cyrilzakka/clinical-trials huggingface dataset:
Causes, Characteristics and Treatment of Hypercalcemia in the Emergency Room of a German Hospital

Patients with hypercalcemia were identified in the patient population of a German emergency department during a 11 year time period and studied regarding reproducibility of elevated calcium values, causes of hypercalcemia, symptoms. acute renal injury, mortality and treatment response.

Patients, who presented to the emergency department of a tertiary German hospital with a total calcium of ≥2.65 mmol/l between January 2010 and March 2021, was retrospectively studied. From the electronic patient records we analyzed if the elevated calcium values were reproducible in follow-up measurements, identified the cause of hypercalcemia, listed the symptoms, investigated a correlation between calcium and creatinine values to study acute renal injury directly due to hypercalcemia, calculated the mortality rate stratified by the calcium value on presentation and studied the treatment response regarding lowering calcium values by different treatments.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Total calcium ≥ 2.65 mmol/l
* Female and male

Exclusion Criteria:

* Age \< 18 years
* Total calcium \< 2.65 mmol/
Studying Biomarkers in Samples From Younger Patients With Malignant Germ Cell Tumor Progression

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies samples from younger patients with malignant germ cell tumor progression.

OBJECTIVES:

* Explore inter-tumoral heterogeneity in DNA methylation by tumor histology.
* Determine the genomic methylation pattern in the tumors.
* Correlate methylation pattern with tumor histology and clinical characteristics.
* Carry out exome capture and massively parallel sequencing on selected germ cell tumors (GCTs) and matched normal tissue.
* Perform exome capture and Solexa sequencing on a selected set of GCTs.
* Validate candidate mutations in an independent set of tumors.
* Determine the expression profile of mRNAs, lincRNAs and microRNAs in the tumors using RNA Seq.

OUTLINE: Archived blood and tumor tissue samples are analyzed for genomic methylation pattern, exome capture and sequencing, and candidate mutations by methylation-specific PCR techniques, single nucleotide polymorphism (SNP) arrays, and Solexa sequencing methods. Results are validated by using pyrosequencing assays and primer-extension assays. Methylation pattern is also associated with each patient's tumor histology and clinical data.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Tumor and blood specimens from patients registered on the Children Oncology Group (COG) Germ Cell Tumor Protocols, and from other study sites for non-COG patients, including Children's Medical Center, Dallas and the Dana-Farber Cancer Institute, Boston
* Patients' clinical data

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Diagnostic Yield of Transvaginal Ultrasonography Versus Sonohysterography in Detection of Ceserean Section Niche

The aim of this study is to compare the identification of CS scar niche between 2D transvaginal ultrasonography alone and with the use of saline infusion as a contrast. Does it differ in the measurements and identification or not.

Cesarean section (CS) rate is increasing in recent practice with a corresponding increase in associated complication. One of these complications is the CS scar defect or 'niche'. A niche forms after CS at the site of hysterotomy of the anterior uterine wall. Recently, it has been demonstrated that niche may be the causative factor for abnormal uterine bleeding, dysmenorrhea, obstetric complications in subsequent pregnancies and possibly subfertility. Therefore, the accurate measurement and description of a niche is becoming increasingly important, for the clinical assessment of gynecological symptoms and for the planning of possible surgical treatment.A niche can be examined using two- (2D) or three- (3D) dimensional transvaginal sonography (TVS), with or without saline or gel contrast, magnetic resonance imaging and hysteroscopy. We will examine about 30 patients of non pregnant women with previous CS having gynecological complications or seeking fertility. All participants will be subjected to 2D vaginal examination to exclude uterine pathology followed by 2D transvaginal ultrasonography with saline infusion using 10-20 ml of sterile Na Cl 0.9% solution injected through the cervix using a 2 mm sterile disposable catheter or IOL Foley catheter. The procedure will be done postmenstrually.

