cyrilzakka/clinical-trials huggingface dataset:
Glucose Monitoring During Threatening Preterm Birth in Patients With and Without Gestational Diabetes Mellitus

This study aims to show whether the hyperglycaemic phases following a treatment with glucocorticoids, as well as blood measurements correlated to high blood glucose levels and insulin resistance, vary significantly between patients with and without gestational diabetes mellitus.

BACKGROUND:

The therapy with glucocorticoids for fetal lung maturation in the case of threatening preterm birth is an long existing part of the obstetric routine procedures. Under this therapy it should not be forgotten, that glucocorticoids can lead to a decrease of the maternal insulin sensitivity as well as they can cause an impaired maternal glucose tolerance.

Therefore a threatening preterm birth as well as the including medical therapy do challenge the glucose metabolism of mother and child.

Gestational diabetes mellitus (GDM) is one of the most common complications during pregnancy, and the numbers are on the rise. GDM is characterized through an insulin resistance during the pregnancy.

High blood glucose level during pregnancy or labour can cause complications like a fetal hypoglycaemia right after birth.

METHODS:

This study includes pregnant women with and without gestational diabetes who are medicated with betamethasone due to threatening preterm birth.

In this study the blood glucose measurements of one week, as well as the measurements of HbA1C, Insulin and Blood Glucose from a blood draw one week after the lung maturation therapy will be considered.

Eligibility Criteria:
Inclusion Criteria:

* female
* gestational age between 23+0 and 34+6
* an oral glucose tolerance test was made and attests a healthy glucose tolerance (control group) a gestational diabetes mellitus (case group)
* threatening preterm birth

Exclusion Criteria:

* missing consent to participate
* age under 18 years
* age over 50 years
* preexistent diabetes (type 1 or 2)
* apparent disease of the thyroid gland
* infectious diseases as HIV or Hepatitis C
* insulin dependent gestational diabetes mellitus
Biomarkers in Inflammatory Bowel Diseases

Ulcerative colitis (UC) and Crohn's disease (CD) are chronic relapsing inflammatory bowel diseases (IBD). At the time of diagnosis it is not possible to predict the course of the disease, which can range from a few flares in a lifetime to uncontrollable disease leading to hospitalization, surgery and stoma. There is a continuous need to improve diagnostic and prognostic tools.

In chronic inflammation diseases there is an excessive turnover of the extracellular tissue. Tissue is broken down to small fragments and released into the circulation. Changes in the amount of these fragments in the blood may provide information on the damage and quality of the affected tissue and may therefore act as objective measure of disease burden and severity - a so called biomarker.

The potential of such biomarkers is evaluated in a combined cross-sectional and longitudinal survey including 300 patients with UC, CD, irritable bowel disease and healthy controls. The patients are followed for up to 1 year. Changes in biomarker are correlated to standard markers of inflammation during active disease and remission.

Perspective The use of new biomarkers may offer a tool to evaluate early changes in the gut of patients with IBD, may be a supplement to the diagnosis, serve as markers for effect of treatment and prognosis, and in time be a good alternative to fecal samples or endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Written informed consent
* and one of:
* for Crohn's disease - active disease: Verified CD diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index \> 4.
* for Crohn's disease - disease in remission: Verified CD diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index ≤ 4.
* Ulcerative colitis - active disease: Verified UC diagnosis according to clinical, endoscopic and histological standard criteria and SCCAI \> 3.
* Ulcerative colitis - in remission: Verified UC diagnosis according to clinical, endoscopic and histological standard criteria and SCCAI ≤ 3.
* Irritable bowel syndrome: Verified IBS according to standard criteria.
* Healthy control: No known chronic diseases which needs continuously medication.

Exclusion Criteria:

* Common to all participants:

  * Patient with ostomy or pouch.
  * The patient has had colon cancer, dysplasia or adenomatous polyps in the colon during the recent 5 year
  * The patient is in a poor general condition.
  * The patient is pregnant at the time of inclusion or has planned pregnancy during the period of study.
  * The patient cannot understand the information material.
* Healthy control:

  * The patient has a chronic disease.
  * IBS symptoms according to standard criteria.
  * The patient has had any type of illness within the last 14 days (for example diarrhea, a cold etc.).
  * The patient has any type of on-going medication or new medication within the last 14 days (except contraceptive pills and vitamins).
Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)

The aim of this study is to compare the use of FDG PET/CT to Ga-68 HA-DOTATATE (abbreviated DOTATATE) PET/CT in patients with active giant cell arteritis (GCA) started on prednisone to understand if DOTATATE can identify more areas of active blood vessel inflammation than FDG.

