cyrilzakka/clinical-trials huggingface dataset:
Intraarticular Analgesia After Total Hip Arthroplasty, a Randomised Study

The purpose of this study is to determine whether wound infiltration with following single-shot bolus injection with local anesthetic and NASIDs are effective in the treatment of postoperative pain after total hip replacement compared to continuous epidural infusion.

Sufficient postoperative pain relief after total hip replacement is necessary to achieve normal mobilisation and a reduction of the surgical stress response. After total hip replacement epidural treatment has proven superior, with regards to pain relief, than treatment with parenteral infusions and periphery nerve blocks. Even though epidural treatment gives excellent pain relief adverse effect as motor block, urine retention, hypotension and itching occurs regularly which delays rehabilitation.

Treatment with the administration of local anesthetic in the operating field has shown its efficiency in reducing postoperative pain with a low incidence of adverse effects after various surgical procedures.

This study compares continuous epidural infusion of ropivacaine added morphine to a new technique, where ropivacaine, ketorolac and adrenaline is used to infiltrate the tissue around the hip joint during surgery, and is injected by an intraarticular catheter 8 hours postoperative.

Data of pain scores, analgesia consumption, adverse effects and mobilisation is collected for the first 4 postoperative days.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted consecutively to primary total hip arthroplasty due to arthrosis

Exclusion Criteria:

* Patients unable to provide informed consent
* Patients with contraindications for spinal anesthesia
* Patients with known hypersensitivity towards the used drugs
* Patients with severe chronic neurogenic pain
* Patients with Rheumatoid arthritis
* Patients with a daily opioid consumption
Study to Estimate the Disease Burden of Acute Rotavirus Gastroenteritis in Children < 5 Years in United Arab Emirates

The purpose of this study is to estimate the disease burden and epidemiology of rotavirus gastroenteritis in children less than 5 years of age, in United Arab Emirates. Acute gastroenteritis cases will be identified from acute gastroenteritis hospitalisation log book and stool samples will be collected from all suspected and confirmed acute gastroenteritis cases.


Eligibility Criteria:
Inclusion Criteria:

* A male or female \< 5 years of age at the time of admission to the study hospital for acute gastroenteritis.
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

* The diagnosis for treatment at the study site does not include acute gastroenteritis.
* The onset of acute gastroenteritis after admission to the hospital i.e. 48 hours after hospital admission.
Quality of Life Associated With a Low-Risk Screening Program for Ovarian Cancer

The goal of this research study is to learn more about how women feel about an ovarian cancer screening program that involves getting a blood test to measure CA 125 levels. This includes finding out about women's quality of life and whether they are concerned or worried about their risk of developing cancer. This study also seeks to find out whether elevated CA 125 levels affect participants in terms of cancer worries or concerns.

Participants in this study will be asked to complete several questionnaires. Participants will be able to fill out the questionnaires in the clinic or if necessary, they can complete them at home. Pre-addressed and stamped envelopes will be provided to mail back if they are completed at home. The questionnaires involve quality of life issues, concerns or worries about cancer risk and beliefs about cancer. It will take 30 minutes or less to complete the questionnaires.

The completed questionnaires can be returned to the research nurse or if the participant prefers or they can be returned to the researchers in the self-addressed stamped envelope that is provided.

This is an investigational study. This study will involve 2400 women who are participating in an ovarian cancer screening program. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Women enrolled on protocol ID01-022

   * Women \> 50 years of age
   * Postmenopausal (\> 12 months amenorrhea)
   * Willingness to return to clinic for annual blood tests, or earlier if indicated
   * Willingness to undergo transvaginal ultrasound if indicated
2. Women who speak and read English

Exclusion Criteria:

1. Women ineligible to be enrolled on protocol ID01-022

   * Prior removal of both ovaries
   * Active non-ovarian malignancy
   * Women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for \> 12 months. They will not be excluded if they are on tamoxifen.
   * High-risk for ovarian cancer due to familial predisposition as defined by the following:

     * Known mutation in BRCA1 or BRCA2
     * Two first or second degree relatives with either ovarian cancer or pre-menopausal breast cancer
     * Ashkenazi Jewish ethnicity with one first degree or two second degree relatives with pre-menopausal breast or ovarian cancer, or if patient herself has had breast cancer.
2. Women who do not speak or read English
Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines

This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe frown lines.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent including authorization to release health information
* Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
* Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity (PFWS) scale
* Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
* Active skin disease, infections or inflammation at the injection sites
* Plan to receive botulinum toxin type A anywhere in the face through the duration of the study
* History of allergy or sensitivity to any botulinum toxin preparations or to any component of the test article
* Current enrollment in an investigational drug or device trial or participation in such a trial within the last 30 days prior to screening through end of trial
Comparison Between Conventional and Digital Workflow in Dental Prosthesis

The aim of this comparative RCT is to evaluate the differences between the entire digital, the combined digital-analogic and the entire analogic workflows of implant-supported and teeth-supported prostheses. It is a three-arms comparative study. The 60 patients are divided into three groups:

* fully digital workflow
* combined digital and conventional workflow
* fully conventional workflow For each patients were evaluated the interproximal (IC) and occlusal contact (OC) and impression time (IT) and the patient satisfaction through a VAS scale.

The null hypothesis is that are no differences between the three groups for each parameter.

This comparative RCT aims to evaluate the differences between the entire digital, the combined digital-analogic, and the entire analogic workflows of implant-supported and teeth-supported prostheses. It is a three-arms comparative study to better focus on the reliability of digital techniques.

Inclusion criteria were good oral health, absence of parafunction, no dental caries or presence of periodontitis, and healthy general conditions.

Exclusion criteria were bad oral health, parafunctions, dental caries or periodontitis, and general health comorbidities that don't allow surgical treatment.

The 60 patients are divided into three groups:

* fully digital workflow: each patient in this group was treated with an exclusively digital workflow, from digital planning of the surgical phase to digital impression and digital manufacturing of prosthetic crowns.
* combined digital and conventional workflow: each patient of this group was subjected to digital planning, and then, the impressions were taken with traditional analogical materials, so the plaster model was converted into a digital model, and there finally was performed a digital manufacturing of prosthetic crown.
* entirely conventional workflow: each patient was treated with an analogical technique. No digital phase was performed.

After prosthetic delivery, each patient were evaluated for interproximal (IC) and occlusal contact (OC), impression time (IT), and patient satisfaction through a VAS scale.

The null hypothesis is that there are no significant differences between the three groups.

Eligibility Criteria:
Inclusion Criteria:

* good oral health
* good general health conditions
* no contraindication to oral surgery and fixed prosthesis
* patients who completed the 6 months follow-up

Exclusion Criteria:

* bad oral health
* bad general health conditions (with multi-drug therapy)
* periodontitis or dental caries susceptibly
* parafunctions presence
* TMJ disorders
* didn't accept the informed consent / treatment planning
Application of Injectable Platelet-Rich Fibrin for the Treatment of Temporomandibular Joint Osteoarthritis

The authors designed a randomized, controlled, double-blind clinical trial after the ethical approval by the University Ethics Committee. The patients with temporomandibular joint osteoarthritis (TMJ-OA) randomly assigned one of the two treatment groups: intra-articular injection of injectable platelet-rich fibrin (i-PRF) after arthrocentesis procedure as i-PRF group and arthrocentesis procedure alone as control group. The primary outcome variable was pain levels at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month. The secondary outcome variables included maximum mouth opening (MMO), lateral and protrusive movements.

The authors designed a randomized, controlled, double-blind clinical trial after the ethical approval by the University Ethics Committee. The patients with TMJ-OA randomly assigned one of the two treatment groups: intra-articular injection of i-PRF after arthrocentesis procedure as i-PRF group and arthrocentesis procedure alone as control group. All treatment procedures were completed by the same experienced surgeon under the local anesthesia. The procedure of arthrocentesis was performed using the standard technique and after arthrocentesis procedure, the i-PRF injection was performed in the test group.

The primary outcome variable was pain levels at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month. The secondary outcome variables included maximum mouth opening (MMO), lateral and protrusive movements.

Eligibility Criteria:
Inclusion Criteria:

* patients with osteoarthritis (OA) of one or two temporomandibular joint (TMJ)
* maximum mouth opening less than 35 mm
* impeded protrusive and lateral movements
* localized pain of the affected joint

Exclusion Criteria:

* systemic or malignant diseases affecting TMJ-OA assessment
* previous invasive or surgical treatments of TMJ unrelated to OA
* edentulous patients
* pregnancy
Exploring Integrative Medicine in Swedish Primary Care

Research over the last years have reported an increased popularity of complementary therapies (CTs) and an integration of CTs into mainstream medical settings, health care organizations and insurance plans. These trends may present both new challenges and new opportunities for health care provision. In Sweden and elsewhere, major challenges include the great variety and quality of CT provision within health care and a lack of national and international recommendations of how integrations of CTs with conventional care should be modelled, i.e. lack of conceptual models for delivering integrative medicine (IM). This may partly be a result of a scarce evidence base in support of IM provision within public health care services, e.g. lack of IM compared to usual care in randomised clinical trials. It remains largely unknown whether comprehensive models of IM are clinically or cost effectively different from conventional care provision.

