cyrilzakka/clinical-trials huggingface dataset:
Pain Perception With Tenaculum Placement

Randomized controlled trial that compares methods of tenaculum placement during intrauterine device insertion and their effect on pain. The two methods being compared are slow tenaculum placement versus tenaculum placement at time of cough. Subjects will be asked to rate their pain using visual analog scale. Primary outcome measured is pain at time of tenaculum placement. Secondary outcomes are overall pain with intrauterine device insertion and provider satisfaction with tenaculum placement.

The two commonly described strategies for tenaculum placement, slow versus having the patient cough while the tenaculum is placed are utilized by providers based on preference and/or their previous training. There is no published study that compares these methods to one another. The investigators aim to compare these strategies, slow tenaculum placement versus the cough method, and their effects on pain at time of placement. 96 subjects will be randomized to each method. The subject will be asked to rate their pain using a 100-mm visual analog scale after speculum placement, after tenaculum is placed, and after completion of the procedure. The provider will be asked to rate their satisfaction with tenaculum placement on a Likert-type 5 point satisfaction scale. 1: not at all satisfied, 2: slightly satisfied, 3: moderately satisfied, 4: very satisfied, 5: extremely satisfied. All data to be collected using REDCap database.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 18 years and older
* Undergoing intrauterine device placement
* English or Spanish speaking

Exclusion Criteria:

* Primary language other than English or Spanish
Comparison of Short Segment Mono-axial and Poly-axial Pedicle Screw Fixation for Thoracolumbar Fractures

Comparison of short segment mono axial and poly axial pedicle screw fixation in thoracolumbar fractures regarding the best correction of the fracture and deformity and the maintenance of the correction.

* Thoracolumbar spine trauma represents the most common area fractured in the spine In a large series of 3,142 patients with traumatic spinal fractures, Wang et al., 2012, reported that 54.9% of the patients had fractures in the thoracolumbar spine. Patients with complete neurological deficits generally have thoracic fractures, possibly due to a small canal diameter when compared to the cervical or lumbar spine Although grouped together, TLST is comprised of injures to the more rigid thoracic spine (T1-T10), the flexible and transitional thoracolumbar junction (T11-L2), more susceptible to injuries, and the lumbar spine L3-5. Early diagnosis and adequate management may improve patients' outcome and decrease its inherent disability.(1)
* Morphological classification of thoraco-lumbar fractures is based on the Magerl classification modified by the AOSpine Classification Group. For this evaluation radiograms and CT scans with multiplanar reconstructions are essential. In some cases additional MR images might be necessary.(2)
* The goal of fracture treatment is to obtain and maintain a stable reduction and early mobilization. A secondary aim is to restore sagittal alignment which has gained increasing emphasis in the last decade.(3)
* Posterior short segment fixation including the proximal and distal adjacent normal vertebrae is the most commonly performed surgery for the vast majority of thoracolumbar fractures, Posterior pedicle screw fixation has been shown to be simple, familiar, efficient, reliable, and safe for the reduction and stabilization of most fractures and remains the most popular technique.(4)
* The aim of our study is to compare between monoaxial short segment pedicle screw fixation and polyaxial short segment pedicle screw fixation

Eligibility Criteria:
Inclusion Criteria:

* Thoracolumbar fractures D4 - L3.
* Neurologically free.
* Age of the patients to be from 20 to 60 years.
* Type A3 and A4 according to the AO classification.

Exclusion Criteria:

* Pathological or Osteoporotic fractures.
* Lumbar degenerative diseases.
* Multisegement spine fractures.
* Poly traumatized patients
A Study of Mouth Rinses in Type 1 and Type 2 Diabetic Participants

