cyrilzakka/clinical-trials huggingface dataset:
A Study of Purified Human Antibodies Administered Subcutaneously to Patients With Multifocal Motor Neuropathy (MMN)

The objective of this study is to assess efficacy, safety, and convenience of purified human antibodies administered under the skin in the treatment of MMN patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with documented clinical diagnosis and electrophysiological evidence of MMN
* Patients who have previously responded to intravenous immunoglobulin (IVIG) and have been on stable treatment with IVIG for at least 12 weeks prior to screening
* Patients treated with the equivalent of ≥0.4g/kg body weight (bw) IVIG per month
* Provision of informed consent by patient

Exclusion Criteria:

* Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) concentration \>2.5 times the upper normal limit (UNL)
* Creatinine concentration \>1.5 times the UNL
* Known allergic reactions to blood products
* Any skin disease interfering with the assessment of injection site reactions
* Any other medical condition, which in the opinion of the investigator, might interfere with successful completion of the protocol
* Any condition likely to interfere with the evaluation of the study drug or satisfactory conduct of the trial
* Participation in a study with an investigational drug within three months prior to enrolment
* Patients treated with the equivalent of \>2.0g/kg bw IVIG per month
Observational Study on Anti-Tat Immune Response in HIV-1-infected Asymptomatic Adult Subjects

The present study is designed as a prospective observational study directed at evaluating the frequency, magnitude, quality and persistence (primary endpoint) of the anti-Tat immune response in HIV-1 infected asymptomatic individuals, and to prospectively evaluate the immunological, virological and clinical outcome of anti-Tat positive versus anti-Tat negative drug naїve subjects (secondary endpoint) in order to determine the impact of anti-Tat immunity on HIV disease progression as well as the potential use of anti-Tat immune response assessment for the clinical and therapeutic management of infected patients. This survey provided important information for the design, planning and conduction of future therapeutic vaccine trials based on the HIV-1 Tat protein in asymptomatic subjects.


Eligibility Criteria:
Inclusion Criteria:

* To be clinically asymptomatic HIV-1 infected individuals with CD4+ T cell counts ≥400/μL
* To be naïve for antiretroviral therapy
* Levels of plasma viremia ≤100,000 copies/ml at baseline
* Age ≥ 18 years
* Signed informed consent

Exclusion Criteria:

* Current therapy with immunomodulators or immunosuppressive drugs or chemotherapy for neoplastic disorders
* Concomitant treatment for HBV or HCV infection
Energy Expenditure in Chronic Kidney Disease

Patients with kidney disease need accurate advice on their diet. Researchers know very little about energy needs and nutritional requirements in kidney patients. Simple tools are needed to calculate calorie requirements so that good bed-side advice can be given to patients, and to allow cost-effective research. This study aimed to measur energy requirements in kidney disease using a gold-standard safe and very accurate method called the "doubly labelled water technique". The study has compared measurements with less costly measurements obtained using a device which measures oxygen content of air breathed out. The study has also measured physical activity levels with questionnaires.

Background The function of the kidneys is to remove waste products of metabolism, and despite advances in treatment of CKD little is known about metabolic rate in renal disease. Increased knowledge about metabolic rate would have numerous potential benefits.

Little is known of the effects of metabolic rate on kidney disease. This study was designed to define the relationship of metabolic rate with degree of kidney function.

Study design and methods In an observational cohort study, the investigators studied Total Energy Expenditure in 80 patients with CKD stage 1-5 using the doubly-labelled water technique over a 14 day period. The group was divided such that half had stage 1-3 CKD and half stage 4-5. All subjects performed a comprehensive metabolic analysis including measurement of Resting Energy Expenditure using indirect calorimetry, bioimpedance, and body size measures. Physical activity was assessed using a Stanford 7 day recall questionnaire.

Data Analysis The data analysed will include determining the relationship between level of kidney disease as measured by eGFR and energy expenditure measured as Resting Energy Expenditure and doubly-labelled water Total Energy Expenditure. This will be determined by regression analysis. Additionally, comparison will be made between subjects with early-moderate (CKD stage 1-3) and advanced (CKD stage 4-5) CKD.

