cyrilzakka/clinical-trials huggingface dataset:
Transcranial Direct Current Stimulation Plus Monoclonal Antibodies Acting on the CGRP Pathway for Migraine

Electrophysiological changes that occur in the brains of migraine patients, lead to the activation of nociceptive centers, including a peripheral neural structure, the trigeminal ganglion (TG), which releases pain-inducing peptides and mostly calcitonin gene-related peptide (CGRP). Monoclonal antibodies acting on the CGRP pathway (CGRP-MAbs) are the first drugs specifically designed for migraine, they inhibit CGRP release from the TG without entering the brain. Not all patients experience benefit from CGRP-MAbs treatment. For this reason, associating these drugs with a non-pharmacological treatment that acts centrally, such as transcranial direct current stimulation, could be effective.

The aim of the study is investigating how the migraine preventive treatment with CGRP-MAbs in association with tDCS, is effective to reduce headache days, days of disabling headache, intensity of pain and consumption of acute treatments. Migraine-related disability, quality of life, sleep disturbance and psychological aspects will also be evaluated. Patients will be randomized into two groups, one will receive active tDCS and one sham tDCS. Both patients and investigators will be blind to the treatment administered (double-blind).

Furthermore, will be evalutated the cortical mechanisms involved in migraine by directly modulating brain physiology via repetitive tDCS in patients with migraine on treatment with CGRP-MAbs. To fulfill this aim, we will assess the EEG correlates of the actual effects of the stimulation in a sham-controlled study, providing the EEG indexes linked to the altered and potentially restored cortical dynamics in migraine.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients, aged between 40 and 70 years, referring to the Headache Center of the University of L'Aquila;
* a diagnosis of migraine with or without aura according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3; https://ichd-3.org/);
* age at onset of migraine \<50 years;
* migraine must have been present for at least ≥ 12 months;
* treated with CGRP-MAbs (erenumab, fremanezumab or galcanezumab) according to clinical practice criteria for 90-180 days since the first subcutaneous administration (this time range was chosen to ensure a stable CGRP pathway inhibition);
* reporting \>4 monthly migraine days in the last 30 days of observation despite treatment with CGRP-MAbs;
* able to discriminate between migraine and tension-type headaches;
* written informed consent to participate in the study

Exclusion Criteria:

* any migraine preventive medication other than CGRP-MAbs;
* secondary migraine;
* epilepsy or any other neurologic condition that may be worsened by transcranial electrical stimulation;
* metallic head implants, cardiac pacemaker or any other device that could malfunction or be displaced by electrical stimulation;
* pregnancy or lactation.
Conventionally vs. Digitally Fabricated Complete Dentures: Clinical Treatment Outcome Differences

Purpose: To compare complete denture outcomes between conventional and digital denture fabrication processes.

Participants: Sixteen edentulous adult patients in the University of North Carolina School of Dentistry Student Clinic who are seeking removable complete dentures.

Procedures (methods): Two complete sets of dentures will be fabricated for each subject: one using the conventional process (A) and the other using a digital process (B). Variability will be assessed by the research team, the treating dental students, an independent prosthodontist, and the patients through quantitative measures. Case selection and results analysis will be evaluated with recognition of the Prosthodontic Diagnostic Index.

Rationale for Study Design An AB/BA (conventional=A, digital=B) crossover design with no wash-out period is flawed for this study, and its weakness is the potential for a carryover effect (benefits or risks associated with treatment A carry over to treatment B). A wash-out period is not feasible for this study because it would require the patient-subjects to suspend use of their dentures for the duration of the wash-out period.

The Investigators have decided to conduct the study using the ABB/BAA crossover design, which does not require a wash-out period and will permit testing and discounting of a possible carryover effect. In addition, this design is more appropriate for a small sample size than the AB/BA design.

The investigators are adding to the scant literature on digital dentures, information that has never before been studied - the retention, aesthetics, and stability of digital dentures compared to conventional dentures. Additionally, the investigators will have longitudinal data on these characteristics regarding digital dentures.

If the Functional Assessment of Dentures (FAD) and the patient evaluation show positive results for the digital dentures, this could lead to increased use of the Computer -Aided Design/ Computer -Aided Manufacturing (CADCAM) fabrication method which, in turn, would allow greater numbers of people to benefit from the advantages of the digital dentures as described earlier in this application (e.g., a better fit, fewer visits with less time in the chair, less biofilm formation, etc.)