The purpose of this study is to evaluate mouth rinse formulations for oral soft tissue tolerance and efficacy in plaque/ gingivitis prevention/reduction in Type 1 and Type 2 diabetics when used twice daily as an adjunct to tooth brushing during a twelve-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Adequate oral hygiene (that is brush teeth daily and exhibit no signs of oral neglect)
* Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment
* Negative pregnancy urine tests (females of child bearing potential only)
* Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study
* A minimum of 20 gradable teeth including 4 molars with scorable both facial and lingual surfaces.Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, teeth with veneers, or third molars will not be included in the tooth count
* Diabetes Type 1 or Type 2-self reported
* An HB A1C level less than (\<) 7.0 percent (%) for Type 1 Diabetes and an HB A1C level of \<8.0% for Type 2 Diabetes
* A mean gingival index greater than or equal to (\>=) 1.85 per the Modified Gingival Index at Baseline
* A mean plaque index \>= 1.95 per the 6 site Turesky modification of the Quigley-Hein Plaque Index at Baseline

Exclusion Criteria:

* Dental prophylaxis within four weeks prior to baseline visit
* More than 3 sites having pocket depths of 5 millimeter (mm) or any sites that are greater than 5 mm in depth
* History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
* A recent history of hypoglycemia requiring medical intervention within the past 30 days
* Use of antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/ immunomodulators during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator
Increasing Colorectal Cancer (CRC) Screening Among Hispanic Primary Care Patients

This study is designed to test a standard mailed intervention (SI) versus a novel decision support and navigation intervention (DSNI). Working with patients and stakeholders, this randomized trial will include 400 Hispanic men and women who are 50 to 75 years of age, patients in community based primary care practices, and are eligible for CRC screening. We will consent, survey, and randomize participants either to the SI Group (n=200) or the DSNI Group (n=200). Study specific aims are to: (1) Assess intervention (DSNI versus SI) impact on overall CRC screening adherence; (2)Assess intervention (DNSI versus SI) impact on CRC screening decision stage; (3) Assess intervention (DNSI versus SI) impact on test-specific CRC screening adherence; and (4) Assess intervention (DNSI versus SI) impact on CRC and knowledge and perceptions.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Self-identifies as being Hispanic or Latino
* 50 to 75 years of age

Exclusion Criteria:

* Previous diagnosis of CRC
* Up to date with CRC screening guidelines.
* Personal history of inflammatory bowel disease
* Personal history of polyps
* Family history of CRC diagnosed before the age of 60 years
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction

Clinical comparison of patients with transthyretin cardiac amyloidosis and patients with heart failure with reduced ejection fraction


Eligibility Criteria:
Inclusion Criteria:

* Age \>65
* ATTRwt diagnosis for patients, either with DPD-scintigraphy or myocardiac biopsy
* informed consent

Exclusion Criteria:

* Alder \<65
* No ATTRwt diagnosis
Efficacy of Cognitive Behavioral to Hypnotherapeutic Treatment of Depression

The purpose of the study is to compare the efficacy of an Hypnotherapeutic Treatment of Depression to Cognitive Behavioral Treatment of Depression in patients with mild to moderate Major Depressive Episodes.

Cognitive Behavioral Therapy (CBT) is considered to be an effective psychological treatment of mild to moderate Major Depressive Episodes. Effective treatments, however, show a reduction of depressive symptoms only up to 50 % (Luty et al., 2007) which is one reason for the modification of the well-established CBT in the last years. Following the 'third wave' approaches of CBT, e.g. Emotion-Focussed Therapy or Mindfulness-Based Cognitive Therapy, techniques like meditation or the use of systemic or Gestalt techniques within CBT has been applied. Within this context, Hypnotherapy-based strategies can also show an improvement of the current state of the art in depression psychotherapy. However, only few studies conducted randomised controlled trials to study the efficacy of hypnosis for depression as e.g. the comparison of cognitive hypnotherapy to CBT-alone (e.g. Alladin and Alibhai, 2007). With the present study, the efficacy of the Hypnotherapeutic Treatment of Depression (HDT) will be compared to the CBT-based Activation-focussed Cognitive Treatment of Depression (ACDT). Both treatments are individually administered and includes 20 sessions. We expect HDT not being inferior to ACDT in the reduction of depressive symptoms after six months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* DSM-5 (Diagnostic and Statistical Manual) criteria for current mild to moderate Major Depressive Episode (MDE)
* Informed consent
* Fluent in German
* Time for weekly therapy sessions
* Stable antidepressant medication since three months

