cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Pre-emptive Analgesia in Children With Molar-incisor Hypomineralization (MIH)

Pain is defined by IASP (International Association for the Study of Pain) as "an unpleasant sensory and emotional experience associated with the damage actual or potential tissue or described in terms that suggest such harm". Episodes of pain and discomfort experienced by children are one of the main factors for fear and anxiety in dentistry, especially those that present the condition of Molar-Incisive Hipomineralization, where we observed increased levels of anxiety in relation to the treatment. In order to improve the painful sensation that patients with Molar-Incisor Hipomineralization present as well as anxiety demonstrated by these patients in face of dental treatment, the objective of present study will be to evaluate the occurrence and degree of pain after procedures dentists with administration of pre-emptive analgesia or placebo, in children with Molar-Incisive Hipomineralization. Fifty patients will be selected in the Pediatric Dentistry courses of the FORP-USP undergraduate course, aged 6 to 12 years, of both sexes, who present at least 2 (two) upper and / or lower molars affected by Molar- Incisors that need some kind of restorative treatment, extraction or endodontic treatment. Also, these patients should present enamel and dentin fractures caused by MIH, atypical restoration and / or atypical caries, and that present pain above the moderate degree (6\>), after stimulation with air/water jet for 5 seconds.


Eligibility Criteria:
Inclusion Criteria:

* present at least 2 (two) upper molars and/or lower affected by Molar-Incisor Hypomineralization
* restorative treatment
* extraction
* endodontic treatment
* pain above the moderate degree (6\>)

Exclusion Criteria:

* patients with suspected of analgesics of any type or presence of acute pain in the last 24 hours before the procedure
* patient with history of hepatopathy
* bleeding hemorrhagic disorders
* hypersensitivity to components
* patients and family members who do not have a telephone or that the children will not under parental supervision in the first 24 hours after care.
Induction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma

To prospectively evaluate the short-term efficacy and toxicity of induction chemotherapy with cisplatin and capecitabine followed by concurrent chemoradiotherapy (CCRT) in the treatment of locally advanced nasopharyngeal carcinoma.

All patients received 3 cycles of induction chemotherapy:cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy. Intensity-modified radiotherapy (IMRT) were used in all patients with the total dose and dose/fraction (Fr) as follows: PTV (planned target volume)_1:70 grays (Gy) at 2 Gy/ Fr, PTV_2:63 Gy at 1.8 Gy/ Fr, PTV_3:56 Gy at 1.6 Gy/ Fr;5 fractions per week. Tumor response was evaluated after 3 cycles of induction chemotherapy and 16 weeks following completion of CCRT according to the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST1.1). All toxicities were gauged based on the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE 4.03).

Eligibility Criteria:
Inclusion Criteria:

* Pathological confirmed nasopharyngeal carcinoma.
* Staged as III to IVB.
* 18-75 years old.
* Performance status ≤2.
* No previous chemotherapy or radiotherapy.
* No concurrent malignancies or a history of other malignancies.
* Adequate bone marrow function (absolute neutrophil count ≥1.5×109/L, platelets ≥100×109/L).
* Adequate liver and renal function (serum bilirubin and serum transaminase levels less than twice the upper limit of normal, creatinine clearance ≥ 60ml/min).
* Without serious co-morbidity.

Exclusion Criteria:

* Stage I-II or IVC.
* Allergic to cisplatin or capecitabine
* Age \<18 or \>75
* Performance Status \>2.
* Without adequate bone marrow or liver function or renal function.
* Severe co-morbidity and can not tolerate chemotherapy.
* Other conditions not suitable for the study on the discretion of charging doctor.
Feasibility of HIFU for Management of Placenta Accreta (HIFU-ACCRETA)

Placental accretion during pregnancy refers to an abnormally deep insertion of the placenta into the uterus, leading to the impossibility of removing the placenta without inducting uterine or surrounding organs lesions. The management of these patients is complex, with two options during caesarean section: hysterectomy or uterine conservative surgery in which the placenta is let in the uterine cavity. These are both at risk of complications, including severe hemorrhage.

High Intensity Focused Ultrasound (HIFU) principle is based on the focusing of ultrasonic waves in a focal zone causing a rapid rise in temperature in the targeted area. This focus results in the creation of a coagulation necrosis tissue lesion. This procedure is guided in real time by an integrated ultrasound imaging cell.

