cyrilzakka/clinical-trials huggingface dataset:
Duodopa Home Titration Using Telemedicine: Evaluation of Use of Resources

The purpose of this study was to evaluate the use of resources during titration of Duodopa at home.

Telemedicine (TM) offers an alternative titration procedure allowing the start of Duodopa infusion at home. The study evaluated the use of resources, measured as the number of contacts and time spent by health care professionals (Duodopa nurse specialists and the study Investigators) and the TM technician, during Duodopa infusion at home. Data was collected from four (4) clinical centers in Sweden. Data collection period for each participant started at the decision to administer Duodopa treatment (Baseline) and ended when the Duodopa titration period was complete. Post-titration, the participants and caregiver were interviewed and the investigators and nurses answered a web based questionnaire on their experiences.

Eligibility Criteria:
Inclusion Criteria:

1. Suitable for Duodopa treatment in accordance with the Swedish Summary of Product Characteristics
2. Motivated and confident to test Duodopa home titration using TM
3. Participants who were able to handle the infusion pump and the TM equipment by themselves or with assistance, as determined by the Investigator
4. Understood and signed the study informed consent form

Exclusion Criteria:

1. Dementia or cognitive decline with Mini Mental State Examination score less than 24
2. Ongoing symptomatic depression, hallucinations or other psychotic behaviors without adequate treatment, as determined by the Investigator
3. Contraindications as described in the Swedish Summary of Product Characteristics: hypersensitivity to levodopa or carbidopa, narrow angle glaucoma, serious liver and kidney disease, severe heart failure, acute myocardial infarction, severe cardiac arrhythmias, recent or acute stroke, contraindications for adrenergic effects; pheochromocytoma, hyperthyroidism, cushing's syndrome, and other contraindications for abdominal surgery
4. Other reasons that made the participant unsuitable for home titration using TM, as determined by the Investigator
TNF-alpha Inhibition in CRPS: A Randomized Controlled Trial

Studying the effects of Etanercept (an anti-Tumor Necrosis Factor alpha) on early Chronic Regional Pain Syndrome (CRPS). Our hypothesis is that Etanercept will improve patient symptoms if given in early CRPS.


Eligibility Criteria:
Inclusion Criteria:

1. Female pediatric Chronic Regional Pain Syndrome (CRPS) patients with unilateral CRPS of the lower extremity, ages 10-17 years of age.
2. Patients must meet CRPS Type I diagnostic criteria and have current evidence of edema, and a temperature difference between the affected and contralateral limb ≥1.0°C.
3. Duration of symptoms less than 4 months.

Exclusion Criteria:

1. Active malignancy or history of malignancy.
2. Active infection.
3. History of Tuberculosis (TB) or TB exposure.
4. Pregnancy.
5. Concomitant disease causing immunocompromise.
6. Concomitant autoimmune disease such as rheumatoid arthritis, psoriasis, ankylosing spondylitis or Crohn's Disease.
7. Poorly controlled psychiatric disease including anxiety, depression or attention deficit hyperactivity disorder.
8. Hepatic or renal impairment as indicated by serum transaminases and/or creatinine ≥ 150% normal value for age.
9. Evidence of or history of demyelinating disease.
Pain, Anxiety, and Comfort Levels in Coronary Angiography

The study was designed as a descriptive study. The universe of the study is İzzet Baysal Training and Research Hospital; It consists of patients who underwent coronary angiography in the coronary intensive care unit.

In the first part, the descriptive information of the patients will be used, and in the second part, "Perianesthesia Comfort Scale", "State/Trait Anxiety Scale" and "General Comfort Scale (GAS)" adapted into Turkish by Üstündağ and Aslan in 2010 will be used. Visual Pain Scale will be used for pain measurement.

It is planned that the data for the Perianesthesia Comfort Scale (PCI) will be collected in the patient's room on the first postoperative day, in approximately 15 minutes, by face-to-face interview method.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years Conscious patients

Exclusion Criteria:

* Patients undergoing intubation
Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

The insertion of long-lasting intravenous device is done under local anesthesia. Currently, in the investigators hospital, no premedication is given to the patients. However, this procedure occurs in a particular emotional context related to the diagnosis of cancer or malign hemopathies.

Therefore, administration of a sedative or anxiolytic drugs before the start of the procedure can be questionable.

