, kidney, cardiac disease that may interfere with study compliance
15. Known allergy or side effects to lubiprostone
16. Non-ambulatory patients: bed-ridden, nursing home resident, etc.