cyrilzakka/clinical-trials huggingface dataset:
Sodium Sensitivity in African Americans

To compare the effects of two levels of dietary sodium on blood pressure in Black men and women, and to determine what factors predict the degree of response.

BACKGROUND:

The study permitted a more precise estimate of the effects of sodium chloride on blood pressure in Blacks and a systematic examination of sodium sensitivity defined by various methods. The results had significance in answering questions about risk factors for blood pressure in Blacks and for defining sodium sensitivity.

DESIGN NARRATIVE:

Double-blind, two-period cross-over. All participants were given six weeks of intensive nutritional counseling to lower 24-hour urine sodium output from an estimated 165 mEq/24 hours at baseline to less than 140 mEq/24 hours. Only those participants who excreted less than 140 mEq /24 hours after six weeks of intensive dietary sodium intervention and had greater than 70 percent adherence to study capsules were eligible for randomization. Eligible subjects were assigned to one of two treatment sequences: 100 mEq of sodium chloride capsules per day during period one followed by placebo capsules during period two; placebo capsules during period one followed by 100 mEq of sodium chloride capsules per day during period two. The major endpoint was change in diastolic and systolic blood pressure. A number of other measures were carried out, including blood chemistries, glucose tolerance (glucose and insulin), insulin resistance, urinary kallikrein, serum renin, and plasma norepinephrine. Other major aims of the trial included testing general new diagnostic criteria for sodium sensitivity, examining predictors of sodium sensitivity, and examining how changes in sodium intake influenced change in specific metabolic parameters. The trial design incorporated careful control of the dietary changes and strict standardization of blood pressure measurement with a random-zero device. The study was extended through June 1997 on FY 1995 funds.

Eligibility Criteria:
No eligibility criteria
HD Mapping of Atrial Fibrillation in Asia Pacific

The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop and Advisor™ HD Grid, Sensor Enabled™ with the EnSite Cardiac Mapping System and the EnSite Automap module in subjects with AF in the real-world environment of the Asian population.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule
2. Subject must be over 18 years of age. (In Japan, the subject must be of 20 years of age or older)
3. Subject is diagnosed with AF as defined by:

   * Documented symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within 7 days of onset
   * Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months
4. Subject is indicated for cardiac electroanatomical mapping and RF ablation procedure to treat AF
5. Subject is planned to have electroanatomical mapping performed with the HD mapping catheters under investigation

Exclusion Criteria:

1. Previous ablation or surgery in the left atria
2. Implanted left atrial appendage occluder
3. Implanted mitral or tricuspid valve replacement
4. Implanted cardiac defibrillator (ICD)
5. Participation in another clinical investigation that may confound the results of this study
6. Pregnant or nursing
7. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
8. Life expectancy less than 12 months
Impact of Coronary Images Used During Patient Education on Coronary Artery Disease and Subsequent Lifestyle Modifications. Is a Picture Really Worth a Thousand Words?

Subjects in this research study have Coronary Artery Disease (CAD). This occurs when there is a build-up of fatty material in the wall of the heart arteries that causes narrowing of the arteries. This could lead to chest pain, a heart attack, weakening of the heart and/or permanent damage to the heart. As part of their normal routine care, subjects had or will have a Percutaneous Coronary Intervention (PCI) to restore the blood flow in the arteries of their heart. During a PCI procedure, pictures are taken of the arteries before and after the treatment of the narrowing in the arteries. These pictures are acquired through angiography which is a way to produce X-ray pictures of the inside of arteries.

After a PCI procedure, there is a possibility for narrowing of the arteries to return. The likelihood of this happening can be greatly reduced by lifestyle changes and adhering to heart medication regimens. It is part of normal, routine care for CAD patients to be given written and verbal information on how to lead a heart healthy lifestyle and to take heart medications properly.

In this research study, the investigators will show half of the patients their before and after images of their heart arteries where the narrowing occurred and was treated. The other half of the patients will not be shown these images. Both groups will still receive information about lifestyle and medications as part of their normal, routine care. At the end of this study, the investigators will compare both groups to see if there are any differences in making lifestyle changes and taking heart medications properly. Additionally, the investigators would also like to see if there are any resulting differences in the amount of hearts attacks or other heart related medical events.


Eligibility Criteria:
Inclusion Criteria:

1. Over the age of 18
2. Able to provide informed consent in English.
3. Undergoing percutaneous coronary intervention for any clinical indication.

