cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Markers of Neuropathic Odontalgia

The DIAMOND study aims to investigate the presence and diagnostic relevance of potential biomarkers of the blood-nerve barrier disruption as surrogate markers of painful post-traumatic trigeminal neuropathic pain in patients presenting with neuropathic odontalgia. The first part of the study explores the proof-of-concept and technical feasibility of intra-epithelial nerve fiber immunostaining in gingival/oral mucosa biopsies and the potential presence of these biomarkers in healthy patients (baseline condition).

Painful Post-Traumatic Trigeminal Neuropathy (PPTTN) defines a neuropathic painful condition affecting the orofacial region, following local nerve trauma, usually secondary to dental treatments (tooth avulsion, root canal treatments....). It often presents as odontalgia of atypical presentation, unresponsive to conventional treatments. The diagnostic is often complex (and often is a diagnosis of elimination), leading to unnecessary iatrogenic dental treatments and insufficient pain relief.

This study aims to explore potential new markers of PPTTN, based on a translational approach following previous preclinical work that showed the importance of the disruption of the blood-nerve barrier in generating post-traumatic neuropathic pain. Several markers of such disruption have been highlighted (such as Claudin-5, Patched-1 and Frizzled-7) that could be specifically downregulated in neuropathic pain conditions (as compared to inflammatory neuritis conditions). As such, these markers could be interesting biomarkers of neuropathic pain. This study aims to explore the presence (and absence) of such markers in healthy vs neuropathic patients respectively.

The first part of the study investigates the technical feasibility of intra-epithelial nerve fiber staining in oral mucosa/gingiva specimens collected in healthy patients (undergoing routine oral surgery procedures) and the immunoreactivity/presence of such biomarkers in those specimens.

Eligibility Criteria:
Inclusion Criteria:

Adult patients (over 18 years old) requiring an oral/dental surgical intervention that will generate gingival/mucosal tissue elimination (as part of the normal surgical procedure)

Exclusion Criteria:

* Patient with a diagnosed odontalgia
* Patient with Painful Post-Traumatic Trigeminal Neuropathy (PPTTN)
* Patient with unexplained pains or a neuropathic pain regardless of its location
* Patient under guardianship or trusteeship
* Patient who refuses to give his/her non-opposition to participate to the study
Physical Activity Program and Energy Intake Control in Obese Adolescents

Acute exercise of high intensity has been shown to induced nutritional adaptations in obese adolescents. Indeed, several studies have shown that about 30 minutes of intensive exercise (above 70% of the adolescents maximal aerobic capacities) can favor reduced-energy consumption at the following meal with no modification of their appetite feelings. Although it is suggested that chronic physical activity programs can induce energy intake modifications, this has never been clearly studied. The aim of this work is to compare different physical activity programs (low vs. high intensity programs) in terms of energy intake, appetite feelings and appetite-regulating hormones, in obese adolescents.

After an first medical visit to ensure that the adolescents have the ability to complete the whole study, the participants will have to complete several clinical examinations:

* anthropometric measurements
* Body composition assessed by DXA
* Maximal aerobic test
* Blood samples (appetite-regulating hormones)
* daily energy intake assessment during a 24h intake exploration.

The adolescents recruited will then be randomly assigned to one of the two intervention groups:

- High Intensity program or moderate intensity program. Those two physical activity programs will last 4-months and will be composed of 3 to 4 exercise sessions per week. The High intensity program will consists in High intensity interval exercises starting at 70% of the adolescents' capacities at the beginning to end around 95%. The moderate intensity program will propose continuous exercises set between 50-65% VO2max.

No energy intake intervention will be performed.

By the end of the 4-months intervention, all the clinical examinations performed before the intervention will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* 12 to 15 years old adolescents
* Obese according to international values for BMI
* Being registered to the national social security insurance
* no eating disorders
* no medications
* metabolic disorders

Exclusion Criteria:

* metabolic disorders
* food disorders
* physical disability
Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis

- Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.

Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking.

- Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis and has frequent muscle cramps

Exclusion Criteria:

* Allergy to cyclobenzaprine
* Encephalopathy.
* Receiving antidepressant drugs
Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Spontaneously Breathing Adult Volunteers

Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the injected bicarbonate will dissolve into carbon dioxide and water and cause a transient increase in the measured exhaled CO2.

The effect is unique to bicarbonate and will not appear once normal saline is injected. the safety of the administration of bicarbonate on the metabolic profile of the volunteers will be assessed by measurement of venous blood pH and electrolytes.

Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the injected bicarbonate will dissolve into carbon dioxide and water and cause a transient increase in the measured exhaled CO2. Arbitrary increase of more than 10%in end-tidal carbon dioxide is considered as a positive response.

The effect is unique to bicarbonate and will not appear once normal saline is injected. the safety of the administration of bicarbonate on the metabolic profile of the volunteers will be assessed by measurement of venous blood pH and electrolytes.

Eligibility Criteria:
Inclusion Criteria:

* ASA I,II
* no cardiovascular or respiratory disease

Exclusion Criteria:

* ASA \> II
* Cardiovascular disease
* Respiratory disease
* renal failure
* metabolic alkalosis
Comparison of Follow-up Protocols in Terms of Fetal, Neonatal and Maternal Results in Intrauterine Growth Retardation

This study will be undertaken to determine whether the frequency of fetal surveillance can be safely reduced from bi-weekly to weekly in the case of fetusus with intrauterine growth restriction.

In this prospective randomized study, the cases whose fetal weight predicted by ultrasonography (USG) between the 28th and 37th weeks of gestation are below 10percentile according to the World Health Organization (WHO) normograms. The cases will be divided into two groups as group 1:weekly and group 2:bi-weekly (twice-weekly) The cases will be evaluated by fetal Doppler, amniotic fluid volume, nonstress test (NST) and maternal preeclampsia tests.Maternal severe hypertension/preeclampsia, category 3 NST, oligohydramnios (after 37 weeks amniotic fluid index \<5; after 34 weeks single deepest pocket \<2 cm) ,pathological doppler (before 34 weeks reverse flow in an umbilical artery , after 34 weeks absent end-diastolic flow in an umbilical artery) in cases of birth decision will be taken. Cases without the above mentioned complications will be delivered between 38 weeks 3 days and 39 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 28-37 weeks pregnant women with estimated fetal weight below 10 percentile
* singlton pregnancy

Exclusion Criteria:

* maternal preeclampsia
* maternal systemic disease (pregestational diabetes, gestational diabetes mellitus a2, antiphospholipid antibody syndrome, chronic kidney disease)
* oligohydramnios (after 34 weeks amniotic fluid index \<5; before 34 weeks single deepest pocket \<2 cm)
* pathological doppler (high umbilical artery resistance index, absence of end-diastolic flow velocity in the umbilical artery, reverse flow in the umbilical artery, brain sparing effect in middle cerebral artery, abnormal ductus venosus flow)
CD70-targeted immunoPET Imaging of Kidney Cancer

The aim of this study is to establish and optimize the \[18F\]RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent in renal cancer (especially clear cell renal cell carcinoma) wil be evaluated.

Histologically confirmed diagnosis of kidney cancer (especially clear cell renal cell carcinoma and papillary renal cell carcinoma) or suspected kidney cancer by diagnostic imaging will be included. Especially patients with suspected metastases or routine follow-up or surveillance or suitable for systemic treatments (e.g., combined immunotherapy and targeted therapies) will undergo \[18F\]RCCB6 immunoPET/CT scans. For clear cell renal cell carcinoma patients receiving systemic treatments, repeated CD70-targeted immunoPET imaging might be performed.

Enrolled patients will undergo whole-body \[18F\]RCCB6 immunoPET/CT scans at 1-2 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of \[18F\]RCCB6 in tumor and normal organs/tissues will be scored visually and quantitatively.

Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracer.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-80 year-old and of either sex；
2. Histologically confirmed diagnosis of kidney cancer (especially clear cell renal cell carcinoma and papillary renal cell carcinoma) or suspected kidney cancer by diagnostic imaging;
3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.

Exclusion Criteria:

1. Pregnancy；
2. Severe hepatic and renal insufficiency;
3. History of serious surgery in the last month;
4. Allergic to antibody or single-domain antibody radiopharmaceuticals.
SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations

This study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's Disease,
* advance stage of disease,
* Modified Hoehn \& Yahr stage II-IV,
* presence of a recognizable 'on' and 'off' state (motor fluctuations) and stable treatment with levodopa for at least 28 days prior to randomization

Exclusion Criteria:

* 'on-off' phenomena or 'yo-yoing' and/or an abrupt unpredictable loss of efficacy unrelated to the timing of L-DOPA administration,
* Prevalent expression of troublesome dyskinesias during 'on' time at waking hours,
* Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists,
* Previous surgery for the treatment of PD
Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children

Testing 3 different caries arresting techniques and the quality of life of a group of preschool children in Mansoura city, Egypt.