Eligibility Criteria:
Inclusion Criteria:

* women with previous CS section scar seeking pregnancy or having gynecological complications

Exclusion Criteria:

* women having other gynecological pathology other than niche
Double-method Comparative Study in Order to Predict the Use of Co-receptors From Type 1 HIV: Phenotypic Study (Trofile ESTA®) and Virologic Response to a CCR5 Antagonist in the Short Term

The summary of the Study is to compare two methods in order to predict how the 1-HIV will use a co-receptor: the use of an accredited test (TROFILE ESTA®) and the viral response to a CCR5 antagonist in the short term.


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to give, sign and date the Informed Consent Form to participate in the Study and to donate their samples for cell and molecular Studies, after receiving the appropriate information about the Study design, the main objective of the Study and the potential risks.
* Patients aged \>18.
* Patients with chronic HIV infection
* Patients with no previous HAART (naïve patients).
* Patients that do not meet HAART starting criteria.
* Viral load \>1.000 HIV RNA copies/mL
* Patients able to understand the Study objectives and able to perform frequent visits to the Study Site.

Exclusion Criteria:

* Prior HAART (regardless of the HAART type).
* Pregnancy or willingness to get pregnant during the Study.
Comparative Study of the Wearing Satisfaction of Two Soft Contact Lens Designs.

To evaluate the wearing satisfaction of a new design of the PureVision soft contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Subject is myopic
* Subjects who wear soft contact lenses that are exchanged at least biweekly at the time consent is obtained.

Exclusion Criteria:

* Systemic disease affecting ocular health
* Using pharmaceuticals that may affect the function of the eyes or lenses.
* Subject possessing corneal infiltrate or corneal ulcers.
Kinect-based Versus Tablet-based Cognitive Training: a Pilot Study With Psychiatric Patients

This study aims to analyze which cognitive training experimental condition - Tablet versus Kinect - results in greater cognitive, mood, quality of life, and functional gains in a sample of chronic psychiatric patients.

Cognitive deficits are a nuclear feature of several psychiatric disorders, leading to a decrease in functional abilities and quality of life. Besides facilitating the inclusion of more ecologically valid stimuli and training tasks, technology-based cognitive training methods allow more dynamic interactions with the cognitive training content, which can result in an enhancement of patients' motivation and engagement in the therapeutic process. The modality of interaction with the cognitive training content may influence patients' response to cognitive training interventions. For instance, cognitive training through the tablet requires essentially hand movements (e.g., interaction with the training tasks by touching the correct stimuli), while cognitive training through the Kinect involves the performance of wide range movements (e.g., interaction with the training tasks by making specific "body" movements to select the correct stimuli). This study aims to analyze which cognitive training experimental condition - Tablet versus Kinect - results in greater cognitive, mood, quality of life, and functional gains in a sample of chronic psychiatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Psychiatric diagnosis;
* Maximum age: 75 years old;
* Relatively preserved language abilities (expressive and receptive language);
* Being able to read and write;
* Having no motor limitations;
* Having no medical history of neurological conditions (e.g., stroke, traumatic brain injury, multiple sclerosis, etc.)
* Preserved visual and auditory acuity;

Exclusion Criteria:

* Experiencing an acute psychiatric episode.
Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec®-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia

To compare the complete cytogenetic response rate in patients with newly-diagnosed chronic-phase chronic myeloid leukaemia treated with Glivec® alone or in combination with interferon at low doses

Open, prospective, multicentre, phase IV, comparative and randomised study

Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly-diagnosed chronic-phase Ph-positive chronic myeloid leukaemia (maximum 3 months as of the diagnosis of the disease, with the date of the cytogenetic study regarded as such).
2. Age between 18 and 72 years (both included).
3. Performance status \< 2 on the ECOG scale (see Annex 3).
4. Secure written or oral informed consent in the presence of a witness and consent for biological samples (annexes 5 and 6).