Eligibility Criteria:
Inclusion Criteria:

1. UNC School of Dentistry Student Clinic patients requiring maxillary and mandibular complete dentures
2. Ages 18 to 99, inclusive
3. Able to read, speak, and understand English
4. Without natural tooth or implant supported overdentures
5. Edentulous in both jaws for at least 6 months
6. Any Prosthodontic Diagnostic Index (PDI) type with a preference given to Types 1-3

Exclusion Criteria:

1. Non-registered patient in UNC School of Dentistry student clinics
2. Patient not able or unwilling to give consent
3. Subject had extractions within last 6 months
Effect of Training Intensity on Health Outcomes in Diabetes

The project will investigate high intensity interval training on the glucose regulation in type 2 diabetic subjects compared to moderate continuous exercise.


Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes Age: 30-70 Non smokers (minimum the last 15 years) Inactive lifestyle (\<2 hours pr. week) BMI \<35 kg/m2

Exclusion Criteria:

Smoking Prior cardiavascular diseases Alcohol intake 14\> units pr. week.
Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy

This study is designed to assess the potential difference in Fasting Plasma Glucose (FPG) lowering efficacy between the two DPP-4 inhibitors vildagliptin and sitagliptin, both after a two weeks treatment on top of metformin.


Eligibility Criteria:
Inclusion Criteria:

Patients with type 2 diabetes 18 to 85 years Metformin monotherapy \> 4 weeks HbA1c 6.5 - 9.5%

Exclusion Criteria:

FPG \> 270 mg/dl Use of other antidiabetic drugs than metformin major cardiovascular event in the last 6 months (MI, stroke...)
E-assisted Follow up Diagnosis of Post Operative Digestive Complications

Postoperative management in digestive surgery has been modernized thanks to improved rehabilitation measures. These measures include an earlier refeeding, mobilization, restriction of infusions (out of a total of 22) and showed their benefit in colorectal, gastric and bariatric surgery. It is thus possible to perform sleeve gastrectomy, bypass, restorations of digestive continuity and colectomies with early discharge or one day surgery.

The most serious complications (fistula, sepsis) occur in the first 10 days postoperatively with an average readmission rate of 10%. Their screening is based on clinical signs (tachycardia, pain) or biological (C-Reactive Protein (CRP) assay on Day 3 or Day 4). It is important to manage these complications early so that their morbidity is lower, resulting in shorter stays and less severity.

The monitoring and safety of patients discharged early are therefore essential and for the moment poorly codified, ranging from simple nursing to follow-up via a health provider. Recently, coordination structures including nurse platform and smartphone follow up app have emerged. Thanks to this system, the patient collects his own history and biological results which allows him to be monitored continuously, as in the hospital. In case of no filling or sign of complication, the nurse platform contacts the patient.

This connected follow-up would make it possible to reinforce the safety of the patient discharged early after a complex digestive procedure performed on an outpatient basis. Its benefit has been poorly evaluated but it is however more and more used by surgeons convinced of its interest especially as it goes in the direction of the development of the outpatient activity requested by the High Authority of Health with economic benefits interesting also the administration of the care structures.

The purpose of the investigator's study is to evaluate the impact of e-assessed follow-up during 10 days after surgery compared to a conventional follow-up. The hypothesis is that this connected follow-up would allow earlier detection of complications requiring rehospitalization (within 48 hours), resulting in faster and less severe treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, age ≥18 years
* Patient hospitalized for colorectal, gastric or bariatric surgery
* Patient for whom an outpatient or enhanced recovery after surgery is performed (expected discharge no later than 4 days after surgery)
* Patient with a computer, tablet or mobile connected to internet
* Patient who agrees to be included in the study and who signs the informed consent form,
* Patient affiliated with a healthcare insurance plan.

Exclusion Criteria:

* Minor patient
* Patient who does not understand French, under supervision or guardianship
* Mentally unbalanced patients or unable to follow the instructions of a connected follow-up, from the point of view of the investigator
* Patient who is unable to give consent
Aalgesic Efficacy of Erector -Spinae Technique With Levobupvicaine in Patients Undergoing Upper Abdominal Cancer Surgery

To study analgesic efficacy \&safety of bilateral erector spinae block for upper abdominal cancer surgery as apart of multimodal analgesia.

Patients will be randomly assigned using computer generated randomization program (http://www.randomizer.org) into two groups, each group of the them consist of 15 patients:

GROUP (A): {CONTROL GROUP} Patient will receive 20 ml of normal saline into interfascial plane between rhomboidus major \&erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side .

Group (B):

Patient will receive 20 mg 0.25% Levobupivacaine bilaterally as above 10 mg each side.

Preoperatively \& post-operatively procedures:

Premedication will be given after complete fasting hours \&after applying standard monitors (non invasive blood pressure, pulse oximetery, ECG, temperature and capnography, an intra-venous 16 gauge cannula will be inserted and secured).