Eligibility Criteria:
Inclusion Criteria:

1. CKD stages 1-5 according to the MDRD equation eGFR
2. Age \>18

Exclusion Criteria:

1. Abnormal thyroid stimulating hormone level or previous thyroid disorder
2. Active malignancy
3. Pregnancy
4. Intercurrent illness or infection
5. Hospital admission in month prior to enrolment
6. Surgery in 4 weeks prior to enrolment
7. HIV, Hepatitis B, Hepatitis C positive status
8. Tuberculosis in the 12 months prior to enrolment.
9. Active vasculitis or connective tissue disorder
10. Organ transplantation.
11. Treatment with immunosuppression, except low dose corticosteroids (\<10mg/day prednisolone).
IMR Assessment in Patients With New Diagnosis of Left Ventricle Dilatation

To establish if, in patients with new diagnosis of left ventricular dilatation without documentation at the coronary artery angiography of significant coronary artery lesions, there is a damage of the coronary microcirculation at the IMR (index of microcirculatory resistance) assessment

The Authors will enroll at the moment of coronary artery angiography patients without history of ischemic heart disease and new diagnosis (at transthoracic echocardiography) of left ventricular dilation.

All patients will undergo coronary artery angiography. To be enrolled, it is necessary to have the absence of significant coronary artery stenosis (angiographic evaluation of the lesion \>40%) in all the vessels (main and side branch).

The Authors will proceed to perform the evaluation of the index of microvascular resistance (IMR). The target vessel will be the left anterior descending artery.

An intracoronary pressure/temperature sensor-tipped guidewire will be used. Thermodilution curves will be obtained during maximal hyperemia. The IMR will be calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time.

Eligibility Criteria:
Inclusion Criteria:

* new diagnosis of left ventricular dilation (dilatative cardiopathy)
* absence of significant (\>40%) coronary artery disease at coronary artery angiography

Exclusion Criteria:

* history of ischemic heart disease
* history of significant valvular disease
* contraindication to hyperemic agent
Reducing Beverages and Sugar and Increasing Physical Activity in Public School Adolescents From Brazil

The main objective is to evaluate the effect on BMI of a school-based program that discourages the consumption of all sweetened beverages, encourages the reduction in sugar intake, and encourages the increase in physical activity among adolescents and their families from a low socioeconomic area.

Specific objectives are:

1. To compare total, lean, and fatty body mass variation in adolescents aged 11 to 14, from 7th and 8th grades from schools under intervention and from the ones not subjected to the intervention program.
2. To compare sweetened beverages consumption and sugar intake before and after the intervention in both groups of schools.
3. To evaluate the impact of the intervention on the selling of sweetened beverages in the cafeterias.
4. To compare change in family expenditures with sweetened beverages and sugar.

Eligibility Criteria:
Inclusion Criteria:

* 5th grades

Exclusion Criteria:

* Pregnancy
Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer

The aim of this study is to evaluate the feasibility of hypofractionated radiation therapy and concomitant chemotherapy with cisplatin for locally advanced head and neck cancer in a high volume brazilian center.

To evaluate if concomitant cisplatin and hypofractionated radiation therapy wold be feasible in a brazilian population.

Patients eligibility criteria:

older than 18 years old Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx. Stage III an IV, with no distant metastasis. ECOG performance status 0-2. Adequate renal and liver function. Good status for radical treatment

Treatment considered feasible if:

1. Patient receive at least 90% of radiation dose (18 of 20 fractions of 275cGy)
2. Patients receive at least 3 of 4 weekly cycles of cisplatin (35mg/m2)
3. Treatment length up to 35 days.
4. Grade 4 toxicity lower than 25%

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx.
* Stage III an IV, with no distant metastasis.
* ECOG performance status 0-2.
* Adequate renal and liver function.
* Good status for radical treatment

Exclusion Criteria:

* Other oncologic treatment before
* Distant metastasis
* History of previous malignancy
Incidence of Second Primary Malignancies in Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US

This study is conducted to estimate population-based incidence rates of second primary malignancies among patients with CRPC similar to those treated with Xofigo. These rates will provide context for second primary malignancy incidence rates from the REASSURE study.