The aim of this study is to prospectively evaluate the potential use of 68-Ga HA-DOTATATE PET/CT for detecting medium-large vessel inflammation in a small number of GCA patients with active disease, as compared to FDG PET/CT, and to understand if DOTATATE uptake correlates with disease activity. Fifteen patients with active GCA (either newly-diagnosed or recently relapsed disease) who are receiving glucocorticoids will be enrolled. Participants will undergo baseline FDG PET/CT and baseline DOTATATE PET/CT scan. Tracer uptake will be described in 8 major vascular territories. DOTATATE PET/CT will be repeated again in 6 months, and tracer uptake will be correlated to clinical disease activity, and medication use.

Eligibility Criteria:
Inclusion Criteria:

Participants must:

1. Meet the revised GCA diagnosis criteria (modified from ref 1)
2. Have either newly-diagnosed or relapsing disease
3. Have active disease (modified from ref 1, to remove ESR/CRP requirements)
4. Have been empirically started on glucocorticoid treatment (or had baseline glucocorticoid dose increased, in the case of relapsers) ≤ 2 weeks of enrolment
5. Participant must be have had (or will be willing to undergo) an urgent FDG-PET/CT as part of routine clinical care.

GCA diagnosis criteria (modified from ref 1, to remove ESR requirement).

1. Age ≥ 50 years
2. And at least 1 of a. or b. :

   1. Unequivocal cranial symptoms of GCA (new headache, scalp or temporal artery tenderness, ischemia-related vision loss, jaw/mouth claudication
   2. Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or hip girdle pain associated with inflammatory stiffness
3. And at least 1 of a. or b.:

   1. Temporal artery biopsy revealing features of GCA
   2. Evidence of large-vessel vasculitis by angiography or cross-sectional imaging study such as magnetic resonance angiography (MRA), computed tomography angiography (CTA), or positron emission tomography-computed tomography (PET-CT)

Exclusion Criteria:

* Patients not meeting the above criteria or who are unable to provide informed consent will be excluded.
Validity and Inter-rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool

The aim of this study is to investigate the validity and Inter-rater reliability for early recognition of spasticity by nurses and physiotherapists using the decision tree tool.

The Spastic Movement Disorder (SMD) Decision Tree was designed as a tool to aid nurses, therapists and other healthcare professions recognize potential signs of disabling spasticity in the upper limb of post-stroke patients. The present study assesses validity and inter-rater reliability of the SMD Decision Tree comparing nurses and therapists with gold-standard procedure performed by rehabilitation doctors. Agreement was tested for "referral to specialist indicated" and "no referral to specialist indicated".

Eligibility Criteria:
Inclusion Criteria:

* Participants with a first sub-acute and chronic infarction of the middle cerebral artery / basal ganglia hemorrhage longer than four weeks after the event
* Between 18-80 years old
* Preserved insight and judgment capacity
* Adequate language and task comprehension, attention span for 15 minutes

Exclusion Criteria:

* Participants with other neurological disorders
* Participants who received BoNT-A treatment \< 3 months before inclusion
* Reduced vigilance and attention span (less than 15 minutes)
* Participants with adult representation
* Participants with severe language impairment / impairment of movement and action sequences
Functional Differences in Effortful Control

The purpose of this study was to learn more about the brain circuits involved with effortful control in healthy adult participants. It was planned that the study would enroll 80 participants to a dual task paradigm pilot while undergoing a fMRI scan to assess brain mechanisms that cause the "depletion effect". This effect refers to the observation that people perform more poorly on effortful control tasks after they have already performed task requiring effortful control. Then subsequent study participants would be given either methylphenidate (also known as 'Ritalin') which is FDA approved and the most widely-used medication for Attention Deficit Hyperactivity Disorder (ADHD) or a placebo, which is a sugar pill. Each participant would also perform some computer tasks that have been shown in previous studies to require effortful control while undergoing an fMRI (functional Magnetic Resonance Imaging) which takes a special kind of picture of the brain. The study's goal was to learn more about the brain mechanisms by which methylphenidate improves effortful control. After enrolling the first 50 participants, the study assessed whether a depletion effect was observed in the dual task paradigm. It was found that there was not: there was no statistically significant difference in effortful control performance comparing subjects who did and did not perform a prior effortful control task. Because the behavioral manipulation failed, it was determined that the drug manipulation portion of the study was no longer justified. Thus, after enrolling 50 participants to the pilot part of the study, the decision was made to terminate the study without beginning the trial of methylphenidate.