Hydroxyzine is the reference molecule for premedication because of its anxiolytic and anti-histaminic properties A new agent, pregabalin, shares also the same properties

The main objective of this study was to compare the efficacy of pregabalin and hydroxyzine on the anxiety score as a premedication during the insertion of long-lasting intravenous device under local anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 18 to 75 years
* Patient schedules for insertion of long-lasting intravenous device

Exclusion Criteria:

* History of previous insertion of long-lasting intravenous device or central intravenous catheter
* long term treatment of gabapentin or pregabalin
* Hypersensitivity to pregabalin or any of the excipients
* Hypersensitivity to hydroxyzine, one of its metabolites, one of the excipients, another derivative of piperazine, aminophylline or ethylene diamine.
* Patient at risk of glaucoma e
* Patient at risk for urinary retention
* Patient severe respiratory failure
* Patient at the general condition not too corrupted (ASA IV)
* Renal failure with creatinin clearance \< 30 ml / min
* Patient not affiliated to Social Security
* Pregnant or lactating
* Patients in emergency situations
* Inpatient without consent
Tumor DNA and MRI/CT Scan Findings in Patients With Grade III or Grade IV Malignant Glioma

RATIONALE: Studying levels of tumor DNA in the samples of blood from patients with cancer may help doctors find out whether the cancer has grown and how much.

PURPOSE: This laboratory study is comparing levels of tumor DNA with MRI and CT scan findings to measure cancer growth in patients with grade III or grade IV malignant glioma.

OBJECTIVES:

* Correlate changes in the level of serum tumor-specific DNA over time with changes in brain tumor size as measured by serial MRI or CT scans in patients with grade III-IV malignant gliomas.

OUTLINE: This is a multicenter study.

Blood samples are collected from patients at baseline and every 2 months thereafter. Tumor and nontumor plasma is extracted. Plasma samples are analyzed by polymerase chain reaction (PCR) to assess the p16_ink4a, p73, and O \^6-MGMT gene promoter methylation profile. Quantitative realtime PCR is performed on samples with tumor-specific DNA to determine the plasma concentrations of each methylated tumor-specific gene and the total plasma tumor-specific DNA concentration. Patients also undergo MRI or CT scans every 2 months.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed malignant brain tumor

  * One of the following grade III or IV supratentorial gliomas:

    * Anaplastic astrocytoma
    * Anaplastic oligodendroglioma
    * Glioblastoma multiforme
* Newly diagnosed or recurrent disease
* Planning to undergo anticancer therapy on a New Approaches to Brain Tumor Therapy (NABTT) Consortium clinical trial

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
PAR I - Patient-to-Annulus Relation I

The Prosthesis-to-Annulus Relation I (PAR I) trial is a German multicenter study assessing the relation between the prosthetic GOA and the area of LVOT as potentially new parameter for the prediction of hemodynamic outcome. The results may possibly guide future valve size selection an may allow prediction of functionally relevant PPM (Patient-Prosthesis-Mismatch)

Great debates revolve around the hemodynamic performance of prosthetic tissue valves. It is influenced by the design and the specific sizing strategy. Design determines the actual geometric orifice area (GOA), sizing strategy the actual size of the selected valve. Currently, hemodynamic performance is generally assessed by determining the effective orifice area (EOA, derived from the continuity equation by relating flow velocities and LVOT area). The question whether a prosthesis patient mismatch (PPM) is present is then addressed by relating EOA to body surface area (EOAi). However, this relation may not be reasonable because EOAi relates flow velocity twice to patient-specific anatomic parameters (LVOT area and body surface area) . Considering this potential methodological flaw, debate and confusion regarding PPM is easily understood, despite the fact that, intuitively leaving a gradient behind after aortic valve replacement cannot be irrelevant. Thus a reliable and comparable method to determine the presence of PPM is needed. In PAR I Trial the relation between true prothetic GOA and LVOT area will be assesses as a potentially new parameter for prediction of hemodynamic outcome, to possibly guide future valve size selection (inclusive valve-in-valve) and to allow the detection of functionally relevant PPM. In the trial it will be assessed how anatomic dimensions of patients and implanted valves relate to each other and whether they allow the prediction of hemodynamic outcome.

Eligibility Criteria:
Inclusion Criteria:1.Patient has an indication for primary, isolated aortic valve implantation 2. Patient is above 18 Years old 3. Patient has signed patient informed consent 4. foreseen implantation of an Epic, Epic supra or Trifecta valve 5. Patient has sinus rhythm

Exclusion Criteria:

1. Patient is younger than 18 years
2. Patient has active endocarditis
3. Patient is not able or does not want to participate on follow-up
4. Patient is pregnant or nursing
5. Surgical widening of outflow tract is planned
6. Left ventricular ejection fraction is smaller than 50%
7. Patient has a mitral valve or tricuspid valve insufficiency or stenosis bigger or equal Grade II
Comparison of Pantoprazole and Ranitidine in Dyspepsia

The H0 hypothesis of the study is there is no difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.

The H1 hypothesis is there is difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.

Dyspepsia is one of the common complaints in emergency department. Proton pomp inhibitors, H2 receptor blockers and anti-acids are common drugs for treating dyspepsia in emergency department. However there is no study in the emergency department comparing the effectiveness of these drugs. So the investigators planned this study which drug is effective in these patients in order to provide a cost-effective treatment in dyspeptic patients.

