cyrilzakka/clinical-trials huggingface dataset:
The Effect of Vitamin D Fortification of Bread and Milk in Danish Families

Approximately 200 families corresponding to 800 persons are included in the study. The study investigate the efficacy of vitamin D fortification of bread and milk on vitamin D status in serum. Participants receive milk and bread twice a week. Half of the participants receive vitamin D fortified products and the other half similar non-fortified products. The study starts in September and runs for 6 months during winter, the period where it is not possible to produce vitamin D in the skin through sunlight exposure. The hypothesis is that the usual fall in vitamin D status can be prevented by vitamin D fortified food.


Eligibility Criteria:
Inclusion Criteria:

* Family with at least one child between the age 4 to 18 years and at least one adult less than 60 years of age
* Permanent address in a specific geographical region.

Exclusion Criteria:

* Use of medication (including dietary supplements with high levels of vitamin D)
* Diseases which influence vitamin D metabolism
* Pregnancy
Pre-Insertion Ultrasound for Lateral-Position Spinal in Cesarean Delivery

The purpose of this study is to evaluate the impact of lumbar ultrasound anatomic mapping using the Accuro device on the number of needle redirections, when performing spinal anesthesia in the lateral decubitus position on patients undergoing elective cesarean delivery.

Training in neuraxial placement most commonly occurs with patients in the sitting position, since it is easy to master. However lateral placement may be preferred in emergent situations and for patient comfort. In order to provide safe and effective anesthesia to parturients, providers must be competent with the technique in both sitting and lateral positions.

Ultrasound examination prior to spinal placement is a safe, non-invasive method of determining depth, midline, and interspinous location. Its use may decrease the number of needle insertions and needle passes in parturients in the sitting position, however little is known about the benefit of ultrasound use in the placement of lateral spinals.

The use of lumbar ultrasound with Accuro may improve success rates, safety, and the education of residents as they learn neuraxial placement in the lateral position. This will be the first study to examine the use of Accuro for lateral neuraxial placement.

The study investigators hypothesize that lumbar ultrasound with the handheld Accuro device by an experienced provider prior to spinal insertion will result in fewer needle redirections compared to palpation of landmarks when performed by anesthesia residents or fellows.

The two arms of the study are as follows:

Group 1: Control Group: sham pre-puncture ultrasound procedure with the handheld Accuro device turned off, followed by a sham marking on the participant's back using the Accuro locator marker attached to the device.

Group 2: Ultrasound Group: pre-puncture ultrasound with Accuro followed by marking placed at the L3-4 interspace in the midline using the attached Accuro locator marker.

All ultrasound exams will be performed by an unblinded physician study investigator.

All study participants will have a spinal anesthetic in lateral position performed by one of the residents or fellows participating in the study.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* 18 years or older
* singleton pregnancy
* at least 37 weeks gestational age
* American Society of Anesthesiologists (ASA) Classification II
* body mass index (BMI) \<35 kg/m2
* plan for elective and scheduled cesarean section with spinal anesthesia

Exclusion Criteria:

* patient refusal of spinal anesthesia
* uncorrected coagulopathy
* infection at the skin site of spinal placement
* increased intracranial pressure
* untreated hemodynamic instability
* history of scoliosis or spine surgery
* BMI \>/=35 kg/m2
* allergy to local anesthetic
* allergy to opioids
A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects

* To determine the mass balance of totalradioactivity following a single IV infusionof (14C)-OPC-61815.
* To determine routes and rates of elimination of total radioactivity following a single IV infusion of (14C)-OPC-61815
* To assess the PK of total radioactivity in plasma and whole blood following a single IV infusion of (14C)-OPC-61815
* To assess the PK of OPC-61815 free form and OPC-41061 in plasma following a single IV infusion of (14C)-OPC-61815


Eligibility Criteria:
Inclusion Criteria:

* Male subjects between 35 and 55 years of age, inclusive; hold a valid Japanese passport and be first generation Japanese, defined as the subject, the subject's biological parent, and all of the subject's biological grandparents being of exclusive Japanese descent, have been born in Japan, and not lived outside of Japan for more than 5 years; with a body mass index between 18.5 and 28.0 kg/m2, inclusive, and a total body weight between 50 and 100 kg, inclusive; in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations at Screening and Check in as assessed by the investigator (or designee); and have a history of a minimum of 1 bowel movement per day.

Exclusion Criteria:

* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion; poor peripheral venous access; participation in a clinical trial involving administration of an investigational drug in the past 90 days prior to dosing; subjects with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in; subjects who have participated in any clinical trial involving a radiolabeled investigational drug within 12 months prior to Check-in.
ChroniSense Polso Wrist Worn Respiration Rate Validation Study

20 volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the Polso Monitoring system

20 volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the Polso Monitoring system.

