cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) After Cardiac Surgery

The purpose of this randomized controlled trial in patients undergoing cardiac surgery is to show that a 3rd generation HES (Hydroxyethyl Starch) solution - Tetraspan® is as good as in terms of safety and effectiveness as the commonly used albumin based solution for volume replacement after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained from the subject or his/her legal guardian before any assessment is performed.
* Male or Female subject, 18 years or older.
* Any elective cardiac surgery

Exclusion Criteria:

* Subjects with impaired liver function defined as an elevated level of ALT and AST over 100 U/L.
* Hyperhydration states (e.g. pulmonary edema, congestive heart failure).
* Renal failure with creatinine blood levels \> 2.5 mg/dL or eGFR \< 30 ml/min (calculated using the DMRD formula).
* Oliguria (UO\<0.5ml\\kg\\hr) or anuria (not related to hypovolemia) more than 12 hours.
* Current Intracranial hemorrhage.
* Current, hard to balance hyperkalemia.
* Severe hypernatremia or severe hyperchloremia.
* Known hypersensitivity to hydroxyethyl starch or to any of the excipients.
McNeill Dysphagia Therapy Program Combined With Transcranial Magnetic Stimulation

This study aimed to investigate the effectiveness of the McNeill Dysphagia Therapy (MDTP) programme combined with Transcranial Magnetic Stimulation (TMS) in individuals with post-stroke dysphagia.

Stroke is a neurological disorder that causes focal or global cerebral dysfunction caused by vascular causes, can last for 24 hours or longer, or may result in death. Many complications occur after stroke, and one of the most common complications is dysphagia After dysphagia, individuals with dehydration, malnutrition, aspiration, aspiration-related pneumonia, sepsis, and even death may result if no precautions are taken. Purpose of dysphagia treatment; It is to ensure that individuals receive their daily water and calorie needs most reliably. Another goal is to switch the patient to oral nutrition as much as possible. McNeill Dysphagia Therapy Programme is a systematic exercise-based therapy program developed for individuals with dysphagia. It is also frequently used in the rehabilitation of stroke, traumatic brain injury, and post-cancer dysphagia. Transcranial Magnetic Stimulation (TMS) is based on the principle of electromagnetic induction. It is a non-invasive method that, together with the magnetic field created by a coil placed on the scalp, causes electrical stimulation in the cerebral cortex and creates neurophysiological arrangements in different parts of the brain. Without the electrode, electrical energy is transferred to the human brain and the cerebral cortex is stimulated. An action potential is created by stimulation in neuronal membranes and causes neurons to fire. Thus, nerve cells are stimulated and the process of reorganization of the brain begins. With the stimulation of the cerebral cortex, the swallowing centre is stimulated and the muscles associated with swallowing are activated. The efficacy of MDTP combined with r TMS, MDTP combined with sham r TMS and r TMS alone will be compared in the intervention of dysphagia after stroke. Patients in all three groups will be subjected to both clinical assessment tools and instrumental evaluation before and after treatment. Data will be evaluated using the Mann Swallowing Ability Assessment Test, Penetration Aspiration Scale, Functional Oral Intake Scale, Visual Analogue Scale, Dynamic Rating Scale of Swallowing Toxicity, Dysphagia Severity Rating Scale

Eligibility Criteria:
Inclusion Criteria:

Dysphagia Diagnosis of ischaemic stroke Over 18 years old Cognitively competent and co-operative

Exclusion Criteria:

Epilepsy or seizure risk record Carry metallic objects in the head (such as arterial clips, plates, screws), eye or brain
A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects

To determine the safety and tolerability of Arformoterol Tartrate in children with asthma

A randomized, double-blind two-way crossover study of three cumulative doses of arformoterol (7.5 ug per nebulization) and levalbuterol (0.63 mg per nebulization) given over a one hour period, followed by a single open-label treatment day with three cumulative doses of arformoterol 15 ug in subjects 2-11 years of age with asthma. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female
* Between Age 2 and 11, inclusive, at the time of consent
* Weight equal to or greater than 15 Kg
* History of physician-diagnosed asthma of at least 2 years duration for children age 6 and older, and at least 1 year duration for children 5 and younger.