Exclusion Criteria:

* A history of lifetime bipolar disorder, psychotic symptoms
* A diagnosis of a chronic Major Depressive Disorder (total duration of two years and more)
* Fulfilling the DSM-5 criteria for current severe MDE or scores in MADRS \>/= 35 or QIDSC16 (Quick Inventory of Depressive Symptomatology) \>/= 16
* Remission of current MDE since more than four weeks prior to inclusion assessment
* Acute risk for suicide
* Severe cognitive impairment (confirmed suspicion with Mini-Mental-State-Test \> 25)
* A dominating primary diagnosis of another axis I disorder including anxiety disorders (e.g. Panic disorder, Posttraumatic Stress Disorder, Anorexia nervosa, Borderline personality disorder), or any severe substance-related abuse or dependence disorder
* A physical illness which would interfere with regular psychotherapy sessions
* Outpatient psychotherapy during the last 12 months
A Study to Assess the Effects of an Oral Dietary Supplement on Overall Facial Appearance Among Healthy Adult Women With Existing Skin Damage From Sun Exposure

The study hypothesis is that Imedeen will show effects on skin health, when compared to placebo over a 6 month intervention period with respect to changes in skin appearance, skin density, moisture, and in fine lines and wrinkles.


Eligibility Criteria:
Inclusion Criteria:

In general good health and have no contraindications to the study product; Have Fitzpatrick Skin Type I-IV as determined by a trained evaluator. Have Glogau Classification of Photoaging of II or III as determined by the investigator.

Exclusion Criteria:

Use of any dietary supplement, over-the-counter or prescription product with the indication of improving the appearance or condition of the skin within one month of baseline.

History of or current disease or condition of the skin that the investigator deems inappropriate for participation (eg, atopic skin, facial scars, psoriasis, eczema, other scaly inflammatory diseases).

Subjects who have had a facial cosmetic procedures (eg, fillers, toxins, facial peel) or invasive surgical procedures (eg, laser treatment or face lift) or other facial treatments by a physician or skin care professional within the last 6 to 9 months from baseline (pending procedure type) or plan to have a treatment during the study.
Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)

The purpose of this randomized clinical trial is to determine if lowering homocysteine levels in renal transplant recipients with a multivitamin will reduce the occurrence of cardiovascular disease outcomes.

The hypothesis of the trial is as follows: Treatment with a high dose combination of folic acid, vitamin B6, and vitamin B12 will reduce the rate of pooled arteriosclerotic cardiovascular disease outcomes (i.e., pooled occurrence of non-fatal and fatal arteriosclerotic outcomes, including coronary heart, cerebrovascular, and peripheral vascular disease events) relative to treatment with an identical multivitamin containing no folic acid, and Estimated Average Requirement amounts of vitamin B6, vitamin B12, among chronic, stable renal transplant recipients

Eligibility Criteria:
Inclusion Criteria:

* 35 - 75 years old
* Had kidney transplant at least 6 months
* Calculated Creatinine Clearance must be 25 mL/min or greater
* Must be willing to stop supplements (B6, B12, folic acid) for 4-6 weeks prior to visit

Exclusion Criteria:

* If pregnant or lactating
* If of child bearing potential and not on birth control
* If any of the following will limit life expectancy to less than 2 yrs:

  * Cancer
  * Congestive heart failure (CHF) (end stage)
  * Liver disease (end stage)
  * Severe pulmonary disease
  * Progressive HIV
  * Any other chronic wasting illness
* If patient had myocardial infarction (MI), stroke, lower extremity amputation above ankle or percutaneous revascularization procedure (coronary, cerebrovascular, lower extremity) in past 2months
* If patient had coronary artery bypass graft (CABG) or abdominal aortic aneurysm (AAA) in past 5 months
* If patient has conditions that prevent reliable study participation e.g., depression, alcohol or drug abuse, other cardiovascular disease (CVD) studies
* If patient has had multi-organ transplant, except kidney/pancreas
The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Bipolar Disorder I or II This Study is Not Being Conducted in the United States.

Bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania, grandiose delusions, and suicidality. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of patients with bipolar disorder type I or II.


