cyrilzakka/clinical-trials huggingface dataset:
Intracervical Block Versus Placebo to Assess Pain Control During Hysterosalpingogram

The purpose of this study is to compare the efficacy of 1% lidocaine intracervical block to placebo for pain control during the performance of a hysterosalpingogram (HSG). We hypothesized that an intracervical block would decrease pain during a hysterosalpingogram.

The hysterosalpingogram (HSG) is an integral part of the evaluation for anatomic etiologies of female infertility. The majority of women regard a hysterosalpingogram as acutely painful since it involves placement of a cervical tenaculum, traction on the cervix, and instillation of dye through a cervical cannula. Different techniques have been employed to attempt to make the procedure less painful, including use of balloon catheters rather than cannulas; however, this has not been shown to be uniformly effective. Previous studies have shown a reduction in overall pain during HSG after pre-medication with oral non-steroidal anti-inflammatory drugs. Benzocaine gel (20%) applied to the cervix has also been shown to reduce pain. Conversely, a study of pre-medication with paracetamol (acetaminophen) showed no statistical improvement in pain perception. Additionally, transcervical intrauterine instillation of lidocaine has been shown in randomized studies to not improve pain scores and may actually increase pain after the procedure is complete A MEDLINE literature search of papers written in English from January 1966 to August 2005, using the keywords "hysterosalpingogram," "analgesia", "paracervical," and "intracervical" did not reveal any prior studies on the use of an intracervical block prior to hysterosalpingography. A paracervical block has been shown to decrease pain with therapeutic abortions, endometrial biopsy, and office hysteroscopy (7, 8). We hypothesized that an intracervical block would also decrease pain during a hysterosalpingogram. A three armed, randomized controlled trial comparing pain control after a 1% lidocaine intracervical block, saline injection or no injection in patients undergoing hysterosalpingogram was performed.

Eligibility Criteria:
Inclusion Criteria:

* All patients without a known cause for their infertility who were undergoing a hysterosalpingogram were eligible for enrollment.
* All subjects were 18 to 40 years of age and married.

Exclusion Criteria:

* Included a history of any allergies to local anesthetics, radio-opaque dye or to anti-inflammatory medications.
Low-level Light Therapy on Treatment of Venous Ulcers Assesed by Nursing Outcome Classification (NOC)

This study compares the effect of adjuvant treatment of Low-level Light Therapy with conventional treatment in the tissue repair of venous ulcers in patients undergoing outpatient nursing consultation. For the evaluation of the cases clinical indicators of Nursing Outcomes Classification have been used.

There are several therapeutics with different mechanisms of action to reach tissue repair.

The conventional treatment of venous ulcers is based on the alternation of exercising the lower extremities with resting, the application of topical treatments associated with compressive therapy, and the use of medications.

Despite the diversity of bandages available, there are still lesions with difficult prolonged healing process. Therefore, Low-level Light Therapy has been used as an adjuvant technological alternative therapy, due to its photochemical effects on the tissues, such as the modulation of inflammation, increase of granulation tissue, contraction of the wound, reduction of the inflammatory process, and reduction of pain. This therapy contributes to accelerate and improve the tissue repair process.

Studies assessed by Nursing Outcomes Classification about the usage of the treatments above combined are not available. Consequently, more robust clinical studies over venous ulcers to evaluate the tissue repair must be proposed using reliable instruments.

Eligibility Criteria:
Inclusion Criteria:

* Presence of venous ulcer
* Availability for weekly appointment
* Acceptance to participate of the research with the signature of the Term of Free and Informed Consent

Exclusion Criteria:

* Morbid obesity
* Active cancer treatment
* Erysipelas
* Cellulitis, lymphangitis and chronic lymphedema
* Usage of immunosuppressants and / or corticosteroids
* Venous ulcer all around the leg
* Presence of coagulation necrosis covering more than 25% of the wound bed.
Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine

This study evaluates the incidence, patient characteristics and outcome of myocarditis after the COVID-19 mRNA vaccination in healthcare professionals.

