cyrilzakka/clinical-trials huggingface dataset:
A Smart Digital Workflow Towards High Precision and Through-Put Production for Removable Partial Dentures

Tooth loss is a major chronic problem in dentistry and edentulous elderly endures poorer quality of life worldwide. Removable partial dentures (RPDs) are the most widely accepted and cost-effective treatment for patients to restore oral functions. RPDs contain three components including the metal framework, denture base and acrylic teeth. Conventionally, RPD fabrication involves tedious clinical and dental laboratory procedures and is time consuming, labour-intensive, and often imprecise, therefore incapable of meeting the growing demands of RPD by an ageing population. The challenges to achieve a high quality and high-throughput RPD service lie in three aspects: 1) accuracy in capturing oral profile; 2) immediate oral information analysis and device design, and 3) automation in production.

Tooth loss is a major chronic problem in dentistry and edentulous elderly endures poorer quality of life worldwide. Removable partial dentures (RPDs) are the most widely accepted and cost-effective treatment for patients to restore oral functions. RPDs contain three components including the metal framework, denture base and acrylic teeth. Conventionally, RPD fabrication involves tedious clinical and dental laboratory procedures and is time consuming, labour-intensive, and often imprecise, therefore incapable of meeting the growing demands of RPD by an ageing population. The challenges to achieve a high quality and high-throughput RPD service lie in three aspects: 1) accuracy in capturing oral profile; 2) immediate oral information analysis and device design, and 3) automation in production.

Towards this goal, we have developed an intelligent RPD design software prototype, SmartRPD, to generate RPD metal framework design using digital scans from patients. SmartRPD processes patient-specific scanned geometry instantly, provide diagnosis analysis and generate the first draft of metal framework design automatically, powered by a teeth geometry segmentation system, knowledge-based design algorithm and 3D geometry engines. Dentists make the final clinical changes and confirmation before sending the 3D digital files for 3D printing. Thereafter, an altered digital scan technique is used to register a precise digital scan of soft tissues under functioning, using the metal framework as a loading impression tray and digitally align to the initial oral scan. This resulted modified master scan file leads to a more accurate setting for the denture base in the subsequent procedures.

Eligibility Criteria:
Inclusion Criteria:

* above the age of 21 years' old
* medically fit
* with prior denture experience
* either maxillary or mandible partial dentate
* partial edentulism with stable occlusion

Exclusion Criteria:

* History of maladaptation to denture use
* With maxillofacial or mandible bone defect(s)
* Known allergic reaction to cobalt chromium metal
Supplementing Neuro-Energy to Aid Cognition

It is projected that by 2030, one in every five Americans will be of retirement age, and this demographic shift is expected to result in more people suffering from dementia. A key feature of the brain is its need for a constant supply of glucose and oxygen to meet the high energy costs of mental activity. This study aims to develop clinically practical, noninvasive imaging methods based on combined positron emission tomography and magnetic resonance imaging to assess brain energy in order to better understand how this critical component of brain health is impacted by aging.

There are now close to six million people in the Unites States living with dementia and this number is only expected to grow as the population continues to age. The current lack of effective treatments for Alzheimer's disease (AD) speaks to the need to better understand the multiple factors that contribute to this complex disease. There is growing evidence that age-related metabolic dysfunction in the brain plays a role in the disease's etiology. This concept has led to treatments aimed at improving brain energy production. Notably, ketogenic dietary supplements have been shown to increase brain ketone metabolism and improve cognitive performance in AD patients. However, the overall benefits to brain metabolism in the AD brain are unknown given the complexity of imaging both oxygen and glucose metabolism in a single session by positron emission tomography (PET). Taking advantage of hybrid PET/MR imaging, this study will combine PET and MRI methods to investigate the effects of a ketogenic supplement on brain oxygen and glucose metabolism in AD patients.