Exclusion Criteria:

* Female subject who is pregnant or lactating.
* Subject who has a history of hospitalization for asthma within one year, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.
* Subject with any history of life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures.
* Subject with a history of cancer.
* Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders.
* Subject with a history of cigarette smoking or use of any tobacco products.
Safety Study of Cervical Sympathetic Block for Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage

To evaluate the feasibility of performing a cervical sympathetic block in patients with severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal SAH.


Eligibility Criteria:
Inclusion Criteria:

1. High grade spontaneous SAH (Fisher Grade III and IV)
2. Secured aneurysm (clipped/coiled)
3. Evidence of severe vasospasm - MCA mean flow velocity \>200 cm/sec and Lindegaard ratio \>6 OR Symptomatic vasospasm with either angiographic evidence (no angioplasty), or at least moderate severity according to TCD criteria (MCA mean flow velocity \>150 cm/sec and Lindegaard ratio \>3, or ACA vasospasm)
4. Age ≥18

Exclusion Criteria:

1. Allergy to local anesthetic or contrast
2. Coagulation disorders with PT \<70%, or INR \>1.4, or PTT \>1.5 times control and/or platelets \<70,000x106/L
3. Use of enoxaparin within 12 hours
4. Use of clopidogrel within 7 days
5. Use of coumadin within 5 days
6. Use of ticlopidine within 14 days
7. Use of intravenous thrombolytics within 10 days
8. Any use of hirudin derivatives during ICU stay
This Study Aims to Determine the Incidence, of Hepatitis B Diagnosis Among Diabetes Mellitus Patients of 0-80 Years of Age

This study is being conducted to assess the risk of hepatitis B (HepB) diagnosis among diabetes mellitus (DM) and non-DM patients of 0-80 years of age with in a large population-based cohort in United Kingdom (UK) using data from the CPRD database.

The study is a retrospective, observational, descriptive, cohort study, in DM and non-DM patients of 0-80 years of age. As a first step the eligible baseline population from CPRD will be defined as per the data quality qualifiers, which include subjects aged 0-80 years, "acceptable for research" registered in practices classified as "up to standard" by the CPRD for the time period 2000- 2012. The following cohorts will be defined from the baseline population:

* DM cohort: Patients diagnosed with type 1 or type 2 DM, as confirmed by diagnosis medical codes with or without a DM related drug or monitoring devices prescription.
* Non-DM cohort: Patients with the absence of personal history of DM diagnosis or antidiabetic drug or monitoring devices prescriptions.

From the above defined cohorts, HepB cases will be identified based on clinical diagnosis codes, Hospital Episodes Statistics (HES) or positive diagnostic laboratory tests results.

Eligibility Criteria:
Inclusion Criteria:

* Subjects, 0 to 80 years of age during the study period.
* Subjects acceptable for research as per CPRD definition:

  * Acceptable flag for research.
* Subjects with at least 12 months of observation time at the time of inclusion in the study:

  * Subjects have to be registered in the CPRD database for at least 12 months at the date of inclusion in the study.
  * Subjects have to be registered in a general practitioner practice classified as 'up to standard' for at least 12 months at the date of inclusion in the study.
* Particular Case of New Born Children.

  * To ensure inclusion of subjects less than 1 year of age, they will be included regardless their observation time in CPRD.
* Inclusion Date

  * Inclusion criteria will be assessed for each calendar year between the Years 2000 and 2012.