The investigators hypothesized that HIFU shots would accelerate the process of placental involution when the placenta is let in the uterine cavity, increasing the chances of uterine preservation and reducing the infectious and hemorrhagic risks in the short and medium term. The aim of this study is to confirm the feasibility and safety of the use of HIFU as a per-caesarean adjuvant treatment for management of placenta accrete let in the uterus for a conservative treatment.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman aged 18 years or older, with a suspicion of placental accretion observed with usual imaging tests (ultrasound, MRI)
* Single pregnancy (singleton)
* For whom a caesarean section has been scheduled
* Wishing to try to preserve her uterus
* Affiliated to a social security scheme or similar
* Having signed informed consent for participation in the study

Exclusion Criteria:

* Major patient protected by law, under guardianship or curatorship
* Patient participating in other interventional research that may interfere with this research
* Placental tumor identified in antenatal
* Grade 3 placental calcification
* Presence of a catheter, stent or vascular prosthesis close to the uterus
EUS Guided Liver Biopsy - Will it Give Better Yield, More Tissue With Less Complication?

Liver biopsy would be done by Endoscopic Ultrasound using Acquire needle.

In this study, we aim to evaluate the tissue adequacy of EUS guided liver biopsy for parenchymal liver disease and to evaluate if diagnostic yield of left lobe is non-inferior to right lobe biopsies and to assess if combination biopsies have better yield than single lobe biopsies. Safety of the procedure and technical success would be noted.

The data would be analysed using SPSS software and needful variables and tests would be used as per statistical requirement.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any undiagnosed hepatic disease (after extensive investigation - serological as well as imaging) requiring a liver biopsy
* Patients of NAFLD who need liver biopsy
* Alcoholic hepatitis patients needing biopsy
* Any patient with unexplained transaminesemia \> 1.5 times ULN needing a liver biopsy as advised by Hepatologist

Exclusion Criteria:

* Any liver Space occupying lesion suspicious of malignancy
* Platelet count \<80,000
* INR \> 1.5
* Pregnancy
* Severe cardiovascular and pulmonary diseases
* Recent use of anti-platelet agents within 5 days of the procedure
* Unwilling to provide informed consent
OCL 500 Treatment of Women With Symptomatic Uterine Fibroids

This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids.

Prior to entering the study, all patients will undergo pre-study assessments including compliance with inclusion and exclusion criteria, laboratory assessments, pelvic examination, and imaging of the pelvis. Following conventional catheter angiography to confirm catheter placement and the uterine vasculature, each patient will undergo transarterial embolization with Occlusin 500 microspheres.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women with symptomatic uterine fibroids
* Willing and able to provide informed consent
* Fibroids visible by ultrasound or non-contrast magnetic resonance imaging
* Fibroids with a minimum diameter of 4cm for a single fibroid or 3cm where there are 2 or more fibroids; minimum total fibroid burden 33cc
* Documented ovulation by Luteinizing Hormone (LH) testing
* Follicle Stimulating Hormone (FSH) value \>40 IU/L within 3 months prior to procedure
* Pelvic examination within 6 months prior to procedure
* Normal Pap smear

Exclusion Criteria:

* Positive pregnancy test
* Uterine size \> 20 weeks gestation
* Fibroids that are more than 50% submucosal
* Individual fibroids \> 12cm in diameter, or total fibroid burden \> 905cc
* Pedunculated subserosal fibroids with an attachment to the uterus less than 50% of the greatest diameter of the fibroid
* Fibroids situated in the cervix
* Abnormally large ovarian arteries
* Uterine pathology other than fibroids
* History of gynecologic malignancy
* Active pelvic infection or history of pelvic inflammatory disease
* Undiagnosed pelvic mass outside the uterus
* History of chemotherapy or radiation to the abdomen or pelvis
* Intra-Uterine Device (IUD) in position
* History of, or ongoing, hemolytic anemia
* Severe cerebrovascular disease defined by a cerebrovascular accident within 6 months of treatment
* Anticoagulant therapy or known bleeding disorder
* Treatment with Gonadotropin Releasing Hormone (GnRH) agonists within the previous 6 weeks
* Received another investigational agent within past 12 weeks
* Compromised hematopoietic function
* Compromised hepatic function
* Compromised renal function
* BMI \> 38
* Claustrophobia
* Contraindication to angiography
* Contraindication to magnetic resonance imaging (MRI) or MRI contrast agents
* Allergy to contrast agents
* Allergy to bovine collagen
* Patient desires to become pregnant, or does not agree to contraception during study
Safety Study of Shenfu (a Chinese Medicine Injection) Used in Hospitals in China

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

Shenfu is kind of Chinese Medicine injection used for treating shock and coronary heart disease in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.

Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can not be found now.

A registry study for Shenfu injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015.

Eligibility criteria Patients who will use Shenfu injection in selected hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Patients using Shenfu injection from 2012 to 2014
Non-use After Stroke: Influence of Applied Force and Precision When Reaching With the Paretic Upper Limb

After a stroke, 80% of patients have an upper limb deficit, limiting activity. Some develop a non-use: they can, but do not, use their paretic limb. Non-use is a general phenomenon applied to all situations where the patient applies unnecessary compensation. Several rehabilitation techniques are effective to counter non-use, but there is insufficient knowledge to choose the most suitable technique. Optimal control theory could help guide these choices. It assumes that the chosen coordination satisfies the constraints of the task (force, amplitude, tolerance) while reducing the cost of the movement. This study will assess non-use by anticipating the sensitivity to the constraints of force and precision deduced from the logic of optimal control. The study authors expect to observe a weakness effect: in a reaching task (i.e. when the person has to touch an object placed in front of them), lightening the paretic arm makes it possible to reduce non-use, and a precision effect: in a reaching task, non-use increases with the required spatial precision.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria specific to the stroke group:

* Patient having had a 1st stroke
* Patient whose stroke occurred more than a month ago.
* Patient having had a supratentorial stroke
* Patient able to touch the opposite knee with the paretic arm

Inclusion criteria specific to the control group:

* Subject who has never had a stroke
* Subject without motor or orthopedic impairment of the upper limbs and in particular of the shoulder

General inclusion criteria:

* Subject who has given free and informed consent.
* Subject who signed the consent form.
* Subject affiliated or beneficiary of a health insurance plan.

Exclusion criteria:

* Pregnant, parturient or breastfeeding subject.
* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient with cognitive disorders incompatible with a good understanding of the use of the device
* Patient with other neurological or osteoarticular history that may limit the performance of the task - criterion left to the deiscretion of the investigator
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis

This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided informed consent
* Subject completes all dosing requirements in feeder study and completes PS0010 study without meeting any withdrawal criteria
* Female subjects of childbearing potential and male subjects with a partner of childbearing potential must continue to use an acceptable method of contraception (as detailed in PS0010) for up to 20 weeks after the last dose of study treatment in PS0011

Exclusion Criteria:

* Subject has previously participated in this study.
* Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
* Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study.
* Subject must have a negative interferon gamma release assay (IGRA) as measured at Week 8 of PS0010
Brain Networks and Consciousness

General anesthesia (GA) is a medically induced state of unresponsiveness and unconsciousness, which millions of people experience every year. Despite its ubiquity, a clear and consistent picture of the brain circuits mediating consciousness and responsiveness has not emerged. Studies to date are limited by lack of direct recordings in human brain during medically induced anesthesia. Our overall hypothesis is that the current model of consciousness, originally proposed to model disorders and recovery of consciousness after brain injury, can be generalized to understand mechanisms of consciousness more broadly. This will be studied through three specific aims. The first is to evaluate the difference in anesthesia sensitivity in patients with and without underlying basal ganglia pathology. Second is to correlate changes in brain circuitry with induction and emergence from anesthesia. The third aim is to evaluate the effects of targeted deep brain stimulation on anesthesia induced loss and recovery of consciousness. This study focuses on experimentally studying these related brain circuits by taking advantage of pathological differences in movement disorder patient populations undergoing deep brain stimulation (DBS) surgery. DBS is a neurosurgical procedure that is used as treatment for movement disorders, such as Parkinson's disease and essential tremor, and provides a mechanism to acquire brain activity recordings in subcortical structures. This study will provide important insight by using human data to shed light on the generalizability of the current model of consciousness. The subject's surgery for DBS will be prolonged by up to 40 minutes in order to record the participant's brain activity and their responses to verbal and auditory stimuli.