135 preschoolers were allocated randomly into 3 groups to receive 3 techniques to evaluate caries arrestment. The first group received 38% silver diamine fluoride, the second received conventional Atraumatic restorative technique and the third group received ultra consevative treatment (UCT). The subjects were followed up at 3, 6 and 12 months to check caries activity according to the ICDAS.

The parents of the children answered the Arabic ECOHIS before treatment and after 3 months to assess oral health related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* healthy children aged 3-5
* residents of mansoura city
* having at least one carious dentine lesion

Exclusion Criteria:

* large carious lesions approximating the pulp
* signs of pulpitis, fistula, abscess.
Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study

The purpose of this study is to compare the operative, anatomic functional outcome as well as the subjective outcome of laparoscopic supracervical hysterectomy and sacropexy compared to laparoscopic hysteropexy (conserving the uterus).

The investigators expect that both laparoscopic procedures are equal in regards to operation time, complication rate, anatomic and functional outcome as well as subjective outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Symptomatic uterus prolapse (uterus \< 300g)
* Patient able to sign the informed consent and to fulfil the follow up visits

Exclusion Criteria:

* Indication: Pathologies of the uterus (postmen. bleeding, high endometrium at ultrasound (\>5 mm), abnormal PAP smear in the last 5 years, bleeding anomalies in premenopausal patients
* General medical contraindications to a surgical operation

  * tumor/ malignant disease
  * bacterial infection at time of surgery
  * drug or medication abuse at time or just before surfer
* Disease which would make a correct assessment of the patient impossible (e.g. psychiatric condition)
* Known hypersensitivity to the implanted materials
* Immaturity, inability to answer/understand questions
* Planned pregnancy
* Participation to other studies (drugs or medical techniques) which could influence the results of this study
Effectivity and Safety of Ultrasound-guided Percutaneously Radiofrequency Ablation for Liver Cancer

To evaluate the safety and efficacy of ultrasonography (US) -guided radiofrequency ablation for liver tumors, the investigators used preoperative and postoperative US/CEUS(contrast-enhanced ultrasonography)/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with small hepatocellular carcinoma (single or multiple nodules of less than 3 cm in diameter), Patients with Child-Pugh A/B, Patients with PLT(platelet count) ≥ 50\*10e9/L and PT(prothrombin time) ≤ 20s.

Exclusion Criteria:

* Patients with blood coagulation dysfunction, ChildPugh score≥3, severe cardiopulmonary disease, intolerant anesthesia and upper gastrointestinal bleeding in shock.
Efficacy and Safety of a Single Low-dose Primaquine for the Clearance of Gametocytes

The purpose of this study is to assess efficacy and safety of a single low-dose Primaquine added to standard artemether/lumefantrine treatment for the clearance of Plasmodium falciparum gametocytes among patients with uncomplicated malaria aged 1 year and above regardless of their G6PD status.

The current gained successes in malaria control are accredited partly to the availability of efficacious and fast acting artemisinins which are also potent against P. falciparum young gametocytes. Nonetheless, mature gametocytes may persist after treatment, contributing to malaria transmission. Conversely, artemisinin resistance is confirmed in South-east Asia, and it may spread to Africa. New control tools have to be integrated to sustain the gained successes, further reduce transmission and curb the spread of resistance.

Primaquine has strong gametocytocidal effect against mature gametocytes and when added to schizonticidal drugs such as artemether-lumefantrine (AL), it rapidly shorten gametocytes carriage duration, halting disease transmission. Nonetheless, its wide scale use has been hampered by a dose-dependent acute hemolytic anemia it causes in glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. Conversely, Artemisinins potentiate primaquine activities, thus a low dose of primaquine would be able to clear falciparum gametocytes.

The World Health Organization recommends addition of 0.25 mg/kg single-dose primaquine to Artemisinin based combination therapies in malaria endemic areas including Africa without testing for G6PD status. Nonetheless, the recommendation, relies on historical data from South-East Asia and among African Americans in the United States. Therefore, this study plans to assess safety and efficacy of 0.25 mg/kg single-dose primaquine added to a standard AL treatment against P. falciparum gametocytes clearance among patients with uncomplicated malaria aged 1 year and above regardless of their G6PD status..

Eligibility Criteria:
Inclusion Criteria:

* Age of 1 year and above and neither pregnant nor breast feeding.
* Weight over 10 kg.
* Body temperature ≥37.5°C) or history of fever in the last 24 hours.
* P. falciparum mono-infection.