Eligibility Criteria:
Inclusion Criteria - Healthy Participants: Males and females, Age 21 - 80 years, BMI of 18.5-30

Inclusion Criteria - Alzheimer's Disease Participants: Positive amyloid and tau biomarkers (as noted by PET imaging, cerebrospinal fluid or blood), Mild cognitive impairment or mild-to-moderate dementia, BMI of 18.5-30

Exclusion Criteria: Contraindications to MRI (claustrophobia, metal implants, pacemakers, etc.), Pregnant or breastfeeding women, Neurological disease (healthy participants only), Mental illness, Overt cardio- or neurovascular disease, Recent participation in any procedure(s) involving radioactive agents
A Research Study Looking Into the Effect of Semaglutide and NNC0480 0389 on Blood Levels of a Birth Control Pill in Woman After Menopause

Novo Nordisk is developing a combination therapy with the investigational drug NNC0480-0389 and an already approved medicine called "semaglutide" for the treatment of type-2 diabetes (T2D). It is expected that the combination will further improve the blood sugar control compared to semaglutide therapy alone. The study will investigate the influence of the combination of semaglutide and NNC0480-0389 on the blood levels of a birth control pill (a combined oral contraceptive consisting of ethinylestradiol and levonorgestrel) and paracetamol. Participants will get semaglutide and NNC0480-0389 as injection under the skin of their belly using a pen-injector. The injections will be given once weekly for 14 weeks. Additionally, participants will at two occasions get paracetamol as soluble tablet in connection with a standardised breakfast meal. Further, participants will get the birth control pill in form of tablets in two periods of 8 days each. Participants will get the combination of semaglutide and NNC0480-0389 as well as paracetamol and the combined contraceptive in any case. The study participation will last up to about 24 weeks. Participants will have 25 visits at the study centre. For 4 of the visits participants will stay at the study centre; the remaining visits will be outpatient. Only healthy postmenopausal women can take part in this study.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal female, aged greater than or equal to 45 years at the time of signing informed consent
* Body mass index between 20.0 and 29.9 kilogram per meter square (kg/m\^2) (both inclusive)
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
* HbA1c greater than or equal to 6.5 % (48 millimoles per mole (mmol/mol)) at screening
* Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic cytochrome P450 enzyme (CYP) pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are routine vitamins, occasional use of paracetamol, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation
* Use of hormone replacement therapy within 4 weeks before first dose of trial product or intention to initiate treatment with hormone replacement therapy during the study
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions
Assessment of Preoperative and Postoperative Ankle Kinematics

The objective is to study the joint kinematics of the prosthetic implant, in terms of translation, rotation, Range of motion and proprioception, in patients treated for prosthetic replacement of the ankle, quantitatively and under physiological load conditions.

Patients will be subjected to the same tests at zero time and 9 months after the implantation of the prosthesis, except for RSA which will be performed only 9 months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for ankle prosthesis
* Potential party able to provide informed consent and sign the approved Informed Consent Form;
* Male or female patients aged 40 to 80;
* Patients available to perform post-operative rehabilitation according to standard protocol, follow-up visits and radiological investigations scheduled for follow-up up up up to 24 months. In addition, patients who are available to perform all study tests, preoperators and follow-up.

Exclusion Criteria:

* Previous total prosthetic replacement of the ankle (revision surgery);
* Severe pre-operative deformity in valgus or varus (\>10 sanguine); BMI\>40 kg/m2;
* Pre-existing abnormalities of walking kinematics (amputations, neuro-muscular diseases, polio, hip dysplasia);
* Severe arthrosis of the knee (Kellgren-Lawrence\>3);
* Severa coxartrosi (Kellgren-Lawrence\>3);
* Previous hip and/or knee prosthesis surgery;
* Total avascular astragalus necrosis or other severe bone loss of the ankle that makes the implantation of standard prosthetic components contraindicated;
* Pregnancy confirmed by positive hcg serum or in vitro diagnostic test or ongoing breastfeeding;
* Active or latent infection of the affected ankle joint or any other systemic infection being treated;
* History of alcoholism, drug or substance abuse intravenously, psychosis, personality disorder/s, poor motivation, emotional or intellectual problems that could make the potential subject unstable for participation in the trial, or any combination of variables which in the opinion of the Principal Investigator should exclude the potential subject;
* Clinically documented acute or chronic pathology, other than the indication for the treatment adopted in this Trial, which could affect life expectancy or make it difficult to interpret the outcome of the potential subject in accordance with the Protocol (e.g., renal, hepatic, cardiac, endocrine, haematological, autoimmune, bone metabolism, crystal deposits or neoplasms);
* Potential subjects with medical conditions that interfere with the ability to participate in a standardized rehabilitation program;
* Participation in any other trial of another drug or experimental device within 60 days prior to the screening visit or administration of that drug or device during the course of this trial.
Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib.

Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in treating non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. An international multi-center clinical study published in 2019 confirmed that double dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, the choice of treatment after resistance to targeted therapy is a hot topic in clinical practice, with 78% of patients in the study above who responded to double-dose osimertinib still showing progression at the time of follow-up. The purpose of this study was to observe the safety and efficacy of intrathecal pemetrexed for leptomeningeal metastasis from lung adenocarcinoma that progressed after a double dose of a third-generation TKI such as osimertinib.

This study is a single arm, open and phase II clinical trial. Consecutive patients with leptomeningeal metastases from lung adenocarcinoma that progressed after a double dose of a third-generation TKI such as osimertinib are enrolled in this study. Concomitant regimen consisted of intrathecal chemotherapy (via lumbar puncture, pemetrexed 15 mg, plus dexamethasone 5 mg, twice a week for 2 weeks as an induction phase, followed by once a week for 4 weeks as a consolidation phase. Thereafter, the maintenance phase is once a month). The RANO proposal for response criteria of leptomeningeal metastasis was used to assess the clinical response in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged between 18 and 75 years.
2. Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations (L858R or Exon19Del).
3. Confirmed diagnosis of leptomeningeal metastasis according to ESMO/ EANO guidelines.
4. Progression after previous double doses of third-generation TKIs such as Osimertinib.
5. Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3.
6. No history of severe nervous system disease.
7. No severe dyscrasia.

Exclusion Criteria:

1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.
2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.
3. Patients with poor compliance or other reasons that were unsuitable for this study
Direct Versus Indirect Pick up of the Locator Retentive Caps:(Within-patient Study)

The purpose of this study will be to evaluate the effect of direct and indirect pick up of the locator retentive caps and compare the clinical results with those of the manufacturer retentive force.

Patient selection:

For this study, 30 patients were selected from the clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University.

According to pick up technique for the locator retentive caps, the overdentures will be classified into two groups as follows; Group1: The retentive caps will be picked up by indirect method on the cast then by the direct method Group2: The retentive caps will be picked up in the patient by the direct method first then by the indirect method.

For both groups, the clinical retention will be measured after using pink and blue retentive inserts respectively.

All implants were inserted using computer-guided implant surgery and conventional loading protocol was used.

Evaluation methods The clinical retention of each insert will be calibrated as regards the manufacturer's value.

Also, the laboratory retention will be assessed for the two groups and calibrated as regards the manufacturer's value.

Measurements will be done immediately, three and six months after each overdenture insertion.

Eligibility Criteria:
Inclusion Criteria:

* ● Free from any systemic disease that may interfere with the osseointegration of implants.

  * Patients will have completely edentulous maxilla and mandible for at least 6 months after the last extraction.
  * Patients will have normal maxilla mandibular relationships.
  * Mandibular arch with residual alveolar ridges covered with firmly attached mucosa.
  * The width of the mandibular ridge in the canine area will be sufficient for the installation of the implants in parallel anteroposterior and mesiodistal directions.

Exclusion Criteria:

* medically compromised patients smokers uncontrolled metabolic diseases ( diabetes mellitus ) uncooperative patients
Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion

The investigators propose in this trial to test a hepatic chemotherapy, consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol, lipid vector, without embolization in the treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with Child-Pugh A/B7.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-proven HCC or according to EASL criteria
* Child-Pugh A or B7
* Disease that is not suitable for resection, ablation or radiofrequency
* Performance Status ECOG 0 or 1
* BCLC A/B or C if Performance Status ECOG = 1
* Measurable lesions according to mRECIST criteria
* No previous treatment with chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) or radioembolisation
* Age superior or equal to 18 years
* Platelets \> 50,000/mm3, Polynuclear neutrophils \> 1000/mm3, Creatininemia \< 150umol/L, Bilirubinemia \< 5 mg/dL
* Absence of heart failure (Ultrasound LVEF \> 50%)
* Women of child-bearing age using an adequate method of contraception throughout treatment
* Men using an adequate method of contraception throughout the treatment and at least 3 months after the end of treatment
* Written informed consent
* National health insurance cover

