cyrilzakka/clinical-trials huggingface dataset:
Perioperative Oral Vitamin D3 Supplementation on Implant Osseointegration

The number of patients treated in Implantology at Nantes University Hospital is 400 per year. This pilot study aims to demonstrate the efficacy of a 6-month oral cholecalciferol supplementation on osseointegration in patients requiring dental implants and presenting with vitamin D deficiency, compared to French patients who have not undergone vitamin D screening

This study will be conducted on patients with vitamin D deficiency or insufficiency who visit the Restorative and Surgical Dentistry Department at the Dental Care Center of Nantes University Hospital for implant surgery. The investigator will present the study to them and record their verbal non-opposition. Clinical data from before the surgery (approximately 3 months prior), during the surgery, and postoperative visits up to 3 months afterward will be included in the OSIVID study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient ≥ 18 years old, candidate for dental implant placement.
* with vitamin D deficiency or insufficiency: 25(OH)D \< 25 ng/L.
* affiliated with a social security scheme.

Exclusion Criteria:

* with a local contraindication for implant placement.
* under guardianship, curatorship, or legal protection
* Pregnant or breastfeeding women
The Prediction Using Diffusion MRI of the Response Evaluation in BRPC in NAT.

To investigate the correlation between pretreatment ADC value of diffusion MRI and pathologic response in patients with borderline resectable pancreatic carcinoma who undergo neoadjuvant therapy.

Aim: The prediction using diffusion-weighted MRI of the response evaluation in borderline resectable pancreatic cancer.

Study design: Single institution. Single arm. Prospective Phase II Study.

Number of case: 28

Patients: The prediction using dMRI of the response evaluation in borderline resectable pancreatic carcinoma (BRPC) in neoadjuvant therapy.

Disease: Pancreatic carcinoma

Method: To investigate the correlation between pretreatment ADC value of diffusion MRI and pathologic response in patients with borderline resectable pancreatic carcinoma who undergo neoadjuvant therapy.

The correlation between pretreatment ADC value of diffusion MRI and pathologic response evaluated by Evans grade in patients with borderline resectable pancreatic carcinoma (BRPC) who undergo neoadjuvant therapy.

1. The correlation between pretreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction.
2. The correlation between posttreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction.
3. The correlation between the ratio of posttreatment/pretreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction.
4. The correlation between pretreatment ADC value of BRPC tumor in a largest diameter and the rate of tumor cell destruction.
5. The correlation between the ratio of posttreatment/pretreatment ADC value of BRPC tumor in a largest diameter and the rate of tumor cell destruction.
6. ADC Cut-off value which predict more than 50% and less than 10% in tumor cell destruction rate.
7. The correlation between the ratio of posttreatment/pretreatment ADC value of BRPC tumor in a largest diameter and the ratio of posttreatment/pretreatment SUV max.
8. ADC Cut-off value and SUV max cut-off value which predict survival time after surgery more than 2 years and less than 2 years.
9. The comparison of the accuracy of prediction for pathological diagnosis at abutment site between the ratio of posttreatment/pretreatment ADC value and CT scan.
10. Three correlation between high ADC value/low ADC value/the ratio of posttreatment/pretreatment ADC value and survival time after surgery.
11. Three correlation between high ADC value/low ADC value/the ratio of posttreatment/pretreatment ADC value and decreasing rate of CA19-9 value.
12. The correlation between tumor's limb sign in diffusion MRI and the rate of tumor cell destruction more than 10%.

Eligibility Criteria:
The patients with borderline resectable pancreatic cancer who is expexted to undergo neoadjuvant therapy and subsequent radical surgery.
Study of NeuroAid In Enhancing Recovery After Stroke

TIERS is a phase II to generate detailed preliminary data on the efficacy of NeuroAid in post-stroke recovery, and to assess the utility of the rehabilitation outcome measure instruments used.


Eligibility Criteria:
Inclusion Criteria:

* Subject had cerebral infarction confirmed by Computed Tomography (CT scan or Magnetic Resonance Imaging (MRI) imaging
* Presents within 1 month after stroke onset
* Presents with motor power of from grade 1 - 4/5 in at least one limb
* Has a pre-stroke modified Rankin score ≤ 1.
* Age between 21 and 80 years old
* Female subjects are eligible to participate in the trial if they are of non childbearing potential (hysterectomy or post-menopausal)
* Subject or legally acceptable representative is willing and able to provide written informed consent
* Subject and carer are willing and able to comply with investigational drug administration schedule.

