cyrilzakka/clinical-trials huggingface dataset:
The Effect of TASH in Patients With HOCM

To examine patients with hypertrophic obstructive cardiomyopathy (HOCM) before and after septal alcohol ablation, to investigate the effect of the treatment in regards to changes in myocardial function, perfusion, invasive hemodynamics and exercise tolerance.

Patients with HOCM who develop symptoms of heart failure are treated initially with non-vasodilating ß-blockers or verapamil to decrease myocardial contractility and heart rate. A substantial part of patients remain symptomatic despite medical treatment. In these patients interventional or surgical treatments (septal reduction therapies (SRT)) to reduce left ventricular outflow tract obstruction (LVOTO) is considered in the presence of moderate to-severe symptoms (New York Heart Association - functional class (NYHA) III-IV) and/or recurrent exertional syncope and an LVOTO gradient ≥50 mm Hg. In some centers, invasive therapy is also considered in patients with mild symptoms (NYHA Class II) who have a resting or maximum provoked gradient of ≥50 mm Hg (with exercise or Valsalva's maneuver) and moderate-to-severe mitral valve regurgitation. Advanced treatment options are alcohol septal ablation (ASA) or surgical myectomy often combined with mitral valve reconstructive surgery. These treatments have similar outcomes in terms of gradient reduction, symptom improvement and exercise capacity

No previous trials have examined the effect of ASA in HOCM with respect to changes in central hemodynamics and myocardial performance during exercise.

24 HOCM patients will be examined prior to ASA, and approximately six-nine months after ASA.

The examination set-up consists of simultaneous 1) transthoracic echocardiography (TTE), 2) right heart catheterization (RHC) and 3) cardiopulmonary exercise test (CPX).

Eligibility Criteria:
Inclusion Criteria:

* Left ventricular wall thickness ≥ 15 mm in one or more myocardial segments that is not explained by loading conditions
* LVOT gradients ≥ 30 mmHg at rest and/or ≥ 50 mmHg at Valsalva's maneuver or exercise
* NYHA ≥ III

Exclusion Criteria:

* \< 18 years
* Fertile women who do not use anti-contraceptives
* Pregnancy
* Patients are allowed to have a pacemaker (eg. an implantable cardioverter defibrillator (ICD)) but cannot be pace-dependent
* Amiodarone treatment
* Persistent or permanent atrial fibrillation/flutter
* Previous SRT
* Alcohol or drug abuse
* Significant co-morbidity (judged by the investigator)
* Patients who cannot give valid consent (e.g. mental illness or dementia) or who do not understand Danish.
Prostasin Levels in Preeclamptic Women

This study will aim to compare maternal serum prostasin levels between women diagnosed with preeclampsia and healthy normotensive pregnant controls. Participants will be divided into two main groups: those with preeclampsia and those with uncomplicated pregnancies. The preeclampsia group will further be subdivided based on the severity of the condition. Maternal serum samples will be collected from all participants, and prostasin levels will be measured using ELISA. Statistical analyses will be performed to evaluate whether prostasin levels are significantly elevated in the preeclampsia group, particularly in those with severe features, and to assess its potential as a biomarker for the condition.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Preeclampsia: Defined by new-onset hypertension (systolic Blood Pressure ≥140 mmHg and/or diastolic Blood Pressure ≥90 mmHg) after 20 weeks of gestation, with or without proteinuria.
* Control Group: Healthy pregnancies without preeclampsia or other significant maternal or fetal complications.

Exclusion Criteria:

* Multiple Pregnancies
* Pregestational Diabetes
* Chronic Hypertension
* Systemic Diseases (Chronic kidney disease, autoimmune diseases)
* Fetal Anomalies
* Premature Rupture of Membranes.
Randomized Study of Midodrine, an Alpha Adrenergic Agonist, in Patients With Neurally Mediated Syncope

OBJECTIVES:

Determine the efficacy of midodrine, a selective alpha 1 adrenergic agonist, in preventing neurally mediated syncope.

PROTOCOL OUTLINE: This is a randomized, double-blind, crossover, placebo-controlled study.

On day one, patients receive either midodrine or placebo. On day three, patients receive the opposite drug.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosis of neurally mediated syncope (vasovagal fainting) Sudden fall in blood pressure AND Slowing of the heart AND Temporary loss of consciousness AND Hemodynamic response to head up tilt --Prior/Concurrent Therapy-- No other concurrent adrenergic agonist or antiagonist --Patient Characteristics-- Fertile patients must use effective birth control
Effect of Selected Rehabilitation Program in Patients With Plantar Fasciitis

This study will be done to investigate the effect of the selected rehabilitation program for PF on plantar fascia thickness, clinical outcomes such as pain, foot function, dorsiflexion ROM and pressure pain threshold and alignment such as rearfoot eversion angle and foot posture index in patients with PF.

