cyrilzakka/clinical-trials huggingface dataset:
Vaccination of Metastatic Breast Cancer Patients With a CD80-modified Allogeneic Cancer Cell Line (KS2422)

In the last few years there has been a great attempt to develop active immunotherapies for breast cancer patients (BCPs) using undefined as well as selected antigens to activate tumor specific T-lymphocytes. The purpose of this phase-I study was to determine the safety and feasibility of vaccinations with an allogeneic breast cancer cell line, KS24.22, genetically modified to express CD80 and Her-2/neu, and to evaluate the efficacy of inducing tumor antigen-specific immune responses in human leukocyte antigen(HLA)-A\*02-matched patients with metastatic breast cancer.

The trial was designed as an open label phase-I. Informed consent was given twice by the patients (1st for HLA-typing, 2nd for participation in the vaccination trial).

The first four vaccinations, which were given every two weeks, were followed by four monthly vaccinations. Additional vaccinations were permitted on request for patients who exhibited stable disease (SD).

Immediately before administration, KS24.22 cells were thawed and lethally irradiated. KS24.22 cells were adjusted to 10E7/ml in Ringer-Lactate-solution, transferred to 1 ml syringes and stored on ice until injected within a time frame of 2h. Vaccinations were given i.d. in the thigh with a total volume of 1 ml divided between two injection sites.

Eligibility Criteria:
Inclusion Criteria:

* proven diagnosis of carcinoma of the breast with distant metastatic disease
* patient received either anthracycline- or taxane-based chemotherapy ("state of the art")
* Karnofsky Score (performance status) 80%
* HLA-\*A0201-positive
* minimum life expectancy of 6 month
* written informed consent
* activation of patient's T-lymphocytes by mitogen antibodies and the cell line used for vaccination

Exclusion Criteria:

* manifestation of CNS metastases
* immunosuppressive disease like AIDS, autoimmune disease
* no serious concomitant systemic medical disorders or active acute or systemic infection
* pregnancy
* chemotherapies or radiotherapies in the 4 weeks preceding study entry
* biological response modifiers (antibodies, TNF, cytokines) or other immune therapies in the 6 weeks preceding study entry (exclusion: hematopoetic growth factors)
* organ transplanted patients
3D-QFR in Non-selected Angiographic Stenosis. A Spanish Multicentre Study.

Physiology-based decision-making about the need for revascularisation in patients with stable coronary heart disease has consistently proven better clinical outcomes than a merely anatomical approach. However, against the current recommendations, revascularisation in most of patients with chronic coronary syndromes still relies on coronary angiography alone. The increase in costs and in procedural complexity of wire-based physiology may explain the latter. Therefore, a novel non-invasive functional quantitative flow ratio (QFR) index was created in order to solve it.

A retrospective and multicentre study is performed to assess the 5-year prognosis of patients undergoing coronary angiography through a centralized QFR analysis. Consecutive participants with confirmed or suspected diagnosis of stable coronary disease who underwent a coronary angiography between 01/01/2015 and 12/31/2015 were included.

Aims of the study:

* To evaluate the prognosis of stable coronary disease depending on the functional assessment of coronary artery disease.
* To determine the % of percutaneous coronary interventions that could be avoided if this study had been carried out through functional assessment of coronary artery disease based on 3-dimensional vessel reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive participants with confirmed or suspected diagnosis of stable coronary disease who underwent a coronary angiography between 01/01/2015 and 12/31/2015.

Exclusion Criteria:

1. Previous coronary artery bypass grafting.
2. \<18 years or \>90 years.
3. Angiographic acquisitions that make it impracticable to perform QFR analysis (patients will be included for descriptive purposes).
4. If a patient has undergone several unscheduled coronary angiographies during the study period, the first will be included as the index case and the following as a follow-up event.
Study of the Sudden Heart Failure Participant Population in the US

An observational study using data from a large US electronic health record database to find participants hospitalized with ADHF who do not have a concurring heart attack


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older on the index date
* At least 6 months of activity in the database
* An inpatient visit with at least one of the following ICD-9 or ICD-10 diagnosis codes (ICD-9 diagnosis codes: 428.xx, 785.51 or ICD-10 diagnosis codes: I50.xx, R57.0) in the primary or secondary position OR mention of "heart failure" on the admission record

Exclusion Criteria:

* An average LVEF ≥ 40 during the hospitalization
* Any code for myocardial infarction (ICD-9 diagnosis code: 410.xx, ICD-10 diagnosis code: I21.xx) or related terms such as "myocardial infarction", "mi", "infarct" or "heart attack" occurring during the index hospitalization