Exclusion Criteria:

* Subject has received thrombolysis
* Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
* Subject has definite indication for full-dose or long-term anticoagulation therapy
* Subject has other significant non-ischemic brain lesion which could affect function disability
* Subject has co-existing systemic diseases: terminal cancer, renal failure (creatinine \>200 μmol/L, if known), cirrhosis, severe dementia or psychosis
* Subject has a history of previous stroke/s
* Subject has participated in another clinical trial within the last three months
* Subject has aphasia or any other cognitive disabilities which prevent cooperation with study instructions
* Subject has dense hemiplegia (grade 0 motor power)
* Subject has haemoglobin level of \<10mg/dl on admission
* Subject has a history of craniotomy or seizures
Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process

The purpose of this study is to test the effects of a videotelephone-delivered patient-partner dual-focused cognitive behavioral stress management intervention on chronic fatigue syndrome (CFS) symptoms and related psychosocial and neuroimmune processes in patients diagnosed with chronic fatigue syndrome. Study tests the hypothesis that videophone-delivered patient-partner cognitive behavioral stress management (T-PP-CBSM) intervention improves patient CFS symptoms relative to a videophone-delivered patient-partner Health Information (PP-T- HI) condition.

The study tests the effects of a 10-week patient-partner focused videophone-delivered cognitive behavioral stress management intervention (T-PP-CBSM) intervention (relaxation, stress awareness, cognitive restructuring, coping skills training, interpersonal skills training) versus a time-attention-matched 10-week patient-partner based videophone-delivered health information (T-PP-HI) (health behavior education on nutrition, sleep and other factors) in men and women with chronic fatigue syndrome (CFS) and their partners. The study evaluates the effects of T-PP-CBSM vs T-PP-HI on patient CFS symptoms, neuroimmune processes--diurnal cortisol regulation and immune regulation (pro-inflammatory:anti-inflammatory cytokine ratio (\[IL-1β + IL-6 + TNF-α\]:\[IL-13 + IL-10\])-and psychosocial functioning at 5 months and 9 months after intervention.

Eligibility Criteria:
Inclusion Criteria:

* men and women diagnosed with chronic fatigue syndrome

Exclusion Criteria:

* no partner
* prior psychiatric treatment for serious psychiatric disorder (e.g., psychosis, suicidality)
* co-morbidity or medical treatment affecting the immune system
* lack of fluency in English
Clinical Effect of Individualized Exercise Prescription for Hypertension With 6-minute Walking Test (6MWT)

Obesity and lack of exercise are one of the reasons for high blood pressure. Exercise can reduce the risk of cardiovascular events by reducing weight and blood pressure. The precise formulation of exercise prescription by cardiopulmonary exercise test (CPET) can effectively control hypertension. Our research group has formulated 50 "exercise prescriptions for hypertension population" in the early stage, but how to further effectively implement them needs to be discussed.

Based on the previous experience of undertaking the project "Exercise Prescription for Hypertensive People" of General Administration of Sport of the People's Republic of China, this research group discussed the important role of intelligent information management in the clinical effect evaluation and effective implementation of exercise prescription for hypertension; To explore the feasibility of making exercise prescription for hypertension based on 6-min walking test, and whether it is not inferior to or equivalent to the accuracy and effectiveness of making exercise prescription by CPET. The relevant results will lay a foundation for exploring the broader adaptation of hypertension exercise prescription to the population.

The 6-minute walking test (6MWT) has good universality and accessibility, and can be used as the basis for formulating exercise prescriptions. According to the consensus of Chinese experts on the application of clinical norms of the six-minute walking test, it is recommended to formulate individualized exercise prescriptions based on the average walking speed of 6MWT calculated from the six-minute walking distance (6MWD), but there is no relevant content about hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Overweight/obesity; Normal or normal high blood pressure after drug use; Grade 1 hypertension (whether taking medicine or not); Having sports habits; Sports risk is low and medium

Exclusion Criteria:

* ≥ grade 2 Hypertension; High-risk hypertensive patients; Malignant hypertension, secondary hypertension, etc; Serious arrhythmia, heart failure, acute myocardial infarction; Severe stroke, liver and kidney insufficiency; Physical dysfunction and failure to cooperate for various reasons; Unable to conduct CPET; The Types and doses of antihypertensive drugs is still in the process of adjustment
A Randomized, Open-label, Single Dose, Parallel Study to Evaluate the Pharmacokinetics Dose Proportionality of GLA5PR GLARS-NF1 Tablet in Healthy Male Volunteers

The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.

GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.

GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site.

To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".

Basically, this system is a triple-layered tablet, comprised of upper and lower layers that swell and draw a sufficient amount of water, plus a highly water - soluble middle layer that rapidly draw water into the tablet core simultaneously.

The water drawn into the tablet (about 3 to 4 times the weight of the tablet itself) functions as an additional media which enables additional and later drug release out of the dosage form. This serves to overcome the shortage of surrounding media that has been reported to be one of the key reasons for mal-absorption of a drug in colon.

As the middle layer induces a rapid water draw into the tablet core, the penetrated water also diffuses to the upper and lower layers, which makes the tablet to rapidly swell and controls drug release.

At virtually the same time, the swollen upper and lower layers form to surround a lateral side of the middle layer, which can, in turn, further control drug release.

This relatively rigid swollen matrix structure makes drug release not affected by surrounding mechanical flux, which can provide relatively consistent in vivo drug release irrespective of degree of gastrointestinal motility.

Eligibility Criteria:
Inclusion Criteria:

* 19\~45 years old, Healthy Adult Male Subject
* 17.5\~30.5kg/m2(BMI) and ≥ 40kg(Body Weight)

Exclusion Criteria:

* SBP ≥ 140mmHg or DBP ≥ 90mmHg
Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer

To acquire blood samples from subjects for various purposes, including: i) determining the sensitivity and specificity of select DNA methylation markers for the detection of various types of cancer, ii) identifying benign conditions that may induce false positive or false negative results, and iii) defining the effects of potential interfering substances, such as chemotherapy drugs.

Whole blood, plasma, and/or serum specimens will be collected from patients with active cancer, patients in cancer remission, patients diagnosed with benign disease, and healthy volunteers. These blood samples will be used to perform various studies to determine the utility of select DNA methylation markers for cancer diagnostic or prognostic indications.

Eligibility Criteria:
Inclusion Criteria:

2.1.1 Age 18 years or older.

2.1.2 A diagnosis of cancer, cancer remission, benign disease (benign tumor, diabetes, liver cirrhosis, chronic hepatitis B or hepatitis C virus infection, Chronic obstructive pulmonary disease, etc.) or apparently healthy volunteers. .

Exclusion Criteria:

2.2.1 Patients that are unwilling or unable to sign the Informed Consent Form will be excluded.

2.2.2 Approximately 50 mL of blood will be drawn from participants within an 8-week period under this protocol. Patients that have already given 50 mL of blood within this time frame will be excluded.
Spinal Aesthesia in Women With Placenta Previa Percreta

Placenta previa percreta is a dangerous complication during surgery. Due to the high risk of hemorrhage, most parturients with placenta previa have to accept cesarean section. In this study investigators compare the effect of different anesthetic techniques on these patients.


Eligibility Criteria:
Inclusion Criteria:

* women with placenta previa and increta-percreta (diagnosed by ultrasound and/or magnetic resonance imaging and confirmed during cesarean section)
* women accepted cesarean section

Exclusion Criteria:

* women with baseline systemic blood pressure higher than 180 mmHg
* women with coagulation disorder
Inhalation Therapy in Ambulant and Hospitalized Patient Using Available Film Sequences From the Internet

There are different therapy strategies for patients suffering on obstructive lung disease like chronic obstructive pulmonary disease (COPD), and asthma bronchial available. One of these strategies includes inhalative drugs, e.g. ß2-mimetics, anticholinergic drugs, or glucocorticoids, which are indicated often and which can be used with different inhalation devices. Dry powder inhalators, and dosieraerosol are used the most in clinical routine. Further strategies in treating obstructive lung disease are innovative systems like Respimat or systems with liquid inhalation. However, the success of the therapy depends on the correct application technique. In the clinical routine a high error rate was observed. Consequently, the initiative of the German league of respiratory tracts published internet-based film sequences in order to demonstrate how to use an inhalator correctly. These films are available in the internet for everyone and can be watched as often as needed in order to improve technique and facilitate training.