Considering previous reports of cardiovascular adverse events, passive surveillance might not identify all myocarditis/myopericarditis cases after COVID-19 vaccination and it is possible that a mild/subclinical myocarditis might be much more prevalent in the population. This research project has three aims: first, provide novel insights regarding the incidence, patient characteristics and outcome of myocarditis. Second, provide a safety net by active surveillance for myocarditis, allowing early initiation of appropriate therapy. Third, provide reassurance to the public regarding myocarditis, as questions have been raised by critics of the pharmaceutical industry that Phase III studies performed by the pharmaceutical industry may have not appropriately captured adverse events.

This study is screening persons undergoing the COVID-19 mRNA booster vaccination of possible development of myocarditis. This approach in detecting myocarditis would help early initiation of the right treatment under close monitoring of the clinical course. Furthermore, this kind of study might also help understand the development of myocarditis and possibly the reasons for sex differences. Myocarditis suspicion is raised when patients present symptoms of acute chest discomfort, myalgia, fever/chills, abnormal ECG, increased concentrations of high-sensitivity cardiac troponin T (hs-cTnT), possibly supported by signs of cardiac inflammation in cMRI (myocardial oedema, myocardial/pericardial late gadolinium enhancement, pericardial effusion). Since the study is performed on health care professionals working in the University Hospital Basel, it is able to monitor more closely the possible side effects of the mRNA vaccination. Consecutive individuals that received a COVID-19 mRNA vaccine booster and undergo a systematic approach to detect myocarditis at the University Hospital Basel will be included.

Eligibility Criteria:
Inclusion Criteria:

* individuals working at the University Hospital Basel, Switzerland
* informed consent available
* 16-65 years old

Exclusion Criteria:

* Refusal to participate at the study
* Cardiac events or cardiac surgery within 30 days prior to study (as these could result in prolonged hs-cTnT elevations and interfere with the diagnosis of myocarditis
Primary Headaches and Irritable Bowel Syndrome.

To assess the relationship between primary headaches and irritable bowel syndrome

The association between primary headaches and functional gastrointestinal disorders has been confirmed by many clinical observations. In most patients during the attacks of headache, apart from various neurological and vascular symptoms, gastrointestinal disturbances occur . Functional gastrointestinal disorders, such as irritable bowel syndrome (IBS), are reported in primary headache patients in periods between the attacks as well. On the other hand 23-53% of IBS patients have frequent headaches.

Migraine typically presents relapsing episodes of symptoms including headache, nausea, vomiting, sensory hypersensitivity and mood changes that last for hours to days . Similar to migraine, IBS is characterized by recurrent abdominal pain or discomfort with altered gastrointestinal motility and visceral hypersensitivity that returns to normal between attacks . Both pain disorders lack detectable organic causes .

An emerging model of the brain-gut axis was proposed to explain migraine and IBS as a result of a genetically sensitive nervous system that develops hyperexcitability over time as a response to multiple environmental and immunological factors.

Cluster headache (CH) characterized by its distinctive circadian and circannual periodicity, implicating the role of the hypothalamus in its underlying pathophysiology. CH and IBS are featuring recurrent attacks of pain that possess relationships with circadian rhythms and potentially hypothalamic derangements.

Tension headache that's associated with pain in head described as feeling like a tight band around head, also show many similarities with IBS such causes for both are unknown, and some studies suggest a possible link that could shed light on shared genetics of both condition .

Eligibility Criteria:
Inclusion Criteria:

* age more than 18.
* both sex.
* history suggestive of any type of primary headaches.
* accept to participate in the study.