Back and neck pain are costly, conventionally managed in primary care and two of the most common conditions treated by CTs. We have developed a comprehensive collaborative consensus model for IM adapted to Swedish primary care. The aim of this pilot study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain.

Study objectives included the exploration of recruitment and retention rates, patient and care characteristics, clinical differences and effect sizes between groups, selected outcome measures and power calculations to inform the basis of a full-scale trial.

Eligibility Criteria:
Inclusion Criteria:

* Back/neck pain with or without headache for at least two weeks and at least three times per week
* Resident of Stockholm County
* Literate in Swedish
* Willing and able to comply with study requirements

Exclusion Criteria:

* Specific pathology and severe causes of back/neck pain such as malignant disease, vertebral fractures and severe or progressive neurological symptoms.
Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy

This study will evaluate the efficacy of BGG492 in reducing the sensitivity to flashing lights of patients with photosensitive epilepsy, using EEG as a readout.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of photosensitive epilepsy

Exclusion Criteria:

- inconsistent photoparoxysmal response when stimulated by photic stimulation

Other protocol-defined inclusion/exclusion criteria may apply.
MRI to Assess the Effect of Non-selective Beta-blocker in Patients With Cirrhosis

Background:

Standardization and new therapeutic treatments of variceal bleeding has significantly reduced the mortality the last 25 years, but there is still a high 6-week mortality around 15-20% and 1-year mortality of about 40%. Cirrhotic patients without prophylactic treatment suffer a risk of 60% of re-bleeding within the first year after the first bleeding episode. Variceal ligation and NSBB are the standard therapy as secondary prophylaxis, while only non-selective beta-blocker (NSBB) is offered as first-line therapy in primary prophylaxis. If portal pressure is reduced to a value below 12 mmHg or by 20% (10% if assessed by intravenous administrations), the risk of bleeding is substantially reduced, but not all patients respond to the treatment with propranolol (40-50%). Hence, patients who are non-responders to NSBB should be offered alternative treatment with e.g. carvedilol, which is a combined alpha-beta-receptor blocker or endoscopic band ligation. Currently, the response to NSBB is assessed invasively during a liver vein catheterization (LVC). Unfortunately, only a few centres in the world can perform this procedure and there are no reliable non-invasive alternatives to assess the respond to NSBB, which is of extreme importance, since non-responders have three fold increased risk of a new variceal bleeding episode.

Aim:

In general the aim of the project is to develop faster and non-invasive methods to evaluate portal hypertension and individual pharmacological response of NSBB in patients with cirrhosis. Furthermore, we expect to detect changes in liver and spleen stiffness as measured by MR-Elastography (MRE) after NSBB and that these depend on the drug-related effects on portal pressure.

Study design and patients:

39 patients with cirrhosis and esophageal varices that require NSBB (propranolol) treatment.

Patients are assessed with LVC, MR-scans, echocardiography and biochemical tests. LVC is the gold standard method to test if patients respond to propranolol treatment. At visit 1. the response to NSBB is defined as a reduction of HVPG ≥10%, or to a HVPG\< 12mmHg after intravenous NSBB administrations during LVC. MRI-scan with intraveneus NSBB administration is performed at visit 2. Minimum 5 days of NSBB wash out between visit 1 and 2.

MR-elastography and Phase Contrast MRI compared to LVC

Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis and esophageal varices that require NSBB treatment
* Patients of more than 18 and less than 78 years of age
* Patients with a portal pressure HVPG ≥ 12mmHg

Exclusion Criteria:

* Patients who are unable to give informed consent
* Patients with absolute contraindication for MRI
* Patients with absolute contraindication for NSBB
* Pregnant women
* Patient with severe hemodynamic comorbidity
Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan.

Vitamin D deficiency is wide spread in South Asian population and is contributing to burden of disease in this region including Pakistan. The relative importance of vitamin D deficiency, mutation in its receptor and maternal and child health has not been established in Pakistan and population based studies are required to explore and avert the maternal and Neonatal complications and consequences of Vitamin D deficiency

The trial will evaluate the effectiveness of Vitamin D supplementation to pregnant women and their Infants. It will be a double blind placebo controlled trial, which will be conducted in a rural district of Pakistan.