Eligibility Criteria:
Inclusion Criteria:

* Epigastric pain
* Older than 18 years old

Exclusion Criteria:

* Diagnosed as cholecystitis, pancreatitis, myocardial infarction, etc.. at the end of the emergency deparment evaluation period.
* Pregnancy
* Patients with unstable vital signs
* Patients used anti-acid, H2 receptor blockers and proton pomp inhibitors in the last one hour.
* Allergy to H2 receptor blockers and proton pomp inhibitors.
* Patients denied to give inform consent and who are illiterate
Enhanced vs. Routine Clear Liquid Intake in Labor

The goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel during labor speeds labor and reduces the rate of cesarean delivery.

Patients will be randomized to placebo or experimental arm of study. In the placebo arm, patients will receive standard clear liquid diet, which includes ginger ale, variety of fruit juices, and plain soup broth. The experimental arm will receive the standard clear liquid diet, and in addition will receive Accel Gel every 3 hours while in labor.

Eligibility Criteria:
Inclusion criteria:

* Nulliparity (first baby)
* Admission with the intent to deliver vaginally
* Gestational age \>36 weeks
* Age ≥ 18

Exclusion criteria:

* Planned cesarean delivery
* Renal Disease
* Preeclampsia
* Diabetes (Pre-gestational or Gestational)
* Allergy to any component of sports drink
* NPO diet by physician
Prediction Models for Risk Score and Prognosis of Intraoperatively Acquired Pressure Injury in Surgical Patients

The study aims to effectively identify the risk of intraoperative acquired pressure injuries (IAPI) in surgical patients through a prospective multicenter approach. It combines indicators from commonly used assessment tools and practical experience judgments to construct a comprehensive assessment framework.

By incorporating various indicators, the study aims to improve the accuracy and reliability of identifying patients at risk of IAPI during surgery. This will help clinicians in making informed decisions and implementing preventive measures to minimize the occurrence of pressure injuries.

The multicenter approach ensures a diverse and representative sample of patients from different surgical settings. This increases the generalizability of the study findings and enhances the applicability of the assessment framework across various clinical settings.

The project's methodology involves collecting data on patient demographics, medical history, surgical procedure details, and assessment tool scores. These data points will be analyzed to identify significant risk factors for IAPI and develop a risk prediction model.

The study also takes into consideration practical experience judgments, which acknowledge the importance of clinical expertise in assessing patients' risk of IAPI. This ensures that the assessment framework is not solely reliant on assessment tools but also incorporates the insights of experienced clinicians.

Overall, this prospective multicenter study aims to contribute to the field by providing a comprehensive and practical approach to identify the risk of IAPI in surgical patients. The findings from this study can be utilized in clinical practice to improve patient outcomes and reduce the incidence of pressure injuries during surgery.


Eligibility Criteria:
Inclusion criteria: All patients who underwent surgery procedure at the participating setting after the study registration.

Exclusion criteria: Patients who have already been diagnosed with pressure injury (stage II and above) before undergoing surgery procedure. Patients/relatives/guardians understand the refusal of data to be used for clinically relevant research. Investigators believe that certain patient conditions may affect the efficacy and safety assessment of this study.
Comparison of the Effects of Truview Laryngoscopy and Macintosh Larygonscopy on Intubation Difficulty Score, Intubation Duration and Intubation Quality in Pediatric Patients Between 2-12 Years

For endotracheal entubation in children mostly Miller and Macintosh blades have been used. On the other hand Truview EVO2 laringoscopes can maintain a better laryngeal view without having a direct sight of the airway and without having to align oral, pharyngeal, and tracheal axes. The aim of this study is to compare the Truview EVO2 laryngoscope and Macintosh laryngoscope in terms of intubation difficulty score, time to intubation and intubation quality score.


Eligibility Criteria:
Inclusion Criteria:

* aged 2-12 pediatric patients

Exclusion Criteria:

* any allergy
* difficult airway history
Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial

Hypothesis: Early use of oral metoclopramide can hasten and improve the establishment of lactogenesis II in mothers after preterm and term deliveries.

The study hopes to show that metoclopramide can be effective to establish and sustain Lactogenesis II for both preterm and term infants.

Hypothesis:

Early Use of oral metoclopramide can hasten and improve the establishment of lactogenesis II in mothers after preterm and term deliveries.

Metoclopramide(Maxolon) promotes lactation by antagonizing the release of dopamine in the central nervous system, thereby increasing prolactin levels, and thus inducing or augmenting breast milk levels. While Metoclopramide has commonly been used to augment breast milk production and relactation, its efficacy in helping to establish lactogenesis II has never been studied in a controlled clinical trial. If effective, it may become a valuable tool in aiding the successful establishment of breastfeeding, particularly in high risk groups such as mothers of preterm babies.