Other protocol defined inclusion/exclusion criteria could apply
Study on the Influence of Dyadic Psychoeducational Intervention on Patients With Maintenance Hemodialysis

This study aims explored the effectiveness of dual psychological intervention strategies in improving the quality of life of MHD patients based on the theoretical guidance of double ABC-X model. To provide a scientific and effective dual psychological intervention strategy for MHD patients and their caregivers, in order to improve the quality of life of MHD patients, and to provide a reference for nurses in clinical blood purification centers to implement psychological intervention.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria of MHD patients were: (1) meeting the diagnostic criteria of CKD; (2) Maintenance hemodialysis at the blood purification center of our hospital for more than 3 months; (3) over 18 years of age; (4) Volunteer to participate in this study.
* MHD caregiver inclusion criteria: (1) over 18 years of age; (2) Responsible for the main care tasks of MHD patients; (3) Volunteer to participate in this study.

Exclusion Criteria:

* Exclusion criteria for MHD patients: (1) Patients with cognitive impairment or audio-visual impairment unable to communicate normally; (2) Patients diagnosed with mental illness or who are receiving medication or psychotherapy for depression.
* MHD caregiver exclusion criteria: (1) Caregivers with cognitive impairment or audiovisual impairment unable to communicate normally; (2) Caregivers suffering from serious heart, brain, liver, kidney and other important organ diseases; (3) carers or paid carers.
Favipiravir Plus Hydroxychloroquine and Lopinavir/Ritonavir Plus Hydroxychloroquine in COVID-19

This is an open-label, non-randomized clinical trial study. The number of 40 COVID-19 patients with moderate severity will be admitted in progressive care units (PCUs) and intensive care units (ICUs) enrolled in the study. The sampling will be purposive and based on the same independent variables, including age, gender, past medical histories, and the situation of the patient at the admission day, and ventilator support. The patients will be allocated into two groups with different regimens. Group "A" (regimen A)will be defined as Favipiravir 1600 mg a first dose and 600 mg in 3 divided doses daily plus 400 mg in 2 divided doses of Hydroxychloroquine every day. The group "B" (regimen B) will be contained 400 mg of Lopinavir/Ritonavirin 2 divided doses plus the first dose (400 mg) of Hydroxychloroquine. Hydroxychloroquine will not be used for adverse drug reactions. The regimen remained at least 7 up to 10 days.

Data will be analyzed using statistical package for social sciences (SPSS) version 18 (SPSS Inc. Chicago, IL, USA) for windows. The variables will be compared using independent and paired T-test for normally distributed variables and Wilcoxon, Chi-square for non-normal distributed variables. The Kaplan Meier test will be used for survival analysis and the one-sample Kolmogorov-Smirnov test for the evaluation of distributions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19
* Requiring hospitalization
* Patient's age between 16 and 100 years
* Signed informed consent form

Exclusion Criteria:

* Receiving other antiviral medications such as (Kaletra, Ribavirin, Oseltamivir)
* Chronic liver or renal failure
* HIV; GI bleeding
* Pregnancy
* Lactation
* QT interval \> 500 ms.
ViBone in Cervical and Lumbar Spine Fusion

Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.

This study is a prospective, multi-center study to evaluate the clinical and radiographic outcomes of ViBone in patients undergoing ACDF or lumbar interbody fusion. Data will be gathered for subjects undergoing ACDF surgery and subjects undergoing lumbar fusion surgery using ViBone. Total enrollment is expected to be approximately 100 subjects. The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo 1-3 level ACDF or lumbar interbody fusion surgery using ViBone. Subjects will be followed for 12 months following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18-80 years of age
* For cervical cases - ACDF surgery at 1, 2, or 3 contiguous levels between C2-C7
* For lumbar cases - lumbar interbody fusion surgery at 1, 2, or 3 contiguous levels between L1-S1
* Patient signed Consent Form with HIPAA Authorization
* Appropriate candidate for surgery
* Patient will adhere to the scheduled follow-up visits and requirements of the protocol including routine patient exams - pre-operative, operative, and at least two post- operative visits (6 and 12 months post-surgery). Pre-operative and post-operative visits include X-ray (required) and CT scan (if available).

Exclusion Criteria:

* Long term use of medications that are known to inhibit fusion or bone metabolism or immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, DMARDs, etc.)
* Treatment with radiotherapy
* Acute or chronic systemic or localized spinal infections
* Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical (for ACDF patients) or lumbar (for TLIF, PLIF, ALIF, or LLIF patients) spine
* Previous pseudoarthrosis at any level of the cervical (for ACDF patients) or lumbar (for
* TLIF, PLIF, ALIF, or LLIF patients) spine
* Nursing mothers or women who are pregnant or plan to become pregnant during the course of the study
* Current or recent history of malignancy or infectious disease. Patients with current or recent history of basal cell carcinoma are eligible.
* Inability to provide informed consent
* Rapid joint disease, bone absorption, osteomalacia, and/or diagnosed osteoporosis (bone density score of ≤-2.5).
* Other medical or surgical conditions which would preclude the potential benefit of surgery, such as congenital abnormalities, immunosuppressive disease, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count.
* Active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection.
Umbilical Cord Blood Therapy for Children With Cerebral Palsy

This study aims to evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy.

Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.

Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain.

On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral Palsy with abnormal muscle tone
* Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
* Willing to comply with all study procedure

Exclusion Criteria:

* Medical illnesses including pneumonia or renal function at enrollment
* Presence of known genetic disease
* Presence of drug hypersensitivity which is related to this study remedy
* Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
* Decision by the principal investigator when there are unexpected events that may affect the outcomes
Treatment of Gingival Recessions with Connective Tissue or Concentrated Growth Factor Membrane Using Tunnel Technique

This randomized controlled clinical study aimed to evaluate the success of the combination of tunnel technique and concentrated growth factor membrane for root coverage in treating multiple gingival recessions and compare with the gold standard connective tissue graft.

The study included 108 defects in 40 patients with Miller Class I and II gingival recession. Gingival recession defects were randomly divided into two groups. Tunnel technique + connective tissue graft was applied to 20 patients in the control group (51 defects) and tunnel technique + concentrated growth factor membrane was applied to 20 patients in the test group (57 defects). The results at baseline and 6 months were evaluated for the following clinical parameters: Mean root coverage, complete root coverage, probing depth, clinical attachment level, gingival recession depth, gingival recession width, keratinized tissue width and gingival thickness.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* periodontally and systemically healthy
* presence of Miller I or II class gingival recession defect in at least two teeth on the buccal aspect of incisors, canine and premolar teeth (≥ 2 mm in depth)
* gingival thickness ≥ 0.8 mm 2 mm apical to the gingival margin
* presence of identifiable cementoenamel junction (CEJ) (step ≤1 mm at the CEJ level and/or presence of a root irregularity/abrasion with identifiable CEJ was accepted
* full-mouth plaque score (FMPS) ≤20%.

Exclusion Criteria:

* smoking
* contraindications for surgical periodontal treatment
* presence of recession defects associated caries, restoration and furcation problems
* use of systemic antibiotics for any reason in the last 3 months.
Effects of Diet on Pregnancy Outcome and Child Obesity

The purpose of the study is to compare 3 different diets in pregnancy, equal in calories, and fats, different in refined grains compared to whole grains as a source of carbohydrates, and in calories from carbohydrate, compared to protein as a source of calories.The hypothesis is that there will be differences in the specified outcomes because the proportions of macronutrients are significant. The primary objective is to detect differences in weight gain.

There will be randomized sequential assignment of pregnant women at the initial clinic visit to Diet A, a high proportion of calories from refined grains as a carbohydrate source, and Diet B, a high proportion of calories from whole grains. Random number assignment is impractical for counseling purposes and blinding not possible. Therefore, randomization by diet assignment by day of initial visit via random number was chosen. If the random number is odd Diet A would be selected, if the random number is even Diet B will be selected for that day.

Eligibility Criteria:
Inclusion Criteria:

* All normal pregnant patients who will be more than three months from term

Exclusion Criteria:

* Illness making it a high risk pregnancy
* Chronic renal disease
* Malignancy
* Congestive heart failure
* Diabetes
* Hypertension
Stanford Cardiac Invasive Electrophysiology Novel Computer Experience

This study will test the ability of computer algorithms to predict successful ablation therapy for atrial arrhythmias.

Patients will be recruited prospectively from among those undergoing ablation for atrial fibrillation (AF) or atrial tachycardias (AT) which may be reentrant or focal. Each patient will undergo careful data collection, including electrogram data and sites of ablation lesions. Ablation will proceed in operator-dependent fashion, and will not be modified in any way for this study. The research question is whether algorithms based on data such as electrograms and details of the ablation performed can predict which patients will have a successful case. Primary endpoints are measures of clinical success defined by (a) acute termination of atrial arrhythmia during the case; (b) long-term reduction in arrhythmia burden; (c) long-term freedom from arrhythmia. Secondary endpoints include (a) identification of sites of arrhythmia termination; (b) improved clinical status.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing catheter ablation for atrial arrhythmias

Exclusion Criteria:

* Inability to sign informed consent
* Expected survival \< 1 year
* Extreme comorbidity, such as advanced NYHA Class III/IV heart failure, dialysis, series stroke.
Apixaban Validation Study - Additional Study on Fresh Samples

The objective is to demonstrate the performances of STA® - Apixaban Calibrator \& STA® - Apixaban Control used in combination with STA® - Liquid Anti-Xa to measure apixaban concentration in plasma. Anti-Xa results will be compared to LCMS (liquid chromatography - mass spectrometry) for validation of the assay. For this study, the anti-Xa assay will be performed on fresh samples only.