Eligibility Criteria:
Inclusion Criteria:

* Right-handedness

Exclusion Criteria:

* Any clinically significant personal or family history of cardiac problems
* Any current Axis I psychiatric disorder (diagnosis as verified by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-IV)
* A previous adequate trial with methylphenidate (Ritalin)
* Currently taking any psychoactive medications
* Any clinically significant medical condition
* Any clinically significant neurological problem (seizures, tics, serious head injury)
* Contraindications to MRI (metal objects in body or claustrophobia)
* Currently pregnant or lactating
* Alcohol or substance abuse (current or in the past 2 years)
* Left-handedness or ambidextrous
* Liver or kidney disease
AdvantAGE: Implementation and Evaluation of an Interprofessional Tranistional Care Model for Frail Older Adults

This clinical trial at the University Department of Geriatric Medicine FELIX Platter in Basel, Switzerland, is designed to evaluate a new transitional care model aimed at helping frail older adults after they get discharged from the hospital. The AdvantAGE study aims to explore the following questions:

* Does the new care model help reduce the number of patients who need to return to the hospital within 90 days?
* How effective is the implementation of this care model?

Participants in the trial will be followed by advanced practice nurses for up to 90 days after hospital discharge. The patients and their caregivers will receive support in coordinating care, managing medications, and learning to manage the patient's health conditions on their own. Additionally, they will have the opportunity to engage in discussions about advanced care planning.


Eligibility Criteria:
Inclusion Criteria:

* Currently admitted to the acute or rehabilitation ward of University Department of Geriatric Medicine
* Reside in Basel-Stadt
* Possess the ability to speak and comprehend the German language
* Scheduled to be discharged to their home
* 65 years or older
* Identified by a clinician as having a high risk of deterioration due to frailty

Additionally, participants must meet at least one of the following criteria:

* diagnosed with a complex chronic disease requiring support in self-management and disease management, or
* facing socially challenging situations such as living alone without a supportive network or lacking a GP, or
* admitted for an acute illness with a brief hospital stay (e.g., infection, cardiac decompensation) and need support in self- and disease management, and continuity of the therapy plan, including close monitoring.

Exclusion Criteria:

* residing in a nursing home or being newly admitted to one
* lacking informal caregivers and exhibiting severe cognitive impairment (MMS ≤23)
* scoring \<50 on the motoric domain of the Functional Independence Measure (FIM)
* having a psychiatric disorder that significantly impacts their ability to manage daily life at time of the discharge
Additional GLP-1 Analogue on CSII Treatment for Poorly Controlled Type 2 Diabetic Patients

Background: Continuous subcutaneous insulin infusion (CSII) has been demonstrated to be an effective clinical tool for intensive insulin therapy in Type 1 diabetic patients. Type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1 (GLP-1) levels. Injection of GLP-1 receptor agonists are associated with improved glycemic control. Nevertheless, the clinical effects and mechanisms are still unclear when additional supplement of GLP-1 analogue in cooperation with intensive CSII treatment for poorly controlled Type 2 diabetes patients. This study is designed to understand the complementary pharmacological effects of GLP-1 analogue on intensive CSII treatment.

Methods: Sixty poorly controlled Type 2 diabetes patients will be admitted to the ward for 6 days CSII intensive treatment. Following the normalization of blood glucose at first 3 days, the patients are randomly assigned with combined therapy with exenatide injection or saline for another 3 days. The clinical assessments of insulin requirement, insulin secretion, insulin resistance glycemic excursions and cytokines will perform immediately during or after the study.

In the poorly controlled type 2 DM, insulin therapy is the treatment of choice to make sugar on target. Actually, however, the general control rate is not good and partially due to the complex etiology in type 2 DM. GLP-1 deficiency is the mostly emphasized in modern practice. In order to study the effect of GLP-1 analogue in insulinized type 2 DM patients, investigators have to optimize the insulin therapy in the first priority. Continuous subcutaneous insulin infusion (CSII) or insulin pump is a viable choice for patients with type 1 or type 2 DM who want close-to-physiologic insulin treatment. By means of the insulin pump therapy, standardized sugar control profile in type 2 DM patients could be achieved in a short time. Investigators can further evaluate the clinical response under GLP-1 analogue or not.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 20 years old
* DM diagnosed \> 2 years
* HbA1c level of 8% to 12%
* Receiving insulin premixed insulin twice daily and total insulin daily dose \> 0.6 u/kg/day

Exclusion Criteria:

* Severe comorbidity, including CHF, CVA, liver cirrhosis, COPD, Cushing's syndrome etc.
* Psychologic problems, including anxiety
* Incorporation, including personal and familial factors
Evaluation of the Efficacy and Safety of the FACET FIXation Implant.