Eligibility Criteria:
Inclusion Criteria:

* Willingness and ability to cooperate during conscious operative procedure for up to 40 minutes
* Clinical diagnosis of Parkinson's disease or essential tremor
* Preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities

Exclusion Criteria:

* Patients with recent use (within one week) of anticoagulant or antiplatelet agent use
* Neurocognitive testing indicating amnestic cognitive deficits
* History of intolerance of propofol or medical indications to use an anesthetic other than propofol
The Use of Topical Anaesthetic in the Banding of Internal Haemorrhoids

The investigators' aim is to assess if they can complete a study measuring the effect of local anaesthetic gel (Instillagel) on reducing pain experienced by patients undergoing a common treatment for haemorrhoids (piles). This treatment is called rubber band ligation and is commonly performed in the investigators'clinics.

A feasibility trial assessing patient recruitment, retention, randomization, and surgeon acceptability of topical anaesthetic use during rubber band ligation of haemorrhoids.

A patient and assessor blinded feasibility trial. The trial population will prospectively be recruited from colorectal surgery outpatients. Patients will be randomized to two groups to receive: lubricating gel (K-Y Jelly) and topical anaesthetic gel (Instillagel) or lubricating gel alone (the standard care).

The intervention group will receive lubricating gel and topical anaesthetic gel (containing lidocaine active ingredient) administered rectally, whilst the control group will receive lubricating gel alone (standard care). This will be carried out in Colorectal Outpatients. The band ligation of the haemorrhoids should occur between 5-10 minutes after administration of the topical anaesthetic/lubricating gel. Pain scores and the use of oral analgesia will be measured immediately after the procedure (5 minutes), upon leaving the clinic (approximately 30 minutes after), at 4 hours, and 72 hours following the procedure. Vasovagal symptoms or other complications will be recorded whilst the patient is in the clinic. At 1 month post procedure, patients will be phoned to determine if any adverse events have occurred.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic grade 1-3 haemorrhoid disease, 18+ years old, English is the first language.

Exclusion Criteria:

* Allergy to active ingredients of Instillagel, Allergy to local anaesthetic, Chronic liver disease, Grade 4 haemorrhoid disease, Pregnancy, Inflammatory bowel disease, Pre-existing anorectal disease.
A Study to Evaluate fMRI of Active DBS Stimulation in Epilepsy

The purpose of this study is to use functional imaging to study the mechanisms of the anterior nucleus of the thalamus (ANT) deep brain stimulation (DBS).

Researchers are testing how changing the settings on deep brain stimulation device (DBS) can help reduce the number and severity of seizures. Functional imaging will be used to study the mechanisms of ANT DBS to optimize the device settings to improve the degree of seizure reduction.

Eligibility Criteria:
Inclusion Criteria:

- Patients who have previously undergone anterior thalamic nucleus deep brain stimulation (DBS) for refractory epilepsy.

Exclusion Criteria:

- Contraindication to MRI; prior brain resective surgery or large area of brain tissue loss (e.g., large area infarction).
Antimicrobial Effect OF Propolis Administrated Through Two Different Vehicles In High Caries Risk Children

Propolis is a natural product collected by bees to seal holes and repair structures in their hives. Recently it has attracted much attention as useful substance applied in medicine and cosmetics thanks to its antimicrobial properties. Contemporary dentistry is an inseparable part of medicine and therefore attempts were made to use propolis in dentistry, as well.

Purpose of the study: to investigate the effect of propolis administered in chewing gum as compared to that incorporated in mouthwash on plaque accumulation, microbial population and patient acceptance.

The study is a two parallel arms randomized controlled clinical trial where 60 high caries risk children of 6-8 years will be selected from outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, after securing the necessary consents. The children will be divided randomly into two equal groups (30 children each).

Eligibility Criteria:
Inclusion Criteria:

* Patients with high caries risk; who have any one of the following condition: visible cavities or radiographic penetration into the dentin, white spots on smooth surfaces, restorations within last three years due to caries.
* Free of any systemic condition.
* Cooperative children according to Frankl rating scale including positive and definitely positive scores.
* Parental acceptance

Exclusion Criteria:

* Previous use of any propolis containing products.
* Received any antibiotic 2 weeks before or during the study.
* Oral infection that compromises the mastication process.