Eligibility Criteria:
Inclusion Criteria:

* History of bipolar disorder type I or II

Exclusion Criteria:

* Other serious medical conditions
* Treatment with antiepileptic medications

Other protocol-defined inclusion/exclusion criteria may apply.
High-frequency Oscillatory Ventilation (HFOV) in Preterm Infants With Severe Respiratory Distress Syndrome (RDS)

Respiratory distress syndrome (RDS) is common in preterm infants born at less than 32 weeks gestation; surfactant and mechanical ventilation have been the standard treatment. However, despite advances in neonatal respiratory care, a considerable number of preterm infants develop chronic lung disease, termed bronchopulmonary dysplasia (BPD), which is associated with neonatal death, prolonged neonatal intensive care stay, and impaired neurodevelopment. High-frequency oscillatory ventilation (HFOV) was developed as a new ventilation technique in the late 1970s. It was expected to result in less BPD and death as a primary model of ventilation compared to conventional ventilation (CV) in the treatment of RDS. However, there is disagreement concerning the advantage of HFOV over CV in the treatment of RDS in preterm infants regarding the prevention of death, BPD, intraventricular hemorrhage, and periventricular leucomalacia in the short term. The purpose of this study was to compare the efficacy and safety of HFOV and CV in preterm infants with severe RDS.

All patients were monitored including blood pressure, heart rate, oxygen saturation, ventilator settings, and arterial blood gases pre- or during mechanical ventilation. PaO2/FIO2 was calculated. After 2 hours ventilation, if PaO2/FIO2 \<200, patients were given rescue surfactant therapy (Curosurf 200mg/kg). A subsequent dose (100mg/kg) was administered when PaO2/FIO2 \<200 12 hours after the previous dose. Surfactant was administered with use of in-line catheters. Suctioning was performed 6 hours after surfactant administration, except for some patients needed suction soon, with use of an in-line suction catheter. Ventilation continued during the administration of surfactant and suctioning.

Eligibility Criteria:
Inclusion Criteria:

1. Preterm infants admitted to the NICU with gestational age \<32 weeks, birth weight \<1500g and less than 24 hours of age
2. Who developed RDS requiring mechanical ventilation
3. Presented a partial pressure of oxygen (PaO2): fraction of inspired oxygen (FIO2) ratio \<200
4. Radiograph criteria of severe RDS

Exclusion Criteria:

1. Infants with genetic metabolic diseases
2. Congenital abnormalities
3. Pneumothorax
4. Grade III-IV intracranial hemorrhage
Heart and Blood Pressure Study: The Effect of Aortic Impedance on Myocardial Relaxation

Does dilation of blood vessels (vasodilation), which decreases aortic stiffness, have a greater effect on heart myocardium relaxation (diastole) than vasodilation which affects mean pressure equally without improving aortic stiffness?

60 subjects, 30 with hypertension and 30 without will attend two visits to the GCRC. At each visit, pulsatile hemodynamics (by using tonometry-a non-invasive means to obtain arterial pressure tracings) and Doppler tissue imaging relaxation velocity (a measurement of myocardial relaxation obtained by echocardiography) data will be collected before and after administration of vasodilator medication. At the first visit, each patient will receive an oral dose of the vasodilator hydralazine (does not effect aortic stiffness), and at the second visit each patient will receive intravenous nesiritide (does effect aortic stiffness). The relationship between timing of the reflected pulse wave and myocardial relaxation velocity will be studied at baseline and following administration of each vasodilator to determine if changing aortic stiffness has an impact on myocardial relaxation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects over the age of 65

Exclusion Criteria:

* Have known or suspected coronary artery disease
* Have known or suspected left ventricular dysfunction
* Have significant valvular, infiltrative, pericardial, or congenital heart disease
* Have a resting systolic blood pressure \< 100 mmHg
* Have had an adverse reaction to nesiritide or hydralazine
* Have a serum creatinine \> 2 mg/dl at Visit 1
Automatic CT-to-patient Registration During Navigated Bronchoscopy and EBUS

Bronchoscopic diagnosis and staging of lung cancer must be gentle and quick, and requires optimal sampling precision.Electromagnetic navigation systems are promising for intraoperative guiding based on maps made of preoperative CT images. Navigation accuracy depends largely on correct alignment of preoperative images to the patient´s position in space during endoscopy. In this study, the accuracy of a new fast and automatic image-to-patient registration method during the initial phase of bronchoscopy is assessed in patients referred for lung cancer investigation.