Exclusion Criteria:

1. Criteria of acceleration or blastic crisis (see Annex 7).
2. When there is a compatible family donor in patients aged under 40 years or a non-relative donor in patients aged under 30 years (in whom allogenic transplant is still regarded as first-line treatment), the possibility of performing an allogenic transplant as first therapeutic option should be considered. In any case, as this aspect is still a matter of debate, it is left up to each group to take the relevant decision depending on the institution's policy.
3. Administration of other treatments before inclusion in the protocol (a maximum of 3 months of monotherapy with hydroxyurea is permitted).
4. Altered hepatic or renal function (SGOT, SGPT, total bilirubin and creatinine \> 1.5 times the upper limit of normality).
5. Uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoralis, serious heart failure (functional class III/IV of the New York Heart Association classification), neuropsychiatric infection or disease (see annex 15).
6. Positive serology for HIV.
7. Record of cancer in the last 5 years (barring basal cell skin carcinoma and cervical carcinoma in situ).
8. Pregnancy or breastfeeding
Sensor Controlled Compliance Evaluation of Compressive Elastic Stockings

Compressive stockings ameliorate functional outcome and quality of life in patients after elective orthopedic foot and ankle surgery. In this randomized controlled trial the investigators want to analyze the effect of compressive stockings after foot and ankle surgery. Additionally the investigators want to evaluate the compliance of the compressive stockings Treatment. Therefore an electronic chip device is implanted into the compressive stockings to monitor wearing time.

Pain and swelling are typical sequelae following surgical procedures at the foot and ankle. While it is known that compressive stockings treatment decreases swelling and improves overall ankle function and quality of life in patients after ankle fracture, the investigators hypothesize that compressive stockings could also ameliorate functional outcome and quality of life in patients after elective orthopedic foot and ankle surgery.

Reduced compliance in wearing compressive stockings after foot and ankle surgery might probably be a limiting factor of this postoperative adjuvant compressive therapy. Therefore the investigators want to evaluate patient´s compliance by using an electronic chip device to monitor wearing behavior.

All patients who will be operated on their feet and ankle are randomized and blindly assigned into either the compressive or control-group. Each group consists of 80 patients (160 patients in total). The compression group includes patients who receive postoperative compression stockings. The control group does not receive any stockings. Regular checks at 6 weeks and 12 weeks postoperatively will be performed in order to assess the following parameters:

1. Foot and Ankle Scores
2. Pain

2. Swelling of the foot and lower limb 3. Wearing compliance by electronically recorded wearing time.

The Information about the implanted sensor, which records the stockings wearing time will be given to the patients after the compressive stockings therapy (6 weeks), so that the patients are not influenced by the fact, that their wearing behaviour had been measured.

After this information, the patients decide if the sensor information may be evaluated by the study team or not.

Eligibility Criteria:
Inclusion criteria:

* all patients with a signed informed consent
* all patients, who underwent hindfoot and middlefoot surgery

Exclusion criteria:

* patients with a externe Fixateur.
* patients with contraindication for the use of compressive stockings
* patients with severe General disease (cancer, rheumatoider Arthritis)
Plasticity Using Stimulation and Habit: A Pilot Open-label rTMS Study for MCI

The goal of this pilot study is to determine whether a high-dose form of non-invasive brain stimulation is a promising and safe treatment for Mild Cognitive Impairment (MCI). Transcranial magnetic stimulation (TMS) is an FDA approved treatment for depression. In studies of TMS for depression and other disorders, individuals have experienced improved cognitive function. Thus, the current study is testing whether TMS is safe, feasible and effective in improving cognition in individuals with MCI.