Exclusion Criteria:

* Intake of medications that can aggravate Headache or IBS.
* Presence of neurological disease other than primary headaches.
* Presence of gastrointestinal disease other than IBS.
Randomized Study Of CP-675,206 or Best Supportive Care Immediately After Platinum-Based Therapy For Non-Small Cell Lung Cancer (NSCLC)

The purpose of this trial is to study how long patients can remain progression free when they receive CP-675,206, compared to how long patients can remain progression free when they receive best supportive care. If you choose to take part, you will be randomized to receive either CP-675,206 as maintenance therapy or best supportive care. Best supportive care means you will not receive any study drug or other treatment for your cancer. Best supportive care could include treatment with antibiotics, analgesic drugs (medicine for pain), blood transfusions or psychosocial and nutritional support, depending on your needs. You have a 50% chance of being randomized to receive CP-675,206.


Eligibility Criteria:
Inclusion Criteria:

* Stage IIIb (with effusion) or stage IV disease that has responded or remained stable after 6 cycles of a platinum containing 1st-line regimen
* Patients must be able to be randomized between 3 and no more than 6 weeks after the last dose of first-line therapy.

Exclusion Criteria:

* No other systemic therapy except 1st-line platinum based treatment
* Symptomatic or uncontrolled brain mets or uncontrolled pleural effusions.
Electrical Stimulation for the Treatment of Chronic Post-Stroke Shoulder Pain Using the Smartpatch System

The purpose of this study is to determine if electrical stimulation (small levels of electricity) reduces post-stroke shoulder pain. This study involves a device called the Smartpatch System. The Smartpatch System delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator).


Eligibility Criteria:
Key Inclusion Criteria:

* At least 21 years of age
* Post-stroke shoulder pain
* At least 6 months after stroke that caused shoulder pain

Key Exclusion Criteria:

* Use of habit-forming (narcotic) medications
* Bleeding disorder
* History of recurrent skin infections
* Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, Multiple Sclerosis, or Complex Regional Pain Syndrome
* Heart arrhythmia or artificial heart valves
* Uncontrolled seizures
* Implanted Electronic Device
* Pregnant
Intelligent Volume Assured Pressure Support to Improve Sleep Quality and Respiratory Events in Patients With Non Invasive Ventilation

Aim of this prospective randomized trial is to compare non invasive ventilation (NIV) with pressure control (BiPAP-ST) to volume assured pressure support (iVAPS) with regards to sleep quality and alveolar ventilation in patients with routine NIV initiation after COPD exacerbation.

20 patients with COPD and chronic hypercapnic respiratory failure will spent two nights on NIV, one with spontaneous timed pressure controlled bilevel ventilation (BiPAP-ST) and one with the advanced mode of intelligent volume assured pressure support (iVAPS). Patients will spend the treatment nights in randomized order under polysomnographic surveillance, including transcutaneous PCO2 measurement. Besides the number of arousals and PCO2 values over night the sleep quality will be judged with regards to especially adjusted respiratory event criteria like unintentional leaks, patient ventilator asynchrony, and decrease of ventilatory drive.

Non invasive ventilation (NIV) is one of the major medical innovations of the last 30 years. Especially continuous positive airway pressure (CPAP) is the established Gold Standard in obstructive sleep apnea (OSA) treatment.

NIV with bilevel ventilation (BiPAP-ST) is the established Gold Standard in acute hypercapnic respiratory failure, especially in exacerbated COPD.

Still, the adaption of CPAP in OSA is less complicated than a bilevel therapy in hypercapnic failure. The adjustment of NIV requires not only the definition of expiration pressure (PEEP) but also of inspiration pressure support. Only adequate pressure difference guarantees effective ventilatory assistance and an improvement of alveolar ventilation. The pressure changes need to be defined by the physician, as well as the breathing frequency.

Ventilation can furthermore be controlled by a target volume (volume controlled) or a target pressure (pressure controlled).

Moreover, patients with respiratory insufficiency are often suffering of significant dyspnoea and are hard to accustom to a respiratory mask.

There is a lack of systematic studies addressing the effects of different ventilator settings on sleep and life quality, as well as studies about the necessary monitoring extent during the NIV initiation.