Furthermore this study aims to provide further information about the documentation of bone metastases in Medicare data and the extent of use of only oral androgen deprivation drugs among patients with Medicare Part D coverage, as well as to estimate overall survival of the study population.

Xofigo (radium-223 dichloride) is an alpha-emitting pharmaceutical, which was approved for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. The long-term safety profile of Xofigo is evaluated in the prospective REASSURE study, which estimates the incidence rates of second primary malignancies in patients with CRPC receiving Xofigo.

To provide context on that, this retrospective study is conducted to estimate background rates of second primary malignancies among patients with CRPC similar to those who are treated with Xofigo.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in both Medicare Parts A and B for at least 1 year before the cohort entry date (minimum lookback period for comorbidities and treatments)
* Primary site code of prostate cancer (International Classification of Diseases for Oncology, Third Edition \[ICD-O-3\] topography code C61.9) in SEER data
* Surgical castration or androgen deprivation therapy after prostate cancer diagnosis; androgen deprivation therapy will be indicated by the use of any of the following drugs: abarelix, bicalutamide, buserelin, cyproterone, degarelix, diethylstilbestrol, estramustine, flutamide, gonadorelin, goserelin, histrelin, leuprolide, medroxyprogesterone, megestrol, nafarelin, nilutamide, polyestradiol, triptorelin
* Evidence that prostate cancer was resistant to surgical castration or androgen deprivation therapy ("castration-resistant prostate cancer"), as indicated by starting one of the following second-line systemic therapies (cohort entry date): abiraterone, cabazitaxel, docetaxel, enzalutamide, mitoxantrone, or sipuleucel-T
* Cohort entry date 01 January 2006 or later
* Age 65 years or older in the US on the cohort entry date

Exclusion Criteria:

* Enrollment in an HMO (Health Maintenance Organization) in the year before the cohort entry date
* Diagnosis of any cancer other than prostate cancer or nonmelanoma skin cancer on or before the cohort entry date
* Any diagnostic code for metastases other than bone metastases or lymph node metastases on or before the cohort entry date
* Any claim for treatment with Xofigo on or before the cohort entry date.
Randomised Clinical Trial to Determine the Effect of Vagus Nerve Neurodynamics on the Neurovegetative Nerve System in People With Chronic Stress.

This unicentric, controlled clinical trial aims to evaluate the effects of vagus nerve neurodynamics and 6 bpm guided breathing, combined with manual therapy, on heart rate variability (HRV) in patients suffering from chronic stress. A total of 62 participants will be randomly assigned into two groups: one receiving guided breathing and neurodynamics with manual therapy, and the other receiving only guided breathing with manual therapy. HRV will be monitored using Polar® H10 sensors. The primary outcome is the change in HRV, measured pre- and post-intervention. The study is ethically approved by the Hospital Clínico San Carlos.

This unicentric, controlled clinical trial investigates the impact of vagus nerve neurodynamics and guided breathing at a rate of 6 breaths per minute (bpm), in conjunction with manual therapy, on heart rate variability (HRV) in patients with chronic stress.

The study involves 62 participants who will be randomly allocated into two groups. Group 1 will receive a protocol of guided breathing combined with neurodynamics and manual therapy, while Group 2 will follow a protocol of guided breathing with manual therapy only.

Each participant will undergo a 15-minute intervention session where HRV will be continuously monitored using Polar® H10 sensors. The intervention will include guided diaphragmatic breathing at 6 bpm to standardize the respiratory rate across participants, ensuring that HRV measurements reflect the effects of neurodynamics rather than respiratory variations.