Eligibility Criteria:
Inclusion Criteria:

* Age 60-85
* English as a first/primary language
* Has been diagnosed with MCI by a healthcare provider within the past two years per National Institute on Aging - Alzheimer's Association (NIA-AA) criteria: (1) Concern regarding cognitive decline reported by patient, informant, or clinician, (2) Objective evidence of impairment for age in 1+ cognitive domains, typically memory, (3) Preserved independent function, (4) no dementia.
* Has met actuarial neuropsychological criteria for amnestic MCI: (1) ≥2 impaired scores (i.e. ≤16th %ile) within one cognitive domain, or (2) ≥1 impaired scores (i.e. ≤16th %ile) in ≥3 cognitive domains, using demographically-corrected normative data. (1) and (2) must include the Memory domain.
* The primary suspected etiology of amnestic MCI must be neurodegenerative, with competing differential diagnoses (e.g. psychiatric disorder, movement disorder, reversible causes, substance use) ruled out as the primary etiology/ies following a clinical evaluation by a healthcare provider.
* Ability to provide independent informed consent, consistent with the MCI diagnostic criterion of preserved independent function.

Exclusion Criteria:

* Dementia diagnosis per the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) or NIA-AA criteria.
* Daily/weekly use of anticholinergics, neuroleptics, sedatives, or bupropion. Stimulant use may be allowed pending investigator review. Cholinesterase inhibitors, NMDA receptor antagonists, and antidepressants are allowed if on a stable regimen of four weeks prior to enrollment.
* History of significant or unstable condition/s that may impact cognition such as significant cardiac, cerebrovascular, or metabolic disease, severe mental illness (e.g. bipolar disorder, psychoses), alcohol or substance use disorder, developmental disorder, or other neurologic disease (e.g. severe brain injury, seizures).
* MRI and TMS contraindications (e.g., implants, claustrophobia, conditions/treatments that lower seizure threshold, taking medications that have short half-lives, no quantifiable motor threshold, active substance use disorder, bipolar disorder).
* Is enrolled in a clinical trial and/or has received an investigational medication within the last 30 days.
Growth Hormone Signaling in Vivo in Humans

Objective: GH induces insulin resistance in muscle and fat and in vitro data indicate that this may involve crosstalk between the signaling pathways of the two hormones.

Aim: To investigate GH and insulin signaling in vivo in human muscle and fat tissue in response to GH, GH receptor blockade and insulin stimulation..

The molecular mechanisms by which GH promotes insulin antagonism are still unclear. Stimulation of lipolysis could be of importance since high plasma FFA levels have been shown to interfere with insulin receptor signaling via inhibition of insulin-stimulated insulin receptor substrate (IRS)-1 associated phosphatidylinositol (PI) 3-kinase activity in human skeletal muscle, resulting in a decreased GLUT4 translocation and glucose transport (6). A recent study, however, was unable to document a suppression in the insulin-stimulated activity of either IRS-1 associated PI 3-kinase or the serin/threonin kinase Akt after GH administration to healthy humans, despite induction of lipolysis and insulin resistance (7). Other studies have shown that acute GH exposure induces insulin resistance in skeletal muscle rapidly and before the subsequent rise in plasma FFA (1;7;8). These observations indicate that GH may cause insulin resistance via a non-FFA mediated mechanism.

The predominant GH signal transduction cascade comprises activation of the GHR dimer, phosphorylation of JAK2 and subsequently activation of Stat5. The intact JAK2/Stat5 pathway is necessary for normal statural growth (9). There is animal and in vitro evidence to suggest that insulin and GH share post-receptor signaling pathways (10). Convergence has been reported at the levels of Stat5 and SOCS3 as well as on protein kinases comprising the major IR signaling pathway; IRS 1/2, PI 3-kinase, Akt and ERK 1/2 (11-14).

Pegvisomant is a GH analog and a competitive reversible GH receptor antagonist, which blocks peripheral GH signal transduction (15). Pegvisomant has been shown to inhibit the necessary conformational change of the GHR dimer and thus constitutes an optimal negative control in GH signaling studies.

