cyrilzakka/clinical-trials huggingface dataset:
Geriatric Care for Older People Hospitalised for COVID-19

Current COVID-19 pandemic implies regular treatment adaptation by physician, according to scientific publication evolution. Older adults are particularly affected by COVID-19, with the higher severe form prevalence and the higher mortality rate. Furthermore older peoples are at high risk of complications cascade, due to the SARS-Voc-2 infection but also because of chronic diseases decompensation. If risk factors in this population have been identified, specific treatments to reduce complications or to be curative are less known. However geriatric care, thanks to its holistic approach, could reduce these complications and improve survival.

Our study aims to determine if geriatric care provided in geriatric COVID-19 hospitalisation units improves survival of older people (aged 65 years and over) at one month in comparison with conventional COVID-19 hospitalisation unit during the first wave in the Montpellier University Hospital. Secondary objectives are to determine if clinical characteristics of older patients are different between conventional and geriatric COVID-19 hospitalisation units, to assess influence of clinical characteristics of older patients on their survival, and to determine wich treatment have been delivered for older people during the COVID-19 pandemic first wave in our hospital in view of bibliographic data available at this time.

COVAGERT is a monocentric, descriptive, observational and retrospective study, including all older adults aged 65 years and over hospitalised in the geriatric COVID-19 and the conventional COVID-19 units of the Montpellier University Hospital during the first wave of the SARS-Cov-2 pandemic (between March 1th 2020 and September 1th 2020). Principal outcome is the survival one months after the RT-PCR positive test. Some data about treatments, medical history, socio-demographic and clinical characteristics will be collected from the medical record.

Statistical analysis will be performed using univariate and multivariate regressions according to the study's objectives.

Results will be useful to determine the bring of geriatric care during the current pandemic, but also to highlight the importance of multidisciplinary assessment in this complex disease and for further emergency medical challenges.


Eligibility Criteria:
Inclusion criteria:

* adult age 65 years or over
* hospitalised for COVID-19 in one of the two hospitalisation unit (conventional or geriatric) during the first COVID19 wave

Exclusion criteria:

- refusal to give the access to her/his medical record
Clinical Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension.

To demonstrate the efficacy and safety of aliskiren given to patients with essential hypertension, at doses of 75 mg, 150 mg and 300 mg alone, and in combination with hydrochlorothiazide (HCTZ)


Eligibility Criteria:
Inclusion Criteria

* Patients with essential hypertension
* Patients who are eligible and able to participate in the study

Exclusion Criteria

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of hypertensive encephalopathy or cerebrovascular accident

Other protocol-defined exclusion criteria may apply.
Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adult Patients

The purpose of this study is to evaluate the immunogenicity and safety of an adjuvanted A(H1N1)v influenza vaccine in HIV-infected and immunosuppressed patients after one and two injections.

The efficacy of an adjuvanted A(H1N1)v influenza vaccine in HIV-infected and immunosuppressed patients is unknown. Therefore we aim to investigate the immunoresponse as assessed by a anti-hemagglutinin assay before, 21 days after the first and 21 days after the second vaccination. The safety of the vaccination will be recorded by a standardized questionaire.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* age \>18
* HIV-1 infection
* cancer
* immunosuppressive treatment

Exclusion Criteria:

* not willing to participate
Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT

The purpose of this study is to assess new low radiation dose techniques for clinical PET/CT scans through intra-individual comparison between a clinical, standard dose scan and a low-dose scan, completed within one week of each other.

Positron Emission Tomography/Computed Tomography (PET/CT) imaging using 18F-FDG is an important, commonly used cancer, neuroscience and cardio-vascular imaging methodology to detect disease and to monitor therapeutic interventions. While considerable technological progress of PET/CT systems has occurred over the last decade, we have not re-evaluated the ability to potentially reduce the radiation burden of the used PET imaging pharmaceutical (FDG).

This early phase trial intends to accomplish the following:

* to validate that the radiation dose burden from the PET imaging pharmaceutical (FDG) can be reduced by more than 50% from the current standard of clinical care (SOC) level without affecting the diagnostic ability;
* to confirm that a low dose approach will be feasible for response assessment;
* to validate that the difference in FDG uptake between imaging 60 min +/- 10 min post injection and 75 min +/- 10 min post injection is independent/equivalent of the injected FDG dose
* to validate a simulation methodology to streamline future dose finding studies for PET imaging pharmaceuticals.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients greater than or equal to 18 years of age
* Patients scheduled for a standard of care PET/CT scan
* For female patients of child-bearing potential, the OSUWMC requirements for receiving the standard of care PET imaging agent and CT examination needs to be met

Exclusion Criteria:

* Participants who are pregnant or lactating
* Prisoners
* Participants incapable of giving informed consent
* Patients unable to lie flat on the scanner for extended periods of time
Quality Improvement in Stroke Prevention (QUISP)