Plantar fasciitis (PF), which constitutes approximately 15% of all foot disorders, is the most prevalent cause of heel pain. It is a long-term degenerative process that is impacted by subtalar pronation and pes planus. One million US patients saw primary care physicians with PF between 1995 and 2000. There is not enough data to determine the best physical therapy management techniques for individuals with heel pain, despite the existence of multiple successful treatment approaches. this study investigated at how a mechanically based rehabilitation program affected patients with PF in terms of foot alignment, plantar fascia thickness, pain, pressure pain threshold, ROM and foot function. The approach included strengthening the plantar intrinsic muscles of the foot, plantar fascia specific stretching and Achilles tendon stretching, and passively correcting the pathomechanics of the foot by low dye tapping and high load resistance exercise for Achilles tendon and windlass mechanism

Eligibility Criteria:
Inclusion Criteria:

* Plantar medial heel pain: most noticeable with initial steps after a period of inactivity, but also worse following prolonged weight-bearing
* Pain with palpation of the proximal insertion of the plantar fascia
* Positive windlass test
* flat foot posture utilizing the foot posture index
* age range from 40 to 60 years

Exclusion Criteria:

* tarsal tunnel syndrome
* atrophy of the fat pad.
* diabetic patients or patients with rheumatoid arthritis
* corticosteroid injection over the last sex months
Vertebral Body Sparing Craniospinal Irradiation for Pediatric Patients With Cancer of the Central Nervous System

This trial studies the feasibility of using intensity modulated proton therapy to deliver craniospinal irradiation while avoiding the bones of the vertebral column. Intensity modulated proton therapy is an advanced radiation therapy modality that uses high energy protons to kill cancer cells and shrink tumors, and may reduce the side effects of treatment by reducing radiation exposure to the spinal column.

PRIMARY OBJECTIVES:

I. To demonstrate the feasibility and safety of using intensity modulated proton therapy to deliver vertebral body sparing craniospinal irradiation in growing children.

Ia. To report the dose received to the vertebral bodies and the dose gradient/heterogeneity within the vertebral body.

Ib. To document, using weekly cone beam computed tomography (CT) of the cervical and lumbar spine, delivered dose in comparison with planned dose after accounting for any errors in patient positioning.

II. To evaluate acute toxicity of vertebral body sparing (VBS) craniospinal irradiation (CSI).

IIa. To report absolute lymphocyte counts over time and occurrence of grade 3-4 hematological toxicity.

IIb. To report the incidence and severity of any grade esophagitis during or within 4 weeks of radiation therapy.

III. To evaluate the feasibility of magnetic resonance imaging (MRI) imaging during CSI therapy as in vivo proton range verification.

IIIa. To demonstrate the feasibility of completing interim non-contrast MRIs of the spine during treatment.

IIIb. To characterize the earliest time point at which radiation induced bone marrow changes can be detected in children receiving proton CSI.

OUTLINE:

Patients undergo intensity modulated proton therapy once daily over 30 fractions and also undergo MRI over 20 minutes during fractions 7, 13, 20, and 30 of radiation in the absence of disease progression or unacceptable toxicity.

After the completion of study treatment, patients are followed up at 4 weeks and then every 3-12 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of central nervous system malignancy requiring craniospinal irradiation.
* Signed informed consent and assent when indicated.

Exclusion Criteria:

* Any contraindication to undergoing MRI (ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial cardiac valves or devices, electrical implants such as cardiac pacemakers or perfusion pumps). Metal fragments, shrapnel, or tattoos near the eye.
* Any major uncontrolled or poorly controlled current illness that would limit compliance with study requirements.
* Pregnant females are excluded. Females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy.
The Role of Central Sensitization on Biopsychosocial Factors in Primary Sjögren's Syndrome

Following the guidance of individuals with primary Sjögren's Syndrome who receive diagnosis, routine medical care, and treatment management, the evaluations will be performed once by the researchers and will take approximately one hour.

In addition, healthy individuals with a similar average age to the evaluation group without any disease diagnosis will be included in the study as a control group. Evaluations of the healthy group will be made once by the researchers and will take approximately one hour.

Data will be collected face to face at the Faculty of Physical Therapy and Rehabilitation, Rheumatology Unit.

Data collection tool of the research:

* Information about patients will be recorded with the Demographic Information Form.
* EULAR Sjögren's Syndrome Disease Activity Index
* EULAR Sjögren's Syndrome Patient Reporting Index
* Primary Sjögren's Syndrome Quality of Life Scale
* BETY-Biopsychosocial Questionnaire
* Central Sensitization Scale
* Pain Catastrophizing Scale
* Hospital Anxiety and Depression Scale
* Multidimensional Fatigue Rating Scale
* Turkish Eating Assessment Tool
* Yale Swallow Protocol
* Test of Mastication and Swallowing Solids
* Dysphagia Limit Test
* Xerostomia inventory


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Primary Sjögren's Syndrome
* 18 years or older

Exclusion Criteria:

* Patients with Secondary Sjögren's Syndrome,
* Patients who are diagnosed with other uncontrolled/clinically important diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
* Having a malignant condition,
* Pregnant individuals in the third trimester,
* Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.
Nutritional Requirements for Vitamin D in Pregnant Women

Randomised, placebo-controlled dose-response intervention study with vitamin D3 in pregnant women.