Eligibility Criteria:
Inclusion Criteria:

* Stable respiratory insufficiency
* Hypercapnia \>50 mmHG
* Clinically required NIV
* Capable of giving consent

Exclusion Criteria:

* Existing ventilatory support
* Invasive ventilation
* Any other severe physical disease that requires immediate medical assistance
* Acute hypercapnic decompensation with pH \<7.30 in routine BGA
* Circumstances that doesn't allow mask ventilation (e.g. facial deformation)
* Participation in a clinical trial within the last 4 weeks
* Pregnancy or nursing period
* Drug addiction
Effectiveness of PEEK Fixed Retainer

A randomized clinical trial is set out to compare the effectiveness of two types of fixed retainer (multistranded stainless steel and PEEK types) in maintaining the stability of lower anterior teeth with less failure rate.

It is a multicenter randomized clinical trial with two arms parallel group. The patients will be randomly divided into two groups, group one: multistranded stainless steel fixed retainer will be used while, and group two PEEK fixed retainer will be used. An intra-oral scan, intra-oral swap and periodontal indices will be taken before starting the treatment (T0), after one month (T1), after 3 months (T2), and after 6 months (T3). Patient perception concerning the fixed retainer will be taken for the patients.

Eligibility Criteria:
Inclusion Criteria:

* Age: 17-32 years.
* Patients with a score of 0-0.5 on Little's irregularity index in the lower arch.
* Patients treated with the pre-adjusted orthodontic appliance (both Extraction and non-extraction cases).
* Patients who have healthy periodontal condition

Exclusion Criteria:

* Patients treated with rapid maxillary expansion or surgically assisted rapid maxillary expansion.
* Patients with a cleft lip / and or palate.
* Patients with a deep overbite and traumatic parafunctional habits such as bruxism and clenching.
* Patients with carious, restored, fractured, or missing lower anterior teeth.
* Patients with medical health problems that may influence gingival health like uncontrolled type II diabetic patient, patients with hormonal disturbances or systemic drug administration that effect on oral health.
* Smokers
Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

Gabapentin is an antiepileptic drug. Its antiemetic effect is demonstrated after laparoscopic surgery, but it is not yet known whether gabapentin is effective in preventing chemotherapy induced emesis.

The purpose of this study is to determine whether the addition of gabapentin to dexamethasone plus ondansetron increase the control of chemotherapy-induced nausea and vomiting.

This was a prospective, double-blind, placebo-controlled study conducted at our institution (Faculdade de Medicina da Fundação ABC and affiliated Hospitals) from April 2009 to April 2010. Patients and personnel involved in the study were blinded to the assigned treatment. The study was approved by the ethics committee of our institution. All the patients provided written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* First course of chemotherapy ( cisplatin or doxorubicin at a dose of at least 50mg per square meter)
* Written informed consent must be obtained before initiating the protocol procedures

Exclusion Criteria:

* ECOG 3
* Nausea and vomiting within the past 1 day
* Gastrointestinal obstruction
* Concurrent use of opioid
* Patients with brain metastases
* History of allergic or other adverse reaction to gabapentin
Development of a Coordinated, Community-Based Medication Management Model for Home-Dwelling Aged in Primary Care

The objective of this randomized controlled trial is to develop a coordinated, multiprofessional medication management model for home-dwelling aged in primary care and to study the effectiveness of this model. The main hypothesis is that the new model helps to identify aged people having potential risks with their medications and thus allows solving these risks.

The demand for long-term home health care services is increasing due the demographic and societal developments. Aged people needing home care are increasingly older, have many chronic diseases and use multiple medicines and thus, are at high risk for drug-related problems (DRPs). In Finland, national and local healthcare and aged care strategies target to allowing aged people (over 65 years) living in their own homes as long as possible. This minimizes the costs of institutionalized care and also targets to add the quality of life of aged people. New approaches and service models are needed to meet these challenges.