Is a secondary prevention intervention, focused on implementation of standardized pre-printed discharge orders for hospitalists, effective at increasing utilization of the following evidence-based treatments 6 months after discharge for ischemic stroke:

1. Treatment with statins,
2. Control of hypertension, and
3. Anticoagulation in patients with atrial fibrillation.

There are several proven strategies for prevention of recurrent ischemic stroke, including use of statins, treatment of hypertension, and anticoagulation in patients with atrial fibrillation. Preliminary analyses suggest that only 9-15% of Kaiser Permanente Northern California's ischemic stroke patients receive optimal care for secondary prevention of stroke. The purpose of this study is to determine whether or not a quality improvement (QI) intervention can improve the care received by stroke patients. This project consists of a randomized trial of standardized stroke discharge order forms to improve adherence with best practices in secondary stroke prevention. The primary research question is: Is a secondary prevention intervention, focused on implementation of standardized pre-printed discharge orders for hospitalists, effective at increasing utilization of the following evidence-based treatments 6 months after discharge for ischemic stroke: (1) treatment with statins, (2) control of hypertension, and (3) anticoagulation in patients with atrial fibrillation.

The primary outcome will be the proportion of patients receiving optimal treatment, as defined by these three goals. The impact of the intervention will be measures as a change after-to-before at intervention hospitals compared to non-intervention (control) hospitals, with the institution as the unit of analysis. Secondary analyses will evaluate the impact of the intervention on each of these components and on 6-month and 1-year rates of mortality, readmission for stroke, and costs of care after discharge.

Eligibility Criteria:
Inclusion Criteria:

Ischemic stroke Kaiser-Permanente Health Plan Member with Pharmacy Benefit Discharged alive to home

Exclusion Criteria:

tpA patients Hemorrhagic stroke TIA Significant comorbidities
Focused Ultrasound in Septic Shock Patients

The investigators hypothesize that lung ultrasound and echocardiography will benefit the septic shock patients by making the treatment more precisely and rapidly. Septic shock patients from multicenter will be enrolled in the study. They will be randomly divided into two groups. The routine treatment group will receive routine treatment according to the SSC guideline. The study group will receive additional ultrasound examination, which will decide the improvement of therapy. Therapy change based on ultrasound results and the prognosis will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* age\>18yr
* survive more than 24hrs
* fulfilled septic shock

Exclusion Criteria:

* age \< 18yr
* pregnant
* DNR
Efficiency of Different Gastrocnemius Stretching Exercises

The primary aim of this study is to investigate the effects of different types and durations of gastrocnemius stretching on the viscoelastic properties of the gastrocnemius muscle, Achilles tendon, and plantar fascia.In addition, pain threshold of the gastrocnemius muscle and plantar fascia, as well as on hamstring tightness will be measured.

The study will include a total of at least 48 individuals who meet the inclusion and exclusion criteria. Subsequently, participants will be randomly assigned to one of four groups for gastrocnemius stretching exercises of different durations and types. Participants in Group I will perform sustained stretching with a towel, those in Group II will perform intermittent stretching with a towel, those in Group III will perform sustained stretching against the wall, and those in Group IV will perform intermittent stretching against the wall. The stretching exercises will be performed under the supervision of one of the researcher. Compliance with the stretching exercise will be evaluated by keeping a daily log.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 25 years
* Having a gastrocnemius muscle tightness in the dominant side

Exclusion Criteria:

* History of lower extremity surgery or trauma
* Diagnosis of fibromyalgia, neurological disease, achilles tendinopathy, metatarsalgia, acute ankle sprain, tarsal tunnel syndrome, or heel pad syndrome
* Having received physiotherapy related to the lower extremities within the last six months
* A body mass index (BMI) above 30 kg/m2
* Having received a local steroid injection within the last six weeks
* The presence of a local infection
* The presence of rheumatic or other systemic inflammatory diseases
* Diabetes or other metabolic diseases
* Nerve compression syndrome
* Currently using painkillers
* Diagnosis of neurological heel pain
* A positive navicular drop test result
* Having engaged in strenuous exercise within the last 24 hours
* Not being fully compliant with the exercise program
Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia

Primary purpose:

Show the pain improvement 3-month after robotic laparoscopic pudendal nerve decompression for pudendal neuralgia.

Primary outcomes:

Pain evaluated on a VAS before surgery and 3-month after surgery or surveillance Improvement is considered if pain decreased by at least 3/10 points on the VAS.