The neurodynamics technique involves passive movements in the cervical region to enhance the functionality of the vagus nerve, potentially influencing HRV. This technique will be applied during the intervention period, with specific movements synchronized with the participants' respiratory cycle.

Prior to the intervention, baseline HRV will be recorded during a 7-minute rest period. Post-intervention HRV measurements will also be taken for 7 minutes while participants remain in a supine position. Data analysis will focus on comparing the HRV changes between the two groups, providing insights into the effectiveness of combining neurodynamics with guided breathing and manual therapy.

The study adheres to ethical guidelines and has received approval from the Medical Research Ethics Committee of Hospital Clínico San Carlos

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 years or older.
* Self-perceived chronic stress for at least six months.
* Willingness to provide informed consent and comply with the study procedures

Exclusion Criteria:

* Consumption of tea, caffeine, energy drinks, alcohol, or tobacco within two hours prior to the study.
* Significant neck pain or headache.
* Carotid sinus syndrome.
* Pregnancy.
* Recent cervical or cardiac surgery.
* Recent significant trauma.
* Cancer.
* Neurological disorders affecting muscle tone.
* Underlying conditions such as diabetes mellitus or arterial hypertension.
* Use of beta-blockers.
* Arrhythmias or other cardiac diseases
Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence

This current project investigates the effect of a single session of right dlPFC repetitive transcranial magnetic stimulation on emotion regulation abilities and craving in alcohol dependent patients and healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Alcohol Dependence
* Currently abstinent

Exclusion Criteria:

* psychoactive medication
* not eligible for MRI (metals or claustrophobia)
* (familial) history of epilepsy
* current psychiatric disorders (besides alcohol dependence)
Generation Of a Lung Biobank for Future Use

The aim is to invite 1,000 patients with symptoms triggering the lung cancer diagnostic pathway or with significant risks of lung cancer, referred to The Royal Marsden NHS Foundation Trust (RMH) referral centres (Kingston Hospital NHS Foundation Trust, Epsom and St Helier University Hospitals NHS Trust, Croydon University Hospitals NHS Foundation Trust or St George's University Hospitals NHS Foundation Trust) over a 1 year period, to complete a life style questionnaire, document lung function tests and to donate a blood sample for storage with a view to testing for a genetic signature and other biomarkers in future studies from this established biobank.

Patients will have been referred under the two week rule (TWR) diagnostic pathway, some will have lung cancer, others not, and other patients will have had a diagnosis of lung cancer by other pathways i.e. non TWR.

There are 3 groups of patients:

Group A - lung cancer patients at any stage and by any non TWR pathway, n=250. Group B - lung cancer patients who were referred initially by the TWR pathway, n=150.

Group C - Subjects referred by the TWR pathway (i.e. with symptoms) who do not have lung cancer, or subjects referred by any pathway who do not have lung cancer but do have radiological changes (that need follow up) or a strong family history of lung cancer, n=600.

A strong family history for this study means 1 or more first degree relatives with lung cancer with at least one individual having lung cancer at age \<50 yrs.

Eligibility Criteria:
Inclusion Criteria:

One of the following criteria:

* Patients with lung cancer at any stage or time in their disease.
* Patients without lung cancer who have been referred by the TWR pathway.
* Patients without lung cancer who have radiological changes on their X-Ray or CT scan that need follow up.
* Patients without lung cancer who have a strong family history of lung cancer. PLUS
* Patients aged \>18 Years
* Patients who have signed informed consent form

Exclusion Criteria:

* Unable to provide informed consent.
* Bleeding disorder or other medical condition that would make a blood sample hazardous.
* Within 3 weeks of chemotherapy or radiotherapy (as low lymphocyte may be associated with poor DNA yield).
Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia.