Exclusion Criteria:

• For the analyses requiring the inclusion of HES data, HES records linked with more than one CPRD patient will be excluded from the analyses.
To Explore the Effect of GH Pretreatment on Clinical Outcomes in Patients With Low Ovarian Reserve

Growth hormone (GH) has been used in the field of assisted reproduction technology for over 30 years. Studies for GH have been exploring in the applicable population, drug dosage, starting time and time limitation. In previous clinical applications, it worked as an adjuvant drug for improving ovarian reactivity. With the development of basic research and clinical applications, the improvement effect on egg quality is gradually recognized. However, which protocol of GH may work well and maximize the clinical effect remains mystery. The investigators' previous self-controlled retrospective research about 380 cases treated with GH found that the average daily injection of GH dose of 2IU for about 6 weeks can significantly improve embryo quality and clinical pregnancy outcomes of the patients with low ovarian response. The new POSEIDON standard clearly groups people with low prognosis and better classifies heterogeneous people, which may help classifying the specific subgroup that benefit most from GH of poor ovarian response (POR). The investigators design a prospective cohort study to explore whether GH low-dose long-term pretreatment can improve the outcome of assisted pregnancy and its possible mechanism in people with low ovarian reserve.


Eligibility Criteria:
Inclusion Criteria:

1. low ovarian reserve(AMH \<1.2ng/ml, or AFC \<5);
2. patients who have not participated in any clinical trials within the three months;
3. patients who voluntarily signed informed consent.

Exclusion Criteria:

1. patients with BMI ≥30kg/m2;
2. patients with medical diseases such as endocrine and metabolic diseases, autoimmune disease, etc;
3. ovarian neoplasm that ≥4 cm in diameter and has no clear pathological diagnosis by surgery;
4. complicated with adenomyosis, endometriosis confirmed by surgery;
5. patients with untreated abnormal intrauterine environment, such as uterine effusion, endometritis, etc;
6. untreated hydrosalpinx.
Characterization of Fingertips Using MRI Images (FINGERS-COMPRESSION)

The objectives was to obtain MRI images of the index finger of the subjects without loading and with loadings (normal and shear forces from 1 to 4N).


Eligibility Criteria:
Inclusion Criteria:

* Active voluntary healthy adult aged 18 to 65, affiliated to a social security scheme
* Stature between 170 and 179cm
* Body mass index (BMI) between 20 and 25
* No previous hand musculoskeletal disorders
* Cognitive level compatible with oral communication, adherence to instructions and understanding of gestures
* Having signed the consent to participate in the study

Exclusion Criteria:

* the subject presents a neurological or orthopedic disorder ;
* the subject presents a pathology that could disturb the task ;
* the subject has an Magnetic Resonance Imaging (MRI) contraindication (wears a pacemaker, insulin pump, prothesis, etc, has claustrophobia, ...)
Muscle Mechanical Response in Exercise.

The muscular response on the main muscles of the propulsive phase of the upper limb in crawl has been evaluated by tensiomyography (TMG), which was carried out through three parameters: activation time (Td), contraction time (Tc) and maximum deformation (Dm).

The objective of this study is to evaluate the hypothesis of changes produced between lactic resistance training with passive rest and lactic resistance training with active rest.

For this, thirty swimmers participated, with an average age of 20 years.


Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 25 years old.
* have a minimum mark or have participated by ranking in a crawl event in the territorial championship of Madrid in the current season belong.
* to the male gender.

Exclusion Criteria:

* subjects who did not meet the minimum age and did not obtain the minimum mark and did not sign the informed consent.
Music Therapy During Hypothermia in the NICU

Background: Hypoxic-ischemic encephalopathy (HIE) is a neurological condition caused by poor oxygenation during the peripartum period. The main strategy to mitigate neurological damage is hypothermic therapy (HT), whose effectiveness-among other factors-depends on adequate pain management. Considering the prevalence of allodynia in this group of patients, routine nursing procedures can become sources of additional stress and pain. Music therapy is used in this population to promote self-regulation and relaxation, and may therefore help reduce pain levels after routine nursing procedures.

Research question: What is the effect of an entrainment-based live music therapy intervention on pain levels in newborns with hypoxic-ischemic encephalopathy undergoing hypothermic therapy after routine nursing procedures? Methodology: A randomized, crossover pilot and feasibility study. Participants will be 22 newborns admitted to the Neonatal Intensive Care Unit (NICU) of the University Hospital Fundación Santa Fe de Bogotá. Participants will receive standard care plus a 15-minute live music therapy session after a routine nursing procedure, or standard care alone. The primary outcome is the Premature Infant Pain Profile-Revised (PIPP-R) scale, which will be assessed through video recordings. Secondary outcomes are vital signs, heart rate variability, and electroencephalography (EEG) recordings.