Exclusion Criteria:

* Evidence of severe illness malaria or danger signs.
* Known allergy to study medications.
* Hemoglobin \<8 g/dl.
* Antimalarials taken within last 2 weeks.
* Blood transfusion within last 90 days and evidence of recent use (within 14 days)of or will be taking other drugs known to cause hemolysis in G6PD deficient subjects.
PrOVE QUERI Project #1

The overall goal of this project is to test two strategies for implementing a shared decision making tool to be used by providers while talking to patients about lung cancer screening. Eight participating sites will be randomized to compare standard implementation with intensive implementation. Additionally, the investigators will determine the factors that were most important for successful implementation of the shared decision making tool. Finally, the investigators will survey patients to evaluate the effects of Decision Precision on patient's knowledge of the risks and benefits of lung cancer screening, the quality of their decision making, and their satisfaction with care.

The overall goal of this quality improvement project is to test two strategies for implementing shared decision making, which incorporates the Decision Precision lung cancer screening tool. The investigators will use multi-site, cluster-based randomization to compare standard implementation with intensive implementation. Additionally, the investigators will determine the factors that were most important for successful implementation of the shared decision making tool. Finally, the investigators will have a human subjects research component to evaluate the effects of Decision Precision on patient's knowledge of the risks and benefits of lung cancer screening, the quality of their decision making, and their satisfaction with care.

Eligibility Criteria:
Inclusion Criteria:

* Patients at participating sites without documented exclusions for lung cancer screening who have had initial lung cancer screening clinical reminders resolved during the recruitment period

Exclusion Criteria:

Exclusions for initial lung cancer screening clinical reminders:

* history of lung, pancreatic, liver or esophageal cancer
* a health factor on file indicating they have a life expectancy of less than 6 months or who already had a chest CT in the past 12 months
Multicenter Study of Fulminant Type 1 Diabetes in China

This study took FT1D（fulminant type 1 diabetes） as the research object, collected the cases of FT1D patients, and described the clinical characteristics of this type of disease. The HLA susceptibility genes of FT1D were identified by PCR and other techniques, taking age-sex-matched healthy subjects as controls and HLA genes as the research entry point.

1. FT1D cases related to different etiologies were collected. The collected case data were the clinical data at the time of hospitalization for the first episode of FT1D, including the history of present illness, past history, vital signs, blood glucose at the onset, blood gas analysis, myocardial enzymes, pancreatic enzymes, glycosylated hemoglobin, C Peptides, islet autoantibodies and other laboratory indicators. Analysis and research are carried out according to factors such as the pathogenesis of the patients, so as to conduct a complete analysis of the pathogenesis characteristics of such patients under the condition of expanding cases, so as to improve the understanding of the disease and the level of diagnosis and treatment of the disease.
2. The study collected 240 patients in the FT1D group and 250 patients in the control group with genetic blood (previous research has been available), analyzed the HLA gene, and compared the risk and frequency of HLA class II alleles, genotypes and haplotypes between the two groups. , to explore the susceptibility risk genes and protective properties of Chinese FT1D patients. According to GADA positive and negative, the comparison of the susceptibility of Chinese FT1D class II HLA genotype, from the perspective of genetics to explore the role of antibodies in the pathogenesis of FT1D.

Eligibility Criteria:
patients with fulminant 1 diabetes

Inclusion Criteria:

1) diabetic ketosis or ketoacidosis occurred soon after the onset of hyperglycemic symptoms; 2) patient presented with plasma glucose ≥16.0 mmol/L and HbA1c \<8.7% at the first visit; and 3) patient had urinary C-peptide excretion \<10 µg/day,fasting serum C-peptide level \<0.10 nmol/L, or postprandial serum C-peptide \<0.17 nmol/L at onset

Exclusion Criteria:

Case reports of previously diagnosed with diabetes were excluded.

Healthy Volunteers

Inclusion Criteria:

* Normal control: The inclusion criteria are as follows: (1) Oral glucose tolerance test (OGTT): fasting blood glucose (FPG) \<5.6 mmol/L and postprandial 2 h blood glucose (PPG) \<7.8 mmol/L. The participants voluntarily signed the informed consent and extracted 3ml of peripheral blood for DNA extraction.

Exclusion Criteria:

* The exclusion criteria were as follows: (1) with heart, brain, liver, kidney or other chronic diseases; (2) with other types of autoimmune diseases; (3) with malignant tumors; (4) with a family history of diabetes.