A range of stable respiratory rates will be elicited from each volunteer test subject. The rates will be approximately 5, 10, 15, 20, 25, 30, 35, 40 and 45 breaths per minute; with some natural variation from these exact numbers.

Each subject will be instrumented with an open system mask that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor will be used as the Accuracy Reference Device (Reference) in this study.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have the ability to understand and provide written informed consent
* Subject is adult over 18 years of age
* Subject must be willing and able to comply with study procedures and duration
* Subject is a non-smoker
* Male or female of any race
* Wrist circumference with the range of 5.5-8 inches (13 to 21cm)

Exclusion Criteria:

* Subject is considered as being morbidly obese (defined as BMI \>39.5)
* Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoo in the optical path which would limit the ability to test sites needed for the study.
* Subjects with known respiratory conditions such as:

  * uncontrolled / severe asthma,
  * flu,
  * pneumonia / bronchitis,
  * shortness of breath / respiratory distress,
  * respiratory or lung surgery,
  * emphysema, COPD, lung disease
* Subjects with self-reported heart or cardiovascular conditions such as:

  * have had cardiovascular surgery
  * Chest pain (angina)
  * heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
  * previous heart attack
  * blocked artery
  * unexplained shortness of breath
  * congestive heart failure (CHF)
  * history of stroke
  * transient ischemic attack
  * carotid artery disease
  * myocardial ischemia
  * myocardial infarction
  * cardiomyopathy
* Self-reported health conditions as identified in the Health Assessment Form

  * diabetes,
  * uncontrolled thyroid disease,
  * kidney disease / chronic renal impairment,
  * history of seizures (except childhood febrile seizures),
  * epilepsy,
  * history of unexplained syncope,
  * recent history of frequent migraine headaches,
  * recent head injury within the last 2 months,
* Cancer / chemotherapy
* Other known health condition should be considered upon disclosure in health assessment form
Evaluation of the Efficacy of Low Level Laser Therapy in Ulnar Neuropathy at the Elbow

The purpose of this study is, to demonstrate the effectiveness of low-level laser therapy on symptoms, clinical and electrophysiological parameters in elbow ulnar neuropathy.

Ulnar neuropathy of the elbow is the second most common entrapment neuropathy of the upper extremity. The ulnar nerve is prone to entrapment due to its anatomical location in the elbow. The most important cause of entrapment occurs as a result of frequent chronic mechanical compression or stretching. Repetitive flexion-extension movement of the elbow increases the pressure in both the cubital tunnel and other potential entrapment sites, causing tension in the ulnar nerve and increased intraneural pressure.

Ulnar neuropathy of the elbow, a detailed history and a comprehensive physical examination are the essential first steps in making the correct diagnosis. In case of doubt, electrophysiological studies, in particular, play an important role in diagnosis by determining both the location of nerve compression and the severity of the disease. There are conservative and surgical methods for the treatment of ulnar neuropathy in the elbow. In most patients, especially in mild and moderate entrapments, conservative treatment is preferred instead of surgery as initial treatment.

Low-level laser therapy, one of the physical therapy modalities, creates photochemical reactions and biostimulation in the cells, interstitial tissue, vascular structure and immune system. Its anti-inflammatory effect is through inhibition of Cyclooxygenase-2 enzyme and a decrease in Prostaglandin E2 levels, and its analgesic effect is by inhibiting nociceptive pathways in peripheral nerves, thus reducing pain. It has been shown to increase nerve regeneration and nerve conduction, reduce the effects of nerve compression, and may stimulate nerve healing thanks to its biophysical effect.

There is no sham-controlled study showing the effectiveness of low-level laser therapy in elbow ulnar neuropathy, the second most common entrapment neuropathy. The study was planned to investigate the effectiveness of low-level laser treatment on symptoms, clinical and electrophysiological parameters in elbow ulnar neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* Ulnar neuropathy at the elbow evidenced by electrophysiological evaluation
* Symptoms onset with more than 1 months

Exclusion Criteria:

* Presence of thenar, hypothenar or intrinsic muscle atrophy,
* Diabetes mellitus
* Hypothyroidism
* Receiving an electrophysiological diagnosis of carpal tunnel syndrome, cervical radiculopathy, brachial plexopathy, thoracic outlet syndrome
* Vascular disease
* Ulnar nerve injury or trauma,
* Malignancy,
* Having received treatment for ulnar neuropathy in the elbow within the last 3 months,
* Using nonsteroidal anti-inflammatory drugs (NSAI) regularly
Risk of Revision Following Knee Arthroplasty in Bariatric Surgery Patients

Previous studies have investigated the outcomes of Knee Arthroplasty (KA) following Bariatric Surgery (BAS), but with substantial limitations as not stratifying for Body Mass Index (BMI) at time of KA or not addressing the type of BAS (gastric bypass, banding or sleeve). Since BMI varies greatly in patients with previous BAS, it is likely that BMI affects outcomes after KA in BAS-operated patients.