This is a three-arm, parallel, double-blind, placebo-controlled dose-response intervention study with vitamin D3. Women will be recruited prior to 18 weeks of gestation and randomised to receive placebo, 10 or 20 mcg/d of vitamin D3 from baseline visit in their first trimester until delivery. Blood samples will be collected at baseline, midpoint and endpoint of the trial, at 10 week intervals, and from the umbilical cord at delivery. A 25-hydroxyvitamin D concentration of 30 nmol/L will be used to denote vitamin D deficiency. Information on maternal anthropometry, diet, lifestyle, sun exposure, blood pressure, iPTH and serum total calcium will also be reported.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years)
* No more than 18 weeks gestation
* In good general health
* Low risk pregnancy
* Not consuming \>10 mcg/d vitamin D from supplements

Exclusion Criteria:

* Current smokers
* Diagnosed hypertension
* Known high-risk pregnancy
* Diagnosed medical illness including diabetes mellitus (Types 1 \& 2), chronic kidney disease or gastro-intestinal diseases or any illness known to interfere with calcium metabolism (e.g. sarcoidosis).
* Consumption of medications known to interfere with vitamin D metabolism
* Consumption of vitamin D (≥ 10 µg/day) or calcium (≥ 650 mg/d) supplements prior to randomization
Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis

Acute kidney injury (AKI) requiring renal replacement therapy is common in critically ill patients. The major causes of AKI are severe sepsis and septic shock requiring effective antibiotic treatment. Patients with sepsis on ICUs usually are haemodynamically instable so that renal replacement therapy is applied using continuous techniques. In recent years, the efficacy of renal replacement therapies has improved, namely by using regional citrate anticoagulation which improves filter lifetime and filter patency. At present, the extent of removal of antibiotic drugs using citrate-anticoagulated CVVHD in critically ill patients has not been investigated thoroughly. Thus, the investigators want to investigate

1. whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during citrate-anticoagulated CVVHD per se
2. whether filter patency during citrate-anticoagulated CVVD remains stable during a treatment period of 72 h


Eligibility Criteria:
Inclusion Criteria:

* Intensive care patients with acute kidney injury requiring continous renal replacement therapy with citrate-anticoagulation
* Age \> 18 y

Exclusion Criteria:

* \< 18 y
* Pregnancy
* Contraindications against citrate-anticoagulation or continous renal replacement therapy
Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Occupancy of SEROQUEL

The aim of this study is to relate pharmacokinetics of two different formulations of quetiapine to PET measured receptor occupancy in the brains of healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Normal MRI scan
* Body mass index 19-30 kg/m2 and weight of 50-100 kg
* Clinically normal physical findings, medical history and laboratory values

Exclusion Criteria:

* Trauma or sickness last 2 weeks before the first PET examination.
* A history or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic, pulmonary, renal disease or other condition as judged by the Investigator
* Any previous participation in a PET study
* Subjects suffer from claustrophobia
Preoperative Planning With PSMA-PET in Melanoma Surgery Trial

This is a non-randomised, single-centre Phase 2 study, investigating whether the diagnostic biomarker, prostate-specific membrane antigen (PSMA), can detect melanoma metastases using PSMA PET/ CT.

The proposed 'Preoperative Planning PSMA-PET in Melanoma Surgery (PPPIMS)' trial is a Phase 2 study, investigating the ability of PSMA as a biomarker to accurately detect melanoma metastases in patients with palpable lymphadenopathy and oligometastatic melanoma. If proven to have diagnostic utility, it may allow more precise 3D lymphatic mapping and identification of tumour in intricate anatomical areas, resulting in more accurate surgical planning. A more precise delineation of nodal disease and metastasis will result in a more accurate and lesser surgical dissection, and consequent reduction in morbidity.

The PSMA-PET-CT will be compared with the standard-of-care imaging, FDG-PET-CT to evaluate utility of this approach. It is of note that FDG-PET CT has a high background FDG uptake normally seen in the brain and liver, and PSMA could potentially be a more favourable tracer if there is less background uptake.