The aim of this work was to further study GH signal transduction pathways in vivo in muscle and adipose tissue from healthy subjects in response to acute and more prolonged GH exposure as well as during hyperinsulinemia. The design also included administration of pegvisomant in an attempt to correct for spontaneous GH secretion.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Healthy
* Not taking medication

Exclusion Criteria:

* Insulin resistance
Understanding Adaptive Challenges Associated With Male-factor Infertility

The purpose of this study is to understand the experience of men and their partners when diagnosed with male-factor infertility while trying to achieve a pregnancy and the skills they use to adapt to this diagnosis.


Eligibility Criteria:
Inclusion criteria:

Men:

* in a partnered relationship with a female
* have been trying without success to conceive a pregnancy
* have been referred due to suspected or diagnosed male-factor infertility
* have the ability to read and write English

Female Partner:

* 18 to 40 years of age
* ability to read and write English

Exclusion criteria:

* living children, either biological or adoptive
* history of vasectomy
Computer-aided Detection of Colorectal Polyps

In this observational pilot study, we assess the diagnostic performance of an artificial intelligence sytem for automated detection of colorectal polyps.

During standard colonoscopy, a substantial number of colorectal polyps can be missend. As shown in a recent meta-analysis, miss rates for adenomas can reach up to 26%. In this study, it is tested whether an artificial intelligence system that highlights colorectal polyps during screening or surveillance colonoscopy in real time can lead to an increased detection of colorectal polyps during the examination.

Eligibility Criteria:
Inclusion Criteria:

* Screening or surveillance colonoscopy

Exclusion Criteria:

* known or suspected inflammatory bowel disease
* uncontrolled coagulopathy
* known polyps or referral for polypectomy
Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm

The SWAF study will compare the performance of a smartwatch combined with Cardiologs Platform algorithm in the detection of Atrial Fibrillation and other arrhythmias with that measured on a manually read 12-lead ECG in subjects hospitalized for cardioversion or AF ablation.

The SWAF study is a prospective, non-significant risk, non-randomized, multicentric, open, comparative, confirmatory study.

Under subject consent, subjects hospitalized for cardioversion or AF ablation will have a smartwatch ECG recording done simultaneously with 12-lead ECG measurement right before the intervention. If a subject is found in Normal Sinus Rhythm he/she will be discharged otherwise the patient will undergo cardioversion and will have simultaneous recordings done a second time after the intervention. All the measurements will be done in accordance with the existing subject monitoring protocol.

Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18, able and willing to participate in the study
* Subjects who are admitted to the hospital for a cardioversion or AF ablation procedure.
* Subjects having read the patient information letter and provided his/her consent to participate in writing, by dating and signing the informed consent prior to any trial-related procedure being conducted

Exclusion Criteria:

* Subjects with paced rhythm or implanted electronic devices
* Pregnant or breast-feeding subjects
Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

The study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese patients with chronic obstructive pulmonary disease (COPD) so that optimal dose(s) could be chosen for testing in later studies.


Eligibility Criteria:
Inclusion Criteria:

* Male and female Japanese aged 40 to 75 years old
* Moderate to severe chronic obstructive pulmonary disease (COPD) with smoking history of at least 20 pack years

Exclusion Criteria:

* History of hospitalization for COPD exacerbation within past 6 months
* Use of long-term oxygen therapy
* History of asthma
* Respiratory tract infection within past 1 month
* Consistently very high or low blood sugar
* Clinically abnormal laboratory values or significant condition
* History of heart failure or heart attack within past 6 months
* History of long QT syndrome or long QT interval in electrocardiogram recorded at screening

Other protocol-defined inclusion/exclusion criteria applied to the study.
Growth and Tolerance of Hypoallergenic Formulas

This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula.


Eligibility Criteria:
Inclusion Criteria:

* Singleton, 12-16 days of age at randomization
* Term infant with birth weight of a minimum of 2500 grams
* Solely formula fed
* Signed Informed Consent and Protected Health Information

Exclusion Criteria:

* History of underlying metabolic or chronic disease or immunocompromised
* Feeding difficulties or formula intolerance