The investigators believe that stratifying for BMI would explain the contradictions with the previous research in this patient group when it comes to the risk of revision after KA.


Eligibility Criteria:
Inclusion Criteria:

* Primary knee arthroplasty due to osteoarthritis

Exclusion Criteria:

* Primary knee arthroplasty due to traumatic osteoarthritis.
Prediction of IBD Disease Activity in Individual Patients Based on PROMs and Clinical Data

The proposed study will use a PROM (Patient report Outcome Measurement)-tool in combination with clinical and biochemical data to train and validate a Relapse Prediction Model for individual patients.

The primary objective is to train and validate a relapse prediction model for individual patients available for daily (remote) care management. Besides that, risk-based care pathways for different prediction outcomes will be evaluated, prediction scores will be correlated to medication type, CRP/Calprotectin and/or endoscopy, and with known IBD clinical risk profiles. Moreover dietary intake will be correlated with the IBD risk profiles.

Study design: Multicentre, retrospective analysis of two prospective cohorts. Study population: Adult IBD patients. Main study parameters/endpoints: The endpoint will be a prediction regarding step-up or step-down in the care pathways. In other words, the percentage of patients in each individual care pathway with agreement between risk score of the individual patient and actual flares during a follow-up time of 24 months. Furthermore insight will be gained in dietary patterns amongst patients with different IBD risk profiles.

No benefits or risks are associated with participating in this study, because only standard of care is given.

Eligibility Criteria:
Inclusion Criteria:

* Adult IBD patients
* Subjects willing and able to sign informed consent
* Own and are able to use a smart phone (Android or iOS)

Exclusion Criteria:

* Unwilling or unable to adhere to the protocol
* Unwilling or unable to adhere to the informed consent
* Age \<18y
Deep Brain Stimulation of the Bilateral Habenula for Treatment-Refractory Obsessive-Compulsive Disorder

Deep brain stimulation (DBS) offers an effective and safe treatment for patients with debilitating, otherwise treatment-refractory obsessive-compulsive disorder(OCD). Although several target areas for DBS have been used for OCD, such as the ventral capsule/ventral striatum and the subthalamic nucleus, not all patients show a clinical response, varying from 10% to 61.5%. Exploring new DBS targets may be a key approach to improve this situation. The habenula is an evolutionarily conserved structure playing an important role in depression, punishment avoiding, reward, addiction, pain and circadian rhythms. The habenula can be considered a promising target for OCD treatment based on the following hypotheses and clinical observations.

1. The lateral habenula DBS has significant clinical antidepressant effects.
2. The habenula plays an important role in the regulation of dopamine and serotonin systems.
3. Selective serotonin reuptake inhibitors, the first line treatment for OCD, are commonly used to treat clinical depression.
4. The habenula serves as a 'negative reward center' that mediates or moderates stress, negative emotions and thoughts, aversive learning, and goal-directed behavior, which are core clinical symptoms and signs of OCD.
5. In our hospital, DBS of the habenula produced a significant improvement in OCD symptoms in one patient who failed to respond to other treatments, including capsulotomy either alone or in combination combined with cingulumotomy.

These theoretical and clinical considerations indicate that the habenula can be seen as a promising DBS target for OCD treatment. This study is focused on the effectiveness of bilateral DBS of the habenula for patients with treatment-refractory OCD. Furthermore, the study is aimed at exploring the influence of DBS of the habenula on brain activity and cognition.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as having primary OCD according to DSM-IV criteria using the Structured Clinical Interview for DSM-IV Axis I disorders;
* YBOCSII score ≥31；
* Duration ≥2 years；
* Refractoriness to therapy was defined as no response or insufficient response following at least 2 treatments with adequate trials or intolerance to two or three selective serotonin transporter inhibitors (SSRIs) and clomipramine, augmentation strategies (antipsychotics) and cognitive behavioral therapy.
* Capacity to provide informed consent (understanding of the study purpose and methods.

Exclusion Criteria:

* Except for those with major depressive disorder and mild anxiety disorders, patients with clinically significant comorbid DSM-IV diagnoses (such as schizophrenia, bipolar II disorder, alcohol or substance abuse in the last 6 months, current tic disorder, or body dysmorphic disorder)
* Patients with severe personality disorders, assessed using the Structured Clinical Interview for DSM-IV Axis II disorders.
* Serious and unstable organic diseases (e.g. unstable coronal heart disease);
* Pregnancy and/or lactation.
Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants

The goal of this clinical trial is to learn more about intestinal regional oxygen saturation measurements made with near-infrared spectroscopy and bladder pressure measurements in infants without risk of intraabdominal hypertension. The main question it aims to answer is if - in comparison to bladder pressure - the regional intestinal oxygen saturation measured with near-infrared spectroscopy is stable in the muscle-relaxed, intubated patients and the awake and non-sedated patient.