Therefore, in this study we aim to evaluate the following aspects:

* amount of wrong applications in ambulant and hospitalized patients (wrong in terms of lack of knowledge on how to use the inhalator or incorrect utilization)
* amount of correct applications in patients who had first used the inhalator incorrectly but improved technique by watching the film sequences
* evaluation of learning success within 2 weeks to 2 months (follow-up visit in the ambulance)


Eligibility Criteria:
Inclusion Criteria:

* male and female patients indicated for inhalative treatment with ß2-mimetics, inhalative steroids, anticholinergic drugs, or a combination of these drugs
* patient was already trained on how to use the inhalator before participating in the study
* age \> 18
* obtained written consent

Exclusion Criteria:

* patients who are incapable to consent or are unable to understand the scope of the trial
* patients who indicate that they do not know how to use the inhalator
Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

The objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery. Participants from the United States and Canada will be recruited for this study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are candidates for routine, uncomplicated cataract surgery.
* Subjects who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
* Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following cataract surgery (postoperative day 1).

Exclusion Criteria:

* Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
* Any intraocular inflammation in either eye (cells or flare score greater than Grade 0 at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the Screening Visit.
* Presence of active external ocular disease: infection or inflammation of the study eye.
* Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
* Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.
Effects of Somatostatin on Liver in ADPKD

Autosomal dominant polycystic kidney disease (ADPKD) is associated with the development of a variety of extrarenal manifestations of which polycystic liver disease is most common. The investigators aimed to assess the changes over time of liver volume in ADPKD patients and whether it is affected by the treatment with the somatostatin analogue, octreotide.

35 ADPKD patients (14 males) aged 34±8 years were randomly assigned to 36 month treatment with placebo (n=18) or octreotide (n=17). Clinical and liver parameters at magnetic resonance (RM) were evaluated at baseline, study end and after 24 months of drug withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of autosomal dominant polycystic kidney and liver disease
* glomerular filtration rate greater than 40 ml/min

Exclusion Criteria:

* diabetes mellitus
* proteinuria greater than 1 g/24 hours
* significant glomerular disease
* urinary tract lithiasis and infections
* symptomatic gallstones
* biliary sludge
* cancer
* pregnant women
* lactanting women
Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing

High burden right ventricular (RV) pacing has been shown to increase cardiovascular mortality, incidence of heart failure (HF), worsen left ventricular (LV) function and accelerate the development of atrial fibrillation (AF). High percentage ventricular pacing and wider paced QRS in the setting of normal baseline LV ejection fractions have consistently been shown to be independent risk factors for pacing-induced cardiomyopathy. Left bundle branch pacing (LBBP) has emerged as a potential alternative pacing mechanism that may avoid LV dyssynchrony and pacing-induced LV dysfunction by mimicking native electrical conduction.

We hypothesize that in patients with high degree AV block with anticipated ventricular pacing \>90%, and an EF \>35% patients undergoing LBBP will demonstrate a significantly lower number of the primary composite endpoint of cardiovascular death, heart failure events, and change in LVESVi as compared to standard RV pacing. Echos will be performed at baseline, 12, 24, and 36 months. NTproBNPs are performed at baseline and follow-up. There will be a core echo lab, and blinded adjudication of ECGs and events.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Patients with an ejection fraction of \>35%
3. Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is \>90% including:

   1. Third degree AV block
   2. Symptomatic or asymptomatic second-degree AV block
   3. First degree AV block ≥ 280ms with a narrow QRS, or ≥ 240ms with an intraventricular delay (QRS duration ≥120ms)
4. Echocardiogram within the last 3 months, with ability to have DICOM images

Exclusion Criteria:

1. Indication for an implantable cardioverter defibrillator
2. Presence of a mechanical tricuspid valve
3. Any prior attempt at implantation of an ICD, CRT, HBP, or LBBP
4. Lack of capacity to consent
5. Other serious medical condition with life expectancy of \<2 years
6. Pregnancy
7. Patients in whom the conduction system abnormality is expected to be transient or recover over time
8. Patients with permanent atrial fibrillation