Ultrasound guided Erector spinae plane block with patient in the sitting position \& skin of the upper back is prepared with 2% chlorhexidine solution. Counting down from c7,the spine of T7 is identified it is corresponding to the tip the scapular spine ,a high frequency ultrasound probe is placed across T7 spine then probe move slowly laterally to identify transverse process of T7 ,So probe is moved to a vertical alignment and erector spinae muscle is visualized lying underneath the trapezius muscle.

Needle gauge will be inserted then 10 ml Levobupivacaine into interfascial plane between rhomboid major \& erector spinae muscle in each side.

General anesthesia will be induced with Fentanyl 0.5 μg/kg, Propofol 2mg/kg, muscle relaxant (Atracurium 0.5 mg /kg) , inhalational anesthesia ( Isoflurane 1-1.5 MAC-or-sevoflurane2-3MAC ) as maintenance of anesthesia with frequent muscle relaxant every 20 minutes to maintain heart rate (HR) and blood pressure within 20% of the basal value. Patients were mechanically ventilated to maintain end tidal (ETCO2) between 35-40 mmHg. The inspired oxygen fraction (FIO2) was 0.5 using oxygen-and-air mixtures with frequent monitoring intraoperatively every 30 minutes, IV fentanyl infusion at rate of 0.1 μg/kg/hr may be used if needed.

Non steroidal anti-inflammatory as ketobrufen will be given intraoperatively at dose of (0.5-0.75mg/kg)then postoperatively every eight hours at the same dose.

The reverse of muscle relaxant with safe extubation will be done at the end of surgery.

-PCA morphine 2mg within five minutes lock out interval will be given postoperatively when there is pain.

Eligibility Criteria:
Inclusion Criteria:

* Patient subjected to major upper abdominal cancer surgery.
* The enrolled age will be from 18-70 years old.
* ASA: I-III, NYHA: I-III.

Exclusion Criteria:

* ASA \& physical status (NYHA) \> III.
* Pregnant women.
* Body mass index \>40 kg/m2.
* Pre-operative opioid consumption.
* Contraindication or patient's refusal of the procedure.
* Un co-operative patient.
* Coagulopathy, skin infection, significant organ dysfunction or drug allergy.
Simple Decompression Versus Anterior Transposition of the Ulnar Nerve

Both simple decompression and anterior transposition of the elbow nerve (ulnar nerve) for acute displaced fractures of the elbow (distal humerus) treated with plate fixation are currently used by surgeons. We want to examine which treatment will overall give better results in regards to arm function and residual pain.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 16 to 60 years of age
* Displaced, distal humerus fracture (OTA 13A or 13C) as seen in radiographs
* Fractures ≤ 28 days post injury
* Closed fractures
* No history of previous ulnar neuropathy or elbow pathology
* Provisin of informed consent

Exclusion Criteria:

* Vascular injury
* History of previous ulnar neuropathy or elbow pathology
* Fractures more than 28 days post-injury
* Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery
* Inability to comply with rehabilitation or form completion
* Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
Evaluation of Dental Implants After Using Several Bone Splitting Techniques

In both full and partial tooth loss, the usage of dental implants for an artificial replacement for missing teeth is a well-known and reasonable treatment modality that leads to high patient satisfaction and enhanced life quality. (1) In both full and partial tooth loss, the usage of dental implants for an artificial replacement for missing teeth is a well-known and reasonable treatment modality that leads to high patient satisfaction and enhanced life quality Because there is insufficient bone volume to support the dimensions of the implants, the horizontal deficiencies of the alveolar ridge obstruct implant-supported rehabilitation, which has an impact on the ultimate prosthetic outcome from both a functional and cosmetic standpoint (2).

The split crest technique reduces treatment time, the number of surgical procedures required, and even the risk of complications for the patients, making it more readily accepted by them. It also allows dental implants to be installed in the same surgical procedure and does not require a donor area to remove the graft. (3) In this study, patients underwent rehabilitation of posterior missing teeth in the narrow mandibular ridge by dental implant after ridge splitting by osseodensification, piezosurgery, or magnetic mallet.

The study's objective is to compare ridge width gain after osseodensification, piezosurgery, or magnetic mallet after ridge splitting with simultaneous implant implantation in individuals with narrow alveolar ridges.

36 patients will be randomly allocated into three groups. Ridge splitting followed by piezo and bone expander will be performed with simultaneous implant placement in group 1.

osseodensification bure will be performed after ridge splitting with simultaneous implant placement in group 2.

magnetic mallet will be performed after ridge splitting with simultaneous implant placement in group 3.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who can to follow-up appointments.
2. Alveolar ridge width of at least 3 mm with sufficient height to place a regular implant.
3. Availability of spongy bone with at least 1 mm in width between the cortical plates.
4. Free of any underlying conditions that can impact bone metabolism.