In case of participation the bladder pressure and the regional intestinal oxygen saturation (measured with near-infrared spectroscopy) will each be measured once intraoperatively and once postoperatively. Patients included in this study will be undergoing an operation which necessitates muscle-relaxation, as well as an indwelling urinary catheter during the operation and for a short-time thereafter for other reasons than this study.


Eligibility Criteria:
Inclusion Criteria:

* Prepped and consented for laparoscopic pyeloplasty or minimal PSARP with perineal or vestibular fistula or lateral thoracotomy for the correction of esophageal atresia
* Age of 12 months old or less at operation
* Legal custodian gives consent

Exclusion Criteria:

* Anterior abdominal wall thickness greater than 12 mm measured on preoperative MRI imaging if available
* Patients planned for additional intestinal surgeries or non-standard pyeloplasty, e.g. pyeloplasty with nephrostoma
* Patients planned for laparoscopic pyeloplasty whose intraoperative urine sample shows pathological results
* Patients with esophageal atresia who experience pulmonary decompensation and need urgent surgery for fistula clipping
This Study Uses the SITS Registry to Find Out When Patients With a Heart Rhythm Disorder (Atrial Fibrillation) Start Treatment With Dabigatran After They Had a Stroke

This is an observational study in patients with non-valvular atrial fibrillation (NVAF) presenting to the hospital with a first acute ischemic stroke based on existing data recorded in the SITS International Registry (located in Sweden) by physicians in several European countries, such as Italy, United Kingdom, Czech Republic, Sweden, Germany, Poland, Spain, Finland, Portugal, Slovakia, Denmark, Estonia, Norway Belgium, Hungary, Slovenia, Croatia, Austria, Lithuania, France, Greece, Netherlands, Ireland, Ukraine and Iceland.

The aim of this study is to explore the current real world use of dabigatran for stroke prevention in NVAF patients in the post-stroke setting. Secondary data from eligible European patients registered in the SITS registry will be considered; countries of origin are not known a priori.


Eligibility Criteria:
Inclusion criteria:

* Patients with non-valvular Atrial Fibrillation (NVAF)
* Patients presenting with their first acute ischemic stroke
* ≥18 years of age

Exclusion criteria:

- Documentation that the patient was enrolled or is planned to be enrolled in an investigational clinical trial at the time of the onset of the index event and for the duration of the data collection
Plyometric and Stability Exercise Protocol in Female Basketball Players

Introduction. Basketball is a high intensity intermittent sport, requiring jumping, running, accelerations and decelerations with changes of direction and lateral movements. Plyometric exercises are a training technique that consists of a cycle of muscle stretching and shortening in which the energy stored in the eccentric phase (lengthening) is released facilitating the production of maximum power in the concentric phase (shortening).

Objective. To analyse the efficacy of a physiotherapy intervention through a protocol of plyometric and stability exercises in the improvement of vertical jump, stability, flexibility and agility in federated female basketball players. The primary variable will be the vertical jump (My jump 2.0). Secondary variables will be stability (Y balance test), flexibility (Sit and Reach) and agility (T-Test).

Methods. Controlled, single-blind clinical study. 20 athletes will be randomised to the experimental and control groups. The intervention of the experimental group will consist of a protocol using plyometric and stability exercises. The athletes included in the control group will not perform any intervention and will continue with their usual routine. The intervention period will last 6 weeks, with a periodicity of 2 weekly sessions of 20 minutes each.


Eligibility Criteria:
Inclusion Criteria:

* Female players over 18 years of age.
* That during the study period they play basketball competing in the 1st Women's Division 1 category of the Basketball Federation of the Region of Murcia.
* That they perform strength exercises at least once a week.
* That they sign the informed consent document.

Exclusion Criteria:

* Players with knee or ankle injuries in the 6 months prior to the study.
* Players who use ankle or knee braces regularly.
* Players with lower limb surgery in the last year.
* Players whose participation is contraindicated by the team doctor, physiotherapist or physical trainer.
A Follow-up Programme for Patients Using Symbicort SMART in Normal Clinical Practice

This patient follow-up programme was designed to describe the extent of Symbicort use in patients prescribed Symbicort as maintenance and reliever therapy in routine clinical practice in comparison with the already documented use of Symbicort as maintenance and reliever therapy in clinical therapies


Eligibility Criteria:
Inclusion Criteria:

* Asthma patients prescribed Symbicort as maintenance and reliever therapy, according to the label, before inclusion in this programme
* signed and dated informed consent(ICF)
* for patients under-age, signed and dated ICF form from both the patient and the patient's parent/legal guardian is required

Exclusion Criteria:

* Involvement in the planning and conduct of the programme (applies to both AstraZeneca staff or staff at the investigational site)