Eligibility Criteria:
Inclusion Criteria:

* Males ≥18 years of age
* Biopsy proven first and recurrent metastatic melanoma with palpable nodal disease who have undergone a staging FDG PET-CT scan as part of routine clinical care and are scheduled for surgery for resection of the primary site

Exclusion Criteria:

* Patients unable to give voluntary written informed consent to participate in this study
* Patients not willing to complete all the study assessments
* Patients who are females
* Patients who are taking androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists.
* Patients who have or have previously been diagnosed with prostate cancer
* Patients who have had Lu-177 PSMA therapy or barium studies within a period of 10 days prior to undergoing PSMA PET-CT scanning
* Patients not fluent in English
Epidural Stimulation for Upper Extremity Function

Restoring upper extremity function in patients with cervical spinal cord injury is extremely important for patients' independence and quality of life.

At present, there are limited options for hand or arm reanimation in this patient population. Nerve transfer is one such option that can partially restore the natural movement of hand or arm function in select patients.

The investigators are interested in understanding whether recovery of hand or arm motor function after nerve transfer can be augmented by cervical epidural spinal cord stimulation.

The study will enroll up to 20 participants in a single arm prospective clinical study. Potential participants will have already had a nerve transfer surgery more than 6 months prior to enrollment and will have also completed post-nerve transfer physical /occupational neurorehabilitation.

At baseline, upper extremity muscle strength, muscle force and nerve health with needle electromyography and neuroimaging will be tested.

Patients will undergo percutaneous (temporary) spinal cord stimulator leads placement in the cervical supralesional spine region.

Week 0-4: Weekly testing of motor function and muscle contraction force with the stimulation turned on versus turned off will be performed. Stimulation parameters for each target upper extremity muscle will also be documented.

Temporary leads will be removed after approximately 4 weeks.

At the last research visit at approximately 6-7 weeks post leads placement muscle strength/force will be assessed to determine the duration of the stimulation effect (if it is sustained). To assess any improvement of nerve health, neuroimaging and electromyography will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and ≤65
* Provides informed consent
* History of upper extremity nerve transfer \> 6 months prior to enrollment
* Completion of standard post-nerve transfer occupational therapy
* Baseline upper extremity strength of \< 5/5 grade with the MRC
* Scheduled to undergo a cervical spinal cord stimulation procedure for chronic pain refractory to first line therapy
* Willing and able to adhere to the study protocol

Exclusion Criteria:

* Central nervous system (CNS) malignancy
* A contraindication to the SCS procedure
* Diagnosis that precludes the patient from full participation in the protocol
* A functional implanted device (pacemaker, vagus nerve device, baclofen pump)
* Botulinum toxin injection in upper extremity muscles \< 6 months prior to enrollment
* For female participants, current/planned pregnancy (females of childbearing age will be asked to take a pregnancy test on the day of the intervention)
* Other factors that prevent participation in the opinion of the surgeon-principal investigator
A Study of the Effects of Ziprasidone for the Treatment of Schizophrenia or Schizoaffective Disorder in Patients Who Were Switched From Other Antipsychotic Drugs

The purpose of this study is to see if differences exist in outcome in patients with schizophrenia or schizoaffective disorder who were switched from other antipsychotics to ziprasidone.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* Outpatients for at least 3 months on treatment with sulpiride, olanzapine, quetiapine, or risperidone and at least a partial beneficial response to typical antipsychotic treatment including for the current episode
* Partial improvement in symptoms that justified a switch to ziprasidone

Exclusion Criteria:

* Diagnosis of major depression or occurrence of moderate depressive symptoms
* Resistance to conventional antipsychotic drugs
* Treatment with other drugs such as antiseizure medications, antipsychotics, antidepressants, or mood stabilizing agents that might interfere with the assessement of the efficacy of ziprasidone
Brain-Gut Yoga for Functional Dyspepsia and Gastroparesis (FD-GP)

The purpose of this research study is to assess whether using a yoga-based intervention in practice is feasible (possible) and acceptable to patients with Functional Dyspepsia and/or Gastroparesis (FD-GP).

This research looks to adapt an existing seated yoga intervention, designed for patients with GI cancer, for testing in patients with disorders of the upper GI tract by conducting a field test with FD-GP patients to assess feasibility and acceptability and refine the adapted intervention.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Functional Dyspepsia or Gastroparesis (FP or GP) diagnosed by a physician using standard criteria
* Signed, written consent

Exclusion Criteria:

* Co-morbid Gastrointestinal or related disorders documents in the medical record: celiac disease, inflammatory Bowel Disease(active), gastrointestinal obstruction (if current in the last 6 months), any GI surgery within the last 6 months), chronic pancreatitis or any pancreatic or biliary disease, cirrhosis or any chronic liver disease other than metabolic associated hepatic disease (MASH), any malignancy (except skin cancer already resected and surgically in remission)
* A positive screen for the following: current psychotic symptoms, elevated suicide risk, active eating disorder, cognitive impairment, current harmful alcohol or substance use
* Does not understand English
* Underwent a regular yoga or other mediative movement practice (tai chi or qi gong) in the past 6 month