The results will be used to complete results obtained previously on frozen samples.

About 60 samples from patients on apixaban meeting inclusion/exclusion criteria will be included in this study. Two sites will be in charge of sample recruitment and anti-Xa testing. A third site will be in charge of LCMS testing.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 75 years,
* Weight ≤ 60 kg,
* Haematocrit below normal values as determined by local laboratory or \< 40% for male and \< 37% for female
* Renal impairment documented (creatinine clearance ≤ 80 mL/min as per Cockcroft -Gault equation) or serum creatinine ≥ 1.5 mg/dL
* Co-medication with aspirin or any other NSAIDs (nonsteroidal anti-inflammatory drugs)
* Co-medication with anti-platelet agents

Exclusion Criteria:

* Patients less than 18 years old
* Patients under other anti-coagulant treatment
* Samples that are not collected, stored, or handled in accordance with sample collection procedures defined above.
Prognosis Value of Non-invasive Methods for the Diagnosis of Chronic Liver Disease

The aim of this retrospective and prospective study is to evaluate the 20-year prognosis value of non-invasive methods for the diagnosis of chronic liver disease for predicting survival and complications of cirrhosis.

All consecutive patients with chronic liver disease will be followed during 20 years.

Eligibility Criteria:
Inclusion Criteria:

* chronic hepatitis C
* chronic hepatitis B
* alcohol liver disease
* non alcoholic liver disease

Exclusion Criteria:

* ascitis
Testing a PTSD m-Health Intervention to Improve Alcohol Treatment Outcomes

The purpose of this study is to learn whether a mobile health application (mHealth App) for posttraumatic stress disorder (PTSD) with brief support can help individuals who are in treatment for alcohol problems.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old
* Currently in addictions treatment
* Meet criteria for a current Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) AUD diagnosis
* A score of 33 or greater on the PTSD Checklist (PCL-5)
* Own a smart phone or other type of Wi-Fi-enabled device with App capabilities

Exclusion Criteria:

* Injection drug use in the past year
* Patients who are unable to speak and/or understand English
* Patients who are currently engaged in specific therapy for PTSD (Prolonged Exposure Therapy, Cognitive Reprocessing Therapy, EMDR)
Effects of Neural Mobilization and Stretching in Piriformis Syndrome

This study compares the effects of piriformis stretching and neural mobilization of the sciatic nerve in individuals with piriformis syndrome, a condition that is frequently characterized by hip and buttock pain and discomfort brought on by the piriformis muscle compressing the sciatic nerve.

In a study involving 40 patients diagnosed with sciatica, researchers aimed to investigate whether neural mobilization of the sciatic nerve or stretching of the piriformis muscle was more effective in treating piriformis syndrome. The patients were divided into two groups, each containing 20 individuals. Group A underwent neural mobilization therapy, while Group B performed piriformis muscle stretches, with both groups receiving treatment three times a week for two weeks. Assessments, including Visual Analog Scale (VAS) for pain, hip range of motion (ROM) in flexion, abduction, and external rotation, as well as the FAIR test, were conducted before and after the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Positive lasegue sign
* Positive piriformis sign
* Tenderness at sciatic notch (over piriformis muscle).

Exclusion Criteria:

* • Prior surgery of lumbar spine (laminectomy)

  * Unrecognized pelvic fracture
  * Known case of renal stones
  * Disc herniation in lumbar spine
  * Myositis ossificans of piriformis muscle.
Plethysmography Curve Variability Depending on the Breath Cycle

The aim of the study is to analyze the variability of plethysmography curve depending on the breath cycle (respiratory rate and tidal volume).

The plethysmography curve measured by finger sensors using pulse oximetry shows the changes in blood volume at the measured site. The presence of respiratory information within the pulse oximeter signal is a well-documented phenomenon. However, previous studies have mainly focused on extracting the respiratory rate from the plethysmography curve. The aim of this study is to analyze the variability of plethysmography curve as a function of both respiratory rate and tidal volume. Furthermore, the aim is to analyze the possibilities of apneic pause detection from the plethysmography curve.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers/students from the Czech Technical University in Prague

Exclusion Criteria:

* any acute illness
* pregnancy
* severe cardiovascular conditions
* severe asthma or other severe respiratory conditions
* diabetes
* hypotension or hypertension