Exclusion Criteria:

1. Patients not able to provide informed consent.
2. Patients without a means for telephone communication.
3. Incarcerated individuals and other special populations.
4. Patients unable to or unwilling to reliably participate in telephone followup.
5. Significant neurologic co morbidities such as cerebrovascular accidents with deficit or developmental delays which may impact learning and/or memory
6. Any medical comorbidity which might result in life-expectancy \< 1 year
7. Any other condition of sufficient severity to impair cooperation in the study- i.e. substance abuse, etc.
Localized Leiomyosarcoma Biomarker Protocol

* Leiomyosarcoma (LMS) is one of the more common soft tissue sarcomas (STS).
* Patients presenting with large, high-grade, localized LMS are at significant risk of developing metastasis following curative surgery.
* Clinical trials of neoadjuvant or adjuvant anthracycline and ifosfamide have suggested that patients with localized STS who are at high-risk of metastasis may benefit from chemotherapy, but the magnitude of benefit in unselected patient population is relatively small.
* Currently, patient age, and tumor size and grade are used to assess risk of metastases and survival
* Studies evaluating tumor response by imaging and histopathology have not established correlation between tumor characteristics as biomarkers for risk of metastasis or sarcoma recurrence.
* Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic LMS and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to, during and after chemotherapy and analyzed for ctDNA and for mutations in genes that are associated with increased risk of developing sarcoma. Tumor tissue will be collected and analyzed for changes in genes. Digital images of the sarcoma from CT or MRI scans obtained during treatment will be obtained for advanced radiomic analysis. Patients will be followed for 2 years after study entry for signs of sarcoma recurrence.
* A biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning.


Eligibility Criteria:
Inclusion Criteria:

* Patients with localized leiomyosarcoma (LMS) of extremity, body wall or retroperitoneum
* Grade 2 or 3, or high-grade LMS
* Tumor size \>5 cm in greatest dimension
* Primary tumor amenable to complete resection
* There is no age requirement
* Participant agrees to receive neoadjuvant doxorubicin and ifosfamide combination chemotherapy
* If pre-operative radiation is administered, it must be administered after chemotherapy. Post-operative radiation may be administered
* Archival tumor tissue (either frozen sample, tissue block containing tumor, or minimum of 4 unstained slides and 1 H\&E stained slide) from diagnostic or pre-treatment biopsy available for study research
Effect of Breast Size on the Electrical Impedance Tomography Measurement

Twenty-two healthy female volunteers were monitored using electrical impedance tomogprahy (EIT) in two different situations. First, with electrode belt placed over the breast tissue and second, with the electrode belt under the breast tissue. The EIT measurement was performed with adjunct spirometric measurement. The changes of regional ventilation related to the breast tissue and the size of breast tissue were evaluated.

The EIT measurement (PulmoVista 500, Dräger Medical, Germany) was performed in supine lying position. On every subject, an electrode belt of proper size based on the measured thorax circumference was placed. It was crucial to find a right position where it was possible to place the electrode belt over the breast tissue and then underneath the breast tissue, without changing the level and the position of the electrode belt on the thorax. Also, the position of the belt had to be between 4th and 6th intercostal space, as recommended by the manufacturer. The change of the position of the belt relative to the breast tissue was performed in a lying position by a slight pull of the buckled belt away from the subject´s body, so the subject could relocate the breast tissue over the belt using her own hands into the position as desired by the researcher.

Eligibility Criteria:
Inclusion Criteria:

* healthy female volunteers

Exclusion Criteria:

* morbid obesity
* standard exclusion criteria for electrical impedance tomography according to the manufacturer
The Clinical and Biomechanical Research of the New Arthroscopic Technique for the Treatment of High-grade Dislocation of the Acromioclavicular Joint

Acromioclavicular joint dislocation is a common disease in shoulder surgery, which mostly occurs in young and middle-aged patients. Severe acromioclavicular joint dislocations of Rockwood type IV, V, and VI require surgical treatment. Among them, the common clinical type IV and type V severe acromioclavicular joint dislocations are often treated with autologous/allogenous tendon transplantation and coracoclavicular ligament reconstruction under shoulder arthroscopy. Although this minimally invasive surgical method has certain advantages over incision surgery, due to factors such as poor healing after tendon transplantation and failure of coracoclavicular fixation, the recurrence rate of postoperative dislocation is still as high as 30%, which seriously affects the prognosis of patients. Therefore, we proposed a new surgical technique of minimally invasive shoulder arthroscopic coracoclavicular suspension fixation and coracoclavicular ligament residual reconstruction, which aims to strengthen the fixation strength of the coracoclavicular space, promote the healing of the coracoclavicular ligament, and reduce the recurrence rate of postoperative dislocation. To improve postoperative shoulder joint function of patients. This project intends to use non-randomized controlled clinical research and biomechanical research to compare traditional surgical techniques with new microscopic techniques in terms of surgical efficacy, postoperative complications, and internal plant fixation strength to establish the therapeutic advantages of the new technology. Its application and promotion provide important clinical evidence to improve the treatment of severe acromioclavicular joint dislocation in the field of shoulder surgery.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive cases of coracoclavicular ligament reconstruction surgery usingTightRope Device With Allograft Augmentation and shoulder arthroscopic reconstruction of coracoclavicular ligament with autologous/allogeneic tendon transplantation.
* Injury type Rockwood type IV and V type severe acromioclavicular joint dislocation
* The time from injury to operation is less than 3 weeks