The present study focuses on the development of a coordinated medication management model which aims to ensure the safe medication practises for home-dwelling aged in primary care. In the previous parts of this study project were developed a model for comprehensive medication review process (CMR) and a Drug-Related Problem Risk Assessment Tool. The present study uses a multistage intervention in which medications are reviewed (prescription review) in a community pharmacy using the SFINX-database to identify clinically significant drug-drug interactions and the Salko-database which identifies potentially inappropriate medications for aged people. In the next stage practical nurses use the Drug-Related Problem Risk Assessment Tool to identify potential risks. The following stages are based on the results from the risk assessment tool. Potential options are, e.g.,physician consultation, more frequent home care visits, counselling given by the community pharmacy or comprehensive medication review (CMR). The CMR process is only targeted to a limited group of study participants with clinically significant DRP who probably will benefit from more comprehensive CMR.

Eligibility Criteria:
Inclusion Criteria:

* Home-dwelling over 65 year-old persons receiving regular home care from the City of Lohja

Exclusion Criteria:

* Home care is not given regularly
Dose Optimization of Rivaroxaban Combined With Rifampicin

The goal of this observational study is to learn about exposure levels of rivaroxaban at different doses in patients with prosthetic joint infection combined with the use of rifampicin. Participants will be collected blood samples to determine rivaroxaban plasma concentration. The main question it aims to answer is to predict the dose adjustment of rivaroxaban combined with the use of rifampin.

This study is a prospective observational study and does not interfere with the normal clinical diagnosis and treatment process. In the case of patients with periprosthetic infection with or without rifampicin, the blood concentration of rivaroxaban was monitored, and the data were further predicted and analyzed by statistical tests and physiological pharmacokinetic models, and suggestions were made for dose optimization.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged\>18 years
* The diagnosis was periprosthetic infection after joint replacement
* Orthopedic operations such as revision of artificial joints, removal of prostheses, debridement, etc. for the treatment of periprosthetic infection
* Rivaroxaban was used to prevent deep vein thrombosis after operation.

Exclusion Criteria:

* Patients allergic to any excipient in rivaroxaban, rifampicin or tablets
* Patients with clinically significant active bleeding
* Patients with significant risk of bleeding
* Patients with liver disease with coagulation abnormalities and clinical-related bleeding risk, including patients with cirrhosis who reached Child Pugh C grade
* Pregnant women and breastfeeding women
* Patients taking combined drugs affecting rivaroxaban metabolism
* Patients who were unable or unwilling to cooperate with the study (Such as mental or memory disorders)
* Patients discontinued without meeting study target days
* Patients with severe renal insufficiency (creatinine clearance rate \< 30ml / min)
Improving Mothers for a Better PrenAtal Care Trial Barcelona

High risk women for growth restricted fetuses will randomized in the second trimester into different strategies applied to the mothers: a stress reduction program based on mindfulness techniques or a nutrition interventional program based on Mediterranean diet.

Randomized controlled trial among women at higher risk to have a growth restricted fetus (30%) according to Royal College of Obstetrics and Gynecology (RCOG) Guidelines. These high-risk women will be randomized in order to evaluate an improvement in several outcomes thanks to different strategies applied to the mothers: a stress reduction program based on mindfulness techniques or a nutrition interventional program based on Mediterranean diet.

Main hypothesis: specific interventions improving maternal lifestyle and well being have a positive impact on pregnancy outcomes as well as on fetal growth and development.

Secondary hypothesis is that interventions to improve maternal lifestyle well being have a positive impact on offspring's outcome later in life, in terms of neurodevelopment and cardiovascular profile, mediated by epigenetic changes in offspring.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age at recruitment ≥18 years
* Speak Spanish fluently
* Viable singleton non-malformed fetus
* High-risk pregnancy to develop FGR.
* 19-23 weeks of gestation

Exclusion Criteria:

* Fetal anomalies including chromosomal abnormalities or structural malformations detected by ultrasound.
* Mental retardation or other mental or psychiatric disorders that impose doubts regarding the true patient´s willingness to participate in the study.
* No possibility to come to additional visits.