Expected outcomes: Through this study, the aim is to improve the comfort and well-being of patients with HIE during TH. In addition, the safety and feasibility of music therapy in this population will be evaluated, seeking to contribute to current knowledge about the mechanisms of music therapy.


Eligibility Criteria:
Inclusion Criteria:

- Neonates diagnosed with neonatal hypoxic ischemic encephalopathy who have undergone hypothermic therapy as part of their medical treatment.

Exclusion Criteria:

* Newborns with a gestational age of less than 35 weeks and a birth weight of less than 1800 grams.
* Newborns in palliative care or with congenital anomalies with a poor prognosis will also be excluded, as will those with preexisting neurological or genetic conditions.
* Furthermore, newborns with a history of serious medical complications that may influence participation in the study, such as pulmonary hypertension or secondary seizure syndrome, will be considered ineligible.
* Finally, patients with an N-PASS score of less than -2 will be excluded.
Molecular Mechanisms and Diagnosis of Mastocytosis

Mastocytosis is a disorder characterized by presence of excessive numbers of mast cells in skin, bone marrow and internal organs. It can affect both children and adults, males and females and individuals from all ethnic backgrounds, although precise demographic information about the affected populations is not available as it is a rare disorder. Mastocytosis in children is generally limited to the skin and follows a self limited course, while it is a disorder of the hematopoietic stem cell associated with somatic mutations of the c-kit gene in most patients with adult-onset of disease. There is no known curative therapy for most patients with systemic mastocytosis. Recent research studies identified several subtypes of disease with distinct clinical and pathologic features, however, a precise understanding of the incidence as well as molecular pathology of different disease subtypes is lacking. This study aims to examine molecular and cellular pathological aspects of disease in patients with mastocytosis and correlate findings with clinical presentation and prognosis. Patients will undergo a routine history and physical examination, and diagnostic tests will be ordered as dictated by each patient's clinical presentation. Blood and bone marrow will be obtained for diagnostic and research purposes. Genetic analysis of the c-kit gene regulating mast cell growth and differentiation will be performed. It is hoped that findings obtained from this study will help to design novel therapies for mastocytosis and other disorders in which mast cells play a critical role.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed or suspected diagnosis of mastocytosis.
* Ability to give informed consent (by the patient or legal guardian if minor)

Exclusion Criteria:

* Inability or not willing to provide informed consent.
Ultrasound for Comparison of Gastric Antral Volume in Pregnants and Non-pregnants

This study evaluates the effectiveness of ultrasound in term pregnant patients posted for elective lower segment cesarean sections and compared them with non pregnant females posted for elective surgeries.

There is increased risk of aspiration in pregnancy due to various reasons i.e. increased progesterone levels, decreased motilin levels and distortion of gastric antrum due to gravid uterus.Ultrasound was proposed to be point of care tool, to assess risk stomach. A comparison with respect to the effectiveness of ultrasound was made in this study. The visibility of gastric antrum by ultrasound in term pregnant females posted for elective lower segment cesarean sections was compared with non-pregnant females posted for elective surgeries.

The secondary aim of the study was to compare the gastric antrum in either groups qualitatively and quantitatively.

Eligibility Criteria:
Inclusion Criteria:Study group- Term pregnant patients, aged between 18 to 45 years, ASA II \& III, having BMI between 18.5 to 30 kg/m2, scheduled for elective lower segment cesarean section.

Control group- Non-pregnant female patients, aged between 18 to 45 years, ASA I \& II, having BMI between 18.5 to 30 kg/m2, scheduled for elective surgery.