Exclusion Criteria:

1. The presence of severe concavity on the vestibular or palatal side of the alveolar ridge.
2. Patients with uncontrolled periodontal diseases.
3. Patients who have undergone radiotherapy in the head and neck area.
4. Smokers or patients with parafunction habits.
Durability of Three Monthly Loading Doses With Faricimab in Treatment-naïve Neovascular Age-related Macular Degeneration

Neovascular Age-Related Macular Degeneration (nAMD) is a one of the leading causes of irreversible vision loss among the elderly in developed countries. The implementation of anti-VEGF therapies in the last decades has significantly improved AMD management. Faricimab (Vabysmo®), a bispecific antibody targeting both Vascular Endothelial Growth Factor A (VEGF-A) and Angiopoietin-2 (Ang-2), offers enhanced disease control by both inhibiting angiogenesis and stabilizing blood vessels to prevent inflammation and leakage. Faricimab is thought to potentially reduce the frequency of injections compared to therapies targeting only VEGF-A. A key aspect of evaluating its efficacy is understanding the interval before the need for subsequent injections following the initial loading dose. Treatment with intravitreal anti-VEGF injections would typically start with three injections administered at four-weekly intervals, however faricimab is recommended to be started with four loading injections. Our department routinely initiates anti-VEGF therapy with 3 loading doses and then follows an observe-and-plan regimen. This routine was continued with faricimab injections as well despite the manufacturer's recommendation of 4 monthly loading doses.

Determining the optimal interval for reinjection is crucial for reducing treatment burden and improving patient quality of life.

This study aims to assess the durability of a loading dose of 3 faricimab injections, the need for a follow-up checkup at 4 weeks post-loading and functional outcomes post-loading in treatment-naive patients with neovascular age-related macular degeneration (nAMD),


Eligibility Criteria:
Inclusion criteria

* Age of 50 years or older
* Treatment-naïve patients diagnosed with nAMD who have received a loading dose with intravitreal faricimab
* Follow-up data available until the next subsequent faricimab injection after the loading dose, OR if no injections were indicated following the loading dose, follow-up data for at least 4 months

Exclusion criteria

* History of previous anti-VEGF treatment.
* Neovascular conditions other than AMD (e.g., choroidal neovascularization due to other causes) or co-existence of other retinal disease in the study eye
* Intraocular surgery in the study eye during the loading dose or prior to the first follow-up visit after the loading dose.
Epirubicin and Cyclophosphamide Compared With Epirubicin and Paclitaxel in Treating Women With Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and cyclophosphamide with epirubicin and paclitaxel in treating women with metastatic breast cancer.

OBJECTIVES: I. Compare the activity and toxicity of epirubicin and cyclophosphamide with that of epirubicin and paclitaxel in patients with metastatic breast cancer.

OUTLINE: Patients are randomized to receive either epirubicin and cyclophosphamide or epirubicin and paclitaxel. Each drug combination is given every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 704 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven carcinoma of the breast with metastases No CNS metastases Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Not specified Sex: Female Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (no greater than 5 times ULN with liver metastases) Renal: Not specified Cardiovascular: Ejection fraction within normal range No history of cardiac disease including myocardial infarction, cardiac failure and angina Other: Not pregnant No prior or concurrent malignancy that is likely to interfere with protocol treatments or comparisons

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy other than adjuvant No prior high dose adjuvant chemotherapy requiring transplantation Cumulative dose of doxorubicin no greater than 300 mg/m2 permitted Cumulative dose of epirubicin no greater than 400 mg/m2 permitted At least 6 months since prior anthracyclines Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery: A Randomized Controlled Trial

Liposomal Bupivacaine (Exparel) has been recently studied as the active agent utilized in various nerve block. Due to its liposomal form allowing for extended delivery, Exparel has been used in various peri-operative nerve blocks among multiple orthopaedic specialties in hopes of achieving improved pain control and decreased opioid use. This study compares the efficacy and effect on opioid use of peripheral nerve blocks and local infiltration with and without Exparel in patients undergoing foot and ankle surgery.

three study groups: A - surgeon infiltrates with exparel on site of surgery; B - anesthesia provides a regional nerve block (popliteal/adductor blocks) with plain local anesthetic (bupivacaine); C - anesthesia provides a regional nerve block (popliteal/adductor) with Exparel/bupivacaine mix. Follow up occurs on postop day 4 via phone call to patient. Measured outcomes include opioid consumption in post anesthesia care unit phase (oral morphine equivalents), block duration, number of opioid pills used by postop day 4, oral morphine equivalent consumption by postop day 4.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing elective orthopaedic foot and ankle surgery at a single institution
* English speaking
* Able to provide consent to surgery and study participation

Exclusion Criteria:

* Non-elective or emergent foot and ankle surgery
* Non-english speaking
* Does not possess medical decision making capacity