I. To investigate time measurement from emergency room admission to first antibiotic administration.

II. To evaluate risk factors for prolonged time to first antibiotic administration.

III. To correlate time measurement with Charlson comorbidity index and multimorbidity patterns.

IV. To investigate the impact of a delayed time to first antibiotic administration on the outcome

In this retrospective cohort study, we plan to include all patients presenting with a community-acquired pneumococcal pneumonia at the University Hospital of Zurich between January 1, 2006 and June 30, 2012 (6½ years). The patients will be identified either with one or more blood culture pairs positive for S. pneumoniae or with a positive pneumococcal urine antigen assay in combination with the clinical diagnosis of CAP, which was based on the presence of select clinical features (e.g., cough, fever, sputum production, and pleuritic chest pain) and is supported by imaging of the lung, usually by chest radiography according to Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of CAP in adults \[11\].

CAP is not considered if the patient is discharged from a hospital less than 7 days before the current hospital admission, if the first blood culture or urinary antigen assay is obtained more than 1 week after hospital admission, or if the patient has no clinical diagnosis of CAP at the time of admission. Patients referred from or transferred to another hospital are excluded.

After identification of eligible patients upon microbiological results, medical records are reviewed using a standardized data collection questionnaire. Comorbidity is determined using the Charlson comorbidity index \[10\]. Additionally, all patients are classified according to the multimorbidity patterns proposed by Holden et al. \[12\]. These are:

1. arthritis, osteoporosis, other chronic pain, bladder problems, and irritable bowel;
2. asthma, chronic obstructive pulmonary disease, and allergies;
3. back/neck pain, migraine, other chronic pain, and arthritis;
4. high blood pressure, high cholesterol, obesity, diabetes, and fatigue;
5. cardiovascular disease, diabetes, fatigue, high blood pressure, high cholesterol, and arthritis; and
6. irritable bowel, ulcer, heartburn, and other chronic pain.

Time calculation is based upon the moment of emergency room (ER) admission.

Eligibility Criteria:
Inclusion criteria: Patients with community-acquired pneumococcal pneumonia, which was confirmed by

1. detection of Streptococcus pneumoniae in blood cultures, tracheal secretion or sputum OR/AND
2. positive urinary pneumococcal antigen AND
3. presence of cough and presence of one of the following signs/symptoms: new focal chest signs; dyspnoea; tachypnoea; fever AND
4. radiologic signs of pneumonia

Exclusion criteria: - Pneumonia of other cause (e.g. non-pneumococcal pneumonia)

* Hospital-acquired or ventilator-associated pneumonia
* Patients referred from or transferred to another hospital
Radiographic Contrast To Differentiate Cavitated From Non-cavitated Tooth Decay

The proposed test is intended to enable dentists to differentiate between cavitated and non-cavitated tooth decay in the areas where teeth are in contact (interproximal surfaces). In these areas, dentists cannot visually inspect for caries, and currently bitewing X-rays (BWs) only correctly detect the presence of enamel decay 15-25% of the time. This low sensitivity can lead to late treatment resulting in unnecessarily large fillings, crowns, pain, root canals, and possible later loss of teeth.

Tooth sites will be recorded by both tooth number, type of surface (mesial, distal, occlusal), cavitated, non-cavitated, healthy. Radiographs will similarly be scored. Although contrast agents are classified as drugs this is not a study of drug properties or effect on cells since the properties of the agent are already well known and its safety record well established. This study will be recording the radiopacity of the contrast agent on healthy tooth surfaces, non-cavitated tooth surfaces and cavitated tooth surfaces. The outcome for each surface type will be presence or absence of a radiopacity on a radiograph which will be made at the one and only visit for each study subject. The radiograph contains the data from the intervention (placement of contrast agent) and the outcome will be assessed some weeks later after the completion of the data collection.

Eligibility Criteria:
Inclusion Criteria:

* Must have a minimum of 2 adjacent teeth so that interproximal surfaces of interest are in contact and hidden from direct visual examination.

The occlusal plane plane should be normal so that the interproximal contact regions are normal.

English or Spanish speaker.

Exclusion Criteria:

* Pregnant women. A person who has participated in a similar study involving dental radiography within the last 12 months.

Fillings must not be present in the regions of interest.