Exclusion Criteria:

* Advanced tumor disease (extrahepatic except pulmonary micronodules \<7mm of tumoral portal vein thrombosis on positron emission tomography are not a contra-indication.)
* Large HCC with liver invasion \>50%
* History of other cancer than HCC and excluding cancers known to have been cured for more than 5 years, or basocellular skin tumors or cervical cancer in situ treated with adequate and curative purpose
* Advanced liver disease (Child B8, B9 or C)
* Contra-indication for the MRI (Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreing body similar to the nervous structure)
* Contra-indication to the injection of the gadolinium-based contrast agents (history of hypersensibility to the gadolinium chelates, meglumine).
* Contra-indication to idarubicin (Hypersensibility to active substance or excipients, cardiopathy with myocardial insufficiency of less than 6 months, serious arrhythmias, serious renal or liver failure, yellow fever vaccine or any other live attenuated vaccine, persistente myelosuppression, previous treatments with idarubicin and/or other anthracyclines or anthracenediones at maximum cumulative doses, stomatitis)
* Contra-indication to Lipiodol (Hypersensibility, proven hyperthyroidism, tromatic injuries, bleeding or recent bleeding)
* Concomitant disease or uncontrolled severe clinical situation
* Uncontrolled severe infection
* Vascular anatomy makes it impossible to perform hepatic intra-arterial treatments
* Pregnancy (Beta HCG positive) or breastfeeding
* Patient who for psychological, social, family or geographical reasons cannot be followed regularly
* Vulnerable person
* Concomitant participation of the patient in another research involving the human person
Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke

The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12 hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a 10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were also analyzed among the three groups.


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke within 12 hours for the first time before entry into the study
* National Institutes of Health Stroke Scale (NIHSS) score between 6 and 25

Exclusion Criteria:

* with lacunar infarction
* with cerebral hemorrhagic infarction
* with epilepsy or epileptic persons
* with history of neurological diseases
* with myocardial infarction,
* with renal and hepatic abnormalities
* with metabolic diseases
* with contraindications to antiplatelet treatments
Lidocaine Spray Plus Oral Celecoxib for Pain Control During Hysterosalpingography

our aims to investigate the effectiveness of10% Lidocaine Spray plus oral celecoxib for Pain Control During Hysterosalpingography

hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye

Eligibility Criteria:
Inclusion Criteria:

* any patient came for Hysterosalpingography

Exclusion Criteria:

* any patient has contraindication to Hysterosalpingography
Sublingual vs Intrauterine MISOPROSTOL Plus Oxytocin Infusion for Prevention of Post-cesarean Hemorrhage in High Risk Pregnant Women: A Double-blind Placebo RCT

Research Objective:

Primary outcome

-To compare efficacy Intrauterine vs Sublingual MISOPROSTOL in addition to Oxytocin in reducing blood loss of post-cesarean section in high risk women

Secondary outcome

-To study Hemoglobin/Hematocrit change, need of uterotonic agents, need of blood transfusion, adverse drug event of Intrauterine vs Sublingual Misoprostol plus Oxytocin compare to Oxytocin alone

Hypothesis:

-Intrauterine MISOPROSTOL plus Oxytocin is not inferior to Sublingual MISOPROSTOL plus Oxytocin in reducing blood loss of post-cesarean section in high risk women

Research Design: Double-blind Randomized Placebo Controlled Trial

Subject: Singleton pregnancy GA 34 wk or more with high risk for postpartum hemorrhage undergo cesarean section with spinal anesthesia in Rajavithi Hospital

Allocated to 3 groups

* group1: Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab
* group2: Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab
* group3: Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab + Placebo sublingually 2 tab

Eligibility Criteria:
Inclusion Criteria:

* ≥35 ปี
* Previous PPH
* Morbid obesity
* Fetal macrosomia
* Polyhydramnios
* Induction/Augmentation of Labour
* Prolonged Labour
* Grand multiparity
* Preeclampsia
* Myoma Uteri

Exclusion Criteria:

* Asthma
* Maternal fever/ Tripple I can't excluded
* coagulopathy
* Placenta previa/ adherens/ abruptio placenta
* Allergy to Prostaglandins/Oxytocin