If shown to be an effective galactogogue, the use of metoclopramide provides an inexpensive and safe means of establishing and sustaining lactogenesis II, indirectly improving the degree and duration of breastfeeding practiced by mothers of both term and preterm infants.

The anticipated benefits are expected to be greatest for preterm infants and their mothers.

Eligibility Criteria:
Inclusion Criteria:

All pregnant women who intend to breastfeed, from 28 weeks to term, who have not met the exclusion criteria

Exclusion Criteria:

1. Patients who have epilepsy or on anti-seizure medications,
2. Patients who have a history of significant depression or are on antidepressant drugs
3. Patients who have pheochromocytoma or uncontrolled hypertension
4. Patients who have intestinal bleeding or obstruction
5. Patients who have a known allergy or prior reaction to metoclopramide, or any other contraindications to the use of metoclopramide
6. Patients who have diabetes and hyperprolactinaemia
7. Patients with HIV infection
8. Current pregnancy complicated by fetal congenital anomalies and multiple fetuses
Sodium Channel Mutations in Patient With the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)

The goal of this observational study is to learn about sodium channel (Nav) mutations in patients with the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES). This study will give more insight into the pathophysiology of ACNES, which is still largely unknown.

The primary objective is to determine if there are mutations of Nav1.7 and Nav1.8 in patients with ACNES. Therefore, one blood sample will be drawn, in which the mutations will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a subject must be diagnosed with ACNES and receive treatment at our outpatient clinic. Additionally, subject has to meet one of the following criteria:

* Known to have a first- or second-degree relative with ACNES;
* Have more than one recurrence of ACNES after a pain free period or ACNES at multiple locations in the abdominal wall;
* Persistent pain after posterior neurectomy.

Exclusion Criteria:

* Inability to understand Dutch language.
* Known neuromuscular or neurodegenerative disease.
Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian, Primary Peritoneal and Fallopian Tube Cancer Patients in India

This is a non-interventional, cross-sectional, multicentre, observational study planned to be conducted at 15 sites across all geographical regions of India. The study targets to enrol 240 patients with approximately 16 patients from each site. Written approval of Independent Ethics Committee (IEC)/ Institutional Review Board (IRB) and written informed consent from willing patients will be obtained prior to the start of the study.

This is a non-interventional, cross-sectional, multicentre, observational study to be conducted at 15 sites from different geographical regions across India. The study targets to enrol 240 patients with nearly 16 patients per site over 6 months. The study will enrol females with diagnosis of ovarian, primary peritoneal, or fallopian tube cancer. No study medication will be prescribed or administered as a part of study procedure.

The study will start only after obtaining written approval of Independent Ethics Committee (IEC) / Institutional Review Board (IRB) and written informed consent of the patient.

The study will start only after obtaining written approval of Independent Ethics Committee (IEC) / Institutional Review Board (IRB) and written informed consent of the patient. Eligible patients will undergo physical examination and data of demographics, vital signs, present/ past history of illness, family history of breast/ovarian cancer, current and previous chemotherapy regimen and current medication will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who provide written informed consent
2. Female ≥ 18 years of age
3. Previously or newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer patients.

Exclusion Criteria:

1. Patient with any medical condition that, in the opinion of the investigator, would interfere with safe completion of the study
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis

Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following initial injection.

Adipose (fat) tissue is removed by lipo-aspiration (this may take up to 40 minutes). The fat is processed on-site to isolate and obtain the MSCs,then proliferate them. The suspension of the cells is injected into the knee joint under ultrasound guidance. (about 20 minutes).

Eligibility Criteria:
Inclusion Criteria:

* Subjects who understand and sign the consent form for this study.
* Age: 40-70, males and females.
* Clinical diagnosis of degenerative arthritis by Radiographic Criteria of Kellgren and Lawrence.
* Patients who can't treat with traditional medication and need a arthroplasty.
* Duration of pain over Grade 4(11-point numeric scale)\> 4 months.

Exclusion Criteria:

* Women who are pregnant or breast feeding or planning to become pregnant during the study.
* Objects who administer with a anti-inflammatory drugs within 14 days prior to inclusion in the study.
* History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications.
* Treatment with intra-articular injection therapy within 2 months prior to screen.
* Other joint diseases except degenerative arthritis : systemic or rheumatic or inflammatory chondropathy, chondrocalcinosis, hemachromatosis, inflammatory joint disease, avascular necrosis of the femoral head, Paget's disease, hemophilic arthropathy, infectional arthritis, Charcot's disease, villonodular synovitis, synovial chondromatosis.
* Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.
* Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus.
* Overweight expressed as body mass index (BMI) greater than 30 (obesity grade II).
* Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.