Exclusion Criteria:Subjects with-

* Gastrointestinal pathology
* On any medication delaying gastric motility
* Systemic lupus erythematosis
* Diabetes mellitus
* Gestational diabetes
* Hypothyroidism Those who were not willing to give consent
Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin

To investigate the effect of steady-state itraconazole on the pharmacokinetics of steady-state of faldaprevir and the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of atorvastatin as well as the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of rosuvastatin


Eligibility Criteria:
Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Improving Negative Symptoms of Psychosis In Real-world Environments

This study will compare Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training (CBSST-CCT) to a goal-focused supportive contact group to see which intervention better improves symptoms and functioning in people with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

MUST BE A RESIDENT OF BROADWAY HOME, SAN DIEGO, OR A SERVICE USER OF THE MEETING PLACE, ARETA CROWELL, OR PROJECT ENABLE.

1. Voluntary informed consent to participate
2. Age 18 to 65
3. DSM-IV diagnosis of schizophrenia or schizoaffective disorder based on MINI/SCID
4. Moderate-to-severe negative symptoms on the Clinical Assessment Interview for Negative Symptoms (CAINS total score \>19)
5. ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed for reading treatment manual)
6. Stable on medications; no changes within 3 months prior to enrollment

Exclusion Criteria:

1. Prior CBT, SST, or CCT in the past 5 years
2. Severe positive symptoms on the Positive and Negative Syndrome Scale (PANSS Delusions, Disorganization, Hallucinations, or Suspiciousness \>5)
3. Severe depression on the Calgary Depression Scale for Schizophrenia (CDSS \>8)
4. Ocular damage/disease/surgery/medications that affect pupil dilation
5. DSM-IV alcohol or substance dependence diagnosis in past 6 months based on the MINI or SCID
6. Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness) .
Investigating the Effect of an Information Video for Neck Injuries in a Emergency Department Setting

A randomized controlled trial (RCT) to investigate the effect of a information video, consisting of a multiprofessional team, on patients with acute Whiplash Associated Disorder (WAD).

Patients seeking medical care at Södersjukhuset Hospital, Sweden, after a motor vehicle accident resulting in neck trauma are offered to be included in the study. Inclusion criterias involve spine fractures, need for in house care, \<18\<65 years of age and low knowledge of the Swedish language.

A randomization is performed with two arms, one being "treatment as usual" i.e. an information folder with physiotherapeutic exercises, the other one being the Information Video.

The patients are contacted per telephone and a questionnaire with baseline data is sent via e-mail within a week after the accident. They also receive a link to the websites with the information.

The follow up time is 6 months and after that the patients receive a new questionnaire with questions regarding neck-specific status (WDQ), health related quality of life (SF-12) and pain.

The primary outcome is level of pain (NRS)

Eligibility Criteria:
Inclusion Criteria:

* Knowledge of the swedish language
* Traffic injury with neck pain

Exclusion Criteria:

* Fractures
* In house care needed
Effectiveness of Myofascial Release Versus Manual Lymphatic Drainage After Breast Cancer Surgery

Objective. To compare the effectiveness of myofascial therapy against manual lymphatic drainage in the reduction of sequelae secondary to conservative surgery and radiotherapy in women who survived breast cancer.

Design. Randomized clinical trial. Site. Faculty of Physiotherapy of the University of Valencia. Participants. Twenty-four patients were included in the study. Interventions. 13 patients were randomly assigned to treatment with myofascial therapy and 11 to receive manual lymphatic drainage.

Main measurements. Pain measured using the Visual Analogue Scale, shoulder joint range, shoulder functionality using the DASH questionnaire, quality of life assessed using the FACT-B questionnaire, and the depressed status of the patients using the PHQ-9 . All of this was assessed before and after treatment, and one month later as follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 30 and 60 diagnosed with breast cancer undergoing conservative / partial surgery.
* Without lymphedema or mild lymphedema.
* They must have finished the coadjuvant treatment.

Exclusion Criteria:

* Women with muscle or tendon lesions in the arm.
* Kin disorders or circulatory pathology.
* Chemotherapy or radiotherapy.
* Surgical history in the area are excluded from the study.