The investigators are proposing a community based introduction of vitamin D supplementation and we intend to understand the complex relationship between vitamin D, the growth factors and maternal and infant anthropometric variables and hope to unravel the reasons of vitamin D deficiency in our population.

The investigators expect that if vitamin D is supplemented to pregnant women and their newborn infants it will inevitably replenish the micronutrient stores and aid to resolve the maternal and neonatal morbidity due to Vitamin D deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women from 20-22 weeks of gestation and their infants, who will agree to take part in this study, will be enrolled.

Exclusion Criteria:

* Pregnant women with pre existing type 1 or type II diabetes
* Women with multiple fetuses, babies (twins, triplets)
* Pregnant women with high level of Vitamin D
* Babies with multiple congenital anomalies
* Babies with serious birth injury, birth asphyxia and serious infections
* Low birth weight less than 1.5
* Refuse to participate in the study
Hepatotoxicity of Antituberculosis Therapy (HAT) Study

Drug-induced liver injury (DILI) is a common side effect in antituberculosis therapy, which interuputs the treatment of TB and leads to a higher proportion of Multidrug-Resistence TB(MDR-TB).The study primalily aims to observe the proportion of DILI in antituberculosis therapy. Furthermore, the secondary objective is to study the proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy in the obersevational study.

Drug-induced liver injury (DILI) is a common side effect in antituberculosis therapy, which interuputs the treatment of TB and leads to a higher proportion of Multidrug-Resistence TB(MDR-TB).The study primalily aims to observe the proportion of DILI in antituberculosis therapy. Furthermore, the secondary objective is to study the proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy in the obersevational study.

Eligibility Criteria:
Inclusion Criteria:

* 1) Patients who are about to start anti-tuberculosis treatment 2) Male or female, age \> 18 years old 3) Voluntary signing of "Subject Informed Consent Form"

Exclusion Criteria:

- 1)A history of taking anti-tuberculosis drugs within 6 months before the treatment; 2)Abnormal liver function before starting anti-tuberculosis treatment; 3)DILI at the time of enrollment. 4)Combined with malignant tumors (including hematological tumors), HIV infection, etc.

5) According to the investigator's judgment, patients who cannot complete this study or who cannot comply with the requirements of this study.
Evaluation of the Pharmacokinetic Profile, Pharmacodynamic Effects, Acceptability and Tolerability of an Oral Amiodarone Solution of 15 mg / mL in Children With Supra Ventricular Tachycardia

The supra ventricular tachycardia is the most common symptomatic arrhythmia in pediatrics. Amiodarone is an antiarrhythmic drug used in this indication. Pharmacokinetic, efficacy and safety data are not known in the pediatric population due to the lack of a suitable specialty available on the market.

The development of an amiodarone oral solution formulation adapted to this age group should provide a therapeutic alternative and collect data on the pharmacokinetics, efficacy, acceptability and tolerability of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Child (boy or girl) with supra ventricular tachycardia diagnosed by ECG recording.
* Child aged 0 to 11 years.
* Child whose parents / legal representative (s) agree to sign a consent form.
* Child whose opinion / agreement has been / has been attempted to be collected.
* Child and parents / legal representative (s) being ready and able to participate in the study, understanding and committing to respect the procedures of the study throughout its duration.
* Child enrolled in a social security scheme.
* Child with a body mass index between the 3rd and the 97th percentile.

Exclusion Criteria:

* A child with a known hypersensitivity to the active ingredient, iodine or any of the excipients of the study formulation.
* Child who has already been treated with amiodarone (as a capsule or with the oral injectable form)
* Impossibility of taking blood samples.
* Hyperthyroidism (TSH \<laboratory low standard).
* Disruption of liver function (ASAT\> 3N and / or ALT\> 3N).
* Renal impairment (Cl creat \<30 mL / min)
* Hepatic insufficiency (TP or factor V \<70%)
* Inotropic support.
* Uncorrected severe ionic disorders.
* Extension of the QTc space before the implementation of the treatment (\> 450 ms).
* Non-paired sinus disease.
* Concomitant treatment with a drug which has an absolute contraindication with amiodarone.
* Child with gastrointestinal disorders such as malabsorption syndrome.
* Weight \<2.5 kg.
* Child whose mother was treated with amiodarone during pregnancy.
* Child who received another product under investigation or participated in another study within 60 days of the start of this study.