Exclusion Criteria:

* Combined with neurovascular injury
* Previous history of ipsilateral shoulder surgery
* The patient refused to sign the informed consent and participate in the trial
Mild Cognitive Impairment, Use of qEEG as a Prognostic Marker

Multi center study of six Memory Clinics in four Nordic countries in validating a prognostic diagnostic investigation of qEEG in Mild Cognitive Impairment (MCI). The study is in two parts, the first one is a follow up of a previous study conducted in 2011-2013 and the second half is new recruitment with two years follow up. End points are diagnosis of a dementing disorder, primarily dementia of Alzheimer´s type.

The Nordic Network in Dementia Diagnostics (NIDD) conducted a study in 2011-2013 on qEEG using a method of Statistical Pattern Recognition (SPR) in six academic Memory Clinics in four Nordic countries. In the current study, those from the former study diagnosed either with Mild Cognitive Impairment (MCI; n= 120) or with Subjective Cognitive Impairment (SCI; n=60) are contacted again and evaluated for cognitive impairment. The EEG registered at entry in the former study is considered in relation to their current diagnosis (SCI,MCI or dementia) and thereby, the prognostic value of the method is evaluated.

In the second part of the study (n=120), new patients evaluated in the Memory Clinics and diagnosed with MCI (not SCI) are invited to participate for a two year follow up.

In the diagnostic work-up, simple screening tests and information from a close relative form the basis of the cognitive status (SCI;MCI, Dementia). In evaluating the cause of cognitive impairment, detailed neuropsychological testing is performed as well as MRI of the brain and CSF for Alzheimer´s markers. qEEG with SPR analysis is registered but the clinician is blinded to its outcome.

The end point in both parts of the study is a diagnosis of a dementing disorder.

Eligibility Criteria:
Inclusion Criteria:

Group 1: Individuals diagnosed with either SCI or MCI during 2011-2013 Group 2: Individuals diagnosed with MCI at entry of the study

-

Exclusion Criteria:

* Age \<50 years or \>85 years
* Medically or psychologically unstable
* Living outside the capital region
Orthodontic Screening in Public Healthcare

The aim of the study is to examine orthodontic screening practises in public health care.

The study aims to assess repeatability of malocclusion evaluation in orthodontic treatment need screening in a publicly funded clinic. The objective treatment need is compared with subjective need for orthodontic treatment.

Eligibility Criteria:
Inclusion Criteria:

* residence in the wellbeing services county catchment area
* willingness to participate in the study

Exclusion Criteria:

* Age under 6 years or over 16 years
* insufficient language skills to be able to understand the questionnaire
Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer

Gemcitabine is a novel analog of the nucleoside deoxycytidine that acts via inhibition of DNA synthesis.Docetaxel is a semisynthetic taxane and promotes microtubule assembly and inhibits microtubule depolymerization.

In this study, patients received gemcitabine 900 mg/m2 on days 1 and 8 plus docetaxel 100 mg/m2 on day 8 with G-CSF support every 3 week.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic, or recurrent esophageal squamous cell carcinoma
* Age \> 18 years
* ECOG performance status 0 - 2
* At least one measurable lesion(s) by RECIST 1.1 criteria
* Life expectancy ≥ 3 months
* At least one cytotoxic chemotherapy regimen (adjuvant chemotherapy will be considered as one regimen if administered within 6 months from the date of study entry) (upto three prior regimens will be allowed)
* Prior radiotherapy must be completed 2 weeks before study entry.
* Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
* Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)
* Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 upper normal limit)
* Written informed consent

Exclusion Criteria:

* Evidence of serious gastrointestinal bleeding
* Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia)
* Serious metabolic disease such as severe non-compensated diabetes mellitus
* History of significant neurologic or psychiatric disorders
* Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
* Pregnant or lactating woman
Analysis of Therapeutic Management Strategies for Anal Suppurations of Crohn's Disease

Determine the optimal therapeutic combination associated with complete clinical and anatomical remission of anal suppurations of Crohn's disease at 12 months.