This is an accuracy study of a new automatic CT-to-patient registration technique for bronchoscopy and endobronchial ultrasound bronchoscopy (EBUS). An in-house research and development navigation platform displays the intraoperative position of the endoscope inside the airways, and shows its exact position in three-dimensional (3D) maps made from the patients' own preoperative CT images. The navigation system is used for acquiring position data from a bronchoscope or EBUS-scope (same sort of output data acquired from both endoscopes in this study) equipped with a position sensor for electromagnetic tracking. From intraoperative position data, the accuracy of the image-to-patient registration and the navigation system accuracy can be calculated. When targeting a certain lymph node or tumor for sampling, the pulmonologist can use electromagnetic navigation combined with preoperative CT images to navigate directly, precisely and accurately to the area of interest. Functional systems for navigated bronchoscopy and EBUS may therefore lead to considerable improvements in lung cancer diagnosis and mediastinal staging.

Eligibility Criteria:
Inclusion Criteria:

* referred to thoracic department St Olavs Hospital due to suspicion of lung cancer
* informed consent

Exclusion Criteria:

* pregnancy
Plasmodium Falciparum Artemisinin Resistance Vietnam

Resistance of Plasmodium falciparum toward Artemisinins, the most important drug for the successful treatment of malaria, has been confirmed in Cambodia. There are few reports from neighbouring countries about delayed parasite rates. The investigators therefore aim to assess parasite clearance in malaria patients in central Vietnam when treated according to national standard guidelines.

General objective To evaluate the efficacy of DHA-PPQ in patients with uncomplicated falciparum malaria in a rural area of Central Vietnam, and to assess the in vitro susceptibility of P.falciparum isolates to DHA and PPQ.

Specific objectives

1. To measure the parasite clearance time in falciparum malaria patients treated with DHA-PPQ.
2. To determine the efficacy of DHA-PPQ at day 42 post-treatment.
3. To assess the in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province.
4. To compare genetic profiles of P.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance;

Eligibility Criteria:
Inclusion Criteria:

* Age: from 6 months of age;
* Fever (body temperature above 37.5C) or history of fever in the previous 24 hours;
* Mono-infection with P.falciparum with parasite density between 500-100,000/µl
* Written informed consent to participate to the trial. For patients aged less than 18 years, an informed consent will be obtained from a parent or a guardian.

Exclusion Criteria:

* Mixed malaria infection;
* Pregnancy or lactation (urine test for β human chorionic gonadotropin to be performed on any woman of child bearing age unless menstruating);
* Concomitant acute illness necessitating specific treatment (antibiotics);
* Underlying chronic severe illness (e.g. cardiac, renal, hepatic diseases, HIV/AIDS).
* Severe malnutrition;
* Danger signs:

  * not able to drink
  * incontrollable vomiting
  * recent history of convulsions (\>1 in 24 hours)
  * unconscious state; neurological impairment
  * unable to sit or stand
* Signs of severe malaria:

  1. Cerebral malaria (unrousable coma)
  2. Severe anaemia (Htc\< 15%)
  3. Renal failure (serum creatinine \> 3 mg/dL)
  4. Pulmonary oedema;
  5. Hypoglycemia (\<40mg/dL)
  6. Shock (systolic BP \< 70 mmHg in adults, 50 in children)
  7. Spontaneous bleeding
  8. Repeat generalized convulsions
  9. Macroscopic haemoglobinuria
  10. Severe jaundice
* Persons who have received quinine, artemisinin or artemisinin derivatives within the last 7 days, 4-aminoquinolines within the last 14 days, pyrimethamine and/or sulfonamides within the last 28 days, or mefloquine within the last 56 days should be excluded from the in vitro testing