Secondary purposes:

* improvement of quality of life
* study of MRI performance to predict pudendal nerve entrapment topography
* show the feasibility and safety of robotic pudendal nerve decompression


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 70 years old
* Pudendal neuralgia according to Nantes criteria
* pudendal nerve entrapment reachable with robotic transperitoneal approach

Exclusion Criteria:

* bilateral pain
* history of pain ≥ 18 months
3-Year Observational Virology Follow-up Study in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals

All subjects in this study have previously been in an Idenix HCV study and received study drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study will not be enrolled in this study.

In this study, researchers will try to find answers to these questions:

* How much (if any) hepatitis C virus is in your blood after stopping your Idenix study drug?
* Is your hepatitis C virus possibly resistant to treatment with the Idenix study drug or similar drugs?

The data obtained from this study will be used to further understand the long-term efficacy of Idenix DAAs used to treat HCV infection and to further understand HCV resistance to Idenix DAAs.

Eligibility Criteria:
Inclusion Criteria:

* Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained
* Have participated in an Idenix-sponsored study of an Idenix DAA
* Received at least 3 consecutive days of DAA treatment in an Idenix-sponsored study
* Agreed to comply with the visit schedule and laboratory tests

Exclusion Criteria:

* Treatment with placebo only, in an Idenix sponsored study
* Antiviral treatment for HCV after participation in an Idenix sponsored study of an Idenix DAA
Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis

The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated statement of informed consent
* Completion of Protocol 307000A
* Negative serum pregnancy test results
* Agreement to adequate contraception, for female patients

Exclusion Criteria:

* Pregnancy or lactation
* History of alcohol or drug abuse
* Inability to administer subcutaneous injections either by self or by caregiver
* Medical, psychiatric or other conditions that compromise the patient's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study
* Any significant change in the patient's medical condition after enrollment in Study 307000A which would have lead to his/her exclusion from participation that study
Swiss Liver Venous Thrombosis Study

The Liver Venous Thrombosis Study is a prospective observational cohort study aimed at collecting clinical data, patient reported outcomes and biological samples of all patients who have been newly and previously diagnosed with liver venous thrombosis in one of the participating hospitals in- and out-patient clinics of the participating centers in Switzerland. All new patients diagnosed with liver venous thrombosis or patients who are currently being treated in one of the participating centers, will be asked to participate in the study.

Background

Outcome measures:

Primary: Liver venous thrombosis recanalization

Secondary: Thrombosis progression, Overall mortality, Major bleeding, Ascites

Objective

* To start a prospective observational cohort study of Liver Venous Thrombosis patients in Switzerland from their primary diagnosis and already diagnosed patients.
* To examine long-term medical outcomes in patients with liver venous thrombosis in Switzerland by defining incidence, risk factors and treatment results
* To prospectively collect data on medical history, serious comorbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, hospital stays, interventions and complications.
* To store in a biobank blood and biological samples, obtained during routine practice

Methods

N/A

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Admitted in hospital or attend outpatient clinic
* Objectively confirmed portal vein thrombosis and/or hepatic vein thrombosis
* Budd-Chiari-Syndrome (BCS), Non-Cirrhotic Intrahepatic Portal Hypertension (NCIPH), Sinusoidal Obstructive Syndrome (SOS), Other Vascular Diseases (Hepatoportal Sclerosis (HC), Nodular Regenerative Hyperplasia (NRH), Obliterative Portal Venopathy (OPV) or Idiopathic Portal Hypertension (IPH))
* Subjects willing to provide informed consent

Exclusion Criteria

* Thrombosis limited to mesenteric or splenic vein
* Inability to sign consent form
* Follow-up not possible
* Cardiovascular, tumoral, pulmonary comorbidity with life expectancy estimated to be less than 6 months
* Portal vein invasion by hepatocellular carcinoma
ERC Via Double-Balloon-Enteroscopy in Patients With Biliodigestive Anastomosis

In patients with biliodigestive anastomosis direct cholangiography (ERC) is due to changed anatomy commonly not possible. The aim of the study is to test the feasibility to perform direct cholangiography in these patients via double-balloon enteroscopy and to compare it to MR cholangiography.


Eligibility Criteria:
Inclusion Criteria:

* Biliodigestive anastomosis; and
* Suspicion of biliary disorder

Exclusion Criteria:

* Exclusion criteria of double-balloon enteroscopy and MR-cholangiography
Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room

To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.

Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations(AVMs). Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study.

Objects: Patients with cerebral arteriovenous malformations, coincident with inclusion and exclusion criterion and admitted in participating organizations.

Methods: Patients will be distributed into 2 groups, including traditional therapy group(control group) and hybrid operating group(trial group), and conduct with traditional neurosurgical management or one-stage hybrid operating management correspondingly. Residual rate of AVM is considered to be the primary observing indicator, and morbidity rate of post-operative complications, post-operative mortality rate, and morbidity rate of neural functional deterioration are secondary indicators.The information of operations will be recorded in detail as evidence of optimization of workflow and technical key knots.