The management of anoperineal suppurations of Crohn's disease is most often based on clinical practice recommendations, the results of randomized controlled trials and also the analysis of monocentric cohort studies from expert centres. In these latter studies, there is an overall improvement in patients during follow-up with a high level of satisfaction (two thirds of cases), often assessed by the operator himself or the clinician who provides therapeutic management. The most striking finding is the one that highlights the use of combined therapeutic strategies combining immunosuppressants, biotherapies, antibiotics, surgical drainage and surgical reconstruction procedures to varying degrees. Thus, the absence of fistula pathway flow in the long term is the consequence of both maintenance treatment with biotherapies and several surgical procedures. When the characteristics of fistula pathways considered healed on clinical examination are analysed by MRI exploration, an active unhealed pathway persists in two thirds of cases, again emphasizing the inadequacy of clinical examination as a means of assessing recovery. For this reason, fistula pathway closure strategies do not provide much greater benefit than simple removal of the drainage loop. Conversely, medical treatment optimization strategies based on MRI evaluation of the therapeutic response have demonstrated high efficacy. It is necessary to (re)define the therapeutic management of patients with anoperineal lesions. This strategy must be based on a better initial stratification of patients based on prognostic factors derived from available scientific data. A second step consists in setting therapeutic efficacy objectives that take into account the control of the inflammatory component of anal Crohn's disease and the preservation of the anatomical and functional capital of the anus. Only a large prospective cohort at the national level provides the opportunity to study these prognostic factors and to specify the level of optimal therapeutic responses

Eligibility Criteria:
Inclusion Criteria:

* Persons over 18 years of age
* People suffering from anal suppuration of Crohn's disease for whom a drainage procedure is planned.
* Person who has received written and oral information about the protocol and has not expressed opposition to participate in the study.

Exclusion Criteria:

* No one who is unable to have an anesthetic, structural or psychological examination by MRI and/or surgery.
* Person planning a planned absence that could hinder participation in the research (travel abroad, relocation, impending transfer);
* Person with an associated pathology that is a priority for care;
* Vulnerable person (minors, persons under guardianship or curatorship, or deprived of their liberty by a judicial or administrative decision
Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients

This study is being conducted to collect additional long-term efficacy and safety data of Aldurazyme® (laronidase) patients with MPS I disease. Patients who were previously enrolled in the Phase 3 Double-Blind Study will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

* The patient or patient's legal guardian must provide written informed consent prior to any protocol-related procedures being performed.
* The patient must have successfully completed Study ALID-003-99 (who received 21 of 26 consecutive weekly infusions).
* The patient has not experienced any safety issues that would contraindicate participation in the Extension study.
* A female patient of childbearing potential must have a negative pregnancy test at entry

Exclusion Criteria:

* The patient is pregnant or lactating.
* The patient has received an investigational drug within 30 days prior to the study enrollment.
* The patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that may significantly interfere with study compliance including all prescribed evaluations and follow-up activities
Timing of Inguinal Hernia Repair in Premature Infants

The purpose of this study is to determine whether early (before NICU discharge) or late (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who have an inguinal hernia.

This is a randomized clinical trial comparing early versus late repair in premature infants with an inguinal hernia (IH) to determine which approach may be safer. Safety in this trial is defined as the freedom from significant adverse events, a reduction in hospital days during the study period, and normal neurodevelopmental testing at 2 years. Costs of each treatment strategy are also important and are being evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Infant with estimated gestational age at birth of \< 37 weeks, 0 days
* In a NICU at participating site
* Diagnosed with an IH per the pediatric surgery team
* Parents and providers willing to randomize the infant

Exclusion Criteria:

* Infant is undergoing another operative procedure and IH repair is planned as a secondary procedure (e.g. fundoplication or G tube is planned, and IH repair is considered a secondary procedure)
* Known major congenital anomaly that impacts neurodevelopmental outcome or chromosomal abnormality
* Family unable to return for follow up and later IH repair; or likely unable to monitor IH as outpatient
Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy

To assess Minimal Residual Disease (MRD)-negative Complete Response (sCR) rate after consolidation treatment with Descartes-08 in patients with high-risk myeloma who have residual disease following induction therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or older at the time of enrollment
* High-risk multiple myeloma patients who complete pre-transplant induction treatment anti- myeloma drug combination (minimum 2 drugs).

Exclusion Criteria:

* Patients who are pregnant or lactating.
* Patients who have any active and uncontrolled infection. No blood cultures are necessary unless clinically indicated.