This is a single center, hybrid retrospective and prospective (ambispective) study to evaluate the safety and efficacy of the Facet Fixation implant.

The main objective is to evaluate the efficacy of the Facet Fixation implant compared with pedicle screw fixation to determine successful fusion in radiographic assessment at more than two years. Fusion is mainly defined as any sign of bony fusion between the facet joints or transverse processes when viewing the postoperative CT-scan at over 2 years.

The primary endpoint is the successful fusion rate in radiographic assessment at more than 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years old at the time of the surgery
* The first back operation in the patient's life was for degenerative lumbar spinal stenosis
* Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw fixation or FACET FIXation implant.
* Patient is able to understand the information related to the study
* Patient consents to participate to the clinical investigation and agrees (non-objection) on the use of his/her personal data.

Exclusion Criteria:

* Patient received FACET FIXation implant or Pedicle Screw fixation with supplemental interbody cages.
* Unilateral Pedicle Screw or FACET FIXation implant.
* Preoperative grade ≥II spondylolisthesis
* Preoperative scoliotic deviations \>25°.
* Protected patient (under legal protection, deprived of liberty by judicial or administrative decision).
* Patient not covered by a social security scheme.
Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer

To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the human epidermal growth factor receptor 2 (HER2) gene.


Eligibility Criteria:
Main Inclusion Criteria:

* Treatment-naive participants with stage II or III invasive breast cancer (proven histologically/cytologically) and with tests showing an overexpressing of HER2.
* Participants have at least 1 bidimensionally measurable lesion according to the World Health Organization (WHO) criteria.
* The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* The participant has an LVEF of at least 55% as assessed by multigated acquisition (MUGA) scan (preferred) or echocardiography.
* The participant has hematology and serum chemistry laboratory test results within specific protocol-defined ranges.
* Women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment period and for 6 months after the last administration of study drug.

Main Exclusion Criteria:

The participant:

* Has received previous cancer therapy for breast cancer.
* Has any history of CHF, angina pectoris, or myocardial infarction.
* Has uncontrolled hypertension.
* Has infection, peptic ulcer, or unstable diabetes mellitus.
* Has been treated with live virus vaccines within 8 weeks before the first administration of study drug.
* Has impaired hepatic or renal function.
* Is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
* Has used an investigational drug within one month before the screening visit.
* Has a known hypersensitivity to any of the study drugs or to their active ingredients.
* Has an inflammatory breast cancer.
* Has had any other malignancies within five years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).

Note: Other inclusion and exclusion criteria may apply.
Effects of Potassium Salts on Blood Pressure and Target Organ Damage

The purpose of this study is to determine the effect of potassium chloride and potassium bicarbonate on blood pressure and also to determine whether increasing potassium intake has beneficial effects on the surrogate markers of target organ damage in cardiovascular disease, as well as on bone health.

Randomised trials have shown that increasing potassium intake lowers blood pressure. However, most previous trials used potassium chloride. Whereas, potassium in fruits and vegetables is not a chloride salt, but a mixture of potassium phosphate, sulphate, citrate, and many organic anions, most of which are precursors of potassium bicarbonate. It is unclear whether non-chloride salt of potassium has greater or lesser effect on blood pressure compared to potassium chloride.

Experimental studies in animals and epidemiological studies in humans suggest that a high potassium intake may have beneficial effects on the cardiovascular system and the kidney, independent of its effect on blood pressure, and also reduce the risk of osteoporosis.

We propose to carry out a randomised double-blind trial to compare potassium bicarbonate with potassium chloride looking at their effect on blood pressure, and also to determine whether these potassium salts have beneficial effects on the cardiovascular system, kidney and bone health.

Comparisons: potassium chloride vs potassium bicarbonate vs placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patients with untreated essential hypertension (sitting systolic blood pressure between 140 and 170 mmHg and/or sitting diastolic blood pressure between 90 and 105 mmHg);
* Age 18 - 75 years.

Exclusion Criteria:

* Individuals younger than 18 or older than 75 years;
* Individuals with impaired renal function with plasma creatinine greater than 120 umol/L for non-blacks or 150 umol/L for blacks;
* Individuals with chronic diarrhea, or history of peptic ulcer;
* Individuals with baseline plasma potassium values greater than 5.0 mmol/L;
* Individuals with severe hypertension i.e. blood pressure \> 170/105 mmHg;
* Individuals with diabetes mellitus;
* Individuals with any secondary cause of hypertension;
* Individuals with malignancy or liver disease;
* Individuals with ischaemic heart disease or heart failure;
* Females who are pregnant or breast feeding or on the oral contraceptive pill.