Eligibility Criteria:
Inclusion Criteria:

* newly ruptured AVM with stable hematoma, selective operation is practical;
* with rupture history;
* recurrent epilepsy, failed in AED management;
* giant AVM with deterioration of neurological functions;
* 1-4 grade AVM (Spetzler-Martin grading system) with no symptom and not located in eloquent area.

Exclusion Criteria:

* \>70 in age, with low rupture risk;
* newly ruptured AVM with unstable hematoma, engaged in emergency operation;
* ≥5 grade in Spetzler-Martin grading system;
* AVM located in hypothalamus, brainstem, cerebellopontine angle;
* cannot tolerant the operation;
* patient or relative refuses to participate the trail.
Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT)

The purpose of AROAAT2001 (SEQUOIA) is to evaluate the safety, efficacy and tolerability of multiple doses of the investigational product, Fazirsiran Injection, administered subcutaneously to participants with alpha-1 antitrypsin deficiency (AATD).

Participants will be enrolled to receive multiple subcutaneous injections of Fazirsiran Injection (also referred to as TAK-999 Injection or ARO-AAT Injection) or placebo. Eligible participants will require a pre-dose biopsy completed as part of the study within the screening window. However, any participant with a biopsy result within 1 year of screening showing no fibrosis does not require a pre-dose biopsy. Only participants who have liver fibrosis will undergo a post-dose biopsy and may continue treatment in an open-label phase.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AATD
* Liver biopsy at Screening indicating liver fibrosis (score less than F4); a patient with no fibrosis may participate based on a previous biopsy conducted within one year
* Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception
* Willing to provide written informed consent and to comply with study requirements
* Non-smoker for at least 1 year
* No abnormal finding of clinical relevance at Screening

Exclusion Criteria:

* Clinically significant health concerns other than AATD
* Previous diagnosis or diagnosis at Screening of definitive liver cirrhosis
* Previous lung or liver transplant due to AATD
* Regular use of alcohol within one month prior to Screening
* Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study involving therapeutic intervention
* Use of illicit drugs within 1 year prior to Screening

NOTE: additional inclusion/exclusion criteria may apply, per protocol
One Year Clinical Evaluation of White Spot Lesions Treated With Newly Introduced Resin Modified Glass Ionomer in Comparison to Resin Infiltration in Anterior Teeth Split Mouth Technique

The aim of this study is to evaluate the addition of new technology of resin modified glass-ionomer in comparison to resin infiltration in treating post-orthodontic white spot lesions; both applies into the same patient's mouth; to reveal which material will have more clinical satisfactory performance inside the oral cavity and to overcome the high expensive cost in treating such clinical cases

Roles and responsibilities:

* Shaimaa Mohammed (SH.M.): Operator and author.Specialist in Air-Force Specialized Hospital.
* Mohamed Riad (M.R.): Main supervisor, data monitoring and auditing, Professor, Conservative Dentistry Department,Cairo University.
* Asma Harhash(A.H.):Co-supervisor, outcome assessor and data collection, Associate Professor, Russian University.
* Omnia Magdy Moustafa (O.M.): Baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents: Assistant lecturer, Conservative Dentistry Department , Faculty of Oral and Dental Medicine Cairo University.
* Ghada Ahmed (G.A.): Data entry and auditing; Assistant lecturer, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Russian University.

Intervention:

A- Preoperative clinical assessment:

1. Explain patient need toward aesthetic needs
2. Digital photos for white spot lesions
3. Recording number of white spot lesions and site. (SH.M.) will apply both materials at the same patient mouth (Split mouth technique) according to the manufacturer's instructions.

   * Intervention: resin modified glass ionomer cement varnish: Vanish™ xt Extended Contact Varnish (3M ESPE Dental)
   * Comparator: resin infiltration (Dental Milestones Guaranteed, Germany).

(A.H) and (SH.M) will assess the outcome measures through the follow up time: immediately after,1 day, 1 week,1 month,3 months, 6 months, 12 months

Eligibility Criteria:
Inclusion Criteria:

1. Post-Orthodontic patients included in this clinical trial toll age of 35 years.
2. Patients with good general health.
3. Patients who will agree to the consent and will commit to follow-up period.
4. Fully erupted anterior teeth with no cavitated lesions.
5. At least one spot lesion on each side in the same jaw

Exclusion Criteria:

1. Patients with any systemic disease that may affect normal healing.
2. Patient with bad oral hygiene.
3. Tetracycline or fluorsis staining.
4. Patients who could/would not participate in all times of follow-up.
5. Untreated periodontal disease was not allowed.
6. Active caries or defective Restorations in 6 anterior teeth.
7. Bleaching history
8. Patients participating in more than 1 dental study.
9. Patient received fluoride varnish during orthodontic treatment.